The Medicines and Healthcare products Regulatory Agency (MHRA) and the British Generic Manufacturers Association (BGMA) have completed a "ground-breaking" partnership project aimed at reducing cost and improving efficiency around communicating important drug safety information to healthcare professionals.
Currently, when important new safety information becomes known about a medicine, all individual drug manufacturers are required by law to send printed literature to all healthcare professionals, including GPs, nurses and pharmacists.
However, the MHRA/BGMA project, which involved 12 individual generics firms required to communicate information for the diabetes drug pioglitazone, communicated the information centrally by the BGMA on behalf of the 12 firms; it was then approved by the MHRA and send to healthcare professionals. This meant the regulator was not required to approve 12 separate applications and the professionals who were sent the mailings received one set of consistent, clear information.
The project is discussed in the MHRA's newly-published fifth report on the Better Regulation of Medicines Initiative (BROMI), an ongoing programme introducing new approaches to medicines regulation while ensuring safeguards to protect public health are maintained. It notes that the BROMI approach used in the project "resulted in a high-quality outcome for healthcare delivery, making an estimated saving of £500,000 in the process."
"Reducing cost, removing unnecessary duplication and improving efficiency is very important in the health care industry, particularly for those operating within the NHS," said BGMA chairman Michael Cann. "This project is a great example of how partnerships between the regulator and provider companies can be very effective in driving through a more streamlined, clearer process which, ultimately, is good news for patients," he said, adding: "in the future, we would like to improve the system further through greater use of electronic communication."
BROMI was launched in 2005, and the fifth report charts progress on the programme's original work streams - patient information, authorisation and pharmacovigilance - but also highlights new priority areas of work in the reclassification of medicines and in regulatory communications, notably the MHRA/BGMA project.
Other key developments include work to further expand the scheme for self-certification of changes to patient information and a reduction of up to 50% in the volume of Anonymised Single Patient Reports (ASPRs) sent out to industry.
"In this fifth report, BROMI has proved once again that it can deliver real change in the way we regulate in the UK, with benefits to the industry regulatory and healthcare professionals," said Dr June Raine, director of vigilance and risk management of medicines at the MHRA.
"The BROMI approach can now act as a model for Europe and will be informing how changes to the European pharmacovigilance legislation are implemented - in the UK and across Europe," she added.
* BROMI is led by the MHRA and is a collaboration of industry, health professionals and government - MHRA, the Department of Health and the Department for Business, Innovation and Skills (BIS).