Background
National PV centres and PV initiatives
National PV centres
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Coordinating of pharmacovigilance activities nationwide;
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Creating awareness on pharmacovigilance among health professionals, healthcare providers, marketing authorization holders and the public;
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Post-marketing surveillance of regulated products;
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Establishing and maintaining a functional national database on ADRs and other medicine related problems to identify unknown or poorly specified adverse effects;
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Leading national and international collaboration on safety issues
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Contributing to the fight against counterfeit medicines
PV initiatives and programmes
Methods
Selection
Data collection
Coding
Type of resource | Definition |
Financial resources | Funding or financial capital |
Technical resources | Materials and infrastructure (e.g. computers, reporting infrastructure) |
Political resources | Law, policy and other legislative instruments |
Human resources | Staff and human expertise |
Social resources | Relationships including collaborations, partnerships and networks |
Type of stakeholder | Definition |
National government | The National Regulatory Agency and the Ministry of Health |
Development partners | Organizations that work with a variety of in-country partners to improve the lives of poor and vulnerable people in developing countries |
Inter-governmental organizations | Organizations comprising mainly of sovereign states |
Public health programmes | Organizations responsible for health services to improve and protect community health |
Academia | Organizations concerned with the pursuit of education, research and scholarship |
Industry | Organizations who market and sell pharmaceutical products |
Analysis
Results
MSH Group 1- Countries with minimal or no capacity for PV
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Country
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Successful experiences
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Successful resources assigned
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Unsuccessful experiences
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Unsuccessful resources assigned
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Angola | • Deployment of PV focal persons to various regions of the country, thus decentralizing PV • ADR reports received through positive collaboration with HIV and Malaria Programmes • Funds received through collaboration with development partners | • Political resource • Social resource • Financial resource | • No PV law to enforce regulations • No dedicated budget for PV • No reporting tools | • Political resource • Financial resource • Technical resource |
Burkina Faso | • Regulatory framework implemented by government • Deployment of PV focal persons to various regions of the country, thus decentralizing PV • Establishment of national technical committees with tools for PV work | • Political resource • Political resource • Technical resource | • No properly recognized National Regulatory Authority • No dedicated budget for PV • No tools to embark on active monitoring | • Political resource • Financial resource • Technical resource |
Cameroon | • Funds received through collaboration with development partners • Continuous receipt of PV literature through established relationship with development partners • PV Decree signed by head of state and minister of health | • Financial resource • Social resource • Political resource | • No dedicated budget for PV • Untrained PV staff • No internet to submit ADR data to VigiFlow | • Financial resource • Human resource • Technical resource |
Cape Verde | • Deployment of PV focal persons to various regions of the country, thus decentralizing PV • Improved reporting infrastructure through TV and radio campaigns • Dissemination of ADR data through publication in peer review journals for Portuguese speaking countries | • Political resource • Technical resource • Technical resource | • No PV law to enforce regulations • Inadequate reporting infrastructure • No dedicated budget for PV | • Political resource • Technical resource • Financial resource |
Eritrea | • Funds received through collaboration with development partners • Trained PV staff • Deployment of PV focal persons to various regions of the country, thus decentralizing PV | • Financial resource • Human resource • Political resource | • No PV law to mandate reporting by industry • Low AEFI reporting due to poor collaboration with EPI • Pharma industry does not monitor the safety of their products | • Political resource • Technical resource • Political resource |
Liberia | • Trained PV staff • Incorporation of PV into curriculum of educational institutions due to effective collaboration with Academia • Availability of tools for active monitoring of drugs from international donors | • Human resource • Social resource • Technical resource | • No dedicated budget for PV • Inadequate human resource for PV activities • No PV law to enforce regulations | • Financial resource • Human resource • Political resource |
Mauritius | • Full membership in the PIDM due to positive collaboration with WHO • Improved reporting infrastructure through collaboration with PHPs • Technical support received through collaboration with development partners and PHPs | • Social resource • Technical resource • Social resource | • Inadequate reporting infrastructure • No dedicated budget for PV • No PV law to enforce regulations | • Technical resource • Financial resource • Political resource |
Niger | • Deployment of PV focal persons to various regions of the country, thus decentralizing PV • Attending trainings with the Head of the NRA, facilitation of travel by Head of NRA • Tools available to embark on district inspections | • Political resource • Political resource • Technical resource | • Inadequate human resource for PV activities • Untrained PV staff • No dedicated budget for PV | • Human resource • Human resource • Financial resource |
MSH Group 2- Countries with basic organizational structures for PV
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Country
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Successful experiences
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Successful resources assigned
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Unsuccessful experiences
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Unsuccessful resources assigned
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Congo-DRC | • Technical support received through collaboration with development partners and PHPs • Introduction of android smartphones to communicate effectively with health practitioners • More trained human resource from Implementation of Drug Therapeutic Committees(DTC) | • Social resource • Technical resource • Human resource | • Inadequate reporting infrastructure • Untrained PV staff • No dedicated budget for PV | • Technical resource • Human resource • Financial resource |
Ethiopia | • Trained PV staff • Introduced PV into national curriculum, to train more human resource for PV • Fulltime MSH employee placed at the national centre to help with PV activities | • Human resource • Human resource • Human resource | • Lack of accredited laboratories • More human resources are needed to deliver on mandate • Poor AEFI reporting infrastructure | • Technical resource • Human resource • Technical resource |
Kenya | • Two ministers of state took part in the launch of the PV system. • Launch of online pharmacovigilance electronic reporting system • Funds provided through joint post market surveillance with PHPs | • Political resource • Technical resource • Financial resource | • More human resources are needed to deliver on mandate • Inadequate reporting infrastructure • No PV law to enforce regulations | • Human resource • Technical resource • Political resource |
Mozambique | • Deployment of PV focal persons to various regions of the country, thus decentralizing PV • Funds for training received through collaboration with WHO • Availability of legal instruments to promote PV | • Political resource • Financial resource • Political resource | • Untrained PV staff • No dedicated budget for PV • Poor collaboration with PHPs | • Human resource • Financial resource • Social resource |
Rwanda | • Trained PV staff • Implemented performance based evaluations for district hospitals • Collaboration with AMRH and EAC-PV harmonization to promote PV activities | • Human resource • Technical resource • Social resource | • Inadequate human resource for PV activities • No dedicated budget for PV • Poor collaboration with PHPs | • Human resource • Financial resource • Social resource |
Senegal | • Trained PV staff • Tools available for data analysis and data sharing • Funds for training received through collaboration with NMCP | • Human resource • Technical resource • Financial resource | • No PV staff with data management expertise • No PV representatives in the regions of the country, only the capital region • No dedicated budget for PV | • Human resource • Political resource • Financial resource |
Sierra Leone | • Adjustment of malaria treatment due to strong collaboration with NMCP • Deployment of PV focal persons to various regions of the country, thus decentralizing PV • Introduced PV into national curriculum, to train more human resource for PV | • Social resource • Political resource • Human resource | • No dedicated budget for PV • Inadequate reporting infrastructure • No PV law to enforce regulations | • Financial resource • Political resource • Political resource |
Zimbabwe | • Donor funding available for PV related projects • Guidance documents and publications available for PV work • AEFI Surveillance systems established since 2001 | • Financial resource • Technical resource • Technical resource | • No internet (Wi-Fi) services to submit data to VigiBase • Inability to generate own funds • Inadequate human resource for PV activities | • Technical resource • Financial resource • Human resource |
Group 4- Countries with basic structures for passive and active surveillance
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Country
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Successful resources
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Unsuccessful resources
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Namibia | • Ministry of Health gave the mandate to setup the national centre • Active surveillance tools available for safety monitoring • Implemented patient reporting system | • Political resource • Technical resource • Technical resource | • Inadequate human resource for PV activities • No dedicated budget for PV • Inadequate spontaneous reporting infrastructure | • Human resource • Financial resource • Technical resource |
Nigeria | • Active surveillance tools available for safety monitoring • Funds for training received through collaboration with PHPs • Guidance documents and publications available for PV work | • Technical resource • Financial resource • Technical resource | • No online reporting infrastructure • Inadequate human resource for PV activities • No PV law to enforce regulations | • Technical resource • Human resource • Political resource |
Experiences involving technical resources
“Launching of the online reporting system has helped, it minimizes the paperwork and it is less tedious than the manual reporting”. (Participant 8).
“We found that doctors have a problem managing serious ADRs in the field. Our smartphone application allows us (national centre) to communicate with doctors in real time”. (Participant 5).
“We have only one national laboratory; we are not able to test samples to verify if they are standard or counterfeit when ADRs are reported to us”. (Participant 7).
Stakeholders
National governments were more often associated with unsuccessful acquisition of technical resources and development partners the most successful acquisition of technical resources.“I have ICSRs, but can’t enter into VigiFlow because we don’t have internet connection all the time”. (Participant 3).
“MSH was instrumental in setting up the national centre. They provided technical resources and then later the national centre was incorporated into the structure of the ministry”. (Participant 12).
“The government has set up national commission with tools to validate ADR reports, they have the authority to withdraw or suspend any medicine from the country”. (Participant 2).
“Vaccine surveillance system is not in place at all at the national centre and the extended programme for immunization, we are currently working on the establishment of such a vaccine surveillance system”. (Participant 6).
“Working with development partners is sometimes difficult because they decide what level to tie their resources and sometimes the resources are not specific for our needs”. (Participant, 9).
MSH country groupings
“The issue of reporting online for instance; for some strange reason we haven’t been able to do something as simple as that”. (Participant 14).
Experiences involving political resources
“The national centre was set up under the NRA with legal framework, guidelines, staff, advisory committee and reporting systems through consultation with all stakeholders”. (Participant, 18).
“With the support of the national government, we introduced pharmacovigilance ambassadors in all 4 regions of our country and this has helped increase ICSR reporting”. (Participant 17).
“Pharmacovigilance is not developed in my country because the processes to implement PV law started in 2003 and is ongoing as of 2015”. (Participant 1).
“We have the regulatory authority act which states to ensure safety of products; it sets the pace that this is the intention of government to eventually enact a PV law”. (Participant 14).
Stakeholders
“To start pharmacovigilance, the government adopted two regulatory frameworks; one formed the regulatory authority and the second formed the national centre. These two documents helped start pharmacovigilance activities in the country”. (Participant 2).
“In the absence of strong regulatory laws, our country has become a dumping ground of fake products. The current law does not specify pharmacovigilance activities making it difficult to prosecute offenders”. (Participant 9).
MSH country groupings
“I came to this meeting with my Director. She is 2 nd to the Minister of Health and she facilitated everything”. (Participant 13).
“We are not an autonomous agency. The whole idea of our national regulatory agency set up was to remove government bureaucracy so that we can do drug regulation without all those levels of reporting to slow us down”. (Participant 14).
Experiences involving financial resources
“We are totally dependent on the Ministry; we do not generate our own income hence we are limited in the number of activities we can undertake”. (Participant 9).
“The national centre does not have the autonomy to submit its own budget to the national regulatory authority”. (Participant 16).
“I don’t belong to the group who discuss budget, it’s the director (of the NRA), I can propose activities, but the director decides whether we do it or not”. (Participant 3).
Stakeholders
“We receive donor funding for PV projects. 50% of our staff are funded by donor projects”. (Participant 18).
“We got financial support from United States Pharmacopeia (USP) and United States Agency for International Development (USAID) to conduct minilabs for malaria and post market surveillance for HIV.” (Participant 8).
“Now we are working well with Global Fund but if tomorrow there is no commitment between Global Fund and the country, our activities will be let down. This is a fear I have.” (Participant, 5).
“(Financial) resources are not very predictable. It takes a lot of efforts to have a budget and still the budget is not enough for our priority activities”. (Participant, 4).
MSH country groupings
“Our funding previously was from donors but now we have funding from government and it is based on our activity plan”. (Participant 12).
Experiences involving human resources
“I have no time to do PV. In the Direction of Pharmacy (national regulatory authority), we have only 6 personnel for all the work and I have other activities to do”. (Participant 13).
“If you train 10 people today, one or two years later only 2 will still be working, the rest disappear to the other organizations”. (Participant 5).
“In Africa most issues are politicized; there have been changes in the system that has weakened the progress we have made in (PV) so far”. (Participant 9).
Stakeholders
“We use the WHO Method (for causality assessment) but we cannot analyse the data with VigiFlow. We need training”. (Participant, 16).
“MAHs sometimes know more about pharmacovigilance than you who is the regulator. It has been a challenge to build the capacity of the national centre staff to regulate the MAHs”. (Participant 14).
“With help from MSH we implemented DTCs in general hospitals to advice the national centre”. (Participant, 5).
“We have a full-time MSH staff placed at the national centre. She is supported by MSH”. (Participant 7).
“The EAC harmonization provides us with various expertise from the different countries, for instance we are the lead in Pharmacovigilance whilst other functions such as medicines registration are performed by different countries”. (Participant 8).
MSH country groupings
Experiences involving social resources
“Through our strong collaboration with the malaria programme, we embarked on joint monitoring and with the evidence collected we switched our first line of malaria drug from Artesunate+Amodiaquine to Artemether-Lumefantrine”. (Participant17).
Stakeholders
“In 2009 the immunization programme embarked on MenAfriVac vaccination campaign. Our country took advantage of this to start some pharmacovigilance activities”. (Participant 13).
“We have good collaborations with malaria, tuberculosis and HIV programmes; majority of our ADRs are from the three programmes. Every quarter we share a report with the programmes, so they can appreciate their contributions”. (Participant, 8).
“We have developed a framework with the universities to incorporate PV into the teaching of medicine, pharmacy and nursing”. (Participant, 7).
“I am here in Accra on invitation of WHO-CC attending a conference. If I get copies of these presentations, we will use them to work better when we go back to my country”. (Participant, 3).
MSH country groupings
“We don’t have funds from the Ministry, sometimes we get support from Global Fund or MSH and it’s not fixed so we are not sure how to plan”. (Participant 1).
“MSH is still giving us technical support for active surveillance as we requested from them but not for routine activities”. (Participant 12).
Discussion
Country | National regulatory authority/national PV centre | Year of joining the PIDM | Included in this study | MSH country group |
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Angola | Direcao Nacional de Medicamentos e Equipmentos | 2013 | □ | Group 1 |
Benin | Direction de la Pharmacie et des explorations diagnostics | 2011 | ||
Burkina Faso | Direction Générale de la Pharmacie, du Médicament et des Laboratoires | 2010 | ||
Cameroon | Direction de la Pharmacie, du Médicament et des Laboratoires | 2010 | □ | |
Cape Verde | Agência de Regulação e Supervisão dos Produtos Farmacêuticos e Alimentares | 2012 | □ | |
Eritrea | National Medicine and Food Administration | 2012 | □ | |
Liberia | Liberia Medicines and Health Products Regulatory Authority | 2013 | □ | |
Madagascar | Direction de la Phamacie, des Laboratoires et de la Médecine Traditionnelle | 2009 | ||
Mauritius | Pharmacy Board, Ministry of Health and Quality of Life | 2014 | □ | |
Niger | Direction de la Pharmacie, des Laboratoires et de la Pharmacopée Traditionnelle | 2012 | □ | |
Sudan | National Medicines and Poisons Board | 2009 | ||
Swaziland | Pharmaceutical Services Department | 2015 | ||
Botswana | Drug Regulatory Services, Ministry of Health and Wellness | 2009 | Group 2 | |
Congo, Democratic Republic | Direction de la Pharmacie et du Médicament. | 2010 | □ | |
Côte d’Ivoire | Direction de la Pharmacie et du Médicament. | 2010 | ||
Ethiopia | Food, Medicine and Health Care Administration and Control of Ethiopia | 2008 | □ | |
Guinea | Direction Nationale de la Pharmacie et du Laboratoire | 2013 | ||
Kenya | Pharmacy and Poisons Board | 2010 | □ | |
Mali | Direction de la Pharmacie et des Médicaments | 2011 | ||
Mozambique | Departamento Farmacêutico | 2005 | □ | |
Rwanda | Department of Pharmaceutical Services | 2013 | □ | |
Senegal | Direction de la Pharmacie et du Médicament | 2009 | □ | |
Sierra Leone | Pharmacy Board of Sierra Leone | 2008 | □ | |
Togo | Direction des Pharmacies, des Laboratoires et des Equipements Technique | 2008 | ||
Zambia | Zambia Medicines Regulatory Agency | 2010 | ||
Zimbabwe | Medicines Control Agency Zimbabwe | 1998 | □ | |
Ghana | Food and Drugs Authority | 2001 | Group 3 | |
Tanzania, United Republic | Tanzania Food and Drugs Authority | 1993 | ||
Namibia | Namibia Medicines Regulatory Council | 2009 | □ | Group 4 |
Nigeria | National Agency for Food and Drug Administration and Control | 2005 | □ | |
South Africa | Medicines Control Council | 1992 | ||
Uganda | National Drugs Authority | 2008 | ||
Egypt | Egyptian Drug Authority | 2002 | N/A | |
Morocco | Direction du Me’dicament et de la Pharmacie | 1992 | N/A | |
Tunisia | Direction de la Pharmacie et du Médicament | 1993 | N/A |