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ORIGINAL ARTICLE
Year : 2020  |  Volume : 23  |  Issue : 4  |  Page : 226-235

Evaluation of pharmacovigilance activities in the national HIV/AIDS, malaria, and tuberculosis control programs using the World Health Organization pharmacovigilance indicators


1 Department of Community Health, Lagos University Teaching Hospital, Idi-Araba, Lagos, Nigeria
2 University of Bordeaux, Inserm, Bordeaux Population Health Research Center, Team Pharmacoepidemiology, UMR 1219; CHU Bordeaux, Service de Pharmacologie Médicale; CIC Bordeaux CIC1401, F-33000 Bordeaux, France
3 Department of Clinical Pharmacology and Therapeutics, University of Benin; Department of Medicine, University of Benin Teaching Hospital, Benin-City, Edo State, Nigeria

Date of Submission14-Sep-2019
Date of Decision27-Nov-2019
Date of Acceptance11-Mar-2020
Date of Web Publication23-Feb-2021

Correspondence Address:
Dr. Chioma Stella Ejekam
Department of Community Health, Lagos University Teaching Hospital, Idi-Araba, Lagos
Nigeria
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DOI: 10.4103/smj.smj_46_19

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  Abstract 


Introduction: Public health programs (PHPs) provide unique opportunities for addressing health issues in resource-limited settings. A major challenge to the implementation of existing PHPs in Nigeria is the absence of effective monitoring of the safety of medicines and vaccines. The introduction of the World Health Organization (WHO) pharmacovigilance (PV) indicators provides a useful tool to address this challenge. Objective: The objective is to assess the structures, processes, and outcomes of PV activities in three selected PHPs (the National Malaria, tuberculosis [TB], and HIV/AIDS) in Nigeria using the WHO PV indicators and identify possible challenges to achieving the outcomes. Materials and Methods: A cross-sectional mixed method study of the PV system in selected PHPs. Data sources were from the Federal Ministry of Health, the National PV Center (NPC), the National Malaria/TB, and HIV/AIDS Control Programs and official documents were reviewed. Data were collected quantitatively using the WHO PV and PHP indicator questionnaires and qualitatively using key informant interviews. Results: The basic structures and tools for carrying out PV activities in the PHPs were in existence but optimal implementation was lacking. Of the 790 adverse drug reaction (ADR) reports from the PHPs to the NPC ADR database, 77% were from the HIV/AIDS Control Programs, 14% from the malaria control program, and 9% from TB program. The interview with representatives of the different programs revealed a consensus of opinion around lack of adequate human resource for PV, poor funding, poor stakeholders' coordination to improve PV reporting across all three programs as well as in the NPC. Conclusion: This study highlighted the magnitude of suboptimal implementation of PV activities evident by the number of reports as against the expected.

Keywords: Adverse drug reaction reporting, evaluation, Nigeria, pharmacovigilance, pharmacovigilance indicators, public health programs


How to cite this article:
Ejekam CS, Fourrier-Réglat A, Isah AO. Evaluation of pharmacovigilance activities in the national HIV/AIDS, malaria, and tuberculosis control programs using the World Health Organization pharmacovigilance indicators. Sahel Med J 2020;23:226-35

How to cite this URL:
Ejekam CS, Fourrier-Réglat A, Isah AO. Evaluation of pharmacovigilance activities in the national HIV/AIDS, malaria, and tuberculosis control programs using the World Health Organization pharmacovigilance indicators. Sahel Med J [serial online] 2020 [cited 2021 Mar 4];23:226-35. Available from: https://www.smjonline.org/text.asp?2020/23/4/226/310024




  Introduction Top


The morbidity and mortality from communicable diseases notably, malaria, tuberculosis (TB), HIV/AIDS, helminthiasis, etc., pose a significant burden in resource limited settings.[1],[2],[3],[4] The deployment of medicines/vaccines to these settings is supported by a global effort to eradicate or significantly reduce the harm caused by these diseases.[2],[3]

In order to ensure the safe deployment and effective use of medicines in public health programs (PHPs),[4],[5],[6],[7] the World Health Organization (WHO) in collaboration with the Global Fund emphasized the need for PV as a requirement in proposal submissions for grant applications from countries.[4],[5],[6],[7],[8],[9],[10],[11]

Nigeria is the most populous country in the African continent with a population of over 190 million people.[12] The total number of drug manufacturing units in Nigeria as at December 31, 2015, according to the Pharmaceutical Council of Nigeria, was 172 with number of pharmaceutical establishments at 4702. A total of 332 medicines are listed on the Essential Medicines List in Nigeria and of these, 15% are to be sold in the informal sector.[13] A national survey in 2012 put substandard and falsified medical products at 6.4% in Nigeria.[14],[15] Pharmacovigilance (PV) activities in Nigeria are coordinated by the National PV Centre (NPC) which also serves as the repository for reported adverse drug reactions (ADR) nationwide. It is situated in the National Agency for Food and Drug Administration and Control (NAFDAC - the drug regulatory agency in Nigeria).[16] The objective of PV is to detect, understand, and prevent ADRs and other drug-related problems, through collection, collation and analyzing reports of suspected ADRs to enable signal detection, their communication, and risk management.[17] The National PV System in Nigeria is based on spontaneous reporting of adverse reactions to medicines and other medicine-related problems; further supported by other active reporting methods.[10],[18],[19],[20],[21],[22] All health-care providers including community health workers, patent medicine dealers, and traditional medicine practitioners are required to report suspected ADRs to medicines, vaccines, cosmetics, medical devices, traditional and herbal remedies. The patients, consumers and the general public are expected to report ADRs as well.[21] The scope of PV also include reporting of medication errors, substandard and counterfeit medicines, lack of effectiveness.[18] ADRs are reported using the ADR form also called the “Yellow form” and the completed form is known as Individual Case Safety Report (ICSR). ICSR is fundamental to effective implementation of spontaneous reporting in PV and safeguarding the public health.[21] Health facilities, PHPs, or organizations where PV activities take place often have a focal or responsible person for PV who collates submitted reports. ICSRs from pockets of PV activities can be sent straight to the NPC either electronically or through the NAFDAC offices in each of the 36 States of Nigeria. It can also be sent to the NPC through the zonal PV center in each of the six geopolitical zones.[21] In handling submitted ICSRs, acknowledgments of reports are sent from the NPC to the reporters, the ICSRs are validated based on certain criteria, primary reporters are contacted and followed up in case of missing information on ICSRs. Validated reports are stored in the local database before submission to the WHO drug monitoring database.[21] Nigeria became the 74th member of the WHO Programme on International Drug Monitoring and commits reports to Uppsala Monitoring Centre, Sweden.[18],[19],[20],[21] According to the NPC, the database had about 16,855 ICSRs as at September 2016.[21]

The regulatory framework for PV system in Nigeria include: Act Cap N1 laws of the Federal Republic of Nigeria 2004; National Medicines Policy 2005; Good PV Practice Regulation; Nigerian National PV Policy 2013.[19],[20] The National PV policy document was publicly launched on the February 7, 2013 and the policy serves as a tool for providing an enabling environment for effective planning, implementation, monitoring, and evaluation of PV activities by all stakeholders inclusive of PHPs.[19],[20]

A number of PHPs exist in Nigeria but the PHPs in focus for this study are the Malaria, HIV/AIDS and TB programs.

The HIV/AIDS Control Program and response in Nigeria is run by the National AIDS/STI Control Program (NASCP) under the Department of Public Health, Federal Ministry of Health Nigeria (FMoH) and National Agency for the Control of AIDS (NACA), an agency under the Presidency. NASCP has the responsibility of providing technical support and policy formulation and direction in control of HIV/AIDS in Nigeria. NASCP works in collaboration with NACA which coordinates multi-sectorial response and facilitates the mobilization of resources for an effective and sustainable response to HIV/AIDS/STIs in Nigeria.

The National Malaria Elimination Program (NMEP) coordinates malaria control activities in Nigeria. The National TB/Leprosy Control program in Nigeria (NTBLCP) is saddled with the mandate of controlling TB, Leprosy and Buruli ulcer in Nigeria.

PV activities have been purportedly introduced to monitor the safety of medicines used in these programs. Despite their operations over time, the depth of integration of PV into these PHPs and its operation has not been evaluated except some aspects of the TB program.[23]

The recent introduction of the WHO PV indicators with provision for assessing PHPs provides objective measures to monitor and evaluate the effectiveness of the PHPs in an articulate and systematic manner.[17],[24] The WHO PV indicators are a set of tools with 63 indicators in total, categorized into Core (27) and Complementary (36) with additional nine (9) indicators for PHPs.[17],[24] Each of these categories have their own structural, process and outcome indicators.[17] The Core indicators are those considered to be highly relevant and useful in characterizing PV. The structural indicators assess the existing key PV structure and systems.[17] The process indicators assess the extent of the PV activities such as the collection through reporting of ADRs while the outcome indicators measure the results that occur as a result of the realization of the goals of PV.[17]

The objective of this study therefore is to assess the structures, processes, and outcomes of PV activities in three selected PHPs (National Malaria, TB, HIV/AIDS) in Nigeria using the WHO PV Indicators and also to identify possible challenges to achieving the outcomes.


  Materials and Methods Top


Study area

The study was carried out in the Federal Ministry of Health, Nigeria with focus on its National Control Programs for Malaria, TB, and HIV/AIDS and the NPC between March 2016 and June 2016.

Study design

It was a cross-sectional mixed method study. Data were collected both quantitatively using WHO PV indicator tool and qualitatively with key informant interview (KII). The quantitative component answered the first objective (the PV structures, processes, and outcomes of each of the PHPs) while the qualitative component answered the second objective, probing further the efforts and challenges toward achieving the desired PV outcomes from the individual perspectives of the key informants.

Study population

The national coordinators of the PHPs, PV focal persons of the selected PHPs and PHP desk officers within the NPC, members of the National Drug Safety Advisory Committee, and the Directors of NPC and NACA.

Data sources

The sources of data included the NPC with its PV database; the FMOH, the desk officers of each PHP in the NPC and the PV desk officers for the various programs: NMEP, NTBLCP, and NASCP including NACA. Others included the operational documents for each of the institutions above (Policy documents; Treatment guidelines; Training manuals; Newsletters and Communication tools, etc.) Documents used in the HIV control programs were GHAIN PV for antiretroviral (ARV) drugs. Training for health-care professionals 2009,[5] National AIDS/STIs Control Program Integrated National Guidelines for HIV Prevention, Treatment and Care 2014,[9] the FMOH ARV Therapy: Prevention and management of adverse effects and Drug interactions. 2013,[25] National Guidelines for HIV/AIDS Treatment and care in Adolescents and adults 2010,[26] and Nigerian National HIV/AIDS Policy 2009.[27] The documents used for the NMEP were National Guidelines for Diagnosis and Treatment of Malaria, 3rd Edition 2015 (Draft copy),[10] National Guidelines and Strategies for Malaria prevention and Control during pregnancy, 2nd Edition May 2014,[28] National Malaria Strategic Plan 2014–2020.[29] The documents reviewed for the NTBLCP were the National Strategic plan for TB control 2015–2020,[8] The NTBLCP Guidelines for programmatic and Clinical management of Drug-Resistant TB in Nigeria 2015,[30] The National TB, Leprosy, Buruli Ulcer management and control Guidelines. 6th Edition, 2014,[31] The National Strategic Plan for TB and Leprosy Control Programme (2010–2015),[32] NTBLCP workers' manual-Revised 5th Edition. 2010,[33] and The NTBLCP Annual Report 2014.[34]

Data collection

The WHO PV Indicator tool consisted of Section A to C. Section A obtained the background information describing the country profile and the milieu within which PV activities took place; the demographics and pharmaceutical scenario; section B obtained information on Core Structural indicators (CST1–10) used to assess the NPC; and section C were the indicators for PH 1–9 used to assess each of the selected PHPs. KII was used to obtain key informants' opinions around the available resources and capacity for PV in PHPs, gaps, and challenges faced in improving ADR reporting and linking PHP to PV activities, interventions to improve ADR reporting in PHPs.

The researcher alone administered the data collection tools both the quantitative and qualitative. Respondents for the quantitative study were the desk officers for PV in each of the PHPs including the desk officers within the NPC responsible for each PHP. The key informants who were staff of the various institutions and programs participated in the interview voluntarily. The data sources for the structural indicators were provided by the staff of the PV and postmarketing surveillance (PV/PMS) directorate of the NPC.

Data analysis

The quantitative data were summarized using proportions while the qualitative data were manually analyzed with a thematic synthesis of the responses from the key informants presented in a tabular form. The description of Nigeria's PV scenario and capacity in the NPC and each of the PHPs was documented. The variables regarding the existence, structure of PV activities in the three-selected PHP were duly outlined. A description of the structure and outcome of the PV activities based on the WHO PV indicators were analyzed.

Ethical considerations

Ethical approval for this study was obtained from the Ethics and Research Committee of the University of Benin Teaching Hospital, Benin City Nigeria (assigned no. ADM/E22/A/VOL. VII/1316 and approved March 21, 2016). Furthermore, permission was granted by the Federal Minister of Health to conduct this study. Every contact person read and signed the Informed consent form, participation was completely voluntary and anonymity was maintained with confidential data handling. The study was mainly observational with low potential to cause harm.


  Results Top


Status of pharmacovigilance in Nigeria as assessed with the core structural indicators

The responses to the assessment questions for the Core Indicator variables are shown in [Table 1].
Table 1: The assessment of core-structural indicators for the national pharmacovigilance system in Nigeria

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The NPC has the following tools for dissemination of information to the public: a website-nafdac.gov.ng; a Quarterly newsletter called PV-PMS News, PV/Food Drug Information Center quarterly Newsletter; Public Alert Notice (print media and Electronic media); Agency sponsored T. V program (feedback on quality and safety issues); Dear Healthcare Provider letter.

Status of the public health program as assessed with the World Health Organization pharmacovigilance indicators

The HIV/AIDS Control Programs: The National AIDS/STI Control Program and National Agency for the Control of AIDS

The findings showed that PV activities are in place within the National HIV/AIDS Control Programs. There is no desk officer in charge of PV at the NASCP office but NACA has a PV officer who liaises with the HIV/AIDS program desk officer at the NPC to document reports of ADRs from ARV drugs. The program reports suspected ADRs to the PV center using the Yellow form recommended nationally. Most of the treatment guidelines and protocols used within this program systematically considered PV and its reporting within their operations and also have attached a sample of the ADR form. According to NACA, an estimated 832,073 people were exposed to ARV in 2015. This includes those previously on ARV, newly initiated, post exposure prophylaxis, and prevention of maternal-to-child transmission. A total of 604 ADR reports were collected for the year 2015 for this PHP. There were no reports on therapeutic ineffectiveness. Accordingly, it was estimated that 1.01 ADRs was reported per 1000 individuals exposed to medicines in the PHP in 2015. There were two reported cases of death following ADR to use of ARV submitted to the NPC in 2015. The estimated number of medicine-related deaths per 1000 individuals was 0.003. The summary of the indicator values for this PHP is shown in [Table 2].
Table 2: The public health program indicator values for the three programs

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The National Malaria Elimination Program

The findings showed that PV activities take place within the NMEP. There is a PV focal person at the NMEP office but the NMEP Office does not get reports of ADRs directly as all reports of suspected ADRs due to antimalarial medications are forwarded directly to the NPC hence the NMEP PV officer liaises with the NPC Malaria Control Program desk officer to get the records for the program documentation. In cases where the NMEP generates reports themselves especially from their peripheral program officers, the program reports suspected ADRs to the PV Center using the national recommended ADR form. Of all the documents reviewed, it was only the National Guidelines for Diagnosis and Treatment of Malaria, 3rd Edition 2015 (draft) that systematically considered PV; the yearly annual reports do not mention PV. A total of 112 ADR reports were collected at the end of 2015 for this PHP. There is no available information on the number of medicine-related hospital admissions and medicine-related deaths per 1000 individuals exposed to medicines in the PHP in 2015, as the number of individuals exposed to medicines in this PHP is not known. However, there is only 1 reported suspected death due to ADR following the use of antimalarials in 2015. The summary of the indicator values for this PHP is shown in [Table 2].

The National Tuberculosis/Leprosy Control Program

The findings showed that PV activities are in place within the National TB Control Program [Table 2]. There is a PV focal person at the NTBLCP office responsible for the records of ADR due to anti-TB drugs collated within the PHP but the office does not get ICSR of ADRs as all suspected ADRs due to anti-TB medications are forwarded directly to the NPC center. The NTBLCP PV officer liaises with the officer at the NPC in charge of TB program to reconcile records for the program documentation. Currently, PV activities in the TB control program are majorly focused on multidrug-resistant TB (MDR-TB). PV data are systematically collected at all the MDR-TB treatment centers in Nigeria, though, with reporting disparity among centers. The NTBLCP reports suspected ADRs to the PV center using the nationally recommended ADR form. The completed forms are often sent to both the NTBLCP and NPC; however, most of the reports from this NTBLCP are from the MDR-TB treatment. The treatment guidelines and protocols in use within this program barely considered PV in their operations. The guidelines for programmatic and clinical management of Drug Resistant TB in Nigeria 2015 mentioned PV and the importance of reporting without including a sample of ADR form in the Annex. The National TB, Leprosy, and Buruli ulcer Management and control Guidelines 6th Edition 2014 also mentioned PV and process of report submission. The workers manual made no mention of PV and ADR reports are not included in the annual reports from this program. A total of 74 ADR reports were collected at the end of 2015 for this PHP while 3 were reports of suspected deaths due to ADR following the use of anti-TB medications. The summary of the indicator values for this PHP is shown in [Table 2].

The synthesis of the KIIs is reflected in the six themes, as shown in [Table 3].
Table 3: Syntheses of responses from the key informants interviewed

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  Discussion Top


This study evaluated the PV operations of PHPs in Nigeria using the WHO PV indicators, augmented with key informants interviews. This tool has been postulated to be better suited for countries in their periodic self-evaluation of the PV systems as the relevant indicators were identified by the national centers during its development.[17],[24]

There seems to be a low level of PV activities at the three different control programs. This is evident in the main operational guidelines/protocols used by the PHPs. Most of their treatment guidelines barely defined PV, without underscoring strategies unique to the PHP or emphasis on PV to make workers see the ethical obligation in being responsible for drugs given to each patient. The HIV/AIDS program seems to be most committed to PV activities and this was supported by its greatest contribution to ADR reports to the country's database, however, none of the PHP programs had ADR reports documented in their annual reports. It is obvious, that the PHPs do not have at the minimum, a documentation of the ADRs following the drugs rolled out under their different programs as they regard this responsibility as that of NPC. There is a PV desk officer in each PHP, but it was observed that the absence of this individual at any time within each program makes it almost impossible to get any information on PV. There are human resources that carry out PV functions but the trained staff capacity is inadequate with few experts in PV. This may be an obvious consequence of inadequate funding. Poor funding for PV and inadequate budget line in the PHPs for PV was a recurring issue noted in this study. This is further supported by the findings. The standard ADR reporting form “Yellow form” in use has the minimum requirements for a valid report; identifiable patient, event, suspect drug, and reporter, however, it does not have relevant fields to report suspected medication errors; therapeutic ineffectiveness and suspected misuse and abuse even when these items are included in the Strategic thrust of the national PV system in Nigeria.[18] Hence, there is need to update the current ADR form to include at least therapeutic ineffectiveness and medication error. This has become absolutely necessary as the quality of medicines particularly in public health is receiving global attention especially in Africa and Asia.[35],[36],[37]

A study in a tertiary hospital in Southwestern Nigeria found a total prescribing error rate of 40.9% being clinically serious and lends support for the inclusion of a medication error field in the current ADR reporting form to aid completeness of data.[38],[39] There are standard operating procedures for PV activities in Nigeria with clear reporting lines from collection to analysis of reports. However, there is still a huge gap in data management and available logistics is very weak.[40]

The NPC has significant challenges in entering the submitted reports into the international database. This is due to the poor access to the internet at the center and again inadequate human resources for PV, hence the backlog of data entry and the delay in updating the database. There is need to provide adequate budgetary allocation and ensure release to stakeholders for PV activities.

The HIV program has consistently contributed about 75% of ADR reports in the Nigerian database over the years.[19],[21],[41] The total number of ADR reports from the PHPs for the year 2015 was 790 out of 1375 total reports in the database at the end of the year 2015. This means the PHPs contributed about 57% of the total reports in the database for the year 2015. The HIV program contributed 77% of the reports (i.e., 604) within the PHP; malaria control program 14% (112) and the TB control program 9% (74). It appears donor requirements may have influenced this pattern and reporting rates. However, stricter regulation should improve reporting to augment donor requirements. The NTBLCP in view of the Directly Observed Therapy Short Course strategy which creates an avenue for more frequent patient contact with the health system should be generating more ADR reports than they are presently doing. Hopefully, the number of reports generated from the NTBLCP will be further enhanced by the “active TB Drug Safety Monitoring and management (aDSM)” concept. The “aDSM” is a TB program component introduced to detect, manage and report suspected or confirmed drug toxicities. It provides for the active, systematic clinical and laboratory assessment of patients on treatment for XDR-TR or with new TB drugs or novel MDR-TB regimens. A study reviewed adverse events following second line anti-TB drug in the MDR-TB centers in Nigeria, the findings revealed that 44% (203) of 460 patients on MDR-TB drugs experienced adverse events and (7%) 14 of them died of second-line drug adverse events.[40] This has raised the essence of observing, documenting and reporting ADRs. The program officers also reported that the health workers in the TB control program find documenting/reporting ADR cumbersome and do not see the need to document drug reactions from most of the first-line anti-TBs as they perceive them as expected side effects. The NPC has mandated that every reaction including supposed “side effects” should be reported. The NTBLCP now uses the “e-TB manager,” a web or desktop-based tool that integrates data across all aspects of TB control, including information on suspected cases, patients, medicines, laboratory testing, diagnosis, treatment, and outcome. It manages all the information needed by national TB control programs. The e-TB manager should assist ADR documentation at the TB Control program to make data easily available to be included in their annual reports. It is currently linked to the MDR-TB program and will gradually be used by every TB center.

With a total number of 1375 ADR reports documented in the national database for 2015 in a country with population of over 180 million people, Nigeria, is definitely lagging behind the WHO recommended 200 reports/million inhabitants/year for adequate reporting.[42]

There are no local medicine safety indicators for routine reporting by the PHPs, hence health workers are not compelled to observe, document, and send in monthly reports. There is need for inclusion of ADR indicator in all PHPs for monitoring and evaluation and subsequent documentation in the National Health Management Information System.

The technology and skills required in the present day PV are grossly deficient in the NPC. The deficient skill has been blamed in part due to high turnover of staff at the NPC, as the highly trained staff either gets posted elsewhere or they leave. Building capacities to improve PV experts through quality training and continuous training of health-care providers on PV becomes imperative. Each PHP should have a unit for PV other than a person dedicated for PV; however, everybody in the program should have an initial training on PV.

PV is not yet incorporated into the national academic curriculum for the different cadres of healthcare providers. It is only available during in-service training and capacity building. Incorporating PV into the academic curriculum is one of the objectives of the PV Policy. Implementing this, will positively influence knowledge, attitude and practice of PV, improve drug safety monitoring and ensure patient safety. The NPC has improved tremendously over the years in their communication strategies on PV to the public and different stakeholders. The National Drug Safety Advisory Committee (NDSAC) is an expert committee set up to provide advice on medicine safety and they are made up of seven members. They are scheduled to meet quarterly.

There were no records of exposed individuals to medicines used in the Malarial Control Programs, largely because the bulk of the medicines used for malaria prophylaxis and treatment could be accessed over the counter and in the informal sector. The use and safety monitoring of these malarial medicines are often not documentable. This constraint with unavailability of data was seen also in TB control program; however, 90,584 persons were documented as notified cases of TB in 2015 (Data source from personal interview with desk officer of the TB control program, March 8, 2016; unreferenced). This figure does not actually capture everyone on anti- TB drugs in the year 2015 as notification is done quarterly, summed up and reported yearly and also, patients who were on anti-TB for the year ending 2014 who spilled over to 2015 would not be captured (Data source from personal interview with desk officer of the TB Control program, March 8, 2016; unreferenced),

The estimated number of individuals exposed to ARV drugs was obtained for the HIV/AIDS program as access to ARV drugs in Nigeria is largely controlled. However, it was noted that a number of private hospitals and individuals procure these drugs privately and it is often not documented.[43]

The strength of this study lies in the fact that it is the first publication using a veritable tool – the WHO PV Indicator to assess PV in PHPs in Nigeria. Furthermore, the deficiencies were highlighted and overtime the trend will be documented. The main limitation is the observation of poor recording keeping which posed a challenge undermining comprehensive documentation.


  Conclusion Top


The study highlighted the existence of basic structure for improving PV; however, there are deficiencies in the process and outcome. There were also inadequate PV experts/trained staff including passive performance of health-care providers in reporting ADR-related problems. The study unveiled the high magnitude of under reporting and poor record keeping as observed in the PV subsystem which may be consequences of poor funding.

Leveraging on resources through effective collaboration with relevant stakeholders/partners and not seeing PV as a sole responsibility of the NPC might enhance medicines' safety monitoring in the country and ultimately quality of care and patient safety.

Acknowledgments

Dr. Anyaike-NASCP and Dr. Joseph Kuye of NTBLCP FMOH and other staff of the Public Health Programs in FMoH, the Minister of Health, DG NAFDAC, Directors and Staff of NPC and respondents who provided technical support and participated in the study.

Financial support and sponsorship

Self-funded.

Conflicts of interest

There are no conflicts of interest.



 
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