Medical Writing Risk Management Using social media as the patient's voice in the benefit-risk assessment of drugs: Are we ready?

Volume 24, Issue 2 - Risk Management

Using social media as the patient's voice in the benefit-risk assessment of drugs: Are we ready?


There is no doubt that the public interest in healthcare-related issues is growing. This, coupled with the surge in the use of social media, leaves the pharmaceutical industry with a set of unique opportunities and challenges. The screening and reporting of adverse drug reactions (ADRs) is of vital importance, and Marketing Authorisation Holders (MAHs) have a responsibility and liability for their drugs. Patients increasingly use social media to share their healthcare experiences, and this is a welcome opportunity for MAHs to learn more about the real-world experience of their products. However, currently this source for ADR reporting is largely underutilised; partly because the data generated are unstructured, but also because our technology for assessing and analysing this information is lagging behind. There is an urgent need for policy, methods, guidelines, and technology platforms to allow patients' voices through social media to be adequately ‘heard’ and incorporated into the benefit-risk assessment of drugs.

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  1. Safety of medicines – A guide to detecting and reporting adverse drug reactions – why health professionals need to take action. World Health Organization [2002; cited 2015 Jan 28]. Available from:
  2. The safety of medicines in public health programmes: Pharmacovigilance an essential tool. World Health Organization [2006; cited 2015 Jan 28]. Available from:
  3. FDA adverse event reporting systems (FEARS). US Food and Drug Administration (FDA) [cited 2015 Jan 28]. Available from:
  4. MHRA adverse drug reactions. Medicines and Healthcare Products Regulatory Agency [cited 2015 Jan 28]. Available from:
  5. Wikibon Blog. The big list of big data infographics [2012 July 24; cited 2015 Feb 09]. Available from:
  6. IACP Center for Social Media. Fun facts. International Association of Chiefs of Police [2010–2015; cited 2015 Feb 09]. Available from:
  7. Wikibon Blog. A comprehensive list of big data statistics [2012 Aug 1; cited 2015 Feb 09]. Available from:
  8. Freifeld CC, Brownstein JS, Menone CM, Bao W, Filice R, Kass-Hout T, et al. Digital drug safety surveillance: Monitoring pharmaceutical products in twitter. Drug Saf. 2014;37(5):343–50.
  9. McGregor F, Somner JE, Bourne RR, Munn-Giddings C, Shah P, Cross V. Social media use by patients with glaucoma: what can we learn? Ophthalmic Physiol Opt. 2014;34(1):46–52.
  10. Banerjee AK, Ingate S. Web-based patient-reported outcomes in drug safety and risk management: Challenges and opportunities? Drug Saf. 2012;35(6):437–46.
  11. Wu H, Fang H, Stanhope SJ. Exploiting online discussions to discover unrecognized drug side effects. Methods Inf Med. 2013;52(2):152–9.
  12. Mao JJ, Chung A, Benton A, Hill S, Ungar L, Leonard CE, et al. Online discussion of drug side effects and discontinuation among breast cancer survivors. Pharmacoepidemiol Drug Saf. 2013;22(3):256–62.
  13. Vaughan Sarrazin MS, Cram P, Mazur A, Ward M, Reisinger HS. Patient perspectives of dabigatran: Analysis of online discussion forums. Patient. 2014;7(1):47–54.
  14. Abou Taam M, Rossard C, Cantaloube L, Bouscaren N, Roche G, Pochard L, et al. Analysis of patients’ narratives posted on social media websites on benfluorex's (Mediator®) withdrawal in France. J Clin Pharm Ther. 2014;39(1):53–5.



Risk Management
President's Message
The changing face of (benefit-)risk management
Pharmacovigilance medical writing: An evolving profession
A shot at demystifying the risk management plan for medical writers
Using social media as the patient's voice in the benefit-risk assessment of drugs: Are we ready?
Special section: Winners of the Geoff Hall Scholarship essay competition
News from the EMA
Profile: An interview with Ingrid Edsman on why attending EMWA conferences is so rewarding!
The Webscout
In the Bookstores
Regulatory Writing: Review process in regulatory writing
Lingua Franca and Beyond
Gained in Translation
Manuscript Writing
English Grammar and Style: Revising medical writing Reasons not rules: Backtracking, pronoun-induced Part 3 - Double syntactic unit revision and syntactic position revision
Out On Our Own

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