Peppermint water case: now the lessons must be learnt

Extemporaneous dispensing has come under scrutiny following last week's court case involving a "catastrophic" dispensing error, which resulted in an infant's death.The case, in which a pre-registration student confused different strengths of chloroform water, has resulted in Boots tightening up its procedures for extemporaneous dispensing. The Royal Pharmaceutical Society is now considering all the issues raised by the tragedy, including whether or not extemporaneous dispensing should continue to be a part of a community pharmacist's practice.The case has also highlighted the fact that, although a supervising pharmacist takes ultimate responsibility, anyone else involved in dispensing a medicine may be accountable in law.RPSGB director of Professional Standards Sue Sharpe said on Tuesday that there were a number of lessons to be learnt by the profession as a whole. A key point is that knowledge cannot be assumed. In its review of the case, the Society will have to look at both educational and professional issues, including training and standards. "Our principal concern must be to make things right for the future," she said.Section 64 of the Medicines Act allows the prosecution of not just the pharmacy owner but also of the pharmacist responsible for the medicine, Mrs Sharpe told C&D. The Act also permits any other person who is involved in the process to be charged. It was for this reason that the pre-registration student was charged, but dispensing technicians could be similarly liable.As the principal enforcement authority, the Society has been involved in the case, but is only now able to take proceedings forward after the case brought by the police has been dealt with. As for the Statutory Committee, Mrs Sharpe said: "We will apply the normal criteria, including action taken after the event, lessons learnt and so on. The issue for the Society is the professional accountability of those involved, and that will be looked at and dealt with in the relatively near future."Whether this means that extemporaneous dispensing will end is unlikely, as consideration must be given to the needs of patients and their expectation to receive a medicine with reasonable promptness, she said. It is also not possible for all preparations to be manufactured industrially. But this must be balanced with the fact that many community pharmacists are now unfamiliar with extemporaneous dispensing procedures. "We would think long and hard before we would want to stop extemporaneous dispensing, but it is an area which we need to look at."Boots pharmacy superintendent Digby Emson explained that the health centre pharmacy where the dispensing error was made was not approved at the time as a pre-registration pharmacy. However, it had been used as one in the past and seemed an ideal place for pre-registration student Ziad Khattab to gain wider experience of some of the competencies required during the pre- registration year. Mr Khattab's approved store was in the centre of Runcorn.Since the event, Boots has introduced an extemporaneous dispensing record book which demands a full record. "We have now made it a procedure that all formulae are recorded in the book and they need to be updated every three months," said Mr Emson.The book requires records to be kept for each individual preparation, with full prescription details, calculations, notes of ingredients used and checks. Local formulae must also be recorded and checked for accuracy and currency. "The key reason for the introduction was to ensure that we had a system in place that regularly reviewed local formulae so that we minimise the risk of this ever happening again," he said.Shortly after the event, Boots notified the health authority that the mixture in question had originated in secondary care and gained some hold in the local primary care setting. Boots has asked that steps be taken to discourage the prescribing of medicines requiring extemporaneous preparation where proprietary equivalents are available.Mr Emson was keen to stress that the company's sympathies remain with the family. It is understood that Boots offered help to them early on and it is expected that further support will be agreed promptly. "We would continue to wish to give the best possible professional service to the people of Runcorn and we will continue to make every effort to do that," he added.THE CASE - KEY POINTSThe original trial for manslaughter had been expected to last three weeks. However, this charge was dropped shortly before the trial began and Mr Khattab and supervising pharmacist Tracey Taylor- Lloyd pleaded guilty to a second charge of `providing a medicine not to the quality specified' under section 64 of the Medicines Act 1968. Ms Taylor-Lloyd was fined #1,000 and Mr Khattab #750. The defendants were working at Boots' Hallwood Health Centre pharmacy near Runcorn, Cheshire, when the error occurred.New-born Matthew Young was prescribed Alderhey Peppermint Water Mixture for colic but died a few days later in hospital. Mr Khattab had used Concentrated Chloroform Water instead of Chloroform Water Double Strength. The mixture, when later sent for testing, was found to have separated out into two phases with a layer of pure chloroform collecting in the bottle.Among the factors commented upon and relating to the error were:* the bottles of chloroform concentrate had no directions for dilution* as Double Strength Chloroform Water was no longer available as a stock item, it had to be prepared from the concentrated stock bottle requiring two stages of extemporaneous dispensing* the formula for the mixture was kept in a ten-year-old book with hand written amendments making it unclear* Ms Taylor-Lloyd did not check each stage of the mixture's preparation individually, but initialled the label on the bottle on final check* the prosecution found it surprising that Mr Khattab said in an interview that he did not realise there was a difference between the concentrated chloroform and double strength chloroform waters, particularly as he had done it before* expert witnesses from academia confirmed that undergraduate students may now have little experience of preparation.At the hearing, the judge, Mr Justice Forbes, repeatedly stressed that the defendants were not criminally responsible for the death of Matthew Young. "In my view two matters led to this tragedy," said the judge. "Different practices in the community pharmacy compared with hospital premises when preparing extemporaneous prescriptions, and ... the existing state of the formula book at the dispensary, exasperated by one principal ingredient no longer being available."The court noted the change in practices that had been introduced since the incident. This includes Boots asking its supplier of chloroform concentrates, Thornton & Ross, to amend labels to give directions for dilution.At the end of the case, the defendants were awarded costs as the charge of manslaughter was dropped.