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• To refresh your knowledge of the classification and assigned schedules of controlled drugs
• To understand the legal framework that underpins the prescribing of medicines
• To be aware of the areas that need to be considered when prescribing controlled drugs
There are multiple acts of law and case law that govern UK prescribing practice. This article examines three important topics for nurses: the classification and prescribing of controlled drugs, including the meaning of medicine classes and schedules; the prescribing of unlicensed medicines, including the difference between unlicensed and off-license medicines; and negligence in prescribing practice. The article outlines the acts of law that are relevant to each topic and provides examples of significant case law or other legal rulings to demonstrate how the law is relevant to nurses’ clinical practice.
Nursing Standard. doi: 10.7748/ns.2024.e12177
Peer reviewThis article has been subject to external double-blind peer review and checked for plagiarism using automated software
Correspondence Conflict of interestNone declared
Rae B (2024) Medicines management for nurses: explaining legal governance. Nursing Standard. doi: 10.7748/ns.2024.e12177
Published online: 08 January 2024
Prescribing is a safety-critical activity due to the high volume of errors made and the potentially serious consequences for patients, which can be life-changing or even fatal (Guthrie et al 2011, Guthrie 2016). Prescribing is also one of – if not the most – commonly applied interventions in healthcare (Elliot et al 2018, Cope et al 2020, NHS Confederation 2021). Clinical governance, up-to-date knowledge and experience are essential factors in safe prescribing, and legal governance provides boundaries that are designed to protect patients. The law provides both restrictions and permissions that govern the clinical practice of prescribers.
This article discusses legal governance in three aspects of prescribing practice in the UK: the classification and prescribing of controlled drugs; the use of unlicensed medicines; and negligence in prescribing. Legal governance is defined as a direct legal ruling in aspects of prescribing practice, either through an act of law or through case law. An act of law, otherwise known as an act of parliament, is a bill that has been approved in the UK House of Commons and House of Lords to create or amend a law (UK Parliament 2023). Case law follows a judge’s ruling in a legal case that creates a precedent and therefore sets a legal standard (University of Exeter 2023).
For all nurses – not only those who have trained as prescribers – knowledge of the legal framework that underpins prescribing, alongside an understanding of which drugs can be prescribed by which healthcare professionals, are vital if nurses are to provide evidence-based practice.
In the UK, there are two acts of law that govern the production, possession and supply of controlled drugs: the Misuse of Drugs Act 1971 and the Misuse of Drugs Regulations 2001 (and subsequent amendments).
The Misuse of Drugs Act 1971 prohibits the unlawful production, possession and supply of illegal or controlled drugs, and outlines the custodial penalties for possession and supply and/or maximum fines. This act prohibits certain activities in relation to controlled drugs such as their manufacture, supply and possession. The penalties for offences are graded according to the ‘harmfulness attributable to a drug when it is misused’, and drugs are defined by three classes: A, B and C. Table 1 shows examples of controlled drugs and their classification.
This table shows a small selection of controlled drugs as examples; the full list of controlled drugs is extensive and classification is detailed by the Home Office (2022)
The Misuse of Drugs Regulations 2001 (and subsequent amendments) defines who is authorised to supply and possess controlled drugs in a professional capacity. According to the 2001 regulations, controlled drugs are divided into five schedules, each specifying the requirements governing activities such as import, export, production, supply, possession, prescribing and record keeping.
A controlled drug’s schedule is determined by its level of medically therapeutic value and the potential for misuse and addiction, and therefore the potential level of harm to society. For example, schedule 1 controlled drugs are those deemed to have no therapeutic value. The Misuse of Drugs Regulations 2001 (and subsequent amendments) also specify which drug schedules can be prescribed by which professions. For example, nurse prescribers are able to prescribe from schedules 2-5.
A drug’s formulation is also a significant factor in its scheduling. For example, codeine phosphate appears in schedules 2 and 5. Schedule 5 drugs have a wide therapeutic value and much less potential for addiction. This means that codeine is available over the counter as a low dose oral formulation at schedule 5. However, the injectable formulation of codeine, which has a narrower medical use and higher potential for addiction, is classified under schedule 2.
Table 2 provides examples of controlled drugs and their assigned schedule.
| Controlled drug schedule | Example drugs | Description |
|---|---|---|
| 1 |
| |
| 2 | ||
| 3 |
| |
| 4 | ||
| 5 |
This table shows a small selection of controlled drugs as examples; the full list of controlled drugs is extensive and scheduling is detailed by the Home Office (2022)
There are three types of non-medical prescribers – independent, supplementary and community. Nurses and other healthcare professionals including midwives, pharmacists, physiotherapists, podiatrists, radiographers and optometrists may train as independent or supplementary prescribers (Society of Radiographers 2020, Health and Care Professions Council 2021). Community prescribers such as some district nurses and health visitors have a limited scope of prescribing.
An independent prescriber can prescribe any medicine for any condition within their clinical competence. Conversely, a supplementary prescriber may prescribe any medicine within their clinical competence provided it has been included in a patient-specific clinical management plan. This plan is an agreement between the independent prescriber, the supplementary prescriber and the patient, and defines the scope of prescribing for an individual patient. It is important to note that under the Prescription Only Medicine (Human Use) Amendment Order 2003 the independent prescriber who signs and oversees the clinical management plan is required to be a doctor or dentist.
The types of controlled drugs that healthcare professionals will be able to prescribe is set by their clinical scope of practice. For example, physiotherapists have a limited formulary of controlled drugs they can prescribe under independent prescriber status, with the specific drugs being identified in the relevant legislation (Misuse of Drugs (Amendment) (No. 2) (England, Wales and Scotland) Regulations 2015).
In 2006, independent nurse and pharmacist prescribers in the UK were first permitted to prescribe controlled drugs under new legislation (The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2006), but only from part of schedule 3. Six years later, further legislation permitted independent nurse and pharmacist prescribers to prescribe most controlled drugs from schedules 2-5 with an important exception – the legislation forbade the prescription of cocaine, diamorphine hydrochloride or dipipanone hydrochloride for individuals who are addicted to those drugs (The Misuse of Drugs (Amendment No.2) (England, Wales and Scotland) Regulations 2012). To be able to prescribe or administer these drugs, the nurse or pharmacist prescriber has to hold a specific license from the Secretary of State (Joint Formulary Committee 2023a).
In terms of supplementary prescribers, the Misuse of Drugs (Amendment) Regulations (2005) states that they can prescribe controlled drugs (from schedules 2-5), but only according to a patient-specific clinical management plan.
A medicine that is prescribed off-license (also called off-label) has a license for a particular condition but can be prescribed to treat another condition if there is no suitable alternative. In the case of prescribing off-license, the medicine’s form does not change, nor is it mixed with any other medicine.
Conversely, an unlicensed medicine is one that is administered to the patient in a form, mixture or combination that is different from the manufactured original, or a medicine that is so new it is administered only during clinical trials and before it has been issued with a license. The mixing of one medicine with another creates a medicine that has not been manufactured, and therefore does not carry a license. Mixing medicines includes combining two or more drugs in a solution for injection, infusion or nebuliser, or crushing and mixing two oral tablets or capsule contents. These are then considered to be new medicines (Medicines and Healthcare products Regulatory Agency 2008).
Mixing medicines is not taking multiple oral medicines at the same time, some of which should not be taken together. For example, neither the antibiotics erythromycin nor clarithromycin should be taken while a patient is also taking the statin atorvastatin (either orally or intravenously; drug interactions have to be considered regardless of the route of administration). This is because the antibiotics inhibit the CYP3A enzyme, resulting in increased availability of the statin and effectively increasing its dose (Abu Mellal et al 2019, National Institute for Health and Care Excellence (NICE) 2023a). However, taking different medicines at the same time does not constitute unlicensed prescribing or mixing of medicines unless they are crushed and combined before administration.
Putting a single medicine in a solution that simply acts as a vehicle for that medicine does not constitute mixing and means that the medicine will still be licensed. For example, putting amoxicillin in sodium chloride 0.9% for intravenous infusion is not unlicensed, because amoxicillin is the active drug and sodium chloride is a vehicle solution (Joint Formulary Committee 2023b).
The Medicines (Exemptions and Miscellaneous Amendments) Order 2009 ensured it was legal for nurse and pharmacist independent prescribers to prescribe off-license and unlicensed medicines. Later, the Human Medicines Regulations 2012 stated that nurse and pharmacist supplementary prescribers can legally prescribe unlicensed medicines. Supplementary prescribers can also prescribe off-license and unlicensed medicines if these are included in a clinical management plan for an individual patient.
When prescribing unlicensed medicines, it is necessary for the prescriber to consider clinical need and why an unlicensed medicine or formulation is the optimal choice given a patient’s particular circumstances. The prescriber’s clinical and pharmaceutical knowledge should lead them to consider the risks versus benefits of the medicine or formulation and its possible side effects (as with any prescription), as well as altered absorption and how changing a medicine’s formulation may also change its bioavailability. For example, removing the contents of a capsule might mean that they are digested and absorbed too soon, with increased or decreased bioavailability (Bentley et al 2015). The prescriber should also understand how mixed medicines interact with each other (Joint Formulary Committee 2023c).
The following two examples demonstrate how care is required by nurses when mixing medicines:
• Example 1 – when prescribing antiemetics for patients receiving palliative care, the corticosteroid dexamethasone is reported to be compatible with the antihistamine cyclizine when mixed in a syringe driver, although these medicines may be incompatible at higher doses (NICE 2021a). However, cyclizine and the prokinetic metoclopramide hydrochloride are not compatible and should not be mixed because cyclizine is an antimuscarinic and blocks the action of metoclopramide (NICE 2021b).
• Example 2 – for patients with respiratory conditions such as asthma, salbutamol and the antimuscarinic medicine ipratropium bromide are compatible when mixed in a nebuliser (Chen et al 2020). This is due to these medicines’ compatible pH levels and aerosol characteristics when mixed, which could otherwise affect the absorption of the medicines (Chen et al 2020). However, it is recommended that any mixing of these two medicines only involves preservative-free formulations, because preservatives can affect the stability of the medicines (Specialist Pharmacy Service 2022a).
• Essential factors in safe prescribing include clinical governance, up-to-date knowledge and experience, alongside legal governance that provides boundaries designed to protect patients
• In the UK, there are two acts of law that govern the production, possession and supply of controlled drugs: the Misuse of Drugs Act 1971 and the Misuse of Drugs Regulations 2001 (and subsequent amendments)
• The types of controlled drugs that healthcare professionals will be able to prescribe is set by their clinical scope of practice
• When prescribing, it is important that nurses consider areas such as drug interactions, drug selection and dose calculation
For the nurse prescriber, clinical guidelines, pharmacological knowledge and optimal communication with pharmacists are essential when navigating which medicines can be mixed. In addition, understanding how different medicines interact with each other is essential for nurses when weighing up the risks and benefits of mixing medicines.
Polypharmacy is a separate topic to unlicensed and off-license prescribing and should also not be confused with mixing medicines. Polypharmacy is referred to as either appropriate or problematic. Appropriate polypharmacy involves multiple medicines being prescribed to treat an individual’s complex or multiple conditions, whereas problematic polypharmacy is where an individual is taking multiple medicines that are not clinically required. For nurses, medication reviews and communication with the patient are important factors in identifying which types of medicines are being taken appropriately (Specialist Pharmacy Service 2022b).
The issue of negligence, where a healthcare professional does not fulfil the required standard of care and as a result the patient sustains injury – be it temporary, life-changing or fatal – is a concern for all prescribers. To prove negligence, three conditions have to be fulfilled (Buckley 2023):
• That there was a duty of care.
• That the duty of care was breached.
• That the injury sustained was directly and demonstrably the result of the given breach of duty of care.
Establishing if a healthcare professional has a duty of care to a patient is perhaps the simplest step because if a patient presents to a healthcare professional – whether by referral, self-presentation or admission to an inpatient service – then the healthcare professional automatically has a duty of care to that patient. Ascertaining whether that duty of care has been breached includes considering whether or not the required standard of care has been met (Miola 2015).
The three conditions required to prove negligence also relate to informed consent. In terms of prescribing practice, it is particularly important to obtain informed consent from the patient and to pay attention to any particular risks to them because of comorbidities, interactions or contraindications with concurrent medicines. For example, if a patient agreed to take the medicines prescribed but was not made aware of the possible side effects or risks and subsequently experienced harm as a result, this could be considered negligent behaviour and a failure in the duty of care on the part of the prescriber because the standards of informed consent would not have been met.
Several legal cases have demonstrated the challenges of establishing whether healthcare professionals have breached their duty of care when prescribing. For example, in the case of Wilsher v Essex Area Health Authority [1988], a junior doctor was initially found to be negligent for prescribing excessive oxygen for a premature baby who sustained blindness due to retrolental fibroplasia (a proliferative vascular retinopathy), which could have been predicted given the excess oxygen that was prescribed. The ruling considered that the doctor was negligent, giving rise to the principle that ignorance is no defence when the error is a result of missing information that is well known and readily available. However, the ruling of negligence was overruled on appeal because the baby had other medical complications and it could not be verified that the doctor’s administration of excess oxygen was the sole cause of the blindness. This case demonstrated that proving that a breach in the standard of care was the direct cause of an injury is not always straightforward.
Another case showed that an absence of critical support skills could result in delay in the provision of necessary medicines to a patient, with severe consequences. In the case of FB v Princess Alexandra Hospital NHS Trust [2017], incomplete history taking and clinical examination by a junior doctor meant that the patient was not prescribed the necessary antibiotics in a timely manner, then developed irreversible brain damage. The initial ruling was that the doctor’s inexperience meant that they could not have been negligent. However, this was overruled on appeal because it was decided that although the doctor had a lack of experience, they were still responsible for the history taking and clinical examination, which should have been part of their basic skill set. In this case, the final ruling was that the doctor was negligent.
Three important areas that nurses need to consider when prescribing are:
• Drug interactions – checking interactions is a critical part of the prescribing procedure. Failure to do so can result in serious side effects and harm to the patient. Drug-to-drug interactions should be considered, for example taking statins concurrently with antibiotics such as erythromycin as mentioned previously. Drug-to-disease interactions are also a consideration; for example, beta-blockers are appropriate for treating arrythmia, but are contraindicated in people with asthma because they can cause bronchospasm and can be potentially fatal (Joint Formulary Committee 2023d).
• Drug selection – selecting the appropriate class of controlled drug as well as the appropriate drug for the patient’s condition is safety-critical and relies on the knowledge and thoroughness of the prescriber. For example, using opioids to treat a patient’s migraine can have suboptimal outcomes such as aggravating nausea and vomiting (Tepper 2012).
• Dose calculation – another form of potentially negligent prescribing is inaccurate dose calculation. For instance, when switching a patient’s prescription from one opioid to another, it must be remembered that the doses required for therapeutic effect may not be the same. For example, prescribing 100mg of pethidine hydrochloride for a patient’s pain would be a reasonable therapeutic dose, but 100mg of diamorphine could be toxic and potentially fatal (Joint Formulary Committee 2023e, NICE 2023b).
The prescribing of controlled drugs is dependent on the profession of the prescriber, and different limitations are placed on each profession. There are also multiple factors to consider when deciding if an unlicensed medicine should be prescribed or not. Negligence in terms of prescribing practice can have severe outcomes as a result of errors, inadequate clinical practice and suboptimal professional judgement. It is important for nurses to remember that legal governance provides clear boundaries that enable prescribing practice. However, legal governance is only part of the framework for optimal clinical practice and nurses should also consider their profession’s clinical standards, experience and knowledge when making prescribing decisions.
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