ISLAMABAD: Pharmacovigilance centres will bet set up at federal and provincial levels where people and medical practitioners could report side effects or any adverse reaction of medicines.
Pharmacovigilance refers to the practice of monitoring the effects of medical drugs after they have been licensed for use, especially in order to identify and evaluate previously unreported adverse reactions.
To strengthen pharmacovigilance in Pakistan, a meeting was held between the Drug Regulatory Authority of Pakistan (Drap) CEO and United States pharmacopoeia experts, Dr Souly Phanovong and Dr Rachida Soulaymani earlier this week to discuss a roadmap for establishment of Pharmacovigilance (PV) Centre in Drap.
After deliberation with the international experts, it was resolved that fully functional PV centre shall be set up at the federal level in DRAP with regional PV centres at provincial levels. In the first phase tertiary care private hospitals shall also be part of the activity for reporting adverse events and effects of any drug.
It was also resolved that a national PV commission and an advisory committee to oversee and supervise the PV activity shall be formed and concerted effort shall be made as early as possible for the approval of PV Rules, 2018 by federal government to provide the legal cover.
Dr Souly and Dr Soulaymani appreciated the online reporting forms developed by Drap and formally inaugurated launching of online reporting form namely Med Vigilance on DRAP’s official website, which gives option for patients, health care professionals and pharma companies to report the adverse effects and events.
In closing remarks, DRAP chief thanked the international experts for sharing their knowledge and experience with the participants with regards to PV concepts, methods and tools. He also requested Dr Soulaymani to develop the PV strategy for Drap centre for the next three years so that signals be detected the earliest stages and appropriate risk minimisation measures be taken for the patients safety. DRAP would make a registration application for PV Centre for attaining full membership of WHO PV Centre at Uppsala, Sweden at an appropriate time.
Published in The Express Tribune, May 12th, 2018.