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Top questions on the minds of QPPV

Posted on December 21st, 2016 by in Pharmacovigilance

PHV Day 2017 Amsterdam

The 2016 Pharmacovigilance Days (PHV Day 2016) kicked off in early April 2016 in Berlin, Germany. Afterwards, the tour continued to Amsterdam, London, Copenhagen, Rome and Paris in October and November. With the objective of bringing together safety experts from the pharmaceutical and healthcare industry to discuss the relevance of drug safety and pharmacovigilance, Elsevier sponsored and joined four key events. In Amsterdam, the event was organized around risk management strategy and innovation in pharmacovigilance; in Paris and Copenhagen the discussion went around the new challenges in 2016; while in Rome experts explored the efficiency and performance of pharmacovigilance systems. There were many questions and discussions that came out of the 2016 Pharmacovigilance Days, some of which I have covered below.

First and foremost – patient centricity

Patient perspective has always been an essential component of drug safety monitoring and risk communication process. With more effort in the industry applied to patient-centric drug development, it becomes increasingly important to incorporate the patients’ voice in the PV systems and process, which adds value back to the patients and enhances the drug benefit-risk profiles. A few speakers reflected on this topic.

Increasing new treatment for rare diseases are becoming available, and many of them may be tested only on small patient groups. Therefore, continuous monitoring of the benefits and risks that patients experience becomes critical. EURORDIS encourages patients to take a proactive role in managing their disease. At PHV Day in Paris, Dr. Mathieu Boudes talked about their patients’ organization involvement programs. In their pharmacovigilance section, the importance of reporting patient experiences is highlighted. Letting other members of the community know when an undesired side-effect is experienced helps to improve the medicines.

Involving patients can be particularly important when prescribing the off-label use of a drug to rare disease patients. A practical example came from a collaborative initiative presented by AstraZeneca and Friedreich’s Ataxia Research Alliance.

In Amsterdam, Essam Ghanem from Keyrus Biopharma shared his view on health authorities’ interactions with patients and healthcare professionals, and how this would impact on decision making. He argued that with many stakeholders involved in the assessment of medicines’ benefit-risk profile throughout the life cycle, transparency and structured B/R assessment framework are the essentials. What’s more, the authorities should take more specific strategies to minimize patient engagement obstacles.

Redefining pharmacovigilance with digital Media

Moving to a patient centric pharmacovigilance means engaging with patients via healthcare professionals, mobile reporting and social media. A growing body of companies have initiated using digital media to connect patients and to distribute information.

Phil Tregunno from MHRA gave an overview of the EU Innovative Medicines Initiative’s WEB_RADA project. He discussed how to utilize the mobile apps and social media for pharmacovigilance, and shared the recent learnings from this project. Data, especially the public data can be difficult to identify. How to process the unstructured data, to collect the meaningful information and pass it on for human interpretation is a tough nut to crack. It turned out that the algorithm sensitivity is quite high; automated tools can identify 9 out of 10 adverse events (AE) across all products, time and data sources. Overall, monitoring social media adverse event reporting has added value in analysis of drug abuse and misuse, pregnancy and lifestyle related treatment. Next, this project is expecting to develop some policy recommendations, and to ensure sustainability of the project outputs and tools and seek the opportunity to embed this into regular use.

With that, how should safety departments in the pharma companies implement the practices? Dr. Marc Zittartz from pharmaSOL presented his opinions during the PHV day in Amsterdam. It is important for the MAH to identify the global and local social media sites and find out how visitors post information on the sites. Then it is recommended to set up regular reporting with the help of automatic notifications. The challenges of collecting AE in social media still exist, for instance, the patient and/or reporter is not identifiable; such information is likely not confirmed by a health care professional. In that sense, it would be better to consider such data as signal detection.

Dr. Sherry Winter has written an article on the same subject: Finding Adverse Event Data on Social Media. Read her findings here.

As I spoke to some pharmacovigilance experts and drug safety experts, I found that there were some common concerns on their minds. PV is shifting from spontaneous reporting to proactive monitoring, which leads to various types of data. How can we align the data reported from different sources? How can we align between different terminologies so that all reporting are kept consistently? And eventually how to build a reliable and efficient risk management system is another concern.

What do you think of patient centricity and social media monitoring in pharmacovigilance? What do you think is the biggest challenge? Let us know.


All opinions shared in this post are the author’s own.

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