Guild of Healthcare Pharmacists
New legislation on medicine supply and administration
Hospital pharmacists and representatives of pharmaceutical companies attended the autumn symposium of the procurement and distribution interest group of the Guild of Healthcare Pharmacists, which was held in Coventry on November 9
New legislation that had come into force this year had clarified the legal situation regarding supply and administration of medicines and gave pharmacists an important role, said Mr IAN SIMPSON (professional secretary, Guild of Healthcare Pharmacists). The new legislation was about supply and administration of medicines, not just prescribing, and comprised:
The Prescription Only Medicines (Human Use) Amendment Order 2000
The Medicines (Pharmacy and General Sale Exemption) Amendment Order 2000
The Medicines (Sale or Supply) (Miscellaneous Provisions) Amendment (No 2) Regulations 2000
Patient Group Directions HSC 2000/026 — applied to England only
The three new statutory instruments allowed supply by wholesale to more bodies and persons than previously and allowed exemption from sections 52, 53 and 58 of the Medicines Act 1968. Mr Simpson said that the original wording of these sections had raised questions, such as what did supply mean? How was a hospital defined? What kinds of directions were acceptable?
The legislation had created exemptions to the Medicines Act, as it allowed the sale, supply and/or administration of medicines, under certain conditions, by: hospitals (both private and NHS); NHS bodies (eg, health authorities, NHS trusts, primary care trusts or, in Scotland, the Common Services Agency); persons other than doctors, dentists or community pharmacies (this might include hospices or private or voluntary activity funded by the NHSE); health professionals assisting doctors and dentists in the provision of national health services (eg, pharmacists, nurses, ophthalmic opticians, chiropodists); and community pharmacies. The above people could supply, sell or administer medicines under these conditions provided they did so:
A. In accordance with the patient-specific, written directions of a doctor or dentist
In accordance with a patient group direction
C. In the course of the business of the hospital
D. Pursuant to an arrangement made with an NHS body
E. A health care professional supplying or administering the drug
Mr Simpson said that, to some extent, the new legislation had clarified the uncertainty over the wording of sections 52, 53 and 58 but suggested that verbal orders might no longer be acceptable. In addition, there was still no definition of what constituted a hospital. The conditions that applied to the new suppliers were as follows:
Hospital — A and C
NHS bodies — A or B and E
Persons other than doctors, dentists or retail pharmacies — A and D, or B, D and E
Health professionals assisting doctors and dentists in the provision of national health services — B and E
Retail pharmacies — B and D
Mr Simpson then went on to describe patient group directions. These were written documents relating to the supply and/or administration of a class of medicine. Directions had to be signed by a doctor or dentist and a pharmacist. The signatories had to be of senior grade and involved in drawing up the direction. Patient group directions were elaborate documents, which had to include such details as a description of the type and quantity of the medicine, the situations under which the drug could or could not be used, when further advice should be sought and what records of supply were required.
As far as the supply chain was concerned, The Medicines (Sale or Supply) (Miscellaneous Provisions) Amendment (No 2) Regulations 2000 allowed supply by wholesale to persons or bodies authorised to supply and/or administer under the other two statutory instruments (The Prescription Only Medicines [Human Use] Amendment Order 2000 and The Medicines [Pharmacy and General Sale Exemption] Amendment Order 2000).
With regard to NHS bodies, it was important to ensure that all supply and/or administration was legal as HSC 2000/026 carried the threat of legal action.
On a happier note, arrangements for supply of medicines by community pharmacists using patient group directions might encourage closer working between hospital and community pharmacy.
The Medicines Act —
sections affected
|
Section 52 Prohibits the sale or
supply of prescription-only and pharmacy medicines (POMs
and Ps) other than from a registered pharmacy and by or
under supervision of a pharmacist
Section 53 Prohibits the sale or supply
of general sales list (GSL) medicines except from
premises which the occupier can close to exclude the
public (ie, a shop not a market stall or car boot)
Section 58 (2)(a) Prohibits the sale or
supply of POMs except in accordance with a prescription.
(2)(b) Prohibits the administration of POMs except to
oneself, by a practitioner or in accordance with the
directions of a practitioner
Sections 52 and 53 do not apply to sale or supply of a
medicinal product: by a doctor or dentist to a patient of
his or to a person who is caring for such a patient; or
in the course of the business of a hospital or health
centre where the product is sold or supplied for the
purpose of being administered (whether in the hospital,
health centre or elsewhere) in accordance with the
directions of a doctor or dentist. |