The Society

Statutory Committee

Phenobarbitone prescription error results in reprimand for pharmacist [more]
Reprimand for allowing unsupervised dispensing [more]
No action taken against preregistration student involved in “peppermint water” tragedy [more]

Phenobarbitone prescription error results in reprimand for pharmacist

The Statutory Committee has reprimanded a Gloucester pharmacist after a child was hospitalised as a result of a prescription being prepared containing almost eight times the prescribed dosage of phenobarbitone.

At its meeting on 13 February the committee inquired into the case of Paul Timothy Wilkin, of Kingsholm Pharmacy, Alvin Street, Gloucester, and the company of which he is superintendent pharmacist, Wilkin Ltd. A complaint had been received from the Council of the Royal Pharmaceutical Society alleging that over-strength phenobarbitone mixture had been supplied under his supervision to a patient after Mr Wilkin, having delegated the preparation of an extemporaneous mixture to a trainee technician, had failed to check the calculations or weighing. It was also alleged that he had failed to reassess the formulation to include a preservative when the volume required was sufficient for six weeks’ supply.

Geoff Hudson, of Penningtons (solicitors) appeared in order to present the facts of the case to the committee.

Mr Wilkin was not present or represented; he had asked for the case to be heard in his absence.

The committee heard that on 8 May 2000, a prescription ordering 500ml of phenobarbitone, 30mg per 5 ml (ie, 0.6 per cent), for a small child had been brought to the pharmacy. The preparation was made up by the trainee technician, shown to Mr Wilkin for checking and given out to the patient’s parent. Mr Wilkin had not checked the weight of phenobarbitone used. The patient was given the medicine over the next three days, after which the child’s mother noticed that the infant had become inactive. The child was taken to hospital, where it recovered. The mixture was analysed and found to contain at least 4.75 per cent of phenobarbitone — almost eight times the dose prescribed. The mixture was also showing signs of contamination by yeasts and bacteria.

When interviewed by one of the Society’s inspectors, Mr Wilkin had explained that the same mixture, in smaller volumes of 100ml or 300ml, had been made up for the same patient on five previous occasions, by the technician under his direct supervision. The formula for the prescription was written in a book kept for extemporaneous prescriptions regularly dispensed. He had wrongly assumed that as the technician had made up the medicine previously, he could accept her assurance that it had been made up according to the formula. He had not told her to discard the mixture and make it up again so he could check the weight of phenobarbitone used. He expressed his mortification that the error had occurred.

Giving the committee’s decision, the chairman (Lord Fraser of Carmyllie, QC) said that while Mr Wilkin had told the inspector that an extemporaneous dispensing record book was kept, it did not include the formula for 500ml of the phenobarbitone mixture, nor was a batch record maintained. He had confirmed that he had not checked the technician’s calculations for ingredients, nor the actual weighings.

Mr Wilkin had been open about the matter and had accepted responsibility. He had stated that the incident was not to be taken as indicative of a general laxity of control or supervision in his pharmacy.

Mr Wilkin had apologised for the distress caused to the child’s parents and pointed out that no similar incident had occurred in his 25 years as a pharmacist. Very supportive references had been received on his behalf and he was a valuable member of the community in which he lived.

However, the dispensing error was a serious matter and amounted to misconduct of a character such as to render Mr Wilkin liable to removal from the register. Exceptionally, given his full admission of fault and responsibility, the committee ordered that Mr Wilkin should be reprimanded.

No further action was ordered against the company.

Reprimand for allowing unsupervised dispensing

A superintendent pharmacist who had been fined for allowing the sale and dispensing of medicines in the absence of a pharmacist, and who had failed to ensure safe custody of Controlled Drugs, has been reprimanded by the Statutory Committee

At its meeting on 14 February, the committee considered the case of Mr Sayyad Qasir Abbas Naqvi, of 16 Raglan Road, Edgbaston, Birmingham, and the company of which he is superintendent pharmacist, G. Goulding Ltd. Information had been received that on 28 April 2000, at Birmingham magistrates’ court, Mr Naqvi and the company had each pleaded guilty to seven offences against the Medicines Act, for which fines totalling £1,400 had been imposed, with £1,000 costs. Further, the Royal Pharmaceutical Society alleged that he had failed to ensure that a pharmacist was in personal control of a pharmacy; failed to ensure safe custody of drugs and failed to store Controlled Drugs in compliance with the Misuse of Drugs (Safe Custody) Regulations 1973.

Geoff Hudson, of Penningtons (solicitors), appeared in order to place the facts of the case before the committee.

David Reissner, of Charles Russell (solicitors), represented Mr Naqvi, who was present at the inquiry, and G. Goulding Ltd.

The committee heard that G. Goulding Ltd owned two pharmacies. One was at 20 Glebe Farm Road, South Yardley, Birmingham, where Mr Naqvi was the regular pharmacist, and the other was close by at 119 Church Lane, Stechford, Birmingham. The offences all concerned the South Yardley pharmacy. On 14 September 1999, an inspector had visited the pharmacy at 9.15am and purchased Veganin tablets from an assistant; no pharmacist was present. About 10 minutes later the inspector returned with a colleague and was told by the assistant that she had dispensed three prescriptions that morning and that they had been checked by the pharmacist at the company’s other pharmacy, 119 Church Lane. It was established that no such checks had been carried out.

The three prescriptions had been for two patients and had ordered a total of seven items including Merbentyl syrup, loperamide capsules, beclomethasone, salbutamol, ipratropium, lactulose and hypromellose. The sale and dispensing of those medicines in the absence of a pharmacist resulted in the prosecution.

Mr Naqvi had arrived shortly after, at 9.30am, and said he had been delayed by school traffic and had had to buy some dog food.

While in the pharmacy the inspector had found two bottles of temazepam elixir on a desk in the dispensary and a part full 100ml bottle of methadone in the same place. Mr Naqvi had said that the temazepam had been ordered in error and he planned to return it. When advised of the storage requirements, he had said that he did not know it had to be kept in the Controlled Drugs cupboard. The methadone, he said, was to be destroyed.

Mr Naqvi said the staff had been told not to sell medicines or hand out prescriptions in his absence.

Following those events, the inspector paid a routine visit on 21 September 2000. A large quantity of patient packs and pots of temazepam tablets were found in open drawers in the dispensary. Mr Naqvi said he thought that type of storage was permitted so long as the temazepam packs were not on display; and he thought the inspector’s advice given on her previous visit referred to the methadone only.

Giving the committee’s decision, the chairman (Lord Fraser of Carmyllie, QC) said that the convictions were admitted. Regarding the temazepam and the methadone found on 14 September 1999, Mr Naqvi had said in evidence that he had taken them out of the Controlled Drugs cabinet when he was tidying it on the previous evening. He said he had been called to the counter to see a patient, locked the cabinet and subsequently forgotten to put them back.

The chairman said that Mr Naqvi should appreciate that the failure to return the methadone and temazepam could also have resulted in criminal proceedings, under the Misuse of Drugs (Safe Custody) Regulations 1973.

It was clear, the chairman said, that the inspector had advised Mr Naqvi at that time that the temazepam should be in the Controlled Drugs cabinet as well as the methadone. Yet at the visit a year later, in September 2000, when the inspector again found temazepam not in the Controlled Drugs cabinet, his explanation was that he had understood her advice to relate only to the methadone.

It defied belief that Mr Naqvi, a well qualified individual carrying on not only the role of pharmacist in charge but that of superintendent pharmacist, should not have known what were the full range of Controlled Drugs and what measures had to be taken to secure their safe custody. Furthermore, it strained the committee’s credulity that what took place on 14 September 1999 was an isolated set of circumstances: that, this once, he had left out methadone, that he happened to be late because of the start of the school term, that an unqualified counter assistant should have sold this pharmacy medicine and then dispensed three prescriptions.

So, in addition to the convictions the committee found the three failures listed by the Society proved. The misconduct was such as to render Mr Naqvi unfit to be on the register. The committee had not been impressed by his conduct. With considerable hesitation, however, said the chairman, it had been decided not to remove Mr Naqvi from the register on this occasion but to reprimand him.

The Society’s inspector for the area would be asked to give Mr Naqvi and his premises the closest scrutiny to ensure that there was a sustained improvement in the way they were run.

No further action was ordered in the case of the company.

No action taken against preregistration student involved in “peppermint water” tragedy

The Statutory Committee has decided to take no action in respect of a preregistration trainee involved in what became known as the “Alder Hey peppermint water” case.

At its meeting on 12 February, the committee inquired into the case of Ziad Khattab, a preregistration trainee, of 3 Albert Road, Eccles, Manchester. Information had been received that on 2 March 2000, at Chester crown court, Mr Khattab had pleaded guilty to, and been convicted of, supplying a medicinal product not of the nature and quality specified in the prescription, contrary to Section 64 of the Medicines Act 1968. He had been fined £750.

Geoff Hudson, of Penningtons (solicitors) appeared in order to place the facts of the case before the committee.

James Pickup, QC, instructed by Pannone & Partners (solicitors), represented Mr Khattab, who was present at the inquiry.

The committee heard that Mr Khattab’s prosecution followed a dispensing error that had tragic consequences. The error had occurred on 29 April 1998, at the Boots The Chemist pharmacy at Hallwood Health Centre, Runcorn, Cheshire, where Mr Khattab worked one day a week. A prescription for a four-day-old infant, ordering 150ml Alder Hey peppermint water, was presented to the pharmacist at the health centre. The pharmacist passed it to Mr Khattab to be made up, believing it would be good experience for him. The formula was kept in a book at the pharmacy and was based on 200ml of the preparation. One of the ingredients was 100ml chloroform water, double strength. This was not a stock item and had to be prepared from concentrated chloroform water.

The formula book was said to be outdated and to contain numerous hand-written amendments. Mr Khattab had said he found it misleading. Although he had had some experience of making up Alder Hey peppermint water at another Boots pharmacy where he worked regularly, he had always had the quantities of the ingredients checked by a pharmacist before mixing them.

On this occasion, Mr Khattab had correctly measured out the required amount of peppermint emulsion, 3.75ml. Instead of measuring out the same quantity of chloroform concentrate, however, he had dispensed 75ml of concentrate and mixed it with the other ingredients. He said he had not realised that there was a difference between the concentrated chloroform water and the double strength chloroform water specified in the formula.

Mr Khattab had passed the finished medicine to the pharmacist. After initialling the label, but not checking the medicine, she had given the bottle, with a measuring syringe, to the baby’s mother. Later that day, when the medicine was being given to the infant, it stopped breathing after a few drops had been administered. The baby suffered cardiac arrest and died in hospital two-and-a-half weeks later. The cause of death was given as cardiorespiratory arrest resulting from the inhalation of chloroform.

Prosecutions of both Mr Khattab and the pharmacist had followed: an initial charge of manslaughter was not proceeded with and the Medicines Act offence substituted. During the trial, prosecuting counsel had referred to “the undesirable difference in practice between hospital and community pharmacies as to the validation of formulae and the use of worksheets in extemporaneous preparations” and to the advice given in The Pharmaceutical Journal of 30 May 1998 (p783), subsequent to the hearing, on the need to check all calculations, to verify the formulae used, the weighings or other measurements, and for the pharmacist to undertake a final review before the product was supplied to the patient.

Giving the committee’s decision, the chairman (Lord Fraser of Carmyllie, QC) said that behind the Medicines Act offence lay a very real, very public, tragedy. The committee had been told what had happened at the trial of Mr Khattab and his pharmacist colleague and the various failings not only of those two people but also the failures that there had been in the system in place, notably a dispensing book in the pharmacy that would have been “pretty well incomprehensible” for anyone to have followed what it was intending to direct.

The committee would have been concerned if the difference in practice between hospital pharmacies and community pharmacies revealed in the case had persisted to the present day. They were relieved to note that was not the case. But the committee reiterated that there was a real importance in having structured supervision for preregistration students whether they were undertaking their preregistration training in a hospital or in a community pharmacy. The importance of that could not be sufficiently stressed.

At one time, said the chairman, Mr Khattab and his colleague had faced the prospect of indictment for manslaughter. In the event, that charge was not insisted upon before the court — quite rightly so. The actual conviction was of a much less serious nature.

Although the matter before the committee would allow it to direct that Mr Khattab’s name should not be registered until it directed otherwise, it was not going to make an such order. The committee had been impressed by the full reports on Mr Khattab’s progress during his current preregistration training [Mr Khattab had started afresh his preregistration training in a hospital] and the significant degree of support being offered to him.

The committee hoped that, as he continued through his period of preregistration training, Mr Khattab’s confidence in his abilities would return. If he put this incident behind him there was no reason why he should not pass his examinations and thereafter follow a successful career in pharmacy.