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).
