DRAP to introduce regulations for post-marketing surveillance of drugs | Pakistan Today

DRAP to introduce regulations for post-marketing surveillance of drugs

Drug Regulatory Authority of Pakistan (DRAP) in collaboration with USP-PQM devised a framework for development of post-marketing surveillance system (PSM) of drugs in Pakistan.

The framework for regulations and guidelines for pharmacovigilance was drafted in a two-day central and inter-provincial consultative meeting on post-marketing surveillance of drugs and pharmacovigilance drug safety reporting organised by Drug Regulatory Authority of Pakistan (DRAP) in collaboration with USP-PQM in Islamabad. Senior officials from provincial governments’ health departments, Gilgit-Baltistan and ICT participated in the meeting.

Addressing to the participants, DRAP Chief Executive Officer (CEO) Dr M Aslam said that this system was required to be supported by all stakeholders including regulators, pharmaceutical companies, medical professionals, doctors, pharmacists and nurses.

“We need to spread awareness through educational campaigns, institutional visits, trainings, workshops and using technical support from WHO and USP-PQM while a country-wide culture will be developed for its reporting system with a positive mindset for larger interest of patients,” he added.

The PSM was a big tool to identify unsafe, fake and counterfeit drugs through pharmacovigilance reporting and could strengthen our campaign against spurious, fake and counterfeit drugs, he added.

He said that, DRAP, as part of pharmacovigilance activity, has already introduced new adverse drugs reaction reporting system and initiated it through the ADR and CIOMS forms on its website, for both healthcare professionals and pharma Industry and most recently it has also enabled online submission of these forms through its website for its database.

DRAP is going for the membership of WHO Uppsala centre for access to ‘Vigiflow’, its global database system for pharmacovigilance reporting and this access will support regulators and medical professionals with latest safety information about the drugs, he added.

Pharmacy Services Director Sheikh Ansar said that more than 80 companies were regularly submitting the ADR reports of their products, on monthly basis. National Pharmacovigilance Center will also perform assessment and risk analysis of those ADRs by a scientific advisory committee. World Health Organisation (WHO) was extending access to international database system “Vigiflow” to linkup our national centre with WHO monitoring center, Uppsala, he added.

‘Linkage with WHO Uppsala centre, where world wide data is shared by many countries Pakistan will also get the benefit of this global PV safety information system to be used for the safety of the local patients’.

Senior international pharmacy consultant Sultan Ghani appreciated these steps taken by the government for introduction of a harmonised pharmacovigilance system across the country. He said that all healthcare professionals, physicians, pharmacists, nurses and pharmaceutical industries were the stakeholders of pharmacovigilance system.

‘We need to develop a culture of ADR reporting among professionals in Pakistan. He emphasised to perform scientific assessment and risk analysis of ADR report and then to take a centralised regulatory steps’.

USP Pakistan Chief Dr Syed Khalid Saeed Bukhari said it was appreciable that first time Pakistan was going to promulgate regulatory guidelines for pharmacovigilance. He further said that USP-PQM would continue support to promotion of quality medicines in Pakistan, in close coordination with DRAP. Provincial representative also presented their existing healthcare structure and future plans for improvement in the system.



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