2022-05-01 19:22:36
The Pharmacy Rebalancing Board made proposals for changes in the law on which the Department of Health and Social Care conducted a consultation in 2018. DHSC has just published its intentions in the light of the consultation responses, one of which was submitted by PLEA – https://www.gov.uk/government/consultations/pharmacy-legislation-on-dispensing-errors-and-organisational-governance/outcome/rebalancing-medicines-legislation-and-pharmacy-regulation-programme-consultation-outcome .
The proposed changes are substantial and they will be made through two statutory instruments, the Pharmacy (Preparation and Dispensing Errors – Hospital and Other Pharmacy Services) Order and the Pharmacy (Responsible Pharmacists, Superintendent Pharmacists etc.) Order. DHSC intends to make only one change to the originally-proposed amendments to the law.
In summary, the statutory defences to prosecutions for dispensing errors that were introduced in relation to community pharmacy in 2018 will be extended to hospital pharmacies provided that certain conditions are met, including a requirement that the hospital has a chief pharmacist whose role will be analogous to that of a superintendent pharmacist in a community pharmacy owned by a body corporate.
In community pharmacies, the roles of superintendent pharmacists and responsible pharmacists will be changed and clarified. 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.
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 save 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 PSNI 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.