The Royal Marsden Hospital Manual of Clinical Nursing Procedures - Lisa Dougherty [526]
Legal and professional issues
Administration of medicines has been one of the most common clinical procedures undertaken by nurses for at least the past 50 years (Shepherd 2002a). With changes in legal, professional and cultural boundaries in healthcare, the role of the nurse has broadened to one of medicines management. Medicines management and specifically medicines administration require thought and professional judgement (Luker and Wolfson 1999, NMC 2008a). All aspects of a medicine’s use must be managed with a multidisciplinary approach to ensure it is supported by a strong evidence base and that the safety and well-being of the patient remain paramount (NMC 2008b, Shepherd 2002a). Nurses are taught how to prepare and administer medication via the common routes during their basic training. This includes calculation, which is vital as any miscalculation of medication dosage represents a potential threat to both patient safety and clinical effectiveness (Weeks et al. 2000). There are now a number of computer-based programmes on infection control and IV therapy, infusion pumps (NHSCLU 2009) and medication dosage calculation problem-solving skills (Weeks et al. 2001) which provide knowledge and competency for nurses.
Legislation
Legislative frameworks, government guidelines and professional regulations govern medicines management in the UK. The primary pieces of legislation are the Medicines Act 1968, European Directives and the Misuse of Drugs Act 1971 (HMSO 1971).
The Medicines Act 1968
European Community Council Directives and Regulations and the Medicines Act 1968 (HMSO 1968) regulate the manufacture, distribution and importation of medicines for human use. The Medicines and Health Care Products Regulatory Agency (MHRA) in the UK and the European Medicines Agency (EMEA) are responsible for the licensing procedures for medicinal products. The availability of products is restricted by defining which of the following legal categories they are in:
prescription-only medicines (POM)
pharmacy-only medicines (P)
general sales list medicines (GSL).
Different requirements apply to the sale, supply and labelling of medicines in each category. In hospitals, medicines can be supplied in line with patient-specific directions, from an appropriate practitioner in relation to the medicine, which in most cases will be an instruction on the patient ward drug chart. This written instruction does not need to comply with the requirements specified for prescriptions but does need to relate to a specific patient. The legislation also allows the supply of prescription-only medicines to be made under a PGD. A PGD needs to be signed by a doctor and a pharmacist. The regulations permit certain registered professionals to supply or administer under a PGD.
In addition to the above, there are also a range of exemptions from the regulations which allow certain groups of health professionals to sell, supply and administer particular medicines direct to patients (Applebe