Open consultation

Proposals to extend medicines responsibilities for paramedics, physiotherapists, operating department practitioners and diagnostic radiographers

Published 5 August 2025

Introduction

Regulated healthcare professionals have been taking on responsibilities for prescribing, supplying and administering medicines (medicines responsibilities) for many years. This supports patients to receive the medicines they require from the professional who is appropriately qualified to help them and means they do not need to see additional professionals simply to access these medicines.

Authorised healthcare professionals can prescribe, supply and administer medicines through a number of different routes, subject to their profession and competence level. More information about these routes is provided in annex A. 

This consultation seeks views on the following proposed changes affecting 4 professional groups:

• extending the list of medicines that paramedics can administer in emergency situations using exemptions within medicines legislation
• extending the list of controlled drugs that physiotherapist independent prescribers are legally able to prescribe
• enabling operating department practitioners to supply and administer medicines using patient group directions (PGDs)
• permitting diagnostic radiographers to train as independent prescribers

This consultation is a further step in the government’s actions to build upon the work of the Chief Professions Officers’ Medicines Mechanisms Programme (CPOMM) and regulatory change delivered last year. See:

• use of exemptions by dental hygienists and dental therapists consultation outcome
• proposal for the use of patient group directions by pharmacy technicians consultation outcome

This government aims to deliver a health service that provides the health and care patients need at the time and place they need it. It is critical that we explore all options to alleviate pressure on clinicians and the wider health service. These proposals aim to make it easier for patients to get the medicines they need when they need them, while maintaining patient safety. This will reduce the need for patients to see additional healthcare professionals just to receive medicines, thereby facilitating timely access to medicines and improving patient experience.

The Department of Health and Social Care (DHSC) is working with the affected sectors to ensure readiness to deliver and promote the uptake of proposals. As well as improving the efficiency of care, the proposals seek to support the use of skills mix across professions, thereby ensuring professionals are fully equipped to deliver the best care to patients. This will in turn support job satisfaction.

This consultation is undertaken by the Secretary of State for Health and Social Care, in relation to England, Wales and Scotland, in conjunction with the Department of Health in Northern Ireland in relation to Northern Ireland (pursuant to section 45(1) of the Medicines and Medical Devices Act 2021 (MMDA)).

Proposals will require amendments to the Human Medicines Regulations 2012 (HMRs) which would apply throughout the United Kingdom.

Proposals relating to controlled drugs will also require amendments to the Misuse of Drugs Regulations 2001 (MDRs) which will apply in England, Wales and Scotland, and the Misuse of Drugs Regulations (Northern Ireland) 2002, which will apply in Northern Ireland.

Proposals will apply in any settings in which relevant professionals work, including the NHS, independent and voluntary sectors. Any subsequent changes to NHS regulations required to implement proposals are matters for each of the devolved governments.

This public consultation is intended to give interested parties and stakeholders the opportunity to inform our final decision. It sets out proposals for each profession within specific sections, and for ease of reference, we have used a standard structure throughout.

Relevant legislation

Human Medicines Regulations 2012

The Human Medicines Regulations 2012 (HMRs) is the main, UK-wide legislative framework for the sale, supply and administration of medicinal products for human use.

Eligibility of individuals to prescribe, supply or administer medicines relies upon both profession and medicine-specific provisions of the HMRs. Any proposals taken forward that require amendment to the provisions of the HMRs will be implemented by a statutory instrument (SI) under enabling powers in the Medicines and Medical Devices Act 2021 (MMDA). Under the MMDA, a public consultation is required to consider proposals to amend the HMRs.

Medicines regulation is a reserved matter (to the UK Parliament) in relation to Scotland and Wales. It is a transferred matter in Northern Ireland which is why changes to the UK-wide HMRs that affect Northern Ireland and made under the MMDA are made by the Secretary of State for Health and Social Care and the Department of Health in Northern Ireland. This consultation is being conducted in the names of the Secretary of State for Health and Social Care (is so far as they relate to England, Wales and Scotland) and jointly with the Secretary of State and the Department of Health in Northern Ireland (in so far as they relate to Northern Ireland).

Medicines and Medical Devices Act 2021

The Medicines and Medical Devices Act (MMDA) became law in February 2021. We propose to make legislative changes using powers in part 2 of the act, which provides powers to make, among other things, amendments to the HMRs. The act provides the Secretary of State for Health and Social Care and the Department of Health in Northern Ireland with powers to amend the existing regulations on human medicines. The MMDA has specific requirements, set out in section 45(1) for consulting publicly on proposed changes to the HMRs, requiring us to reconsult on proposals that were already consulted on publicly prior to the MMDA coming into force.

Misuse of Drugs Regulations 2001

Any changes implemented regarding the prescribing, supply or administration of controlled drugs will also require amendment to the Misuse of Drugs Regulations 2001 (MDRs) to ensure the 2 regimes operate in unison where relevant. We will be engaging the Advisory Council for the Misuse of Drugs (ACMD) for advice regarding the implications and risks surrounding controlled drugs ahead of making any changes to the MDRs. Following this, changes to the MDRs will need to be taken forward by the Home Office. The MDRs apply only to England, Wales and Scotland. The Misuse of Drugs Regulations (Northern Ireland) 2002 will need to be amended separately, and this will be undertaken by the Department of Health in Northern Ireland.

1. Paramedics

This section of the consultation presents proposals to make additions to the current lists of medicines that paramedics are legally able to administer under exemptions in the Human Medicines Regulations 2012 (HMRs).

Introduction to the paramedic profession

Paramedics are statutory regulated health professionals. As of April 2025, there are currently 40,497 paramedics registered with the Health and Care Professions Council (HCPC) in the UK.

Paramedics are autonomous, first contact practitioners who work in a range of settings including responding to 999 calls. They are trained in all aspects of emergency care, ranging from acute problems such as cardiac arrest, strokes, spinal injuries and major trauma, to urgent problems such as minor illness and injury. Paramedics work alongside a range of other professionals in emergency care including emergency care assistants, ambulance care assistants and patient transport service drivers. Paramedics undertake full clinical assessments and make decisions regarding the care patients require.

A paramedic’s scope of practice involves the immediate treatment and stabilisation of patients at the patient’s side. The majority of paramedics work in pre-hospital and out of hospital settings, and care and treat, refer or discharge patients at the scene. For patients needing hospital care, they continue treatment and care while transporting patients to hospital and waiting to hand over.

Paramedics who have developed their skills beyond the entry level of their profession, by undertaking additional higher or postgraduate education, take on specialist or advanced paramedic roles. All education undertaken to become a specialist or advanced paramedic is done at higher education institutions at diploma, degree (BSc) or masters (MSc) level.

The College of Paramedics is the professional body that represents paramedics and the ambulance profession in the UK.

Professional regulation for paramedics

All paramedics, whether working in the NHS, private or voluntary sectors, must be registered with HCPC. The term ‘paramedic’ is a protected title by law.

HCPC sets the standards of proficiency for paramedics that all registrants have to meet in relation to their education, proficiency, conduct, performance, character and health. These are the standards that HCPC considers necessary for safe, effective practice. Registrants must meet all these standards and meet the standards relevant to their scope of practice to stay registered. They must complete continued professional development and complete a professional declaration every 2 years thereafter to confirm they have continued to practise and continue to meet these standards.

Current routes for paramedics to prescribe, supply and administer medicines

The HMRs define some medicines as prescription-only medicines (POMs). These medicines normally need to be prescribed by a doctor or another prescriber before they can be administered or supplied to a patient. However, there is a range of exemptions from these restrictions that allow certain groups of health professionals to supply and/or administer particular medicines directly to patients.

Paramedics have been able to administer POMs on their own initiative in emergency or certain identified clinical situations through exemptions in the HMRs since 1992. These enable paramedics across all levels of practice to administer medicines listed in schedule 17 of the HMRs for the immediate, necessary treatment of sick or injured persons without the requirement for a prescription, directions of a prescriber or a patient group direction. Paramedics are also able to administer medicines listed in schedule 19 of the HMRs in emergency situations. Exemptions remain the main mechanism to administer medicines across all levels of practice, most commonly to deliver immediate treatment to patients with urgent, emergency and critical care needs, such as pain relief and resuscitation. 

In addition, paramedics are able to work under patient specific directions (PSDs) and patient group directions (PGDs). Advanced practitioner paramedics were granted legal permission to train to become supplementary or independent prescribers in 2018. Paramedic independent prescribers may prescribe most licensed medicines, within national and local guidelines for any condition within the practitioner’s area of expertise and competence, including from a restricted, profession-specific list of 5 controlled drugs. They may also mix medicines prior to administration and direct others to do so (excluding controlled drugs).

Manchester Arena Inquiry

Following the Manchester Arena bombing in 2017, an inquiry took place that considered how preparedness for, and response to, mass casualty events could be improved. It found that in the aftermath of the Manchester Arena bombing, analgesia (including controlled drugs) was either delayed or not provided, and that this was in part due to the complexities of administering analgesia. The Manchester Arena Inquiry (MAI) report notes that:

the provision of analgesia has a number of benefits including the humanitarian value of relieving pain, the ability to provide additional treatment such as splinting which can be a painful process and assists in evacuating casualties who might otherwise not be able to be moved.

The MAI recommended that: 

The Department of Health and Social Care and the Medicines and Healthcare products Regulatory Agency (MHRA) should consider urgently whether the regulatory regime should be altered to enable analgesia, such as fentanyl lozenges or sufentanil sublingual tablets, to be given by paramedics to injured persons.

An NHS England Task and Finish Group was established to review the MAI’s recommendations in relation to analgesia. The group considered the recommendations and formally submitted their findings to DHSC in August 2024, recommending changes to enable paramedics to administer fentanyl to injured persons. This includes administration to those who require analgesia in the aftermath of a mass casualty event.   

Proposal for paramedics

We are proposing that paramedics are able to administer the following 7 drugs directly to patients without a prescription under exemptions in schedule 17 of the HMRs within their scope of professional practice:

• 3 controlled drugs:
  • lorazepam (by injection)
  • midazolam (by injection)
  • 3 forms of fentanyl (oral transmucosal, intranasal, intravenous)
• 4 prescription-only medicines (POMs):
  • dexamethasone
  • magnesium sulfate
  • tranexamic acid
  • flumazenil

Proposals to enable paramedics to administer lorazepam (by injection), midazolam (by injection), dexamethasone, magnesium sulfate, tranexamic acid and flumazenilare are the same as those consulted on through CPOMM in 2020. Initial engagement with relevant professional bodies and regulators suggests that these proposals do not need updating and represent a valuable intervention to make it more convenient and safer for patients to get the medicines they need at the time and place they need them. The Commission for Human Medicines (CHM) is also supportive of these proposals.

We are proposing the additional inclusion of fentanyl (oral transmucosal, intranasal, intravenous) to take forward the recommendations of the Manchester Arena Inquiry report (volume 2) and the NHS England Task and Finish Group in August 2024.

Case for change for paramedics

Paramedic practice, the roles of paramedics and models of service delivery have evolved considerably since 2011 when the list of medicines that paramedics can administer under exemptions was last reviewed. To meet the changing needs of the healthcare system in relation to urgent and unscheduled care, and advancing medicines technology, action is needed.

Paramedics are currently able to supply and administer all of the listed medicines other than fentanyl using PSDs or PGDs. While these can be effective mechanisms, they also carry downsides. PSDs require the direct involvement of an appropriate prescriber and can therefore be subject to delays if a prescriber is not available. PGDs can be very effective, however, they are developed through a robust governance process, which can involve significant resource in cost and time.

The exemptions mechanism, however, would offer a straightforward mechanism to enable all paramedics to administer medicines promptly as long as this falls within their scope of practice and competence. This is particularly pertinent for parenteral medicines for use in acute and emergency situations, such as head injury.

There is currently no provision for paramedics to legally administer fentanyl, so this proposal would be introducing that for the first time, based on the recommendations of the Manchester Arena Inquiry as summarised above.

Furthermore, enabling the administration of these medicines through the use of exemptions, will support:

• improved access to pain relief for patients, supporting better recovery trajectories and ultimately leading to better outcomes
• increased capacity in the system, relieving the need to develop, implement and maintain PGDs
• clearer lines of clinical responsibility and accountability

The proposed additions to the paramedic exemptions list should ensure that patients receive timely access to medication, by enabling paramedics to administer medicines indicated by best clinical evidence from a comprehensive exemptions list, without delay.

Questions

You will be asked 7 questions about enabling paramedics to administer the following 7 additional medicines to their patients under exemptions in schedule 17 of the HMRs:

• lorazepam (by injection)
• midazolam (by injection)
• 3 forms of fentanyl (oral transmucosal, intranasal, intravenous)
• dexamethasone
• magnesium sulfate
• tranexamic acid
• flumazenil

To what extent do you agree or disagree with the proposal to enable paramedics to administer each of the 7 medicines to their patients using exemptions?

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

If you have any further views on this proposal, please outline them here. (Optional, maximum 150 words)

Training and governance for paramedics

There are 85 HCPC-approved paramedic pre-registration programmes in the UK. The majority of pre-registration programmes are now delivered through a formal partnership between ambulance trusts and a university and the remainder by NHS ambulance organisations training centres.

The use of exemptions is embedded within all of the pre-registration paramedic education and training, the curricula provided by education providers are approved by HCPC and therefore, paramedics are qualified to use exemptions upon registration with HCPC. All programmes include training and education content relating to the use of medicines used under exemptions and using other mechanisms such as PGDs where the medicine is required in paramedic practice. If proposals are implemented, then no further changes to education programmes will be required as HCPC-approved pre-registration programmes do not refer to specific medicines. Paramedics would be professionally accountable for their decisions to administer medicines through exemptions, including actions and omissions, and must ensure they provide evidence-based care within their scope of practice and competence. Local clinical governance arrangements will provide day to day assurance, and anyone who has concerns about a practitioner’s fitness to practise could raise these with HCPC.

No central funding will be required for training. The administration of medicines through these exemptions is locally governed, with organisations responsible for developing, authorising and maintaining the necessary training and guidance. While the changes may increase demand for relevant training, uptake is optional and driven by local need, with costs covered through local training budgets.  

All aspects of controlled drugs management are overseen by a controlled drug accountable officer (CDAO) in each organisation who is accountable for the governance where controlled drugs are used.

Clear national guidance (from the National Institute for Health and Care Excellence (NICE) and the Specialised Pharmacy Service, for example) on the use of these medicines and medicines mechanisms already exists. We will work with the College of Paramedics and relevant organisations to ensure profession specific guidance and training packages are updated and promoted should we go ahead with implementing proposals. Measures for safe storage are already in place for the existing list of medicines including the storage and safe custody requirements for controlled drugs as detailed in the Misuse of Drugs (Safe Custody) Regulations 1973 and the Misuse of Drugs (Safe Custody) (Northern Ireland) Regulations 1973.

Questions

To what extent do you agree or disagree that the training and governance measures for paramedics are sufficient to keep patients safe? 

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

If you have any further views regarding training and governance for paramedics, please outline them here. (Optional, maximum 150 words)

If you have any other comments regarding the medicines responsibilities of paramedics, please include them here. (Optional, maximum 150 words)

If you have any comments or evidence relating to the accompanying impact assessment, please include them here. (Optional, maximum 150 words)

2. Physiotherapists

This section of the consultation presents proposals to make additions to the current list of controlled drugs that physiotherapist independent prescribers are able to prescribe.

Introduction to the physiotherapist profession

Physiotherapists diagnose and treat movement-related conditions caused by factors such as injury, disease, disability and ageing. Physiotherapists work in various settings including hospitals, GP practices and community care settings. The Chartered Society of Physiotherapy represents the profession in the UK. As of April 2025, there are currently 76,920 physiotherapists registered with the Health and Care Professions Council (HCPC) in the UK. Areas of practice include:

• diagnosing and treating disorders of movement, function and human performance caused by activity or inactivity, injury, disease, disability, ageing and lifestyle; particularly where it affects muscles, bones, joints, the nervous system, heart, circulation and lungs
• maximising independence and empowering people and populations through health promotion, preventative healthcare, treatment and rehabilitation
• assessing and providing physiotherapy diagnosis and planning treatments for a range of musculoskeletal, cardiovascular, respiratory and neurological conditions

After registration, physiotherapists can choose to develop their skills and experience in one particular specialty, as well as acquire new skills at a postgraduate level. These experienced and additionally trained physiotherapists are known as enhanced, advanced or consultant physiotherapist practitioners. 

Professional regulation for physiotherapists

The purpose of professional regulation is to protect the public. All physiotherapists, whether working in the NHS, private or voluntary sectors, must be registered with HCPC. The terms ‘physiotherapist’ and ‘physical therapist’ are protected titles by law. HCPC sets standards of proficiency for physiotherapists that all registrants have to meet in relation to their education, proficiency, conduct, performance, character and health. These are the standards considered necessary for safe, effective practice. Registrants must meet all these standards and meet the standards relevant to their scope of practice to stay registered. They must undertake continued professional development and complete a professional declaration to HCPC every 2 years to confirm that they continue to practise and continue to meet these standards.

Current routes for physiotherapists to prescribe, supply and administer medicines

Physiotherapists have been able to supply and administer medicines for many years, through the use of patient specific directions (PSDs) and patient group directions (PGDs). Physiotherapists working at an advanced level are also able to prescribe medicines for their patients using either supplementary or independent prescribing.

When working as supplementary prescribers, physiotherapists can prescribe any medicine that is referred to within a patient’s clinical management plan (CMP). However, for services in which the team is fragmented across sites, where there is no medical input, or when patients require a medicine that is not included in the CMP, use of supplementary prescribing can be difficult, and patients may need to see other prescribers to receive some or all of the medicines they need.

Independent prescribing

Advanced physiotherapist practitioners who have undergone additional HCPC-approved training can practise as independent prescribers as well as supplementary prescribers. All prescribing programmes approved for physiotherapists by HCPC offer preparatory education towards dual annotation as supplementary and independent prescribers.

Physiotherapist independent prescribers in England, Wales, Scotland and Northern Ireland can prescribe from a restricted list of 7 controlled drugs, namely:

• temazepam (schedule 3) - oral administration
• lorazepam (schedule 4 Part I) - oral administration
• diazepam (schedule 4 Part I) - oral administration
• dihydrocodeine tartrate (schedule 5) - oral administration
• morphine sulfate (schedule 2 and 5) - subcutaneous (SC) or intramuscular (IM) injection and oral administration
• fentanyl (schedule 2) - transdermal administration
• oxycodone hydrochloride (schedule 2) - oral administration

The medicines are listed in 5 schedules or groups, and each has different levels of control (see annex B).

There are additional annotations on HCPC register for physiotherapists who are either supplementary prescribers or independent prescribers.

Proposal for physiotherapist independent prescribers

We are consulting on proposed changes to enable physiotherapist independent prescribers to prescribe the following 4 controlled drugs within their scope of professional practice:

• codeine phosphate (schedule 2 and 5) - oral administration
• tramadol hydrochloride (schedule 3) - oral administration
• pregabalin (schedule 3) - oral administration
• gabapentin (schedule 3) - oral administration

This would be in addition to the 7 they can already prescribe. It is worth noting that physiotherapist independent prescribers were previously able to prescribe tramadol, gabapentin and pregabalin prior to changes in their controlled drug scheduling.

This proposal is the same as the one developed by NHS England and consulted on through CPOMM in 2020. Initial engagement with relevant professional bodies and regulators suggests that the proposal does not need updating and represents a valuable intervention to make it more convenient and safer for patients to get the medicines they need at the time and place they need them. The Commission for Human Medicines (CHM) is also supportive of this proposal.

Case for change for physiotherapist independent prescribers

Physiotherapist independent prescribers can currently prescribe a limited range of controlled drugs that can be vital in managing musculoskeletal and neuropathic pain and supporting timely recovery. However, the current prescribing restrictions mean that physiotherapist independent prescribers cannot prescribe certain controlled drugs, including:

• tramadol hydrochloride - reclassified as a schedule 3 controlled drug in 2014
• pregabalin and gabapentin - added to schedule 3 in 2019 following a Home Office consultation
• codeine phosphate - a schedule 5 controlled drug

This has resulted in several limitations:

• patients often need to be referred to another prescriber to access these medicines, causing avoidable delays
• continuity of care may be disrupted, particularly in services led by physiotherapist independent prescribers
• additional appointments are required, increasing demand on GPs and other prescribers.

These delays can have a direct impact on patient outcomes, especially where timely pain management is essential to recovery and rehabilitation. Expanding the list of controlled drugs that physiotherapist independent prescribers can prescribe would bring the following benefits:

• enabling patients to access appropriate pain relief promptly and directly from their physiotherapist independent prescriber, improving both outcomes and patient experience
• supporting more efficient service delivery by reducing reliance on other prescribers and making best use of physiotherapist independent prescribers’ clinical expertise
• reducing pressure on NHS services, including primary care, by avoiding unnecessary referrals and appointments

Questions

You will be asked 4 questions about enabling physiotherapist independent prescribers to prescribe the following 4 additional controlled drugs to their patients within their scope of professional practice:

• codeine phosphate (schedule 2 and 5) - oral administration
• tramadol hydrochloride (schedule 3) - oral administration
• pregabalin (schedule 3) - oral administration
• gabapentin (schedule 3) - oral administration

To what extent do you agree or disagree with the proposal to enable physiotherapist independent prescribers to prescribe each of the 4 medicines to their patients?

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

If you have any further views on this proposal, please outline them here. (Optional, maximum 150 words)

Training and governance for physiotherapists

Eligible advanced practitioner physiotherapists wishing to qualify as independent prescribers must successfully complete an HCPC-approved prescribing programme. Upon successful completion, they will receive an annotation on the HCPC register as a physiotherapist independent prescriber.

Prescribing education programmes are a minimum of 38 days in duration, including supervision in clinical practice, and are delivered as multi-professional programmes. The core content of these programmes is consistent across all non-medical prescribers, with profession-specific elements and practice-based assessments ensuring differentiation where required. Programmes are delivered at either level 6 (degree level) or level 7 (master’s level). Additional considerations related to the prescribing of controlled drugs are incorporated into the education programmes. If proposals are implemented to enable physiotherapist independent prescribers to prescribe the additional 4 controlled drugs, no further changes to education programmes will be required as HCPC standards for prescribing do not refer to specific medicines.

Physiotherapist independent prescribers would be professionally accountable for their decisions to prescribe, including actions and omissions and must ensure they provide evidence-based care within their scope of practice and competence. Local clinical governance arrangements will provide day to day assurance, and anyone who has concerns about a practitioner’s fitness to practise could raise these with HCPC.

No central funding will be required for training. Independent prescribing of medicines for advanced practitioner physiotherapists is locally governed, with organisations responsible for developing, authorising and maintaining the necessary training and guidance. While the changes may increase demand for relevant training, uptake is optional and driven by local need, with costs covered through local training budgets.  

Clear national guidance (from NICE and the Chartered Society of Physiotherapy for example) on the use of these medicines already exists, and we will work with relevant organisations to ensure it is updated as necessary and promoted among the profession should we go ahead with implementing proposals.

All aspects of controlled drugs management are overseen by a controlled drug accountable officer (CDAO) in each organisation who is accountable for the governance where controlled drugs are used.

Questions

To what extent do you agree or disagree that the training and governance measures for physiotherapist independent prescribers are sufficient to keep patients safe? 

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

If you have any further views regarding training and governance for physiotherapist independent prescribers, please outline them here. (Optional, maximum 150 words)

If you have any other comments regarding the medicines responsibilities of physiotherapist independent prescribers, please include them here. (Optional, maximum 150 words)

If you have any comments or evidence relating to the accompanying impact assessment, please include them here. (Optional, maximum 150 words)

3. Operating department practitioners

This section of the consultation presents a proposal to enable operating department practitioners (ODPs) to supply and administer medicines using patient group directions (PGDs).

Introduction to the ODP profession

ODPs help patients to prepare for a surgical operation by providing care during the assessment, planning, delivery and evaluation of perioperative care. Perioperative care is healthcare provided to a patient before, during and after a surgical operation. In recent years, we have also seen more ODPs working outside of operating departments, for example in emergency departments. As of April 2025, there are currently 16,921 ODPs registered with the Health and Care Professions Council (HCPC) in the UK. Most ODPs will work across the 3 stages below, according to their scope of practice:

• anaesthetic phase: ODPs work with the anaesthetists to prepare the patient for the anaesthetic and assist with monitoring the patient during surgery
• surgical phase: ODPs use detailed knowledge of the surgical procedure and any potential complications that may occur to ensure that the patient is properly cared for in theatre
• post-anaesthetic care phase: ODPs monitor, assess and support the patient as they recover from the anaesthetic. If patients suffer from pain or postoperative conditions such as nausea, ODPs make clinical decisions to administer certain prescribed medicines

The professional bodies representing ODPs across the United Kingdom are the Association for Perioperative Practice and the College of Operating Department Practitioners.

Professional regulation for ODPs

ODPs are a statutory regulated healthcare professional - the term ‘operating department practitioner’ is a protected title in law and all ODPs must be registered with HCPC. ODPs must successfully complete a HCPC-approved degree or diploma course before being eligible to register. Education and training related to medicines is a vital component of the pre-registration curriculum. Graduates from all pre-registration programmes must meet the HCPC standards of proficiency for ODPs as the baseline for safe and effective practice.

Once registered, ODPs must show that they are completing regular education, and that they continue to meet the standards of proficiency and to work safely and effectively within their scope of practice, in order to maintain their registration.

Current routes for ODPs to prescribe, supply and administer medicines

ODPs are currently able to use PSDs to administer or supply a medicine. ODPs use this mechanism extensively to administer a number of medicines to patients including antiemetics (to treat or prevent nausea and vomiting), analgesics (to treat pain) and other controlled drugs as part of a perioperative regimen. Hence, medicines knowledge and administration techniques are included in pre-registration education and supported through continued professional development (CPD).

However, there are limitations to the use of PSDs as they require direct input from an appropriate prescriber for each patient.

Proposal for ODPs

We are proposing to enable ODPs to use PGDs to supply and administer medicines to their patients within their scope of professional practice. This would include being able to supply and administer from a restricted list of controlled drugs, as detailed in annex C.

PGDs are written instructions for medicines, including certain controlled drugs, to be supplied and/or administered by health professionals to patients who share the same medical condition or other features. They contain information about which health professionals can supply or administer the medicine, which patients they can see, and when they should involve a doctor. PGDs are not a type of prescription.

This proposal is the same as the one developed by NHS England and consulted on through CPOMM in 2020. Initial engagement with relevant professional bodies and regulators suggests that the proposal does not need updating and represents a valuable intervention to make it more convenient and safer for patients to get the medicines they need at the time and place they need them. The Commission for Human Medicines (CHM) is also supportive of this proposal.

Case for change for ODPs

ODPs are currently able to use PSDs to administer or supply a medicine. PSDs are useful in many care settings. They are individually tailored to the needs of a single patient, wide-reaching and can encompass controlled drugs. However, there are certain limitations to their use:

• they require direct input from an appropriate prescriber
• they can be restrictive when access to a prescriber is problematic or if the service provided is non-prescriber led
• organisations may limit locally who is authorised to supply and/or administer medicines using PSDs

Avoidable delays in patient care occur when ODPs are unable to supply or administer appropriate medicines under existing arrangements. This often results in patients needing to wait for another health professional, to receive the medicines required.

Enabling ODPs to administer medicines through PGDs would draw the benefits of:

• enabling patients to access appropriate medicines in a timely and effective manner, leading to improved patient outcomes and experience, for example, the prompt provision of appropriate analgesia will reduce patients’ pain and distress in addition to facilitating a timely discharge from the perioperative environment
• reducing resource usage and promoting cost effectiveness, as ODPs could administer the medicine without requiring the intervention of doctors and other health professionals, therefore increasing efficiency of service delivery by maximising appropriate use of all professionals in the team

In addition, we propose that it is appropriate to enable ODPs to supply and administer from a restricted list of controlled drugs (detailed in annex C) through PGDs, in line with several other professions that use PGDs. This would be beneficial as ODPs have cause to administer certain controlled drugs (for example, sedatives like midazolam (schedule 3)) during their practice.

Question

To what extent do you agree or disagree with the proposal to enable ODPs to supply and administer medicines using PGDs?

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

If you have any further views on this proposal, please outline them here. (Optional, maximum 150 words)

Training and governance for ODPs

PGDs are locally written and locally governed, and it is for the relevant organisation to agree appropriateness for the use of PGDs within a clinical service. However, NICE provides national guidelines on the writing, authorising, implementation and use of PGDs. The NHS Specialist Pharmacy Service team also provides expert pharmaceutical support and guidance relating to all aspects of the use of PGDs, including when controlled drugs can be supplied or administered under a PGD.

Not all professions that use PGDs can legally administer controlled drugs under a PGD. Where the administration of controlled drugs is permitted, PGDs can be written to include only certain controlled drugs (see annex C). All aspects of controlled drugs management are overseen by a controlled drug accountable officer (CDAO) in each organisation who is accountable for the governance where controlled drugs are used. This includes being familiar with the PGDs for controlled drugs, should any be in place in the organisation.

Under the proposal, all HCPC registered ODPs would be eligible to supply and administer medicines using the PGD mechanism. NICE strongly advises that ODPs should receive specific training on the use of PGDs (as is currently encouraged for all health professionals using this mechanism), and publishes a competency framework as part of its national guidelines setting out the skills and knowledge expected by those who undertake the writing, reviewing, implementation and use of PGDs. Responsibility for training and governance would lie at a local organisation level and would align with arrangements already in place for other professions that use the PGD mechanism. ODPs and their employer would therefore be responsible for ensuring that PGDs were only used by those who had completed necessary training and were therefore equipped to supply and administer medicines safely to patients through this mechanism. 

ODPs would be professionally accountable for their decisions, including actions and omissions, and must ensure they provide safe, evidence-based care within their scope of practice and competence. Local clinical governance arrangements will provide day to day assurance, and anyone who has concerns about a practitioner’s fitness to practise could raise these with HCPC.

As mentioned above, clear national guidance (for example, from the Specialised Pharmacy Service) on the use of the PGD mechanism already exists. We will work with the College of ODPs and relevant organisations to ensure guidance and training is promoted among the profession should we go ahead with implementing proposals.

PGDs are locally written and locally governed, and it is for the relevant organisation to agree appropriateness for the use of PGDs within a clinical service. ODPs wishing to use this mechanism would receive specific training on the use of PGDs, and be further supported by national guidance, local clinical governance arrangements and professional regulation.

No central funding will be required for training. The supply and administration of medicines through PGDs is locally governed, with organisations responsible for developing, authorising and maintaining the necessary training and guidance. While the changes may increase demand for relevant training, uptake is optional and driven by local need, with costs covered through local training budgets.  

Questions

To what extent do you agree or disagree that the training and governance measures for ODPs are sufficient to keep patients safe? 

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

If you have any further views regarding training and governance for ODPs, please outline them here. (Optional, maximum 150 words)

If you have any other comments regarding the medicines responsibilities of ODPs, please include them here. (Optional, maximum 150 words)

If you have any comments or evidence relating to the accompanying impact assessment, please include them here. (Optional, maximum 150 words)

4. Diagnostic radiographers

This section presents a proposal to enable diagnostic radiographer practitioners working at an enhanced, advanced or consultant (EAC) level to become independent prescribers of medicines. Diagnostic radiographers working at this level will be referred to as ‘EAC diagnostic radiographers’ for this consultation.

Introduction to the diagnostic radiographer profession

Diagnostic radiographers work mainly within the imaging departments of hospitals or in community settings such as community diagnostic centres (CDCs). They take lead responsibility for the management and care of patients undergoing a spectrum of clinical imaging examinations, together with associated image interpretation. Diagnostic radiographers administer intravenous contrast agents and other associated medicines as part of a diagnostic examination to help identify or exclude an illness or disease and to monitor progress following treatment initiated by a referring clinician. As of April 2025, there are currently 48,437 radiographers registered with the Health and Care Professions Council (HCPC) in the UK. Of these, about 41,600 are estimated to be diagnostic radiographers, who work at a range of levels, broadly categorised according to the Society of Radiographers (SoR) (the professional body for registered UK radiographers) as practitioner, enhanced, advanced and consultant. These levels reflect the increasing clinical responsibility, autonomy and leadership within the profession as follows:

• practitioner radiographers are at the entry level in the profession, and provide essential knowledge, skills and behaviours to diagnostic imaging. This is the level at which the largest number of radiographers practise
• enhanced radiographers have developed specialised skills beyond those of newly qualified practitioners, often focusing on specific modalities or procedures but working under protocols or supervision
• advanced radiographers, also known as advanced clinical practitioners (ACPs), practise autonomously across 4 pillars of advanced practice (clinical, leadership, education and research) and often take on complex clinical decision-making and service development. This is underpinned by a master’s level award or equivalent
• consultant radiographers are the most senior clinical experts, leading on strategic service design, research and education, and playing an important role in shaping policy and workforce development

Professional regulation for diagnostic radiographers

Diagnostic radiographers are statutorily regulated health professionals under HCPC. The terms ‘radiographer’ and ‘diagnostic radiographer’ are protected titles. HCPC sets the standards that all radiographers must meet in relation to their education, proficiency, conduct, performance, character and health. These are the minimum standards that HCPC considers necessary to protect members of the public.

Registrants must meet all these standards when they first register and complete a professional declaration every 2 years thereafter, to confirm they have continued to practise and meet the standards. 

Current routes for diagnostic radiographers to prescribe, supply and administer medicines

Diagnostic radiographers have extensive experience of the safe and effective use of medicines, including contrast agents, within their scope of practice. They routinely supply or administer medicines using patient group directions (PGDs), and sometimes also with patient specific directions (PSDs). They can also train as supplementary prescribers, enabling them to prescribe any medicine that is referred to within a patient’s clinical management plan (CMP). However, in practice very few have done so, as the use of CMPs is not appropriate in the majority of diagnostic interventions.

Proposal for EAC diagnostic radiographers

We are proposing to enable all HCPC-registered EAC diagnostic radiographers with sufficient experience and completion of an HCPC-approved post-registration independent prescribing programme, to become independent prescribers following completion of approved training and annotation on the HCPC register. This would not replace other existing medicines mechanisms available to diagnostic radiographers (for example, PGDs).

We are also proposing that EAC diagnostic radiographers who train to become independent prescribers are able to mix licensed medicines prior to administration and direct others to mix. The proposal explicitly excludes independent prescribing of unlicensed medicines by radiographers due to the limited application outside research, the complexity of governance and patient safety.

In practice, most radiographers’ prescribing will mainly involve the POMs commonly used in clinical imaging, depending on their scope of practice. These include:

• intravenous iodine-based and gadolinium-based contrast media
• intravenous antispasmodics
• oral bowel preparations and contrast agents
• intravenous saline

For experienced advanced and consultant-level practitioners working beyond routine imaging - such as in frailty services or cardiac imaging - prescribing will align with their training, competence, and authorisation. In these cases, it typically covers a small number of additional POMs.  

This proposal is based on the one consulted on by NHS England in 2015 (PDF, 603 KB). The 2015 proposal related to all radiographers and resulted in changes enabling therapeutic radiographers to train to become independent prescribers in 2016. At the time, the Commission for Human Medicines (CHM) was not supportive of the case for EAC diagnostic radiographers to become independent prescribers. This was in part due to concerns raised by the Royal College of Radiologists, who did not support independent prescribing for diagnostic radiographers, believing that existing mechanisms such as PGDs worked sufficiently well and noting that many, if not most, radiologists did not prescribe anything other than diagnostic contrast media. As a result, the same change was not implemented for EAC diagnostic radiographers in 2016. In 2021, the issue was taken back to CHM for consideration. The proposal was updated to limit EAC diagnostic radiographers’ independent prescribing explicitly to exclude the prescribing of unlicensed medicines or any controlled drugs. Following further discussion, the Royal College of Radiologists’ concerns were addressed, and they were supportive of the proposal. Therefore, in 2021 CHM updated its advice to recommend that EAC diagnostic radiographers should be given the right to train as independent prescribers.

We are therefore now proposing to bring EAC diagnostic radiographers in line with therapeutic radiographers. Initial engagement with relevant professional bodies and regulators suggests that the proposal does not need updating and represents a valuable intervention to make it more convenient and safer for patients to get the medicines they need at the time and place they need them.  

Case for change for EAC diagnostic radiographers

Demand for all diagnostic examinations, especially CT and MRI scans, continues to rise in line with overarching health system aims of preventing illness and achieving early diagnosis. Diagnostic radiographers are central to these diagnostic services and often operate at advanced levels of practice - particularly in cancer pathways, emergency care and rapid diagnostics. Many services are now radiographer-led, with minimal or no medical oversight, including community-based facilities such as CDCs. Despite this, all diagnostic radiographers must currently rely on other professionals to prescribe or authorise medicines, either through a prescription, a PSD or a PGD.

While PSDs and PGDs are effective for planned care, they:

• require involvement of an appropriate prescriber
• can cause delays when prescribers are unavailable
• may not support services that are non-prescriber led or run in out-of-hours settings

In contrast, independent prescribing would enable EAC diagnostic radiographers to:

• assess, diagnose and prescribe for patients within their scope of practice
• provide prompt access to appropriate medicines, improving care and experience
• work more flexibly and autonomously, reducing reliance on radiologists

This will reduce the risk of interrupted care, rebooked appointments and diagnostic delays - ultimately improving outcomes. Independent prescribing would also facilitate the development of innovative, patient-centred pathways, enabling radiographer-led services to offer more holistic care. For example, where patients present with complications, pain or side effects during imaging or treatment planning, radiographers would be able to respond immediately rather than seeking authorisation from another clinician. This will also promote the development of skill mix in clinical teams and has the potential to reduce pressure on radiologists.

Question

To what extent do you agree or disagree with the proposal to enable EAC diagnostic radiographers to train as independent prescribers?

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

If you have any further views on this proposal, please outline them here. (Optional, maximum 150 words)

Training and governance for diagnostic radiographers

Diagnostic radiographers would need to complete a HCPC-approved training course and HCPC annotation on their registration before being able to independently prescribe.

Radiographer training programmes already include specific training on the pharmacology of drugs commonly encountered within diagnostic imaging settings, and the theory and practice of supply and administration of medicines.

Not all diagnostic radiographers would be expected to become independent prescribers. The safety of patients is paramount and the strict eligibility criteria for acceptance on independent prescribing education programmes reflect this. In line with other professions that are able to train as independent prescribers, it is proposed that all diagnostic radiographer entrants to the training programme would need to meet the following requirements: 

• normally hold at least 3 years’ relevant post-qualification experience within the clinical area in which they will be prescribing
• registered with HCPC as a diagnostic radiographer
• has a profession practice in an environment where there is an identified need for the individual to regularly prescribe
• able to demonstrate support from their employer or sponsor, including confirmation that the entrant will have appropriate supervised practice within the clinical area in which they are expected to prescribe. If self-employed, must be able to demonstrate an identified need for prescribing and that all appropriate governance arrangements are in place
• able to demonstrate medicines and clinical governance arrangements are in place to support safe and effective independent prescribing
• have a designated prescribing practitioner (DPP), who is normally a practitioner recognised by the employer or commissioning organisation as having experience in the relevant field of practice and training and experience in the supervision, support and assessment of trainees
• have a DPP who has agreed to provide the student with opportunities to develop competences in prescribing and the ability to supervise, support and assess the student during their clinical placement
• working at an enhanced, advanced, or consultant practitioner or equivalent level
• able to demonstrate how they reflect on their performance and take responsibility for their own continuing professional development (CPD), including development of networks for support, reflection and learning
• in Northern Ireland (NI):
  • provide evidence of an Access NI check within the last 3 years
• in Scotland:
  • be a current member of the Protection of Vulnerable Groups (PVG) scheme

HCPC has the authority to set standards for prescribing and approve education programmes for the provision of radiographer independent prescribing training. Prescribing education programmes are a minimum of 38 days in duration, including supervision in clinical practice, and are delivered as multi-professional programmes. The core content of these programmes is consistent across all non-medical prescribers, with profession-specific elements and practice-based assessments ensuring differentiation where required. Programmes are delivered at either level 6 (degree level) or level 7 (master’s level). Once trained, radiographer independent prescribers would be required to have an annotation on the HCPC register as an independent prescriber. This would require them to undertake appropriate steps to maintain their skills and competence in keeping with HCPC standards for prescribing. Employers would be responsible for ensuring that there is a need for a radiographer to undertake independent prescribing responsibilities before the radiographer embarks on training.

EAC diagnostic radiographers would be professionally accountable for their decisions to prescribe, including actions and omissions and must ensure they provide evidence-based care within their scope of practice and competence. In relation to prescribing, this means that a radiographer must only prescribe within their scope of professional practice - where they have the appropriate knowledge, skills and experience to do so safely. Local clinical governance arrangements will provide day to day assurance, and anyone who has concerns about a practitioner’s fitness to practise could raise these with HCPC.

Clear national guidance (from the Specialised Pharmacy Service, for example) regarding independent prescribing already exists. We will work with the Society of Radiographers and relevant organisations to ensure profession specific guidance is updated and promoted should we go ahead with implementing proposals.

Questions

To what extent do you agree or disagree that the training and governance measures for EAC diagnostic radiographers are sufficient to keep patients safe? 

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

If you have any further views regarding training and governance for EAC diagnostic radiographers, please outline them here. (Optional, maximum 150 words)

If you have any other comments regarding the medicines responsibilities of EAC diagnostic radiographers, please include them here. (Optional, maximum 150 words)

If you have any comments or evidence relating to the accompanying impact assessment, please include them here. (Optional, maximum 150 words)

5. Legal considerations

National Health Service Act 2006

The National Health Service Act 2006 also places several duties on the Secretary of State that apply to decisions taken in relation to NHS and public health functions. They are as follows:

1. To promote a comprehensive health service (section 1 of the NHS Act 2006). The Secretary of State is required to continue the promotion in England of a comprehensive health service designed to secure improvement in:

• the physical and mental health of the people of England
• the prevention, diagnosis and treatment for physical and mental illness

These proposals are aligned with the duty to promote a comprehensive health service. They will enable more professionals across the NHS to safely prescribe, supply and administer medicines. This, in turn, will ensure that patients receive timely access to the medicines they need to appropriately prevent, diagnose or treat physical and mental illness.

2. To act with a view to securing continuous improvement in the quality of services (section 1A of the NHS Act 2006). The Secretary of State is required to exercise his NHS functions with a view to securing continuous improvement in the quality of services provided to individuals.

These proposals are aligned with the duty to secure continuous improvement in the quality of the health service. The proposals aim to enable local systems to improve the quality of service they provide through implementing efficiencies. For example, through ensuring that patients do not need to see additional health professionals just to receive the medication they need. This could lead to a more streamlined end-to-end experience of care for patients. This would also take pressure off clinical teams, thus enabling better use of clinicians’ time.

3. To have regard to the NHS Constitution for England (section 1B). Regard must be given to the values, principles, pledges and rights in the NHS Constitution.

The NHS Constitution has been taken into account when developing the proposals in this consultation. In particular, this has included considering the following principles:

• principle 1: the NHS provides a comprehensive health service available to all
• principle 3: the NHS aspires to the highest standards of excellence and professionalism
• principle 4: the patient will be at the heart of everything the NHS does
• principle 6: the NHS is committed to providing the best value for taxpayers’ money

As set out above, these proposals will enable more professionals across the NHS to safely prescribe, supply and administer medicines thus promoting a comprehensive health service. This could in turn lead to patients receiving medicines more quickly and to a more streamlined end-to-end experience of care for patients. Proposals will enable more professionals to undergo additional training and upskilling, therefore supporting excellence and professionalism. Proposals will enable local systems to implement efficiencies, thus supporting value for money within the NHS.

4. To have regard to the need to reduce health inequalities (section 1C of the NHS Act 2006). With their functions in relation to the NHS, the Secretary of State must have regard to reducing inequalities between the people of England with respect to the benefits that they can obtain from the NHS.

We do not anticipate the proposals having unequal impacts or contributing to health inequalities and our assessment is that proposals would benefit patients broadly across services where these professions practise. It is possible that proposals will have varying degrees of uptake in different regions of the UK. We will need to monitor this during the implementation phase to ensure there are no unintended consequences on regional health inequalities.

5. To promote research (section 1E of the NHS Act 2006). In exercising his functions in relation to the NHS, the Secretary of State must promote:

• research on matters relevant to the NHS
• the use in the NHS of evidence obtained from research

We do not consider this duty to be affected by the proposals in this consultation.

6. To secure education and training (section 1F of the NHS Act 2006). The Secretary of State must exercise his NHS (and other) functions to secure an effective system for the planning and delivery of education and training for the persons employed, or considering becoming employed, in the NHS or connected activities.

The proposals will require the roll-out of additional training to certain NHS professionals to implement. Additional training will be managed locally, and we have engaged closely with relevant regulators and professional bodies to ensure the proposals as they relate to education and training are appropriate and implementable.

7. To review treatment of providers (section 1G of the NHS Act 2006). The Secretary of State is required to keep under review any matter that might affect the ability of healthcare providers to provide NHS services or the reward available to them for doing so.

We do not consider the proposals would affect the ability of healthcare providers to provide NHS services or the reward available to them for doing so.

8. To report on workforce systems (section 1GA of the NHS Act 2006). The Secretary of State must, at least once every 5 years, publish a report describing the system in place for assessing and meeting the workforce needs of the health service in England.

We do not consider this duty to be affected by the proposals in this consultation.

Family Test

The Secretary of State must consider, where sensible and proportionate, whether to apply the Family Test when making policy. The Family Test questions are:

• what kind of impact might the policy have on family formation?
• what kind of impact will the policy have on families going through key transitions such as becoming parents, getting married, fostering or adopting, bereavement, redundancy, new caring responsibilities or the onset of a long-term health condition?
• what impacts will the policy have on all family members’ ability to play a full role in family life, including with respect to parenting and other caring responsibilities?
• how does the policy impact families before, during and after couple separation?
• how does the policy impact on those families most at risk of deterioration of relationship quality and breakdown?

We have considered the Family Test and believe the proposals will not have a negative impact in relation to any of the relevant questions.

The proposals could have an indirect positive impact on families’ role in providing care through enabling more effective and efficient care closer to communities - for example, EAC diagnostic radiographers working in community diagnostic facilities.

Environmental duties

The Environment Act 2021 requires ministers of the crown, and those making policy on their behalf, to have ‘due regard’ to the environmental principles policy statement when making policy.

Ministers must identify the potential environmental effects (positive and negative) of the proposed policy and consider the 5 environmental principles:

• integration
• prevention
• rectification at source
• polluter pays
• precautionary

Ministers must incorporate the relevant principles in a proportionate manner.

Following consideration of this duty and the 5 principles, we do not consider that there will be any disproportionate environmental impacts as a result of these changes.

We consider that the use of medicines in the NHS in general may have some negative secondary (indirect) environmental effects. These include indirect greenhouse gas emissions, and contamination of the environment from the production and freight of medicines procured by the NHS. However, the changes to regulations proposed here will have no material additional impact on the production or freight of medicines procured by the NHS in comparison with the counterfactual (where the regulations are not updated), as we do not expect proposals to lead to an increase in the use of medicines in the NHS. Proposals will only change rules regarding who can prescribe, supply or administer medicines to the patients.

These proposals support local systems to implement efficiencies, for example, ensuring that patients do not need to see additional health professionals (for example doctors) just to receive the medication they need, which may, in turn, contribute to reduced travel requirements for patients and healthcare staff. This could lead to an indirect positive impact on greenhouse gas emissions.

Public sector equality duty (PSED)

This duty comprises 3 equality objectives, each of which needs to be considered separately. Ministers have regard to the need to:

1. Eliminate discrimination, harassment, victimisation and any other conduct that is prohibited by or under the Equality Act 2010.
2. Advance equality of opportunity between persons who share a relevant protected characteristic and persons who do not share it.
3. Foster good relations between persons who share a relevant protected characteristic and persons who do not share it.

The protected characteristics covered by this duty are:

• age
• disability
• gender reassignment
• marriage and civil partnership
• pregnancy and maternity
• race
• religion or belief
• sex
• sexual orientation

We do not consider that these proposals would have an impact on objectives 1 and 3 (see above). On the second objective regarding equality of opportunity, we do not consider that these proposals will have an adverse or disproportionate impact on individuals with protected characteristics. These proposals are intended to enable more appropriately trained professionals to supply, prescribe or administer medicines to patients, and may reduce delays and improve access to care across a range of clinical settings. We consider that proposals will benefit all patients, including those who share protected characteristics.

Northern Ireland considerations

In Northern Ireland new policies must be screened under section 75 of the Northern Ireland Act 1998, which places a statutory duty on public authorities, to mainstream equality in all its functions.

In addition, new or revised policies must be rural proofed in line with the Rural Needs Act (NI) 2016, which requires public authorities to have due regard to rural needs. To support this, we are actively engaging with the Northern Ireland Department of Health to ensure these statutory duties are considered as part of our policy development. We do not consider that our proposals risk impacting different people differently with reference to their protected characteristics nor geography (that is, rural need). These proposals are intended to enable appropriately trained professionals to provide timely, safe and effective care directly to patients, and may improve access to care across settings and areas, including in rural areas.

Question

Do you agree or disagree with our initial conclusions about the impact that the proposals will have in terms of the statutory duties of the Secretary of State?

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

If you have any further views regarding the statutory duties of the Secretary of State, please outline them here. (Optional, maximum 150 words)

How to respond

Please respond using the online survey.

Do not provide personal data when responding to free-text survey questions. Any personal data included will be removed prior to analysis of these responses and will therefore not be considered in the consultation outcome.

The consultation is open for 12 weeks and will close at 11:59pm on 28 October 2025. If you respond after this date, your response will not be considered.

If you have any queries on this consultation, contact prescribingpolicy@dhsc.gov.uk. Do not send your consultation answers or any personal information to this email address.

Consultation questions

Individual respondents must live or work in the UK to take part in this survey. Organisations must operate or provide services in the UK.

About you

In what capacity are you responding to this survey?

• An individual sharing my personal views and experiences
• An individual sharing my professional views
• On behalf of an organisation

Questions for professionals

Which of the following best describes you?

• A registered healthcare professional
• A manager or other member of staff working in the healthcare sector
• Other, please specify

Where do you work?

• England
• Scotland
• Wales
• Northern Ireland

What is your role?

• Paramedic
• Physiotherapist
• Operating department practitioner
• Diagnostic radiographer
• Doctor or medical practitioner
• Pharmacist
• Other, please specify

Questions for organisations

What is the name of your organisation?

What type of organisation are you responding on behalf of?

• Business
• Not for profit organisation
• Academic institution
• Public sector body
• Other, please specify

Where does your organisation operate or provide services?

Select all that apply.

• England
• Wales
• Scotland
• Northern Ireland
• The whole of the UK
• Outside the UK

Which professions would you like to answer questions about?

Select all that apply.

• Paramedics
• Physiotherapists
• Operating department practitioners
• Diagnostic radiographers

Section 1: paramedics

The following questions are about enabling paramedics to administer 7 additional medicines to their patients under exemptions in schedule 17 of the HMRs.

To what extent do you agree or disagree with the proposal to enable paramedics to administer lorazepam (by injection) to their patients using exemptions?

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

To what extent do you agree or disagree with the proposal to enable paramedics to administer midazolam (by injection) to their patients using exemptions?

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

To what extent do you agree or disagree with the proposal to enable paramedics to administer 3 forms of fentanyl (oral transmucosal, intranasal and intravenous) to their patients using exemptions?

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

To what extent do you agree or disagree with the proposal to enable paramedics to administer dexamethasone to their patients using exemptions?

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

To what extent do you agree or disagree with the proposal to enable paramedics to administer magnesium sulfate to their patients using exemptions?

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

To what extent do you agree or disagree with the proposal to enable paramedics to administer tranexamic acid to their patients using exemptions?

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

To what extent do you agree or disagree with the proposal to enable paramedics to administer flumazenil to their patients using exemptions?

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

If you have any further views on this proposal, please outline them here. (Optional, maximum 150 words)

Paramedics are already qualified to use exemptions upon registration with HCPC. Paramedics using exemptions would be further supported by national guidance, local clinical governance arrangements and professional regulation, as detailed in the ‘Training and governance for paramedics’ section of this consultation document.

To what extent do you agree or disagree that the training and governance measures for paramedics are sufficient to keep patients safe? 

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

If you have any further views regarding training and governance for paramedics, please outline them here. (Optional, maximum 150 words)

If you have any other comments regarding the medicines responsibilities of paramedics, please include them here. (Optional, maximum 150 words)

If you have any comments or evidence relating to the accompanying impact assessment, please include them here. (Optional, maximum 150 words)

Section 2: physiotherapist independent prescribers

The following questions are about enabling physiotherapist independent prescribers to prescribe 4 additional controlled drugs to their patients.

To what extent do you agree or disagree with the proposal to enable physiotherapist independent prescribers to prescribe codeine phosphate (by oral administration) to their patients?

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

To what extent do you agree or disagree with the proposal to enable physiotherapist independent prescribers to prescribe tramadol hydrochloride (by oral administration) to their patients?

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

To what extent do you agree or disagree with the proposal to enable physiotherapist independent prescribers to prescribe pregabalin (by oral administration) to their patients?

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

To what extent do you agree or disagree with the proposal to enable physiotherapist independent prescribers to prescribe gabapentin (by oral administration) to their patients?

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

If you have any further views on this proposal, please outline them here. (Optional, maximum 150 words)

Physiotherapist independent prescribers must successfully complete a HCPC-approved prescribing programme and receive an annotation on the HCPC register before being able to prescribe. Physiotherapists are further supported by national guidance, local clinical governance arrangements and professional regulation, as detailed in the ‘Training and governance for physiotherapists’ section of this consultation document.

To what extent do you agree or disagree that the training and governance measures for physiotherapist independent prescribers are sufficient to keep patients safe?

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

If you have any further views regarding training and governance for physiotherapist independent prescribers, please outline them here. (Optional, maximum 150 words)

If you have any other comments regarding the medicines responsibilities of physiotherapist independent prescribers, please include them here. (Optional, maximum 150 words)

If you have any comments or evidence relating to the accompanying impact assessment, please include them here. (Optional, maximum 150 words)

Section 3: operating department practitioners (ODPs)

The following questions are about enabling ODPs to use PGDs to supply and administer medicines to their patients.

To what extent do you agree or disagree with the proposal to enable ODPs to supply and administer medicines using PGDs?

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

If you have any further views on this proposal, please outline them here. (Optional, maximum 150 words)

PGDs are locally written and locally governed, and it is for the relevant organisation to agree appropriateness for the use of PGDs within a clinical service. ODPs wishing to use this mechanism would receive specific training on the use of PGDs, and be further supported by national guidance, local clinical governance arrangements and professional regulation, as detailed in the ‘Training and governance for ODPs’ section of this consultation document.

To what extent do you agree or disagree that the training and governance measures for ODPs are sufficient to keep patients safe? 

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

If you have any further views regarding training and governance for ODPs, please outline them here. (Optional, maximum 150 words)

If you have any other comments regarding the medicines responsibilities of ODPs, please include them here. (Optional, maximum 150 words)

If you have any comments or evidence relating to the accompanying impact assessment, please include them here. (Optional, maximum 150 words)

Section 4: diagnostic radiographers

The following questions are about enabling diagnostic radiographers working at an enhanced, advanced or consultant (EAC) level of practice, with sufficient experience and completion of an HCPC-approved post-registration independent prescribing programme, to train as independent prescribers.

To what extent do you agree or disagree with the proposal to enable EAC diagnostic radiographers to train as independent prescribers?

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

If you have any further views on this proposal, please outline them here. (Optional, maximum 150 words)

EAC diagnostic radiographers would need to complete a HCPC-approved training course and receive an HCPC annotation on their registration before being able to independently prescribe. In line with other professions that are able to train as independent prescribers, diagnostic radiographer entrants to the training programme would need to meet specific requirements, including demonstrating that they have sufficient experience, and are working at an enhanced, advanced or consultant level of practice. EAC diagnostic radiographers would be further supported by national guidance, local clinical governance arrangements and professional regulation, as detailed in the ‘Training and governance for diagnostic radiographers’ section of this consultation document.

To what extent do you agree or disagree that the training and governance measures for EAC diagnostic radiographers are sufficient to keep patients safe? 

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

If you have any further views regarding training and governance for EAC diagnostic radiographers, please outline them here. (Optional, maximum 150 words)

If you have any other comments regarding the medicines responsibilities of EAC diagnostic radiographers, please include them here. (Optional, maximum 150 words)

If you have any comments or evidence relating to the accompanying impact assessment, please include them here. (Optional, maximum 150 words)

Section 5: legal considerations

The following questions are regarding our assessment of the Secretary of State’s statutory duties in relation to our proposal.

Do you agree or disagree with our initial conclusions about the impact that the proposals will have in terms of the statutory duties of the Secretary of State?

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

If you have any further views regarding the statutory duties of the Secretary of State, please outline them here. (Optional, maximum 150 words)

Annex A: medicines responsibilities   

Authorised healthcare professionals can prescribe, supply and administer medicines through the following different and important routes, subject to their profession and competence level.

Independent prescriber

These are prescribing healthcare professionals who are responsible and accountable for the assessment of patients with undiagnosed or diagnosed conditions and for decisions about the clinical management required, including prescribing. The following professions can all qualify as independent prescribers:

• nurses
• pharmacists
• physiotherapists
• podiatrists
• therapeutic radiographers
• paramedics
• optometrists

Supplementary prescribing

This is a voluntary partnership between a doctor or dentist and supplementary prescriber, and the patient. Supplementary prescribing requires a clinical management plan (CMP) to be in place prior to prescribing for a patient, so is only appropriate for longer term management of clinical conditions. The following professions may become supplementary prescribers:

• nurses
• midwives
• optometrists
• pharmacists
• physiotherapists
• podiatrists
• paramedics
• therapeutic radiographers
• diagnostic radiographers
• dietitians

Once qualified, they may prescribe most medicines (including controlled drugs from schedules 2 to 5) within their clinical competence, according to the CMP.  

Relevant prescriber

This term refers to all those groups with legal prescribing rights. Those groups are doctors, dentists, qualified supplementary prescribers, qualified independent prescribers, or health professionals from approved countries.

Exemptions

These are provisions in the Human Medicines Regulations 2012 that permit certain groups of people and medicines specified in the regulations to be sold, supplied and/or administered to patients without the need for a prescription, PDG or PSD.

Patient group direction (PGD)

A written direction that allows the supply and/or administration of a specified medicine or medicines, by certain health professionals, to a defined group of patients requiring treatment of a specific condition.  

Patient specific direction (PSD)

A written instruction to a certain health professional to supply or administer a medicine to a named patient who has been assessed on an individual basis by the appropriate prescriber who then prescribes the medicine. The PSD then enables the relevant professional to administer or supply the medicine to the patient.

Annex B: scheduling of controlled drugs

The MDRs define the categories of persons authorised to supply, possess, prescribe and administer controlled drugs in their professional capacities and set out the conditions under which these activities may take place. Under the MDRs, drugs are classified into 5 schedules, each outlining the specific requirements for activities such as import, export, production, supply, possession, prescribing and record keeping.

The following information is taken from the British National Formulary, where you can also browse drug monographs by A to Z.

Schedule 1

Schedule 1 includes drugs not used medicinally such as hallucinogenic drugs (for example LSD), ecstasy-type substances, raw opium and cannabis. A Home Office licence is generally required for their production, possession or supply. A controlled drug register must be used to record details of any schedule 1 controlled drugs received or supplied by a pharmacy.

Schedule 2

Schedule 2 includes opiates (for example diamorphine hydrochloride (heroin), morphine, methadone hydrochloride, oxycodone hydrochloride, pethidine hydrochloride), major stimulants (for example, amphetamines), quinalbarbitone (secobarbital), cocaine, ketamine and cannabis-based products for medicinal use in humans. Schedule 2 controlled drugs are subject to the full controlled drug requirements relating to prescriptions, safe custody (except for quinalbarbitone (secobarbital) and some liquid preparations), and the need to keep a controlled drug register (unless exempted in schedule 5). Possession, supply and procurement is authorised for pharmacists and other classes of persons named in the MDRs.

Schedule 3

Schedule 3 includes the barbiturates (except secobarbital, now schedule 2), buprenorphine, gabapentin, mazindol, meprobamate, midazolam, pentazocine, phentermine, pregabalin, temazepam and tramadol hydrochloride. They are subject to the special prescription requirements. Safe custody requirements do apply, except for any 5,5 disubstituted barbituric acid (for example, phenobarbital), gabapentin, mazindol, meprobamate, midazolam, pentazocine, phentermine, pregabalin, tramadol hydrochloride or any stereoisomeric form or salts of the above. Records in registers do not need to be kept (although there are requirements for the retention of invoices for 2 years).

Schedule 4

Schedule 4 includes in Part I drugs that are subject to minimal control, such as benzodiazepines (except temazepam and midazolam, which are in schedule 3), non-benzodiazepine hypnotics (zaleplon, zolpidem tartrate, and zopiclone) and Sativex®. Part II includes androgenic and anabolic steroids, clenbuterol, human chorionic gonadotrophin (HCG), non-human chorionic gonadotrophin, somatotropin, somatrem and somatropin. Controlled drug prescription requirements do not apply and schedule 4 controlled drugs are not subject to safe custody requirements. Records in registers do not need to be kept (except in the case of Sativex®).

Schedule 5

Schedule 5 includes preparations of certain controlled drugs (such as codeine, pholcodine or morphine) which due to their low strength, are exempt from virtually all controlled drug requirements other than retention of invoices for 2 years, and nitrous oxide.

Annex C: the supply and administration of controlled drugs under patient group directions

Only certain controlled drugs are legally eligible to be included in a PGD, in accordance with the MDRs. The Specialist Pharmacy Service (SPS) has a helpful webpage regarding the supply and/or administration of controlled drugs under a PGD, which provides some further explanation. 

The following controlled drugs that may be considered for inclusion in a PGD:

• schedule 2: morphine, diamorphine, ketamine - note: the use of morphine and diamorphine is by registered nurses and pharmacists only, for the immediate necessary treatment of a sick or injured person (except for treating addiction)
• schedule 3: midazolam
• schedule 4: all drugs, including benzodiazepines - note: anabolic steroids and any injectable preparation used for treating addiction must not be included in a PGD
• schedule 5: all drugs, including codeine

Annex D: legal basis and assessment of the matters set out in section 2 of the Medicines and Medical Devices Act 2021

The Medicines and Medical Devices Act 2021 came into force on 11 April 2021. We propose to make legislative changes using powers in part 2 of the act, which provides powers to make, among other things, amendments to the HMRs.

This consultation is conducted in line with the requirement to consult in section 45(1) of the act.

Section 2 of the act provides that patient safety must be the overarching objective of the appropriate authority when making regulations. Section 2 requires that when assessing whether regulations would contribute to the overarching objective of safeguarding public health, the appropriate authority must have regard to 3 factors:

1. The safety of human medicines and that the benefits of doing so outweigh any risks
2. The availability of human medicines
3. The likelihood of the relevant part of the United Kingdom being seen as a favourable place which to:

• carry out research relating to human medicines
• conduct clinical trials
• manufacture or supply human medicines

As set out in section 2(3) of the act, where regulations under section 2(1) may have an impact on the safety of human medicines, the appropriate authority may make the regulations only if the authority considers that the benefits of doing so outweigh the risks.

The appropriate authority is the Secretary of State for Health and Social Care in relation to Great Britain and, in relation to Northern Ireland, it is the Northern Ireland Department of Health and the Secretary of State jointly. The consultation obligation applies to both the Secretary of State and Northern Ireland Department of Health, and both will make the final decision on making any legislative changes under section 2(1).

Below we have assessed the proposals against each of the factors set out in section 2.

Safety

The proposals to extend the medicines responsibilities of non-medical professionals are designed to ensure the highest levels of safety for patients. The likelihood of any increased risk in inappropriate administration of medicines is considered to be low, and extending access to medicines administration, supply and prescribing mechanisms has the potential to improve the quality of patient care. Proposals will enable local systems to implement efficiencies, for example, ensuring that patients do not need to see additional health professionals (for example, doctors) just to receive the medication they need, thus reducing delays in the provision of care. This could lead to a more streamlined end-to-end experience of care for patients. This would also take pressure off clinical teams, thus enabling more efficient use of clinicians’ time. We therefore consider that the benefits of the proposals outweigh any potential patient safety risks. 

Availability

Proposals have the potential to improve timely access to medicines by enabling more patients to receive all their care, at a single point in time, from one professional (where it is appropriate). This could enable patients to receive the treatment they need faster than if they needed to wait for another healthcare professional to prescribe, supply or administer the medicine they require. We do not anticipate any wider impacts on medicines supply, procurement or delivery that could adversely impact the availability of medicines.

Favourability

We do not consider it likely that proposals will have a significant impact on the UK being seen as a favourable place to carry out research, conduct clinical trials or manufacture and supply medicines. Proposals could go some way in demonstrating that the UK is able to adapt and innovate to make the best use of its clinical workforce to provide patients with timely access to medicines. This could have an indirect positive effect on the likelihood of the UK being seen as a favourable place in which to conduct clinical trials or carry out research relating to human medicines.

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