State Legislation to Prevent Diversion of Opioids in Hospice Programs: A Deeper Look Into Ohio Law.

The problem of opioid diversion and its contribution to the opioid epidemic are well known nationally, existing even within hospice care. Proper disposal of opioids may be a critical factor in reducing diversion. In 2014, Ohio implemented legislation requiring a hospice employee to destroy or witness disposal of all unused opioids within a patient's plan of care. The purpose of this study was to determine the impact of Ohio Revised Code 3712.062 on hospice programs' policies and procedures to prevent opioid diversion in the home. Directors of Ohio-licensed hospices were surveyed to assess the percentage of programs with a written policy in place for disposal of opioids and to calculate a compliance score based on responses to survey questions assessing compliance with legislation components. Fifty-two surveys were completed (39.4%). All survey respondents reported having a written policy in place. A 95.5% average compliance score was calculated, with the largest disparity occurring with timing of opioid disposal. While Ohio Revised Code 3712.062 requires opioid disposal at the time of patient's death or when no longer needed by the patient, only 84% of respondents report disposing opioids upon discontinuation. Overall, a high compliance rate was seen among hospice programs indicating such regulation is manageable to meet.

A technical analysis of medicines request-related decision making in Brazilian courts.

OBJECTIVE: To analyze judicial requests for medications that are covered by the pharmaceutical assistance components of the Sistema Único de Saúde (SUS - Brazilian Unified 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 identified. Of the medications requested, 14.3% should have been available through SUS primary care, 19.5% were classified under the exceptionally dispensed medications component of the SUS, and 66.2% were not on any official 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.

Rational therapeutics: health-related elements in lawsuits demanding medicines.

OBJECTIVE: To characterize the main medical, scientific 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 certificates 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 justified medicine demands may compromise rational drug use.

[Conflicts and impasses in the judicialization of the supply of medicines: circuit court rulings on claims brought against the State of Rio de Janeiro, Brazil, in 2005]. / Conflitos e impasses da judicialização na obtenção de medicamentos: as decisões de 1 feminine instância nas ações individuais contra o Estado do Rio de Janeiro, Brasil, em 2005.

Based on an analysis of individual claims for provision of medicines brought by users of the Unified National Health System (SUS) against the State of Rio de Janeiro, Brazil, in the year 2005, this study aims to discuss the action and behavior of the court system in ruling on these suits. The study adopted a semi-qualitative exploratory documental research design, analyzing key aspects related to the claims, such as type of medication claimed by the plaintiff, wording of the court rulings, and the key elements used by judges in trying the cases. According to the analysis of the lawsuits and the concepts of judicialization and official standardization of medicines, the study concludes that when ruling on the provision of medicines, the court system grants the claims as submitted without considering the standardization of medicines adopted by the Ministry of Health, thus exercising excessive court intervention in health policy.

Conflitos e impasses da judicialização na obtenção de medicamentos: as decisões de 1ª instância nas ações individuais contra o Estado do Rio de Janeiro, Brasil, em 2005 / Conflicts and impasses in the judicialization of the supply of medicines: circuit court rulings on claims brought against the State of Rio de Janeiro, Brazil, in 2005

Partindo-se de uma análise das ações judiciais individuais para o fornecimento de medicamentos propostas por usuários do Sistema Único de Saúde (SUS) contra o Estado do Rio de Janeiro, Brasil, no ano de 2005, este estudo tem como objetivo discutir a atuação e o comportamento do Poder Judiciário no julgamento dos referidos processos judiciais. O estudo corresponde a uma pesquisa documental exploratória, de caráter quali-quantitativo, na qual foram analisados alguns aspectos relacionados às ações judiciais, tais como, o tipo de medicamento pleiteado, o teor das decisões proferidas e os fundamentos mais freqüentes utilizados pelos magistrados no julgamento das ações. Com base no resultado da análise das ações, do conceito de judicialização e da padronização oficial em matéria de medicamentos, concluiu-se que, ao decidir sobre o fornecimento de medicamentos, o Poder Judiciário concede os pedidos formulados sem considerar a padronização de medicamentos adotada pelo Ministério da Saúde, exercendo assim uma excessiva intervenção na política de saúde.

Based on an analysis of individual claims for provision of medicines brought by users of the Unified National Health System (SUS) against the State of Rio de Janeiro, Brazil, in the year 2005, this study aims to discuss the action and behavior of the court system in ruling on these suits. The study adopted a semi-qualitative exploratory documental research design, analyzing key aspects related to the claims, such as type of medication claimed by the plaintiff, wording of the court rulings, and the key elements used by judges in trying the cases. According to the analysis of the lawsuits and the concepts of judicialization and official standardization of medicines, the study concludes that when ruling on the provision of medicines, the court system grants the claims as submitted without considering the standardization of medicines adopted by the Ministry of Health, thus exercising excessive court intervention in health policy.

Controlled substances in long-term care pharmacy: part 2.

Complying with state and federal requirements for controlled substances is crucial for all pharmacies. Specific regulations regarding how controlled substances are ordered, prescribed, dispensed, and stored, as well as strict requirements for disposal and record-keeping, require specific policies and procedures. For pharmacies that primarily dispense medications to long-term care facilities, there can be some unique challenges.

[Can court injunctions guarantee access to medicines in the public sector? The experience in the State of Rio de Janeiro, Brazil]. / Mandados judiciais como ferramenta para garantia do acesso a medicamentos no setor público: a experiência do Estado do Rio de Janeiro, Brasil.

There are increasing numbers of legal suits concerning access to medicines brought against the Rio de Janeiro State Health Department. The situation indicated the need for a study to clarify the underlying issues. A sample of 389 court suits from January 1991 to December 2001 (stratified by year) was used. A cross-sectional design was used to describe and analyze the legal suits in relation to the responsibilities defined under the Unified National Health System (SUS). Results suggest major delays in court decisions. Most suits are filed by the Public Defender's Office for users of the National Health System. The most frequent cases involve medicines for the cardiovascular and nervous systems, many of which involve continuous use. Prescribing practices are institutionalized through the inclusion of the most frequently prescribed drugs in public financing lists, which makes rational drug use difficult to achieve. Municipalities are not fulfilling their responsibility to supply medicines to users, and the State is thus encumbered with these responsibilities. However, the State does not adequately supply medicines to the municipalities. The apparent lack of awareness among both lawyers and clients generates stress between the Executive and Judiciary branches and limits the resources for collective pharmaceutical services.