The Drug Regulatory Authority of Pakistan (DRAP) aims to provide a holistic Pharmacovigilance system in the country. Public Health Programs are key stakeholders involved in the reporting, assessment, and risk communication of various unwanted effects arising after using drugs, vaccines, and other therapeutic goods. Reporting of Adverse Events associated with the use of therapeutic goods exclusively being used by PHPs is essential to a pharmacovigilance system.
The key objectives of pharmacovigilance activities in public health programs are:-
- To improve public health and safety in relation to the use of therapeutic goods in PHPs;
- To detect problems related to the use of therapeutic goods and associated risk communication in a timely manner
- To encourage the safe, rational, and more effective use of therapeutic goods.
This guideline will assist the Public Health Programs (PHPs) in the enhancement of pharmacovigilance activities, and provide guidance on communication channels among PHPs and Pharmacovigilance Centres for collaborative working to synergize activities within the National Pharmacovigilance system of Pakistan.
DRAP published the draft of these guidelines on its website on 23rd April 2022 inviting the comments of stakeholders on the draft. After a thorough consultation and careful consideration, the first edition of the guidelines on the pharmacovigilance activities in the public health programs is finalized. Nevertheless, anyone can still furnish his/her comments on the guidelines using our comments submissions methods for consideration in the future editions of the document.
Please click to view the document, GUIDELINES ON PHARMACOVIGILANCE FOR PUBLIC HEALTH PROGRAMMES
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