Chapter 2 Control of medicines in hospital and community
After reading this chapter, you should be able to:
INTRODUCTION
On the establishment of the NHS in 1948, the range of safe and effective medicines available to the prescriber was very limited indeed. Most of the drugs that are now taken for granted were not even a gleam in the eye of the molecular chemist in 1948. Safe and effective cardiovascular drugs, anticancer agents, oral diuretics and psychoactive drugs did not exist. In the 1940s and early 1950s, simple, although not always harmless, inorganic and organic chemicals and products of very dubious composition, derived from naturally occurring products, were still widely prescribed. Natural products remain a very important source of valuable medicines, but today we have sophisticated methods of extraction, purification and standardisation that, in the case of licensed medicines, guarantee consistency of quality. Methods of drug delivery were also very basic indeed, with oral solid dosage forms adequate but crude by today’s standards. Simple oral liquid preparations were often poorly formulated, foul-tasting and inconvenient to use. Although some quality assurance procedures were in place, these were aimed at testing the final product rather than controlling the whole manufacturing process.
The Medicines Act of 1968 marked a new beginning in the control of all aspects of the production, testing and marketing of medicines. Some idea of the progress made in the development of medicines over the past 80 years can be gained from the summary shown in Table 2.1. The need for effective control systems has developed accordingly. In 2005, the Commission on Human Medicines (CHM) replaced the Committee on Safety of Medicines and the Medicines Commission. The duties of the CHM are based on the need of ministers for advice on major policy matters relating to medicines.
Table 2.1 Development of medicines over 80 years
| Decade | Drug(s) developed |
|---|---|
| 1920s | Insulin |
| 1940s | Penicillin and streptomycin |
| 1950s | Chlorpromazine, corticosteroids and thiazide diuretics |
| 1960s | Benzodiazepines, ampicillin, vinblastine, melphalan, propranolol and cytarabine |
| 1970s | Cefalexin, enflurane, doxorubicin, clotrimazole, naproxen, streptokinase and cimetidine |
| 1980s | Clozapine, salmeterol, lisinopril, goserelin, erythropoietin and ranitidine |
| 1990s | Monoclonal antibodies, colfosceril and lamotrigine, third-generation cephalosporins, anticancer agents, and products such as insulin lispro produced by recombinant techniques using sophisticated biological methods |
| 2000s | Gene therapy, more drugs from natural sources, more emphasis on chemoprevention, cell/organ transplantation; safer drugs |
LEGAL CLASSIFICATION OF MEDICINAL PRODUCTS
The supply, storage and use of all medicinal products are controlled by the Medicines Act 1968. Three classes of products are defined in the Act; these are shown in Box 2.1. Legislation for controlled drugs (CDs) is provided by the Misuse of Drugs Act 1971. The Medicines Act is concerned primarily with regulating the legitimate use of medicines; the Misuse of Drugs Act is mainly concerned with the prevention of the abuse of CDs.
Box 2.1 Classes of products defined by the Medicines Act 1968
Certain legal requirements apply to the sale, supply, dispensing and labelling of each class of medicinal product. These requirements are applicable mainly in the community, for example sale/supply of medicines by community pharmacists and others. In hospital practice, all medicines are treated in the same way, no distinction being made between the different classes listed in Box 2.1. However, CDs are subject to additional security and recording requirements. The key elements of the legislation that affect practice directly or indirectly are described below.
PRESCRIPTION-ONLY MEDICINES
There are three classes of prescription-only medicines (PoM):
The administration of medicines in hospitals is normally covered by a health authority policy statement that permits administration of medicines only in accordance with the written prescription of a medical, dental or nurse practitioner. The only exception to this rule is when a patient group direction has been set up (see p. 87).
LABELLING OF MEDICINAL PRODUCTS
Standard labelling requirements are described in the Act. This is a matter for the pharmacist or manufacturer to comply with (Figs 2.1 and 2.2). The main particulars included on a label of a medicinal product are listed below; it is important to note that the information on the label must be clear, legible, comprehensible and in English.
STORAGE OF MEDICINAL PRODUCTS IN HOSPITAL
Separate locked cupboards are required for the following:
SELF-ADMINISTRATION SYSTEMS (IN HOSPITALS)
When it is considered appropriate for a patient to self-administer her or his medicines, an individual locked patient medication cabinet will be required (see p. 116).
PATIENTS’ OWN DRUGS
On admission to hospital, patients are encouraged to bring with them their current medicines. This enables current therapy to be validated, and, if appropriate, the medicines can be used. There appear to be a number of advantages in using patients’ own drugs in hospital, although there may be risks involved (Fradgley and Pryce 2002). To avoid these risks, a quality checklist for assessment of patients’ own drugs should be used (Fradgley and Pryce 2002). If it is decided to use patients’ own drugs, suitable arrangements must be made for safe storage of the drugs. Separate storage in a locked individual patient medication cabinet may be appropriate, especially if the patient is to self-administer medicines. It should be remembered that the medicines brought in by patients are the patients’ property, and permission should be sought either to use them or to dispose of them.
CONTROLLED DRUGS
Drugs of addiction that produce dependence (see Ch. 14), such as diamorphine and pethidine, require special controls. The Misuse of Drugs Act 1971 and the Misuse of Drugs Regulations 2001 regulate the importation, export, supply and use of such drugs. Offences involving CDs are dealt with taking into account all circumstances, including the harmful nature of the drug that is misused and the quantities involved. The debate on how such offences should be dealt with in the community continues. In general, a more relaxed attitude to ‘minor’ offences appears to prevail. In the realm of clinical practice, however, offences involving CDs are always treated as major incidents.
Within the regulations, five schedules are defined. The details in the schedules are not of great practical interest to nurses, but aspects of supply, possession, prescribing and record keeping are important. Most drugs used in clinical practice are subject to schedule 2 requirements. Schedule 3 includes barbiturates and temazepam. Strictly according to the law, records are not required to be kept of temazepam, but in view of the great potential for abuse CD records are made.
LEGISLATION AND RESPONSIBILITY OF STAFF
PRESCRIBING WITHIN THE NHS
The following regulations also apply in the community.
PRESCRIBING CDS OUTWITH THE NHS (SCHEDULE 2 AND 3 CDS)
ORDERING
A separate page should be used for each product (Fig. 2.3). The nurse signs and dates the order, adding her or his designation. Unless the order has all the necessary detail written in the correct manner, the pharmacist cannot supply the drug.
The whole order book is sent to the pharmacy department where the pharmacist prepares the order and signs the requisition. The person acting as messenger for the return of drugs to the ward or department also signs the requisition. The original requisition is then retained in the pharmaceutical department. In situations in which supply of a CD is required outwith normal working hours and there is no pharmacy on site, the order may be faxed to the central pharmacy department, followed by confirmation by telephone. In rural hospitals, it may be necessary to have two CD order books, because one may be in transit between the hospital and the pharmacy department.
DELIVERY AND RECEIPT TO WARDS AND DEPARTMENTS
On receipt of supplies of a CD and the order book by a ward or department, two nurses – one of whom is a registered nurse – should check the drugs against the copy requisition. If all is found to be correct, the copy requisition is signed (Fig. 2.4) and the order book retained in the ward or department. If there is any discrepancy, the pharmacy should be notified at once.
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