National Pharmacovigilance Centre, DRAP issued draft guidelines on promoting Pharmacovigilance activities in Public Health Programs (PHPs).

Drug Regulatory Authority of Pakistan (DRAP) aims at providing a holistic system of Pharmacovigilance in the country. Public Health Programs are key stakeholders involved in the reporting, assessment and risk communication of various un-wanted effects arising after the use of 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:-

  1. To improve public health and safety in relation to the use of therapeutic goods in PHPs;
  2. To detect problems related to the use of therapeutic goods and associated risk communication in a timely manner
  3. To encourage the safe, rational and more effective use of therapeutic goods.

This guideline will assist the Public Health Programs (PHPs) for enhancement of pharmacovigilance activities, and provide a guidance on communication channels among PHPs and Pharmacovigilance Centres for collaborative working to synergize activities within the National Pharmacovigilance system of Pakistan.

Stakeholders can submit their comments and suggestions with 15 days of uploading of this document using prescribed format to submit comments (link to access table of comments), and forward via email to npc@dra.gov.pk, copying at aqsa.hashmi@dra.gov.pk, or can post at mailing address, Director, Pharmacy Services, 3rd floor TF Complex, 7th Mauve Area, G-9/4, Islamabad.

Please click here to view draft guidance document GUIDELINES ON PHARMACOVIGILANCE FOR PUBLIC HEALTH PROGRAMMES