manual on management of drugs

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CHAPTER 1 INTRODUCTION 1.Ensuring an adequate supply of safe and effective drugs of acceptable quality is an integral part of the health policy of Sri Lanka. Appropriate legislation and regulations are provided to implement such a policy. Provision of Essential Medicines is one of the elements in the primary health care package. Pharmaceuticals play a crucial role in preventive and curative healthcare. Drugs are a vital and an expensive component in the provision of health services .A fair proportion of the health budget (11%) is invested in pharmaceuticals. To ensure maximum benefit from such investment, it is essential that the drug requirements should be based on realistic estimates. Rational prescribing and efficient drug management with a sense of cost and quality consciousness are equally important. 2.The Ministry of Health spent Rs.5.34 billion in 2007 on the drugs required for the health institutions in the state sector. The drug budget was Rs. 2.81 Billion in 2000. The present drug budget is around 10% of the total health expenditure and that amounts to Rs.3000 (Approx.30US $) per person annually. The expenditure on drugs (state sector) in Sri Lanka from 2000 to 2007 is illustrated in Figure 1. Value (Rs. Million) 6000 5000 4000 3000 2000 1000 0 2000 2001 2002 2003 2004 2005 2006 2007 Year Figure1.The expenditure on drugs in Sri Lanka (2000-2007) 1
Table1presents the amounts spent on pharmaceuticals for different provinces/special institutions in Sri Lanka (2007) Name of province / institution 2 Total in Rs. Million Central 197.489302 North Central 154.054582 North Eastern 278.554384 North Western 236.804810 Sabaragamuwa 146.339028 Southern 137.386175 Uva 175.964453 Western 344.807785 National Hospital of Sri Lanka 613.494117 Other Teaching Hospitals Except NHSL & Sri 1603.656660 Jayawardenepura Hospital) Institutions belonging to other Ministries 71.688140 (Armed forces, Police, Local Government Institutions, Prison, Estate Hospitals etc Semi Government Institutions(Sri 46.998660 Jayawardenepura Hospital & Vijaya Kumarathunga Hospital) Private Customers including private healthcare 17.143790 institutions Source – Medical Supplies Division Table 1: The amounts spent on pharmaceuticals for different provinces/special institutions Sri Lanka does not practice a strict referral system for patient care. A patient has free access to any hospital. Bypassing smaller medical institutions with limited facilities does occur and is encouraged by the high literacy rate in the country. The patients are aware that they will receive a higher quality of care in the larger institutions. Thus, underutilization of the smaller institutions and overcrowding and over-utilization of major health institutions is common. Provincial boundaries are often crossed. These facts are needed to be considered in interpreting the amounts spent for different provinces / institutions. The Provincial and Regional Directors decide on the respective allocations to the institutions under their purview, on the recommendations of the Provincial Drug Review Committees.
Page 2 and 3: MANUAL ON MANAGEMENT OF DRUGS SECON
Page 4 and 5: MESSAGE BY THE SECRETARY/ MINISTRY
Page 6 and 7: ACKNOWLEDGEMENT It is a great pleas
Page 8 and 9: Dr. J. M. J. Munasinghe Dr. K. C. L
Page 10 and 11: ABBREVIATIONS AD CP CDD CDDA D(F) D
Page 12 and 13: CONTENTS Message by the Hon. Minist
Page 14 and 15: X Form for Drug sample for quality
Page 18 and 19: 3.The expenditure on drugs has been
Page 20 and 21: of poisons, opium, and dangerous dr
Page 22 and 23: (Medical Technology & Supplies) No
Page 24 and 25: c) NDQAL for quality assurance of d
Page 26 and 27: Deputy Director General (Finance) D
Page 28 and 29: (d) The Institutional Drug Therapeu
Page 30 and 31: CHAPTER 4 ESTIMATION OF ANNUAL REQU
Page 32 and 33: Step 2 Identify the stock available
Page 34 and 35: In the case of institutions under t
Page 36 and 37: oard appointed by him and a report
Page 38 and 39: Head of the Institution may add any
Page 40 and 41: ii. Injections costing Rs. 25.00 or
Page 42 and 43: 42. Delivery schedules are planned
Page 44 and 45: CHAPTER 6 CARE IN PRESCRIBING DRUGS
Page 46 and 47: CHAPTER 7 DISTRIBUTION AND LOGISTIC
Page 48 and 49: the institution. Records of the inv
Page 50 and 51: RMSD or institutional stores, the o
Page 52 and 53: CHAPTER 8 QUALITY ASSURANCE OF DRUG
Page 54 and 55: ioavailability. Further, in apprais
Page 56 and 57: x. Details of any preservative adde
Page 58 and 59: To request institutions to inform t
Page 60 and 61: CHAPTER 9 STORAGE OF DRUGS. 1. Prop
Page 62 and 63: xi. Storage of vaccine in the refri
Page 64 and 65: CHAPTER 10 MONITORING OF CONSUMPTIO
Page 66 and 67:
ii. VEN analysis ( See annexure XV
Page 68 and 69:
9. Monitoring of quality of drugs;
Page 70 and 71:
alance as per ledger, actual balanc
Page 72 and 73:
1.3 In case of institutions coming
Page 74 and 75:
Ampoules should be crushed and buri
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ANNEXURE I1: Main functions of Medi
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I - Annual stock holding cost as a
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Anti Rabies cell culture vaccine. (
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unobservable (animal dead, killed,
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on D0, D3, D7, D14 & D30. 6.1.2 For
Page 86 and 87:
All patients who receive rabies PET
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Monthly return for vaccine consumpt
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Death in the house / outside a Medi
Page 92 and 93:
2.2 In case of major exposures: 2.2
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ANNEXURE - V MyNo……/…../….
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Advertisement Screening Unit Unit o
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ANNEXURE VIII (To be amended To: My
Page 100 and 101:
ANNEXURE X ……………………
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6. Quality failure of registration
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ANNEXURE XIII Lot Card SR No……
Page 107 and 108:
ANNEXURE XV VEN Analysis This analy
Page 109:
Sample Guidelines for VEN Category
Page 112 and 113:
Unsatisfactory clinical response, a
Page 114 and 115:
Local Agents of supplier (on reques
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