Medicines Formulary Policy

Document Control Summary

Ratified by: / Compliance and Clinical Practice Standards Group
Date ratified: / Feb 2015
Date of publication: / Feb 2015
Nameof originator/author: / Dianne Adams Chief Pharmacist
Accountable Director / Dr E Whicher, Medical Director
Date issued: / Feb 2015
Review date: / Feb 2017
Target audience: / All Trust staff involved with the prescribing, dispensing and administration of medicines
Department: / Drugs and Therapeutics Committee
Policy number: / TWC 21h

Version Control Summary

Version / Date / Status / Comment/Changes
3.1 / 2.1 Request for a new item to be added to the formulary
2.1.2 Requesting consultant to attend the relevant DTC meeting
2.1.4 and Appendix E -template for independent pharmacy MI appraisal
2.1.12 New medicine reviews and SDTC1 applications will be uploaded on Insite.
2.2 Request to use a NF drug for a specific patient by a specific consultant
2.2.9 Unsuccessful SDTC 2 applicants may appeal to the Medical Director and the Chief Pharmacist (may take up to 4 weeks to consider)
3.2 / Appendix D Venlafaxine XL indications added to Venlafaxine IR
Appendix D Gluteal Paliperidone LAI for loading doses during inpatient admission added
2.1.7 Interval of 6 months added.
3.3 / Feb 2015 / 2.2.7, 2.3.5, Appendix C wording re DTC Chair involvement in applications for NF medicines
2.2.9 conditions may be attached to approvals of NF medicines
2.2.10 & Appendix G second opinion in the event of rejection of NF request
2.2.14 SOADs not to be used to circumvent Trust policy concerning rejected requests for NF medicines
Appendix D Aripiprazole (Consilient) for mania (as per Abilify SmPC) added to red list (may not be transferred to GPs)
General wording tidy-up e.g. clinical director
Equality impact assessment now Appendix H

Contents

Executive Summary

1Introduction

2Purpose

2.1Request for a new item to be added to the Formulary (see also Appendix A)

2.2Request to use a Non-Formulary drug for a specific patient by a specific consultant (see also Appendix A)

2.3Unlicensed medicines

2.4General Practitioner agreement to continue an unlicensed medicine or a medicines used for an unlicensed indication.

3Duties

4Ratification process

5The development of this policy, including consultation process

6Training needs

7Monitoring compliance and effectiveness of this policy

Appendix AFlowchart for new medicine requests

Appendix BForm SDTC1

Appendix CForm SDTC2

Appendix DUnlicensed indications for licensed medicines or unlicensed medicines (“off-label prescribing”) approved by the Drugs & Therapeutics Committee

Appendix EIndependent drug review template for the Drug & Therapeutics Committee

Appendix FRequest for GP to continue supply of a medicine for unlicensed use or product

Appendix GSecond opinion checklist

Appendix HEquality Impact assessment

EXECUTIVE SUMMARY

The South West London and St. George’s Mental Health NHS Trust (SWLSG) Drugs & Therapeutics Committee (DTC) is responsible for managing the entry of mental health medicines into use within the Trust and the maintenance of the Trust’s Mental Health Medicines Formulary.

This includes licensed, unlicensed and off-label (unlicensed use of licensed medicines) use of mental health medicines.

Non-mental health medicine use within the Trust is guided by the Medicine Formularies of the local acute trusts, according to geographical location. Links to local non-mental health formularies may be found on the medicines pages of the intranet.

1.Introduction

It is considered good practice for a Trust to have a policy detailing its approach to the managed entry of medicines, including unlicensed medicinal products, and medicinal products used outside the terms of their licence. Benefits include

  • improving patient outcomes by optimising the use of medicines
  • supporting the inclusion of patient factors in decision-making about medicines
  • improving local care pathways
  • improving collaboration between clinicians and commissioners
  • improving quality by reducing inappropriate variations in clinical care
  • improving quality through access to cost-effective medicines
  • supporting the supply arrangements of medicines across a local health economy
  • supporting financial management and expenditure on medicines across health communities
  • supporting prescribers to follow guidance published by professional regulatory bodies in relation to medicines and prescribing.

Whilst there are acknowledged risks associated with the use of unlicensed medicines, and the use of licensed medicines for unlicensed indications, this policy provides guidance for Trust prescribers, and details a framework within which Trust prescribers mustoperate, thus enabling the Trust to manage the associated risks.

This policy provides a means of assessing and monitoring medicines use within the Trust, and, in the case of unlicensed or off-label use of medicines, thereby minimising the risk of harm to patients, and minimising the likelihood of claims against the Trust and individual prescribers.

1.1Licensed Medicines

All medicinal products marketed in the U.K. must have received a Marketing Authorisation (MA), issued by the Medicines and Healthcare products Regulatory Agency (MHRA).or European Medicines Agency (EMA). The licensed indications, dose, route etc for any product may be found in the Summary of Product Characteristics (SmPC). This details the clinical indications, precautions, dose, method of administration and age group of patients for which the drug may be used. It gives some assurance as to the quality, safety and efficacy of the product, and to a certain extent places liability on the manufacturer for adverse events arising from the use of the product.

1.2Unlicensed medicines and medicines being used outside of the terms of the MA.

Unlicensed medicinal products are products that have not received a MA in the UK or EMA approval. These may be imported, or alternatively produced as “Specials” in the U.K. by large reputable companies, small independent companies or within hospital pharmacies and are referred to in the following text as UMPs.

Examples

-Pirenzepine: Imported as no longer commercially available in UK

The use of licensed medicines outside of the terms of the MA is also known as “off-label” prescribing, and includes prescribing for unlicensed indications, at higher than licensed doses, by routes and to age groups not included in the licence, etc. Also included are those situations where the form of a preparation is changed before administration (e.g. tablets need to be crushed, capsules opened, etc). They are referred to in the following text as OLMPs.

Examples
-Olanzapine prescribed in excess of the maximum licensed dose of 20mg per day
-Hyoscine hydrobromide “Kwells” for hypersalivation
-Lamotrigine in bipolar disorder
-Fluoxetine prescribed for children
  • The practice of using UMPs or OLMPs is provided for in the Medicines Act (1968).
  • Since UMPs have not usually been subjected to the rigorous independent assessment of efficacy and safety applied to licensed products, their use may carry a higher level of risk for patients.
  • The ultimate responsibility for prescribing any drug lies with the prescriber who signs the prescription, who is professionally accountable for her/his judgement. Consequently, a clinician prescribing an UMP or OLMP is professionally accountable and personally responsible for any adverse consequences arising from its use. This also applies to products licensed within other European countries, but not the UK.
  • The manufacturer is only likely to be found liable if harm results from a defect in the product, thus putting a greater responsibility on individual prescribers and the Trust.
  • 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. They must have sufficient knowledge, information or experience to show they are acting reasonably and in the best interests of their patients.
  • A practitioner’s medical defence organisation may require advance warning of the prescription of UMPs or OLMPs.
  • The manufacturer’s patient information leaflet may be inappropriate for OLMP use, and may be non-existent for UMPs or “specials”. In the latter case, a locally prepared information leaflet must be made available to the patient.
  • There are some UMPs which cannot be obtained via a community pharmacy. In this situation, the clinician/Trust will need to supply the whole course of treatment.

1.2.1Use of imported medicines unlicensed in U.K.

  • The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1999 (S.I. 1999/4), which came into force on 1st February 1999, relates to the importation of medicines which do not have a valid U.K. or European MA. It requires that a minimum of 28 days written notice should be given to the MHRA prior to importation.
  • Approval from the MHRA is required before a medicinal product can be imported. The MHRA can veto importation on a number of grounds (e.g. safety, lack of information). There is a limit as to the quantity that may be imported. Specialist importers of medicinal products, who hold a Wholesaler Dealer (Import) License, are generally used to obtain the product.
  • It must be noted that the importation of medicinal products is not a reliable system of procurement, and continuity of supply cannot be guaranteed. Additionally, such products tend to be comparatively much more expensive.
  • Before any imported medicinal product may be supplied, the pharmacist must ensure that there is a Summary of Product Characteristics and Patient Information Leaflet (PIL) available in English.

1.2.2Specials

  • For some drugs, there may not be licensed, commercially available products, or there may not be a comprehensive range of licensed presentations (e.g. no oral liquid preparation). In these situations, such a product may be obtained as a “Special” (e.g. clonidine liquid or colecalciferol liquid), which is an unlicensed product obtained from either a hospital or commercial supplier with a Specials Manufacturing Licence.
  • If procured from a “Specials” manufacturer, the purchasing pharmacist is considered in law to be the manufacturer, and is liable as such.
  • Prescribers should be aware of such “Specials” which they may prescribe. A list of “Specials” in routine use will be noted in the Trust Mental Health Drugs Formulary.

N.B.The use of unlicensed medicines in clinical trials is outside the scope of this policy. See the Clinical trials policy.

2.1 Request for a new item to be added to the Formulary (see also Appendix A)

2.1.1Requests for new medicines to be added to the Formulary or re-considered in light of new information must be made by consultants. Such requests must have formal support from the Trust clinical speciality lead and the appropriate Clinical Director (CD), as appropriate.

2.1.2A form “Consultant Application for product to be added to the SWLSG’s Drug Formulary” (Form SDTC 1) Appendix B should be completed and sent to the Chair of the DTC via the DTC Secretary (Chief Pharmacist). At the Chair’s discretion, if insufficient information is provided, the form may be returned to the applicant to provide additional supporting information. Forms completed by the pharmaceutical industry will not be accepted.The request will be considered at the next possible DTC meeting, where the requesting consultant, or one with expertise in that field, should attend to present the evidence.

2.1.3For certain new medicines, especially where there will be widespread and multi-speciality interest, the DTC may proactively commission an independent review by Pharmacy Services. Where a new drug is supported by NICE, then a full review is not necessary. However the DTC will still consider its place in therapy within the Trust’s formulary, by considering each new NICE guidance related to mental health or substance misuse.

2.1.4In these circumstances, an independent appraisal of the newly requested medicine is obtained, or prepared under the auspices of the DTC, with input from the Medicines Information department.This will be prepared using the Pharmacy MI independent appraisal template (Appendix E).

2.1.5The DTC will, in dealing with any request, consider the clinical and cost-effectiveness of the new medicine, and the impact on primary as well as secondary care.

2.1.6Applicants will be notified by the secretary as to when the DTC will consider their application.

2.1.7The decision of the DTC on any particular request will be one of the following:-

  • the medicine be accepted unconditionally, for full inclusion in the Formulary
  • the medicine be accepted into the Formulary, subject to certain restrictions (e.g. Consultant prescribing only, limitations of patient group, e.g. ‘for treating resistant depression only’, as part of a protocol, etc)
  • the medicine be rejected. An unsuccessful application may only be resubmitted in the light of new evidence or changed circumstances, after an interval of at least 6 months.

2.1.8Decisions of the DTC are endorsed by the Compliance and Clinical Practice Standards Group(as at Jan 2014).

2.1.9Decisions of the DTC are formally shared with primary care by way of the SWL Mental Health Interface Prescribing Forum and with secondary care Trusts via the sharing of the minutes of the Trust DTC.

2.1.10The result of the application will be notified to the applicant in writing by the Chair of the DTC.

2.1.11Applicants who are unsuccessful in their requests for the addition of new medicines to the Formulary have the right of appeal. This should initially be to the Chair of the DTC, then to the Medical Director if necessary, and if still unsuccessful to the Compliance and Clinical Practice Standards Group(as at Jan 2014).

2.1.12New completed medicine drug reviews and completed SDTC-1 applications will be uploaded onto InSite by Pharmacy Services

2.2Request to use a Non-Formulary drug for a specific patient by a specific consultant (see also Appendix A)

2.2.1On admission

There may be occasions where a patient is admitted under the care of the Trust on a non-formulary medicine (SWLSTG’s formulary for MH medicines and SGH/KHT/ESH formularies for physical healthcare medicines, according to location). A formulary alternative should be considered on admission.

2.2.2If a formulary alternative is unsuitable, the consultant must complete a “Consultant Application for a Non-Formulary medicine for a Specific Patient” (Form SDTC 2) Appendix C for sending to the Principal Pharmacist (or deputy), before a limited supply (initially one week, max 8 weeks) of the medicine is authorised.

2.2.3Consideration must be given by the consultant during this 8 week period to a switch to a formulary drug before any further purchasing is permitted.

2.2.4Should continuation be necessary after this 8 week period, the consultant must discuss the request with the Principal Pharmacist (or deputy), and a second “Consultant Application for a Non-Formulary medicine for a Specific Patient” (Form SDTC 2) must be submitted by the consultant for consideration and approval (if appropriate) by the Chair of the DTC (or deputy in the event of absence or conflict of interest), before the medicine may continue to be supplied.

2.2.5DTC deputies for this purpose include the vice DTC Chairperson and the Clinical Director members of the DTC.

2.2.6Each request is considered on an individual basis and a decision may take up to 5 working days from the receipt of the fully completed application.

2.2.7Initiation

If a consultant wishes to initiate a non-formulary drug, the consultant must discuss the request with the DTC Chair and Principal Pharmacist (or deputy), and submit a “Consultant Application for a Non-Formulary medicine for a Specific Patient” (Form SDTC 2) for consideration and approval (if appropriate) by the Chair of the DTC (or deputy in the event of absence or conflict of interest), before the medicine may be supplied.

2.2.8Each request is considered on an individual basis and a decision may take up to 5 working days from the receipt of the fully completed application.

2.2.9Conditions and time-limitations may be attached to approvals. Applicants mustensure prescribers comply with any conditions attached to the approval of a NF drug and feedback to the DTC Chair after the initial approval period, so that prescribing practice outwith the formulary can be monitored and, if required, approval for ongoing treatment obtained.

2.2.10Applicants who are unsuccessful in their requests for non-formulary drugs for patient-specific use may undertake an in-depth medication and previous medical history review, to facilitate a second opinion by a DTC consultant who is not from the same directorate. This approach should initially be discussed with the DTC Chair who will identify a suitable second opinion consultant. See Appendix G for checklist. A second opinion may take up to 4 weeks from receipt of the completed review by the second opinion doctor. The review and the second opinion must be recorded in the patient’s notes.

2.2.11Applicants who are not satisfied with the second opinion may appeal. This should be to the Chief Pharmacist and the Medical Director. Appeals may take up to 4 weeks to consider.

2.2.12Conditions and time-limitations may be attached to any approval of appeals. Applicants must ensure prescribers comply with any conditions attached to the approval of a NF drug and feedback to the DTC Chair after the initial approval period, so that prescribing practice outwith the formulary can be monitored and, if required, approval for ongoing treatment obtained.

2.2.13Repeated requests (more than three in one year from the same consultant) for the same non-formulary medicine will necessitate a submission for Formulary inclusion (see above).

2.2.14General Practitioners in SWL observe the same medicines formulary as the Trust, hence they must not be asked to prescribe non-formulary (NF) medicines as a means of circumventing Trust policy. Any such request will invariably be reported back to the Trust via the CCG as all GPs use software on their e-prescribing systems which immediately flags up the use of a NF medicine. If prescribers wish a GP to start or continue the prescribing of a NF medicine, for which DTC permission has been given, this should be mentioned in the clinical letter to avert the possibility of such areport being made.

2.2.15SOADs must not be asked by the responsible clinician to support or recommend the prescribing of NF medicines as a means of circumventing Trust policy.

2.3Request to use unlicensed medicines and off-label use of licensed medicines

2.3.1The prescribing of UMPs within the Trust may only be initiated by a consultant psychiatrist, unless included in the Trust Mental Health Drugs Formulary.

2.3.2UMPs and OLMPs should only be used where there is no suitable alternative product licensed in the U.K and, before considering the prescription of an UMP or OLMP, doctors should assure themselves that there is a responsible body of medical opinion supporting their use of the drug. Where this may be in doubt, discussing the matter with senior colleagues, either/both within or/and outside the Trust, may be appropriate. Any such discussions must be recorded on the application forms.

2.3.3Approval for all proposed unlicensed and off-label prescribing should be sought by the prescriber from the Drugs and Therapeutics Committee, with supporting information, before use. If the committee feels that the supporting information is insufficient, and that the prescribing could be regarded as experimental, then it may recommend that a clinical trial should be considered.