Questions and answers about the consultation on controlled drugs

A Department of Health consultation includes proposals to update the limited list of controlled drugs that may be prescribed by independent prescriber physiotherapists.

What is this consultation about?

This consultation proposes adding another 4 controlled drugs to the existing list of seven controlled drugs that physiotherapist independent prescribers may prescribe.

Does this apply UK wide?

The consultation has been agreed by all four devolved countries of the United Kingdom. Current Regulations relating to controlled drugs apply in Great Britain (England, Wales and Scotland), with Norther Ireland having its own Regulations. Therefore, Northern Ireland would need to enact its own legislation to enable any changes as a result of this consultation to have effect there.

What is a controlled drug?

It is a substance that is regulated by both the Misuse of Drugs Act and The Misuse of Drugs Regulations because it is known to be particularly dangerous or open to abuse. Those that are classified as medicines have additional prescription requirements in place and may also have other types of control in place to ensure their safe use.

What controlled drugs can independent prescriber physiotherapists currently prescribe?

HCPC annotated physiotherapist independent prescribers can prescribe the following 7 controlled drugs, by the routes listed:

  1. Morphine (oral and injectable)
  2. Fentanyl(transdermal)
  3. Oxycodone (oral )
  4. Dihydrocodeine (oral)
  5. Temazepam (oral)
  6. Diazepam (oral)
  7. Lorazepam (oral)

Which controlled drugs are proposed to be added to the list?

Codeine, Tramadol, Gabapentin and Pregabalin.

Why does the list need adding to?

Changes to the licensing and scheduling arrangements of some of the proposed additions medicines mean that physiotherapist independent prescribers currently cannot prescribe them, despite having prescribed them safely in the past. In addition, there has been an increase in the number of physiotherapist prescribers working in advanced practice, FCP, primary care and community services roles, as well as private practice.

This means that physiotherapy independent prescribers need to be able to prescribe relevant medicines that are key to the pharmacological management of a number of frequently occurring conditions that most physiotherapists can expect to encounter regularly in their everyday work. This will enhance the potential for patients to have improved and timely access to medicines appropriate to their care and maximise the clinical benefits of physiotherapeutic interventions and rehabilitation.

Why do physiotherapist independent prescribers currently not have full-formulary controlled drug rights?

There is currently no robust patient-centered case of need that physiotherapist independent prescribers need access to the full formulary of controlled drugs. The deficiencies of the limited list of controlled drugs approved in 2015 have been identified with proposals that a further four controlled drugs are added to the list.

Can I de-prescribe a controlled drug if it is not on the approved list?

No. Although you may be reducing the amount of a controlled drug that has already been prescribed, you are still making a prescribing decision. This means you must work within a lawful prescribing framework in order to change the instructions relating to how to take a POM.

What will happen if the proposed changes are not recommended?

Physiotherapists must only independently prescribe the seven controlled drugs as currently set out in Regulations.

What will happen if the proposed changes are recommended?

Work will continue at legislative level to update the limited list of controlled drugs that physiotherapist independent prescribers can prescribe to include up to four new controlled drugs. Regulations must be changed before any additional controlled drug can be prescribed.

Why are gabapentin and pregabalin controlled drugs?

These POM medicines were up-classified to Schedule 3 controlled drug status on 01 April 2019, following concerns that these medicines were being obtained illegally and misused in society. This means that whilst they can still be prescribed for medical use, but there are now tighter controls in place for their use. Physiotherapist independent prescribers cannot currently prescribe these medicines, despite being able to do so before 01 April 2019.

Why is tramadol a controlled drug?

Tramadol was up-classified to a Schedule 3 controlled drug on 10 Jun 2014 following an increasing number of reports of significant harm including death due to misuse of tramadol and its diversion to illegal use.

Why is codeine a controlled drug when you can buy codeine over the counter?

Codeine has always been a controlled drug. However, depending on the dose and route of administration, some low does tablets can be sold ‘over the counter’. Higher does are POM and subject to additional controls.

Further questions – general

What is non-medical prescribing?

This is the prescription of ‘prescription only medicines’ (POMs) by a registered health professional other than a doctor or dentist. Current non-medical healthcare professional groups who hold non-medical prescribing rights are nurses, pharmacists, optometrists, and the allied health professions (AHPs) of physiotherapists, podiatrists, radiographers, dieticians, and paramedics. Non-medial prescribing includes both ‘supplementary prescribing’ and ‘independent prescribing’.

What is independent prescribing?

Independent prescribing is the process by which a registered practitioner is wholly responsible and accountable for the decision to prescribe a POM based on the assessment and diagnosis of a patient’s presenting condition.

What is supplementary prescribing?

Supplementary prescribing is the process by which a doctor or dentist work in voluntary partnership with a non-medical prescriber and the patient to determine the POMs to be used in the management of the patient’s condition. The POMs to be used are documented in advance of the prescribing occurring in an agreed patient-specific written document called clinical management plan (CMP). This process is specific to the patient and professionals named on the CMP.

How long have physiotherapists been able to prescribe medicines?

Physiotherapists have been able to qualify as supplementary prescribers since 2005 and independent prescribers since 2013. They have also been able to prescribe from a limited list of controlled drugs since 2015.

How are medicines regulated?

Three different pieces of law control the use of medicines in the UK. The Human Medicines Regulations 2012 controls the use of all products defined as medicines and those professions that are authorised prescribers. The Misuse of Drugs Act 1971 controls all substances, not just medicines, that are considered to be open to abuse and dangerous. These substances are collectively referred to as ‘controlled drugs’. The Misuse of Drugs Regulations 2001 categorises controlled drugs to ensure that patients who require controlled drugs for prescribed medical needs can have access to them under special prescribing controls known as ‘scheduling’.

What controlled drugs can supplementary prescriber physio’s prescribe?

HCPC annotated physiotherapist supplementary prescribers can prescribe any controlled drug, provided it is listed within the Clinical Management Plan agreed with a Doctor, *before* the prescribing activity occurs.

Is it safe to allow physiotherapists to independently prescribe controlled drugs?

Yes. Patient safety remains of paramount importance. Physiotherapist independent prescribers have completed a university level post-registration education programme and are registered as prescribers with the HCPC. They are required to meet HCPC standards of proficiency for prescribers, as well as the ordinary standard of proficiency for physiotherapists, and the standards of conduct, performance and ethics for registrants. They must also and work to the CSP’s Practice Guidance for Prescribers. They are required to work within their organisational clinical governance frameworks and they are accountable to the HCPC for their actions and are required to keep their skills up to date.

Are physiotherapists insured to independently prescribe medicines including controlled drugs?

Yes. Physiotherapists who are employed are covered vicariously by their employer. Physiotherapists relying on the CSP indemnity scheme are covered subject to the policy terms and conditions.

Can a physiotherapist working in one clinical area as an independent prescriber be able to prescribe if they move to a new clinical area?

If the new clinical area requires the physiotherapist to work as an independent prescriber then the organisation and the physiotherapist would need to ensure that all local clinical governance arrangements are in place before they could work as a non-medical prescriber. In addition the physiotherapist must ensure they were educated, trained and competent in prescribing the medicines required in their new clinical area.

Will successful completion of an independent prescribing training programme automatically allow physiotherapists to independently prescribe controlled drugs?

They will only be able to independently prescribe the limited list of controlled drugs set out in Regulations.

How will Doctors or GPs know what a physiotherapist has prescribed?

Physiotherapists will communicate any prescribing decision to all relevant members of a patient’s healthcare team - including GPs and all other clinicians. This may be done by making entries in a common patient record, by letter, fax or secure email (NHS-NHS) which will be included in the medical record. It may also be done via the ‘phone in emergency situations.

How will physiotherapists know what other medicines a patient is taking?

Prescribing is predicated upon having access to the primary patient record. Physiotherapists must not prescribe for an individual without access to appropriate medical records. Prescribing controlled drugs may also require additional checks and controls to ensure patient safety and prevent misuse and abuse.

Will prescribing costs increase?

This is not anticipated. Evidence shows that physiotherapist prescribers often prescribe less frequently than other professionals for the same conditions as physiotherapists are able to offer advice, self-management, exercise and manual and electrophysical therapies as adjunctive interventions which may reduce the need for pharmacological management. Physiotherapist independent prescribers play a key role in de-prescribing and thus reducing the amount of medicines a patient takes as part of an ongoing review of the overall management strategy of a patient’s condition

Relates to England only: 

What will be the cost impact of physiotherapist independent prescribing on Clinical Commissioning Groups (CCGs) and/or Primary Care Networks (PCNs)?

This will be a local arrangement and one that the prescribing panel in some CCGs / PCNs will influence. In certain areas, the prescribing budget is held centrally and all prescribers access this through Standard Operating Procedures and existing care pathways. It would be the local Governance and Finance Board’s responsibility to set this aspect of medicines management.

How does the HCPC show that a physiotherapist is qualified to prescribe?

The HCPC register shows an additional entry to show that an individual has successfully completed post-registration training as a prescriber. The HCPC only annotates individuals who successfully complete the training and pass the required assessment; those who do not complete the training or pass the required assessment (and therefore do not meet the necessary standards) cannot be annotated. The HCPC approves the education programmes delivering training in independent prescribing. Approving those programmes means that education programmes meet the standards that the HCPC sets. Members of the public, employers and others can check that a physiotherapist is registered and annotated via the HCPC website.

Are physiotherapists able to issue private prescriptions?

Yes, physiotherapist independent prescribers can issue private prescriptions for any medicine within their competence and scope of practice.

Who bears legal and professional responsibility for the actions of physiotherapist prescribers?

Physiotherapist prescribers are professionally responsible for their own actions. Where a physiotherapist has an annotation on the HCPC register as a prescriber and prescribes as part of his or her role with the consent of the employer, the employer may also be held vicariously liable for the prescribing actions of the physiotherapist.

Why are controlled drugs regulated separately from other POMs?

Controlled drugs are medicines that are known to have a higher risk of misuse or abuse because of their effects and/or are linked with addiction and dependence with continued use. This means their use needs to be closely monitored to ensure patient safety.

Can physiotherapists mix controlled drugs prior to administration to the patient?

No. There would need to be a specific provision in the Misuse of Drugs Regulations to enable mixing of controlled drugs by physiotherapists. Physiotherapists are only able to prescribe, and administer where appropriate, from limited list of CDs in isolation.

Further questions – principles:

What training and competences do physiotherapist prescribers have?

Prescribing is an advanced practice activity. Physiotherapists who want to become independent prescribers must complete an HCPC approved prescribing training programme at a UK university. In order to aces the course they must meet the entry requirements as set out in the curriculum framework for programmes. Once qualified, physiotherapist prescribers must continue to demonstrate they meet the HCPC Proficiencies for Prescribers, the Single Competency Framework for all prescribers, and follow CSP Practice Guidance for Prescribers.

What supervision and CPD do physiotherapist prescribers have?

Once qualified, physiotherapist prescribers must continue to demonstrate they meet the HCPC Proficiencies for Prescribers, the Single Competency Framework for all prescribers, and follow CSP Practice Guidance for Prescribers. Physiotherapist prescribers are required to re-new their HCPC registration every two years and continue to meet the HCPC standards for CPD

What are the responsible regulatory and governing bodies for physiotherapist independent prescribers?

The HCPC regulates physiotherapists and physiotherapy practice by its processes of individual registration, requirements for CPD, fitness to practise procedures, approval of prescribing programmes and annotation of prescribers to the register. The CSP is the professional body and trade union for physiotherapists and provides Quality Assurance Standards of Practice, Code of Behaviours and Values, and Practice Guidance for Prescribers.

What is the professional ethos of physiotherapist independent prescribing?

All physiotherapist must work within their individual scope of practice and this means they must be educated, trained and competent for the roles they undertake. They must work with the regulatory framework for physiotherapists and should follow guidance provided by the CSP. Local medicines management governance, multidisciplinary team working, and clinical audit and supervision underpin good continuing professional development.

What is the scope of physiotherapist independent prescribing?

A physiotherapist independent prescriber may prescribe any licensed medicine from the British National Formulary, within national and local guidelines, for any condition within their area of competence within the overarching framework of human movement, performance and function. Independent prescribers may also mix medicines prior to administration and prescribe from a restricted list controlled drugs as set out in Regulations.

What safety mechanisms are in place for safe physiotherapist independent prescribing?

Physiotherapist cannot be independent prescribers until they have successfully competed an HCPC approved training programme and received an additional annotation to their HCPC registration. Participation in CPD is embedded in the physiotherapy profession from the undergraduate education programme standards through to the HCPC standard for proficiencies for physiotherapists in general and for prescribers specifically. It is a requirement for NHS roles for CPD to be maintained in respect f an individual’s scope of competence which may be used to support individual clinical supervision and appraisal. Advice and support from local NMP leads for new and existing prescribers is embedded into practice. Pharmacovigilance is embedded into education programmes and clinical practice. Physiotherapist independent prescribers are expected to follow any local formulary for prescribing and to report any adverse reactions through the Yellow Card Scheme.

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