USE OF UNLICENSED/SPECIALISED MEDICINES IN ROCKFIELD MEDICAL CENTRE
Introduction
Medicines legislation requires that medicinal products be licensed before they are marketed in the UK. The Marketing Authorisation provides assurance of the safety and efficacy of the drug in relation to a specified use, which has been reviewed and accepted by an official expert body. It also defines the legal status of the product and ensures its quality. Circumstances may arise where it is necessary to prescribe a patient an unlicensed product or a licensed product outside its licensed use (off-label). This guideline provides recommendations for prescribing in such circumstances. It is important to note that responsibility for prescribing unlicensed products or unlicensed use of licensed medicines remains with the prescriber, including overseeing the patient’s care, monitoring and any follow up treatment. Prescribers have a right to refuse to take over prescribing responsibilities where circumstances do not fulfil criteria set by GMC in Good Practice in Prescribing and Managing Medicines and Devices 2013
Definitions
1. Unlicensed products
These are products without a Market Authorisation. Unlicensed products are not subject to stringent control by the Licensing Authority (The MHRA), and neither prescribers nor pharmacists can make the same assumptions of quality, safety and efficacy about unlicensed products as they do for licensed medicines. They may be licensed in another country via their licensing body e.g. EMA/FDA.
“Specials” are included within this definition.
Specials are unlicensed medicinal products manufactured in the UK for human use which have been specially prepared to meet a prescription ordered for individual patients without the need for the manufacturer to hold a marketing authorisation for the medicinal product concerned. Specials are prescribed where the licensed medicinal product is not available in a formulation or strength required for an individual patient e.g. liquid preparation for patients with swallowing difficulties.
2. Unlicensed use of a licensed medicinal product (“off-label”)
This is where a licensed medicinal product is prescribed for an indication or otherwise in a manner that is not recommended in its Marketing Authorisation (often referred to as “off-label” use). Although there are a number of circumstances in which this may arise, it is likely to occur most frequently in prescribing for children and prescribing in palliative care. Currently, pharmaceutical companies do not usually test their medicines on children and, as a consequence, cannot apply to license their medicines for use in the treatment of children. The use of medicines that have been licensed for adults, but not for children, is often necessary in paediatric practice. Often in prescribing in palliative care unlicensed routes of administration are used e.g. subcutaneous usage of product licensed for intravenous or intramuscular use.
Recommendations for Prescribing.
1. Unlicensed products
Unlicensed products should NOT be prescribed in primary care. Where an unlicensed product is initiated in secondary care, prescribing and monitoring of patient should remain with specialist team.
Exceptions where unlicensed products may be prescribed in primary care:
– Where there is an approved shared care guideline for prescribing a specific unlicensed product for a specific indication.
– Where product prescribed is a “special” Before a special is prescribed, prescriber should ensure there is no licensed alternative which would better serve the patient’s needs.
– Where prescribing is part of specialist service operating in primary care.
2. Unlicensed use of a licensed medicine (“off-label”)
Unlicensed use of a licensed medicinal product may be recommended in the following circumstances:
– Where there is a recognised body of evidence in support of such therapeutic use e.g. listed in BNF or BNF for children, NICE guidance, and other national guidance.
– Where there is an approved guideline e.g. Verapamil for cluster headache
– Where treatment is initiated by consultant or consultant provided the primary care prescriber has previous knowledge on the use of the medicine ‘off label’ for the condition being treated.
-The secondary care provider is able to provide the primary care provider with sufficient information on evidence base to demonstrate safety and efficacy on the use of the medicine ‘off label’ for the condition being treated.
N.B. The prescriber will bear responsibility for treatment; it is therefore important that, the prescriber, understands the patient’s condition as well as the treatment prescribed and can recognise any adverse side effects of the medicine, should they occur.
For information on licensed indications for medicines healthcare professionals should refer to the BNF (www.bnf.org), BNF for Children (www.bnfc.org) and Summary of Product Characteristics (www.medicines.org.uk)
Good Practice Guidance
When prescribing any unlicensed medicines or licensed medicine for unlicensed use, the prescriber must
– be satisfied that an alternative, licensed medicine would not meet the patient’s needs or where a suitably licensed medicine that would meet the patient’s need is not available (for example if there is a temporary shortage in supply) or the prescribing forms part of a properly approved research project.
– be satisfied that there is a sufficient evidence base and/or experience of using the medicine to demonstrate its safety and efficacy
– take responsibility for prescribing the medicine and for overseeing the patient’s care, monitoring, and any follow up treatment, or ensure that arrangements are made for another suitable doctor to do so
– make a clear, accurate and legible record of all medicines prescribed and, where you are not following common practice, your reasons for prescribing an unlicensed medicine
Information for patients about the licence for their medicines
– Prescribers must give patients (or their parents or carers) sufficient information about the medicines you propose to prescribe to allow them to make an informed decision.
– Some medicines are routinely used outside the terms of their licence, for example in treating children. In emergencies or where there is no realistic alternative treatment and such information is likely to cause distress, it may not be practical or necessary to draw attention to the licence. In other cases, where prescribing unlicensed medicines is supported by authoritative clinical guidance, it may be sufficient to describe in general terms why the medicine is not licensed for the proposed use or patient population. You must always answer questions from patients (or their parents or carers) about medicines fully and honestly.
– If you intend to prescribe unlicensed medicines where that is not routine or if there are suitably licensed alternatives available, you should explain this to the patient, and your reasons for doing so.
-You should be careful about using medical devices for purposes for which they were not intended.
Rockfield Medical Centre policy on prescribing unlicensed/specialised medication
- The legal responsibility for prescribing resides with the person signing the prescription, not the person recommending the prescription.
- Prescribers must be satisfied that they are happy to take responsibility for prescribing, monitoring and following up any prescriptions they provide.
- The default policy for Rockfield Medical Centre is not to prescribe unlicensed medication on the recommendation of other prescribers unless in exceptional circumstances.
- If a request is received to prescribe unlicensed medication, it should be discussed with the GP Partners to see if they are happy to prescribe. Until this discussion can take place, or if the GP Partners are not happy to take over prescribing, the responsibility for prescribing resides with the person recommending the prescription.
- This also applies to medication which is licensed but with restricted indications such as ‘expert supervision’, or requiring specialised monitoring which is not part of GMS.
- Requests to prescribe ‘amber list’ medication under a shared care arrangement will be considered on a case by case basis. Due to the difficulties with follow up in the private sector, we are unlikely to agree to prescribe under shared care arrangements with the private sector – see Appendix I below.
Appendix I
REQUEST BY INDEPENDENT SECTOR PROVIDER FOR GP TO PRESCRIBE “AMBERLIST” MEDICATION
FAO Dr XXXXXXX,
Regarding YYYYYYY; DOB; ADDRESS; HCN
Dear Dr XXXXXXX
The practice has received a request for us to prescribe ZZZZ.
This is an “amber-list” medication. GPs are not obliged to prescribe amber-list meds without assurances about followup. Regrettably this practice has seen occasions where follow-up in the private sector has not occurred as planned leaving GPs in a very difficult position.
We will consider all requests individually but we must be clear about next planned review interval. Additionally in order that we can maintain the same standard of governance where either (1) a patient’s monitoring results become abnormal or (2) where a patient does not attend for monitoring we require to have a mobile number for contacting the private specialist responsible for the amber list recommendation.
If this is not possible the practice is unlikely to be able to consider the requirements for a shared care agreement are met.
The choices for private Drs are then either •
- Issue a private prescription themselves mindful of the need for repeat prescriptions in some instances.
- Refer the patient to themselves or a colleague under the NHS (the DHSSPSNI guidance is clear that there is no probity issue with this)
We hope that this clarifies matters for private Drs and will help to avoid confusion for patients. We have attached some appendices for further reading.
https://www.bma.org.uk/media/1563/bma-prescribing-in-general-practice-april-2018.pdf
If a patient has been seen privately in secondary care and is given a private prescription, is it acceptable for them to come to their GP and ask for it to be converted to an FP10?
If a GP receives a letter from a private consultation advising/suggesting a course of action then it may be appropriate for a script to be issued on an {HS21} if the GP agrees with the advice.
The prescriber takes clinical responsibility for monitoring, so the GP must ensure that they are able to accept this responsibility. If the drug is one that a GP would not normally initiate, then it may be prudent to await a full communication from the private consultant.
Even then, replacement of the private prescription with a {HS21} may not be appropriate and the patient may need to be advised of this.
Can my GP refuse to give me a prescription that my consultant asked them to provide?
Yes, your GP may refuse because the person who signs the prescription is legally liable for the prescribing and the consequent effects of that drug. Some drugs which may be very familiar to consultants in a specialised area of medicine can be potent drugs of which a GP will have little experience (for example many cancer drugs or specialised treatment for diseases such as rheumatoid arthritis – the group called ‘biologicals’).
Where a GP considers that it is inappropriate for them to issue a prescription on the advice of a third party, responsibility for provision will rest with the doctor making the recommendation.
Referral of Private Patients to HPSS Lists
2.12 Patients who choose to be treated privately are entitled to HPSS services on exactly the same basis of clinical need as any other patient.
2.13 Where a patient wishes to change from private to HPSS status, consultants should help ensure that the following principles apply: • any patient seen privately is entitled to subsequently change his or her status and seek treatment as a HPSS patient; • any patient changing their status after having been provided with private services should not be treated on a different basis to other HPSS patients as a result of having previously held private status;
http://www.ipnsm.hscni.net/download/document-library/HSSMD1603.pdf
THE REGIONAL GROUP ON SPECIALIST DRUGS – IMPLEMENTATION OF RED/AMBER LISTS – 1 MAY 2003
Amber List Drug: Responsibility for prescribing may be transferred from secondary to primary care with the agreement of an individual GP and when agreed shared care arrangements have been established.
AMBER LIST It is recommended that amber list drugs are appropriate for shared care, responsibility for prescribing may be transferred from secondary to primary care when agreed shared care arrangements have been established. The GP would normally undertake prescribing responsibility provided he/she was content that sufficient information was available to do so.
Concern about the prescribing/monitoring of a specific product should be discussed between parties. It is recommended that shared care agreements should be drawn up following local discussion and agreement by prescribing parties.
Criteria for products which may become part of shared care agreements (Amber List):
Circumstances which meet all of the following criteria may allow a product to be used as part of a shared care arrangement, following agreement by both prescribing parties involved:
1. A shared care proposal has been drawn up following joint discussions of the parties.
2. The shared care agreement:
- provides a comprehensive summary of treatment.
- defines the responsibility of the consultant and GP for monitoring and adjusting treatment.
- defines the referral procedure from hospital to GP.
- defines the back-up facilities available to the GP from the hospital with which the agreement is made.
3. The GP is satisfied that he/she has all the information and support needed to prescribe and to monitor the patient.
4. If a product is not licensed for the proposed indication, full justification for its use is given by the consultant to the GP