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Oviya MedSafe - WHO VigiAccess, EU Pharmacovigilance Pearls & Indian Breakthroughs

Dear Colleagues,

As a fellow pharmacovigilance aficionado, I believe our discipline has not seen a more promising month than the one that passed by. I wish to elucidate to you the reasons behind this optimism, in this May 2015 edition of Oviya MedSafe’s newsletter!

First and foremost, we witnessed the World Health Organization (WHO) launch the VigiAccess website on 17-April-2015, with the aims of improving patient safety, increasing transparency and encouraging the reporting of adverse effects from medicinal products. VigiAccess is a web application which could be used by anybody to access information on reported cases of adverse events associated with over 150000 medicines and vaccines. VigiAccess gives users access to statistical data from the more than 10 million cases reported from over 120 countries contained in VigiBase, the WHO database of suspected adverse reaction reports maintained by the Uppsala Monitoring Centre (UMC) in Sweden. To read more about the background and advantages of this phenomenal development, please click here.

Moving on to Europe, it is important for us to note that the European Medicines Agency (EMA) has clarified on the pharmacovigilance reporting requirements for donated products that treat neglected conditions. According to the EMA, Marketing Authorisation Holders (MAHs) are required to report all suspected Adverse Drug Reactions (ADRs) occurring in the European Union (EU) or in third countries which are brought to their attention, which rule holds good for donated products too, as this data is relevant to the overall safety profile of a product. MAHs are also required to submit serious suspected ADRs from outside the EU to the EU’s pharmacovigilance database, EudraVigilance. Non-serious ADRs too are expected to be reported, but this could be done as a tabulated summary and submitted regularly.

It might be worth recalling that the EU pharmacovigilance legislation in 2012 mandated the reporting of all suspected ADRs resulting from medication errors, with pharmaceutical companies and national regulatory agencies in the EU Member States being obliged to enter these adverse events in EudraVigilance. This obligation becomes more significant now, as the EMA, on behalf of the EU Regulatory Network, has released two draft good practice guides that aim to improve the reporting, evaluation and prevention of medication errors by regulatory authorities and pharmaceutical industry throughout the EU. I take this opportunity to appeal to you to please send your comments, if any, to the EMA well ahead of their deadline of 14-June-2015.

Meanwhile, certain breakthroughs have happened in Indian Pharmacovigilance, which I was fortunate enough to be an active part of. The Indian Medical Association (IMA), India’s largest professional association of medical practitioners, has extended its support to the Pharmacovigilance Programme of India (PvPI) by offering to partner with PvPI technically and operationally through the IMA College of General Practitioners (IMA CGP), an academic wing of the IMA that caters to the professional development needs of the general practitioners across the country. During a meeting held between the PvPI officials and the representatives of IMA CGP in the presence of the Drug Controller General of India (DCGI), it was proposed that IMA CGP Headquarters at Chennai, India will be recognised as ‘PvPI Collaborating Centre for Safe Use of Medicines’. Kindly refer to the news reported on Pharmabiz and on Express Pharma for more information.

Further, the PvPI officials along with representatives of the DCGI also had a round table meeting with pharmacovigilance experts from various global pharmaceutical companies, which I had the privilege of coordinating. The meeting was quite productive and its proceedings are expected to be published in due course. Please visit our photo gallery to view the pictures clicked during these meetings.

Last but not the least, I am proud to mention that an International Conference on ‘Roles and Responsibilities of Pharmacist in Chronic Disease Management, Adverse Drug Reactions and Therapeutic Drug Monitoring‘ was organized at Coimbatore (the city that houses our global delivery centre) by PSG College of Pharmacy with co-sponsorship from the Department of Science and Technology, Government of India, in which I was invited to speak on pharmacovigilance as a career for pharmacists and interact with the delegates as part of a panel of renowned doctors, hospital administrators and national & international speakers. Some pictures of this conference too are available on our photo gallery page mentioned above.

Signing off for now, to meet you with more exciting developments in June 2015,

With thanks & regards,
Dr J Vijay Venkatraman
MBBS, F. Diab., MBA., FPIPA (UK)
Managing Director & CEO,

Oviya MedSafe
Pharmacovigilance Consulting & Drug Safety Services
Coimbatore, India & London, UK

India Office: +91-422-2444442
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