Superintendent pharmacists have always been responsible for the management of pharmacy businesses owned by companies so far as concerns the keeping, preparing and dispensing of medicines, except those on a general sale list. The law was changed in 2008 to require every pharmacy to have a responsible pharmacist who has a legal duty to ensure the safe and effective running of the pharmacy where they work.
In 2018, the Department of Health and Social Care (DH) conducted a consultation on recommendations by the rebalancing board to change the legal responsibilities of superintendents and responsible superintendents. Many consultation responses disagreed with the proposals for change.
Predictably, there were often opposing views from owner organisations like the National Pharmacy Association (NPA) and employee representatives like the Pharmacists’ Defence Association (PDA). On the other hand, there were occasions when the NPA and the PDA were united in their opposition to the proposals.
Nevertheless, with one exception (see below), the government has announced its intention to implement all the rebalancing board’s proposals.
The changes include:
Superintendent pharmacists
Superintendents must be a senior manager of the pharmacy business owned by a company. A senior manager will be someone who plays a significant role in the making of decisions about how the whole, or a substantial part of the activities of, the retail pharmacy business are operated. The DH believes that this new role will ensure that superintendents have the seniority and influence to allow for them to appropriately make decisions about how the retail pharmacy business is run, in the best interests of patients and the public.
This role will relate to the sale and supply of all medicines from registered premises – currently, the role does not extend to medicines on a general sale list. However, the role will be limited to the business on registered premises. For example, if general sale medicines are sold in part of a supermarket that is not registered as a pharmacy, the superintendent will not be responsible for the sales.
Superintendents will have a new general duty to secure the safe and effective running of the retail pharmacy business so far as concerns the retail sale and supply of all medicines by that business. In this way, superintendents will become responsible for systemic errors in the business, which could have been reasonably foreseen and did not align with good professional practice.
Other proposed changes in the law will allow superintendent pharmacists to be the superintendent of more than one company. This will make sense for pharmacy groups that have more than one company and currently require a different superintendent for each one. In addition, companies that include the word “chemist” in their name will no longer be required to include the superintendent on its board of directors. This is a small but welcome recognition there is no need to treat businesses differently depending on the name they choose.
Responsible pharmacists
The role of responsible pharmacists will be clarified and distinguished from the role of superintendents. Whereas the superintendent is intended to be the professional lead within a body corporate and is responsible for the safe and effective running of all pharmacy premises under their control, the responsible pharmacist is the person in charge of an individual pharmacy on a given day. The responsible pharmacist will still have a legal duty to ensure the safe and effective running of that pharmacy.
Responsible pharmacists would not have overarching responsibility for organisation-wide policies such as standard operating procedures (SOPs). For example, where a particular SOP may not be in the best interest of a patient, the responsible pharmacist would have autonomy to be able to temporarily adjust or choose not to follow the procedure.
Responsible pharmacists currently have a legal duty to establish, maintain and keep procedures under review. This duty will be removed. Instead, this responsibility will become part of the new general duty of superintendents.
The law will clarify that:
- A responsible pharmacist is needed when either a pharmacy is actually open to the public for selling or supplying medicines or when medicines are being assembled, prepared or dispensed at or from the premises with a view to sale or supply, for example the preparation of medicines outside of opening hours.
- A responsible pharmacist will still have to be on duty for all sales, including general sale medicines, even if the responsible pharmacist is absent from the premises. In a change from the original proposals, a responsible pharmacist will not be required if premises are closed to the public and medicines are merely being put on shelves.
- Responsible pharmacists hold their responsibility only when they are designated as the responsible pharmacist. Unlike superintendent pharmacists whose responsibilities are not time-limited, as soon as a responsible pharmacist signs out, their responsibilities will end.
- A responsible pharmacist’s duty will relate to the operation of the pharmacy business ‘at or from’ the particular premises (including home deliveries of medicines) for which the responsible pharmacist is in charge.
The responsible pharmacist’s current legal duty to keep certain records, such as a responsible pharmacist log, will be removed.
Professional rather than legal duties
A key feature of the proposals is to remove legal obligations from superintendents and responsible pharmacists and instead empower the General Pharmaceutical Council (GPhC) and Pharmaceutical Society of Northern Ireland (PSNI) to make rules and publish standards for pharmacy owners and pharmacy professionals to follow. These rules and standards may include:
- Whether responsible pharmacists can be absent from pharmacies.
- Extending the professional responsibilities of superintendent pharmacists beyond medicines to clinical and public health services.
- If a pharmacist is the superintendent of more than one company, what the superintendent should and should not be doing.
- Exceptions to the general rule that a responsible pharmacist may only be in charge of one pharmacy at a time.
- Spelling out the professional responsibilities of superintendents and of responsible pharmacists.
- The qualifications and experience of superintendent pharmacists and responsible pharmacists.
The draft Pharmacy (Responsible Pharmacists, Superintendent Pharmacists etc.) Order 2022 was laid before parliament on April 28 and the procedural parts of the order are due to become law after 28 days ie on May 26. The rest – including the substantive changes – will come into force on a day appointed by the Privy Council.
When these changes to the law are added to the forthcoming widening of hub-and-spoke dispensing, and future changes in the law of supervision, community pharmacy law will have undergone a dramatic modernisation.
David Reissner is chair of the Pharmacy Law & Ethics Association