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ABPI publishes updated guidance on pharmacovigilance and digital media

In a guest blog, the ABPI's Esteban Herrero-Martinez explains what changes to European pharmacovigilance legislation mean for ABPI members
ABPI London offices

The healthcare industry uses digital media for a number of purposes, including raising disease and treatment awareness, corporate awareness, clinical trial enrolment, recruitment and patient support. With people engaging on health issues more and more online, it is essential that companies are up to date on the latest legislative requirements for monitoring medicine safety, which is typically referred to as pharmacovigilance.

The ABPI Pharmacovigilance Expert Network (ABPI PEN) published guidance on the management of safety information from company sponsored websites in 2011 to help companies to comply with their legal obligations. In July 2012, updated European pharmacovigilance legislation came into force and the ABPI guidance has been updated to ensure it is consistent with the new legislation.

Module VI of the Good Pharmacovigilance Practice guidances for the new legislation provided some medium term certainty on the regulatory requirements for pharmacovigilance in digital media, which are largely unchanged from what they were prior to the legislative revision.  As a result, the ABPI PEN has expanded the scope of the original guidance to include requirements for both company sponsored and non-company sponsored digital media. The guidance has been renamed 'Guidance notes on the management of adverse events and product complaints from digital media' and has been published today; it is free to download from the ABPI website .

What this means for company sponsored websites
The ABPI PEN recognises the value to companies of using company sponsored websites, and especially social media, to communicate externally.  In fact, the new European pharmacovigilance legislation calls for increased participation by patients and consumers in the pharmacovigilance process and company sponsored websites can be useful tools to this end. It is important to remember though that companies must comply with the ABPI Code of Practice during these interactions.  The Prescription Medicines Code of Practice authority (PMCPA) issues helpful guidance for the industry on digital communications which companies should consult.

Companies have a high degree of control over company-sponsored websites, which are important sources of safety information and can be designed to facilitate pharmacovigilance. Web pages can provide access to adverse event reporting tools or include free text fields, to report suspected side effects. Other components like 'Terms and Conditions' or formal site registration can be used to enable companies identify and contact users to validate and follow-up on safety information. Moderation processes can also be implemented for companies to define actions to be taken in response to safety information being posted.

On company-sponsored websites, details of all adverse events or product complaints for the company's products needs to be collected and documented.  The date the information was posted on the site and the date that anyone from the company or working on behalf of the company first becomes aware of the information must also be acknowleged. 

What this means for non-company-sponsored websites
To comply with the requirements in Module VI in the new legislation, if a company, or contracted third party, chooses to participate in activities on non-company-sponsored sites and identifies an adverse event or product complaint, this needs to be forwarded to the company pharmacovigilance department within one business day.

Companies may release company sponsored apps for smart phones and tablet computers, where the app user can post comments on a non-company-sponsored site such as the app store through which the app is made available. Companies would not routinely be required to monitor app review comments posted on these platforms which are considered non-company sponsored digital media. However, if the company periodically reviews these comments for other purposes, any adverse event or product complaint identified should be collected and reported appropriately.  Adverse event reporting is performed according to strict timelines but as there is no legal requirement to monitor non-company sponsored sites. Day zero is the day that the company first becomes aware of the adverse event or product complaint. Content generated via the app itself is to be treated as a company sponsored digital activity. 

Companies may become aware of adverse events or product complaints on non-company-sponsored public portals or micro-blogging sites where content can be viewed by many site users. The company has a responsibility to follow-up these reports and should consider the most appropriate method of follow-up to protect patient confidentiality. For example, the company may direct the site user to contact the company via the company website, email or phone to provide further information.

Where do we go from here?
Despite the ABPI guidance now covering pharmacovigilance requirements for both company-sponsored and non-company sponsored websites, we still firmly believe an updated regulatory framework is needed to ensure safety data from digital sources is used appropriately. The regulatory requirements for monitoring safety in digital media are contained in the implementing guidance to the pharmacovigilance legislation, not in primary legislation and change could happen relatively quickly should agreement be reached on an updated approach.

At the time of the 2011 guidance, the ABPI PEN published a white paper calling for a more appropriate approach to the monitoring of safety from non-company sponsored websites which we continue to stand by today. The debate on how to best match regulatory requirements to the reality of available data continues in light of the continually expanding and evolving body of data that is generated online.

We strongly support all efforts to improve the quantity and quality of adverse events reported by patients and healthcare professionals, but we should have a regulatory system that is appropriate and can practically deal with the vast and heterogeneous body of data available online as well. 

If you have any questions on the content of the guideline or on ABPI's work in pharmacovigilance, please contact Esteban Herrero-Martinez, ABPI Head of Regulatory Affairs (EHerrero-Martinez@abpi.org.uk).

Article by
Esteban Herrero-Martinez

is Head of Regulatory Affairs at the Association of the British Pharmaceutical Industry. You can email him if you want to know more about the ABPI's work in pharmacovigilance

8th April 2013

From: Regulatory

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