Safety, Quality, Efficacy: Regulating Medicines in the UK

SAFETY, QUALITY, EFFICACY: REGULATING MEDICINES IN THE UK
Appendix 2
Study Methodology
Work at the Medicines Control
Agency
We reviewed a wide range of performance data and
management information, reports by other auditors and
business planning documents. Where possible, we
shadowed selected Agency staff at internal meetings and
inspection visits to laboratories.
Work with Agency stakeholders
We interviewed key stakeholders representing:
! industry (Association of British Pharmaceutical
Industry Regulatory Affairs Group; British Association
of Research Quality Assurance; Proprietary
Association of Great Britain)
! patients/consumers (Consumers' Association;
Macmillan Cancer Relief; National Patient Safety
Agency)
! healthcare professionals (British Medical Association;
National Pharmaceutical Association; Royal
Pharmaceutical Society of Great Britain)
! European Commission (European Medicines
Evaluation Agency)
Survey-based work
In August 2002, we commissioned DOCTORS.net.uk
which obtained the views of a sample of 1220 hospital
and General Practice doctors through an electronic
survey. We sought doctors' views on:
! The Yellow Card Scheme and adverse reaction
reporting generally;
! The quality of information provided to healthcare
professionals by the Agency; and
! The quality of patient information leaflets.
We commissioned Ipsos UK's Capibus service to carry
out a representative public omnibus survey of 2000
members of the public aged 15 years or over who used
either prescription or over-the-counter medicines or
both. We sought their views on:
! Adverse reaction reporting;
! Herbal medicines;
! Patient information leaflets and packaging of
medicines;
! Medical information sources; and
! Buying medicines over the internet.
High-level benchmarking
We compared the Agency with equivalent medicines
regulatory authorities through visits to:
! L'Agence Française de Sécurité Sanitaire des
Produits de Santé (France);
! The Medicines Evaluation Board Agency (The
Netherlands);
! The Medical Products Agency (Sweden);
! The Drugs and Therapeutics Division (Canada); and
! The Center for Drug Evaluation at the Food and Drug
Administration (USA).
These comparisons are set out in more detail at
Appendix 9.
appendix two
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