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The Pharmaceutical Journal Vol 265 No 7127 p894
December 16, 2000 Letters

Patient Group Directions

Patient specific directions

From Mr I. G. Simpson, FRPharmS

SIR,—In your otherwise excellent report on my address to the autumn symposium of the procurement and distribution group of the Guild of Healthcare Pharmacists (PJ, December 2, p830), you quote me as saying the new legislation is about supply and administration of medicines, not just prescribing. What I actually said was that the new legislation is not about prescribing at all, although it was mistakenly cited as such in the NHS plan, and that it is not just about patient group directions, but is also about patient specific directions.
I should also like to take the opportunity to comment on Jo Raffaitin's useful article on "Patient group directions and the law" (PJ, December 9, p851). As the title suggests, this is mainly about patient group directions. Mrs Raffaitin does mention that the new legislation also allows supply or administration of medicines in accordance with a patient specific written direction, but I feel that more emphasis should be given to this. Hospitals (both private and NHS) and NHS bodies are authorised to supply or administer medicines in accordance with the patient specific written direction of a doctor or dentist, and the written direction does not need to comply with the detailed requirements for a prescription specified in Article 15(2) of the Prescription Only Medicines (Human Use) Order 1997. This is important, because most supply and administration of medicines in hospitals takes place in this way. Although Section 55(1) of the Medicines Act does not require the directions to be written, the new legislation makes it clear that the directions must be both written and patient specific. This is now a legal requirement, rather than a matter of good practice,
as recommended in Medicines, Ethics and Practice.1
Mrs Raffaitin does not make any mention of supply or administration by a person, other than a doctor, dentist or person conducting a retail pharmacy, pursuant to an arrangement with an NHS body. The legislation gives no indication of who such a person might be. However, HSC 2000/0262 points out that the legislation applies to services in the private and voluntary sector funded by the NHS, and it also refers to walk-in centres and NHS funded family planning clinics. It is thought that these services and premises are covered by this clause. The NHS Executive has confirmed that it also refers to private and voluntary hospices where medicines are supplied to the hospice by the NHS, or where the NHS funds the supply (personal communication, NHSE). Thus, supply and administration of medicines under both patient group direction and patient specific written direction can take place in these establishments, in the same way as in NHS hospitals.
Mrs Raffaitin is right to draw attention to the NHSE document "Controls assurance standard: medicines management". Under this document, hospital chief pharmacists are given responsibility for ensuring the safe and secure handling of medicines throughout the hospital. Taking into account the new legislation, they should therefore ensure that all supply or administration in the hospital is carried out in one of three ways: (i) in accordance with a prescription, (ii) in accordance with a patient specific written direction of a doctor or dentist, or (iii) in accordance with a patient group direction.
Finally, a word about indemnity insurance. The Society's Code of Ethics and professional standards requires a pharmacist to ensure that all professional activities are covered by professional indemnity insurance or equivalent arrangements.3 Pharmacists who are employed by an NHS body are covered by the NHS clinical negligence scheme for any negligent acts which they may commit in the course of their work. In the event of a problem, members of the Guild of Healthcare Pharmacists are provided with personal legal and professional advice and representation, independent of that provided by their employing NHS body. It is the view of the guild's council that these two elements, ie, the NHS clinical negligence scheme and the personal legal advice and representation provided through guild membership, together satisfy the Society's ethical requirements. Therefore, pharmacists who are employed by the NHS and are guild members should not require any additional indemnity insurance to cover them if they are involved in drawing up, signing or operating PGDs as part of their NHS employment.

Ian G. Simpson Professional Secretary Guild of Healthcare Pharmacists

References
1. Administration of prescription only medicines in hospital. Medicines, ethics and practice (no 24). London: Royal Pharmaceutical Society; 2000. p5.
2. HSC 2000/26. Patient group directions (England only). Bradford: NHS Executive; 2000.
3. Standards for professional indemnity. Medicines, ethics and practice (no 24). London: Royal Pharmaceutical Society; 2000. p86.