Safety of mRNA COVID-19 vaccines among persons 15- years and above in Ghana: A cohort event monitoring study.

Introduction: The development of COVID-19 vaccines during the pandemic occurred with an unprecedented speed, requiring extraordinary post-approval safety monitoring to facilitate ongoing evaluation of their benefit-risk profile. In Ghana, the Food and Drugs Authority granted emergency use authorization to six of these vaccines including the two mRNA COVID-19 vaccines, namely, Pfizer-BioNTech and Moderna COVID-19 vaccines. The objective of the study was to estimate the incidence of adverse events following immunization (AEFIs) and adverse events of special interest (AESIs) in persons vaccinated with mRNA COVID-19 vaccines, and to identify factors associated with the development of AEFIs.

Achieving patient engagement in pharmacovigilance: from high-income countries to lower and -middle-income countries with focus on Africa.

Introduction: Patient engagement in pharmacovigilance (PEP) has been shown to improve information on adverse drug reactions (ADRs), which may not be found in reports from healthcare professionals. This review shows that there is paucity of information on PEP in lower-middle-income countries (LMICs), particularly Africa. It provides insights into PEP in high-income countries (HICs) compared with Africa to help identify the disparities and system challenges in Africa.

Adverse events following COVID-19 vaccination: A comprehensive analysis of spontaneous reporting data in Ghana.

Vaccines are important public health tools and formed part of the fight against the COVID-19 pandemic. Five COVID-19 vaccines were given Emergency Use Authorization in Ghana and deployed during the pandemic. Early phase trials of the vaccines were mostly not conducted in Africans.

Medication errors by caregivers in the homes of children discharged from a pediatric department in Ghana.

Background: Medication errors (MEs) by caregivers at home are a cause of morbidity and mortality, shortly after discharge from the hospital.

Objectives: The objective of this study was to determine the rate and types of MEs at the homes of children discharged from a hospital in Ghana and to explore the factors associated with these errors.

Design: This was a cross-sectional study of infants and children discharged from the hospital to review medication administration practices.

Expanding regulatory science: Regulatory complementarity and reliance.

Drug regulatory institutions, infrastructures, and systems are becoming increasingly interconnected across national boundaries and increasingly global in outlook. This process is reflected in the broadening and deepening application of the principles and practice of Regulatory Reliance, and parallel initiatives to strengthen the capacities of regulatory institutions in low- and middle-income countries (LMICs). Although these developments are important and constructive, they have tended to be framed in terms of the transfer of systems, knowledge, and skills from relatively "mature" regulatory agencies in high-income countries (HICs) to less-well-resourced regulatory agencies in LMICs.

First results from the lessons learnt from the deployment of the Med Safety App for reporting adverse drug reactions in Ghana.

Background: The use of mobile phone technology for reporting adverse drug reactions (ADRs) in pharmacovigilance is relatively new.The objective of the study was to explore challenges and facilitators for the use of the Med Safety App for reporting ADRs in Ghana. A comparative evaluation of ADR reports received through the app and the standard paper-based form was also conducted.

Under-reporting of adverse drug reactions: Surveillance system evaluation in Ho Municipality of the Volta Region, Ghana.

Background: Adverse Drug Reactions (ADRs) can occur with all medicines even after successful extensive clinical trials. ADRs result in more than 10% of hospital admissions worldwide. In Ghana, there has been an increase of 13 to 126 ADR reports per million population from 2012 to 2018.

Strengthening Blood Regulatory Systems to Tackle Africa's Unmet Needs for Blood and Blood Products.

Background: Assuring the quality and safety of blood and blood components is an essential element of health care in all countries and requires government commitment and legal frameworks. Ineffective regulation of blood and blood components has far-reaching consequences that are not limited to the affected countries but also have extensive global implications.

Summary: In this review, we summarize the work of the project BloodTrain funded by the German Ministry of Health within the framework of the Global Health Protection Programme to strengthen regulatory structures in Africa that are imperative to guarantee the improved availability, safety, and quality of blood and blood products.

Evaluation of pharmacovigilance systems for reporting medication errors in Africa and the role of patients using a mixed-methods approach.

Background: Reviewing the epidemiological profile of medication errors (MEs) reported by African countries and the systems put in place to report such errors is crucial because reporting plays an important role in improving patient safety. The objectives of this study were to characterize the profile of spontaneously reported MEs submitted by African countries to VigiBase; the World Health Organization (WHO) global database of individual case safety reports, describe systems in place for reporting these errors, and explore the challenges and facilitators for spontaneous reporting and understand the potential role of patients.

Methods: In the present study, we used, a mixed-methods sequential explanatory design involving a quantitative review of ME reports over a 21-year period (1997-2018) and qualitative interviews with employees from African countries that are members of the WHO Program for International Drug Monitoring (WHO PIDM).

Evaluation of the adverse events following immunization surveillance system, Ghana, 2019.

Background: With over 80% of children worldwide vaccinated, concerns about vaccine safety continues to be a public health issue. Ghana's Adverse Events Following Immunization surveillance started in 1978 with the objective to promptly detect and manage AEFI cases either real or perceived. Periodic evaluation of the surveillance system is critical for optimal performance; hence we evaluated the system to assess its attributes, usefulness and system's performance in meeting its objectives.

Preliminary findings from stimulated spontaneous reporting of adverse drug reactions during COVID-19 pandemic: an experience from Ghana.

Background: The novel coronavirus disease 2019 (COVID-19) is an ongoing pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). There is limited information on the safety of drugs used for the treatment of COVID-19.

Objective: Objective of this study is to describe the pattern of stimulated spontaneous adverse drug reaction (ADR) reports received from healthcare professionals for SARS-CoV-2 positive patients in Ghana and lessons learnt particularly for low- and middle-income countries.

Barriers to healthcare workers reporting adverse events following immunization in four regions of Ghana.

Despite didactic training on adverse events following immunization (AEFI) in Ghana, the reporting ratio of AEFI was 1.56 per 100,000 surviving infants in 2015, below the minimum reporting ratio of 10. We aimed to estimate the proportion of health care workers (HCWs) reporting AEFI and to identify barriers to reporting.

Factors that influence the intention to use mobile phone caller tunes for patient reporting of adverse drug reactions: a qualitative study.

Background: Patient reporting of adverse drug reactions (ADRs) is low in low- and middle-income countries, in part because of poor awareness to report. With the increase in mobile subscription, mobile phones can be used as a platform to disseminate information on ADRs. The aim of this study was to qualitatively assess the potential of using mobile phone caller tunes (the message or sound the caller hears before the receiver answers the call) to encourage patient reporting of ADRs.

Patient preferences and expectation for feedback on adverse drug reaction reports submitted in Ghana.

Background: Personalized feedback received for spontaneous adverse drug reaction (ADR) reports serves as motivation for future reporting and the effectiveness of the feedback is dependent on the medium used in delivering the information.

Objective: Explore expectation for feedback from patients on ADR reports submitted to the National Pharmacovigilance Centre (NPvC) in Ghana and the preferred medium for receiving the feedback information.

Methods: Cross-sectional study using structured questionnaire administered through face-to-face interview from August to September 2016 to patients selected by convenience sampling.

Reporting of adverse events following immunizations in Ghana - Using disproportionality analysis reporting ratios.

Background: Timely reporting of safety information post vaccination is pivotal for the success of any vaccination program. Reports of adverse events following immunization (AEFI) of 6 different vaccinations from Ghana were analysed for signals.

Methods: De-identified data from active surveillance for AEFIs after 2009 AH1N1 influenza, yellow fever, meningitis, measles-rubella, pneumococcal-rotavirus and human papilloma virus vaccinations were used.

Patients' Perspectives on Adverse Drug Reaction Reporting in a Developing Country: A Case Study from Ghana.

Introduction: Recent efforts to introduce direct patient reporting into pharmacovigilance systems have proved that patient reports contribute significantly to medicine safety, but there is a paucity of information relating to patients' perspectives regarding adverse drug reaction reporting in developing countries.

Objective: The objective of this study was to explore patients' knowledge, attitudes, behaviours and opinions on spontaneous adverse drug reaction reporting in Ghana.

Methods: A cross-sectional study using questionnaires administered through face-to-face interviews was carried out from 25 August, 2016 to 20 September, 2016 with 442 patients aged 18 years and above selected by convenience sampling from two community pharmacies in urban and rural Ghana.

Experiences and Lessons From Implementing Cohort Event Monitoring Programmes for Antimalarials in Four African Countries: Results of a Questionnaire-Based Survey.

Introduction: Cohort event monitoring (CEM) is an intensive method of post-marketing surveillance for medicines safety. The method is based on prescription event monitoring, which began in the 1970s, and has since been adapted by WHO for monitoring the safety of medicines used in Public Health Programmes. CEM aims to capture all adverse events that occur in a defined group of patients after starting treatment with a specific medicine during the course of routine clinical practice.