Memorandum by the General Medical Council
(PS 92)
PATIENT SAFETY
1. The General Medical Council is the independent
regulator of doctors in the UK. We are independent of Government
as the dominant provider of healthcare in the UK; and independent
of dominance by any particular interest.
2. Our statutory purpose is to protect, promote
and maintain the health and safety of the public by ensuring proper
standards in the practice of medicine.
3. We are undertaking an ambitious programme
of reform, set out in The GMC's Proposals on Healthcare Professional
Regulation (November 2006) and reflected in the Government`s
White Paper Trust, Assurance and Safety—The Regulation
of Health Professionals in the 21st Century (February 2007).
OUR APPROACH
TO REGULATION
4. The GMC aims to help doctors by creating
a regulatory environment within which professionalism can flourish.
Regulation must therefore be about more than just taking disciplinary
action. As the Report of the Bristol Inquiry (2001) stated, medical
regulation "involves all matters affecting the performance
of the individual ... and covers initial education, training,
appraisal, continuing professional development and, where relevant,
disciplinary action."
5. We have promoted a four layer model of regulation:
(b) Team based regulation.
(c) Workplace regulation.
Personal regulation
6. Doctors must:
(a) Regulate their own practice, which includes
practising within the limits of their knowledge and skills.
(b) Show commitment to a common set of values, conduct
and relationships that underpin the trust the public has in doctors.
(d) Use knowledge, clinical skills and judgement
to protect and restore human well-being.
Team based regulation
7. Team members must:
(c) Work in partnership with members of the wider
healthcare team.
(d) Act when a colleague's conduct, performance
or health puts patients at risk.
Workplace regulation
8. The NHS and other healthcare providers
must:
(c) Create an organisational infrastructure to
support doctors in the exercise of their professional responsibilities.
(d) Take prompt and effective action if actual
or emerging impairment puts patients at risk.
National regulation
9. The GMC must:
(c) Determine and promote the principles and
values that underpin good practice.
(d) Take firm, fair, action to protect patients
and the public interest when fitness to practise is impaired.
(e) Reinforce, promote and facilitate personal,
team based and workplace based regulation.
HOW THE
GMC EXERCISES ITS
ROLE
Controlling entry to the medical register
10. Doctors applying for registration in
the UK are assessed against the requirements laid out in the Medical
Act 1983. As part of the registration process we carry out a number
of checks to validate the doctor's identity, qualifications, fitness
to practise and, where permitted under EU law, knowledge of English.
This is effected through identity checks, verification of original
documentation, primary source verification with universities and
other regulators.
11. We have information sharing agreements in
place with other regulators to obtain information about doctors
who have been subject to disciplinary action. This alerts us to
doctors whose applications may need to receive additional investigation
or consideration before their registration is granted. The GMC
also conducts the PLAB test (Professional and Linguistics Assessment
Board) which demonstrates that an International Medical Graduate
has reached the required standard to practise safely in the UK.
Licensing and revalidation
12. In autumn 2009, we will introduce licences
to practise. This will represent a major step toward the introduction
of revalidation.
13. Doctors will need registration with a licence:
(a) If they want to hold a position as a doctor
in the NHS or independent sector, on a permanent or locum basis.
(b) If they want to write prescriptions, sign
death certificates or exercise any of the other legal privileges
currently reserved for registered medical practitioners.
(c) Or if their employer, those who contract
their services or another party require them to hold a licence.
14. All doctors holding registration with
a licence will be required to participate in revalidation, normally
every five years. Revalidation will be a single process with two
potential outcomes: relicensing for all licensed doctors; and
recertification for doctors on the GP Register or Specialist Register.
15. The aims of revalidation are:
(a) To confirm that licensed doctors practise
in accordance with the GMC's generic standards.
(b) To confirm that doctors on the GMC's specialist
register or GP register continue to meet the standards appropriate
for their specialty.
(c) As a backstop to identify for further investigation
and remediation where appropriate doctors whose practice is impaired
or may be impaired.
16. Revalidation will require doctors to
demonstrate to the GMC, normally every five years, that they continue
to practise in accordance with the standards set by the GMC and,
for those on the Specialist or GP Registers, by the relevant Royal
College or Faculty.
17. Revalidation will give patients a regular
assurance that licensed doctors are up to date and fit to practise.
It is not primarily designed to find doctors whose fitness to
practise is impaired but to promote excellence in clinical practice
and, through supporting the professional development of doctors,
enhance patient safety.
18. In order for revalidation to succeed
local clinical governance must be demonstrably effective and the
lines of accountability for patient safety, particularly within
primary care, need to be clear.
Education and training
19. The GMC works to promote patient safety
by maintaining standards in education and training. The GMC's
role is to set the standards and outcomes for basic medical education
at the undergraduate level, the first year of the foundation programme
of post graduate training and in continuing professional development
(CPD). The GMC also runs a quality assurance programme for basic
medical education and with the Postgraduate Medical Education
and Training Board PMETB) is developing a quality assurance programme
for the foundation programme.
20. Our guidance, Tomorrow's Doctors,
sets out the GMC's standards for the knowledge, skills and behaviours
that undergraduate medical students in the UK should learn. This
includes expected competencies relating to prescribing—further
information about this subject can be found in Annex 1. These
standards then provide the framework that UK medical schools use
to design their own detailed curricula and schemes of assessment.
A revised draft version of Tomorrow's Doctors was published
for consultation in December 2008.
21. As endorsed by the Health Select Committee
in its report on Modernising Medical Careers, PMETB will
merge with the GMC in 2010. For the first time, the GMC will be
the regulator for all stages of medical education and training.
Determining and promoting good practice
22. In addition to our core guidance, Good
Medical Practice, we publish and regularly updates a range
of ethical guidance for doctors. Those publications provide a
benchmark for evaluating a doctor's performance and help doctors
to deal with the challenges of daily practice. Examples include
guidance on consent for treatments and explaining risk to patients
(revised in 2008); guidance on confidentiality and the disclosure
of personal patient information which is currently being revised
following extensive consultation and is due to be published in
Autumn 2009; and draft guidance on end of life care which will
be published for consultation in Spring 2009.
23. Patient experience and feedback is an important
part of improving the quality of healthcare and improving awareness
of risks to patient safety. Although our guidance is addressed
to doctors, it is also intended to demonstrate to the public what
standards they can expect from their doctor. We recently launched
an online, interactive version of Good Medical Practice on
our website to make our standards more accessible to patients
and the public. We also aim to raise awareness of all new guidance
as widely as possible once it is published.
Taking firm, fair action to protect patients
24. Our fitness to practise procedures make
a significant contribution to safeguarding patient safety. The
most serious complaints against doctors are referred to fitness
to practise hearing.
25. Our interim orders powers allow us to act
quickly to suspend or restrict a doctor's right to practise while
our investigations continue.
26. Fitness to practise panels can erase
a doctor from the register, suspend registration or impose conditions
on registration.
27. The purpose of our fitness to practise
procedures is to consider whether action needs to be taken to
protect the public interest for the future, by removal or restriction
of a doctor's right to practise. The purpose is not in order to
punish doctors or to provide redress for complainants. Where appropriate,
in cases that do not require GMC action on registration, we redirect
the complaint or enquiry to the NHS or other healthcare provider.
28. In 2008 we launched Patient's Help,
an online information resource aimed at educating the public and
advice organisations. It shows the public how and where to lodge
a complaint about a doctor and includes an interactive map for
local advice centres across the UK. Typically, we receive around
5,000 complaints a year, most of which are suitable for local
resolution. The aim of the online information resource is to help
the public direct their complaint to the correct place so it can
be dealt with more quickly and effectively.
Reinforcing, promoting and facilitating personal,
team based and workplace based regulation
29. The Government's proposals for the establishment
of a network of `Responsible Officers' were incorporated in the
Health and Social Care Act 2008. Responsible Officers will be
a senior doctor within a healthcare organisation with specific
and personal responsibility for those aspects of clinical governance
linking to medical revalidation and to the conduct and performance
of doctors working in or for the organisation.
30. The four layer model highlights the importance
of effective local clinical governance. The Government`s White
Paper Trust, Assurance and Safety—The Regulation of Health
Professionals in the 21st Century set out proposals for a
network of local GMC Affiliates. Last autumn the GMC launched
two year-long pilots, in London and West Yorkshire to study the
role of GMC Affiliates. The pilots aim to establish whether the
appointment of medical and lay Affiliates at regional level will
help to link up national and local regulation and provide faster,
more effective resolution of complaints and concerns about doctors
in England.
31. The GMC has signed a Memorandum of understanding,
information sharing agreement, with a wide range of organisations
to help us work together effectively and efficiently to protect,
promote, and maintain the health and safety of the public. Typically
they commit the GMC and the partner body to the sharing of information
and cross-referral of concerns. Organisations with whom we work
in this way include the Crown Prosecution Service, Nursing and
Midwifery Council, Healthcare Commission, Health and Safety Executive,
National Clinical Assessment Service and NHS Quality Improvement
Scotland.
CONCLUSION
32. We approach to regulation is based on
the fostering of professionalism and the support of doctors at
every stage of their careers. We believe that greater professionalism
will encourage support high quality healthcare and contribute
to continuous improvement in patient safety.
33. We will continue to work with the health
departments in all four countries of the UK, with the NHS and
other healthcare providers, with medical schools and medical Royal
Colleges, with system regulators, and with the medical profession
to enhance patient safety.
February 2009
Annex 1
PRESCRIBING AND TOMORROW'S DOCTORS
1. In his oral evidence to the Committee
on 22 January 2009 Professor David Webb suggested that UK graduates
are not well prepared for prescribing, due to a perceived decline
in the teaching of pharmacology in medical schools.
2. To ensure that concerns about prescribing
are understood and addressed by medical schools, the GMC supported
the establishment by the Medical Schools Council of the Safe Prescribing
Working Group, chaired by Professor Robert Lechler, which included
Professor Webb. The Working Group produced a Statement of competencies
in relation to prescribing required by all Foundation doctors.
3. The GMC is consulting on the draft of
a third edition of Tomorrow's Doctors, our standards for
undergraduate medical education. As Professor Webb told the Committee,
this consultation draft "enshrines" the competencies
drawn up by the Safe Prescribing Working Group. It also reflects
the conclusions of research commissioned by the GMC into the skills
of UK medical graduates.
4. The Tomorrow's Doctors consultation
draft states that graduates must be able to:
"Prescribe drugs safely, effectively and
economically.
| (a) | Establish an accurate drug history, covering both prescribed and other medication.
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| (b) | Plan appropriate drug therapy for common indications, including pain and distress.
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| (c) | Provide a safe and legal prescription.
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| (d) | Calculate appropriate drug doses and record the outcome accurately.
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| (e) | Provide patients with appropriate information about their medicines.
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| (f) | Access reliable information about medicines.
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| (g) | Detect and report adverse drug reactions.
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| (h) | Demonstrate awareness that many patients use complementary and alternative therapies, and awareness of the existence and range of these therapies, why patients use them, and how this might affect other types of treatment that patients are receiving."
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5. The draft also addresses the issue of therapeutics, specifically
that graduates must:
"Demonstrate knowledge of drug actions and pharmacokinetics,
drug side effects and interactions including effects on the population,
such as the spread of antibiotic resistance."
6. The standards enshrined in Tomorrow's Doctors are
those required at a key transition in the continuum of medical
education and training. It sets outcomes required for graduation
and for a doctor to begin the two year Foundation Programme. The
Foundation Programme curriculum states:
"The Foundation Programme is designed to bridge the gap
between undergraduate and specialist medical training. It builds
on undergraduate training to allow foundation doctors to demonstrate
performance in the workplace rather than competence in isolated
test situations".
7. All Foundation Programme doctors must work in approved
practice settings that include a framework of clinical governance
and provision for appropriate supervision and appraisal arrangements.
This management context allows graduates to develop their clinical
skills without compromising patient safety.
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