The Pharmaceutical Journal
Vol 269 No 7228 p870-872
14 December 2002

Striking-off for pharmacist who refused help for his drug dependency [more]

"Outstanding pharmacist" reprimanded after unlicensed preparation of cytotoxic injections [more]

Equagesic use without prescription leads to reprimand [more]

Reprimand after dispensing errors by pharmacist who was "easily distracted" [more]

Striking-off for pharmacist who refused help for his drug dependency

An Australian pharmacist who suffered from a polysubstance dependency and who had purchased quantities of ephedrine and other medicines for his own purposes has been struck of the register by the Statutory Committee

At its meeting on 24 April 2002, the committee resumed its inquiry, adjourned from 12 October 2001, into the case of John C. Gould, whose registered address is 6 Mary Park Gardens, Bishop's Stortford, Hertfordshire. A complaint had been received from the Council of the Royal Pharmaceutical Society alleging that at various dates between December 1998 and April 2001 Mr Gould had self-prescribed medicines with a known potential for misuse and had made emergency supplies of medicines to himself in circumstances in which such supplies were inappropriate. The self-prescribed emergency supplies included amoxicillin capsules and salbutamol inhalers and the medicines he had purchased for his own use included quantities of ephedrine tablets and Sudafed tablets.

Mr Gould was also alleged to have practised while he had difficulty in concentrating and to have dispensed Viscotears against a prescription calling for olive oil.

David Bradly, of counsel, instructed by Penningtons (solicitors), appeared at the hearings on 11 and 12 October 2001 to present the facts of the case to the committee, and Geoff Hudson of Penningtons appeared on 24 April 2002.

Mr Gould was present at the first hearing, at which he was represented by Luke Blackburn, of counsel, instructed by Lee, Davis & Co (solicitors). He did not attend the second hearing, when he was represented by Michael Casson, of Lee, Davis & Co.

Dependence

Giving the committee's decision, the chairman (Lord Fraser of Carmyllie, QC) said that all the matters of complaint about Mr Gould had been established. It had also been shown that Mr Gould had a polysubstance dependence. Regrettably, in spite of advice from the committee and others, he had not been prepared to contemplate treatment for that condition.

He had given extended and at times less than clear evidence at the initial hearing and seemed to have regarded the Society and the committee as lacking insight. In fact, it was he who had lacked insight into his own condition.

Mr Gould had now returned home to Australia and it appeared he had undergone treatment there and was making progress. The committee had been invited to accept an undertaking that he would not practise as a pharmacist without its prior consent. However, said the chairman, the committee took such a serious view of the conduct complained of that, having received a further adverse report about him, it directed that Mr Gould's name should be removed from the register.

He had three months in which to appeal against the decision.

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"Outstanding pharmacist" reprimanded after unlicensed preparation of cytotoxic injections

A former hospital pharmacist whose company made cytotoxic preparations for hospital patients has been reprimanded by the Statutory Committee for failing to meet appropriate standards for aseptic manufacture. The committee pointed out that pharmacy departments outsourcing such preparations should satisfy themselves that the supplier was properly licensed or carry out an audit of the premises.

On 18 and 19 March the committee resumed its inquiry, adjourned from 17 and 18 July 2001, into the case of Kisor K. Solanky and his pharmacy company Prepack Direct Ltd, both of 6 Mowbray Road, New Barnet, Barnet, Hertfordshire. Mr Solanky is superintendent pharmacist of the company.

Patients put at risk

A complaint had been received from the Council of the Royal Pharmaceutical Society alleging that in the operation of arrangements for the manufacture of cytotoxic products for injection Mr Solanky had failed to comply with Standard 4 of the Society's Code of Ethics, which covers dispensing procedures for the supply of prescribed medicines for hospital patients. It was alleged that this failure put at risk patients to whom those products were to be administered, and that he was in breach of principle three and principle one of the code of ethics.

Nigel Fleming, QC, instructed by Penningtons (solicitors) presented the facts of the case to the committee at all the hearings.

Mr Solanky was present at all the hearings and was represented by Richard Lissack, QC, instructed by Charles Russell (solicitors), who also represented the company.

The committee heard that Mr Solanky's company supplied a number of National Health Service hospital trusts with cytotoxic preparations for injection to specified patients on many occasions between the end of March 2000 and the end of January 2001. Mr Solanky had allowed the hospitals to understand that the cytotoxic preparations had been prepared at his pharmacy under the terms of a licence from the Medicines Control Agency. However, the licence he held did not relate to aseptic products.

When inspectors from the Society and the MCA visited Mr Solanky's premises on 1 February 2001, they had found that the conditions under which the products were being prepared did not comply with acceptable standards for products for injection.

It was pointed out, for the Society, that aseptic cytotoxic products were usually used for immunocompromised patients and had to be made to the highest standards. When a hospital outsourced such products, made on a "just in time" basis for direct dispensing to patients, the pharmacy department had to be satisfied as to quality. It did this by purchasing from licensed premises or carrying out an audit to ensure the premises and procedures came up to good manufacturing practice standards. When Mr Solanky contracted to supply aseptic cytotoxic products, he had told hospital staff that his premises were registered as a pharmacy, which was true, and that he had a manufacturer's licence. Although it was clear that the hospital staff believed Mr Solanky was preparing the products in a unit licensed for the purpose, he did nothing to correct that belief.

Shelf life

In due course, the hospital asked that the shelf life of the products should be increased. Rather than a 24-hour period, a four- or five-day shelf life was requested for cytarabine and seven days for methotrexate — products that suppress immune responses and so leave patients vulnerable to infection. The hospitals, however, continued to believe they were dealing with products produced at a licensed site and Mr Solanky did nothing to inform them otherwise.

Giving the committee's decision, the chairman (Lord Fraser of Carmyllie, QC) said that under section 10 of the Medicines Act, the company was entitled to assemble or manufacture certain medicinal products. However, as a pharmacist with relevant experience of the NHS hospital sector, Mr Solanky knew, or should have known, that the standards of preparation were not acceptable for products to be administered by injection.

The chairman said he had little difficulty in understanding the point of the complaint where the request for extended shelf life had been made and Mr Solanky had supplied the products without modifying his procedures. He was, he said, less confident as to the clarity of the standard to be observed where the injections were made up on a "just in time" basis.

The case had resulted in a proper focus being given to this important area of preparation of medicinal products. 'Medicines, ethics and practice: a guide for pharmacists' now set out the requirements for aseptic dispensing services from non-licensed units (paragraph 22, page 92). The committee regarded that as a desirable inclusion in the guide and trusted that what was required of any pharmacist undertaking such a service was clearly understood.

Mr Solanky had accepted that his arrangements at the pharmacy had failed to comply with the standards in the Code of Ethics and that he had put patients at risk (although there was no evidence of actual harm). The matter was a serious one and amounted to misconduct such as to render Mr Solanky unfit to be on the register.

Mitigation

In considering whether to direct his removal, however, the committee had to consider a number of matters in mitigation, continued the chairman. Mr Solanky, when working as a pharmacist at a famous hospital, had been one of the outstanding pharmacists of his generation in his field. A consultant at that hospital had attended the hearing and had provided a very full reference for him.

Further, there was currently no real risk of any repetition by Mr Solanky of the failures leading to his appearance and the public might be better served by having him back at his research and development than by having him struck off. With regard to the company, if it was to continue with its prepack concept, the committee had been assured that nothing would be done on any premises that was not permitted under a MCA licence.

The committee directed that Mr Solanky should be reprimanded. No further action was taken against the company.

Lord Fraser added that the criteria for quality when a hospital pharmacy department outsourced preparations — namely, that the department must be satisfied as to quality by purchasing from licensed premises or carrying out an audit to ensure the premises and procedures came up to good manufacturing practice standards — were proper and necessary. It did not seem to the committee to be particularly onerous for a pharmacy department to check the terms of the licence simply by asking to see it or alternatively to carry out an audit of the premises. If either of those things had been done at the outset, none of the problems in this "lengthy and difficult" case would have arisen.

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Equagesic use without prescription leads to reprimand

A pharmacist in Scotland who failed to operate a safe system for a repeat medication service and who ordered quantities of Equagesic tablets for her own use without prescription has been reprimanded by the Statutory Committee.

At its meeting on 23 April, the committee inquired into the case of Fiona M. Smith, of 61 Currievale Drive, Currie, Midlothian. A complaint had been received from the Council of the Royal Pharmaceutical Society alleging that Mrs Smith had taken for personal use 1,000 Equagesic tablets from the pharmacy at which she had been employed when only 100 had been authorised by a private prescription. No entries had been made in the private prescription register or the patient medication records, nor had the prescription been endorsed to indicate that a supply had been made.

Failure to operate safe systems

It was also alleged that Mrs Smith had failed to operate a safe system for the operation of a repeat medication service at the pharmacy. She had not ensured that repeat prescriptions had been ordered in time for patients to receive prescription-only medicines dispensed weekly in Dosette boxes; she had not maintained patient medication records for those patients provided with a repeat medication service; and she had failed to operate a safe system for dealing with dose changes for patients receiving dose boxes or for checking dispensed medicines in those boxes against prescriptions and Dosette card instructions.

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

Mrs Smith was present at the inquiry but was not represented.

The committee heard that between January 2000 and June 2001, Mrs Smith had been pharmacist in charge at the Balerno Pharmacy, Main Street, Balerno. During the week of 14 May 2001, the pharmacist proprietor of the pharmacy had been unable to locate certain prescriptions for medicines dispensed to patients via Dosette boxes. Mrs Smith had explained that she had not ordered repeat prescriptions in respect of medication currently being supplied from the pharmacy but said that the situation would be rectified.

Then, on 18 May 2001, the proprietor found at the pharmacy some dispensed National Health Service prescriptions for weekly medication dated as far back as December 2000 and February 2001. Ms Smith had said they were isolated incidents. However, further investigation showed that a number of late requests for repeat prescriptions had been made. In one case the request was 107 days late. Mrs Smith was given a written warning about her operation of the repeat medication system.

In early June 2001 it was noticed that the dosage cards on some of the Dosette boxes did not match the corresponding prescriptions and that errors had been made in dispensing. In one case, the prescription ordered ranitidine tablets 150mg, one to be taken at night, but the card directed one in the morning and one at night. In another case, while the prescription ordered bumetanide tablets 1mg, two tablets to be taken twice daily, the card stated four tablets at breakfast and four at lunch. In a third instance, the prescription ordered frusemide 40mg, two to be taken daily, and the card stated one to be taken daily. Mrs Smith had been dismissed.

Giving the committee's decision, the chairman (Lord Fraser of Carmyllie, QC) said that some of the errors might have been prompted by the pharmacy's complicated series of removals between premises in March and April 2001. Although that would appear to account for some of the errors and delays, it could not wholly excuse the conduct. The errors were in direct contravention of the Medicines Act 1968.

Mrs Smith had challenged none of the errors. Her explanation for checking the medication against the card in the box and not against the prescription was that it was "probably total laziness on my part".

Equagesic dependence

However, it was the complaint relating to the Equagesic tablets that caused greater concern. From February 2000, Mrs Smith had been ordering in quantities of 100. Some 1,000 had been ordered but only 100 were authorised by a valid private prescription. Mrs Smith had been ordering those tablets for herself and taking them without a prescription; she had not made the appropriate entries in the private prescription register, had not kept a patient medication record and had not annotated the prescription to indicate a supply had been made. As a pharmacist, she appreciated that Equagesic was a prescription-only medicine and that it induced dependence similar to that of barbiturates.

Mrs Smith had assured the committee that following her dismissal from employment she had taken no Equagesic. The Committee had no reason to doubt her word. However, if she returned to taking that product, the consequences for her could be very serious.

The committee found Mrs Smith guilty of professional misconduct and reprimanded her.

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Reprimand after dispensing errors by pharmacist who was "easily distracted"

A Yorkshire pharmacist who made dispensing errors has been reprimanded by the Statutory Committee

At its meeting on 24 April 2002, the committee inquired into the case of Baldev K. Flora, of 28 Hessle Mount, Leeds, West Yorkshire. A complaint had been received from the Council of the Royal Pharmaceutical Society alleging that Miss Flora had been responsible for a series of errors in the dispensing and labelling of prescribed medicines.

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

Sara Morgan, of Brooke North (solicitors) represented Miss Flora, who was present at the inquiry.

The committee was told of a number of dispensing errors made by Miss Flora at the pharmacy she owned and ran at 7 The Parade, Cottingly, Bradford, West Yorkshire. It was said she had had only a few days' holiday since purchasing the business some six years previously.

On 28 December 2000, against a prescription for three 10mg ampoules of methadone, a patient had been supplied with one 10mg ampoule of methadone and two 100mg ampoules of pethidine. The error had come to light when the patient asked the prescriber for pethidine for his next prescription, because he preferred its effect to that of methadone. The doctor reported the matter to the police, who advised Miss Flora on the care and attention she should give such matters and informed the Society's inspector for the area. The inspector visited Miss Flora and discussed her dispensing procedures..

Subsequently, the inspector received two separate complaints from patients who had had medicines dispensed at the pharmacy. One patient told him that after she had received medicines wrongly labelled she had kept notes. In February 2001 her medicines had been labelled with another person's name and medicine description on the label. In March 2001 she had received, in addition to her medicines, another patient's prescription form. Then, in April 2001, her medicines, although correct, had again been labelled with another person's name and medicine description.

In May, the patient had presented a prescription which included 28 Monomax SR 60mg capsules, one to be taken in the morning, two x 30 fluoxetine capsules 20mg, two to be taken in the morning, and two x 28 spironolactone tablets 25mg, one to be taken daily. She had received one box of Monomax SR 60mg labelled as 30 fluoxetine capsules 20mg, two to be taken in the morning, and a box containing 30 fluoxetine 20mg labelled as 56 spironolactone 25mg, one to be taken daily; other items had been dispensed correctly.

Another patient complained that, on a prescription for co-codamol tablets 30mg + 500mg and Adizem XL 300mg capsules, Miss Flora had dispensed co-codamol 8 mg + 500mg and Adizem XL 300mg labelled as Adizem XL 120mg.

Repeated errors

Giving the committee's decision, the chairman (Lord Fraser of Carmyllie, QC) said that a number of errors had occurred on a repeated basis over a relatively short period. Miss Flora did not dispute that the errors had been made and had offered no coherent explanation for making them.

Since those incidents, Miss Flora had stated that she had rearranged her Controlled Drugs cabinet, in line with advice given, to avoid any similar error. She had also set in place an elaborate system for checking prescriptions before they were handed out to patients.

However, she had shown an "almost obsessive" focus on detail without any real alertness as to what checking was about. When it had been pointed out to her that when one person had had someone else's name on his or her prescription, another patient might have had that person's name on their prescription, she did not seem to appreciate that that might be a matter which could cause alarm to the other patient.

There was evidence of "a lot of chit-chat" going on in the pharmacy and it seemed that Miss Flora was easily distracted in the course of her work. It was not the elaboration of checking that mattered; it was the concentration and attention given to the activity that was important, the chairman emphasised. It was important that there was a proper separation of the checking from the dispensing. When an assistant helped with dispensing, it would be safer if the functions of making up a prescription and checking it had been dispensed correctly were performed separately.

With a warning that if there were any similar dispensing errors in future they could not be dealt with leniently, the committee ordered that Miss Flora should be reprimanded.

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