U.K.'s MHRA To Build App For Adverse Event Reporting
By Cyndi Root
The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) announced in a press release that it will be leading an initiative to develop an application (app) for adverse drug reaction (ADR) reporting. The WEB-RADR project is a three-year collaboration with MHRA, European regulators, the pharmaceutical industry, and academics. The app is intended for consumers and healthcare professionals to report adverse drug reactions via smartphones. Additionally, the consortium will look to social media discussions to gather information about medicines.
Mick Foy, Group Manager in the MHRA’s Vigilance and Risk Management of Medicines division, said, “The growing use of smartphones and tablets by patients and healthcare professionals creates a need for reporting forms to be provided on these platforms to ensure regulators receive ADR reports that are easy to access and complete.”
WEB-RADR
The WEB-RADR project officially started on September 01, 2014 and is expected to last 36 months. Pharmacovigilance experts will gather information and deliver recommendations to the international community. The consortium intends to develop information technology tools as well as policy and guidance for the reporting of ADRs. The Innovative Medicines Initiative, a public private partnership between the European Commission and European Federation of Pharmaceutical Industries and Associations, is funding the project. Novartis Pharma AG is the main coordinator of the consortium, which includes industry participants from Janssen, Bayer, AstraZeneca, Sanofi-Aventis Research & Development, UCB Pharma, and Amgen.
Mobile applications are the primary target, however observing user comments in social media is another goal on the path to ensuring medicines out on the market are safe. User testing and academic research will also be part of the program, which is designed to meet the needs of many stakeholders. Mr. Foy stated that Facebook, Twitter, specialty sites, and blogs are valuable sources of information and the consortium intends to use them ethically, anonymizing data to protect privacy.
Current state of ADR reporting
The MHRA regulates medicines and medical devices as an executive agency of the Department of Health. Recently, MHRA published a letter in the British Medical Journal (BMJ) titled, “Unhelpful information about adverse drug reactions.” Author Kirin Tan and others state that adverse drug reaction information is inconsistent, excessive, poorly presented, and obscured by symptoms not related to the drug. They suggest that these issues represent a barrier to patient care as many patients choose not to undertake treatment due to this information.