Adherence to guidelines in the use of biological agents to treat psoriasis in Brazil

BMJ Open. 2014 Mar 5;4(3):e004179. doi: 10.1136/bmjopen-2013-004179.

Abstract

Objective: In São Paolo, Brazil, patients can appeal to the courts, registering law suits against the government claiming the need for biological agents for treatment of psoriasis. If the lawsuits are successful, which is usually the case, the government then pays for the biologic agent. The extent to which the management of such patients, after gaining access to government payment for their biologic agents, adheres to authoritative guidelines, is uncertain.

Methods: We identified patients through records of the State Health Secretariat of São Paulo from 2004 to 2011. We consulted guidelines from five countries and chose as standards only those recommendations that the guidelines uniformly endorsed. Pharmacy records provided data regarding biological use. Guidelines not only recommended biological agents only in patients with severe psoriasis who had failed to respond to topical and systemic therapies (eg, ciclosporin and methotrexate) but also yearly monitoring of blood counts and liver function.

Results: Of 218 patients identified in the database, 3 did not meet eligibility criteria and 12 declined participation. Of the 203 patients interviewed, 91 were still using biological medicine; we established adherence to laboratory monitoring in these patients. In the total sample, management failed to meet standards of prior use of topical and systemic medication in 169 (83.2%) patients. Of the 91 patients using biological medicine at the time of the survey, 23 (25.2%) did not undergo appropriate laboratory tests.

Conclusions: Important discrepancies exist between clinical practice and the recommendations of guidelines in the management of plaintiffs using biological drugs to treat psoriasis.

Keywords: Clinical Pharmacology.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Anti-Inflammatory Agents / adverse effects
  • Anti-Inflammatory Agents / therapeutic use
  • Antibodies, Monoclonal / therapeutic use
  • Biological Factors / adverse effects
  • Biological Factors / therapeutic use*
  • Blood Cell Count
  • Brazil
  • Female
  • Guideline Adherence* / legislation & jurisprudence
  • Humans
  • Legislation, Drug
  • Liver Function Tests
  • Male
  • Middle Aged
  • Practice Patterns, Physicians' / legislation & jurisprudence
  • Practice Patterns, Physicians' / standards*
  • Psoriasis / drug therapy*
  • Young Adult

Substances

  • Anti-Inflammatory Agents
  • Antibodies, Monoclonal
  • Biological Factors