Pharmacovigilance in Africa Contributing Factors for it s development Pr R. Soulaymani Bencheikh, M. Squalli, R. Ouled Errkhis, S. Skalli, R. Benkirane, A. Khattabi First African Rabat 12-13 December 2013
Africa 30 million km² - 54 countries - 1 billion inhabitants
Africa 30 million km ² - 54 countries - 1 billion inhabitants English Ghana, Nigeria, South Africa, Namibia, Tanzania, Zimbabwe, Sierra Leone, Uganda, Cameroun, Eritrea, Kenya, Sudan, Zambia, Botswana, Egypt, Gambia, Lesotho, Liberia, Malawi, Swaziland French Algeria, Morocco, Tunisia Madagascar, Togo, Senegal, Benin, Burkina Faso, Burundi, Congo, Cote d ivoire, Djibouti, Gabon, Mali, Mauritania, Niger,R.D.C, Rwanda, Chad, republic centre africa, comores, Maurice, Seychelles, guinea Other Mozambique, Ethiopia Angola, G. Bissau, Equatorial G, Somalia,Cape Verde, sao tomé et Principe, Libya.
Africa 30 million km ² - 54 countries - 1 billion inhabitants Health expenditure in percentage of PIB: 2.7 (Mauritani) to 12.2 (Malawi) Health professionals per 1000 inhabitants: From 0.03 Niger to 2.3 in Djibouti Drugs manufactured in the country: Morocco, Egypt, South Africa : More than 85% Tunisia: 40% - Algeria: 33% - Other African countries: 0 to 10% English Ghana, Nigeria, South Africa, Namibia, Tanzania, Zimbabwe, Sierra Leone, Uganda, Cameroun, Eritrea, Kenya, Sudan, Zambia, Botswana, Egypt, Gambia, Lesotho, Liberia, Malawi, Swaziland French Algeria, Morocco, Tunisia Madagascar, Togo, Senegal, Benin, Burkina Faso, Burundi, Congo, Cote d ivoire, Djibouti, Gabon, Mali, Mauritania, Niger,R.D.C, Rwanda, Chad, republic centre africa, comores, Maurice, Seychelles, guinea Other Mozambique, Ethiopia Angola, G. Bissau, Equatorial G, Somalia,Cape Verde, sao tomé et Principe, Libya.
Introduction Pharmacovigilance in Africa is considered as very weak Pharmacovigilance is no more seen as a luxuary activity Pharmacovigilance is in the heart of: Drug Safety, Rational use of drugs Patient Safety Performance of Public Health Programmes
Aims of the presentation What is the Actual situation of Pharmacovigilance? What are the contributing factors for it s development? Is there any differences between regions and/or countries? What are the lessons to be learned? No Global and objective study has been performed to quantify the performance of PV in Africa
Pharmacovigilancedevelopment Perfo rmance of Pharma acovigilance
Pharmacovigilancedevelopment Ressources - Structure - Legislation - Material and Humain ressources Perfo rmance of Pharma acovigilance
Pharmacovigilancedevelopment Ressources - Structure - Legislation - Material and Humain ressources Process: data is - gathered, - analyzed - reported to UMC Perfo rmance of Pharma acovigilance
Pharmacovigilancedevelopment Ressources Process: data is Impact - Structure - Legislation - Material and Humain ressources - gathered - analyzed - reported to UMC - Drug Safety - Patient safety - Spread of information Perfo rmance of Pharma acovigilance
Study: performed by WHO CC Rabat during 2013 Data collection 1. Survey 2. UMC Data 3. Literature collection of Data List of Indicators 1 : 28 1. Structural Indicators: 10 2. Process Indicators: 11 3. impact Indicators: 7 Material and Methods Score Attribution 2 : 1. Each Indicator 2. Stuctural, Process and impact group of Indicators 3. Total performance Analysis: 1. Simple and comparative Description 2. Comparaison of performance between régions and countries 2. Determination of significant contributing Factors for PV development (Bivariate analysis and correlations) 1: PHARMACOVIGILANCE INDICATORS: A practical guide for National and Regional Pharmacovigilance Centres, Healthcare facilities and Public Health Programmes 2: Indicator-Based Pharmacovigilance Assessment Tool Manual.
Results Countries that received the questionnaire The responding countries Taux de réponse:79,5%
African Membership to WHO/UMC Official Members: 81% Associate Members:16% Not Members : 3% North America Europe Latin america and the caribbean Asia Oceania Africa World Official 2 41 14 24 4 32 117 Associate 0 3 6 13 1 6 29 Total of countries member of the UMC 2 44 20 37 5 38 146
Joining WHO/UMC Groupe1 (4 countries): More than 20 years Seniority Groupe2 (4 countries): between 10 and 20 years Seniority Groupe3 (30 countries) : Less than 10 years Seniority
Results Ressources - Structure - Legislation - Material and Humain ressources
Ressources - Structure - Legislation - Material and Humain ressources Results: structural Indicators 100% 90% 80% 70% No information; 1 No information; 1 No information; 1 No information; 1 No; 1 No; 3 No; 8 No; 7 No; 8 No; 15 60% 50% 40% 30% Yes; 27 Yes; 23 Yes; 24 Yes; 22 Yes; 29 20% Yes; 15 10% 0% Existence of PV center National policy, legislation Financing Existence of full time personnel Existence of standard ADR reporting forms Existence of case management system in place
Ressources - Structure - Legislation - Material and Humain ressources Results: structural Indicators 100% 90% 80% No; 4 No; 11 No information; 2 No information; 1 No; 6 70% No; 16 60% 50% 40% 30% Yes; 27 Yes; 20 Yes; 24 20% Yes; 13 10% 0% Communication facilities Possession of VigiFlow National commission Technical committee
Ressources - Structure - Legislation - Material and Humain ressources Results: Structural Indicators Scoring Mean score: 10,96 ±3,83 (of 16). Minimum: 1 Maximum: 15 16 14 12 10 8 13 11 8 15 9 7 12 10 14 14 14 14 8 11 11 8 15 15 7 12 12 14 11 13 14 13 14 15 6 4 2 1 4 2 0
Results - gathered - analyzed - reported to UMC Process: data is
Who report to PV centres in africa?
Process: data is - gathered -analyzed - reported to UMC Results: Causality assessment 100% 90% 80% 70% No information ; 6; 19% Method of causality assessment Number of countries 60% 50% 40% 30% 20% 10% 0% Yes; 22 71% No ; 3;10% Causality assessment WHO method 17 French Method 8 Naranjo 4
Process: data is - gathered - analyzed - reported to UMC Result How Africa is repoting
Process: data is - gathered - analyzed - reported to UMC Results Growth reporting from Africa: 6 424 to 59 841
Process: data is - gathered - analyzed - reported to UMC Results: Reporting to UMC 8 Millions ICRS Africa has the lowest rate of reporting
Process: data is - gathered - analyzed - reported to UMC Results Who report in Africa 50% : South Africa and Morocco 81.5%: five countries
Process: data is - gathered - analyzed - reported to UMC Process Indicators Scoring Mean score: 8±3,46 (of 20). Minimum: 0 Maximum: 16 18 16 14 13 14 14 13 16 12 10 8 6 4 9 4 7 10 6 9 11 9 10 8 4 9 6 11 9 9 4 7 4 7 7 11 8 5 7 2 0 0
Result Impact - Drug Safety - Patient safety - Spread of information
Impact - Drug Safety - Patient safety - Spread of information Integration of PV inphp 100% 90% 80% No information ; 5 No information ; 6 No information ; 6 No information ; 6 70% 60% No; 8 No; 10 No; 10 No; 11 50% 40% 30% 20% Yes; 18 Yes; 15 Yes; 15 Yes; 14 10% 0% Immunisation VIH/Sida Tuberculosis Malaria Integration of PV in the public health programs
Impact - Drug Safety - Patient safety - Spread of information Results: Impact indicators 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 12 2 15 2 Average completeness score of reports sent the UMC Under Between Above No information 8 14 9 Regularity Number of Countries publications Burkina Faso 6 Burundi 1 Egypt 1 Ethiopia 1 Ghana 6 guinea 1 Kenya 12 South Africa 19 Mali 2 Morocco 6 Mozambique 1 Nigeria 15 Uganda 6 Rwanda 3 Senegal 19 Tanzania 2 Togo 2 Tunisia 2
Impact - Drug Safety - Patient safety - Spread of information Result: Impact Indicators Scoring Mean score: 4,19 ±2,1 (of 9) Minimum: 1 Maximum: 8 9 8 7 6 5 4 4 6 4 4 4 4 5 6 7 5 4 5 8 8 6 5 6 6 7 6 3 2 1 1 3 1 2 1 1 3 1 2 3 2 0
Result: PV performance Scoring Mean score: 24,29 ± 7,78 (of 45) Minimum: 3 Maximum: 34 40 35 30 25 20 15 10 5 0 30,7 5 2 6 8 7 8 6 3 5 4 6 6 4 4 5 4 14 16 6 7 4 13 14 11 10 9 9 13 8 7 9 8 7 11 9 7 5 10 15 12 13 14 14 11 14 15 14 14 15 13 14 14 11 12 12 13 10 2 7 15 3 9 11 4 2 6 5 9 11 7 4 7 8 9 8 1 4 11 15,7 3 1 4 4 7 8 1 6 4 1 6 10 1 2 Structure Outcome Impact
What are the contributing factors for Pharmacovigilance development?
Possible contributing factors for PV development? PV Development Leadership Advocacy Continuty
Possible contributing factors for PV development? Drug Policy PV Development Total Pharmaceutical expenditure (per capita) Number of pharmaceutical industry Leadership Advocacy Continuty
Possible contributing factors for PV development? Health Development Drug Policy PV Development Expenditure on Health (% of GDB, per capita) work health density Hospitals beds (per 10000) WHO ranking Total Pharmaceutical expenditure (per capita) Number of pharmaceutical industry Leadership Advocacy Continuty
Possible contributing factors for PV development? Country specificity Human development Health Development Drug Policy PV Development GDP per capita, Human development index multidimensional poverty index Expenditure on Health (% of GDB, per capita) work health density Hospitals beds (per 10000) WHO ranking Total Pharmaceutical expenditure (per capita) Number of pharmaceutical industry Leadership Advocacy Continuty
Results: contributing Factors HD ( P=0,822397), Health factors scores ( P=0,6) don t explain the performance of PV Size of population (P=0,03) -GDP per capita (P=0,01) -Multidimensional poverty index (P = 0,008) seems to have an effect on PV performance
Performance of PV and membership seniority in the WHO program of PV When the seniority of membership in the WHO program of PV increases by one year the average score of the performance increase of 0.6 units
Contributing Factors Pharmaceutical development Contributing Factors Alpha Beta R2 F statistic P-value Total pharmaceutical expenditure (million $) 25,431 0,1 0,1 2,1557 0,1 Pharmaceutical expenditure per capita 24,159 0,1 0,16 4,1012 0,05 Number of pharmaceutical industry 23,707 0,033 0,69 6,4806 0,019254 Pharmaceutical Factors Score 18,697 3,882 0,45 23,7821 0,000039
Lessons learnt There is a good progress in all African countries but with a significant disparity Geographic situation, Country Development, Health Systems Development, Human Development index, GDP per Capita don t seem to have an effect on PV Performance Size of population, language, Membership Seniority in WHO programme and pharmaceutical development Seem to have an effect on PV on PV performance 13/01/2014 41
Lessons learnt Concept and Principles of PV need TIME to be fully understood Leadership and dedicated personnel is essential Advocacy and continuity are a sine qua non condition for PV Viability Minimum established staff is essential Linkages with international network are essential Need for PV to be recognized and promoted and by PHP Health authority and international support is needed Networking with regional and international groups must continue 13/01/2014 42
Thank you for your attention