The threat of therapeutic Nihilism.

Abstract

Paediatricians need to move to protect our ability to prescribe for children in our care. There is a particularly pressing problem in paediatric gastroenterology. Many of us, on both sides of the Atlantic, were taken aback by the recent prohibition of the prokinetic cisapride. In the United Kingdom the Committee on Safety of Medicine and the Medicines Control Agency (MCA), the equivalent of the U.S. Food and Drug Administration, issued a circular to all doctors stating that this agent should not be used in the paediatric population. Many viewed this as an unhelpful evidence-free statement that made it difficult for paediatric gastroenterologists to use this agent, which now has an accepted place in the management of gastroesophageal reflux. In some centres its use was abandoned. On enquiry, the agency replied that it could not support the use of unlicensed drugs in the paediatric population although it accepted that some of these agents were used widely. In paediatric gastroenterology, this is a pressing problem that threatens to deny us the liberty of doing the best for our patients. When using drugs outside their license, the doctor assumes individual responsibility and is denied the ready access to drug information contained in data sheets and formularies for licensed agents. Some physicians are concerned about the potential medico-legal issues that can arise from off-license prescribing. The British National Formulary (BNF) published by the British Medical Association and the Royal Pharmaceutical Society of Great Britain is an excellent source of information. It devotes one page to prescribing in children and makes no mention of this dilemma. The picture in gastroenterology is bleak. For pediatric gastroesophageal reflux, licensing for children under 12 years is limited to one H2 blocker and one proton pump inhibitor. No prokinetic agent is licensed. For the constipated child, no bulking agent or stimulant laxative is licensed for children under the age of 6 years with the exception of sodium picosulphate, which is licensed for children older than 2 years. The osmotic laxatives are licensed in younger children. For children with inflammatory bowel disease, within license, we have little to offer our patients other than sympathy. The only agents licensed for children younger than 12 years are sulphasalazine for children older than 2 years and predsol suppositories! All others medications are not recommended for children with the exception of prednisolone, for which no information is provided. Azathioprine is not indicated for adults or children with inflammatory bowel disease, although in the introductory paragraph its use as an unlicensed agent is mentioned. The situation is completely unsatisfactory. There are three possible solutions available to us. First, we can continue to ignore the regulations and prescribe for the children in our care disregarding the licensed status of the drugs we use. At the moment, we have little choice but to pursue this line, but it cannot be seen as a long-term solution. Second, we could demand through the MCA or FDA that pharmaceutical companies obtain a license for use of drugs in children within more common indications. This would bring a welcome increase to paediatric pharmacological research, but it would not answer the problem of prescribing for younger children with conditions that are rare in their age group-a common feature of GI practice. Our gastroenterology societies should put pressure on national bodies to move in this direction. The third solution embraces the use of consensus statements. Such statements, based upon all available evidence, include the experience and practice of experts in the field and may extend to suggesting who might prescribe certain drugs. There are many examples where this has proved a useful basis for prescribing in paediatrics. The imminent publication of the formulary for children by the Royal College of Paediatrics and Child Health is welcome. In the meantime, the paediatric gastroenterologist cannot be constrained by the current licensing arrangements. Our responsibilities to our patients include the choice of the best drug and its prescription, with appropriate care, to children in well-informed families. A little more support and recognition of this problem would be welcome from our colleagues in the regulatory bodies. Simon J Newell, MD, FRCPCH, FRCP Consultant & Senior Clinical Lecturer in Neonatal Medicine & Paediatric Gastroenterology, St. James's University Hospital, Leeds, UK