Abstract

IntroductionMedicines have the potential to cause adverse drug reactions and because of this Zimbabwe monitor reactions to medicines through the Adverse Drug Reaction Surveillance System. The Medicines Control Authority of Zimbabwe monitors reactions to medicines through the Adverse Drugs Reactions Surveillance System. The system relies on health professionals to report adverse drug reactions to maximize patient safety. We report results of an evaluation of the Adverse Drugs Reactions Surveillance System in Kadoma District.MethodsA descriptive cross-sectional study was conducted using the updated CDC guidelines in six health facilities in Kadoma City. Data were collected using a pretested interviewer administered questionnaire, checklists and records review. Data was analyzed using Epi InfoTM to calculate frequencies and means. Qualitative data were analyzed manually. Written informed consent was obtained from all study participants.ResultsThe surveillance system did not meet up to its objectives as it failed to detect the adverse drug reactions and there was no monitoring of increases in known events. Fewer than half (43%) of the participants were aware of at least 2 objectives of the surveillance system but 83% of health workers willing to participate. However the system was not acceptable, 79% did not perceive the system to be necessary with the majority saying ''why should we fill in the forms when the reactions were already known or minor''. Though the system was supposed to identify potential patient risk factors for particular types of events health workers were reluctant to participate as evidenced by only one form filled out of 20 reactions experienced in the district. The system was simple as the notification form has 16 fields which require easily obtainable information from the patient records.ConclusionThe surveillance system was not useful and was not acceptable to health workers but was simple and stable. Health workers lacked knowledge. Sharing of results with the Medicines Control Authority of Zimbabwe through the Matrons facilitated training of health workers in Kadoma City. Health workers were encouraged to notify any drug reaction and to completely fill in the notification forms. Patients were also encouraged to report any drug reaction to health care workers.

Highlights

  • IntroductionIn Zimbabwe this is monitored through the Adverse Drug Reaction Surveillance System (ADRSS) which has the following objectives: to detect new, unusual or rare adverse drug reactions; to monitor increases in known events; to identify drugs with increased number of reported events; to assess the safety of newly licensed drugs

  • Medicines have the potential to cause adverse drug reactions and because of this Zimbabwe monitor reactions to medicines through the Adverse Drug Reaction Surveillance System

  • In Zimbabwe this is monitored through the Adverse Drug Reaction Surveillance System (ADRSS) which has the following objectives: to detect new, unusual or rare adverse drug reactions; to monitor increases in known events; to identify drugs with increased number of reported events; to assess the safety of newly licensed drugs

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Summary

Introduction

In Zimbabwe this is monitored through the Adverse Drug Reaction Surveillance System (ADRSS) which has the following objectives: to detect new, unusual or rare adverse drug reactions; to monitor increases in known events; to identify drugs with increased number of reported events; to assess the safety of newly licensed drugs This system is monitored by the Medicines Control Authority of Zimbabwe (MCAZ) with heavy reliance on health professionals to report adverse drug reactions to maximize patient safety [1]. The ability of an ADR monitoring system to help prevent druginduced injury depends on three factors: there must be a high probability that adverse drug effects will be identified and reported; reports must be reviewed and validated by experts; review results must be fed back to the relevant parties and appropriate regulatory action must be taken. This diagram shows how the system should operate Figure 1

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