Devices and desire to prescribe
‘Business Dilemmas’
MDU medico-legal adviser Dr Nicola Lennard (right) who previously worked at the Medicines and Healthcare Products Regulatory Agency, discusses two clinical scenarios concerning the regulation of medical devices and medicines
Dilemma 1
What to do about his pacemaker?
QThree years ago, I fitted an implantable cardioverter defibrillator in a 65-year-old man with heart arrhythmia.
Since then, the patient has attended my clinic for yearly check-ups to ensure the device is still functioning correctly.
However, the latest routine tests have shown up a problem with one of the defibrillator leads.
Should I report this to the regulator and what should I tell the patient?
A Although the patient might not have come to any harm, this clearly has the potential to compromise his treatment and you should report such adverse incidents to the Medicines and Healthcare Products Regulatory Agency (MHRA), as well as the device manufacturer.
It is also possible that other clinicians have reported similar problems, which means the MHRA may be able to combine your findings and theirs to establish a clearer picture of the risk to other patients.
Report the incident as soon as possible via the recently combined drug and device Yellow Card Scheme reporting site.
Alternatively, you can request a report form by phone or email from the MHRA. The device manufacturer is also obliged to report the matter to the regulator, but you should not discount your own responsibility.
The MHRA will record the details and triage the incident to determine the requirement for further investigation. You should receive an acknowledgement and you will be advised of the nature and outcome of any investigation.
As well as investigating possible faults, the MHRA analyses trends in reported adverse incidents to determine whether other action to protect patients is needed, such as the issuing of a device alert or amending device usage instructions.
You should inform the patient as soon as possible that you have discovered a potential problem. The patient is likely to be shocked, anxious or even angry and the best thing to do at this stage may be to listen and empathise.
However, as soon as he is ready, you will need to discuss the implications for his health and the treatment options, such as more frequent or detailed screening or device replacement, helping him weigh up the risks and benefits of each.
This patient may request replacement of the affected device – though the risks of this may be greater than leaving the device in situ – but offering more frequent and detailed device interrogation.
The MHRA will post updates on its website as more detail becomes available and the clinical advice may develop over time.
It might also be appropriate to discuss a referral for specialist counselling if the patient has difficulty in coming to terms with what has happened.
Dilemma 2
GP won’t issue a repeat scrip
QI am an endocrinologist and I have just seen a patient with polycystic ovary syndrome (PCOS).
She is currently on hormone therapy prescribed by her GP, but is distressed by her facial hirsutism and acne and has read about a diuretic that can help with this symptom.
I have some experience of this drug and think this is worth trying, but her GP says he is unhappy about issuing repeat prescriptions when the drug is not licensed for this purpose and the patient is already benefiting from the hormone treatment.
What should I do?
AWhile you should normally prescribe licensed medications within the terms of the licence issued by the MHRA, the licensing arrangements do permit doctors to prescribe unlicensed drugs and to use drugs for unlicensed indications if they judge this to be ‘in the best interest of the patient on the basis of available evidence’.
Doctors have legal responsibility for the drugs they prescribe and you should follow the GMC’s specific guidance on this subject.
This states that you must be satisfied that there is sufficient evidence or experience of using the medicine to demonstrate its safety and efficacy and that a licensed alternative would not suit the patient’s needs.
You will need to explain to the patient that the drug is not licensed for treating PCOS when obtaining her consent and inform her of the risks, including possible side-effects and contra-indications.
This discussion, the patient’s consent and your reasons for prescribing an unlicensed medicine should be clearly recorded.
As the prescribing doctor, the GMC expects you to take responsibility for prescribing the medicine and for overseeing the patient’s care, monitoring and any follow-up treatment or make sure that arrangements are made for another suitable doctor to do so.
If the GP is to manage the patient’s ongoing treatment, he or she would need to be confident that they have sufficient reason to believe that it is in the patient’s best interests that they understand the medication prescribed, and could recognise any adverse effects.
You may wish to have a discussion with the patient’s GP about the drug’s safety and potential value in this case, based on your experience and the available evidence.
It may be helpful if you provide the GP with appropriate references for the effectiveness of the medication, and make yourself available to answer any questions they may have. If satisfied, the GP may then be happy to prescribe the drug, but the decision is ultimately theirs.
If the GP agrees to prescribe the drug, he or she will be responsible for their own prescribing of the drug, but it may be helpful to set up a formal shared care agreement.
It may also be necessary to draw up a protocol for the use of the drug and approval should be sought from the clinical commissioning group to ensure compliance with any local guidelines on prescribing.