Skip to main content

National Audit Office report: Safety, Quality, Efficacy: Regulating Medicines in the UK

Safety, Quality, Efficacy: Regulating Medicines in the UK

"The Medicines Control Agency has a good record and its work is highly respected around the world and forms a model in many countries. But it needs to do more to communicate directly with health professionals and the public and improve the effectiveness of its safety messages. The Agency, and its successor after merger with the Medical Devices Agency, must build on its strong position to maintain an influential position in the European regulatory environment."

"The Medicines Control Agency has a good record and its work is highly respected around the world and forms a model in many countries. But it needs to do more to communicate directly with health professionals and the public and improve the effectiveness of its safety messages. The Agency, and its successor after merger with the Medical Devices Agency, must build on its strong position to maintain an influential position in the European regulatory environment."

Sir John Bourn

 

The Medicines Control Agency (MCA) has a good track record, nationally and internationally, in protecting public health and in ensuring that medicines are in general safe, of good quality and effective if used properly. But, according to a National Audit Office report, it needs to do more to improve the quality of information and advice provided to the public and make sure that messages about suspected adverse reactions to drugs get through to clinicians and others.

Head of the National Audit Office Sir John Bourn today reported to Parliament on the work of the MCA, the body responsible for regulating medicines in the UK. He concludes that the system for monitoring the safety of licensed medicines is leading edge. A rigorous inspection regime for medicines development and distribution ensures that they are also generally of high quality.

But better reporting by clinicians of adverse reactions to drugs is needed. The Agency has made reporting of suspected adverse reactions to drugs easier and open to a wider group of health professionals and later this year – through NHS Direct – patients and consumers. Even so, under the voluntary scheme clinicians report only a quarter or fewer of such suspected reactions. The Agency does not routinely measure the effectiveness of its safety warnings but has developed a strategy to improve the management and communication of risks which it is now looking to implement. Patient information leaflets enclosed with medicines are often found by the public to be unhelpful and confusing. Many consumers read only part of the information provided and around one in ten never read the leaflet at all. The Agency is pressing the case in Europe for more user-friendly information and is working with others to reduce medication errors attributed to confusing packaging and labelling.

There are also some risks to the public from unregulated medicines, including those bought over the internet. The MCA has recognised that illegal sales of prescription medicines over the internet are growing and is addressing the problem. The majority of herbal medicines on sale in the UK are unlicensed, although European legislation to regulate them is currently being discussed. Just like conventional medicines, they can have side effects and interact adversely with other medicines. The Agency has taken regulatory action to protect public health when specific problems with such products have arisen, but risks need to be communicated to the public better.

The MCA is due to merge with the Medical Devices Agency (MDA) in April 2003, and there are some key issues ahead. Pharmaceutical licensing and regulation in Europe are becoming increasingly centralised and the new Agency will need to focus on continuing to protect UK public health, while maintaining its existing strong position to influence developments in Europe.

The MCA must provide a service to industry while observing its overriding aim of protecting public health. While there are safeguards in place to prevent any conflict of interest, some stakeholders are concerned that there is the potential for such conflicts, especially as the Agency is fully funded by industry fees. The Department of Health is to clarify the MCA’s objectives when it merges with the MDA.

According to today’s report, the MCA should consider whether its public profile enables it effectively to provide information which will contribute to the safe and effective use of medicines and in what ways this profile can be strengthened. It should build on its existing regional networks, and work with others, such as hospital and community pharmacists and consultants, to disseminate key information on medicines safety more effectively to both health professionals, including GPs, and the public.

The Agency should also build on actions already taken to ensure that the Drug Alert distribution system for recall of defective medicines across the UK reaches all appropriate health professionals, especially in the light of widened prescribing powers and recent changes in the structures of the NHS.

 

Publication details:

ISBN: 0102920214 [Buy a hard copy of this report from TSO]

HC: 255 2002-2003

Published date: January 16, 2003