From 1 October 2009, new legislation will come into force that will affect the running of all registered pharmacy premises in both the community and hospital sectors, and in all four countries of the United Kingdom.
In a nutshell, the personal control requirement in the Medicines Act 1968 will be replaced with the “responsible pharmacist” requirement. Pharmacy owners, superintendents, hospital trust chief pharmacists and responsible pharmacists themselves will need to get to grips with what is required of them under:
- The Medicines Act 1968 (as amended)
- The Medicines (Pharmacies) (Responsible Pharmacist) Regulations 2008 — which set out the requirements in a new section (72A) of the Act in more detail
- The Royal Pharmaceutical Society’s and the Pharmaceutical Society of Northern Ireland’s professional standards and regulatory guidance — which set out professional obligations
Department of Health guidance on changes to the 1968 Act and the Regulations is to be issued shortly. Meanwhile, the responsible pharmacist Regulations are published on the Office of Public Sector Information website (www.opsi.gov.uk).
Draft professional guidance from the Society was published for consultation in The Pharmaceutical Journal on 17 January 2008. The key requirements relating to changes to sections 70 to 72 and the new section 72A of the Act and the Regulations are set out in the Box on page 92.
These legislative changes only concern the concept of personal control. As yet, there is no change to the pharmacist supervision requirements in the Medicines Act and NHS legislation. It is also important to be aware that these changes only relate to the sale and supply of medicines from registered pharmacy premises — i.e. not NHS services that do not involve the sale and supply of medicines.
How does this new legislation impact on hospital pharmacy?
Although the concept of the responsible pharmacist is the same as “personal control” — i.e. safe working under the authority of the pharmacist in charge of the pharmacy — it is not dependent on the physical presence of the pharmacist alone. There must be procedures and systems in place. This is familiar ground in the hospital sector.
However, the implementation of this legislation could be challenging in secondary care because the Medicines Act was largely written with community pharmacy premises in mind where, in the majority of cases, only one pharmacist is present in the pharmacy. The hospital pharmacy model is quite different with pharmacies usually manned by several pharmacists and where there may be a separation of clinical and managerial functions. For instance, a duty pharmacist, often newly registered, may provide clinical oversight to the dispensing process and be on the premises for all the time he or she is on duty. However, a senior, more experienced pharmacist may have overall responsibility for clinical, managerial and procedural issues. Because he or she may not be on the premises for the majority of the time, the legislation would require the duty pharmacist to be the responsible pharmacist.
As this legislation only applies to registered premises, chief pharmacists may wish to review which parts of the hospital actually need to be registered, by considering which activities need to be undertaken on registered premises and which may be undertaken using the exemptions under sections 10 and 55 of the Medicines Act. For example, inpatient and outpatient manufacturing and dispensing for patients under the care of the hospital do not need to be undertaken on registered premises, whereas the manufacture and supply of medicines to other NHS trusts or the sale of P medicines — e.g. if a product is cheaper to buy than the prescription charge — can only be undertaken on registered premises.
Responsible pharmacist legislation — key requirements
The Medicines Act 1968 (as amended)
Under sections 70 to 72:
The pharmacy owner, superintendent or hospital chief pharmacist must:
- Ensure each registered pharmacy has a responsible pharmacist in charge of the business insofar as it concerns the retail sale or supply (e.g. on prescription) of medicines
The responsible pharmacist must:
- Display a notice, conspicuously, in the pharmacy stating that he or she is in charge for the time being, detailing his or her registration number
Under the new section 72A:
A statutory duty is placed on the responsible pharmacist to secure safe and effective running of the pharmacy by:
- Establishing (if not already established), maintaining and reviewing procedures designed to secure the safe and effective running of the pharmacy in relation to the sale or supply of medicine
- Making and maintaining a record that must be made available at the pharmacy of who is responsible at any day and at any time
A statutory duty is placed on the pharmacy owner (or the superintendent pharmacist or hospital chief pharmacist) to:
- Ensure the responsible pharmacist keeps the record as required
- Preserve the record for at least the period set out in the regulations
The Medicines (Pharmacies) (Responsible Pharmacist) Regulations 2008
The Regulations specify:
- The minimum areas to be covered in the pharmacy procedures, including: ordering, storage, disposal, dispensing or sale of medicines; which pharmacy staff may carry out specified tasks; how the pharmacy should operate when the responsible pharmacist is absent
- The minimum information to be included in the pharmacy record, including: the name and registration number of the responsible pharmacist; the dates and time she or she became the responsible pharmacist; the date and time he or she left and returned to the premises during the time he or she was the responsible pharmacist
- That the responsible pharmacist may be absent for a maximum of two hours per day during the pharmacy’s business hours, subject to complying with conditions for absence
- That GSL medicines may continue to be sold during the absence of the responsible pharmacist
Failure to keep or preserve the pharmacy record will be a criminal offence. All other breaches will be considered as a matter of professional conduct by the regulatory bodies.
There is no change in the statutory role of the superintendent or chief pharmacist. Within the hospital sector the responsible pharmacist remains subject to the directions of the chief pharmacist. However, the chief pharmacist should not fetter the responsible pharmacist in the exercise of his or her duty.
Since the responsible pharmacist only has to establish procedures if they do not already exist, the chief pharmacist or a senior pharmacist could set up model procedures. But responsible pharmacists must be empowered to satisfy themselves that the procedures will ensure the safe and effective running of the pharmacy with respect to the sale and supply of medicines and must be able to change them if necessary.
The procedure for running the pharmacy when the responsible pharmacist is absent for up to two hours and not contactable is likely to be more straightforward in the hospital sector compared with community, since it will usually be relatively easy to enlist another pharmacist as a suitable contact.
Further guidance may be needed for implementing this legislation in the hospital sector and discussions are ongoing between the Guild of Healthcare Pharmacists and the DH.
Clinical services that do not involve the sale or supply of medicines are not covered by this legislation. It would not, for example, be the responsible pharmacist’s job to ensure proper procedures were in place, etc, for the provision of services such as medicines use reviews, disease management clinics that do not involve the supply of medicines or ward pharmacy services.
The purpose of this legislation is to free up time to allow the pharmacist to deliver more clinical services. However, it is unlikely that its implementation will achieve this to any great extent. This is more likely to happen when forthcoming changes are made to rules around supervision.
The author acknowledges the work of the Guild of Healthcare Pharmacists in its response to the Department of Health consultation on the responsible pharmacist.