Responsible pharmacist regulations by the end of the month

Regulations setting out the roles of responsible pharmacists in community pharmacies are expected to be laid before Parliament by the end of September 2008, according to Jeannette Howe, head of pharmacy at the Department of Health, who was speaking at the British Pharmaceutical Conference held in Manchester from 7–9 September 2008. The regulations will come into force on 1 October 2009.

Mrs Howe explained that ministers have deliberately not made the regulations too complex or detailed and that further practical information on implementation will be set out in two sets of guidance — factual guidance issued by the UK health departments, and professional standards and regulatory guidance issued by the Royal Pharmaceutical Society and the Pharmaceutical Society of Northern Ireland.

“By structuring it in that way it provides a more flexible approach so that we can respond to developments in the future,” she said.

She also indicated that the regulations could later be reviewed in the light of experience.

Priya Sejpal, head of professional ethics at the Society, said that the Society is aiming to publish professional standards and regulatory guidance three months in advance of the regulations coming into force.

“These standards will support the Code of Ethics. They will detail the ‘must dos’ and ‘should dos’ of the responsible pharmacist. The regulatory guidance will also describe how those standards will be enforced,” said Ms Sejpal.

She added that a steering group will be convened to consider the detail of the standards and will comprise representatives from each of the three devolved countries, as well as patients, pharmacists and technicians from a variety of backgrounds. The standards will be subject to an eight-week public consultation at the beginning of 2009.

Rob Darracott, chief executive of the Company Chemists’ Association, drew attention to several practical issues that he believes need to be addressed, for example, clarification of the separate roles of, and relationship between, superintendent pharmacists and individual responsible pharmacists.

Mark Koziol, chairman of the Pharmacists’ Defence Association, argued that the responsible pharmacist regulations add “a quantum leap” in responsibility to the current concept of personal control.

Referring to the additional statutory duty of responsible pharmacists to secure the safe and effective running of the pharmacy, he said: “Let us not sleepwalk into a scenario where we take a massive heap of additional responsibility onto the shoulders of the individual pharmacist and simply say that this is merely a rebadging of the old personal control regulations because . . . it is something far more significant than that.”

He believes that there are serious practical operational issues that are still to be resolved and suggested that “we go back to the drawing board”. He added that close collaboration is needed between representatives of the Government, the regulator, employers and employees.

However, Mrs Howe emphasised that the regulations largely reflect what goes on within the profession now. “I think the regulations are practical and can be made to work,” she said.

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