Jan-Mar, 2011 - Indian Journal of Pharmacy Practice

Indian Journal of Pharmacy Practice 

ijopp 

The Official Publication of APTI 

EDITOR - IN - CHIEF 

Dr. Shobha Rani R. Hiremath 

Shobha24@yahoo.com 

ASSOCIATE EDITORS 

Dr. G. Parthasarathi 

Partha18@airtelmail.in 

Dr. Pramil Tiwari 

ptiwari@niper.ac.in 

ASSISTANT EDITORS 

Mr. Ramjan Shaik 

ramjanshaik@gmail.com 

Mrs. Mahvash Iram 

mahvashiram@gmail.com 

Editorial Board Members 

Dr. Anil Kumar, Chattisgarh 

Dr. Atmaram P. Pawar, Pune 

Dr. Claire Anderson, Nottingham, UK 

Dr. Dhanalakshmi Iyer, Mumbai 

Prof. Ganachari M S, Belgaum 

Dr. Geeta.S, Bangalore 

Dr. Hukkeri V.I, Ratnagiri (Dist) 

Dr. Krathish Bopanna, Bangalore 

Prof. Mahendra Setty C.R, Bangalore 

Dr. Miglani B D, New Delhi 

Dr. Mohanta G.P., Annamalai Nagar 

Dr. Nagavi B.G, Ras Al-Khaimah, UAE 

Dr. Nalini Pais, Bangalore 

Dr. Rajendran S.D, Hyderabad 

Dr. Ramananda S.Nadig, Bangalore 

Dr. Revikumar K G, Cochin 

Dr. Sampada Patawardhan, Mumbai 

Dr. Sriram. S, Coimbatore 

Dr. Sreekant Murthy, Philadelphia, USA 

Dr. Sunitha C. Srinivas, Grahamstown, RSA 

Dr. Suresh B, Mysore 

Dr. Tipnis H.P, Mumbai 

Disclaimer: The editor-in-chief does not claim any responsibility, 

liability for statements made and opinions expressed by authors 

EDITORIAL OFFICE 

INDIAN JOURNAL OF PHARMACY PRACTICE 

An Official Publication of Association of Pharmaceutical Teachers of India 

H.Q.: Al-Ameen College of Pharmacy, 

Opp. Lalbagh Main Gate, Hosur Road, Bangalore 560 027, INDIA 

Mobile: +91 9845399431 | +91 9845659585 | +91 9900434646 

+91 9916069842 | Ph: +91 80 22234619; Fax: +91 80 22225834 

Printed and Published by: Prof. B.G. Shivananda, Secretary, on behalf of Association of Pharmaceutical Teachers of India 

Printed at : Graphic Point, #55/44, 4th ‘B’ Cross, K.S. Garden, lalbagh Road, Bangalore - 560 027. Ph: 080-2227310 

www.ijopp.org | ijopp@rediffmail.com


ijopp 

Editorial 

Review Articles 

♦HER2/neu vaccines fight against Breast Cancer 

Rajasekhar P ............................................................................................................................................................. 1- 13 

♦Contribution of drug interactions to burden of preventable ADR'S: Approches to predict and prevent drug interactions. 

Raval D K, Saraswathy N, Meghani N M, Shah H K ................................................................................................14 -17 

♦Survey and evaluation of various epidemiological factors in a multiethnic diabetic Population in ras Al-Khaimah, UAE. 

Smitha F, Meenakshi J, Padma R, Multani S K .......................................................................................................18 - 25 

♦Impact of educational interventions on Adverse Drug Reaction reporting 

Ganachari M S, Patil PA, Soham S, Nidhi Z ........................................................................................................... 26 - 31 

Contents 

♦Awareness about ways of transmission of AIDS and its treatment among university students in Pakistan 

Tehzeeb-ul-Nisa, Imran Qadir M, Hibba-tul-Baseer, Dure-Shehwar, Farzana C, Irfan M ...................................... 32 - 35 

♦Study of prescribing patterns of antibiotics used in the management of various infectious diseases 

Azizullah S G, Jabeen G, Shobna J, Kaleemuddin S, Mohiuddin ........................................................................ 36 - 40 

♦A study on prescription pattern of antihypertensives 

Preethi M, PraveenKumar NVRT, Lekshmi S, Manna PK, Mohanta GP, Parimalakrishnan S, 

Sudarshan S. ............................................................................................................................................................41- 44 

♦Evaluation of prescribing pattern of clinicians in out-patient departments of a South Indian teaching hospital 

Ramesh A, Suhaj A ................................................................................................................................................45 - 49 

♦Impact of patient counseling on Knowledge, Attitude, Practice and Quality of Life in patients with Type II Diabetes 

mellitus and Hypertension. 

Praveena P, Usman S, Deepika B, Raghu Kumar V, Mohanta G P, Manna P K, Manavalan R. ........................... 50 -54 

♦Influience of pharmacist provided education on Quality of Life in patients with HIV/AIDS-a study 

Ramesh A, Dinesh K, Nagavi B G, Mothi S N, Parthasarathy G............................................................................. 55 - 60 

♦Drug use and dosing in patients with renal impairment 

Veera Raghavulu B, Shravani K, PrabhakarReddy V, Manohar Babu S ................................................................ 61 - 67 

♦Prescription errors in Guntur district of Andhra Pradesh- A retrospective study 

Pulla Reddy M, Vijayapandi P, Aruna kanth CH, karthikeyan R ............................................................................ 68 - 70

Dear Readers, 


ijopp 

Editorial 

As pharmacists we should always keep ourselves abreast of the latest developments in the field of medicines. 

Currently the concept of personalized medicine is receiving much attention all over the world. Drug therapy is now moving 

from right drug for the disease to individualization of therapy. 

As we have all seen at some point or the other, drug response can vary from patient to patient. 

The aim of individualized treatment is to match the right drug to the right patient and, in some cases, even to design the 

appropriate treatment for patients according to their genotype. 

Pharmacogenomics, a branch of pharmacology deals with the influence of genetic variation on drug response and has 

presently caught the attention of researchers globally. 

After extensive research in this field, it has been found that Single Nucleotide Polymorphism (SNP), the variations in DNA, 

at a single base are actually responsible for the variations in drug response among patients. These SNPs are the markers 

that can correlate drug response and genetic makeup. 

Possible genetic markers for diseases such as cancers, heart diseases, diabetes, bipolar disorders and schizophrenia have 

been identified. For e.g. Allele A1 at polymorphism A correlates with coronary artery disease and the individuals with this 

may be at an increased risk for the same. Risk genes for schizophrenia are on chromosomes 22, chromosome 13 and 

chromosome 8. 

Individuals of any age could be tested to determine the risk profiles for the occurrence of future disease. Infants can be tested 

for genetic diseases at birth. 

In gene profiling, DNA and protein chips are used, for e.g. p53 DNA chip is used popularly for the identification and gene 

screening of cancer risks. 

SNP genotyping is also helpful to track the path of infectious diseases. Pharmacogenomic data can establish an early 

warning system for severe infections due to a particular sensitive genetic makeup of the patient. 

Severe adverse reactions to drugs can be prevented with the help of pharmacogenomics. For e.g. carbamazepine, an 

antiepileptic drug causes Stevens-Johnson Syndrome, a life threatening reaction in few patients and upon analysis it is 

understood that HLA-B*1502 gene is responsible for the same . 

The doctor while treating certain cases where there is a need, can now actually get the patient's genome analyzed to 

prescribe the drugs that are most effective and having least adverse effects to the individual patients. Though the method is 

very expensive, it can prove worthy in saving a few lives. 

Thus, Pharmacogenomics is the new hope of personalised medicine. 

Our readers are invited to share their views on the latest happenings in the field as “letter to editor”. 

I request you all to send quality research articles, case reports and review articles as always. 

Looking forward for write ups in variety of topics and varied research work in this year. 

Dr. Shobha Rani R. Hiremath 

Editor-in-Chief 

www.ijopp.org | ijopp@rediffmail.com


Association of Pharmaceutical Teachers of India 

HER2/neu vaccines fight against Breast Cancer 

Rajasekhar P 

Department of Biotechnology, Sreenidhi Institute of Science and Technology, Yamnampet, Ghatkesar, R.R.District, 

Andhra Pradesh, India. 

A B S T R A C T 

Breast cancer is the most common diagnosed cancer among women. Breast cancer is a malignant tumour that starts from cells of the breast. In 

recent decades, medical science has uncovered some important reasons why breast cancers do not all behave alike. One of those reasons has 

to do with HER2, the human epidermal growth factor receptor 2. The HER2/neu oncogenic protein is a well-described tumour antigen that has 

been immunologically defined in patients with multiple different tumour types that overexpress HER2/neu. HER2 receptors are the product of a 

gene also called HER2, which is expressed in the normal, milk-producing cells (known as epithelial cells) that line the ducts of the breast. A result 

of HER 2 positive is important, as it indicates that the cancer can be treated with Herceptin in combination with other chemotherapy drugs. If 

cancer is diagnosed as HER2 positive, it is most likely aggressive. Regardless of tumour type, endogenous immunity to HER2/neu has two 

predominant characteristics. First, pre-existent immunity is detectable in only a minority of the patients, and secondly, detectable HER2/neu 

specific immunity is of low magnitude. Thus, initial vaccine strategies have focused on boosting HER2/neu immunity to a higher magnitude in 

patients with pre-existent low-level immunity and creating it in the majority of patients vaccinated. Early results from clinical trials demonstrate 

that significant levels of HER2/neu specific T-cell and immunity can be generated with active immunization and that the immune response is 

durable after vaccinations have ended. Furthermore, despite the generation of CD8+ and CD4,T cells responsive to HER2/neu, there is no 

evidence of autoimmunity directed against tissues that express basal levels of the protein. Vaccines that stimulate antibody immunity against 

HER2/neu may also be of benefit in the treatment or prevention of HER2/neu overexpressing cancers. The development of cancer vaccines 

targeting the HER-2/neu oncogenic protein may be useful adjuvants to standard therapy and aid in the prevention of relapse in patients whose 

tumours overexpress the protein. Starting treatment as soon as possible will help improve survival, as well as help to prevent recurrence. 

Key Words: Breast cancer, HER2/neu, vaccine. 

Submitted: 2/2/2011 

Accepted: 14/2/2011 

INTRODUCTION 

The breast is the upper ventral region of humans which are 

modified sudoriferous (sweat) glands which produce milk in 

women, and in some rare cases, in men. The breasts of a 

female contain the mammary glands, which secrete milk used 

to feed infants. Both men and women develop breasts from 

the same embryological tissues. However, at puberty, female 

sex hormones, mainly estrogen, promote breast development 

which does not occur in men. As a result, women's' breasts 

become far more prominent than those of men. Each breast 

has one nipple surrounded by the areola. The color of the 

areola varies from pink to dark brown and has several 

sebacious glands. In women, the larger mammary glands 

within the breast produce the milk. They are distributed 

throughout the breast, with two-thirds of the tissue found 

Address for Correspondence: 

Dr. RAJASEKHAR PINNAMANENI, Taduvayi, Jangareddigudem Mandal, West Godavari 

District, Andhra Pradesh-534 447. India 

E-mail: pinnamaneniraj@gmail.com 

Indian Journal of Pharmacy Practice Volume 4 Issue 1 Jan-Mar, 2011 

within 30 mm of the base of the nipple. These are drained to 

the nipple by between 4 and 18 lactiferous ducts, where each 

duct has its own opening. The network formed by these ducts 

is complex, like the tangled roots of a tree. It is not always 

arranged radially, and branches close to the nipple. The ducts 

near the nipple do not act as milk reservoirs but lactiferous 

sinuses do not, in fact, exist. Instead, most milk is actually in 

the back of the breast, and when suckling occurs, the smooth 

muscles of the gland push more milk forward. The remainder 

of the breast is composed of connective tissue (collagen and 

elastin), adipose tissue (fat), and Cooper's ligaments. The 

ratio of glands to adipose tissues rises from 1:1 in nonlactating 

women to 2:1 in lactating women (Fig. 1). 

Breast cancer originates from breast tissue, most commonly 

from the inner lining of milk ducts or the lobules that supply 

the ducts with milk. Cancers originating from ducts are 

known as ductal carcinomas; those originating from lobules 

are known as lobular carcinomas. There are many different 

types of breast cancer, with different stages (spread), 

aggressiveness, and genetic makeup; survival varies greatly 

1

Rajasekhar P- HER2/neu Vaccines fight against Breast Cancer 

Fig.1: Female breast is made up mainly of lobules (milk-producing 

glands), ducts (tiny tubes that carry the milk from the lobules to the 

nipple), and stroma (fatty tissue and connective tissue surrounding 

the ducts and lobules, blood vessels, and lymphatic vessels). 

Fig.2: Treating HER2 Positive Breast Cancer 

depending on those factors. Computerized models are 

available to predict survival. With best treatment and 

dependent on staging, 10-year disease-free survival varies 

from 98% to 10%. Worldwide, breast cancer comprises 

10.4% of all cancer incidences among women, making it the 

second most common type of non-skin cancer (after lung 

cancer) and the fifth most common cause of cancer death. 

Breast cancer is about 100 times more common in women 

than in men, although males tend to have poorer outcomes due 

to delays in diagnosis. 

Breast cells have receptors on their surface and in their 

cytoplasm and nucleus. Chemical messengers such as 

hormones bind to receptors, and this causes changes in the 

cell. Breast cancer cells may or may not have three important 

receptors: estrogen receptor (ER), progesterone receptor 

(PR), and HER2/neu. HER2/neu stands for "Human 

Epidermal growth factor Receptor 2" and is a protein giving 

higher aggressiveness in breast cancers. It is a member of the 

Erb B protein family, more commonly known as the 

epidermal growth factor receptor family. HER2/neu has also 

been designated as CD340 and p185. It is encoded by the 

HER2 gene that sends control signals to the cells, telling them 

to grow, divide, and make repairs. A healthy breast cell has 2 

copies of the HER2 gene. Some kinds of breast cancer get 

started when a breast cell has more than 2 copies of that gene, 

and those copies start over-producing the HER2 protein. As a 

result, the affected cells grow and divide much too quickly. 

Knowing the HER2 status is an important part of diagnosis 

(Fig. 2). 

Function 

HER2 is a cell membrane surface-bound receptor tyrosine 

kinase and is normally involved in the signal transduction 

pathways leading to cell growth and differentiation. It is 

encoded within the genome by HER2/neu, a known protooncogene. 

HER2 is thought to be an orphan receptor, with 

none of the EGF family of ligands able to activate it. 

However, ErbB receptors dimerise on ligand binding, and 

HER2 is the preferential dimerisation partner of other 

1 

members of the ErbB family. The HER2 gene is a 

protooncogene located at the long arm of human chromosome 

2 

17(17q21-q22). 

HER2 and cancer 

Approximately 15-20 percent of breast cancers have an 

amplification of the HER2/neu gene or overexpression of its 

3 

protein product (Fig.3). Overexpression of this receptor in 

breast cancer is associated with increased disease recurrence 

and worse prognosis. Because of its prognostic role as well as 

its ability to predict response to trastuzumab (Herceptin US 

brand name), breast tumours are routinely checked for 


2


Fig.3: Three-dimensional structure of the human epidermal growth 

factor 2 (HER-2) protein monomer with subdomains I-IV labelled 

Positive vs. Negative Test Results 

If the breast cancer is tested for HER2 status, the results will 

be graded as positive or negative. If the results are graded as 

HER2 positive, it means that the HER2 genes are overproducing 

the HER2 protein, and that those cells are growing 

rapidly and creating the cancer. If the results are graded HER2 

negative, then the HER2 protein is not causing the cancer. 

Treatment forHER2 positive breast cancer 

overexpression of HER2/neu. Overexpression also occurs in 

other cancer such as ovarian cancer, stomach cancer, and 

biologically aggressive forms of uterine cancer, such as 

4 

uterine serous endometrial carcinoma. 

The oncogene neu is so-named because it was derived from a 

rodent glioblastoma cell line, which is a type of neural 

tumour, hence 'neu.' HER2 is named because it has a similar 

structure to human epidermal growth factor receptor, or 

HER1. ErbB2 was named for its similarity to ErbB (avian 

erythroblastosis oncogene B), the oncogene later found to 

code for EGFR. Gene cloning showed that neu, HER2, and 

ErbB2 were the same. 

HER2 is co-localized, and thus most of the time co-amplified 

with the gene GRB7, which is also a proto-oncogene (active 

in e.g. breast cancer, testicular germ cell tumour, gastric 

cancer, and esophageal cancer). 

Tests for HER2 breast cancer 

ImmunoHistoChemistry (IHC) - this test measures the 

production of the HER2 protein by the tumour. The test results 

are ranked as 0, 1+, 2+, or 3+. If the results are 3+, the cancer is 

HER2-positive. 

Herceptin (trastuzumab) is a drug which is currently being 

used to treat HER2 positive breast cancer. It is a targeted 

therapy, and is also referred to as an immune treatment. This 

drug will be given intravenously, once every 2-3 weeks. Once 

it is in the regulatory system, Herceptin targets the HER2 

protein production (Fig. 4). This helps to stop the growth of 

the HER2 positive cancer cells. 

Some results of Herceptin treatment include shrinkage of 

HER2 positive tumours, before surgery; gets rid of HER2 

positive cancer cells that have spread beyond the original 

tumour and helps prevent recurrence (return) of the HER2 

positive cancer if it was a 2 cm or larger tumour, or if the 

cancer had spread to the lymph nodes. 

Clinically, HER2/neu is important as the target of the 

monoclonal antibody trastuzumab (marketed as Herceptin). 

Trastuzumab is only effective in breast cancer where the 

HER2/neu receptor is overexpressed. One of the mechanisms 

of how traztuzumab works after it binds to HER2 is by 

5 

increasing p27, a protein that halts cell proliferation. 

Overexpression of the HER2 gene can be suppressed by the 

amplification of other genes and the use of the drug Herceptin. 

Research is currently being conducted to discover which 

disregulated genes may have this desired effect. Another 

Fig.4: Trastuzumab complexed with HER-2 protein.s 

extracellular subdomain II 

Fluorescence In Situ Hybridization (FISH) - this test uses 

fluorescent probes to look at the number of HER2 gene copies 

in a tumour cell. If there are more than 2 copies of the HER2 

gene, then the cancer is HER2 positive. 

HER2 is a gene, is it inherited 

This genetic problem is not inherited from the parents. The 

most likely cause of this problem is aging, and wear and tear 

on the body. It is not yet known if environmental factors 

(pollution, smoke, fumes) are part of the cause of this 

problem. 


3


3 

monoclonal antibody, Pertuzumab , which inhibits 

dimerization of HER2 and HER3 receptors, is in advanced 

clinical trials. 

The expression of HER2/ERBB2 protein is regulated by 

estrogen receptors. Furthermore estradiol and tamoxifen 

acting through the estrogen receptor normally down regulates 

the expression of HER2/ERBB2. However when the ratio of 

the coactivator AIB-3 exceeds that of the corepressor PAX2, 

the expression of HER2/ERBB2 is upregulated in the 

presence of tamoxifen leading to tamoxifen resistant breast 

6,7 

cancer. 

Vaccines to fight cancer 

A vaccine is a very common way of building up the immune 

system to fight infection. Using vaccines to fight breast cancer 

is relatively new, however, and still considered experimental. 

A vaccine for breast cancer may consist of an antigen cocktail 

of weakened or essentially dead elements of breast cancer 

cells that could stimulate an antibody response. The cancer 

vaccine might be prepared from one's own deactivated cancer 

cells, or from extracts of breast cancer cells cultivated in a 

laboratory. Vaccines like this are only available in clinical 

trials. But as soon as these vaccines are proven effective and 

win FDA-approval, they will become available outside of 

clinical trials. 

The vaccine is given by injection (usually under the skin). 

Once the immune system becomes aware of the antigens in 

the vaccine, it responds by making antibodies. Hopefully 

these antibodies will able to attack and destroy any remaining 

cancer cells. Later, if any new cancer cells appear, the 

circulating antibodies of the vaccine-educated immune 

system would destroy them also. 

Challenges of cancer vaccines 

Although vaccines have a strong track record in fighting 

many serious infections (such as polio, mumps, and measles), 

they are very much in the experimental stage for cancer. One 

problem is the way cancer progresses. It begins when one of 

the normal cells becomes abnormal and starts multiplying out 

of control, generation after generation. Each generation 

produces variations. 

Eventually the cancer has countless faces, with a limitless 

variety of antigens that need to be targeted by antibodies. The 

cancer vaccine, however, results in a limited number of 

antibodies against the specific cancer cell antigens that were 

in the original vaccine preparation. These antibodies may not 

be effective against the full range of newly developing cancer 

cells. 


In addition, an effective vaccine must summon antibodies that 

target the bad cells and leave normal cells alone. The trick is to 

catch the cancer cells as soon as they form, and make the 

vaccine with cancer cell parts that are not shared by normal 

cells. 

Researchers are investigating ways to identify cancer cells at 

this very early stage. This could be done perhaps with 

chemicals that would tag the problem cells, and then alter 

them enough so that the immune system perceives them as 

abnormal and attacks them. 

Cancer patients can be immunized with vaccines 

targeting tumour antigens and develop antigen specific 

immune responses. 

Several cancer vaccine studies have demonstrated that 

patients can develop tumour antigen specific immune 

responses post-immunization, and that these immune 

responses are associated with only minimal side-effects. A 

variety of vaccine strategies, as well as vaccines targeting 

different tumour antigens, have been shown to be 

immunogenic using highly quantitative assays to assess the T 

cell response. As examples, in a recent phase I study, patients 

with advanced breast and ovarian cancer were vaccinated 

with autologous dendritic cells (DC) pulsed with HER2/neuor 

MUC1-derived peptides. Intracellular interferon gamma 

chromium (IFN) staining and Cr-release assays were used to 

assess response; peptide-specific cytotoxic T lymphocytes 

(CTL) were detected in five out of 10 patients In addition, 

MAGE3- and CEA peptide specific CD8+ T cells were 

observed in one patient treated with MUC1 peptide pulsed 

DCs and MUC1 peptide-specific T cells were observed in 

8 

another patient vaccinated with HER2/neu-derived peptides. 

Another strategy that elicited measurable tumour antigen 

specific immunity involved vaccination with a replicationdefective 

avipox vaccine containing the gene for CEA. In a 

phase I study, 20 patients with advanced CEA expressing 

carcinomas were immunized with the recombinant vaccine. 

Three different dose levels were used and the majority of 

patients vaccinated with the two higher dose levels had 

statistically significant increases in CEA-specific CTL 

9 

precursors after vaccination, as compared to baseline. Two of 

3 patients at the lowest dose also had a significant increase in 

precursor frequency after immunization. Finally, in a phase I 

study by Lee et al, forty-eight patients with high-risk resected 

stage III/IV melanoma were immunized with two tumour 

10 

antigen epitope peptides derived from gp100 and tyrosinase. 

The peptides, in incomplete Freud's adjuvant, were 

4


administered with or without IL-12. Thirty-seven of 42 

patients showed positive immune responses post vaccination 

by flow cytometry assays using tetramers constructed with 

gp100 and tyrosinase peptides. Studies such as these 

increasingly demonstrate that patients with cancer can be 

vaccinated against antigens expressed by their tumours. 

Clinical investigations are now focusing on what types of 

immune responses generated would predict therapeutic 

efficacy and how to optimize immunity based on particular 

vaccine strategy. 

HER2/neu protein is a well-defined tumour antigen in 

variety of solid tumours and an established candidate 

antigen for eliciting tumour specific immunity 

The HER2/neu protein consists of an extracellular ligand 

binding domain, a short transmembrane domain, and 

11,12 

cytoplasmic protein tyrosine kinase domain. Binding of 

ligand to the extracellular domain (ECD) leads to 

dimerization that stimulates the tyrosine kinase activity of the 

receptor and triggers autophosphorylation of residues within 

the intracellular cytoplasmic domain. These phosphorylated 

residues then serve as anchoring sites for signalling molecules 

involved in the regulation of intracellular signaling cascades 

11 

and, thus, malignant cell growth. 

HER2/neu protein is a good vaccine target from both a 

biologic and an immunologic standpoint. HER2/neu has been 

most extensively studied within the framework of breast 

cancer where it is known to be overexpressed in about 30% of 

all breast cancer and is associated with a poor clinical 

13 

prognosis. Subsequently, it has been shown by many 

investigators that patients with a variety of different tumour 

types that overexpress the HER2/neu protein can have both 

14 

antibody and T cell immunity directed against HER2/neu. 

Investigations of HER2/neu specific antibodies in patients 

with breast cancer demonstrate that responses can be detected 

in patients with early stage disease indicating that the 

presence of antibodies is not simply a reflection of tumour 

15 

burden. Furthermore, detection of antibodies to HER2/neu 

also correlated to protein overexpression in the patient's 

primary tumour. Antibodies to HER2/neu have been found in 

the sera of patients with colon cancer; titers of >1:1000 were 

detected in 8 of 57 (14%) of patients with colorectal cancer 

compared to 0 of 200 (0%) of the normal control population. 

Similar to the immune response in breast cancer patients, the 

ability to detect HER2/neu antibodies correlated with 

overexpression of the protein in the patient's primary 

16 

tumour. 

Moreover, in prostate cancer detection of HER2/neu specific 

antibodies was most prevalent in the subgroup of patients 

17 

with androgen independent disease. Existent T cell 

immunity to the oncogenic protein, both T helper and CTL, 

have been detected in patients with HER2/neu 

overexpressing tumours. The identification of T-cells that can 

respond to HER2/neu indicates a portion of the T cell 

repertoire will recognize this self-antigen. CD4+ T cell 

responses were evaluated in patients with advanced stage 

18 

HER2/neu positive tumours. A minority, approximately 

10% of patients were found to have antibody and T cell 

immunity directed against HER2/neu. Cytotoxic T cells 

(CTL) capable of lysing HER2/neu overexpressing tumour 

cell lines have been identified in both the peripheral blood and 

tumours of patients bearing a variety of HER2/neu 

19-24 

overexpressing tumours. Testing of vaccine strategies 

targeting a tumour antigen where there is already some level 

of pre-existent immunity may facilitate assessment of the 

generation of immunity after vaccination. Presumably, it is 

easier to boost a low-level pre-existent immune response than 

prime naïve T cells to recognize a self-protein. Generating an 

active immune response directed against the HER2/neu 

protein has several potential clinical advantages. Portions of 

this transmembrane protein are likely to be available to both 

the class I and II antigen processing pathways, thus, 

stimulating both a T helper cell and a cytotoxic T cell (CTL) 

immune response. In addition to CTL, antibody immunity 

could potentially be generated by active immunization 

against appropriate epitopes involved in receptor signalling. 

Durable concentrations of functional antibodies binding the 

extracellular domain (ECD) of the growth factor receptor 

could have therapeutic impact. Vaccination, if effective, 

would stimulate immunologic memory and could result in the 

prevention of relapse after standard therapy, such as surgery 

and radiation. 

HER2/neu protein serves as a model antigen for testing 

immunization strategies targeting self proteins 

Recent studies have identified self-proteins as tumour 

25-27 

antigens. These proteins are not mutated and are clearly 

25-27 

immunogenic in patients with cancer. Many of these 

proteins are present at much higher concentrations in 

malignant cells than in the normal cells. Indeed, the peptide 

repertoire display in the MHC when a protein is 

overexpressed may be distinctly different from the peptides 

present in resting MHC where that same protein is present at 

basal levels. HER2/neu vaccine development has focused on 

strategies that will allow tolerance to be circumvented. Early 

studies have evaluated peptide vaccines to stimulate 


5


immunity to HER- 2/neu. The ability to mount an immune 

response is related to the immunodominance of specific 

antigenic determinants during natural immunologic 

processing of intact protein antigens. 

However, only a minor fraction of potential determinants in 

an antigen are presented in an immunodominant manner, 

28 

while the remaining peptides are ignored. Physiological 

mechanisms of immunologic tolerance to self prevent the 

induction of an immune response to self proteins, such as 

HER2/neu. Dominantly processed self-determinants are 

28,29 

thought to be efficient in tolerance induction. However, in 

every self-antigen, there are sequestered determinants that are 

unable to induce tolerance, therefore, could be 

28 

immunogenic. These subdominant epitopes may trigger the 

threshold for T-cell activation and immune recognition if they 

are presented in abundance, such as when a self-protein 

becomes overexpressed. 

Overexpression of the HER2/neu protein may result in 

subdominant peptides being presented in higher 

concentration in the major histocompatibility complex 

(MHC), thus, triggering a T cell response. Abundance of 

subdominant epitopes in MHC molecules expressed on 

cancer cells could result in overexpressed self-proteins 

functioning as tumour specific antigens. An alternative 

hypothesis is that subdominant epitopes are more effectively 

presented by efficient antigen presenting cells (APC) such as 

dendritic cells (DC) and that DC are activated by 

inflammatory signals from the local tumour immune 

30 

microenvironment. 

Studies in animal models have shown that peptide based 

vaccines can effectively immunize against neu in animal 

models. Several groups have used rats as an experimental 

model for neu. Rat neu is highly homologous to human neu 

and has similar basal tissue distribution as human. Previous 

investigators had shown that rats could not be immunized 

with rat neu protein in the context of rat ECD in a vaccinia 

31 

vector. Subsequent investigations validated those findings 

by vaccinating rats with purified rat neu in a classic 

32 

immunization regimen Rats were tolerant to rat neu. 

However, rats could be effectively immunized with rat neu 

peptides designed for eliciting CD4+ T cell responses. 

Antibody and T cell responses specific for both the 

immunizing peptides and protein were generated in the 

32 

peptide immunized animals. 

Pre-clinical development of HER2/neu peptide based 

vaccines for the generation of T cell immunity 

Translating the development of peptide vaccines from 

animals into humans required the identification of 

appropriate peptide epitopes. Both class I and class II binding 

peptides have been identified. Computer modeling programs 

have been effective in predicting potential immunogenic 

epitopes of self proteins such as HER2/neu and early studies 

have focused on evaluating constructed peptides for signs of 

immune reactivity in patients with HER2/neu positive 

14 

tumours. Rongcun and colleagues identified HER2/neu 

specific HLA-A2.1 restricted CTL epitopes, which were able 

to elicit CTL that specifically killed peptide-sensitized target 

cells, and, most, importantly, a HER2/neu-transfected cell 

33 

line and autologous tumour cells. 

A similar strategy involves defining candidate epitopes by 

34 

their MHC-binding motif and class I affinity. Identified high 

affinity peptides are then tested for in vitro reactivity with 

peripheral blood mononuclear cells (PBMC) from normal 

donors and the ability to induce tumour reactive CTLs. Many 

peptides that bind A*0201 also exhibit degenerate binding to 

multiple alleles thus, an A2 supertype multi-epitope vaccine 

35 

could be designed to provide broad population coverage. 

Modelling programs to predict class II epitopes are also 

widely available. An example is the computer protein 

sequence analysis package, T Sites, which used two searching 

algorithms. The first is the AMPHI algorithm for identifying 

motifs according to charge and polarity patterns. The second 

is the Rothbard and Taylor algorithm for identifying motifs 

36 

according to charge and polarity patterns. Each of the 

searching algorithms has empirically been successful in 

identifying a substantial proportion (50-70%) of helper T cell 

36,37 

epitopes in foreign proteins. HER2/neu peptides predicted 

by both algorithms were constructed and were 15-18 amino 

14 

acids in length. PBMC, obtained from breast cancer patients 

with HER2/neu overexpressing tumours were analyzed for a 

proliferative T cell response to HER2/neu potential 

immunogenic peptides. Seven of 26 HER2/neu specific 

putative class II peptides tested demonstrated the ability to 

elicit T cell responses, in vitro, in at least 20% of breast cancer 

14 

patients evaluated. 

The ability of a single peptide to generate immune responses 

in multiple individuals of diverse MHC backgrounds is not 

unique. Universal epitopes for class II have been defined for 

38,39 

tetanus toxoid. Investigations such as those described 

above, lay the foundation for the first generation of human 

clinical trials of HER2/neu specific cancer vaccines, focusing 

on peptide immunization. 

Human clinical trials of vaccines targeting the HER2/neu 

oncogenic protein; generating T cell immunity 

Indian Journal of Pharmacy Practice Volume 4 Issue 1 Jan-Mar, 2011 6


Vaccines designed to stimulate a cytotoxic T cell response 

to HER2/neu 

The cytotoxic T cell has been considered the primary effector 

cell of the immune system capable of eliciting an anti-tumour 

response. The predominant experimental method of 

stimulating a CTL response in vivo has been to vaccinate 

individuals with tumour cells or viruses recombinant for 

tumour antigens that can infect viable cells so that proteins are 

expressed inside the cell and are processed and presented in 

the MHC class I antigen processing pathway. An alternative 

effective vaccination strategy to elicit CTL uses a single 

soluble peptide that is identical or similar to naturally 

processed peptides that are present in class I MHC molecules 

along with adjuvant. An HLA-A2 binding peptide, p369-377, 

derived from the protein sequence of HER 2/neu ECD has 

been used extensively in clinical trials to generate CTL 

specific for cells overexpressing HER2/neu in vivo via active 

immunization. 

In an initial clinical study, HLA-A2 positive patients with 

metastatic HER2/neu overexpressing breast, ovarian, or 

colorectal carcinomas were immunized with 1 mg of p369- 

377 admixed in incomplete Freund's adjuvant (IFA) every 3 

40 

weeks. Peptide specific CTL were isolated and expanded 

from the peripheral blood of patients after 2 or 4 

immunizations. The CTL could lyse HLA matched peptide 

pulsed target cells but could not lyse HLA matched tumours 

expressing the HER2/neu protein. Even when tumours were 

treated with IFN to upregulate class I, the CTL lines generated 

from the patients would not respond to the peptide presented 

endogenously on tumour cells. An additional problem in 

using single HLA binding epitopes is that without CD4+ T- 

cell help, responses generated are short lived and nondurable. 

More recently a similar study was performed, 

immunizing patients with p369-377 using GM-CSF as an 

41 

adjuvant. GMCSF is a recruitment and maturation factor for 

skin DC, Langerhans cells (LC) and theoretically may allow 

more efficient presentation of peptide epitopes than standard 

adjuvants such as IFA. 

Six HLA-A2 patients with HER2/neu-overexpressing 

cancers received 6 monthly vaccinations with 500 mcg of 

HER2/neu peptide, p369-377, admixed with 100 mcg of GM- 

CSF. The patients had either stage III or IV breast or ovarian 

cancer. Immune responses to the p369-377 were examined 

using an IFN ELIspot assay. Prior to vaccination, the median 

precursor frequency, defined as precursors/106 PBMC, to 

p369-377 was not detectable. Following vaccination, 

HER2/neu peptide-specific precursors developed to p369- 

377 in just 2 of 4 evaluable subjects. The responses were 

short-lived and not detectable at 5 months after the final 

vaccination. Immunocompetence was evident as patients had 

detectable T cell responses to tetanus toxoid and influenza. 

These results demonstrate that HER2/neu MHC class I 

epitopes can induce HER2/neu peptide-specific IFNproducing 

CD8+ T cells. However, the magnitudes of the 

responses were low, as well as short-lived. Theoretically, the 

addition of CD4+ T cell help would allow the generation of 

lasting immunity. 

A successful vaccine strategy in generating peptide specific 

CTL capable of lysing tumour expressing HER2/neu and 

resulting in durable immunity involved immunizing patients 

with putative T-helper epitopes of HER2/neu which had, 

embedded in the natural sequence, HLA-A2 binding motifs of 

HER2/neu. Thus, both CD4+ T cell help and CD8+ specific 

epitopes were encompassed in the same vaccine. In this trial, 

19 HLA-A2 patients with HER2/neu overexpressing cancers 

received a vaccine preparation consisting of putative 

42 

HER2/neu helper peptides. Contained within these 

sequences were the HLA-A2 binding motifs. Patients 

developed both HER2/neu specific CD4+ and CD8+ T cell 

responses. The level of HER2/neu immunity was similar to 

viral and tetanus immunity. In addition, the peptide-specific T 

cells were able to lyse tumour. The responses were long-lived 

and detectable for greater than 1 year after the final 

vaccination in selected patients. These results demonstrate 

that HER2/neu MHC class II epitopes containing 

encompassed MHC class I epitopes are able to induce longlasting 

HER2/neu-specific IFN-producing CD8 T cells. 

Vaccines designed to stimulate a T helper response to 

HER2/neu 

Pre-existent immune responses to HER2/neu are of low 

magnitude. Stimulating an effective T helper response is a 

way to boost antigen specific immunity as CD4+ T-cells 

generate the specific cytokine environment required to 

support an evolving immune response. Furthermore, either 

CTL or antibody immunity may have an effect on HER2/neu 

overexpressing tumour growth. Targeting CD4+ T cells in a 

vaccine strategy would result in the potential to augment 

either of these arms of the immune system. 

Putative T helper subdominant peptide epitopes, derived from 

the HER2/neu protein sequence, were predicted by computer 

modeling, and screened for immune reactivity using PBMC 

14 

from patients with breast and ovarian cancer. Vaccines were 

generated each composed of three different peptides, each 15- 

18 amino acids in length . Patients with advanced stage 



HER2/neu overexpressing breast, ovarian, and non-small cell 

lung cancer were enrolled and 38 patients finished the 

43 

planned course of 6 immunizations. Patients received 500 

mcg of each peptide admixed in GM-CSF in an effort to 

44 

mobilize LC in vivo as an adjuvant to peptide immunization. 

Ninety-two percent of patients developed T cell immunity to 

HER2/neu peptides and over 60% to a HER2/neu protein 

domain. Thus, immunization with peptides resulted in the 

generation of T cells that could respond to protein. 

Furthermore, at 1-year followup, immunity to the HER2/neu 

protein persisted in 38% of patients. Immunity elicited by 

active immunization with CD4+ T helper epitopes was 

durable. An additional finding of this study was that epitope 

spreading was observed in 84% of patients and significantly 

correlated with the generation of HER2/neu protein-specific 

T cell immunity (p=0.03). Epitope, or determinant spreading, 

45 

is a phenomenon first described in autoimmune disease and 

has been associated with both MHC Class I- and MHC Class 

46,47 

II-restricted responses. Epitope spreading represents the 

generation of an immune response to a particular portion of an 

immunogenic protein and then the natural spread of that 

immunity to other areas of the protein or even to other 

antigens present in the environment. In this study, epitope 

spreading reflected the extension of a significant T cell 

immune response to portions of the HER2/neu protein that 

were not contained in the patient's vaccine. Epitope spreading 

represents a broadening of the immune response and could 

indicate endogenous processing of antigen at sites of 

30 

inflammation initiated by a specific T cell response. That is, 

the initial immune response can create a microenvironment at 

the tumour-site that enhances the presence of local immune 

effector cells present. These immune cells, e.g. APC and T 

cells, may begin to respond more effectively to tumour 

antigen that is present in the body. Another recently reported 

vaccine trial immunizing breast and ovarian cancer patients 

with autologous DC pulsed with MUC-1 or HER2/neu 

8 

peptides resulted in epitope spreading. In this trial 10 patients 

were immunized. Half the patients developed CD8+ T cell 

precursors to their immunizing peptides. 

Moreover, some patients developed new immunity to other 

tumour antigens expressed in their cancers such as CEA and 

MAGE-3. Most clinical trials of cancer vaccines focus on the 

detection of a newly generated immune response or the 

magnitude of the antigen specific immune response elicited 

after active immunization. However, if epitope spreading 

indicates an immune microenvironment capable of producing 

an endogenous polyclonal immune response, it may be an 

endpoint that could potentially reflect an improved clinical 

outcome. 

Methods to augment immunity to HER2/neu in clinical 

trials of HER2/neu specific vaccines 

Recent studies have evaluated vaccine strategies focused to 

maximize the role of the most efficient APC, the DC or skin 

LC, in eliciting effective immunity to self. One such strategy 

is to use cytokines involved in DC production and maturation 

as vaccine adjuvants. Flt3-ligand (FL) is a cytokine which, 

when administered systemically, can increase numbers of 

48 

circulating DC greater than 40 fold. Human DC generated by 

the administration of FL have been shown to be functional and 

48 

can stimulate T cells in vitro. Furthermore, activation of DC 

in vivo by FL has been shown to be an effective way of 

circumventing tolerance during active immunization in 

49 

animal models. Studies have been performed in the neu 

transgenic mouse, immunizing the animals to a self-tumour 

antigen, neu, using FL as a vaccine adjuvant to mobilize DC in 

50 

vivo. The timing of vaccine administration corresponded to 

51,52 

the kinetics of in vivo DC mobilization in animals ; early 

administration when few circulating DC are present, 

midpoint administration when DC precursors are increasing 

the peripheral blood, and finally vaccination at the end of the 

FL cycle when DC are at peak concentrations. During a 10- 

day administration of FL a HER2/neu ICD protein vaccine 

was administered at 3 time-points. Animals receiving the 

vaccine midpoint in the FL cycle generated HER2/neu ICD 

specific immunity whereas mice immunized at the end of the 

FL cycle did not. In general, neu specific immunity generated 

using FL resulted in T cells that predominantly secreted IFN, a 

Type 1 associated cytokine, rather than IL-4, a Type 2 

50 

associated cytokine. 

Mobilizing DC in vivo as a vaccine adjuvant to augment 

HER2/neu specific immunity 

Based on the data generated in rodent models, 10 patients with 

HER2/neu overexpressing cancers were enrolled to receive a 

HER2/neu peptide-based vaccine targeting the ICD of the 

53 

HER2/neu protein. The peptides in the vaccine were the 

same as those used in one of the arms of the trial described 

43 

above. All patients received FL 20 mcg/kg/day s.c. for 14 

days. Five patients received the HER2/neu peptide-based 

vaccine alone intradermally midpoint in one FL cycle and 5 

patients received the vaccine admixed with 150 mcg of GM- 

CSF intradermally midpoint in the FL cycle. Including FL as a 

vaccine adjuvant was effective in boosting the precursor 

frequency of IFN secreting HER2/neu specific T cells. After 



the completion of all immunizations, patients in each group 

developed detectable IFN producing T cell specific for the 

ICD protein. The small sample size of each group, however, 

did not allow a statistically significant comparison of immune 

responses between the FL alone and FL with GM-CSF arms. 

Recent investigations have demonstrated FL and GM-CSF 

may stimulate different subsets of DC in vivo and that the 

cytokine microenvironment elicited, either Type 1 or Type 2, 

is markedly influenced by the particular DC subset generated. 

Evaluating a murine model of cancer, using tumours 

engineered to express either GM-CSF or FL, demonstrated 

GM-CSF engineered cells were more potent in inducing an 

54 

anti-tumour response. GM-CSF elicited a diverse cytokine 

environment consisting of both Th1 and Th2 immune 

effectors. In contrast, immune responses generated with FL 

expressing tumour cells were specifically restricted to a Th1 

54 

phenotypic response. Data from human clinical trials using 

FL as a vaccine adjuvant support that FL is associated with the 

development of a strong Type 1 response. The detection of 

antigen specific cytokine production without concomitant 

measurable clonal proliferation has been reported and is 

potentially a reflection of a strongly restricted Type 1 

55 

response. 

Balancing immunity with autoimmunity in cancer 

vaccine development 

The addition of FL in the vaccine regimen was associated with 

the development of autoimmune phenomenon in some 

patients. In general, the vaccine regimens including FL were 

well tolerated. One patient had grade 1 serologic 

abnormalities (ANA, anti-SSA, anti-dsDNA). A second 

patient, who had Stage IV breast cancer, developed grade 2 

toxicity with serologic abnormalities and self limiting Sicca 

syndrome characterized by dry eyes and dry mouth 3 months 

after the completion of the vaccine regimen. This patient did 

not develop any detectable immunity to HER2/neu peptides 

or protein after active immunization. None of the patients 

immunized on any reported HER2/neu specific vaccine trial 

developed any evidence of autoimmune phenomenon 

directed against tissues that express basal levels of 

HER2/neu. 

HER2/neu specific vaccines designed at stimulating 

functional antibody immunity 

Studies in both animals and human demonstrate that infusion 

of high concentrations of neu specific antibodies can mediate 

an anti-tumour response. For example, in a murine breast 

cancer tumour model, investigators show that 50% of animals 

did not spontaneously develop breast cancer when treated 

56 

with a neu-specific antibody directed against the ECD. 

These successful results in animal models have been 

translated to human clinical trials. Several investigations 

indicate passive HER2/neu antibody infusion may have a 

marked therapeutic effect in patients with HER2/neu 

57,58 

overexpressing tumours. Recent clinical trials show an 

overall response rate of 26% when a HER2/neu specific 

monoclonal antibody, trastuzumab, is used as first line 

59 

monotherapy. Furthermore, when trastuzmab was used in 

conjunction with chemotherapy in patients with metastatic 

HER2/neu overexpressing breast cancer, a longer time to 

disease progression, overall response rate, and longer 

duration of response was observed than in those patients who 

58 

received chemotherapy alone. Data such as these are 

evidence that an antibody response against HER2/neu may 

have a therapeutic benefit. In addition, studies of antibody 

infusion provide a target concentration target for the level of 

antibody needed to potentially mediate that anti-tumour 

60 

response. The drawback with passive antibody infusion, 

however, is that the monoclonal antibodies are short-lived and 

are cleared from the circulation. A vaccine strategy, which 

would generate an endogenous antibody response may result 

in more durable antibody levels. This type of strategy would 

be potentially useful in both treatment of HER2/neu 

overexpressing cancer and protection from tumour 

recurrence or development. 

Generation of HER2/neu specific antibody immunity 

after a peptide based vaccine 

Antibody responses were assessed in the patients immunized 

with a HER2/neu peptide based vaccine designed to elicit T 

43 

helper responses. The peptides chosen for immunization 

14 

were potential T helper epitopes. Vaccinating patients to 

augment a CD4+ T cell response, however, may stimulate a 

concomitant B cell response to neu as has been shown in 

32 

animal models. Sixty-two patients were evaluable for the 

assessment of antibody immunity to HER2/neu. Forty-seven 

percent of all patients developed an antibody response to 

HER2/neu peptides, range 0-21.6 mcg/ml. Antibody 

responses to the HER2/neu protein, after peptide 

immunizations however, were detected in only 23% of 

patients, range 0-9.3 mcg/ml. Furthermore, the magnitude of 

the HER2/neu protein specific antibody response elicited 

after peptide immunization was of lower magnitude than the 

antibody response generated to a control foreign antigen 

immunization with KLH (mean 0.5 mcg/ml vs. mean 16.5 

mcg/ml respectively). 



HER2/neu specific monoclonal antibodies, such as 

trastuzumab, have been shown to elicit an anti-tumour 

response when used alone or in combination with 

58,59 

chemotherapy. In preclinical models, inhibition of tumour 

growth required antibody concentrations between 1 and 23 

60 

mcg/ml. Clinical studies of trastuzumab have targeted a 

minimum serum trough concentration of 10 mcg/ml as a level 

61 

considered necessary for a therapeutic response in humans. 

The level of HER2/neu specific antibodies elicited on this 

study did not fall into the range of what would be expected to 

stimulate a therapeutic response. Preclinical investigations 

are ongoing to determine peptide epitopes that may elicit 

functional HER2/neu specific antibody immunity. 

Defining functional HER2/neu specific antibody epitopes 

for use in cancer vaccines 

Another aspect of peptide epitope prediction would be to 

identify peptide portions of the HER2/neu ECD that would be 

appropriate to target with an antibody response. Although 

many HER2/neu specific antibodies inhibit the growth of 

cancer cells, some antibodies have no effect on cell growth, 

62 

while others even actively stimulate cancer growth. This 

wide range of biological effects is thought to be related to the 

epitope specificity of the antibodies and to consequent 

62 

changes in receptor signalling. An alternative to the use of 

passive antibody therapy would be active immunization 

against the HER2/neu ECD. However, inappropriately 

induced immune responses could have untoward effects on 

cancer growth. Therefore, it is crucial to identify epitopes on 

HER2/neu that are targeted by stimulatory and inhibitory 

antibodies in order to ensure the induction of a beneficial 

endogenous antibody response. 

In a recent study, investigators constructed HER2/neu gene 

fragment phage display libraries to epitope-map a number of 

HER2/neu specific antibodies with different biological 

62 

effects on tumour cell growth. Regions responsible for 

opposing effects of antibodies were identified and then used 

to immunize mice. The epitopes of three antibodies, N12, 

N28, and L87 were successfully located to peptide epitope 

binding regions of HER2/neu. While N12 inhibited tumour 

cell proliferation, N28 stimulated the proliferation of a subset 

of breast cancer cell lines overexpressing HER2/neu. The 

peptide region recognized by N12 was used as an immunogen 

to selectively induce an inhibitory immune response in mice. 

Mice immunized with the peptide developed antibodies that 

recognized both the peptide and native HER2/neu. More 

importantly, HER2/neu specific antibodies purified from 

mouse sera were able to inhibit up to 85% of tumour cell 

proliferation in vitro. This study provides direct evidence of 

the functional relationship of HER2/neu specific antibodies 

generated by active immunization. Using peptide regions that 

contain multiple inhibitory B cell epitopes is likely to be 

63 

superior to the use of single epitope immunogens. 

CONCLUSION 

Since the HER2/neu protein was first identified a decade ago 

significant progress has been made in understanding the 

function of the molecule in cancer initiation as well as the 

development of HER2/neu targeted therapies that are in 

human clinical trials today. Whereas passive infusion of 

HER2/neu specific antibodies has already shown great 

promise as a therapeutic, active immunization with 

HER2/neu specific vaccines are just starting human clinical 

trials. Although effective immunization of cancer patients is a 

significant scientific hurdle, it is one that can be 

accomplished. The prevention of recurrence of HER2/neu 

overexpressing tumours would be aided by the development 

of an anti-tumour immune response and the generation of 

immunologic memory specific for HER2/neu after effective 

vaccination. 

Ultimately, we will be using the best defense to fight cancer, 

the human immune system. It is a very challenging thing to 

do. We hope we have reached a point where we can make it 

useful to patients. 

Abbreviations 

APC: antigen presenting cell; CEA: carcinoembryonic 

antigen; CTL: cytotoxic T cell; DC: dendritic cell; ECD: 

extracellular domain; FL: Flt-3 Ligand; GM-CSF: 

granulocyte macrophage stimulating factor; HLA: human 

leukocyte antigen; ICD: intracellular domain; IFA: 

incomplete Freund's adjuvant; IFN: interferon gamma; IL: 

interleukin; IVS: in vitro stimulation; LC: Langerhans cell; 

MHC: major histocompatibility antigen; MUC: mucin; 

NSCLC: non-small cell lung cancer; PBMC: peripheral blood 

mononuclear cell; TCR: T cell receptor; Th: T helper cell. 

REFERENCES 

1. Olayioye MA. Update on HER2 as a target for cancer 

therapy: intracellular signalling pathways ErbB2/HER2 

and family members. Breast Cancer Res 2001; 

3(6):385–389. 



2. Coussens L, Yang-Feng TL, Liao YC, Chen E, Gray A, 

Mc Grath J, Seeburg PH, Libermann TA. Tyrosine 

Kinase Receptor with Extensive Homology to EGF 

Receptor Shares Chromosomal Location with neu 

Oncogene. Science 1985; 230(4730):1132–1139. 

3. Entrez Gene: ErbB2 v-erb-b2 erythroblastic leukemia 

viral oncogene homologue 2, neuro/glioblastoma derived 

o n c o g e n e h o m o l o g u e ( a v i a n ) . 

http://www.ncbi.nlm.nih.gov/sites/entrezDb=gene&C 

md=ShowDetailView&TermToSearch=2064. 

4. Santin AD, Bellone S, Roman JJ, McKenney JK, 

Pecorelli S. Trastuzumab treatment in patients with 

advanced or recurrent endometrial carcinoma 

overexpressing HER2/neu. Int J Gynaecol Obstet 2008; 

102(2):128–131. 

5. Le XF, Franz P, Robert B. HER2-targeting antibodies 

modulate the cyclin-dependent kinase inhibitor p27Kip1 

via multiple signaling pathways. Cell Cycle 2005; 

4(1):87–95. 

6. Study sheds new light on tamoxifen resistance. Cordis 

News. Cordis. 2008. http://cordis.europa.eu/fetch 

CALLER=EN_NEWS&ACTION=D&SESSION=&R 

CN=30093. 

7. Hurtado A, Holmes KA, Geistlinger TR, Hutcheson IR, 

Nicholson RI, Brown M., et.al. Regulation of ERBB2 by 

oestrogen receptor-PAX2 determines response to 

tamoxifen. Nature 2008; 456 (7222): 663. 

8. Brossart P, Wirths S, Stuhler G. Induction of cytotoxic T- 

lymphocyte responses in vivo after vaccinations with 

peptide-pulsed dendritic cells. Blood 2000; 96:3102- 

3108. 

9. Marshall JL, Hawkins MJ, Tsang KY. Phase I study in 

cancer patients of a replication-defective avipox 

recombinant vaccine that expresses human 

carcinoembryonic antigen. J Clin Oncol 1999; 17:332- 

337. 

10. Lee P, Wang F, Kuniyoshi J. Effects of interleukin-12 on 

the immune response to a multipeptide vaccine for 

resected metastatic melanoma. J Clin Oncol 2001; 

19:3836-3847. 

11. Olayioye MA, Neve RM, Lane HA, Hynes NE. The ErbB 

signaling network: receptor heterodimerization in 

development and cancer. Embo J 2000; 19:3159-3167. 

12. Samanta A, LeVea CM, Dougall WC, Qian X, Greene MI. 

Ligand and p185c-neu density govern receptor 

interactions and tyrosine kinase activation. Proc Natl 

Acad Sci 1994; 91:1711-1715. 

13. Slamon DJ, Clark GM, Wong SG. Human breast cancer: 

correlation of relapse and survival with amplification of 

the HER2/neu oncogene. Science 1987; 235:177-182. 

14. Disis ML, Cheever MA. HER2/neu oncogenic protein: 

issues in vaccine development. Crit Rev Immunol 1998; 

18:37-45. 

15. Disis ML, Pupa SM, Gralow JR. High-titer HER2/neu 

protein-specific antibody can be detected in patients with 

early-stage breast cancer. J Clin Onc 1997; 15:3363- 

3367. 

16. Ward RL Hawkins N, Coomber D, Disis ML Antibody 

immunity to the HER2/neu oncogenic protein in patients 

with colorectal cancer. Hum Immunol 1999; 60:510-515. 

17. McNeel DG, Nguyen LD, Storer BE. Antibody immunity 

to prostate cancer associated antigens can be detected in 

the serum of patients with prostate cancer. J Urol 2000; 

164:1825-1829. 

18. Disis ML, Knutson KL, Schiffman K, Rinn K, McNeel 

DG. Pre-existent immunity to the HER2/neu oncogenic 

protein in patients with HER2/neu overexpressing breast 

and ovarian cancer. Breast Cancer Res Treat 2000; 

62:245-252. 

19. Ioannides CG, Whiteside TL. T cell recognition of human 

tumours: implications for molecular immunotherapy of 

cancer. Clin Immunol Immunopathol 1993; 66:91-106. 

20. Yoshino I, Goedegebuure PS, Peoples GE. HER2/neuderived 

peptides are shared antigens among human nonsmall 

cell lung cancer and ovarian cancer. Cancer Res 

1994; 54:3387-3390. 

21. Peoples GE, Goedegebuure PS, Smith R. Breast and 

ovarian cancer-specific cytotoxic T lymphocytes 

recognize the same HER2/neu-derived peptide. Proc Natl 

Acad Sci, USA 1995; 92:432-436. 

22. Peiper M, Goedegebuure PS, Izbicki JR, Eberlein TJ. 

Pancreatic cancer associated ascites-derived CTL 

recognize a nine-amino- acid peptide GP2 derived from 

HER2/neu. Anticancer Res 1999; 19:2471-2475. 

23. Brossart P, Stuhler G, Flad T. HER2/neu-derived peptides 

are tumour-associated antigens expressed by human renal 

cell and colon carcinoma lines and are recognized by in 

vitro induced specific cytotoxic T lymphocytes. Cancer 

Res 1998. 58:732-736. 



24. Kono K, Rongcun Y, Charo J. Identification of 

HER2/neu-derived peptide epitopes recognized by 

gastric cancer-specific cytotoxic T lymphocytes. Int J 

Cancer 1998; 78:202- 208. 

25. Pardoll DM. A new look for the 1990s. Nature 1994; 

369:357-358. 

26. Houghton AN. Cancer antigens: immune recognition of 

self and altered self. J Exp Med 1994; 180:1-4. 

27. Disis ML, Cheever MA. Oncogenic proteins as tumour 

antigens. In: Alt F, Marrack P, eds. Current Opinion in 

Immunology. Vol. 5. London: Current Biology Ltd.; 

1996; 637-642. 

28. Sercarz EE, Lehmann PV, Ametani A. Dominance and 

crypticity of T cell antigenic determinants. Annu Rev 

Immunol 1993; 11:729-766. 

29. Nanda NK, Sercarz EE. Induction of anti-self-immunity 

to cure cancer. Cell 1995. 82:13- 17. 

30. Sercarz EE. Driver clones and determinant spreading. J 

Autoimmun 2000; 14:275-277. 

31. Bernards R, Destree A, McKenzie S. Effective tumour 

immunotherapy directed against an oncogene-encoded 

product using a vaccinia virus vector. Proc Natl Acad Sci 

U S A 1987; 84:6854-6858. 

32. Disis ML, Gralow JR, Bernhard H. Peptide-based, but not 

whole protein, vaccines elicit immunity to HER2/neu, an 

oncogenic self-protein. J Immunol 1996; 156:3151-3158. 

33. Rongcun Y, Salazar-Onfray F, Charo J. Identification of 

new HER2/neu-derived peptide epitopes that can elicit 

specific CTL against autologous and allogeneic 

carcinomas and melanomas. J Immunol 1999; 163:1037- 

1044. 

34. Keogh E, Fikes J, Southwood S. Identification of new 

epitopes from four different tumour-associated antigens: 

recognition of naturally processed epitopes correlates 

with HLA-A0201-binding affinity. J Immunol 2001; 

167:787-796. 

35. Feller DC de la Cruz V. Identifying antigenic T-cell sites. 

Nature 1991; 349:720-721. 

36. Roscoe DM, Jung SH, Benhar I. Primate antibody 

response to immunotoxin: serological and computeraided 

analysis of epitopes on a truncated form of 

Pseudomonas exotoxin. Infect Immun 1994; 62:5055- 

5065. 

37. Bisset LR, Fierz W. Using a neural network to identify 

potential HLA-DR1 binding sites within proteins. J Mol 

Recognit 1993; 6:41-48. 

38. Panina-Bordignon P, Tan A, Termijtelen A. Universally 

immunogenic T cell epitopes: promiscuous binding to 

human MHC class II and promiscuous recognition by T 

cells. Eur J Immunol 1989; 19:2237-2242. 

39. Valmori D, Sabbatini A, Lanzavecchia A, Corradin G, 

Matricardi PM. Functional analysis of two tetanus toxin 

universal T cell epitopes in their interaction with DR1101 

and DR1104 alleles. J Immunol 1994; 152:2921-2929. 

40. Zaks TZ, Rosenberg SA Immunization with a peptide 

epitope (p369-377) from HER2/neu leads to peptidespecific 

cytotoxic T lymphocytes that fail to recognize 

HER2/neu+ tumours. Cancer Res 1998; 58:4902-4908. 

41. Knutson KL, Schiffman K, Cheever MA, Disis ML. 

Immunization of cancer patients with a HER2/neu, HLA- 

A2 peptide, p369- 377, results in short-lived peptidespecific 

immunity. Clin Cancer Res 2002; 8:1014-1018. 

42. Knutson KL, Schiffman K, Disis ML. Immunization with 

a HER2/neu helper peptide vaccine generates HER- 

2/neu CD8 T-cell immunity in cancer patients. J Clin 

Invest 2001; 107:477-484. 

43. Disis ML, Gooley TA, Rinn K. Generation of T-cell 

immunity to the HER2/neu protein after active 

immunization with HER2/neu Peptide-based vaccines. J 

Clin Oncol 2002; 20:2624-2632. 

44. Disis ML, Bernhard H, Shiota FM. Granulocytemacrophage 

colony-stimulating factor: an effective 

adjuvant for protein and peptide-based vaccines. Blood 

1996; 88:202-210. 

45. Lehmann PV, Forsthuber T, Miller A, Sercarz EE. 

Spreading of T-cell autoimmunity to cryptic determinants 

of an autoantigen. Nature 1992; 358:155-157. 

46. el-Shami K, Tirosh B, Bar-Haim E. MHC class I- 

restricted epitope spreading in the context of tumour 

rejection following vaccination with a single 

immunodominant CTL epitope. Eur J Immunol 1999; 

29:3295-3301. 

47. Vanderlugt CJ, Miller SD. Epitope spreading. Curr Opin 

Immunol 1996; 8:831-836. 

48. Maraskovsky E, Daro E, Roux E. In vivo generation of 

human dendritic cell subsets by Flt3 ligand. Blood 2000; 

96:878-884. 



49. Pulendran B, Smith JL, Jenkins M. Prevention of 

peripheral tolerance by a dendritic cell growth factor: flt3 

ligand as an adjuvant. J Exp Med 1998; 188:2075-2082. 

50. Smorlesi A, Shiota F, Disis ML. Flt3-ligand (Flt3l), as a 

vaccine adjuvant, results in the generation of antigen 

specific IFN producing T cells after immunization. 

Proceedings of the American Association for Cancer 

Research 1999; 40:313-313. 

51. Lynch DH. Induction of dendritic cells (DC) by Flt3 

Ligand (FL) promotes the generation of tumour-specific 

immune responses in vivo. Crit Rev Immunol 1998; 

18:99-107. 

52. Maraskovsky E, Brasel K, Teepe M. Dramatic increase in 

the numbers of functionally mature dendritic cells in Flt3 

ligand-treated mice: multiple dendritic cell 

subpopulations identified. J Exp Med 1996; 184:1953- 

1962. 

53. Disis ML, Rinn K, Knutson KL. Flt3 ligand as a vaccine 

adjuvant in association with HER2/neu peptide- based 

vaccines in patients with HER2/neu-overexpressing 

cancers. Blood 2002; 99:2845-2850. 

54. Mach N, Gillessen S, Wilson SB. Differences in dendritic 

cells stimulated in vivo by tumours engineered to secrete 

granulocyte-macrophage colony-stimulating factor or 

Flt3- ligand. Cancer Res 2000; 60:3239-3246. 

55. vanderVeen RC, Dietlin TA, Pen L, Gray JD. Nitric oxide 

inhibits the proliferation of T-helper 1 and 2 lymphocytes 

without reduction in cytokine secretion. Cell Immunol 

1999; 193:194-201. 

56. Katsumata M, Okudaira T, Samanta A. Prevention of 

breast tumour development in vivo by downregulation of 

the p185neu receptor. Nat Med 1995; 1:644-648. 

57. Cobleigh MA, Vogel CL, Tripathy D. Multinational study 

of the efficacy and safety of humanized anti-HER2 

monoclonal antibody in women who have HER2- 

overexpressing metastatic breast cancer that has 

progressed after chemotherapy for metastatic disease. J 

Clin Oncol 1999; 17:2639-2648. 

58. Slamon DJ, Leyland-Jones B, Shak S. Use of 

chemotherapy plus a monoclonal antibody against HER2 

for metastatic breast cancer that overexpresses HER2. 

NEJM 2001; 344:783-792. 

59. Vogel CL, Cobleigh MA, Tripathy D. First-line herceptin 

monotherapy in metastatic breast cancer. Oncology 2001; 

61 S2:37-42. 

60. Leyland-Jones B, Arnold A, Gelmon K. Pharmacologic 

insights into the future of trastuzumab. Ann Oncol 2001; 

12:S43-47. 

61. Baselga J, Tripathy D, Mendelsohn J. Phase II study of 

weekly intravenous recombinant humanized antip185HER2 

monoclonal antibody in patients with 

HER2/neu-overexpressing metastatic breast cancer. J 

Clin Oncol 1996; 14:737-744. 

62. Yip YL, Smith G, Koch J, Dubel S, Ward RL. 

Identification of epitope regions recognized by tumour 

inhibitory and stimulatory anti-ErbB-2 monoclonal 

antibodies: implications for vaccine design. J Immunol 

2001; 166:5271-5278. 

63. Dakappagari NK, Douglas DB, Triozzi PL, Stevens VC, 

Kaumaya PT. Prevention of mammary tumours with a 

chimeric HER2 B-cell epitope peptide vaccine. Cancer 

Res 2000; 60:3782-3789. 




Contribution of drug interactions to burden of preventable ADR'S: Approches 

to predict and prevent drug interactions. 

Raval D K, Saraswathy N, Meghani N M, Shah H K 

SVKM's NMIMS School of Pharmacy & Technology Management., Vile-Parle (W), MUMBAI - 400056. INDIA. 


During the course of treatment, drug prescribed to patients produce certain effects other than desired or expected effects. These are referred as 

adverse drug reactions which concern both patient as well as physician. People usually attribute these effects to either overdose or 

inappropriate medications or more drugs are prescribed by physician. ADRs are one of the leading causes of morbidity and mortality in health 

care and also associated with increased cost of treatment. Now a day's incidence of ADRs increases exponentially after a patient is on 4 or more 

medicines. Drug interaction represents 3-5% of preventable ADRs. Hence efforts are necessary to reduce unnecessary prescribing and this is 

where it becomes important to understand basic drug interactions. Given a choice between no treatment and effective treatment with a risk of 

toxicity, physician usually selects latter one. Our job is to maximize the benefit and minimize the risk, but before we can minimize the risk, we 

must first be able to assess it accurately. Thus, health care practitioner must develop their own system of approach to prevent undesirable drug 

interactions; up-to-date database is valuable as well as frequent consultation with other members of healthcare team, like pharmacists and 

nurses, is essential. 

Key Words: Drug interactions, adverse drug reactions, Burden. 

Submitted: 17/11/2010 

Accepted: 30/12/2010 

INTRODUCTION 

An interaction is said to occur when effect of one drug is 

changed by presence of other drug(s), food, drink or 

1 

environmental chemicals. When therapeutic combination 

could lead to an unexpected change in condition of the patient, 

this would be described as an interaction of potential clinical 

significance. The incidence of adverse drug reactions has 

been estimated between 2.2 to 30% in hospitalized patients 

2-5 

and 9.2 to 70.3% in ambulatory patients. Drug interactions 

are important in clinical practice and accounts for 2 to 5% for 

6 

preventable ADR's. 

system failure is lack of knowledge of pharmacovigilance to 

the individuals actually involved in prescribing i.e, the 

physician. 

Following chart will show the factors responsible for ADR's: 

Fig 1: predisposing factors which influences the ADR's 

Why ADRs are so high 

There are several reason which indicates the reason for having 

high incidence of ADRs which include 1) number of drug 

prescribed are high, 2) increasing number of new drugs in 

market, 3) the lack of formal system for monitoring adverse 

7 

drug reactions. The cost of management of drug induced 

illness is very high also. Fortunately, there are various studies 

which indicate that most of ADR's are preventable provided 

that drugs are used rationally. Most common reason for 


Raval DK, SVKM's NMIMS School of Pharmacy & Technology Management., Vile-Parle 

(W), MUMBAI - 400056. INDIA. 

8 

What Kind of Drug Requires Special Attention 

Some drugs with a little low quantity than expected will cause 

no effect or with little high quantity than expected will be 

dangerous. This is called having “narrow therapeutic index” 

and if patient is prescribed such drug then any interaction 

could be dangerous or fatal. 


14

Raval DK- Contribution of Drug Interactions to Burden of Preventable ADR'S: Approches to Predict and Prevent Drug Interactions 

Drugs to watch out for include: 

1) some drugs used to treat depression 

2) some antihistamines, 

3) drugs to control heart rhythm, 

4) some pain killer derived from opium, 

5) drugs to thin blood, including coumadin, 

6) methadone and buprenorphine 

7) drugs to treat erectile dysfunctions, like Viagra 

8) some drugs used to treat tuberculosis, mainly rifampin. 

Reasons for drug interactions 

Prescribing pattern of the drug is the major factor which is 

responsible for drug interactions and some of the reason for 

drug interactions can include 

1) Drug interactions can occur even before drugs enter the 

body due to drug or formulation incompatibility, or at any 

point in the process of absorption, distribution, metabolism, 

and elimination. 

Drug withdrawal 

Drug interaction 

Non-drug therapies 

Diagnostic tests and procedures 

Underlying illnesses 

Intercurrent illnesses 

Timing of events 

Common, spontaneous events 

Transient, episodic events 

Irreversible events 

Tolerance 

Specific treatment clouding dechallenges. 

Prophylactic treatment clouding rechallenges. 

Fig 2: incidence of ADR reported by health care professionals 

and consumers. 

2) Drugs can bind to each other in IV lines or the GI tract, 

preventing absorption and reducing systemic availability. 

3) Several important interactions occur through competition 

at drug transporters. 

4) Finally, interactions can occur at the level of drug action, 

such as the combination of verapamil, a calcium channel 

blocker, and a β-blocker. Both slow the heart rate by different 

mechanisms, and the combination is relatively 

contraindicated because heart block can result. 

5) A large number of important interactions do occur in the 

liver and GI tract due to changes in the rates of drug 

metabolism brought about by other medicines that are 

inducers or inhibitors of drug metabolism. 

9 

Source of difficulty in reporting ADR's 

Before a given clinical manifestation or event can be labeled 

as an ADR, there are two separate requirements that should be 

met: (1) the event must, in fact, be 'adverse'; and (2) a drug 

must be demonstrated, within 'reasonable' likelihood, to be 

the cause. 

9 

Difficult factors in establishing the causal link of ADRs 

Recently introduced drug 

Multiple drugs 

Number of ADR's Reported in Last Ten Years. 

This above graphical presentation shows that consumer 

incidence of ADR is very high and it is increasing year by 

year. Also consumer of drug is also becoming aware about 

drug and reporting adverse drug reaction which is the 

requirement to reduce the adverse drug reactions. Of this, as 

literature says, 3-5% of reactions are preventable and this 

reactions are mainly due to drug interactions. It is clearly 

observed that drug interaction is a kind of burden to the 

adverse drug reactions which could have been prevented. 

Various approaches to prevent drug interactions and 

ADR's 

Prescribing pattern is the major reason due to which incidence 

of drug interactions increases so increasing awareness 

amongst the health care professionals is the major goal. There 


15


are misconceptions of health care professionals regarding 

reporting ADR which should be clarified which includes 

1) All ADR's are reported by the time a drug is marketed. 

2) Hard to determine, if a drug is responsible for evidence. 

So it is essential to clarify their doubts and feedback should be 

provided so that reporting will increase. 

Drug Interaction Monitoring Program 

Occurrence of drug interactions should be monitored closely 

in susceptible patients and in patients on drug combinations 

with likelihood of interactions. A team consisting of 

physician, pharmacologists, pharmacists and nurses should 

keep a close eye on the patient's conditions, medication and 

the prognosis. For the early detection and prevention of DIs 

there is a need for establishing DI monitoring programs. 

Monitoring program should identify the DIs occurring in the 

hospital, develop intervention strategies and evaluate the 

impact of the interaction. 

The identification of the DIs can be done by maintaining the 

patient profile and checking the interactions based on the 

existing literature. The interactions should be categorized 

based on their severity. Following these steps, strategies 

should be made in order to prevent the occurrence of 

interactions, at least the severe ones. The intervention 

strategies may include peer group discussion, discussion 

among the Drug and Therapeutics Committee (DTC) 

members and discussion with junior doctors etc. Following 

the intervention the impact of the intervention should be 

analyzed by comparing the incidence with the pre 

intervention data. The importance of DIs should be taught to 

the medical students, pharmacists and nurses so that a team 

effort can be made by them in the future. 

Benefits of Reporting ADR's 

An ongoing ADR-monitoring and reporting program can 

provide benefits to the organization, pharmacists, other health 

care professionals, and patients. These benefits include (but 

are not limited to) the following. 

1. Providing an indirect measure of the quality of 

pharmaceutical care through identification of preventable 

ADRs and anticipatory surveillance for high-risk drugs or 

patients. 

2. Complementing organizational risk-management activities 

and efforts to minimize liability. 

3. Assessing the safety of drug therapies, especially recently 

approved drugs. 

4. Measuring ADR incidence. 

5. Educating health care professionals and patients about drug 

effects and increasing their level of awareness regarding 

ADRs. 

6. Providing quality-assurance screening findings for use in 

drug-use evaluation programs. 

7. Measuring the economic impact of ADR prevention as 

manifested through reduced hospitalization, optimal and 

economical drug use, and minimized organizational liability. 

Role of Pharmacist 

Pharmacists should exert leadership in the development, 

maintenance, and ongoing evaluation of ADR programs. 

They should obtain formal endorsement or approval of such 

programs through appropriate committees (e.g., a pharmacy 

and therapeutics committee and the executive committee of 

the medical staff) and the organization's administration. In 

settings where applicable, input into the design of the program 

should be obtained from the medical staff, nursing staff, 

quality improvement staff, medical records department, and 

[10, 11-13] 

risk managers. The pharmacist should facilitate 

1. Analysis of each reported ADR, 

2. Identification of drugs and patients at high risk for being 

involved in ADRs, 

3. The development of policies and procedures for the ADRmonitoring 

and reporting program, 

4. A description of the responsibilities and interactions of 

pharmacists, physicians, nurses, risk managers, and other 

health professionals in the ADR program, 

5. Use of the ADR program for educational purposes, 

6. Development, maintenance, and evaluation of ADR 

records within the organization, 

7. The organizational dissemination and use of information 

obtained through the ADR program, 

8. Reporting of serious ADRs to the FDA or the manufacturer 

(or both), and 

9. Publication and presentation of important ADRs to the 

medical community. 

Direct patient care roles for pharmacists should include 

patient counseling on ADRs, identification and 


16


documentation in the patient's medical record of high-risk 

patients, monitoring to ensure that serum drug concentrations 

remain within acceptable therapeutic ranges, and adjusting 

doses in appropriate patients (e.g., patients with impaired 

renal or hepatic function). 

REFERENCES 

1. Stockley I H. Drug interaction: a source book of adverse 

interaction, their mechanisms, clinical importance and 

management. 5th ed. Pharmaceutical Press, London 1999. 

2. Gosney M, Tallis R. Prescription of contraindicated and 

interacting drugs in elderly patients admitted to hospital. 

Lancet 1984; 1:564-567 

3. Kinney E. Expert system detection of drug interactions: 

results in consecutive patients. Comput Biomed Res 

1986; 19: 462-467. 

4. Dambro MR, Kallgren MA. Drug interaction in a clinic 

using COSTER. Comput Biol Med 1988; 18:31-38, 

5. Shinn AF, Shrewsbury RP, Anderson KW. Development 

of a computerized drug database (MEDICOM) for use in a 

patient specific environment. Drug Inf J 1983; 17:205- 

210. 

6. Classen DC, Pestotnick SL, Evans RS, Burke JP. 

Computer surveillance of adverse drug events in hospital 

patients. JAMA 1991; 266: 2847-2851. 

7. Bates DW. Spell N, Cullen DJ et al. The costs of adverse 

drug reactions in hospitalised patients. JAMA 1997; 277: 

301-307. 

8. Fact sheet number 407, Drug Interactions, revised edition 

2009. 

9. Kramer MS Difficulty in assessing adverse effects of 

drugs, Br. J. clin. Pharmac. (1981), 11, 105S-110S. 

10.Karch FE, Lasagna L. Toward the operational 

identification of adverse drug reactions. Clin Pharmacol 

Ther. 1977; 21:247–254. 

11. S w a n s o n K M , L a n d r y J P, A n d e r s o n R P. 

Pharmacycoordinated, multidisciplinary adverse drug 

reaction program. Top Hosp Pharm Manage. 1992; 

12(Jul):49–59. 

12. Flowers P, Dzierba S, Baker O. A continuous quality 

improvement team approach to adverse drug reaction 

reporting. Top Hosp Pharm Manage. 1992; 12(Jul): 

60–67. 

13. Guharoy SR. A pharmacy-coordinated, multidisciplinary 

approach for successful implementation of an adverse 

drug reaction reporting program. Top HospPharm 

Manage. 1992; 12(Jul):68–74. 


17



Survey and evaluation of various epidemiological factors in a multiethnic 

Diabetic Population in Ras Al-Khaimah, UAE. 

1 2 3 4 

Smitha F , Meenakshi J , Padma R , Multani S K 

Department of Pharmacy Practice, RAK College of Pharmaceutical Sciences, RAK Medical and Health Sciences 

1, 3 

University, Ras Al Khaimah, UAE. 

Department of Pathology, RAK College of Medical Sciences, RAK Medical and 

2 

Khaimah, UAE. 

Health Sciences University, Ras Al 

4 

Endocrinologist, Al Zahrawi Hospital. Ras Al Khaimah, UAE 



Diabetes Mellitus is a major public health problem in UAE with a prevalence rate reaching 24% in national citizens and 17.4% in expatriates. In 

the year 2010, UAE is ranked as the second highest worldwide for diabetes prevalence. However, there is a lack of epidemiological data on the 

prevalence of diabetes in UAE and other Arab countries. Hence, the present study was undertaken. The data was evaluated for the following 

parameters like the predisposing factors, associated co-morbidities and the prescription pattern in diabetic patients. This retrospective study 

included data collected from the case records of all the diabetic patients who visited the out-patient clinic of department of endocrinology and 

diabetes of a private hospital in Ras Al Khaimah, UAE. Case records of 143 subjects (123 were males and 20 were females) with type-II diabetes 

mellitus were analyzed in the study. The mean age of the patients was 46.69 ± 7.70 years and the mean age at onset of type-II diabetes mellitus 

2 

was 39.83 + 7.60 years. The mean BMI of the study population was 26.8 + 3.78 kg/m . The associated co-morbidities were hypertension 

(58.7%), dyslipidemia (87.4%) and both hypertension and dyslipidemia (47.6%). The most commonly prescribed antidiabetic drug class was 

biguanides (metformin) followed by suphonylureas (glimeperide), thiazolidinediones (rosiglitazone) and DPP4 Inhibitors (vildagliptin). As 

monotherapy, metformin was the preferred drug of choice. The most prevalent multiple drug therapy was a three drug combination of 

glimeperide, metformin and rosiglitazone. This study strongly highlights the need for patient education on diet control, lifestyle modifications, 

use of antidiabetics and concomitant drugs, monitoring of blood glucose and aggressive treatment of diabetes to prevent associated 

complications. 

Keywords: Diabetes mellitus, predisposing factors, co-morbidities, prescription pattern, anti-diabetic drugs. 



Smitha C F, Department of Pharmacy Practice, RAK College of Pharmaceutical Sciences, 

RAK Medical and Health Sciences University,P O Box 11172 Ras Al Khaimah, UAE. 

E- mail: smithafrancis2003@yahoo.co.in 


18

Smitha F - Survey and evaluation of various Epidemiological Factors in a Multiethnic Diabetic Population in Ras Al Khaimah, UAE. 

Gender 

Mean Age 

Mean BMI 

Waist Circumference 

Family History 

Table 1: Patient Demographic Status 

123 male (86.01%) 

20 female (13.98%) 

39.83 ±7.6 years 

2 

26.8±3.78kg/m 

95.26+ 9.37 

76.3% 


19


Appendix 

RAK Medical & Health Sciences University 

Data collection form 

Name of the hospital : 

Name of the treating doctor : 

File number : 

Contact no : 

Ethnicity : 

Occupation : 

Age : 

Sex : 

Duration of diabetes : 

Age of onset : 

Family history of diabetes : 

Height : 

Weight : 

BMI : 

WC : 

BP : 

Marital status : 

Lifestyle factors : sedentary/active 

Exercise : 

Diet : veg/ non-veg 

Smoking : 

Alcohol : 

Co-morbidities : 

DIAGNOSIS: ………………………………………………………………………………… 





Table 2: Monotherapy 

No of Patients 

Table 3: Combination therapy 


22









Impact of educational interventions on Adverse Drug Reaction reporting 

1 2 1 1 

Ganachari M S* , Patil P A , Soham S , Nidhi Z 

1 

Department of Pharmacy Practice, KLE University's College of Pharmacy, Belgaum-590010, Karnataka, India 

2 

Department of Pharmacology, Jawaharlal Nehru Medical College, Belgaum-590010, Karnataka, India 




Adverse Drug Reactions (ADR) have become a major health concern. This study was carried out to determine the impact of educational 

interventions with the assistance of pharmacist on the knowledge and attitudes of healthcare professionals for ADR and its reporting. In preintervention 

survey, healthcare professionals were surveyed using a questionnaire to assess their knowledge and attitudes regarding ADR and 

its reporting and obtain their suggestions to improve ADR reporting. After this survey, 2 workshops were conducted on pharmacovigilance. One 

teaching program was conducted for nursing staff. Informative booklets on Guidelines for reporting ADR were prepared and distributed to all 

healthcare professionals. After this a post intervention survey was conducted to reassess the knowledge and attitudes of healthcare 

professionals regarding ADR reporting. In pre-intervention survey, 124 had experienced ADR in their day to day practice, while only 84 had 

reported ADR. In post-intervention survey, 111 had reported an ADR. In pre-intervention survey, 116 knew the definition of ADR, 49 knew the 

grading of ADR based on severity, while 30 knew grading based on causality. In post intervention survey, 127 healthcare professionals knew the 

definition of ADR, 81 knew the grading of ADR based on severity while, 77 knew the grading of ADR based on causality. Lack of awareness, lack 

of assistance, busy schedule, lack of incentives, inadequate availability of ADR reporting forms were identified as major barriers in ADR 

reporting. This study shows that there is a need to create awareness and impart knowledge to healthcare professionals regarding ADR and its 

reporting. If adequate practical training and education is given consistently, then definitely the attitude of healthcare professionals can be 

changed and ADR reporting can be improved. 

Key Words: Adverse Drug Reactions, healthcare, educational intervention 

INTRODUCTION 

According to World Health organisation, Adverse Drug 

Reaction (ADR) is “a reaction which is noxious and 

unintended and which occurs at doses normally used in 

humans for prevention, diagnosis or therapy of disease, or for 

1 

the modification of physiological functions” ADRs are the 

major cause of morbidity and mortality in the patients, 

resulting in increased length of stay in hospital and in turn 

2 

increased cost of healthcare . ADRs are also one of the major 

3,4 th th 

causes of hospitalisation. ADRs are 4 to 6 leading cause of 

death in United States only after heart disease, cancer, stroke, 

5 

pulmonary disease and accidents. 

With numerous drugs entering into the market, ADRs have 

become very important clinical issue for patient safety. 

Though the medicines are assessed for safety and efficacy by 

the clinical trials before marketing, it is very difficult to 


M. S. Ganachari, Professor and Head, Department of Pharmacy Practice, KLE University's 

College of Pharmacy, Nehru Nagar, Belgaum-590010, Karnataka, India 

Email: msganchari@gmail.com 

identify all the rare ADRs as well as actual incidence due to 

small sample size, short duration and restricted study criteria. 

Hence it is essential to monitor the drugs for ADRs. Health 

care professionals play a very important role in ADR 

reporting. Health care professionals help in identification of 

6,7 

signals and evaluate the safety of drugs by reporting ADR. 

As the doctors are the first ones to use any new drug entering 

the market, they play a key role in identifying any adverse 

effects of the drugs. Information provided by them could be of 

much help to assess the safety of any drug. Hence, it becomes 

essential to motivate the healthcare professionals to report 

any adverse drug reactions they come across. 

Studies have shown that educational interventions can 

improve ADR reporting by health care professionals. Hence 

this study was carried out to determine the impact of 

educational interventions on the knowledge and attitudes of 

healthcare professionals for ADR and its reporting. 

METHOD 

This prospective cross-sectional study was carried out after 

procuring approval from Institutional Ethics Committee. The 


26

Ganachari MS- Impact of Educational Interventions on Adverse Drug Reaction Reporting 

study was conducted in a Tertiary Care Hospital in a South 

Indian city. The study was conducted in three phases: 

1. Pre-interventional survey 

2. Interventions 

3. Post-intervention survey 

One hundred and sixty three health care professionals 

(includes doctors, nurses and pharmacists) were surveyed 

using a questionnaire to assess their knowledge regarding 

pharmacovigilance and obtain their suggestions to improve 

pharmacovigilance activity. The pharmacist took verbal 

consent from all the participants and explained them the 

purpose of the survey. Each health care professional was 

explained the questionnaire and then the questionnaire were 

handed over to the participants to fill. After conducting the 

pre-intervention survey, all the filled questionnaires were 

analysed to determine the knowledge and attitudes of health 

care professionals for pharmacovigilance and suggestions 

made by them to improve pharmacovigilance activities in the 

hospital. 

After pre-interventional survey, teaching program was 

carried out to create awareness among nursing staff regarding 

pharmacovigilance. A book on guidelines for reporting 

adverse drug reactions in the hospital was developed and 

distributed to all the healthcare professionals. Book contained 

all the details like definition of ADR, grading of ADR based 

on severity and causality, importance of ADR reporting, how 

and where to report ADR and information to be included 

while reporting ADR. Two workshops were conducted on 

“Pharmacovigilance” to improve knowledge regarding ADR 

and its reporting systems among the healthcare professionals. 

The workshops elaborated on: ADR, its definition, grading of 

ADR based on severity and causality, importance of ADR 

reporting, global ADR reporting systems and guidelines on 

ADR reporting. In these workshops, healthcare professionals 

were given practical exposure of filling an ADR reporting 

forms by providing them dummy ADR cases. ADR reports 

Drop boxes were made available with sufficient number of 

reporting forms at each nursing stations. 

After the educational interventions, a post intervention survey 

was conducted using same questionnaire that was used in preintervention 

survey. Same healthcare professionals were 

approached and provided the questionnaire to fill. After 

attending all the questions the questionnaire was retrieved and 

data was analysed. 

Student's paired t-test was used to analyse the change in 

knowledge and attitude and determine the significance. 

RESULTS 

Demography 

During the study period, 163 health care professionals 

participated in the pre-intervention survey and 150 

participated in post-intervention survey. For analysis of data 

only those 150 participants were considered who participated 

in both the surveys. Out of these 150 participants, 58 were 

doctors (physicians, house surgeons, residents), 72 were 

nurses and 20 were pharmacists. There were 13 dropouts 

(7.97%) as these healthcare professionals could not be 

contacted for various reasons. 

Attitudes of the healthcare professionals toward ADR and 

its reporting 

Out of 150 healthcare professionals in the pre-interventional 

survey, only 84 (56.0%) had actually reported an ADR. Out of 

these healthcare professionals who reported ADR, 46 

(30.67%) had reported it verbally, 10 (6.67%) had reported it 

in written form while, 28 (18.67%) had reported ADR 

verbally as well as in written form. These healthcare 

professionals had reported ADR to either colleagues (56, 

37.33%) or pharmacists working in pharmacovigilance group 

(44, 29.34%). Out of the total 38 respondents who had 

reported ADR in written form, 18 had reported ADR in last six 

months. Out of 66 (44.01%) healthcare professionals who had 

never reported an ADR, 18(12.0%) felt that due to lack of time 

they had never reported an ADR, while 4 (2.67%) were not 

interested to report an ADR. Eleven (7.33%) felt that not 

reporting an ADR does not affect the patient care, while 59 

(39.34%) were not aware where to report an ADR. 

In post-intervention survey, out of 150 healthcare 

professionals, 111(74.01%) said that they had reported an 

ADR, out of which 51 (34.0%) had reported it verbally, 27 

(18.0%) had reported it in written form while 33 (22.0%) had 

reported it verbally as well as in written form. Eighty six 

(57.33%) had reported ADR to colleagues while 67 (44.67%) 

had reported it to pharmacists. Out of these total 60 healthcare 

professionals who had reported an ADR in written form, 30 

had reported ADR in past six months. This also shows that 22 

professionals started reporting ADR after intervention. There 

is improvement in the attitude of healthcare professionals 

towards ADR reporting but statistically it is not significant 

(p= 0.1335 using paired t- test). 

Table 1 shows the number of healthcare professionals and 

their attitudinal responses in pre-interventional survey and 

post-interventional survey. 



No. 

1 

2 

3 

4 

5 

Attitude questions 

Do you experience ADRs 

in your day to day practice 

Have you ever reported ADR 

that you came across Yes 

Doctors 

n1=58 

Doctors 

N1=58 

Nurses 

n2=72 

Nurses 

N2=72 

Pharmacists Pharmacists 

n3=20 N3=20 

Total 

n=150 

Total 

N=150 

32.00% 32.00% 40.00% 40.00% 10.66% 10.66% 82.66% 82.66% 

20.00% 28.67% 25.33% 32.67% 10.67% 12.67% 56.00% 74.00% 

No 18.67% 10.0% 22.67% 15.33% 2.67% 0.67% 44.01% 26.00% 

If yes, how do you report 

Verbal 10.67% 12.00% 17.33% 18.67% 02.67% 03.33% 30.67% 34.00% 

Written 02.67% 10.67% 02.67% 

Both 06.67% 06.00% 05.33% 

To whom* 

06.0% 01.33% 01.34% 06.67% 18.00% 

08.00% 06.67% 08.00% 18.67% 22.00% 

Colleague’s 14.00% 24.00% 15.33% 21.33% 08.00% 12.00% 37.33% 57.33% 

Pharmacist 06.67% 18.67% 12.67% 14.00% 10.00% 12.00% 29.34% 44.67% 

If no, why* 

No Time 

Not interested 

Does not effect patient care 

Not aware where to report 

Table 1: Attitude of healthcare professionals for ADR reporting 

04.67% 02.00% 05.33% 04.00% 02.00% 0.67% 12.00% 60.67% 

0% 0% 02.67 % 0% 0% 0% 02.67% 0% 

06.00 % 02.67% 01.33 % 0% 0% 0% 07.33% 02.67% 

16.00% 08.67% 22.67% 07.33% 0.67% 0% 39.34% 16.00% 

* sum of % not equal to 100% as the multiple answers can be chosen for the question. n, n1, n2, n3 are pre intervention results and N, N1, N2, N3 are 

post intervention results. Comparison of attitude of healthcare professionals in pre- and post- intervention survey: p= 0.1335 using paired t- test. 

Knowledge of healthcare professionals regarding ADR 

and its reporting 

While considering knowledge regarding ADR and its 

reporting, 116 (77.33%) knew the definition of ADR in preinterventional 

survey. Forty nine (32.66%) healthcare 

professionals knew the grading of ADR based on severity, 

while 30 (20.0%) knew the grading, based on causality. 

Ninety four (62.67%) health care professionals knew the 

relationship between ADR and patient characteristics, 113 

(75.33%) knew the relationship between ADR and 

prescription errors and 97 (64.66%) were aware of 

relationship between ADR and patient education. Only 62 

(41.33%) healthcare professionals knew the information to be 

included to report an ADR. 

After the educational interventions for healthcare 

professionals, in the post-interventional survey, 127 (84.67%) 

healthcare professionals knew the definition of ADR. 81 

(54.0%) healthcare professionals knew the grading of ADR 

based on severity while, 77 (51.33%) knew the grading of 

ADR based on causality. One hundred and fifteen (76.67%) 

healthcare professionals knew the relationship between ADR 

and patient characteristics, while 130 (86.67%) knew the 

relationship between ADR and prescription errors and 118 

(78.67%) were aware of relationship between ADR and 

patient education. One hundred and twenty four (82.67%) 

healthcare professionals knew the information to be included 

to report an ADR. There is statistically significant 

improvement in the knowledge of healthcare professionals 

(p =0.0078**). 

Table 2 shows the number of healthcare professionals and 

their responses related to knowledge of ADR and its 

reporting, in pre-interventional survey and postinterventional 

survey. 

Barriers to ADR reporting 

Various barriers to ADR reporting mentioned by healthcare 

professionals are shown in the figure 1. It was identified in pre 

intervention survey that maximum number of healthcare 

Fig.1: Barriers to ADR reporting identified during pre- and postintervention 

survey and change in ADR reporting during that period. 


28


No. 

1 

2 

3 

4 

Knowledge questions 

Do you know definition 

of ADR 

Doctors 

n1=58 

Doctors 

N1=58 

Nurses 

n2=72 

Nurses 

N2=72 

Pharmacists Pharmacists 

n3=20 N3=20 

Total 

n=150 

Do you know grading 

12.00% 18.67% 13.33% 25.33% 07.33% 10.00% 32.66% 

of ADR 

Are you aware of relationship between ADR and, 

Patient characteristics 

Prescription errors 

Patient education 

Do you know information 

included to report ADR 

Table 2: Knowledge of healthcare professionals 

Total 

N=150 

32.67% 34.67% 35.33% 37.33% 09.33% 12.67% 77.33 % 84.67% 

30.67% 34.00% 20.00% 30.67% 12.00% 12.0% 62.67% 76.67% 

30.00% 35.33% 34.00% 38.67% 11.30% 12.67% 75.33% 86.67% 

27.33% 34.0% 25.33% 32.0% 12.00% 12.67% 64.66% 78.67% 

15.33% 32.67% 16.00% 37.33% 10.00% 12.67% 41.33% 

54.00% 

82.67% 

5 

Do you think awareness of 

ADR will improve reporting 

35.33% 38.67% 46.67% 46.67% 12.67% 13.33% 94.67 98.67% 

6 

Are you aware of ADR 

grading based on causality 

07.33% 21.33% 06.00% 18.67% 06.67% 11.33% 20.00% 51.33% 

7 

Are you aware of recent 

drug withdrawn 

21.33% 28.67% 22.00% 30.67% 10.67% 12.67% 54.00% 72.0% 

n, n1, n2, n3 are pre intervention results and N, N1, N2, N3 are post intervention results. Comparison of 

knowledge of healthcare professionals in pre- and post- intervention survey: p= 0.0078** using paired t- test. 

professionals felt that lack of awareness regarding ADR 

reporting system is the major deterrent to ADR reporting. 

After educational interventions, only about half of them felt 

that lack of awareness is barrier to ADR reporting 

Suggestions to improve ADR reporting 

Various suggestions were provided by healthcare 

professionals to improve ADR reporting. One hundred and 

forty three (95.34%) suggested that inclusion of 

pharmacovigilance in Under Graduate and Post Graduate 

curriculum can improve ADR reporting. One hundred and 

forty five (96.67%) healthcare professionals felt that 

establishing pharmacovigilance centre can facilitate ADR 

reporting. Compulsory reporting was suggested by 126 

(84.0%) healthcare professionals as another option to 

improve ADR reporting. Eighty two (54.67%) healthcare 

professionals felt that prescription monitoring can also help in 

identifying ADR and early ADR reporting. Seventy eight 

(52.0%) health care professionals also felt that legal 

compulsion to report can improve ADR reporting. 

DISCUSSION 

In pre-intervention survey 84 healthcare professionals had 

reported ADR previously, though 124 had experienced ADR 

in their day to day practice. Sixty two healthcare professionals 

had never reported ADR. The reason for under reporting 

mentioned were lack of awareness, lack of time, lack of 

interest and disbelief that reporting does not affect patient 

care. Similar reasons were identified as discouraging factors 

8,9, 10, 11, 12 

to reporting an ADR in various other studies. Hence 

various steps like educational interventions to create 

awareness for ADR reporting and utilising assistance of 

pharmacist to report ADR are needed to be taken in the 

directions to overcome these deterrents. Studies have shown 

13,14,15,16 

that creating awareness can improve ADR reporting. 

The effect of educational interventions can be observed from 

the results of post-intervention survey which clearly showed 

that there is an improvement in attitude towards ADR 

reporting with increased number of healthcare professionals 

reporting the ADR. The results show that there is 

improvement in attitude towards ADR reporting, but it is not 

significant (p= 0.1335 using paired t- test). This may be 

attributed to short term interventions. Further studies should 

be done to assess the change in attitude after continuous and 

long term interventions. It is also important to note that there 

is significant improvement in the knowledge of ADR and its 

reporting system (p= 0.0078 using paired t- test). There is 

7.34% increase in knowledge regarding ADR definition, 

while 21.34% increase in knowledge regarding grading of 

ADR based on severity and 31.33% improvement in 

knowledge regarding grading of ADR based on causality. 

Increased number of healthcare professionals now knew the 

information to be included while reporting an ADR, which 

can facilitate ADR reporting. Hence results of this study are 



consistent with the results of previous studies in which 

educational interventions had played an important role in 

13,14,17 

creating awareness for ADR and its reporting. 

Busy schedule and lack of assistance were found to be 

deterrent in ADR reporting. The same reason was identified as 

8,10 

barrier in many other studies. Hindering factors like busy 

schedule and lack of assistance can be overcome by provision 

of assistance by clinical pharmacists. The same was done to 

overcome these deterrent factors. Pharmacists were 

appointed to assist the doctors and nurses in filling ADR 

forms and reporting ADR. Previous studies have shown that 

the ADR reports submitted by pharmacists provide valuable 

18 

information, which is complimentary to physician's reports. 

Studies have also shown that pharmacists have adequate 

19 

knowledge for reporting an ADR and their assistance can 

20,21,22 

definitely improve ADR reporting. Moreover in most 

countries as the pharmacist are considered eligible to report, 

they can also forward adverse drug reaction reports to 

national centres. It is found that reports from pharmacists are 

more complete and appropriate when compared to other 

22 

healthcare professionals. According to International 

Pharmaceutical Federation (FIP), “An important clinical 

responsibility of the pharmacist is in the early detection of 

ADRs and other drug-related problems as well as monitoring 

the effectiveness of medicines. The pharmacist, as a part of 

the healthcare team, is a source of both information and 

critical evaluation of drug information. The pharmacist's 

expertise is vital to the application of the safety profile of a 

23 

medicine to the needs of a particular patient”. Many studies 

have shown that pharmacists have highly positive attitude and 

believe that ADR reporting is their professional 

responsibility, indicating that appropriate education 

regarding reporting can make significant improvement in 

18,19 

ADR reporting. Pharmacists must understand their role in 

promoting safe use of medicines and hence actively involve in 

detection as well as reporting of ADRs. 

Inadequate availability of ADR reporting forms was 

identified as another discouraging factor for reporting ADR. 

To overcome this, ADR reporting forms were made freely 

available at the nursing stations in all the wards. ADR drop 

boxes were provided in each ward so that it becomes easy for 

doctors and nurses to fill the ADR form and drop in the ADR 

drop box while working in the wards only. The reports were 

later collected by the pharmacists and patients were followed 

up by them for more detailed information. This reduced the 

burden on doctors and nurses to submit ADR reports to ADR 

reporting centres. Moreover this whole process becomes less 

time consuming. Studies have shown that providing ADR 

reporting forms in sufficient quantity to the healthcare 

24 

professionals can raise the number of ADR reporting. Same 

was seen in our study where there was increased reporting of 

ADR in written form after providing ADR reporting forms 

and ADR drop boxes at nursing stations. 

Thus this study shows that by overcoming the barriers 

mentioned by healthcare professionals, the ADR reporting 

can be improved. Though the improvement is not statistically 

significant which may be attributed to short term study 

interventions, but if the long term interventions are done 

continuously, then there might be statistically significant 

improvement in attitude towards ADR reporting. 

Few healthcare professionals also felt that lack of 

incentives/remuneration could be a barrier to ADR reporting. 

A study had shown that providing remuneration for reporting 

an ADR can considerably increase the rates of reporting drug 

reactions, but more evaluation of the use of remuneration is 

26 

required. 

Other suggestions like inclusion of pharmacovigilance in 

UG/PG curriculum and establishment of pharmacovigilance 

centre in tertiary care hospitals are worth considering and 

implementing to improve ADR reporting. It is important to 

note here that teaching the students right from the Under 

Graduate level regarding pharmacovigilance can stimulate 

them towards pharmacovigilance and major obstacles like 

lack of awareness can be overcome. Majority of the 

participants suggested that compulsory reporting or legal 

compulsion to report can improve ADR reporting. This 

suggestion is also valuable as it is found that maximum 

number of ADR reports come from nations in which ADR 

27 

reporting is compulsory. 

CONCLUSION 

This study shows that there is a direct need to create 

awareness among the health care professionals regarding 

ADR and its reporting. The study also proves that with 

adequate practical training and education, the attitude of the 

health care professionals can be influenced positively which 

may in turn have positive impact on number of ADRs 

reported. Pharmacist can play a very important role in 

facilitating pharmacovigilance activities by assisting doctors 

and nurses in reporting ADR. There is a need to conduct and 

encourage Continuing Professional Development to 

consistently stimulate healthcare professionals to report ADR 

and ensure patient safety. 



REFERENCES 

1. World health organization collaborating centre for 

International drug monitoring. Geneva: World health 

o r g a n i z a t i o n . 1 9 8 4 , W H O p u b l i c a t i o n 

DEM/NC/84.153(E). 

2. Classen DC, Pestotnik SL, Evans S, Lloyd JF, Burke JP. 

Adverse Drug Events in Hospitalized patients: excess 

length of stay, extra costs and attributable mortality. 

JAMA 1997; 227(4): 301-306. 

3. Pirmohamed M, James S, Meakin S, Green C, Scott AK, 

Walley TJ et al. Adverse drug reactions as cause of 

admission to hospital: prospective analysis of 18820 

patients. BMJ 2004; 329: 15-19. 

4. Brvar M, Fokter N, Bunc M, Mozina M. The frequency of 

adverse drug reaction related admissions according to 

method of detection, admission urgency and medical 

department specialty. BMC Clinical pharmacology 2009; 

9:8. 

5. Lazarou J, Pomeranz BH, Corey PN. Incidence of 

Adverse drug reactions in hospitalised patients: A Meta 

analysis of prospective studies. JAMA 1998; 279(15): 

1200-1205. 

6. Wysowski DK, Swartz L. Adverse drug event 

surveillance and drug withdrawals in the United States, 

1969-2002: the importance of reporting suspected 

reactions. Arch Intern Med 2005; 165:1363-1369. 

7. Ahmad SR. Adverse drug event monitoring at the food 

and drug administration: Your report can make a 

difference. J Gen Intern Med 2003; 18:57-60. 

8. Ekman E, Backstrom M. Attitudes among hospital 

physicians to the reporting of adverse drug reactions in 

Sweden. Eur J Clin Pharmacol 2009; 65(1):43-46. 

9. Zolezzi M, Parsotam N. Adverse drug reaction reporting 

in New Zealand: implication for pharmacists. 

Therapeutics and clinical risk management 2005; 

1(3):181-188. 

10. Oshikoya KA, Awobusuyi JO. Perceptions of doctors to 

adverse drug reaction reporting in a teaching hospital in 

Lagos, Nigeria. BMC Clinical Pharmacology 2009; 9:14. 

11. McGettigan P, Golden J, Conroy RM Arthur N, Feely J. 

Reporting of adverse drug reactions by hospital doctors 

and response to intervention. Br J Clin Pharmacol 1997; 

44(1):98-100. 

12. Belton KJ, Lewis SC, Payne S, Rawlins MD. Attitudinal 

survey of adverse drug reaction reporting by medical 

practitioners in the United Kingdom. Br J Clin Pharmacol 

1995; 39(3):223-226. 

13. Figueiras A, Herdeiro MT, Polonia J, Gestal-Otero JJ. An 

educational intervention to improve physician reporting 

of adverse drug reactions. A clustered randomized 

controlled trial. JAMA 2006; 269(9):1086-1093. 

14. Scott HD, Renshaw AT, Rosenbaum SE, Waters WJ, 

Green M, Andrews LG et al. Physician reporting of 

adverse drug reactions- results of the Rhode Island 

adverse drug reaction reporting project. JAMA 1990; 

263(13):1785-1788. 

15. Davis D, Thomson O'Brien MA, Freemantle N, Wolf FM, 

Mazmanian P, Vaisey AT. Impact of formal Continuing 

Medical Education: Do conferences, workshops, rounds 

and other traditional continuing education activities 

change physician behaviour or healthcare outcomes 

JAMA 1999; 282(9):867-874. 

16. Davis DA, Thomson MA, Oxman AD, Haynes RB. 

Changing Physician performance- A systematic review 

of the effect of continuing medical education strategies. 

JAMA 1995; 274(9):700-705. 

17. Tabali M, Jeschke E, Bockelbrink A, Witt CM, Willich 

SN, Ostermann T et al. Educational intervention to 

improve physician reporting of adverse drug reaction 

(ADRs) in a primary care setting in complementary and 

alternative medicine. BMC Public Health 2009; 9:274. 

18. Gedde-Dahl A, Harg P, Stenberg-Nilsen H, Buajordet M, 

Granas AG, Horn AM. Characteristics and quality of 

adverse drug reaction reports by pharmacists in Norway. 

Pharmacoepidemiol Drug Saf 2007; 16:999-1005. 

19. Green CF, Mottram DR, Rowe PH, Pirmohamed M. 

Attitudes and knowledge of hospital pharmacist to 

adverse drug reaction reporting. Br J Clin Pharmacol 

2001; 51(1):81-86. 

20. Winstanley PA, Irvin LE, Smith JC, Orme ML, 

Breckenridge AM. Adverse drug reactions: a hospital 

pharmacy based reporting scheme. Br J Clin Pharmacol 

1989; 28:113-116. 

21. Ramesh M, Parathasarthi G. Adverse drug reactions 

reporting: Attitudes and Perceptions of medical 

practitioners. Asian Journal of Pharmaceutical and 

Clinical Research 2009; 2(2):10-14. 



22. Kees VanGroothest MD, Olsson S, Couper M, Berg LJ. 

Pharmacists' role in reporting adverse drug reactions in an 

international perspective. Pharmacoepidemiol Drug Saf 

2004; 13:457-464. 

23. FIP statement of policy. The role of the pharmacist in 

pharmacovigilance. International Pharmaceutical 

Federation. Brazil;2006. Available from: URL: 

http://www.fip.org/www/uploads/database_file.phpid= 

273&table_id= 

24. Castel JM, Figueras A, Pedros C, Laporte JR, Capella D. 

Stimulating adverse drug reaction reporting: effect of a 

drug safety bulletin and of including yellow cards in 

prescription pads. Drug Saf 2003; 26(14):1049-1055. 

25. Granas AG, Buajordet m, Stenberg- Nilsen H, Harg P, 

Horn AM. Pharmacists' attitudes towards the reporting of 

suspected adverse drug reactions in Norway. 

Pharmacoepidemiol Drug Saf 2007; 16:429-434. 

26. Feely J, Moriarty S, Conner PO. Stimulating reporting of 

adverse drug reactions by using a fee. BMJ 1990; 300:22- 

23. 

27. UR35. Uppsala reports October 2006. [online] October 

2006 [cited Jun 2010]. Available from: URL: www.whoumc.org/graphics/9628.pdf 




Awareness about ways of transmission of AIDS and its treatment among 

university students in Pakistan 

1 1 

Tehzeeb-ul-Nisa, Imran Qadir M *, Hibba-tul-Baseer, Dure-Shehwar, Farzana C , Irfan M 

College of Pharmacy, G.C. University, Faisalabad, Pakistan 

1 

Institute of Pharmaceutical Sciences, University of Veterinary and Animal Sciences, Lahore, Pakistan. 


To assess knowledge of students about AIDS, its ways of transmission and its treatment. Students (N = 500) at a public university in the Pakistan 

completed a questionnaire during November 2008 to February 2010 assessing knowledge of students about AIDS, its ways of transmission and 

its treatment. 99.00% students knew that AIDS is incurable. But less number of students were aware about the different ways of transmission of 

AIDS. It is concluded from the study that the knowledge about the ways of transmission of AIDS must be increased to prevent the disease. 

Key Words: AIDS, transmission, Awareness, knowledge 


Accepted: 21/12/2010 

INTRODUCTION 

Human immunodeficiency virus (HIV) is the causative agent 

of acquired immunodeficiency syndrome (AIDS). HIV is a 

member of the genus Lentivirus of family Retroviridae. Most 

of the Lentiviruses are responsible for a variety of 

neurological and immunological diseases, but not directly 

1,2 

implicated in malignancies. 

AIDS was first properly defined by Centers for Disease 

Control (CDC), USA in December 1981 as a disease causing 

acquired immunodeficiency. AIDS is an appropriate name 

because people acquire the condition rather than inheriting it; 

because it results in a deficiency within the immune system 

and because it is a syndrome with a number of manifestations, 

3 

rather than a single disease. In 1983, Luc Montagnier and his 

co-workers at the Pasteur Institute in France first discovered 

4 

the virus that causes AIDS. They called it lymphadenopathyassociated 

virus (LAV). A year later, Robert Gallo and 

associates of the United States confirmed the discovery of the 

virus, but they renamed it human T-lymphotropic virus type- 

5 

III “HTLV-III”. The dual discovery led to considerable 

scientific disagreement, and it was not until President 

Mitterrand of France and President Reagan of the USA met, 

the major issues were resolved. In 1986, both the French and 

the U.S. names for the virus itself were dropped in favour of 

6 

the new term, human immunodeficiency virus. 


M. Imran Qadir, 

E-mail: mrimranqadir@hotmail.com 


HIV transmission from one person to the other requires a 

direct exchange of body fluids, such as blood or blood 

products, breast milk, semen, or vaginal secretions, most 

commonly as a result of sexual activity or the sharing of 

needles among drug users. Such transmission may also occur 

from mother to baby during pregnancy or at birth. Saliva, 

tears, urine, feces, and sweat do not appear to transmit the 

3,6,7,8 

virus. 

Pakistan is one of the developing countries of South Asia. 

Reporting the country's first case in 1987, the National AIDS 

Control Program (NACP) of the Government of Pakistan 

reports a cumulative total of 1813 HIV/AIDS cases and an 

estimated HIV prevalence of 0.1 % as of October 2001. 

Pakistan enjoyed with the low prevalence phase of epidemic 

from 1987 to 2003. By 1999, approximately three-fourths of 

reported HIV infections in Pakistan occurred in migrant 

workers returning from the Arab Gulf states. Since then, 

HIV/AIDS infections are increasingly being found among 

injecting drug users (IDUs), commercial sex workers 

(CSWs), and prison inmates. In 2003, an outbreak of HIV 

among injecting drug users (IDUs) in one city heralded the 

onset of HIV epidemic in the country. Currently the national 

average prevalence of HIV among injecting drug users is 

nearly 20%. It has been reported that throughout the world, 

the most rapid increase in HIV infection is in Southeast Asian 

countries including India and Pakistan. From the United 

Nations and Government report, the number of HIV/AIDS 

cases has been increased upto 85,000 ranging from lowest 

estimate 46,000 to highest estimate 210,000. 

33

Imran Q M-Awareness about ways of transmission of AIDS and its treatment among university students in Pakistan 

(http://en.wikipedia.org,www.un.org.pk/unaids,www.pacpn 

wfp.gov.pk, www.amfar.org). 

OBJECTIVES 

AIDS is incurable disease. Only the way to escape from AIDS 

is the prevention from its transmission. Objective of the 

present study was to investigate the extent of knowledge of 

the student about the treatment and ways of transmission of 

AIDS. 

Methodology 

A questionnaire was developed and the study was conducted 

from November 2008 to February 2010. A total of 500 

students from different departments of GC University, 

Faisalabad, Pakistan were invited to participate in the study. 

Faisalabad is the third largest city of Pakistan and is known for 

its textile industry, in fact known as the Manchester of 

Pakistan. Faisalabad district had a population of about 5.4 

million. 

The questionnaire as given in Appendix 1 contains 5 

questions regarding awareness about ways of transmission 

and treatment of AIDS: What is AIDS What is infective 

agent of AIDS What are the ways of AIDS transmission 

What is treatment of AIDS What are the ways for prevention 

from AIDS The results were compared by making the 

percentage among the respondent. 

RESULTS 

Out of 500 students, 348 answered the questionnaire and the 

remaining did not responded. Knowledge of the students of 

GC University, Faisalabad, Pakistan about AIDS in percent of 

the total respondent is given in Table.1. 78.74% of the 

students did not know what is AIDS Knowledge of the 

students of GC University, Faisalabad, Pakistan about 

infective agent of AIDS is given in Table.2. 58.91% students 

knew that HIV is the infective agent of AIDS. Knowledge of 

the GC university students about treatment of AIDS is given 

in Table.3. 99.00% students knew that AIDS is incurable. GC 

University students' knowledge about ways of transmission 

of AIDS is given in Table.4. 53.74% people knew that AIDS 

may be transmitted by unprotected sex. Only 4.02% people 

knew that AIDS may be transmitted by mother to child during 

feeding and birth. 48.85% people knew that AIDS may be 

transmitted by sharing unsterilized instruments/injections. 

43.67% people knew that AIDS may be transmitted by 

transfusion of contaminated blood. 

DISCUSSION 

AIDS is an infectious disease caused by the human 

immunodeficiency virus (HIV). Researches are being done to 

9 

invent the medicines for treatment of AIDS. However, now a 

10 

days prevention is approachable than treatment. Prevention 

may be only possible when the people know the ways of 

transmission of AIDS. Many of the factors that contribute to 

Table.1 Knowledge of the students of GC University, Faisalabad, Pakistan about AIDS (% of Respondent) 

Sl.No What is AIDS Male Female Toatal 

1 A disease which damage immune system 7.47 12.07 19.54 

2 Wrong information 

1.15 0.57 1.72 

3 Have no information 

25 53.74 78.74 

Table.2. Knowledge of the students of GC University, Faisalabad, Pakistan about infective 

agent of AIDS (% of Respondent) 

Sl.No Causative agent of AIDS Male Female Toatal 

1 Virus (HIV) 

20.40 38.51 58.91 


1.15 0.29 1.44 


17.24 22.41 39.65 

Table.3. Knowledge of the students of GC University, Faisalabad, Pakistan 

about treatment of AIDS (% of Respondent) 

Sl.No Treatment of AIDS Male Female Toatal 

1 Incurable 

38.70 61.19 99.00 


0.09 0.02 0.11 


0 0 0 


34

Imran Q M-Awareness about ways of transmission of AIDS and its treatment among university students in Pakistan 

Table 4: Knowledge of the students of GC University, Faisalabad, Pakistan about 

ways of transmission of AIDS (% of Respondent) 

Sl.No Ways of AIDS transmission Male Female Toatal 

1 Unprotected sex 

28.74 25.00 53.74 

2 Mother to child during feeding and birth 0.57 3.45 4.02 

3 

4 

5 

6 

Sharing unsterilised instruments/injections 

Transfusion of contaminated blood 

Wrong information 

Wrong information 

18.97 29.88 48.85 

12.64 31.03 43.67 

4.31 5.46 9.77 

9.48 13.51 22.99 

the spread of HIV are inextricably link to social structures and 

conditions that shape individual abilities to control exposure 

to risk of infection in Pakistan. Poverty is a major 

development concern in Pakistan, and may be an important 

facilitating factor in the further spread of HIV. The poor suffer 

not just limitations in income but such limitations also 

increase the likelihood that those who are most vulnerable are 

the least able to protect themselves from HIV infection, and 

once infected, are the least able to gain access to the health and 

social support that they need. Gender inequalities may also 

play a significant role in further spread of HIV in Pakistan. 

Pakistani women in general have lower socioeconomic status, 

less mobility, and less decision-making power than do 

Pakistani men, all of which contribute to their vulnerability to 

HIV. 

Some individuals and groups are especially vulnerable to 

HIV/AIDS due to their social status, particular behavior 

patterns, or other special characteristics. Female sex workers 

(FSW) and female migrant workers are for the most part 

unable to negotiate safer sexual practices, are often exploited 

and abused, and have little resources due to their marginal 

social status and because of limited legal protection. Injecting 

drug users (IDUs) are at high risk of HIV infection because 

they often engage in unsafe practices such as the sharing of 

needles and syringes. 

CONCLUSION 

Almost all the students of GC University, Faisalabad, 

Pakistan know that AIDS is incurable. But few students were 

aware about the ways of transmission of AIDS. A strategy to 

increase the knowledge of students about the ways of 

transmission of AIDS should be developed as the infection 

and spread of AIDS may only be prevented by knowledge. 

Some suggested strategies include conducting conferences, 

workshops, training course and also to organize 1 day camps 

to impart knowledge to the students about AIDS. 

REFERENCES 

1. Gardner MB, Endres M, Barry PA. The simian 

retroviruses: SIV and SRV. In: The retroviridae (Levy JA, 

ed). New York (NY): Plenum Press 1994:133-276. 

2. Luciw PA. Human immunodeficiency virus and their 

replication. In: Field virology (Fields BN, Knippe DM, 

Howley PM, eds). Philadelphia (PA): Lippincott-Raven 

1996:1881-1952. 

3. Connor S, Kingman S. The search for the virus, the 

scientific discovery of AIDS and the quest for a cure. 

Penguin Books 1998:14 

4. Barre-Sinoussi F, Chermann JC, Rey F, Nugeyre MT, 

Chamaret S, Gruest J, et.al. Isolation of a T-lymphotropic 

retrovirus from a patient at risk for Acquired Immune 

D e f i c i e n c y S y n d r o m e ( A I D S ) . S c i e n c e 

1983;220:868–871. 

5. Popovic M, Sarngadharan MG, Read E, Gallo RC. 

Detection, isolation, and continuous production of 

cytopathic retroviruses (HTLV-III) from patients with 

AIDS and pre-AIDS. Science 1984; 224:497-500. 

6. Coffin J, Haase A, Levy JA, Montagnier L, Oroszlan S, 

Teich N, et.al. What to call the AIDS virus. Nature 1986; 

321:310. 

7. Blankson JN, Persaud D, Siliciano RF. The challenge of 

viral reservoirs in HIV-1 infection. Annu Rev Med 2002; 

53:557-593. 

8. Busch MP, Amad Z El, Sheppard HW, Ascher MS, Lang 

W. Primary HIV-1 Infection. N Engl J Med 1991; 

325:733. 

9. Qadir MI, Malik SA. HIV Fusion Inhibitors. Rev Med 

Virol 2010, 20:23-33. 

10. Kain WD. Population Education News 1992; 19(4):14- 

16. 


35



Study of prescribing patterns of antibiotics used in the management of 

various infectious diseases 

Azizullah S G*, Jabeen G, Shobna J, Kaleemuddin S, Mohiuddin 

Bharat Institute of Technology (Pharmacy), Mangalpally (V) Ibrahimpatnam, Rangareddy (Dist), A.P, India, 501510. 




The Antibiotic prescribing patterns, Demographic profile and Prevalence of Infectious diseases were prospectively studied in 110 (67 male and 

43 female) hospitalized patients suffering with various infectious diseases at KIMS, Secunderabad over a period of 9 months. The patients were 

distributed into different age groups. Patients less than 20 years were excluded from the study. The maximum number of patients 37 (33.63%) 

was in the age group of 60-69 and the least number of patients 2 (1.8%) were found in 20-29 age group. The Body Mass Index of most of the 

patients 64 (58.18%) were found to be in the normal range, 20 (18.2%) patients were found to be as underweight and 26 (23.62%) patients were 

scrutinized as overweight. 57 (52.72%) patients underwent dual therapy, 38 (34.56%) patients underwent triple therapy and 7 (6.36%) patients 

underwent monotherapy and 7 (6.36%) patients were treated with more than three drugs. The present study reveals that, dual therapy 

(Cilastin+Imipenem) was maximally used in the management of various types of infectious diseases. The CNS infections were present as major 

infections, in majority of patients during the study period. Diabetes mellitus was found to be present as a major co-morbid condition in majority of 

patients along with Hypertension, Hypothyroidism and Seizures. 

Key words: Antibiotics, Demographic profile, Seizure, Hypothyroidism. 

INTRODUCTION 

Despite decades of dramatic progress in their treatment and 

prevention, infectious diseases remain a major cause of death 

and debility and are responsible for worsening the living 

conditions of many millions of people around the world. 

Infections frequently challenge the physician's diagnostic 

skill and must be considered in the differential diagnoses of 

syndromes affecting every organ system.1 

Antibiotics are the most frequently prescribed drugs among 

hospitalized patients especially in intensive care and surgical 

department. Programs designed to encourage appropriate 

antibiotic prescriptions in health institutions are an important 

element in quality of care, infection control and cost 

containment.2-5 

Antibiotics were once considered 'miracle drugs' and have 

been used for decades to effectively treat a variety of bacterial 

infections. Unfortunately, widespread use and misuse 

worldwide have led to the emergence of 'super bugs' and other 

drug-resistant bacteria.6–8 Unnecessary use of antibiotics has 


Azizulla SG, Bharat Institute of Technology (Pharmacy), Mangalpally (V) Ibrahimpatnam, 

Rangareddy (Dist), A.P, India, 501510. 

Email : azizghori2005@yahoo.co.in 


also given rise to an increased risk of side effects, high costs 

and effects requiring medical attention. 

The purpose of this study is to create awareness among the 

physicians about the efficient and rational prescribing pattern 

systems of various medications especially antibiotics in order 

to make sure the usage of antibiotics in a rational way. 

The serious complications and unwanted reactions reported 

due to inappropriate prescribing of antibiotics, has been found 

to be increasing predominantly. Hence, these consequences 

made me to urge in carrying out the study. 

MATERIAL AND METHODS 

The study was performed at KIMS Hospital, Secunderabad. A 

prospective observational study was carried out for a period 

of 9 months in 110 hospitalized patients by scrutinizing the 

inpatients case sheets. All the patients treated with Antibiotics 

for various infections, admitted in Intensive care unit of 

KIMS hospital, patients who were willing to participate, were 

included in the study. Patients below the age of 18 years and 

patients who are not willing to participate in the study were 

excluded. Patients were divided into different groups 

according to their age and sex. Data for the present study was 

collected by scrutinizing inpatient case sheets. The data 

collected was analyzed for the prescribing patterns of 

36

Azizulla S G - Study of prescribing patterns of antibiotics used in the management of various infectious diseases 

antibiotics and demographic profile of the patients. 

The patients enrolled in the study were grouped based on the 

number of Antibiotics prescribed. 

Group 1-Monotherapy-Single Antibiotic was used, Group 2- 

Dual therapy-Two Antibiotics were used, Group 3-Triple 

therapy-Three Antibiotics were used and Group 4- More than 

three Antibiotics were used. 

RESULTS AND DISCUSSION 

Demographic Profile 

Gender Distribution: 

The results reveal that 67 patients were male and 43 patients 

were females out of 110 patients. Careful literature reveals 

that there is no correlation between gender and occurrence of 

infections. 

Age Distribution: 

Table 1 shows the distribution of patients recruited for the 

study in different age groups. The results reveals that 

maximum number of patients (37) were found to be in age 

group of 60-69, followed by 31 patients belongs to the age 

group of 50-59.only (2) patients were found to be in the age 

Table1: Age (in years) distribution 

Age in years (Yrs) No. of patients Percentage (%) 

20-29 02 1.8 

30-39 09 8.2 

40-49 22 20 

50-59 31 28.2 

60-69 37 33.63 

70-79 06 5.45 

80-89 03 2.72 

Total(*N) 110 100 

Table 2: Educational status 

Occupation No. of patients Percentage (%) 

Grade-0 

(uneducated) 36 32.72 

Grade- 1 

(up to 9 th standard) 28 25.45 

Grade-2 

(SSC/Inter) 26 23.63 

Grade-3 

(Graduates/postgraduates) 20 18.20 

Total (*N) 110 100 

group of 20-29. 

Careful literature study reveals that there is no correlation 

between age and occurrence of infections. 

Educational Status: 

Table 2 shows the Educational status of the patients recruited 

for the present study. The results reveal that the maximum 

number of patients 36 was belonged to grade-0 i.e. 

Uneducated, least number of patients 20 were belonged to 

grade-3 (graduates and postgraduates). Careful literature 

study reveals that there is no correlation between educational 

status and occurrence of infections 

Body Mass Index (BMI): 

Table 3 shows the BMI of the patients recruited for the present 

study. The results reveal that the maximum numbers of 

patients i.e.; (64) were found to be of normal BMI. Only 20 

patients were belonged to underweight group. 

Prescription Patterns: 

For the purpose of analyzing the prescribing patterns of 

Antibiotics in the treatment of Infections the 

pharmacotherapy was classified as Monotherapy, Dual 

therapy, Triple therapy and more than three. The results reveal 

that the maximum numbers of patients i.e.58 were underwent 

dual therapy followed by 38 patients with triple therapy. 7 

patients of each were underwent with More than three and 

Monotherapy respectively. 

Monotherapy: 

Table 5 shows the Types of Monotherapy followed during the 

Table 3: Body Mass Index (BMI) 

BMI No. of patients Percentage (%) 

Underweight (27.5) 26 23.62 

Total (*N) 110 100 

Table 4: Prescription patterns 

Therapy No. of patients Percentage (%) 

Monotherapy 07 6.36 

Dual therapy 58 52.72 

Triple therapy 38 34.56 

More than three 07 6.36 

Total 110 100 


37


study period. The results reveal that out of 7 patients, who 

underwent Monotherapy, Amikacin was found to be used in 4 

patients followed by Meropenem in 3 patients. 

Dual Therapy: 

Table 6 shows the Details of Dual therapy used during the 

study period. The results reveal that out of 58 patients who 

underwent Dual therapy, Cilastin+Imipenem was used in 15 

patients followed by 8 patients of each were found to be 

treated with Ofloxacin + Ornidazole, Cefipime + Tazobactum 

respectively. 7 patients were treated with Piperacillin + 

Tazobactum. Only 2 patients were found to be treated with 

Meropenem + Fluconazole. 

Triple Therapy: 

Table 7 shows the details of Triple therapy. The results reveal 

that, out of 38 patients who underwent triple therapy, 17 

patients were treated with Ceftrioxone + Cilastin + Imipenem 

followed by 13 patients treated with Amikacin + Piperacillin 

+ Tazobactum. Only 3 patients were treated with Amikacin + 

Salbactum + Cefipyrazone. It was found that in triple therapy 

at least one fixed dose combination present in single branded 

drugs were used along with another drug. 

Table5: Drugs used in Monotherapy 

Mono Therapy No. of patients Percentage (%) 

Amikacin 04 57.14 

Meropenem 03 42.86 

Total(*N) 07 100 

Table 6: Drugs used in Dual therapy 

Sl. Dual therapy No. of Percentage 

No patients (%) 

1 Cilastin + Imepenem 15 25.86 

2 Meropenem + Vancomycin 04 6.89 

3 Fluconazole + Colomycin 04 6.89 

4 Ofloxacin + Ornidazole 08 13.79 

5 Piperacillin + Tazobactum 07 12.06 

6 Colomycin + Imepenem 03 5.17 

7 Cefazolin + Amikacin 04 6.89 

8 Meropenem + Teicoplanin 03 5.17 

9 Cefipime + Tazobactum 08 13.79 

10 Meropenem + Fluconazole 02 3.49 

Total(*N) 58 100 

Table 7: Drugs used in Triple therapy 

Triple Therapy No. of Percentage 

patients (%) 

Ceftrioxone + 

(Cilastin+Imipenem) 17 44.7 

Amikacin 

(Piperacillin + Tazobactum) 13 34.21 

Amikacin 

(Salbactum + Cefipyrazone) 03 7.89 

Fluconazole 

(Cefipime + Tazobactum) 05 13.17 

Total (*N) 38 100 

Table 8: Therapy in which More than three drugs has been used 

More than 3 Drugs No. of Percentage 

patients (%) 

1.(Piperacillin + Tazobactum) 

+ 

(Cilastin + Imipenem) 04 57.14 

2.(Amoxycillin + Clavulanic 

acid) + 

(Salbactum + Cefipyrazone) 

+ 

(Cilastin + Imipenem) 03 42.86 

Total (*N) 07 100 

More Than Three drugs: 

The table 8 shows the details of More than 3 drugs that were 

used. The results reveals that 4 patients were treated with 4 

antibiotics which were found in two fixed dose combination 

followed by 3 patients treated with 6 antibiotics which were 

found in three fixed dose combinations. 

Details of Infections: 

The results reveal that CNS Infections were found to be 

present in majority of patients ie; 51 patients, followed by 35 

patients with UTI and 22 patients with RTI. 

Details of Comorbidities found during the study: 

The results reveal that majority of the patients were found 

with multiple comorbidities i.e. 67 patients followed by 31 

patients with Single co morbidity and 12 patients without 

comorbidity were found. 

Details of Single Co-morbidity: 

The results reveal that Diabetes mellitus was found to be 

present in 21 patients out of 31 patients having single co 

morbidity and 10 patients with Hypertension 


38


Details of Multiple Co-morbidities: 

The results reveal that out of 67 patients having multiple 

comorbidities 31 patients were found with Diabetes mellitus 

+ Hypertension followed by 12 patients with Diabetes 

mellitus + Seizure, 9 patients with Diabetes mellitus + 

Hypothyroidism and 8 patients with Diabetes mellitus + 

Hypertension + Hypothyroidism. 

CONCLUSION 

As there is a strong epidemic rise of Infectious diseases in our 

country, the present prospective study was carried out to 

assess the Prescribing patterns of antibiotics. 

In order to find out the prevalence of Infectious diseases the 

age range was divided as per the need. During the study, the 

maximum number of patients ie; 37 were found to be in the 

age group of 60-69 years. 

Further it was found that 64 patients were to be of normal 

weight. 

The Prescription patterns used to treat the various infections 

in the present study, reveals that Dual therapy ie; (Cilastin + 

Imipenem) was maximally used. 

The CNS infections were present as major infections in 

majority of the patients ie; 51 during the study period. 

Diabetes mellitus was found to be present as a major comorbid 

condition in majority of patients along with 

Hypertension, Hypothyroidism and Seizures. 

In India, the role of clinical pharmacy is still in infancy stage, 

but the clinical pharmacist can keep the physicians abreast 

about the latest antibiotics and their usage, in order to make 

sure the use of antibiotics in a rational way. 

The present study was restricted only for a period of 9 months 

so therefore the exact prescription pattern cannot be revealed, 

in order to do so the study should be carried out for a long 

period of time. 

ACKNOWLEDGEMENTS 

The authors are thankful to Dr. Bhaskar Rao, Director of 

KIMS, Secunderabad, Andhra Pradesh, India for providing 

necessary facilities to carry out this research project. We are 

thankful to Dr. Chalapathi Rao, Director, Education 

Department, KIMS. The authors are also grateful to all 

doctors who supported during this project in KIMS. 

REFERENCES 

1. Kasper and Hauser “Harrison's principles of internal 

medicine”.16th edn:Boston;Mc Graw-Hill Medical 

publishing division (p) LTD;2005,695. 

2. Goldman DA, Weinstein RA, Wenzel RP. Strategies to 

prevent and control the emergence of antimicrobial 

resistant micro-organisms in hospital. JAMA 1996; 

275:234-249. 

3. Stevenson RC, et al. Measuring the saving attributable to 

an antibiotic prescription policy. J Hosp Infect 1988; 

11:16-25. 

4. Lesar TS, Briceland LL. Survey of antibiotic control 

policies in university-affiliated teaching institutions. Ann 

Pharmacother 1996; 30:31-34. 

5. Strum W. Effects of a restrictive antibiotics policy on 

clinical efficacy of antibiotics and susceptibility patterns 

of organisms. Eur J Microbiol Infect Dis 1990; 9:381- 

389. 

6. Russell AD, et.al. Possible link between bacterial 

resistance and use of antibiotics and biocides. Antimicrob 

Agents Chemother 1998; 42:2151. 

7. Arason VA, et.al. The role of antimicrobial use in the 

epidemiology of resistant pneumococci: a 10-year follow 

up. Microb Drug Resist 2006; 12:169–176. 

8. Paulsen IT, et.al. Role of mobile DNA in the evolution of 

vancomycin-resistant Enterococcus faecalis. Science 

2003; 299: 2071–2074. 

9. Kumari Indira K.S et.al., Antimicrobial prescription 

patterns for common acute infections in some rural & 

urban health facilities of India, Indian J Med Res August 

2008; 128:165-171. 

10. Rocio Fernandez Urrusuno et.al., Antibiotic prescribing 

patterns and hospital admissions with respiratory and 

urinary tract infections, Eur J Pharmacology 2008; 

64:1005-1011. 

11. Robert A. Fowler et.al., Variability in Antibiotic 

Prescribing Patterns and Outcomes in Patients with 

Clinically Suspected Ventilator-Associated Pneumonia 

Chest 2003; 123(3):835-844. 

12. Christopher H S, Chan et.al., A prospective study of 



antibiotic prescribing patterns and clinical outcomes in 

patients with community-acquired pneumonia, J Hong 

Kong Med Assoc 1991; 43(4):226-229. 

13. Yanina Balabanova et.al., Antimicrobial prescribing 

patterns for respiratory diseases including tuberculosis in 

Russia: a possible role in drug resistance, Journal of 

Antimicrobial Chemotherapy 2004; 54:673–679. 

14. Norberto Krivoy et.al., Antibiotic prescription and cost 

patterns in a general intensive care unit, Pharmacy 

Practice 2007; 5(2):67-73. 

15. Kees J. Gortera et.al., Risk of recurrent acute lower 

urinary tract infections and prescription pattern of 

antibiotics in women with and without diabetes in 

primary care, Oxford journals medicine family practice 

2010; 27(4):379-385. 

16. Cecilia Big et.al., Viral Infections of the Central Nervous 

System: A Case-Based Review, Clinical Medicine & 

Research November 2009:864-869. 

17. Svein Gjelstad et.al., GPs' antibiotic prescription patterns 

for respiratory tract infections - still room for 

improvement, Scandinavian Journal of Primary Health 

Care December 2009; 27(4):208–215. 

18. Lifang Dong et.al., Antibiotic prescribing patterns in 

village health clinics across 10 provinces of Western 

China, Journal of Antimicrobial Chemotherapy 2008; 

62:410–415. 




A study on prescription pattern of Antihypertensives 

Preethi M*, PraveenKumar N V R T, Lekshmi S, Manna P K, Mohanta G P, Parimalakrishnan S, 

Sudarshan S. 

Department of Pharmacy, Annamalai University, Annamalai Nagar – 608002. Tamil Nadu, India. 



Accepted: 16/12/2010 

Hypertension is a universal disease and knowledge of existing prescribing patterns in the treatment of hypertension can provide useful 

information for improving clinical practice in this field. The aim of our present study was to identify and evaluate the prescribing pattern of 

antihypertensives. This was a prospective observational study and was approved by IRB. Out of 1262 prescriptions, the overall sex distribution 

of study population showed 62.6% of male and 37.4% of female patients. Total distribution of patients with respect to age group showed that 

highest number of patients was found in the age group of 60-69 years (31.3%) and least was found between 20-29 years age group (1.1%). 

Majority of males in the study population (43.29%) were found to have both the habits of smoking and alcohol. Among concomitant diseases that 

were related to hypertension Coronary artery disease was highest (67.78%) and giddiness was least (1.7%). In case of diseases unrelated to 

hypertension Type II diabetes mellitus was observed as highest (38.7%) and acute gastroenteritis was recorded least (5.68%). Overall 43.5% 

patients were treated with single antihypertensive drug and 53.8% were treated with antihypertensive drug combinations. The study revealed 

that in monotherapy category six classes of drugs were used that includes ACE Inhibitors, loop diuretics, calcium channel blockers, β- Blockers, 

followed by Angiotensin II antagonists and K Sparing Diuretics. ACE Inhibitors were prescribed most whereas K Sparing diuretics were least 

used. From the results of this study, we concluded that there is a considerable scope of improvement for the use of diuretics. 

INTRODUCTION 

Hypertension is a common disease that is defined as 

persistently elevated arterial blood pressure (BP). Although 

elevated BP was perceived to be necessary for adequate 

perfusion of essential organs, it is now identified as one of the 

most significant risk factors for cardiovascular disease in the 

world wide. Hypertension is the most common 

cardiovascular disease. Pooling of epidemiological studies 

shows that hypertension is present in 25% urban and 10% 

rural subjects in India. An estimate reveals that there are 31.5 

million hypertensive patients in rural and 34 million in urban 

populations. A total of 70% of these would be Stage I 

hypertension (systolic BP 140-159 and/or diastolic BP 90-99 

1 

mmHg. 

Antihypertensive agents are among the most used therapeutic 

classes. The approach to the pharmacological treatment of 

hypertension is guided by international recommendations, 

and adherence to treatment is known to result in effective 

prevention of cardiovascular risk. Although many drug 


Motaparthi Preethi, Pharm D Intern, Department of Pharmacy, Annamalai University, 

Annamalai Nagar – 608002.Tamil Nadu, India 

E-mail : motaparthi_preethi@yahoo.co.in 

classes are effective in prevention of cardiovascular events 

i.e., diuretics, β-blockers, calcium channel blockers, 

angiotensin converting enzyme inhibitors, guidelines differ 

with regard to which drug class is to be considered as first 

choice for the initial treatment of hypertension with no 

complications.² 

Thiazide diuretics have been recommended by the seventh 

th 3 

report of the joint National Committee (JNC 7 ) and the 

4 

British Hypertension society as the preferred first-line 

antihypertensive due to its affordability and evidence on its 

efficacy in the prevention of cardiovascular events in those 

5 

with hypertension. 

OBJECTIVES 

The present study was conducted to identify and evaluate the 

prescribing pattern of antihypertensives. 

METHODOLOGY 

The study was prospective observational study and conducted 

in tertiary medical teaching hospital situated in the South 

India. Patients with hypertension of either sex, above 18years 

of age, with or without co morbidities who met the inclusion 

criteria were included in the study. Hypertensive patients who 

were pregnant and patients with significant hepatic and renal 


41

Preethi M- A Study on prescription pattern of Antihypertensives 

disease were excluded from the study. The Institutional 

Human Ethical Committee of Annamalai University, 

Chidambaram approved the study. 

Fig.2: Distribution of study population with respect to age group 

STUDY DESIGN 

Patient enrollment 

Patients were enrolled in the study based on inclusion and 

exclusion criteria. Following patient enrollment, baseline 

information was collected on a standard data documentation 

form which contained patient name, age, date of admission, 

inpatient number, date of discharge, social history, reason for 

admission, past medical and medication history. 

Materials 

1. Patient standard data collection form. 

2. Prescriptions of the patients. 


A total of 1262 patients who met the inclusion criteria were 

selected for the study. The following were results obtained. 

Out of 1262 patients, the overall sex distribution of the study 

population showed that there were more (63.6%) male 

patients as male patients were at higher risk for hypertension 

compared to female patients (37.4%) and this is illustrated in 

Fig 1. 

It was found that majority of the study population were 

admitted to the hospital with chief complaints of chest pain 

318(36.25%), followed by Breathlessness 202(23.03%), and 

cough with breathlessness 115(13.11%). The other reasons 

for admission were vertigo, epistaxis, and weakness. These 

reasons were related to hypertension and as cardiac disease is 

major risk factor for hypertension more patients were 

admitted with complaint of chest pain (fig 4). 

Among the reasons unrelated to hypertension diabetes 

mellitus was found highest with 43.75% followed by cough 

with expectoration 111(28.83%), abdominal pain 48(12.46%) 

and others 15.06% (fig 5). 

Fig.3: Demographic data based on social habits: 

Total distribution of patients with respect to age group 

showed that highest number of patients were found between 

the age group of 60-69years 395(31.3%) followed by 27.5% 

between the age group of 50-59years and least number of 

patients were found between 20-29 age group with 1.10% 

(Fig 2). 

Majority of males in the study population 342(43.3%) were 

found to have both habits of smoking and alcohol followed by 

habit of only alcohol consumption 169(21.39%), only 

smoking 149(18.86%). Only 16.45% were found to be non 

smokers and non alcoholics (Fig 3). 

Fig.4: Reasons for admission observed in study population 

related to hypertension 

Fig.1: Demographic data based on sex 


42


Among concomitant diseases that were related to 

hypertension it was found that coronary artery disease was 

highest 568(67.78%) followed by Cardio Vascular Accident 

173(20.64%) and least was found be giddiness with 1.7% 

(fig6). 

Coming to diseases unrelated to hypertension Type II diabetes 

mellitus was highest 125(38.7%) followed by Chronic 

Obstructive Pulmonary Disease 48(14.9%), Bronchial 

Asthma 44(13.62%) and least was to be both Acute 

Gastroenteritis and lower respiratory tract infections with 

24(7.43%). Systemic hypertension cases were found to be 

101(8%). As cardiac diseases are major risk factors more 

cases were present (fig 7). 

Overall, 549(43.5%) patients were treated with a Single 

antihypertensive drug and 679(53.8%) were treated with 

antihypertensive drug combinations. Antihypertensive drug 

combinations were used more because majority of patients 

had uncontrolled blood pressure levels. 

The study revealed that in monotherapy category six classes 

of drugs were used. These were ACE Inhibitors 298(54.28%), 

loop diuretics 88(16.02%), calcium channel blockers 

91(16.57%), β- Blockers 29(5.3%), followed by Angiotensin 

Fig.5: Reasons for admission observed in study population 

unrelated to hypertension 

Fig.7 Distribution of patients with respect to concomitant 

diseases unrelated to hypertension 

II antagonists 24(4.37%) and K Sparing Diuretics. Among 

Monotherapy, ACE Inhibitors were prescribed most because 

these are effective and cheaper and K Sparing diuretics are 

least used as these were costlier (fig 8). 

Among those who were treated with drug combinations, 

70.25% received two drugs, and a two drug combination of 

ACE Inhibitors and Loop diuretics were given to majority of 

patients with 27.25% followed by ACE inhibitors and β- 

blockers with 26.2% and the drug combination β- blocker and 

Ag II Antagonist was least prescribed with 1.04% (fig 9). 

In three drug combination therapy combination of ACE 

Inhibitors, β-blockers and loop diuretics were prescribed 

major with 25.54% and least prescribed were combination of 

Ag II Antagonist, β-blocker and ACE Inhibitor with 2.7% (fig 

10). 

In combination therapy 27.68% received three drugs, usage of 

four drugs is uncommon and only 2.06% patients were 

prescribed four drug combinations (fig 11). 

A total of about 34 hypertensive patients were not prescribed 

any of the anti hypertensive drug. 

Fig.6: Concomitant diseases observed in study population 

related to hypertension 

Fig.8: Single drug therapy: 


43


Fig.9: Two drug combination 

In studies conducted by Samir Malhotra, R. S. Karan, 

P.Pandhi, Sanjay Jain showed that among 1076 prescriptions 

evaluated β-adrenoreceptor blocking agents were most 

prescribed with 51% followed by calcium channel blockers 

(47%), and ACEI (46%). combination therapy was used 

commonly than monotherapy. In two combination therapy, a 

drug combination of ACEI and β-blocker were prescribed 

most with 39.9%, in three drug combination therapy a 

combination of ACEI, β-blocker and calcium channel blocker 

were prescribed more with 11.9% and in four drug 

combination therapy, the most commonly prescribed was a 

combination of ACEI, β-blocker, calcium channel blocker 

and α-blocker with 0.7%. 

CONCLUSION 

Fig.10: Three drug combination: 

Despite the availability of a wide range of antihypertensive 

drugs, hypertension and its complications are still important 

causes of adult morbidity and mortality. More than 50% of 

treated hypertensive patients have a blood pressure greater 

than 140/90mm Hg (uncontrolled hypertension). The present 

study represents the current prescribing trend for antihypertensive 

agents and it highlights certain shortcomings in 

the existing prescribing practice. There is a considerable 

scope for improvement, particularly the under-utilization of 

diuretics in the present prescribing pattern of antihypertensive 

drugs. In our study, it was observed that the 

treatment for patients depends upon the condition and 

severity of the patient as well as experience of the physician, it 

may or may not reflect the JNC VII. 

REFERENCES 

1. Hum J. Trends in hypertension epidemiology in India. 

Hypertens 2004 Feb; 18(2):73-78. 

Fig.11: Four drug combinations: 

2. Messerli HF, Grossman E, Goldbourt U. Are betablockers 

are efficacious as first line therapy for 

hypertension in the elderly : A Systemic review. JAMA 

1998; 279:1903-1907. 

3. The seventh report of the Joint National Committee 

(JNC) on Prevention, Detection, Evaluation and 

Treatment of high Blood Pressure. US Department of 

Health and Human Services; May, 2003. 

4. British hypertension society guidelines for hypertension 

management 1999. BMJ 319(7210) 630-635. 

Note: The other 34 patients were not prescribed any of the antihypertensives 

5. Amery A, Birkenhager W, Brixko P, Bulpitt C, Clement D, 

Deruyttere M, et.al. Mortality and morbidity results from 

the European working party on high blood pressure in the 

elderly trial. Lancet 1985; 1:1349–1354. 




Evaluation of prescribing pattern of clinicians in out-patient departments of A 

South Indian teaching hospital 

Ramesh A*, Suhaj A 

Department of Pharmacy Practice, JSS College of Pharmacy, Mysore- 15. 



Accepted: 21/12/2010 

A prospective study was conducted to study the drug usage pattern of clinicians in out-patient departments at a South Indian tertiary care 

teaching hospital. WHO prescribing indicators were used to asses the prescribing behavior of the clinicians in four select out-patient 

departments such as Medicine, Orthopaedics, Paediatrics and Surgery. Randomly 15 to 20 prescriptions per day were selected for review. 

Average number of drugs prescribed per prescription was found to be 2.32. Percentage of drugs prescribed from W.H.O essential drug list was 

found to be 75%. Number of prescriptions with antibiotics and injections were 23% and 5% respectively. Average consultation time with each 

patient was found to be 6-10 minutes. Percentage of drugs prescribed by generic name was found to be 5%. Results of the study showed a 

considerable scope for improving the prescribing pattern of clinicians in OPD clinics. Generic prescribing and continuing education on rational 

use of drugs may improve the prescribing behaviour. Preparation and distribution of a hospital formulary may further strengthen the rational use 

of drugs. 

Keywords: Prescribing pattern, Out Patient Department, WHO Prescribing indicators 

INTRODUCTION 

Drug therapy is primarily initiated to prevent, cure or control 

1 

the diseases in human beings. Selection of medicines mainly 

depends on the extent of the anticipated benefits and the 

minimum unwanted effects with the medication. No drug is 

considered to be safe, even when prescribed in therapeutic 

doses. Appropriate selection of drugs helps in achieving the 

desired therapeutic outcomes in patients. In recent times, drug 

therapy is becoming more complex, thus making appropriate 

prescribing increasingly challenging. Drug related mortality 

and morbidity are indeed becoming serious concern for 

patients and health care professionals. This is warranting 

rational selection of medicines for treating patients. 

According to World Health Organization (WHO), rational use 

of drugs requires that patients' receive medications 

appropriate to their clinical needs, in doses that meet their 

own individual requirements, for an adequate period of time, 

1 

and at the affordable cost. WHO has listed out 366 drugs as 

2 

essential drugs that can take care of majority of the diseases. 

WHO has developed certain indicators to evaluate the drug 

usage pattern in various health care facilities. They are 

prescribing indicators, patient indicators, facility indicators 


Dr. Ramesh Adepu, Professor, Department of Pharmacy Practice, JSS College of 

Pharmacy,Mysore- 570 015. 

Email: adepu63@rediffmail.com 

and complimentary indicators. These indicators are used to 

monitor treatment practices and prescribing behavior of the 

3 

clinicians. 

Process of diagnosis and prescribing pattern in tertiary care 

teaching hospital is a complex process. Heavy patient load, 

huge number of pharmaceutical formulations with irrational 

combinations, non-availability of evidenced-based treatment 

guidelines, and pressures from the pharmaceutical companies 

are certain factors that influences the drug prescribing 

practices of clinicians in tertiary care teaching hospital. This 

may often lead to inappropriate prescribing. 

Jagadguru Shree Shivarathreeshwara (JSS) Hospital, Mysore 

is a multi specialty tertiary care teaching hospital. On an 

average of 500-600 patients are being treated in out-patient 

departments (OPD) of various specialties such as medicine, 

orthopedics, pediatrics, surgery, psychiatry, neurology, 

nephrology, urology, pulmonology, gynecology, dermatology 

on daily basis. Consultants, senior doctors, junior doctors and 

postgraduates treat the patients in these out-patient 

departments. Prescribing pattern may vary based on their 

position, qualification and experience. Thus, it is necessary to 

assess the prescribing practices of the clinicians at JSS 

Hospital. The present study is designed to analyze the drug 

usage pattern of clinicians using WHO prescribing indicators 

in selected out-patient departments of JSS Medical College 

Teaching Hospital, Mysore. 


45

Ramesh A- Evaluation of Prescribing Pattern of Clinicians in out-patient Departments of A South Indian Teaching Hospital 

METHODOLOGY 

This is an open labelled prospective study, conducted over a 

period of eight months. The Institutional ethical committee of 

JSS College of Pharmacy approved the study and permission 

was also taken from the Medical Superintendent of JSS 

Medical College Teaching Hospital. 

Collection of data 

Medication records of patients visiting the out-patient clinics 

of Medicine, Paediatrics, Orthopaedics, and Surgery 

departments were reviewed on daily basis. Prescriptions were 

selected randomly (about 15-20 prescriptions per day) and 

reviewed for the purpose of the study. Therapeutic data like 

name of the drugs, dose, route, frequency, duration, total 

number of drugs per prescription, number of antibiotics and 

injections per prescription and average consultation time with 

each patient were collected and documented in a suitably 

designed documentation form. 

Analysis of collected data 

All the collected data was subjected for analysis using WHO 

prescribing indicators. From the collected data, the average 

numbers of drugs per prescription, the percentage of drugs 

prescribed from essential drug list (compared with WHO 

essential drug list), the percentage of encounters with 

antibiotics and injections prescribed and the average 

consultation time with each patient were assessed. 

RESULTS 

Data was collected over a period of 36 days in each out-patient 

department clinics of pediatrics, medicine, orthopedics and 

surgery. During the study period, 2122 patients visited and 

received 2,108 prescriptions from the selected OPD clinics. 

Fourteen patients did not receive any prescription. Details of 

number of prescriptions reviewed from each department are 

presented in Table 1. 

Number of drugs prescribed 

In the present study, 492 (23%) prescriptions contain one 

drug, 794 (37%) prescriptions contain two drugs, 479 (23%) 

prescriptions contain three drugs, and 337 (16%) 

prescriptions contain four drugs. Details of the drugs 

prescribed in each department are presented in Table 2. 

Average number of drugs per prescription 

During the study period, a total of 4,895 drugs were 

prescribed in 2108 prescriptions. The average number of 

drugs per prescription was found to be 2.32. Details of 

average numbers of drugs per prescription are presented in 

Table 3. 

Number of drugs from WHO essential drug list 

Among 4,895 drugs prescribed, 3,686 (75%) drugs belong to 

WHO essential drug list. Number of drugs prescribed from 

WHO essential drug list was found to be high in medicine 

department (83%), followed by paediatrics department 

(80%), surgery department (70%), and least were found in 

orthopaedics department (65%). Details of drugs prescribed 

from WHO essential drug list is presented in Table 4. 

Table 1. Number of prescriptions reviewed from each department 

Department Number of prescriptions (%) 

Paediatrics 522 (25) 

Medicine 536 (25) 

Orthopaedics 540 (26) 

Surgery 510 (24) 

Total 2108 (100) 

Table 3: Details of average number of drugs per Prescription. 

Department 

Total No. of 

drugs 


prescriptions 

Average No. 

of drugs per 

prescription 

Paediatrics 984 522 1.88 

Medicine 1657 536 3.09 

Orthopaedics 1122 540 2.07 

Surgery 1132 510 2.22 

Total 4895 2108 2.32 

Number 

of drugs 

Table 2: Number of drugs prescribed in each department 

No. of prescriptions in Departments 

Paediatrics Medicine Orthopaedics Surgery 

Total (%) 

1 231 044 146 071 492 (23) 

2 153 106 244 291 794 (37) 

3 105 149 112 113 479 (23) 

4 033 231 038 035 337 (16) 

5 000 006 000 000 006(00.28) 


46


Table 4: Number of drugs from WHO essential drug list. 

Total number of Number of drugs 

Department 

drugs prescribed from WHO list (%) 

Paediatrics 984 788 (80) 

Medicine 1657 1382 (83) 

Orthopaedics 1122 724 (65) 

Surgery 1132 192 (70) 

Total 4895 3686 (75) 

Prescriptions with injections: 

Of the 2,108 prescriptions reviewed during the study period, 

110 prescriptions contained 134 injections. Among 134 

injections prescribed, majority injections [73% (n=98)] 

belong to analgesics (diclofenac), followed by tetanus toxoid 

18% (n=24), triamcinolone 6% (n=8) and followed by 

vitamin-D injection 3% (n=4). Details of the injections 

prescribed in each department are presented in Table 5. 

Prescriptions with antibiotics 

Out of 2,108 prescriptions reviewed during the study period, 

478 (23%) prescriptions contained antibiotics. Among them, 

467 (98%) prescriptions contained one antibiotic, two 

antibiotics were found in four prescriptions and four 

antibiotics were found in seven prescriptions. Details of the 

prescriptions with antibiotics are presented in Table 6. 

Percentage of drugs prescribed by generic name 

Among 4895 drugs prescribed, only 244 (5%) drugs were 

prescribed by generic name. Prescriptions given by brand 

name may have risk of wrong drug dispensing, as many brand 

names sound similar and confusing. Pharmaceutical 

companies spend great percentage of amount for marketing 

the brands. If clinicians prescribe drugs by generic names, 

cost of the drugs may be reduced by 40 –60% and the patients 

may be economic benefited. 

Average consultation time per patient 

During the study period, 2,122 patients visited the OPD 

clinics of the selected departments. In the present study, the 

consultation time was found to be 6-10 minutes for majority 

of patients who visited the OPD clinics. Details of 

consultation time per patient are presented in Table 7. 

DISCUSSION 

Prescriptions' containing one drug was more in paediatrics 

out-patient department compared to other out-patient 

departments. Because, many patients diagnosed in 

Table 5: Details of Injections prescribed from each department 

Drugs Route of Indication 

Number of patients 

Total (%) 

prescribed administration 

Pediatrics Medicine Orthopedics Surgery 

Diclofenac IM Pain 00 22 56 20 98 (73) 

Tetanus- toxoid IM Injuries 00 04 08 12 24 (18) 

Triamcinolone Intradermal Keloid 00 00 00 08 08 (6) 

Vitamin-D IM Vitamin-D 04 00 00 00 04 (3) 

Deficiency 

Number of 

Antibiotic 

Table 6: Details of the number of antibiotics prescribed from each department 

No. of patient in Department 


Total (%) 

1 129 114 20 204 467(98) 

2 04 00 00 00 4(1) 

3 02 05 00 00 7(1) 

Consultation 

time (in min) 

Table 7: Average consultation time per patient 

Number of patients 


Total (%) 

 


47


paediatrics department were with upper respiratory tract 

infections and fever. Recommended treatment for fever is 

paracetamol. Upper respiratory tract infections may not 

require antibiotics; hence clinicians prescribed only cough 

syrup to manage the situation. Prescriptions containing two 

drugs were more from surgery outpatient department. This is 

mainly because; most frequent causes for patients to visit the 

surgery department OPD clinics were APD or gastritis. The 

present study results reveal that, clinicians prescribe one 

Proton pump inhibitor and one deworming agent in majority 

cases. Prescriptions containing three and four drugs were 

more from medicine out-patient department. This is because, 

patients visit the medicine OPD clinics are often with comorbid 

conditions such as hypertension with diabetes or APD 

or other cardiovascular problems. Thus clinicians used more 

drugs. 

In the present study, average number of drugs per prescription 

was found to be 2.32. This average may be considered as 

normal. In a study conducted in Manipal teaching hospital in 

Pokhara, Nepal to assess the prescribing pattern of the 

doctors, the average number of drugs prescribed per 

4 

prescription was reported as 2.15. In another study conducted 

in Singapore to assess the prescribing behavior of doctors in 

Alexandra Hospital, Singapore, the results of the study 

reveals that, average number of drugs per prescription was 

5 

reported as 2.6. Another hospital based study conducted in 

India to assess the prescription pattern by the doctors using 

defined daily dosage (DDD) concept also reported that 

6 

average number of drugs per prescription as 2.5. Other 

hospital based studies have reported figure of 3-5 drugs per 

7,8 

prescription. The findings of the present study are similar to 

the findings of the above studies. More number of drugs in a 

prescription may increase the risk for potential drug-drug 

9 

interactions and adverse drug reactions. As a result; patients 

may not get the best possible therapeutic benefit. 

WHO has defined essential drugs as those that satisfy the 

10 

health care needs of the majority of the population. As per 

the latest WHO essential drug list, 366 drugs are considered as 

essential drugs. Drugs listed in the essential drugs list are safe, 

efficacious and economical. Thus, WHO encourages 

clinicians to choose drugs from essential drug list (EDL). In 

the present study, the results reveal that 75% of drugs were 

chosen from essential drug list. This percentage is considered 

to be high when compared with the studies conducted in other 

places. In a similar study conducted in Madurai city, results 

report that number of prescribed drugs belongs to essential 

11 

drug list was 51%. In another study conducted in Pokhara, 

Nepal, in a tertiary care teaching hospital, number of drugs 

4 

used from the essential drug list was 40%. When compared to 

the findings of other studies, the findings of the present study 

suggest that, prescribers are more rational in the selection of 

drugs. 

Among the injectables prescribed, diclofenac was found to be 

high in orthopaedics department. This is mainly because 

patients visit orthopaedics department OPD clinics with 

complaints of bone and joint inflammation. Although 

diclofenac is not listed in essential drug list, often it is 

frequently used to relieve inflammatory conditions because 

of its efficacy. Other injectable drugs which were used due to 

the situational demand. 

Infectious diseases are considered as major cause of 

10 

morbidity and mortality in developing countries. In treating 

the infections, antibiotics are often misused. Studies in India 

and overseas also have shown great irrationality in antibiotic 

usage. In the present study, prescriptions given with 

antibiotics were 23% of the total prescriptions. Majority 

antibiotics were used in surgery followed by paediatrics 

department. Drug categories prescribed were penicillins, 

cephalosporins, flouroquinolones and macrolides. Among the 

cephalosporins prescribed, only cephalexin is present in the 

essential drug list. Where as cefuroxime, cefotaxim and 

cefpodoxime are not present in essential drug list. From the 

category of flouroquinolones, only ciprofloxacin is present in 

the essential drug list and levofloxacin, ofloxacin, 

norfloxacin are not recommended in essential drug list. 

Among the macrolides, azithromycin and erythromycin are 

present in essential drug list, where as roxithromycin is not 

listed in the essential drug list. The findings of the present 

study show that antibiotics are inappropriately used. 

Irrational use of antibiotics may develop microbial resistance 

to antibiotics. This further warrants using higher antibiotics, 

which may pose financial burden to the patients. In the present 

study, only one antibiotic was used for treating majority 

infections. Two and four antibiotics were used in case of 

tuberculosis in paediatrics and adult population. In a study 

conducted in Kathmandu Medical University, pertaining to 

the antibiotic usage, the results revealed that number of 

12 

antibiotics used in patients were 2-3 which is very high 

compared to the results of the present study. 

An appropriate diagnosis is an important component in the 

rational drug therapy. For correct diagnosis, clinicians should 

spend more time in evaluating the signs, symptoms and 

laboratory investigations. So more the consultation time 

better the chances of right diagnosis. In the present study, the 



consultation time was found to be 6-10 minutes for majority 

of patients who visited the OPD clinics. This may be because 

of heavy patient load. 

CONCLUSION 

In conclusion, results of the study showed a considerable 

scope for improving the prescribing pattern of drugs in OPD 

clinics. Improvement can be observed, if prescribers are 

provided with feed back, continuing education on rational use 

of drugs and prescribing by generic names. Preparation and 

distribution of a hospital formulary may further strengthen the 

rational use of drugs. 


The authors are sincerely thankful to JSS Mahavidyapeetha, 

Principal, JSS College of Pharmacy, Dr. G. Parthasarathi, 

Head and other staff of Dept. of Pharmacy Practice, and 

Physicians of JSS Medical College Teaching Hospital, 

Mysore. 

REFERENCES 

1. Francisco A, Edson P, Sergia M S, Leonardo G, Jose M, 

Luiza H P, et al. Analysis of medical prescriptions 

dispensed at health centers in Belo Horizonte, Minas 

Gerais, Brasil. Cadernos de Saude publica-Avaliacao de 

prescricoes medicas avidas 2003;1-13. 

th 

2. The 14 WHO Model List of Essential Medicines. 

Geneva, March 2005. 

3. Mahendra B, Anil Kumar, Shrinivas K. Study on the 

Prescribing and Dispensing Practices of NSAID at 

Punjab University Health Centre. The Indian Journal of 

Hospital Pharmacy 2006; XLIII(2):64-68. 

4. Ravishankar, Partha P, Shenoy N. Prescribing pattern in 

medical out-patients. Clinmed May 2002; 16:1-8. 

5. Yap K B, Chan K M. The prescribing pattern of hospital 

doctors. Singapore Med J 1998; 39(11):496-500. 

6. Srishyla MV, Krishnamurthy M, Nagarani MA, Clare 

SM, Andrade C, Venkataraman BV. Prescription audit in 

an Indian hospital setting using the DDD (Defined Daily 

Dose) concept. Indian J Pharmacol 1994; 26:23-28. 

7. Kumar H, Gupta U, Garg KC, Agarwal KK. A study of 

trend of drug usage in a hospital unit. Indian J Pharmacol 

1986; 18:50-53. 

8. Sood B, Verma RK, Gulati PV. Diagnosis and treatment in 

a general hospital. The clinician 1984; 48:263-270. 

9. Neis SA, Spielberg SP. Principles of therapeutics In: 

Gilman GA, Hardman JG, Limbird LE, Molinoff PB, 

Ruddon PW, editors. The pharmacological basis of 

therapeutics. McGraw-Hill, New York 1995: 43-62. 

10. Molly Thomas. Rational Drug use and the Essential Drug 

Concept. In G Parthasarathi, Karin Nyfort-Hansen, Milap 

C Nahata. A textbook of clinical pharmacy practice. First 

publication. Orient Longman Private Limited 2004; 72- 

83. 

11. George Kutty, Narmada Sambasivam, Nagarajan M. A 

study on prescribing pattern in Madurai city. Indian 

Journal of Pharmacology 2002; 34: 361-362. 

12. Pallike N. Prescribing pattern of Antibiotics in pediatric 

hospital of Kathmandu Valley. Kathmandu University 

Medical Journal 2004; 2:6-12. 




Impact of patient counseling on Knowledge, Attitude, Practice and Quality of 

Life in patients with Type II Diabetes mellitus and Hypertension. 

* 

Praveena P , Usman S, Deepika B, Raghu Kumar V, Mohanta G P, Manna P K, Manavalan R. 

Department of Pharmacy Practice, Annamalai University, Annamalai Nagar, Chidambaram, Tamil Nadu, India. 



The aim of this study was to assess the impact of pharmacist provided patient counseling on treatment outcomes and quality of life in 

hypertensive and type II diabetes mellitus patients, improving their knowledge, attitude and practice. It was a randomized prospective controlled 

study. Patients selected were divided into control and test groups. Patients in the test group were counseled and given information about the 

management of the disease, whereas control group received the information only at the end of the study. The follow up was carried out over a 

period of six months in which the KAP and quality of life of the patients was assessed. The scores were evaluated and statistically analyzed. A 

comparative study was made between the pre counseling and post counseling scores of control and test groups. A total of 41 patients, 21 control 

and 20 test were included in the study. A statistically significant difference (p 0.001).The control group scores of both PCS and 

MCS were not significantly different even after counseling. A significant difference (p

Praveena P- Impact of patient counseling on Knowledge, Attitude, Practice and Quality of Life in patients with Diabetes mellitus Type II and Hypertension. 

It is well documented that safe and effective drug therapy 

occurs most frequently when patients are well informed about 

medications, their use and life style modifications necessary 

2 

for the management of disease. Hence KAP studies can be 

carried out to assess the patient's knowledge, attitude and 

practice towards disease. Patient counseling can be used as 

an aid to assess and improve it. The ultimate goal of 

counseling is to provide information about Knowledge, 

Attitude and Practice (KAP) needed for disease management, 

3 

thereby enhancing therapeutic outcomes. The therapeutic 

outcomes indirectly reflects the Quality of Life (QoL) of the 

patients. This study was undertaken to assess the role of 

patient counseling in self management of blood sugar and 

blood pressure levels by patients with coexisting diabetes and 

hypertension. This study was designed to increase the 

awareness among patients and other health care professionals 

about the importance of patient counseling. This study should 

focus on the Knowledge, Attitude, Practice and quality of life 

in patients with both diabetes and hypertension to assess the 

impact of patient counseling. 

METHODS 

The study was prospective randomized study. It was 

conducted for a six months period i.e from November 2009 to 

April 2010, at Rajah Muthaiah Medical College Hospital 

(RMMCH), Annamalai University in Chidambaram, Tamil 

Nadu, India. This study was designed to assess KAP and QoL 

scores of patients with diabetes and hypertension. The study 

was approved by the institutional ethics committee. 

Patient enrollment: 

Patients with both diabetes type 2 and hypertension of either 

sex with age above 30 years of age with or without comorbidities 

, who consented to participate were enrolled in the 

study using the inclusion and exclusion criteria. The enrolled 

patients were divided into control and test groups. 

Baseline data was collected using patient data collection 

form. Baseline blood pressure , blood sugar levels were 

measured. KAP, QoL scores were obtained through patient 

counseling. The follow-up was carried out over a period of 2 

months. The control group patients were given basic 

information whereas the test group were given extensive 

counseling, and education about disease management. The 

control group was provided with detailed education after the 

study was completed. 

MATERIALS 

Relevant patient data needed for the study was obtained from 

1) Patient data collection form 

2) Patient's prescriptions 

3) Patient interview 

4) KAP questionnaire 

5) Short form- 12 ( SF-12) 

KAP questionnaire : This questionnaire was designed to 

assess the patient's knowledge about their disease and their 

attitude, practice in disease management. It contained 25 

questions of which 18 are knowledge questions and attitude, 

practice questions were 7. 

Short Form - 12: This quality of life questionnaire contains 

12 questions which measures Physical Component 

Summary(PCS), Mental Component Summary(MCS). 

Data analysis : In the analysis of KAP questionnaire for the 

knowledge questions, each question was scored as one (1) for 

a correct answer and as zero (0) for an incorrect answer. For 

the practice questions, adhering to the guidelines for disease 

management or instructions from the patient's health care 

provider merited a score of 1; nonadherence was given a score 

of 0. QoL was given a score from 0-100 for both PCS and 

MCS.Student's t test was used to analyze and compare the pre 

counseling and post counseling blood pressure levels and 

blood sugar levels and KAP, QoL scores. A p value less than 

0.001 was considered significant. 

RESULTS 

A total of 50 patients were enrolled in the study of which 41 

patients [control(21), test(20)] who completed al follow up 

visits were included in analysis. The other 9 patients withdrew 

from the study for unknown reasons. Out of 41 patients in the 

study 26(63.4%) were female and 15(36.5%) were male. 

There was no significant difference seen between the baseline 

values of the two groups with respect to education level and 

number of medications being used. The age distribution was 

as follows 

1. 30 to 40 years of age are 05 patients (12.1%) 



KAP study 

KAP questionnaire contains a total of 25 questions of which 

18 are knowledge questions and 7 are attitude/practice 

question. 



Comparison of KAP scores at baseline and final follow-up 

At baseline all patients had poor KAP scores. At the end of the 

study patients in the test group who received extensive 

counseling about disease management showed significant 

difference in their KAP scores when compared to baseline 

data (p0.01).(Table1 and 2), (Figure 1 

and 2). 

Comparison of pre-counseling and post-counseling QoL 

scores 

At baseline patients of both test and control groups showed 

poor quality of life. The post counseling PCS scores of final 

Table 1: Effect of Patient Counsling on Knowledge Outcomes 

Mean±SEM 

group Pre counseling Post counseling 

Control (21) 9.762±0.32 10.10±0.217 

Test (20) 8.7±0.317 11.95±0.5355 

*P value < 0.01 is significant as calculated by t- test. 

Fig. 1: Effect of Patient Counseling on knowledge outcomes 

follow-up showed significant difference from that of precounseling 

scores at baseline. No significant difference was 

found incase of control group. MCS scores were not 

significantly improved for both test and control groups. 

(Table 3 and 4), (Figure 3 and 4) 

Comparison of pre-counseling scores of Therapeutic 

outcomes with post-counseling scores at final follow-up 

A significant reduction in systolic and diastolic blood 

pressure and blood sugar levels was found at the final followup. 

(Table 5,6 and 7). The graphical representation of 

significant difference of systolic blood pressure levels, 

diastolic blood pressure levels and blood sugar levels was 

Table 3: Effect of Patient Counseling on Physical Component 

Summary(pcs): 

Mean±SEM 


Control (21) 42.48±2.136 44.77±1.342 

Test (20) 44.19±1.342 49.71±.622 

Fig 3: Effect of Patient Counseling on Physical Component 

Summary(pcs): 

Table 2: Effect of Patient Counseling on Attitiude and Practice outcomes 

Mean±SEM 


Control (21) 3.571±0.2809 3.810±0.2026 

Test (20) 3.2±.22 5.1±.1433 

Fig. 2: Effect of Patient Counseling on Attitude and Practice outcomes 

Table 4: Effect of Patient Counseling on Mental Component 

Summary(mcs): 

Mean±SEM 


Control (21) 46.68±1.125 46.33±0.910 

Test (20) 47.78±1.761 48.55±1.168 

Fig. 4: Effect of Patient Counseling on Mental Component 

Summary(mcs): 


52


Table 5: Effect of Patient Counseling on Blood 

Pressure Levels(systolic): 

Mean±SEM 


Control (21) 139.3±1.629 138.6±1.73 

Test (20) 131.3±2.483 125.8±1.324 

Fig 5: Effect of Patient Counseling on Blood 

Pressure Levels(systolic): 

Table 7: Effect of Patient Counseling on Blood Sugar Levels 

Mean±SEM 


Control (21) 130.6±7.144 128.3±5.5733 

Test (20) 131.4±8.144 116.0±.765 

Fig 7: Effect of Patient Counseling on Blood Sugar Levels 

Table 6: Effect of Patient Counselingon Blood Pressure 

Levels (diastolic): 

Mean±SEM 


Control (21) 90.24±1.707 88.33±1.260 

Test (20) 90.00±1.308 84.75±1.056 

Fig. 6: Effect of Patient Counselingon Blood Pressure 

Levels (diastolic): 

with hypertension understanding of their disease, drug 

therapy, and lifestyle changes i.e disease management (blood 

sugar and blood pressure levels) and quality of life. 

Knowledge, Attitude and Practice 

Subish Palaian, Leelavathy D Acharya et al. , evaluated the 

results of counseling in selected diabetic patients about their 

knowledge, attitude and practice and concluded that patient 

counseling by a clinical pharmacist improved knowledge 

scores, but this improved knowledge did not lead to 

4 

appropriate attitudes or practice. In this study at baseline all 

patients had poor knowledge, attitude and practice towards 

their disease. At the end of the study patients in the test group 

who received extensive counseling about disease 

management showed significant difference in their KAP 

scores when compared to baseline data. 

Quality of life (QOL) 

shown (Figure 5,6 and 7). 

DISCUSSION 

The management of hypertension and diabetes requires longterm 

treatment which may cause side effects that impair 

quality of life and lead to problems with medication 

adherence. Studies have shown that when community 

pharmacists were involved in the care of these patients, 

significant improvements in Knowledge, Attitude, practice, 

Quality of Life, blood pressure levels and blood sugar levels 

of patients were achieved. Our study evaluated the impact of 

pharmacist-provided counseling in terms of diabetic patients 

The quality of life in diabetic patients with hypertension was 

assessed using Short Form-12 (SF-12) where the Physical 

Component Summary (PCS) and Mental Component 

Summary(MCS) were assessed separately. The mean PCS 

scores before counseling and after counseling for test group 

were found to be significantly different when compared to 

control group which are not significant. No significant 

difference was observed between the mean MCS scores of pre 

counseling and post counseling test and control groups. From 

this statistical analysis it was found that patient counseling 

had improved quality of life with respect to Physical 

component Summary. The MCS was not affected by patient 

counseling. 



Blood Pressure and Blood sugar levels 

Mean scores of systolic, diastolic blood pressure and blood 

sugar levels before counseling and after counseling for test 

groups were found to be significantly different.(p< 0.001). 

Mean scores of systolic, diastolic blood pressure and blood 

sugar levels before counseling and after counseling for 

control group were not significantly different.(p>0.001). This 

implies that the improvement in knowledge, attitude and 

practice decreased the blood pressure and blood glucose 

levels which ultimately improved quality of life (PCS). 

LIMITATIONS 

Our study has limitations with respect to attitude and practice 

scores as these were assessed based on patient interview 

instead of observing the patient's actual practice for disease 

management. Our sample size is small and confounding 

factors like patient counseling and knowledge attained by 

other sources was not considered. 

CONCLUSION 

Health related quality of life is increasingly viewed as a 

therapeutic outcome and is gradually gaining the same level 

of importance as clinical or physiological outcome 

parameters. (eg: blood pressure, blood sugar levels) this study 

aimed to assess impact of pharmacist provided patient 

education on treatment out comes, KAP& QOL of patients 

with coexisting diabetes and hypertension. 

At base line all patients had poor knowledge and attitude 

towards their disease and thus poor QOL (PCS, MCS). At the 

end of the study patients of test group received extensive 

counseling regarding their disease and its management 

showed greater improvement in treatment outcomes (blood 

pressure & blood sugar levels), KAP& QOL than in patients 

in control group. 

Our study confirms that improvement in knowledge of the 

disease and its management had positive impact on treatment 

outcomes and quality of life (PCS). At the same time it is 

noticed that counseling had no effect on mental component 

summary of the patient's quality of life. This study thus 

emphasis the impact of pharmacist provided patient 

counseling on KAP & QOL in patients with diabetes mellitus 

type-II and hypertension. 

REFERENCES 

1. Hsueh W A, Anderson P W. Hypertension, the endothelial 

cell, and the vascular complications of diabetes mellitus. 

Hypertension 1999; (20) :253-263. 

2. Parthasarathi G, Karin Nyfort-Hansen, Milap c Nahata. A 

Textbook of Clinical Practice Pharmacy: Essential 

th 

concepts and skills. 4 edition. 2007:43 -53. 

3. Roger and Walker. Clinical Pharmacy and Therapeutics. 

th 

4 edition. 2005; 265-275,629-650. 

4. Subhish P, Leelavathy D A, Padma Guru M, Ravi Shankar 

P, Nidin Mohan N, Nibu P N. Knowledge, Attitude and 

practice outcomes: Evaluating the impact of counseling 

in hospitalized diabetic patients in India, Journal of 

Pharmacotherapy, 2006, 31(7): 381-396. 

5. Viral N S, Kamdar P K. Assessing the knowledge, 

attitudes and practice of type 2 diabetes among patients of 

Saurashtra region, Gujarat. International Journal of 

Diabetes in Developing Countries 2009; 29(3): 118-122. 

6. Weinberger M, Kirkman M. The relationship between 

glycemic control and health-related quality of life in 

patients with non-insulin-dependent diabetes mellitus. 

Med Care 1994;32:1173–1181 

7. Kapur A, Shishoo S, Ahuja MMS. Diabetes care in India: 

Physicians perceptions attitudes and practices (DIAPP-2 

study). Int J Diabetes Dev Countries 1998;18:124–130. 

8. Line A, Bovette P. KAP on hypertension in a country in 

epidemiological transition. Hypertension 1998; 31:1136- 

1145. 

9. Rubin RR, Peyrot M. Quality of life and diabetes. 

Diabetes Metab Res Rev 1999; 15(3):205-218. 

10. Bardage C. Hypertension and health-related quality of 

life an epidemiological study in Sweden. Journal of 

Clinical Epidemiology 2002; 54( 2): 172-181. 

11. Heather P W, Joli D F, Kelly R, Elinor C C. Assessment of 

patient knowledge of diabetic goals, self-reported 

medication adherence, and goal attainment. Pharmacy 

practic, 2006; 4(4): 183-190. 

12. Amanda H, William W. Health related quality of life and 

treatment compliance with diabetes care. Disease 

management 2006, 9(4), 195-200. 

13. Ramesh A, Rasheed A, Nagavi B G. Effect of patient 

counseling on quality of life in type-2 diabetes mellitus 

patients in two selected South Indian community 

pharmacies: A study. Indian J Pharm Sci 2007; 69: 519- 

24. 




Influience of pharmacist provided education on Quality of Life in patients with 

HIV/AIDS-a study 

1 2 3 4 1 

Ramesh A* , Dinesh K , Nagavi B G , Mothi S N , Parthasarathy G 

1 

Department of Pharmacy Practice, JSS College of Pharmacy, SS Nagara, Mysore – 570 015 

2 

Manager, Bangalore. , 

3 

Dean, RAK Medical & Health Sciences, Dubai. 

4 

Chairman, Asha Kirana, Center for AIDS Care and Research, Mysore, India. 




An open labeled cross sectional study was conducted to assess the influence of patient counseling on Quality of Life (QoL) in patients living with 

HIV/AIDS (PLWA). Patients meeting the eligibility criteria were enrolled in to the study. Knowledge, attitude and practices (KAP) of the patients 

towards the disease management was analysed by using a suitably designed and validated KAP questionnaire at base line and at final follow up 

for all the patients. Structured counseling was provided to patients regarding the disease, drugs and life style modifications. Validated and 

Kannada translated WHO-QoL questionnaire was administered to assess the influence of education on health related quality of life (HRQoL) on 

all the enrolled patients. Paired't' test was used to assess the changes in QoL scores from baseline to final follow up. Sixty four patients 

completed all follow ups of the study. Demographic parameters like employment, income, education and absence of symptoms showed 

significant influence on QoL. Patients, who were on symptomatic treatment, showed significant improvement only in psychological (p

Ramesh A- Influience of pharmacist provided education on Quality of Life in patients with HIV/AIDS-a study 

6 

with HIV. Unlike developed nations where Anti-Retroviral 

Treatment (ART) is the management standard, in developing 

nations counseling and treatment of opportunistic infections 

(OIs) are the strategies of disease management. This strategy 

is neither resource intensive nor requires extensive use of 

7 

technology. 

Objective of this prospective study was to assess the impact of 

education / counseling on knowledge, attitude and practice 

(KAP) and QoL in patients living with HIV 

MATERIALS AND METHODS 

The present study was a prospective cross sectional 

observational study conducted at a South Indian NGO centre 

for AIDS care and research over a period of nine months. 

Patients meeting the inclusion criteria were enrolled in to the 

study after obtaining the written informed consent. 

Institutional ethical committee has approved the study. 

Study pharmacist received the suitable education and training 

from the AIDS counselors before initiating the project. The 

demographic, clinical, lab and medication information of the 

enrolled patients was documented in a suitably designed 

patient profile form and the information was kept 

confidential. Enrolled patients were classified as 

asymptomatic and symptomatic according to the WHO 

staging. Validated Kannada version of Knowledge, Attitudes 

and Practices (KAP) questionnaire containing questions 

regarding HIV infection, mode of transmission, prevention, 

treatment/cure, life style modifications and myths and 

misconception about the disease was administered at baseline 

and final follow up to assess the patients' knowledge, 

perception and management of the disease. 

Kannada translated and validated WHO Health related QoL 

8 

questionnaire brief version (WHO – QoL BREF) containing 

26 items covering four domains such as physical, 

psychological, social, and environmental domains was 

st nd 

administered at base line, 1 ,2 , and final follow ups. Scores 

in each domain range from 4 - 20, and higher scores reflected 

the better QoL. 

The study pharmacist provided the education to the enrolled 

patients about their infection, medications, nutrition and life 

style modifications complimented with suitably designed 

information leaflets. Patients were also counseled about the 

difference between being HIV positive and having AIDS, 

prevention and management of opportunistic infections. 

Psychological counseling was also provided to reduce the 

stressors associated with HIV disease to the patients and also 

to their care givers. 


Paired t-test and correlation coefficient were used to assess 

the statistical significance of the results. 


A total of 98 patients satisfying the inclusion criteria were 

enrolled in to the study. Among them 64 (65%) patients 

completed all the follow ups and the remaining 34 (35%) 

patients were considered as dropouts due to personal and 

health reasons. Demographic details, disease history, 

medication history of the study patients were presented in 

Table.1. 

Age (Year), Mean 

18-30 

31-45 

>45 

Sex 

Male 

Female 

Marital status 

Married 

Unmarried 

HIV risk factor 

Sex 

Blood and needles 

Others 

Educational Level 

Illiterates 

Primary/high school 

SSLC 

Pre-university 

Degree 

Employment 

Employed 

Unemployed / Housewives 

Income/Month (Rs) 

10,000 

Patients on ART 

Disease Stage 

Asymptomatic 

Symptomatic 

Table 1: Demographic details of the study subjects 

35 (56%) 

22 (34%) 

7 (10%) 

41 (64%) 

23 (36%) 

50 (78%) 

14 (22%) 

57 (86%) 

5 (11%) 

2 (3%) 

20 (31%) 

11 (19%) 

17 (25%) 

5 (10%) 

11 (15%) 

42(65 %) 

22 (35%) 

-- 

50 (78%) 

8 (12%) 

6 (10%) 

10 (15%) 

29 (40%) 

35 (60%) 

Influence of education on improvement of scores of the 

knowledge, attitude and practices (KAP) was presented in 

Figure. 1 

The WHO - QOL BREF Questionnaire was used to assess the 

quality of life in HIV infected patients. The scores of all the 

domains i. e. physical health, psychological domain, social 

56


Fig.1.Pre and Post counseling Knowledge, Attitude 

and Practices (KAP) scores 

Fig.2: Comparison of change in QoL scores from 

Base Line to Final Follow up 

KAP Questions 

1. HIV infection spreads by unprotected sex, blood transfusion, sharps 

and needles. 

2. Symptoms of HIV/AIDS include weight loss, persistent fever, diarrhea, 

cough and opportunistic infections 

3. The disease will be cured if the symptoms of the infection are cured. 

4. Other infections may occur if the disease is not treated with suitable anti 

retroviral drugs. 

5. Shaking hands, sharing the food and clothes with HIV patients may 

transmit the infection. 

6. Patients with HIV/AIDS can do their routine job. 

7. HIV patients can have sex with their partners using condoms. 

8. Counseling to relatives and friends of HIV patients may motivate them to 

support the HIV patients 

9. Regular follow up with the doctor and taking antiretrovirals agents may 

keep the infection in control. 

10. Hygienic practices, nutritious diet, rest and medication adherence will 

improve the health condition 

relationship and environmental domain were calculated. 

Higher scores indicated better quality of life. 

QoL scores of patients with symptomatic treatment in various 

follow ups are given in Table.2 and the QoL scores of patients 

receiving ART in various follow ups are given in Table.3. The 

overall QoL scores of the enrolled patients are given in 

Figure.2. 

QOL is a dynamic continuum, relating to many aspects of 

one's life. Social relationships, financial situations, workrelated 

issues, physical limitations, and intellectual 

challenges all play a role in determining QOL and satisfaction 

within the health care setting. Self-perception of how these 

factors negatively or positively influence one's QOL also 

9,10 

exerts a strong influence. 

Quality of life outcomes are important in persons with HIV 

because of prolonged physical and psychosocial 

consequences of the disease. The stress and loss associated 

with HIV/AIDS is profound and often compounded by 

societal stigma. Persons with HIV/AIDS face many problems 

in day-to-day living and their ability to cope influences their 

quality of life and the disease progression. Monitoring and 

enhancing quality of life during the disease trajectory 

becomes more important than following the disease and 

providing symptomatic relief. This study was conducted to 

identify common quality of life domains affected due to HIV 

infection and strategies to improve better quality of life as the 

disease is chronic with poor prognosis. 

Table. 2. Change in QoL Scores in Different Domains at Baseline and each Follow up in Patients 

Recieving Antiretroviral Therapy 

DOMAINS Baseline Follow Up-1 Follow Up-2 

Physical health 

Psychological 

domain 

Social 

relationship 

Environmental 

domain 

10.56 

10.00 

11.00 

13.56 

10.78 (p>0.05) 

11.22 ( p=0.002 ) 

12.00 ( p=0.002 ) 

13.67 (p>0.05) 

11.44 (p=0.009) 

(p=0.04) 

11.44 ( p0.05) 

12.22 ( p0.05) 

13.22 (p>0.05) 

(p>0.05) 

Follow Up-3 

13.56 (p=0.007) 

(p=0.02) 

(p>0.05) 

13.67 ( p0.05) 

(p>0.05) 

13.22 ( p0.05) 

13.22 (p>0.05) 

(p>0.05) 

(p>0.05) 


57


Table 3: Change of QoL scores in various follow ups in patients receiving symptomatic treatment 

DOMAINS Baseline Follow Up-1 Follow Up-2 Follow Up-3 

Physical health 

Psychological 

domain 

Social 

relationship 

Environmental 

domain 

10.18 

9.64 

10.24 

12.01 

9.90 (p>0.05) 

10.54 ( p=0.001 ) 

11.12 ( p=0.001 ) 

12.35 (p>0.05) 

10.07 (p>0.05) 

(p>0.05) 

11.28( p0.05) 

11.75 ( p0.05) 

11.26 (p>0.05) 

(p>0.05) 

10.01 (p>0.05) 

(p>0.05) 

(p>0.05) 

11.36 ( p0.05) 

(p>0.05) 

11.72 ( p0.05) 

(p>0.05) 

11.35 (p>0.05) 

(p>0.05) 

(p>0.05) 

During the course of the study, 35% of the enrolled patients 

dropped out from the study due to fear of their serostatus 

disclosure, dissatisfaction with medical services, absence of 

symptoms, financial problems and transportation difficulties. 

Majority study subjects were male and married and in many 

cases both partners got infected. In most of the cases, the 

source of infection was through sexual route attributing to the 

fact that the safe sexual practices are poor in our population. 

The educational background of the study subjects ranges from 

illiterates to university graduates. This indicates that 

HIV/AIDS is not a disease that confines to a particular 

segment of the society. Half of the study population has 

income less than Rs. 3000 per month and was found as a major 

barrier for poor affordability to antiretroviral therapy. 

Knowledge and awareness regarding the disease plays an 

important role in the patient's practices towards the 

management of the disease. A validated KAP questionnaire 

was administered at base line and final follow up to assess the 

influence of the patient counseling. At base line, the subjects' 

knowledge was good with respect to transmission, risk 

factors, however many of the respondents were having poor 

knowledge regarding symptoms, treatment, prognosis of the 

disease, and lifestyle modifications. A significant 

improvement was observed in the overall KAP scores at the 

final follow up suggesting the influence of education. Many 

studies have corroborated the influence of counseling on 

2,3 

knowledge and therapeutic outcomes. 

Many patients believe that HIV could be transmitted through 

mosquito bite, sharing food, clothes and other utility items. 

This is mainly due to myths and misconceptions prevailing in 

our society. During the counseling these myths can be 

removed. Many patients were unaware regarding the 

prognosis of the disease due to lack of information. Structured 

patient education offers moral support addresses certain 

issues like ART usage, lifestyle modifications, safe sex 

10,11 

practices. 

Validated WHO-QoL brief version, a quality of life 

instrument administered on study population at base line and 

all the subsequent follow ups. WHO-QOL brief version is a 

generic questionnaire and has been extensively applied on 

people with medical illness including HIV, and shown to be 

reliable and valid. This questionnaire measures the QoL 

mainly on four domains. These domains are physical health, 

psychological, social relationship and environmental domain. 

Previous studies have shown that physical, psychological and 

social functions were impaired in people living with 

12,13 

HIV/AIDS. This was the reason for selecting WHO-QoL 

questionnaire for our study in order to target these domains in 

assessing quality of life. 

In the present study, patients receiving symptomatic 

treatment reported to score low QoL scores compared to the 

patients on ART. This may be due to inadequate medical care. 

In patients on ART, it was observed that the scores in 

psychological and social relationship domain were decreased. 

This poor score may be due to social stigma and social 

isolation by the friends and relatives. In order to overcome 

this problem, counseling to their relatives and friends may 

14 

improve the acceptance of the patient by the society. 

The quality of life scores at baseline were correlated with 

socio demographics and illness related variables. The lack of 

significant association between QoL scores and variables 

such as age, gender, and source of infection is consistent with 

2 

previous findings. Some studies have also found that women 

15 

reported lower levels of QoL compared to men. But this 

trend was not observed in our study population. The variable 

of age shown an influence on QoL scores as the age advances 


58


the physical deterioration of the organs will influence the 

physical domain. Nevertheless we did not find this trend in 

our study and our findings are consistent with other many 

11 

studies, which found no relationship between QoL and age. 

A significant association of QoL scores and marital status was 

observed in our study. This may be due to the fact that, 

married persons may have greater resource constraints and 

more numbers of people being infected (spouse and / or 

16 

children) which will further hamper the quality of life. In the 

present study a non significant association was observed 

between the employment and QoL. Many studies have shown 

that the association between QoL and work status is primarily 

related to physical health rather than dimensions of well 

being. 

The most significant finding of our study is the strong 

association between stage of infection (symptomatic or 

asymptomatic) and QoL, highlighting the relationship 

between the QoL and number, frequency and severity of HIV 

related symptoms. Higher education and higher income level 

were associated with better quality of life because these 

patients scored higher on environmental domains than their 

counterparts with low education and low-income group. 

The psychological domain assesses the patients' mental 

health that includes bodily image, negative feeling, positive 

feeling, self-esteem, spirituality/personal beliefs, thinking, 

learning, memory and concentration. At base line the scores 

were disrupted due to the stress associated with HIV disease. 

Improvements in most items were observed in subsequent 

follow-ups. This improvement was observed due to 

behavioural interventions in the form of counseling and 

psychological support. The impact of behavioural 

interventions to assist patients in dealing with the stress of the 

17 

disease has been well documented in the literature. 

Moreover, many studies were observed that in stressful life 

events, psychological counseling improves the adverse 

15 

effects of stressors. 

The social relationship domain comprises the assessment of 

social support, personal relationship and sexual activity. The 

scores at base line on all items were adversely affected 

because of fear and stigma associated with the disease. 

Counseling the patient's spouse/husband, relatives and 

friends helped in improving the acceptance of patient. Social 

acceptance improved the QoL scores in subsequent follow 

1 

ups. Murdaugh C et.al described that social support is the 

major factor in improving quality of life in HIV infection. The 

major components of social support are emotional and 

2 

informational support. Susan S et.al showed that satisfaction 

with informational support will be a good predictor for better 

QoL. 

Physical health includes work capacity, energy/fatigue, 

mobility, pain, sleep, rest and dependence on medicines and 

medical aids. This domain was affected predominantly in 

symptomatic patients. Improvement was observed especially 

in patients receiving antiretroviral therapy, but this 

improvement was not seen in patients who were on treatment 

for opportunistic infections. Many studies have shown the 

improvement of HIV related constitutional symptoms in 

7 

patients receiving antiretroviral therapy. 

Environmental domain includes the assessment of 

satisfaction of the patients with education, financial status, 

medical facilities, home environment, transportation etc. At 

baseline environmental domain had better scores but later the 

scores were found declined may be due to dissatisfaction with 

medical facilities, poor cooperation from family members 

and inadequate transportation facilities to ART centers. 

Improvement in overall quality of life scores was not 

consistent with all the patients. Patients on antiretroviral 

treatment showed significant improvement in overall QoL 

compared to those receiving only symptomatic treatment for 

opportunistic infections. This lack of improvement in QoL 

may be attributed to decline in physical health and increase in 

18 

medical expenses due to frequent illness. 

This study concludes that structured education provided by 

the pharmacist to patients living with AIDS improved their 

awareness regarding the disease, coping with disease related 

challenges and in turn improved the overall quality of life 

scores showing a strong association of education with 

therapeutic outcomes and QoL. 


Authors whole heartedly thank JSS University, Principal, JSS 

College of Pharmacy, all the counselors at Asha Kirana and all 

the patients who participated in the study. 

REFERENCES 

1. Murdaugh C. Health-related quality of life in HIV 

disease: Achieving a balance. J Asso Nurses in AIDS 

Care. 1998;9:59-71. 

2. Susan S, J Mohr, N Singh et al. Quality of life in patients 

with human immunodeficiency virus infection: impact 

of social support, coping style and hopelessness. Int. J 

STD AIDS. 1999;10:383-391. 


59


3. Nunes JA. Raymond SJ. Nicholas PK et.al. Social 

support, Quality of life, Immune function, and Health in 

persons living with HIV. J Holis Nursing. 1995;13:174- 

198. 

4. Lubeck DP, Fries JF. Changes in quality of life among 

persons with HIV infection. Qual Life Res. 1992;1:359- 

66. 

5. Gaitunde V R. HIV disease in India: Treatment 

Guidelines. YRG Care. 2000; 51-57 and 71-77. 

6. Sandra A N. The role of Pharmacists in Caring for 

People Living with HIV/AIDS: A Canadian Position 

Paper. Canadian J Hosp Pharm 2000;53:92-103. 

7. Richard D, Gerber, William R, Lender king, et.al. 

Quality of life Evaluation Trial of Zidovudine Therapy 

in Patients with Mildly Symptomatic HIV Infection. 

Ann Intern Med 1992;116:961-966. 

8. World Health Organization. WHOQOL-BREF. 

Introduction, Administration, Scoring and Generic 

Version of the Assessment. Field Trial Version 1996 

Dec. 

9. Sousa KH, Holzemer WL, Henry SB et.al. Dimensions 

of health-related quality of life in persons living with 

HIV disease. J Advanced Nursing. 1999;29:178-87. 

10. Berra K. The Effect of Lifestyle Interventions on 

Quality of Life and Patient Satisfaction with Health and 

Health Care. J Cardio Nursing. 2003;18:319-325. 

11. Prabha S C. Psychological and sexual adjustment 

among persons living with HIV. MADHYAM. 2000; 

20-24. 

12. Bing EG, Hays RD, Jacobson LP et.al. Health-related 

quality of life among people with HIV disease: results 

from the Multicenter AIDS Cohort Study. Qual Life 

Res. 2000;9:55-63. 

13. Spirig R. Support groups for people living with 

HIV/AIDS: a review of literature. Journal of the 

Association of Nurses in AIDS Care. 1998;9:43-55. 

14. Sherbourne CD, Hays RD, Fleishman JA, et.al. Impact 

of psychiatric conditions on health-related quality of 

life in persons with HIV infection. Am J 

Psychiatry.2000;157:248-54. 

15. Sowell RL, Seals BF, Moneyham L et.al. Quality of life 

in HIV-infected women in the south-eastern United 

States. AIDS Care. 1997; 9:501-12. 

16. Cunningham WE, Shapiro MF, Hays RD et.al. 

Constitutional symptoms and health-related quality of 

life in patients with symptomatic HIV disease. Am J 

Med.1998; 104:129-36. 

17. Hays RD, Shapiro MF. An overview of generic healthrelated 

quality of life measures for HIV research. Qual 

Life Res. 1992; 1:91-7. 

18. Globe DR, Hays RD, Cunningham WE. Associations of 

clinical parameters with health-related quality of life in 

hospitalized persons with HIV disease. AIDS Care. 

1999; 11:71-86. 

19. Franchi D, Wenzel RP. Measuring health-related 

quality of life among patients infected with Human 

Immunodeficiency virus. Clinical Infectious Diseases. 

1998; 26:20-6. 




Drug use and dosing in patients with renal impairment 

Veera Raghavulu B*, Shravani K, PrabhakarReddy V, ManoharBabu S. 

St. Peter's Institute of Pharmaceutical Sciences, Vidyanagar, Hanumakonda, Warangal, Andhra Pradesh, India. 



INTRODUCTION 

Chronic kidney disease is a worldwide public health problem 

with an increasing incidence and prevalence, poor outcomes, 

1 

and high costs. Current evidence suggests that some of these 

adverse outcomes can be prevented or delayed by early 

2 

detection and treatment. Many drugs and metabolites are 

eliminated through the kidney. Inappropriate use of drugs in 

patients with renal impairment (RI) may therefore be harmful 

3,4 

and have deleterious effects. The use of drugs in patients 

with reduced renal function can give rise to problems for 

5 

several reasons: reduced renal excretion of a drug or its 

metabolite may cause toxicity; sensitivity to some drugs and 

is increased even if elimination is unpaired; many side-effects 

are tolerated poorly by patients with renal impairment; some 

drugs are not effective when renal function is reduced; many 

of these problems can be avoided by reducing the dose or by 

6 

using alternative drugs. The aim of this study to know the 

drug use and dosing prescribed for patients with reduced renal 

function. The objective was to identify the use of renal risk 

drugs and frequency of drug-related problems in relation to 

risk rules in renal impairment, establishing the frequency of 

inappropriate dosing at the time of discharge in accordance 

with renal function. 

METHODS 

All medication records of the renal impaired patients who had 

been discharged from general medicine department from the 

Rohini Multispeciality hospital through the discharge 

counseling service during the period of December 2009 to 

June 2010 were studied. A data collection form was specially 

prepared for this purpose. Renal function of each patient was 

estimated by calculating the estimated GFR based on the 

average of the last 2 serum creatinine levels during admission. 

Each drug in the prescription of each patient was analyzed 

critically whether it could be prescribed in patients with 

impaired renal functions. Dosage adjustments are usually 


Veera Raghavulu. Bitra, St. Peter's Institute of Pharmaceutical Sciences, Vidyanagar, 

Hanumakonda, Warangal, Andhra Pradesh, India. 

E-mail: raghavab27@yahoo.com 


7,8,9 

recommended when the GFR decreases to 50 ml/min. 

Therefore in all patients with an estimated GFR less than 

2 

51ml/min/1.73m , prescriptions at discharge were reviewed 

to identify the need for dosage adjustment related to renal 

function and for contraindications. 

Inclusion criteria: 

Renal impaired and renal transplanted patients (eGFR < 

2 

51ml/min/1.73m ) of both sex, 

Adults and children were included in this study. 

Exclusion criteria: 

2 

Patients who had eGFR > 50ml/min/1.73m 

Pregnant and lactating women. 

Classification of drug related problems (DRPs) 

DRPs were defined in accordance with the definition of 

Pharmaceutical Care Network Europe: a drug related 

problem is an event or circumstance involving drug therapy 

that actually or potentially interferes with desired health 

10 

outcomes. The patient were assessed for DRPs of 12 

categories: need for an additional drug i.e. according to 

evidence-based guidelines, unnecessary drug, non-optimal 

drug, non-optimal dose, no further need of drug, drug 

interaction, need for monitoring, adverse drug reaction 

(ADR), medical chart error, compliance problems, therapy 

discussions and counselling to patients in need of drug 

10 

information. For the DRP drug interaction, only those 

regarded to be clinically important, were included. 

DATA SOURCE 

To assess the need for dosage adjustment, we referred to the 

following Drug prescribing in renal failure: dosing guidelines 

7 

for adults , Clinical Nephrotoxins: Renal Injury from Drugs 

8 

and Chemicals and Drug Dosing Adjustments in Patients 

with Chronic Kidney Disease. If guidelines differed among 

these references, either the lowest percentage of the usual 

dose or the maximum interval prolongation was applied. 

To evaluate the drug-drug interactions, we referred to the 

following handbooks: 

61

Veera Raghavulu B - Drug use and Dosing in Patients with Renal Impairment 

Stockley's Drug Interactions: a source book of interactions, 

11 

their mechanisms, clinical importance and management , 

Drug Interaction Facts 2005. Facts and Comparisons: 

12 

A to Z Drug Facts and MED facts: Pocket guide of drug 

13 

interactions. 

STATISTICAL ANALYSIS 

The data were analyzed in SPSS 15.0 for Windows. To test for 

differences between patients with mild, moderate and severe 

renal impairment, one way ANOVA independent samples 

were used. P-values

Comparison of the three grades of RI with total number of 

b 

drugs, renal risk drugs per patient, number of DRP per patient 

and other risk factors were made. Significant differences were 

found as shown in the table 2. 

Renal risk drugs 

A total of 1718 drugs were found to be prescribed for 215 RI 

patients. Of 1718 drugs, 551 were found to be renal risk 

drugs. Table 3 shows the category of renal risk drugs: 299 

(53%) drugs were those that required dosage adjustments, 

219 (40%) were drugs to be used with caution and 33 (6%) 

drugs which were to be avoided. Drugs recommended to be 

avoided were used by 9 patients in mild RI; 4 patients in 

moderate RI and 14 patients in severe RI. 

Risk rule for 

drugs in RI 

Dose Adjustment 

Reduce dose in mild to 

moderate RI 

Reduce dose in 

severe RI 

Start with small doses 

Caution 

Caution 

Caution, monitor serum 

concentration 

Increased cerebral 

sensitivity 

Avoid 

Avoid in mild to 

moderate RI 

Avoid in severe RI 


No. of 

patients 

Of 215 renal impaired patients, 153 patients used two or more 

renal risk drugs. 

b 

The most common DRP for all patients with RI irrespective 

of their severity was non-optimal dose (75) as compared to 

non-optimal drug (33) or drug-drug interactions (56) or the 

need for monitoring (34) (Table 6). 

Generally there was a trend towards an increasing number of 

non-optimal drug and drug-drug interaction with 

deteriorating renal function 

The commonest drug classes used in renal impaired patients 

b 

linked to DRP were Anti-bacterials (52 occurrences), ACE 

inhibitors (26 occurrences), oral hypoglycaemic drugs (15 

occurrences), allopurinol (12 occurrences), ranitidine (9 

Table 3: USE OF RENAL RISK DRUGS IN 215 PATIENTS WITH RENAL IMPAIRMENT (RI) AND FREQUENCY OF DRUG-RELATED 

PROBLEMS (DRPs) IN RELATION TO RISK RULES IN RI (n=551) 

No. of renal risk No. of renal risk 

drugs identified in drugs associated 

b 

each category (% with DRPs (% of 

of drugs on discharge) renal risk drugs) 

183 299(17 %) 73(24 %) 112 

113 

70 

19 

135 

110 

16 

36 

27 

13 

14 

157 

122 

20 

219 (13 %) 

160 

19 

40 

33 (2 %) 

16 

17 

24 (15 %) 

47 (39 %) 

4 (20 %) 

35 (16 %) 

22 (14 %) 

13 (68 %) 

0 

33 (100 %) 

16 (100 %) 

17 (100 %) 

No. of 

b 

DRPs 

46 

60 

6 

43 

25 

18 

0 

41 

23 

18 

Most frequent 

drugs associated 

b 

with DRP 

cefixime, quinapril 

Ranitidine, 

allopurinol 

Benzodiazepines 

Enalapril, quinapril 

Ciclosporin, 

sulphamethoxazole 

Metformin, 

spironolactone 

nitrofurantoin 

Aspirin, glimepride, 

glipizide 

a 

The number of patients in each main risk rule category is lower than the sum of patients in subgroups. The reason is that each patient 

b 

may belong to more than one of the subgroups, see Subjects and methods section. DRPs included: non-optimal drug, non-optimal 

dose, drug-drug interaction and need for monitoring. 

Table 4: Renal Risk Drugs as Proportions of all Drugs used by Various Degrees of Renal Impairment 

Renal impairment No. of Patients No. of drugs No. (%) of renal Ratio of renal risk 

(No. of drugs risk drugs drugs/all drugs per 

per patient) 

patient (mean) 

Mild (eGFR 20-50 mL/ 

2 

minute/1.73 m ) 48 352 (7.33) 109 (31) 0.29 

Moderate (eGFR 10-20 mL/ 

2 

minute/1.73 m ) 89 745 (8.37) 223 (30) 0.28 

Severe (eGFR < 10 mL/ 

2 

minute/1.73 m ) 72 621 (7.96) 216 (35) 0.34 


63


No. of renal risk 

drugs used 

Table 5: Distribution of 551 renal risk drugs in 215 Patients with Renal Impairment 

No. of patients No. of patients No. of patients 

required dosage required drugs to required drugs to 

adjustments n=183 be used with be avoided n=27 


patients used renal 

risk drugs n=215 

caution n=135 

Single drug 47 12 3 62 

Two drugs 45 41 8 60 

Three drugs 41 32 5 42 

Four drugs 16 16 2 17 

Five drugs 12 12 3 12 

Six drugs 18 18 6 18 

Seven drugs 2 2 0 2 

Eight drugs 2 2 0 2 

b 

Table 6: Comparison of Mild, Moderate and Severe Renal Impaired Patients with Regard to DRP 

b 

b 

b 

b No. of DRP in No. of DRP in No. of DRP in 

DRP 

mild RI n=48 moderate RI n=89 severe RI n=78 

Non-optimal dose 7 17 51 

Non-optimal drug 12 4 17 

Drug-drug interaction 22 21 13 

Need for monitoring 16 9 9 

Table: 7 Comparison of Mild, Moderate and Severe Renal Impaired Patients with Regard to 

b 

mean number Of DRP per Patient 

b 

DRP 

b 

b 

b 

No. of DRP per No. of DRP per No. of DRP per 

patient for mild patient for moderate patient for severe 

RI (mean) n=48 RI (mean) n=89 RI (mean) n=78 

Non-optimal dose 0.15 0.19 0.65 

Non-optimal drug 0.25 0.05 0.22 

Drug-drug interaction 0.17 0.19 0.63 

Need for monitoring 0.46 0.23 0.17 

Table 8: Comparison of Mild, Moderate and Severe Renal Impaired Patients 

b 

Mild vs 

DRP 

Mild vs Mild vs Moderate 

Moderate 

Moderate RI Severe RI vs SevereRI 

vs SevereRI 

Non-optimal dose NS < 0.05 < 0.05 < 0.01 

Non-optimal drug < 0.01 NS < 0.01 < 0.0001 

Drug-drug interaction NS < 0.01 < 0.01 NS 

Need for monitoring < 0.01 < 0.01 NS < 0.001 

occurrences), aspirin (8 occurrences) and atenolol (4 

occurrences). 

In 299 drugs for 162 patients required dosage adjustments 

according to renal function as recommended by guidelines. 

This adjustment was done in 224 drugs. The other 75 drugs 

were not adjusted involving 27 % of the patients. Table 9 

shows required versus implemented dosage adjustments 

according to guidelines in patients with renal impairment. 

Of the 551 renal risk drugs, 33(6 %) drugs which were 

recommended to be avoided according to renal function as per 

7 

guidelines were prescribed to the 27 patients with renal 

impairments (RI). Table 10 shows the list of these drugs used. 



b 

Fig. 1: Distribution of the drug-related problems (DRP ) per patient in 

hospitalized patients with different stages of renal function 

Fig.2: No. of Occurrences of drugs 

Egfr 

10-50 

mL/min/1.73 m 


DISCUSSION 

Drugs recommended to be used with caution, avoided or 

given with dose adjustment (renal risk drugs) in the case of 

reduced renal function were commonly used in patients with 

Renal Impairment (RI). Apparently, the recommendations 

were only followed to a limited degree, as the utilization rates 

of renal risk drugs were high in patients with severe RI than in 

patients with mild to moderate RI. 

We found that in general, more drugs were prescribed per 

patient in the patients with moderate to severe renal 

impairment than in patients with mild renal impairment. The 

main reason for this was that the patients in the former group 

were older and had more accompanying co-morbidities: for 

example diabetes and hypertension, which evoke decline of 

renal function in addition to the genuine age-related decline. 

Thus, the pharmacotherapy of the elderly becomes more 

abundant and more complex, contributing to the high 

proportion of renal risk drugs being used in patients with 

moderate to severe RI. 

The identification of high numbers of DRPs in patients with 

renal impairment is probably a result of special awareness of 

DRPs within the multidisciplinary team, particularly so 

among the clinical pharmacists who, among other tasks, were 

specifically screening for DRPs. Attention to the occurrence 

of DRPs is a valuable way of monitoring drug therapy, 

helping physicians and other health care workers to act and 

adjust drug regimens before adverse events arise. Hege 

Salvesen Blix et al showed that among these, particular 

attention should be paid to the DRPs such as non-optimal 

dose, need for monitoring, non-optimal drug, drug 

interactions and adverse drug reactions, since these occurred 

more frequently in patients with non-adequate renal function, 

and besides, with a trend of more frequent occurrence with 

14 

increased severity of renal impairment. Our study identified 

DRPs such as non-optimal dose, need for monitoring, nonoptimal 

drug and drug-drug interactions, in patients with 

reduced renal function. DRPs were frequently associated with 

the use of renal risk drugs. 

The recommendation lists for renal risk drugs are long and 

include many drugs in common use, also drugs which are 

important and beneficial for patients with certain renal 

15 

diseases, for example, ACE inhibitors. Usually such 

substances do not create problems. However, these drugs 

must be used cautiously. Moreover, the drug 

recommendation lists address only single substances and do 

not give any guidance on how to handle the combination of 

several renal risk drugs. Combinations of renal risk drugs may 

increase the hazards for patients with reduced renal function. 

We found that most patients received not only one renal risk 

drug but a combination of two or more. The question of how to 

combine renal risk drugs has not been addressed in the 

literature. 

The study by Vidal L et al (2005), shown that remarkable 

variations in definitions and recommendations, based on 

scarce data, make the available sources of these guidelines 

16 

less reliable . Physicians may refrain from dosage 

adjustments because of these confusing and often conflicting 

sources. A dynamic alert system would be useful to monitor 

the dosage of certain drugs in relation to a patient's renal 

function. Linking medication data to renal function 

parameters offers the clinical pharmacist the ability to check 

medication profiles more quickly and accurately, which 

seems to be the solution to reducing medication errors and 

17 

improving pharmaceutical care. Further research is 

necessary before the specifications of such a system can be 

developed according to the needs and wishes of pharmacists 

and physicians. 

LIMITATIONS 

By performing this study in only one hospital, there is the 

possibility that our findings represent a unique situation. The 

time of discharge was chosen for the analysis because these 

patients are leaving the hospital with medication prescribed 

primarily for chronic use. Because patients with impaired 

renal function are vulnerable for an adverse drug event after 

hospitalization, drugs should be prescribed judiciously. 

Monitoring medication records at discharge could be a useful 

18 

tool to prevent rehospitalization. 

In our population, renal function was estimated using 

Modification of Diet in Renal Disease (MDRD) equation. 

This equation was developed in patients with chronic kidney 

disease, who were predominantly white and did not have 

diabetic kidney disease or a kidney transplant. The equation 

has been validated for African Americans but no other ethnic 

groups. The authors report that this method is more accurate at 

19 

estimating GFR than the Cockcroft and Gault equation. 

However, the equation assumes that all patients have a body 

2 

surface area (BSA) of 1.73 m . For patients with a BSA less 

2 

than 1.73 m the eGFR is likely to overestimate their kidney 

2 

function and for patients with a BSA greater than 1.73 m the 

eGFR is likely to underestimate their kidney function. Use of 

the patient's actual BSA will overcome this problem, but this 

requires the patient's height and weight to be available. 

CONCLUSION 

A clinical pharmacist in a nephrology unit is a valuable asset 

in monitoring drug dosing in RI patients. These patients are 



often prescribed with drugs that have to be used with caution 

or avoid or dose reduced according to the grade of renal 

5 

impairment. The British National Formulary , Drug 

7 

prescribing in renal failure: dosing guidelines for adults and 

Renal drug handbook which gives a valuable guidance to 

clinical pharmacists on ward rounds in nephrology unit. 

These Guidelines can be implemented in a dynamic alert 

system that could help physicians and pharmacists to adapt 

drug dosing in patients with renal impairment. Such a 

computerized knowledge system, which would select patients 

at risk and link laboratory data to pharmacy data, can provide 

uniformity in dosing advice regardless of the healthcare 

professional. This would lead to continuous and 

comprehensive screening of all contraindicated drugs and 

inadequate dosages. It should be remembered that the Official 

reduced doses recommended in product literature are often 

exceeded in practice, especially after lower doses have been 

tried. We believe that the above mentioned are essential to 

optimize pharmaceutical care for RI patients. 


Authors wish to acknowledge T. Jayapal Reddy, Director, 

St.Peter's Institute of Pharmaceutical Sciences, Warangal 

(A.P) for the infrastructural facilities and moral support. 

REFERENCES 

1. Levey AS, Coresh J, Balk E et al. National Kidney 

Foundation practice guidelines for chronic kidney 

disease: evaluation, classification, and stratification. Ann 

Intern Med 2003; 139:137–147. 

2. St Peter WL, Khan SS, Ebben JP, Pereira BJ Collins AJ, 

Chronic kidney disease: the distribution of health care 

dollars. Kidney Int 2004; 66:313–321 

3. Turnheim K. Drug therapy in the elderly. Exp Gerontol 

2004; 39: 1731–1738 

4. Manian FA, Stone WJ, Alford RH. Adverse antibiotic 

effects associated with renal insufficiency. Rev Infect Dis 

1990; 12:236–249 

5. British National Formulary, 54th ed. London: British 

Medical Association and Royal Pharmaceutical Society 

of Great Britain, 2007. 

6. Ashley Caroline, Clare Introduction to Renal 

Therapeutics, Pharmaceutical Press, 2008. 

8. Marc E. BROE DE, George AP, Clinical Nephrotoxins: 

rd 

Renal Injury from Drugs and Chemicals, 3 ed. Springer 

Science+Business Media, LLC, 2008. 

9. Myrna Y. Harleen, Drug Dosing Adjustments in Patients 

with Chronic Kidney Disease, American Academy of 

Family Physicians, Am Fam Physician 2007; 75:1487- 

96. 

10. DRP-classification: van Mil Consultancy, 

Pharmaceutical Care Network Europe, V3.01. 2002 

11. Stockley's IH. Drug Interactions: a source book of 

interactions, their mechanisms, clinical importance and 

management, 8 th ed. Pharmaceutical Press, 2008. 

12. David S. Tatro, Tatro DS (ed). Drug Interaction Facts 

2005. Facts and Comparisons, St. Louis,MO, 2005. 

13. George R. Bailie,Curtis A. Johnson, Nancy A. Masonand 

Wendy L, St. Peter. MED facts: Pocket guide of drug 

interactions, Nephrology pharmacy associates, Bone 

Care International, Inc.2000. 

14. Salvesen HB, Kirsten KV, Moger TA and Reikvam A. 

Use of renal risk drugs in hospitalized patients with 

impaired renal function—an underestimated problem. 

Nephrol Dial Transplant (2006) 21: 3164–3171 

15. Shlipak MG. Pharmacotherapy for heart failure in patients 

with renal insufficiency. Ann Intern Med 2003; 

138:917–924 

16. Vidal L, Shavit M, Fraser A et al. Systematic comparison 

of four sources of drug information regarding adjustment 

of dose for renal function. BMJ 2005; 331:263–266. 

17. Schiff GD, Klass D, Peterson J, Shah G, Bates DW. 

Linking laboratory and pharmacy: opportunities for 

reducing errors and improving care. Arch Intern Med 

2003;163:893-900. 

18. Wasserfallen J, Livio F, Buclin T, Tillet L, Yersin B, 

Biollaz J. Rate, type, and cost of adverse drug reactions in 

emergency department admissions. Eur J Intern Med 

2001;12:442-447. 

19. Poggio ED, Wang X, Greene T, Van Lente F, Hall PM. 

Performance of the modification of diet in renal disease 

and Cockcroft-Gault equations in the estimation of GFR 

in health and in chronic kidney disease. J Am Soc Nephrol 

2005;16:459-466.. 

7. Aronoff GR, Berns JS, Brier ME, et al. Drug prescribing in 

renal failure: dosing guidelines for adults. 4th ed. 

Philadelphia: American College of Physicians, American 

Society of Internal Medicine, 1999. 




Prescription errors in Guntur district of Andhra Pradesh- A retrospective 

study 

1 1 2 3 

Pulla Reddy M* , Vijayapandi P , Aruna kanth C H , karthikeyan R 

1 

Department of Pharmacology, The Erode College of Pharmacy & Research Institute, Erode -638112, T.N. 

2 

Department of Analytical Chemistry,Governor States University, Illinois, Chicago, U.S.A. 

3 

Department of pharmacognosy, Vignan Pharmacy College, Vadlamudi, Guntur. 


During the course of treatment, drug prescribed to patients produce certain effects other than desired or expected effects. These are referred as 

adverse drug reactions which concern both patient as well as physician. People usually attribute these effects to either overdose or 

inappropriate medications or more drugs are prescribed by physician. ADRs are one of the leading causes of morbidity and mortality in health 

care and also associated with increased cost of treatment. Now a day's incidence of ADRs increases exponentially after a patient is on 4 or more 

medicines. Drug interaction represents 3-5% of preventable ADRs. Hence efforts are necessary to reduce unnecessary prescribing and this is 

where it becomes important to understand basic drug interactions. Given a choice between no treatment and effective treatment with a risk of 

toxicity, physician usually selects latter one. Our job is to maximize the benefit and minimize the risk, but before we can minimize the risk, we 

must first be able to assess it accurately. Thus, health care practitioner must develop their own system of approach to prevent undesirable drug 

interactions; up-to-date database is valuable as well as frequent consultation with other members of healthcare team, like pharmacists and 

nurses, is essential. 

Key Words: Drug interactions, adverse drug reactions, Burden. 



INTRODUCTION 

The screening of prescriptions and intervention process 

commences with the pharmacist's initial assessment for 

completeness and legibility of the prescriptions. Prescription 

deficiencies formed a large proportion of errors identified in 

1 

prescription screening . This is mainly due to the attitude of 

some prescribers who are always in a hurry and hence 

unwilling to spend a little more time in writing clear and 

complete prescriptions. However the extra time spent on the 

prescription will help to ensure that the patient receives the 

treatment that is intended by the prescriber. Additionally, the 

prescriber will be well compensated for the time taken by not 

2 

having to answer enquires from pharmacist . Errors in 

prescribing may be classified into two main types, errors of 

omission and errors of commission. Errors of omission are 

defined as prescriptions with essential information missing, 

while errors of commission involve wrongly written 

3 

information in the prescriptions . Non-compliance with 

prescription writing requirements involves mainly errors of 


Raval DK, SVKM's NMIMS School of Pharmacy & Technology Management., Vile-Parle 

(W), MUMBAI - 400056. INDIA. 

4 

omission. A study by Ingrim et al ., in an outpatient pharmacy 

department found that the overall rate of prescription noncompliance 

was 14.4%. In this study, the pharmacist spent 

16.3 hours each day for correcting prescription errors. Other 

studies found that the rate of prescribing errors between 2.6% 

5-11 

to 15.4% . Studies on the types of prescribing errors in India 

appeared scarce in the literature. Therefore, the present study 

was conducted to evaluate the extent of non-compliance with 

prescribing writing requirements. 

MATERIAL AND METHODS 

Material: Photocopies of prescriptions were collected from 

different pharmacy stores in Guntur district of Andhra 

Pradesh, India 

Duration: The study was conducted during January 2009 to 

November 2009. 

Inclusion Criteria: Prescriptions having at least one 

prescription error were included in this study. 

Methods 

Parameters of Audit for Standard format of the prescription 

1. Patient identity: Name and address of the patient. Also 

age and weight in case of pediatric patients. 


68

Pulla Reddy M - Prescription Errors in Guntur district of Andhra Pradesh- A retrospective study 

2. Date on which the prescription was issued. 

Fig 1: Percentage errors committed in the total screening prescriptions 

3. Superscription symbol: Rx meaning “take thou” or 

“recipe”. 

4. Inscription: which includes the name of drugs, dose, 

dosage forms, and total amount of medication prescribed. 

5. Subscription: the dispensing and compounding 

instructions to the pharmacist as regards to form and 

quantities to be dispensed or supplied. 

6. Transcription or Signa: the direction to the patient for use 

of drugs. 

7. Prescriber's identity: Name, address and qualification. 

Retrospective Screening of Prescriptions 

The study was conducted in five different pharmacy stores in 

Guntur district of Andhra Pradesh state, India. The pharmacy 

stores receiving more than 100 prescriptions per day and was 

operated by at least one registered pharmacist; one trainee 

pharmacist and one pharmacy assistant were included in this 

study. The study involved retrospective screening of new 

prescriptions received by the above pharmacies. A researcher 

with pharmacy training but not a staff of the pharmacy 

collected the prescriptions during the study and screened 

them retrospectively. Any prescription that did not comply 

12, 13 

with one or more of the legal or prescription requirements 

would be considered as non -compliance and this was 

recorded in the standard form. 

RESULTS 

Totally 256 prescriptions were received during the study. Out 

of which 231 prescriptions were identified and included 

which contained atleast one prescription error. Of these 

prescriptions, 70.5% did not follow at least one of the legal or 

procedural requirements and the errors are classified in table 1 

& Fig 1. It was further noted that 172 prescriptions had 

mentioned diagnosis in it. Of the 231 prescriptions 37% of 

patient's hadn't completely purchased the ordered 

prescription. The researcher who screened the prescriptions 

Table 1: Classification of Prescription Errors based on Standard 

17 

Format of the Prescription (n=231) 

Errors Frequency Percentage Error (%) 

Patient ’ s identity 3 36 

Age 62 11 

Sex 163 2 

Date 19 3 

Registration number 15.5 26.8 

Prescriber’s name 4.7 70.5 

Prescriber’s signature 0.8 8.2 

was unable to read many prescriptions while pharmacist in 

charge had managed to read these prescriptions. 

DISCUSSION 

Out of 256 prescriptions, only 25 prescriptions complied with 

all the legal requirements of the Standard prescription. This 

alarms a need of clear writing and completeness of 

prescriptions from physician's side. Some useful points for 

2,14 

prescription writing have been suggested elsewhere. These 

included writing the patients full name, printing the name of 

drugs especially those newly marketed medications and those 

infrequently prescribed agents, indicating the strength and 

dosage form of all drugs prescribed even if only single 

strength or dosage form is available. The rate of noncompliance 

to the legal or procedural requirements varied 

from 70.5% without physician's registration number. The 

seriousness of such noncompliance will lead to open ends to 

the quack doctors. The absence of the patient's age and sex 

would not normally prevent the dispensing of the 

prescription. It could be easily resolved with the patient or the 

holder of the prescription if required. Whereas absence of the 

prescribers signature would invalidate the prescription and 

cause in convenience to the patient and staff involved. This 

especially crucial if the prescription was for psychotropic or 

controlled drugs. More than 25.54 % of the prescriptions don't 

have diagnosis in it. This may be more helpful in the case 

where the patient visits another doctor during their drug 

therapy. Whether a prescription is legible or not depends on 

the assessor's familiarity with the handwriting of the 

prescriber as well as information provided in the prescription. 

This has been demonstrated in the present study where the 

researcher faced difficulties in reading many prescriptions as 

compared to the pharmacist of that pharmacy who managed to 

read all prescriptions. However, it should be emphasized that 

prescriptions should be easily read by anyone involved in the 

dispensing activities since the prescriptions could be filled by 


69

Pulla Reddy M - Prescription Errors in Guntur district of Andhra Pradesh- A retrospective study 

any pharmacy. This is especially important since many drugs 

tend to have similar names such as ambroxil, amoxil, cetrizet, 

14 

cetricet, losec, lasix. This type of error may be reduced if the 

indication of the drug prescribed or the medical problem of 

the patient is also written in the prescription as suggested by 

15 

Robinson. It is demonstrated that an elegant and clear 

prescription can cut transaction errors by 84% and save more 

16 

than 2.5 million dollars in adverse drug reaction. Therefore, 

all prescriptions should be clearly and adequately written and 

if possible printed to prevent such medication errors. The 

implementation of electronic prescription will probably 

eliminate some of these problems. 

CONCLUSION 

The results of the present study show a low compliance rate to 

the legal and procedural requirements in prescription writing. 

This alarms a need for pharmacy and medical educators to 

further emphasize the importance of writing clear and 

complete prescriptions. It also calls for the implementation of 

educational and monitoring programs to bring more 

awareness to all concerned so as to reduce the rate of noncompliance 

and hence minimize the occurrence of 

prescribing errors. 

REFERENCES 

1. Rupp MT, Schondelmeyer SW, Wilson GT, Krause JE. 

Documenting prescribing errors and pharmacist 

interventions in community pharmacy practice. Am 

Pharm 1988; NS28(9):30-37. 

2. Cohen MR, Davis NM. Complete prescription orders 

reduce medication errors. Am Pharm 1992; NS32:24-25. 

3. Rupp MT. Screening for prescribing errors. Am Pharm 

1991; NS31:71-78. 

4. Ingrim NB, Hokanson JA, Guernsey BG, Doutre WH, 

Blair CW Jr, Verrett TJ. Physician noncompliance with 

prescription writing requirements. Am J Hosp Pharm 

1983; 40:414- 417. 

5. Christensen DB, Campbell WH, Madsen S, Hartzema 

AG, Nudelman PM. Documenting outpatient problem 

intervention activities of pharmacists in an HMO. Med 

Care 1981; 19:105- 117. 

6. Folli HL, Poole RL, Benitz WE, Russo JC. Medication 

error prevention by clinical pharmacists in two children's 

hospital. Pediatrics 1987; 79:718-722. 

7. Morrill GB, Barreuther C. Screening discharged 

prescriptions. Am J Hosp Pharm 1988; 45:1904-1905. 

8. Hawkey CJ, Hodgson S, Norman A, Daneshmend TK, 

Garner ST. Effect of reactive pharmacy intervention on 

quality of hospital prescribing. BMJ 1990; 300:986-990. 

9. Bates DW, Boyle DL, Vander Vliet MB, Schneider J, 

Leape LL. Relationship between medication errors and 

adverse drug events. J Gen Intern Med 1995; 10:199-205. 

10. Lesar TS, Briceland L, Stein DS. Factors related to errors 

in medication prescribing. JAMA 1997; 277:312-317. 

11. Lesar TS, Lomaestro BM, Pohl H. Medication 

prescribing errors in a teaching hospital. A 9-year 

experience. Arch Intern Med 1997; 157:1569-1576. 

12. Aiken, M.G. and Pugh, A. L.G. pharmaceutical practice, 

st 

1 Ed., Churchill living stone, Edinburg, 1991:61-72 

13. Allen, L.V.Jr. Remington's. The science and practice of 

th 

pharmacy 20 Ed., B.I. Publications, India, 2000:1706- 

1715. 

14. Aronson JK. Confusion over similar drug names: 

Problems and solutions. Drug Safety 1995; 12(3):155- 

160. 

15. Robinson A. An ounce of prevention could eliminate 

most prescription-writing errors. Can Med Assoc J 1994; 

151:659-661. 

16. Bates, D.W., Leape, L.L., Cullen DJ, et al. Effect of 

Computerized Physician Order Entry and a Team 

Intervention on Prevention of Serious Medication Errors 

JAMA, 1998;280:1311-1316. 

17. Neville, R.G., Robertson, F., Livingstone, S., Crombie, 

I.K, Classification of prescription errors, Journal of the 

Royal College of General Practitioners, 1989;39:110- 

112. 


70

Jan-Mar, 2011 - Indian Journal of Pharmacy Practice

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?