AASSSSEESSSSMMEENNTT OOFF TTHHEE PPHHAARRMMAACCEEUUTTIICCAALL SSEECCTTOORR IINN EETTHHIIOOPPAA OOccttoobbeerr,, 22000033 AAddddiiss AAbbaabbaa,, EEtthhiiooppiiaa Federal Democratic Republic of Ethiopia World Health Ministry of Health Organization TABLE OF CONTENTS Page Acknowledgement v Acronyms vii List of Figures viii List of Tables ix Executive Summary x Chapter I Introduction 1 1. Geographical and socio-demographic and data 1 2. The Health Sector 1 3. The Pharmaceutical Sector 3 7 Chapter II Over all context of the study 1. The Problem 8 2. General Objectives 8 3. Specific Objectives 8 4. Study Design and Methodology 8 4.1 Sampling Unit and Sample Size 8 4.2 Sampling Procedure 9 4.3 Survey Instruments 9 4.4 Data Collection and Co-ordination of the Survey 9 4.5 Data Management 10 4.6 Scope and Limitations of the Data 10 11 Chapter III Findings and interpretation of the results 1. Accessibility of key essential drugs 11 1.1 Availability of key essential drugs 11 ii 1.2 Stock out duration 13 1.3 Percentage of prescribed drugs dispensed to patients 14 1.4 Affordability of key essential drugs 16 2. Quality 18 2.1 Adequacy of drug storage in facilities 18 2.2 Presence of expired drugs at facility level 20 3. Rational Drug Use 22 3.1 Average number of drugs prescribed per encounter 24 3.2 Percentage of antibiotic use 24 3.3 Percentage of injections use 26 3.4 Percentage of prescribed drugs included in the EDL 26 3.5 Adequacy of labeling of drugs 26 3.6 Patient knowledge 28 3.7 Availability of STGs/ EDLs in health facilities 28 3.8 Assessment of treatment practice 30 3.8.1 Treatment of diarrhea (non-bloody, watery) in children 30 • Prevalence of ORS use 30 • Prevalence of use of antibiotic 32 • Prevalence of use of anti-diarrhea and antispasmodic drugs 32 3.8.2 Treatment of non-pneumonia ARTI 32 3.8.3 Treatment of mild/ moderate pneumonia 34 • Prevalence of use of first line antibiotics 34 • Prevalence of use of more than one antibiotic 35 4. Household Survey 36 40 Chapter IV Conclusion and Recommendations 1. Conclusion 40 2. Recommendations 41 iii 42 References 44 Annexes Annex I National Regional States of Ethiopia 44 Annex II Six and four-tier health care delivery systems in Ethiopia 45 Annex III Distribution of Health Facilities and Households Surveyed 46 Annex IV List of Key Essential Drugs 47 Annex V Summary of national indicators 48 iv ACKNOWLEDGMENT The assessment of the pharmaceutical sector in Ethiopia was commissioned by the Federal Ministry of Health and conducted with the financial and technical assistance of the World Health Organization (WHO). The project was centrally coordinated by Mr Alemayehu Lemma, head of Pharmacy Administration and Supply Service (PASS) of the MOH and Mr Bekele Tefera, National Professional Officer (NPO) for Essential Drugs and Medicines policy (EDM) program of WHO Ethiopia. Miss Hadas Adugna (expert, PASS) also served as co-coordinator and field supervisor. The first draft of the study report was written by Mr Bekele Tefera, NPO/EDM of WHO Ethiopia and was reviewed by a consensus building work shop conducted on 26 August 2003 G.C. This final report, also prepared by Mr Bekele Tefera, has incorporated the comments and suggestions given by the work shop participants and the other contributors mentioned below. We would like to thank Mrs Simona Chorliet (WHO consultant) and Mr Marthin Authon (WHO consultant), who served as resource persons during the training of data collectors, supervisors and heads of Health Service and Training Departments of the six surveyed regions. We gratefully acknowledge the contribution of Mrs Helen Tatah and Mrs Diane Whitney of WHO/Geneva as well as Mr Marthin Authon for reviewing and commenting on the first draft of the report. The over all technical guidance of Mrs Diane Whitney on the report writing and the special support of Mrs Helen Tata to the study deserve special mention. Special thanks go to the following pharmacists and General Medical Practionres (GPs) who served as data collectors: Mr Tesfaye W/Kidan (Pharmacist, Tigray), Dr Atakliti Tsegaye (GP, Tigray), Dr Abebe Tefera (GP,Amhara), Mr Wosagne Muluneh (Pharmacist, Amhara), Mr Shewarega Ejersa (Pharmacist, Oromiya), Dr Nuri Shikmal (GP,Oromiya), Miss Mihiret Tilahun (SNNPR), Dr. Daniel Gemechu (GP, SNNPR), Dr Musse Kassa (GP, Beishangul –Gumuz), Mr Mathewos Haileyesus (Pharmacist, Benishangul-Gumuz), Miss Hirut Debela (Pharmacist, Addis Ababa), and Dr Mohammed Gemechu (GP, Addis Ababa). Many thanks go to the following professionals who served as supervisors in each survey region: Mrs Sofanit Mengistu ( Pharmacist, Tigray), Mr Gashaw Shiferaw (Pharmacist, Amhara), Mr Abdlumelik Ibro (Pharmacist, Oromiya), Mr mulugeta Asfaw (Pharmacist, SNNPR), Mr Haji Berisso (Pharmacist, Benishangul-Gumuz) and Mr Tamiru Yigletu (Druggist, Addis Ababa). v We would like to acknowledge with gratitude the contribution of all people who participated in the workshop representing the following institutions and associations: Health Service and Training Departments as well as Pharmacy Teams of all the regional health bureaus; Health Service and Training Department of the Federal Ministry of Health; PHARMID, Essential Services for Health in Ethiopia, (ESHE); School of Pharmacy (Addis Ababa university); WHO; Health, Population and Nutrition (HPN) donor group; Ethiopian Pharmacy Association; Ethiopian Medical Association and Public Health Association. Our gratitude is due to all the staff of all Public Health Care Facilities, Regional Drug Stores and Private Drug Retail Outlets surveyed for their time and effort in providing the necessary information. Lastly, we would like to extend our sincere thanks to Dr Sam Muzuki, medical officer for ICP/IMCI in the WHO country office, who proof-read the final draft report as well as to all those who assisted in one way or another to make the study a success. vi ACRONYMS ADR Adverse Drug Reaction ANOVA Analysis of Variance ARTI Acute Respiratory Tract Infection Company DACA Drug Administration and Control Authority E. C. Ethiopian Calendar ECA Economic Commission for Africa EFY Ethiopian Fiscal Year EDL Essential Drugs List EDM Essential Drugs and Medicines policy ETB Ethiopian Birr FDRE Federal Democratic Republic of Ethiopia G. C. Gregorian calendar GMP Good Manufacturing Practice GDP Gross Domestic Product GNI Gross National Income HSDP Health Sector Development Program IMCI Integrated Management of Childhood Illness LIDE List of Drugs for Ethiopia Max Maximum Min Minimum MOH Ministry of Health NBE National Bank of Ethiopia NDL National Drugs List of Ethiopia NDP National Drug Policy NGO Non-Governmental Organization NHP National Health Policy ORS Oral Rehydration Salt PASS Pharmaceutical Administration and Supply Service PHARMID Pharmaceuticals and Medical Supplies Service and Wholesale Share company PHCF Public Health Care Facility PHCU Primary Health Care Unit PPD Planning and Programming Department PDRO Private Drug Retail Outlet RDS Regional Drug Stores RHB Regional Health Bureau SNNPR Southern Nations, Nationalities, Peoples Region STG Standard Treatment Guideline TGE Transitional Government of Ethiopia US$ United States Dollar WB World Bank WHO World Health Organization vii LIST OF FIGURES Page Figure 1 Availability of key essential drugs in the public and private sector 12 Figure 2 Availability of key essential drug in PHCFs in six regions 12 Figure 3 Availability of key essential drugs by level of PHCFs 13 Figure 4 Key essential drugs stock out by level of PHCFs 14 Figure 5 Key essential drugs stock out in PHCFs in five regions 14 Figure 6 Extent of dispensing of prescribed drugs in PHCFs of six regions 15 Figure 7 Extent of dispensing of prescribed drugs in PHCFs by level of 15 PHCFs Figure 8 Affordability of key essential drugs in public and private sectors 16 Figure 9 Availability of key essential drugs in PHCFs of six regions 17 Figure 10 Affordability of essential drugs by level of PHCFs 17 Figure 11 Storage condition in PHCFs in six regions 19 Figure 12 Storage condition by level of PHCFs 20 Figure 13 Magnitude of expiry of key essential drugs in PHCFs in six 21 regions Figure 14 Magnitude of expiry of key essential drugs by level of PHCFs 21 Figure 15 Prevalence of antibiotic and injection use by level of PHCFS 25 Figure 16 Prevalence of antibiotic and injection use in PHCFs in six regions 25 Figure 17 Adequacy of labeling and patient knowledge by level of PHCFs 27 Figure 18 Adequacy of labeling and patient knowledge in PHCFS of six 27 regions Figure 19 Availability of Standard Treatment Guidelines by level of PHCFs 29 Figure 20 Availability of Standard Treatment Guidelines in PHCFS of five 29 regions Figure 21 Pattern of treatment of uncomplicated diarrhea in children by 31 level of PHCFs Figure 22 Pattern of treatment of uncomplicated diarrhea in children in six 31 regions Figure 23 Prevalence of antibiotic use in the treatment of non-pneumonia 33 ARTI by level of PHCFs Figure 24 Prevalence of antibiotic use in the treatment of non-pneumonia 33 ARTI in six regions Figure 25 Pattern of treatment of mild to moderate pneumonia by level 34 PHCFs Figure 26 Pattern of treatment of mild to moderate pneumonia in the six 35 regions viii LIST OF TABLES page Table 1 Total health budget allocation before and 10 years after the 2 introduction of the NDP Table 2 Summary of national indicators on Access 11 Table 3 Storage condition rating 18 Table 4 Summary of national indicators on quality 19 Table 5 Summary of national indicators or rational drug use in PHCFs 23 Table 6 Age and sex distribution of respondents 36 Table 7 Disease symptoms 36 Table 8 Types of consultations 37 Table 9 Outcomes of consultations 37 Table 10 Extent of dispensing of prescribed medicines 37 Table 11 Reasons for not obtaining prescribed medicines 38 Table 12 Compliance status 38 Table 13 Sources of medicines used by the respondents 39 ix EXCUTIVE SUMMARY The assessment of the pharmaceutical sector in Ethiopia was conducted from November – December 2002 G.C by PASS in collaboration with the World Health Organization Country Office. The assessment was mainly based on a cross-sectional survey carried out in five national regional states (Tigray, Amahra, Oromia, SNNPR, Benishangul-Gummuz) and Addis Ababa. It involved 7 hospitals, 19 health centers, 85 health stations, 5 regional drug stores of PHARMID, 24 private pharmacies/ drug shops and 490 households. This represents respective percentage sample sizes of 11.3%, 5.5%, 4.6% 71.4% and 5.4% of the hospitals, health centers, health stations, regional drug stores and private pharmacies/drug stores found in the surveyed regions. The main objective of the study was to identify strengths and weaknesses in the pharmaceutical sector and give recommendations for improvement. Specifically, it was to see whether the target outcomes of the pharmaceutical sector (i.e. access, quality assurance and rational drug use) have been achieved and also determine whether Ethiopia has the necessary structures and mechanisms in place for improving its pharmaceutical sector. The study has shown that the necessary structures and mechanisms required for the implementation of the NDP are more or less in place and a lot of achievements have been made. However, weaknesses in the implementation of the proclamation and some elements of the NDP were noted. For example, all manufacturers except one operate without having “certificate of competence” from DACA. Only drugs imported by the private sector are subjected to registration. The drug registration process is not linked to inspection of manufacturing sites abroad. The allocated drug budget was inadequate as revealed by a low per capita government drug budget of ETB 1.6(US$ 0.18), which is much lower than the target set in HSDP I (US$ 1.25) and the WHO’s recommendation of US$ 1.00. There is no proper stock management in health facilities as revealed by absence of stock control tools such as stock card in 60 % of the surveyed health facilities. Moreover, there is no specific NDP implementation plan that sets responsibilities, budget and time line although some elements of the NDP are incorporated in HSDPI. Monitoring and evaluation of the NDP was not included as an element of the policy itself. The results of the survey have also revealed the following short comings in relation to achievement of the major out come of the implementation of the policy: Accessibility of drugs The national average for availability of key essential drugs in health facilities was 70%, 85% and 91 % for public health facilities, regional drug stores and private drug retail out lets, respectively. The figures are lower than the ideal value of 100 % and the 100 % target set in HSDP I. x