The Pharmaceutical Journal Vol 264 No 7101 p906-911
June 17, 2000 The Society

June Council meeting

Concern that new controls on generics prices will compromise patients

The President of the Royal Pharmaceutical Society is to write a strongly worded letter to the Department of Health expressing concern that its proposed new controls on the National Health Service price of generic medicines could compromise patients.
At its meeting on June 6 and 7, the Society's Council decided that the letter should emphasise the potential effect on patients of the decision to impose statutory maximum prices for most generic medicines and to abolish the Drug Tariff Category D system of reimbursement for medicines in short supply, as announced by Lord Hunt (Parliamentary Under-Secretary of State for Health) on April 20 (PJ, April 29, p642).
The Council made its decision following debate on a motion proposed by Mr Argomandkhah. The motion read: "The Council of the Royal Pharmaceutical Society of Great Britain, in conjunction with the Pharmaceutical Services Negotiating Committee, the National Pharmaceutical Association and the Company Chemists Association, will take all reasonable steps to: (1) convey to the Department of Health the potential for problems that will be faced by pharmacists in purchase and supply of certain generic products following Lord Hunt's statement; (2) convey to the Department of Health the potential for problems that will be faced by the patients attempting to have their prescriptions dispensed for certain generic products following Lord Hunt's statement; (3) should any shortages occur as a result of Lord Hunt's statement and any Department of Health policy, inform the public of the reasons behind these shortages."
Mr Argomandkhah said that the Society should convey the message to the Department of Health that it should consider the patients' and the public perspective and the effect that Lord Hunt's statement would have on them.
The PRESIDENT replied that she totally commended the sentiment behind the motion. She would be happy to write to the Department to say that the Society felt it was totally inappropriate that the patient should be compromised. The letter would of course be appropriately worded. She hoped that Mr Argomandkhah would accept the undertaking that a letter would be written.
Mr ARGOMANDKHAH replied that he wanted the membership to know that the Society had done something. He was happy to agree with the President's suggestion and to withdraw his motion.
The PRESIDENT said she had already had discussions on the issue and had expressed the Society's anxiety. That would be reinforced with a letter, provided the Council agreed. (Agreed.) The President invited points that members of Council would like included in the letter.
Mr EMSON supported the President's suggestion. He did not speak for the PSNC, but he was certain that the CCA and the NPA would be willing to forward copies of their submissions.
Mr KIRIT PATEL felt that a letter was not the answer. The Society had kept quiet for too long. The implications of the statement were tremendous for the retail sector. He felt it was over-reaction by the Department to a short-term problem. He was sorry the motion had been withdrawn and said he might consider putting a motion down for the next meeting if something was not done.
The PRESIDENT pointed out that she had given an undertaking to write a strong letter.
Mrs REMINGTON hoped the letter would stress the damaging effect in community pharmacy. As chief pharmacist at Addenbrooke's hospital, Cambridge, she had already sent Lord Hunt a long paper on the matter. A number of generics companies which were saying that they would not supply. It was a major issue for both sectors.

Council expenses

The Council agreed to seek an amendment to the Society's Byelaws to make provision for Council members to be reimbursed for expenditure personally incurred in having to employ a locum pharmacist while engaged on Council business. The Byelaw wording would include a cap of £200 a day, but the Council agreed that for the current year the maximum payable would be £160 a day.
Introducing the draft Byelaw amendment, the SECRETARY AND REGISTRAR said that its wording had been prepared to reflect discussions that had taken place with the Department of Health. She stressed that reimbursement could only be made for expenditure incurred by a member of Council personally and not for expenditure by a company for which a member worked.
Mr NATHAN said that there appeared to be an inequity if a single handed pharmacist who operated his business as a limited company would not be able to make a claim despite being out of pocket to the same extent as a sole proprietor.
Mrs SHARPE (director of professional standards) said the legal consequence of operating through a third party limited entity was that any reimbursement would have to go to the person who owned the business, which was the company. It was accepted that there were inequities; but the Society would move outside its powers if it reimbursed third party entities for expenditure incurred in releasing somebody to attend Council.
Mr CURPHEY said that he operated a limited company. For the past 11 years he had paid all the expenses incurred on Council business from his personal current account. He would continue to claim expenses because it was his personal expense and not his company's expense. He did not think there was any problem for the small proprietor who was a limited company provided the expense came out of his after-tax money. The problem was for employees of larger companies.
The Council agreed to reword the proposed Byelaw amendment to make it clear that that the expenditure had to be incurred by the member of Council personally and that reimbursement to a body corporate could not be allowed.

Infringements

Catalogue of shortcomings The Council agreed that immediate action should be taken against a pharmacist in relation to an alleged catalogue of shortcomings in his professional practice.
The Infringements Committee heard that on February 21 an inspector had arrived at the pharmacy at 9.25am and had been able to purchase a pharmacy medicine, Solpadeine, from an assistant. The pharmacist had not arrived until 9.40am. The inspector had also found that a prescription for Canesten HC had been dispensed before the pharmacist's arrival.
Examining the pharmacy's patient medication record system, the inspector had also allegedly found evidence of the supply of prescription medicines, including a Controlled Drug product, in advance of the receipt of a valid prescription. The inspector had discovered that the pharmacy's PMR system was not registered with the Data Protection Registrar's office.
The inspector had also allegedly found examples of shortcomings involving matters such as record-keeping, storage and labelling, all of which had been the subject of informal advice given to the pharmacist after previous inspections in recent years.
The committee was also advised of a number of further alleged shortcomings discovered by the inspector during a routine post-opening visit to new pharmacy premises opened by the pharmacist in April. In addition, the inspector had found that the pharmacy's former premises, now trading as a photographic shop, still carried restricted titles and were still registered as a pharmacy.
On the committee's recommendation, the Council agreed that the pharmacist should be prosecuted for the alleged unsupervised sale of Solpadeine and unsupervised dispensing on Canesten HC. A complaint would be made immediately to the Statutory Committee about the other matters reported by the inspector.

Risky practice On the recommendation of the Infringements Committee, the Council agreed to make a complaint to the Statutory Committee about two pharmacists in relation to an allegedly risky practice that had come to light following a patient's death after the administration of morphine.
The coroner's inquest had heard that a 100ml bottle of morphine sulphate solution 10mg/ml had been dispensed from a pharmacy and supplied to the hospice where the patient was staying. There had been no dose on the label, but the product had complied in every other respect with the prescription. The solution had been extemporaneously dispensed, but no indication of expiry had been included on the label.
The solution had not been used at the hospice but had been transferred with the patient to a nursing home. Several months later, a nurse had administered the solution, following instruction on a drug chart which she had understood required a dosage of 5-10ml. The patient had later died and the coroner had returned a verdict of death by misadventure.
The committee heard that for about 20 years a practice had operated at the pharmacy in which, when requiring repeat medicines, the hospice would prepare a request using a duplicate book and pass it to the doctor who was a member of the hospice medical team. The nurse producing the request would also fax a copy to the pharmacy. The doctor would write a prescription which would be collected by, or sent to, the pharmacy.
It appeared that on the relevant occasion a preregistration trainee, under supervision, had prepared the solution against a faxed prescription that contained no dosage instructions. The trainee had queried with the pharmacist in charge whether the practice was legal and had been assured that it was for that hospice. The medicine had been delivered to the hospice and, when the prescription had arrived, it had been checked and the fax had been destroyed. No action had been taken about the dosage. It had been suggested that, because the hospice had requested the product, its staff knew how to administer it under the doctor's directions.
The committee observed that supply against a faxed copy of a request to a doctor contravened the Misuse of Drugs Regulations and supply without a dose breached the Medicine Act 1968, while dispensing against a fax of a request infringed the Code of Ethics.
The committee noted that the pharmacist in charge had worked in the pharmacy for about 30 years. The pharmacy had been taken over by a pharmacy company in 1992. The committee recommended, and the Council agreed, that a complaint should be made to the Statutory Committee about the pharmacist in charge, who had allegedly implemented an inherently risky practice, and the company's superintendent pharmacist, in relation to the conduct of the pharmacy business on the occasion described and the company's failure to identify and stop the practice.

Viagra sales The Council agreed that the Society should prosecute a pharmacist who had allegedly sold Viagra without prescription to an investigative reporter from a national newspaper.
The Infringements Committee heard that the reporter had been sold five loose tablets in an unlabelled brown tablet bottle. It was alleged that he had not been asked for his name and address or for details of his doctor, had not been asked whether he had been prescribed the product previously and had not been given any advice about the use of the product.
The committee also heard that, when investigating the matter, one of the Society's inspectors had allegedly found a number of discrepancies relating to supplies of Viagra and a number of irregularities in relation to the emergency supply of prescription-only medicines generally.

Emergency contraception

The Secretary and Registrar reported that the Practice Committee and the Law and Ethics Committee were considering the Society's response to the Medicines Control Agency's consultation letter (MLX 263) proposing that levonorgestrel should be reclassified as a pharmacy medicine for emergency contraception (PJ, May 27, p788).
Mr CURPHEY (chairman of the Practice Committee) said that the response would cover current Council policy on deregulation of medicines. It would highlight the sexual health strategy on extending access and would point out Council's views on free supply. It was significant that the MLX mentioned that the Society would be producing guidance for pharmacists to ensure that the process was done properly. That showed an intention to do things properly.
Mr Curphey said that the expert advisory group, at its first meeting, had considered best practice in the event of the appearance of a P category medicine. The hot issues were privacy, confidentiality, under-age requests, record-keeping, third party requests, advance purchases and referrals to general medical practitioners and to other organisations. His job was to get the group's opinions into a form that would offer advice to the professional standards directorate in developing professional standards and guidance that would go through the Law and Ethics Committee and thence to the Council.