"Enhancing pharmacovigilance in Nigeria: Challenges faced by NAFDAC in monitoring of Adverse Drug Reactions in Nigeria." by Chinedum Odigbo
by
Finbarr Sheehy
| Oct 26, 2020
Nigeria, for a long have time been characterised by challenges in the medical sphere. This has given rise to increased mortality and morbidity rates in Nigeria. Apart from the challenges faced, there exists a low level of monitoring of adverse drug reactions. Drugs being authorised into the market are scarcely monitored to ascertain if there exist other side effects not observed in the clinical trials. Regulatory agency(NAFDAC) responsible for monitoring of drugs in the post-market authorisation period have not been effective in the dispensing of their duties which has contributed to the increased rate of mortality and morbidity in Nigeria.
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Objectives:
1. To determine if NAFDAC possesses the capability to monitor and address reported ADR cases.
2. To identify the factors that hinder NAFDAC from effectively monitoring ADR in Nigeria.
3. To proffer solutions that will help boost ADR monitoring by NAFDAC.
Methodology:
RESEARCH APPROACH: Quantitative
RESEARCH METHODS: Descriptive research method.
RESEARCH PHILOSOPHY: Positivism.
PROBABILITY SAMPLING: Simple random sampling method.
SAMPLE SIZE DETERMINATION: Cochran’s formula was adopted.
METHODS OF DATA COLLECTION: Primary research was used.
RESEARCH INSTRUMENT: Close-ended electronic survey questionnaire.
VALIDITY OF THE RESEARCH INSTRUMENT: Face validity and content validity
RELIABILITY OF THE RESEARCH INSTRUMENT: Cronbach’s alpha coefficient was used.
METHOD OF DATA ANALYSIS: Statistical Package for Social Sciences using descriptive statistics.
ACCESS & ETHICAL CONSIDERATION: Participants were given the free will to decide to participate in the study or not, were duly informed about keeping their identities hidden and information confidential.
Findings:
As revealed by the research findings, one of the challenges affecting NAFDAC’s effective monitoring of ADR is the inconsistent training of staff on latest developments in ADR monitoring. Not keeping staff abreast with recent developments in the monitoring of ADRs is a significant factor that hinders the effective practice of ADR monitoring by the regulatory agency. As a result, regular trainings where staff’s knowledge are updated with current trends with respect to ADR monitoring should be conducted. It is without doubt that ADR monitoring stems from the reporting of ADRs. One of the factors limiting NAFDAC’s ineffective monitoring of ADR is the reluctance of medical practitioners and consumers to report ADR cases. And the when ADR cases are not reported, the practice of monitoring cannot be carried out.
Analysis:
The analysis of this study have revealed that most NAFDAC staff understand the concept of ADR monitoring.This has provided the study with a solid foundation for answering its research questions because responses given by the study’s participants can be trusted due to their understanding of the study’s main subject matter – ADR monitoring. It was discovered from the analysis that monitoring of ADRs would impact positively on the safety of public health and that a positive relationship exists between ADR monitoring and reduction in ADR cases. These findings reveal the significant role ADR monitoring plays in safeguarding the public health of the people of a nation. In the health sector of every nation, it is advisable for ADR monitoring to be taken seriously due to the significant role it plays in protecting the strength of a nation.
Conclusions:
The researcher concludes that of a truth the Nigerian regulatory agency, NAFDAC has the capability to effectively monitor and address ADR issues but that attention should be given to the use of technological solutions in the carrying out of ADR monitoring practices as seen in Kenya. This would in turn increase the agency’s effectiveness in the monitoring of ADRs in the nation. Moreover, the staff revealed some other factors that hinder the effective monitoring of ADRs by NAFDAC. These factors include; poor and inconsistent training of staff, poor administration of the agency, corruption and conflict of interest, lack of qualified manpower, reluctance of most healthcare professionals to report ADR issues, and consumers who refuse to report ADR experiences after consumption of a drug.