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NATIONAL GUIDELINES FOR HIGH-COST DRUGS IN BRAZIL: ACHIEVEMENTS AND CONSTRAINTS OF AN INNOVATIVE NATIONAL EVIDENCE-BASED PUBLIC HEALTH POLICY

Published online by Cambridge University Press:  03 April 2013

Paulo D. Picon ,
Alberto Beltrame  and
David Banta
Paulo D. Picon
Affiliation:
Department of Internal Medicine – Federal University of Rio Grande do Sul, Chair of the Technical Group for Creation of Brazilian Guidelines for High-Cost Medicines
Alberto Beltrame
Affiliation:
Former Secretary of Health Care, Brazilian Ministry of Health
David Banta
Affiliation:
University of Maastricht
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Abstract

Introduction: The translation of best evidence into practice has become an important purpose of policy making in health care. In Brazil, a country of continental dimensions with widespread regional and social inequalities, the dissemination and use of the best-evidence in policy making is a critical issue for the healthcare system.

Objectives: The main purpose of this study is to describe an evidence-based public health policy with special emphasis on guidelines creation for high-cost medicines. We also describe how that strategy was diffused to the judiciary system and to other parts of the healthcare system.

Results: We present an 11-year follow-up of a national project for creating and updating guidelines for high-cost medicines in Brazil. A total of 109 national guidelines were published (new or updated versions) for 66 selected diseases, the first such effort in Brazilian history. The project influenced the Brazilian legislature, which has recently established a Federal Law requiring national guidelines for any new technology listed for payment by the Brazilian public healthcare system.

Conclusion: We were able to involve many different stakeholders in a partnership between academia and policy makers, which made possible the widespread dissemination of the clinical practice guidelines. Problems and constraints were also encountered. This evolving public health strategy might be useful for other developing countries.

Keywords

Clinical practice guidelinesPharmaceuticalsHealth technology assessment
Type
POLICIES
Information
International Journal of Technology Assessment in Health Care , Volume 29 , Issue 2 , April 2013 , pp. 198 - 206
Copyright
Copyright © Cambridge University Press 2013

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References

REFERENCES

1.Banta, D, Almeida, RT.The development of health technology assessment in Brazil. Int J Technol Assess Health Care. 2009;25(Suppl 1):255–259.CrossRefGoogle ScholarPubMed
2.Paim, J, Travassos, C, Almeida, C, Bahia, L, Macinko, J.The Brazilian health system: History, advances, and challenges. Lancet. 2011;377:1778–1797.CrossRefGoogle ScholarPubMed
3.Levi, GC, Vitória, MA.Fighting against AIDS: The Brazilian experience. AIDS. 2002;16:2373–2383.CrossRefGoogle ScholarPubMed
4.Biehl, J, Petryna, A, Gertner, A, Amon, JJ, Picon, PD.Judicialisation of the right to health in Brazil. Lancet. 2009;373:2182–2184.CrossRefGoogle ScholarPubMed
5.Schwartsmann, G, Picon, PD.When drugs are worth more than gold! Lancet Oncol. 2007;8:1049–1050.CrossRefGoogle ScholarPubMed
6.Beltrame, A.Ampliação do Acesso a Medicamentos de Alto Custo – Uma Análise da Política Brasileira [dissertation]. Rio de Janeiro (RJ): Instituto de Medicina Social – UERJ; 2002. http://www.obsnetims.org.br/adm/arq/dissertacao/4229550.pdf (accessed March 13, 2013).Google Scholar
7.[No authors listed]. Introduction to the EUR-ASSESS Report. Int J Technol Assess Health Care. 1997;13:133–143.CrossRefGoogle Scholar
8.Murray, C, Frenk, J.World Health Report 2000: A step towards evidence-based health policy. Lancet. 2001;357:1698–1700.CrossRefGoogle ScholarPubMed
9.Picon, PD, Beltrame, A.Ministério da Saúde. Protocolos Clínicos e Diretrizes Terapêuticas – Medicamentos Excepcionais. Porto Alegre (RS): Gráfica e Editora Pallotti; 2002.Google Scholar
10.Picon, PD, Gadelha, MIP, Beltrame, A. Ministério da Saúde. Secretaria de Atenção à Saúde. Protocolos Clínicos e Diretrizes Terapêuticas. Brasília (DF): Ministério da Saúde; 2010. http://portal.saude.gov.br/portal/arquivos/zip/pcdt_livro_volume1_2010.zip (accessed March 13, 2013).Google Scholar
11.Picon, PD, Gadelha, MIP, Beltrame, A, Banta, HD. Brazilian Ministry of Health. Department of Health Care. Clinical practice guidelines for pharmaceutical treatment of selected diseases. e-version. São Paulo (SP): Kitmais; 2011. http://www.hospitalalemao.org.br/haoc/repositorio/17/documentos/word_biblioteca/1-10-iniciais_ing_revAline_Denise_Picon_FINAL.pdf (accessed March 13, 2013).Google Scholar
12.Haynes, B, Haines, A.Barriers and bridges to evidence based clinical practice. BMJ. 1998;25;317:273–276.CrossRefGoogle Scholar
13.Pronovost, PJ, Berenholtz, SM, Needham, DM.Translating evidence into practice: A model for large scale knowledge translation. BMJ. 2008;337:a1714.CrossRefGoogle Scholar
14.Schwamm, L, Fayad, P, Acker, JE III, et al.Translating evidence into practice: A decade of efforts by the American Heart Association/American Stroke Association to reduce death and disability due to stroke: A presidential advisory from the American Heart Association/American Stroke Association. Stroke. 2010;41:1051–1065.CrossRefGoogle Scholar
15.Shaneyfelt, TM, Mayo-Smith, MF, Rothwangl, J.Are guidelines following guidelines? The methodological quality of clinical practice guidelines in the peer-reviewed medical literature. JAMA. 1999;281:1900–1905.CrossRefGoogle ScholarPubMed
16.Coyle SL; Ethics and Human Rights Committee, American College of Physicians-American Society of Internal Medicine. Physician-industry relations. Part 1: Individual physicians. Ann Intern Med. 2002;136:396–402.CrossRefGoogle Scholar
17.Coyle SL; Ethics and Human Rights Committee, American College of Physicians-American Society of Internal Medicine. Physician-industry relations. Part 2: Organizational issues. Ann Intern Med. 2002;136:403–406.CrossRefGoogle Scholar
18.Davidoff, F, DeAngelis, CD, Drazen, JM, et al.Sponsorship, authorship, and accountability. N Engl J Med. 2001;345:825–826.CrossRefGoogle ScholarPubMed
19.Kjaergard, LL, Als-Nielsen, B.Association between competing interests and authors’ conclusions: Epidemiological study of randomised clinical trials in the BMJ. BMJ. 2002;325:249.CrossRefGoogle ScholarPubMed
20.Montaner, JS, O'Shaughnessy, MV, Schechter, MT.Industry-sponsored clinical research: A double-edged sword. Lancet. 2001;358:1893–1895.CrossRefGoogle ScholarPubMed
21.Krug, BC, Schwartz, IV, Lopes de Oliveira, F, et al.The management of Gaucher disease in developing countries: A successful experience in southern Brazil. Public Health Genomics. 2010;13:27–33.CrossRefGoogle ScholarPubMed
22.Rieder, CR, Schestatsky, P, Socal, MP, et al.A double-blind, randomized, crossover study of prosigne versus botox in patients with blepharospasm and hemifacial spasm. Clin Neuropharmacol. 2007;30:39–42.CrossRefGoogle ScholarPubMed
23.Picon, PD, Guarany, FC, Socal, MP, et al. Implementation of Brazilian guidelines for botulinum toxin: A three-year follow-up of a cost-reduction strategy in the public health system of Rio Grande do Sul, Brazil. Oral presentation of the 4th Health Technology Assessment International Annual Meeting; June 17–20, 2007; Barcelona, Spain.Google Scholar
24.Ministério da Saúde do Brasil. Portaria do Gabinete do Ministro GM/MS/639. D.O.U. Brasília 16 de junho de 2000.Google Scholar
25.Ministério da Saúde do Brasil. Portaria do Gabinete do Ministro GM/MS/01. D.O.U. Brasília 23 de julho de 2002.Google Scholar
26.National Institutes of Health. National Institutes of Health Consensus Development Conference Statement: Management of hepatitis C: 2002—June 10-12, 2002. Hepatology. 2002;36(Suppl 1):S3–20.CrossRefGoogle Scholar
27.Picon, PD, Camozzato, AL, Lapporte, EA, et al.Increasing rational use of cholinesterase inhibitors for Alzheimer's disease in Brazil: Public health strategy combining guideline with peer-review of prescriptions. Int J Technol Assess Health Care. 2010;26:205–10.CrossRefGoogle Scholar
28.Grimshaw, JM, Thomas, RE, MacLennan, G, et al.Effectiveness and efficiency of guideline dissemination and implementation strategies. Health Technol Assess. 2004;8:1–72.CrossRefGoogle ScholarPubMed
29.Francke, AL, Smit, MC, de Veer, AJ, Mistiaen, P.Factors influencing the implementation of clinical guidelines for health care professionals: A systematic meta-review. BMC Med Inform Decis Mak. 2008;8:38.CrossRefGoogle ScholarPubMed
30.Michie, S, Johnston, M.Changing clinical behaviour by making guidelines specific. BMJ. 2004;328:343–345.CrossRefGoogle ScholarPubMed
31.Rashidian, A, Eccles, MP, Russell, I.Falling on stony ground? A qualitative study of implementation of clinical guidelines’ prescribing recommendations in primary care. Health Policy. 2008;85:148–161.CrossRefGoogle Scholar