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Background WHO pharmacovigilance indicators have been recommended as a useful tool towards improving pharmacovigilance activities. Nigeria with a myriad of medicines related issues is encouraging the growth of pharmacovigilance at peripheral centres. This study evaluated the status of pharmacovigilance in tertiary hospitals in the South-South zone of Nigeria with a view towards improving the pharmacovigilance system in the zone. Methods A cross-sectional descriptive survey was conducted in six randomly selected tertiary hospitals in the South-South zone of the country. The data was collected using the WHO core pharmacovigilance indicators. The language of assessment was phrased and adapted in this study for use in a tertiary hospital setting. Data is presented quantitatively and qualitatively. Results A total of six hospitals were visited and all institutions had a pharmacovigilance centre, only three could however be described as functional or partially functional. Only one centre had a financial provision for pharmacovigilance activities. Of note was the absence of the national adverse drug reaction reporting form in one of the hospitals. The number of adverse drug reaction reports found in the databases of the centres ranged from none to 26 for the previous year and only one centre had fully committed their reports to the National Pharmacovigilance Centre. There were few documented medicines related admissions ranging from 0.0985/1000 to 1.67/1000 and poor documentation of pharmacovigilance activities characterised all centres. Conclusion This study has shown an urgent need to strengthen the pharmacovigilance systems in the South-South zone of Nigeria. Improvement in medical record documentation as well as increased institutionalization of pharmacovigilance may be the first steps to improve pharmacovigilance activities in the tertiary hospitals.

Background/Introduction: The establishment of the WHO Program of International Drug Monitoring commenced with countries in Europe and America in 1968 and it was after 30 years that the first African countries were admitted. The less developed countries, Africa constituting a substantial number, with their minimal resources have in the last two to three decades established Pharmacovigilance (PV) systems many of which remain weak and contending with many challenges. Reporting rates of Individual Case Safety Reports (ICSRs) remain low and the trajectory unimpressive. Where policies exist, there are usually terse statements embedded in other pharmaceutical documents. In order to further strengthen PV in these settings, there is need to develop a policy document to serve as a non-intimidating engaging tool for obtaining commitment from stakeholders and serving as a guide to action in the PV scenario. Objective/Aim: To discuss the development of a Standalone PV policy document not limited to Ministries of Health (MOHs), National Medicines Regulatory Authorities (NMRAs), Market Authorization Holders (MAHs) and even Health Care Professionals (HCPs) as a tool for advocacy to address the overlooked engagement and collaboration of multiple stakeholders. Methods: A clear understanding of the PV system, structure and processes is an essential initial step. This is followed by identification and invitation of stakeholders required for the engagement exercise. The process of development requires the involvement of government and other major operators in the health and pharmaceutical systems (MOH, NMRA, MAHs) as well as the public-consumer. The Policy Framework and Provisions should be duly addressed taking into consideration the various elements ensuring good PV practices and a consensus reached. The zero draftis developed by a core team and is subjected to multiple reviews amongst stakeholders. Following clarifications and inputs from policy organs of government the necessary endorsements, approval is obtained from the executive arm of government. Results: The application of the above in Nigeria and Eswatini has resulted in the development of National PV Policy documents. The implementation framework accompanying the documents and a recently developed guidance document is facilitating implementation. Conclusion: The Standalone PV Policy when properly developed following intense stakeholder engagement and applied is likely to serve as a tool for advocacy, increased awareness and strengthening of PV in resource-limited settings without undermining other statutory laws and regulations.

Introduction: The growth of pharmacovigilance (PV) in resource limited settings (RLS) in Africa has been slow. It is yet to achieve the maturity required to ensure safety of medicines deployed in the setting. One of the key factors highlighted as hindering this growth is the inadequacy of funding [1,2]. Objective: This paper presents the result of a survey assessing the prevailing pharmacovigilance funding landscape in African countries, including factors hindering and measures likely to improve sustainable funding. Methods: A standardized questionnaire was developed in English with French and Portuguese translations and effectively distributed to 35 African countries during the period July 2020 to October 2021. The information sought related to features and operation of the PV system, sources of and factors impacting on PV funding. Suggestions were solicited in free text format on hindrances and measures to improve sustainable PV financing. The information was requested from the Head of the National Pharmacovigilance Centres (NPC). The data collected were handled qualitatively, analysed and presented descriptively. Values were expressed as range and median. A thematic synthesis was carried out to aggregate the free text responses. Results: The questionnaire was completed by NPCs in 24 African countries (response rate of 68.6%); with National Medicines Regulatory Agency (NMRA) and NPC in 22/24 (91.7%) and 20/24 (83.3%) countries respectively. Again, 20/24 (83.3%) countries are in the WHO Programme for International Monitoring (PIDM). Number of staff/NPC was 5 with staff ratio NPC:NMRA of 1:11. PV activities were funded mainly by Governments and donor agencies. The mode of support was by cash grants, technical and other logistics channeled mainly through the NMRA and Public Health Programmes (PHP). Few countries 9/23 (39.1%) had a clear budget line within government budgets and 85.7% had their funding linked to the NMRA. Factors identified as hindering PV funding included-lack of awareness of the importance of PV and poor prioritisation in the national scheme, unfavourable legal environment, non-generation of revenue, poor budgetary allocation, diversion of funds etc. Measures suggested to improve PV financing include adequate prioritisation and political goodwill, improved legal environment with increased annual budgetary allocation, revenue generating activities etc. Conclusion: In all, funding of pharmacovigilance in Africa is inadequate, seemingly arbitrary. lacking legislative provisions and tied to the NMRA with significant donor funding channelled through the NMRA and PHP. There is need for PV financing to be backed by statute which will ensure sustainable funding and implementation of measures likely to improve funding

Background/Introduction: The increasing awareness of the importance of medicines safety amongst the population on the African continent necessitated the development of a national policy on pharmacovigilance (PV) that ensures multistakeholder participation of various actors concerned with the use of medicines. Moreover, a consensual document taking into cognisance stakeholders inclusive of the conventional Ministry of Health (MOH), National Medicines Regulatory Authority (NMRA) and Market Authorization Holders (MAH) as well as patients/consumers is likely to embrace issues of medicine safety in-depth without undermining other extant statutory laws and regulations. Such a document is likely to strengthen PV with increased reporting of adverse drug reactions which has been low due to several prevailing factors in resource limited settings. The use of a Standalone PV document will obviate the present situation where PV policies are embedded as terse statements in other health and pharmaceutical policy documents. Objective/Aim: To present a practical outline for use in the development of a PV Policy document. Methods: The initial step was an advocacy engagement at government levels on the need for a policy document as a tool to further strengthen PV. The arrow head was the National Drug Safety Advisory Committee (Nigeria) and the PV Unit (Eswatini). Following approval, the responsible organs of Government on Policy development as well as the MOH and the NMRAs carried out further preparatory work. Multisectoral stakeholders were then identified and invited for a number of intense discussions on various aspects of the PV system. A framework was developed so as to capture the processes and note the provisions for the various elements of the Policy. A zero draft was developed by a core team and further circulated for notification, clarifications, inputs etc. from stakeholders and a general call for comments. Subsequent drafts had the input of other organs in the system to avoid conflicts with extant laws and regulations. Following a final stakeholder engagement, the draft was forwarded to the requisite organs and the MOH for endorsement and thereafter approval was granted by the Executive/Management Results: The process was used in the development of PV policy documents for Nigeria [2, 3] and Eswatini [4] in 2010 and 2020, respectively. Conclusion: The consensual development of the policy documents with intense multisectoral stakeholder engagement provides a tool likely to enhance the enabling environment and ensure collaboration of health and non health functionaries in PV activities without undermining statutory laws and regulations.

Background/Introduction: The implementation of the active drug safety monitoring and management scheme (aDSM) instituted by the World Health Organization (WHO) [1-3] has witnessed different levels of progress in different countries world-wide [4]. Broad based collaboration among stakeholders is critical for the success of the scheme. The primary stakeholders in Nigeria are the national drug regulatory body, NAFDAC (National Agency for Food and Drug Administration and Control) and the NTBLCP (National Tuberculosis and Leprosy Control Program). The PAVIA project (funded by EDCTP) strengthened collaboration between these stakeholders in Nigeria [5], which has a yearly estimate of 21,000 incidence of multidrug/rifampicin-resistant tuberculosis [6]. Objective/Aim: To ascertain the implementation of the aDSM scheme in an era of enhanced support from external collaborators, such as the PAVIA project by describing: (a) the total number of adverse drug reactions (ADRs) reported (b) proportions of ADRs associated with the new antituberculosis and repurposed drugs (c) characteristics of the ADRs and (d) the collaboration among the primary stakeholders. Methods: Individual case safety reports (ICSR) submitted to the NAFDAC database by the NTLCP from 2017 to 2021 were extracted and analyzed. The new antituberculosis drugs requiring aDSM were bedaquiline and delamanid, combined with the repurposed drugs (capreomycin, clofazimine, cycloserine, ethambutol, kanamycin, levofloxacin, linezolid, moxifloxacin, and pyrazinamide). The ADRs submitted to the NAFDAC database by the NTBLCP and the characteristics of the ADRs were the basis for assessing the collaboration. Summary statistics was applied for the analysis. Results: The NTBLCP submitted a total of 284 reports to the NAFDAC database: 251/284 (88%) were from the repurposed drugs and 33/284 (12%) from bedaquiline [29/33 (88%)] and delamanid [4/ 33 (12%)]. ADRs were most frequently reported for men [285/499 (57%)] and the age range, 18-44 years [353/510 (69.2%)]. Vomiting, hypokalemia, and arthralgia [69 (13.2%) vs 55 (10.5%) vs 47 (9.1%)] had the highest reporting frequency and gastrointestinal, ear and labyrinth and nervous system disorders were the frequently reported system organs affected by the ADRs [108 (20.6%) vs 102 (19.5%) vs 93 (17.7%)]. Prolonged hospitalization (18/3.4%) was the frequently reported indicator for classifying ADRs as serious. Overall, there were 10 (1.9%) fatalities. Conclusion: The submission of ADRs reports to NAFDAC by the NTBLCP, evidenced by the reported ADRs and their characteristics suggests collaboration by our definition. Nigeria tends to be progressing implementing the aDSM scheme.

Adverse events following immunization (AEFIs), especially if serious, may impact vaccine recipients' quality of life and financial well-being and fuel vaccine hesitancy. Nigeria rolled out COVID-19 vaccination in 2021 with little known about the impact of AEFIs on an individual's quality of life. No study in Africa has explored the health and financial impact of AEFIs. We explored patient-reported outcomes (PROs) of adverse events after COVID-19 vaccination and documented the lived experiences of those with serious AEFIs to understand the effect on their health, financial well-being, and attitude to future vaccinations. We conducted a convergent mixed-methods study using the RAND 36-item health survey and in-depth interviews to collect PROs on vaccine recipients in Nigeria. Eight health scale scores and two summary composite scores were used to measure the health-related quality of life outcomes from the survey and inductive analysis was used to identify themes from the interview scripts. The results of both studies were integrated in a joint display to highlight areas of concordance. In total, 785 survey responses were analyzed (53% females, 68% aged 18–30 years). Responders reporting an AEFI were 58%, of whom 62% received the first dose only. Younger age and first vaccine dose (p < .001 respectively) were associated with experiencing an AEFI. Not reporting an AEFI was associated with better quality of life, measured as higher scores on all eight SF-36 Health scales and the physical and mental component summary scores. All six interviewees with serious AEFIs experienced physical, mental, and financial distress. Some expressed a strong negative attitude toward future COVID-19 vaccinations but not toward vaccines for routine immunization. AEFIs negatively impact the health and financial well-being of affected individuals and their attitude to future vaccinations, especially if serious. Understanding the impact of AEFIs on people is important and should inform future policies and interventions. The results of our study can inform policy and planning for future mass vaccination campaigns in LMICs. •Adverse events negatively affected vaccine recipients' health related quality of life.•Serious AEFIs impact recipients' health and financial well-being.•Individual experiences with the system established to support those with AEFI varied.•Outcomes that are important to individuals should inform policy planning and implementation.

Drug–drug interactions are preventable causes of adverse events. Different factors have been recognized as important predictors of drug–drug interactions but few studies have addressed these predictors in patients admitted into medical wards of a tertiary hospital in Nigeria hence this study. This was a retrospective study conducted using case records of patients admitted into the medical wards between January 1 and December 31, 2020. Patients were selected using a systematic random sampling method. Socio‐demographic details including age, gender, number of comorbidities, and number of medications prescribed and diagnosis were collected on days 1, 3, and at discharge. Potential drug–drug interactions were checked using Lexi‐interact® software. Analysis was set at p < 0.05. A total of 430 case records were included in this study based on the inclusion criteria. Lexi‐interact recorded a prevalence of (217) 50.5% on day 1, (146) 34.0% on day 3, and (290) 67.4% at discharge. A significant association (p < 0.05) was found between the potential drug–drug interactions (DDI) and an increased number of medicines prescribed on all the days of admission. Also, patients without certain infectious or parasitic diseases have reduced odds of developing DDI. There is a need for continuous monitoring of medications from admission to discharge especially in the elderly, those on multiple medications, certain infectious or parasitic diseases, and comorbidities as these impact on DDIs.

Background The exposure of health care professionals (HCP) to patients with coronavirus disease-2019 (COVID-19) in the course of performing their professional duties may expose them to contracting the virus. This may likely increase their tendency to self-medicate for prevention or treatment of perceived infection. Aim This study determined the prevalence of COVID-19 related self-medication and its determinants among HCPs in three tertiary hospitals in Southern Nigeria. Method This was a cross-sectional study that enrolled 669 adult HCPs from three tertiary hospitals in three Southern Nigerian States using a non-probability convenience sampling method. A structured self-administered questionnaire was used for data collection. Data entry and analysis were done using IBM SPSS version 22. Results The mean age of the respondents was 35.6 ± 8.7 years. Two hundred and forty-three respondents (36.3%) reported having practiced COVID-19 related self-medication. The commonly used medications were ivermectin, azithromycin, vitamin C, chloroquine and zinc. Factors associated with self-medication were older age (p =  < 0.0001), being pharmacist (p = 0.03), higher income (p =  < 0.0001), previous COVID-19 testing (p < 0.001). Predictors of self medication were > 44 years (Adjusted Odd Ratio[AOR]:2.77,95% Confidence Interval [CI]: 1.62–4.75, p =  < 0.0001), previous COVID-19 testing (AOR = 2.68, 95% CI: 1.82–3.94, p =  < 0.0001). Conclusion About one-third of HCPs practiced COVID-19 related self-medication. HCPs that are often assumed to be health literate may not necessarily practice safe health behavior. Regular health education of the HCPs on implications of self-medications is highly recommended. There should also be formulation and effective implementation of policies that regulate purchase of medications.

Background: An important factor hindering the growth of pharmacovigilance (PV) in resource-limited settings is the lack of adequate funds to establish a functional National Pharmacovigilance System. Consequently, the crucial function of monitoring and ensuring the availability of safe medicines in these settings cannot be guaranteed considering the peculiarities of diseases and medicines used. Objectives: The objective of this paper is to provide an overview as to the availability of potential sources of funds, which could be explored to ensure Medicine Safety and to proffer a potential framework likely to ensure sustainable funding of PV in Africa. Methods/processes: The process of developing this framework entailed a review of PV financing in some developed economies, a landscape study of funding of PV in some African countries, an in-depth understanding of the PV system and the organisational structure and nexus between the regulatory agencies and National Pharmacovigilance Centre. Critical points for consideration included the sources of funds, revenue pool, the disbursement of funds, budgeting and expenditure profile and the legal framework. Consultative meetings, webinars and interviews with experts were carried out. Results: The findings showed that most of the PV systems were mainly integrated into the regulatory agencies regarding operational and fiscal governance with few facilities being independent of the regulatory agencies. The main source of funding was from the government with significant donor funding which is ad hoc and non-sustainable. Several potential sources were identified but yet to be exploited. There were no legal provisions for PV financing. A framework likely to ensure sustainable PV financing is suggested to capture all available sources of funding, mine the potential sources providing a sizeable pool of revenue to address its activities and enabling legal framework which will engender autonomy. Furthermore, it will address the nexus between the regulatory agencies and the PV outfits, thus enabling appropriate share of resources and blockage of diversions. Conclusion: In all, addressing the various elements identified in this study and providing the legal provisions which guarantees some degree of autonomy will provide a sustainable mechanism for PV funding in the resource-limited setting of Africa. Plain language summary Funding models for pharmacovigilance in resource-limited African countries An important factor hindering the growth of pharmacovigilance (PV) in resource-limited settings following their entry into the WHO Programme of International Drug Monitoring is the lack of adequate funds to establish a functional National Pharmacovigilance System. This article provides an overview of various potential sources of funds in these settings and how they can be harnessed to fund PV. We undertook a review of PV financing in developed settings and carried out a landscape study of funding of PV in some African countries, as well as having an in-depth understanding of the PV system and the organisational structure. The nexus between the regulatory agencies and National Pharmacovigilance Centre was noted. We took into account the sources of funds, revenue pool, the disbursement of funds, budgeting and expenditure profile and the legal framework for the different African countries. We also identified the prevalent and potential sources of funds for PV. Consultative meetings, webinars and interviews with experts in PV were carried out as well. We discovered that most of the PV facilities were mainly integrated into the regulatory agencies regarding operational and fiscal governance with few facilities being independent of the regulatory agencies. The main source of funding was from the government with significant donor funding which is ad hoc and non-sustainable. Several potential sources were identified but yet to be exploited. There were no legal provisions for PV financing. We have now proposed funding models that may lead to increased revenue for PV in these countries as well as suggesting that a legal framework be provided to guarantee sustainability and address the nexus between the regulatory agencies and the PV outfits to ensure an appropriate share of resources and blocking diversions.

Zinc phosphodiesterase (ZiPD) participates in the maturation of tRNA precursors. The roles of metal ions in promoting phosphoryl transfer reaction on zinc phosphodiesterase (ZiPD) activity have not been fully characterized. Therefore, this study investigated the effects of some metal ions on phosphodiesterase activity of ZiPD as well as the binding site and binding affinity of the metal ions. ZiPD activity was measured by monitoring the rate of hydrolysis of bis-para-nitrophenyl phosphate (bis-pNPP) in the presence of some selected divalent metal ions (Mn , Co , Mg and Zn ). The results obtained revealed that Mn at 1 mM activated ZiPD activity by 4-fold with binding affinity score of 1.795. Co at 0.5 mM activated ZiPD activity by 2-fold with binding affinity score of 1.773. Mg at 0.5 mM enhanced the binding affinity of ZiPD for bis-pNPP but did not increase the turnover rate of ZiPD. Zn at 1.5 mM activated ZiPD activity by 2-fold via increased affinity of ZiPD for bis-pNPP. In conclusion, the findings from this study showed that Mn and Zn are the most effective stimulatory ions of ZiPD for bis-pNPP while Zn exerted the highest binding affinity of ZiPD for bis-pNPP.