Rational therapeutics : health-related elements in lawsuits demanding medicines

OBJECTIVE: To characterize the main medical, scientifi c and health-related procedural elements upon which decisions are made in individual lawsuits demanding medicines that are considered essential to the Court of Justice. METHODS: Retrospective descriptive study based on 27 cases ruled on by the Court of Appeals in Rio de Janeiro, Southeastern Brazil, in 2006. The original proceedings were solicited from the Central Archive of the Court of Justice of the State of Rio de Janeiro and were photographed and analyzed in full. RESULTS: Prescriptions and medical certifi cates were present in 100% of the lawsuits. All prescriptions lacked conformity to legislation. No expert medical reports were added, and only 7.4% of the lawsuits presented complementary examinations. In spite of the scarcity of medical information present in the records, all of the demands were granted. CONCLUSIONS: The admission of judicial demands devoid of clinical and diagnostic substantiation results in managerial and health-related constraints on the health system. Besides creating havoc in standard pharmaceutical services, badly justifi ed medicine demands may compromise rational drug use. DESCRIPTORS: Pharmaceutical Services, legislation & jurisprudence. Drug Prescriptions. Judicial Decisions. Legislation, Health.


INTRODUCTION
The assertion of the right to healthcare in the Brazilian legal system, combined with persisting unequal access to health goods and services, including medicines, 11 has encouraged a resort to judicial protection and an increase in lawsuits to assure this right.The ph enomenon has been called the judicialization of health.
In the early 1990s, lawsuits targeted medications for HIV/AIDS and current lawsuits address several additional treatments.a They also reveal that it is diffi cult for the judicial system and the judicial procedure itself to ensure compliance with the principles of universality and equity of the Brazilian Health System and it's National Drug Policy guidelines.This is especially the case in the selection of essential medications and the promotion of the rational use of medicines (RUM). 1,3,6,7,13,14 is the State's constitutional duty to provide comprehensive pharmaceutical care to its citizens, and it is the citizens' right to compel the judicial branch to a Organização Pan-Americana da Saúde.Ministério da Saúde.Avaliação da assistência farmacêutica no Brasil: estrutura, processo e resultados.Brasília; 2005.
force the public administration to meet this obligation.It is also a constitutional duty of the State to protect the health of its citizens, which can only be realized if the State provides access to medicines via mechanisms that ensure the rational use of those drugs.
Prescription medicines play a critical role in lawsuits.Medical professionals are responsible for a signifi cant portion of healthcare costs through their diagnostic and/or therapeutic decisions.Rational prescription, related to rational use of and adherence to medications, thus influencing treatment outcome, is one component of these decisions.However, prescription is also infl uenced by the physical conditions of care and certain characteristics of the health professional, such as knowledge, expertise, professional training, and current understanding of the effi cacy and safety of both old and new drugs.Moreover, according to Teixeira, 12 the United States pharmaceutical industry infl uences the continued education of health professionals and also promotes off-label prescriptions.This results in a return on investment of up to three times the amount spent on continued education.
Rational prescription, a fundamental component of the promotion of RUM, 15 is one of the greatest challenges facing public management of pharmaceutical care.This is especially true for new and more expensive medicines.Therefore, most lawsuits are granted with a medical prescription as the only procedural evidence. 3,4,14ven the importance of health judicialization and its challenges to the new political-institutional relationships between the health and judicial sectors, the present study aims to characterize the main medical, scientifi c and health-related procedural elements supporting the rulings on those lawsuits considered essential.

METHODS
A descriptive retrospective study was conducted.The unit of analysis was the legal process brought by a citizen, regarding a supply of medicine, against a state entity in Rio de Janeiro, Southeastern Brazil.Lawsuits fi led through 31 December 2007 were included if they met the following conditions: they were fi rst heard in the District Court, they had a fi nal ruling in the Court of Appeals in 2006, and their summary judgment contained the keywords "medicine" and "essential."These criteria enabled an analysis of the conduct of proceedings in two distinct legal courts: that is, from the author's fi rst application until the fi nal legal ruling in the Court of Appeals by the Court of Justice of the State of Rio de Janeiro (CJ/RJ).In addition, access was available to all of the original documents that were part of the legal process.
Of the 3,456 lawsuits concerning the keyword "medicine" decided in the Court of Appeals in 2006 and available on the CJ/RJ site, 162 had originated at the district court level and used the terms "medicine" and "essential" in their summaries.The 27 lawsuits with a fi nal verdict declared and fi led were requested from the CJ/RJ Central Archive and photographed.
The procedural, medical, scientifi c and health-related elements of the lawsuits were analyzed by the following primary variables: author's legal representation; defendant; time elapsed between procedural steps; legal requirements; result of rulings; existence of appeals; presence of medical prescription; appropriateness of medical prescription relative to good prescription practices; presence of medical document; complementary examinations and medical report; diagnosis; demanded medicines; medicine register in Agência Nacional de Vigilância Sanitária (ANVISA -National Health Surveillance Agency); and presence of on the Brazilian List of Essential Medicines (RENAME) and other offi cial lists.
The appropriateness of the medical prescription relative to general and legal principles of good prescription practice was based on 14 minimum criteria of federal norms -Federal Laws n. 5991/73 b and n. 9787/99; c Decree n.SVS/MS 344/98 d and CFF Ruling n. 357/2001.e " The appropriateness and good prescription practice principles were considered to be in agreement only when the criteria were met for all the prescribed medicines in a case.
The medicines were classified by the Anatomical Therapeutic Chemical Classifi cation (ATC), 2 whereas the diagnosis was classified by the International Classifi cation of Diseases, tenth edition (ICD-10). 8The presence of the medicine on offi cial lists was verifi ed by searches in RENAME 2002 (valid at that time) and in the Lists of the Pharmaceutical Assistance Programs (PAP) from the Ministry of Health, until 2006, identifi ed by Pontes Júnior 9 (2007).Register in ANVISA was verifi ed at the respective regulating agency's site.
The project was approved by the Committee on Ethics in Research from the Escola Nacional de Saúde Pública Sérgio Arouca at Fiocruz on 24 March 2008 (protocol 32/08).

RESULTS
Of the 27 authors, 19 were represented by the Public Defender of the State of Rio de Janeiro.The State of Rio de Janeiro appeared most frequently as the defendant (seven lawsuits).In 11 lawsuits, though there was more than one defendant, the emphasis was placed on the State and the Municipality of Rio de Janeiro (six lawsuits).
All injunctions were granted and confi rmed by the decisions handed down in the District Court, and the decisions were further confi rmed in the Court of Appeals.In three lawsuits, the judge made some type of demand before the preliminary decision.Of the 27 pleadings, 16 were accepted in the exact terms of the pleading.In 11 cases, a supply of similar medicines was granted.Finally, in fi ve cases, the supply was linked to the demonstration of a prescription given by a SUS doctor.The defendant appealed the preliminary decision in only one lawsuit and appealed the decision in 16 lawsuits.There was no appeal of the judgment rendered by the Court of Appeals to the Superior Court of Justice and/or the Federal Supreme Court.
The median time interval between procedural steps of interest is shown in Table 1.
In every process, there was an attached prescription, and in three instances, there were two prescriptions, thus resulting in a total of 30 prescriptions for analysis.Half of the prescriptions were generated by the SUS (six from university hospitals and nine from other SUS units), whereas 13 came from private doctors and two from mutual health associations.
None of the prescriptions was found to be compliant with the general and legal principles of good prescription practice, and a median of fi ve non-compliant criteria were found for each prescription (Table 2).
In seven cases of prescriptions that contained specially controlled substances, there was no notifi cation of a prescription attached to the process.In the four cases where all of the special prescriptions were attached, none of them was compliant with the requirements of the Ordinance d that standardizes the prescription of controlled medicines in Brazil.
There was a medical document confi rming the disease in all of the lawsuits.In fi ve of the lawsuits, a "medical certifi cate" and a prescription appeared for the same document.There was no medical report in any of the 27 lawsuits, and in only two of the lawsuits there were complementary examinations attached.Table 3 shows the relationship between present and absent medical documents in the lawsuits.
Five of the eight explicit justifi cations for the prescription referred to an unsatisfactory response to treatment with a previously selected medicine, whereas only four demands even referenced previous treatment.In one particular case, there was justifi cation for only one prescription, yet this medicine was not being demanded in the lawsuit.
Twenty-seven main diagnoses and 24 secondary ones were mentioned.Taking all diagnoses into consideration, circulatory system diseases were the most frequent, at 33.3%, with hypertensive diseases following at 15.7%.Diseases of the musculoskeletal system and connective tissues were diagnosed in 13.7% of the cases, whereas mental and behavioral disorders were mentioned in 11.8% of the diagnoses.
Although the median number of medicines demanded per lawsuit was four, the number ranged from one to 12.There was a demand for other inputs in two of the lawsuits, and included blood glucose meters, physiological saline and syringes.On the whole, there were 116 medicines demanded, one of which was illegible and could not be identifi ed.From the 115 that were analyzed, 104 contained a single active compound, and 11 were combinations in a fi xed dose.It was possible to classify 93 different active compounds.
In only one case (0.9%), in which foscarnet was demanded, a valid register was not found in ANVISA for its active compound.
Twenty-one (77.8%) lawsuits demanded all the prescribed medicines.In more than half (57.4%) of the lawsuits, the demanded medicines belonged to an offi cial list of free supply.Specifi cally, 45.2% belonged to RENAME 2002, and 32.2% belonged to other lists with an emphasis (13.9%) on the list of the Unusual Medication Program.However, in 22 (81.5%)lawsuits, there was a demand for at least one medicine that was not included on the offi cial list.
In the fi ve lawsuits where all of the demanded medicines belonged to an offi cial list, there was at least one drug that was an exceptional circumstance drug dispensing .From the total of seven demanded medicines in those lawsuits, six belonged to the list exceptional circumstance drug dispensing , and they were provided in the SUS for the treatment of the author's respective pathology, as classifi ed by the ICD-10.In one of those cases, although the indication was not provided for the current Ordinance that approves the Exceptional Circumstance Drug Dispensing Component of Medications (Ordinance MS/GM n. 2.577/2006), f it was provided for the previous Ordinance (Ordinance MS/GM n. 1.318/2002) g that was still in force on the date when the lawsuit originated (Table 5).
Of the 49 medicines that do not belong to offi cial lists, 46 could be classifi ed up to the 5 th level of the ATC.The most frequent ones were bromazepam (8.7%), propatylnitrate (6.5%), and capecitabine, carvedilol, and clonidine, each of which shows a frequency of 4.3%.None of the drugs was included in RENAME 2006.However, carvedilol (6.25-mg pills), beclometasone dipropionate (aerosol, 200 mcg/dose) and enalapril (10-mg pills) were included in RENAME 2008.

DISCUSSION
The low number of cases analyzed constitutes both the main limitation and the strongest point of the study.More specifi cally, the small sample size prevented generalization from the results, while enabling the analysis of the legal processes in their entirety for the fi rst time.Despite the small number of initial legal requirements, all of the preliminary injunctions were granted, and the defendants were not usually willing to appeal.The median time between the preliminary decision and the judgment of the merits of the lawsuit (151 days) indicates that the use of medicine supplied by court order is generally prolonged by months, without reevaluation of the appropriateness of the medication for the health needs of the plaintiff, as Messeder et al 7 (2005) previously mentioned.The absence of any reference to this kind of procedure being conducted in the court fi les supports this hypothesis.
The almost absolute acceptance of demands has also been reported by Marques & Dallari 6 (2007), Borges 1 (2007) and Romero h (2008), indicating a certain homogenization, or even an automation, of the judgment of certain lawsuits.This frequent acceptance may also indicate that the State does not exercise its role as protector of healthcare.Its consistent technical defenses demonstrate the inappropriateness of determined prescriptions, the existence of available therapeutic alternatives in the SUS, and the possible damages that a particular prescribed medicine may cause the user.
The dominance of prescriptions originating from the SUS, observed here, was also observed in other studies, 3,7,14,h suggesting a failure in public policies regarding medicine.This shortcoming may be characterized by non-guaranteed access, a delay in incorporating new drugs into offi cial lists or the non-adherence of professionals in the public network to such lists. 7,14 is concerning that none of the analyzed prescriptions complied with all of the selected guidelines for good prescription practices.These have all been granted by the judicial branch without requiring any compliance with the current health laws.
Errors in prescriptions may lead to a series of problems associated with the use of drug, such as medicine replacement and/or the substitution of pharmaceutical forms during dispensing, using wrong route administration , errors in dosing, use of medicine beyond the time required or failure to comply with the prescribed treatment. 5,10Considering that the focus of lawsuits demanding medicines, from a legal point of view, is the health of the litigating patient, it is important that the court demand adherence to minimum requirements, legal and otherwise, to ensure a safe and appropriate prescription.Another noteworthy fact is the low percentage of generic drugs prescribed, particularly by the SUS, as the Federal Law n. 9.787/1999 c establishes the enforcement of prescribing generic drugs .
The careful and responsible consideration of cases involving medicines, for the sake of the good health of the litigating patient, cannot disregard clinical and diagnostic substantiation.Although almost all of the analyzed lawsuits included a medical certifi cate, but this document is generally limited to determining a disease or diseases without supplying further information.Because of this, most of the legal procedures do not include any explicit justifi cation for prescriptions or any information about previous treatment, disease evolution, complementary examinations or diagnoses according to ICD-10.
What was discussed in many of lawsuits is the advantage of, or even the need for, a particular drug that is not incorporated by the SUS, despite therapeutic alternatives already incorporated for the treatment of the same disease. 7,14In those cases, it does not seem reasonable to discard an explicit justifi cation for the prescription of a medicine different from the one belonging to an offi cial list.Moreover, as long as there is no need for the courts to refer to a technical organization or to a medical expert to grant the preliminary injunction, as the delay may result in even greater damage to the plaintiff's health, 1 it is certainly perplexing that those procedures are completely absent throughout the entire legal process.
A frequent complaint among health managers is that the demand fordrugs not registered in the ANVISA has not received much attention from Brazilian studies of the judicialization of health.The few studies that have explored the issue of unregistered medicines have found that anywhere from 1% to 10% of the legal cases involve unregistered medicines. 3,6The register of drugs in ANVISA plays an important role when evaluating the risks and benefi ts of the drug and taking into account the disease for which it is being prescribed.Federal Law n. 6.360/1976 i expressly forbids the industrialization, sale or delivery for consumption of any medicine not registered with the Ministry of Health.
The current study did not allow a deep analysis of the diagnoses of the authors of the lawsuits.Chronic diseases, such as those of the nervous and cardiovascular systems, were among the most frequent, as in the study by Messeder et al 7 (2005), which was also conducted in Rio de Janeiro.
The high frequency of lawsuits in the State of Rio de Janeiro for medicines from the SUS lists was also reported by Messeder et al 7 (2005) and Borges 1 (2007).However, the present study observed that, in 80% of the lawsuits, at least one drug was not on the offi cial lists.h Because lawsuits generally demand all of the prescribed drugs, it is reasonable to suppose that medicines that are not on the lists are the main motivation for demanding lawsuits.
The data also suggest an important role of exceptional circumstance drug dispensing in the generation of lawsuits.This fact may indicate both persistent failure in the management of this component of pharmaceutical care and successful attempts to circumvent offi cially established criteria for appropriate dispensing in the SUS.The simple specifi cation of diagnosis, devoid of confi rming medical examinations, although admittedly insuffi cient to provide safe and responsible dispensing of specially prescribed drugs in the SUS, has been suffi cient to obtain a supply of medicine via a lawsuit.
This makes the legal path faster, less bureaucratic and, therefore, very attractive despite the fi nancial and managerial implications for the SUS and the consequent health implications for the individual.The acceptance of these lawsuits, despite the lack of clinical and diagnostic substantiation in court fi les of the analyzed processes, reinforces such hypotheses.
Rational access to medicines is the basic purpose of and premise behind pharmaceutical care.To this end, all of the lawsuits are connected to medicines, whether from the judicial or the executive branch, should unequivocally contribute to this purpose.
Health policies, including pharmaceutical ones and those related to the selection of essential medicines and their products, such as lists and therapeutic formularies and protocols, are examples of successful initiatives of healthcare management aimed at the promotion of RUM in Brazil.Unfortunately, those policies do not always serve the needs of the patient.This may be due to negligence in a policy's formulation, as is the case with the lack of specifi cation of clear criteria for dealing with peculiarities (i.e., procedures and/or materials that are not predicted by the policies), or due to negligence in the healthcare system (i.e., delay in updating drug lists and protocols).
Legal intervention may contribute to the promotion of RUM, providing that a lawsuit is clinically and pharmacologically substantiated.The acceptance of lawsuits devoid of such substantiation, or based only on a medical prescription, places managerial and health-related constraints on the healthcare system.Additionally, it prevents the formulation and implementation of pharmaceutical care policies, encourages the unreasonable use of medicines and often damages the already suffering health of the plaintiff, whom the State has the constitutional duty to protect.

Table 1 .
Minimum, median and maximum time (in days) elapsed between procedural steps.State of Rio de Janeiro, Southeastern Brazil, 2006.
Distribution of fi rst application and fi nal verdict (order) from Court of Appeals 397 129 782Source: Court of Justice, Rio de Janeiro, Brazil

Table 2 .
Compliance of medical prescriptions with general and legal principles of good prescription practices.State of Rio de Janeiro, Southeastern Brazil 2006.

Table 3 .
Medical documents attached to the selected lawsuits.State of Rio de Janeiro, Southeastern Brazil, 2006.
a Written justification of the prescription of that active ingredient at the expense of available therapeutic alternatives.

Table 4 .
Medicines more frequently requested in the selected lawsuits, classified by the fifth level of the Anatomical, Therapeutic and Chemical Classifi cation and by their presence in the Essential Medications List 2002.State of Rio de Janeiro, Southeastern Brazil, 2006.

Tabela 5 .
Special medicines demanded in lawsuits where all medicines requested belonged to some National Health System list, their respective diagnosis and compliance with Ordinance 2.577/2006.State of Rio de Janeiro, Southeastern Brazil,2006.Legal Court, Rio de Janeiro, Brazil a Although it is not provided in the previously mentioned Directive, this indication was provided in the previous edition (Directive MS/GM n. 1.318/2002)19 in force at the beginning of the lawsuit.