Islamabad: (Parliament Times) Drug Regulatory Authority of Pakistan (DRAP) in collaboration with USP-PQM organized a central and inter-provincial consultative meeting on 17-18 August at Islamabad, on Post Marketing Surveillance of drugs and Pharmaco-vigilance drug safety reporting.
Senior officials from provincial government’s health department, Gilgit Baltistan, and ICT participated in the meeting and devised a framework for development of post marketing surveillance system of drugs in Pakistan. Addressing to the participants, Dr. M. Aslam, CEO, DRAP highlighted the features of new regulation drafted for pharmaco-vigilance (PV) and post marketing activities (PMS) of drugs in Pakistan, in line with international practices to ensure safety of population. This system is required to be supported by all stake holders including regulators, pharmaceutical companies, medical professionals, doctors, pharmacists, nurses. We need to spread awareness through educational campaigns, institutional visits, trainings, workshops and using technical support from WHO and USP-PQM, a country wide culture will be developed for its reporting system with a positive mind set for larger interest of patients. PMS is a big tool to identify unsafe, fake, counterfeit drugs through PV reporting and can strengthen our campaign against spurious, faked and counterfeit drugs. He further added that, DRAP, as part of pharmaco-vigilance activity, has already introduced new Adverse Drugs Reaction reporting system and initiated through the ADR and CIOMS forms on its website, for both healthcare professionals and Pharma Industry and most recently it has also enabled on-line submission of these forms through its website for its data base. DRAP is also introducing Bio-study Rules and Code of Ethics for pharmaceutical companies interaction with medical professional, which are under active process. DRAP is developing National Pharmacovigilance centre which has already been initiated and will work in coordination with provinces who will develop their provincial centres. DRAP is going for the membership of WHO Uppsala centre for access to ‘Vigiflow’, its global data base system for pharmacovigilance reporting and this access will support to regulators and medical professionals with latest safety information about the drugs, in the larger patient interest. CEO thanked the organizers, experts and participants for attending this important consultative meeting on drug safety reporting, which is also an important component for recognition of Pakistan’s regulatory framework, internationally.
Director, Pharmacy Services, Mr. Sheikh Ansar updated the participants that more than 80 companies are 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 Organization (WHO) is extending access to international database system “Vigiflow†to linkup our national centre with WHO monitoring center, Uppsala. 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. Provincial representative also presented their existing healthcare structure and future plans for improvement in the system. Representative from Government of Punjab health department shared interesting projects of pharmacovigilance and on-line drug sale licenses system, which were appreciated by all. KPK government representative explained the development for pharmacovigilance in the province. Representative of Sindh presented their situation for this system development. Representatives of government of Baluchistan, Galgit-Baltistan and ICT presented the current situation and future plans. The central presentation about the whole system, its current application and future plans, was presented by the Pharmacy services division, of DRAP. Participants appreciated the efforts of DRAP along with USP-PQM for developing this safety system and pharmacovigilance regulations, in line with international best practices.
Mr. Sultan Ghani, Senior international pharmacy consultant also participated in the meeting. He appreciated these steps taken by government for introduction of a harmonized pharmacovigilance system across country. He told that all healthcare professionals, Physicians, Pharmacists, Nurses, etc. and Pharmaceutical industries are the stake holders of pharmacovigilance system of a country. We need to develop a culture of ADR reporting among professionals in Pakistan. He emphasized to perform scientific assessment and risk analysis of ADR report and then to take a centralized regulatory steps. Meeting participants drafted a framework for regulations and guidelines for pharmacovigilance, along with addition expert advices to further improve. USP chief of party, Pakistan, Dr. Syed Khalid Saeed Bukhari expressed his gratitude to all participants and told that its appreciable that first time Pakistan is going to promulgate regulatory guidelines for pharmacovigilance. He further resolve that USP-PQM will continue support for promotion of quality medicine in Pakistan, in close coordination with DRAP.
