1. 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

2. 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

5. 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

6. Information resources on ADRs