The DSRU had coverage in the BMJ last week following the issue of the press release below. The article is available to BMJ subscribers here.
“The DSRU is calling on GPs to help improve patient safety by providing vital information on possible adverse drug reactions.
DSRU conducts Post Authorisation Safety Studies (PASS) in which the safety of newly licensed drugs is monitored using its own bespoke data collection methodology, known as Modified Prescription Event Monitoring (MPEM). This allows DSRU direct access to GPs to request information about any events experienced by patients after they’ve been prescribed a specific drug.
DSRU collates and analyses the data, typically from up to 10,000 patients, and reports any evidence of suspected adverse drug reactions.
DSRU has completed more than 140 such studies since it was established in 1981. Nearly 15,000 GP surgeries have been involved, including more than 50,000 GPs and 3.8 million patients.
As a result of DSRU research, drugs can be suspended or even withdrawn if they are proved to put patients at risk. For example, a drug for osteoporosis (strontium ranelate, marketed as Protelos) was discontinued in 2017 after DSRU’s research team discovered it increased the risk of venous thromboembolism.
Professor Saad Shakir, DSRU director, said: “Our studies help keep patients safe. The more data we can capture, the more robust our findings. While we’re delighted so many GPs have already supplied vital information about their patients, we’re calling on more to do the same. There are other sources of patient data, such as the Clinical Practice Research Datalink (CPRD), that we can also use. But this doesn’t allow for more precise questions and the very latest patient information that could make the difference in uncovering a problem.”
DSRU’s unique methodology allows researchers to obtain more detailed, accurate information that’s more difficult to ascertain from CPRD data, such as stop dates, reasons for stopping and indications. The stop date allows DSRU to accurately determine the end of treatment. This was important when DSRU conducted research on rivaroxaban (a direct oral anticoagulant) as researchers needed to know if bleeding events occurred during treatment. The ‘indication’ enables DSRU researchers to stratify study results by indication. For example, when studying the safety of an anti-diabetic medicine, it was important to determine whether the patient actually had type II diabetes.
The methodology also allows DSRU to contact GPs easily to obtain further follow-up information about individual patients.”