British journalist, biographer and statesman John Morley stated, “Evolution is not a force but a process.”
In an effort to continuously improve the efficacy of drugs and health outcomes for patients, the healthcare industry gradually evolves to meet changing regulations, make the most of new technologies and communication channels, and cater to individuals and their unique needs.
With the evolution of the healthcare industry comes the need to change the way, frequency or guidelines by which product safety is monitored and reported. We look to these top 3 trends as indicators of what’s to come for Pharmacovigilance:
1) Proactive Pharmacovigilance
Our reactive pharmacovigilance system is transforming into a proactive, benefit-risk management system in order to fully adapt to modern technology and the growing need of consumers to receive immediate and reliable information through any channel. The consequences of taking a reactive approach can be disastrous – halting a clinical study, delaying drug approval, recalling a marketed drug; as well as brand damage, class action suits, and exorbitant fines. Moving forward, pharmaceutical and biotechnology companies must not only monitor for adverse events, but also proactively assess and manage drug risk throughout a product’s lifecycle. Developing a pharmacovigilance risk management plan with a risk minimization action plan (RiskMAP) for high risk products is becoming ever more essential.
2) Social Media and Digital Health
Social media is becoming an integral part of healthcare and product safety. More than 40% of consumers say that information found via social media affects the way they deal with their health.3 Of respondents 18 to 24 years of age, 90% say they would trust medical information shared by others on their social media networks.4 Of adults, 30% say they are likely to share information about their health on social media sites with other patients, 47% with doctors, 43% with hospitals, 38% with a health insurance company, and 32% with a drug company.5 These statistics show that there is value in pharmaceutical and biotechnology companies taking a more proactive approach to social media monitoring as well as utilizing social media to provide accurate health and drug related information to patients/consumers. Proactive monitoring could provide early warning of new adverse events or clinical information that helps guide drug development and avoid preventable litigation.
There were 8.3 million fitness trackers, smart watches and other connected wearables bought by consumers in 20121. Just three short years later that number has grown significantly with an estimated 51 million wearables predicted to be purchased in 2015, alone.2 Will the exponential growth of digital health devices become fundamental for delivering high quality care? It stands to reason that proactively monitoring patient health through digital health devices could provide insight into reducing the number and severity of adverse events.
3) Personalized Medicine
Personalized medicine will identify a patient’s biological and disease characteristics, taking into account the patient’s genetic, anatomical, and physiological characteristics, to tailor specific therapies for an individually optimized benefit-risk balance. It promises to increase benefits, reduce risks, and improve the efficacy of many products for individuals. While progress in regenerative medicine and stem cell research offers hope for some of the most personalized products imaginable, this progress also brings to light a new safety paradigm. Different risk profiles might be anticipated due to different genetic mutations which may bring about more adverse drug responses and drug interactions.
Personalized medicines will also require more complex labeling since they might only be safe and effective in particular sub-populations or might need to be administered in different doses to different sub-populations. In cases where a therapeutic product is approved with a diagnostic device, the label of the two products must be consistent. Currently, there are more than 100 approved drugs with labels that contain information on genomic biomarkers (including gene variants, functional deficiencies, expression changes, and chromosomal abnormalities).
These trends give us something to consider when developing our 2016 pharmacovigilance plans.
