Prescribing and related regulatory matters

by TheEditor

Categories: Diagnosis, Law, Medicine

 This article is intended to be of assistance:
  1. To medical doctors and other qualified persons undertaking or participating in medication reviews.
  2. To other staff who may be assisting doctors with arrangements for medication reviews.
  3. In understanding some of the complexities of prescribing as against ‘prescription‘.
  4. Gaining a deeper appreciation of the risks to be considered and managed.
  5. Appreciating the regulatory framework surrounding prescribing.
  6. To trainee doctors or other practitioners, who prescribe or re-write prescriptions.

[Disclaimer at end of this article applies (click to view).] This article cannot cover every aspect of prescribing.

Prescribing is not simply the writing of a prescription. The GMC states in its guidance, Prescribing and managing medicines and devices content, that prescribing is a term “.. used to describe many related activities, including supply of prescription only medicines, prescribing medicines, devices and dressings on the NHS and advising patients on the purchase of over the counter medicines and other remedies. It may also be used to describe written information provided for patients (information prescriptions) or advice given.” (para 4).

What the GMC says is descriptive and not a definition as such because it outlines only some of the ‘many related activities‘. In other words not because an activity is not included in the above, means it is ‘not prescribing’. What this means is that the term can include activities related to prescribing treatments. Therefore this could include relevant physical investigations or examinations. Importantly for psychiatrists, is that electroconvulsive therapy (ECT) is a prescribed treatment (Royal College of Psychiatrists Position Statement on Electroconvulsive Therapy (ECT) 2017, p5)

The GMC’s prescribing guidance at para 51 states:

Whether you prescribe with repeats or on a one-off basis, you must make sure that suitable arrangements are in place for monitoring, follow-up and review, taking account of the patients’ needs and any risks arising from the medicines.

The consequence of the GMC guidance is this: prescribing is not simply writing a script followed by a letter of instruction to the GP and / or other health professionals. Critically, other factors related to ‘duty of care’ outlined in the guidance impacts on prescribing, and which requires careful study.

In effect ‘medication reviews‘ become a review of ‘prescribing‘ i.e. not simply the new prescription or repeating what is already prescribed to a patient. (See below).

Whilst all of the guidance is important, some aspects may need particular attention.

Mindmap of GMC’s regulatory guidance


Initiating treatment
Starting treatment or advising on starting treatment means that a doctor is very responsible for a number of things. The following is not a complete list:

  1. Safety of the patient.
  2. Appropriateness of treatment i.e. ensuring that sound reasoning comes to bear on diagnosing the patient’s condition and the treatment is well matched.
  3. Balancing projected benefits to risks, for the patient in the current environment of care and any future environments.
  4. Ensuring that the patient is consenting, or that some other robust legal process covers the administering of treatments.
  5. Ensuring that the patient and other health professionals who follow will understand all that is required for the safe management of the treatment

Not specifically in the GMC guidance is the issue of ‘cognitive bias’, which is often an unconscious thing. See article at the MDU Journal ‘Cognitive bias and diagnosis heuristics‘ that,   “….10% of clinicians admit to having made a diagnostic error over the preceding year, 40% of diagnoses about which clinicians were certain proved wrong at post-mortem, and there was a psychological inertia to changing diagnosis – even if alternatives were suggested by colleagues or decision support tools – with clinicians remaining wedded to their original formulation.

Doctors practising psychiatry, are in not infrequently in particularly difficult situations where diagnosis is unclear, or there are numerous confounding factors. The GMC makes no exceptions for those doctors – nor can they avoid, circumvent or escape the reach of the guidance. In this area of work where physical examination and investigations often do not assist diagnosis, it is of high importance that any diagnoses made are well documented and reasoned. Treatment rationales need similar diligence.

It is reasonable to expect that doctors initiating treatments are prepared to handover all relevant matters in writing and/or by ‘oral handover’. GMP at para 12 covers handover under collaboration. Handover is important to new health professionals because, they may read records but not recognise the salience of some particular issue. The latter can happen because ‘meanings’ in written clinical records, often do not carry emphasis or salience. This is a natural handicap of turning thoughts into text (or vice versa).

Medication or treatment reviews

All of the GMC’s guidance applies to ‘medication reviews’ and reviews of treatment. This is serious business. Safety, appropriateness and respect for patients’ Rights, are at the heart of the guidance. The guidance applies to each and every doctor, whether or not they are aware of it.

It would be impracticable for each doctor to address each line of the guidance in writing up repeat medication. What the guidance – which includes repeat prescriptions – means, is that each doctor must or should be very aware of the issues, in all acts related to repeating a prescription and demonstrating application of the principles. The GMC is also very clear at para 5 that , “Serious or persistent failure to follow this guidance will put your registration at risk.

It gets more serious because greater responsibility is placed on doctors to know and apply national guidance and/or guidance from other authoritative bodies:

Para 11, “You should take account of the clinical guidelines published by the:

  1. NICE (England)
  2. Scottish Medicines Consortium and Health Improvement Scotland (including the Scottish Intercollegiate Guidelines Network) (Scotland)
  3. Department for Health, Social Services and Public Safety (Northern Ireland)
  4. All-Wales Medicines Strategy Group (Wales)
  5. medical royal colleges and other authoritative sources of speciality specific clinical guidelines.”

Doctors who are not well prepared for treatment reviews, or do not have sufficient time to consider carefully the patient, put their practice and careers at risk.  Some may not like all this. Doctors ‘likes’ are irrelevant. What is relevant is putting “.. your registration at risk.” Doctors who are overworked or rushed by work pressures leading to mistakes, will find that using the latter as a defence does not go a long way – if or when they arrive at the GMC or the courts. Many become surprised, feel treated unfairly and become bitter. All this is wrapped in a large body of so-called ‘medical law’ – which is beyond the scope of this article.

Conducting medication or treatment reviews

The following mind map is only a summary (click for larger view):

Potential legal implications

Doctors in training

Doctors in training, who may be in a rush, need to be most aware of this guidance. The acceptance of authority from a senior doctor to prescribe or administer, is not a ‘get out of jail free card’, for causing death or serious injury. This means that where a ‘junior’ or trainee doctor is in doubt, they would need to consult further where doubt or concern arises, before prescribing on directions of a senior doctor. The status of being junior or trainee, places particular responsibility on these doctors to seek supervision where they lack expertise. This means that junior doctors need to be aware of the limits of their competence. Good medical practice says that, “..you must recognise and work within the limits of your competence and that you must keep your knowledge and skills up to date.

Trainee psychiatrists involved in delivering ECT need to be very aware of every aspect of the guidance. Consent to treatment procedures and their accuracy, are important. The trainee will need to check under which provisions of legal consent regulated by the Mental Health Act 1983 apply. Where consent forms are missing, or are not found, it would be wise to stop and find the relevant forms before proceeding. The author is aware of  a situation many years ago, where the forms were missing – the doctor took the word of a nurse that consent had been obtained, delivered the ECT, and then found out hours later that there was no consent or SOAD MHA certificate covering ECT.

Senior doctors

Consultants and other career grade doctors are equally bound by the guidance. However, greater responsibility may be placed on them when they prescribe directly, repeat prescriptions, supervise trainees, or advise other doctors. A whole lot of ‘advising’ happens by email and telephone conversation these days. The GMC’s guidance para 60 – 66 covers this.

60 Before you prescribe for a patient via telephone, video-link or online, you must satisfy yourself that you can make an adequate assessment, establish a dialogue and obtain the patient’s consent in accordance with the guidance at paragraphs 20 – 29.

61 You may prescribe only when you have adequate knowledge of the patient’s health, and are satisfied that the medicines serve the patient’s needs. You must consider:

  1. the limitations of the medium through which you are communicating with the patient
  2. the need for physical examination or other assessments
  3. whether you have access to the patient’s medical records.

In order to demonstrate compliance with guidance on ‘remote prescribing’, doctors would do well to document what they know and do not know – and record their decision-making process. All this takes time. From experience, trainee doctors and some senior doctors, tend to be deficient in this area. The robust reasons for a ‘remote decisions and prescribing’, need to be clear for the satisfaction of legal scrutiny. “Really?“, I can hear some of my colleagues baulking at this. Note that in Good Medical Practice (which the prescribing guidance refers to) it is stated, para 12. You must keep up to date with, and follow, the law, our guidance and other regulations relevant to your work. This does not mean that everybody has to be a lawyer. Many doctors discover at Coroner’s courts or disciplinary hearings at the GMC how the law is applied.

Conclusion

  1. All medical doctors have very serious responsibilities for prescribing.
  2. ‘Prescribing’ is  a very broad term that includes a number of other related activities.
  3. The GMC’s guidance on prescribing is essential reading for all doctors.
  4. Ignorance of any part of it, will attract risk of being struck off or being seriously disciplined.


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