While the UK laws that control the prescribing and the supply of medicines may seem complex, they actually impose few constraints on staff working in a hospital setting. The Medicines Act of 1968, passed in the wake of the thalidomide disaster, regulates the activity of the pharmaceutical industry, making it illegal for any medicine to be marketed for human use in the United Kingdom without a product licence (marketing authorisation). These are issued by the Licensing Authority (the Ministers of Health) on the advice of the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA also oversees the manufacture, promotion and distribution of medicines, while the Committee on Safety of Medicines (CSM) advises the agency on their efficacy, quality and safety. While these licences are not published, the relevant provisions, including indications for use, recommended precautions and dose ranges, are summarised in the manufacturer’s Summary of Product Characteristics (SPC). These summaries can now be accessed via the Internet (www.medicines.org.uk), as can copies of the manufacturer’s Patient Information Leaflet (PIL) be drafted to make key information available in a more accessible format.

However, the 1968 Act was deliberately framed in such a way that it did not restrict ‘clinical freedom’, and it exempts doctors and dentists from many of the constraints placed on drug companies. It is, therefore, perfectly in order for a doctor to recommend, or administer, a drug for which no product licence exists. The Act, and EC Directive 89/341/EEC, also made it clear that a doctor could use an unlicensed drug in clinical trials, or give an unlicensed product that has been specially prepared or imported, for a particular (‘named’) patient. It is also acceptable for a doctor to use, or recommend the use of, a drug in a dose, by a route, for a condition or for a group of patients, which differs from those mentioned in the manufacturer’s product licence (so-called ‘off label’ or ‘off licence’ use). It is also legal for such a drug to be dispensed by a pharmacist or administered by a nurse or midwife. Legislation in America, and in many other countries, has adopted a broadly similar approach.

This legal freedom placed doctors under a heavy legal, moral and professional obligation to ensure that the recommendations they make about drug use are well founded. Such problems become acute when a manufacturer offers no advice with regard to the use of a drug for children of less than a certain age, as is, for example, currently true of almost all drugs used to manage hypotension and hypertension in childhood. Such problems can turn children into ‘therapeutic orphans’. Manufacturers are often reluctant to bear the cost of sponsoring the trials necessary to support a change to the original marketing licence or the cost of collating all the information published in the scientific literature after a product’s first commercial launch so the licence can be updated. Here it becomes particularly important for the doctor to be sure that the use to which they are putting a product is reasonable and prudent in the light of such scientific information as is available in print. This compendium is one aid to that end. The BNF for Children

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