Since its inception in 2004, the Pharmacovigilance Department of the Pharmacy and Poisons Board (PPB) in Kenya has been leading efforts to ensure that medicines in circulation are safe to consumers. However, the Department has faced major challenges, among them under-reporting of adverse drug events (ADRs) by health workers and staff shortages, which have severely limited its ability to conduct its duties. It is important that health care workers are aware that reporting ADRs and medication errors can significantly promote patient safety.
The study aimed to examine the knowledge, attitudes and practices of healthcare workers on pharmacovigilance at Kenyatta National Hospital, and to identify barriers to effective implementation of pharmacovigilance.
The study was conducted in 2 parts. The first part involved an analysis of adverse drug reactions reports collected at the Kenyatta National Hospital since 2012 to date. All official yellow suspected adverse reaction reporting forms were collected and analysed using Stata version 10.to explore the hospitals’ reporting trends and elicit the patterns emerging from them.
The second component involved a qualitative baseline survey of healthcare workers that assessed, in turn, the knowledge, attitude and practice of pharmacovigilance. This entailed conducting structured in-depth interviews with key informant healthcare workers (clinicians, pharmacists and nurses) at Kenyatta National Hospital in Nairobi. Deductive thematic analysis was used to establish, categorize and describe themes and patterns emerging from the qualitative data. Written informed consent was sought from every respondent before the interview. Approval to conduct the study was sought from The University of Nairobi/Kenyatta National Hospital Ethics and Research Committee and The Kenyatta National Hospital.
A total of 27 reports were collected and 48% of all collected reports came from the comprehensive care centre, while 22.3% were from the pharmacy units and the medical wards. Pharmacy personnel submitted the bulk of the adverse reaction reporting forms (85.2%). Forty eight percent of the reported adverse drug reactions were severe in nature, while 35% of the reported reactions affected mainly the skin. Anti retrovirals formed the bulk of the suspected causative agents, while Cotrimoxazole was the most suspected cause of skin reactions. The patient’s allergy status (P=0.020) and diagnosis (p=0.040) were seen to be the major determinants of ADR severity.
The interviews showed that ADRs are a major clinical concern, where health workers testified to encountering ADRs either daily, every one or two admission cycle of patients or once in awhile. These ADRs were however, not recorded in the official yellow suspected ADR forms but rather in patient files. Lack of training/awareness of pharmacovigilance, the tools used and the proper channel of reporting was also observed among majority of the health workers interviewed.
The study established that adverse drug reactions reporting rates are very low at the Kenyatta National Hospital despite almost 70% of the interviewed healthcare workers acknowledging that ADRs are very common and occur daily. The study found out that only 23.1% of the interviewed healthcare workers (mainly the pharmacists) had been trained on pharmacovigilance and that the larger proportions of health workers (86.9%) were unaware of the pharmacovigilance practices laid out in the hospital and in the country. These findings call for continuous training sessions to be conducted to the health workers so as to integrate pharmacovigilance in their daily practice.
|PROPOSAL ABSTRACT - FATHIYA HAMUMI.pdf||24.35 KB|
|THESIS ABSTRACT - Fathiya Said Hamumy.pdf||102.62 KB|