Prescribing

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2 Prescribing

H. Marlow, C. Whittlesea

• Prescribers need to assess and manage the potential benefits and harms of treatment.

• Patients should receive cost-effective medication appropriate to their clinical needs, in doses that meet their requirements and for an adequate period of time.

• Respect for patient autonomy, obtaining consent and sharing decision making is a fundamental part of the prescribing process.

• The consultation is a fundamental part of clinical practice and requires effective interpersonal reasoning and practical skills.

• Using a consultation framework is recommended to ensure relevant issues are covered.

• Prescribing is a complex mix of factors – evidence, external influences and cognitive biases – and these should be recognised.

To prescribe is to authorise by means of a written prescription the supply of a medicine. Prescribing incorporates the processes involved in decision making undertaken by the prescriber before the act of writing a prescription. Historically, prescribing has been the preserve of those professionals with a medical, dental or veterinary training. As the role of other health care professionals such as pharmacists and nurses has expanded, prescribing rights have in turn been extended to them. The premise for this development has been that it better utilises the training of these professional groups, is clinically appropriate and improves patient access.

Regardless of the professional background of the individual prescriber, the factors that motivate them to prescribe a particular medicine are a complex mix of evidence of effectiveness and harm, external influences and cognitive biases. A rational approach to prescribing uses evidence and has outcome goals and evaluates alternatives in partnership with the patient. With the advent of new professional groups of prescribers (non-medical prescribers), it is increasingly important to understand the components of rational and effective prescribing, and the influences on this process. There is a need for a systematic approach to prescribing, and an understanding of the factors that influence the decision to prescribe a medicine. These issues will be covered in the following sections. Initially, the fundamentals of rational and effective prescribing will be discussed, followed by a brief outline of the acquisition of prescribing rights by pharmacists and the associated legal framework. The final section will cover the prescribing process and the factors that influence this.

Rational and effective prescribing

Prescribing a medicine is one of the most common interventions in health care used to treat patients. Medicines have the potential to save lives and improve the quality of life, but they also have the potential to cause harm, which can sometimes be catastrophic. Therefore, prescribing of medicines needs to be rational and effective in order to maximise benefit and minimise harm. This is best done using a systematic process that puts the patient at the heart of the process (Fig. 2.1).

Fig. 2.1 A framework for good prescribing

(from Background Briefing. A blueprint for safer prescribing 2009 © Reproduced by permission of the British Pharmacological Society.)

What is meant by rational and effective prescribing?

There is no universally agreed definition of good prescribing. The WHO promotes the rational use of medicines, which requires that patients receive medications appropriate to their clinical needs, in doses that meet their own individual requirements, for an adequate period of time, and at the lowest cost to them and their community. However, a more widely used framework for good prescribing has been described (Barber, 1995) and identifies what the prescriber should be trying to achieve, both at the time of prescribing and in monitoring treatment thereafter. The prescriber should have the following four aims:

• Maximise effectiveness

• Minimise risks

• Minimise costs

• Respect the patient’s choices.

This model links to the four key principles of biomedical ethics: beneficence, non-maleficence, justice and veracity, and respect for autonomy, and can be applied to decision making at both an individual patient level and when making decisions about medicines for a wider population, for example in a Drug and Therapeutics Committee. One of the strengths of this model is the consideration of the patient’s perspective and the recognition of the inherent tensions between the four key aims.

Another popular framework to support rational prescribing decisions is known as STEPS (Preskorn, 1994). The STEPS model includes five criteria to consider when deciding on the choice of treatment:

• Tolerability

• Effectiveness

• Simplicity.

Inappropriate or irrational prescribing

Good prescribing is sometimes defined as the lack of irrational prescribing. Prescribing can be described as irrational for many reasons:

• Poor choice of a medicine

• Polypharmacy or co-prescribing of interacting medicine

• Prescribing for a self-limiting condition

• Continuing to prescribe for a longer period than necessary

• Prescribing too low a dose of a medicine

• Prescribing without taking account of the patient’s wishes.

Inappropriate or irrational prescribing can result in serious morbidity and mortality, particularly when childhood infections or chronic diseases such as hypertension, diabetes, epilepsy and mental disorders are being treated. Inappropriate prescribing also represents a waste of resources and, as in the case of antimicrobials, may harm the health of the public by contributing to increased antimicrobial resistance. Finally, an over-willingness to prescribe stimulates inappropriate patient demand and fails to help the patient understand when they should seek out support from a health care professional.

Pharmacists as prescribers and the legal framework

Evolution of non-medical prescribing

Independent prescribing is defined as ‘prescribing by a practitioner (doctor, dentist, nurse, pharmacist) who is responsible and accountable for the assessment of patients with undiagnosed or diagnosed conditions and for decisions about the clinic management required including prescribing’ (DH, 2006).

In 1986, a report was published in the UK (‘Cumberlage report’) which recommended that community nurses should be given authority to prescribe a limited number of medicines as part of their role in patient care (Department of Health and Social Security, 1986). Up to this point, prescribing in the UK had been the sole domain of doctors, dentists and veterinarians. This was followed in 1989 by a further report (the first Crown report) which recommended that community nurses should prescribe from a limited formulary (DH, 1989). The legislation to permit this was passed in 1992.

At the end of the 1990s, in line with the then UK government’s desire to widen access to medicines by giving patients quicker access to medicines, improving access to service and making better use of the skills of health care professionals, the role of prescriber was proposed for other health care professionals. This change in prescribing to include non-medical prescribers (pharmacists, nurses and optometrists) was developed following a further review (Crown, 1999). This report suggested the introduction of supplementary prescribers, that is, non-medical health professionals who could prescribe after a diagnosis had been made and a clinical management plan drawn up for the patient by a doctor (Crown, 1999).

Supplementary prescribing

The Health and Social Care Act 2001 allowed pharmacists and other health care professionals to prescribe. Following this legislation, in 2003, the Department of Health outlined the implementation guide allowing pharmacists and nurses to qualify as supplementary prescribers (DH, 2003). In 2005, supplementary prescribing was extended to physiotherapists, chiropodists/podiatrists, radiographers and optometrists (DH, 2005).

Supplementary prescribing is defined as a voluntary prescribing partnership between an independent prescriber (doctor or dentist) and a supplementary prescriber (nurse, pharmacist, chiropodists/podiatrists, physiotherapists, radiographers and optometrists) to implement an agreed patient-specific clinical management plan with the patient’s agreement. This prescribing arrangement also requires information to be shared and recorded in a common patient file. In this form of prescribing the independent prescriber, that is the doctor or if appropriate the dentist, undertakes the initial assessment of the patient, determines the diagnosis and the initial treatment plan. The elements of this patient-specific plan, which are the responsibility of the supplementary prescriber, are then documented in the patient-specific clinical management plan. The legal requirements for which are detailed in Box 2.1. Supplementary prescribers can prescribe Controlled Drugs and also both off-label and unlicensed medicines.

Non-medical independent prescribing

Following publication of a report on the implementation of nurse and pharmacist independent prescribing within the NHS in England (DH, 2006), pharmacists were enabled to become independent prescribers as defined under the Medicines and Human Use (Prescribing; Miscellaneous Amendments) Order of May 2006. Pharmacist independent prescribers were able to prescribe any licensed medicine for any medical condition within their competence except Controlled Drugs and unlicensed medicines. The restriction on Controlled Drugs included those in Schedule 5 (CD Inv.POM and CD Inv.P) such as co-codamol. At the same time, nurses could also become qualified as independent prescribers (formerly known as Extended Formulary Nurse Prescribers) and prescribe any licensed medicine for any medical condition within their competence, including some Controlled Drugs. Since 2008, optometrists can also qualify as independent prescribers to prescribe for eye conditions and the surrounding tissue. They cannot prescribe for parenteral administration and they are unable to prescribe Controlled Drugs.

Following a change in legislation in 2010, pharmacist and nurse, non-medical prescribers, were allowed to prescribe unlicensed medicines (DH, 2010).

From the above it should be evident that in the UK suitably qualified pharmacists can prescribe as either supplementary or independent prescribers.

Accountability

Prescribers have the authority to make prescribing decisions for which they are accountable both legally and professionally. Accountability when prescribing covers three aspects – the law, the statutory professional body and the employer.

The law of Tort, the concept of a ‘civil wrong’, includes clinical negligence. In such a claim, the patient needs to demonstrate that the prescriber caused them injury or damage. For this allegation to be substantiated the patient needs to prove that the prescriber owed them a duty of care, that this duty of care was breached and that this caused the injury identified, and also that the injury was foreseeable. The law of Tort also permits actions for breach of confidentiality and also for battery, should a patient be treated without consent. Therefore, prescribers (independent and supplementary) are legally and professionally accountable for their decisions. This includes decisions not to prescribe and also ensuring that the prescription is administered as directed. The legal responsibility for prescribing always lies with the individual who signed the prescription. In addition, prescribers also have a responsibility to ensure the instructions are clear and not open to misinterpretation.

If a prescriber is an employee then the employer expects the prescriber to work within the terms of his/her contract, competency and within the rules/policies, standard operating procedure and guidelines, etc. laid down by the organisation. Therefore, working as a prescriber, under these conditions, ensures that the employer has vicarious liability. So should any patient be harmed through the action of the prescriber and he/she is found in a civil court to be negligent, then under these circumstances the employer is responsible for any compensation to the patient. Therefore, it is important to always work within these frameworks, as working outside these requirements makes the prescriber personally liable for such compensation. To reinforce this message it has been stated that the job descriptions of non-medical prescribers should incorporate a clear statement that prescribing forms part of the duties of their post (DH, 2006).

Ethical framework

Four main ethical principles of biomedical ethics have been set out for use by health care staff in patient–practitioner relationships (Beauchamp and Childress, 2001). These principles are respect for autonomy, non-maleficence, beneficence, justice and veracity and need to be considered at all points in the prescribing process.

Autonomy

Autonomy recognises an individual patient’s right to self-determination in making judgements and decisions for themselves and encompasses informed patient consent. Respect for autonomy is therefore a form of personal liberty which freely permits patients to choose whether they wish to have treatment in accordance with their own plans.

Confidentiality

Confidentiality is a fundamental right with respect to patient autonomy. Therefore, patients have the right to confidentiality, and consent is required to disclose information regarding their health and treatment.

Consent

Obtaining consent from a patient for treatment can be divided into three components: voluntariness, information and competency. Consent is invalid when it is given under pressure or coercion. Therefore, it is important that consent is obtained for each act and not assumed because this is a routine assessment or procedure and therefore can be carried out automatically. It is essential the patient understands their diagnosis, the benefit and rationale of the proposed treatment and the likelihood of its success together with the associated risks and consequences, for example side effects. Therefore, a prescriber needs to discuss these aspects with the patient. In addition, potential alternative treatments should also be discussed to allow the patient to make a comparison with the proposed plan. The prognosis if no treatment is prescribed should also be discussed. Such a wide-ranging discussion may require more than one appointment and reinforces the necessity for an ongoing patient–professional relationship focused on the needs of the patient. Associated with this is the need to determine if the patient has the competency to make decisions for themselves with respect to vulnerable groups such as those who have learning disabilities, children and the elderly. Young people aged 16 and 17 are normally presumed to be able to consent to their own treatment.

Gillick competence is used to determine if children have the capacity to make health care decisions for themselves. Children under 16 years of age can give consent as long as they can satisfy the prescriber that they have capacity to make this decision. However, with the child’s consent, it is a good practice to involve the parents in the decision-making process. In addition, children under 16 may have the capacity to make some decisions relating to their treatment, but not others. So it is important that an assessment of capacity is made related to each decision. There is some confusion regarding the naming of the test used to objectively assess legal capacity to consent to treatment in children under 16, with some organisations and individuals referring to Fraser guidance and others Gillick competence. Gillick competence is the principle used to assess the capacity of children under 16, while the Fraser guidance refers specifically to contraception (Wheeler, 2006).

The Mental Capacity Act (2005) protects the rights of adults who are unable to make decisions for themselves. The fundamental concepts within this act are the presumption that every adult has capability and should be supported to make their own individual decision. The five key principles are listed in Box 2.2. Therefore, any decision made on their behalf should be as unrestrictive as possible and must be in the patient’s own interest, not biased by any other individual or organisation’s benefit. Advice regarding patient consent is listed in Box 2.3.

Box 2.2 Overview of the five principles of the Mental Capacity Act

• A person is assumed to have capacity unless it is established that he/she lacks capacity.

• A person should not be treated as unable to make a decision unless all practical steps to enable him/her to do this have been taken without success.

• A person cannot be treated as unable to make a decision because he/she makes an unwise decision.

• Acts or decisions made for or on behalf of a person who lacks capacity must be in that person’s best interests.

• Before an act or decision is made, the purpose has to be reviewed to assess if it can be achieved as effectively in a way that is less restrictive of the person’s rights/freedom of action.

Box 2.3 Advice on patient consent

• Take care when obtaining consent.

• Give the patient understandable information about all significant possible adverse outcomes.

• Ensure the patient has the opportunity to ask questions/consider his/her options.

• Document the advice/warnings provided in the patient’s notes.

• Invite the patient to sign to say that he/she understands, and accepts the risks explained.

• Record in the patient’s notes if they decline to undergo a treatment/procedure.

Non-maleficence

At the heart of the principle of non-maleficence is the concept of not knowingly causing harm to the patient. The principle is expressed in the Hippocratic Oath. This obligation not to harm is distinct from the obligation to help others. While codes of all health care professionals outline obligations not to harm clients, many interventions result in some harm, however transitory. Sometimes one act can be described as having a ‘double effect’, that is, two possible effects: one good effect (intended) and one harmful effect (unintended). The harmful effect is allowed if proportionally it is less than the good effect. Therefore, it is important for prescribers to review both the potential positive effects of treatment, for example symptom control, and the negative effects, for example side effects. It is also important to consider both acts of commission and omission, as a failure to prescribe can also cause harm to the patient.

Beneficence

This is the principle of doing good and refers to the obligation to act for the benefit of others that is set out in codes of professional conduct, for example, pharmacists’ code of ethics and professional standards and guidance (Royal Pharmaceutical Society of Great Britain, 2009). Beneficence is referred to both physical and psychological benefits of actions and also related to acts of both commission and omission. Standards set for professionals by their regulatory bodies such as the General Pharmaceutical Council can be higher than those required by law. Therefore, in cases of negligence the standard applied is often that set by the relevant statutory body for its members.

Justice and veracity

This last principle is related to the distribution of resources to ensure that such division or allocation is governed by equity and fairness. This is often linked to cost-effectiveness of treatment and potential inequalities if treatment options are not offered to a group of patients or an individual. However, as a prescriber it is important to consider the evidence base for the prescribed medicine and also to review the patient as an individual to ensure the treatment offered adheres to this principle. This principle of fairness and freedom from discrimination therefore encompasses Human Rights including the need for assessment of medication as part of the Disability Discrimination Act. Health care professionals have a duty under this act to make reasonable adjustments to ensure that all patients have the same opportunity for good health. Therefore, a prescriber should also assess with the patient that the medication prescribed can be accessed by them. Veracity or ‘truth telling’ underpins both effective communication and patient consent.

Professional frameworks for prescribing

Each professional regulatory body has standards to which their members must adhere. Members are accountable to such bodies for their practice and can be sanctioned by these bodies if their actions do not adhere to these standards. Therefore, individuals will be held accountable by their respective statutory body for their prescribing decisions.

The professional standards for pharmacists are defined within ‘Medicines, Ethics and Practice’ and contain additional requirements for pharmacists who are qualified as non-medical prescribers and also good practice guidance (Royal Pharmaceutical Society of Great Britain, 2009). This guidance provides advice on a wide range of areas including self-audit, promotions, gifts from drug companies, written agreement with the employing organisation describing the prescriber’s scope of practice, liability and indemnity arrangements, competency to prescribe and not just prescribing and dispensing a medicine.

Off-label and unlicensed prescribing

For a medicine to be licensed for use in a specific country, the manufacturer must obtain a marketing authorisation, formerly called the product license. This details the patients, conditions and purpose under which the medicine is licensed for use. Any medicine which does not have a marketing authorisation for the specific country where it is prescribed is termed ‘unlicensed’. Unlicensed medicines prescribed include new medicines undergoing clinical trial, those licensed and imported from another country but not licensed in the country where they are to be used. It also includes ‘specials’ manufactured to meet a specific patient’s needs or produced when two licensed medicines are mixed for administration.

However, if a licensed medicine is prescribed outside that specified in the marketing authorisation then this is described as ‘off-label’. This happens in practice, for example many medicines are not licensed for use in children but are prescribed for them. In addition, some established medicines are prescribed for conditions outside their marketing authorisation, for example amitriptyline for neuropathic pain and azathioprine in Crohn’s disease. The British National Formulary includes information on off-label use as an annotation of ‘unlicensed indication’ to inform health care professionals. The details of a medicine’s marketing authorisation are provided in the Summary of Product Characteristics.

The company which holds the marketing authorisation has the responsibility to compensate patients who are proven to have suffered unexpected harm caused by the medicine when prescribed and used in accordance with the marketing authorisation. Therefore, if a medicine is prescribed which is either unlicensed or off-label, the prescriber carries professional, clinical and legal responsibility and is therefore liable for any harm caused. Best practice on the use of unlicensed and off-label medicines is described in Box 2.4. In addition, all health care professionals have a responsibility to monitor the safety of medicines. Suspected adverse drug reactions should therefore be reported in accordance with the relevant reporting criteria.

Box 2.4 Advice for prescribing unlicensed and off-label medicines

(from Drug Safety Update, 2009; 2: 7, with kind permission from MHRA)

Consider

• Before prescribing an unlicensed medicine be satisfied that an alternative licensed medicine would not meet the patient’s needs.

• Before prescribing an off-label medicine be satisfied that such use would better serve the patient’s needs than an appropriately licensed alternative.

• Before prescribing an unlicensed medicine or using an off-label medicine:

– be satisfied that there is a sufficient evidence base and/or experience of using the medicine to show its safety and efficacy;

– take responsibility for prescribing the medicine and for overseeing the patient’s care, including monitoring and follow up;

– record the medicine prescribed and, where common practice is not being followed, the reason for prescribing the medicine; you may wish to record that you have discussed this with the patient.

Communicate

• You give patients, or those authorising treatment on their behalf, sufficient information about the proposed treatment, including known serious or common adverse drug reactions, to enable them to make an informed decision.

• Where current practice supports the use of a medicine outside the terms of its license, it may not be necessary to draw attention to the license when seeking consent. However, it is a good practice to give as much information as patients or carers require or which they see as relevant.

• You explain the reasons for prescribing an off-label medicine or prescribing an unlicensed medicine where there is little evidence to support its use, or where the use of the medicine is innovative.

Prescribing across the interface between primary and secondary care

When a patient moves between care settings, there is a risk that a ‘gap’ in care will take place. These ‘gaps’ in care are almost always as a result of poor communication and frequently involve medicines, particularly when the patient is discharged from hospital into a community setting. So far, there is no evidence-based solution to these problems. The primary care prescriber with the responsibility for the continuing management of the patient in the community may be required to prescribe medicines with which they are not familiar. The prescriber should be fully informed and competent to prescribe a particular medicine for his/her patient. Supporting information from the hospital, in the form of shared care guidelines, can help inform the prescriber about medicines with which they may not be very familiar. Overall, the decision about who should take responsibility for continuing care or prescribing treatment after the initial diagnosis or assessment should be based on the patient’s best interests rather than on the health care professional’s convenience or the cost of the medicine. However, it is legitimate for a prescriber to refuse to prescribe where they consider they have insufficient expertise to accept responsibility for the prescription or where the product is of a very specialised nature and/or requires complex ongoing monitoring. Professional bodies are developing principles for communication between health care professionals in primary and secondary care to improve patient safety.

Clinical governance

Clinical governance is defined as ‘the system through which NHS organisations are accountable for continuously improving the quality of their services and safeguarding high standards of care, by creating an environment in which clinical excellence will flourish’ (DH, 1998). It is a process embraced by the NHS to ensure that the quality of health care embedded within organisations is continuously monitored and improved. Clinical governance parallels corporate governance within commercial organisations and as such provides a systematic set of mechanisms such as duties, accountabilities and rules of conduct to deliver quality health care.

Clinical governance is described as having seven pillars:

• Patient, service user, carer and public involvement

• Risk management

• Clinical audit

• Staffing and management

• Education, training and continuing professional development (CPD)

• Research and clinical effectiveness

• Use of information.

Within the NHS, standards of practice have been developed and monitored to ensure risks are managed and controlled. As part of this framework the performance of staff is also assessed and remedial action taken, if required. NHS organisations have clinical governance requirements for their staff which include requirements for non-medical prescribing.

Professional bodies have also incorporated clinical governance into their codes of practice. The four tenants of clinical governance are to ensure clear lines of responsibility and accountability; a comprehensive strategy for continuous quality improvement; policies and procedures for assessing and managing risks; procedures to identify and rectify poor performance in staff. Therefore, the professional bodies such as those of pharmacists, nurses and optometrists have also identified clinical governance frameworks for independent prescribing as part of their professional codes of conduct. The General Pharmaceutical Council, the UK pharmacy regulator, code of practice provided a framework not only for the individual pharmacist, non-medical prescriber, but also for their employing organisation. Suggested indicators for good practice are detailed in Box 2.5.

Box 2.5

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