Table 3.

Summary of details of included studies and quality assessment scores

Author(s) and publication year	Study aim	Study design	Study setting	Pharmacovigilance system level	Sample size	Methods	Evaluation tool(s)	Aspects evaluated by the study	Study limitations	Quality Score (out of 36)
Abiri and Johnson [37]	To evaluate the current status of PV in Sierra Leone through a comprehensive and system-based approach that covered the Pharmacy Board of Sierra Leone, healthcare facilities and Public Health Programmes	Descriptive cross-sectional study	Sierra Leone	National medicines regulatory authority, health facilities, and Public Health Programmes (PHPs)	14 Participants	Structured interviews with key informants from the Pharmacy Board of Sierra Leone (PBSL), six hospitals, and six Public Health Programmes (PHPs), as well documentary review	Indicator-Based Pharmacovigilance Assessment Tool (IPAT)	1—Policy, law and regulation; 2—Systems, structures and stakeholder coordination; 3—Signal generation and data management; 4—Risk assessment and evaluation; and 5—Risk management and communication	Small sample size recruited through convenience sampling. Use of a score of 60% as a threshold for the overall functionality of the pharmacovigilance system despite no evidence from IPAT	30
Allabi and Nwokike [38]	To draw up a portrait of policy documents and practical actions in the areas of PV, quality control of Artemisinin-based Combination Therapies (ACTs) and monitoring of resistance of ACT in Republic of Benin (situational analysis), identification of the main barriers which prevent their implementation and the discussion focus on the recommendations for towards the establishment of an effective and functional PV system in Benin	Not reported	Republic of Benin	PV systems in drug regulation system (DPM), National malaria control programme (NMCP), known as “Programme National de Lutte Contre le Paludisme” (PNLP) in Benin), quality control of drugs centre (LNCQ) and the biggest teaching hospital (CNHU)	68 physicians, 45 pharmacists and 43 pharmaceutical company representatives, key informants from the National Laboratory of Drugs Control Quality (LNCQ), Directorate of Pharmacy and Drug Regulations (DPM), National Malaria Control Programme (NMCP) and the Director of the teaching hospital in Cotonou: Centre National Hospitalier Universitaire (CNHU)	Interviewer administered semi-structured questionnaire with physicians, pharmacists, and pharmaceutical company representatives; focus groups and structured interviews with representatives from the NMCP (Programme National de Lutte Contre le Paludisme (PNLP)), the National Laboratory of Drugs Control Quality (Laboratoire National de Control de Qualité (LNCQ)), DPM and the director of the CNHU-teaching hospital; and documentary review	Semi-structured questionnaire based on adverse drug reaction reporting and reasons for non-reporting; no framework reported for focus groups; structured interviews and documentary review based on Indicator-Based Pharmacovigilance Assessment Tool (IPAT); SWOT analysis	Semi-structured questionnaire: knowledge, attitude and practice relating to spontaneous reporting of adverse drug reactions, specific questions examining the ADRs related to Artemisinin-based Combination Therapy (ACT), reasons for non-reporting and important factors in a decision to report; focus groups: Assess the practice and problems in the pharmacovigilance system and quality control of ACTs and ways to solve these problems; structured interviews and document review: 1—Policy, law and regulation; 2—Systems, structures and stakeholder coordination; 3—Signal generation and data management; 4—Risk assessment and evaluation; and 5—Risk management and communication; strengths, weaknesses, opportunities and threats used to make recommendations	Not reported	28
Alshammari et al. [48]	To investigate and provide an overview of the current situation and on the activities of the national pharmacovigilance centres in Arab countries	Cross-sectional study	Arab countries (members of the League of Arab States)	National Pharmacovigilance Centres	15 countries: Algeria (AL), Egypt (EG), Jordan (JO), Iraq (IQ), Kuwait (KW), Libya (LB), Lebanon (LE), Morocco (MA), Oman (OM), Palestine (PA), Kingdom of Saudi Arabia (KSA), Sudan (SU), Tunisia (TN), United Arab Emirates (UAE), and Yemen (YE)	Self-administered questionnaire by representatives of National Pharmacovigilance Centres	A previously conducted survey carried out by WHO Uppsala Monitoring Centre (UMC)	1—Country and respondent background information; 2—Overview of the PV programme; 3—Spontaneous reporting; 4—PV activities; 5—level of support, including funding, staff, and software; 6—Usefulness of information from PV activities; and 7—Registry availability; also, presence of a designated national centre/department that conducts PV activities	Pertinent information missing. Programme features and development plans might have changed since the time of the study. Not all countries responded	31
Barry et al. [39]	To conduct a comparative assessment of the current national PV system at the respective National Medicines Regulatory Authorities in Ethiopia, Kenya, Rwanda, and Tanzania for future targeted capacity-building interventions to be carried out by the PROFORMA project	Cross-sectional descriptive study	Ethiopia (ET), Kenya (KE), Rwanda (RW), and Tanzania (TZ)	National Pharmacovigilance Centres housed within the National Medicines Regulatory Authorities	Between two and four NMRA staff members working in PV from each country	Structured interviews with key informants (NMRA staff working in PV) and documentary review	East African Community (EAC) Harmonized Pharmacovigilance Indicators tool (derived from the WHO pharmacovigilance indicators and the IPAT) supplemented with a few additional indicators from the WHO Global Benchmarking Tool (GBT) for evaluation of national regulatory systems	EAC Indicators tool: 1—Policy, law, and regulation; 2—Systems, structures, and stakeholder coordination; 3—Signal generation and data management; 4—Risk assessment and evaluation; and 5—Risk management and communication; WHO Global Benchmarking Tool: 1—Guidelines ensuring encouragement of different stakeholders to report ADRs and AEs to the Marketing Authorisation Holder (MAH) and/or NMRA; 2—Legal provisions and regulations allowing NMRA to require safety and effectiveness studies; 3—Legal provisions, regulations, and guidelines requiring designation of a person as in charge of the vigilance system	Findings for some of the indicators may have changed since the assessment. Some personal knowledge, experience, and opinions of the regulators were not possible to verify from other sources	30
Barry et al. [40]	To assess and compare the pharmacovigilance systems and practices within the Neglected Tropical Disease (NTD) programmes in Ethiopia, Kenya, Rwanda, and Tanzania	Cross-sectional descriptive study	Ethiopia (ET), Kenya (KE), Rwanda (RW), and Tanzania (TZ)	Public Health Programmes	2–3 National NTD programme staff members in Kenya, Tanzania, and Rwanda, and 1 from Ethiopia	Structured interviews with key informants (staff members from the national NTD programme) and documentary review	East African Community (EAC) Harmonized Pharmacovigilance Indicators tool for Public Health Programmes (PHPs) (derived from the WHO pharmacovigilance indicators and the IPAT)	1—Systems, structures, and stakeholder coordination; 2—Signal generation and data management; 3—Risk assessment and evaluation; and 4—Risk management and communication	Not possible to verify all of the information gathered through structured interviews	30
Chan et al. [52]	To review the status of the development of pharmacovigilance in the Association of Southeast Asian Nations (ASEAN) and the relevance of quantitative signal detection algorithms (QSDA) in the ASEAN context. Also to compare the findings in these countries against the more established agencies in Australia, Canada, Japan, South Korea, Switzerland, the UK and the US	Not reported	ASEAN member countries and a group of non-ASEAN countries having close working relations in the area of PV with Singapore: Australia, Canada, Japan, South Korea, Switzerland, UK, and the USA	National Pharmacovigilance Centre	16 countries: 9 ASEAN countries with Myanmar excluded: Brunei Darussalam (BR), Cambodia (KH), Indonesia (ID), Lao People’s Democratic Republic (LA), Malaysia (MY), Philippines (PH), Singapore (SG), Thailand (TH), and Vietnam (VT); and 7 non-ASEAN countries: Australia (AU), Canada (CA), Japan (JP), South Korea (SK), Switzerland (CH), UK, and the USA	Self-administered questionnaire by representatives of National Pharmacovigilance Centres	No tool specified for the questionnaire	1—An overview of the national PV programme; 2—Range of PV activities; 3—Spontaneous ADR reporting and size of the ADR records; 4—Source of ADR information—the importance of the different post-marketing surveillance tools for safety monitoring; 5—Management of ADR reports and signal detection; and 6—The relevance of a QSDA in their respective countries	Limited the survey to all ASEAN countries and seven non-ASEAN countries. A more comprehensive comparison would be to survey a representative sample from all other countries to make a comparison of the status of PV in the ASEAN. Survey responses were focussed on QSDAs and tools only. There was no testing of the reliability of the questionnaire. A substantial number of the survey questions were descriptive. The study did not capture the types and volume of medicines used in the various countries	31
Ejekam et al. [47]	Assess the structures, processes, and outcomes of pharmacovigilance activities in three selected public health programmes (National Malaria, Tuberculosis (TB), HIV/AIDS) in Nigeria using the WHO Pharmacovigilance Indicators and identify possible challenges to achieving the outcomes	Cross-sectional mixed-method study	Nigeria	Public Health Programmes	National PV centre and 3 Public Health Programmes	Structured and semi-structured interviews with key informants from National PV Centre and PHPs and documentary review	WHO Pharmacovigilance Indicators	1—PV structures, processes, and outcomes of each of the PHPs, 2—Efforts and challenges towards achieving the desired PV outcomes from the key informants’ perspectives	Poor recording keeping undermining comprehensive documentation	30
Kabore et al. [41]	To evaluate Burkina Faso’s early-stage drug safety monitoring system through a comprehensive system-based approach	Descriptive cross-sectional study	Burkina Faso	National Medicines Regulatory Authority (NMRA), public health programmes (PHPs) and hospitals	16 participants (1–3 participants per institution)	Structured interviews with key informants from the National Medicines Regulatory Authority (NMRA), six PHPs, and five hospitals, as well as documentary review	Indicator-Based Pharmacovigilance Assessment Tool (IPAT)	1—Policy, law and regulation; 2—Systems, structures and stakeholder coordination; 3—Signal generation and data management; 4—Risk assessment and evaluation; and 5—Risk management and communication; and opinions regarding the current PV system	IPAT limitations: 1. IPAT’s sensitivity and specificity have not been established; 2. Possible imprecision in the quantification of responses in the scoring process; 3. The assessment was reliant on respondents’ declarations; 4. Local adaptation may be necessary due to the tool’s limited testing and validation. Limitations related to evaluation process: Generalisability and reproducibility of the study may be affected due to limited sample in number and diversity	33
Kaewpanukrungsi and Anantachoti [54]	To assess the performance of the Thai National Pharmacovigilance Centre (NPVC) to identify gaps and areas for future improvement	Not reported	Thailand	National Pharmacovigilance Centre	10 participants (8 from the national pharmacovigilance centre and 2 executive staff from the Thai FDA)	Interviews (using semi-structured questionnaires) with and observation of NPVC staff, in-depth interviews with Thai FDA executive staff, and documentary analysis	Open-ended questions: Domains and indicators for NPVC performance assessment	1—Policy, law, plan and structural support, 2—Safety surveillance, 3—Risk management, and 4—Communication of safety information	Not reported	26
Maigetter et al. [42]	To describe the PV systems in India, Uganda, and South Africa. Also, to analyse the extent to which the three countries conformed to the minimum pharmacovigilance requirements by the WHO	Not reported	India (IN), Uganda (UG), and South Africa (SA)	National Pharmacovigilance Centres in Uganda and South Africa, and Regional Pharmacovigilance Centres in Maharashtra State, India	39 participants (20 from India, 8 from Uganda, and 11 from South Africa)	Documentary review of academic literature and policy reports, and interviews with key informants	WHO minimum requirements for functional pharmacovigilance system	Documentary review: pharmaceutical regulation, including regulatory frameworks and capacity; use of medicines; and PV, including descriptions of the adverse event (AE) reporting systems. Interviews: Regulatory systems and policies concerning PV	Reliance on interviews with key informants. Some details regarding budget and staff, as well as composition and functioning of the national advisory committee, were not uniformly available	33
Mugauri et al. [44]	To evaluate the antiretroviral- adverse drug reaction (ARV-ADR) surveillance system in Harare City to identify the reasons for underreporting and recommend solutions	Descriptive cross-sectional study and surveillance system evaluation	Harare City, Zimbabwe	National Pharmacovigilance Centre	52 Health Personnel involved in the ARV-ADR surveillance from 2 hospitals and 17 clinics	Documentary review of patient records and notification forms issued by the hospitals and clinics, as well as interviews with healthcare workers using an interviewer-administered questionnaire	Updated Centres for Disease Control and Prevention (CDC) guidelines for Evaluating Public Health Surveillance Systems and checklist derived from the WHO assessment criteria for a PV system’s stability status (WHO PV Indicators)	Questionnaire: determine health workers' knowledge of the operations and usefulness of the surveillance system; Checklist: evaluates the availability of reporting forms, case definitions and means for communication. Patient records: number of ARV-ADR cases documented, captured, and missed by the surveillance system. Hospital and clinic notifications: evaluating system simplicity, data quality, completeness, acceptability, sensitivity, timeliness and representativeness. PV indicator checklist: core as well as complimentary process indicators, and core outcome indicators	Not reported	29
Muringazuva et al. [43]	To evaluate the Adverse Drug Reaction Surveillance System (ADRSS) to assess the system performance and reasons for not notifying on time	Descriptive cross-sectional study and surveillance system evaluation	Kadoma City, Zimbabwe	Regional Pharmacovigilance System	47 health workers from six health facilities which offered Mass Drug Administration (MDA)	Interviewer administered questionnaire, checklists, and record review (outpatient registers, reports on the ADRSS, meetings' minutes)	Updated Centres for Disease Control Prevention (CDC) Guidelines for Evaluating Public Health Surveillance Systems	System simplicity, stability, acceptability, and completeness; Interviewer administered questionnaire information on health worker knowledge on the ADRSS and to assess the attributes of the ADRSS; checklist was used to assess for the availability of the resources needed for running the ADRSS	Availability of only one notification made it difficult to assess the quality of data	34
Mustafa et al. [51]	To investigate the adverse drug reaction (ADR) reporting system and to suggest possible ways of improving the method of reporting	Prospective observational study	Lahore, Pakistan	Regional health facilities (hospitals)	84 Doctors and 52 Pharmacists from 30 different hospitals in Lahore	Structured interviews using investigator administered questionnaires	A questionnaire based on different ADR systems of developed countries, literature evaluation, and published research articles	Questionnaire 1: General hospital information including ADR systems; Questionnaire 2: Doctors’ and pharmacists’ demographics, knowledge, and attitude to ADR reporting	Not reported	25
Nwaiwu et al. [45]	To evaluate pharmacovigilance practices in pharmaceutical companies in Nigeria	Descriptive study	Lagos, Nigeria	Pharmaceutical Companies	31 companies	Self-administered questionnaire distributed to designated company staff	Questionnaire adapted from existing drug safety laws and guidance and online pharmacovigilance auditing checklists	Basic pharmacovigilance requirements	The sampling method used is prone to selection bias and sampling error. The companies that participated in the study may have differed from companies that did not	27
Opadeyi et al. [46]	To assess the status of pharmacovigilance structure, processes, outcomes and impact in the South-South zone of Nigeria using the WHO PV indicators	Cross-sectional descriptive study	South-South Zone of Nigeria	Regional health facilities (hospitals)	6 Hospitals	Structured interviews with focal pharmacovigilance persons or committees in hospitals and review of hospital records	Modified WHO Pharmacovigilance Indicators (Core Indicators)	Background information, structural indicators, process indicators, outcome/impact indicators	The absence of trained PV personnel hindered the provision of results for the PV process indicators. Structural PV indicators fail to fully capture the pharmacovigilance system's functionality. Overall poor documentation limited the indicators' derivation. Outcome/impact indicator derivation required an in-depth survey which young PV systems are unable to execute. Need for a scoring system to quantify the indices to highlight deficiencies in numerical terms	33
Qato [49]	To describe the current landscape of pharmacovigilance in the Arab and Eastern Mediterranean (EM) region	Descriptive cross-sectional study	Arab and Eastern Mediterranean Region countries	National Pharmacovigilance Centre	21 countries: Afghanistan (AF), Algeria (AL), Comoros Islands (CO), Djibouti (DJ) (excluded from final mean calculations), Egypt (EG), Jordan (JO), Iran (IR), Iraq (IQ), Kuwait (KW), Libya (LB), Lebanon (LE), Morocco (MA), Oman (OM), Pakistan (PK), Palestine (PA), Qatar (QA), Saudi Arabia (KSA), Sudan (SU), Tunisia (TN), the UAE, Yemen (YE)	Self-administered questionnaires by pharmacovigilance leadership (official national contact for the WHO Programme for International Drug Monitoring (PIDM))	Combination of WHO Pharmacovigilance Indicators and Indicator-Based Pharmacovigilance Assessment Tool (IPAT)	Three domains of pharmacovigilance performance: Structure, process, and impact	Not all countries in the geographical region of interest were represented either due to non-response or incomplete responses to the questionnaire. The survey was only developed in English. Potential for reporting bias	31
Rorig and de Oliveira [57]	To evaluate the implementation and operation of the pharmacovigilance programme in the pharmaceutical industry	Not reported	Brazil	Pharmaceutical companies	50 companies	Self-administered questionnaire by pharmaceutical companies' PV sector, regulatory affairs sector, or customer support service	Not reported	1—Company identification, its origin and the characterisation or absence of a PV programme; 2—Information relating to factors required for PV programme implementation; 3—Pharmacovigilance programme results, and information about notifications reception and how this was treated	Not reported	25
Shin et al. [55]	To survey the collection and management of adverse effect reports in 21 Asia–Pacific Economic Cooperation (APEC) countries, compare the PV status and systems by country, and finally, to harmonise PV regulation in the APEC region	Not reported	Asia‐Pacific Economic Cooperation (APEC) region countries	National Pharmacovigilance Centre	15 countries: Australia (AU), Brunei (BN), Chile (CL), Indonesia (ID), Malaysia (MY), Mexico (MX), Papua New Guinea (PG), Peru (PE), Philippines (PH), Singapore (SG), Taiwan (TW), Thailand (TH), Japan (JP), South Korea (SK), and the USA	Self-administered questionnaires by heads of PV teams from PV agencies	Modified WHO Pharmacovigilance Indicators	Three domains: Structure, process, and outcome of pharmacovigilance system	Not all countries in the region responded to the survey. Did not include all questions and answers from WHO's PV indicators. The tendency for arbitrary interpretation regarding questions on regular pharmacovigilance education	31
Suwankesawong et al. [53]	To explore the current landscape and identify challenges in PV activities among Association of Southeast Asian Nations (ASEAN) countries	Cross-sectional study	ASEAN countries: Brunei Darussalam, Cambodia, Indonesia, Lao People’s Democratic Republic (PDR), Malaysia, Myanmar, Philippines, Singapore, Thailand and Vietnam	National Pharmacovigilance Centre	8 countries: Cambodia (KH), Indonesia (ID), Laos (LA), Malaysia (MY), the Philippines (PH), Singapore (SG), Thailand (TH), and Vietnam (VT)	Self-administered questionnaire by ASEAN countries' PV representatives and contact persons	WHO minimum requirements for a functional national pharmacovigilance system	PV systems' function and performance were measured and compared based on: Indicators related to the average numbers of individual case safety reports (ICSR), presence of signal detection activities and subsequent action, contributions to VigiBase	Application of WHO requirements to national PV systems only, therefore findings may not be generalisable to pharmacovigilance in the entire community	31
Wilbur [50]	To inventory national pharmacovigilance programmes in place for Arabic-speaking countries in the Middle East	Not reported	Arabic-speaking Middle Eastern countries	National Pharmacovigilance Centre	11 countries: Bahrain (BH), Egypt (EG), Iraq (IQ), Jordan (JO), Kingdom of Saudi Arabia (KSA), Kuwait (KW), Oman (OM), Palestine (PA), Qatar (QA), United Arab Emirates (UAE), and Yemen (YE)	Self-administered questionnaire by the head of centres responsible for medication safety	Uppsala Monitoring Centre Assessment of Country Pharmacovigilance Situation questionnaire (February 2008)	General programme information; level of support; PV activities; suspected ADR reporting and subsequent data use; and medication safety advocacy	Certain responses may be different since the original deployment of the questionnaire. The accuracy and completeness of the information provided could be affected depending on the individual completing the questionnaire. Not all countries formally participated so regional situations are not fully described	24
Zhang et al. [56]	To assess the current status of ADR reporting and monitoring in pharmaceutical manufacturers, drugstores, and medical institutions in China	Cross-sectional study	Chinese provinces (East: Jiangsu and Guangdong; West: Shaanxi and Sichuan; and Centre: Henan and Hebei)	Pharmaceutical manufacturers', drugstores', and medical institutions' pharmacovigilance systems	589 institutions (194 pharmaceutical manufacturers, 191 drugstores, and 204 medical institutions)	Self-administered questionnaire by ADR reporters in charge of drug safety (e.g. heads of vigilance units and drug safety coordinators) at Pharmaceutical manufacturers, drugstores, and medical institutions	A questionnaire based on previous studies	1—Current status of the ADR monitoring system; 2—Basic resources for ADR reporting; 3—ADR reporting; and 4- Other PV activities	Data might not fully reflect current adverse drug reaction monitoring and reporting systems in China. It was assumed that the respondents had full access to all current, relevant information. The information supplied by respondents was not verified or validated. The study did not target all the adverse drug reaction reporting and monitoring institutions or all 34 provinces in China. Only three institution types were included, and data collection focussed on the institutional level rather than the individual level. Low response rate	32