The Association of the British Pharmaceutical Industry (ABPI) has published best practice guidance for the management of safety information in company sponsored websites, to help companies meet their regulatory obligations in this situation.
According to the ABPI, an estimated 80% of internet users search for health information on-line, making it the third most popular online pursuit after e-mail and using a search engine. Imperial College research found that 70% of UK patients use the internet to search for health information with a third deciding not to visit their general practitioner afterwards.
And, in Europe in 2007, 143 million adults went online for health information, and 63.6 million searched for pharmaceutical information (+/- 80% of consumers turn online for health information)
The ABPI says: “‘Pharmaceutical company sponsored websites’ can be important sources of safety information and designed to facilitate the pharmacovigilance process. For example, sites can provide links or access to internal/external reporting based tools or include free text fields, which allow the public to report suspected adverse drug reactions. Other components such as the “Terms and Conditions for Use” or a formal site registration process can be utilised to obtain information that enables MAHs to identify and contact users in order to validate and follow-up on safety information. A moderation process can be implemented which allows companies to define moderation activities which would include actions to be taken in response to safety information being posted. Finally blogging policies, ‘netiquettes’ and disclaimers can also be utilised. These features and processes allow companies to have a high degree of control over how safety information generated on pharmaceutical company sponsored sites is managed.”
This guidance is not an official regulatory guidance. Anyway, it helps the drafting of an implementing guidance to improve uncertainty about the use and development of social media as an industry tool.
Click here to access the Guidance notes on the management of adverse events and product compliants from pharmaceutical company sponsored websites.
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