In April 1998 a GP’s prescription for peppermint water to treat a baby’s colic was made up by a pre-registration trainee in a branch of Boots the Chemists. The preparation contained a 20-fold excess of chloroform, and the baby died as a result.
The trainee and the young pharmacist in charge of the premises on the day were charged with manslaughter, which was changed on the day of the trial, nearly two years later, to an offence under Section 64 of the Medicines Act 1968, of supplying a medicinal product not of the nature and quality specified. Both defendants pleaded guilty, the pharmacist being fined £1,000 and the trainee £750. (1)
Following the normal procedure when a pharmacist has been convicted of a criminal offence, the case was reported by the court to the Statutory Committee of the Royal Pharmaceutical Society, and the two defendants subsequently appeared before it.
The pharmacist received a reprimand, and no action was taken against the pre-registration trainee, leaving him free to register once he had completed his training. (2,3)
During the trial these facts came to light:
- The pharmacy where the incident occurred was not registered for pre-registration training.
- The trainee had been working there regularly for one day per week for several months (the Society’s regulation permit a maximum of seven days experience per year in a pharmacy not registered for training).
- The pharmacist under whose supervision the trainee was working was not registered as a tutor and could not be because she did not have sufficient post-registration experience.
There were two unusual aspects to the case. In the first place, it was the first time that either a pharmacist or a non-qualified member of staff working under a pharmacist’s supervision had been charged with manslaughter following a dispensing error.
Normally in such cases, even those where a patient has suffered harm, the charge brought is the Medicines Act offence that was eventually proceeded with.
Also, it is only the supervising pharmacist and, if a limited company, the company and it superintendent pharmacist who are considered for prosecution, as non-qualified staff are considered to be working under the pharmacist’s supervision.
The Society has the responsibility of enforcing the Medicines Act, and the normal procedure would be for the case to be reported to the Society’s Professional Standards Directorate, which would refer it to the Infringements Committee, which would decide whether to prosecute.
The Committee would at the same time decide whether to refer the pharmacist(s) involved to the Statutory Committee for breaches of Code of Ethics.
The other unusual aspect of the case was that the company and its superintendent pharmacist were not prosecuted or involved in the case in any way.
I was a member of the Society’s Council for 15 years between 1986 and 2002. During that time I was a member of the Infringements Committee for all but three years, and was chairman of it for five of those.
Of all the cases considered by the Committee while I was a member the ‘Peppermint Water’ case was probably the one with the most serious and tragic outcome, and it certainly had the highest public profile, being reported by all the national news media.
Usually cases where dispensing error led to harm to a patient would be referred to the Infringements Committee. It would not only examine evidence for criminal prosecution but would also look at the circumstances surrounding the situation, to see if there had been any apparent negligent or unethical behaviour that might merit referral to the Statutory Committee.
I considered that the company had a case to answer as it had been responsible for the trainee being in the branch on the day that the incident occurred, and that the Society’s regulations on pre-registration training (Byelaw XX) had not been complied with.
I had expected the case to be referred to the Infringements Committee at some stage, but I was not duly concerned when it was not initially as I knew that it had been taken out of the Society’s hands by the police with the manslaughter charge. However, I thought that once the court case was over it would be brought to the Committee.
After the court case I asked the Professional Standards Directorate when the case would be brought to the Infringements Committee, and I was told that it could not be until the Statutory Committee had dealt with the case against the two individuals involved.
By July 2001 I was concerned that the case had not come before the Committee and I asked again, this time to be told that it was not going to be. When I asked why I was given the following reasons:
- The superintendent pharmacist had only been in post for three weeks and therefore could not be held responsible.
- Following the incident the company took immediate steps to make sure that a similar situation could not occur again.
- The police took no action against the company or its superintendent.
I was not completely satisfied with these explanations, for reasons which I give below, and was considering how to take the matter forward when I received a letter from a member of the Society, which said that he was concerned about the case and had made a direct complaint about it to the chairman of the Statutory Committee, who had referred it to the Professional Standards Directorate ‘without direction’.
He had received a letter from the Directorate stating that it would not be taking any action against the company or its superintendent, for much the same reasons as had been given to me.
I then decided to take the matter up with the Secretary and Registrar to get the case brought to the Infringements Committee. I outlined the reasons for the case not having been referred, and said that I considered them to be unsatisfactory for the following reasons:
- A superintendent pharmacist is accountable for the professional conduct of a business from the moment of his appointment, even if not responsible for the situation. If it was thought unfair to take action against the new superintendent, his predecessor, who though no longer legally responsible, was in post when the arrangement was set up and could be called to account.
- Throughout my service on the Infringements Committee, pharmacists called to account almost invariably claimed they had taken steps to ensure whatever had gone wrong could never happen again, but that this rarely if ever was accepted as a reason for complete exoneration
- There had been many instances of reference to the Statutory Committee or other disciplinary action against pharmacists, even though the police had decided to take no formal action.
Following discussions with the Secretary and Registrar it was decided to ask a long-standing Privy Council appointee member of Council and the Infringements Committee to consider the issue. He felt that there was a case to answer and it was eventually brought to the Committee in April 2002.
The Committee at that point decided to take no further action, mainly because of the time that had elapsed since the incident.
The Statutory Committee had recently become critical of the Society for its delay in bringing cases, although this was sometimes for reasons outside its control. In some cases it had taken no action against pharmacists brought before it because of this.
I had two main motives for pursuing this matter. The first was to see equality of treatment for all members of the Society and all pharmacy companies. During my time on the Infringements Committee I have seen many pharmacists and companies disciplined, and the outcome of the error in this case was as serious as any I have known.
I consider that any error involving a fatality, where there is evidence of non-compliance with the Society’s Code of Ethics or Byelaws by a pharmacist or pharmacy company, should be examined by the Committee.
My second reason for pursuing the matter concerned public interest. This was a high profile case that had national media coverage. Following recent medical scandals like Bristol and Alder Hey, health professions are now expected to be open and transparent when things go wrong.
I believe that both the Society’s members and the public have the right to be informed of the outcome of this case, I do not want the Society to be accused of trying to brush awkward cases like this under the carpet.
The cause of the tragic error at the heart if this case was that the pre-registration trainee was not clear on the relationship between concentrated and double strength chloroform waters.
Although chloroform waters are still used in making extemporaneous preparations they are less often used than in the past. Whilst older pharmacists may be familiarity with the relationships between the various strengths, there are real problems for younger practitioners. No current standard reference texts contain information on chloroform waters.
I have suggested before (4) that this information should be re-introduced into Martindale, in which it has not appeared since the 30th edition published in 1993, and that a section on dilutents and vehicles, including waters and concentrated waters, should be included in the BNF.
One positive outcome of my pursuing this case is that it is now the policy of the Professional Standards Directorate for all cases of errors involving fatalities to be referred to the Infringements Committee.
References:
- Boots pharmacist and trainee cleared of baby’s manslaughter.
Pharm J 2000; 264:390-392 - Reprimand for pharmacist in “peppermint water” case.
Pharm J 2002; 227-228 - No action against pre-registration student involved in “Peppermint Water” tragedy.
Pharm J 2001; 267:211-212 - Nathan A. Poor numeracy of students (letter).
Pharm J 2000; 264:592
Alan Nathan was a member of the Royal Pharmaceutical Society’s Council until May 2002 and a former chairman of its Council’s Infringements Committee.