A  Comparative Study of the Pharmacovigilance System in Nigeria and Ghana using WHO-Indicator Based Pharmacovigilance Assessment Tool. (IPAT)

A Comparative Study of the Pharmacovigilance System in Nigeria and Ghana using WHO-Indicator Based Pharmacovigilance Assessment Tool. 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(IPAT) Seun Sunday Onasanya, Peter Yamoah, Frasia Oosthuizen This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-2216812/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background: Nigeria and Ghana are both members of the World Health Organization (WHO) Program for International Drug Monitoring (PIDM) operated by the Uppsala Monitoring Centre (UMC) in Sweden. The PIDM currently includes more than 150 countries and has an increasing influence on public health decisions and the development and implementation of Pharmacovigilance (PV) systems. The requirements to join the WHO PIDM include submission of 20 reports in the internationally accepted E2B format to UMC and a formal letter from the ministry of health requesting to join the program. Even though the two countries are members of the WHO PIDM, they have different capacities. Purpose of the study: To assess and determine the functionality, scope of operation, strengths and limitations of the national pharmacovigilance systems in Nigeria and Ghana using WHO PV indicators as standard. Method: National PV documents backed by law and other statutory documents governing the PV systems of both Nigeria and Ghana were examined using the WHO indicators. Indicator–based Pharmacovigilance Assessment (IPAT) was developed by WHO to assess PV systems, PV in the two countries were compared by reviewing the government policies on PV. The staff of the pharmacovigilance unit of the National Medicines Regulatory Authorities (NMRAs) were interviewed using the WHO Pharmacovigilance Indicators tool. The responses were recorded, and the data collected were analyzed. Results: The PV systems in Nigeria and Ghana were supported by law and regulations in line with international standards. The standard operating procedures for reporting, processing, and communicating suspected adverse event reports from stakeholders of PV were in place in both countries. The Physician density per 1000 population in Nigeria and Ghana is 0.38 and 0.10 respectively. The two countries did not meet the 200 reports of suspected ADRs reported by 1 million of the population in 2020. There is no product quality report form, medication error reporting form or treatment error reporting form in either country. Nigeria and Ghana both have a designated budget for pharmacovigilance activities and an electronic ICSR reporting system. The national pharmacovigilance systems in the two countries do not have access to data on drug utilization. Conclusion: The national pharmacovigilance systems in the two countries have a policy and legal frameworks defined by law and regulation to conduct pharmacovigilance activities. However, the two national PV systems are at different levels of dimension and performance concerning conducting PV activities. Varied targeted and directed interventions are needed to strengthen the PV systems in two countries to enable evidence-based decision making for patient safety. Background Medications and Vaccines have benefits and are also considered harmful even when administered within therapeutic doses. Though preventable, these harmful effects are termed adverse drug reactions (ADRs), which are among the significant causes of death in recent times. (WHO, 2021 ). Pharmacovigilance (PV) is considered an essential instrument to reduce medicines' ADRs in public health and medical practice. (WHO, 2010 ) Despite the increase in access to medications in Nigeria and Ghana, there has not been a direct proportion of development in Pharmacovigilance (PV) practices in these two countries; this may be partly due to various challenges in ensuring the safety of medicines and the licensing of newer molecules to be added to essential drug list by the regulatory bodies. (Opadeyi et al., 2018 ). Other reasons may include inappropriate use of medication, inappropriate prescribing, overwhelmed healthcare institutions and healthcare workers, weak or fragmented drug control/legislation, unlicensed drug markets (at which harmful pharmaceuticals are often sold), inadequate record-keeping of medication exposures and outcomes, including lack of adequate recording of adverse events. The World Health Organization (WHO) Program for International Drug Monitoring (otherwise known as the WHO Pharmacovigilance Program) has as its primary goal to adopt strategic global pharmacovigilance principles which address these challenges and meet the health needs of low- and middle-income countries. Medicines, vaccines, and cosmetics have been used to diagnose, prevent, and treat diseases. (WHO. 2019). In addition to their benefits, medicinal products also elicit side effects in humans; these side effects present as unexpected and harmful. Regulatory Authorities (RAs) were bounded by national policies to safeguard the people’s health and the general welfare in their countries. The primary objective of RAs is to protect the public from unsafe medicinal products (SIAPS, 2013 , WHO 2019 ). They are also saddled with the responsibilities of preventing the irrational use of medications and reducing to the barest minimum the availability of fake, substandard, and adulterated medicinal products (Ndomondo-sigola et al., 2017). Availability of drugs for various diseases of public health interest is improving in Africa mainly due to the commitment of national governments through the National regulatory agencies, which were established to manage conditions of public health concern like human immunodeficiency virus (HIV), tuberculosis, and other tropical diseases affecting humans. (Olsson et al., 2015 ). However, the pace at which medicinal product is being made available in Africa is not on par with the ability of the RAs to ascertain the safety of medicines (Isah et al., 2012 ). There are 54 RAs in Africa, and each has a varying capacity in terms of PV activities, yet most of them are incapable of performing critical functions expected of RAs (WHO, 2018 ). There are 54 countries in Africa, and out of these, only 25 had minimal or no pharmacovigilance capacity. Only four of the 54 countries had pharmacovigilance systems with the capability to detect, evaluate, and prevent safety issues, indicating the limited abilities of these countries to monitor medicines’ safety. (David, 2015 ). It should, however, be noted that the concept of pharmacovigilance covers such areas as product quality, medication errors, and therapeutic ineffectiveness, as well as adverse drug reactions ADRs (WHO, 2018 ). These areas are essential to the drug regulatory authorities, consumers, and clinicians. Performance metrics such as IPAT are necessary to monitor and evaluate pharmacovigilance and medicine safety systems in countries (WHO, 2015 ). Efforts to assess and compare PV activities in countries promote the safety of the patients and improve efforts to strengthen PV operations in such countries. (EMA.2022). PV assessment in countries can also help to define the elements of a sustainable PV strategy and suggest areas for improvements as the basis to plan for improved public health and safety of medicines (Radecka et al., 2018 ). PV evaluation will equally help establish the current capacity for medication safety in a country and allow longitudinal measurement of progress after various intervention programs to improve PV activities in the concerned countries are implemented. (Babigumira et al., 2014 ) Nigeria and Ghana are current members of the Program for International Drug Monitoring (PIDM), an arm of WHO operated by the Uppsala Monitoring Centre (UMC) in Sweden. Members of The PIDM are currently more than 150 countries. This made PIDM to have an increasing influence on public health decisions and the development and implementation of (PV) systems. Avorn ( 2018 ) submitted that The National Regulatory Authorities (NRAs) that house the PV centers have been created in various countries and they are responsible for developing PV activities and ensuring that ADRs reporting systems work correctly either manually or via the Internet. These reports will be collated and transferred to WHO (UMC) in Sweden and stored in the VigiBase™ global database. Ghana Food Drug Authority(FDA) joined the WHO PV program as the 65th member in 2001 and as the first country in West- Africa, while Nigeria National Agency for Food Drug Administration and Control (NAFDAC) joined in 2004 (WHO, 2021 ). The conditions for joining the WHO PIDM include submitting 20 reports in the internationally accepted E2B format to UMC and a formal letter from the ministry of health requesting to join the program (WHO, 2018 ). Even though the two countries are members of the WHO PIDM, they have different PV capacities. The Internet has enabled medication regulatory bodies in various countries to connect and cooperate more effectively in reporting ADRs and accessing information. It has equally helped to make prompt decisions on the use of medicines at the national and local levels. Moreover, it also helps make information available on PV, and specific information about medicinal products is made accessible and available to professionals and members of the public through RA’s websites. Hence, ADR reporting and RA’s operations and responsibilities have become more visible. This paper aims to determine and assess how the PV system operates in Nigeria and what its areas of responsibility are, compared with Ghana, using IPAT PV indicators as standard. The study, therefore, analyses and assesses the PV systems in these two countries through their RAs: the National Agency for Food and Drugs Administration and Control (NAFDAC) in Nigeria and the Food and Drugs Agency (FDA) in Ghana, to identify gaps between the two and suggests the area of improvement. Methods This was a cross-sectional descriptive study aimed at comparing the PV systems in Nigeria and Ghana using the WHO indicators, Indicator–based Pharmacovigilance Assessment Tool (IPAT). IPAT was a tool developed by WHO to assess PV systems. PV in the two countries was compared by reviewing the government policies on PV and interviewing stakeholders in the National PV directorate/center in NAFDAC, Nigeria, and FDA, Ghana, respectively. The IPAT tool utilizes evidence-based options analysis and development of relevant and appropriate recommendations which reflects each of the two countries’ local realities, existing regulatory capacity, and priorities, identifying system gaps, and resource availability. Additionally, this indicator-based approach allows longitudinal progress measurement after the recommended interventions are implemented. IPAT is embedded with a performance system that monitors and evaluates drug safety and PV activities. IPAT functions with 43 indicators subdivided into 26 core and 17 supplementary indicators. The core and additional indicators collectively consider these Medicine safety and PV components five: (i) policy, law, and regulation; (ii) systems, structures, and stakeholder coordination; (iii) signal generation and data management; (iv) risk assessment and evaluation; and (v) risk management and communication. These WHO PV indicators are responded to using the National Policy on Pharmacovigilance and other official handbooks from national regulatory bodies available in the public domain, as well as interviews with the stakeholders of PV at the National PV center in Nigeria and Ghana. The reviewed policies included the Federal government of Nigeria, National Pharmacovigilance Policy and Implementation framework, 2011& 2012. National Drug Policy 2005, National Quality Assurance Policy for Medicine and Other Health Products 2015, National Agency for Food and Drugs Administration, and Control Act. Ghana National Drug Policy 2004. FDA, Guidelines for Qualified Person for Pharmacovigilance 2012, 2015 and PV System in Ghana, 2016. An interview with stakeholders having a sizeable responsibility and in-depth knowledge of each country's national pharmacovigilance system. In both cases, the stakeholders are the director of PV centers or their designates who have given their informed consent. They were requested to share the legal and statutory documents and other relevant information as it relates to the PV system in Ghana and Nigeria. The Pharmacist in charge of PV designated by the Director of PV and Post-Marketing Surveillance, on PV operations and activities in Nigeria and Ghana shared sensitive information about safety medication actions taken between 2016 to 2019 in both countries ,which are not readily available to the public. The core and additional indicators served as a standard on which the interviews were based. The data from the PV assessment of Ghana and Nigeria were collected and entered into a template designed for the study. This template was designed to accommodate the five pharmacovigilance sections of the WHO indicators. A comparison of the performance indicators of Ghana and Nigeria is presented using the tables below. Results Results are based on the five significant indicators from which other indicators stem. These five major indicators are highlighted below: 1 Governance, Policy, Law, and regulation 2 Systems, Structure, and Stakeholder Coordination. 3 Signal generation and Data Management 4 Risk assessment and Evaluation 5 Risk Management and communication These summarized the core indicators and complementary indicators Table 1 Summary of Pharmaceutical Market in Nigeria and Ghana. This table compares information about the scope of Pharmaceuticals in the two countries under review (Nigeria and Ghana) ,including the Gross Domestic Product (GDP) and health status indicators like the Number of Physicians and Midwives per 1000 population. Parameters Country(Nigeria) Country(Ghana) Population (July 2020 estimate) 191.000 Million 31.07 million Gross national income per capita (PPP international 2013) $ 5,360.000 $ 5,480.000 Physician density per 1000 population (2019) 0.380 0.100 Nursing & Midwifery Personnel density (Per 1000 Population) 2019 1.589 2.700 G.D.P per Capital (2019) 2,028.200 2,275.77 Market size Pharmaceuticals (USD 2019) 607.000 Million 589.000 Million Number of Medicine registered in (2019) 58,016.000 61,515,000 Total Expenditure on healthcare per capita $ (2019) 217 78 Table 2 Pharmacovigilance Governance at National Levels This table summarizes and compares the PV activities in the two countries using the IPAT indicators as the yardstick. Such areas as Policy, law, and regulations in the two countries, How PV signals are generated, managed, and transmitted, PV systems, and how risks are assessed, evaluated, organized, and communicated in the two countries are highlighted. Indicators Nigeria Ghana Regulatory Register Present Present The governance structure is mandated by regulation and in Practice. Yes Yes Sections of Law and regulations related to Safety and medicine Poison and Pharmacy Act, Cap 366 of 1960, Food and Drugs Act Cap 150 of 1990, Counterfeit and fake drugs (miscellaneous provisions) Act, Cap 73 of 1990. Pharmacists Council of Nigeria, Act 91 of 1992. The Food and Drugs Law 1992 (PNDCL 305B) and the Pharmacy Act, 1994(Act489). Traditional Medical Practice Act2000 (Act 575). National Drug Policy in August 1999. Food &Drugs Law (PNDCL 305B) 1992, as amended by the Food & Drugs ( Amendment Act) Act 523, 1996 Industry reporting of Serious Adverse drug effects (ADE, S) is mandated. (expedite reporting required) Yes Yes Reporting timeline for marketed products ( serious) 7 Calendar days 15 calendar days Reporting timeline for marketed products (nonserious) 28 Calendar days 60 calendar days Periodic safety update reports required (PSUR) Yes (Every 28 days) Yes (Every six months) Reporting timeline for Clinical trials (SUSAR) Seven days Three days Monitoring period of new medicine required. Six months Two years Table 3 Showing Government policy and regulatory framework of PV in Nigeria and Ghana Indicators Nigeria Ghana PV/Medicine Safety Policy Available Available (but not in the public domain) PV/Medicine Safety in National medicine legislation Yes Yes PV/Medicine Safety in National medicine legislation Yes Yes MAH is mandated by law to report severe adverse drug reactions to the National Regulatory Authority. (NRA) No No MAH is required to conduct post-market Surveillance per stringent regulatory authority Standards Yes Yes Legal provisions for Product quality assurance Available Available Legal provision for Promotion and advertisement. Available Available Regulatory framework Yes Limited Table 4 Showing system, structure, and Stakeholder’s Coordination of PV in Nigeria and Ghana Indicators Dedicated Budget available for PV activities or PV-Centers Nigeria Limited Ghana Available The annual budgetary allocation for PV activities or PV Centers Limited Available Funds provided by MOH or donors towards PV activities in 2018 Yes Information not available The global fund for PV Yes Yes Existence of a quality control lab/unit with a clear Mandate, structure & function Yes (PQRST) Yes (PQRST) Key Testing of Pharmaceuticals. (Non-biodegradable products) / Q - Testing of biological products such as Vaccines / R- Participation in registration activities / S- Inspection of Industry Quality Control laboratories / T- Collaboration with the Inspectorate to test Samples Table 5 Showing Risk Assessment and Evaluation (Quality Control Laboratories and PV information Centers in Nigeria and Ghana Indicators Nigeria Ghana Quality Control lab under the National Regulatory Agency functions of QC lab. Yes Yes QC lab has a documented Quality Management System Yes Yes The WHO prequalifies QC No No PV center has a clear mandate, lab structures, and function Available Available PV information center Available Available Dedicated Staff for PV Limited Available Budget for PV Non Limited National guidelines for PV Available Available SOPs for PV and Quality Control Available Available Medicine Safety advisory committee Absent Absent Quality control committee Absent Present Table 6 Showing PV Stakeholders Coordination in Nigeria and Ghana Core PV reference materials in PV centers Available Available Core PV topics present in Pre-service training Curricula No Yes Health workers trained in PV & Medicine Yes Yes PV stakeholders Coordination mechanism Available Available WHO program for international drug monitoring membership Available Available Quality Management System for PV & Quality assurance Available Available Table 7 Showing Data Management, Risk Management, and Communication Presence of a system for Coordination and collation of PV data from all Sources in the Country Available (Not functional) Yes Presence of a local database system for collating PV data from all sources Post, & Electronics/ in Person By Post, Electronics Methods by which reporting forms are typically collected and transmitted to the PV Center / Unit In Person Electronics &in-person PV data transmission complies with the E2B format Yes Yes The data method used Not specified Reporting Odd Ratio. Key BCPNN - Bayesian Confidence Propagation neural network / ROR -Reporting Odds ratio / RRR - Relative Risk ratio Table 8 Showing Risk Management and Communication in Nigeria and Ghana. Presence of a consumer reporting form Present Present Presence of suspected ADR reporting form Available Not available Product quality reporting form Not Available Not Available Medication error reporting form Not Available Not Available Treatment failure reporting form. Not Available Not Available Table 9 Medicine Safety Regulation Action taken beside ADR Reporting, Between January 2019 and September 2019. This table contains information besides ADR reporting but is not readily available to the general public on the websites. Most of the information from interviews with the PV stakeholders in the two countries is also presented here. Indicators Nigeria Ghana Product Recalls 54 36 Withdrawal of Product License Nil Nil Suspension of Marketing authorization Nil Nil MOH memo/Circular referencing Safety data. Yes Yes Medicine Safety information addressed Yes Yes Regularly published medicine safety bulletins. Yes ( NAFDAC website) Yes (Online) Unregistered products/medicine in the Pharmaceutical market less than 3% No No Medicine safety issues identified from external sources and acted on Yes Yes The time from ADR signal generation to communication to healthcare workers and the public is less than three weeks. Yes Yes Public/community education activities on PV Limited Yes Medicine safety action was taken other than ADR reporting Yes Yes Data sets were generated as shown in the result, but data sharing was not applicable. ata are available [from the authors / at URL] with the permission of [third party]. The data that support the findings of this study are available from the corresponding author, [author initials], upon reasonable request Limitations of the Study All the core and structural indicators developed by the WHO are 63 (Abiri &Johnson, 2019 ). All were not assessed in this study. Instead, PAT indicators are used. This meant that the pro data collection process is purely based on the IPAT indicator used, information available on Nigeria and Ghana RA’s websites, and response to interviews granted by the stakeholders of PV in Nigeria and Ghana. A significant limitation of the study is that inferences were made for most of the indicators relying on the information provided by the stakeholders of PV in Nigeria and Ghana. Some other inferences were made for other indicators based on the information available on the RA’s website for Nigeria and Ghana at the time of data collation and collection. Another limitation to the study is that the validity and the authenticity of the information available on the website of RAs in Nigeria and Ghana, are accurate as, at the time, inferences were made on the indicators using that information. WHO ( 1998 ) defined evaluation as the objective assessment of the relevance, adequacy, progress, efficiency, effectiveness, and impact of a course of action concerning objectives while considering the resources and facilities deployed. Hence, a PV evaluation and assessment based only on a few indicators (IPAT) is not likely to provide a complete evaluation and review of the PV systems in both countries (Nigeria and Ghana). This fact is further corroborated by CDC, (2001), who submitted that multiple indicators are needed for tracking the PV system’s implementation and effects. However, the total number of indicators necessary to perform a proper evaluation is likely to vary depending on the aim and objectives of the PV evaluation. Based on the purpose and objectives of this study, addressing the complete set of IPAT indicators that were itemized at the introduction of the article in the study is enough to provide a satisfactory PV evaluation and assessment. Discussions The essence of the study is to assess and compare the performance of national PV activities in Nigeria and Ghana. The study is directed to the National medicine regulatory agencies (NMRA) of the two countries to provide a general overview of the current status and performance of the PV systems. In Nigeria and Ghana, the NMRAs possess the policy and legal frameworks authorized by law and regulation to conduct PV activities in their respective countries. The existence of rules, laws, and regulations supporting the PV system is an indication that the countries are committed to maintaining and improving the rational use of medications and access to excellent and standard medicines made available in the pharmaceutical systems. (Barry et al. 2019). The measure of the health status as indicated by the Physician per 1000 of the population is 0.380 and 0.100, respectively, for Nigeria and Ghana. (WHO 2019 ). This figure is far below the standard as stipulated by WHO. World Bank data ( 2019 ) which is one physician per 1000 population. Countries like Cuba and Canada have 8.4 and 2.4 respectively. It is saddening to note that most physicians trained in Nigeria and Ghana migrate to the United States and the United Kingdom after graduation, these countries already had 2.8 and 5.6 Physicians per 1000 population in 2019, yet Physicians migrate to these countries for better reward packages and greener pastures.(Opadeyi et al.2018) The Nursing and Midwifery population per 1000 in 2019 is 1.589 and 2.700, respectively for Nigeria and Ghana. (World Bank data, 2019 ). The world health report (2006) concluded that at least an estimated 2.5 medical staff (nurses and midwives) per 1,000 people must be available to provide the minimum health coverage with essential primary. Ghana was able to meet this criterion with 2.7, while Nigeria fell short of the number of Nurses and Midwives per 1000. The implication is that fewer nurses are available to provide healthcare services than the number required to provide adequate healthcare delivery in Nigeria. Nigeria has a slightly higher market size in terms of Pharmaceuticals than Ghana, with an estimate of $ 607 million in 2019 as against $ 589 million in Ghana. (World Bank data, 2019 ). Still, Ghana registered 61,515 number of medicine between 2016–2019, while Nigeria registered 58,016 within the same years. Nigeria had a total healthcare expenditure per capita of $ 217, while Ghana had $ 78. (World Bank data, 2019 ). The Market Authorization Holders (MAHs) involvement in the activities of national pharmacovigilance systems in the two countries is inadequate. In Nigeria, MAHs are expected to contribute to the pharmacovigilance system to improve compliance in both countries. MAHs are expected to contribute to the pharmacovigilance system. This needs to be strengthened to the level of regulation and implementation rather than based on guidelines alone. Generally speaking, the regulatory activities for pharmacovigilance in Nigeria and Ghana is in line with current international standards, and all the regulatory pharmacovigilance centers had the systems and structures to conduct PV activities. In 2020, Ghana’s FDA, reached WHO Global Benchmark Tool (GBT) performance maturity level 3, joining the National regulatory authority of Tanzania (TMDA) and got the WHO-GBT in 2018 as the first country in Africa. This means Ghana’s FDA & TMDA are stable institutions and well-functioning, with an integrated regulatory PV system (WHO, 2020 ). Olison et al. (2010) submitted that the number of ADR reports received from Africa is not sufficient to identify significant drug-related issues. They further went on to encourage African countries to report more because the safety information sourced from the WHO global database might not always be relevant for local settings in individual countries. This is important because data from countries with similar demographics, genetic background, nutritional status and background, and co-morbidities should be in one data repository, such as the WHO VigiBase database so that analysis of the pooled data can be done to provide relevant solutions( Olison et al., 2010). The NRAs of both countries are faced with limited financial and human resources. The national PV systems in both countries have a specific budget for pharmacovigilance activities; however, even with allocated budgets for PV activities, the budgets need to be improved so that they are well-matched with the resource requirements for enforcement of the respective PV regulations and guidelines in both countries. Financing and continuous financing of PV activities is essential for maintaining PV activities in both Countries. A situation whereby the budget is not available or small as the case in the two countries will not help PV operation in the two countries. During the study period, Nigeria was in the process of implementing new regulations and guidelines concerning PV policy, the last one was reviewed and implemented in 2012. It is therefore imperative that in the new policy or guidelines, issues related to human resources and budgetary allocation for PV activities be emphasized. The national PV system in both Countries does not have comprehensive pre-service PV training, even though it is recently included in the Pharm D curriculum in the Nigerian Pharmacy program, the impact of the pre-service pharmacovigilance training is yet to be felt either in Nigeria or Ghana.. Preservice pharmacovigilance education is a sustainable and cost-effective intervention that strengthens health systems (SIAPS, 2013 ). The pre-service PV training in the two countries needs to be strengthened across different healthcare professional training programs. Trainees for pre-service pharmacovigilance training are future healthcare professionals, and it is important that they understand their role in the safety monitoring and safe use of medicines. As reported by Mirhaba et al., (2015) Lack of knowledge of the reporting processes of suspected AEs is the main cause of underreporting. Hence, Pre-service PV training across different healthcare professional programs (Pharmacy, Nursing, and Medicine) when made to include the ADR reporting process may promote reporting according to Lopez et al., (2009). This inclusion of higher learning institutions that provide training for healthcare professionals as stakeholders in the national pharmacovigilance system is crucial for the sustainability of the programs and it will enhance PV performance in both countries. WHO recommends an ADRs report of 200 per 1 million population in a particular year. Nigeria and Ghana are perpetually categorized as under-reporting in the years under review because they both generated less than 200 reports per 1 million of their population. Hence, Stakeholder coordination needs to be strengthened to increase reporting. Several ways by which ADRs reporting can increase in the two countries include direct patient reporting, effective electronic reporting systems, and mobile phone reporting applications. All these may increase the number of reports. Nigeria and Ghana do have data on drug importation with NAFDAC and Ghana FDA but none of the two PV systems had a source of data on consumption and prescription of medicines. This suggests that the national PV systems do not have information on the level of drug utilization in the two countries. Drug utilization data at the national level are very important to weigh the potential risk of drug-related harm and assess the public health impact of ADRs. The national PV systems should establish a mechanism to capture medicine utilization data which is the denominator for calculating the rate of reporting ADRs, prioritizing safety signals, and able to assess the impact of regulatory actions. Generally speaking, most of the information captured in this study was verified using sources of documentation such as legal documents, guidelines, training materials, terms of reference, and national policy papers. Conclusion It is pertinent to note that the national PV systems in Nigeria and Ghana are supported by legal instruments and guidelines. Updated regulations or guidelines aiming at complying more with international standards in PV is currently in the pipelines in Ghana and it’s on the verge of being introduced in Nigeria. Despite having legal support and pharmacovigilance systems and structures, limited stakeholder involvement and engagement in the pharmacovigilance systems manifested in very low reporting rates in both countries. In both countries, data collection, management, signal analysis, and decision-making procedures in place.. However, at the time of the assessment, the PV systems did not have the full capacity to systematically identify problems related to pharmaceutical products like Product efficacy and medication error in healthcare delivery systems. In other to have an effective PV system in both countries, there is a need to formulate and implement strategic PV interventions that will involve all relevant stakeholders, including public health programs, healthcare facilities and professionals, academic institutions, and patients, to build a standard national PV system. The PV systems and structures in Ghana and Nigeria have some similarities still, they also do have some slight differences, and therefore, targeted interventions directed at addressing the immediate needs of the individual countries should be designed. The researchers are registered pharmacists in South Africa, Ghana, and Nigeria who are also in academia. Declarations Ethical Approval and Informed Consent. The ethical approval was granted by the Biomedical Research Ethical Committee (BREC) of the University of KwaZulu-Natal on July 30 th , 2020, with protocol reference number: BREC/00001035/2020. The NAFDAC also granted approval on the 24 th of June, 2020, via reference number NAFDAC/PV/PMS/MDG/I/IX to carry out the study. Ghana FDA granted approval to conduct research on PV studies in Ghana on 11 th January 2021 via reference number FDA/HPT/SMC/SMD/VGU/21/0006. Informed consent was sought and given by the stakeholders of PV in Nigeria (NAFDAC) and Ghana (FDA) that granted the interviews. Consent for Publication All the authors, give their consent for the publication of the details within the manuscripts to be published in the BMC Health Services Research Journal. Data Availability Statement Data sets were generated as shown in the result, but data sharing was not applicable. Data are available from the authors with the permission of BREC, University of KwaZulu-Natal. The data that support the findings of this study are available from the corresponding author, (S.S.Onasanya), upon reasonable request. Competing Interest The authors declare that they have no known competing financial or personal interest that could have appeared to influence the work reported in this paper. Funding The authors received no funding for this research. Authors’ Contributions Author Role in the study Onasanya S.S Data collection and Interpretation of the results. Conduct interviews with PV stakeholders in Ghana and Nigeria. Writing of the manuscript Yamoah P. Supervises the manuscript writing Reviews the final draft of the manuscript for submission to the journal Oosthuizen F Supervises the manuscript writing Reviews the final draft of the manuscript for submission to the journal Acknowledgments : My sincere appreciation goes to the Director General of NAFDAC, The Director of PV and Post-Marketing Directorate, Dr. Fajemirokun, Pharmacist Onu, Pharmacist Seun Adesanya, NAFDAC. The Chief Executive Officer of FDA, Ghana, The Director of PV and Post-Marketing Directorate, and Head of Safety Monitoring Department. Pharm. Tolu Oliyide, my colleague, practicing in Ghana, Pharm. Eric. Of Ghana FDA and Pharm. Funke Sopeinmann, a Pharmacist with the WHO. References Abiri OT, Johnson WCN. (2019). Pharmacovigilance systems in resource-limited settings: an evaluative case study of Sierra Leone. J Pharm Policy Prac. 2019;12(1):8. Avorn J. (2018).Learning about the safety of drugs — A half-century of evolution. 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Effectiveness of Pharmacovigilance: Multifaceted educational intervention related to the knowledge, skills and attitudes of multidisciplinary hospital staff. Clinics.72.51–57. WHO. Terminology. A glossary of technical terms on the economics and finance of health services Copenhagen. World Health Organization—Regional Office for Europe; 1998. WHO. (2010). Minimum Requirements for a functional Pharmacovigilance System. World Heal. Organ, 14–15. WHO. (2015). Pharmacovigilance indicators-a practical manual for the assessment of pharmacovigilance systems. 2015. https://www.who.int/medicines/areas/quality_safe . WHO. (2018). Essential medicines and health products: improving the quality of medical products for universal access. WHO. Joining the WHO Program for International Drug Monitoring. Joining WHO Program or International Drug Monitoring; 2019. https://www.who.int/medicines/areas/qualitysafety/safetyefficacy/ . WHO. (2019).Seventh- second world health assembly: Access to medicine and vaccines. Report by the Director-General. Provisional agenda item 11.7. WHO. (2020). WHO-listed authority WLA. https://www.who.int/initiatives/who-listed-authority-reg-authorities/MLA4 . WHO. (2021). Members of the WHO Program for International Drug Monitoring. https://who-umc.org/about-the-who-programme-for-international-drug-monitoring/member-countries/ . WHO. Vaccine Safety basics. E-Learning Course: Rumors and Crises; 2021b. World Bank Data. (2019) https://data.worldbank.org/indicator/SH.MED.PHYS.ZS . Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-2216812","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":176695482,"identity":"8abba552-4e70-4751-b8d7-f00c25c3c95d","order_by":0,"name":"Seun Sunday Onasanya","email":"data:image/png;base64,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","orcid":"https://orcid.org/0000-0002-6918-7032","institution":"University of KwaZulu-Natal College of Health Sciences","correspondingAuthor":true,"submittingAuthor":false,"prefix":"","firstName":"Seun","middleName":"Sunday","lastName":"Onasanya","suffix":""},{"id":176695483,"identity":"ad0e3390-bbba-4365-be71-49c927d56624","order_by":1,"name":"Peter Yamoah","email":"","orcid":"","institution":"University of Health and Allied Sciences, Ghana","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Peter","middleName":"","lastName":"Yamoah","suffix":""},{"id":176695484,"identity":"4158d71c-a14e-4ea4-8aec-f91989f2b596","order_by":2,"name":"Frasia Oosthuizen","email":"","orcid":"","institution":"University of KwaZulu-Natal, Durban, South-Africa","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Frasia","middleName":"","lastName":"Oosthuizen","suffix":""}],"badges":[],"createdAt":"2022-10-29 16:32:01","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-2216812/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-2216812/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":36333913,"identity":"b5db1d05-7860-4a2c-8e11-bf9350b03ef0","added_by":"auto","created_at":"2023-04-26 15:23:04","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":413345,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-2216812/v1/13dabcc9-8458-40ac-bdcd-be671f765082.pdf"}],"financialInterests":"","formattedTitle":"A Comparative Study of the Pharmacovigilance System in Nigeria and Ghana using WHO-Indicator Based Pharmacovigilance Assessment Tool. (IPAT)","fulltext":[{"header":"Background","content":"\u003cp\u003eMedications and Vaccines have benefits and are also considered harmful even when administered within therapeutic doses. Though preventable, these harmful effects are termed adverse drug reactions (ADRs), which are among the significant causes of death in recent times. (WHO, \u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e2021\u003c/span\u003e). Pharmacovigilance (PV) is considered an essential instrument to reduce medicines' ADRs in public health and medical practice. (WHO, \u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e2010\u003c/span\u003e)\u003c/p\u003e \u003cp\u003eDespite the increase in access to medications in Nigeria and Ghana, there has not been a direct proportion of development in Pharmacovigilance (PV) practices in these two countries; this may be partly due to various challenges in ensuring the safety of medicines and the licensing of newer molecules to be added to essential drug list by the regulatory bodies. (Opadeyi et al., \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e2018\u003c/span\u003e). Other reasons may include inappropriate use of medication, inappropriate prescribing, overwhelmed healthcare institutions and healthcare workers, weak or fragmented drug control/legislation, unlicensed drug markets (at which harmful pharmaceuticals are often sold), inadequate record-keeping of medication exposures and outcomes, including lack of adequate recording of adverse events.\u003c/p\u003e \u003cp\u003eThe World Health Organization (WHO) Program for International Drug Monitoring (otherwise known as the WHO Pharmacovigilance Program) has as its primary goal to adopt strategic global pharmacovigilance principles which address these challenges and meet the health needs of low- and middle-income countries.\u003c/p\u003e \u003cp\u003eMedicines, vaccines, and cosmetics have been used to diagnose, prevent, and treat diseases. (WHO. 2019). In addition to their benefits, medicinal products also elicit side effects in humans; these side effects present as unexpected and harmful. Regulatory Authorities (RAs) were bounded by national policies to safeguard the people\u0026rsquo;s health and the general welfare in their countries. The primary objective of RAs is to protect the public from unsafe medicinal products (SIAPS, \u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e2013\u003c/span\u003e, WHO \u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e2019\u003c/span\u003e). They are also saddled with the responsibilities of preventing the irrational use of medications and reducing to the barest minimum the availability of fake, substandard, and adulterated medicinal products (Ndomondo-sigola et al., 2017). Availability of drugs for various diseases of public health interest is improving in Africa mainly due to the commitment of national governments through the National regulatory agencies, which were established to manage conditions of public health concern like human immunodeficiency virus (HIV), tuberculosis, and other tropical diseases affecting humans. (Olsson et al., \u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e2015\u003c/span\u003e). However, the pace at which medicinal product is being made available in Africa is not on par with the ability of the RAs to ascertain the safety of medicines (Isah et al., \u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e2012\u003c/span\u003e). There are 54 RAs in Africa, and each has a varying capacity in terms of PV activities, yet most of them are incapable of performing critical functions expected of RAs (WHO, \u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e2018\u003c/span\u003e). There are 54 countries in Africa, and out of these, only 25 had minimal or no pharmacovigilance capacity. Only four of the 54 countries had pharmacovigilance systems with the capability to detect, evaluate, and prevent safety issues, indicating the limited abilities of these countries to monitor medicines\u0026rsquo; safety. (David, \u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e2015\u003c/span\u003e). It should, however, be noted that the concept of pharmacovigilance covers such areas as product quality, medication errors, and therapeutic ineffectiveness, as well as adverse drug reactions ADRs (WHO, \u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e2018\u003c/span\u003e). These areas are essential to the drug regulatory authorities, consumers, and clinicians. Performance metrics such as IPAT are necessary to monitor and evaluate pharmacovigilance and medicine safety systems in countries (WHO, \u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e2015\u003c/span\u003e). Efforts to assess and compare PV activities in countries promote the safety of the patients and improve efforts to strengthen PV operations in such countries. (EMA.2022). PV assessment in countries can also help to define the elements of a sustainable PV strategy and suggest areas for improvements as the basis to plan for improved public health and safety of medicines (Radecka et al., \u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e2018\u003c/span\u003e). PV evaluation will equally help establish the current capacity for medication safety in a country and allow longitudinal measurement of progress after various intervention programs to improve PV activities in the concerned countries are implemented. (Babigumira et al., \u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e2014\u003c/span\u003e)\u003c/p\u003e \u003cp\u003eNigeria and Ghana are current members of the Program for International Drug Monitoring (PIDM), an arm of WHO operated by the Uppsala Monitoring Centre (UMC) in Sweden. Members of The PIDM are currently more than 150 countries. This made PIDM to have an increasing influence on public health decisions and the development and implementation of (PV) systems. Avorn (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2018\u003c/span\u003e) submitted that The National Regulatory Authorities (NRAs) that house the PV centers have been created in various countries and they are responsible for developing PV activities and ensuring that ADRs reporting systems work correctly either manually or via the Internet. These reports will be collated and transferred to WHO (UMC) in Sweden and stored in the VigiBase\u0026trade; global database.\u003c/p\u003e \u003cp\u003eGhana Food Drug Authority(FDA) joined the WHO PV program as the 65th member in 2001 and as the first country in West- Africa, while Nigeria National Agency for Food Drug Administration and Control (NAFDAC) joined in 2004 (WHO, \u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e2021\u003c/span\u003e). The conditions for joining the WHO PIDM include submitting 20 reports in the internationally accepted E2B format to UMC and a formal letter from the ministry of health requesting to join the program (WHO, \u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e2018\u003c/span\u003e). Even though the two countries are members of the WHO PIDM, they have different PV capacities.\u003c/p\u003e \u003cp\u003eThe Internet has enabled medication regulatory bodies in various countries to connect and cooperate more effectively in reporting ADRs and accessing information. It has equally helped to make prompt decisions on the use of medicines at the national and local levels. Moreover, it also helps make information available on PV, and specific information about medicinal products is made accessible and available to professionals and members of the public through RA\u0026rsquo;s websites. Hence, ADR reporting and RA\u0026rsquo;s operations and responsibilities have become more visible.\u003c/p\u003e \u003cp\u003eThis paper aims to determine and assess how the PV system operates in Nigeria and what its areas of responsibility are, compared with Ghana, using IPAT PV indicators as standard. The study, therefore, analyses and assesses the PV systems in these two countries through their RAs: the National Agency for Food and Drugs Administration and Control (NAFDAC) in Nigeria and the Food and Drugs Agency (FDA) in Ghana, to identify gaps between the two and suggests the area of improvement.\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003eThis was a cross-sectional descriptive study aimed at comparing the PV systems in Nigeria and Ghana using the WHO indicators, Indicator\u0026ndash;based Pharmacovigilance Assessment Tool (IPAT). IPAT was a tool developed by WHO to assess PV systems. PV in the two countries was compared by reviewing the government policies on PV and interviewing stakeholders in the National PV directorate/center in NAFDAC, Nigeria, and FDA, Ghana, respectively.\u003c/p\u003e \u003cp\u003eThe IPAT tool utilizes evidence-based options analysis and development of relevant and appropriate recommendations which reflects each of the two countries\u0026rsquo; local realities, existing regulatory capacity, and priorities, identifying system gaps, and resource availability. Additionally, this indicator-based approach allows longitudinal progress measurement after the recommended interventions are implemented.\u003c/p\u003e \u003cp\u003eIPAT is embedded with a performance system that monitors and evaluates drug safety and PV activities. IPAT functions with 43 indicators subdivided into 26 core and 17 supplementary indicators. The core and additional indicators collectively consider these Medicine safety and PV components five: (i) policy, law, and regulation; (ii) systems, structures, and stakeholder coordination; (iii) signal generation and data management; (iv) risk assessment and evaluation; and (v) risk management and communication. These WHO PV indicators are responded to using the National Policy on Pharmacovigilance and other official handbooks from national regulatory bodies available in the public domain, as well as interviews with the stakeholders of PV at the National PV center in Nigeria and Ghana. The reviewed policies included the Federal government of Nigeria, National Pharmacovigilance Policy and Implementation framework, 2011\u0026amp; 2012. National Drug Policy 2005, National Quality Assurance Policy for Medicine and Other Health Products 2015, National Agency for Food and Drugs Administration, and Control Act. Ghana National Drug Policy 2004. FDA, Guidelines for Qualified Person for Pharmacovigilance 2012, 2015 and PV System in Ghana, 2016.\u003c/p\u003e \u003cp\u003eAn interview with stakeholders having a sizeable responsibility and in-depth knowledge of each country's national pharmacovigilance system. In both cases, the stakeholders are the director of PV centers or their designates who have given their informed consent. They were requested to share the legal and statutory documents and other relevant information as it relates to the PV system in Ghana and Nigeria. The Pharmacist in charge of PV designated by the Director of PV and Post-Marketing Surveillance, on PV operations and activities in Nigeria and Ghana shared sensitive information about safety medication actions taken between 2016 to 2019 in both countries ,which are not readily available to the public. The core and additional indicators served as a standard on which the interviews were based. The data from the PV assessment of Ghana and Nigeria were collected and entered into a template designed for the study. This template was designed to accommodate the five pharmacovigilance sections of the WHO indicators. A comparison of the performance indicators of Ghana and Nigeria is presented using the tables below.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eResults are based on the five significant indicators from which other indicators stem. These five major indicators are highlighted below:\u003c/p\u003e \u003cp\u003e1 Governance, Policy, Law, and regulation\u003c/p\u003e \u003cp\u003e2 Systems, Structure, and Stakeholder Coordination.\u003c/p\u003e \u003cp\u003e3 Signal generation and Data Management\u003c/p\u003e \u003cp\u003e4 Risk assessment and Evaluation\u003c/p\u003e \u003cp\u003e5 Risk Management and communication\u003c/p\u003e \u003cp\u003eThese summarized the core indicators and complementary indicators\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003e\u003cb\u003eSummary of Pharmaceutical Market in Nigeria and Ghana.\u003c/b\u003e This table compares information about the scope of Pharmaceuticals in the two countries under review (Nigeria and Ghana) ,including the Gross Domestic Product (GDP) and health status indicators like the Number of Physicians and Midwives per 1000 population.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"3\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eParameters\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eCountry(Nigeria)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eCountry(Ghana)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePopulation (July 2020 estimate)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e191.000 Million\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e31.07 million\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGross national income per capita (PPP international 2013)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cspan\u003e$\u003c/span\u003e 5,360.000\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cspan\u003e$\u003c/span\u003e 5,480.000\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePhysician density per 1000 population (2019)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0.380\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.100\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNursing \u0026amp; Midwifery Personnel density (Per 1000 Population) 2019\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1.589\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2.700\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eG.D.P per Capital (2019)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2,028.200\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2,275.77\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMarket size Pharmaceuticals (USD 2019)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e607.000 Million\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003e589.000 Million\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNumber of Medicine registered in (2019)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e58,016.000\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e61,515,000\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTotal Expenditure on healthcare per capita \u003cspan\u003e$\u003c/span\u003e (2019)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e217\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e78\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003e\u003cb\u003ePharmacovigilance Governance at National Levels\u003c/b\u003e This table summarizes and compares the PV activities in the two countries using the IPAT indicators as the yardstick. Such areas as Policy, law, and regulations in the two countries, How PV signals are generated, managed, and transmitted, PV systems, and how risks are assessed, evaluated, organized, and communicated in the two countries are highlighted.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"3\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIndicators\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNigeria\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eGhana\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eRegulatory Register\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePresent\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003ePresent\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eThe governance structure is mandated by regulation and in Practice.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSections of Law and regulations related to Safety and medicine\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePoison and Pharmacy Act, Cap 366 of 1960, Food and Drugs Act Cap 150 of 1990, Counterfeit and fake drugs (miscellaneous provisions) Act, Cap 73 of 1990. Pharmacists Council of Nigeria, Act 91 of 1992.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eThe Food and Drugs Law 1992\u003c/p\u003e \u003cp\u003e(PNDCL 305B) and the\u003c/p\u003e \u003cp\u003ePharmacy Act, 1994(Act489).\u003c/p\u003e \u003cp\u003eTraditional Medical Practice Act2000\u003c/p\u003e \u003cp\u003e(Act 575). National Drug Policy in\u003c/p\u003e \u003cp\u003eAugust 1999. Food \u0026amp;Drugs Law\u003c/p\u003e \u003cp\u003e(PNDCL 305B) 1992, as amended by\u003c/p\u003e \u003cp\u003ethe Food \u0026amp; Drugs ( Amendment Act)\u003c/p\u003e \u003cp\u003eAct 523, 1996\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIndustry reporting of Serious Adverse drug effects (ADE, S) is mandated. (expedite reporting required)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eReporting timeline for marketed products ( serious)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e7 Calendar days\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e15 calendar days\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eReporting timeline for marketed products (nonserious)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e28 Calendar days\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e60 calendar days\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePeriodic safety update reports required (PSUR)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eYes (Every 28 days)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eYes (Every six months)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eReporting timeline for Clinical trials (SUSAR)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eSeven days\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eThree days\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMonitoring period of new medicine required.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eSix months\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eTwo years\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eShowing Government policy and regulatory framework of PV in Nigeria and Ghana\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"3\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIndicators\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNigeria\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eGhana\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePV/Medicine Safety Policy\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAvailable\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eAvailable (but not in the public domain)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePV/Medicine Safety in National medicine legislation\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePV/Medicine Safety in National medicine legislation\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMAH is mandated by law to report severe adverse drug reactions to the National Regulatory Authority. (NRA)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMAH is required to conduct post-market Surveillance per stringent regulatory authority Standards\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eLegal provisions for Product quality assurance\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAvailable\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eAvailable\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eLegal provision for Promotion and advertisement.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAvailable\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eAvailable\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eRegulatory framework\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eLimited\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab4\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eShowing system, structure, and Stakeholder\u0026rsquo;s Coordination of PV in Nigeria and Ghana\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"3\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIndicators\u003c/p\u003e \u003cp\u003eDedicated Budget available for PV activities or PV-Centers\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNigeria\u003c/p\u003e \u003cp\u003eLimited\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eGhana\u003c/p\u003e \u003cp\u003eAvailable\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eThe annual budgetary allocation for PV activities or PV Centers\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eLimited\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eAvailable\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFunds provided by MOH or donors towards PV activities in 2018\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eInformation not available\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eThe global fund for PV\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eExistence of a quality control lab/unit with a clear Mandate, structure \u0026amp; function\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eYes (PQRST)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eYes (PQRST)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eKey\u003c/h2\u003e \u003cp\u003eTesting of Pharmaceuticals. (Non-biodegradable products) / Q - Testing of biological products such as Vaccines / R- Participation in registration activities / S- Inspection of Industry Quality Control laboratories / T- Collaboration with the Inspectorate to test Samples\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab5\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 5\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eShowing Risk Assessment and Evaluation (Quality Control Laboratories and PV information Centers in Nigeria and Ghana\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"3\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIndicators\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNigeria\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eGhana\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eQuality Control lab under the National Regulatory Agency functions of QC lab.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eQC lab has a documented Quality Management System\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eThe WHO prequalifies QC\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePV center has a clear mandate, lab structures, and function\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAvailable\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eAvailable\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePV information center\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAvailable\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eAvailable\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDedicated Staff for PV\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eLimited\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eAvailable\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBudget for PV\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNon\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eLimited\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNational guidelines for PV\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAvailable\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eAvailable\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSOPs for PV and Quality Control\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAvailable\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eAvailable\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMedicine Safety advisory committee\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAbsent\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eAbsent\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eQuality control committee\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAbsent\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003ePresent\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab6\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 6\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eShowing PV Stakeholders Coordination in Nigeria and Ghana\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"3\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCore PV reference materials in PV centers\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAvailable\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eAvailable\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCore PV topics present in Pre-service training Curricula\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHealth workers trained in PV \u0026amp; Medicine\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePV stakeholders Coordination mechanism\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAvailable\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eAvailable\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWHO program for international drug monitoring membership\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAvailable\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eAvailable\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eQuality Management System for PV \u0026amp; Quality assurance\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAvailable\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eAvailable\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab7\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 7\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eShowing Data Management, Risk Management, and Communication\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"3\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePresence of a system for Coordination and collation of PV data from all Sources in the Country\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAvailable (Not functional)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePresence of a local database system for collating PV data from all sources\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePost, \u0026amp; Electronics/ in Person\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eBy Post, Electronics\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMethods by which reporting forms are typically collected and transmitted to the PV Center / Unit\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eIn Person\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eElectronics \u0026amp;in-person\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePV data transmission complies with the E2B format\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eThe data method used\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNot specified\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eReporting Odd Ratio.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cstrong\u003eKey\u003c/strong\u003e \u003cp\u003eBCPNN - Bayesian Confidence Propagation neural network / ROR -Reporting Odds ratio / RRR - Relative Risk ratio\u003c/p\u003e \u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab8\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 8\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eShowing Risk Management and Communication in Nigeria and Ghana.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"3\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePresence of a consumer reporting form\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePresent\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003ePresent\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePresence of suspected ADR reporting form\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAvailable\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eNot available\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eProduct quality reporting form\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNot Available\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eNot Available\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMedication error reporting form\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNot Available\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eNot Available\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTreatment failure reporting form.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNot Available\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eNot Available\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab9\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 9\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003e\u003cb\u003eMedicine Safety Regulation Action taken beside ADR Reporting, Between January 2019 and September 2019.\u003c/b\u003e This table contains information besides ADR reporting but is not readily available to the general public on the websites. Most of the information from interviews with the PV stakeholders in the two countries is also presented here.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"3\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIndicators\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNigeria\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eGhana\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eProduct Recalls\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e54\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e36\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWithdrawal of Product License\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNil\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eNil\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSuspension of Marketing authorization\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNil\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eNil\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMOH memo/Circular referencing Safety data.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMedicine Safety information addressed\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eRegularly published medicine safety bulletins.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eYes ( NAFDAC website)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eYes (Online)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eUnregistered products/medicine in the Pharmaceutical market less than 3%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMedicine safety issues identified from external sources and acted on\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eThe time from ADR signal generation to communication to healthcare workers and the public is less than three weeks.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePublic/community education activities on PV\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eLimited\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMedicine safety action was taken other than ADR reporting\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eData sets were generated as shown in the result, but data sharing was not applicable. ata are available [from the authors / at URL] with the permission of [third party]. The data that support the findings of this study are available from the corresponding author, [author initials], upon reasonable request\u003c/p\u003e "},{"header":"Limitations of the Study","content":" \u003cp\u003eAll the core and structural indicators developed by the WHO are 63 (Abiri \u0026amp;Johnson, \u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e2019\u003c/span\u003e). All were not assessed in this study. Instead, PAT indicators are used. This meant that the pro data collection process is purely based on the IPAT indicator used, information available on Nigeria and Ghana RA\u0026rsquo;s websites, and response to interviews granted by the stakeholders of PV in Nigeria and Ghana. A significant limitation of the study is that inferences were made for most of the indicators relying on the information provided by the stakeholders of PV in Nigeria and Ghana. Some other inferences were made for other indicators based on the information available on the RA\u0026rsquo;s website for Nigeria and Ghana at the time of data collation and collection. Another limitation to the study is that the validity and the authenticity of the information available on the website of RAs in Nigeria and Ghana, are accurate as, at the time, inferences were made on the indicators using that information.\u003c/p\u003e \u003cp\u003eWHO (\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e1998\u003c/span\u003e) defined evaluation as the objective assessment of the relevance, adequacy, progress, efficiency, effectiveness, and impact of a course of action concerning objectives while considering the resources and facilities deployed. Hence, a PV evaluation and assessment based only on a few indicators (IPAT) is not likely to provide a complete evaluation and review of the PV systems in both countries (Nigeria and Ghana). This fact is further corroborated by CDC, (2001), who submitted that multiple indicators are needed for tracking the PV system\u0026rsquo;s implementation and effects. However, the total number of indicators necessary to perform a proper evaluation is likely to vary depending on the aim and objectives of the PV evaluation. Based on the purpose and objectives of this study, addressing the complete set of IPAT indicators that were itemized at the introduction of the article in the study is enough to provide a satisfactory PV evaluation and assessment.\u003c/p\u003e \u003c/div\u003e"},{"header":"Discussions","content":"\u003cp\u003eThe essence of the study is to assess and compare the performance of national PV activities in Nigeria and Ghana. The study is directed to the National medicine regulatory agencies (NMRA) of the two countries to provide a general overview of the current status and performance of the PV systems. In Nigeria and Ghana, the NMRAs possess the policy and legal frameworks authorized by law and regulation to conduct PV activities in their respective countries. The existence of rules, laws, and regulations supporting the PV system is an indication that the countries are committed to maintaining and improving the rational use of medications and access to excellent and standard medicines made available in the pharmaceutical systems. (Barry et al. 2019).\u003c/p\u003e \u003cp\u003eThe measure of the health status as indicated by the Physician per 1000 of the population is 0.380 and 0.100, respectively, for Nigeria and Ghana. (WHO \u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e2019\u003c/span\u003e). This figure is far below the standard as stipulated by WHO. World Bank data (\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e2019\u003c/span\u003e) which is one physician per 1000 population. Countries like Cuba and Canada have 8.4 and 2.4 respectively. It is saddening to note that most physicians trained in Nigeria and Ghana migrate to the United States and the United Kingdom after graduation, these countries already had 2.8 and 5.6 Physicians per 1000 population in 2019, yet Physicians migrate to these countries for better reward packages and greener pastures.(Opadeyi et al.2018)\u003c/p\u003e \u003cp\u003eThe Nursing and Midwifery population per 1000 in 2019 is 1.589 and 2.700, respectively for Nigeria and Ghana. (World Bank data, \u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e2019\u003c/span\u003e). The world health report (2006) concluded that at least an estimated 2.5 medical staff (nurses and midwives) per 1,000 people must be available to provide the minimum health coverage with essential primary. Ghana was able to meet this criterion with 2.7, while Nigeria fell short of the number of Nurses and Midwives per 1000. The implication is that fewer nurses are available to provide healthcare services than the number required to provide adequate healthcare delivery in Nigeria. Nigeria has a slightly higher market size in terms of Pharmaceuticals than Ghana, with an estimate of \u003cspan\u003e$\u003c/span\u003e 607\u0026nbsp;million in 2019 as against \u003cspan\u003e$\u003c/span\u003e 589\u0026nbsp;million in Ghana. (World Bank data, \u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e2019\u003c/span\u003e). Still, Ghana registered 61,515 number of medicine between 2016\u0026ndash;2019, while Nigeria registered 58,016 within the same years. Nigeria had a total healthcare expenditure per capita of \u003cspan\u003e$\u003c/span\u003e217, while Ghana had \u003cspan\u003e$\u003c/span\u003e78. (World Bank data, \u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e2019\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThe Market Authorization Holders (MAHs) involvement in the activities of national pharmacovigilance systems in the two countries is inadequate. In Nigeria, MAHs are expected to contribute to the pharmacovigilance system to improve compliance in both countries. MAHs are expected to contribute to the pharmacovigilance system. This needs to be strengthened to the level of regulation and implementation rather than based on guidelines alone. Generally speaking, the regulatory activities for pharmacovigilance in Nigeria and Ghana is in line with current international standards, and all the regulatory pharmacovigilance centers had the systems and structures to conduct PV activities.\u003c/p\u003e \u003cp\u003eIn 2020, Ghana\u0026rsquo;s FDA, reached WHO Global Benchmark Tool (GBT) performance maturity level 3, joining the National regulatory authority of Tanzania (TMDA) and got the WHO-GBT in 2018 as the first country in Africa. This means Ghana\u0026rsquo;s FDA \u0026amp; TMDA are stable institutions and well-functioning, with an integrated regulatory PV system (WHO, \u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e2020\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eOlison et al. (2010) submitted that the number of ADR reports received from Africa is not sufficient to identify significant drug-related issues. They further went on to encourage African countries to report more because the safety information sourced from the WHO global database might not always be relevant for local settings in individual countries. This is important because data from countries with similar demographics, genetic background, nutritional status and background, and co-morbidities should be in one data repository, such as the WHO VigiBase database so that analysis of the pooled data can be done to provide relevant solutions( Olison et al., 2010).\u003c/p\u003e \u003cp\u003eThe NRAs of both countries are faced with limited financial and human resources. The national PV systems in both countries have a specific budget for pharmacovigilance activities; however, even with allocated budgets for PV activities, the budgets need to be improved so that they are well-matched with the resource requirements for enforcement of the respective PV regulations and guidelines in both countries. Financing and continuous financing of PV activities is essential for maintaining PV activities in both Countries. A situation whereby the budget is not available or small as the case in the two countries will not help PV operation in the two countries. During the study period, Nigeria was in the process of implementing new regulations and guidelines concerning PV policy, the last one was reviewed and implemented in 2012. It is therefore imperative that in the new policy or guidelines, issues related to human resources and budgetary allocation for PV activities be emphasized.\u003c/p\u003e \u003cp\u003eThe national PV system in both Countries does not have comprehensive pre-service PV training, even though it is recently included in the Pharm D curriculum in the Nigerian Pharmacy program, the impact of the pre-service pharmacovigilance training is yet to be felt either in Nigeria or Ghana.. Preservice pharmacovigilance education is a sustainable and cost-effective intervention that strengthens health systems (SIAPS, \u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e2013\u003c/span\u003e). The pre-service PV training in the two countries needs to be strengthened across different healthcare professional training programs. Trainees for pre-service pharmacovigilance training are future healthcare professionals, and it is important that they understand their role in the safety monitoring and safe use of medicines. As reported by Mirhaba et al., (2015) Lack of knowledge of the reporting processes of suspected AEs is the main cause of underreporting. Hence, Pre-service PV training across different healthcare professional programs (Pharmacy, Nursing, and Medicine) when made to include the ADR reporting process may promote reporting according to Lopez et al., (2009). This inclusion of higher learning institutions that provide training for healthcare professionals as stakeholders in the national pharmacovigilance system is crucial for the sustainability of the programs and it will enhance PV performance in both countries.\u003c/p\u003e \u003cp\u003eWHO recommends an ADRs report of 200 per 1\u0026nbsp;million population in a particular year. Nigeria and Ghana are perpetually categorized as under-reporting in the years under review because they both generated less than 200 reports per 1\u0026nbsp;million of their population. Hence, Stakeholder coordination needs to be strengthened to increase reporting. Several ways by which ADRs reporting can increase in the two countries include direct patient reporting, effective electronic reporting systems, and mobile phone reporting applications. All these may increase the number of reports.\u003c/p\u003e \u003cp\u003eNigeria and Ghana do have data on drug importation with NAFDAC and Ghana FDA but none of the two PV systems had a source of data on consumption and prescription of medicines. This suggests that the national PV systems do not have information on the level of drug utilization in the two countries. Drug utilization data at the national level are very important to weigh the potential risk of drug-related harm and assess the public health impact of ADRs. The national PV systems should establish a mechanism to capture medicine utilization data which is the denominator for calculating the rate of reporting ADRs, prioritizing safety signals, and able to assess the impact of regulatory actions.\u003c/p\u003e \u003cp\u003eGenerally speaking, most of the information captured in this study was verified using sources of documentation such as legal documents, guidelines, training materials, terms of reference, and national policy papers.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eIt is pertinent to note that the national PV systems in Nigeria and Ghana are supported by legal instruments and guidelines. Updated regulations or guidelines aiming at complying more with international standards in PV is currently in the pipelines in Ghana and it\u0026rsquo;s on the verge of being introduced in Nigeria. Despite having legal support and pharmacovigilance systems and structures, limited stakeholder involvement and engagement in the pharmacovigilance systems manifested in very low reporting rates in both countries. In both countries, data collection, management, signal analysis, and decision-making procedures in place.. However, at the time of the assessment, the PV systems did not have the full capacity to systematically identify problems related to pharmaceutical products like Product efficacy and medication error in healthcare delivery systems.\u003c/p\u003e \u003cp\u003eIn other to have an effective PV system in both countries, there is a need to formulate and implement strategic PV interventions that will involve all relevant stakeholders, including public health programs, healthcare facilities and professionals, academic institutions, and patients, to build a standard national PV system. The PV systems and structures in Ghana and Nigeria have some similarities still, they also do have some slight differences, and therefore, targeted interventions directed at addressing the immediate needs of the individual countries should be designed.\u003c/p\u003e \u003cp\u003eThe researchers are registered pharmacists in South Africa, Ghana, and Nigeria who are also in academia.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthical Approval and Informed Consent.\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp;The ethical approval was granted by the Biomedical Research Ethical Committee (BREC) of the University of KwaZulu-Natal on July 30\u003csup\u003eth\u003c/sup\u003e, 2020, with protocol reference number: BREC/00001035/2020. The NAFDAC also granted approval on the 24\u003csup\u003eth\u003c/sup\u003e of June, 2020, via reference number NAFDAC/PV/PMS/MDG/I/IX to carry out the study. Ghana FDA granted approval to conduct research on PV studies in Ghana on 11\u003csup\u003eth\u003c/sup\u003e January 2021 via reference number FDA/HPT/SMC/SMD/VGU/21/0006. Informed consent was sought and given by the stakeholders of PV in Nigeria (NAFDAC) and Ghana (FDA) that granted the interviews.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for Publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll the authors, give their consent for the publication of the details within the manuscripts to be published in the BMC Health Services Research Journal.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData Availability Statement \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp;Data sets were generated as shown in the result, but data sharing was not applicable. Data are available from the authors with the permission of BREC, University of KwaZulu-Natal. The data that support the findings of this study are available from the corresponding author, (S.S.Onasanya), upon reasonable request.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting Interest\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no known competing financial or personal interest that could have appeared to influence the work reported in this paper.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors received no funding for this research.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026rsquo; Contributions\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"1\" cellpadding=\"0\" cellspacing=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eAuthor\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eRole in the study\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eOnasanya S.S\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eData collection and Interpretation of the results. Conduct interviews with PV stakeholders in Ghana and Nigeria.\u003c/p\u003e\n \u003cp\u003eWriting of the manuscript\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eYamoah P.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eSupervises the manuscript writing\u003c/p\u003e\n \u003cp\u003eReviews the final draft of the manuscript for submission to the journal\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eOosthuizen F\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eSupervises the manuscript writing\u003c/p\u003e\n \u003cp\u003eReviews the final draft of the manuscript for submission to the journal\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgments\u003c/strong\u003e:\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; My sincere appreciation goes to the Director General of NAFDAC, The Director of PV and Post-Marketing Directorate, Dr. Fajemirokun, Pharmacist Onu, Pharmacist Seun Adesanya, NAFDAC. The Chief Executive Officer of FDA, Ghana, The Director of PV and Post-Marketing Directorate, and Head of Safety Monitoring Department. \u0026nbsp;Pharm. Tolu Oliyide, my colleague, practicing in Ghana, Pharm. Eric. Of Ghana FDA and Pharm. Funke Sopeinmann, a Pharmacist with the WHO.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eAbiri OT, Johnson WCN. (2019). Pharmacovigilance systems in resource-limited settings: an evaluative case study of Sierra Leone. J Pharm Policy Prac. 2019;12(1):8.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAvorn J. (2018).Learning about the safety of drugs \u0026mdash; A half-century of evolution. \u003cem\u003eNew Engl J Med. 2018;365(23):2151\u0026ndash;2153. doi: 10.1056/NEJMp1110327\u003c/em\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBabigumira JB, Stergachis A, Choi HL, Dodoo A, Nwokike J, Garrison LP. (2014). A framework for assessing the economic value of pharmacovigilance in low- and middle-income countries. \u003cem\u003eDrug Safety\u003c/em\u003e. 2014;37:127\u0026ndash;34.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBarry A, Olsson S, Minzi O, Bienvenu E, Makonnen E, Kamuhabwa A.(2020). Comparative assessment of the national pharmacovigilance systems in East Africa: Ethiopia, Kenya, Rwanda and Tanzania. Drug Saf. 2020;43(4):339\u0026ndash;50.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDavid L. Strengthening pharmacovigilance system. Special issues in pharmacovigilance in emerging countries. 30. 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Perceived barriers to reporting adverse drug events in hospitals: a qualitative study using theoretical domains framework approach. \u003cem\u003eImplement Sci. 2015;10(1):1\u0026ndash;10\u003c/em\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eNdomondo-Sigonda M, Miot, JNaidoo, S, Dodoo A, Kaale E. Medicines regulation in Africa: current state and opportunities. Pharm Med. 2017;31(6):383.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eOlsson S, Pal SN, Stergachis A, Couper M. (2010). Pharmacovigilance activities in 55 low- and middle-income countries a questionnaire based analysis. \u003cem\u003eDrug Saf. 2010;33(8):689\u0026ndash;703.\u003c/em\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eOlsson S, Pal SN, Dodoo A. Pharmacovigilance in resource-limited countries. 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E-Learning Course: Rumors and Crises; 2021b.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWorld Bank Data. (2019)\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://data.worldbank.org/indicator/SH.MED.PHYS.ZS\u003c/span\u003e\u003cspan address=\"https://data.worldbank.org/indicator/SH.MED.PHYS.ZS\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"","lastPublishedDoi":"10.21203/rs.3.rs-2216812/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-2216812/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground:\u003c/strong\u003e Nigeria and Ghana are both members of the World Health Organization (WHO) Program for International Drug Monitoring (PIDM) operated by the Uppsala Monitoring Centre (UMC) in Sweden. The PIDM currently includes more than 150 countries and has an increasing influence on public health decisions and the development and implementation of Pharmacovigilance (PV) systems. The requirements to join the WHO PIDM include submission of 20 reports in the internationally accepted E2B format to UMC and a formal letter from the ministry of health requesting to join the program. Even though the two countries are members of the WHO PIDM, they have different capacities.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePurpose of the study: \u003c/strong\u003eTo assess and determine the functionality, scope of operation, strengths and limitations of the national pharmacovigilance systems in Nigeria and Ghana using WHO PV indicators as standard.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethod: \u003c/strong\u003eNational PV documents backed by law and other statutory documents governing the PV systems of both Nigeria and Ghana were examined using the WHO indicators. Indicator–based Pharmacovigilance Assessment (IPAT) was developed by WHO to assess PV systems, PV in the two countries were compared by reviewing the government policies on PV. The staff of the pharmacovigilance unit of the National Medicines Regulatory Authorities (NMRAs) were interviewed using the WHO Pharmacovigilance Indicators tool. The responses were recorded, and the data collected were analyzed.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults: \u003c/strong\u003eThe PV systems in Nigeria and Ghana were supported by law and regulations in line with international standards. The standard operating procedures for reporting, processing, and communicating suspected adverse event reports from stakeholders of PV were in place in both countries. The Physician density per 1000 population in Nigeria and Ghana is 0.38 and 0.10 respectively. The two countries did not meet the 200 reports of suspected ADRs reported by 1 million of the population in 2020. There is no product quality report form, medication error reporting form or treatment error reporting form in either country. Nigeria and Ghana both have a designated budget for pharmacovigilance activities and an electronic ICSR reporting system. The national pharmacovigilance systems in the two countries do not have access to data on drug utilization.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusion:\u003c/strong\u003e The national pharmacovigilance systems in the two countries have a policy and legal frameworks defined by law and regulation to conduct pharmacovigilance activities. However, the two national PV systems are at different levels of dimension and performance concerning conducting PV activities. Varied targeted and directed interventions are needed to strengthen the PV systems in two countries to enable evidence-based decision making for patient safety.\u003c/p\u003e","manuscriptTitle":"A Comparative Study of the Pharmacovigilance System in Nigeria and Ghana using WHO-Indicator Based Pharmacovigilance Assessment Tool. 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