Under-reporting of ADRs – why not use an app?

Whilst the reporting of spontaneous adverse drug reactions (ADRs) is recognised as an important tool in building a drugs pharmacovigilance profile it is poorly supported by healthcare professionals (HCPs) and under-reporting is a major problem.

Various initiatives have been introduced to address this problem including adding patients to the range of potential reporters and a recent study showed that patient reporting of ADRs to the UK Yellow Card Scheme (YCS) improved signal generation by:

  • reporting different drug–ADR pairs and generating different serious drug reactions (SDRs) from healthcare professionals (HCPs)
  • generating SDRs that may be considered important in the context of pharmacovigilance
  • generating additional SDRs when combined with data from HCP reports
  • providing information that may be valuable when assessing the likelihood of a causal association between a particular drug and reaction.

However, in the same report only 8.5% of the surveyed population had heard of the YCS and, of these, only three had self-reported to the YCS the last time they had a side effect (two reported it online and one by post). Clearly, despite extensive marketing campaigns public awareness of the YCS remained an issue.

Maybe there is another way – according to a recent survey of consumers in France, Germany, Poland, Spain, the UK and the USA, 52% of respondents with a mobile handset had a smartphone. Another survey in 2012 found that 81% of HCPs in Europe and 91% in the US had a smartphone.

Consider the scenario – a patient has an appointment with a HCP (doctor, nurse, pharmacist) and both have smartphones. A drug is prescribed for the patient and at the same time the HCP transmits, with the patients permission, a link to their smartphone. The link allows the patient to install a mobile app on their smartphone that enables them to report ADRs quickly and easily to the HCP, if appropriate, the pharma company or the regulator.

How might that impact the the problem of under-reporting spontaneous ADRs?

Posted in Apps, Events, Patient Safety, Regulation, Software Development