An Assessment of the Pharmaceutical Sector in Ghana

Publication date: 2002

- - 1 TABLE OF CONTENTS TABLE OF CONTENTS----------------------------------------------------------------------------------1 FOREWORD ------------------------------------------------------------------------------------------------3 ACKNOWLEDGEMENTS-------------------------------------------------------------------------------4 ABBREVIATIONS -----------------------------------------------------------------------------------------5 INTRODUCTION ------------------------------------------------------------------------------------------7 A) Demographic and health characteristics------------------------------------------------------------------------------------ 7 B) Health and health policy-------------------------------------------------------------------------------------------------------- 8 C) Health system structure -------------------------------------------------------------------------------------------------------- 8 Health care financing ------------------------------------------------------------------------------------------------------------- 9 D) The Pharmaceutical Sector ---------------------------------------------------------------------------------------------------- 9 i) Drugs supply system --------------------------------------------------------------------------------------------------------- 11 ii) Key pharmaceutical indicators --------------------------------------------------------------------------------------------- 12 iii) Pharmaceutical sector surveys--------------------------------------------------------------------------------------------- 12 STUDY DESIGN AND METHODOLOGY --------------------------------------------------------- 13 Objectives of the survey ---------------------------------------------------------------------------------------------------------- 13 Methodology ------------------------------------------------------------------------------------------------------------------------ 13 a) Level I indicators ------------------------------------------------------------------------------------------------------------- 13 b) List of Level II indicators --------------------------------------------------------------------------------------------------- 13 c) List of household survey indicators---------------------------------------------------------------------------------------- 14 d) Training and Sampling ------------------------------------------------------------------------------------------------------ 14 e) The survey--------------------------------------------------------------------------------------------------------------------- 14 FINDINGS ------------------------------------------------------------------------------------------------- 15 Note on the use of medians and averages ------------------------------------------------------------------------------------ 15 Comparisons with previous surveys indicators ----------------------------------------------------------------------------- 15 Index of findings section---------------------------------------------------------------------------------------------------------- 15 Exchange rate -------------------------------------------------------------------------------------------------------------------- 15 Level I: Structures and processes of country pharmaceutical situation ----------------------------------------------- 15 Level II: Core indicator results ------------------------------------------------------------------------------------------------- 16 a) Summary of the Level II core indicator results -------------------------------------------------------------------------- 16 b) Accessibility to drugs-------------------------------------------------------------------------------------------------------- 17 c) Quality of drugs--------------------------------------------------------------------------------------------------------------- 20 d) Rational drug use------------------------------------------------------------------------------------------------------------- 21 Household survey results--------------------------------------------------------------------------------------------------------- 28 a) Characteristics of survey population--------------------------------------------------------------------------------------- 28 b) Symptoms and source of first consultation ------------------------------------------------------------------------------- 29 c) Prescribing and obtaining the prescribed drugs -------------------------------------------------------------------------- 30 d) Taking prescribed drugs----------------------------------------------------------------------------------------------------- 30 e) Estimated family weekly income/ total weekly household expenses ------------------------------------------------- 30 2 INTERPRETATION OF RESULTS------------------------------------------------------------------ 31 Access to Medicines --------------------------------------------------------------------------------------------------------------- 31 Quality ------------------------------------------------------------------------------------------------------------------------------- 32 Rational Use of Medicines ------------------------------------------------------------------------------------------------------- 32 Household Survey ----------------------------------------------------------------------------------------------------------------- 33 CONCLUSIONS AND RECOMMENDATIONS -------------------------------------------------- 34 Conclusions: Positive aspects and areas for improvement identified--------------------------------------------------- 34 b) Summary of recommendations (directly from findings section) ----------------------------------------------------- 35 c) Other (overall) recommendations------------------------------------------------------------------------------------------- 37 ANNEXES-------------------------------------------------------------------------------------------------- 38 Annex 1: Questionnaire on structures and processes of country pharmaceutical situation (Level 1)----------- 39 Annex 2: Results of previous surveys in Ghana----------------------------------------------------------------------------- 40 Annex 3: Designation of key drugs, guidelines and geographic /facility sampling ---------------------------------- 41 Annex 4: Survey forms (Level II, Household) ------------------------------------------------------------------------------- 43 3 FOREWORD Periodic shortages, high prices and lack of sustainable financing mechanisms are major barriers to access to medicines. Also the quality and safety of medicines are often compromised due to lack of good storage and distributions systems and an effective logistics management procedure. To ameliorate the situation in the case of our country the Ghana National Drugs Programme was introduced in 1997 as part of a first Five-Year Medium Term Strategic Framework (1997-2001). The aim of the programme was to improve access to essential medicines through a comprehensive master-plan that addresses all issues of management, including the development of a national drug policy and subsequent legislation, procurement and distribution of drugs, financial management of drug revolving funds at various levels and issues concerning rational use of drugs and quality control of drugs. A baseline survey of the pharmaceutical sub-sector was implemented in 1998 to guide introduction of interventions. Although monitoring of the sector was ongoing especially in relation to the rational use of medicines, it became necessary to evaluate the interventions after five years of implementation to establish the current situation as a means of engendering a future strategy for the Drug Programme. This survey was undertaken in 2002 by the Ministry of Health in collaboration with the World Health Organization to determine the status of the Pharmaceutical sector in relation to the management of the drug supply cycle and rational use of medicines. The survey was important because it provided a clear picture of national and institutional problems inherent in the pharmaceutical sector. The WHO survey package for monitoring and assessing country pharmaceutical situations was used for this exercise. It provides a cost –effective means of determining availability of essential medicines, the safety, efficacy and quality of those medicines and whether they are rationally used. It helps countries to pinpoint the strengths and weaknesses of their pharmaceutical sector and prioritize areas for intervention. Follow up surveys can be undertaken to assess the impact of interventions and to monitor pharmaceutical trends over time. This report would serve as a guide to strengthen the pharmaceutical sector and to prioritise strategies. It would assist in defining relevant strategies for technical collaboration and further serve as a guide for advocacy, and Information, Education and Communication about rational use of medicines. 4 ACKNOWLEDGEMENTS This Pharmaceutical Sector Baseline survey was commissioned by the Ministry of Health and conducted with financial and technical assistance of the World Health Organisation, Department of Essential Drugs and Medicines Policy/Drug Action Programme and the WHO Country Office Ghana in collaboration with Health Action International - Africa. The Ghana National Drugs Programme also provided technical and logistical support. In addition the contribution of the following people at the various stages of the survey is also acknowledged. The support of Mr Sam Boateng, Director of Stores Supplies, and Drug Management and Mr. Felix Yellu, the Chief Pharmacist and Mr Divine Asiama, Programme Manager of the Ghana National Drugs Programme is very much appreciated. Resource persons for training of fieldwork team: ƒ Dr. Ivy Osei, Ghana Health Service Research Unit ƒ Dr. T.N. Awua-Siaw, Institutional Care Division, Ghana Health Services ƒ Mrs. Martha Gyansa-Lutterodt, Ghana National Drugs Programme ƒ Mrs. Helen Tata, , Department of Essential Drugs and Medicines Policy, WHO Geneva ƒ Dr. Ogori Taylor, Essential Drugs and Medicines Policy National Professional Officer, WHO Nigeria ƒ Mrs. Joyce Addo-Atuah, Essential Drugs and Medicines Policy National Professional Officer, WHO Ghana Regional/Fieldwork Data Teams: ƒ Dr. Dominic Dobbin and Yaw Kankam-Dwumah, Ashanti Regional Health Administration ƒ Dr. S. Gordon and Stephen K. Korang, Brong Ahafo Regional Health Administration ƒ Dr. T.E. Thompson and Edith Andrews, Greater Accra Regional Health Administration ƒ Dr. William Gudu and Diana Awuni, Upper East Regional Health Administration ƒ Stephen Bonnah, Isaac Annan, Henry Hammond and Susie Kabe, Catholic Drug Centre, Health Action International (HAI) Data Entry, processing and analysis: ƒ Ms. Loretta Bannerman ƒ Dr. Daniel Kojo Arhinful, Noguchi Memorial Institute for Medical Research (NMIMR) Report writing: ƒ Dr. Daniel Kojo Arhinful, Noguchi Memorial Institute for Medical Research (NMIMR) ƒ Dr. Ivy Osei, Health Research Unit ƒ Mrs. Martha Gyansa-Lutterodt, Ghana National Drugs Programme ƒ Mrs. Joyce Addo-Atuah, Essential Drugs and Medicines Policy National Professional Officer, WHO Ghana ƒ Ms Edith Andrews, Essential Drugs and Medicines Policy National Professional Officer, WHO Ghana ƒ Department of Essential Drugs and Medicines Policy, WHO Geneva: Helen Tata, Diane Whitney, Martin Auton 5 ABBREVIATIONS ARI Acute Respiratory Infections C& C Cash and Carry CHAG Christian Health Association of Ghana CMS Central Medical Stores DMS District Medical Stores EML Essential Medicine List EDM Essential Drugs and Medicines Policy (WHO) GDHS Ghana Demographic and Health Surveys GNDP Ghana National Drugs Programme GDP Gross Domestic Product GPRS Ghana Poverty Reduction Strategy HAI Health Action International HIPC Highly Indebted Poor Country INRUD International Network for Rational Use of Drugs MoH Ministry of Health NDP National Drugs Policy NGO Non-Governmental Organisation NMIMR Noguchi Memorial Institute for Medical Research NPO National Professional Officer ORS Oral Re-hydration Salts RDF Revolving Drug Fund RDU Rational Drug Use RMS Regional Medical Stores RUM Rational Use of Medicines SDP Service Delivery Point SOP Standard Operating Procedure STG Standard Treatment Guidelines TRIPS Trade Related Aspects of Intellectual Property Rights WHO World Health Organisation 6 EXECUTIVE SUMMARY Monitoring, evaluating, and assessing the pharmaceutical situation in countries are important for determining if people have access to essential medicines that are safe, efficacious, and of good quality, and that these medicines are being used properly. The World Health Organization in collaboration with Health Action International – Africa, supported the Ministry of Health in carrying out a baseline survey assessing the pharmaceutical situation based on Levels I and II indicators as described in the Operational Package for Monitoring and Assessing the Pharmaceutical Situation in Countries. This survey was undertaken in 2002 to describe the current status of the pharmaceutical sector in Ghana in relation to the rational use of medicines, storage and management and people’s access to essential medicines. The method was a cross sectional descriptive drug use indicator study covering both prescribing and dispensing practices on rational use of medicines and drug management, stock management and access to medicines in the community. Using standard indicators, data were collected for the availability of key essential medicines, duration of stock-outs, rational use of medicines, household health care-seeking behaviour and access to prescribed medicines. Four regions of the country were selected through a combination of purposive and random sampling based on their geographic and socioeconomic profiles. The study units comprised of public health facilities, pharmacies in the public and private sectors, public drug warehouses and households within 5km of a public health facility. These were surveyed at regional, district and sub-district levels. The outcome measures were percentage of prescribing indicators, patient care indicators, facility indicators and access to medicines (including availability and affordability). The median percentage availability of key medicines was 78.6% in public health facilities, and 82.2% in public sector warehouses. The median stock out duration of the basket of key medicines in public health facilities and district warehouses was found to be 78 days (~2.5 months) and 50.7 days (~1.5 months) respectively. The median antibiotic and injection use in public health facilities was found to be 43.3% and 30% respectively. The majority of the households sought healthcare from public health services, and 98% of the people surveyed could not obtain prescribed drugs due to economic and availability factors. This baseline survey provides key information that will be used to plan and implement interventions to address under-performing areas identified in the assessment, which affect access, quality and rational use of essential medicines. Although there have been tremendous improvement in the pharmaceutical sector over the past six years resulting from the activities of GNDP, there is still the need to emphasize the setting up of appropriate systems to monitor the pharmaceutical sector regularly. Greater efforts should be directed at drug management practices in public drug outlets to improve their efficiency This survey provides a baseline for periodic review of work in the pharmaceuticals area so that adjustments may be made according to needs and performance. 7 INTRODUCTION A) Demographic and health characteristics Ghana is a tropical country situated on the west coast of Africa between latitudes 4 and 11 degrees north, and bounded by Côte d’Ivoire on the west, Burkina Faso on the north and Togo on the east. The population of Ghana, according to the 2000 population census, 1 is 18.4 million, out of which 50.2% are female and 49.8% are male. The population growth is 2.6% (2000 census) and the total fertility rate 5.5 (GDHS, 1998). Life expectancy at birth is 57 years, and 46% of the population is below the age of 15. About 60% of the population live in the rural areas. The average population density is 77 per sq km, a ranging from 897 in Greater Accra Region to 31 in Northern Region. The principal religions are Christianity, Islam and African traditional religion. The country has a mixed economy, consisting of a dominant agricultural sector (small-scale peasant farming) which absorbs about 60% of the total adult labour force, a relatively small capital intensive modern sector dominated by mining and a few other industrial activities, and a rapidly expanding informal sector dominated by petty traders, small artisans, technicians and small businessmen. The national per capita income is about US$ 400. The inflation level is about 18%, annual growth rate 4% (2001 Budget Statement and Economic Policy, February 2002) and population growth rate around 3%. The national literacy rate is 47.9 with an urban/rural distribution of 63% and 39%; the female literacy rate is 36.4% with urban/rural distribution as 51.7/28.4 (Core Welfare Indicator Questionnaire Survey, 1997). A decline in economic performance due to internal and external factors has negatively affected the performance of all sectors, including health, with limited resources. The population living below the poverty line has fallen from about 54 % in 1991–1992 to just fewer than 40% in 1998– 1999 (Ghana Statistical Services, 2000). Inter-regional inequalities still persist; for example, the incidence of poverty fell most sharply in Accra and the forest localities, whereas it barely declined in savannah areas. Table 1: key social and economic indicators1 Indicator 1998 2001 2002 Population, total 18.4 million 19.7 million 20.1 million Population growth (annual %) 2.2 1.8 1.6 Life expectancy (years) . 55.9 54.9 Fertility rate (births per woman) . 4.1 4.0 Infant mortality rate (per 1,000 live births) . 57.0 . Under 5 mortality rate (per 1,000 children) . 100.0 . Births attended by skilled health staff (% of total) 44.3 . . Child immunization, measles (% of under 12 months) 73.0 81.0 . Prevalence of HIV (female, % ages 15-24) . 3.0 . Illiteracy total (% age 15 and above) 31.0 27.3 26.2 Illiteracy female (% of age 15 and above) 40.0 35.5 34.1 GNI, Atlas method (current US$) 7.1 billion 5.8 billion 5.4 billion GNI per capita, Atlas method (current US$) 390.0 290.0 270.0 GDP (current $) 7.5 billion 5.3 billion 6.0 billion GDP growth (annual %) 4.7 4.0 4.5 GDP implicit price deflator (annual % growth) 17.0 34.6 20.2 Value added in agriculture (% of GDP) 36.0 35.9 34.7 Value added in industry (% of GDP) 25.3 25.2 24.9 Value added in services (% of GDP) 38.7 38.9 40.3 Exports of goods and services (% of GDP) 33.9 52.2 51.0 Imports of goods and services (% of GDP) 46.7 70.5 67.1 Gross capital formation (% of GDP) 23.1 24.0 22.7 1 Source: World Development Indicators database, August 2003 8 B) Health and health policy2 The epidemiological situation of Ghana is similar to other sub-Saharan countries, i.e. a predominance of communicable disease conditions, under-nutrition and poor reproductive health with emerging importance of non-communicable diseases such as neoplasm, diabetes and cardiovascular diseases. The Ministry of Health is responsible for policy formulation, planning, and donor co-ordination and resource mobilization. The Ghana Health Service is responsible for service delivery under the management of the Director-General. There is a Ghana Health Service Council which oversees the activities of the GHS. The teaching hospitals are autonomous with governing management boards. There is a variety of providers in the public, private and informal sectors. It is estimated that the private providers account for about 40% of the total patient care nationally.4 There is also a Coalition of Nongovernmental Organizations (NGOs) working in the health sector. The Christian Health Association of Ghana (CHAG) is an umbrella organization which brings together Christian mission hospitals and clinics. They provide a significant portion of the health services. Overall, more than 60% of the population (92% in urban and 45% in rural areas) have access to health services. Access is defined as living within one hour travel time (by any available means) from the health facility. The government estimates showed that half the population does not have access when the travel time is halved. In March 2001, the government adopted the Highly-Indebted Poor Country (HIPC) Initiative. A key component of the HIPC Initiative is the Ghana Poverty Reduction Strategy (GPRS). The strategy includes support for human resource development and access to basic services, such as health, HIV/AIDS control, population management, water, sanitation and education. The GPRS outlines interventions for all sectors in the period 2002–2004.11 The strategies are as follows: ƒ Bridging equity gaps in the access to quality health services ƒ Ensuring sustainable financing arrangements that protect the poor ƒ Enhancing efficiency in service delivery. C) Health system structure Public sector health service provision is offered through a network of hospitals, clinics, health centres and maternity homes that are organised at five levels: community, sub district, district, regional and national. Community and sub district levels offer primary care while secondary services are provided by district and regional levels. At the moment, tertiary services are provided by two teaching hospitals in Accra and Kumasi. Lower level providers are supposed to refer to the level immediately above them but this is not always adhered to. Preventive health care is also given prominence especially at the district and sub-district levels. There is a strong collaboration here between the Ministry of Health and other health related ministries and agencies such as water and sanitation, local government, agriculture, housing and environment. The contribution of mission health facilities to Ghana’s health care is also significant. This is channelled through the Christian Health Association of Ghana (CHAG). Private clinics and hospitals also operate under the umbrella of Private Medical and Dental Practitioners Association of Ghana. Table 2 below presents a summary of numbers of existing facilities in both government and private sectors. 2 WHO cooperation strategy 2002-5 9 Table 2: Distribution of health facilities in Ghana Public facilities Teaching hospital 2 Regional hospital 9 Government district hospital 81 Quasi governmental district hospital 23 Government polyclinics 10 Quasi governmental polyclinics 0 Government health centres and clinics 863 Quasi governmental health centres and clinics 57 Maternity homes 217 Mission (NGO) and private facilities3 Private hospital 89 NGO/mission hospital 52 Private polyclinic 0 Mission health centres and clinics 118 Private health centres and clinics 350 Health care financing Since independence, public health care services in Ghana has been characterised by state finance. The government provides the bulk of the expenditure but donor assistance also constitutes a substantial source of funding. For example when capital expenditures are excluded, donor pooled funds in 2000 constituted 20% of public health expenditure (Arhinful 2003). Since the mid 1980’s economic difficulties have compelled the introduction of user charges. Mechanisms to increase economic accessibility have led to attempts to implement health insurance and encourage generic prescribing. Recent major reforms include the creation of the Ghana Health Service. D) The Pharmaceutical Sector Historically the availability of drugs in Ghana has gone through trying times. In order to achieve optimal availability and use of essential drugs, the ministry of health has undertaken a number of measures to improve the situation. The first essential drugs list with therapeutic guidelines was published in 1983 which has subsequently undergone reviews. The current edition was published in 2000. A comprehensive review of the pharmaceutical sector was also undertaken in 1994, which identified a number of major problems within the sector. Principal among these were inappropriate use of drugs, poor procurement, storage and distribution practices, inadequate financial management systems for drugs, leading to erosion of capital of the revolving drug funds and inappropriate quality assurance. The review process resulted in the formulation of a master plan for the pharmaceutical Sector that formed the basis for the setting up of Ghana National Drugs Programme (GNDP) in 1997. The overall objective has been to strengthen the pharmaceutical sector in order to ensure that all inhabitants in Ghana have access to essential drugs that are safe, effective, and affordable, of good quality and that are rationally used in both public and private sector. Since its inception, the GNDP has spearheaded the launching of a National Drugs Policy (NDP), clinical pharmacy training programme, and workshops for health personnel in various 3 2003 (unpublished) 10 institutions and retraining of chemical sellers. However, as in most developing countries, inadequate control of drug promotion and drug dispensing by untrained prescribers particularly of herbal drugs has left a wide gap in the promotion of rational drug use. In general while several activities have been carried out to promote rational prescribing and dispensing in the public sector, a lot remains to be done in the private sector. Other factors that hinder rational drug use include lack of objective drug information, drug adverts and promotion on both prescribers and consumers. An up-coming edition of Ghana’s NDP deals with intellectual property rights as contained in the TRIPS agreement (Trade Related Aspects of Intellectual Property Rights). It also covers local production of antiretroviral drugs necessitated by the importance of HIV/AIDS in the disease profile of the country. 11 i) Drugs supply system 4 Like many other countries in sub-Saharan Africa in the 1980s, Ghana adopted economic structural adjustment policies, including the introduction of selected cost recovery initiatives in the social sectors. In the health sector, Hospital Fees Legislation was introduced in 1985, and, in 1992, the cash and- carry (C&C) system for pharmaceutical supply to outpatients throughout the MOH system was introduced (Asenso-Okyere et al. 1998). The C&C system was inspired by structural adjustment programs and the “Bamako Initiative,” spearheaded by UNICEF and implemented in many developing countries, especially Africa. The initiative was based on the theory that charging for drugs would help finance and, therefore, improve the delivery of primary health care services. The scarcity of pharmaceuticals in Ghana’s public sector had led to the organic development of pharmaceutical fee schemes within many MOH facilities, and the idea of improving pharmaceutical supply throughout the system with financing from user fees was easily accepted. Within the C&C system, each MOH facility was expected to have a self-financing revolving drug fund (RDF) by repurchasing the products with the revenues from the sale of pharmaceuticals. There are a series of RDFs cascading down each institutional level within the MOH. There is a large RDF at the Central Medical Stores (CMSs) level, 10 smaller RDFs in each of the Regional Medical Stores (RMS), and RDFs in every hospital and service delivery point (SDP). At each level of the system, the facility usually marks up the basic purchase price paid for a product. As originally envisioned, these mark-ups were intended to cover the cost of repurchasing the products, including allowances for losses, inflation, duties (at the CMS level), and costs directly related to products, such as insurance and casual labor for handling. Fixed percentages for mark-ups at each level were established by the MOH. However, actual practice has often deviated from these official MOH mark-ups, and the official policies have changed over time. The Ghana MOH currently has in place a number of vertical public sector supply chains based on the type of health commodity. While integration is currently taking place to look at a more rationale way to combine the essential drug, contraceptive, and non-drug consumable supply chains, policy changes necessary to support this have not yet evolved. Currently, drugs are purchased by the CMS through international competitive bidding (ICB) and through local private suppliers. The RMS and teaching hospitals are meant to procure drugs through the CMS and from the local private sector. All the regional hospitals and SDPs are, in turn, expected to procure from the RMS in their respective regions. While it is MOH policy for facilities to procure through the public system, except in cases of unavailability, it has been observed that there are significant private sector purchases at all levels. Although integration is taking place, there are still a number of district medical stores who procure from both the RMS and the local private sector. The teaching and regional hospitals and several SDPs are supplied by an RMS, District Medical Stores (DMS), and, in many cases, procure drugs through the local private sector. The transportation system for essential drugs is undergoing a policy review within the MOH. Currently, lower level facilities are required to either provide their own transportation or pay for the transport of drug procurements. The CMS is now considering providing no-charge transportation to the RMS. Whether those savings will cascade to the SDPs remains unclear. The 4 Ghana Pharmaceutical Pricing Study; Policy Analysis and Recommendations July 2003 12 private sector, however, provides free transportation to facilities that engage in private sector procurement. This, naturally, was a key consideration in decisions by facilities to choose private over public sector suppliers ii) Key pharmaceutical indicators Date of National Drug Policy 2002 Date of Essential Drug List 2000 Date of National Standard Treatment Guidelines 2000 Public sector drugs expenditure $ 90 million (2000) Public sector per capita drugs expenditure $5 (2000) Pharmaceutical sector market value Number of registered pharmacists 1400 (2003) Number of registered pharmacy technicians 608 (2003 Number of Pharmacy Technologists 400 (2003) Annex 1 contains a more detailed overview of the pharmaceutical sector through the completed questionnaire on the structures and processes of the pharmaceutical situation in Ghana (Level I indicators). iii) Pharmaceutical sector surveys In 1990 and 1993, studies on the pharmaceutical sector were carried out in Ghana with technical support by the Ghana branch of the International Network for Rational Use of Drugs (INRUD). After the inception of the GNDP a baseline study of the pharmaceutical sector was undertaken in 1998. This covered rational use of medicines, procurement and financing medicine requirements. In 2000 another study on knowledge, attitudes, practices and beliefs (KAPB) on community use of medicines was carried out. Annex 2 contains the results of several previous surveys carried out in the pharmaceutical sector between 1990 and 2000. 13 STUDY DESIGN AND METHODOLOGY Objectives of the survey The survey had the following overall objectives: • To know if people have access to essential drugs • To determine if essential medicines are being used properly • To collect baseline information on the pharmaceutical sector from available facility data sets in order to obtain a clear picture of national and institutional problems and thereby identify priorities in the implementation of the revised NDP Methodology The survey was conducted according to the WHO “Operational Package for Monitoring and Assessing the Pharmaceutical Situation in Countries – (Working Draft November 2002). The package contains survey tools for two levels of core indicators and a household survey tool: Level I - Structural and Process Indicators: were used to assess the existing structures and processes in the national pharmaceutical system. Level II - Outcome indicators: supported Level I indicators by providing specific data about the important pharmaceutical outcomes The household survey form complemented the level I and II indicators by examining issues on access and use of drugs in the community. Level I and II indicators are almost entirely focused on health structures and people visiting health facilities. This survey tool ensures data are collected about treatment-seeking behaviour and drugs consumption. The list of indicators is presented below and a description of the purpose of each indicator, together with instructions on how to collect, record and process the data can be found within the operational package. a) Level I indicators See Annex 1 for the questionnaire (completely filled) b) List of Level II indicators See Annex 4 for survey forms (Survey forms 1 – 13) Access Availability of key drugs in public health facilities and district warehouses supplying the public sector Stock out duration in public health facilities and district warehouses supplying the public sector % of prescribed drugs dispensed or administered to patients at public health facility dispensaries Affordability of key drugs (treating pneumonia without hospitalization) at public health facility dispensaries and private drug outlets Quality % of expired drugs in public health facility dispensaries, private drug outlets and district warehouses supplying the public sector Adequacy of storage in public health facility dispensaries and warehouses supplying the public sector Rational use of drugs % of drugs adequately labelled at public health facility dispensaries % of patients with adequate knowledge on how to take their drugs correctly at public health facility dispensaries Average number of drugs per prescription at public health facility dispensaries and public health facilities % of patients prescribed antibiotics at public health facilities % of patients prescribed injections at public health facilities % of prescribed drugs on the essential drugs list at public health facilities Availability of standard treatment guidelines at public health facilities Availability of essential drugs list at public health facilities Prescribing according to STG 14 c) List of household survey indicators Also see Annex 4 for survey form (Survey form 14) Symptoms and source of consultation Common disease symptoms reported Sources of consultation Prescribing and obtaining the prescribed drugs Proportion of prescribed drugs obtained by patients Primary reasons for not obtaining all prescribed drugs Taking the prescribed drugs Completion of course of prescribed drugs Family income/expenditure Average weekly income Proportion of income spent of drugs d) Training and Sampling Adaptation of the survey forms for Ghana, training of data collectors, field-testing and district and facility sampling were carried out at the training workshop held 11-15 October 2002. Annexes 3 and 4 contain a summary of adaptations, the districts and facilities sampled and the adapted survey forms. In order to ensure a fair representation, the ten regions in Ghana were divided into four categories, according to the following criteria and four of them subsequently selected. ƒ Socio-economic profile ƒ Proximity to the Central Medical Stores ƒ Presence of a particular strong support to the regional drugs programme The four regional categories comprised the following: ƒ Greater Accra, ƒ Eastern region, Central region and Volta region ƒ Western region, Ashanti and Brong Ahafo ƒ Northern, Upper-East and Upper West region Within each region, the following facilities and households were selected based on a combination of purposive and systematic random sampling: ƒ public health facilities including the regional, a district hospital and 3 health centres (in this survey public health facility refers to either government or private-not-for- profit/NGO health facility) ƒ 5 private pharmacies/drug outlets/chemical sellers close to the selected public health facility ƒ 1 central/district drugs warehouse/storage facility ƒ 15 households within 5km of each selected public health facility. e) The survey The survey was carried out during November 2002. Patients were interviewed and information from patient records in health facilities was collected retrospectively as described in the operational package. Further information was gathered from facility records, observation and interviews of health facility staff, private pharmacies/drug outlet staff and household members. 15 FINDINGS Note on the use of medians and averages Median and average values are presented in the summary table below. However, as averages can be skewed by outlying values, median values are used unless otherwise stated throughout the presentation of results and discussion as a better representation of the midpoint value. Comparisons with previous surveys indicators Annex 2 contains a summary of results from previous pharmaceutical surveys. Comparisons within the findings section are limited to those that show a marked difference, as it is not certain that the methodologies were the same and hence the results are not fully comparable. Index of findings section Page Level I: Structures and processes of country pharmaceutical situation 32 Level II: Core indicators 14 Household survey 25 Exchange rate The exchange rate used is that of the time of the survey (August/September 2002): 1US$ = 8481 Cedis (November 2002) Level I: Structures and processes of country pharmaceutical situation The questionnaire on structures and processes of country pharmaceutical situation (Level I indicators) completed in September 2003, by the Ministry of Health, may be found in Annex 1: Page 32. 16 Level II: Core indicator results a) Summary of the Level II core indicator results Public sector facilities Indicator Median Average Access Availability of key drugs 78.6% 73.9% Average stock out duration 78.0 days 79.5 days % of prescribed drugs actually dispensed to patients 89.2% 89.4% Affordability: adult 1.17 days 1.16 days Affordability: child 1.11 days 1.06 days Quality Adequacy of storage 68.8% 67.6% % of expired drugs 0% 3.7% Rational drug use Number of drugs prescribed per patient contact 3.33 3.48 % patients receiving antibiotics 43.3% 42.8% % patients receiving injections 30.0% 34.9% % drugs prescribed on EDL 96.1% 93.9% Adequacy of labelling 0% 7.2% Patient knowledge 56.7% 50.5% Prescribing according to NSTG % ORS 80.0% 76.6% % antibiotics 50.0% 53.1% Diarrhoea in children % anti-diarrhoeals and/or anti- spasmodics 0% 0% % first line antibiotic 100% 91.1% Mild/ moderate pneumonia in under 5’s % receiving > 1 antibiotic 33.3% 37.0% Non-pneumonia ARI % antibiotics 80% 81.2% NSTG in the facility 94.4% EML in the facility 88.9% Warehouses supplying public sector Availability of key drugs 82.2% 82.2% Average stock out duration 50.7 days 39.3 days Adequacy of storage 50% 66.1% % of expired drugs 0% 0% Private drug outlets Availability of key drugs 85.7% 83.5% % of drugs expired 0% 1.8% Affordability: adult 1.17 days 1.22 days Affordability: child 1.39 days 1.43 days 17 b) Accessibility to drugs Availability of key drugs in public health facilities, private drug outlets and public sector warehouses ƒ the median availability in public health facilities private drug outlets and public sector warehouses was found to be 78.6%, 85.7% and 82.2% respectively ƒ 1 in 20 public health facilities had less than 50% availability ƒ 60% public health facilities had greater than 75% availability ƒ all public sector warehouses had greater than 78% availability Availability of key drugs in public health facilities - distribution by facilities 0% 5% 35% 60% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% <25% 25-50% 50-75% >75% % availability - range % fa ci lit ie s median = 78.6% Recommendation: Investigate the reasons for the variations in availability in public health facilities - especially the minority of facilities that had less than 50% availability Stock-out duration in public health facilities and public sector warehouses ƒ the median stock-out duration of the basket of key drugs in public health facilities and public sector warehouses was found to be 78.0 days (2.5 months) and 50.7 days (1.5 months) respectively ƒ Almost 1 in 3 public health facilities (29.4%) had a stock-out duration of greater than 3 months; 1 in 10 (11.8%) had a stock-out duration of greater than 6 months Stock-out duration in public health facilities - distribution by facilities 29.4% 35.3% 17.6% 11.8% 0.0% 20.0% 40.0% 60.0% 80.0% 100.0% <1 month 1-3 months 3-6 months >6 months number of months - range % fa ci lit ie s median = 78.0 days 18 Recommendation: Investigate the reasons for the large variations in stock out duration in public health facilities - especially the almost one third with a stock out duration of greater than 3 months 19 Percentage of prescribed drugs actually dispensed to patients in public health facilities ƒ The median percentage of drugs actually dispensed or administered at public health facilities was found to be 89.2% ƒ More than 80% of drugs prescribed were actually dispensed or administered in 94.8% of facilities ƒ More than 90% of the drugs prescribed were actually dispensed or administered in 47.4% of facilities % prescribed medicines dispensed or administered - distribution of facilities 5.3% 31.6% 15.8% 26.3% 21.1% 0.0% 20.0% 40.0% 60.0% 80.0% 100.0% <80% 80-85% 85-90% >90% >95% % drugs actually dispensed - range % fa ci lit ie s median = 89.2% Affordability of key drugs in public health facilities and private drug outlets ƒ Based on this the lowest Government workers salary5, the number of hours of work needed to pay for a course of treatment for a child with pneumonia without hospitalisation is on average 25% more in a private drug outlet than a public health facility Median number of days work necessary for the lowest paid Government worker for a full course of treatment 6 Treatment of pneumonia for: Public health facility Private drug outlet Adult 1.17 1.17 Child 1.11 1.39 5 7200 Cedis 6 See Annex 3 for details of treatment regimens 20 c) Quality of drugs Storage conditions in public health facilities and public sector warehouses ƒ The median percentage adequacy of storage conditions from a checklist of minimum storage criteria in public health facilities and public sector warehouses was found to be 70.3% and 50% respectively ƒ Of the criteria not met, the majority of public health facilities did not have satisfactorily clean shelves (55%), stored drugs on the floor (62.5%), did not store drugs in a systematic way (72.5%) and did not maintain and monitor cold storage with a temperature chart (70%) % dispensaries/stores rooms in the facilities meeting each criteria 7 Working locks 90% Storage clean shelves 45% Pest free 70% Secured ceiling 95% Windows have good air vents 92.5% No direct sunlight access 65% Moisture free 95% Drugs not stored on floor 37.5% Storeroom separate from dispensing room 82.5% Drugs sorted in a systematic way 27.5% Stock record system 80% Cold storage and temperature chart. 30% Recommendation: Identify storage deficiencies and design interventions for implementation to address these poor or not adequate storage conditions in public health facilities Presence of expired drugs in public health facilities, private drug outlets and public sector warehouses ƒ The median percentage of expired drugs was found to be 0 in public health facilities, public sector warehouses and private drug outlets; however the average % expired drugs was found to be 3.7%, 0% and 1.8% respectively ƒ 20% of public health facilities and 10% of private drug outlets were found to have some expired drugs on their shelves Recommendation: The Ministry of Health should strengthen mechanisms to ensure that no expired drugs are found on the shelves in both the public and private sectors 7 results for dispensary and store areas combined 21 d) Rational drug use Number of drugs prescribed per patient contact at public health facilities ƒ The median number of drugs prescribed per patient at public health facilities was found to be 3.4 (i.e. each patient received 3 or 4 drugs) (average 3.46) ƒ 5 out of 6 facilities (84.2%) were prescribing more than 3 drugs to each patient; in 6 (15.8%) prescribing more than 4 drugs per patient; and 1 in 6 (15.8%) prescribing less than 3 drugs per patient; 1 ƒ Results from a similar survey 8 in 1998 reported an average of 4.6 drugs per patient – this survey reporting average of 3.46 drugs per patient shows an apparent improvement Number of drugs prescribed per patient in public health facilities - distribution by facilities 0.0% 15.8% 68.4% 15.8% 0.0% 20.0% 40.0% 60.0% 80.0% 100.0% 1 to 2 2 to 3 3 to 4 more than 4 number of items -range median = 3.4 Recommendation: Investigate and develop interventions as to why 1 in 6 facilities can prescribe an average of less than 3 drugs per prescription and why 1 in 6 facilities need to prescribe an average of more than 4 drugs per prescription 8 See Annex 2 for more detail 22 Percentage of patients receiving an antibiotic at public health facilities ƒ The median percentage of patients receiving one or more antibiotic in public health facilities was found to be 43.3% (average 42.8%) ƒ In 42.2% of facilities, less than 40% of the patients received an antibiotic, whereas in 21% of facilities more than half the patients received an antibiotic ƒ Results from a similar survey9 in 1998 reported an average of 54% of patients receiving an antibiotic – this survey reporting an average of 42.8% shows an improvement % patients receiving an antibiotic - distribution of results 0% 20% 40% 60% 80% 100% facility median value % patients receiving an antibiotic - distribution by facilities 21.1% 21.1% 36.8% 10.5% 10.5% 0.0% 20.0% 40.0% 60.0% 80.0% 100.0% <30% 30-40% 40-50% 50-60% >60% % patients receiving an antibiotic - range % fa ci lit ie s median = 43.3% Recommendations: Investigate and develop interventions on the wide variations found in the use of antibiotics – especially why more than 1 in 5 facilities (21%) are prescribing antibiotics to more than half of the patients Identify, develop and continue implementing interventions to further decrease the number of patients receiving antibiotics 9 See Annex 2 for more detail 23 Percentage of patients receiving an injection at public health facilities ƒ The median percentage of patients receiving one or more injection in public health facilities was found to be 30% (average 34.9%) ƒ In 21.1% of facilities, less than 20% of the patients received an injection, whereas in 31.6% of facilities more than 40% the patients received an injection; in 10.5% of facilities, greater than 70% of patients received an injection ƒ Results from a similar survey10 in 1998 reported 42% of patients receiving an antibiotic – this survey reporting an average of 34.9% shows an improvement % patients receving an injection - distribution by facilities 5.3% 15.8% 31.6% 15.8% 21.1% 0.0% 10.5% 0.0% 20.0% 40.0% 60.0% 80.0% 100.0% <10% 10-20% 20-30% 30-40% 40-50% 50-70% >70% % patients receving an injection - range median = 30% Recommendations: Investigate and develop interventions on the wide variations found in the use of injections – especially why more than 1 in 10 facilities (10.5%) to greater than 70% of patients receive an injection, whereas in 1 in 5 facilities (21.1%) less than 20% of the patients receive an injection Identify, develop and continue implementing interventions to further decrease the number of patients receiving injections 10 See Annex 2 for more detail 24 Percentage of prescribed drugs on EDL in public health facilities ƒ The median percentage of drugs prescribed that were on the EDL in public health facilities was 96.1% which is consistent with similar surveys carried out in 199811 ƒ In 73.7% of facilities were prescribing from the EDL more than 95% of the time ƒ In 10.6% of facilities were prescribing from the EDL less than 90% of the time Prescribing according to EDL - distribution by facilities 5.3% 0.0% 0.0% 5.3% 15.8% 73.7% 0.0% 20.0% 40.0% 60.0% 80.0% <60% 60-70% 70-80% 80-90% 90-95 95-100 % prescribing on EDL - range median = 96.1% Recommendation: Investigate and develop interventions as to why a minority of facilities are not prescribing consistently according to the EDL Adequacy of labelling at public health facilities ƒ The median adequacy of labelling 12 at public health facilities was found to be zero ƒ In 84.2% of facilities there were no adequate labels; no facility had more than 60% of labels adequate Adequacy of labelling - distribution by facilities 84.2% 0.0% 10.5% 5.3% 0.0% 0.0% 20.0% 40.0% 60.0% 80.0% 100.0% 0% 0-30% 30-50% 50-60% >60% % adequate labels - range median = 0% Recommendation: Develop, disseminate and enforce clear guidelines and training on the importance of labelling for dispensed drugs. This should include consumer-targeted and community-based information, education and communication campaigns 11 See Annex 2 for more detail 12 an adequate label was defined as a label containing the name and quantity of drug, the dosage and frequency, and duration of treatment 25 Adequacy of patient knowledge of how to take drugs at public health facilities ƒ The median adequacy of patient knowledge on how to take their drugs13 at public health facilities was found to be 56.7% ƒ In 42.1% of facilities less than half of the patients had adequate knowledge ƒ In only around 1 in 6 facilities (15.8%) did greater than 75% of patients have adequate knowledge Adequacy of patient knowledge - distribution by facilities 26.3% 15.8% 42.1% 15.8% 0.0% 20.0% 40.0% 60.0% 80.0% 100.0% <25% 25-50% 50-75% >75% % adeqacy of knowledge- range median = 56.7% Adequacy of labelling and patient knowledge 0.0% 57.0% 0.0% 20.0% 40.0% 60.0% 80.0% 100.0% adequate labelling adequate knowledge Recommendations: Develop, disseminate and enforce clear guidelines and training on the importance of ensuring that patients know how to take their drugs correctly. These initiatives should include consumer-targeted and community-based information, education and communication campaigns. 13 adequate patient knowledge was defined as the patient being able to correctly give the name of all the drugs or state what the drugs are for, and how often they should be taken 26 Availability and prescribing according to STG’s and EDL at public health facilities ƒ The National Standard Treatment Guidelines (2000) were found in 94.4% of the facilities, which compared with 73% in a similar survey in 1998 14 ƒ The EDL was found in 96.1% of facilities Diarrhoea in children under 5 years15 ƒ The median percentages of child patients with diarrhoea at public health facilities that were prescribed ORS was 80% ƒ The median percentages of child patients with diarrhoea at public health facilities prescribed an antibiotic was 50% Prescribing by group of drugs in children under 5 with diarrhoea 80% 50% 0% ORS antibioitic antidiarrhoeal/antispasmodic % children under 5 prescribed ORS - distribution by facilities 11.8% 11.8% 58.8% 17.6% 0.0% 20.0% 40.0% 60.0% 80.0% 100.0% <50% 50-75% 75-99% 100% % prescribed ORS - range median = 80% 14 See Annex 2 for more detail 15 National standard treatment guideline for diarrhoea in a child under 5 years recommends: ORS only 27 % children under 5 prescribed an antibiotic - distribution of facilities 0.0% 11.8% 41.2% 29.4% 17.6% 0.0% 20.0% 40.0% 60.0% 80.0% 100.0% 0 0-25% 25-50% 50-75% >75% % prescribed an antibiotic - range median = 50% Mild/moderate pneumonia in children under 5 years16 ƒ In all cases, a first line antibiotic was prescribed, however in 33% of cases, more than 1 antibiotic was prescribed Acute respiratory tract infection17 ƒ The median percentage of patients prescribed an antibiotic for ARI was 80% ƒ In 26.7% of facilities, all patients were prescribed an antibiotic for ARI, only in 6.7% of facilities were less than half the patients prescribed an antibiotic % patients prescribed an antibiotic for non-pneumonia ARI - distribution by facilities 6.7% 13.3% 53.3% 26.7% 0.0% 20.0% 40.0% 60.0% 80.0% 100.0% <50% 50-75% 75-99% 100% % prescribed an antibiotic - range median = 80% Recommendations Investigate and develop interventions for the treatment of diarrhoea in children <5 years: why are 50% of children receiving antibiotics and why are 20% of children not receiving ORS? Investigate and develop interventions why more than one antibiotic is being prescribed fro mild/moderate pneumonia in 33% of cases Investigate and develop interventions to address the very poor adherence to the standard treatment guideline for ARI 16 National standard treatment guideline for mild/moderate pneumonia in a child under 5 years recommends: 1st line antibiotic: amoxicillin 17 National standard treatment guideline for acute respiratory tract infection recommends: no antibiotic 28 Household survey results a) Characteristics of survey population Sex of survey population male 44% female 56% Age distribution of survey population < 1 year 6% 1-5 years 17% 6-15 years 11% 16-54 years 51% >55 years 15% 29 b) Symptoms and source of first consultation Common disease symptoms reported ƒ Fever, cough and diarrhoea accounted for 84.4% of the reported symptoms Reported symptoms fever 35% cough 14% diarrhoea 9% headache 9% general body pains 6% lower abdominal pain 6% palpitations 2% vomiting 2% others 17% Sources of consultation ƒ The 64% consulted a clinic or hospital in the public or private sectors ƒ 7% consulted a pharmacy or drug seller ƒ 5% consulted a traditional healer ƒ 13% self-medicated or used drugs remaining after another illness ƒ 67.6 consulted a public, private or mission/NGO health facility ƒ 32.4% consulted a pharmacy or drug seller Sources of consultation on illnesses traditional healer, 4.1% did nothing, 1.0% self, friend or family advice, 11.1% used medicines remaining from previous illness, 2.4% drug seller, 19.9% health facility in the mission/NGO sector, 4.4% health facility in the private sector, 7.8% health facility in the public sector, 55.4% pharmacy, 12.5% 30 c) Prescribing and obtaining the prescribed drugs ƒ The proportion of consultations that resulted in drugs being prescribed was 95.1% ƒ Of the drugs prescribed, the following proportions were obtained: All of the drugs dispensed 73.4% Some of the drugs dispensed 24.7% None of the drugs dispensed 1.8% Primary reasons for not obtaining all of the prescribed drugs: ƒ In 98% of cases, availability and price were stated as the primary factors ƒ Of these 67% related to availability in either the public or private sectors and ƒ 31% related to price and/or availability of money Primary reason for not obtaining the prescribed medicines all drugs available at public sector facility 57% high price 6% not enough money 25% No time 2% not all drugs available at private pharmacy 4%not all drugs available at mission/NGO facility 6% d) Taking prescribed drugs ƒ 1 in every 5 patients did not take the full course of prescribed drug All was taken 78.7% Some was taken 20.9% None was taken 0.4% e) Estimated family weekly income/ total weekly household expenses ƒ Average household income was found to be Cedis 167,069 (US$19.70) ƒ For those reporting ill, the average total amount spent on drugs as a proportion of total household expenses during the period of the last week of the study was 28.5% 31 INTERPRETATION OF RESULTS Access to Medicines Availability, long stock out durations and affordability are three major factors that affect access to medicines for most people in resource poor settings, Ghana being no exception. The results of the study clearly show these phenomena especially in public health facilities across the country. This stems from the organizational structure and procurement policies of essential medicines which are based both on the principles of decentralization and the autonomy of each facility within the drug management and distribution system (i.e. CMS»RMS» facility). Each facility is responsible for making its own procurement decisions. The decentralized aspect of the system has both positive and negative consequences that affect rationale procurement decisions, pricing, and hence availability of medicines. In general, MOH procurement rules state that a Regional Medical Store must look to the Central Medical Store first to source its pharmaceutical supply needs. If the CMS is unable to meet these needs, and the requested item is out of stock, then the RMS can buy from the open market. For lower level facilities, a similar approach is to be followed by going to the RMS first and then only when the RMS is unable to supply can the health facility turn to the private sector. The results obtained reflect this trend for the public sector. If the availability of medicines in the warehouse is less it affects availability at the facility level. Another factor which affects availability and stock out duration is distance from the Central Medical Stores. Logistics especially in the area of transportation is a major hindrance to facilities which are situated very far from the CMS. This is usually noted with regions like the three northern regions including upper Upper East region which was part of the survey. The availability at private drug outlets was better because they are profit oriented institutions and they depend solely on sales for their income and therefore cannot afford not to have the basic drugs on their premises. Lack of funds to purchase items as they run out is faced by some facilities. The drug revolving funds which are meant solely for drugs are used for other activities that the institutions find to be equally important. In some facilities the internally generated funds from other services is not enough to run the clinics and the heads are forced to borrow funds from the pharmacy to top up for the other services. These funds are sometimes borrowed to be repaid, but most often they are not paid back into the drug revolving funds, resulting in de-capitalization of the RDF leading to non availability and stock out of certain items. Poor inventory and financial management issues worsen the problem of availability. In certain facilities prescribing habits hinder availability of some drugs which in turn affects the stock out duration. Only certain drugs are prescribed in certain facilities depending on the prescribing habits of those prescribing in the facility resulting in the expiration of other drugs which are not “favourites” for prescription. The activities of medical representatives who promote certain medicines force some facilities to stock only the medicines which are constantly being promoted. In such a case the pharmacy will stock only those drugs which are fast moving and leave other essential drugs which are slow moving. Poor inventory and financial management could also stem from lack of skills for those in charge of the drug supply management Affordability of medicines for the poor is a major barrier to access. It is catastrophic for an individual to use a whole days wage to pay for the treatment of pneumonia. 32 The results of most quality of care surveys have shown that attendance at health care facilities are affected by the inability of clients to pay for health care services. The government of Ghana recognizes that ensuring equitable, secure and sustainable access to essential medicines is a core element of the national strategy for improving health outcomes of the population. Efforts to improve access continue to face major challenges in a rapidly changing nationa0l and international policy environment. In the pursuit of improving access to health care the Government has introduced the National Health Insurance Scheme (NHIS). A key purpose of the NHIS is to share the risk and burden of pharmaceutical and health care costs across the population and therefore, improve equity of access. The National Health Insurance Scheme was necessitated given the increasing public concerns about the inequities inherent in the system of cost recovery known as “cash and carry”. It is hoped that the National Health Insurance scheme if it is well implemented will reduce the burden of the direct out-of –pocket –at-point-of-service user payments, involved in the “Cash and Carry” system and therefore improve overall access to healthcare including access to medicines Quality The absence of quality assurance procedures in healthcare facilities and warehouses is shown in results obtained in the survey, Lack of supervision and the presence of staff who unmotivated is realised in the fact that shelves were found to be dirty and drugs stored on the bare floor. Anybody who works in a store has knowledge of the fact that drugs should not be stored directly on the bare floor. This situation needs to be investigated if the quality of drugs is to be maintained for the end user. The problem of expired drugs can be attributed to poor inventory management. The presence of expired drugs on the shelves of both public and private facilities is of grave concern. What if expired drugs are being given to unsuspecting patients and such drugs causing other undesired effects in the population. Irrational prescribing could also lead to the presence of expired drugs. If public sector facilities were made to operate in a businesslike manner such situations would scarcely arrive. Rational Use of Medicines Indicators for the rational use of medicines are those that are regularly monitored in public health facilities. These indicators have improved over the years since awareness was created, but even so some of the indicators have not done as well as expected. Even though the Food and Drugs Board have standards for labelling this is not adhered to in public health facilities hence the adequacy of labelling is a far cry from the standard. There is need to enforce labelling standards. The inadequacy of patients’ knowledge on how to take drugs at certain public health facilities could stem from the clarity of the message given, the compactness of the message and the presentation of the message. All these can affect the dispensing time, and considering the fact that there are always a lot of patients waiting at public health facility dispensaries for the medication, the dispensing times can be compromised. This situation even gets worse when the patients start quarrelling that they have been waiting for too long at the dispensary. This is not to find an excuse for the lack of clients’ knowledge on how to take their medication at public health facilities. The still remains that if clients do not have adequate knowledge on their medications then all the efforts that is being put into getting patients better is going to waste. There is need for dispensers to have time to collect feedback on messages given to patients to see their understanding of the information given them. 33 The Standard Treatment Guidelines (STG) and the Essential Medicines Lists were found to be widely available in public health facilities but then the results obtained from prescribing according to the STG did not match the availability of the documents in the facilities. This shows that even though the documents have been widely circulated they are not being used effectively because of the lack of enforcement. The bearing is that the drugs and therapeutics committees in the facilities are not executing their duties efficiently if even they exist. It is necessary to investigate why these documents which cost so much money are not being adhered to and develop interventions to address the poor adherence to the STG. Household Survey The majority of the symptoms reported in the household surveys could be due to the period of the year in which the survey was conducted. This was during the harmattan period when a lot of fever and cough symptoms are reported due to the weather conditions. It is gratifying to note that majority of the people consulted a health facility when they were ill. It has been assumed that the first point of call for community members who are ill is a pharmacy or chemical seller shop but the results obtained here disproves that notion. The proportion of consultations that resulted in the prescription of drugs (95.1) confirms the anecdote that for every ill there is a pill. The Ghanaian population is used to being given medicines anytime they visit a health facility and if they are not given medicines they tend to feel that the doctor is not a good doctor, this is probably why the number of consultations that resulted in a prescription were so high. As was found in the health facility and private medicines outlet surveys the main barriers to access are affordability and availability and this has been discussed extensively. Incomes are not too high and this makes healthcare unaffordable to most people since they have to pay out of pocket at the point of service delivery. Patients’ knowledge on taking prescribed medication has a bearing on whether the patient would take the medication or not. The facility surveys show that adequate information is not given to patients on the importance of taking all their medicines and this is reflected in the household surveys where one in every five patients did not take the full course of prescribed drug. It is well noted that the percentage of family income being used on medicines is too high and this has received considerable attention by government who is doing all it can to improve access to healthcare for its people. - - 34 CONCLUSIONS AND RECOMMENDATIONS Conclusions: Positive aspects and areas for improvement identified Indicator Positive aspects emanating from the survey Areas for improvement apparent from the survey ACCESSIBILITY TO DRUGS Availability of key drugs 60% public health facilities had greater than 75% availability 1 in 20 public health facilities had less than 50% availability Stock-out duration 29.4% of public health facilities had a stock-out duration of greater than 3 months; 11.8% greater than 6 months % prescribed drugs actually dispensed More than 80% of drugs prescribed were actually dispensed or administered in 94.8% of the facilities Affordability More than a days wages of the lowest paid government worker are required to pay for a course of treatment of a child with pneumonia in both the public and private sectors QUALITY OF DRUGS Adequacy of storage Storage conditions overall were found to be reasonable in terms of security, temperature and moisture control and having a stock management system Unclean shelves, drugs stored on the floor, not organising drugs in a systematic fashion and not properly monitoring the cold chain where common shortfalls in good storage practices Presence of expired drugs Expired drugs were found on the shelves of public health facilities and private drug outlets RATIONAL DRUG USE Number of drugs prescribed per patient There has been an apparent reduction in the average number of drugs prescribed (similar survey in 199818) 84.2% of facilities are prescribing more than 3 drugs to each patient % patients receiving an antibiotic In 42.2% of facilities, less than 40% of the patients received an antibiotic. There has been an apparent reduction in the antibiotic prescribing (similar survey in 199819) There are very wide differences in the proportion of patients which receive antibiotics. In 21% of facilities more than half the patients received an antibiotic % patients receiving an injection In 21.1% of facilities, less than 20% of the patients received an injection. There has been an apparent reduction in the injection prescribing (similar survey in 199820) In 31.6% of facilities more than 40% the patients received an injection 18 See Annex 2 for more detail 19 See Annex 2 for more detail 20 See Annex 2 for more detail 35 Indicator Positive aspects emanating from the survey Areas for improvement apparent from the survey Prescribing according to the Essential Drugs List In 73.7% of facilities were prescribing from the EDL more than 95% of the time In 10.6% of facilities were prescribing from the EDL less than 90% of the time Adequacy of labelling Median adequacy of labelling at public health facilities was found to be zero Adequacy of patient knowledge In 42.1% of facilities less than half of the patients had adequate knowledge Availability of NSTGs and EDL The National Standard Treatment Guidelines (2000) were found in 94.4% of the facilities. The EDL was found in 96.1% of facilities Prescribing according to STG 80% of children with diarrhoea were prescribed ORS 50% of children with diarrhoea were prescribed an antibiotic. More than one antibiotic was prescribed in 33% of cases. 80% patients were prescribed an antibiotic for ARI b) Summary of recommendations (directly from findings section) Access to drugs ƒ Investigate the reasons for the variations in availability in public health facilities - especially the minority of facilities that had less than 50% availability ƒ Investigate the reasons for the large variations in stock out duration in public health facilities - especially the almost one third with a stock out duration of greater than 3 months Quality of drugs ƒ Identify storage deficiencies and design interventions for implementation to address these poor or not adequate storage conditions in public health facilities ƒ The Ministry of Health should strengthen mechanisms to ensure that no expired drugs are found on the shelves in both the public and private sectors Rational drug use ƒ Investigate and develop interventions as to why 1 in 6 facilities can prescribe an average of less than 3 drugs per prescription and why 1 in 6 facilities need to prescribe an average of more than 3 drugs per prescription ƒ Investigate and develop interventions on the wide variations found in the use of antibiotics – especially why more than 1 in 5 facilities (21%) are prescribing antibiotics to more than half of the patients ƒ Identify, develop and continue implementing interventions to further decrease the number of patients receiving antibiotics ƒ Investigate and develop interventions on the wide variations found in the use of injections – especially why more than 1 in 10 facilities (10.5%) to greater than 70% of patients receive an injection, whereas in 1 in 5 facilities (21.1%) less than 20% of the patients receive an injection ƒ Identify, develop and continue implementing interventions to further decrease the number of patients receiving injections 36 ƒ investigate and develop interventions as to why a minority of facilities are not prescribing consistently according to the EDL ƒ Develop, disseminate and enforce clear guidelines and training on the importance of labelling for dispensed drugs. This should include consumer-targeted and community-based information, education and communication campaigns ƒ Develop, disseminate and enforce clear guidelines and training on the importance of ensuring that patients know how to take their drugs correctly. ƒ These initiatives should include consumer-targeted and community-based information, education and communication campaigns. ƒ Investigate and develop interventions for the treatment of diarrhoea in children <5 years: why are 50% of children receiving antibiotics and why are 20% of children not receiving ORS? ƒ Investigate and develop interventions why more than one antibiotic is being prescribed fro mild/moderate pneumonia in 33% of cases ƒ Investigate and develop interventions to address the very poor adherence to the standard treatment guideline for ARI - - 37 c) Other (overall) recommendations • Pharmaceutical sector indicators should be monitored regularly to see the effectiveness of effects of interventions and policies • Conduct operational research to assess factors that cause specific problems and constraints to best practices • There is the need to carry a study on the role of peddlers • Critically investigate the difficulties inherent in the management of drugs from the central level to the periphery, standardise and disseminate SOP’s; strengthen information systems • Provide training to managers within the procurement and distribution chain. This should include training for private sector and private not for profit groups in the pharmaceutical sector. The training should focus on forecasting, procurement, storage and distribution of to prevent stock outs. • The Ministry of Health, the Ghana Health Service, consumer associations together with the general public to lobby for reduction in prices of essential medicines. Advocacy should aim at reducing/removing tariffs and taxes on all essential medicines both in the public and private sectors. • Rational drug use concepts should be part of the training curricula of all health professionals and part of ongoing in-service training so as to reinforce the concepts to ensure sustained change • Private drug outlets should be included in improving the rational use of drugs activities • Investigate innovative factors that what would motivate better adherence to the Standard Treatment Guidelines to use in the development and launch of the next edition • There should be regular monitoring of the use of the standard treatment guidelines; dispensers should be encouraged to dialogue and give feedback to prescribers so they would know their prescribing habits and try to improve prescribing to conform to the Standard Treatment Guidelines. • Improve drug labelling to include visual labelling for illiterate patients • Public/consumer education should target the social and cultural aspects of medicines use particularly in relation to the consequences of inappropriate and unnecessary use of injections and antibiotics; education on compliance with treatment should be emphasized. The use of the popular media ought to be continued and strengthened. Promote patient rights • Institutionalize drug and therapeutic committees (DTC) in all health facilities to improve the correct efficient and cost effective management of drugs and also to ensure effective monitoring of the indicators at facility level. DTC members should be adequately trained and empowered to carry out their duties • Strengthen the national health insurance scheme to improve (financial) access to drugs • GNDP should direct some of its activities to the private and not-for-profit sectors - - 38 ANNEXES 1 Questionnaire on structures and processes of country pharmaceutical situation (Level I) (completed September 2003) 2 Results of previous surveys in Ghana 3 Designation of Key Drugs, Guidelines and Geographic / Facility Sampling 4 Survey Forms (Level II, Household) WHO/EDM “CountryEN” Country Survey 2003 DK = Don’t Know Annex 1: Questionnaire on structures and processes of country pharmaceutical situation Country 68Ghana (AFRO) Date (dd/mm/yyyy) 24/09/2003 Name of respondent(s) Position(s) 2003 Latest WHO Data 1. NATIONAL MEDICINES (DRUG) POLICY (NMP) 1.1 Is there a National Medicines Policy (NMP) document? (See glossary for a definition of NMP.) If no, skip to 1.4. Yes/No/Don’t Know Yes Yes Is it an official or draft document? Official/Draft/Don’t Know Official Draft What year was it last updated? Year 2002 1.2 Is there an NMP implementation plan that sets activities, responsibilities, budgets, and timeline? Yes/No/Don’t Know Yes If yes, when was it last updated? Year 2003 1.3 Is the NMP integrated into a published/official national health policy/plan? If yes, when was it last updated? Yes/No/Don’t Know Yes Year 2002 1.4 Is there a national policy on traditional and complementary/ alternative medicine (TM/CAM) either as part of the medicines policy or health policy or as a separate document? (TM/CAM is defined in the glossary.) Yes/No/Don’t Know Yes If yes, when was it last updated? Year 2002 1.5 Has a national assessment/indicator study been conducted? If yes, what areas have been studied and when was the most recent study covering each area conducted? Yes/No/Don’t Know Yes Overall pharmaceutical situation: Yes/No/Don’t Know Yes Year 2002 Rational use/prescription audit: Yes/No/Don’t Know Yes Year 2002 Access: Yes/No/Don’t Know Yes Year 2002 2. LEGISLATION/REGULATION 2.1 Is there a medicines law? If yes, when was it last updated? Which of the following areas are covered by medicines legislation and when was each last updated? Yes/No/Don’t Know Yes Year 1996 Establishment of regulatory authority: Yes/No/Don’t Know Yes Year 1996 Marketing authorisation of pharmaceuticals: Yes/No/Don’t Know Yes Year 1996 Manufacturing of medicines: Yes/No/Don’t Know Yes Year 1996 Distribution of medicines: Yes/No/Don’t Know Yes Year 1996 Promotion & advertising of medicines: Yes/No/Don’t Know Yes Year 1996 Importation of medicines: Yes/No/Don’t Know Yes Year 1996 Exportation of medicines: Yes/No/Don’t Know Yes Year 1996 Licensing & practice of prescribers: Yes/No/Don’t Know Yes Year 1972 Licensing & practice of pharmacy: Yes/No/Don’t Know Yes Year 1994 Herbal medicines (See glossary for definition): Yes/No/Don’t Know Yes Year 1999 Empowers inspectors to enter premises and collect samples and documentation: Yes/No/Don’t Know Yes Year 1996 Requires transparency, accountability and code of conduct in regulatory work: Yes/No/Don’t Know Yes Year 1992 2.2 System and operation of medicines registration: a) Is marketing authorisation required for medicines to be sold? If yes, how many medicinal products have been approved to be marketed? (express as number of dosage forms & strengths) Yes/No/Don’t Know Yes Total______1801 Is marketing authorisation required for herbal medicines to be sold? If yes, how many herbal medicinal products have been approved to be marketed? (express as number of dosage forms & strengths) (See glossary for a definition of herbal medicines) Yes/No/Don’t Know Yes Total______288 b) Are there detailed written guidelines, including reference guidelines and criteria, for submitting applications for the registration of medicinal products? Are there guidelines covering the registration of herbal medicines? Yes/No/Don’t Know Yes Yes/No/Don’t Know Yes c) Is the WHO Certification Scheme certificate required as part of the marketing authorisation process? Yes/No/Don’t Know Yes d) Is INN used in the registration of medicines? Yes/No/Don’t Know Yes e) Is a list of all registered products publicly accessible? Yes/No/Don’t Know Yes 39 WHO/EDM “CountryEN” Country Survey 2003 DK = Don’t Know 2003 Latest WHO Data (Registered product is defined in the glossary.) 2.3 Is there a computerised registration system that facilitates retrieval of information on registered products? (Registration system is defined in the glossary.) Yes/No/Don’t Know Yes Is there a medicines regulatory authority website providing publicly accessible information on any of the following: legislation, regulatory procedures, prescribing information (such as indications, counterindications, side effects, etc.), authorised companies, and/or approved medicines? Yes/No/Don’t Know Yes 2.4 Is licensing a requirement? (Licensing is defined in the glossary.) If yes, is it based on site inspection of: Yes/No/Don’t Know Yes Manufacturers: Yes/No/Don’t Know Yes Importers/wholesalers: Yes/No/Don’t Know Yes Retail distributors/pharmacies: Yes/No/Don’t Know Yes 2.5 Are there written national guidelines/codes/checklists for the inspection of: Manufacturers: Yes/No/Don’t Know Yes Importers/wholesalers: Yes/No/Don’t Know Yes Retail distributors/pharmacies: Yes/No/Don’t Know Yes 2.6 Is prescribing by generic name obligatory in the: Public sector: Yes/No/Don’t Know Yes Private sector: Yes/No/Don’t Know No Is generic substitution permitted at: (Generic substitution is defined in the glossary.) Public pharmacies: Yes/No/Don’t Know Yes Private pharmacies: Yes/No/Don’t Know Yes 2.7 Is promotion/advertisement of medicines regulated by: Company self-regulation: Yes/No/Don’t Know No Government agency or medicines regulatory authority: Yes/No/Don’t Know Yes Are civil society/non-governmental organisations involved in review, assessment, or surveillance of promotion/ advertisement of medicines? Yes/No/Don’t Know No Do regulations on promotion/advertisement of medicines include: (See glossary for the distinction between promotion and advertisement.) Published ethical criteria for medicines promotion: Yes/No/Don’t Know Yes Pre-approval for promotional materials: Yes/No/Don’t Know Yes Pre-approval for advertisement materials: Yes/No/Don’t Know Yes Explicit prohibition on advertising prescription medicines: Yes/No/Don’t Know Yes Detailed restrictions on advertising non-prescription medicines: Yes/No/Don’t Know Yes 2.8 Are adverse drug reactions (ADR) monitored? If yes, what is the total number of each of the following for the most recent year for which data is available? Yes/No/Don’t Know Yes Total number of validated ADR reports received: ____957 (Year 2001-2003) DK Total number of reporting physicians: ____5 (Year 2003) DK Total number of physicians in country: ____1915 (Year 2001) DK Are ADR of herbal medicines monitored? Yes/No/Don’t Know Yes 3. QUALITY CONTROL OF PHARMACEUTICALS 3.1 Testing of medicines samples collected last year for regulatory purposes (i.e. including drug registration and post- marketing surveillance, but excluding testing done in conjunction with procurement activities): Total number of samples Total number of samples collected: ____1058 Don’t Know Total number of samples tested: ____1012 Don’t Know Total number of samples that failed identity or assay: ____135 Don’t Know 3.2 Where have the above samples (see 3.1) been tested: Percentage of total samples tested Government quality control laboratory: 92% Don’t Know Local academic institutions: 8% Don’t Know Quality control laboratory in another country: 0% Don’t Know Private quality control laboratory: 0% Don’t Know 40 WHO/EDM “CountryEN” Country Survey 2003 DK = Don’t Know 2003 Latest WHO Data 4. ESSENTIAL MEDICINES LIST (EML) 4.1 Are there Essential Medicines Lists (EML)? (An Essential Medicines List is a government-approved selective list of medicines or national reimbursement list) Total number of medicines Year of last update Total no. Meds Year up- dated National EML: Yes/No/DKYes 530____ 2000 1996 State or provincial list: Yes/No/DKNo ____ List for primary health care: Yes/No/DKYes ____ 4.2 Are EMLs being used in: Public sector procurement: Yes/No/Don’t Know Yes Public insurance reimbursement: Yes/No/Don’t Know Yes Private insurance reimbursement: Yes/No/Don’t Know Don't know 4.3 Are local herbal medicines included on the national EML? Yes/No/Don’t Know No 5. MEDICINES SUPPLY SYSTEM 5.1 Who is responsible for public sector drug procurement and distribution? What percentage of the total cost is each responsible for? Ministry/Department of Health: Procurement Yes/No/DKYes 40% Distribution Yes/No/DKYes 40% Non-governmental organisation (NGO): Yes/No/DKYes 30% Yes/No/DKYes 30% Private institution contracted by the government: Yes/No/DKYes 20% Yes/No/DKYes 20% Individual health institutions: Yes/No/DKYes 10% Yes/No/DKYes 10% 5.2 Is government procurement limited to medicines on the EML? Yes/No/Don’t Know Yes If no, is a percentage of the budget set aside for non-EML items? Yes/No/Don’t Know What is the percentage? % 5.3 Type of tender and percentage of the total cost for each: (Tender is the process by which competing bids are entered for a particular contract.) National competitive tender: Yes/No/DKYes Percentage of total cost 18% International competitive tender: Yes/No/DKYes 80% Negotiation/direct purchasing: Yes/No/DKYes 2% 5.4 Is drug registration a prerequisite for government purchases? Yes/No/Don’t Know Yes 6. MEDICINES FINANCING 6.1 What is the total public or government budget for medicines in US$ for the most recent year for which data is available? $ ___________ , Year 6.2 Are there guidelines on medicines donations that cover the public sector, the private sector, or non-governmental organisations (NGO)? Public Sector Yes/No/DKYes Private Sector Yes/No/DK Don't know NGO Yes/No/DK Don't know 6.3 Which medicines are free at primary public health facilities: All medicines are free of charge: Yes/No/Don’t Know No Malaria medicines are free: Yes/No/Don’t Know No Tuberculosis medicines are free: Yes/No/Don’t Know Yes Sexually transmitted diseases medicines are free: Yes/No/Don’t Know No HIV/AIDS-related medicines are free: Yes/No/Don’t Know No Medicines are free to those who cannot afford them: Yes/No/Don’t Know Yes Medicines are free for children under 5 years of age: Yes/No/Don’t Know Yes Medicines are free for pregnant women: Yes/No/Don’t Know Yes Medicines are free for elderly persons: Yes/No/Don’t Know Yes No medicines are free of charge: (Don’t Know ) 6.4 Which fees are charged in public health facilities: Registration/Consultation fees: Yes/No/Don’t Know Yes Dispensing fees: Yes/No/Don’t Know Yes Flat fees for medicines: Yes/No/Don’t Know No Flat rate copayments: Yes/No/Don’t Know No Percentage copayments: (Co-payments cover part of the cost of medicines, the other part being paid by an insurer or government.) Yes/No/Don’t Know No 6.5 Is revenue from fees or drug sales used to pay the salaries of public health personnel in the same facility? Always/Frequently/Occasionally/Never/DK Occasionally 6.6 Health insurance: (Health insurance is any prepayment scheme for health care costs additional to but excluding subsidies funded through the Ministry of Health budget.) What percentage of the population has health insurance? Public All/Some/None/DK Some Private All/Some/None/DK Some Public Private Are medicines covered by health insurance? All/Some/None/DK Some All/Some/None/DK Some 41 WHO/EDM “CountryEN” Country Survey 2003 DK = Don’t Know 2003 Latest WHO Data Of the covered medicines, what percentage of the cost is covered: % % 6.7 Is there a pricing policy on medicines that covers the public sector, the private sector, or non-governmental organisations? If yes, does it apply to: Public sector Yes/No/DKYes Private sector Yes/No/DKNo NGO Yes/No/DKNo All medicines, some or none: All/Some/None/DK All All/Some/None/DK None All/Some/None/DK None Is maximum wholesale mark up established in laws/regulations: Yes/No/DKYes Yes/No/DKNo Yes/No/DKNo If yes, amount: 10% % % Maximum retail mark up established in laws/regulations: Yes/No/DKYes Yes/No/DKNo Yes/No/DKNo If yes, amount: 15% % % Duty on imported raw pharmaceutical materials: Yes/No/DKNo Yes/No/DKYes Yes/No/DK Don't know Duty on imported finished pharmaceutical products: Yes/No/DKNo Yes/No/DKYes Yes/No/DK Don't know 7. ACCESS TO ESSENTIAL MEDICINES 7.1 In your opinion, what percentage of the population has regular access to essential medicines (i.e. minimum of 20 most essential medicines available and affordable at public and private facilities within a one-hour walking distance)? 90% 7.2 What percentage of: The population is within one-hour walking distance to: Public health facility 90% Private health facility % Public or private retail drug outlet % Facilities have essential medicines available: 90% % % The population can afford essential medicines at: 40% % % 8. PRODUCTION 8.1 What is the medicines production capability in the country? Research and development of new active substances: Yes/No/Don’t Know No Production of pharmaceutical active starting materials: Yes/No/Don’t Know No Formulation from pharmaceutical starting materials: Yes/No/Don’t Know Yes Repackaging of finished dosage forms: Yes/No/Don’t Know Yes 8.2 For each of the following types of local production, indicate number of factories and total annual sales in US$ for the most recent year for which data is available: Starting materials: Number of factories ____ Sales in US$ $ ____ Year Don’t know DK Finished products: ____ $ ____ DK Products containing active substances developed/marketed for the first time during the last 5 years: ____ $ ____ DK 8.3 What is the total volume and US$ value of the medicines market? Generic medicines compose what percentage of market volume and value? Volume ____, Value $ ____ Volume ____%, Value ____% 9. RATIONAL USE OF MEDICINES 9.1 Are there standard treatment guidelines (STGs) produced by the health ministry/department for major conditions? (STGs are recommendations about how to treat a clinical condition.) National STG: Yes/No/DKYes Number of conditions/ diseases 150____ Year of publication or review 2000 Year of publication or review STG for hospital level: Yes/No/DKYes 150____ 2000 STG for primary health care level: Yes/No/DKYes 150____ 2000 9.2 Is there a National Medicines Formulary manual? (A formulary manual contains summary drug information.) If yes, does it cover only medicines on the Essential Medicines List? Yes/No/Don’t Know Yes Yes/No/Don’t Know Yes What year was it last published/reviewed: Year 2000 9.3 Are any of the following aspects of the essential medicines concept generally part of the basic curricula in most health training institutions/universities for: (Essential medicines are those that satisfy the priority health care needs of the population. See glossary for a definition of problem-based pharmacotherapy.) Doctors: Essential Medicines List Yes/No/DKYes Standard Treatment Guidelines Yes/No/DKYes Problem- based pharmaco- therapy Yes/No/DKYes Rational prescribing Yes/No/DKYe Nurses: Yes/No/DKYes Yes/No/DKYes Yes/No/DKYes Yes/No/DK Don't know Pharmacists: Yes/No/DKYes Yes/No/DKYes Yes/No/DKYesYes/No/DKYe Pharmacy assistants: Yes/No/DKYes Yes/No/DKYes Yes/No/DKYesYes/No/DKYe Paramedical staff: Yes/No/DKNo Yes/No/DKNo Yes/No/DKNo Yes/No/DKNo 9.4 Are there independent publicly or non-commercially funded obligatory continuing education programs which include use 42 WHO/EDM “CountryEN” Country Survey 2003 DK = Don’t Know 2003 Latest WHO Data of medicines for: Doctors: Yes/No/Don’t Know Yes Nurses/midwives/paramedical staff: Yes/No/Don’t Know Yes Pharmacists: Yes/No/Don’t Know Yes Pharmacy aides/assistants: Yes/No/Don’t Know No 9.5 Is there a public or independently funded nationally accessible (e.g. by phone) medicines information centre or service co-ordinated by the Ministry of Health, academia, and/or a non-commercial non-governmental organisation that provides information on demand to: Prescribers: Yes/No/Don’t Know Yes Dispensers: Yes/No/Don’t Know Yes Consumers: Yes/No/Don’t Know Yes 9.6 Has there been any public education campaign concerning rational medicines use in the previous two years conducted by Ministry of Health/non-governmental organisation/academia on the following topics: Use of antibiotics: Yes/No/Don’t Know Yes Use of injections: Yes/No/Don’t Know Yes Other topics/issues: Yes/No/Don’t Know Yes 9.7 How often do the following personnel prescribe at the primary health care level in the public sector? Doctors: Always/Frequently/Occasionally/Never/DK Always Nurses/midwives/paramedical staff: Always/Frequently/Occasionally/Never/DK Always Pharmacists: Always/Frequently/Occasionally/Never/DK Frequently Pharmacy aides/assistants: Always/Frequently/Occasionally/Never/DK Occasionally Personnel with less than one month formal health training: Always/Frequently/Occasionally/Never/DK Don't know 9.8 Is there a government department with a specific mandate to promote the rational use of medicines and co-ordinate medicines use policies? Yes/No/Don’t Know Yes 9.9 What proportion of facilities have a drugs and therapeutics committee? (A drugs and therapeutics committee promotes the safe and effective use of medicines in the facility or area under its jurisdiction) Referral hospitals: All/Most/Half/Few/None/Don’t Know All General hospitals: All/Most/Half/Few/None/Don’t Know Few Regions/provinces: All/Most/Half/Few/None/Don’t Know Half Is there a mandate for drugs and therapeutics committees in the national medicines policy? Yes/No/Don’t Know Yes 9.10 Is there a national strategy to contain antimicrobial resistance? Yes/No/Don’t Know No Is there a national reference laboratory to coordinate epidemiological surveillance of antimicrobial resistance? Yes/No/Don’t Know Yes Is there a funded national intersectoral task force to coordinate the implementation of interventions to promote appropriate use of antimicrobials and prevent the spread of infection? Yes/No/Don’t Know No 9.11 Are the following medicines sold over the counter without any prescription? Antibiotics: Always/Frequently/Occasionally/Never/DK Frequently Injections: Always/Frequently/Occasionally/Never/DK Frequently 10. INTELLECTUAL PROPERTY RIGHTS PROTECTION AND MARKETING AUTHORIZATION (See glossary for definitions of terms used in this section.) 10.1 Is patent protection legally provided for pharmaceutical products? If yes, indicate: Yes/No/Don’t Know Yes Year introduced: 1992 Type: Process/Product/Both/Don’t Know Duration of patent validity: 10 years; renewable another 10 years 43 WHO/EDM “CountryEN” Country Survey 2003 DK = Don’t Know 2003 Latest WHO Data 10.2 Which intellectual property right protection regime/activities are provided for traditional medical knowledge? TRIPS: Yes/No/DK Don't know Year introduced Duration of data protection Sui generis regimes: Yes/No/DK Don't know Digital library: Yes/No/DK Don't know National inventory of medicinal plants: Yes/No/DK Don't know Others: Yes/No/DK Don't know None: (DK ) 10.3 TRIPS Agreement (Agreement on Trade Related Aspects of Intellectual Property Rights): a) Is your country a World Trade Organization Member? If no, skip to 10.4 Yes/No/Don’t Know Yes b) Has national legislation been modified to implement the TRIPS Agreement? If yes, what year did it go into effect? Yes/No/Don’t Know No Year Bill before parliament c) Is your country availing itself of the transitional period provided by Article 65 of the TRIPS Agreement? Yes/No/Don’t Know Yes d) If your country is a least-developing country (LDC), has it availed itself of the transitional period accorded to LDCs in Article 66 of the TRIPS Agreement? Yes/No/DK/Country not an LDC Country not an LDC 10.4 Have parallel importing provisions on pharmaceuticals been incorporated into national legislation? If yes, have these provisions been applied? Yes/No/DK/Currently being discussed Yes Yes/No/DK/Currently being discussed Currently being discussed 10.5 Have compulsory licensing provisions for pharmaceuticals been incorporated into national legislation? If yes, under what conditions? National emergency: Yes/No/DK/Currently being discussed Yes Yes/No/Don’t Know Yes Public non-commercial use: Yes/No/Don’t Know Yes Remedying anti-competitive practices: Yes/No/Don’t Know Yes Other: Yes/No/Don’t Know 10.6 Are generic pharmaceutical manufacturers allowed to use patented inventions for the purpose of obtaining marketing approval prior to patent expiration? Yes/No/DK/Currently being discussed Yes COMMENTS ABOUT INDICATORS AND VALUES Item Number Comment 6.1 Information not readily available 8.2 Information not available 8.3 Information not available 44 Questionnaire on structures and processes of country pharmaceutical situation Glossary of Terms: Advertisement: A set of activities undertaken to advertise medicines. It is usually targeted to the general public and it is usually limited to over-the-counter medicines. Compulsory licensing: This term is used when the judicial or administrative authority is allowed by law to grant a license, without permission from the holder, on various grounds of general interest (absence of working, public health, economic development, and national defence). “Working” of a patent is the execution of the invention in the country of registration. Co-payments: Co-payments cover part of the cost of medicines, the other part being paid by an insurer or government. Drugs and therapeutics committee: A drugs and therapeutics committee promotes the safe and effective use of medicines in the facility or area under its jurisdiction. Essential Medicines List: An Essential Medicines List is a government-approved selective list of medicines or national reimbursement list. Essential medicines: Essential medicines are those that satisfy the priority health care needs of the population. Generic substitution: The practice of substituting a product, whether marketed under a trade name or generic name, by an equivalent product, usually a cheaper one, containing the same active ingredient(s). Health insurance: Health insurance is any prepayment scheme for health care costs additional to but excluding subsidies funded through the Ministry of Health budget. The purpose of question 6.6 is to identify how much protection the population has against exposure to the cost of medicines at the time people are sick. Prepaid financing is the usual method for providing such protection. Public funding through the (prepaid) Ministry of Health budget is the most widespread form of prepayment. Question 6.5 attempts to identify additional prepayment protection (percentage of the population covered and degree of protection against medicine costs) such as private or employer-based health insurance, community prepayments schemes, social health insurance (health care funded through social security systems), etc. Herbal Medicines: Herbal medicines are plant-derived material or preparations with therapeutic or other human health benefits, which contain either raw or processed ingredients from one or more plants. Herbal medicines include herbs, herbal materials, herbal preparations and finished herbal products, which are classified in the medicines category according to a national regulatory framework. Finished herbal products and mixture herbal products may contain excipients in addition to the active ingredients, however, finished products or mixture products to which chemically defined active substances have been added, including synthetic compounds and/or isolated constituents from herbal materials, are not considered to be herbal. In some countries, herbal medicines may also contain, by tradition, natural organic or inorganic active ingredients which are not of plant origin. Licensing: Licensing is a system that subjects all premises to evaluation against a set of requirements before a specific activity (e.g. manufacturing, storage etc.) is authorised to take place. Medicines formulary manual: A formulary manual contains summary drug information. National medicines (drug) policy (NMP): A national medicines policies is an expression of the government’s goals and priorities for the medium to long term for the pharmaceutical sector. It also identifies the main strategies for attaining them. It provides a framework within which the activities of the pharmaceutical sector can be coordinated. It covers both the public and private sectors, and involves all the main actors in the pharmaceutical field. Parallel importing: Parallel importation is importation, without the consent of the patent-holder, of a patented product marketed in another country either by the patent-holder or with the patent-holder’s consent. Parallel importation enables promotion of competition for the patented product by allowing importation of equivalent patented products marketed at lower prices in other countries. Problem-based pharmacotherapy: Problem-based pharmacotherapy is a problem-based practical approach to teaching prescribing. Promotion: A set of activities undertaken to promote prescription of prescription-only medicines. It is usually targeted to health providers only and it is usually forbidden to target the general public. Registered products: Products that have been evaluated for quality, safety and efficacy and thence authorised for marketing. Registration system: A system that subjects all products to evaluation of quality, safety and efficacy before they are authorised for marketing. Standard Treatment Guidelines (STG): STGs are recommendations about how to treat a clinical condition. Tender: Tender is the process by which competing bids are entered for a particular contract. Traditional medical knowledge: Knowledge related to traditional medicine (see definition of Traditional medicine and complementary/alternative medicine). 45 Traditional medicine and complementary/alternative medicine (TM/CAM): Traditional medicine is the sum total of the knowledge, skills, and practices based on theories, beliefs and experiences indigenous to different cultures, whether explicable or not, used in the maintenance of health as well as in prevention, diagnosis, improvement or treatment of physical and mental illnesses. The terms “complementary medicine” and “alternative medicine” can be used interchangeably with “traditional medicine” in some countries. The term “complementary and alternative medicine” can also be used to refer to a broad set of health care practices that are not part of the country’s own tradition and are not integrated into the dominant health care system. Transitional period: TRIPS provides transitional periods during which countries are required to bring their national legislation and practices into conformity with its provisions. The latest dates for WTO Members were/are: 1996 for developed countries; 2000 for developing countries (as a general rule); 2005 for developing countries who had not introduced patents before joining the WTO; and 2006 for least-developed countries (extended to 2016 by the Doha Declaration). The TRIPS Agreement specifically recognizes the economic, financial, administrative and technological constraints of the least-developed countries. It therefore provides the possibility for further extension of the transitional period. TRIPS Agreement (Agreement on Trade Related Aspects of Intellectual Property Rights) Article 65: Transitional Arrangements 1. Subject to the provisions of paragraphs 2, 3 and 4, no Member shall be obliged to apply the provisions of this Agreement before the expiry of a general period of one year following the date✸of entry into force of the WTO Agreement. 2. A developing country Member is entitled to delay for a further period of four years the date of application, as defined in paragraph 1, of the provisions of this Agreement other than Articles 3, 4 and 5. 3. Any other Member which is in the process of transformation from a centrally-planned into a market, free-enterprise economy and which is undertaking structural reform of its intellectual property system and facing special problems in the preparation and implementation of intellectual property laws and regulations, may also benefit from a period of delay as foreseen in paragraph 2. 4. To the extent that a developing country Member is obliged by this Agreement to extend product patent protection to areas of technology not so protectable in its territory on the general date of application of this Agreement for that Member, as defined in paragraph 2, it may delay the application of the provisions on product patents of Section 5 of Part II to such areas of technology for an additional period of five years. 5. A Member availing itself of a transitional period under paragraphs 1, 2, 3 or 4 shall ensure that any changes in its laws, regulations and practice made during that period do not result in a lesser degree of consistency with the provisions of this Agreement. Article 66: Least-Developed Country Members 1. In view of the special needs an requirements of least-developed country Members, their economic, financial and administrative constraints, and their need for flexibility to create a viable technological base, such Members shall not be required to apply the provisions of this Agreement, other that Articles 3, 4 and 5, for a period of 10 years from the date of application as defined under paragraph 1 of Article 65. The Council for TRIPS shall, upon duly motivated request by a least-developed country Member, accord extensions of this period. 2. Developed country Members shall provide incentives to enterprises and institutions in their territories for the purpose of promoting and encouraging technology transfer to least-developed country Members in order to enable them to create a sound and viable technological base. ✸ [WIPO note] January 1, 1995 46 40 Annex 2: Results of previous surveys in Ghana Comparisons within the findings section are limited to those that show a marked difference, as it is not certain that the methodologies were the same and hence the results are not fully comparable. Indicator Year 1990 1993 1998 2002 Number of facilities 77 16 Source of data INRUD SURVEY INRUD SURVEY GNDP BASELINE SURVEY MOH/WHO SURVEY ACCESS Availability of Key Drugs in Public health facilities 73.9% Availability of Key drugs in Regional Medical Stores 82.2% Availability of Key Drugs in Private Pharmacies 83.5% Stock out duration in Public Health Facilities 79.5days Stock out duration in Regional Medical Stores 39.3 days % of prescribed drugs dispensed in public health facilities 89.4 Affordability of Key Drugs in public health facilities: adult 1.16 days wage Affordability of Key Drugs in public health facilities: child 1.06 days wage Affordability of key drugs in private pharmacies; adult 1.22 days wage Affordability of key drugs in private pharmacies; child 1.43 days wage QUALITY % of expired drugs in public health facilities 3.7% % of expired drugs in private pharmacies 1.8% % expired drugs in regional medical stores 0% Adequacy of storage in public health facilities 67.6% Adequacy of storage in regional medical stores 66.1% RATIONAL USE OF MEDICINES Average number of drugs per prescription 4.3 4.6 3.48 % patients prescribed antibiotics 46.6% 54.0% 42.8% % patients prescribed injections 55.7% 42.0% 34.9% % drugs prescribed on EML - 92.0% 93.9% % drugs prescribed in their generic names 59.4% 74.0% - % prescriptions with written diagnosis - 70.0% - % drugs adequately labelled 12.0% - 7.2% %of patients with adequate knowledge on dosage 76.0% - 50.5% Availability of STG at public health facilities 94.4% Availability of EML at public health facilities 88.9% Prescribing according to NSTG: Diarrhoea in children % ORS 76.6% % Antibiotics 53.1% % anti diarrhoeals and/or antispasmodics 0% Mild/moderate pneumonia in children <5: % first line antibiotic 91.1% %receiving >1 antibiotic 37% Non-pneumonia ARI ; % antibiotics 81.2% - - 41 Annex 3: Designation of key drugs, guidelines and geographic /facility sampling List of key drugs (14) (Survey forms 1, 2, 10, 11, 12) Amoxicillin capsules 250mg Amoxicillin suspension/syrup 125mg/5ml Benzoic acid + salicylic acid ointment 6% + 3% Chloroquine syrup 80mg base/5ml Chloroquine tablets 150mg base Cotrimoxazole tablets 480mg Ferrous sulphate tablets 200mg Folic acid tablets 5mg Iodine Solution Mebendazole tablets 100mg Oral Rehydration Salts (ORS) Paracetamol syrup 120mg/5ml Paracetamol tablets 500mg Tetracycline eye ointment 1% STGs in force at the time (Survey form 8) Condition Document Year Diarrhoea Ghana national standard treatment guideline 2000 Mild/moderate pneumonia: child <5 Ghana national standard treatment guideline 2000 Acute respiratory tract infection Ghana national standard treatment guideline 2000 c) Treatment regimen for drugs to treat outpatient pneumonia (Survey form 4, 9) Drug Strength Unit No. of units per treatment regimen Regimen Adults: amoxicillin capsule 250mg 1 42 500mg three times a day for 7 days Children: Amoxicillin syrup/ suspension 125mg/5 ml 100ml 2 x 100ml 250mg three times a day for 7 days d) Designation of Essential Drug List (EDL) and Standard Treatment Guidelines (STG) for Availability of Guidelines Indicator (Survey form 7) Document year EDL National 2000 STG National 2000 42 e) Districts and Facilities Sampled Region Health facility Greater Accra Mamprobi polyclinic Pediatokope HC Old Ningo Ridge Hospital Brong Ahafo Amanten HC Yamfo HC Abesim HC Guaso Hospital Upper East Bongo Health Centre Zuarungu HC Kasina Nankana East HC Sandema Hospital Ashanti Tepa District Hospital Manponteng HC Kumawu Kumasi South Hospital Annex 4: Survey forms (Level II, Household) [1–14] Survey form 1: Public health facility pharmacy Indicator: % of expired drugs Availability of key drugs Facility Date Location Investigator Key drugs to treat common conditions [A] Price In stock Yes=1, No=0 [B] Expired drugs in stock Yes=1, No=0 [C] 1. ORS 2. Cotrimoxazole tabs 3. Chloroquine tablets 4. Chloroquine syrup 5. Ferrous tabs 6. Folic acid 7. Mebendazole 8. Tetracycline Eye Ointment 9. Iodine 10. Benzoic acid/salicylic acid 11. Paracetamol tablets 12. Paracetamol syrup 13. Amoxycillin Suspension 14. Amoxycillin capsules [A1] = Total no. of key drugs = Total “yes” [B1] = Total “yes” [C1] = [B2] = % in stock = [B1] ÷ [A1] x 100 = [C2] = % expired = [C1] ÷ [A1] x 100 = Notes: [A] List of 10-15 key drugs previously identified at national level must be printed before starting the survey. The process is described on page 21. Add the total number of key drugs [A1]. [B] Mark “1” if stock is available (even if only one dosage form is available). Mark “0” if the drug is not physically available. Add the total at the bottom [B1]. Calculate the percentage in stock [B2] by dividing the total in stock [B1] by the total number of key drugs [A1] and multiplying by 100. [C] For all drugs in stock, check if expired or not. If any of the product is expired, mark “1” for yes. Add all the “Yes” answers [C1]. Calculate the percentage expired [C2] by dividing the total expired [C1] by the total number of key drugs [A1] and multiplying by 100. Public Health Facility Pharmacy Facility #____ (1-30) 50 Survey form 2: Public health facility pharmacy Indicator: Stockout duration Facility Date Location Investigator key drugs to treat common conditions (only collect data for drugs with records covering at least six months) [A] No. of days out of stock [B] No. of days covered by the review [C] Equivalent no. of days/year [D]=[B]x365÷[C] [D] 1. ORS 2. Cotrimoxazole tabs 3. Chloroquine tablets 4. Chloroquine syrup 5. Ferrous tabs 6. Folic acid 7. Mebendazole 8. Tetracycline Eye Ointment 9. Iodine 10. Benzoic acid/salicylic acid 11. Paracetamol tablets 12. Paracetamol syrup 13. Amoxycillin Suspension 14. Amoxycillin capsules [A1] = Total no. of key drugs = [D1] = Sum of [D] = [E] = Average number of stockout days = [D1] ÷ [A1] = Example: Key drugs to treat common conditions (only collect data for drugs with records covering at least six months) [A] No. of days out of stock [B] No. of days covered by the review [C] Equivalent no. of days/year [D]=[B] x 365÷ [C] [D] Cotrimoxazole 90 180 182.5 Paracetamol 30 365 30 Total no. of key drugs [A1] = 2 [D1] = Sum of [D] = 212.5 [E] = Average number of stock out days = [D1] ÷ [A1] = 106.25 Notes: [A] List of 10-15 key drugs previously identified at national level must be printed in before starting the survey [A]. The process is described on page 21. Add the total number of key drugs [A1]. [B] Go through the stock cards covering the review period. Indicate the number of days that each drug is not available or marked “0” on the stock card [B]. A drug is considered in stock if any equivalent product is available in either generic or branded form. [C] The review should cover a six month to one year period. Indicate the number of days actually reviewed for each drug [C]. [D] Compute the equivalent number of stockout days per year for each drug [D] by multiplying [B] by 365 and dividing by [C]. Add the total number of stockout days [D1]. [E] Calculate the average number of stockout days [E] by dividing the total number of stockout days [D1] by the total number of key drugs [A1]. Public Health Facility Pharmacy Facility #____ (1-30) 51 Survey form 3: Public health facility pharmacy Indicator: Adequate storage Facility Date Location Investigator Checklist Store Room Yes=1, No=0 [A] Dispensing Area/Room Yes=1, No=0 [B] 1. There are working locks in the storeroom. 2. Storage area and shelves are clean (no dust or litter). 3. No evidence of pests is seen in the area. 4. There is a secure ceiling. 5. There are windows that can be opened or there are air vents. 6. No direct sunlight enters the area (glass window panes are painted white or there are curtains/blinds to protect against sunrays). 7. Area is free from moisture (leaking drains and taps). 8. Drugs are not stored directly on the floor. 9. There is a separate storage and dispensing area for issuing drugs. 10. Drugs are sorted in a systematic way (alphabetical, first expiry-first out). 11. There is stock record system. 12. There is a cold storage with temperature chart. Rating Total “Yes” [A1] = Total “Yes” [B1] = Public Health Facility Pharmacy 52 Survey form 4: Public health facility pharmacy Indicator: Affordability of key drugs (treating adults and children with pneumonia without hospitalization) Facility Date Location Investigator Drug/INN and Preparation [A] Unit price (inj. vial, tablet, or capsule) [B] No. of units needed to complete treatment [C] Total cost of treatment [D]= [B] x [C] [D] Affordability [F] = [D] ÷ [E] [F] Adult drug of choice: Amoxycillin 250 mg Capsule 42 Child drug of choice: Amoxycillin 125mg/5ml syrup 2 X 100 mls bottles [E] = Lowest daily government salary = 7,200 cedis Notes: [A] Before the survey, identify antibiotic drug of choice (based on standard treatment guidelines) that are being used for adult and child pneumonia [B] The field worker will indicate the unit price in the local currency. If there are flat charges paid for each drug given to patients, then this amount should be recorded as the price of the drug. Indicate “0” if drugs are given free. Add cost of syringe to unit price, if applicable. [C] Before starting the field test, check the STG to determine the number of units needed for the duration of treatment. Print this number on the form for each drug listed. [D] Calculate total cost of treatment [D] by multiplying the unit price [B] by the number of units needed [C]. Only one drug (antibiotic) should be used to calculate cost of treatment and not a combination of drugs. [E] Record the lowest daily salary of government worker/public servant. [F] Calculate the affordability of the treatment [F] by dividing the total cost of treatment [D] by the lowest daily government salary [E]. Example: Drug/INN and Preparation [A] Unit price (inj. vial, tablet, or capsule) [B] No. of units needed to complete treatment [C] Total cost of treatment [D]= [B] x [C] [D] Affordability [F] = [D] ÷ [E] [F] Adult drug of choice: Procaine penicillin 1g 1 mill IU 280 for injection plus syringe 3 840 11.2 Child drug of choice: Amoxicillin 25 mg/ml suspension in 100 ml bottle 220 per bottle 1 220 2.93 [E] = Lowest daily government salary = 75 Public Health Facility Pharmacy Facility #____ (1-30) 53 Survey form 5: Public health facility: Rational drug use - Prescribing indicator form Indicators: Average number of drugs % patients receiving injection % drugs on EDL % patients receiving antibiotics Facility Date Location Investigator Type (R/P) [A] Patient Gender (M/F) [C] Date of Rx No. of drugs prescribed [D] Antibiotics Yes=1, No=0 [E] Injections Yes=1, No=0 [F] No. of drugs on EDL [G] 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. 28. 29. 30. [B] = Total no. of cases = [C1] = Total no. of females = [D1] = Sum of [D] = [E1] = Sum of “Yes” = [F1] = Sum of “Yes” = [G1] = Sum of [G] = [C2] = Total no. of males = [D2] = Average no. of drugs = [D1] ÷ [B] = [E2] = % antibiotics =[E1]÷[B] x100= [F2]= % injections = [F1]÷[B] x100= [G2]= % on EDL = [G1]÷[D1] x100= Notes: [A] Select from outpatient treatment records 30 patients seen within the last 12 months (R = retrospective); or, if records are not available, from patients currently being treated (P = prospective). Record whether patient is selected retrospectively or prospectively [A]. Sample of cases can be a combination of P and R. The patient selection process is described on pages 20-21. [B] Record the total number of cases reviewed. [C] Record the total number of females[C1] and the total number of males [C2] reviewed. [D] Record the number of drugs prescribed for each case [D]. Sum the total number of drugs prescribed for all patients [D1]. Calculate the average number of drugs prescribed [D2] by dividing the total number of drugs prescribed [D1] by the total number of patients cases reviewed [B]. [E] Indicate “0” if no antibiotic was prescribed and “1” if one or more types of antibiotics were given. Sum the total number of cases with antibiotics [E1]. Calculate the percentage of cases with antibiotics [E2] by dividing the total number of cases with antibiotics [E1] by the total number of cases reviewed [B] and multiplying by 100. [F] Indicate “0” if no injection was given and “1” if one or more injections were given. Sum the total number of cases with injections [F1]. Calculate the percentage of cases with injections [F2] by dividing the total number of cases with injections [F1] by the total number of cases reviewed [B] and multiplying by 100. [G] Record the number of drug prescribed for the case which are included on the EDL [G]. Sum the total number of drugs for all cases which are listed on the EDL [G1]. Calculate the percentage of prescribed drugs included on the EDL [G2] by dividing the total number of drugs for all cases which are listed on the EDL [G1] by the total number of drugs prescribed for all cases [D1] and multiplying by 100. Public Health Facility Facility #____ (1-30) 54 Survey form 6: Public health facility: Rational drug use - Patient care form Indicators: % of drugs dispensed % of patients who know how % drugs with adequate label to take drugs Facility Date Location Investigator Patient Gender (M/F) [A] No. of drugs prescribed [B] No. of drugs dispensed [C] No. of drugs adequately labeled [D] Patient has adequate knowledge Yes=1, No=0 [E] 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. 28. 29. 30. [A] = Total no. of cases = [B1]= Sum of [B] = [C1]= Sum of [C] = [D1]= Sum of [D] = [E1]= Sum of [E] = [A1]=Total no. of females = [A2]=Total no. of males = [B2]=Average no. of drugs = [B1]÷[A]= [C2]=% dispensed = [C1] ÷ [B1] x 100= [D2]=% adequately labeled = [D1] ÷ [C1] x 100 = [E2]=% of patients with adequate knowledge = [E1] ÷ [A] x 100 = Notes: [A] Interview 30 patients leaving the dispensing area/pharmacy. The process is described on page 21. Record the total number of cases [A], the total number of females [A1], and the total number of males [A2]. [B] Record the number of drugs prescribed for each patient [B]. Sum the number of drugs prescribed for all patients[B1]. Calculate the average number of drugs prescribed [B2] by dividing the total number of drugs prescribed for all patients [B1] by the total number of cases [A]. [C] Record how many drugs (chemical entity, INN, generic) were given to each patient. Sum the total number of drugs given to all patients [C1]. Calculate the percentage of drugs dispensed [C2] by dividing the number of drugs given to all patients [C1] by the total number of drugs prescribed [B1] and multiplying by 100. [D] Check to see if drugs are adequately labeled (name of drug, dosage and duration plus any additional criteria specified by the country). A drug is adequately labeled only if all criteria are met. Sum the total number of adequately labeled drugs [D1]. Calculate the percentage of drugs which are adequately labeled [D2] by dividing the total number of adequately labeled drugs [D1] by the total number of drugs dispensed [C1] and multiplying by 100. [E] Determine if patient has adequate knowledge about the drugs dispensed. Ask patient if he/she knows how to take each drug. Indicate: “1” If patient can correctly give the name of all drugs or state what the drugs are for and how they should be taken plus any additional criteria specified by the country. “0” If the patient cannot give the name of even one drug, cannot state what a drug is for, does not know how to take one of the drugs given, or does not meet any additional criteria specified by the country. Sum the total number of patients with adequate knowledge [E1]. Calculate the percentage of patients with adequate knowledge [E2] by dividing the number of patients with adequate knowledge [E1] by the total number of cases [A] and multiplying by 100. Public Health Facility Facility #____ (1-30) 55 Survey form 7: Public health facility Indicator: Availability of STG for common local conditions Availability of Essential Drug List (EDL) at the facility Facility Date Location Investigator Standard treatment guidelines (STG) available at facility Yes=1, No=0 National STG STG for Upper Respiratory Tract Infection STG for Pneumonia STG for Diarrhoea STG for Malaria STG for Tuberculosis STG for Sexually Transmitted Infections Others (describe): EDL available at the facility Yes=1, No=0 National EDL Provincial/District Health Facility EDL Others (describe): Public Health Facility Facility #____ (1-30) 56 Survey form 8: Public health facility Indicator: % tracer cases treated using recommended treatment Facility Date Location Investigator Case (Yes=1, No=0) [A] Diseases/Drug prescribed 1 2 3 4 5 6 7 8 9 10 Total “yes” [B] Total no. of cases [C] Percentage [D]= [B])[C] x100 [D] Diarrhoea in Children under age 5 ORS Antibiotic Antidiarrheal and/or Antispasmodic Mild/moderate Pneumonia in Children under age 5 Any one of 1st line antibiotics (Procaine penicillin, Amoxicillin, Cotrimoxazole) Anyone receiving >1 antibiotic Non-pneumonia acute respiratory tract infection (ARI) Antibiotic [E] Tracer condition 4: (optional) Drug 1: Drug 2: Drug 3: [E] Tracer condition 5: (optional) Drug 1: Drug 2: Drug 3: Notes: [A] Select at random 30 patients (10 with diarrhea, 10 with pneumonia, and 10 with ARI). Choose only single disease encounters. If sufficient patients are not available in the general outpatient records, use the under 5 ledgers. Always write “1” or “0” to indicate each drug received. [B] Sum the total number of yes responses for each row. [C] Record the total number of cases reviewed for each row. [D] Calculate the percentage of patients receiving each drug [D] by dividing the number of patients who received each medicine [B] by the number of cases reviewed for the disease [C] and multiplying by 100. [E] Countries may choose to include other tracer diseases for assessment of compliance to STG or recommended treatment protocol. If other tracer diseases are included, print up to three drugs to be used to measure adherence to these guidelines before starting the survey. Public Health Facility Facility #____ (1-30) 57 Survey form 9: Private pharmacy Indicator: Affordability of key drugs (treating adults and children with pneumonia without hospitalization) Facility Date Location Investigator Drug/INN and Preparation [A] Unit price (inj. Vial, tablet, or capsule) [B] No. of units needed to complete treatment [C] Total cost of treatment [D]= [B] x [C] [D] Affordability [F] = [D] ÷ [E] [F] Adult drug of choice: Amoxycillin 250 mg Capsule 42 Child drug of choice: Amoxycillin 125mg/5ml syrup 2 X 100 mls bottles [E] = Lowest daily government salary = 7,200 cedis Notes: [A] Before the survey, identify antibiotic drug of choice (based on standard treatment guidelines) that are being used for adult and child pneumonia [B] The field worker will indicate the unit price in the local currency. If there are flat charges paid for each drug given to patients, then this amount should be recorded as the price of the drug. Indicate “0” if drugs are given free. Add cost of syringe to unit price, if applicable. [C] Before starting the field test, check the STG to determine the number of units needed for the duration of treatment. Print this number on the form for each drug listed. [D] Calculate total cost of treatment [D] by multiplying the unit price [B] by the number of units needed [C]. Only one drug (antibiotic) should be used to calculate cost of treatment and not a combination of drugs. [E] Record the lowest daily salary of government worker/public servant. [F] Calculate the affordability of the treatment [F] by dividing the total cost of treatment [D] by the lowest daily government salary [E]. Example: Drug/INN and Preparation [A] Unit price (inj. Vial, tablet, or capsule) [B] No. of units needed to complete treatment [C] Total cost of treatment [D]= [B] x [C] [D] Affordability [F] = [D] ÷ [E] [F] Adult drug of choice: Procaine penicillin 1g 1 mill IU 280 for injection plus syringe 3 840 11.2 Child drug of choice: Amoxicillin 25 mg/ml suspension in 100 ml bottle 220 per bottle 1 220 2.93 [E] = Lowest daily government salary = 75 Private Pharmacy Facility #____ (1-30) 58 Survey form 10: Private pharmacy Indicator: % of expired drugs Availability of key drugs Facility Date Location Investigator Key drugs to treat common conditions [A] In stock Yes=1, No=0 [B] Expired drugs in stock Yes=1, No=0 [C] 1. ORS 2. Cotrimoxazole tabs 3. Chloroquine tablets 4. Chloroquine syrup 5. Ferrous tabs 6. Folic acid 7. Mebendazole 8. Tetracycline Eye Ointment 9. Iodine 10. Benzoic acid/salicylic acid 11. Paracetamol tablets 12. Paracetamol syrup 13. Amoxycillin Suspension 14. Amoxycillin capsules [A1] = Total no. of key drugs = Total “yes” [B1] = Total “yes” [C1] = [B2] = % in stock = [B1] ÷ [A1] x 100 = [C2] = % expired = [C1] ÷ [A1] x 100 = Notes: [A] List of 10-15 key drugs previously identified at national level must be printed before starting the survey. The process is described on page 21. Add the total number of key drugs [A1]. [B] Mark “1” if stock is available (even if only one dosage form is available). Mark “0” if the drug is not physically available. Add the total at the bottom [B1]. Calculate the percentage in stock [B2] by dividing the total in stock [B1] by the total number of key drugs [A1] and multiplying by 100. [C] For all drugs in stock, check if expired or not. If any of the product is expired, mark “1” for yes. Add all the “Yes” answers [C1]. Calculate the percentage expired [C2] by dividing the total expired [C1] by the total number of key drugs [A1] and multiplying by 100. Private Pharmacy Facility #____ (1-30) 59 Survey form 11: Central/district warehouse Indicator: % of expired drugs Availability of key drugs Facility Date Location Investigator Key drugs to treat common conditions [A] In stock Yes=1, No=0 [B] Expired drugs in stock Yes=1, No=0 [C] 1. ORS 2. Cotrimoxazole tabs 3. Chloroquine tablets 4. Chloroquine syrup 5. Ferrous tabs 6. Folic acid 7. Mebendazole 8. Tetracycline Eye Ointment 9. Iodine 10. Benzoic acid/salicylic acid 11. Paracetamol tablets 12. Paracetamol syrup 13. Amoxycillin Suspension 14. Amoxycillin capsules [A1] = Total no. of key drugs = Total “yes” [B1] = Total “yes” [C1] = [B2] = % in stock = [B1] ÷ [A1] x 100 = [C2] = % expired = [C1] ÷ [A1] x 100 = Notes: [A] List of 10-15 key drugs previously identified at national level must be printed before starting the survey. The process is described on page 21. Add the total number of key drugs [A1]. [B] Mark “1” if stock is available (even if only one dosage form is available). Mark “0” if the drug is not physically available. Add the total at the bottom [B1]. Calculate the percentage in stock [B2] by dividing the total in stock [B1] by the total number of key drugs [A1] and multiplying by 100. [C] For all drugs in stock, check if expired or not. If any of the product is expired, mark “1” for yes. Add all the “Yes” answers [C1]. Calculate the percentage expired [C2] by dividing the total expired [C1] by the total number of key drugs [A1] and multiplying by 100. Central/ District Warehouse Facility #____ (1-5) 60 Survey form 12: Central/district warehouse Indicator: Stockout duration Facility Date Location Investigator Key drugs to treat common conditions (only collect data for drugs with records covering at least six months) [A] No. of days out of stock [B] No. of days covered by the review [C] Equivalent no. of days/year [D]=[B]x365÷[C] [D] 1. ORS 2. Cotrimoxazole tabs 3. Chloroquine tablets 4. Chloroquine syrup 5. Ferrous tabs 6. Folic acid 7. Mebendazole 8. Tetracycline Eye Ointment 9. Iodine 10. Benzoic acid/salicylic acid 11. Paracetamol tablets 12. Paracetamol syrup 13. Amoxycillin Suspension 14. Amoxycillin capsules [A1] = Total no. of key drugs = [D1] = Sum of [D] = [E] = Average number of stockout days = [D1] ÷ [A1] = Notes: [A] List of 10-15 key drugs previously identified at national level must be printed in before starting the survey [A]. The process is described on page 21. Add the total number of key drugs [A1]. [B] Go through the stock cards covering the review period. Indicate the number of days that each drug is not available or marked “0” on the stock card [B]. A drug is considered in stock if any equivalent product is available in either generic or branded form. [C] The review should cover a six month to one year period. Indicate the number of days actually reviewed for each drug [C]. [D] Compute the equivalent number of stockout days per year for each drug [D] by multiplying [B] by 365 and dividing by [C]. Add the total number of stockout days [D1]. [E] Calculate the average number of stockout days [E] by dividing the total number of stockout days [D1] by the total number of key drugs [A1]. Example: Key drugs to treat common conditions (only collect data for drugs with records covering at least six months) [A] No. of days out of stock [B] No. of days covered by the review [C] Equivalent no. of days/year [D]=[B] x 365÷ [C] [D] Cotrimoxazole 90 180 182.5 Paracetamol 30 365 30 Total no. of key drugs [A1] = 2 [D1] = Sum of [D] = 212.5 [E] = Average number of stock out days = [D1] ÷ [A1] = 106.25 Central/ District Warehouse Facility #____ (1-5) 61 Survey form 13: Central/district warehouse Indicator: Adequate storage Facility Date Location Investigator Checklist Store Room Yes=1, No=0 [A] 1. There are working locks in the store room. 2. Storage area and shelves are clean (no dust or litter). 3. No evidence of pests is seen in the area. 4. There is a secure ceiling. 5. There are windows that can be opened or there are air vents. 6. No direct sunlight enters the area (glass window panes are painted white or there are curtains/blinds to protect against sunrays). 7. Area is free from moisture (leaking drains and taps). 8. Drugs are not stored directly on the floor. 9. There is a separate storage and dispensing area for issuing drugs. 10. Drugs are sorted in a systematic way (alphabetical, first expiry-first out). 11. There is stock record system. 12. There is a cold storage with temperature chart. Rating Total “Yes” [A1] = Central/ District Warehouse Facility #____ (1-5) 62 Survey form 14: Household: Access and use of medicines Facility_________________Location _____________________Investigator _________________ Ask if anyone in the household has been ill in the last two weeks, excluding hospital admission. If yes, complete form. If no, go to next household. 1. Sex of person who has been ill (record only one illness episode per household, even if more than one person has been ill) □ Male □ Female 2. Age (in years) of person who has been ill □ Under 1 □ 1–5 □ 6–15 □ 16–54 □ 55 and older 3. Educational attainment of household head □ No Education □ Primary □ Secondary □ Vocational □ University □ Post graduate 4. What were the person’s symptoms? (mark one or more) □ Diarrhoea □ Cough □ Fever □ Others (specify) _____________________________________________________________ 5. What was the person’s diagnosis, if any? ______________________________________________ 6. What was done? (mark one or more) □ Consulted traditional healer □ Consulted public health clinic/hospital □ Consulted private health clinic/hospital □ Consulted mission/NGO clinic □ Consulted pharmacist □ Consulted drug seller □ Sought advice from friend/neighbour/family □ Bought medicine without consultation □ Used medicine left from another illness □ Did nothing (If no one was consulted, skip to question 12) 7. Was medication prescribed? □ Yes □ No 8. Which medicines were obtained? □ All □ Some □ None 9. If not all, why not? (mark one or more) □ Price was too high □ Did not have enough money □ Not able to borrow enough money □ Too many medicines were prescribed □ Did not believe all the medicines were needed □ Started to feel better □ No time to get all the medicines □ Traditional healer did not have all the medicines □ Public pharmacy did not have all the medicines □ Private pharmacy did not have all the medicines □ Mission/NGO facility did not have all the medicines □ Drug seller did not have all the medicines □ Already had some of the medicines at home □ Other 10. How much of the prescribed medicine was taken? □ All □ Some □ None Amount Mark an X through the source as numbered (1–10) 11. What medicines were used? (include traditional medicines) (list one per line) spent out-of-pocket in local currency (write “0” if free) 1. Traditional healer 2. Public health centre/hospital 3. Private health centre/hospital 4. Mission/NGO facility 5. Drug store 6. Private pharmacy 7. Local store/marketplace 8. Friends/neighbours/family 9. Medicines already owned 10. Other 1 2 3 4 5 6 7 8 9 10 1 2 3 4 5 6 7 8 9 10 1 2 3 4 5 6 7 8 9 10 1 2 3 4 5 6 7 8 9 10 1 2 3 4 5 6 7 8 9 10 1 2 3 4 5 6 7 8 9 10 [A]=Total amount spent on medicines_________ 12. [B] = Total household expenses last week in local currency = ________________________ 13. [C] = Total amount spent ÷ total household expenses last week x 100 = [A] ÷ [B] x 100 =_______________ Household # ____ (1-25) Geographic Area 63

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