Tuesday, June 14, 2011

The British Pharmaceutical Industry Issues Social Media Guidance for Adverse Event Reporting

Posted by Princess Eva Angelica at 5:55 AM
Once again the Brits have beaten the US in issuing useful guidelines for social media use by the pharmaceutical industry! As I reported back in April, 2011, the Prescription Medicines Code of Practice Authority (PMCPA), which oversees the self-regulatory code of the Association of the British Pharmaceutical Industry (ABPI), published "informal guidance" providing the drug industry advice on how to use online communications (see here).

I learned today from a tweet by @dawidge (a Pfizer employee) that the ABPI Pharmacovigilance Expert Network (PEN) published GUIDANCE NOTES ON THE MANAGEMENT OF ADVERSE EVENTS AND PRODUCT COMPLAINTS FROM PHARMACEUTICAL COMPANY SPONSORED WEBSITES (find the document here).

The guidance addresses three different ways that pharmaceutical companies may learn of adverse events (AEs) through social media:
  1. "Listening in" -- Monitoring social media sites allows a company to "listen to" or "see" what the public are discussing, saying or sharing about the company itself, diseases, conditions, and treatment options.
  2. "Giving out" -- Many social media sites allow companies to initiate one-way communications to share important messages with the public, where interactive dialogue is not permitted or practical.
  3. "Engaging with" -- Engaging, exchanging and participating in interactive communication with the public. This type of activity is performed in both company and non-company sponsored sites.
I found a couple of interesting suggestions in these guidelines:

Companies Should Declare Involvement and Responsibilities
The guidelines state that "The company’s involvement in the social media site must be transparent to the users." Even when just "listening in," the company "should declare its presence by registering on the site using the company name." The ABPI concedes that "this may not be practicable or possible for buzz-monitoring type activities" that are usually carried out by third parties. "In addition," says ABPI, "it is also recommended that the company disclose the length of time it intends to sponsor the site (if known) and how it intends to screen and use any user-generated content."

ABPI also recommends that regulated companies "ensure that all staff involved in the social media channel are appropriately trained for performing pharmacovigilance related activities." That would include moderators and third-parties hired by the companies.

These are EXACTLY the kinds of disclosures from pharmaceutical companies that I suggested in a previous Pharma Marketing Blog post (see "Fair Social Media Practice Principles: Rules for Third-Party Engagement in Patient/Physician Social Networks" and respond to my survey).

Collecting AEs on Social Media Sites
ABPI recommends that company owned sites "be designed to facilitate the pharmacovigilance process" through use of "free text fields" and access to "internal/external reporting based tools which allow users to report suspected adverse drug reactions." One such tool might be a Adverse Event Reporting Widget (see "Using Social Media in a Crisis: Distribute a Product Safety Widget Is One Idea").

ABPI says that details of ALL AEs "should be collected and document, regardless of:
  • Seriousness of the event
  • Whether there is an identifiable reporter
  • Whether any adverse events are listed in the product’s Summary of Product Characteristics
  • Whether a definite causal relationship or link to the product has been stated
  • Whether the stakeholder or patient has already reported the event to the competent authority or says they have reported it to the company"
That's quite different than what commenters from the US drug industry told the FDA (see "Social Media and the Future of Adverse Event Reporting"). The US industry said such a collection regime would be too onerous.

Regarding the identity of the reporter of an AE, ABPI says an e-mail address would be considered acceptable and even a screen name would be acceptable IF the screen name allowed for contact to be made. ABPI recommends companies implement "a formal site registration process" that can be utilised to obtain information enabling regulated companies  to "identify and contact users in order to validate and follow-up on safety information." During registration, users should give consent for the company to follow-up with a user should they report AEs, says ABPI. "It should also be made clear that personal information may be processed on internal company databases and sent to regulators."

[This post originally appeared in Pharma Marketing Blog
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