Unlicensed Medicines Policy

Who Should Read This Policy Target Audience All Consultant/Senior Medical Staff All Junior Medical Staff All Non-Medical Prescribers All Pharmacy Staff All Nursing Staff Version 1.0 February 2016

Ref. Contents Page 1.0 Introduction 4 2.0 Purpose 4 3.0 Objectives 4 4.0 Types of Unlicensed Medicines 4 4.1 Off-Label Use 5 4.2 Liability 5 4.3 Process - Flow Chart for Unlicensed Medication Use 7 4.4 Application Process 8 4.5 Authorisation for use 9 4.6 Procurement of Unlicensed Medicines 10 4.7 Prescribing 10 4.8 Administration 10 4.9 Dispensing 11 4.10 Monitoring of Adverse Events 11 5.0 Procedures connected to this Policy 12 6.0 Links to Relevant Legislation 12 6.1 Links to Relevant National Standards 13 6.2 Links to other Key Policies 15 6.3 References 15 7.0 Roles and Responsibilities for this Policy 16 8.0 Training 19 9.0 Equality Impact Assessment 19 10.0 Data Protection and Freedom of Information 20 11.0 Monitoring this policy is working in practice 20 Appendices 1.0 Request and Risk Assessment for New Unlicensed Use of Medicines 21 2.0 Information for patients on Unlicensed Medicines 22 Version 1.0 February 2016 2

Explanation of terms used in this policy Licensed Medicines - are products used to prevent or treat a medical condition e.g. tablets, capsules, liquid medicines, injections, inhalers, creams, eye drops, ointments, suppositories, patches that have been granted a marketing authorisation and can be placed on the market in the UK Unlicensed medicines - are medicinal products that are not authorised for marketing in the UK Specials - are unlicensed medicines which have been specially prepared by the holder of a Manufacturers Specials Licence or imported in response to, or in anticipation of, the order of a doctor or a non-medical independent prescriber, to meet the special needs of individual patients Medicines and Healthcare Products Regulatory Agency (MHRA) a UK government agency, is the licensing authority in the UK for the advertising and selling of all medicinal products Marketing Authorisation - is issued for medicines which meet the required standards of safety, quality and efficacy and will state which illness the medicine can be used for, the ages of the patients it can be used for, how much to give and how to administer it Manufacturers Specials Licence - a licence issued by the Medicines Healthcare Products Regulatory Agency (MHRA) to organisations wishing to place unlicensed medicines on the market in the UK. Further details of the controls applying to Manufacturers Specials Licenses are given in MHRA Guidance Note 14 Off-label - a licensed medicine used in a way that is different to that described in the licence because it is judged to be in the best interests of the patient on the basis of available clinical evidence Prescriber - a healthcare professional that is legally authorised to prescribe a medicinal product, including medical and non-medical prescribers Medication error - any preventable event that may cause or lead to inappropriate medication use and/or patient harm while the medication is in the control of the healthcare professional, patient or carer Care Quality Commission (CQC) - the independent regulator of all health and social care services in England Independent Mental Capacity Advocate (IMCA) - The Mental Capacity Act 2005 introduced the role of the IMCAs as a legal safeguard for people who lack the capacity to make specific important decisions including and about serious medical treatment options. IMCAs are mainly instructed to represent people where there is no one independent of services, such as a family member or friend, who is able to represent the person. Standard Operating Procedure (SOP) - a laid-down procedure detailing all relevant steps and activities to be followed in carrying out a given process, procedure, or in a given situation Policy - sets out the aims and principles under which services, divisions, or units will operate. A policy outlines roles and responsibilities, defines the scope of the subject covered, and provides a high level description of the controls that must be in place to ensure compliance Version 1.0 February 2016 3

1.0 Introduction In the UK, medicinal products can only be placed on the market after a marketing authorisation has been granted by the Medicines and Healthcare Products Regulatory Agency (MHRA). The authorisation signifies that the medicine concerned meets the appropriate quality standards and is safe and effective for its intended use. In order to meet the needs of some patients, it is sometimes necessary that they receive treatment with a product that has not been authorised for use in the UK i.e. an unlicensed medicine. The law allows for the import, manufacture and supply of unlicensed medicinal products (commonly known as 'specials') subject to certain conditions in order to meet a patient s special clinical needs. Unlicensed medicines should only be used when there are no licensed products available and if their use can be clearly justified clinically and pharmaceutically to meet the special needs of individual patients. As unlicensed products are not subject to stringent control by the licensing authority, neither prescribers nor pharmacists can make the same assumptions of quality, safety and efficacy as they do for licensed medicines. Therefore, a governance process examining safety, efficacy and pharmaceutical quality must take place as part of the request and approval for the use of any unlicensed medicine. No new unlicensed medicinal product may be used without the prior approval of the Trust s Medicines Management Committee. 2.0 Purpose The aim of this policy is to explain the controls and governance procedures in place to manage the risk associated with the procurement and use of unlicensed medicines. 3.0 Objectives Promote the highest standards of medicines management to safeguard patients and minimise the risk associated with the use of unlicensed medicines The approval, procurement, prescribing and supply of all unlicensed medicines is managed safely and legally in accordance with best practice Compliance with the Care Quality Commission s Fundamental Standard for Safe Care and Treatment regarding the safe management of medicines, below which the provision of regulated activities and the care people receive must never fall Make clear the responsibilities of the trust and its employees, when dealing with unlicensed medicines Detailed record-keeping is completed and records maintained in accordance with MHRA guidance 4.0 Types of Unlicensed Medicines There are four broad categories of unlicensed medicines: 1. Those derived from licensed materials e.g. liquid preparations for those unable to swallow, or creams or ointments not commercially available. They may be prepared under a manufacturer s specials licence by a commercial manufacturer such as a registered pharmacy preparing products under an exemption of the Medicines Act. Version 1.0 February 2016 4

2. Products waiting for a licence to be granted in the UK. These medicines may be available from a UK manufacturer or be imported. In some cases, the product may be licensed in another country. They are usually supplied on a named patient basis 3. Those medicines which have had their marketing authorisation abandoned, revoked, suspended or not renewed 4. Those medicines which are part of a clinical trial; the exception would be where a medicine already has a marketing authorisation and is used in accordance with the authorisation during the trial 4.1 Off-Label Use A UK licensed medicine may also be used in a different population, different condition, or at a different dose to that which the medicine was originally tested for. The off-label uses of most medicines have not been subject to safety and efficacy assessments that are preconditions of the approval processes required for a marketing authorisation to be granted - this is classified as unlicensed use. Although there are a number of circumstances in which this may arise, it is likely to occur most frequently in prescribing for children. Currently pharmaceutical companies do not usually test their medicines on children and as a consequence, cannot apply to license their medicines for use in the treatment of children. The use of medicines that have been licensed for adults but not for children is often necessary in paediatric practice. Off-label use will be automatically treated as low risk and approval must only be sought from the Chief Pharmacist or the Deputy Chief Pharmacist before initiating treatment. All off-label use of medicines listed in the British National Formulary for Children (BNFC) are automatically approved. 4.2 Liability In general, unlicensed products have not been subjected to the same level of rigorous testing that licensed products have. Liability in any compensation claim caused by a medicinal product can only be passed on to the manufacturer when the product is licensed and has been used within the terms of that licence. Therefore, prescribing an unlicensed medicine places greater responsibility on individual prescribers within the Trust. The ultimate responsibility lies with the prescriber who signs the prescription and is professionally accountable for his or her judgement. The prescriber may be called upon to justify his actions in the event of an adverse reaction. There are two main ways an injured person may seek compensation: by proving negligence liability or strict liability. 4.2.1 Negligence Liability Prescribers have a duty in common law to take reasonable care and to act in a way consistent with the practice of a responsible body of their peers of similar professional standing. In using an unlicensed medicine, the prescriber must act responsibly and with reasonable care and skill; not to meet these standards lays the prescriber open to claims of negligence liability. 4.2.2 Strict Liability (Liability without Fault) The Product Liability Directive (EEC/85/374) and the Consumer Protection Act 1987, makes the producer or supplier liable for damage caused by a defect in the product. The product can be considered defective on the basis of what the patient is entitled Version 1.0 February 2016 5

to expect. This may be affected by the verbal and written information and warnings given to the patient. Version 1.0 February 2016 6

4.3 Process - Flow Chart for Unlicensed Medication Use CONSULTANTS ONLY ANY PRESCRIBER URGENT NEW ONE OFF REQUEST PLEASE COMPLETE ULM FORM (APPENDIX 1) NEW ONE OFF REQUEST PLEASE COMPLETE ULM FORM (APPENDIX 1) ADD TO ULM DATABASE FOR DIVISIONAL USE PLEASE COMPLETE ULM FORM (APPENDIX 1) WISH TO PRESCRIBE ULM FOR DRUG ALREADY ON ULM DATABASE FOR GIVEN DIVISION APPROVAL BY CHAIR OF MMC / CHIEF PHARMACIST OR DEPUTY CHIEF PHARMACIST SUBMIT TO MMC FOR DECISION PRIOR TO PRESCRIBING ENSURE THAT:- CONSENT PROCESS HAS BEEN CARRIED OUT IN LINE WITH BEST PRACTICE PATIENT INFORMATION LEAFLET HAS BEEN SUPPLIED (APPENDIX 3) INDICATION FOR THE MEDICATION IS RECORDED IN THE PATIENT S NOTES Version 1.0 February 2016 7

4.4 Application Process The following process must be followed prior to prescribing for all new unlicensed medicines. An application and risk assessment should be made using the form in Appendix 1. The Medicines Management Committee will consider all applications and maintain a list of approved, unlicensed medicines within the formulary. In considering each application, the Committee will need the following information (outlined in the application form): - Which drug is required and in what form? - What condition the drug is being used to treat? - Rationale for prescribing - Duration of use - For products that require continuation post discharge: who will prescribe, is a shared care document needed etc. - The cost of the product, based on current hospital purchase price and estimated annual cost impact on the Trust 4.4.1 Risk Assessment Unlicensed medicines can generally be categorised into one of the three categories of risk detailed below. The examples below are for guidance only. Category Low Risk Preparations Examples i) A preparation obtained from a trusted specials manufacturer, where the licensed formulation is unsuitable for a particular patient ii) Topical dermatology emollient preparations iii) Preparations commonly used in paediatric practice, which are listed in the BNF for children iv) A preparation which has relinquished its licence on commercial grounds or a low risk preparation which has never sought a licence Medium Risk Preparations i) Licensed preparations used outside the licensed indication ii) A preparation licensed within other EU countries (or a country with a mutual recognition agreement) but not licensed in the UK iii) A preparation where a UK licence has never been sought and is not considered a low risk preparation High Risk Preparations i) A preparation which has been withdrawn from the EU market on safety grounds ii) A preparation produced by a manufacturer outside of the EU (or a country with a mutual recognition agreement) The degree of risk depends upon the circumstances in which a medicine is prescribed. A medicine which has had its licence revoked or suspended is likely to Version 1.0 February 2016 8

be a higher risk than one which is unlicensed because a suitable formulation is not available. The risk assessment should ensure that contra-indications, side effects, precautions and the potential for harm are identified and accurately assessed in relation to the clinical condition. Following a clinical risk assessment, the prescriber should be satisfied that: There is no licensed alternative available that adequately meets the patient s needs There is sufficient robust evidence and consensus among peers to support use Any risks to the patient are outweighed by the potential benefit The patient consents to the use of an unlicensed product and is fully aware of any risks, potential side effects etc. 4.5 Authorisation for use The Medicines Management Committee approves the use of all unlicensed medicines new to the Trust. This can be a retrospective process in the case of urgent clinical need as explained below. When considering a request to approve an unlicensed medicine, the Committee must take all reasonable steps to ensure that there is no suitable licensed alternative product available. The Committee will review the supporting clinical data and take a view on the likelihood of supply chain difficulties, the possibility of interruptions to patient treatment, and any consequences. Approval will be granted if the Committee is satisfied that the drug requested is necessary for patient care and there is evidence for use. It is expected that expenditure on unlicensed medicines will be managed within the constraints of the existing drug budget By its nature, drug treatment does often need to be commenced at short notice and gaining the appropriate approval from the Committee prior to treatment may not be possible. At such times, an application for patient specific approval can be considered by the Chief Pharmacist in discussion with the Medical Director and a decision taken. The patient specific request will then be presented to the full committee at its next meeting for formal assessment and approval. 4.5.1 Trust Register The Chief Pharmacist oversees the Trust s approved unlicensed medicines register within pharmacy ensuring it is maintained and kept up to date on behalf of the Medicines Management Committee. The register contains a database of an approved list of unlicensed medicines authorised by the committee and supplied within the Trust. The database will hold the following information: Each completed Request and Risk Assessment Form for every approved unlicensed medicine for use within the Trust List of groups approved to prescribe unlicensed medicines Formulary status Any other additional information relevant to the product Version 1.0 February 2016 9

All records will be kept for 5 years to comply with Statutory Instrument SI1994/3144 MHRA-The Human Medicines Regulations 2012, (part 5). 4.6 Procurement of Unlicensed Medicines The local NHS SLA Provider is responsible for ensuring that unlicensed medicines are procured from reputable suppliers and for quarantine, packaging and labelling inspection. In addition, ensuring that all unlicensed medicines are licensed in the country of origin or a certificate of analysis or conformance is requested for each unlicensed product ordered. Some manufacturers, importers or distributors of unlicensed medicines may require a letter from the prescriber documenting evidence of the specific need for the particular unlicensed medicine. 4.7 Prescribing Prescribers may prescribe unlicensed medicines and medicines for purposes for which they are not licensed but to do so they must adhere to the following good practice: 1. Be satisfied that it would better serve the patient's needs than an appropriately licensed alternative 2. Be satisfied that there is a sufficient evidence base and/or experience of using the medicine to demonstrate its safety and efficacy. The manufacturer's information may be of limited help in which case the necessary information must be sought from other sources 3. Take responsibility for prescribing the medicine and for overseeing the patient's care, monitoring and any follow up treatment, or arrange for another doctor to do so 4. Make a clear, accurate and legible record of all medicines prescribed and, where you are not following common practice, your reasons for prescribing the medicine 4.7.1 Transfer of Care within the Trust - patients already initiated on an unlicensed medicine and requiring continued treatment under the care of a new consultant and clinical team, the initiating consultant will inform the receiving consultant about the unlicensed medicine. The receiving consultant will then decide if continuation of the unlicensed medicine is still in the best interests of the patient. 4.7.2 Transfer of Care to the Trust - patients already initiated on an unlicensed medicine for mental health or physical health within another organisation or their GP, the receiving consultant will assess and determine whether the medicine is still required; further make contact with the originating prescriber if there is any uncertainty over the appropriate use of the medication. 4.8 Administration Nursing staff involved in the administration of unlicensed or off-label medication should be: Made aware of its status Given information to administer and use the product safely Be informed of any potential problems and how to deal with them It is the responsibility of each registered nurse to satisfy themselves that the medicine may be administered safely and wherever possible there is acceptable evidence for the intended use of the unlicensed medicine. Version 1.0 February 2016 10

4.8.1 Patient Consent and Information Prior to the administration of unlicensed medicines, staff should ensure appropriate informed consent is in place. Patients should be given sufficient information by the prescriber, for them to be aware that they are being prescribed an unlicensed medicinal treatment, and for them to make an informed choice to consent. A suitable Patient Information Leaflet is available in Appendix 2. A record of the consent should be recorded in the patient s notes. There are limited circumstances where involving patients in decisions on unlicensed drug use is inappropriate and impractical e.g. clinical emergency, or an unconscious patient. If a patient lacks the ability to comprehend the information, the patient s representative should be fully informed of the intention to use an unlicensed medicine and where there is no immediate family, ward staff should arrange for an Independent Mental Capacity Advocate (IMCA) to support them. Unlicensed medicines can be included in a treatment plan when a patient lacks capacity and is sectioned under the Mental Health Act. T2, T3 and Section 62 forms must be completed in the normal way. The indication should be recorded on the form in accordance with best practice. Health professionals must respect the right of patients, carers and parents to participate in discussions regarding the health care of the patient and to seek to ensure that these decisions are properly informed. No additional steps, beyond those taken when prescribing licensed medicines are required to obtain the consent of patients and parents/carers for the use of unlicensed medicines. 4.9 Dispensing Pharmacy staff involved in the dispensing of unlicensed medicines will ensure that requests for unlicensed medicines are processed in accordance with Trust procedures. This will include the following: - where appropriate, communicate with patients the implications of using the unlicensed medicine - if appropriate, make arrangements for patients to have continuing supplies of treatment - make appropriate records of supply - ensure an English translation (or equivalent) patient information leaflet is issued with all unlicensed medicines where available - communicate clearly and in a timely manner with the patient and prescriber on the procurement, availability and supply of the unlicensed medicine 4.10 Monitoring of Adverse Events Adverse drug reactions and defective products are to be reported and handled in the same way as licensed medicines. All healthcare professionals should report serious adverse drug reactions to the Medicines and Healthcare Regulatory Agency using the Yellow Card System http://yellowcard.mhra.gov.uk/ and to the Medicines Management Committee via DATIX, the Trust Incident reporting system. However, an unlicensed medicine s adverse reactions profile is usually less well known than those, which are licensed. It is therefore important that everyone Version 1.0 February 2016 11

involved i.e. doctors; pharmacists and nurse, patients, parents or guardians of patients must be vigilant in the monitoring and reporting of any adverse effects. 5.0 Procedures connected to this Policy Security of FP10 Prescription Pads Medicines Management in Crisis Resolution and Home Treatment Teams 6.0 Links to Relevant Legislation The Human Medicines Regulations 2012 The regulations replaced most of the Medicines Act 1968 and about 200 statutory instruments with a simplified set of rules following a review of the UK s medicines legislation. The regulations implemented European directive 2001/83/EC relating to medicinal products for human use (the medicines directive) and set out a comprehensive regime for the authorisation of medicinal products for human use; for the manufacture, import, distribution, sale and supply of those products; for their labelling and advertising; and for pharmacovigilance. The regulations also introduced greater involvement of patients and healthcare professionals in reporting medicine safety issues. The Human Medicines Regulations 2012 (SI 2012/1916) regarding the use of unlicensed medicines This directive states that no relevant medicinal product may be placed on the market unless a marketing authorisation (formerly called a product licence) has been issued by the MHRA. This Marketing Authorisation (MA) signifies that the medicine concerned meets the appropriate quality standards and is safe and efficacious for its designated use. Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (Part 3) These regulations introduce the new fundamental standards, which describe requirements that reflect the recommendations made by Sir Robert Francis following his inquiry into care at Mid Staffordshire NHS Foundation Trust. They enable the Care Quality Commission to pinpoint more clearly the fundamental standards below which the provision of regulated activities and the care provided to people must not fall, and to take appropriate enforcement action where we find it does. Part 3 has two sections: Section 1 describes the requirements relating to persons carrying on or managing a regulated activity. Section 2 introduces the fundamental standards below which the provision of regulated activities and the care people receive must never fall. They came into force for all health and adult social care services on 1 April 2015. Regulation 8: General Regulation 9: Person-centred care Regulation 10: Dignity and respect Regulation 11: Need for consent Version 1.0 February 2016 12

Regulation 12: Safe care and treatment Regulation 13: Safeguarding service users from abuse and improper treatment Regulation 14: Meeting nutritional and hydration needs Regulation 15: Premises and equipment Regulation 16: Receiving and acting on complaints Regulation 17: Good governance Regulation 18: Staffing Regulation 19: Fit and proper persons employed Regulation 20: Duty of candour Regulation 20A: Requirement as to display of performance assessments The Human Rights Act 1998 One of the main laws protecting human rights in the UK, it contains a list of 16 rights (called articles) which belong to all people in the UK, and outlines several ways that these rights should be protected. These rights are drawn from the European Convention on Human Rights, which were developed by the UK and others in the aftermath of World War II. The Human Rights Act may be used by every person resident in the United Kingdom regardless of whether or not they are a British citizen or a foreign national, a child or an adult, a prisoner or a member of the public. The Human Rights Act has two main aims, to promote a culture of human rights by making sure that basic human rights underpin the workings of government at the national and local level and enabling access to human rights here at home, instead of only being able to go to the European Court of Human Rights It does this by placing a legal duty on all public authorities, including NHS organisations and staff and mental health tribunals carrying out public functions, to respect and protect human rights in everything that they do. This means that public authorities have legal responsibilities for respecting, protecting and fulfilling human rights. This duty is important in everyday situations because it enables individuals to challenge poor treatment and to negotiate better solutions. 6.1 Links to Relevant National Standards Care Quality Commission s Fundamental Standards introduced 1 April 2015 Regulation 11: Need for consent Where a person lacks mental capacity to make an informed decision, or give consent, staff must act in accordance with the requirements of the Mental Capacity Act 2005 and associated code of practice. Discussions about consent must be held in a way that meets people s communication needs. This may include the use of different formats or languages and may involve others such as a speech language therapist or independent advocate. Consent may be implied and include non-verbal communication such as sign language or by someone offering their hand when asked if they would like help to move. Consent must be treated as a process that continues throughout the duration of care and treatment, recognising that it may be withheld and/or withdrawn at any time. Version 1.0 February 2016 13

When a person using a service or a person acting lawfully on their behalf refuses to give consent or withdraws it, all people providing care and treatment must respect this. Regulation 12: Safe care and treatment The intention of this regulation is to prevent people from receiving unsafe care and treatment and prevent avoidable harm or risk of harm. Providers must assess the risks to people s health and safety during any care or treatment and make sure that staff have the qualifications, competence, skills and experience to keep people safe. Medicines must be supplied in sufficient quantities, managed safely and administered appropriately to make sure people are safe. Medicines and Healthcare products Regulatory Agency MHRA (2014) Guidance Note 14: The supply of unlicensed medicinal products ( specials ) This guidance has been updated following the consolidation of medicines legislation into the Human Medicines Regulations 2012 and takes into account the outcomes of relevant European court cases. An unlicensed medicinal product may only be supplied in order to meet the special needs of an individual patient. An unlicensed medicinal product should not be supplied where an equivalent licensed medicinal product can meet the special needs of the patient. Responsibility for deciding whether an individual patient has special needs which a licensed product cannot meet should be a matter for the doctor, dentist, nurse independent prescriber, pharmacist independent prescriber or supplementary prescriber responsible for the patient s care. Examples of special needs include an intolerance or allergy to a particular ingredient, or an inability to ingest solid oral dosage forms. These examples are not exhaustive. The least acceptable products are those that are unlicensed in the country of origin, and which are not classed as medicines in the country of origin (but are in the UK). For example, the use of products from countries where they are classed as supplements, not pharmaceuticals, and may not be made to expected standards of pharmaceutical GMP. These should be avoided whenever possible. Record-keeping requirements (1) Where the sale or supply of a medicinal product relies on the exemptions under regulations 167, 168 or, subject to paragraph (4), 169, the person who sells or supplies the product must maintain for at least five years a record showing (a) the source from which and the date on which the person obtained the product; (b) the person to whom and the date on which the sale or supply was made; (c) the quantity of the sale or supply; (d) the batch number of the batch of that product from which the sale or supply was made; and (e) details of any suspected adverse reaction to the product so sold or supplied of which the person is aware or subsequently becomes aware. (2) The person must make the records available for inspection by the Licensing Authority on request. (3) The person must notify the Licensing Authority of any suspected adverse reaction to the medicinal product which is a serious adverse reaction. Version 1.0 February 2016 14

6.2 Links to other Key Policies Medicines Prescribing Policy Medicines play a significant role in the care of the people who use our services and creating an effective system for managing medicines in an appropriate and timely manner is a vital component of providing the best possible care, positive outcomes and reducing incidents of harm. The policy describes the procedures and good practice that should be used by staff when prescribing medication to people who use our services and to make clear the legal and professional standards that are expected from them. Medicines Errors Policy Medication is the most common medical intervention within the NHS and particularly within mental health. Whilst every care is taken by individuals and the organisation when managing medication, errors involving medicines are sometimes inevitable due to human involvement. Medication errors are defined as patient safety incidents involving medicines in which there has been an error in the process of prescribing, dispensing, preparing, administering, monitoring, or providing medicine advice, regardless of whether any harm occurred This policy describes the procedure that must be followed when a medication error occurs. The procedure describes the immediate action to be taken to ensure patient safety, the grading of errors (where appropriate) and longer term actions to ensure that individuals, teams and the wider organisation can learn lessons. Non-Medical Prescribing Policy Prescribing practice within the NHS today consists of medical prescribing by doctors and non-medical prescribing by specially trained nurses, pharmacists and allied health professionals such as physiotherapists. The policy explains how non-medical prescribing operates within the Trust. Non-medical prescribing can improve patient care by ensuring timely access to medicines and treatment for patients who would otherwise have to wait to see a doctor; it also releases doctors to care for patients with more complex health care needs. 6.3 References Medicines and Medical Devices Regulation: Medicines and Healthcare products Regulatory Agency April 2008 The supply of unlicensed medicinal products ( specials ). MHRA Guidance Note 14: Medicines and Healthcare products Regulatory Agency 2014 Good practice in prescribing medicines General Medical Council (2008) Guidelines on the use of unlicensed medicines and the use of licensed medicines for unlicensed indications. West Midlands Dispensary Managers Group Electronic Medicines Compendium (emc) http://www.medicines.org.uk/emc/ Prescribing specials: Five guiding principles for prescribers. National Prescribing Centre. (NPC) (2011) Version 1.0 February 2016 15

7.0 Roles and Responsibilities for this Policy Title Role Key Responsibilities Medical Teams / Non-Medical Prescribers Adherence - Familiarise themselves with this policy and adhere to its principles in order to be able to respond to the immediate needs of patients and service users - Initiate and continue unlicensed medicines provided they are included on a directorate approved list of unlicensed medicines and within their specialty and competence - Ensure that the use of the unlicensed medicine is justified by the clinical condition of the patient and no appropriately licensed alternative treatment is available - Keep their knowledge up to date in order to be aware when they prescribe a licensed medicine in an unlicensed way and pharmacists will assist in identifying these situations where possible - Ensure the patient/representative has been informed that an unlicensed medicine is to be used, and the reasons why it is necessary to use an unlicensed medicine as part of the treatment and ensuring that Trust policy relating to informed patient consent is complied with - Ensure the rationale for unlicensed use of medicines is recorded in patients notes as appropriate - Ensure other prescribers within their team caring for their patients receiving the unlicensed medicine are familiar with the status of the medicine and know the protocols that control its use - Ensure incidents of patient reactions are recorded and reported to the MHRA via the yellow card scheme - Ensure that where responsibility for ongoing care is to be transferred to the patient s general practitioner, the general practitioner is informed of the unlicensed status of the medicine and that he or she is willing to accept clinical and legal responsibility for prescribing. The Trust is responsible for continuing treatment if the GP will not accept responsibility for continuing care - Attend training applicable to their role - Ensure they are competent to carry out their prescribing responsibilities and be accountable for their actions - Comply with all Trust policies this is a condition of employment and a breach of this policy may result in disciplinary action - Ensure any errors or incidents relating to this policy and area of practice are reported on DATIX, the Trust s electronic incident reporting system - If a member of staff has concerns about the way this policy is being implemented or about this area of practice in general, they should raise this with their line manager. If they feel unable to raise the matter with them, he/she may write to an Executive Director. If they feel unable to raise the matter with an Executive Director, he/she may write to the Chairman or a Non-Executive Director. If he/she is unsure about raising a concern or requires independent advice or support, they can contact: - their Trade Union representative - the relevant professional body - the NHS Whistleblowing Helpline - 08000 724 725 Version 1.0 February 2016 16

Title Role Key Responsibilities Ward Managers / Trust Pharmacy Team Consultant Medical Staff Group Non-Medical Prescribing Leads Non-Medical Prescribers Forum Group Quality and Safety Groups Deputy Director of Nursing Medicines Management Committee Clinical Directors/ Heads of Nursing/ General Managers Day to Day Monitoring - Support the implementation and monitoring of this policy - Provide support and advice to prescribers as necessary - Ensure all incidents, complaints and claims relating to this area of practice and policy are reported Unlicensed Medicines Policy Implementation - Ensure that their medical team receives, implements and complies with this policy - Request the supply of an unlicensed medicine not on the Trust Register using the application form in Appendix 1 - Lead discussions around this topic area and policy with their medical team - Undertake clinical audits to review and improve current prescribing practice - Implement strategies and innovations to improve current prescribing practice - Nominated experienced non-medical prescriber who acts as the lead for their Group Group Lead - Main point of contact for all non-medical prescribers within their Group - Keep the Group Quality and Safety Group informed of all issues and developments relating to non-medical prescribing - Forum for non-medical prescribers to raise and discuss all issues relating to prescribing practice Forum for NMPs - Chair of the Forum can escalate issues where necessary to the Medicines Improvement Group, Professional Advisory Group or Medicines Management Committee as appropriate - Monitor and review all incidents, complaints and claims relating to this area of practice and policy within their Group - Review prescribing practice to ensure that it is applied appropriately and in line with this policy Monitoring - Receive the results and recommendations of all related completed clinical audits and be responsible for monitoring action plans to implement changes to current practice until completion Non-Medical Prescribing Lead Scrutiny and Performance Operational Leadership - Lead on the strategic development of the implementation of non-medical prescribing throughout the organisation - Lead on strategies and innovations to improve current practice - Chair of the trust-wide Non-Medical Prescribers Forum - Oversee the governance of medicines management across the Trust - Ensure assessment and approval of all requests for specific drugs or classes of drugs to be on the Trust s Approved Unlicensed Medicines Register - Advise and scrutinise drug budgets on the financial implications of new drug developments and on the cost effective use of medication with responsibility linked to prescribers - Receive specific issues in relation to the delivery, development and monitoring of medicines management - Review all policies, guidelines and procedures including PGD s, SOP s affecting drug use or medicines management - Ensure policy distribution, implementation and compliance on relevant wards, units and services within their group - Ensure staff have received sufficient training and/or are competent to implement the policy - Ensure professional standards of record keeping are maintained - Lead discussions around this topic area and policy at Group Quality and Safety Group meetings - Oversee the completion of audits in respect of this topic area and policy - Provide updates on this area of practice and policy within their Group to the Quality and Safety Steering Group Version 1.0 February 2016 17

Title Role Key Responsibilities Chief Pharmacist Medical Director Medicines Lead Executive Lead Unlicensed Medicines Policy - Authorise, in conjunction with the Chair of MMC or Deputy Chief Pharmacist, new unlicensed medicines for use that are to be used as a temporary substitute for an unavailable licensed preparation, before they can be formally assessed and approved by MMC - Oversee the unlicensed medicines database within pharmacy ensuring it is maintained and kept up to date - Ensure the Trust complies with national guidance relating to the prescribing of medicines - Ensure that Groups are fully informed of their role in maintaining the required standards of practice relating to prescribing - Day to day management for all aspects of the safe and secure handling of medicines within the Trust - Lead on strategies and innovations to improve current prescribing practice - Policy lead/author of this policy - Lead responsibility for the implementation of this policy - Allocate resources to support the implementation of this policy - Chair of the Trust s Medicines Management Committee - Ensure any serious concerns regarding the implementation of this policy are brought to the attention of the Board of Directors Version 1.0 February 2016 18

8.0 Training What aspect(s) of this policy will require staff training? No specific training as competency is achieved as part of the qualification to prescribe as a medical practitioner Non-Medical prescribing Which staff groups require this training? Is this training covered in the Trust s Mandatory and Risk Management Training Needs Analysis document? If no, how will the training be delivered? Who will deliver the training? How often will staff require training Who will ensure and monitor that staff have this training? Medical Staff N/A N/A N/A N/A N/A Non-Medical Prescribers Please refer to Non-Medical Prescribing Policy for further details No specific training is required as competency is achieved as part of the qualification to practice as a nurse practitioner or other healthcare professional Nursing Staff N/A N/A N/A N/A N/A Information and training on the use of unlicensed medicines and the policy Pharmacists and Pharmacy Staff No Internally within the Pharmacy Department Chief Pharmacist will identify suitably experienced senior staff On Induction Chief Pharmacist NB: For prescribers and nursing staff, information on unlicensed medicines and off-label use will be included in medical induction, nurse training and medicines management updates and newsletters. 9.0 Equality Impact Assessment Black Country Partnership NHS Foundation Trust is committed to ensuring that the way we provide services and the way we recruit and treat staff reflects individual needs, promotes equality and does not discriminate unfairly against any particular individual or group. The Equality Impact Assessment for this policy has been completed and is readily available on the Intranet. If you require this in a different format e.g. larger print, Braille, different languages or audio tape, please contact the Equality & Diversity Team on Ext. 8067 or email EqualityImpact.assessment@bcpft.nhs.uk Version 1.0 February 2016 19

10.0 Data Protection and Freedom of Information This statement reflects legal requirements incorporated within the Data Protection Act and Freedom of Information Act that apply to staff who work within the public sector. All staff have a responsibility to ensure that they do not disclose information about the Trust s activities in respect of service users in its care to unauthorised individuals. This responsibility applies whether you are currently employed or after your employment ends and in certain aspects of your personal life e.g. use of social networking sites etc. The Trust seeks to ensure a high level of transparency in all its business activities but reserves the right not to disclose information where relevant legislation applies. 11.0 Monitoring this policy is working in practice What key elements will be monitored? (measurable policy objectives) Where described in policy? How will they be monitored? (method + sample size) Who will undertake this monitoring? How Frequently? Group/Committee that will receive and review results Group/Committee to ensure actions are completed Evidence this has happened Requests to MMC for the unlicensed use of medication are completed Key staff are discharging their duties to prescribe medicines safely and effectively Trust Register and database for unlicensed medicines is accurate and up to date How the side effects of prescribed medication are monitored 4.4 Pharmacy staff receiving requests by any other method 6.0 Every incident or complaint involving the unlicensed use of medication is routinely reported on DATIX Trust s Incident Reporting System and collated into a report 4.4.1 Regular inspections of the register and database 4.9 All severe + unexpected side-effects arising from prescribed medication must be reported on the Trust s Incident Reporting System DATIX Chief Pharmacist Annually Medicines Management Committee MH, LD, CYPF Quality and Safety Groups Monthly Medicines Management Committee Chief Pharmacist Quarterly Medicines Management Committee Chief Pharmacist reviews all DATIX medication entries to detect trends and provides a report Quarterly Medicines Management Committee Medicines Management Committee Medicines Management Committee Medicines Management Committee Medicines Management Committee Minutes of Meetings Completed Action Plans and minutes of Meetings Completed Action Plans and minutes of Meetings Completed Action Plans and minutes of Meetings Version 1.0 February 2016 20

Appendix 1 Unlicensed Medicines Policy Request and Risk Assessment for New Unlicensed Use of Medicines (ULM Form) This form should be completed by the Consultant with assistance from a divisional pharmacist each time a new unlicensed medicine is required. The completed form is to be submitted to Medicines Management Committee for approval to use the product within the Trust. Only in the case of urgent clinical need, with approval from the Medical Director, Chief Pharmacist or Deputy Chief Pharmacist may the single use of a new unlicensed medicine be authorised outside of MMC with a completed form still being required at the time but submitted formally to the next MMC meeting. Before completing this form you must have read and understood the unlicensed medicines policy and you must be aware of your responsibilities under this policy. NB: Parts 1, 2, 3, 4 & 6 to be completed by Consultant, Part 5 to be completed by Pharmacy. Part 1: Unlicensed Medicine Details Approved (Drug) name: Proprietary (Brand) name if known: Dose Form: Strength: Manufacturer (if known): Part 2: Patient Details Is this to be used for a single patient only? Single Patient Only Patient Name: NHS Number: Ward/Unit: : Site: Yes / No Multiple Patients p Approximate number of patients per year: Part 3: Clinical Details Indication: Dose Range: Frequency: Route: Expected Duration: Version 1.0 February 2016 21

Why is an unlicensed medicine use being considered? 1. Pharmaceutically equivalent licensed product temporarily unavailable Yes / No 2. Equivalent UK licensed product unavailable / unsuitable (explain) 3. Other (give details) Part 4: Clinical Evidence for Unlicensed Medicine Is there any evidence to support its use for the proposed indication? If not, is there any evidence to support its use for other indications? Is there any evidence to support its proposed administration schedule? Yes / No Yes / No Yes / No Is the active drug currently in a licensed product for use via the same route? Is the product licensed for the specific indication in an EU member state? Is the product licensed for the specific indication in a non-eu state? If yes, please state which Are other centres using this medicine? Yes / No Yes / No / Not Known Yes / No / Not Known If yes, name: Yes / No / Not Known If yes, name: Version 1.0 February 2016 22

Please summarise below any published evidence to support the use of the Unlicensed unlicensed Medicines medicine Policy use and any previous clinical experience with the medicine: References (attach copies to this application where these are available/appropriate): Authors: Title: Journal / Issue No Volume / Year: What are the risks to the patient of NOT using this medicine? List any side-effects or toxic effects that have been reported Describe any monitoring required: List any significant interactions: List any contraindications and any other risks to the patient: List any precautions, including precautions in use and pharmaceutical precautions: Version 1.0 February 2016 23

Is there a Patient Information Leaflet appropriate for intended use? Yes* / No / Not Known (*Please attach) and any special instructions How will the patient obtain further supplies? Is there a need for an effective shared care protocol (ESCA)? (If yes, then this will be required) Part 5: Procurement Details to be completed by Pharmacy Where is the medicine to be obtained from? Describe any expected problems associated with continuity of supply: What is the cost of the product? List any additional/indirect costs involved in obtaining this medicine: Part 6: Details of person(s) completing form Consultant Name: Version 1.0 February 2016 24

Division / Speciality: Unlicensed Medicines Policy Contact Number: Email address: I have read and understood the Unlicensed Medicines Policy and accept responsibility for use of this medicine. Consultant Signature: Date: Clinical Pharmacist Name: Pharmacist Signature: Date: Part 7: Outcome of Risk Assessment Medicines Management Committee approved? Yes / No Reasons if not approved: Restrictions on prescribing: Date of review: (Max 3 years) Name: Signed by MMC Chair:.. Date: *Inform consultant sponsor *Inform group pharmacist (to update database as required) *Retain application for 5 years Version 1.0 February 2016 25

Appendix 2 Unlicensed Medicines Policy What is this leaflet about? Information for patients on Unlicensed Medicines Please read this leaflet carefully August 2015 Edition You have been given this leaflet by your doctor or pharmacist because the medicine prescribed,, is not licensed, or it is being prescribed for a condition,..., not covered by its licence. We want to reassure you that we have thought very carefully about the best medicine for you. Why are medicines licensed? The manufacturers of medicines must apply to the government for a product licence if they want to sell their medicine in the UK. They show the government s medicines and healthcare products regulatory authority (MHRA) that their medicine works for the illness to be treated, that it does not have too many side effects or risks, and has been made to a high standard. How do manufacturers test medicines? To be sure that a medicine works and is safe, the manufacturer has to try it first on a small number of people in what is called a clinical trial. Information from clinical trials is given to the MHRA when the manufacturer applies for a licence. Version 1.0 February 2016 26