Legal aspects of prescribing
Benjamin Flavell, Advanced Clinical Practitioner, Whittington Health NHS Trust, London, UK. Email: email@example.com
Paramedic independent prescribing is in its infancy and there are limitations to the range of medicines that can be prescribed when compared with other professions undertaking independent prescribing. Medication and prescribing errors are common events within the NHS in England, resulting in a substantial number of litigation and fitness-to-practise proceedings against other professions in relation to prescribing and medicines management. It is foreseeable that paramedic independent prescribers could also find themselves subject to legal action. This article considers a fictitious scenario where a patient suffers harm as a result of a prescribing decision and the legal implications for the prescriber. Key words l Prescribing l Advanced practice l Litigation l Clinical negligence l Paramedic l Non-medical prescribing
Accepted for publication:2 September 2021
The scope of paramedic practice is wider than ever before—in part, thanks to the addition of paramedics to the growing list of professions eligible to become independent prescribers in 2018 (College of Paramedics (CoP), 2021a). Independent prescribing is far removed from the narrow range of medicines which paramedics can administer by exemption under Schedules 17 and 19 of the Human Medicines Regulations (HMR) 2012. In an ambulance setting, the immediacy of administration and proximity to the patient ensures efficacy and adverse effects can usually be monitored and acted on. In contrast paramedic independent prescribers working in primary or secondary care settings may initiate longer term treatments in patients with complex medical and drug histories, and with variable clinical supervision. Early adopters of paramedic prescribing have identified concerns in relation to inadvertent patient harm, litigation and possible resulting harm to the profession (Stenner et al, 2021).
The fears of early adopters are not unfounded; there are an estimated 237 million medication errors in England annually (25% of which are prescribing errors), costing the NHS £98 million, as well as 1700 deaths (British Medical Journal, 2020). In all, 25% of fitness-to-practise referrals to the Nursing and Midwifery Council (NMC) (2021) concern medicines management, while the Medical Defence Union (MDU) (2017) reports rising rates of clinical negligence claims against nurse practitioners. At the time of writing, there had not been any referrals to the Health and Care Professions Council (HCPC) in relation to paramedic prescribing.
This article will discuss the legal aspects of prescribing and how they apply to the paramedic independent prescriber, including which medicines can be legally prescribed and legal issues that arise when a prescribing decision is thought to have harmed a patient.
The right to prescribe Paramedic independent prescribers may currently legally prescribe all licensed medicines and offlicence/off-label licensed medicines for accepted clinical uses where no alternative is available, but may not prescribe unlicensed medicines (CoP, 2021b). Paramedic independent prescribers cannot prescribe controlled drugs, pending a change in the Misuse of Drugs Regulations (MDR) 2001 (CoP, 2021b; Pharmaceutical Services Negotiating Committee, 2021). Gallagher (2021) argues that the relationship between the HMR and MDR has been misinterpreted and that under regulation 214 of HMR, paramedics could legally prescribe specific controlled drugs, without requiring additional amendments to the MDR. While this is an interesting analysis, it is not advisable for any paramedic independent prescriber to choose to interpret the legislation in this way as it is contrary to the view of Health Education England, the CoP and the HCPC. Anyone doing so would likely find themselves subject to legal scrutiny.
The list of controlled drugs in the MDR is vast. Alongside the more familiar Class A opiates and benzodiazepines are zopliclone, a Class C nonbenzodiazepine indicated for use in insomnia, and the recently reclassified anticonvulsants and anxiolytics pregabalin and gabapentin, commonly prescribed for neuropathic pain (NHS England, 2019). It is foreseeable that a controlled drug could be mistakenly prescribed without realising its status; therefore, prescribers should ensure they are aware of the classifications of drugs commonly used in their practice, and carefully check the classification of unfamiliar drugs before prescribing.
Vol 13 No 10 • Journal of Paramedic Practice