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.

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.

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.

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.

Building relationships

Non-verbal communication is important and can be used by the prescriber to gain information from the patient. Facial expressions and body posture can give clues about how the patient is feeling, for example anxious or tired. Proximity and eye contact are also important to determine if the patient is activity engaged in the conversation or are they distracted. Such non-verbal clues, for example anxiety, tiredness and pain, can then be explored verbally with the patient.

The prescribers also need to review their own non-verbal communication to ensure this reinforces the verbal message they are giving to the patient. For example, doctors who face the patient, make eye contact and maintain an open posture were regarded by their patients to be more interested and empathic (Harrigan et al., 1985). Also health care professionals in primary care who demonstrated non-verbal intimacy (close distance, leaning forward, appropriate body orientation and touch) had increased patient satisfaction (Larsen and Smith, 1981).

As eye contact is an important non-verbal form of communication, obtaining information from patient records and documenting the consultation could undermine these skills. Therefore, it is important to read notes in advance of the consultation and avoid writing up the outcome while the patient is speaking. Indicating to the patient that references need to be made to their record or information documented ensures the patient is informed about the break in the consultation. This strategy should be adopted for both paper and computer-based records.

Developing rapport is also essential to building an effective patient–prescriber relationship. This can be achieved by providing an accepting response to the patient’s concerns and expectations. This is achieved by acknowledging the patient’s views and valuing their contribution and accepting this information in a non-judgemental way. This does not necessarily mean that the prescriber agrees with information but that they accept that this is a legitimate view from the patient’s perspective. This can be reinforced by summarising the patient’s view. The prescriber should acknowledge the patient’s coping efforts and self-care. Avoiding jargon and explaining complex concepts in simple terms, to enable patients to understand the diagnosis and management, is also important.

Providing structure

This is important in the patient–prescriber consultation to enable the five key stages to be effectively completed. The prescriber needs to establish the boundaries for the consultation, that is, the time available and the topics covered and termination of the consultation. Therefore, as the power in the consultation is with the prescriber, it is his/her responsibility to guide the consultation and involve the patient. This is to ensure a patient-centred collaborative partnership is established. This can be achieved by using problem identification, screening and agenda-setting skills. The use of a logical sequence, signposting from one part of the consultation to the next and including an initial and end summary, will provide an effective structure to the consultation.

Initiating the session

During the first stage of the consultation the prescriber needs to greet the patient and confirm his/her identity. They should also ensure the environment for the consultation is appropriate for maintaining eye contact and ensuring confidentiality. The prescriber should also introduce him/herself, his/her role and gain relevant consent. During this stage the prescriber must demonstrate respect for the patient and establish a patient-centred focus. Using initially open and then closed questions the prescriber needs to identify the patient’s problem/issues. By adopting this approach and actively listening, the prescriber is able to confirm the reason for the consultation and identify other issues. This allows the prescriber to negotiate an agenda for the next stages of the consultation through agreement with the patient and taking into account both the patient and prescriber’s needs. This initial stage is vital for the success of the consultation as many patients have hidden agendas which, if not identified at this stage, can lead to these concerns not being addressed. Beckman and Frankel (1984) studied doctors’ listening skills and identified that even minimal interruptions by doctors to initial patients’ statements at the beginning of the consultation prevented patients’ concerns from being expressed. This resulted in either these issues not being identified at all or they were raised by patient’s late in the consultation

Gathering information

The aim of this stage is to explore the problem identified from both the patient and prescriber’s perspective to gain background information which is both accurate and complete. Britten et al. (2000) identified that lack of patient participation in the consultation led to 14 categories of misunderstanding between the prescriber and patient. These included patient information unknown to the prescriber, conflicting information from the patient and communication failure with regard to the prescriber’s decision. During this stage the illness framework, identified by exploring the patient’s ideas, concerns, expectations and experience of his/her condition and effect on his/her life, is combined with the information gained by the prescriber through his/her biomedical perspective. This encompasses signs, symptoms, investigations and underlying pathology. Assimilation of this information leads the prescriber to a differential diagnosis. By incorporating information from both viewpoints, a comprehensive history detailing the sequence of events can be obtained using questioning, listening and clarification. This ends with an initial summary where the prescriber invites the patient to comment and contribute to the information gathered.

Physical examination

At the start of this stage it is important to again obtain the patient’s consent for any examination by explaining the process and rationale for the assessment. The environment, for example room temperature and screening for the examination, is important and the prescriber should review this to ensure the patient’s comfort.

Explanation and planning

This stage of the consultation incorporates three aspects: the differential diagnosis/hypothesis, the prescriber’s management plan (investigations and alternative treatments), explanation and negotiating the plan of action with the patient.

In one UK study, doctors were found to overestimate the extent to which they completed the tasks of discussing the risk of medication, checking the ability of the patient to follow the treatment plan and obtaining the patient’s input and view on the medication prescribed (Makoul et al., 1995).

In order to successfully accomplish this stage of the consultation, the prescriber needs to use a number of skills and also to involve the patient. The prescriber should ensure he/she gives the correct type and amount of information. This is done by assessing the patient’s prior knowledge by employing both open and closed questions. By organising the information given into chunks which can be easily assimilated the prescriber can then check the patient understands the information given. Questioning the patient regarding additional information they require also helps to ensure the patient’s involvement and maintains rapport. The prescriber must determine the appropriate time to give explanations and also allow the patient time to consider the information provided. Signposting can also be a useful technique to employ during this stage. Once again the language used should be concise, easy to understand and avoid jargon. Using diagrams, models and written information can enhance and reinforce patient understanding. The explanation should be organised into discreet sections with a logical sequence so that important information can be repeated and summarised. Box 2.6 summarises the issues the prescriber should consider before prescribing a medicine.

To achieve shared understanding and shared decision making, it is important to incorporate the patient’s perspective by relating the information given to the patient’s illness framework. The patients also need to have the opportunity to ask questions, raise doubts and obtain clarification. This can be undertaken effectively by taking the patient’s beliefs, culture, abilities and lifestyle into account when discussing treatment options, for example fasting during Ramadan, or use of memory aids to support adherence. The prescriber should also explain his/her rationale for the management plan identified and also discuss possible alternatives. By involving and negotiating with the patient in this way, a mutually acceptable treatment plan can be identified which allows the patient to take responsibility for his/her own health.

Closing the session

The effectiveness of the end of a consultation is as important as the preceding stages. A number of steps are undertaken during the closing stage. These include agreeing a contract with the patient as to the next steps to be taken by both patient and prescriber, for example additional investigations and/or referral. Safety net strategies are also employed and discussed, so the patient can identify unexpected outcomes or treatment failure and also understand who and how to contact the prescriber or another health care professional if appropriate. The end summary is an essential component of this stage and is used to briefly and accurately identify the management plan established during the previous stage in the consultation. This is followed by final checking that the patient has understood and consented to this management plan. At the end of the consultation the patient is given another opportunity to ask any final questions.

The informed patient

Health care is moving to a position of greater shared decision making with patients and development of the concept of patient autonomy. This is being supported through the better provision of information for patients about their prescribed medicines. The EU directive 2001/83 (European Commission, 2001) requires that all pharmaceutical products are packaged with an approved PIL, which provides information on how to take the medicine and possible adverse effects. Other important developments that have increased patients’ access to information, albeit of variable quality, include the role of the media in general and the amount of attention they give to health and health-related matters, the emergence of the Internet, and the development of patient support groups. The reporting in the media of concerns regarding the safety of MMR vaccine and the subsequent rapid drop in MMR vaccinations rates in children is a good example of the importance of these developments in influencing patients and prescribing.

Direct advertising of medicines to patients is allowed in the USA and New Zealand, but not in Europe. Advertising medicines in this way is clearly effective in increasing sales of medicines, as evidenced by the increased spending and prescriptions for advertised drugs, compared to non-advertised drugs in these countries. This has led to concern that direct to consumer advertising encourages unnecessary and inappropriate use of medication. In the UK, education for patients may be provided by the manufacturer through sponsored disease awareness campaigns but there is concern that these encourage individuals to seek advice or treatment from their doctor for conditions that have been incorrectly self diagnosed. These campaigns may also help to raise awareness of conditions that have not been well managed in the past. However, they can also act as covert advertisements for prescription. Such campaigns, which may be established by a drug company with or without the endorsement of a patient group, often take place at the same time as a drug’s launch and may involve aggressive promotion. As a consequence there have been calls to control the influence of companies on the production of disease awareness campaigns that impact on the individual patient, who then exerts pressure on the prescriber for a specific medicine.

Local and national guidelines

Guidelines for the use of a medicine, a group of medicines or the management of a clinical condition may be produced for local or national use. They can be useful tools to guide and support prescribers in choosing which medicines they should prescribe. Ideally, guidelines should make evidence-based standards of care explicit and accessible, and aid clinical decision making. The best-quality guidelines are usually those produced using systematically developed evidence-based statements to assist clinicians in making decisions about appropriate health care for specific clinical circumstances. In the UK, there is an accreditation scheme to recognise organisations who achieve high standards in producing health or social care guidance. Examples of accredited guidelines are those produced by NICE (National Institute for Health and Clinical Excellence, www.nice.org.uk) and SIGN (Scottish Intercollegiate Guideline Network, www.sign.ac.uk). Local guidelines are often developed to provide a local context and interpretation of national guidance, and offer guidance on managing patients between primary and secondary care. However, despite the availability of good quality accessible clinical guidelines, implementation in practice remains variable.

Clinical decision support systems are increasingly popular as a way of improving clinical practice, and influence prescribing. These often utilise interactive computer programs that help clinicians with decision-making tasks at the point of care, and also help them keep up-to-date, and support implementation of clinical guidelines. Clinical knowledge summaries (www.cks.nhs.uk) is a decision support system developed for use in primary care that includes PILs, helps with differential diagnosis, suggests investigations and referral criteria, and gives screens that can be shared between the patient and the prescriber in the surgery.

Incentives

In an effort to contain prescribing costs, some health care systems use direct incentives to influence clinical behaviour and, in particular, prescribing. The incentives, which are usually financial, may be direct to the prescriber or offer some benefits to the prescriber’s patients. They can have a significant impact on prescribing practice. Typically, primary care doctors are given indicative prescribing budgets and are expected to meet the prescribing needs of their patients from within this budget. Financial incentive schemes to reward good fiscal management of prescribing budgets and improve the quality of prescribing are used to encourage prescribers to change their practice. Incentive schemes usually influence what is prescribed, rather than whether a prescription is written. The most effective schemes are simple to understand, have achievable targets, and require information about prescribing patterns to be readily available. However, incentives schemes for prescribing need to be managed carefully in order not to create perverse incentives, such as increasing the referral of patients to another part of the health care system, or causing an increase in overall health care costs.

Provision of comparative (benchmarking) information

The provision of benchmarked information on comparative prescribing patterns to primary care doctors is an important influence on prescribing behaviour. Using appropriate benchmarking data brings the behaviour of practices into a local and national context. Benchmarking can provide the basis for making clinicians aware of the potential for change and allows them to understand the potential outcome of any actions. Various prescribing indicators have been developed both locally and nationally to measure and compare quality and cost-effectiveness of prescribing. Ideally, indicators used should be evidence based, utilise available data sources and be validated.