In case anyone needs guidance on prescribing to show to their doctor here it is. Doctors must repect your wishes and make appropriate investigations. As there is no information anywhere to say that a dose of only 100 mg is sufficient for treatment of alcohol there is no moral or legal justification for a doctor to prescribe at that level. There is also no evidence anywhere to say that higher doses of Baclofen are in any way dangerous. If your doctor disagrees, show him the guidance and ask him to show you what information he is relying on. He won't be able to find any and if he stays at 100mg he is in breach of his code of ethics and can be reported to the GMC for consideration of disciplinary action against him
Here is the guidance:
"Dear Mr
Thank you for your email where you have raised concerns ... relating to off-label prescribing of baclofen. I am responding on behalf of my colleague Suzanne Wood and I apologise for the delay in getting back to you. I hope this has not caused too much inconvenience.
It may be helpful if I begin by explaining our role. As the statutory regulator for the medical profession, we license doctors to practise medicine in the UK and issue guidance for doctors on the general standards of good practice that we expect them to adhere to in all aspects of their medical practice. Good Medical Practice is our core ethical guidance for doctors and this is supported by a range other topic-specific guidance documents.
We are not in a position to advise doctors about the suitability or otherwise of particular treatments as our remit does not extend to collecting, analysing or disseminating clinical information. We do not therefore, produce clinical guidance. Information about the effectiveness of medical treatments, and the risks and benefits attached to them, is available from a wide range of sources including government health departments and regulatory agencies, the medical royal colleges, and independent organisations such as medical research journals and other publications.
It is the role of the Scottish Intercollegiate Guidelines Network (SIGN) to develop evidence-based clinical practice guidelines for the NHS in Scotland. The guidelines help doctors provide effective and appropriate healthcare in the management of patients? clinical conditions. You can view on their website information about proposing a guideline topic: Suggest a Guideline Topic.
There are a number of principles in Good Medical Practice and our supplementary ethical guidance which are relevant to your query.
Good Medical Practice makes clear that doctors must follow the guidance on providing good clinical care (paragraphs 2‑11), keeping their knowledge and skills up to date (paragraphs 12‑13) and on maintaining and improving their performance (paragraph 14).
You note your concern about the doctor?s refusal to investigate your wife's condition and treatment. Paragraph 2 of Good Medical Practice is quite clear that in providing good clinical care, doctors must adequately assess the patient?s condition, provide or arrange advice, investigations or treatments where necessary and to refer a patient to another practitioner, when this is in the patient?s best interests.
We expect doctors to provide effective treatments based on the best available evidence (see paragraph 3c of Good Medical Practice). They must also do their best to ensure that any treatment they offer is in the patient?s best interests, and they must be satisfied that the prescribing is safe and responsible. Our guidance Good practice in prescribing medicines provides good practice advice on prescribing: It states that doctors must:
b. Be in possession of, or take, an adequate history from the patient, including: any previous adverse reactions to medicines; current medical conditions; and concurrent or recent use of medicines, including non-prescription medicines.
c. Reach agreement with the patient on the use of any proposed medication, and the management of the condition by exchanging information and clarifying any concerns. The amount of information you should give each patient will vary according to factors such as the nature of the patient's condition, risks and side effects of the medicine and the patient's wishes. Bearing these issues in mind, you should, where appropriate
i. Establish the patient's priorities, preferences and concerns and encourage the patient to ask questions about medicine taking and the proposed treatment
ii. Discuss other treatment options with the patient
iii. Satisfy yourself that your patient has been given appropriate information, in a way they can understand, about: any common adverse side effects; potentially serious side effects; what to do in the event of a side-effect; interactions with other medicines; and the dosage and administration of the medicine; (see Consent: patients and doctors making decisions together)
iv. Satisfy yourself that the patient understands how to take the medicine as prescribed
v. Satisfy yourself that the patient is able to take the medicine as prescribed.
As you are aware, this guidance includes advice on prescribing medicines for use outside the terms of their label (off-label). It states:
19. You may prescribe medicines for purposes for which they are not licensed. Although there are a number of circumstances in which this may arise, it is likely to occur most frequently in prescribing for children...
20. When prescribing a medicine for use outside the terms of its licence you must:
a. Be satisfied that it would better serve the patient's needs than an appropriately licensed alternative
b. Be satisfied that there is a sufficient evidence base and/or experience of using the medicine to demonstrate its safety and efficacy. The manufacturer's information may be of limited help in which case the necessary information must be sought from other sources
c. Take responsibility for prescribing the medicine and for overseeing the patient's care, monitoring and any follow up treatment, or arrange for another doctor to do so (see also paragraphs 25-27 on prescribing for hospital outpatients)
d. Make a clear, accurate and legible record of all medicines prescribed and, where you are not following common practice, your reasons for prescribing the medicine.
Our guidance Consent: patients and doctors making decisions together sets out principles for good practice in making decisions. A core principle of this guidance is that doctors must work in partnership with patients to ensure good care. This means listening to patients and respecting their views about their health; responding to their questions, concerns and preferences; and sharing with patients the information they want and need such as the treatment options available to them.
Taking all of this into account, doctors should make reasonable efforts to investigate potential treatments that are brought to their attention and as you note, where the manufacturer?s information on off-licence use is limited then doctors must use other sources, for example advice from medical royal colleges. Where a medicine is outside of their area of competence they should consult and seek advice from colleagues or other bodies where appropriate. But the GMC is not in a position to order a doctor to provide the treatment that you, or your wife, many want. Doctors have to use their professional judgement to make good decisions based on the best available evidence, seeking advice where appropriate, to ensure that the medicines they prescribe are appropriate and responsible and in the patient?s best interests.
In response to your question about indemnity insurance, doctors have a duty to arrange their own liability insurance with a medical defence body of their choice to cover any part of their practice not covered by an employer's indemnity scheme. For further information you may wish to contact the Medical Defence Union (UK wide) or the Medical and Dental Defence Union of Scotland.
I hope this is helpful in explaining our role and our guidance on the issues you have raised.
Yours sincerely
Olivia Stapleton
Policy Officer
Standards & Ethics Section
Telephone: 0020 7189 5378
Website: GMC | Home
The GMC has published new guidance for doctors on research. Good practice in research and Consent to research provide a framework to guide doctors? decisions throughout all stages of a research project. Go to www.gmc-uk.org/guidance/research_guidance to read the guidance."
Here is the guidance:
"Dear Mr
Thank you for your email where you have raised concerns ... relating to off-label prescribing of baclofen. I am responding on behalf of my colleague Suzanne Wood and I apologise for the delay in getting back to you. I hope this has not caused too much inconvenience.
It may be helpful if I begin by explaining our role. As the statutory regulator for the medical profession, we license doctors to practise medicine in the UK and issue guidance for doctors on the general standards of good practice that we expect them to adhere to in all aspects of their medical practice. Good Medical Practice is our core ethical guidance for doctors and this is supported by a range other topic-specific guidance documents.
We are not in a position to advise doctors about the suitability or otherwise of particular treatments as our remit does not extend to collecting, analysing or disseminating clinical information. We do not therefore, produce clinical guidance. Information about the effectiveness of medical treatments, and the risks and benefits attached to them, is available from a wide range of sources including government health departments and regulatory agencies, the medical royal colleges, and independent organisations such as medical research journals and other publications.
It is the role of the Scottish Intercollegiate Guidelines Network (SIGN) to develop evidence-based clinical practice guidelines for the NHS in Scotland. The guidelines help doctors provide effective and appropriate healthcare in the management of patients? clinical conditions. You can view on their website information about proposing a guideline topic: Suggest a Guideline Topic.
There are a number of principles in Good Medical Practice and our supplementary ethical guidance which are relevant to your query.
Good Medical Practice makes clear that doctors must follow the guidance on providing good clinical care (paragraphs 2‑11), keeping their knowledge and skills up to date (paragraphs 12‑13) and on maintaining and improving their performance (paragraph 14).
You note your concern about the doctor?s refusal to investigate your wife's condition and treatment. Paragraph 2 of Good Medical Practice is quite clear that in providing good clinical care, doctors must adequately assess the patient?s condition, provide or arrange advice, investigations or treatments where necessary and to refer a patient to another practitioner, when this is in the patient?s best interests.
We expect doctors to provide effective treatments based on the best available evidence (see paragraph 3c of Good Medical Practice). They must also do their best to ensure that any treatment they offer is in the patient?s best interests, and they must be satisfied that the prescribing is safe and responsible. Our guidance Good practice in prescribing medicines provides good practice advice on prescribing: It states that doctors must:
b. Be in possession of, or take, an adequate history from the patient, including: any previous adverse reactions to medicines; current medical conditions; and concurrent or recent use of medicines, including non-prescription medicines.
c. Reach agreement with the patient on the use of any proposed medication, and the management of the condition by exchanging information and clarifying any concerns. The amount of information you should give each patient will vary according to factors such as the nature of the patient's condition, risks and side effects of the medicine and the patient's wishes. Bearing these issues in mind, you should, where appropriate
i. Establish the patient's priorities, preferences and concerns and encourage the patient to ask questions about medicine taking and the proposed treatment
ii. Discuss other treatment options with the patient
iii. Satisfy yourself that your patient has been given appropriate information, in a way they can understand, about: any common adverse side effects; potentially serious side effects; what to do in the event of a side-effect; interactions with other medicines; and the dosage and administration of the medicine; (see Consent: patients and doctors making decisions together)
iv. Satisfy yourself that the patient understands how to take the medicine as prescribed
v. Satisfy yourself that the patient is able to take the medicine as prescribed.
As you are aware, this guidance includes advice on prescribing medicines for use outside the terms of their label (off-label). It states:
19. You may prescribe medicines for purposes for which they are not licensed. Although there are a number of circumstances in which this may arise, it is likely to occur most frequently in prescribing for children...
20. When prescribing a medicine for use outside the terms of its licence you must:
a. Be satisfied that it would better serve the patient's needs than an appropriately licensed alternative
b. Be satisfied that there is a sufficient evidence base and/or experience of using the medicine to demonstrate its safety and efficacy. The manufacturer's information may be of limited help in which case the necessary information must be sought from other sources
c. Take responsibility for prescribing the medicine and for overseeing the patient's care, monitoring and any follow up treatment, or arrange for another doctor to do so (see also paragraphs 25-27 on prescribing for hospital outpatients)
d. Make a clear, accurate and legible record of all medicines prescribed and, where you are not following common practice, your reasons for prescribing the medicine.
Our guidance Consent: patients and doctors making decisions together sets out principles for good practice in making decisions. A core principle of this guidance is that doctors must work in partnership with patients to ensure good care. This means listening to patients and respecting their views about their health; responding to their questions, concerns and preferences; and sharing with patients the information they want and need such as the treatment options available to them.
Taking all of this into account, doctors should make reasonable efforts to investigate potential treatments that are brought to their attention and as you note, where the manufacturer?s information on off-licence use is limited then doctors must use other sources, for example advice from medical royal colleges. Where a medicine is outside of their area of competence they should consult and seek advice from colleagues or other bodies where appropriate. But the GMC is not in a position to order a doctor to provide the treatment that you, or your wife, many want. Doctors have to use their professional judgement to make good decisions based on the best available evidence, seeking advice where appropriate, to ensure that the medicines they prescribe are appropriate and responsible and in the patient?s best interests.
In response to your question about indemnity insurance, doctors have a duty to arrange their own liability insurance with a medical defence body of their choice to cover any part of their practice not covered by an employer's indemnity scheme. For further information you may wish to contact the Medical Defence Union (UK wide) or the Medical and Dental Defence Union of Scotland.
I hope this is helpful in explaining our role and our guidance on the issues you have raised.
Yours sincerely
Olivia Stapleton
Policy Officer
Standards & Ethics Section
Telephone: 0020 7189 5378
Website: GMC | Home
The GMC has published new guidance for doctors on research. Good practice in research and Consent to research provide a framework to guide doctors? decisions throughout all stages of a research project. Go to www.gmc-uk.org/guidance/research_guidance to read the guidance."
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