Análise técnica para a tomada de decisão do fornecimento de medicamentos pela via judicial

Abstract

OBJECTIVE:To analyze judicial requests for medications that are covered by the pharmaceutical assistance components of the Sistema Único de Saúde (SUS -Brazilian Unifi ed Health System). METHODS:We analyzed 81 judicial requests for medications in the State of São Paulo between 2005 and 2009. The details of these cases were obtained electronically from the Court of Justice of the State of São Paulo. Directives that regulate pharmaceutical assistance were consulted to identify judicially requested medications that are covered by the SUS. To assess the level of evidence supporting the use of these medications to treat the clinical indications described, we consulted the Thomson Micromedex® database. RESULTS:The number of individual medications requested in each case ranged from 1 to 7; in total, 77 different pharmaceuticals agents were identifi ed. Of the medications requested, 14.3% should have been available through SUS primary care, 19.5% were classifi ed under the exceptionally dispensed medications component of the SUS, and 66.2% were not on any offi cial list. Medications of the exceptionally dispensed medications component showed better clinical evidence when indicated for the treatment of medical conditions covered by the Clinical Protocols and Therapeutic Guidelines of Brazil's Ministry of Health. CONCLUSIONS:The judicial process has been used to ensure access to medications that are covered by the SUS and to request access to those that are not covered. Our assessment of the level of available evidence reinforces the need for technical analysis in the decision-making process in cases of judicially requested medications.

Studies published in indexed journals on lawsuits for medicines in Brazil: a systematic review

“…The first year of the publications included in the review was 2005, and there was a peak in the years 2010 and 2011. The data refer to studies done in the states of Pernambuco 5 , Rio Grande do Sul 2,6 , Minas Gerais 7,8 , Rio de Janeiro 9,10,11,12 , and São Paulo 13,14,15,16,17 , besides one article that collected data directly from the Ministry of Health in Brasilia 18 . The studies that examined the most lawsuits (between 2,000 and 2,927 cases) were done in the states of São Paulo, Rio de Janeiro, and Santa Catarina 7,12,14,16,19 .…”

“…As for the data sources, the majority of the studies analyzed the legal proceedings (83.3%), and one study only examined the initial lower court rulings 13 , while another examined both initial rulings and the results of appeals 9 . The main data sources were: State Health Departments (41.2%) and the São Paulo State Online System for Monitoring Legal Proceedings (17.6%) ( Table 2).…”

“…Three articles 2,6,10 (17.6%) examined petitions for advance relief or other types of court injunctions, and the results were the following: two studies showed 100% of such petitions 6,10 and one 98% 2 . The majority of the studies (76.5%; n = 13) collected specific data to determine whether there was more than one defendant in the suits, four conducted this analysis 2,6,9,10 , in two of them the defendants were states and municipalities 9,13 and in the others the defendants were states, municipalities, and the Federal Government 2,6 . Characteristics of the claims examined in the articles Table 4 shows the characteristics of the type of drug involved in the claim, type of health care service (public versus private), supply of the drug to the patient, presence of the drug on standard government lists, and registration of the drug in Brazil.…”

“…Insulin glargine was among the most frequent drugs (n = 5), followed by adalimumab, etanercept, and infliximab (n = 4)... it should read: ...Twelve articles 2,6,7,8,9,10,11,13,16,17,18,19 also examined the most frequent drugs in the claims. Insulin glargine was among the most frequent drugs (n = 4), followed by adalimumab, etanercept, and infliximab (n = 3)...…”

“…• On page 5, second column, fourth paragraph, line 53, where the text reads: ...Ten studies specified whether the medicines were on the official lists for pharmaceutical care and the RENAME (the Brazilian National List of Essential Drugs)... it should read: ...Eleven studies 2,8,9,10,11,12,13,14,15,18,20 specified whether the medicines were on the official lists for pharmaceutical care and the RENAME (the Brazilian National List of Essential Drugs)...…”