RxISK.org, the first free independent website for researching and reporting prescription drug side effects, is adding two enhancements in the first week of June. Researchers will be able to access patient stories and the official assessment of side effect causality.
Narratives shared by patients with their permission and without personal identifiers, will now be available.
According to Dr. Dee Mangin, RxISK.org’s Chief Medical Officer, “the best way to understand the impact of drug side effects is to read personal stories. Stories have the details that matter to people, that they can relate to. People notifying their drug side effects have given permission to share, in the hope that this will be helpful to others.”
She adds, “a description of somebody else’s experience on a drug is more helpful to both patients and doctors than just reading numbers and statistics – it provides meaning. This will help people understand whether what they are experiencing is the same as others, what to expect and what may be helpful.”
RxISK will now indicate which drug side effects have an officially acknowledged causal link.
RxISK’s CEO, Dr. David Healy, says: “our new content comes from a database of established side effects created by the European Medicines Agency (EMA) and updated to 30 June 2012. It has been compiled by EMA and partners from the Summary of Product Characteristics (SPC) for medicines authorized in the EU. The SPC is required before a medicine is marketed. EMA has extracted information on gender, causality, frequency, and class warnings from section 4.8 (Undesirable Effects) of the SPC. The SPC requirement is relatively new so not all drugs are covered yet.”
RxISK.org is owned and operated by Data Based Medicine Americas Ltd. (DBM). DBM’s founders have international reputations in early drug-side-effect detection and risk mitigation, pharmacovigilance, and patient-centered care. Although drug side effects are known to be a leading cause of death and disability, less than 5% of serious drug side effects are reported. DBM’s mission is to capture this missing data directly from patients through RxISK’s free drug side effect reporting tool and use this data to help make medicines safer for all of us.
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