TRUST POLICY FOR PRODUCTION OF DRUG THERAPY GUIDELINES Version 6 Name of responsible (ratifying) committee Formulary & Medicines Group Date ratified 18th July 2014 Document Manager (job title) Guidelines Pharmacist Date issued 07th August 2014 Review date 06th August 2016 Electronic location Clinical Policies Related Procedural Documents Key Words (to aid with searching) Version Tracking Version Date Ratified Brief Summary of Changes Author 6 18.07.2014 No content changes. Layout and spelling corrections only. M. Bennett-Marsden 5 18.1.2013 Updated to reflect new guidelines pharmacist role/s M. Bennett-Marsden Trust policy for the production of drug therapy guidelines: Version 6 Review date: 06/08/2016 Issue Date: 07/08/2014 Page 1 of 6 CONTENTS QUICK REFERENCE GUIDE....................................................................................................... 3 1. INTRODUCTION.......................................................................................................................... 3 2. PURPOSE ................................................................................................................................... 3 3. SCOPE ........................................................................................................................................ 3 4. DEFINITIONS .............................................................................................................................. 3 5. DUTIES AND RESPONSIBILITIES .............................................................................................. 3 6. PROCESS ................................................................................................................................... 4 7. TRAINING REQUIREMENTS ...................................................................................................... 4 8. REFERENCES AND ASSOCIATED DOCUMENTATION ............................................................ 4 9. EQUALITY IMPACT STATEMENT .............................................................................................. 5 10. MONITORING COMPLIANCE WITH AND EFFECTIVENESS OF THE POLICY ......................... 5 Trust policy for the production of drug therapy guidelines: Version 6 Review date: 06/08/2016 Issue Date: 07/08/2014 Page 2 of 6 QUICK REFERENCE GUIDE This policy describes the process for the preparation, approval, publication, audit and review of Portsmouth Hospitals NHS Trust Drug Therapy Guidelines. 1. Drug Therapy Guidelines are developed in order to improve patient safety and limit risk by provision of concise, structured, evidence-based clinical and pharmaceutical information on a range of medicines management topics relevant to the treatment of patients under the care of practitioners working for Portsmouth Hospitals NHS Trust. 2. Information on relevant adverse incidents will be reported to the specified Guideline Project Manager for action and will be considered in the production of new or revised Drug Therapy Guidelines. This does not negate the need for the document author and others involved in the process to be aware of and follow the detail of this policy. 1. INTRODUCTION The Policy for the Production of Drug Therapy Guidelines covers the processes involved in the preparation, approval, publishing, audit and review of Portsmouth Hospitals NHS Trust Drug Therapy Guidelines. 2. PURPOSE The purpose of this policy is to ensure the consistent preparation, approval, publishing, audit and review of Drug Therapy Guidelines. 3. SCOPE This policy applies to all Portsmouth Hospitals NHS Trust staff involved with the preparation of Drug Therapy Guidelines. ‘In the event of an infection outbreak, flu pandemic or major incident, the Trust recognises that it may not be possible to adhere to all aspects of this document. In such circumstances, staff should take advice from their manager and all possible action must be taken to maintain ongoing patient and staff safety’ 4. DEFINITIONS Drug Therapy Guidelines: Guidance documents prepared to assist healthcare staff in the safe prescribing, preparation, control and administration of medicines for specific clinical conditions. 5. DUTIES AND RESPONSIBILITIES Guideline Project Manager A member of pharmacy staff will be designated by the Clinical Pharmacy Manager to manage the process of development of a Drug Therapy Guideline, including establishing and leading a Guideline Development Group and ensuring that the requirements of this policy are adhered to. Guideline Development Group A group will be established by the Guideline Project Manager to develop the content of the proposed Drug Therapy Guideline including review of evidence and undertaking consultation with intended users of the guideline and other relevant stakeholders. The Guideline Development Group should be multidisciplinary and include members with experience and expertise in the relevant area. Trust policy for the production of drug therapy guidelines: Version 6 Review date: 06/08/2016 Issue Date: 07/08/2014 Page 3 of 6 Ratifying body The PHT Formulary and Medicines Group will be responsible for the approval of Drug Therapy Guidelines. The Guideline Project Manager will submit the draft Drug Therapy Guideline together with the completed form PHPS07001 (see below) detailing the process of development, consultation and preparation of the guideline. The Formulary and Medicines Group will check that the draft Drug Therapy Guideline • is based on the best available evidence and is technically accurate • is not discriminatory along the adult age continuum, unless there is clear evidence for agedefined contra-indication and this is recorded. • is discriminatory for paediatrics if appropriate; • has undergone multi-disciplinary consultation with the relevant stakeholders The Formulary and Medicines Group will record ratification of the Drug Therapy Guidelines in the meeting notes, together with any conditions e.g. agreed minor amendments to be made prior to publication. If more than minor changes are required the Formulary and Medicines Group may request that a revised draft is presented to the committee for ratification. The required amendments will be documented in the meeting notes. The development, ratification and publication of all other Trust procedural documents is detailed in the Trust Procedural Documents Development and Management Policy. 6. PROCESS The actions to be taken to comply with this policy are described in PHPS Work Instruction PHPSWI07001 All Drug Therapy Guidelines will follow the format specified in this Work Instruction. The Guideline Project Manager will document the development of the Drug Therapy Guideline on form PHPSF07001 including the sources of information and all references used and the methods used to interpret and assess the strength of evidence for the key recommendations. In particular there should be an explicit link between major recommendations and the level of supporting evidence. The methods used to formulate the recommendations will be documented including how the views of stakeholders not on the Guideline Development Group were taken into account. An equality impact assessment will be carried out and documented in PHPSF07001 Following ratification by the Formulary and Medicines Group the Guideline Project Manager will make any necessary amendments and prepare a final version ready for publishing. This will be passed to the guidelines pharmacist for publishing on the intranet in accordance with PSWI021. 7. TRAINING REQUIREMENTS All personnel involved in the development, ratification and publication of Drug Therapy Guidelines must be aware of this policy. There are no specific training requirements. 8. REFERENCES AND ASSOCIATED DOCUMENTATION Portsmouth Hospitals NHS Trust Procedural Documents Development and Management Policy. Portsmouth Hospitals Pharmacy Service Work Instruction PHPSWI07001 Portsmouth Hospitals Pharmacy Service Form PHPSF07001 Trust policy for the production of drug therapy guidelines: Version 6 Review date: 06/08/2016 Issue Date: 07/08/2014 Page 4 of 6 9. EQUALITY IMPACT STATEMENT Portsmouth Hospitals NHS Trust is committed to ensuring that, as far as is reasonably practicable, the way we provide services to the public and the way we treat our staff reflects their individual needs and does not discriminate against individuals or groups on any grounds. This policy has been assessed accordingly 10. MONITORING COMPLIANCE WITH AND EFFECTIVENESS OF THE POLICY The Formulary and Medicines Group will ensure that any Drug Therapy Guidelines submitted for ratification comply with the requirements of this policy and may refuse to approve the publication of any Drug Therapy Guidelines that have not been developed in accordance with this policy. The Formulary and Medicines Group will require the submission of PHPSF07001 together with the draft guideline to provide assurance that the Drug Therapy Guideline has been developed (or reviewed, in the case of previously published Drug Therapy Guidelines) in line with this policy. Trust policy for the production of drug therapy guidelines: Version 6 Review date: 06/08/2016 Issue Date: 07/08/2014 Page 5 of 6 Appendix 1 Drug Therapy Guideline Template (Renal/Paed*) Drug Therapy Guideline No Issued: date posted on intranet TITLE Subject (alphabetical search) Introduction This guidance supports The objectives of this guideline are This guideline applies to all (specify any restrictions to patient group) patients under the care of practitioners working for Portsmouth Hospitals NHS Trust. Recommendations Subheading Subheading Content text … Key References Evidence Base Name, Post manages this guideline (ext XXXX) See Trust Policy for the Production of Drug Therapy Guidelines Approved by: Formulary & Medicines Group Review date: (+2yrs unless otherwise stated) Date Page x of y Control date: insert date that rolls over each day Trust policy for the production of drug therapy guidelines: Version 6 Review date: 06/08/2016 Issue Date: 07/08/2014 Page 6 of 6