Patient Safety - Health Committee Contents


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:

    (a) Personal regulation.

    (b) Team based regulation.

    (c) Workplace regulation.

    (d) National 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.

    (c) Put patients first.

    (d) Use knowledge, clinical skills and judgement to protect and restore human well-being.

Team based regulation

  7.  Team members must:

    (a) Accept responsibility for the team as a whole.

    (b) Accept responsibility for others in the team.

    (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:

    (a) Ensure that doctors are fit for their roles.

    (b) Operate effective clinical governance.

    (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:

    (a) Control entry to the medical register; and ensure that doctors on the register are up to date and fit to practise.

    (b) Set educational standards for medical schools; and coordinate all stages of medical education.

    (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.
(b)Plan appropriate drug therapy for common indications, including pain and distress.
(c)Provide a safe and legal prescription.
(d)Calculate appropriate drug doses and record the outcome accurately.
(e)Provide patients with appropriate information about their medicines.
(f)Access reliable information about medicines.
(g)Detect and report adverse drug reactions.
(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."

  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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Prepared 7 September 2009