Understanding scope of practice and accountability when prescribing

Introduction

Over the past two decades, legislative changes in the UK have expanded the roles of pharmacists, empowering them to take on responsibilities that were once the sole domain of doctors and other healthcare professionals, such as prescribing^​1,2​. Pharmacist prescribers are navigating an increasingly complex landscape, where terms such as ‘prescribing’, ‘independent prescriber’, ‘accountability’, ‘scope of practice’ and ‘autonomy’ hold significant meanings, yet can often be perceived as nebulous. Understanding these concepts in depth is crucial for fostering professional confidence and competence.

This article is aimed at demystifying these concepts, providing a clear and comprehensive understanding of the legal and professional foundations of scope of practice, its connection to accountability and the obligations that prescribers must uphold. By exploring these terms, pharmacist prescribers will be better equipped to navigate their expanding roles effectively.

Prescribing

In the context of pharmacy practice, the term ‘prescribing’ is a polysemous term, meaning that it has several meanings depending on the context. In literal terms, prescribing is simply the act of authorising a medicine-related decision by issuing a prescription. Historically, it denoted the act of setting down a rule or direction in advance, which perfectly aligns with providing written instructions for the use of medicines, as per its current application in healthcare. 

In contemporary healthcare, ‘prescribing’ as a term encompasses not only the act of writing a prescription, but also a broader set of competencies related to prescribing practice. The broader skills and knowledge are outlined by the ‘Royal Pharmaceutical Society (RPS) Competency Framework for All Prescribers’^​3​. This distinction is particularly important when discussing prescribing training for pharmacists because it highlights skills such as decision-making, communication and patient-centred care. In contrast, these broader competencies may be viewed by other disciplines, such as medicine, as inherent to typical medical management. This distinction helps to facilitate more productive discussions about prescribing between disciplines.

Independent prescriber

In 2003, the law in the UK was changed to allow for supplementary prescribing by pharmacists, which involves a formalised partnership with a senior clinical decision maker and patient. This was a significant step towards recognising the potential of pharmacists in patient care. However, it still required pharmacists to operate under the formalised supervision of another healthcare professional^​1​.

The more transformative change came in 2006, when new laws came in to permit pharmacists to train as independent prescribers. The term ‘independent prescriber’ is a statutory legal designation and an annotation to the pharmacy professional registration. While the term ‘prescriber’ alone might have been sufficient, legislators likely chose this terminology to clearly differentiate it from supplementary prescribing, while also emphasising a significant shift in accountability^​2​.

Since the introduction of this change, the majority of pharmacists have pursued the independent prescriber qualification later in their careers — until 2022, the General Pharmaceutical Council (GPhC) requirements prevented less experienced pharmacists from enrolling on a prescribing course^​4​. Consequently, the collective consciousness of the pharmacy profession has strongly associated this qualification with practising ‘independently’ to a more advanced level. But this is about to change: from 2026, all newly registered pharmacists will also be independent prescribers^​5​. As a result, it is now more important than ever that there is understanding that ‘independent’ relates to professional accountability in relation to prescribing decisions, as opposed to describing a way of working. 

Professional accountability

Professional accountability is a cornerstone of pharmacy practice, especially for those in prescribing roles. It is often conflated with responsibility but, while related, these concepts are distinct. Responsibility refers to the duties and tasks that a professional is expected to perform and can sometimes be delegated. In contrast, accountability is about being answerable for those duties, including the outcomes of one’s decisions and actions, and it seldom can be delegated.

Accountability means that pharmacist prescribers must be able to justify their actions and decisions to various stakeholders, including patients, colleagues, employers, regulatory bodies and legal entities, such as the courts. This accountability is formalised through professional registration and adherence to regulatory frameworks, such as those set by the GPhC in the UK^​6​. A crucial difference in accountability when prescribing is the legal requirement to obtain informed consent before initiating treatment. This involves ensuring that the patient understands the risks, benefits and alternatives of a treatment and agrees to proceed.

In 2015, the Montgomery versus Lanarkshire Health Board ruling reinforced this by establishing that healthcare professionals must disclose material risks and reasonable alternatives, emphasising shared decision-making and ethical patient–prescriber relationships^​7​. Pharmacist prescribers must also be prepared to explain and justify their prescribing decisions when questioned (see Box 1).

This level of transparency ensures that pharmacists are not only fulfilling their responsibilities but also adhering to the highest standards of patient care and safety. Typically, this is facilitated through effective documentation. Accurate and thorough record-keeping is essential in demonstrating that the standards of care have been followed. Detailed documentation of the prescribing process, including the rationale for decisions, shared decision-making, informed consent, follow-up and safety-netting serves as the medicolegal record. This record provides evidence that the pharmacist has acted competently, responsibly and professionally. For more on effective record keeping, see ‘Writing patient notes: a guide for pharmacists’.

However, being accountable for a prescribing decision does not mean that the decision should be made in isolation or ‘independently’. Leveraging the collective knowledge and experience of colleagues, more experienced peers, other disciplines, specialists and patients is often essential. By consulting with others, pharmacist prescribers can strengthen their decisions and ensure they are based on the best available evidence. This collaborative approach not only enhances the quality of care, but also supports pharmacists in staying within their scope of practice, helping to ensure that all decisions are safe and appropriate. 

Scope of practice

Contemporary discourse around pharmacy practice often implies that the concept of ‘scope of practice’ is limited to prescribing, but this is not the case. Pharmacists are also restricted from activities, such as performing surgical procedures. However, for the purposes of this discussion, the focus will remain on pharmacist prescribing.

In effect, the concept of ‘scope of practice’ is a mechanism to make the ever-expanding nature of healthcare more manageable. According to the RPS, scope of practice refers to the prescribing activities a healthcare professional carries out within their professional role(8). It also says the healthcare professional must have the required training, knowledge, skills and experience to deliver these activities lawfully, safely and effectively^​8​. Given the complexity of modern healthcare, it is not possible for one person to know or do everything — better then, to focus on a specific area.

Scope of practice is different to ‘specialism’, as the latter implies practising to an advanced level, as opposed to a scope of practice that may very well be practised competently at a foundation or advanced level. Scope of practice in relation to prescribing is not a statutory legal requirement per se, but it does act as an important mechanism to operationalise and govern prescribing within regulatory requirements for organisations. It underpins the basis on which an organisation provides vicarious liability insurance, covering situations where a patient may be harmed and a negligence claim is made. Essentially, a scope of practice, often in the form of a document, outlines the range of medicines that the organisation considers an acceptable risk for the prescriber to handle, based on demonstrated competence in safely prescribing those medicines^​9​. It is important to note that prescribing within a scope of practice does not override clinical judgement or absolve the prescriber of accountability. Prescribers must apply the same level of scrutiny to their decisions to ensure that every prescribing decision is safe and appropriate for the patient.

A common approach to scope of practice is the ‘exclusive’ approach (see Box 2). Here, an organisation maintains tight control over what can and cannot be prescribed. This limitation is designed primarily to preserve patient safety, although it may unintentionally leave prescribers inflexible to the needs of patients — particularly when a prescriber has a lot of clinical decision support around them.

Over time, there has been a notable appetite by organisations for scopes of practice that can be applied more flexibly. An example of this might be an ‘inclusive’ approach to prescribing scope whereby the organisation leaves it to the prescriber to judge whether or not they are able to make a competent prescribing decision in a given situation. Inclusive scopes of practice should have guard rails, such as restrictions on high-risk medicines, high-risk patients and high-risk situations. High-risk situations might include, for example, when on-call in secondary care or signing repeat prescriptions in GP practice. Prescribing within such an expansive framework must be inherently collaborative, rather than done in isolation. This is because the prescriber would likely have less depth of knowledge across such a broad range of conditions being treated. 

A third approach might be a synthesis of the two approaches. Operating an exclusive model when working in more isolated settings (e.g., clinic environment) and an inclusive model in settings where clinical decision support is abundant (e.g., ward or MDT environment). 

Autonomy

Autonomy is generally defined as having the capacity to make an informed, uncoerced decision^​10​. In the context of healthcare, it refers to the ability of healthcare professionals to exercise their clinical judgement and make decisions that best serve the needs of their patients, within the framework of ethical and legal boundaries^​5,11​. The concept of autonomy is integral to the role of a pharmacist prescriber, yet it must be tempered by the recognition that prescribing decisions should not be made in a vacuum. Instead, these decisions should be informed by collaboration with patients and other healthcare professionals where possible, ensuring that they are well-rounded, safe and tailored to the individual needs of the patient^​6​.

The emphasis on collaboration is crucial because it enriches the decision-making process. By engaging with the collective expertise of multidisciplinary teams, including patients, pharmacist prescribers can enhance their understanding of complex cases, access specialist knowledge and ultimately deliver better patient outcomes^​12​. This approach also aligns with the principles of patient-centred care, where decisions are made with — rather than for — the patient, considering their values, preferences and needs^​13​.

Thus, autonomy in prescribing is best viewed — not as an isolated exercise of power — but as a dynamic process that involves making empowered decisions, often through collaboration. This understanding of autonomy ensures that pharmacist prescribers are both confident and competent in their roles, equipped to navigate the complexities of modern healthcare while ensuring that their decisions are safe, effective and aligned with the best interests of their patients^​6​.

Summary 

Pharmacist prescribers must have a clear understanding of concepts such as accountability, scope of practice and autonomy. 

Accountability means being answerable for your actions and is a responsibility that cannot be delegated. Prescribers are solely accountable for their prescribing decisions (i.e. independent), but reaching these decisions should involve shared decision-making with patients and informed consent for treatments to minimise the risk of negligence. 

The scope of prescribing practice defines the boundaries of prescribing activities and is essential for governance and risk management within organisations. While broader scopes provide greater flexibility, they often require enhanced clinical support, especially for practitioners at the foundation level. Autonomy in prescribing is about making informed, uncoerced decisions and is a vital aspect of competent prescribing. However, autonomy does not equate to working independently, and prescribing decisions are often safer and more effective when made through collaborative practice.

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