Chapter 6 Clinical governance and safety in the use of medicines

After reading this chapter, you should be able to:

• outline the types of errors that can occur with the prescribing and dispensing of medicines

• explain the rationale for a no-blame reporting culture

• detail the role of the nurse in ensuring safe administration of medicines.

INTRODUCTION

Safety is a patient’s right and the obligation of all health professionals (Barach and Moss 2001). Systems of healthcare provide a framework within which individual patient care is provided. The concept of clinical governance provides overall guidance to all healthcare staff on the need for high standards in all aspects of patient care. This should be seen as a background to this chapter.

CLINICAL GOVERNANCE/QUALITY STRATEGY

Clinical governance is defined by Scally and Donaldson (1998) as ‘a framework through which NHS organisations are accountable for continually improving the quality of their services and safeguarding high standards of care by creating an environment in which excellence in clinical care will flourish’. Health professionals have always worked within their own professional guidelines and relied on their employer to provide facilities, equipment and other resources to enable them to practise safely and effectively. No systematic methods of improving the quality of service were available until the concept of clinical audit was introduced to the NHS in the 1990s. Despite some success within the audit approach, it became clear that sustained progress in improving the quality of care could be achieved only by establishing a quality strategy and by a change in the culture of the NHS (see Box 6.1). Well-publicised failures in the NHS in the late 1990s have given added impetus to the need for change. Attitudes at all levels within the NHS have come under intense public scrutiny. Professional bodies and their members must now revalidate all aspects of the quality of care for which they are responsible. Effective leadership at all levels is essential so that the planning for quality services on the basis of the objective criteria can take place. Implicit in the need to improve the quality of patient care is the need to ensure that safe systems of work are in place throughout the particular organisation. The introduction of clinical governance provides NHS organisations with a powerful imperative to focus on tackling adverse health care events.

Box 6.1 Quality strategy for the NHS

Standards

• National Institute for Health and Clinical Excellence and Health Technology Board for Scotland

• National service frameworks

• Quality Improvement Scotland

Local duty of quality

• Clinical governance

• Controls assurance

Ensuring quality of individual practice

• NHS performance procedures

• Annual appraisal

• Revalidation

Scrutiny

• Commission for Health Improvement

• Education inspection visits

Learning mechanisms

• Adverse incident reporting

• Learning networks

• Continuing professional development

Patient empowerment

• Better information

• New patient advocacy service

• Rights of redress

• patients’ views sought

• patients’ involvement throughout NHS

Underpinning strategies

• Information and information technology

• Research and development

• Education and training

A report from the USA shows that 44 000–98 000 unnecessary deaths result each year from a range of preventable errors in hospitals in the USA (Weingart and Wilson 2000). A study from Australia produced even higher error rates. NHS reporting and information systems provide a patchy and incomplete picture of the scale and nature of the problem of serious failures in healthcare. However, every year nearly 10 000 people are reported to have experienced serious adverse reactions to drugs (Department of Health 2000). One study (Ridley et al. 2004) looked at 21 589 prescriptions (15.3 new prescriptions/patient) written over a 4-week period within 24 critical care units in the UK. Eighty-five per cent (18 448 prescriptions) were error-free, but 3141 (15%) prescriptions had one or more errors. The five most common incorrect prescriptions were for potassium chloride (10.2% errors), heparin (5.3%), magnesium sulphate (5.2%), paracetamol (3.2%) and propofol (3.1%). Most of the errors were minor, having no serious adverse effects, but 618 (19.6%) errors were considered significant, serious or potentially life-threatening.

Unfavourable comparisons have been made between the safe systems used in the aviation industry and those used in the medical professions. Nolan (2000) places great emphasis on the need to design systems that can help prevent errors and to make them detectable.

Human error is often a contributory factor in drug errors, but inadequate systems of drug management may also be implicated. Reason (2000) outlines the distinguishing features of a ‘high reliability’ organisation. In such organisations, human error is expected and systems are put in place to enable the workforce to keep errors to a minimum, to recognise errors when they occur and to cope with the consequences of error. Built into this approach is the need to use each error as a learning experience and to change systems accordingly.

All the key elements are designed to interact with the overall aim of improving the quality of care within the NHS. Clinical governance at local level is supported by the national structures and mechanisms outlined in Box 6.1. Without the supporting framework at national level, clinical governance has only limited potential to improve the overall quality of patient care. Safe and effective systems of medicine management play a very significant role in patient care.

ERRORS IN THE MANAGEMENT OF MEDICINES

With the ever increasing complexity of drug therapy and the need for many patients to receive multiple-drug therapy, the potential for errors in the administration of medicines is great. Indeed, one of the highest risk areas of nursing practice is the administration of medicines (Scholz 1990). A busy, moderately sized hospital might need 5000–10 000 individual doses each day (Ferner 1995). A medical ward with 30 beds may have as many as 60 products in use at any one time and could keep in stock a range of 200 medicinal products, excluding lotions, sterile fluids, etc. Factors other than complexity of therapy also contribute to errors in the administration of medicines.

An error in the administration of medicines may be, at best, inconvenient for the patient or, at worst, catastrophic. In order to gain a balanced perspective, it is necessary first to form a working definition of an error. This is best done by considering how, in practical terms, the overall objective of drug therapy (i.e. therapeutic benefit for the patient with minimal adverse effects) is most likely to be achieved. The assumption is made that the prescriber has taken all relevant factors into account before prescribing and that the choice of drug, dose, route, etc. is appropriate in every respect. To achieve therapeutic benefit for the patient, it is obviously essential to ensure that the right dose of the right drug is administered at the right time by the right route. Adherence by all healthcare staff to recognised drug procedures is clearly a prerequisite at all times.

Adverse drug reactions and interactions (see Ch. 10) should be avoided if at all possible. However, if an adverse drug reaction is unavoidable, the effect on the patient should be minimised. It therefore follows that monitoring of the patient is essential. All adverse reactions to drugs should be reported to the prescriber.

The National Patient Safety Agency (NPSA) has adopted the US National Coordinating Council definition of a medication error as ‘any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of a health professional, patient or consumer’.

Such acts may relate to one or more of the practical aspects discussed above. It is obvious that it is not possible to comply to the letter with all aspects of medicine administration throughout all courses of drug therapy for all patients. Clearly, it is essential that, on every occasion, the correct dose of the correct drug is administered by the correct route. However, it must be recognised that it is often not possible to administer all medicines exactly at the time indicated on the prescription, owing to the time required to complete a medicine round. This is technically an error but will seldom be of clinical significance. There are occasions, however, when the timing of the administration of certain medicines is of vital importance to the patient, such as, for example, with preoperative medication. Whatever the pressures, every effort must be made to eliminate errors by maintaining the highest possible standards of practice.

The definition given above is something of an oversimplification, because it does not reflect all the factors that may contribute to a drug error. Indeed, it is probably impossible to develop a definition that does include all the factors and issues that may contribute to or arise from a drug error. This is because drug administration is a multidisciplinary process that may well involve a chain of events (a cascade) from manufacturer, distributor, prescriber, pharmacist, hospital managers in all disciplines, nurse and possibly patient. Table 6.1 outlines some of the issues for health professionals (and others) who may become involved in a drug error or its consequences.

Table 6.1 Issues linked with drug errors

Stage/source	Aspects to be taken into account
Manufacturer/distributor and faulty product	• Full and prompt recall of affected product undertaken • Investigations of cause and corrective measures taken • May incur significant costs both to supplier and NHS • Purchasers may lose confidence
Prescribing error	• May not be detected by pharmacy • Could result in an administration error
Dispensing error	• Can misinterpret prescriber’s intentions • Error can be made in compounding or dispensing product • Dispensing systems may need to be reviewed • Training may be required for pharmacy staff
Administration error	• May result in loss of trust from patient or colleagues • Potential for damage to nurse’s confidence and professional future
Patient	• May unwittingly or knowingly take medicines incorrectly • Can misinterpret prescriber’s instructions • Many factors influence patient compliance (see Ch. 7)
General	• When errors result in a fatality, manslaughter charges may be made • Can strain/damage professional relationships • Disciplinary action may be taken by professional body or employer • Clear distinction needs to be made between organisational system failure and individual accountability

SOURCES OF ERRORS

A number of significant potential sources of drug errors are outlined in Box 6.2. It is hoped that by providing this overview, the complex and interactive nature of drug errors will be demonstrated. Seldom will a drug error arise because of the actions or inactions of one individual. A cascade effect is often seen.

Box 6.2 Potential sources of drug errors

• Non-adherence to set procedures

• Communications failures

• Failure to comply with drug administration procedures

• Failure to review/cancel prescriptions

• Wrong transcription of information

• Misinterpretation/lack of information on purposes of therapy

• Inadequate training on drug administration procedures

• Use of unofficial abbreviations, non-standard terminology

• Inadequate policies and procedures, poorly designed documents

• Pressure on staff time, interruptions

• Lack of pharmaceutical services, failure to act on pharmaceutical information/advice

• Failure to identify product correctly, misreading labels

• Confusion with drug names; generic and proprietary products

• Poor labelling/packaging

• Calculation of doses

• Drug interactions

• Failure to note a known drug allergy

• Chemical incompatibility: drug additives to parenteral fluids

• Complex drug regimens: variable doses, non-standard intervals

• Improper use of equipment, including infusion pumps

• Failure to identify patient correctly

• Special regimens at extremes of age

• Clinical trials: inadequate information

• Involvement of a third party: possible confusion of roles

• Unauthorised manipulation of dosage form (e.g. crushing slow-release tablet)

THE PRESCRIBER

Full responsibility rests with the prescriber to state clearly and without ambiguity the medicines the patient is to be given. Well-designed prescribing documents undoubtedly contribute to more accurate drug therapy. However, adherence to the prescribing policy is essential if errors are to be avoided, irrespective of the sophistication of the system used. Bad handwriting is probably the commonest potential source of error. Confusion between product names that look alike, especially when badly written, is a well-recognised source of error, e.g. co-codamol, co-codaprin and other approved names with the co-prefix. Even when clearly written, these words have a similar shape. Unofficial abbreviations for medicines are always open to misinterpretation and should not be used. Those who prescribe, dispense and administer medicines should never accept badly written instructions. The omission of essential information (e.g. the strength of the drug) may result in assumptions being made about what is required. When cancellation of a prescription lacks precision, the medicine may continue to be given to the possible detriment of the patient. Errors can arise when the wrong route is prescribed or the patient is not suitable to receive the medicine, i.e. when a patient with existing renal failure is prescribed a non-steroidal anti-inflammatory drug. Electronic prescribing and dispensing systems have the potential to improve the overall quality of prescribing. Such systems are no substitute for effective training and teaching of all staff involved in the use of medicines.

Maxwell and Walley (2002) contrast the training programme available to nurse prescribers with the minimal time currently available for teaching medical students the skills needed to use medicines safely. It is hoped that the General Medical Council will provide clear directions to the UK medical schools about the need for the learning and assessment of the skills needed to use medicines safely, effectively and cost-effectively (Maxwell and Walley 2002). Although the optimum use of medicines can be achieved only by effective team working, the prescribing process is clearly fundamental. If this process is flawed, the patient is highly unlikely to gain benefit from the therapy.