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

Abstract

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). Descriptive statistics were used to summarize key variables of interest. Results A total of 4,205 ME reports were submitted by African countries to VigiBase representing 0.4% of all reports in the database. Only 15 countries out of the 37 WHO PIDM members from Africa contributed ME to reports, with 99% (3,874) of them reports originating from Egypt, Morocco, and South Africa. The reasons given for low reporting of MEs were weak healthcare and pharmacovigilance systems, lack of staff capacity at the national centers, illiteracy, language difficulties, and socio-cultural and religious beliefs. Some facilitators suggested by the participants to promote reporting included proactive engagement of patients regarding issues relating to MEs, leveraging on increased technology, benchmarking and mentoring by more experienced national centers. Sixteen of the twenty countries interviewed had systems for reporting MEs integrated into adverse drug reaction reporting with minimal patient involvement in seven of these countries. Patients were not involved in directly reporting MEs in the remaining 13 countries. Conclusions MEs are rarely reported through pharmacovigilance systems in African countries with limited patient involvement. The systems are influenced by multifactorial issues some of which are not directly related to healthcare.

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

“…An earlier study found limited systems in African countries for patients to report these errors for appropriate action. 34 To prevent medication errors, caregivers in our study have adopted tools and support systems that were found to reduce these errors as shown in an earlier study. 5 …”

Awareness, Actions, and Predictors of Actions on Adverse Drug Reaction Reporting among Patients Attending a Referral Hospital in Southern Highland Tanzania

“…In countries where the patient reporting system is well established and effective, it noted that raising awareness among patients/consumers about the significance of reporting and encouraging their participation in medication safety are crucial to the success of the program [ 21 ]. In addition, a lack of knowledge, difficulty with reporting procedures, and a lack of feedback have been cited as bottlenecks in consumer reporting [ 6 , 16 ]. The findings necessitate the use of various available platforms, including social media, television, and radio to educate the public and consumers regarding PV and the importance of reporting ADRs [ 5 , 14 , 18 ].…”

“…In developed countries, consumer/patient reporting systems started in the 1960s, however, the practice is new in low-middle-income countries [ 15 ]. In many countries, lack of resources and financial constraints has been associated with the poor promotion of consumer reporting systems [ 6 , 12 , 16 ]. Reported barriers to ADR reporting include lack of interest, reluctance, complacency, ignorance, and lack of incentives [ 12 ].…”

“…World Health Organization (WHO) defnes ADR as a response to a drug that is noxious and unintended which occurs at a standard dose used for prophylaxis, diagnosis, treatment of a disease, or modifcation of a physiological function [1]. In European Union, ADR causes about 200,000 deaths and cost around Euro 79 billion annually [2] and in England, ADRs contribute to 16.5% of all hospital admission and a projected annual cost of 2.21 billion [3]. ADR generally results in additional treatment costs for patients and the healthcare system, as well as prolonged hospital stays, rehospitalizations, morbidity, and mortality [4,5].…”