The regulator has launched a project, WEB-RADR, to see if patients’ social media posts about their medicines can help collect information on drug side effects. It is also working on a phone app for healthcare professionals and the public to report suspected ADRs to regulators.
The head of MHRA’s Vigilance and Risk Management of Medicines division said the app could report adverse events and also “send accurate, timely and up-to-date medicines information to patients, clinicians, and caregivers.”
“Additionally the recent growth of social media platforms such as Facebook, Twitter and the many specialist sites and blogs has given rise to many people sharing their medical experiences publicly on the internet,” said Mick Foy.
“Such data sharing, if properly harnessed, could provide an extremely valuable source of information for monitoring the safety of medicines after they have been licensed.”
Standard forms: ‘bottlenecks’
A paper published by Boston University scientists in Drug Safety earlier this year said adverse events are under-reported – by 86% in one report – on existing forms, and are frequently delayed by data processing.
Patients often do not report side effects directly, but pass on information via the pharmaceutical industry, lawyers or doctors, creating bottlenecks where information may be lost or misinterpreted.
Eighty per cent of adverse drug reports and 35% of vaccine reports are sent to the US Food and Drug Administration (FDA) by the pharma industry and not by patients.
But while official channels see under-reporting, the Boston study found many patients share information on social media and online health forums, sometimes using hashtags for regulatory agencies (#FDA), manufacturers (#Pfizer) or specific products (#accutaneprobz).
Twitter: 3 times the complaints
The authors looked for Twitter posts describing adverse effects, including slang and casual language, and matched them to medicines and medical terms.
For instance they coded the tweet “So much for me going to sleep at 12. I am wide awake thanks prednisone and albuterol” with the side effect “insomnia.” Similarly, tweets about “brain zaps” from antidepressants were converted to “paraesthesia”.
The scientists compared the terms they found with public data from FAERS (the FDA Adverse Event Reporting System) for the same drugs, and found three times as many adverse event reports on Twitter than reported to the FDA in the same timeframe.
They did not yet recommend directly pasting individual tweets into post-marketing safety databases, but said the posts could be used to signal a potential problem and gather ideas about further testing via formal studies.
In June this year the FDA launched OpenFDA, a project allowing public access to data on reported drug reactions. The programme asked developers to build their own smartphone applications for patients to compare their own side effects to recorded incidents.
Source: Digital Drug Safety Surveillance: Monitoring Pharmaceutical Products in Twitter, Drug Safety 2014; 37(5): 343–350.