MESSAGE BY THE HON. MINISTER OF HEALTHCARE & NUTRITION It is with great pleasure that I am releasing this message which is to be published in the 3rd Edition of the “Manual of management of Drugs. ” Sri Lanka is one of the few countries that provides health care free of charge to whole of its population. His Excellency Mahinda Rajapaksha believes that by investing in free healthcare, we can produce a healthy work force that can contribute positively towards the development of the country. As a major proportion of health expenditure is on drugs, the contents of this publication are extremely important.
The latest edition of this publication includes the revisions made to accommodate the changes due to the setting up of provincial councils and devolution of authorities to provincial health ministries and I hope that it will significantly contribute towards the better management of drugs in the institutions under the Ministry of Healthcare & Nutrition and Provincial council. I would like to thank to the officials of my Ministry for their hand work in publishing this revised edition and especially wish to appreciate the efforts of the Director of the Medical Supplies Division and the Director of the Medical Technology &Supplies.
Hon. Nimal Siripala de Silva Minister of Healthcare & Nutrition. 2 MESSAGE BY THE SECRETARY/ MINISTRY OF HEALTHCARE & NUTRITION I am pleased to release this message for the 3 rd edition of the “Manual of Management of Drugs”. Sri Lanka has based its healthcare system on the Primary Healthcare approach and one of the key areas in this approach is the supply of pharmaceuticals which take up a sizable portion of the health budget.
In order to achieve the maximum benefit from this sizable investment, it is necessary to ensure proper management of drugs. Hence this publication is very important in this context. The first 2 editions of this book have been widely used by healthcare professionals and administrators not only from Sri Lanka but from numerous regions in the world. I anticipate that this edition too, which has taken into account the numerous changers that have taken place especially with the devolution of management of Health Services to the provinces will be well received.
I also wish to thank all the officials from the Ministry of Healthcare & Nutrition especially the Director of the Medical Supplies Division and the Director of the Medical Technology & Supplies for their valuable contribution in publishing this book. Dr. H. A. P. Kahadaliyanage Secretary/Ministry of Healthcare & Nutrition 3 PREFACE It is with pleasure that I write this preface to the 3 rd edition of the “Manual on Management of Drugs. ” This Manual, first published in May 1987 and revised in June 1993, was well received both nationally and internationally.
It is widely known and used by those involved in the drug supply system in Sri Lanka. Over the fifteen years the contents of the manual were discussed at various workshops and meetings and the views expressed noted. Far reaching changes also took place in the drug management system, with the setting up of the Regional MSD in provincial councils. There was thus a need for a revision of the manual, and this second revision is the result. I am thankful to all those who were involved in revising this edition.
Special mention must be made of Director, MSD and his staff, Director, MT & S and his staff, and all the contributors who actively participated and contributed much towards this revision. It is my hope that this manual will contribute positively towards the ready availability and efficient management of essential drugs in the health care institutions in Sri Lanka. Dr. U. A. Mendis Director General of Health Services Ministry of Healthcare & Nutrition ACKNOWLEDGEMENT 4 It is a great pleasure for me to have contributed to the 2 nd Revision of the Manual on Management of Drugs.
The manual is the standard reference for those who are involved in the management of pharmaceuticals at different institutions with different responsibilities in the public sector, for example health care institutions of different levels, MSD, RMSD, Offices of RDHS, SPC, etc. The cost of pharmaceuticals to the Ministry of Health has been increasing over the years due to multiple reasons such as opening up of new units, expansion of health care delivery system, epidemiological transition from communicable disease to non communicable, and the invention of new drugs which are costlier.
Though the budgetary allocation has been increasing every year, there is always a gap between the cost of estimated requirements and available funds. Therefore efficient management of available resources in the pharmaceutical supply chain by all stakeholders at each level is very important. In this context, the Manual on Management of Drugs would be of immense use. In working to this end, I have been fortunate in having the assistance of a group of distinguish contributors.
I am very grateful to the contributors who have endeavored to this manual as up to date and comprehensive as possible in spite of the heavy involvement in their routine work. I owe a special word of thanks to Prof. R. L. Jayakody for his valuable suggestions and guidance in completing this manuscript. The financial assistance of WHO towards this publication is acknowledged with thanks. At last, but not least the encouragement support extended by Dr U. A. Mendis, DGHS is very much appreciated. Dr. B. V. S. H. Beneragama Director Medical Supplies Division 5 EDITORIAL BOARD Dr. U. A. Mendis Dr.
B. V. S. H. Beneragama Dr. K. D. Jayalath Ms Chinta Abayawardana Director General of Health Services Director/ Medical Supplies Division Deputy Director/Medical Technology& Supplies Office Chief Pharmacist / Ministry of Health CONTRIBUTORS Late Dr. B. F. S. Samaranayake Dr. J. M. W. Jayasundara Bandara Mr. Ajith Priyadharshana Dr. Hector Weerasinghe Dr. R. Wimal Jayantha Dr. P. Samarakoon Prof. R. L. Jayakody Prof. Rohini Fernandopulle Dr. A. G. Warnakulasuriya Dr. S. Hapuarachchi Mrs. Dharma de Silva Dr. A. K. S. B. de Alwis Dr. Neelamani S. R. Geeganage Dr. Omala Wimalarathne Dr. J. M. J.
Munasinghe Director/Medical Technology & Supplies office Deputy Director General (Dental Services) Director /National Drug Quality Assurance Laboratory Director /National Hospital, Sri Lanka Director /Lady Ridgeway Hospital for Children Director /Medical Services Professor of Pharmacology/ University of Colombo Professor in Pharmacology University of Colombo Consultant Anaesthesiologist/ NHSL Consultant Anaesthesiologist/ NHSL Director /Nursing, Ministry of Health Director of Health Services, Kurunegala Deputy director Health Services, Badulla Consultant Virologist / Medical Research Institute Clinical Pharmacologist/ Medical Research Institute 6 Dr. K. C. L.
Jayakody Dr. S. K. A. Gamage Mr. K. Kanagarathnam Mr. R. L. A. Warakagoda Mr. L. Karunathilake Mr. P. Thanabalasundaram Mrs. B. Balachandran Mr. S. A. Kuruppu Mr. P. D. Munidasa Mrs. Thilaka Dharmadasa Mr. M. P. Kurruppu Mr. E. A. Piyadasa ofHealth Mr. K. L. S. W. de Silva Mr. W. E. W. M. S.
Bandara Mr. N. A. A. S. Nettasinghe Mr. G. D. Nimalsiri Mr. E. D. Weerarathne Mrs. S. M. Attapattu Mr. W. S. Padmalal Mr. B. V. Priyantha Medical Superintendent /General Hospital, Ampara. Medical Superintendent / Genaral Hospital, Kegalle Assistant Director/Medical Supplies Division Chief Pharmacist/ Medical Technology & Supplies office Chief Food & Drug Inspector/ Medical Technology & Supplies office Chief Pharmacist/ OPD /National Hospital of Sri Lanka Chief Pharmacist, IDD / National Hospital of Sri Lanka Pharmaceutical Analyst/ National Drug Quality Assurance Laboratory. Former Chief Pharmacist/ National Drug Quality Assurance Laboratory.
Chief Pharmacist/ National Drug Quality Assurance Laboratory. DGM (Technical & Laboratory), StatePharmaceuticals Corporation Chief Accountant / Ministry Assistant Director/Medical Supplies Division Assistant Director/Medical Supplies Division Assistant Director/Medical Supplies Division Actg. Assistant Director/Medical Supplies Division Actg. Assistant Director/
Medical Supplies Division H/S. C. O Drugs/ Medical Supplies Division Store Keeper/ Medical Supplies Division PPA/ Medical Supplies Division 7 Mr. A. M. Upali Kularathne Mr. S. Anton Uthayakumar Mr. E. A. C. G. S. Edirisinghe Mr. W. B. P. Dharmadasa Mr. Arjuna Pathmaperuma Mr. D. B. D. G. H. Gunathilaka Mr. B. M. W. Balasooriya Ms.
B. Poornima R. Cooray Ms. G. Upeksha I. Aponso Ms. G. P. Savini G. Senadheera Mr. P. Madarasinghe . Store Keeper/Medical Supplies Division O. I. C/Regional Medical Supplies Division, Mannar Pharmacist / Medical Technology & Supplies office Pharmacist / Medical Technology & Supplies office Pharmacist / Medical Technology & Supplies office Pharmacist / Medical Technology & Supplies office Pharmacist / Medical Technology & Supplies office Pharmacist / Medical Technology & Supplies office Pharmacist / Medical Technology & Supplies office Pharmacist /Medical Technology & Supplies office Food & Drug Inspector, Medical Technology & Supplies office 8.
ABBREVIATIONS AD CP CDD CDDA D(F) DC DCP DDG DDS DHC DHO DP DRMP DTCO D/PHVS DD DDG (LS) DESC DGHS DHS DRA FR GMP HSCO ID IDD MCH MOH MSD MT & S NDQAL NORAD OIC ORS OT : Assistant Director : Chief pharmacist : Cosmetics, Devices and Drugs :
Cosmetics, Devices and Drugs Authority : Director (Finance) : Dental Clinic : Director Campaign : Deputy Director General : Divisional Drug Store : Divisional Health Center : Divisional Health Officer : Divisional Pharmacist : Divisional Registered Medical Practitioner : District Tuberculosis Control Officer : Director/ Public Health Veterinary Service : Deputy Director : Deputy Director General (Laboratory Services) :
Drug Evaluation Sub Committee : Director General of Health Services : Department of Health Services : Drug Regulatory Authority : Financial Regulations : Good Manufacturing Practices : Head Stock Control Officer : Infectious Diseases : In-Door Dispensary : Maternal and Child Health : Medical Officer of Health : Medical Supplies Division : Medical Technology &Supplies : National Drug Quality Assurance Laboratory : Norwegian Agency for Development Co-operation : Officer in charge : Oral Rehydration Salts :
Operating Theater 9 ODD OPD PDHS PPA RDHS RMSD SDHC SMO STV SV SH SK SLSI SPC TAC TB WHO : Out-Door Dispensary : Out Patient Department : Provincial Director of Health Services : Programme planning Assistant : Regional Director of Health Services : Regional Medical Supplies Divisions : Sub Divisional Health Services : Senior Medical Officer : Stock Transfer Voucher : Stock Verification : Secretary Health : Store Keeper : Sri Lanka Standards Institute : State Pharmaceuticals Corporation : Technical Advisory Committee : Tuberculosis : World Health Organization 10 CONTENTS Message by the Hon.
Minister of Healthcare & Nutrition Message by the Secretary/ Ministry of Healthcare & Nutrition Preface Acknowledgement Editorial Board and Contributors List of Abbreviations Content Page Chapter 1 Chapter 2 Introduction Policy Framework Chapter 3 Organizational structure and functions of the state health sector drug management system Chapter 4 Chapter 5 Chapter 6 Chapter 7 Chapter 8 Estimation of annual requirements of drugs Receipts, issues and stocks control Care in prescribing drugs Distribution and logistics Quality assurance of drugs 11 Chapter 9 Chapter 10.
Chapter 11 Storage of drugs Monitoring of consumption of drugs Disposal of expired/spoilt drugs and minimizing wastage ANNEXURES I II III IV The main functions of the Office of Director MT &S The main functions of MSD Lead Time, Re-Order Level (ROL), Economic Order Quantity (EOQ), Safety Stock Level (SSL) Monthly Return and Request for Vaccine /Serum, Monthly return for vaccine consumption, Guidelines for the procedure to be followed in a case of death due to human rabies and disposal of the body Amendments to the General Circular No.
Ol-12002, Prevention of rabies by anti rabies post exposure therapy (PET), Monthly return of vaccine consumption Re-distribution of Short Dated/ Non moving surplus stocks, Re-distribution of Short Dated/ Non moving Surplus stocks Organizational structure of Office of MT & S Organizational structure of NDQAL Quality assurance of drugs at peripheral units, district hospitals, base and provincial hospitals Part XI – CDD Regulations: Procedure for taking samples for test, examination, analysis or clinical trials V VI VII VIII IX 12 X XI XII XIII XIV XV XVI XVII Form for Drug sample for quality testing (complaint / surveillance).
Recall procedure for quality failed pharmaceuticals as approved by the Technical Advisory Committee Medical Supplies Division – cold chain record Lot card ABC Analysis VEN Analysis Report of adverse reactions to medicines, vaccines, devices, traditional remedies and cosmetics Quality assurance of vaccines XVIII Return of quality failed medical supplies to MSD (Circular No. WMS-02/66/2007) XIX Specimen of quarterly return on disposal of medical supplies
LIST OF TABLES Table 1: The amounts spent on pharmaceuticals for different provinces/special institutions Table 2: Model chart of quantity available Table 3: Quarterly return of availability of stocks Table 4: Schedule to supply items to institute Table 5: Format for local purchase report to D/MSD Table 6: Indenting format Table 7: Minimum amount of dosage units required (sample size) for issuing a complete report Table 8: Monitoring of Drugs.
13 Table 9: Periodic disposal of all medical supplies by the institutions Table 10: Write off authorities LIST OF FIGURES Figure1: The expenditure on drugs in Sri Lanka (2000-2007) Figure 2: Management cycle of pharmaceuticals Figure 3: Organization chart of drug management 14 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. 15 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) Table1presents the amounts spent on pharmaceuticals for different provinces/special institutions in Sri Lanka (2007) Name of province / institution Central North Central North Eastern North Western Sabaragamuwa Southern Uva Western National Hospital of Sri Lanka Other Teaching Hospitals Except NHSL & Sri Jayawardenepura Hospital) Institutions belonging to other Ministries (Armed forces, Police, Local Government Institutions, Prison, Estate Hospitals etc Semi Government Institutions(Sri Jayawardenepura Hospital & Vijaya Kumarathunga Hospital).
Private Customers including private healthcare institutions Total in Rs. Million 197. 489302 154. 054582 278. 554384 236. 804810 146. 339028 137. 386175 175. 964453 344. 807785 613. 494117 1603. 656660 71. 688140 46. 998660 17. 143790 Value (Rs.Million).
16 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. 3. The expenditure on drugs has been increasing each year because of the increased demand for better services, escalating unit cost on drugs, changing pattern of morbidity (heart diseases, cancer, diabetes) and the like. At the same time the efficient use of the available drugs is seen to receive some setbacks. Some of the reasons are over-prescribing, pilferage and wastage.
4. While the Government is committed to the provision of drugs free to all the clientele,there is an urgent need on the part of all officials in the health system responsible for procuring, distributing, storing, prescribing and dispensing whether at national, provincial, regional or institutional level, to imbibe a sense of economy and effectiveness to the management of drugs.
5. In this context this manual describes certain processes and procedures to be strictly adhered to by all concerned, to preserve the quality and ensure the efficacy and safety of the drugs used in order to enable the patients to receive a greater benefit at a given cost. In developing this manual all the existing rules, regulations and procedures with regard to management of drugs issued from time to time as departmental circulars, guidelines etc. have been reviewed, revised and simplified.
In addition an educational approach is used with a view to ensuring that the contents are well understood and easily amenable to practice by all the staff involved in the drug management system. 17 CHAPTER 2 POLICY FRAMEWORK 1. The Government of the Democratic Socialist Republic of Sri Lanka undertakes to provide free health care services to every citizen in the country.
Primary Health Care is the key approach to attaining this goal. The supply of essential drugs is a major element in this approach. 2. (i) Cosmetics Devices and Drugs (CDD)Act The Cosmetic, Devices and Drugs Act No. 27 of. 1980 (as amended by Act No. 38 of 1984, No. 25 of 1987 and No 12.
of 1993) provides the legislative framework to control the use of cosmetics, medical devices and medicinal drugs in the country. The regulations under the CDD Act were published in Gazette Extraordinary No. 378/3 of 02/12/1985 and further amendments were made from time to time.
The Act controls: (a)Registration (b)Manufacture (c)Importation (d)Transportation (e)Sale ( Retail and Wholesale ) (f)Labelling 18 (g)Advertising (h)Distribution of drug samples (i)Testing (j)Disposal of outdated or spoilt drugs Steps are being taken to amend the existing Act to strengthen the areas such as clinical trials, neutraceuticals, dietary supplements and functional foods.
(ii) Poisons, Opium and Dangerous Drugs (Amended) Act. Poisons, opium and dangerous drugs ordinance (Chapter 218) as amended by Act No 13 of 1984 regulates, (a)Importation (b)Storage (c) Distribution and (d) Use of poisons, opium, and dangerous drugs.
3. The main provisions of the CDD Act with regard to the drugs are : (i) Only drugs which are registered with the Authority can be manufactured, imported, offered for sale or used in the country; (ii)Licenses are required for importation, manufacture, wholesale trade/ retail trade, and transportation of drugs. (iii)All drugs registered with the Cosmetics, Devices and Drugs Authority (CDDA) should conform to specified standards.
(iv)Labelling on the packs and advertisements regarding drugs should conform to the relevant regulations. 4. The Director General of Health Services (DGHS) is the CDDA. A Technical Advisory Committee (TAC) has been set-up under this Act to advise the Hon. Minister of Health on matters pertaining to the implementation of the Act Composition of the Technical Advisory Committee:
• Director General of Health Services – Chairman • Deputy Director General of Health (Laboratory Services) • Director, Medical Technology & Supplies – Secretary • Director, Medical Supplies Division • Director, National Drug Quality Assurance Laboratory 19 • • • • • • • • • • • • • • • • Professor of Pharmacology of the University of Colombo Pharmacologist of the
Medical Research Institute Chairman of the State Pharmaceuticals Corporation Government Analyst Consultant Physician nominated by the Minister of Health Consultant Surgeon nominated by the Minister of Health a Consultant Physician nominated by the College of Physicians a representative of the Pharmaceutical Manufacturers’ Association nominated by that Association a representative of the Sri Lanka Standards Institution, nominated by the Minister in charge of the subject of Industries a representative of the Pharmaceutical Society of Sri Lanka nominated by that Society a representative of the Sri Lanka Medical Association nominated by that Association a representative of the Independent Medical Practitioner’s.
Association nominated by that Association a representative of the College of General Practitioners of Sri Lanka nominated by that College a representative of the Sri Lanka College of Obstetricians and Gynaecologists nominated by that College a representative of the Sri Lanka Dental Association, nominated by that Association a representative of the Pharmaceutical Traders Association (at present known as Sri Lanka Chamber of Pharmaceutical Industry), nominated by that chamber.
The DGHS is the Chairman of the TAC and the Director Medical Technology and Supplies (DMT&S) is the Secretary. Based on the powers delegated by the DGHS, the DMT&S functions as the CDDA. 5.
Four Sub Committees have been set up by the TAC, namely: (a) Drugs Evaluation Sub-Committee(DESC) to review and make recommendations on drugs submitted for registration ; (b) Cosmetics Evaluation Sub-Committee to review and make recommendations on cosmetics submitted for registration ;
20 (c) Devices Evaluation Sub-Committee to review and make recommendations on medical devices submitted for registration ; (d) Advertisements Sub-Committee to screen advertisements of drugs and to make recommendations on the information given in the advertisements. 6. To implement the CDD Act and the Regulations therein, Authorized Officers have been appointed by the Hon. Minister of Health from the following categories of government officers.
• Provincial Directors* and Regional Directors of Health Services*, • Medical Officers of Health • Divisional Pharmacists • Food & Drugs Inspectors • Public Health Inspectors Cosmetics, Devices and Drugs should be addressed to the Director (Medical Technology & Supplies) No 120, Norris Canal Road, Colombo 10. (Tel: 011-2695173, 011-2687743, 011-2687744, Fax: 011-2 2689704, Email: cdda@health. gov. lk ).
7. All correspondence regarding matters pertaining to the regulation of 8. Registration of Drugs Registration of drugs is one of the main functions of the CDDA. The first step of drug registration procedure is the evaluation of the manufacturer for compliance to Good Manufacturing Practices (GMP) standards. Applications for registration of drugs are accepted only if the production facilities of the relevant manufacturer conform to required standards of GMP.
Evaluation of foreign manufactures is done by evaluating their company profiles while local manufactures are inspected by a team of officers attached to the Office of MT&S and the National Drug Quality Assurance Laboratory (NDQAL) for GMP compliance. Every foreign manufacture has to appoint an agent in Sri Lanka who is responsible for registration and other activities related to their products in Sri Lanka.
The manufacturer should submit registration applications to the Office of D/MT&S through the local agent along with samples for quality testing. The DESC comprises of specialists in medical and pharmaceutical fields and, administrative sector of the Ministry of Health makes recommendations on registration of drugs. Quality, safety and efficacy are 21 considered as the main criteria for registration.
The DESC makes use of the WHO GMP certification scheme on the quality of pharmaceutical products moving in international commerce to assess GMP standards and registration status of the product in the country of manufacture. Approval of the product for registration or refusal of the same by the D/MT&S is based on the recommendations of the DESC. The registered drugs are entered in a register maintained at the D/MT&S office and periodically published through government gazette notifications. Work pertaining to drug registration is carried out at the office of the D/MT&S with the assistance of the NDQAL. 9.
The operational policies adopted by the government to ensure adequate supply of essential medicines to all patients seeking care at government institutions are: a) Procurement of drugs which are registered with the CDDA based on their generic names, wherever generic names are available; b) To encourage local manufacturers to produce essential Medicines within the country in a phased manner subject to their technoeconomic feasibility and granting a duty free concession for all raw material used in their pharmaceutical formulations and 20% rebate for locally manufactured products;
c) Development and periodical revision of a List of Essential medicines for Sri Lanka with separate lists for different levels of health care institutions depending on the services provided and facilities available. 22 CHAPTER 3 ORGANIZATIONAL STRUCTURE AND FUNCTIONING OF THE STATE SECTOR DRUG MANAGEMENT SYSTEM 1. In order to ensure that all drugs required by the institutions are available in required quantities at all times to serve the needs of the patients, Medical Supplies Division (MSD) of the Ministry of Health follows a management cycle, the major activities of which are depicted in Figure 2. 23 Figure 2: Management cycle of pharmaceuticals 2.
To support implementation of these activities, an organizational framework exists within the Ministry of Health, that comprises of the, a) CDDA (Office of D/MT&S) for registration of drugs. The main functions of the MT &S are detailed in Annexure 1. b) The Medical Supplies Division at the central level for estimation, storage, distribution and monitoring of drugs.
The main functions of the MSD are detailed in Annexure I1. c) NDQAL for quality assurance of drugs. d) The State Pharmaceuticals Corporation (SPC) for procurement e) Regional Medical Supplies Divisions (RMSD) at regional level (26 in number)for storage and distribution for provincial council institutions.
f) A drug store in each health care institution. The organization chart of the same is depicted in Figure 3 24 Figure 3: Organization chart of drug management 3. (a) The MSD of the Ministry of Health is responsible for the consolidation of annual requirements of drugs for the institutions under the Central Ministry and the Provincial Councils.
National indents so developed are passed on to the SPC for procurement. The drugs so procured are sent to the MSD by the SPC for storage and distribution to all the institutions. (b) The management cycle begins in August of the current year (year 1) with the preparation of institutional estimates for the next year (year 2).
Institutions should send their estimates by October of current year (year 1) to MSD. The MSD consolidates the estimates, forecasts the annual requirements and places the orders with the SPC before the expiry of January of next year (year 2). These orders are scheduled to be supplied during year 3.
As mentioned above, institutional estimates for year 2 are cumulated during the period from November (year 1) to January (year 2) to form the national requirement of drugs which would lead to; • Forecasting and placing orders with SPC for year 3. • Identification of additional requirement for year 2 and place supplementary orders with SPC. 25 • Distribution of year 2 requirements of the institutions.
In addition to the above functions, MSD also orders and supplies the annual requirements of surgical dressings, radio pharmaceuticals, X-ray films and chemicals, surgical consumables, surgical non-consumables, laboratory chemicals & glassware, dental consumables and dental non-consumables on indents through the SPC. Medical gases are purchased by institutions directly from medical gas suppliers. Printed forms and counterfoil books are also distributed by the MSD. The supplier is the Government Printing Department.
Director, MSD and his staff periodically visit and monitor the activities in relation to drug management in the respective provinces / institutions. 4. Drug Therapeutic Committees (Drug Review Committees) form a very useful forum for the monitoring of efficient management of drugs. The forum allows for decision-making by consensus among representatives of different units involved in the management of drugs.
It is, therefore essential that Drug Therapeutic Committees at: a) National Level b) Provincial Level c) Regional Level and d) Institutional level are established and that they functions regularly. (a)National Drug Therapeutic Committee (Drug Review Committee) A National Drug Therapeutic Committee should be established at the Office of DGHS. The recommended membership for this committee is: • Director General of Health Service- Chairman.
• Deputy Director General (Laboratory Services) • Deputy Director General (Finance) • Director Medical Supplies Division (MSD)- Secretary • D/MT&S • D/NDQAL • All the Provincial Directors of Health Services • Chairman –SPC • Directors of all Teaching Hospitals • Directors of Specialized Campaigns 26 This committee should meet quarterly.
The functions of the committee would be to monitor supply, distribution and consumption of drugs at national, provincial, and institutional levels. (b)Provincial Drug Therapeutic Review Committee (Drug Review Committee) The Provincial Drug Therapeutic Committee should be established at the Office of the Provincial Director of Health Services, the recommended membership for this committee is; • Provincial Director of Health Services (PDHS) – Chairman • Regional Director of Health Services of the District • Medical Superintendents of Provincial /District General/Base Hospitals in the Province • Consultants from Provincial / District General/ Base Hospitals • Accountant/PDHS. Office • Provincial /Divisional Pharmacists (Secretary) • Regional Epidemiologists/MOO – M. C. H.
• Officer in Charge – R-MSDD • Chief Pharmacists of the Provincial / District General / Base Hospitals • Co-opted members decided by the Chairman This committee should meet quarterly. The functions of the committee would be to monitor supply, distribution and consumption of drugs at provincial, regional, and institutional levels. (C)Regional Drug Therapeutic Committee (Drug Review Committee) A Regional Drug Review Committee should be established at the Office of the Regional Director of Health Services (RDHS). The recommended membership of this committee is: • RDHS – Chairman • Regional Epidemiologist(RE) • Medical Officer (Maternal and Child Health) • Regional Dental Surgeon (RDS) • Accountant/RDHS Office 27.
• • • • • • • • Medical Officers in charge of specialized campaigns Officer in charge (O i/c) of Regional Medical Supplies Division (RMSD) Divisional Pharmacist (Secretary) Divisional Registered Medical Practitioner (RMP) All Officers in charge of institutions in the Region Regional Food & Drug Inspector Chief Pharmacists of Provincial /District General/ Base Hospitals Superintendent MLTT of the Region This committee should meet once in two months. A copy of the minutes should be sent to the Director/MSD. The functions of the committee would be to monitor supply, distribution and consumption of drugs at regional and institutional levels.