KNOWLOLEDGE TRANSFER IN BRAZIL Case studies from SUS Collaborating Centre

Prof. Augusto Guerra, PhD Juliana de Oliveira Costa, MPH

Federal University of Minas Gerais Brazil

Contact: augustoguerrajr@ufmg.br

contato@ccates.org.br

Minas Gerais State Health Authority recently organized the State pharmaceutical assistance and is now facing new demands in a context of restricted budget.

SUS COLLABORATING CENTRE

INTRODUCTION

• 19 million people

• growing elderly population

• crescent new-drugs scenario

→ Need of procedures for prioritizing and evaluating what might be delivered for citizens. ↘ To help address these problems ↙ A partnership between Academia and

Government was established to enforce the incorporation of clinical

evidence into decision-making

Collaborating Centre CCATES

• To evaluate the compliance of individual requests for treatment with the Brazilian or the State Protocols;

• To produce Technical Appraisals of judicial requests for medicines and specific demands about medicines utilization;

• To support judicial and administrative decisions.

SUS COLLABORATING CENTRE

OUR MAIN ACTIVITIES

→ Academic Detailing Pilot Project: Dissemination of SUS Protocols evidence → Technical appraisals: To support judicial and administrative decisions

We will presente here

Specialized Medicines Component of Pharmaceutical Assistance (High cost drug program)

• Comprises high-cost treatment

– e.g.:

• Gaucher’s disease: USD 300,000.00 per patient year

• Schizophrenia: USD 2,000.00

• Physician must fill in an administrative request explaining the case and proving that the patient fulfills the inclusion criteria

• CCATES team evaluate the compliance to the Brazilian or the State Protocols of all Minas Gerais State requests for high cost drugs (more than 100,000 per year)

Academic detailing for Alzheimer’s disease

• Dementia disorders are the most common diseases among the elderly in Brazil, reducing their social and occupational activities. – Alzheimer’s disease 60% of dementia cases

• Drug therapy according to Brazilian Protocols – Cholinesterase inhibitors (donezepil, galantamine and rivastigmine)

• In 2012 - 12% of requests were denied as a result of poor filling of the request

Academic detailing for Alzheimer’s disease

• Academic detailing:

• Visit of a trained person (health professional or not) to health professionals in their own settings (hospital, nursing home, office) -> one-on-one visits

• The Pilot Program

• Focus on the Clinical Protocol and Therapeutic Guidelines for Alzheimer’s disease to improve future prescribing

Academic detailing for Alzheimer’s disease Results

• 1st step: Seminar about the Pilot Project, the disease and its treatment

• Audience:

– Physicians 64,3%

– Residents 28,6%

– Other health professional 7,1%

Questionnaire answered by participants of Seminar 1

• 79% of participants found the Pilot Project

relevant and were willing to receive a visit

from a CCATES facilitator

• 30% had more than one difficulty related

to the requests of Alzheimer’s treatment: –50,0% in fullfilling the requests –50,0% in the amount of time it requires –28,6% had doubts about the Protocol –14,3% other

• 2nd step: Study of clinical cases from both accepted and denied requests

– Revision of 165 randomly selected requests from October 2012 to July 2013

– 80% of compliance to Clinical Protocols on 10 items evaluated

– 38% of cases were sent back to the patient/physician

– Important information lacking to analysis (e.g. educational level)

– From cases sent back, 65% were returned again, since prescribers did little or no modification

No rejection occurred because it was not an Alzheimer's disease, but by incorrect reporting of cognitive tests, either by incongruity between them, lack of practical

application or by non-observance of the protocol exclusion criteria.

Academic detailing for Alzheimer’s disease Results

• 3rd step: Elaboration of the material to be

delivered to physiscians:

– Handouts for patients and caregivers

– Three different bulletins for Physicians,

wich were delivered in a folder with

CCATES and UFMG logos, along with

bussiness cards.

Academic detailing for Alzheimer’s disease Results

In addition, we provided other material to support the visit: ‒ Clinical Protocols and Therapeutic Guidelines of the Ministry of Health, volumes 1

and 2. ‒ Book "Multidimensional Assessment of the Elderly“ ‒ Pen drive containing all the material needed to request medicines in the

Specialized Component.

• 4th and 5th steps: Training and visiting

Academic detailing for Alzheimer’s disease Results

Team: eight pharmacists with knowledge of SUS and evidence-based medicine concepts.

Two-day training covering academic detailing techniques and principles, Alzheimer’s disease, and simulation of visits.

Facilitators received a bussiness card, a badge, the support materials and a list of prescribers to be visited

Physicians: selected randomly from CCATES database.

Criteria: requested at least three times medicines for the treatment of Alzheimer’s disease during the year prior to the study.

37 physicians were visited, at least twice, including psychiatrists, neurologists, geriatricians and general practitioners

Academic detailing for Alzheimer’s disease Results

• 6th step: Satisfaction survey by telephone evaluating acceptability, relevance

and the quality of the Academic Detailing received -> soft measures.

– 28 physicians participated

85.7% (24)

67.9% (19)

71.4% (20)

71.4% (20)

92.9% (26)

60.7% (17)

75.0% (21)

53.6% (15)

71.4% (20)

Academic detailing for Alzheimer’s disease Lessons learned

• The success of Academic Detailing depends on several factors; among the main ones are programming and carefully training to address a topic considered relevant to clinical practice.

• The attractiveness of visits and the support material should be targeted and carefully planned to ensure prescriber confidence in the disseminated content and to address the barriers identified for changing behavior.

• The physicians do not seem to be a barrier to evidence-based medicine utilization. The barrier may be the way their practice works, since they allege to not have time to keep-up with science publications ad the bureaucracy.

• Most of physicians were receptive to visits, which shows that they are receptive to new information as well.

Academic detailing for Alzheimer’s disease Lessons learned

• Main evidence to use this technique was for the dissemination of clinical protocols and compliance with its recommendations, but Academic Detailing can also be used to track issues, challenges and suggestions of the prescribers. – They suggested the Protocol and the request formularies to be simplified

• In this case, the perception of the prescribers would help to update or

develop new protocols, possibly increasing their acceptability and the rate of implementation of its recommendations.

• The prescribers’ perceptions are an important source for the identification of problems and formulation of actions.

Technical Appraisals

• Used to:

– Evaluate litigated Health Tecnologies

– evaluation of the technology usefulness is needed

• Ministry of Health Guideline for Technical Apraisals

• Sumarize the cientific evidence of:

– Efficacy/Effectiveness

– Safety

– Cost-effectiveness

– Decisions of international agencies such as NICE and CADTH.

• Quality of the evidence and strength of a recommendation: GRADE system

– “the extent to which we can be confident that the desirable effects of an intervention outweigh the undesirable effects”

Technical Appraisals Executive Summary

Includes the group of

patients that benefits from

the use of the technology

and if there is any alternative

available from SUS

Main part of the Technical

Appraisals

Contains the level of

recomendation of the

technology

• Weak against

• Weak in favor

• Strong against

• Strong in favor

Technical Appraisals Exemples

Efficacy and safety of temozolomide in the treatment of low grade astrocytomas

Eficacy and safety of ranibizumab and bevacizumab in the treatment of Age-Related Macular Degeneration

Amphotericin B formulations for the treatment of fungal infections in patients with HIV/AIDS

Efficacy and safety of sorefenib in the treatment of liver cancer

Efficacy and safety of rituximab for the treatment of systemic lupus erythematosus

Efficacy and safety of zoledronic acid for the treatment of osteoporosis

Efficacy and safety of sertraline and citalopram for the treatment of depression

Efficacy and safety of medicines based on Cannabis sativa extract for the treatment of epilepsy in Rett Syndrome

Treatment of diabetic neuropathic pain: Efficacy, safety and cost-effectiveness of pregabalin and the association of vitamin B12, uridine and cytidine

From 2012 to 2015: 37 Technical Apraisals were published

Efficacy and safety of drug-eluting stents in the treatment of coronary artery disease

Ischemia time on renal graft survival: Efficacy of perfusion machine

Technical Appraisals Key points of a Knowledge transfer

The team that develops the Technical Appraisals is independent and free of conflicts of interests

The Technical Appraisal answers a specific question using the evidence-based medicine principles

Gives a clear recommendation

It is written in a plain language

It is available full text at Ministry of Health and CCATES websites

www.ccates.org.br

rebrats.saude.gov.br/sisrebrats

Technical Appraisals