2022-11-02 14:33:05
On 1 December 2022, the Pharmacy (Responsible Pharmacists, Superintendent Pharmacists etc.) Order 2022 and the Pharmacy (Preparation and Dispensing Errors – Hospital and Other Pharmacy Services ) Order 2022 will come into force.
The Orders are based on recommendations of the Pharmacy Rebalancing Board.
The Pharmacy (Responsible Pharmacists, Superintendent Pharmacists etc.) Order 2022
The Pharmacy (Responsible Pharmacists, Superintendent Pharmacists etc.) Order 2022 amends the Medicines Act 1968 by making substantial changes to the respective legal duties of superintendent pharmacists and responsible pharmacists. We summarised the changes in our News item on 1 May 2022 and we are repeating the summary below.
Superintendent pharmacists must be a person with a significant role in the making of decisions about how the whole or a substantial part of the activities of the retail pharmacy business is run.
Currently, a superintendent pharmacist’s role does not extend to general sale list medicines. When the law is changed, superintendents will have a legal duty to secure the safe and effective running of the pharmacy business so far as concerns the sale and supply of all medicines.
Superintendents will be permitted to be the superintendent of more than one company and, if the company has the word “chemist” in its name, the superintendent will no longer have to be a member of the board.
The law will make it clear that a responsible pharmacist’s legal duty to secure the safe and effective sale and supply of medicines only relates to the particular premises where they are designated as the responsible pharmacist and only while they are on duty (whereas a superintendent pharmacist’s responsibilities are not time-limited). The duty will cover sales and supplies at or from the pharmacy premises, so as to cover home deliveries.
The current record-keeping obligations of responsible pharmacists will be removed.
A responsible pharmacist will have to be on duty for all sales, including general sale medicines and also when medicines are being assembled, prepared or dispensed. However, a responsible pharmacist will not have to be on duty if medicines are merely being put on shelves.
The GPhC and, in Northern Ireland, the Pharmaceutical Society of Northern Ireland will be empowered to make rules and standards covering a number of matters that will no longer involve legal obligations. Amongst other things, the 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 Pharmacy (Preparation and Dispensing Errors – Hospital and Other Pharmacy Services) Order
This Order will amend the Medicines Act 1968 by providing a due diligence defence if a hospital pharmacist is prosecuted for making a dispensing error that harms a patient. A similar defence was introduced in 2018 for errors made in community pharmacies. In the case of hospital pharmacies (and some other pharmacies such as prisons), the defence will be subject to conditions, one of which is that the hospital has a chief pharmacist. The chief pharmacist does not have to have the title as such, but must be a pharmacist who plays a significant role in
(i) the making of decisions about how the whole or a substantial part of the activities of the pharmacy service are to be managed or organised, or
(ii) the actual managing or organising of the whole or a substantial part of those activities,
(b) has the authority to make decisions that affect the running of the pharmacy service so far as concerns the sale or supply of medicinal products, and
(c) is responsible for securing that the pharmacy service is carried on safely and effectively.