Drugs manufacturing and distribution in the UK are subject to regulations to ensure that products with a 'marketing authorisation' or licence conform to internationally agreed standards.
By signing a prescription a doctor accepts responsibility for that prescription and must be satisfied that the treatment is clinically appropriate and that the patient is suitably informed and gives valid consent. The doctor must be familiar with potential side-effects, interactions and any monitoring requirements.
An unlicensed product must be supplied in accordance with the Medicines for Human Use (Marketing Authorisations Etc) Regulations 1994, schedule 1.
However there is an exemption from the need for a marketing authorisation where a drug is supplied to fulfil a 'special need' as defined by the prescriber, in response to their bona fide order for use on a named-patient basis. For example, an unlicensed product may be requested temporarily when a suitable licensed product is unavailable.
The regulations limit the amount of stock held and the supplier (including prescribing and dispensing doctors) must keep records relating to the source, persons to whom the drug was supplied, quantity and batch number of the unlicensed product, and details of any adverse reactions for five years.
The prescriber must report serious adverse drug reactions using the Yellow Card system. These regulations do not apply to off-label prescribing, where a licensed drug is prescribed outside the terms of its marketing authorisation.
A patient who suffers damage as a result of a prescribed drug can make a claim under the Consumer Protection Act 1987. Under the Act, strict liability rests with the manufacturer if there is a defect in the product. In determining what constitutes a defect the court considers the purposes for which the product is marketed and any instructions or warnings given. When a drug is prescribed off-licence or off-label, the prescriber rather than the manufacturer may be held responsible.
A prescriber may be held strictly liable under the Act if, at the request of anyone who has suffered damage from the product, they cannot identify the manufacturer or the person who supplied it. Keeping accurate records when prescribing off-label or off-licence is vital to avoid this.
The prescribing of unlicensed drugs or of licensed drugs off-label should be limited to circumstances where there is no suitable licensed alternative. The prescriber should revert to the licensed product as soon as possible. Everyone in the supply chain should be made aware if a drug is being prescribed off-licence or off-label. Specialists in secondary care should inform the GP, particularly if the GP is to be asked to continue prescribing.
Some medicines are routinely prescribed outside the terms of their licence, for example, in paediatrics. The GMC advises that 'where current practice supports the use of a medicine in this way it may not be necessary to draw attention to the licence when seeking consent'. Where an unlicensed drug is prescribed, or the reasons for prescribing off-label are not well supported, the patient must be made aware of this.
A detailed record should be kept of any drugs prescribed and the justification for their use. All healthcare organisations should have local policies for prescribing off-licence or off-label and GPs should make sure they are familiar with them.
Dr Page is a medico-legal adviser at the Medical Protection Society, www.medicalprotection.org/uk
Examples of unlicensed or off-label prescribing
Triplovax instead of MMR vaccine
In 2005, demand for MMR vaccine exceeded supply and additional doses of an unlicensed vaccine (Triplovax) were imported from Germany. The DoH issued a circular, reassuring practitioners of the quality and safety of the imported product.
In these circumstances, although the prescriber takes responsibility for the administration of the unlicensed vaccine, the existence of DoH guidance in support of its use makes it unlikely that any claim for negligence against the prescriber would succeed.
Sodium valproate for migraine
A Surrey GP says: 'It is not unusual for us to receive a request from a specialist to prescribe off-label. Recently the local neurologist asked me to prescribe sodium valproate for one of my patients with severe migraine.' He adds that he has also been asked to prescribe unlicensed drugs. 'On one occasion I was asked to prescribe melatonin for an autistic child with a sleep disorder.' In circumstances such as these it is for the GP to decide whether or not they agree to the request. The GP and the specialist concerned should check that they meet the requirements.
- Manufacturer may escape liability.
- The prescribing doctor is responsible.
- There is no obligation to prescribe.
- The patient should be made aware of the circumstances.
- Should only consider when there is no suitable licensed alternative.
www.mhra.gov.uk for 'The Supply of Unlicensed Relevant Medicinal Products for Individual Patients', MHRA Guidance Note 14, revised August 2006.
www.opsi.gov.uk for the Medicines for Human Use (Marketing Authorisations Etc) Regulations 1994.