Springer Nature sponsored the annual meeting of the International Society of Pharmacovigilance (ISoP) Middle East Chapter under the Adis Pharmacovigilance brand, held on the 20th of September 2018 in Dubai. ISoP is an international non-profit organisation which aims to promote pharmacovigilance and enhance the safety and proper use of drugs worldwide.
The pharmaceutical market is growing in the Middle East, with more than 350 companies in the pharmaceutical/fine chemical industry. While global pharma companies are entering the Middle East market, and locally produce and sell innovative and branded drugs, there is also a rising generic consumption which is underpinned by local pharma companies as well as Indian generic companies; this is shown by their presence in government procurement.
The ISoP Middle East Chapter was formed in 2015 and its objectives include fostering collaboration between Pharmacovigilance stakholders across the East region and sharing of experiences to shape the new Arab guidelines. Therefore it was no surprise that a recurring theme of the 2018 chapter meeting was the differing safety regulations among the Middle East countries, and the recognition that this presents a big challenge in the region. Therefore the importance of harmonization in regulations and administrative procedures was emphasised throughout the meeting. Other highlights included the importance of the partnership with academia in order to increase the awareness of pharmacovigilance in the academic sector, and a great eagerness to advance pharmacogivilance practices across the Middle East to improve patient safety.
Adis Pharmacovigilance were fortunate to have the opportunity to give a presentation on “Local literature monitoring: balancing the benefits and burdens”. Local literature monitoring, where information comes from various non-indexed sources, is time consuming in contrast to the global literature monitoring using bibliographic databases. We shared our experiences in this regulatory activity, including the existing situation in local literature monitoring as well as motives and pain points behind the current practices. We also offered our views on different approaches used, gained from such experience with our customers. The presentation was well received by the audience, as many members confirmed this was a pain point and were keen to compare approaches with their peers.
Having seen first hand such a diversity in approach to local literature monitoring, we at Adis Pharmacovigilance advocate for greater sharing of practices for this activity, to work towards a consistent application of the regulatory guidelines across the industry. We also advocate for a pragmatic approach that is based on evidence and risk, so that efforts are focused on local literature sources that will actually contribute to the end goal of furthering patient safety.