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The study undertook to determine and quantify the factors influencing the prescribing and subsequent use of new drugs in neonatal and paediatric medicine in National Health Service (NHS) and private hospitals, using written questionnaires and telephone interviews.
A survey of the structure of the Drug Formulary/Aproved List and Drug and Therapeutics Committee/Medical Advisory Committee in place in each hospital was conducted to determine the request and approval processes for the introduction of new drugs.The factors influencing these processes were determined by surveying the requests for new drugs made from 1st June 1996 until 31st May 1997.
Thirteen out of the 14 NHS hospitals surveyed had a formal procedure for the introduction of new drugs and only 1 out of 10 private hospitals. Two of the major private hospital groups were proposing to introduce approved lists or systems for the management of new drugs, however their Medical Advisory Committees (MAC) were advisory only and pharmacists were generally not members.
The factors influencing the request and approval processes for new drugs were mainly clinical and financial, and were determined mainly from pharmacist's feedback of the Drug and Therapeutics Committee discussion. In the private hospitals the introduction was influenced by experience of the new drug in the NHS and different financial considerations. From these surveys, the clinical and financial considerations for the introduction and subsequent use of sevoflurane and amethocaine gel (Ametop®) were studied in more depth, by surveying medical, pharmacy and nursing staff to determine the changes in perception of these new drugs. The study found that the clinical and financial benefits perceived at the time of introduction changed with clinical experience and influenced subsequent prescribing patterns. These perceived benefits were generally based on marketing literature unless there was personal involvement in clinical trials.
Sevoflurane was found to be a quicker, smoother agent for induction, having greater safety and tolerability than existing agents, therefore replacing these agents for induction and in some cases maintenance of anaesthesia, despite its greater cost and smell (described as 'manure-like').
The expectations of amethocaine gel were not fulfilled because, although the incidence of erythema, itching and blistering were recognised in the pre-marketing literature the consequences of these adverse reactions in practice were not fully appreciated. Amethocaine gel still offered certain clinical advantages such as quicker onset of action for day case surgery, but the anticipated cost savings were not attained.
The change in perception of sevoflurane and amethocaine from its introduction and subsequent use appeared to correlate between medical, pharmacy and nursing staff in NHS and private hospitals. Comments from medical staff were based on their clinical experience, those by pharmacists were based on the pharmacological/ pharmacokinetic/ financial aspects and those of nursing staff on their practical experience. More information about these changes was ascertained over the telephone. The changes in perception were supported by Coleman's study (1966) which found that colleagues were of little use in the information phase of product diffusion, but that the role of peer relationships gained in importance as the product was on the market longer. This multi-factorial shift in perception from what a new drug could offer to what it does offer in reality determines its fate in the longer term.
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