Hospital Pharmacist
Vol 9 No 8 p248
September 2002

Review of circulars and official publications
by Alex Bower, MRPharmS

The Department of Health (DoH) issued the document, "Provision of patient information with dispensed medicines: guidance note" on 1 August. By means of this document, the DoH is seeking comments on a proposal to provide a statutory defence against breach of copyright for health care professionals who produce copies of patient information leaflets (PILs) to meet their obligations under European Community directive 2001/83/EC.

Hospital pharmacists will be aware that the requirement to provide a PIL can give rise to enquiries from patients when the medicine is used for an off-licence indication. This is a relatively frequent occurrence in hospitals, especially when children are being treated. The guidance does not indicate how this problem should be resolved. In the absence of a suitable statement in the relevant summary of product characteristics, the use of posters and/or the provision of further information to the patient explaining that some statements in the PIL may not apply in their own case, seems sensible. Amending the PIL itself does not seem to be an option since the wording is approved at the time that the product is granted a licence. A PIL should be supplied to those who are self-administering drugs in hospital, and the availability of PILs should be made known to all other patients. Hospital pharmacists should ensure that they are complying with these requirements.

A one-off grant will be made to all retail pharmacy businesses to help meet the costs of complying with the law, and discussions are proceeding on the possibility of an addition to the "global sum" for what is regarded as a "modest additional burden". There is no reference to any funding for hospital pharmacy departments.

The situation with PILs and the issue of supplying drugs in original packs is not satisfactory. In other EC member states, medicines are marketed in original packs and the same should apply in the UK. The argument that to do this would add cost without benefit to patients is unconvincing. Issues of patient safety, patient empowerment and quality of care should prevail. Placing hospital pharmacists in a position where they infringe copyright law while attempting to comply with EC regulations is unacceptable. Even if the proposal resolves the copyright issue, the other issues would have to be addressed. Hospital pharmacists should take the opportunity offered by this document to make their feelings known. The deadline for comments is 24 October.

The NHS Modernisation Agency has issued the paper "Critical care programme: AHP [Allied Health Professions] and HCP [Health Care Scientists] advisory group: the role of health care professionals within critical care services: June 2002." The paper highlights the contribution that each of the professions covered can make to critical care. A section on clinical pharmacy provides a useful summary of the role of clinical pharmacists and recommends that basic critical care should be a core skill for all such pharmacists. Acute trusts are required to fund at least a 0.05–0.1 whole-time equivalent Grade D specialist clinical pharmacist per bed, depending on the nature of clinical care provided.

Hospital pharmacists engaged in critical care should make sure that the contents of the clinical pharmacy section are brought to the attention of those engaged in developing critical care services. Collaborative working with all health care professions is essential. There was a time when hospital pharmacists guarded the separateness of the profession to avoid being categorised as either a profession supplementary to medicine or a profession allied to medicine since these descriptions appeared to suggest a subordinate role for pharmacists and ran the risk of linking the profession for purposes of pay bargaining with other disciplines that have different training requirements. Hospital pharmacists may wish to debate any concerns they have with being categorised as an AHP the next time they have a tea break together! The paper is here.

" 'Making a difference': reducing burdens in hospital" was issued by the DoH in July. The document indicates that guidance will be issued in September on extending the role of nurses to include intravenous administration of drugs. Hospital pharmacists will no doubt be involved in training programmes. The section entitled "Patient discharge — medicines management" is particularly relevant for hospital pharmacy managers. The key points are:

• Patients' own drugs and self-administration schemes. A national contract for bedside medicine lockers will be in place by April 2003. A mechanism to share and spread good practice will be determined

• Original packs for discharge. Guidance will be issued on the transfer of funds between primary and secondary care to facilitate the process

Further guidance on these points is expected in September and will be the subject of a future review. It is hoped that the guidance will be similar to the Welsh document reviewed last month (Hospital Pharmacist 2002;9:210) in recognising the potential impact of the changes on hospital pharmacy staff and the need to provide resources for the initiative. The guidance to be issued could herald a major re-engineering exercise for the supply of medicines in hospitals that will necessitate close working with primary care. The document is available on the internet as a PDF (490K).

The Scottish Office issued HDL(2002)56 entitled "Extension of nurse prescribing in NHSScotland: introduction of the nurse prescribers' extended formulary" on 5 July. This indicates the arrangements for the supply and use of prescription forms. A booklet: "Extending independent nurse prescribing within NHSScotland — a guide for implementation" is available separately. Hospital pharmacists should be aware of this development of prescribing roles although it may not impact directly on secondary care.

The National Patient Safety Agency issued its first "Patient Safety Alert" on 23 July. Potassium chloride concentrate solutions should be removed from stock in wards and clinics, and restricted to pharmacy departments and critical care areas in cases where they are required for urgent use. A second practitioner must carry out a check before the administration of these products. Documentation should be as for controlled drugs. Hospital pharmacy managers should ensure that the requirements of the alert are fully implemented.

  * PDF files on PJ Online require Acrobat Reader 4 or later.

Mr Bower is a consultant pharmacist