When it comes to the healthcare and pharmaceutical sector, social media strategies and campaigns are relatively still in their infancy. This is driven primarily by the regulatory environment – although in reality, social media permeates many other industries around the world.
Pharmacovigilance (PV) is the process of monitoring, researching, collating, reporting, analysing, and evaluating information from patients and healthcare providers on any Adverse Event (AE) or Medical Error that they may experience with any form of medication, medical device, or other medicinal product that they use. With this process, we and our clients have the opportunity to identify new information about products and prevent harm towards patients and consumers.
PV was first established in 1961 in a case report by an Australian doctor, who suspected a link between phocomelia (lethal foetal deformities) and thalidomide. A drug that was commonly used during pregnancy at the time, Thalidomide was given as an antiemetic and sedative agent to pregnant women, but evidence revealed that it caused severe and tragic consequences for their unborn children. Since then, PV has played an important role in medicine worldwide.
When dealing with PV, adverse drug reactions (ADRs) are the main concern. They can be defined as any unwanted or harmful reaction experienced by a patient or clinical trial subject administered a medicinal product, and which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal product, whether or not related to the medicinal product. As a result, they can have a considerable impact on patient safety, and on pharmaceutical company finances and reputation when ignored. Overall, despite the increasing number of ADR reports, many remain unreported and because of this, suggestions have been made to monitor social media platforms and find unreported ADRs that have been highlighted in users’ posts.
The aim of reviewing social media for PV should be to enhance patient safety by analysing information in an accurate, concise, and timely manner, and thereby ensuring the efficiency and accountability of PV activities. In a world where engagements (likes, reactions, reposts and comments on posts) are becoming more common online, it is vital that the healthcare and pharmaceutical industry implement these key areas into their PV strategy.
At Solaris Health we undertake ‘PV awareness introduction’ training, followed by annual PV training with our clients to ensure our process is robust and the client’s PV and product training is current. Our social media PV methodology involves monitoring and then notifying the relevant individuals of the pharmaceutical company of any comments in social media posts from users that: contain inappropriate, offensive, or discriminatory language; promote an unaffiliated organisation, event, product, or website. Identification is just one part of our process – the team are trained to ensure each PV report is handled promptly and efficiently through client AE reporting forms, confirmation receipts, and case IDs – all of which is further reinforced by our monthly reconciliation reports. We work closely with every client team to guarantee a bespoke process suited to their needs and, most importantly, ensuring compliance.
To learn more about this service offering and how we could carry out PV monitoring for your business, please do not hesitate to get in touch; just drop an email to Dipesh.Patel@solarishealth.com and we will happily talk to you about how we can make your social media strategies and campaigns more regulatory compliant for you.