A Boots pharmacist (Miss Lisa Taylor-Lloyd of Kestral Drive, Crewe) and a former preregistration trainee (Mr Ziad Khattab of Alton Road, Eccles) have been cleared of manslaughter charges arising from the death of a baby after the Crown Prosecution Service asked the judge, Mr Justice Forbes, to rule that there had been no criminal intent and to direct not guilty verdicts.
As reported last week (p356), the judge fined Miss Taylor-Lloyd £1,000 and Mr Khattab £750, after they pleaded guilty to a charge of not supplying “a medicine of the nature or quality demanded” (a Medicines Act 1968 Section 64 offence).
The charge arose from the death of three-week-old Matthew Young after he had been prescribed peppermint water to treat colic when he was four days old (PJ, May 30, 1998, p768). The prescription had been dispensed at the Boots pharmacy at Hallwood Health Centre, Runcorn. Mr Khattab had made up the peppermint water so that it contained an excessive amount of chloroform.
Inviting the not guilty direction, Mr Peter Hughes, QC, prosecuting, told Chester Crown Court on March 4 that there was real doubt over whether Mr Khattab’s university and preregistration training would have left him fully appreciable of chloroform water in its concentrated and other forms. In expert reports, Dr Jonathan Cooke (director of pharmacy, South Manchester University Hospitals trust) and Professor Clare Mackie (head of the Robert Gordon university school of pharmacy, Aberdeen) had come to the same conclusion. A bottle of concentrated chloroform water used to prepare the prescription bore no instructions for dilution or warning that dilution was required.
The court was told that the prescription in the case (see above) called for 150ml of Alder Hey peppermint water, 2.5ml to be taken before feeds.
The recipe in the Boots formula book was for a 200ml quantity of “non-alcoholic peppermint water” and called for: concentrated peppermint emulsion 5ml; chloroform water, double strength 100ml; and purified water to 200ml.
The prescription was one of a batch of pre-signed prescriptions used at the health centre with the baby’s details having been entered after it had been signed, the court heard.
Professor Mackie had also commented on significant differences in practice between supervision levels in hospital pharmacy and community pharmacy. In hospitals it was standard practice for all work on extemporaneous preparations to be properly verified and checked and for worksheets to be completed. That was not the case in community pharmacy. Immediately following the death, the Royal Pharmaceutical Society had warned all pharmacists to check extemporaneous prescriptions (PJ, May 30, 1998, p783).
Mr Hughes added that the health centre pharmacy had not been recognised for preregistration training. Mr Khattab would only have been allowed to work there for seven days in the year. In fact, he had been working there one day a week. He was expected to work under the supervision of a tutor pharmacist. Miss Taylor-Lloyd was not a tutor pharmacist. To become one it was necessary to have three years’ post-qualification experience, whereas she had only 21 months’ experience.
It was apparent from her interview that she would not have been in a position that a tutor pharmacist would have to be in to understand the degree of supervision needed by a trainee, Mr Hughes told the court.
Turning to the Medicines Act charge, Mr Hughes said that Mr Khattab had been asked by Miss Taylor-Lloyd to prepare a bottle of Alder Hey peppermint water.
“I thought it would be good experience for him,” she had said in a police interview.
She knew that Mr Khattab had made the product before, so she felt confident that he could do it, Mr Hughes went on. The formula was kept in a large book which had been in use for, perhaps, 10 years and needed to be revised. The quantities in the formula were for 200ml of a non-alcoholic peppermint water. The prescription specified 150ml, so the ingredients would have to be reduced, needing 3.75ml of peppermint emulsion and 75ml of double strength chloroform water.
Chloroform water used to be available in concentrated, double strength and single strength, Mr Hughes told the court. The formula was out of date, double strength chloroform water was no longer in use and was not stocked at the Hallwood pharmacy. Mr Khattab would have had to substitute concentrated chloroform water and dilute to 75ml. This was straightforward by taking 3.75ml of the concentrated chloroform water and diluting it to 75ml.
Referring to the formula book, Mr Hughes said that someone had at some stage written in concentrated chloroform water 5ml. Other quantity figures had also been written in. He said that, according to Mr Khattab, the entry in the book was in small print and he did not appreciate the significance of this.
One of the dispensers had seen Mr Khattab with the prescription, had noticed that it was for 150ml peppermint water and had realised that he would have to adjust the quantities. She had told him that he would need 3.75ml of concentrated chloroform water and 3.75ml of peppermint emulsion. She noted the details on a piece of paper for him. She also advised him that the 10ml measure had been broken and to use a 5ml syringe to measure the concentrates. Having done so, she returned to her own work believing that he had understood. It was not part of her work to supervise Mr Khattab or to check that he had got things right.
Mr Khattab had told the police that he had experience of preparing peppermint water. He knew that the formula book was misleading and had been further confused by the fact that he also worked at another Boots pharmacy at Runcorn where concentrated chloroform water was used, rather than double strength chloroform water. The error Mr Khattab had made was to put 75ml of concentrated chloroform water into the 150ml of mixture for Matthew Young, rather than 3.75ml. In his police interview, Mr Khattab had said that he had not realised there was any difference between concentrated chloroform water and double strength chloroform water.
“We find that statement surprising, particularly as he had done it before,” Mr Hughes said. However, he added that Professor Mackie and Dr Cooke said that pharmacy graduates now had limited experience of preparation and that Mr Khattab might not have realised the difference, particularly as there was no dilution specified on the label. Miss Taylor-Lloyd had not checked Mr Khattab’s work. She had initialled the label on the bottle, certifying that it had been checked and handed it to Matthew’s mother with a syringe.
Mr Hughes said that the result had been catastrophic. The moment Matthew’s father started to give the peppermint mixture he had realised that something was wrong. Matthew suffered a cardiac arrest and was rushed to Alder Hey hospital where he was treated in intensive care. Matthew suffered severe brain damage and died two-and-a-half weeks later.
Miss Taylor-Lloyd had a statutory duty to supervise, Mr Hughes said. The Society gave guidance on this in its standards of good professional practice. He outlined six circumstances that Miss Taylor-Lloyd should have borne in mind:
- The prescription was for a new-born baby
- This was an extemporaneous preparation, which was now rare
- The formula in the book was confusing and not a clear and straightforward set of instructions; two of the ingredients were concentrates in small quantities, the formula was out of date and referred to double strength chloroform water
- She had worked with Mr Khattab before and had not formed a favourable view of his abilities
- Having delegated the task she knew he was having difficulties and did not intervene
- She initialled the bottle without going through any routine checks
Mr Hughes told the court that under Section 64 of the Medicines Act 1968, it was not for the prosecution to prove gross negligence, or negligence at all, if a defective medicine was supplied. It was for the defendants to show all due diligence.
Mr Brian Leverson, defending Miss Taylor-Lloyd, said that she had seen Mr Khattab preparing the mixture before and that she had no reason to find making up the percentages of chloroform confusing. She had also seen that the correct bottles and ingredients had been used.
Mr Richard Ferguson, defending Mr Khattab, said that he came from a family of professionals which had moved to England from Iraq when he was five years old. He came from a family of pharmacists, with both his mother and brother in practice. He told the court that Mr Khattab had been working at a health centre which was not registered as a training pharmacy under by-laws and that the level of supervision was not sufficient. Mr Khattab had sought advice and had misinterpreted what was said.
Mr Ferguson said that Mr Khattab remained keen to pursue a career in pharmacy, but that he would have to undergo counselling as he had suffered a great deal of mental anguish over the incident.
Sentencing, Mr Justice Forbes said that it was clear that the defendants were not criminally responsible for the death of Matthew Young.
“The death of Matthew was a tragedy which should never have happened,” he said. “He died as a result of what should have been nothing more serious than colic wind.”
The judge outlined two major points that arose from the case — differences between practices in community and hospital pharmacy, and the state of the formula book at Hallwood health centre, which was out of date. He said that he took account of the fact that both defendants had worked hard to get where they were and that they both faced hearings before the Royal Pharmaceutical Society’s Statutory Committee in the future.
“The custody threshold has not been passed and it would be quite inappropriate in this case,” he said. “But each of you failed to show due diligence in the dispensing of this solution.” He based the fines on the defendants’ abilities to pay.
Boots superintendent’s statement
In a statement after the case, Mr Digby Emson (superintendent pharmacist, Boots the Chemists) said: “We must not forget that this was a tragic incident where a child has died. Our deepest sympathies continue to be with Matthew’s parents and family.
“We cannot imagine the grieving that Matthew’s parents and family have been through and we know that everyone who has been involved in this incident has been seriously affected by it. This is particularly the case for our two employees who had to undergo a very difficult ordeal.
“Immediately following the incident we reinforced our existing procedures. We were pleased that the judge noted these changes and we will carefully consider all that has been said in court. We will take prompt action to implement any further lessons and share them with the rest of the profession. We are determined to do everything we can to ensure the highest professional standard in all our pharmacies.”
Boots changes procedures and seeks label for concentrates
Boots the Chemists has changed its procedures for extemporaneous dispensing and is working with manufacturers on label changes for concentrated ingredients in order to reduce the risk of dispensing errors.
In an interview with The Journal on March 7, Mr Digby Emson (superintendent pharmacist, Boots the Chemists) said that the peppermint water incident (see above) had brought to the fore the issue of whether extemporaneous dispensing should be carried out in community pharmacies.
Mr Emson said that he expected Boots pharmacists to make their own judgments on extemporaneous dispensing, taking into account such factors as the urgency of the medication, but that he now wished to review company policy and would consider whether guidelines were needed on when products should be prepared in pharmacies and when they should be obtained from a specials manufacturer.
After the incident, the company had introduced extemporaneous dispensing record books for pharmacy use. Boots would make these available to members of the profession who might wish to use them.
Previously, Mr Emson went on, extemporaneous dispensing had been expected to be subject to Boots’s standard checking procedures. In the majority of cases this provided the necessary safeguards. Exactly what checking was carried out had been for individual pharmacists to decide in order to meet their obligations under the Medicines Act 1968 and the profession’s Code of Ethics.
Mr Emson said that the prescription that gave rise to the incident called for Alder Hey peppermint water. This was made to an accepted formula used by pharmacies in the vicinity and had been in use for many years. The death of Matthew Young was the result of a tragic dispensing error.
Immediately after the incident, the company had written to the local health authority about what had happened. The HA had recommended medical practitioners no longer to prescribe peppermint water and to use equivalent proprietary products instead.
Addressing the question of Boots’s local preregistration training arrangements, Mr Emson attributed the non-approval of the Hallwood health centre pharmacy for preregistration training to an administrative error. For many years both the health centre pharmacy and Boots’s Runcorn store were approved for training. Trainees were based at the town-centre store and spent a limited amount of time at the health centre in order adequately to demonstrate their competence. The company had failed to reapply for approval of the health centre pharmacy. Approval had not been withdrawn by the Royal Pharmaceutical Society.
Boots had provided full support for the pharmacist and preregistration trainee involved, Mr Emson went on. It had appointed and paid for separate legal representation for each of them so that they were independently represented throughout the investigative process and the legal case. In the event, the judge had ordered that the defence costs, so far as the manslaughter charges were concerned, should be met from public funds. The company also had a “help service” and an occupational health service that had been available to the staff involved. Throughout the case, the company had continued to employ the two, but not in any professional areas. It would now need to decide, with the Society’s help, what would be an appropriate course, bearing in mind that the pharmacist might face a Statutory Committee inquiry, as would the preregistration trainee, should he seek registration as a pharmacist.
Mr Emson, who had been superintendent pharmacist for three weeks when the incident occurred, said that Boots had good incident reporting procedures and that there had been nothing to indicate concern prior to this dispensing mistake.
He said that the baby’s parents had not instigated civil proceedings against Boots. The company had indicated to them that it would deal sympathetically with any civil claim.
From PJ, March 18, 2000, p427
In our account of the proceedings at Chester Crown Court on March 4, when two Boots employees pleaded guilty to supplying a medicine not of the nature or quality demanded (PJ, March 11, p390), we reported that a dispenser had told one of defendants that he would need 3.75ml of concentrated chloroform water and 3.75ml of peppermint emulsion to prepare the medicine. She had noted the details on a piece of paper, the court was told by prosecuting counsel. Readers should note that counsel for the defence told the court that, when interviewed by police, the dispenser had said that she could not remember writing down 3.75ml of concentrated chloroform water. He said that there had been a misunderstanding between the defendant and the dispenser.