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European Pharmaceutical Contractor

Taking the Plunge

 

The pharmaceutical industry and its regulators have been slow to adopt social media as a means for interacting with consumers. Overcoming the challenges that this vast pool of patient opinions poses can offer a modern solution to pharmacovigilance.

The use of social media sites such as blogs, Facebook, Twitter and LinkedIn have become commonplace today, with many industries embracing the technology and its widespread use to promote their products and engage consumers in twoway conversation. The pharmaceutical industry, however, seems to be struggling with this new technology, unsure of the correct approach to its use and fearful of the ramifi cations of adverse event reporting via social media forums.

The industry was content with Web 1.0 – the one-way, non-interactive sites that marked the beginning of the internet era. However, as Web 2.0 has taken hold, many questions have arisen regarding the posting of possibly inaccurate content and the legal responsibilities of pharmaceutical companies for monitoring these sites.

A Current Look at Social Media

Social media has experienced explosive growth in recent years. Since the advent of blogs and the fi rst social networking sites of the early 2000s, numerous sharing sites have become commonplace and are visited daily by people around the world. Facebook, the world’s most popular social media site, currently has more than 800 million active users – 11 per cent of the world’s population. Although Facebook leads the pack by a long shot, other sites boast staggering numbers as well. LinkedIn now has more than 100 million active users, while Twitter has approximately 175 million users and sees 8,900 tweets per second. As of July 2011, there are an estimated 164 million active blogs (up from 3 million in 2004), and the popular video-sharing site YouTube sees nearly 2 hours of video uploaded each second.

With more consumers using social media, it is not surprising that they are turning to Web 2.0 sites for healthcare purposes as well. A 2011 PwC Health Research Institute Consumer Survey found that nearly one third of consumers have used social media for healthcare purposes (1). In a similar survey by the Pew Research Center as part of their Internet and American Life Project, it was found that of the 74 per cent of adults who use the internet, 80 per cent have looked online for information about health topics such as specifi c diseases or treatments – that’s 59 per cent of all adults. Additionally, one in four users consults online reviews of drugs or treatments, while one fi fth of adult users search online to fi nd others with health concerns similar to their own (2).

These American studies are most likely representative of countries throughout the world, as social media use among European and other countries is commensurate with that of the US population. It is interesting to note, however, that according to the Pew Internet survey, only four per cent of users have posted their experiences with a particular drug or medical treatment online.

Social Media and the Pharmaceutical Industry

The ever-growing presence of social media has caused a great deal of uneasiness in pharma, an industry known for strict regulations and carefully controlled content. While the industry was comfortable with the Web 1.0 format, which allowed for the presentation of truthful, scientifi cally accurate information, the growth of Web 2.0 has led to much debate regarding the monitoring of social media sites and the correct handling of adverse events that could be reported via these platforms.

Many in the pharmaceutical industry are uncomfortable with the values embraced by social media users – immediacy, spontaneity and information that’s ‘good enough’ if not 100 per cent accurate. In an industry governed by strict rules regarding the accuracy of information, the idea that there may be user-generated information on the web that is not completely accurate is a daunting one. The fear of this content is great – if inaccurate information or an adverse event is posted, who is responsible for reporting on and correcting the information?

Despite the fear of entering this new territory, some pharmaceutical companies have determined that the risk is worth taking. Among the worldwide pharmaceutical industry, there are approximately 100 Twitter accounts, 120 Facebook sites, 60 YouTube accounts, 37 brand-sponsored communities and 30 blogs (3). Pfizer has even developed a social media response flow chart to guide staff in responding when products encountered online are mentioned(4). An interesting note, however, is that one is not likely to find adverse events on any of the abovementioned sites, as most of them have comments turned off or require approval before posting comments.

One major reason for the lack of presence by the pharmaceutical industry on social media sites is the elusive guidance on the subject by the FDA, whose policies are generally followed by many other countries around the world. The organisation’s most recent draft guidance on Responding to Unsolicited Requests for Off-Label Information about Prescription Drugs and Medical Devices, released in late December 2011, includes a section on unsolicited requests encountered through emerging electronic media, yet stops short of providing a framework for companies to follow in responding to adverse events reported through social media. The European Medicines Agency (EMA) has also offered no guidance on the subject (5).

It is interesting to note that the FDA has its own Facebook page, although the page is mainly used to post press releases and external links. Additionally, the page’s comment policy states that the organisation cannot respond directly to comments and is unable to answer questions about specific healthcare situations. This cautious, one-way approach to social media mirrors the stance that the pharmaceutical industry has taken.

Adverse Event Reporting via Social Media

In a recent study by Visible Technologies, the social media mentions of 224 overthe- counter and prescription brands were tracked, collected and analysed over a 30-day period. The study found that only three out of every 1,000 mentions (less than 0.5 per cent) contained a report of an adverse event, and only one in seven posts with a reported adverse event contained enough information to meet the four AE reporting criteria established by the FDA – an identifiable patient, identifiable reporter, specific medication and an adverse event (6). A random survey of 500 messages on health-related Google and Yahoo! sites by Nielson Online found similar results – only one message of the 500 contained a reportable adverse event, a 0.2 per cent occurrence (7).

Best Practices in Social Media

In November 2009, the FDA held a public hearing on the use of social media by pharmaceutical companies. Attendees of the hearing came to the following consensuses:

  • Pharmaceutical companies should only be held responsible for content they have originated or sponsored
  • Transparency is paramount
  • Companies are responsible for making reasonable efforts to monitor product references in social media and respond where appropriate, but should not be expected to police the entire internet

Conclusion

A well-monitored social media site can improve health literacy and ease the transmission of reliable information. However, clarity is still required in a number of areas, including specific guidelines on a company’s responsibility for monitoring online discussions of adverse events and whether the company’s online presence, for example via advertising or posting messages in an online forum, changes that responsibility. Another question concerns the case of a broader safety incident – in this case, should a company proactively reach out to monitor adverse events that may be reported online, and/or should it use consumer-generated media sources to post information for consumers to report adverse events directly to the FDA? And finally, if a message is discovered weeks or months after it was originally posted, does this delay affect the company’s responsibility for follow-up?

Although there are several unknowns and questions that need to be answered regarding the use of social media, it is not an excuse for avoiding the medium altogether. If we are truly putting patients first, then we must overcome the fear of the unknown and welcome the opportunity to engage in two-way conversation with the public. If the industry doesn’t take on this challenge and meet the expectations of consumers, it faces a clear risk of being left behind.

References

  1. Manhattan Research, Press Release, More than one-quarter of US adults use their mobile phones for health information and tools, 19th October 2011.
  2. Visit: http://pewinternet.org/Reports/2011/ Social-Life-of-Health-Info.aspx
  3. Dose of Digital blog, January 2012, available at www.doseofdigital.com/ healthcare-pharma-social-media-wiki
  4. Visit: http://blog.contentmanagement connection.com/Home/31036
  5. Cutting Edge Information EPharma Series, Part One, available at www.iirusa. com/upload/wysiwyg/New%20Media/ Ferrell_WP1.pdf
  6. Visible Technologies: Pharmaceutical Industry Report: Adverse Event Reporting in Social Media, November 2011
  7. Nielsen Online, Listening to Consumers in a Highly Regulated Environment, August 2008, available at http://blog.nielsen.com/ nielsenwire/wp-content/uploads/2009/11/ Nielsen-Online-Healthcare-Practice_ Social-Media-Adverse-Event-Reporting_ nov09.pdf

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Elizabeth E Garrard is Chief Safety Officer for Drug Safety Alliance, Inc. Elizabeth provides leadership in strategic planning, analysis, development, implementation and measurement of all aspects of drug safety medical services, including signal management and risk evaluation and mitigation strategy. Prior to joining Drug Safety Alliance, she gained valuable pharmacovigilance experience with GlaxoSmithKline. Her career also includes the development of HIV, oncology and infectious disease pharmaceutical care plans for Coram Healthcare. Elizabeth is a licensed pharmacist and a member of the Drug Information Association (DIA) and the American Society of Health System Pharmacists.
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