assessment of over-the-counter medicine labels in india for Patient ...

Article
assessment of over-the-counter medicine labels
in india for patient information
Joshi M.P., Vaidya R.X., De Sousa E., Mangaonkar Sneha
Goa College of Pharmacy, Goa.
Introduction:
In most countries of the world, there exists a category of OTC
(Over the Counter) medicines. However, in India, there is no such
designated category. As such, as a norm, in India, those medicines
which do not, by law, require a prescription, are considered as nonprescription
(or OTC) medicines. OTC medicines are an important
component in health care, allowing the freedom to the patient
to self-medicate for treating minor, common health problems, at
lower costs and without having to spend time and costs of visiting
a doctor.
Although OTC medicines are supposed to be relatively safe,
readily available and consumed by patients without a physician’s
consent, it is very important that the patients have access to
sufficient information to make an informed choice for the proper use
of these medicines. It is important to realize that like prescription
medicines, even OTC medicines can cause unwanted side effects
if not used correctly.
The label of OTC medicines plays an important role in conveying
valuable information to the patient. We undertook a small study
to evaluate whether medicine labels of OTC medicines in India
provide sufficient information to the patients (For choosing these
OTC medicines, we used the criteria that they were non-prescription
medicines in India as well as most other countries).
Objective: The objective of this study was to evaluate whether:
1. OTC medicine labels (primary) have adequate information for
patients to make proper self-medication choices.
2. Additional information is available to patients through patient
package inserts or on secondary packages (wherever
applicable).
3. The information provided is readable and can be clearly
understood.
Experimental Methods and Results:
We took a total of 100 OTC medicines randomly from a
pharmacy, covering various categories of medicines and various
dosage forms like tablets, capsules, liquid orals and external
preparations. The labels of these medicines were then assessed
based on the “Drug Facts” label guidelines provided by the United
States Food and Drug Administration (US FDA) for OTC medicine
labelling. The proposed labelling includes various components, and
we studied these components as specified by Drug Facts standard
labelling format, with the following results:
1. Label to include : Active ingredient along with its strength :
Results:
All the 100 labels examined mentioned the active ingredients
along with their potency/strength.
2. Label to include : Therapeutic category/purpose :
55% of the labels did not disclose the therapeutic category.
3. Label to include : Uses /indications for which medicine can be
utilized :
Although a significant percentage (75%) mentioned the indications
for the medicine, 25% of the labels failed to do so.
4. Label to include: Warnings related to common adverse effects,
drug interactions, contraindications, precautions, overdosage,
when it is appropriate to seek medical advice and special
conditions like pregnancy & breast-feeding. This also includes
admonitions to keep out of reach of children :
Results:
90% of the labels failed to enumerate the adverse effects of the
medicine.
86% did not state what is to be done in case of overdose
92% gave no information regarding usage in pregnancy and
breastfeeding
87% of the labels did not mention of the possible drug interactions,
contraindications and precautions.
73% labels did not even advise to seek medical guidance.
Only 36% labels mentioned that the medicine is required to be
kept out of the reach of children.
5. Label to include : Directions including how much to be taken,
dosage interval, maximum dose allowed per day and the dose
for children :
Almost half of the medicines (46%) did not mention the amount to
be used, while 34% did not mention the dosing interval. 85% of
the medicines did not state the maximum dose allowed. Out of the
15% which did state the maximum dose, 20% were ambiguous
with the details. It was also observed that 70% of the medicines
failed to specify the dose for children. Only 1 label included
instructions for use in Devanagiri script.
6. Label to include: The product’s inactive ingredients to help
consumers avoid ingredients that may cause an allergic
reaction.
None of the labels included the inactive ingredients (other than
saying in some cases, the solvent/base used).
7. Label to include: Storage conditions.
Even though a large percentage (88%) of the labels provided
the storage conditions, 64% of them were imprecise and difficult
to understand. Nearly 85% of the labels were found without a
specific temperature. Furthermore, storage conditions were often
mentioned using terms which the common man are not familiar
with. The exact temperature was rarely mentioned.
*Email Id: rajxvaidya@gmail.com
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8. Besides, we also assessed the label for 2 more criteria :
1. Label to include: Legibility to find out whether the label is easily
readable, read with difficulty or with the aid of a magnifying
glass.
40% of the medicine labels were clearly read only with the aid of
a magnifying glass as the font size was too small. 22% of drug
labels were read with difficulty leaving just around 38% which
could be read easily. This suggests that 62% of the labels are
read with much effort.
1. Label to include: Additional information through patient
package inserts, information on secondary packages (wherever
applicable): Patient package inserts are useful for providing
additional information to the patient.
Out of the 100 medicines examined, only 3 included a patient
package insert. Many a times, secondary packagings of
medicines are also given to the patient as additional protection
for their medicines or as attractive packs. These secondary
packages can also be used to convey valuable information to the
patient. In 56% of the cases, a secondary package was found
to be available to the patient, yet only 36% of them gave more
information on its label than the primary package.
Another finding was that 76% of the medicines were not
advertised. On the positive side, all the 100 labels did provide
required details of manufacture and expiry of the medicines. These
are also crucial requirements for medicine safety.
Conclusion:
The study thus revealed that there is limited space available
on the primary package of medicines. In cases where there was a
secondary package, and a scope for providing additional information
was available, yet the information was not provided. The study also
revealed that the required information provided on OTC medicine
labels in India is usually quite insufficient for the patient to make a
“responsible” decision for self-medication.
Suggestions:
There is a clear need for a specific OTC category of medicines in
India, with clear-cut laid down guidelines for their complete labelling.
The label of OTC medicines should contain sufficient information,
for example on lines with the Drug Facts label recommended by
US FDA, so that the patient gets sufficient information.
There is also a need to considerably improve and organize the
labelling of OTC medicines, so that they are simple, straightforward,
and easy to read. The labels should also be printed in languages
patients will comprehend. If critical information cannot be included
on the primary label, suitable patient package inserts should be
included with the medicine.
Bibliography:
1. OTC Drug Fact Label [internet] 2009 [updated 2009 May 28].
Available from: http://www.fda.gov/Drugs/ResourcesForYou/
Consumers/ucm143551.htm
2. AHFS Drug Information. USA: ASHP; 2004.
Book Review
Title: Editing Pharmacy
Author - Dr. B.D. Miglani
Publisher - Association of
Pharmaceutical Teachers of
India, Bangalore, Karnataka.
I am very happy that the
Association Pharmaceutical
Teachers of India (APTI) has
brought out “Editing Pharmacy”
authored by Dr. B.D. Miglani.
This book has been written to
recapture and preserve the
editorials which Dr. Miglani contributed to Indian Journal of
Hospital Pharmacy. It is, no doubt, an important publication by
a distinguished pharmacist.
Right from his joining for a B.Pharm Degree in Punjab University,
and, thereafter, his 3 months training in dispensary at the Victoria
Jubilee Hospital attached to Medical College at Amritsar and
then working as Chief Pharmacist at the Lady Hardinge Medical
College Hospital for a decade, a noble thought inspired Dr.
Miglani to upgrade the standard of Pharmacy and create a better
image of the pharmacists in community. In December 1963, at
the time of the 15 th Pharmaceutical Congress in Pilani, it was
largely to his call; it was decided to organize a forum of Indian
Hospital Pharmacists’ Association (IHPA) with whom he had his
lifelong attachment. The book has captured the editorials by Dr.
B.D. Miglani from May 1964 to the end of 2007.
The editorials covered a vast array of subjects like various
committees formed both at central and state levels on Hospital
Pharmacy, establishment of NIPER, issues pertaining to
amendments to the Pharmacy Act, Drugs’ and Cosmetics Act
and Implementation of Section 42 of Pharmacy Act. Through
these editorials he made forceful appeals for better pay scales
for Hospital Pharmacists. The editorials drew attention to topics
pertaining to academic, scientific and technical subjects. During
the large span of over 4 decades, these editorials portray the
history of Pharmaceutical development in India thus making this
book a unique and invaluable history document.
Many developments happened to the profession of pharmacy in
India since India’s independence and Dr. B.D. Miglani’s unique
strength has been to voice his frank opinion on each landmark
event through these editorials. The fascinating range of subjects
covered in the book has influenced many to make hospital
pharmacy as career.
Dr. B.D. Miglani’s unique contribution to understanding
of hospital pharmacy is of highest possible level and the
profession will always remain grateful to him for his exemplary
leadership.
Reviewed by:
Mr. Prafull D. Sheth,
FIP Vice President &
Professional Secretary, SEARPharm Forum
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