The Pharmaceutical Journal
Vol 271 No 7262 p217-220
16 August 2003

Society summary

August Council meeting

Society to seek broader powers to regulate retail pharmacy premises

The Council of the Royal Pharmaceutical Society has decided that the Society should seek broader powers in relation to the registration of retail pharmacy premises in order to address problems resulting from the limitations of the current statutory framework.

Among the powers sought would be the ability to refuse, suspend or revoke the registration of premises that did not meet requirements set by the Society, and the ability to disbar from controlling pharmacy businesses any pharmacist or pharmacy company director who is convicted of a serious criminal offence or has been found to have defrauded the National Health Service.

The Council made its decisions at its meeting on 5 and 6 August, on the recommendation of the Modernisation Steering Group.

The steering group emphasised the need to introduce an overall system of quality assurance to minimise the risk of damage to patients and the public. It said that the system should cover the supply of medicines, the standards of the premises and the standards of the professionals involved. It should provide controls relating to the ordering, storage, sale or supply, disposal and security of medicines and poisons.

The group also suggested that legislation on registered premises needed updating to take account of changes in pharmacy practice and ownership over the past 40 years. The group saw a need for clarification of the roles of the Society's Registrar and the Government Minister with regard to entering premises on to the register, and believed it should be possible to refuse registration of premises for valid reasons.

The group thought that the proposed Section 60 order could enable much-needed improvements as a matter of urgency and that in the longer term there should be a more fundamental review of the basis of the system for regulating premises.

The Council accepted 10 recommendations related to applications to register pharmacy premises or to amend registered details:

(1) The statutory requirement for the relevant Government Minister to approve applications to register pharmacy premises should be repealed.

(2) The Council should have power to specify requirements for premises registration beyond those in current legislation.

(3) The Society should have power to impose sanctions when requirements are not met, including issuing a notice to improve and power to refuse, suspend or revoke registration of premises in specified circumstances.

(4) Pharmacy owners should have a statutory right of appeal against a decision to refuse, suspend or revoke registration of premises.

(5) Amendments to registered details should be notified to the Society within a statutory period and registration of premises would become void in the absence of such notification.

(6) There should be a statutory duty on a superintendent pharmacist to notify the Society of his resignation from that position (in the event of the superintendent's death or incapacity, the duty would fall on the corporate body).

(7) When the owner of premises is required to appoint a superintendent pharmacist but the Society does not receive confirmation of such an appointment within a specified time, the Society should have power to remove the premises from the register.

(8) The Society should have power to annotate the register of premises to indicate specialist pharmacies.

(9) The Society should have power to raise fees to cover relevant costs, including transferring ownership of pharmacy premises, reinspecting premises when required and amending register details (such as registered office address or superintendent pharmacist's name).

(10) The Society should have power to review the level of fees relating to premises in the light of any future changes in the regulatory regime.

On the steering group's further recommendation, the Council also agreed that owners of pharmacy premises should be required to provide the Society annually with a signed declaration that should include: confirmation of the pharmacy's ownership (including details of the registered address and the identity of all directors); details of any convictions of any director or pharmacist owner in the previous 12 months; where appropriate, confirmation by the superintendent pharmacist responsible for the conduct of the business that he still occupies that position and will inform the Society forthwith if the position changed; confirmation that the premises meet the Society's minimum requirement for registration; and evidence that the professional activities undertaken are covered by adequate professional indemnity arrangements.

The declaration would have to be signed by the owner or in the case of a partnership by each partner or in the case of a body corporate the superintendent pharmacist. The Registrar should have power to remove summarily from the register any premises in respect of which no declaration was received or an incomplete declaration was received.

Finally, the Council agreed three further recommendations designed to ensure that pharmacy owners and superintendents are fit to be in such a position and are able to control the operation of the business effectively. The first of these was that all pharmacists who own pharmacy businesses, whether as sole proprietors or as partners, or who act as superintendent pharmacists, should pay the full-time retention fee (the Society's current Byelaw to this effect does not cover partners).

The second recommendation was that all pharmacy owners and superintendents should be freely able to visit their premises and be in a position to control how the business will be run. Thirdly, it was agreed that any pharmacists or pharmacy company directors (including non-pharmacist directors) who have been found guilty of a serious criminal offence and/or have been the subject of an investigation by the NHS Counter Fraud Service in which the outcome was adverse, should not be able to own, to continue to own or to have a directing or controlling interest in a pharmacy business.

Stakeholders' interests

The Council agreed that the reformed Council, in exercising its functions, should have proper regard to the interest of stakeholders, including pharmacists and registered pharmacy technicians. This would be in addition to the duty of co-operation with certain stakeholders already agreed by the Council.

The Council noted that the Order establishing the Nursing and Midwifery Council included a similar requirement and agreed that it seemed reasonable and appropriate. It could also provide reassurance that the reformed Council would have regard to the interests of the profession as well as those of the public.

The inspectorate

The Council approved a recommendation of the Modernisation Steering Group that the forthcoming Section 60 Order should include a provision that the Society should maintain an inspectorate. The aim would be to secure the inspectorate's functions and powers, to ensure that these are consistent with those of the reformed Society and to ensure the adequate funding of the inspectorate.

The Council was reminded that the Society's inspectors were currently appointed under the Poisons Act 1972 and authorised under the Medicines Act 1968 to carry out an enforcement role in relation to medicines. The steering group believed that the inspectorate could be left out on a limb if it was not recognised in the new Section 60 Order.

The Council accepted a further recommendation that proposals should be drawn up for the full funding of the inspectorate through ring-fenced inspection fees plus funding from the Government for enforcement work.

The steering committee pointed out that the Society currently relied heavily on premises registration and retention fees for funding the inspectorate's enforcement work, with its educational work subsidised through the Society's general income streams. Although it could be argued that the inspectorate should be fully funded by the Government, the steering group saw it as important that the Society retained a degree of control over the inspectorate's functions.

Privy Council involvement in Society appointments

The Council approved three recommendations concerned with the involvement of the Privy Council in appointments within the Society. It agreed that the Society should no longer have to seek Privy Council approval for the appointment of examiners and inspectors, but it also agreed that Privy Council should appoint both the chairman and deputy chairman of the new Disciplinary Committee.

In the case of examiners, the Council accepted that the advice of the Privy Council office had been useful in ensuring robust appointment procedures. However, there seemed no good reasons for Privy Council to have to give its approval, which could delay confirmation of appointments by several months.

In the case of inspectors, the Council noted that Privy Council approval might be seen to add to the inspectors' credibility, but since the approval process involved no additional checks, it did not seem to add any real value, and it could delay confirmation of appointments by up to three months.

With regard to the appointment of the legally qualified chairman and deputy chairman of the Disciplinary Committee, the modernisation steering group, after taking additional advice, had given further consideration to a previous Council decision that the chairman should be appointed by the Society's Appointments Committee. Although other regulatory bodies appointed legally qualified chairmen for their disciplinary committees without external approval, the Society was different in that it had powers relating not only to individual professionals but also to corporate bodies and their directors. Its committee therefore needed a chairman of particularly high calibre. The system under which the Privy Council appointed the Statutory Committee chairman had worked well, and continuing that system would help to ensure the calibre of chairman required for the new committee. It also seemed sensible for the legally qualified deputy chairman to be appointed in the same way.

Dispensing errors

The Council agreed to seek a change to Section 64 of the Medicines Act 1968 to the effect that a single dispensing error would no longer automatically be a criminal act. Section 64 was seen as an anomaly, in that an equivalent error by another health professional would not automatically be a crime.

The Council also believed that the current situation, which could deter pharmacists from seeking advice, conflicted with the ethos of the National Patient Safety Agency, which aimed to ensure that lessons were learned from adverse event so as to help avoid their repetition.

Methods of payment for retention and premises fees

The Council agreed to extend the range of methods by which the annual members' and premises retention fees may be paid to include the use of debit and credit cards, including card payment through the Society's website.

The Council also agreed to amend the process for collection of fees by direct debit so that in the event of a failed payment further applications for payment would be made before cancelling the direct debit mandate.

A further decision was the approval in principle of the use of the Society's bank's automatic forms and payments processing system for the collection of the annual fees. A preliminary investigation suggested that this might be a lower cost solution than improving the Society's in-house process, provided that satisfactory commercial terms could be agreed and some technical issues resolved.

The Council made its decisions as the result of a review of the Society's processes for collecting retention fees. The main issues behind the review were the unsatisfactory length of time before members and premises were removed from the register for non-payment and the difficulties the Society has experienced in managing the collection and processing of fee payments.

Grandparent clause criteria for dispensing assistants' training

The Council approved criteria for a "grandparent clause" in relation to the Society's decision that by January 2005 all dispensing assistants should be trained to, or be undertaking training for, a minimum standard equivalent to the Scottish/National Vocational Qualifications level 2 qualification in pharmacy services.

The aim of the grandparent clause is to allow existing dispensing assistants to prove their competence and continue working in their present roles without the need to obtain a new qualification.

The criteria were based on two requirements. The first was the completion of a prior course. A list of past and present suitable dispensing assistant courses would be developed. It would include pharmacy technician courses allowed for qualification under the pharmacy technician grandparent clause (to accommodate pharmacy technicians who wished to continue working as dispensing assistants rather than register as technicians).

The second criterion was a declaration of competence by a supervising pharmacist. The declaration would take a modular form based on the modular unit structure of the pharmacy services S/NVQ level 2. For those members of staff who had not completed a recognised prior course, the supervising pharmacist would have to assess competence against each standard contained in the relevant units of S/NVQ. Similarly, members of staff who wished to be judged competent in a unit not covered by their recognised prior course would also have to undergo competency assessment by a supervising pharmacist against the standards in that unit.

The Council agreed that the practice division would develop the relevant documentation so that it would be available by 1 January 2004 at the latest, to allow employers at least a year to pass dispensing assistants through the grandparent exemption process.

To account for staff not currently practising but returning to work after January 2005, exemption under the grandparent clause would be permitted until the end of 2005, after which all staff would be expected to meet the minimum training standard through an S/NVQ or equivalent course.

The Council also agreed that the declaration of competence would remain the property of the dispensing assistant as proof of exemption under the grandparent clause. A copy would be sent to the Society.

The Society would keep records of those accepted under the grandparent clause, including which units they had been deemed competent in and the name of the pharmacist who had assessed their competence. After January 2005, a staff member who wished to undertake roles for which their competence had not been assessed would have to complete the relevant S/NVQ unit or equivalent.

When the proposed criteria were considered by the Council, the TREASURER referred to the declaration of competence by a supervising pharmacist and asked how the Society would ensure that the pharmacists concerned were competent and able properly and objectively to assess their assistants to the extent that a declaration of competence signed by them was meaningful in a quality assured way. Most pharmacists had had no formal training in how to make such assessments.

DIGBY EMSON said that there was a need to keep a sense of proportion in terms of what the risks were. Although it was not perfect, the Society already had a system of tutoring and signing off preregistration trainees, where the risks were higher than for dispensing assistants. he would would enter a plea for a sense of proportion.

NIGEL GRAHAM (head of practice) said that the assessment of competence had been recognised. The three centres for pharmacy postgraduate education had been written to and it was expected that underpinning support on the assessment of competence would be in place.

Answering a further question, Mr Graham said that there would not be a "grandparents' register". It would simply be a database holding the information submitted.

Staff Pension Fund Trustees

The Council approved the appointment as a director for the Society's staff pension fund of an external director with expertise in trusteeship of pension funds. The new director would be in addition to the four Council members and two pension fund members who serve as trustees.

The Council also agreed that Christine Glover and Nicholas Wood should be appointed as to fill two vacancies for Council member directors of the fund. It was noted that all directors were given appropriate training.

"Ask about medicines week"

The Society's support for, and input into, "Ask about medicines week" (see News Feature, PJ, 5 July, p10) was emphasised during the Council meeting.

The Council was reminded that the campaign, which would take place in England and Wales from 12 to 18 October, was designed to promote concordance. It is being run by a consortium made up of the Medicines Partnership (a Government-backed initiative to promote concordance), the Doctor Patient Partnership (a British Medical Association project to improve the relationship between doctors and their patients) and Promoting Excellence in Consumer Medicines Information (a group devoted to improving patient medicines information).

CHRISTINE GLOVER said that the initiative spanned a huge range of partners, including the pharmaceutical industry, professional bodies and patient bodies. It was hoped that the week would make people confident enough to ask about their medicines. The Society had fed into the initiative. It was a good opportunity to raise pharmacists' profile because clearly the place to ask about medicines was in pharmacies.

HEMANT PATEL said that he supported the initiative but was concerned at the practical implications for a busy pharmacy if there were to be a sudden increase in the proportion of people asking questions about their medicines.

Dr NICOLA GRAY said she was a member of the PECMI steering group. The initiative was modelled on similar initiatives in America and Australia. It had been brewing for several years and she had been keen to get pharmacists involved. She had talked to people in the building about it and was disappointed that the messages were only now going out to pharmacists, because it could have been started earlier.

There was a huge opportunity for the pharmacist to be right at the centre of the campaign week. While she appreciated the possible demands on community pharmacists, engagement with patients in talking about medicines was exactly what a vision for pharmacy in the future was all about. Pharmacists would have to make the time to do it. It was much broader than just pharmacy, but pharmacists should be putting themselves at the centre.

OLIVIA TIMBS (editor, The Pharmaceutical Journal) said that the Council should be aware that The Journal was supporting the initiative and had been promoting it for the past six months. It would be publishing a special themed issue, as would the BMJ.

PAT HOARE said that it was a matter of regret that the initiative had not appeared on the agenda for the last meeting of the Community Pharmacists Group Committee — or indeed the previous meetings. She was grateful that Mrs Glover had picked the point up and brought it before the Council.

Statutory fees for 2004

The Council agreed to seek approval for an increase in the statutory fees from 1 January 2004. Most fees would rise by about 5 per cent, but some would increase by a larger amount to reflect more accurately the costs of the specific activities to which they relate. (see this page).