Thalidomide: Legal and Medical Perspectives Current Regulatory Approach Good morning, I’m here to talk about the MHRA experience to spontaneous ADR reporting by patients. Most of the findings here are from an internal MHRA Review. The primary objective of this ADR analysis was to identify areas of potential interest on which to focus the YC strategy in order to strengthen the Scheme over the coming year. The report analyses subsections of spontaneous ADR data; looking at overall ADR statistics, including fatal, serious, focussing on direct reporter sources and the overview of the mechanisms of reporting. This report also includes the outcomes of reporting through signal identification. This report specifically excludes ADR reports received via the swine flu portal (online from July 09 to mid March 10) so as not to skew analysis of the data. I’m going to talk through some of the highlights from the analysis and finish by outlining the key points on which we propose recommendations for the EAG to consider and support. Published evaluation of patient reporting using MHRA data?? AVERY et al; pilots Dr June Raine Director Vigilance & Risk Management Medicines and Healthcare products Regulatory Agency 20 November 2012

PRESS RELEASE CHMP concluded that the benefits of Thalidomide outweigh its risks for treatment of multiple myeloma…. Clinical studies have shown that adding Thalidomide can prolong survival time by about 18 months in newly-diagnosed multiple myeloma patients over 65 years of age as compared to patients…. 16 April 2008

Clinical Practice Research Datalink 10 million active patients 25 years of data 98 million hospital referrals 2.5 billion prescriptions Children’s and Pregnancy Datamart by end year

Information resources on ADRs