Position Statement: Controlled drugs in Schedule 8 which a registered nurse prescriber or registered midwife prescriber may prescribe within Schedules 2 and 3 – Misuse of Drugs Regulations, 2017

In publishing this position statement, the aim of the Irish Pain Nurses and Midwives Society is to ensure that, in accordance with the Health Service Executive (HSE) National Service Plan 2024,¹ all registered nurse and midwife prescribers working in the field of pain management are working “at the optimum of their professional scope of practice” (p45).

Since its introduction in 2007, it has been demonstrated that nurse and midwife medicinal product prescribing is safe and appropriate.² Consequently, there has been incremental changes in the regulation of this expanded role since its inception.

When nurse prescribing was first introduced, the original controlled drugs included in Schedule 8: Part 1 were limited to oral, intravenous or intramuscular morphine sulphate, and oral codeine phosphate;³ this was expanded in 2017 to include buprenorphine, dihydrocodeine, fentanyl, morphine tartrate, oxycodone, and pethidine via a variety of routes.⁴ At this time, parts 2 and 4 (drugs for palliative and neonatal care respectively) were also expanded, and part 5 (drugs for use in mental health or intellectual disability) was created.

Subsequently, in 2018, the initial requirement for the Collaborative Practice Agreement (CPA) for registration and authority to prescribe was removed by the Nursing and Midwifery Board of Ireland.⁵ Legislation was also amended in 2018, enabling the registered nurse or midwife prescriber to prescribe exempt medicinal products.⁶

While welcoming these changes, the Irish Pain Nurses and Midwives Society maintains that Schedule 8 ultimately continues to act as a barrier to effective pain management. The professionals best placed to assess and treat the patient are limited to a relatively narrow selection of analgesic agents, some of which are outdated and no longer supported by high-quality evidence. For example, the use of pethidine is discouraged in favour of other opioids.⁷

Furthermore, there are analgesic agents and strategies recommended in best-practice guidelines which do not appear on the schedule, such as tapentadol, epidural fentanyl, and ketamine. Tapentadol has similar efficacy to more commonly used opioids, has a superior side effect profile, fewer drug-drug interactions, and is associated with lower rates of abuse than oxycodone.⁷

While fentanyl does appear on Schedule 8, the epidural route is not included. This is in spite of Level I evidence which demonstrates that the analgesic effect with epidurals is enhanced with the addition of fentanyl⁸ and evidence demonstrating that epidurals with fentanyl accelerate the return of gastrointestinal transit after abdominal surgery compared with an opioid-based regimen.⁹

Multiple systematic reviews confirm that ketamine has a role in the management of postoperative pain.^{10,11,12,13,14} Perioperative ketamine reduces opioid consumption, pain intensity and nausea and vomiting, reduces the incidence of chronic pain after certain surgical procedures, and is also effective in patients who are opioid tolerant.⁷ Ketamine is also associated with fewer side effects requiring intervention compared to morphine.¹⁵

Given the benefits that drugs such as tapentadol, epidural fentanyl, and ketamine may have in the management of pain, nurses and midwives working at specialist and advanced practice level in pain management will recommend their use in selected patients.

In the context of Schedule 8, the likely result is that a registered nurse or midwife prescriber must request a prescription for the recommended regimen from a medical practitioner. This results in reduced continuity of care, unnecessarily introduces opportunity for error, and in the case of the Advanced Nurse Practitioner, undermines the ability to undertake a complete episode of care for the patient.

The International Association for the Study of Pain¹⁶ asserts that governments and healthcare institutions have an obligation “to establish laws, policies and systems that will help to promote, and will certainly not inhibit, the access of people in pain to fully adequate pain management. Failure to offer such management is a breach of the patient’s human rights” (p1).

In 2012, changes were made to The Misuse of Drugs Regulations of 2001 to allow nurse and midwife prescribers in the United Kingdom to prescribe all schedule 2-5 drugs where clinically appropriate and within their scope of practice, with the exception of replacement therapies for addiction.¹⁷ The Irish Pain Nurses and Midwives Society asserts that a similar arrangement with the abolition of Schedule 8 is the most logical, practical, and safe option for nurse and midwife prescribers practising in the Republic of Ireland.

PARTS 1-5: Controlled Drugs in Schedule 8 which a Registered Nurse Prescriber or Registered Midwife
Prescriber may prescribe within Schedules 2 and 3 – Misuse of Drugs Regulations, 20175

Authors