Pharmacovigilance Practice within some Pharmaceutical Companies and Public Health Sectors

Bruna Beri Mbonn Njeba
Pharmacotoxicology and Pharmacokinetics, University of Yaounde 1
June, 2018
 

Abstract

Context: The drug discovery and development processes is designed to ensure that medicines have the right quality, are safe and efficacious. However, the number of patients who are exposed to drugs at approval is only a fraction of the target final patient population. Therefore, understanding the safety of medicines can only be finally achieved after the drug is on the market through post marketing surveillance or pharmacovigilance. Pharmacovigilance is defined by WHO as “the science and activities related to the detection, assessment, understanding and prevention of adverse drug effects or any other possible drug-related problems”. Health professionals, patients, drug manufacturers and drug regulatory authorities are therefore highly involved in the practice of pharmacovigilance.
Cameroon imports 95 % of drugs and health care products. Therefore, an effective understanding of the knowledge, attitude and practice of Pharmacovigilance will help to elaborate the development of our pharmacovigilance systems.
Objective: This study had as aim; to investigate the knowledge, attitude and practice of pharmacovigilance in some pharmaceutical companies and among the public health actors.
Methodology:
A cross sectional, descriptive and analytical study was conducted in the Yaounde Central Hospital (a Reference hospital), 50 pharmacies of the Mfoundi District and in 11 Pharmaceutical company representative offices in Yaounde. The study focused on Health professionals (General Practitioners, specialists, pharmacists, dentists, nurses and midwives) and Pharmaceutical company representative office supervisors and our drug regulatory authority, the Department of Pharmacy, Drugs and Laboratories (DPML). The survey was conducted using a pre- tested self- administered questionnaire. The questionnaires for health professionals comprised of questions on knowledge (6), questions on attitude (5) and questions on practice (5). That for pharmaceutical company representative office supervisors comprised of 7 knowledge, 4 attitude and 9 practice questions. The questionnaire for the DPML had knowledge (3), attitude (3) and practice (9). The data for health professionals and pharmaceutical companies was entered and analyzed using Epi-Info Version 3.5.4 statistical software and presented using Microsoft Excel spreadsheet. As scoring criteria, the model suggested by Essi et al in 2013 was used.
Results:
A total of 162 professionals composed of 11 (6.8%) Pharmaceutical companies representative office supervisors, 101(62.3%) Hospital personnel and 50(30.9%) Pharmacy personnel.
These populations are further subdivided into Hospital personnel comprising 8(4.9%) Specialists, 47(29%) General practitioners, 10(6.2%) Dentists, 30(18.5%) Nurses and 6(3.7%) midwives. Pharmacy personnel comprised of; 4(2.5%) Advanced level, 3(1.9%) HND (Higher National Diploma) or pharmacy technicians, 4(2.5%) bachelors holders and 39(24.1%) pharmacists.
In the general appreciation of knowledge, 58% of pharmacy personnel, 52.9% of hospital personnel and 65.7% of pharmaceutical company representative supervisors had the right appreciation. For attitudes, 52% of pharmacy personnel, 43.4% of hospital personnel and 53.3% of pharmaceutical company representative supervisors had the expected results. For practice, 25.1% of pharmacy personnel, 17.5% of hospital personnel and 44.6% of pharmaceutical company representative supervisors had the right practice.
This summed up to give a general appreciation of 33% for pharmacy personnel, 28% for hospital personnel and 39% for pharmaceutical companies, had a better appreciation of pharmacovigilance.
Conclusion
Generally there is little applicable knowledge which determines the poor attitudes developed towards pharmacovigilance among the health professionals and pharmaceutical companies leading to poor practice. Given that these are key actors in the pharmacovigilance system, these results are seen to cause the problem of underdevelopment in our Pharmacovigilance systems. If these three principal elements are improved upon, there will be an evident turn of events regarding the development of our pharmacovigilance system as a whole.


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