[Evolution of the legal and normative framework surrounding the practice of hospital pharmacy and the correct use of drugs in Quebec]. / Évolution du cadre juridique et normatif entourant l'exercice de la pharmacie hospitalière et le bon usage des médicaments au Québec.

OBJECTIVES: The objective was to identify the main texts applicable to the practice of pharmacy in Quebec, then count the specific number of recommendations and criteria and describe the evolution of the legal and normative framework. METHODS: This is a descriptive and retrospective study of the main texts applicable to the legal and normative framework for the practice of pharmacy on January 1st, 2019. RESULTS: A total of 107 texts relating to the practice of pharmacy in Quebec were identified. They come from the legislator (53.1 %), the Order of pharmacists (26.1 %) or other organizations (20.8 %). These were laws/regulations (n=59), contributing to the optimal use of drugs (n=18), relating to hospital pharmacy management (n=18), the provision of pharmaceutical care (n=11), drug preparation (n=3), oncology practice (n=2) or health and safety at work (n=1). Thirty-three texts were considered for enumeration of recommendations and explicit criteria, for a total of 235 recommendations and 3703 explicit criteria applicable to the practice of hospital pharmacy in Quebec. CONCLUSION: There is a significant increase in the number of texts, recommendations and criteria applicable to the practice of hospital pharmacy in Quebec. Compliance with this legal and normative framework appears to be a considerable challenge for hospital pharmacists. It seems worthwhile to further promote discussion with text-issuing agencies in order to keep the search for compliance realistic.

Comprehensive Legislative Reform to Protect the Integrity of the 340B Drug Discount Program.

The 40B Drug Discount Program (340B Program) is a federally facilitated program that requires drug manufacturers to provide steep discounts on outpatient prescription drugs to qualifying safety net health care providers. The federal program is intended as a safeguard to ensure access to affordable drugs to the indigeut. However, over the last two decades safety net health care providers have exploited financial incentives under the 340B Program at the expense of drug manufacturers and patients, including the most needy and vulnerable populations-they are committed to serve. Although the federal government has been applauded for increasing effortsto combat health care fraud and abuse including recovering $3.3 billion in 2014, federal officials and the general public have paid markedly less attention to pervasive abuse of the 340B Program. In 2014, drug purchases of 340B-designated drugs totaled $7 billion and are expected to increase to $12 billion: by 2016 as a result of the expansion of the program under the Affordable Care Act. The 340B Program has completely lost its way, and comprehensive legislation is necessary to realign the program with its intent.

Judicialização da medicina no acesso a medicamentos: reflexões bioéticas / Judicialización de la medicina en el acceso a medicamentos: reflexiones bioéticas / Judicialization of medicine in the access to drugs: bioethical reflections

O artigo trata da judicialização da medicina voltada ao acesso a medicamentos, situação persistente que causa agravos ao sistema público de saúde. Objetiva apresentar os pontos básicos desta prática realizando reflexão bioética, mediante revisão bibliográfica e sistematização do material levantado. Os resultados mostram que a judicialização da medicina vem tomando cada vez mais vulto e não terá condições de sustentar-se por muito tempo. A bioética, multidisciplinar, pode sugerir algumas soluções. Conclui-se que as decisões do Judiciário deveriam contemplar a complexidade da vida humana, não apenas garantindo medicamentos. Seria importante a comunicação entre a saúde e a Justiça para discussões e elaborações de pareceres, bem como refletir sobre o significado individual do pedido e obtenção das medicações por via judiciária. Isto poderia revelar questões pessoais e qualidade de vida, preservando a ambas.

El artículo trata de la judicialización de la medicina en el acceso a los medicamentos, situación persistente que causa empeoramiento al sistema de salud pública. Presentar puntos básicos de esta práctica realizando una reflexión bioética mediante revisión bibliográfica y sistematización del material recogido. Los resultados permiten observar que la judicialización de la medicina está creciendo y no tendrá condiciones de sostenerse por mucho tiempo. La bioética, multidisciplinaria, puede sugerir algunas soluciones. Se concluye que las decisiones del Judicial deberían contemplar la complejidad de la vida humana, no sólo garantizando medicamentos. Sería importante la comunicación entre la salud y la Justicia para discusiones y elaboraciones de opiniones, así como reflejar acerca del significado individual del pedido y obtención de las medicinas a través del judicial. Esto podría revelar asuntos personales y de calidad de vida, preservando a ambas.

This article discuse about judicialization of medicine in the access to drugs, a persistent health status that causes injuries to the public system of health. We exposed the basic points to such practice to provide a bioethical discussion of the processes, through bibliographic revision and the systematization of the collected material. It is possible to note that the judicialization of medicine has increasingly been taking relevance and it will no longer be able to be supported. The multidisciplinary Bioethics may suggest some solutions. It is concluded that Judiciary decisions would contemplate the complexity of human life, not just assuring drugs. It would be important the communication between health and justice for discussions and opinion elaboration, as well as discussing on the individual meaning of the request and obtaining medications by judiciary means. This could reveal personal issues and quality of life, by preserving both ones.

Comparison of hospital pharmacy practice in France and Canada: can different practice perspectives complement each other?

OBJECTIVE: To compare hospital pharmacy practice in France and Canada by identifying similarities and differences in the two institution's pharmacy activities, resources, drug dispensing processes and responsibilities. SETTING: Centre hospitalier universitaire Sainte-Justine (SJ), Montréal, Québec, Canada and Hôpital Robert Debré (RD), Paris, France, are two maternal-child teaching hospitals. They share a similar mission focused on patient care, teaching and research. METHOD: The data were gathered from annual reports, department strategic plans and by direct observation. MAIN OUTCOME MEASURE: The description and comparison of the legal environment, hospital demographics, pharmacy department data, drug dispensing processes and pharmacist activities in the two institutions. RESULTS: The Centre hospitalier universitaire Sainte-Justine and Hôpital Robert Debré are similar with respect to their mission and general demographics; number of beds, annual hospital expenditures, number of admissions, visits and childbirths. The respective pharmacy departments differ in allocated resources. The main operational differences concern compounding, quality control programs and clinical activities. The French department also manages medical devices, medical gases, blood derivatives and the sterilisation unit. These comparisons highlight the more patient-oriented Canadian hospital pharmacy practice against the more product-oriented French hospital practice Factors contributing to these differences include academic curriculum, the attention paid to the legal environment by professional bodies, staffing patterns and culture. CONCLUSION: There are differences between the hospital pharmacy practice in the studied hospitals in Canada and France. Hospital pharmacy practice in France seems to be more product oriented, and the practice in Canada seems more patient oriented.

Organizations join forces against Joint Commission medication rules.

Leading emergency medicine organizations debate new standards on prescription review and medication reconciliation with the Joint Commission on Accreditation of Healthcare Organizations. Every medication given to patients in the ED must be reviewed by a pharmacist unless there is an urgent need to give the drug. All patients who present to the ED must have a full reconciliation of all of their medications. If the patient or family members cannot complete medication reconciliation, their primary care physician or pharmacy must be contacted.

A systems approach to identifying inappropriate use of controlled substances: the need for balance.

BACKGROUND: The diversion, abuse, and inappropriate use of controlled substances remain of concern among health care practitioners, insurers, and policy makers in the United States. The principle of "balance" represents a need to establish a system of control to prevent abuse, trafficking, and diversion of controlled substances, while ensuring their medical availability for legitimate patients. ADMINISTRATIVE DATABASES TO STUDY OUTCOMES AND QUALITY OF CARE: Some models employ pattern recognition within administrative health databases, for example, to examine outcomes and quality of medical care and monitor fraudulent behaviors and inappropriate medical care. Patients' use of resources or variations in practitioners' practice patterns can be examined. A SYSTEMS APPROACH TO ADDRESS INAPPROPRIATE USE OF CONTROLLED SUBSTANCES: A systems approach would require collaboration with medical and pharmacy directors, systems analysts, coding experts, legal experts, and clinicians to develop the claims-based model. Once a patient and/or practitioner with possible diversion or abuse are identified, a second step is required to distinguish inappropriate and appropriate behaviors and medical care. CONCLUSION: Programs to detect misuse of controlled substances must be validated through clinical research, and a consensus should be reached as to what constitutes a breach of accepted medical practice.

The case for bar coding: better information, better care--and better business.

Bar coding, pervasive in almost all other industries, has been slow to infiltrate the healthcare setting. for years, disparate systems, a lack of standardization, and an absence of significant market incentives have hindered healthcare providers, IT vendors, and drug manufacturers alike in adopting bar coding technology. But thanks to a proposed FDA rule issued last Spring, bar coding is is edging its way to the top of many IT priority lists. By mid-2004, the final rule should be passed, which will require all drugmakers to bar code prescription drug products at the unit dose level. The bar code will identify the drug, manufacture, strength of the medication, and dosage.

Scanning for higher profits. The FDA's plan to require bar codes on commonly used medical products will do more than improve patient safety.

Omnipresent bar coding is going to get even more visible. The Food and Drug Administration has pledged to approve later this year a plan requiring bar codes on every dose of medication administered in hospitals. The FDA's initiative is garnering praise for both its capacity to improve patient safety and potential to save money.

Bar code bandwagon.

The Food and Drug Administration issued a proposed rule in March requiring bar codes on all medications. Most expect that the technology will be commonplace in hospitals before the FDA's three-year window. A handful of systems are leading the way.