Safety, Quality, Efficacy: Regulating Medicines in the UK

SAFETY, QUALITY, EFFICACY: REGULATING MEDICINES IN THE UK
3.27 The World Health Organisation's Uppsala Monitoring
Centre in Sweden has organised a series of meetings
between drug safety experts from around the world to
discuss improving the communication of drug safety
information. The conclusions were set out in a book 9
published in May 2002, which recommended that
regulators, as well as industry, should contribute more to:
a climate of openness about medicines; empowering
consumers through information about their medicines;
informing the public more effectively about the risk/benefit
balance; and improving education about medicines.
3.28 The Agency recognises that there is scope to put safety
messages across more effectively by improving the
quality of information it provides. In the light of
experience gained from the publicity surrounding recent
medicines safety issues, for example on the third
generation oral contraceptive and the MMR vaccine, in
2002 it revised procedures for public communications
with the aim of providing more balanced and tailored
information to the public.
3.29 The Agency has also developed a source of information
on herbal medicines and potential adverse interactions
for use by the public as part of its website, although this
has not been advertised to the public generally.
3.30 In a MORI poll of the public, conducted on behalf of the
independent Science Media Centre in April 2002, some
61 per cent of people questioned expected science to
guarantee a medicine was safe, although in reality any
medicine involves a balance between risks and benefits.
The creation of the new merged agency - the Medicines
and Healthcare products Regulatory Agency - with a
new Agency Chair who is expected to maintain a much
higher public profile, brings the opportunity to explore
new methods of disseminating safety and other
information on medicines to the public. It also brings
the opportunity to raise awareness of the Agency's work
more generally and improve the quality of public debate
about medicines safety, although to do so may require a
more explicit allocation of funding to this activity.
cited the Food and Drug Administration in the United
States, which regularly holds public meetings on drug
safety issues. They would like to see a similar approach in
the UK.
3.32 The Committee on Safety of Medicines is responsible for
providing expert advice and monitoring decisions about
medicines safety, e.g. on whether to withdraw a
marketing authorisation or increase the warnings
attached to a particular medicine. Its members are
expert physicians, toxicologists, pharmacists and
pharmacologists from a range of disciplines in the UK.
The Medicines Commission is a broader-based
committee, which is required to include at least one
member with wide and recent experience of the
pharmaceutical industry. It hears appeals by applicants
on licensing decisions and advises Ministers on these
and on medicines policy generally.
3.33 The committees have two and one lay representatives
respectively. However, lay members are not always
included on working groups of the Committee on Safety
of Medicines. In view of the highly technical nature and
large volume of the information discussed by the
Committees, the consumer groups we spoke to
considered that there was scope to review the level of
support to lay members, to ensure it enables them to
contribute effectively to decision-making.
Greater openness in consultations could
improve policy-making
3.34 The Consumers' Association told us they welcomed the
opportunities offered by the Agency to respond to
consultation requests on policy issues, and frequently
do so. But they were concerned that the Agency did not
publish in full the results of such consultation exercises
or provide feedback to those organisations that
responded. This concern was shared by the National
Pharmaceutical Association, the national body of
Britain's community pharmacy owners.
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Consumer and patient groups would like to
see stronger lay representation in medicines
decision-making
3.31 All medicines carry the risk of side-effects. Whether these
are acceptable depends on the severity of the condition
they are designed to treat and the individual circumstances
of the patient. The public is also becoming increasingly
aware, through reporting in the media, of the risks involved
in taking medicines for more minor conditions, as well as
vaccines. Consumer and patient groups told us they were
concerned that the Agency and the Committee on Safety
of Medicines does not routinely involve patient groups in
decision-making where a difficult risk/benefit balance is
involved, or seek their views explicitly. For example, they
Better links with the health professions
could improve the safe and effective use
of medicines
3.35 Doctors' representatives we consulted told us that
although many doctors were familiar with the Committee
on Safety of Medicines as the source of urgent safety
alerts, fewer were aware of the Agency's role as protector
of public health or source of information on medicines.
One reason may be that, whilst medical students receive
technical tuition on the potential for adverse reactions
and interactions with medicines, their undergraduate
education does not cover the arrangements in place for
licensing and monitoring medicines or a discussion of
the role of the Agency. Only some doctors, such as those
who go on to study clinical pharmacology at the
9 Dialogue in pharmacovigilance: more effective communication, the Uppsala Monitoring Centre, May 2002