General Pharmaceutical Council Guidance for Registered Pharmacies Preparing Unlicensed Medicines
This guidance applies only to the process of preparing an unlicensed medicine by (or under the supervision of) a pharmacist in a registered pharmacy in Great Britain, under the exemptions and circumstances described in the law.
- Source: pharmacyregulation.org
- Pharmacy Resource: Guidance
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Off-label or unlicensed use of medicines: prescribers’ responsibilities
Healthcare professionals may have more responsibility to accurately prescribe an unlicensed medicine or an off-label medicine than when they prescribe a medicine within the terms of its licence.
- Source: gov.uk
- Pharmacy Resource: Update
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Information and Guidance on the Prescribing and Use of Unlicensed Pharmaceutical Specials
East of England NHS Collaborative Procurement Hub
This document is to be used for information by medical healthcare professionals to provide guidance on the nature, prescribing and supply of special medicines. The objective of the document is to highlight their individual responsibilities, the risks involved and to make an overall contribution to preserving the safety of patients.
- Source: eoecph.nhs.uk
- Pharmacy Resource: Toolkit
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Specials Prescribing Optimisation Tool List (SPOT-List)
This bulletin aims to provide information on how to optimise prescribing either by offering alternatives, or by suggesting how to contain prescribing of the particular special.
- Source: prescqipp.info
- Pharmacy Resource: Bulletin
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The supply of unlicensed medicinal products (“specials”)
Medicines and Healthcare Products Regulatory Agency Guidance Note
This Guidance Note provides advice on the manufacture, importation, distribution and supply of unlicensed medicinal products for human use (commonly described as “specials”) which have been specially manufactured or imported to the order of a doctor, dentist, nurse independent prescriber, pharmacist independent prescriber or supplementary prescriber for the treatment of individual patients.
- Source: gov.uk
- Pharmacy Resource: Guidance
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Royal Pharmaceutical Society Professional Guidance for the Procurement and Supply of Specials
This professional guidance for the procurement and supply of pharmaceutical Specials is an update of Royal Pharmaceutical Societyguidance first published in 2012. This guidance aims to support pharmacists and their teams to work with prescribers, patients and carers to ensure the safe and appropriate procurement and supply of Specials. Optimising the treatment of all patients for whom no suitable licensed medicine is available, regardless of the care setting where the patient is being treated.
- Source: rpharms.com
- Pharmacy Resource: Guidance
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Prescribing Specials
Guidance for the prescribers of Specials
The Royal Pharmaceutical Society (RPS), the professional body for pharmacists and pharmacy, is delighted to publish this professional guidance for the prescribers of Specials. This is an update of the resource first published in 2011 by the National Prescribing Centre. In 2011 the National Prescribing Centre became part of the National Institute for Health and Care Excellence (NICE). The Royal Pharmaceutical Society (RPS) is updating the guidance in agreement with NICE and the intention is that RPS will maintain the guidance in the future.
Prescribers and pharmacists both have a responsibility to ensure that where Specials are prescribed they are the most appropriate choice and patients are supported to use them effectively.
- Source: rpharms.com
- Pharmacy Resource: Guidance
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This White Paper sets out to explore the true cost of selecting a higher risk alternative and how a well regulated and high quality Specials sector can provide value to the NHS. Through a series of case study scenarios, it looks at what happens when patient need and safety is compromised to the extent that there is additional cost incurred to the NHS. In all of these cases this additional cost has exceeded the initial cost of providing a Special in line with the established guidance.
- Source: apsm-uk.com
- Pharmacy Resource: White Paper
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Use of “Specials” – Guidelines for good practice and points to consider
Derbyshire Medicines Management
Specials are unlicensed medicines and should only be prescribed when there is no available licensed medicine which fully meets the patient’s special clinical needs.
Ongoing need should be reviewed and if necessary a change in medication or route of administration should be considered. The alteration of medication formulations (e.g. crushing tablets) to aid administration to patients with swallowing difficulties will render a licensed preparation unlicensed.
- Source: derbyshiremedicinesmanagement.nhs.uk
- Pharmacy Resource: Guideline
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Specials and expensive liquids guideline
Derby and Derbyshire Clinical Commissioning Group
This guideline contains a list of commonly prescribed medicines and alternative methods of administration for patients with swallowing difficulties, feeding tubes or for patients prescribed unlicensed ‘specials’ medication.
- Source: derbyshiremedicinesmanagement.nhs.uk
- Pharmacy Resource: Guideline
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European Alliance for Access to Safe Medicines – When Is a Medicine Not a Medicine?
This report examines what can happen when other factors enter the equation. For example, when money clouds the issue. Or when regulatory vagaries or loopholes exist. The EAASM has researched and uncovered a number of disturbing incidences of what can happen when healthcare decisions are made as a result of considerations other than the patient’s best interests. They make shocking reading.
- Source: eaasm.eu
- Pharmacy Resource: Report
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Following the publication of the EAASM report “When is a Medicine Not a Medicine”, the Alliance held a stakeholder round-table in London. The main output from the meeting was a Consensus Statement on the patient safety implications around the use of unlicensed and off-label medicines.
- Source: eaasm.eu
- Pharmacy Resource: Concensus Statement
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Any medicine intended for market approval in Europe must undergo a rigorous analysis of its safety and efficacy in the disease population in question. Approval of a medicine comes about after an extensive analysis of the benefit versus the potential risks posed by that medicine in that patient population. The robust European regulations in force are there to safeguard patient safety.
- Source: efpia.eu
- Pharmacy Resource: Position Paper
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Good practice in prescribing and managing medicines and devices: Prescribing unlicensed medicines
General Medical Council Guidance
The term ‘unlicensed medicine’ is used to describe medicines that are used outside the terms of their UK licence or which have no licence for use in the UK.
- Source: gmc-uk.org
- Pharmacy Resource: Guidance
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Academy of Managed Care Pharmacy Position Statement On Off-Label Use of Pharmaceuticals
The Academy of Managed Care Pharmacy (AMCP) supports off‐label use of FDA‐approved drugs when medically appropriate and necessary, but opposes government‐mandated coverage of specific pharmaceuticals, whether for FDA‐approved or off‐label uses.
- Source: amcp.org
- Pharmacy Resource: Position Statement
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What gives? Non-approved or off-label indications: a panacea or quagmire?
There are many situations in which it is clinically reasonable, and sometimes preferable, to use a medication for a non-approved indication.
- Source: albertadoctors.org
- Pharmacy Resource: Newsletter
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Ten Common Questions (and Their Answers) About Off-label Drug Use
This article introduces and answers 10 questions regarding OLDU in an effort to clarify the practice’s meaning, breadth of application, acceptance, and liabilities.
- Source: mayoclinicproceedings.org
- Pharmacy Resource: Journal Article
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The Use of Unlicensed Medicines or Licensed Medicines for Unlicensed Applications in Paediatric Practice
This statement, originally produced in 2000, was updated in 2013 by the Joint Standing Committee on Medicines, a committee of the Royal College of Paediatrics and Child Health and the Neonatal and Paediatric Pharmacists Group.
- Source: rcpch.ac.uk
- Pharmacy Resource: Statement
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Using Standardised Strengths of Unlicensed Liquid Medicines in Children
NPPG and the Royal College of Paediatrics and Child Health (RCPCH) strongly recommend that when children require unlicensed liquid medications, they should receive the RCPCH and NPPG recommended strength, where one exists.
- Source: rcpch.ac.uk
- Pharmacy Resource: Position Statement
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Legal requirements for children’s medicines
Medicines and Healthcare Products Regulatory Agency
Information on PIPs, paediatric studies and variations to children’s medicines.
Documents
- Legal requirements for children’s medicines
- Implementation of changes to product information
- Where paediatric data is assessed
- Source: gov.uk
- Pharmacy Resource: Various
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Medicines information leaflets cover many of the medicines that are prescribed or recommended to children by health professionals. They answer your questions about how and when to give the medicine, what to do if you forget to give the medicine or give it twice, and any possible side-effects.
Medicines for Children is a partnership programme by the Royal College of Paediatrics and Child Health (RCPCH), Neonatal and Paediatric Pharmacists (NPPG) and WellChild. Find out more about what we do.
- Source: medicinesforchildren.org.uk
- Pharmacy Resource: Medicines Information Leaflets
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Evidence summaries: unlicensed and off-label medicines ((ESUOMs) provide a summary of the published evidence for selected unlicensed or off-label medicines that are considered to be of significance to the NHS, usually when there is no licensed medicine for the condition requiring treatment or no licensed medicines are appropriate for a significant proportion of people requiring treatment.
The aim of ‘ESUOMs’ is to provide information about an unlicensed or off-label medicine that is being considered for use in circumstances where there are no clinically appropriate licensed alternatives.
- Source: nice.org.uk
- Pharmacy Resource: Evidence Summaries
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This report makes ten balanced recommendations on the prescription of a drug outside the narrow terms of its market authorisation, while remaining within current psychiatric practice.
- Source: rcpsych.ac.uk
- Pharmacy Resource: Report
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Appendix 2 Adult Services: Approved unlicensed and off-label use of medicines
Appendix 3 Mental Health Services for Older People: Approved unlicensed and off-label use of medicines
Appendix 4 Children’s and Young Peoples Service: Unlicensed and off-label prescribing guidance
Appendix 5 Substance Misuse Services: Approved Unlicensed and off-label recommendations
- Source: tewv.nhs.uk
- Pharmacy Resource: Guidelines
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Off-label prescribing: 7 steps for safer, more effective treatment
Psychiatrists often resort to off-label prescribing, not only for insomnia but also to treat schizophrenia-spectrum disorders, unipolar and bipolar affective disorders, anxiety disorders (especially obsessive-compulsive disorder), mental disorders related to general medical conditions, dementia, and personality disorders
- Source: mdedge.com
- Pharmacy Resource: Journal Article
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Off-label prescribing in psychiatric practice
This article reviews the nature and extent of this aspect of prescribing, outlines when it may be appropriate and makes recommendations for a suggested procedure when prescribing medication ‘off-label’.
- Source: cambridge.org
- Pharmacy Resource: Journal Article
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Question
- What is the clinical effectiveness and safety of sublingual crushed buprenorphine for treating opioid dependency?
- What is the clinical effectiveness and safety of sublingual crushed buprenorphine-naloxone for treating opioid dependency?
- What are the evidence-based guidelines regarding the administration of crushed buprenorphine or crushed buprenorphine-naloxone for the treatment of opioid dependency?
- Source: cadth.ca
- Pharmacy Resource: Report
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There are many generally accepted off licence (“off-label”) usages of contraception.
- Source: fsrh.org
- Pharmacy Resource: Statement
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Mixing of medicines prior to administration in clinical practice: medical and non-medical prescribing
Following recommendations from the Commission on Human Medicines, medicines regulations were amended in December 2009 to enable doctors and other prescribers to mix medicines themselves and to direct others to mix medicines.
These changes apply not only to palliative care, but to all clinical areas where the mixing of medicines prior to administration is accepted practice and supported by the employer’s policies for delivery of healthcare.
The Commission also agreed parameters, principles and key points on mixing of medicines. The intention is to enable accepted good practice to continue.
- Source: gov.uk
- Pharmacy Resource: Guidance
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Mixing of medicines prior to administration in clinical practice — responding to legislative changes
It is common practice for healthcare professionals to mix one or more medicines together before administration to a patient. This is permissible under medicines legislation where one product is a vehicle for the administration of another. However, mixing two licensed medicines where one is not a vehicle for the administration of the other, results in a new, unlicensed product being produced. Prior to recent legislative changes, the law restricted mixing practice to:
- Doctors and dentists mixing medicines and then administering to a patient
- Pharmacists mixing medicines to the specification of a doctor or dentist
- Holders of a manufacturing licence.
The NPC has produced this resource for both organisations and practitioners. It is not intended that this document replaces any generic guidance or professional codes of conduct from the professional regulatory bodies, but should be read in conjunction with them. It provides advice and tools which will help with the implementation of the guidance points.
- Source: webarchive.org.uk
- Pharmacy Resource: Guidance
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Use of medicines outside of their UK marketing authorisation in pain management and palliative medicine
This is a consensus document prepared on behalf of the British Pain Society in consultation with the the Association for Palliative Medicine of Great Britain and Ireland.
This document summarises the views of the Association for Palliative Medicine (APM) and the British Pain Society in relation to the use of drugs outside of their UK marketing authorisation beyond their product licence in clinical practice.
- Source: britishpainsociety.org
- Pharmacy Resource: Publication
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Use of medicines outside of their UK marketing authorisation in pain management and palliative medicine – information for patients
This is a consensus document prepared on behalf of the British Pain Society in consultation with the Association for Palliative Medicine of Great Britain and Ireland.
This leaflet explains how some medicines are used differently to how they were originally developed and approved. Sometimes there are clinical situations when the use of medicines outside the terms of their licence (‘off-label’) or the use of unlicensed medicines may be judged to provide you with the best or most suitable treatment.
- Source: britishpainsociety.org
- Pharmacy Resource: Patient Leaflet
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Specials Recommended by the British Association of Dermatologists for Skin Disease
On behalf of the BAD Specials Working Group 2018
Most prescribing uses licensed medicines whose safety and efficacy are assured. For many common dermatological diseases including psoriasis and eczema, the range of licensed medicines is limited. As a result, Dermatology prescribing may rely significantly on unlicensed creams and ointments (known as ‘Specials’) containing tars, dithranol, salicylic acid, steroids and other active constituents in a range of concentrations and bases. This is of particular concern in primary care where lack of effective price controls and a mechanism to ensure independent scrutiny of product quality has increased costs and concern about standards. To address these concerns, and help optimise quality of care, adherence to the revised British Association of Dermatologists (BAD) list of preferred Specials (2018) is encouraged.
- Source: bad.org.uk
- Pharmacy Resource: Publication
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British Association of Dermatologists’ guidelines for the safe and effective prescribing of azathioprine 2011
6-MP and 6-TG have never found their way into routine dermatological practice and these guidelines relate to azathioprine and its extensive on- and off-label applications for inflammatory dermatoses.
- Source: bad.org.uk
- Pharmacy Resource: Guideline
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Finasteride for Hair Loss in Women
The role of androgens (testosterone and dihydrotestosterone) in male pattern hair loss is clear, but the role of androgens in female pattern hair loss remains obscure, as many women with female pattern hair loss do not have elevated serum testosterone levels or clinical signs of hyperandrogenism.
- Source: dpic.org
- Pharmacy Resource: Healthcare Professional Article
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Prescribing Unlicensed Medicines – A brief guide
The Royal College of Ophthalmologists
In the UK, eye units use a wide range of licensed medicines to treat their patients, but it is recognised that for some patients their needs may only be met by unlicensed medicines or licensed medicines used outside their product licence (‘off label use’).
- Source: rcophth.ac.uk
- Pharmacy Resource: Guide
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Ophthalmic Special Order Products
The Royal College of Ophthalmologists and the UK Ophthalmic Pharmacy Group have updated the Ophthalmic Specials Guidance document to reflect changes to the products list. The guidance is primarily for healthcare professionals, but patients are also encouraged to ask their doctor, consultant or pharmacist about the medicines that they are prescribed, both licensed and unlicensed.
- Source: rcophth.ac.uk
- Pharmacy Resource: Guidance
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- Source: dorsetccg.nhs.uk
- Pharmacy Resource: Guideline
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Melatonin (SPOT-List)
Unlicensed melatonin products (tablets/capsules/oral solution) contribute to high spend in the NHS. The net ingredient cost in England for all melatonin products is over £22.6 million.
- Source: prescqipp.info
- Pharmacy Resource: Bulletin
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Examination of the Evidence for Off-Label Use of Gabapentin
The intent of this review is to tie the media concerns to clinical evidence obtained from a thorough literature review so that managed care pharmacists and physicians will be better prepared to address the subject of appropriate use of gabapentin.
- Source: amcp.org
- Pharmacy Resource: Journal Article
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Sildenafil in Esophageal Motility Disorders
Recently it has been speculated that phosphodiesterase type 5 (PDE5) inhibitors, specifically sildenafil, may be helpful in treating some esophageal motility disorders.
- Source: dpic.org
- Pharmacy Resource: Healthcare Professional Article
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Off-Label: Technically Unproven, But Not Out of Bounds
Today, the concept of prescribing a medication off-label is far from a rogue decision by a practitioner when it comes to choosing the best course of treatment for patient care. Indeed, it is not uncommon or new for ophthalmic drugs, technically unproven as a Food & Drug Administration (FDA) approved indications, to be prescribed off-label.
- Source: reviewofoptometry.com
- Pharmacy Resource: Journal Article
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Nurse and midwife independent prescribing of unlicensed medicines
Nursing and Midwifery Council Circular
On 21 December 2009 legislation was amended to allow nurse and midwife independent prescribers to prescribe unlicensed medicines for those in their care on the same basis as doctors, dentists and supplementary prescribers.
- Source: nmc.org.uk
- Pharmacy Resource: Prescribing Circular
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Pharmacy Resources Last Checked: 24/09/2021