Chapter 15: Medicines optimization: ensuring quality and safety
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Source: Adapted from RPS ([318]).
Legislation relating to medicines
Legislative frameworks, government guidelines and professional regulations govern medicines management in the UK. The primary pieces of legislation are the Human Medicines Regulations ([133]) and the Misuse of Drugs Act ([215]) (see the section below on controlled drugs (CDs) for information on the Misuse of Drugs Act).
The Human Medicines Regulations ([133])
The Human Medicines Regulations ([133]) set out a comprehensive regimen for:
- the authorization of medicinal products for human use
- the manufacturing, importing, distribution, sale and supply of those products
- the products’ labelling and advertising
- pharmacovigilance.
The regulations were the result of a review of UK medicines legislation by the MHRA and a subsequent consolidation of changes in the law pertaining to medicines for humans since the enactment of the Medicines Act ([194]). The regulations replaced nearly all UK medicines legislation, including most of the Medicines Act ([194]) and over 200 other statutory instruments.
A number of policy changes were introduced through the regulations to help ensure that medicines legislation is currently fit for purpose. Relevant changes included:
- Medicines legislation allows health professionals and others to sell, supply and/or administer medicines by way of exemptions from the usual restrictions. The regulations removed a number of obsolete exemptions, amended or extended some current exemptions, and introduced some new exemptions in order to reflect modern clinical practice.
- There were updates to the process by which independent hospitals, clinics and agencies are able to continue using patient group directions to ensure processes reflect changes to the registration requirements for these organizations.
- The regulations consolidated provisions enabling a pharmacist, if in the exercise of their professional skill and judgement they believe it is appropriate to do so, to make changes to a prescription relating to the name of the product or its common name; directions for use of the product; and precautions relating to the use of the product. The regulations removed the requirement for the pharmacist to attempt to contact the prescriber before making such changes.
The regulations are comprehensive but in terms of medicines optimization they lay out the legal framework for the prescribing, sale and supply of medicines. In addition, they lay out the requirements for labelling of medicines, patient information leaflets and packaging. They also regulate the licensed status of medicines. Apart from some exemptions of specific categories of persons and situations when a prescription‐only medicine may be administered without a prescription, there is no reference in the regulations to administration of medicines. The regulations state that a person may not parenterally administer (other than to themselves) a prescription‐only medicine unless they are an appropriate practitioner other than a European Economic Area (EEA) health professional or are acting in accordance with the directions of such an appropriate practitioner. There are no regulations relating to medicines administered by the oral or other routes if there is a prescription.
Medicine administration is regulated primarily through professional regulation and governmental guidance, as well as the application of good clinical governance.
Independent prescribers, supplementary prescribers and patient group directions
The Human Medicines Regulations ([133]) and subsequent amendments (in 2013 and 2018) state that in addition to medical practitioners and dentists, a number of other healthcare professionals can train to become independent prescribers (IPs) and/or supplementary prescribers (SPs). Furthermore, patient group directions (PGDs) allow specified medicines to be given without a prescription.
Independent prescribers
Independent prescribing allows nurses, pharmacists and other healthcare professionals (as outlined below) who have successfully completed an accredited prescribing course and are registered as IPs to prescribe any medicine including unlicensed medicines (DH [66]) for any medical condition. This includes CDs (Human Medicines Regulations [133]) but only within the healthcare professional's own level of experience and competence, and in accordance with the relevant professional codes. For nurses this is the Nursing and Midwifery Council's (NMC) Code (NMC [257], Public Health England [291]), while other professions have equivalent ethical codes and requirements. Prescribing must also be considered to be part of that nurse's role.
The full list of healthcare professionals who can become IPs is as follows:
- nurses
- optometrists
- paramedics (since 2018)
- pharmacists
- physiotherapists
- podiatrists
- therapeutic radiographers.
IPs, except optometrist IPs, can prescribe medicines for any medical condition within their competence. Optometrist IPs are restricted to prescribing for ocular conditions affecting the eye and surrounding tissue only. Nurse and pharmacist IPs can prescribe any controlled drugs (CDs) except cocaine, dipipanone or diamorphine for the control of addiction. They can prescribe these drugs for other conditions. Physiotherapist and podiatrist IPs can prescribe a restricted list of CDs (see Table 15.1) while optometrist IPs are not permitted to prescribe CDs. There are proposed changes to the legislation that would permit therapeutic radiographer and paramedic IPs to prescribe a range of CDs.
Table 15.1 Controlled drug (CD) prescribing by independent prescribers
Profession | CDs permitted | Notes |
---|---|---|
Nurse | All CDs with the exception of cocaine, dipipanone and diamorphine for the treatment of addiction. | |
Optometrist | Not permitted. | |
Paramedic | Proposed changes to legislation still to be considered by the Home Office. | Likely to be a list of CDs for use in emergency situations. No date presently known – check current legislation. |
Pharmacist | All CDs with the exception of cocaine, dipipanone and diamorphine for the treatment of addiction. | |
Physiotherapist | Restricted to:
| |
Podiatrist | Restricted to diazepam, dihydrocodeine, lorazepam and temazepam for oral administration only. | |
Therapeutic radiographer | Proposed changes to legislation still to be considered by the Home Office. | No date presently known. Check current legislation. |
All IPs with the exception of optometrist IPs can authorize an emergency supply of medicines but not for Schedule 1, 2 or 3 CDs, with the exception of phenobarbital for the treatment of epilepsy. Nurse and pharmacist IPs can prescribe unlicensed medicines, subject to accepted good clinical practice, while physiotherapists, podiatrists, optometrists and therapeutic radiographers are limited to ‘off‐label’ medicines (i.e. licensed medicines used outside their marketing authorization, again subject to accepted good clinical practice). Presently, paramedic IPs cannot prescribe any unlicensed medicines or prescribe off label.
Supplementary prescribers
Supplementary prescribing has been defined as ‘a voluntary prescribing partnership between an IP and an SP to implement an agreed patient specific clinical management plan with the patient's agreement’ (DH [60]). Amendments to the Prescription Only Medicines (Human Use) Order ([290]) and the NHS regulations allowed supplementary prescribing by suitably trained nurses from April 2003. SPs prescribe in partnership with a doctor or dentist (the IP) and are able to prescribe any medicine, including CDs and unlicensed medicines, that are listed in an agreed clinical management plan. The plan is drawn up with the patient's agreement, following diagnosis of the patient by an IP and following consultation and agreement between the independent and SPs (DH [60], pp.6–7). A range of other professions can be SPs, including some that currently are not permitted to be IPs (Human Medicines Regulations [133]). Practitioners who are SPs have to successfully complete a course of accredited training and be annotated on their professional register as such.
The following professions can be SPs:
- chiropodists
- dietitians
- midwives
- nurses
- optometrists
- paramedics
- pharmacists
- physiotherapists
- radiographers.
All prescribing carried out by an SP must be subject to the practitioner's clinical competence and within an agreed clinical management plan with the patient and IP partner. SPs can prescribe CDs (with the exception of cocaine, dipipanone and diamorphine for the treatment of addiction) and unlicensed medicines, subject to accepted good clinical practice, if they are included in the clinical management plan. Community nurse prescribers can prescribe a range of dressings, appliances and licensed medicines that are listed in the Nurse Prescribers’ Formulary (BNF [25]).
The key principles that underpin supplementary prescribing are:
- the importance of communication between the prescribing partners
- the need for access to shared patient records
- the need for the patient to be treated as a partner in their care and to be involved at all stages in decision making, including regarding whether part of their care is delivered via supplementary prescribing (NPC [258]).
Independent and supplementary non‐medical prescribers must demonstrate the competencies outlined in the Royal Pharmaceutical Society's Prescribing Competency Framework. This framework is supported by all prescribing professions and accredited by the National Institute for Health and Care Excellence (NICE) (RPS [318]). The competency framework was developed to set out what good prescribing looks like. It has 10 competencies divided into two domains: ‘The Consultation’ and ‘Prescribing Governance’. Within each competency there are a number of statements that describe the activities or outcomes the prescriber should be able to demonstrate. The domains and competencies, along with some example statements, are outlined in Table 15.2.
Table 15.2 Royal Pharmaceutical Society's Prescribing Competency Framework
Domain | Competency | Example statements | ||||||
---|---|---|---|---|---|---|---|---|
The Consultation | Assess the patient |
| ||||||
Consider the options |
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Reach a shared decision |
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Prescribe |
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Provide information |
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Monitor and review |
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Prescribing Governance | Prescribe safely |
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Prescribe professionally |
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Improve prescribing practice |
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Prescribe as part of a team |
|
Patient group directions
Patient group directions (PGDs) allow healthcare professionals to supply and administer specified medicines to predefined groups of patients without a prescription (NICE [251]). PGDs were defined in Health Service Circular 2000/026 as ‘written instructions for the supply or administration of medicines to groups of patients who may not be individually identified before presentation for treatment’ (DH [59]). Both the NICE guidance and original legislation identify that the preferred method of providing clinical care involving supplying and/or administering medicines should be on an individual, patient‐specific basis, usually involving a prescriber. However, it is recognized that there may be situations where PGDs offer an advantage for patient care, without compromising patient safety, and there are clear arrangements for governance and accountability in place. A tool is available (SPS [339]) to help organizations and potential authors and signatories of PGDs to think about and follow necessary procedures before and during the stages of developing and authorizing PGDs, including determining whether the use of a PGD is appropriate.
PGDs must be used only by named and authorized registered health professionals who can legally supply and/or administer medicines using a PGD in line with the Human Medicines Regulations ([133]). Healthcare professionals who may supply or administer medicines using a PGD are:
- pharmacists
- registered chiropodists and podiatrists
- registered dental hygienists
- registered dental therapists
- registered dietitians
- registered midwives
- registered nurses
- registered occupational therapists
- registered optometrists
- registered orthoptists
- registered orthotists and prosthetists
- registered paramedics
- registered physiotherapists
- registered radiographers
- registered speech and language therapists.
PGDs must only include medicines with a UK marketing authorization (i.e. licensed medicines), although off‐label use of a licensed medicine can be included in a PGD when it is clearly justified by best clinical practice. It is a requirement that the PGD states that the medicine is being used outside the terms of the marketing authorization. ‘Black triangle medicines’ (i.e. those subject to close adverse drug reaction monitoring and reporting) can also be included when clearly justified by best clinical practice and when the black triangle status is stated on the PGD. If antimicrobials are included on a PGD, care should be taken not to jeopardize local and national strategies to combat antimicrobial resistance and healthcare‐associated infections, and a local specialist in microbiology must agree that a PGD is needed.
Schedule 4 and 5 CDs can be included in a PGD, while nurses and pharmacists can supply and/or administer diamorphine or morphine for the immediate necessary treatment of sick or injured persons.
The contents of a PGD are laid out in the legislation (Human Medicines Regulations [133], NICE [251]) A PGD should be developed by a multidisciplinary PGD working group with a named lead author. The group must include a doctor (or dentist), a pharmacist and a representative of any other professional group using the PGD. Institutions should have a multidisciplinary PGD approval group, and the group may be an existing local medicines decision‐making group, such as a drug and therapeutics committee or medicines management committee.
Similar guidance is available for Scotland (NES [225]).
Unlicensed and off‐label medicines
The MHRA states:
A marketing authorisation or product licence defines a medicine's terms of use: its summary of product characteristics outlines, among other things, the indication(s), recommended dose(s), contraindications, and special warnings and precautions for use on which the licence is based, and it is in line with such use that the benefits of the medicine have been judged to outweigh the potential risks. Furthermore, a licensed medicine: has been assessed for efficacy, safety, and quality; has been manufactured to appropriate quality standards; and when placed on the market is accompanied by appropriate product information and labelling.(MHRA [211])
However, there are clinical situations when the use of unlicensed medicines or use of medicines outside the terms of the licence (i.e. ‘off label’) may be judged by the prescriber to be in the best interest of the patient on the basis of available evidence. Such practice is particularly common in certain areas of medicine, for instance in paediatrics, where difficulties in the development of age‐appropriate formulations mean that many medicines prescribed for children are used off label or are unlicensed (MHRA [211]).
At present, the following healthcare professionals can prescribe unlicensed medicines:
- doctors
- dentists
- independent nurse and pharmacist prescribers
- in some circumstances, SPs (who can be pharmacists, nurses, midwives, community nurses, optometrists, physiotherapists, radiographers, or chiropodists or podiatrists).
In addition to these health professional groups, the following can prescribe a licensed medicine off label:
- nurse IPs
- pharmacist IPs
- optometrist IPs.
However, all healthcare professionals who can prescribe as outlined above are subject to their individual clinical competence, the professional codes and ethics of their statutory bodies, and the prescribing policies of their employers (MHRA [211]).
The responsibility that falls on healthcare professionals when prescribing an unlicensed medicine or an off‐label medicine may be greater than when prescribing a licensed medicine within the terms of its licence. Prescribers should pay particular attention to the risks associated with using unlicensed medicines or using a licensed medicine off label. These risks may include adverse reactions, product quality issues, and discrepant product information or labelling (e.g. absence of information for some unlicensed medicines, information in a foreign language for unlicensed imports, and potential confusion for patients or carers when the patient information leaflet is inconsistent with a medicine's off‐label use) (MHRA [211]).