The Association of the British Pharmaceutical Industry (ABPI) has published a guidance that suggests best practices for managing adverse events and other pharmacovigilance data from the internet and social media tools.
According to the ABPI, today’s array of blogs, tweets, online communities and other digital information represent a plethora of potentially important safety data that could compliment traditional pharmacovigilance methodologies. However, such information is not currently being accessed, analysed or even considered relevant by many stakeholders, partly because present legislation does not support marketing authorisation holders in “fulfilling their obligation to collect and analyse all safety data they become aware of”, according to the ABPI.
“The ABPI Pharmacovigilance Expert Network has become increasingly concerned that the complex regulatory requirements for pharmacovigilance, brought in to protect patients at a time of information scarcity, are now acting as a barrier to the use of this information as an important additional resource to protect public health,” explained a white paper issued by the ABPI entitled Pharmacovigilance and the Internet: A Call for Change.
The ABPI’s Guidance notes on the management of adverse events and product complaints from pharmaceutical company sponsored websites were put together as a compilation based on current legislative requirements, and have also been shared with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). The notes set out a number of points and activities for consideration, including “listening in” on social media sites, engaging in one-way communication to share messages, engaging with the public via interactive communication. Although the notes emphasise the regulatory and legal considerations in these areas, they also explain that social media is a valuable tool for communicating externally with customers.
According to the ABPI, eight in ten internet users search for health information online. Research from the UK’s Imperial College also added that 70% of UK patients use the internet to search for health information, with a third deciding not to visit their general practitioner afterwards. Not all of the sites visited are sponsored by pharma companies; in particular, many internets users visit online healthcare discussion communities or blogs, but pharma tends to shy away from these ‘non-pharmaceutical sponsored websites’. Such websites pose a number of challenges, but can also provide valuable information. The notes do not discuss the use of non-pharmaceutical sponsored websites, but the subject is examined in the ABPI white paper.
“Pharmacovigilance data from non-pharmaceutical company sponsored sites should not be ignored, but it is unique and must be treated differently. A new regulatory strategy must be found that will enable the use of this data pragmatically, focusing on the key outcomes of improving medicine safety and away from rigid regulatory reporting requirements,” said ABPI.
The ABPI proposes that companies should have no routine obligation to collect and follow-up on individual adverse events that arise from non-pharmaceutical company sponsored websites. “Data from this channel is best treated as an adjunct to conventional sources,” said the ABPI. “Marketing authorisation holders and regulators should therefore work harmoniously to adopt a more scientific approach to aggregate analysis of this data to help generate or confirm potential signals.”
Although the information disseminated by the ABPI does not represent official regulatory guidance, the agency is hopeful that its work will ultimately lead to improved protection for patients. In a video, Dr Esteban Herrero-Martinez, ABPI Regulatory Manager, said: “Timing is crucial however, we have new pharmacovigilance, or drug safety, legislation that was approved in Europe in December 2010, and the implementing guidance for this legislation is currently being drafted. We have an opportunity now to influence the drafting of this implementing guidance to improve the current situation.”