The Pharmaceutical Journal
Vol 276 No 7399 p530
6 May 2006

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Responsibility sauce — what's good for the goose is good for the gander

By Michael Reynolds

Supervision, in general terms, has differing meanings depending upon which dictionary is used. There are also differing interpretations offered by various management consultant organisations.

However, the world of community pharmacy has evolved its own legal definition resulting from a number of legal challenges and judgments over the years. Supervision, as far as pharmacists are concerned, is enshrined in law.

The Medicines Act 1968, and before that the Pharmacy and Poisons Act 1933, states, in relatively simple terms, that the sale or supply of a medicine may only be made by a pharmacist or someone acting under the supervision of a pharmacist and that a retail pharmacy business must be under the personal control of a pharmacist. These statements have not changed at all over the years although the accepted definition of control or supervision has. The Royal Pharmaceutical Society’s Code of Ethics and Standards requires that dispensing must be under the supervision of a pharmacist, who must be able to intervene and advise. There is now the challenging redefinition proposed by the Society, with active consideration of this aspect by the Department of Health on behalf of the Government.

Individual pharmacists who own their community pharmacy as sole proprietors are responsible for themselves. Limited companies, however, have been granted their own legal status. Designated as a body corporate, each has to appoint an individual pharmacist to act as superintendent pharmacist for the company. The superintendent has the legal responsibility for its pharmaceutical activities. Any employed local community pharmacist is responsible for ensuring that the requirements of the superintendent pharmacist are complied with. Infringements of the law are dealt with by the Society’s Statutory Committee. It all appears to be highly sensible and simplistic.

In the past, if a pharmacist employed or engaged by a body corporate made a serious dispensing error, for example, both the superintendent and the local pharmacist could present themselves before a Statutory Committee hearing. Should the same body corporate have a second error, regardless of whether it is the same pharmacist or not, then the same superintendent would once more need to appear before the Statutory Committee. For any pharmacist to appear more than once before this committee was, and still is, considered serious. There is the possibility that the committee could direct that the superintendent’s name should not remain on the Register. In the past, this prospect was never allowed to occur. The livelihood of the superintendent was protected by the simple expedient of changing the appointment immediately after the first appearance.

Although there have been no changes in primary legislation, there has been a subtle change in the deliberations of the Statutory Committee to the benefit of pharmacy superintendents.

Over recent years, arguments have been put to the Statutory Committee by solicitors representing superintendent pharmacists that, since the superintendent was not actually present when the offence occurred, the superintendent was not directly responsible for the offence and the responsibility for the offence rested solely with the employed pharmacist.

Additionally, the pharmacy superintendent had dictated what his company’s internal rules were in respect of pharmaceutical matters. This had fulfilled the duties and was sufficient to protect the superintendent from any blame. It was the pharmacist who had transgressed and it was the pharmacist’s sole responsibility, not the superintendent’s. The Statutory Committee on behalf of the Society concurred with that argument.

“Supervision” has not been debated or argued over in any court of law for many years. Relatively recently, the Society, in its deliberations, has been formally introducing the idea that perhaps supervision could now be redefined and possibly have a less restrictive definition. The suggestion of “relaxation” has been discussed with an apparently keen Department of Health. Even “remote supervision” has been put on the agenda. Some controversy has already surrounded all these ponderings. The intention of the new contract is to make it easier for pharmacists to move away from the dispensing bench. To formalise all these deliberations in line with other already introduced new contract requirements the Department of Health intends issuing additional Regulations. It has already indicated that primary legislation is not to be amended. So we are now anticipating what may be contained within the small print of the secondary legislation currently promised by the Government.

In the meantime, we can only postulate as to the future. Modernisation has seen the introduction of clinical governance, standard operating procedures and other paperwork requirements under the new NHS contract, all of which have been granted legal status. Concurrently with this, we also have the new requirement that pharmacy technicians will (must) be registered with the Society. Pharmacy technicians are required to undertake continuing professional development and are also now becoming formally accredited as checkers. All this adds a new dimension to an exciting future.

Today, despite the Medicines Act, the superintendent, with the agreement and understanding of the Society through the Statutory Committee, has passed the responsibility buck to the local pharmacist, based mainly on the simple argument that he or she was not actually present. Indeed, this is reinforced by the fact that it is now seriously suggested that the intended new secondary legislation includes a requirement to nominate a local community pharmacist as the “responsible pharmacist”.

However, it is my personal view that, with the possible support of the human rights legislation and with the precedent already set and accepted, the local community pharmacist, despite all the SOPs etc, could reason, very cogently, at a Statutory Committee hearing, that they were also “not actually present” during the occurrence of a misdemeanour in their legal absence. It could be properly argued that the absence was entirely due to supplying an advanced or enhanced contracted legal requirement.

Responsibility sauce for the superintendent goose must surely also be responsibility sauce for the local community pharmacist gander. To observe a future test case involving supervision will be more than fascinating. It is, perhaps, not so much a sauce, but thick soup.