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10.09.2009 "MHRA unlicensed medicines consultation – pharmacy bodies respond"

The Association of Independent Multiple pharmacies (AIMp), Company Chemists’ Association (CCA) and National Pharmacy Association (NPA) have responded to the MHRA informal consultation on the review of unlicensed medicines.

The pharmacy bodies have emphasised three main areas:

1. As there is already a requirement to obtain patient consent for the use of unlicensed medicines, there is no need to introduce additional 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

2. The patient information leaflet should emphasise the need to report suspected reactions promptly to the pharmacist.

Pharmacists are under a professional obligation to report an adverse drug reaction including completing and returning a ‘yellow card’ to the licensing authority.

3. If a specials manufacturer is 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.

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. Pharmacists need to be aware of delays in order for the patient’s treatment to be discussed with the prescriber, and if necessary, an alternative product prescribed.

The CCA’s position on unlicensed medicines can be found under the CCA Policy section of our web site.

The full consultation response “MHRA Informal consultation on the review of unlicensed medicines” can be requested from communications@npa.co.uk.