Lecture 7: NICE: National Institute for Health and Care Excellence

Which guidance is likely to be relevant to pharmacy practice?

(All of the above) i.e. public health guidance, clinical guidelines, technology appraisals, medical devices and diagnostics

Case Study 4) A 62 year-old male lorry driver has come in for elective hip replacement. How should he be managed?

*AT ADMISSION* -Offer mechanical VTE prophylaxis with any one of: -->anti-embolism stockings (thigh or knee length), used with caution -->foot impulse devices -->intermitten pneumatic compression devices (thigh or knee length) -Continue until patient's mobility no longer significantly reduced. *1-12 HOURS AFTER SURGERY* -Provided there are no contraindications, offer pharmacological VTE prophylaxis -Choose one of: -->dabigatran, started 1-4 hours after surgery -->fondaparinux, started 6 hours after surgical closure, provided haemostasis has been established -->LMWH (or UFH21), started 6-12 hours after surgery -->rivaroxaban, started 6-10 hours after surgery. Continue pharmacological VTE prophylaxis for 28-35 days.

How can quality standards be used?

-As a *PROVIDER* of care: can use NICE guidance + quality standards to ensure and demonstrate that you provide high quality care, based on the best available evidence -As a *USER* of care services: they support you in choices about who provides care for you, and in knowing what to expect from a good quality care service -As a *COMMISSIONER* (with commissioning services using NICE quality standards): promotes integration of health + social care, and can support you in ensuring the services you provide in commission are high quality

Core principles of NICE's work

-Based on best available evidence of what works and what it costs -Independent and unbiased expert committees -Patient, service user and carer involvement -Genuine consultation -Regular review -Open & transparent process -Social values & equity considerations

What guidance, standards and advice (on safe and effective care) NICE produce:

-Clinical guidelines -Public health -Social care -Interventional procedures -Technology appraisals -Medical technologies -Diagnostics -Highly specialised technologies -Medicines practice -Quality Standards

The *importance* of NICE guidance to patients, service users and carers

-Confidence in the clinical system, staff looking after me, -Understand what treatment to expect -Better patient experience and outcomes -Empowers people to make choices about their own care

Case Study 3) The obstetric team are reviewing their policy on pre-admission advice for women due to be admitted for an elective caesarean and ask you to advise on the drugs they should be using for VTE prevention. How would you respond?

-Consider offering combined VTE prophylaxis with mechanical methods and lMWH (or UFH for patients with renal failure) to women who are pregnant or have given birth within the previous 6 weeks who are undergoing surgery, including caesarean section. -Offer mechanical and/or pharmacological VTE prophylaxis to women who are pregnant or have given birth within the previous 6 weeks only after assessing the risks and benefits and discussing these with the women and with healthcare professionals who have knowledge of the proposed method of VTE prophylaxis during pregnancy and post partum. Plan when to start and stop pharmacological VTE prophylaxis to minimise the risk of bleeding.

Case Study 5) 79 year-old woman, previously health, dances and physically and mentally sound in for an elective day-case hand operation. What should she be offered?

-Do not routinely offer VTE prophylaxis -After assessing risks and discussing with patient: -->consider offering mechanical VTE prophylaxis -->consider offering LMWH (or UFH23) 6-12 hours after surgery. -Is all day-case surgery exempt?

The *importance* for health professional

-Guides practice -Brings together what the research tells us in the context of what is already known -Pragmatic approach to clinical problems seen every day -Helps me to keep my practice up to date-PROFESSIONAL REGULATION! -Health professionals should take NICE guidance into account when deciding what treatments to give people

Medicines and Prescribing

-NICE offers guidance and advice for delivering quality, safety and efficiency in the use of medicines -Guidance + advice on medicines management, optimisation and use (*medicines practice guides*) -Specific medicines advice e.g. new, unlicensed and off-label medicines and medicines and prescribing briefings (*evidence summaries*) -A *network of associates* who work with organisations and individuals at a local level -A *medicines awareness service*, including commentaries and alerts, and NHS access to the *BNF*

Assessing Cost Effectiveness

-Probability of rejection increases with Cost per QALY (exponentially)

Case Study 1) 49 year-old man with BMI of 45 admitted for elective bariatric surgery. He has no additional bleeding risks. The local protocol advises that he is likely to have reduced mobility for 5-7 days. The junior doctor asks for your advice?

-Should have mechanical prophylaxis on admission -Fondaparinux or LMWH (stop when mobility reduced)

Case Study 2) 64 year-old man, previously healthy, was admitted to hospital this morning, with an acute thrombotic stoke. He's unable to speak, lacks fine motor control and move his lower limbs. He hasn't seen his GP for many years and takes no regular medication. You're the clinical pharmacist on the stoke unit and the junior doctor asks for your advice about VTE prevention-what should you recommend?

-VTE risk assessment done? -LMWH Rx?

The *process* NICE follows

1) Topical selection 2) Referral to NICE 3) Scope 4) Draft guidance 5) Consultation 6) Final guidance 7) Opportunity for appeal 8) Review, usually every 3 hours (whole process=6-24 months)

Who decides what NICE will recommend?

=Independent committees of experts

-->Medicines practice guidelines

=NICE offers guidance, advice and support for delivering quality, safety + efficiency in the use of medicines *PUBLISHED*: -developing and updating local formularies -patient group directions (PGDs) -antimicrobial stewardship *IN DEVELOPMENT*: -the safe use and management of controlled drugs (March 2016)

-->Clinical guidelines

=Set out the appropriate clinical care for patients with a *specific* disease or condition. E.g. diabetes, hypertension and thematic topics such as medicines adherence. -Clinical and cost effectiveness -Provide recommendations, based on evidence, on how you best identify, refer, diagnose, treat and manage patients -Are *advisory* rather than compulsory, but should be taken into account by clinicians when planning care for individual patients

Which guidance is the NHS legally required to implement IN ENGLAND?

=Technology appraisals

Quality Standards for Quality Improvement

=They don't restate regulatory requirements or national minimum standards. Where there is overlap, statements are mutually supportive and complementary

What is NICE?

=World leader in setting national standards for high quality care (health + social care) and promoting healthy living -April 2013, renamed CARE -Evidence-based guidance and other products from NICE resolve uncertainty about best quality care and what represents value for money

Quality Adjusted Life Years (QALYs)

=combines both quantity and health-related quality of life (QoL) into a single measure of health gain -gives a "common currency" -QoL (utility) determined using validated questionnaires -conversion to numerical utility values reflecting preferences over health (INSERT PIC OF GRAPH!!!)

-->Interventional procedure guidance

=considers whether a procedure used for diagnosis or treatment is safe and works well enough to be used routinely -safety and efficacy -protects patient's safety and supports healthcare staff to introduce new treatments and tests into practice in a responsible way -covers procedures used for diagnosis or treatment that involves: -->making cut/hole to gain access to inside of patient's body -->gaining access to a body cavity (e.g. stomach) WITHOUT cutting into body -->using electromagnetic radiation -mainly considers new procedures but might look at more established procedures if uncertainty about their safety or how well they work

-->Diagnostics guidance

=helps the NHS in the adoption of clinically and cost effective medical diagnostic technologies -efficacy + cost effectiveness of innovative medical diagnostic technologies that have potential to improve key clinical decisions, which lead to improved treatment choice or improvements to quality of life -covers all types of measurements and tests that are used to evaluate a patient's conditions, such as laboratory and pathology tests, imaging, physiological measurements and endoscopy -supports the adoption of clinically and cost effective innovative medical diagnostic technologies into practice quickly

-->Medical technology guidance

=makes recommendations about the benefits for patients and for the NHS o new or novel medical technologies -e.g. medical devices that deliver treatment such as those implanted during surgical procedures, technologies that give greater independence to patients, and diagnostic devices or tests used to detect or monitor medical conditions -looks at the 'case for adoption'. Evaluates the claimed benefits and recommends use if the technology offers advantages to patients and/or the NHS, including saving resources -the claimed benefits, if the NHS were to adopt the product in place of standard care, are reviewed against the evidence submitted and expert advice

-->Public Health Guidance

=makes recommendations aimed at preventing ill health and encouraging people to live a health and active lifestyle. E.g. smoking cessation, skin cancer prevention, needle and syringe programmes -assesses how effective and cost-effective activities, policies and strategies are in preventing disease or improving health using the most up to date evidence -may focus on a particular topic (e.g. smoking), a particular population (such as pregnant women) or a particular setting (such as schools) -aimed at all professionals, commissioners and providers with a direct or indirect role in public health, not only in NHS but in local authorities, wider public, voluntary, community and private sectors.

-->Social care guidance

=provide recommendations on 'what works' in terms of both the effectiveness and cost-effectiveness of social care interventions and services *PUBLISHED*: -managing medicines in care homes -social care of older people with multiple long-term conditions *IN DEVELOPMENT*: -transition between inpatient hospital settings and community or care home settings for adults with social care needs

Economic Evaluation

=the comparitive analysis of alternative courses of action in terms of both their costs and consequences -costs=value of extra resources used (loss to other patients) -consequences=value of health gain for this patient group

Dilemma of a clinician

Balance between *Responsibility to INDIVIDUAL*: -individual patient's best interest, -no considerations of opportunity costs, -patient centered care AND *Responsibility to SOCIETY*: -public health interest -accountability to tax payers -opportunity cost considerations -value for money

Calculating a QALY:

Example: -Patient X has a serious, life-threatening condition. -Continues on standard treatment; he will live for 1 year and his QoL will be 0.4=0.4 QALY -Receives new medicine: he will live for 1 year 3 month (1.25 years), with a QoL= 0.75 QALY -[Quantity of life scores: 0=worst possible health, 1= best possible health] -If new treatment cost is £10,000 and standard is £3,000 -The difference in treatment costs (£7,000) is divided by the QALYS gained (0.75-0.4=0.35) to calculate the cost per QALY. -So new treatment cost=£20,000 per QALY

--> Quality Standards

Goes: Evidence->Guidance->Quality Standards 1) *Evidence* =Research studies-experimental + observational, quantitative + quality, process evaluations, descriptions of experience, case studies 2) *Guidance* =A set of systematically developed recommendations to guide decisions for a particular area of care or health issue 3) *Quality Standards* =a concise set of statements designed to drive and measure priority quality improvements

Appraisal Committees

Members: -Statisticians -GPs -Lay members -Public health physicians -Health economists -Clinical pharmacists -Nurses -Surgeons -Consultant physicians -NHS management -Clinical pharmacologists -Psychiatrist -Professional allied to medicine -Paediatrician

-->Technology appraisals

NICE regulations: In England, NHS is required to provide funding and resources for medicines + treatments recommended by NICE through its *technology appraisal programme, normally within 3 months from date of publication.* -You have the *RIGHT* to drugs and treatments that have been recommended by NICE for use in the NHS, if your doctor says they are clinically appropriate for you

NICE stands for:

National Institute for Health and Care Excellence

How to identify local priorities for quality improvement

o NICE quality standards can highlight key areas for improvement. An initial assessment should consider for each statement within the quality standard: -whether the statement is relevant to the organisation -how the current service compares to the statement -source of information to evidence this -what actions/resources would be required to improve the service so that it meets the quality standard statement -an initial assessment of risk associated with not making these improvements