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General and Risk Management, Patient Safety (including: medication errors, quality control)
Drug safety monitoring in the northern region of Zambia
  1. K. Ponshano
  1. 1The Copperbelt University, Kitwe, Zambia


Background The Copperbelt University Health Services (CBU Health) has been designated by the Pharmaceutical Regulatory Authority (PRA) as its agent for coordinating pharmacovigilance in Copperbelt, Luapula, Northern, North Western and Western Provinces. Adverse drug reactions (ADRs) are the major concern for hospital admissions. Nearly one quarter of the patients are admitted due to adverse drug reactions.

Purpose CBU Health's purpose includes encouraging the reporting of adverse drug reactions (ADRs) as well collecting and collating all ADR reports from health institutions in the five provinces. This report covers our experiences from May 2008.

Materials and methods Beginning in early May this year, CBU Health has been visiting health institutions in the study areas on a monthly basis. Activities include holding discussions with health workers, distributing ADR forms and collecting ADR reports. Once collected these reports are entered into the ADR Register at CBU Health and thereafter causality is assessed. A report is then prepared for the PRA on a quarterly basis. At the PRA, serious ADRs are noted and recommendations made to the Ministry of Health.

Results One hundred and fifty (150) ADRs were collected May – December, 2010. These reports were obtained from twenty-one (21) institutions in the Copperbelt. The reports have all been documented and assessed using the WHO Causality Method. Most of the ADRs reports were caused by antiretroviral drugs (ARVs) and some by antimalarial drugs like artemether/lumefantrine – Coartem. Fifty reports were sent to the Uppsala Monitoring Centre Vigiflow for further analysis.

Conclusions Pharmacovigilance is the science relating to the detection, assessment, understanding and prevention of the adverse effects of drugs. It is an important public health specialty as drug safety awareness can lead to better patient outcomes and reductions in drug-related morbidity. Our results show that pharmacovigilance is becoming an integral part of clinical care in Zambia for patient safety.

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