DLM Module 16 PDF - Prescribing Medicines

Medicines are the most common intervention used in the management of medical conditions, both by individuals self-treating and by health professionals prescribing, administering or supplying. To prescribe, is to authorise in writing the supply of a medicine (usually but not necessarily a prescriptio...

Medicines are the most common intervention used in the management of medical conditions, both by individuals self-treating and by health professionals prescribing, administering or supplying. To prescribe, is to authorise in writing the supply of a medicine (usually but not necessarily a prescription-only medicine), for a named patient but is more than the task of writing the prescription as it encompasses assessment, consultation and governance.This module covers the regulatory and governance aspects of prescribing. After successful completion of this module, you should be able to: Identify types of prescriber and prescribing, and the role of patient group directions Understand some key elements of professional guidance and accountability for prescribing practice Describe the governance, monitoring and legal requirements of prescribing controlled drugs From the Syllabus [https://fflm.ac.uk/wp-content/uploads/2020/06/DLMRegulations-Final.pdf] Candidates should have an understanding of the medico-legal issues relating to prescribing medicines. Examples of question topics might include: GMC, GDC and NMC guidance on prescribing; Medico-legal issues involved in prescribing controlled drugs (including regulatory requirements) Medico-legal issues involved in unlicensed and off label prescribing Prescribers may be medical or non-medical: Medical prescribers include doctors and dentists Non-medical prescribers include nurses, pharmacists, paramedics and physiotherapists Different types of prescribers have different permissions relating to e.g. prescribing Controlled Drugs, unlicensed medicines or authorising an emergency supply of a medicine. Doctors have the broadest range of permissions, with variation between non-medical prescribers, dependent on the profession. More information on the differing levels of permissions is available at: PSNC - Who can prescribe what? (a site principally for pharmacy contractors but contains an easy to use list) There are two types of prescribing, independent and supplementary: Independent prescribers are practitioners responsible and accountable for the assessment of patients with previously undiagnosed or diagnosed conditions and for decisions about the clinical management required, including prescribing. Supplementary prescribing is a partnership between an independent prescriber (a doctor or a dentist) and a supplementary prescriber to implement an agreed Clinical Management Plan for an individual patient with that patient’s agreement. Candidates should be familiar with the following: GMC - Good practice in prescribing and managing medicines and devices GDC - Guidance on prescribing medicines What are PGDs? Patient group directions (PGDs) are written instructions for the supply or administration of medicines to groups of patients who may not be individually identified before presentation for treatment. This allows non-prescribing health professionals (from those professions listed in the Regulations) to administer or supply medicines to patients in defined circumstances under the authority of the PGD. The health professional must be named within the PGD and have received any necessary training stipulated within it. The majority of clinical care involving administering and/or supplying medicines should be provided on an individual patient-specific basis. PGDs should be reserved for limited situations in which this offers an advantage for patient care, without compromising patient safety, and where there are clear governance arrangements and accountability. So, how are PGDs drawn up? The content of and authorisation requirements for PGDs are set in legislation (The Human Medicines Regulations 2012). PGDs are drawn up by a multi-disciplinary group and the authorising signatories include- a senior doctor (or dentist) a senior pharmacist an organisational representative a representative of any professional groups practising under the PGD Where the healthcare service is not commissioned or provided by the NHS, as in police custody, there is an additional requirement for authorisation by an independent doctor who is not employed or engaged by, and does not provide services under arrangements made with, any police force. The issue, by administration or supply, of medicines under the authorisation of a PGD by a health professional is NOT prescribing. How are PGDs used? Health professionals practising under PGDs, clinically assess the patient before determining if a PGD meets their needs. The health professional must comply exactly with the criteria within the PGD regarding inclusion/ exclusion criteria, clinical condition(s) covered, dose etc. No variation is allowed. The PGD will specify whether the health professional can administer a dose of medicine and/or supply the patient with a pack (with appropriate labelling). Health professionals cannot leave doses of medicines for administration to the patient by another person as this is delegation which is not permitted in the Regulations. See FFLM - Safe and secure administration of medication in police custody for further information relevant to this setting See NICE medicines practice guidelines - MPG2 Patient group directions which covers good practice for developing, authorising, using and updating patient group directions, and advice on whether a PGD is needed. To support safe and effective prescribing, resources are available from professional and regulatory bodies. These include: A Competency Framework for All Prescribers. Royal Pharmaceutical Society 2016 describes good prescribing looks like, setting out 10 competencies covering the two domains of ‘the consultation’ and ‘prescribing governance’. https://www.rpharms.com/resources/frameworks/prescribers-competencyframework what Good practice in prescribing and managing medicines and devices. General Medical Council 2021 expands on the guidance provided for doctors in the GMC’s ‘Good Medical Practice 2019 update’. https://www.gmc-uk.org/ethical-guidance/ethicalguidance-for-doctors/prescribing-and-managing-medicines-and-devices Guidance on prescribing medicines General Dental Council supplementary guidance including ‘Guidance on prescribing medicines’ and ‘High-level principles for remote consultations and prescribing’. https://www.gdc-uk.org/information-standards-guidance/standards-andguidance/gdc-guidance-for-dental-professionals Standards of proficiency for nurse and midwife prescribers. Nursing and Midwifery Council 2006 details the standards for the education of prescribers and standards for prescribing practice. This has been replaced in Jan 2019 by the Royal Pharmaceutical Society's Competency Framework for all Prescribers. https://www.rpharms.com/resources/frameworks/prescriberscompetency-framework Standards of conduct, performance and ethics. Health and Care Professions Council 2016 for professionals on this register, such as paramedics. https://www.hcpcuk.org/standards/standards-of-conduct-performance-and-ethics/ Familiarise yourself with the frameworks and the content of this professional guidance before we move on to cover some key areas. a) Prescribing for self, friends or family An important factor when prescribing for a patient is that you have a professional relationship with them, with clear boundaries, which allows objectivity and impartiality. Clearly, when prescribing for friends, family and especially for oneself the ability to be objective and impartial is unlikely if not impossible. This is particularly important in relation to Controlled Drugs because of the potential for habituation, misuse and addiction. This includes drugs in Schedules 4 and 5 (e.g. benzodiazepines, codeine). Practitioners prescribing for self, family or friends are at risk of attracting criticism from others and possible referral to their regulatory body. If you consider that it is essential to prescribe, then a contemporaneous record must be made including the justification for doing so and your relationship to the patient where relevant. Notify your/ the patient’s General Practitioner or other relevant practitioner (unless the patient withholds consent) of the medicines prescribed and other pertinent information. Guidance from professional regulators, medical defence organisations and other professional indemnity providers is that prescribers should not prescribe Controlled Drugs for these groups other than in exceptional circumstances where no other person is available who can prescribe, and where the treatment is immediately necessary to save a life, avoid serious health deterioration or alleviate otherwise uncontrollable pain or distress. The Nursing and Midwifery Council (NMC) provide ‘Useful information for prescribers’ to be used alongside the Competency Framework for Prescribers: https://www.nmc.org.uk/standards/standards-for-post-registration/standardsfor-prescribers/useful-information-for-prescribers/ b) Remote prescribing When it is necessary to use telephone or other non face-to-face medium to prescribe medicines or other treatment for a patient, consider how informed consent will be obtained. Before deciding to prescribe a medicine, the practitioner, with the patient, must make an assessment to include an adequate history (either taken or have access to) of: recent use of medicines from any source, illegal drug use, previous adverse reactions to medicines, other medical conditions. The practitioner will need to gain agreement from the patient to the proposed treatment having explained the risks and benefits, side effects, how to take the medicine, arrangements for any monitoring, follow up or review. Ask yourself the questions: Can I make an adequate assessment based on the information I have? Do I need to carry out a physical examination or other assessment? Do I have access to the patient’s medical record? Can I establish a dialogue with the patient? Can I obtain the patient’s informed consent? Where there is any uncertainty that these criteria have been met, then it is inadvisable to prescribe remotely. Practice example: In police custody it is generally now routine for the healthcare professional who first assesses a detainee to be a nurse or paramedic. If the patient does not fit the criteria for administration of medicine under a specific PGD, or if the nurse/paramedic wants to seek advice, the Forensic Physician(FP) may find themselves in a situation where they are remotely authorising the administration of medication by phone (backed up by written/ electronic confirmation) – remote prescribing. The FP must ensure that the information they have is adequate and sufficiently reliable to provide confidence that the medicine is indicated and appropriate. If there is any doubt about the assessment, then the FP should take any steps necessary to gain that assurance and may decide they need to see the patient. Visual links, such as video-link, Skype®, can provide extra information but also have inherent risks. See links below for further guidance. Useful links: GMC - Remote consultations and prescribing via telephone, video-link or online: https://www.gmcuk.org/ethical-guidance/ethical-hub/remote-consultations The MDU - Prescribing guide: https://www.themdu.com/guidance-andadvice/guides/prescribing The MDU - Understanding the risks of online consultations: https://www.gponline.com/understanding-risks-onlineconsultations/article/1440537 In the UK, the Licensing Authority for human medicines is the Medicines and Healthcare Products Regulatory Agency (MHRA), an executive agency of the Department of Health and Social Care under the overall responsibility of the Secretary of State for Health and Social Care. The MHRA is responsible for regulating all medicines and medical devices in the UK and for implementing and enforcing policy on behalf of the government. The MHRA explains the benefits of a licensed medicine and when it may be necessary to use an unlicensed or off-label medicine: ‘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. 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.’ An unlicensed medicine or licensed medicine used off-label may be necessary when there is no applicable medicine that meets the needs of the particular patient. This could be, for instance, when prescribing for a child where there is no product licensed for use in children, or as clinical experience with new medicines develops, new indications often emerge for which the medicine has therapeutic value. When prescribing medicines ‘offlabel’ or outside the terms of the license, the liability for patient harm resulting from the use of the medicine passes to the prescriber or their employer. Many organisations develop policies to manage the perceived risks such as the requirement for a sound evidence-base to support and justify the unlicensed use of medicines and obtaining informed consent from the patient (or their parent/carer) before the medicine is prescribed. Working within such policies provides protection for the prescriber. This is a colour-coded system that provides guidance on prescribing responsibilities for medicines. It is usually applied to a locality formulary. The rationale is to provide clear understanding of where clinical and prescribing responsibility lies between specialists and General Practitioners. The classification of drugs is decided by clinicians in a locality often by a Drug and Therapeutics committee or similar group comprising consultants, GPs and pharmacists from primary and secondary care. There may be variation in classification of drugs between different localities dependent on the shared care arrangements agreed at local level. The most basic system has three groups – green, amber and red. Green drugs are appropriate for prescribing in primary and secondary care and within the competencies of the prescriber Amber drugs are appropriate for shared care – responsibility for prescribing may be transferred from secondary to primary care with the agreement of an individual GP Red drugs for specialist use in secondary care or competent clinician only Some localities may use additional categories, such as blue drugs categorised as being appropriate for prescribing in primary and secondary care and within the competencies of the prescriber, however they are either alternative choices (i.e. second/third line) or may only be prescribed in specific indications or circumstances. Professional clinical and practice guidance is provided within the United Kingdom by professional bodies such as the Royal Colleges and by government accountable organisations. The National Institute for Health and Care Excellence (NICE) provides national guidance and advice to improve health and social care. It is a ‘Non Departmental Public Body’ accountable to the Department of Health and Social Care but operationally independent of the government. NICE guidance is officially England only because of the way NICE was established in legislation, however agreement with the devolved countries to provide certain products and services means that Wales, Scotland and Northern Ireland decide how the guidance applies in their country. The All Wales Medicines Strategy Group is a statutory advisory Welsh Assembly-sponsored public body that provides advice on medicines management to the Welsh Government. The Scottish Medicines Consortium is part of Health Improvement Scotland and provides advice to NHS Scotland about the value to patients of newly licensed medicines. It also reviews new formulations of, and new ways to use, established medicines. The Northern Ireland government committed in 2013 to follow the recommendations made by NICE. Where NICE has not assessed a medicine or technology Northern Ireland may follow the recommendations of the Scottish Medicines Consortium. Following the publication of the recommendations of the Shipman Inquiry’s Fourth Report the Government published a response in 2004 Safer Management of Controlled Drugs which introduced changes to strengthen governance systems to monitor CDs including: the restriction of CD prescription validity to 28 days; for designated healthcare organisations to appoint a CD Accountable Officer to ensure arrangements for CD management are robust; for healthcare providers holding CDs to have in place a standard operating procedure with which all personnel comply; a duty of collaboration between local and national agencies, including professional regulatory bodies, police forces and the Care Quality Commission to share intelligence and agree joint action where there is evidence of misuse on controlled drugs issues. Controlled Drug Accountable Officer (CDAO) The roles and responsibilities of CDAOs in England are governed by the Controlled Drugs (Supervision of Management and Use) Regulations 2013. Regional Lead CDAOs are responsible for all aspects of CD management are required to set up CD Local Intelligence Networks (CD LINs) in their area to share concerns and good practice comprising organisational CDAOs, Clinical Commissioning Group representative, regulators and agencies as set out in the regulations cascade alerts relating to incidents of local concern such as patients or healthcare professionals fraudulently obtaining CDs, prescriptions organise the issue of a prescriber identification number to clinicians wishing to obtain private CD prescription forms Comparable legislation applies to all UK countries, follow the links to arrangements in England, Wales, Scotland and Northern Ireland. Controlled Drug Liaison Officer (CDLO) The CDLO is a police officer whose remit is to police CDs within the health service. CDLOs usually work collaboratively with Regional Lead CDAOs and may attend CD Local Intelligence Network meetings providing an update for members on fraudulent activity and intelligence relating to illicit drugs and diverted prescription medicines. More information is available at: https://www.apcdlo.org/ Prescribing CDs When prescribing CDs there are a range of factors to consider: the legal requirements of prescription writing for Schedule 2 and 3 CDs clinical need the patient’s personal values and preferences Prescription requirements for CDs that are subject to the prescription requirement (Schedule 2 and 3 preparations) Must be: indelible signed by the prescriber include the date on which they were signed specify the prescriber’s address A machine written prescription is acceptable, but the prescriber’s signature must be handwritten. All prescriptions for CDs subject to the prescription requirement must always state: the name and address of the patient (use of a PO Box is not acceptable); in the case of a preparation, the form (the dosage form e.g. tablets must be included on a Controlled Drugs prescription irrespective of whether it is implicit in the proprietary name e.g. MST Continus, or whether only one form is available), and, where appropriate, the strength of the preparation (when more than one strength of a preparation exists the strength required must be specified); to avoid ambiguity, where a prescription requests multiple strengths of a medicine, each strength should be prescribed separately (i.e. separate dose, total quantity, etc); for liquids, the total volume in millilitres (in both words and figures) of the preparation to be supplied; for dosage units (tablets, capsules, ampoules), state the total number (in both words and figures) of dosage units to be supplied (e.g. 10 tablets [of 10 mg] rather than 100 mg total quantity); the dose, which must be clearly defined (i.e. the instruction ‘one as directed’ constitutes a dose but ‘as directed’ does not); it is not necessary that the dose is stated in both words and figures; the words ‘for dental treatment only’ if issued by a dentist. Private prescription forms Private prescriptions for Controlled Drugs in Schedules 2 and 3 must be written on specially designated forms which are provided by local NHS England area teams in England (form FP10PCD), local NHS Health Boards in Scotland (form PPCD) and Wales (form W10PCD); in addition, prescriptions must specify the prescriber’s identification number (or a NHS prescriber code in Scotland). Prescriptions to be supplied by a pharmacist in hospital are exempt from the requirements for private prescriptions. Additional information is available in the British National Formulary (BNF). Clinical and professional considerations Because of the risks inherent in the use of CDs, it is essential that the prescribing of CDs and the monitoring of their effect is carried out within a structured framework to minimise that risk and protect the benefits. NICE Guideline NG46 Controlled drugs: Safe use and management (April 2016) produced a suite of recommendations including a section on prescribing. These are summarised here. When making prescribing decisions consider: the benefits and the risks (including dependency, overdose and diversion) all prescribed and non-prescribed medicines the person is taking. Whether the person is opioid naïve evidence-based information sources When prescribing: document clearly the indication and regimen in care record check the person’s clinical need and adjust the dose if appropriate for a good balance between benefit and harm discuss with the person the arrangements for review and monitoring treatment be responsive to questions on the prescribing decision from other health professionals ensure ‘when required’ CDs have clear instructions on when and how to take in the care record or on the prescription to include maximum daily amount or frequency of doses take into account any supplies the person has when prescribing, reviewing or changing controlled drug prescriptions, prescribers should follow local (where available) or national guidelines and take into account the appropriate route, dose (including dose conversions or equivalence), formulation use a recognised opioid dose conversion guide when prescribing, reviewing or changing opioid prescriptions to ensure that the total opioid load is considered when prescribing CDs outside of general practice, inform the person’s GP of prescribing decisions NICE BNF Medicines guidance - guidance on prescribing GMC - Good practice in prescribing and managing medicines and devices GDC - Guidance on prescribing medicines PSNC - Who can prescribe what? FFLM - Safe and secure administration of medication in police custody NICE medicines practice guidelines - MPG2 Patient group directions A Competency Framework for all Prescribers – Royal Pharmaceutical Society 2016 Standards of conduct, performance and ethics – HCPC 2016 GMC - Remote consultations via telephone, video-link or online The MDU - Prescribing guide The MDU - Understanding the risks of online consultations BNF – Controlled drugs and drug dependence CR229. Detainees with substance use disorders in police custody: Guidelines for clinical management (fifth edition) Safer management of controlled drugs – DH 2004 Controlled Drugs (Supervision of Management and Use) Regulations 2013 NICE Guideline NG46 Controlled drugs: Safe use and management (April 2016)