NHS QIS & NICE Advice defi nitions & status
NHS Quality Improvement Scotland 2006 First published August 2006 You can copy or reproduce the information in this document for use within NHSScotland and for educational purposes. You must not make a profit using information in this document. Commercial organisations must get our written permission before reproducing this document. www.nhshealthquality.org
Contents 1 NHS QIS Standards 1 2 SIGN Clinical Guidelines 2 3 NHS QIS Health Technology Assessments (HTAs) 3 4 NHS QIS Best Practice Statements 4 5 NHS QIS Evidence Notes 5 6 SMC Advice 6 7 NICE Multiple Technology Appraisals (MTAs) 7 8 NICE Single Technology Appraisals (STAs) 8 9 NICE Interventional Procedures Programme (IPP) Guidance 9 10 NICE Clinical Guidelines 10 11 Confidential Enquiries 11 12 Clinical Guidelines 12 Appendix I Summary 13
This document is provided as guidance to NHSScotland from NHS Quality Improvement Scotland (NHS QIS) on its products and other relevant documents and advice. This document will be reviewed by June 2007. 1 NHS QIS Standards Source & Target Audience NHS QIS Standards Development Team Target audience - Health professionals NHS management, public Definition and Comments Standards are statements of levels of performance that patients should expect from NHSScotland. They are based on evidence relating to clinical practice, feasibility and service provision that is responsive to patients needs and views. They cover the key issues relating to the provision of safe, effective and patient-focused care and treatment. NHS QIS standards apply to all parts of NHSScotland. Those that are labeled essential are to be met wherever the service is provided. Those that are desirable are developmental in that they are met in some parts of the service and demonstrate levels of performance which other providers of a similar service should strive to achieve. Status in Scotland Essential standards are obligatory and desirable standards are recommended for NHSScotland.
2 SIGN Clinical Guidelines Source & Target Audience SIGN Target audience - Health professionals NHS management, public Definition and Comments Clinical guidelines have been defined as systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances. Guidelines are tools for making decisions in health care more rational, for improving the quality of health care delivery and for strengthening the position of the patient. SIGN has the responsibility to produce clinical guidelines for NHSScotland. The evidence-based guidelines developed by SIGN are derived from a systematic review of the scientific evidence followed by the considered judgement of the guideline development group. SIGN guidelines provide recommendations for effective and safe practice in the management of clinical conditions where variations in practice are known to occur and where effective care may not be delivered uniformly throughout Scotland. Status in Scotland SIGN guidelines are recommended for NHSScotland and should be taken into account when services are being developed. Implementation of SIGN guidelines is the responsibility of NHS Boards and their operating divisions, reinforced by the twin levers of clinical governance and NHS QIS. SIGN guidelines provide the evidence base for many of the standards developed by NHS QIS. When elements of SIGN guidelines are incorporated into NHS QIS essential standards, they are obligatory.
3 NHS QIS Health Technology Assessments (HTAs) Source & Target Audience NHS QIS Health Services Research & Assessment Unit Target audience Policy makers, health professionals NHS management Definition and Comments NHS QIS informs local and national decisions by providing advice on the clinical and cost effectiveness of new and existing health technologies. The term health technology (intervention) is used internationally and includes drugs, devices, procedures and modes of intervention used in prevention, diagnosis, treatment or rehabilitation of health conditions. HTAs consider the medical, social, ethical and economic implications of the development, diffusion and use of health technology. They aim to provide rigorous and timely advice that is of practical use to decision makers at all levels about value for money and the resources required for implementing HTA recommendations. The HTA report is the scientific document that discusses the evidence and supports the recommendations. It assesses the clinical effectiveness, economic evaluation, organizational issues and patients issues on a health technology. Status in Scotland HTAs are recommended for NHSScotland which should take account of the advice and ensure that recommended drugs and treatment are made available to meet clinical need. Understanding Our Advice is a shorter easy to read booklet for nonhealth professionals.
4 NHS QIS Best Practice Statements Source & Target Audience NHS QIS Practice Development Unit Target audience - Health professionals (particularly nurses, midwives and allied health professionals) Definition and Comments Best Practice Statements focus on nursing, midwifery and allied health professional practice. They describe best and achievable practice in a specific area of care. Best Practice Statements reflect the current emphasis on delivering care that is patient-centred, feasible and fair, and attempt to reduce existing variations in practice. The common practice that should follow their implementation will allow comparable standards of care for patients wherever they access services. The term best practice reflects the commitment of NHS QIS to sharing local excellence at national level. Best Practice Statements are endorsed by the Chief Nursing Officer as a tool for nurses, midwives and other health professionals in implementing change or improving care. Status in Scotland Best Practice Statements are recommended good practice for NHSScotland.
5 NHS QIS Evidence Notes Source & Target Audience NHS QIS Health Services Research & Assessment Unit Target audience - health professionals (particularly health planners) Definition and Comments Evidence Notes are short summaries which highlight key issues for health service planners and practitioners and direct them to robust sources of evidence (or lack of evidence) on a particular topic or clinical area which is believed important for NHSScotland. They are used to inform decision making by health planners. Status in Scotland Evidence Notes do not make recommendations for NHSScotland.
6 SMC Advice Source & Target Audience SMC Target audience - NHS management, Area Drug and Therapeutics Committees Definition and Comments The remit of the Scottish Medicines Consortium (SMC) is to provide advice to NHS Boards and their Area Drug and Therapeutics Committees (ADTCs) across Scotland about the status of all newly licensed medicines, all new formulations of existing medicines and any major new indications for established products (licensed from January 2002). This advice is made available as soon as practical after the launch of the product involved. SMC excludes the assessment of vaccines, branded generics, non-prescription-only medicines (POMs), blood products, plasma substitutes and diagnostic drugs. The review of device-containing medicines is confined to those licensed as medicines by the Medicines and Health Products Regulatory Agency (MHRA)/ European Medicines Evaluation Agency (EMEA). The SMC process requires pharmaceutical companies to complete a New Product Submission form. To make a recommendation soon after the launch of a product requires the submission to be made ahead of product launch. The status of SMC advice is set out in a Health Department Letter (HDL), HDL (2003) 60 and a subsequent HDL on single technology appraisals in HDL (2006) 29 issued on 12 May 2006. Status in Scotland SMC review is mandatory for newly licensed medicines and provides the advice on newly licensed medicines in Scotland. Unique drugs accepted for use for specific conditions are obligatory and must be introduced in NHSScotland to an agreed national programme. Drugs accepted for use for conditions where alternative drug treatments already exist are subject to local NHS Board decisions. Normally a NICE Multiple Technology Appraisal of a drug supersedes the SMC advice on the drug. See Section 7 NICE Multiple Technology Appraisals and Section 8 NICE Single Technology Appraisals.
7 NICE Multiple Technology Appraisals (MTAs) Source & Target Audience NICE Target audience - Health professionals NHS management, public Definition and Comments NICE multiple technology appraisals (MTAs) provide recommendations on the use of new and existing medicines and treatments within the NHS in England and Wales, such as: medicines medical devices e.g. hearing aids or inhalers diagnostic techniques surgical procedures e.g. repairing hernias health promotion activities e.g. ways of helping people with diabetes manage their conditions. NHS QIS processes each MTA involving one Scottish expert on each MTA throughout the whole process, and an expert group of 4-5 to review the draft NICE MTA. Status in Scotland For NHS QIS-validated MTAs, NHSScotland should take account of the advice from NHS QIS and ensure that recommended drugs and treatment are made available to meet clinical need. Email alert sent to NHSScotland at time of NICE MTA publication advising whether MTA is valid for Scotland or not. 1 If the MTA is deemed to be valid for Scotland, the status is the same as for NHS QIS HTAs above. There is no three month timeframe for implementation as there is for MTAs in England and Wales. 2 If the MTA is deemed not valid for Scotland, the status is discussed with Scottish Executive Health Department. Footnote In England the status of NICE technology appraisals is that NHS organisations should fund and resource medicines and treatments recommended, usually within three months of NICE issuing guidance.
8 NICE Single Technology Appraisals (STAs) Source & Target Audience NICE Target audience - Health professionals NHS management, public Definition and Comments From mid-2006, NICE will start to publish single technology appraisals (STAs). This is a new, rapid process for assessing drugs and other treatments to sit alongside its standard process. The process for evaluating drugs is similar to SMC. The STA process covers all health technologies and will enable single new drugs, and existing drugs with new indications to be assessed more rapidly than the NICE MTA. Consequently, it will produce faster guidance for England and Wales on a small number of selected drugs chosen by the Department of Health which have already been, or are close to being, licensed. Under the new STA process NICE will ask for a single submission of evidence from the drug s manufacturer, carry out an independent assessment of this evidence, and move quickly to the final (appeal) stage of the process where the draft recommendations are in line with the licence. Status in Scotland SMC remains the source of advice for newly licensed medicines. NICE STAs have no formal status in Scotland and are for information only for NHSScotland. For NHSScotland, there is no change to the status quo and SMC will remain the main source of advice in Scotland for the use of newly licensed medicines under the terms of the Health Department Letter (HDL (2003) and subsequent HDL (2006) 29 issued on 12 May 2006. The publication of NICE STAs will be monitored, and their impact assessed, by NHS QIS, SMC and SEHD. The status of NICE STAs will be reviewed after the first 15 NICE STAs are published. Footnote In England the status of NICE technology appraisals is that NHS organisations should fund and resource medicines and treatments recommended, usually within three months of NICE issuing guidance.
9 NICE Interventional Procedures Programme (IPP) Guidance Source & Target Audience NICE Target audience - Health professionals NHS management, public Definition and Comments NICE makes recommendations about whether interventional procedures used for diagnosis or treatment are safe enough and work well enough for routine use. An interventional procedure is a procedure used for diagnosis or treatment that involves one of the following: Making a cut or a hole to gain access to the inside of a patient s body - for example, when carrying out an operation or inserting a tube into a blood vessel. Gaining access to a body cavity (such as the digestive system, lungs, womb or bladder) without cutting into the body - for example, examining or carrying out treatment on the inside of the stomach using an instrument inserted via the mouth. Using electromagnetic radiation (which includes X-rays, lasers, gamma-rays and ultraviolet light) - for example, using a laser to treat eye problems. Most of the procedures NICE looks at are new. Exceptionally, NICE may be asked to issue urgent guidance where new evidence raises questions about the safety or efficacy of an established procedure. Where guidance is needed urgently, NICE may issue interim guidance. When NICE issue interim guidance, it will usually go on to issue final guidance at a later date following a fuller review of the evidence. In January 2004, Scotland became a full participant in IPP (see HDL (2004) 4) and Scotland is included in the circulation of IPP guidance directly from NICE. NHS Boards and their operating divisions should check whether NICE has issued guidance before carrying out a new procedure. If NICE has not issued guidance, seek approval through their Board s clinical governance arrangements and ensure that patients have given informed consent before carrying it out. Status in Scotland It is obligatory for NHSScotland to follow NICE IPP guidance if these procedures are provided by NHS Boards. Footnote In England NHS organisations should check whether NICE has issued guidance before carrying out a new procedure. If NICE has not issued guidance, they should seek approval from their NHS trust s clinical governance committee and ensure that patients have given informed consent before carrying it out.
10 NICE Clinical Guidelines Source & Target Audience NICE Target audience - Health professionals NHS management, public Definition and Comments NICE clinical guidelines are recommendations on the appropriate treatment and care of people with specific diseases and conditions within the NHS in England and Wales. Clinical guidelines are based on the best available evidence. Guidelines help healthcare professionals in their work, but they do not replace their knowledge and skills. Some NICE clinical guidelines have been considered in Scotland on an ad hoc basis e.g. multiple sclerosis, fertility assessment and treatment, and caesarean section. Status in Scotland No formal status in Scotland. Footnote In England the status of NICE clinical guidelines is that NHS organisations should review current management of clinical conditions and consider the resources and time need to implement the guidelines. 10
11 Confidential Enquiries Source & Target Audience NPSA Target audience - Health professionals, NHS management Definition and Comments The National Patient Safety Agency (NPSA) has had responsibility for the three confidential enquiries from April 2005. The three confidential enquiries carry out research into the way patients are treated to identify ways of improving the quality of care 1.Confidential Enquiry into Maternal and Child Health (CEMACH) (formerly Confidential Enquiry into Maternal Deaths (CEMD) and Confidential Enquiry into Stillbirths and Deaths in Infancy (CESDI)) covers England, Northern Ireland, Wales, and Scotland. Participation in CEMD only is funded by NHS QIS through the Scottish Programme for Clinical Effectiveness in Reproductive Health (SPCERH). 2.National Confidential Enquiry into Patient Outcome and Death (NCEPOD) (formerly the National Confidential Enquiry into Perioperative Deaths) England, Northern Ireland & Wales. NCEPOD does not operate in Scotland but has links with the Scottish Audit of Surgical Mortality (SASM). SASM audits deaths associated with surgery in Scotland. Status in Scotland Results of confidential enquiries are recommendations and should assist and inform both health professionals regarding their practice and NHSScotland in its local decisions regarding healthcare provision. 3.National Confidential Inquiry into Suicide and Homicide by People with Mental Illness (NCISH) covers England, Northern Ireland, Scotland (funded directly by SEHD) & Wales. The Confidential Enquiries publish reports summarising key findings and recommendations arising from the information they gather. They aim to identify changes in practice that might improve the quality of clinical practice and reduce the number of deaths. Footnote In England the status of Confidential Enquiries is the same as in Scotland. 11
12 Clinical Guidelines Source & Target Audience Various professional and other organisations Target audience Health professionals Definition and Comments Many professional organisations (such as Royal Colleges, special interest groups and overseas guideline agencies) develop guidelines and make recommendations for clinical practice. The methodology used in the production of such guidelines may be systematic or consensus based. There are no current quality assurance mechanisms in place to assess such guidelines. They may be influential in the management of many conditions. Status in Scotland No formal status in Scotland. Footnote In England, as in Scotland, these clinical guidelines have no formal status. 12
Appendix I Summary NHS Quality Improvement Scotland (NHS QIS) is a Special Health Board responsible for improving the quality of healthcare delivered by NHSScotland. In summary the role of NHS QIS is to: Provide advice and guidance to NHSScotland on effective clinical practice. Set clinical and non-clinical standards of care. Review and monitor the performance of NHSScotland. Support NHS staff in improving services. Promote patient safety and implementation of clinical governance. The last addition to NHS QIS was the Scottish Intercollegiate Guidelines Network (SIGN) which joined in January 2005. The Scottish Health Council and the Scottish Medicines Consortium (SMC) are part of the NHS QIS family but their work and recommendations are independent of NHS QIS. These organisations, along with similar organisations such as the National Institute of Health and Clinical Excellence (NICE) within the UK, produce a number of publications that enable NHSScotland to achieve its goals of providing improved and quality healthcare. These publications can be categorised generally as: Standards Health technology assessments (HTAs) Best Practice Statements (BPSs) Evidence Notes (ENs) SMC recommendations SIGN Clinical Guidelines NICE Multiple Technology Appraisals (MTAs) and Single Technology Appraisals (STAs). Each of these publications has a specific remit and is targeted at specific audiences, including health policy makers, NHS management, health professionals and the public. The scope, purpose and authority of these publications vary as outlined in the table. The status of the recommendations varies, for example, from obligatory for SMC advice for unique drugs, or an expectation that all NHS boards have essential clinical governance arrangements in place for new interventional procedures, or that NHS boards should take account of advice from HTA reports and NICE multiple technology appraisals to ensure that recommended drugs or treatments are made available to meet clinical need. Clinical Guidelines, Evidence Notes and Best Practice Statements influence the implementation of new or revised clinical strategies to raise the standards of healthcare delivery in Scotland. 13
NHS QIS Advice: Definitions and Status Summary Table Publication Source Target audience NHS Quality Improvement Scotland (NHS QIS) - the target audience is in Scotland 1. Standards NHS QIS - Standards Development Team Health professionals, NHS management, public 2. SIGN Clinical Guidelines SIGN Health professionals, NHS management, public 3. HTAs NHS QIS - Health Services Research & Assessment Unit Policy makers, NHS management, health professionals 4. Best Practice Statements NHS QIS - Practice Development Unit Health professionals (particularly nurses, midwives & allied health professionals) 5. Evidence Notes NHS QIS - Health Services Research & Assessment Unit Health professionals (particularly health planners) Scottish Medicines Consortium (SMC) - the target audience is in Scotland 6. SMC Advice SMC NHS Boards, Area Drug & Therapeutics Committees 14
Definition, remit and status in Scotland Standards are statements of performance patients should expect from NHSScotland and are applicable to all parts of NHSScotland. Essential standards are expected to be met wherever the service is provided, and desirable standards are recommended for NHSScotland. Recommendations for effective practice to be taken into account when services are developed for the management of clinical conditions where variations in practice are known to occur and where effective care may not be delivered uniformly throughout Scotland. When elements of SIGN guidelines are incorporated into NHS QIS essential standards, they are obligatory. HTAs report the clinical effectiveness, economic implications, organisational impact and patients issues with regards to health technologies/medicines. HTAs are recommended for NHSScotland which should take account of the advice from NHS QIS and ensure that recommended treatments are made available. Focusing specifically on nursing, midwifery & allied health professions. BPSs describe best and achievable practice in specific areas of care emphasising delivering care that is patient centered, feasible and fair, and attempt to reduce existing variations in practice. Best Practice Statements are endorsed by the Chief Nursing Officer and are recommended good practice for NHSScotland. Evidence notes do not make recommendations for NHSScotland; they are short summaries which highlight key issues for health service planners and practitioners and direct them to robust sources of evidence (or lack of evidence) on a particular topic or clinical area which is believed important for NHSScotland. They are used to inform decision making by health planners. Recommendations on the use of all newly licensed medicines, all new formulations of existing medicines and any major new indications for established products. NHS Boards are required to follow SMC recommendations and ensure that unique drugs accepted for use by SMC are available uniformly within 3 months of the publication or within timeframes specified in national implementation plans. SMC review is mandatory for newly licensed medicines; recommendations can be available for launch. The status of SMC advice is set out in a Health Department Letter (HDL), HDL (2003) 60 and a subsequent HDL on single technology appraisals in HDL (2006) 29 issued on 12 May 2006. 15
NHS QIS Advice: Definitions and Status Summary Table continued Publication Source Target audience National Institute for Health and Clinical Excellence (NICE) - the target audience is in England and Wales, and Scotland where appropriate (NICE MTAs and IPP guidance) 7. Multiple Technology Appraisals (MTAs) NICE Health professionals, NHS management, public 8. Single Technology Appraisals (STAs) NICE Health professionals, NHS management, public 9. Interventional Procedures Programme (IPP) Guidance NICE Health professionals, NHS management, public 10. Clinical Guidelines NICE Health professionals, NHS management, public National Patient Safety Agency (NPSA) - for confidential enquiries the target audience varies and is usually in England, Wales and Northern Ireland, and Scotland if it participates in the enquiry 11. Confidential Enquiries NPSA Health professionals, NHS management Other 12. Clinical Guidelines Various professional & other organisations Health professionals 16
Definition, remit and status in Scotland Recommendations on the use of new and existing medicines and treatments within the NHS in England and Wales. Scottish expert is usually involved in each NICE MTA, and a Scottish expert group of 4-5 reviews the draft appraisal. For NHS QIS-validated MTAs, NHSScotland should take account of the advice and evidence from NHS QIS and ensure that recommended drugs and treatment are made available to meet clinical need. SMC remains the main source of advice in Scotland for the use of newly licensed medicines under the terms of the Health Department Letter (HDL (2003) 60) issued in November 2003 and a subsequent HDL on single technology appraisals in HDL (2006) 29 issued on 12 May 2006. However, the publication of NICE STAs will be monitored, and their impact assessed, by NHS QIS, SMC and SEHD. The status of NICE STAs will be reviewed after the first 15 NICE STAs are published. Recommendations on whether interventional procedures used for diagnosis or treatment are safe and efficacious for routine use in the NHS. NHSScotland is a full participant in IPP. NHS Boards and their operating divisions should check whether NICE has issued guidance before carrying out a new procedure. If NICE has not issued guidance, seek approval through their Board s clinical governance arrangements and ensure that patients have given informed consent before carrying it out. It is obligatory to follow IPP guidance if those procedures are provided by NHS Boards. Recommendations on the appropriate treatment and care of people with specific diseases and conditions within the NHS in England and Wales. No formal status within Scotland as SIGN has the responsibility to produce clinical guidelines for NHSScotland. Some NICE clinical guidelines have been considered on an ad hoc basis. Confidential Enquiries aim (through research and audit) to identify changes in practice that might improve the quality of clinical practice and reduce the number of deaths. Reports summarise key findings and recommendations arising from the information they gather to assist and inform both health professional regarding practice, and the NHS in its local decisions regarding healthcare provision. Guidelines developed by professional and other organisations (international, European & British) with recommendations for clinical practice. They have no formal status but may be influential in the management of many conditions. 17
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