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Medicines for children, published in June 1999, was prepared under the direction of the Medicines Committee, a joint committee of the Royal College of Paediatrics and Child Health (RCPCH) and the Neonatal and Paediatric Pharmacist’s Group. The aim is to provide information on the drugs currently given to children for prescribers, dispensers, carers, families and children, health service managers, the Department of Health, and the courts. A secondary but equally important aim is to identify those recommended drugs that need to be subject to further clinical trials, or controlled use, or national surveillance.
An illustration of the need for such a formulary arose in 1990 when a number of Health Authorities averred that only licensed medicines should be prescribed, dispensed, and administered in their hospitals. Paediatricians wrote to the RCPCH (then the British Paediatric Association) expressing their concern. Managers are often not aware that the licence is not a licence to administer the medicine, it is a licence to sell it. The Medicines Control Agency gives market authorisation. Patients might be at a considerable disadvantage if they were only given medicines in the form and dosage the pharmaceutical industry present them, and if they were given only those drugs for which there is sufficient evidence to satisfy the Marketing Authority for a licence to be granted for the proposed usage.
Some drugs we recommend for the benefit of children have no licence at all—for example, medicines used in the treatment of children with rare metabolic diseases. The Medicines Committee’s initial response to this was to prepare Drug bulletins on these drugs and send them to members. This information is now incorporated in the new formulary.
Many drugs given to children do have a licence but they are used off label. This is a complex issue. The drug may be off label for many reasons. Doctors have a duty to prescribe in the best interests of their patients. They must be well informed about the illness for which the medicine is given and the unique characteristics of each patient, as well as the properties of the drug concerned. That a Marketing Authority has scrutinised the facts and given its approval for a particular use is reassuring, but doctors must consider far more than that when they prescribe a drug.
There are many excellent sources of information on prescribing for children. We explored working within theBritish National Formulary framework, but the British National Formulary is constrained by the information in the datasheets and summaries of product characteristics, and could not move to where we wished to be. We looked at the current hospital formularies. They have differing styles and objectives. It is increasingly demanding to keep them up to date. So we began afresh. The Nuffield Foundation gave a generous grant to the RCPCH, which allowed us to appoint a formulary coordinator. After much discussion we elected to separate the guidance on use from the drug information, and to list the drugs in alphabetic order. We then, through our professional bodies, invited paediatricians and pharmacists to link together and produce a section on guidance with information on the drugs recommended. There have been contributions from all over the UK.
These first drafts were balanced for content and presentation and reviewed by the members of the formulary committee. A second draft then went to the reviewers who were from a range of disciplines. There were areas of disagreement, and no doubt there will be more. Identifying such territories is itself a worthwhile exercise. The text was then adjusted according to the reviewers suggestions as far as possible, and the drafts considered again by the formulary committee. A third draft was prepared, which was more concerned with format and presentation. Our aim was to be as clear, balanced, relevant, and consistent as possible.
The formulary is in four sections, guidance on prescribing, drug monographs, special foods, and indexes. In particular, the drug monographs give generic names where possible, it gives the dosages in age bands, it states what the prescriber or dispenser should know before the drug is prescribed or dispensed, and it gives the licence status. But it does not give the endless list of possible rare reactions, nor all the drug formulations available. The professional will still have to refer occasionally to the “Compendium of datasheets and summaries of product characteristics”, andMartindale (The Pharmaceutical Press).
There is much more to do—for example, an abridged version to fit in residents’ pockets, electronic versions so that hospitals can prepare dedicated guidance, simpler statements to compliment product information leaflets, information suitable for parents and children. And we will need to establish a databank. Over 50% of the drugs listed are either unlicensed or used outside the licensed indications. These need to be individually reviewed and identified for further trials, or controlled use, or focused surveillance.