Reporting of adverse drug reactions: evaluation of knowledge, attitude and practice among hospital pharmacists in Ashanti Region

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Date
July, 2016
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Abstract
Spontaneous adverse drug reaction (ADR) reporting helps in the detection of serious, unexpected and unusual ADRs. Healthcare professionals play an integral part in the success of every pharmacovigilance programme. Even though the pharmacovigilance programme of Ghana was launched in 2001, under-reporting of ADRs by pharmacists and other health professionals has been the bane of the programme. Data on factors that contribute to the low reporting rate in Ghana is however limited. The main objective of this study was to assess the knowledge, attitudes, and practice of pharmacovigilance among hospital pharmacists in Ashanti Region of Ghana. The study was a cross-sectional survey of 120 hospital pharmacists across 38 hospitals; grouped as government (27), quasi-government (9) and private (2). The self-administered questionnaire was piloted and wordings rephrased to eliminate any ambiguity. Information from the returned questionnaire was coded and entered into SPSS version 20 software. The results were presented as mean ± standard deviation, frequencies, and percentages. Charts were drawn with MS Excel, 2013. The knowledge of the pharmacists in ADR reporting procedure was assessed by their answers to 12 specific knowledge questions. The score obtained by each respondent was graded as poor, average, good, very good or excellent. The rate of ADR reporting was calculated by dividing the number of pharmacists that reported an ADR by the number that saw an ADR, and the result multiplied by 100. The participant response rate in this study was 79.2%. Of the 95 pharmacists who completed the questionnaire, 43 (45.7%) had seen a patient with suspected ADR in the past one year prior to the study, however only 29 (69%) of them reported them by completing the ADR form. Reasons given for not reporting the ADRs included “reaction commonly reported for the suspected drug” (46.2%), “reporting form not available in the hospital” (38.5%), and “I do not know the reporting procedure” (38.5%). Over 80% of respondents have adequate knowledge of the reporting procedure, with tertiary hospital pharmacists having lesser knowledge than their counterparts in the primary and secondary hospitals in the reporting procedure [p = 0.026]. Overall, there was no statistically significant difference between age of respondents (p = 0.534), rank (p = 0.384), level of hospital (p = 0.524), or place of practice (p = 0.732) and ADR reporting. Refresher training on drug safety and ADR reporting, making available ADR forms, introducing electronic reporting of ADRs, and introducing pharmacovigilance as a major course into pharmacy education curriculum were some of the strategies suggested by respondents to improve ADR reporting. The ADR reporting rate among the hospital pharmacists in Ashanti Region was 69%. Majority of pharmacists involved in this study had adequate knowledge in the reporting procedure. Lack of time or heavy workload, absence of ADR reporting form, and inability of some pharmacists to recognize and diagnose ADRs were some factors that contributed to under-reporting of ADRs in the Ashanti Region. To further improve the reporting rate, refresher courses in drug safety and ADR reporting should be periodically conducted for hospital pharmacists. ADR reporting forms should also be made readily available in the wards, consulting rooms and pharmacies, and pharmacovigilance training in pharmacy schools should be intensified to equip the newly trained pharmacist to diagnose and report ADRs to align with FDA policy.
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A Thesis submitted to the Department of Clinical and Social Pharmacy, Faculty of Pharmacy and Pharmaceutical Sciences, College of Health Sciences in partial fulfilment of the requirement for the degreeMaster of Science Clinical Pharmacy.
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