Unlicensed Medicines

 

JURISDICTION:  CCA & AIMp


DERIVATION

Joint policy position developed in response to an MHRA informal consultation on the interim report of the review of unlicensed medicines.

 

SUMMARY OF POLICY

The CCA and AIMp policy position is that:

·       There should be no additional legislation for the prescribing of unlicensed medicines; this is adequately covered by existing professional obligations.

·       Unlicensed medicines should be quality assured through standards for manufacturers.

·       Every manufactured unlicensed medicine should be accompanied by a patient information leaflet detailing product information.

·       There should be no requirement to label products as “unlicensed medicines” as this may cause unnecessary confusion and concern among the general public.

 

BACKGROUND

The MHRA has issued an interim report on the responses to the concept paper issued in February 2008 as part of the review of unlicensed medicines. The aim of the report was to summarise progress made on the review of unlicensed medicines, to explain the direction of thinking of the review, and to seek feedback on emerging ideas for reform. Under the current arrangements, an unlicensed medicine can be ordered by a practitioner to meet the special needs of an individual patient. It can then be manufactured in the UK by a licensed manufacturer or be imported into the UK under a notification scheme (i.e. ‘specials’).  The review covers only these, and does not cover off label prescribing, preparation of unlicensed medicines in a pharmacy, or mixing of medicines in palliative care.  However, it is recognised that regulatory changes affecting the arrangement for ‘specials’ could have an impact on the preparation of unlicensed medicines in a pharmacy and vice versa.

 

DETAILED POLICY POSITION

Legislative changes

We believe that patient awareness and involvement in decision making over the prescribing of an unlicensed medicine can be achieved through good practice and professional guidance rather than through changes in legislation. The provision of any medical treatment is generally subject to the informed consent of the patient. If there is no suitable licensed product to meet the needs of the patient, the prescriber should provide sufficient information to allow the patient to give informed consent to the treatment with the unlicensed product.  This requirement to involve the patient in the decision to prescribe is no different to the prescribing of licensed medicines – it is only the provision of the additional information about the consequences of using an unlicensed medicine that differs. As there is already a requirement to obtain consent, there is no need to introduce additional legislation.

 

The prescriber must, of course, be aware of the unlicensed status of medicines before they can effectively discuss this with the patient. The status is not always obvious, as some products that formerly were licensed retain their name when the licence is relinquished, and some products prescribed may be available in both licensed and unlicensed forms (which may occur when a licensed product becomes unavailable, and the dispensing pharmacist needs to prepare or procure the preparation of an unlicensed version). We suggest that:

1.       Information should be made available in computerised prescribing systems, so that prescribers know whether the product ordered is the subject of a licence.

2.       Where the prescriber knowingly prescribes an unlicensed medicine, and has provided information to the patient and secured consent to that treatment, this should be indicated on the prescription so that the pharmacist is aware.

3.       Where there is no such indication on the prescription that the prescriber has knowingly prescribed an unlicensed medicine, the pharmacist should, if an unlicensed product is to be supplied, discuss this with the patient and or prescriber, to ascertain whether the patient is aware of the treatment with an unlicensed product and has given consent to that, before the medicine is prepared or procured.

 

 Given that the making of an annotation in (2) above, or the discussion with the patient and or prescriber in (3) above, will impose an additional workload it must be adequately funded.

 

Quality standards

With regard to the development of guidelines covering expectations of quality standards for unlicensed medicines, we believe that where unlicensed products are ordered by a pharmacist to meet the special needs of an individual patient, the quality controls normally associated with licensed medicines, such as stability testing, retention samples and sterility testing are inappropriate as this would increase the time for manufacture, and increase cost.  There is a need for proportionate safeguards, and this can be achieved by licensing the manufacturer, establishing suitable standards of manufacture and ensuring use only of appropriately assured raw materials. The consolidation of orders, or the pre-planning of ordering, may in some cases provide greater opportunities for quality control, but that is not appropriate for many of the one-off individual orders.  Therefore, to avoid a two tier system of quality control, dependent on whether consolidation of orders takes place, the efforts to enhance quality should be process driven, not dependent on end-product testing.

 

Product information

We are of the view that supplying a patient information leaflet with all unlicensed medicines would in some cases be impossible to comply with.  In some cases there may be a delay in production of a bespoke leaflet.  The manufacturer will not necessarily know the purpose for which the unlicensed product is provided.  But, patients must be informed appropriately of the medicines they are prescribed, to ensure safe use. We therefore suggest that every manufactured unlicensed medicine should be accompanied by a patient information leaflet setting out the composition of the product, explaining that the product is unlicensed but is prepared to the specification prescribed, and should be administered in accordance with the prescriber’s directions.  Possible contra-indications or interactions should be included.  Advice to report adverse effects should be included (see below).

 

We are not in favour of labelling a product as an “unlicensed medicine” as it may impair the patient’s confidence in their treatment regardless of any conversations they may or may not have had. Healthcare professionals understand the meaning of ‘unlicensed’ in this context; however, the use of this term has the potential to cause confusion and concern amongst the general public.

 

Pharmacovigilance

The CCA supports any action to clarify and strengthen pharmacovigilance given the higher risk associated with unlicensed medicines. The patient information leaflet should emphasise the need to report suspected reactions promptly to the pharmacist, who is under a professional obligation to report an ADR including completing and returning a ‘yellow card’ to the licensing authority.

 

Regulatory reform arrangements

It is our view that the procurement of an unlicensed medicine from a manufacturer for an individual patient against the prescription of a prescriber who has chosen that product on clinical grounds may be urgent, and the processes of ‘listing’ particular products or requirements for notification must not undermine the ability of a manufacturer to respond promptly to such an order. If as a result of the implementation of any of the options means that a specials manufacturer will be unable to supply a ‘special’ within a short time frame (perhaps 72 hours), then there should be a requirement for the manufacturer to communicate this to the pharmacist, so that the patient’s treatment can be discussed with the prescriber, and if necessary, an alternative product can be prescribed.

 

We believe that community pharmacists must be able to exercise their rights under the section 10 exemption and prepare a ‘special’ if in their judgement this is the best course of action to ensure high quality and timely patient care. If the time taken to procure ‘specials’ is extended, there may be delays to patient treatment.  Whilst pharmacists can be trusted to prepare a ‘special’ only within their competence and with appropriate skills, facilities and raw materials, the time burden for this preparation may reduce the time available for other, equally pressing matters.  The fact that procurement of a special may have been the preferred method of obtaining the appropriate product means that the pharmacist’s time and other resources may be stretched if specials cannot be obtained in a timely manner.

 

SUPPORTING EVIDENCE/DOCUMENTATION

MHRA consultation documents

http://www.mhra.gov.uk/Howweregulate/Medicines/Medicinesregulatorynews/CON046472

 

 

 

8 September 2009