The quality of research on judicialization and its influence on public policies on access to medicines in Brazil: a systematic review

Lyra, Pollyanna Farias Castro Pereira de; Araújo, Dyego Carlos Souza Anacleto de; Santos Júnior, Genival Araújo dos; Sodré-Alves, Bárbara Manuella Cardoso; Jesus, Elisdete Maria Santos de; Lyra Jr., Divaldo Pereira de; Quintans Jr., Lucindo José

doi:10.1590/1413-812320212611.29142020

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ARTICLE • Ciênc. saúde coletiva 26 (11) • Nov 2021 • https://doi.org/10.1590/1413-812320212611.29142020 copy

The quality of research on judicialization and its influence on public policies on access to medicines in Brazil: a systematic review

A qualidade das pesquisas sobre judicialização e sua influência nas políticas públicas de acesso aos medicamentos no Brasil: uma revisão sistemática

Authorship SCIMAGO INSTITUTIONS RANKINGS

Abstract

Patients without access to medicines often resort to the judicial system. However, no systematic review has discussed the quality of studies and the factors that may influence the access to medicines from judicialization. This study aimed to characterize the quality of research on access to judicialized medicines and their influence on public policies in Brazil. A search was conducted in the LILACS, PubMed/Medline, Scopus, and Web of Science databases using the terms “judicialization” and “medication”. Two reviewers identified articles that met the inclusion criteria. Only studies written in English, Portuguese, or Spanish published from 1990 to 2018 were included. The study selection resulted in a final sample of 45 articles. The retrospective descriptive design was the most common methods, based on reports and lawsuits. A high level of heterogeneity among the studies hindered the comparison and generation of evidence capable of supporting judges’ decisions based on technical-scientific criteria. This review showed that studies were heterogeneous and had low methodological quality. Moreover, they did not propose viable solutions for health managers and formulators to face the problem.

Key words:
Right to health; Medicines; Judicial decisions; Access to medicines; Drug costs

LILACS = 146
(“Judicial Role” OR “Judicial Roles” OR “Role, Judicial” OR “Roles, Judicial” OR “Judicial Action” OR “Action, Judicial” OR “Actions, Judicial” OR “Judicial Actions” OR “Court Action” OR “Action, Court” OR “Actions, Court” OR “Court Actions” OR “Judicial Consent” OR “Consent, Judicial” OR “Judicial Bypass” OR “Bypass, Judicial” OR “judicial decisions” OR “judicial decision” OR “judicialization” OR “judicializations”) AND (“Brazil”) AND (“pharmaceutical preparations” OR “pharmaceutical preparation” OR “Preparations, Pharmaceutical” OR “Pharmaceutic Preparations” OR “Preparations, Pharmaceutic” OR “Pharmaceutical Products” OR “Products, Pharmaceutical” OR “Pharmaceuticals” OR “Pharmaceutical” OR “Drugs” OR “Drug” OR “Medicine” OR “Medicines”)
PUBMED = 54
((“Pharmaceutical Preparations”[Mesh]) OR (((((((((((((“pharmaceutical preparations”) OR (“pharmaceutical preparation”)) OR (“Preparations, Pharmaceutical”)) OR (“Pharmaceutic Preparations”)) OR (“Preparations, Pharmaceutic”)) OR (“Pharmaceutical Products”)) OR (“Products, Pharmaceutical”)) OR (“Pharmaceuticals”)) OR (“Pharmaceutical”)) OR (“Drugs”)) OR (“Drug”)) OR (“Medicine”)) OR (“Medicines”))) AND ((“Judicial Role”[Mesh]) OR ((((((((((((((((((((“Judicial Role”) OR (“Judicial Roles”)) OR (“Role, Judicial”)) OR (“Roles, Judicial”)) OR (“Judicial Action”)) OR (“Action, Judicial”)) OR (“Actions, Judicial”)) OR (“Judicial Actions”)) OR (“Court Action”)) OR (“Action, Court”)) OR (“Actions, Court”)) OR (“Court Actions”)) OR (“Judicial Consent”)) OR (“Consent, Judicial”)) OR (“Judicial Bypass”)) OR (“Bypass, Judicial”)) OR (“judicial decisions”)) OR (“judicial decision”)) OR (“judicialization”)) OR (“judicializations”))) AND (Brazil)
SCOPUS = 472
( ALL ( “Brazil” ) ) AND ( ( ALL ( “Judicial Role” ) OR ALL ( “Judicial Roles” ) OR ALL ( “Role, Judicial” ) OR ALL ( “Roles, Judicial” ) OR ALL ( “Judicial Action” ) OR ALL ( “Action, Judicial” ) OR ALL ( “Actions, Judicial” ) OR ALL ( “Judicial Actions” ) OR ALL ( “Court Action” ) OR ALL ( “Action, Court” ) OR ALL ( “Actions, Court” ) OR ALL ( “Court Actions” ) OR ALL ( “Judicial Consent” ) OR ALL ( “Consent, Judicial” ) OR ALL ( “Judicial Bypass” ) OR ALL ( “Bypass, Judicial” ) OR ALL ( “judicial decisions” ) OR ALL ( “judicial decision” ) OR ALL ( “judicialization” ) OR ALL ( “judicializations” ) ) ) AND ( ( ALL ( “pharmaceutical preparations” ) OR ALL ( “pharmaceutical preparation” ) OR ALL ( “Preparations, Pharmaceutical” ) OR ALL ( “Pharmaceutic Preparations” ) OR ALL ( “Preparations, Pharmaceutic” ) OR ALL ( “Pharmaceutical Products” ) OR ALL ( “Products, Pharmaceutical” ) OR ALL ( “Pharmaceuticals” ) OR ALL ( “Pharmaceutical” ) OR ALL ( “Drugs” ) OR ALL ( “Drug” ) OR ALL ( “Medicine” ) OR ALL ( “Medicines” ) ) )
WEB OF SCIENCE = 76
(TS=(“Pharmaceutical Preparation”) OR TS=(“pharmaceutical preparations”) OR TS=(“Preparations, Pharmaceutical”) OR TS=(“Pharmaceutic Preparations”) OR TS=(“Preparations, Pharmaceutic”) OR TS=(“Pharmaceutical Products”) OR TS=(“Products, Pharmaceutical”) OR TS=(“Pharmaceuticals”) OR TS=(“Pharmaceutical”) OR TS=(“Drugs”) OR TS=(“Drug”) OR TS=(“Medicine”) OR TS=(“Medicines”)) AND (TS=(“Judicial Role”) OR TS=(“Judicial Roles”) OR TS=(“Role, Judicial”) OR TS=(“Roles, Judicial”) OR TS=(“Judicial Action”) OR TS=(“Action, Judicial”) OR TS=(“Actions, Judicial”) OR TS=(“Judicial Actions”) OR TS=(“Court Action”) OR TS=(“Action, Court”) OR TS=(“Actions, Court”) OR TS=(“Court Actions”) OR TS=(“Judicial Consent”) OR TS=(“Consent, Judicial”) OR TS=(“Judicial Bypass”) OR TS=(“Bypass, Judicial”) OR TS=(“judicial decisions”) OR TS=(“judicial decision”) OR TS=(“judicialization”) OR TS=(“judicializations”)) AND (Brazil)
EMBASE = 70
(‘judicial role’ OR ‘judicial roles’ OR ‘role, judicial’ OR ‘roles, judicial’ OR ‘judicial action’ OR ‘action, judicial’ OR ‘actions, judicial’ OR ‘judicial actions’ OR ‘court action’ OR ‘action, court’ OR ‘actions, court’ OR ‘court actions’ OR ‘judicial consent’ OR ‘consent, judicial’ OR ‘judicial bypass’ OR ‘bypass, judicial’ OR ‘judicial decisions’ OR ‘judicial decision’ OR ‘judicialization’ OR ‘judicializations’) AND (‘pharmaceutical preparations’ OR ‘pharmaceutical preparation’ OR ‘preparations, pharmaceutical’ OR ‘pharmaceutic preparations’ OR ‘preparations, pharmaceutic’ OR ‘pharmaceutical products’ OR ‘products, pharmaceutical’ OR ‘pharmaceuticals’ OR ‘pharmaceutical’ OR ‘drugs’ OR ‘drug’ OR medicine’ OR ‘medicines’) AND (‘Brazil’)

	Item N^o	Recommendation	n (%)
Title and abstract	1	Indicate the study’s design with a commonly used term in the title or the abstract. Provide in the abstract an informative and balanced summary of what was done and what was found	44 (97,8)
Introduction
Background/rationale	2	Explain the scientific background and rationale for the investigation being reported	42 (93,3)
Objectives	3	State specific objectives	8 (17,8)
Objectives	3	Prespecified hypotheses	3 (6,7)
Methods
Study design	4	Present key elements of study design early in the paper	37 (82,2)
Setting	5	Describe the setting, locations, and relevant dates, including periods of recruitment, exposure, follow-up, and data collection	42 (93,3)
Participants	6	(a) Cross-sectional study-Give the eligibility criteria, and the sources and methods of selection of participants	17 (37,8)
Variables	7	Clearly define all outcomes, exposures, predictors, potential confounders, and effect modifiers. Give diagnostic criteria, if applicable	33 (73,3)
Data sources/ measurement	8	For each variable of interest, give sources of data and details of methods of assessment (measurement). Describe comparability of assessment methods if there is more than one group	41 (91,1)
Bias	9	Describe any efforts to address potential sources of bias	7 (15,6)
Study size	10	Explain how the study size was arrived at	31 (68,9)
Quantitative variables	11	Explain how quantitative variables were handled in the analyses. If applicable, describe which groupings were chosen and why	38 (84,4)
Statistical methods	12	Describe all statistical methods, including those used to control for confounding. Explain how missing data were addressed. Cross-sectional study-If applicable, describe analytical methods taking account of sampling strategy	23 (51,1)
Results
Participants	13	Report numbers of individuals at each stage of study-eg numbers potentially eligible, examined for eligibility, confirmed eligible, included in the study, completing follow-up, and analysed	17 (37,8)
Descriptive data	14	Give characteristics of study participants (eg demographic, clinical, social) and information on exposures and potential confounders	43 (95,6)
Outcome data	15	Report numbers of outcome events or summary measures	31 (68,9)
Main results	16	Give unadjusted estimates and, if applicable, confounder-adjusted estimates and their precision (eg, 95% confidence interval). Make clear which confounders were adjusted for and why they were included. Report category boundaries when continuous variables were categorized. If relevant, consider translating estimates of relative risk into absolute risk for a meaningful time period.	44 (97,8)
Other analyses	17	Report other analyses done-eg analyses of subgroups and interactions, and sensitivity analyses	8 (17,8)
Discussion
Key results	18	Summarise key results with reference to study objectives	44 (97,8)
Limitations	19	Discuss limitations of the study, taking into account sources of potential bias or imprecision. Discuss both direction and magnitude of any potential bias	20 (44,4)
Interpretation	20	Give a cautious overall interpretation of results considering objectives, limitations, multiplicity of analyses, results from similar studies, and other relevant evidence	42 (93,3)
Generalisability	21	Discuss the generalisability (external validity) of the study results	9 (29,0)
Other information
Funding	22	Give the source of funding and the role of the funders for the present study and, if applicable, for the original study on which the present article is based	16 (35,6)

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E-mail: cienciasaudecoletiva@fiocruz.br

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[1] Collaborations

PFCP Lyra, DP Lyra Jr. and LJ Quintans Jr. were responsible for the concept of the theme. PFCP Lyra, DCSA Araújo and GA Santos Jr collected the material. PFCP Lyra, EMS Jesus, BMCS Alves, DCSA Araújo and DP Lyra Jr. analyzed the material found. PFCP Lyra, BMCS Alves, EMS Jesus, DCSA Araújo and GA Santos Jr. wrote the first draft. PFCP Lyra, DP Lyra Jr. and LJ Quintans Jr. conducted critical reviews. All authors have approved the final version of this manuscript.