Understanding drug exceptional access programs (DEAPs) in Canada, and their associated social and political issues.

Drug exceptional access programs (DEAPs) exist across Canada to address gaps in access to pharmaceuticals. These programs circumvent standard procedures, raising epistemic, economic, social and political issues. This commentary provides insights into these issues by revealing the context and procedures on which these programs depend.

Improving Drug Supply Chain Security.

This Viewpoint discusses the importance of the Drug Supply Chain Security Act and the need for pharmaceutical supply chain safeguards.

How Technical Innovations May Help to Prevent Drug Shortages in Switzerland.

In this work, we investigated the technical feasibility of 'on-demand' production of selected drugs to cover their demand for a time window of 90 days. We focused on two sub-processes 'automated chemical synthesis' and 'formulation in micropellets'  to enable personalized dosing. The production of drugs 'on-demand' is challenging, important, but also attractive. Switzerland could thus gain access to an additional instrument for increasing resilience for supply-critical drugs. The biggest challenge in the case study presented here is the scalability of automated chemical synthesis and the application range of micropellet formulations.

Assessment of the Global Fund-supported procurement and supply chain reforms at the Ethiopian Pharmaceuticals Supply Agency: a mixed-methods study.

OBJECTIVE: The Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund) partnered with the Ethiopian Pharmaceutical Supply Agency (EPSA) in 2018-2019 to reform procurement and supply chain management (PSCM) procedures within the Ethiopian healthcare system. This assessment sought to determine the impact of the reforms and document the lessons learnt. DESIGN: Mixed-methods study incorporating qualitative and quantitative analysis. Purposive and snowballing sampling techniques were applied for the qualitative methods, and the data collected was transcribed in full and subjected to thematic content analysis. Descriptive analysis was applied to quantitative data. SETTING: The study was based in Ethiopia and focused on the EPSA operations nationally between 2017 and 2021. PARTICIPANTS: Twenty-five Ethiopian healthcare decision-makers and health workers. INTERVENTION: Global Fund training programme for health workers and infrastructural improvements OUTCOMES: Operational and financial measures for healthcare PSCM. RESULTS: The availability of antiretrovirals, tuberculosis and malaria medicines, and other related commodities, remained consistently high. Line fill rate and forecast accuracy were average. Between 2018 and 2021, procurement lead times for HIV and malaria-related orders reduced by 43.0% relative to other commodities that reported an increase. Many interview respondents recognised the important role of the Global Fund support in improving the performance of EPSA and provided specific attributions to the observed successes. However, they were also clear that more needs to be done in specific critical areas such as financing, strategic reorganisation, data and information management systems. CONCLUSION: The Global Fund-supported initiatives led to improvements in the EPSA performance, despite several persistent challenges. To sustain and secure the gains achieved so far through Global Fund support and make progress, it is important that various stakeholders, including the government and the donor community, work together to support EPSA in delivering on its core mandate within the Ethiopian health system.

Digitalization enhancement in the pharmaceutical supply network using a supply chain risk management approach.

One major issue in pharmaceutical supply chain management is the supply shortage, and determining the root causes of medicine shortages necessitates an in-depth investigation. The concept of risk management is proposed in this study to identify significant risk factors in the pharmaceutical supply chain. Fuzzy failure mode and effect analysis and data envelopment analysis were used to evaluate the risks of the pharmaceutical supply chain. Based on a case study on the Malaysian pharmaceutical supply chain, it reveals that the pharmacy node is the riskiest link. The unavailability of medicine due to unexpected demand, as well as the scarcity of specialty or substitute drugs, pose the most significant risk factors. These risks could be mitigated by digital technology. We propose an appropriate digital technology platform consisting of big data analytics and blockchain technologies to undertake these challenges of supply shortage. By addressing risk factors through the implementation of a digitalized supply chain, organizations can fortify their supply networks, fostering resilience and efficiency, and thereby playing a pivotal role in advancing the Pharma 4.0 era.

Impact of China's National Centralized Drug Procurement Policy on pharmaceutical enterprises' financial performance: a quasi-natural experimental study.

Introduction: In China, the interest relationship between pharmaceutical enterprises and medical institutions has harmed the healthy development of pharmaceutical enterprises. In November 2018, the National Centralized Drug Procurement (NCDP) policy was published. The NCDP policy severs the interest relationship and significantly impacts on pharmaceutical enterprises's financial performance. Methods: Using the implementation of China's National Centralized Drug Procurement (NCDP) policy as a quasi-natural experiment, this study evaluated the impact of participation in the NCDP policy on pharmaceutical enterprises' financial performance. We developed a difference-in-difference model to estimate the change in financial performance after NCDP implementation, based on financial data on Chinese listed pharmaceutical enterprises. Results: We found that the bid-winning enterprises' financial performance significantly improved after participating in NCDP. This may be related to lower costs, market share expansion, and increased research and development investment by the bid-winning enterprises. Discussion: To further promote the high-quality development of pharmaceutical enterprises in China, the government should expand the variety of drugs on the NCDP list (NCDP drugs), while improving the drug patent protection system and the policies to support the bid-winning enterprises.

The Problem of Limited-Supply Agreements for Medicare Price Negotiation.

This Viewpoint discusses how limited-supply agreements (introduction of generic products in reduced volumes) might thwart efforts to negotiate lower prices on prescription drugs in the US.

National Drug Shortages Affect Patient Care.

Navigating record-high, ongoing shortages.

Pediatric Drug and Other Shortages in the Age of Supply Chain Disruption.

This Viewpoint lists the top 3 pediatric drugs and product shortages, considers the federal government's and manufacturers' ethical duty to protect children, reviews the causes for the shortages, and suggests policy changes that could help fill in the gap.

Ministério da Saúde incorpora dois medicamentos ao SUS para tratamento de anemia

O Ministério da Saúde incorporou no Sistema Único de Saúde (SUS) dois medicamentos para tratamento da anemia, após análise da Comissão Nacional de Incorporação de Tecnologias no SUS (Conitec).

Access to Medicines Is Critically Important for Consumers.

In modern times, there has been an enormous explosion of therapeutic options for various conditions, conferring what would, at times, be a bewildering spectrum of choices for prescribers. In some ways, the issue has moved beyond whether a treatment is available or not, beyond the subtleties of choice in terms of efficacy, and even beyond the balance of potential benefit compared with the possibility of treatment-related harm. For many, the primary consideration is simply: access.

University Pharmacy: from the foundation to the Pandemic times of Covid-19

Abstract The University Pharmacy Program (FU), from the Federal University of Rio de Janeiro (UFRJ), was created based on the need to offer a curricular internship to students of the Undergraduate Course at the Faculty of Pharmacy. Currently, it is responsible for the care of about 200 patients/day, offering vacancies for curricular internships for students in the Pharmacy course, it has become a reference in the manipulation of many drugs neglected by the pharmaceutical industry and provides access to medicines for low-income users playing an important social function. Research is one of the pillars of FU-UFRJ and several master and doctoral students use the FU research laboratory in the development of dissertations and theses. As of 2002, the Pharmaceutical Care extension projects started to guarantee a rational and safe pharmacotherapy for the medicine users. From its beginning in 1982 until the current quarantine due to the COVID-19 pandemic, FU-UFRJ has been adapting to the new reality and continued to provide patient care services, maintaining its teaching, research, and extension activities. The FU plays a relevant social role in guaranteeing the low-income population access to special and neglected medicines, and to pharmaceutical and education services in health promotion.

Análise das solicitações de medicamentos não padronizados de um hospital universitário terciário / Analysis of requests for non-standard medicines from a tertiary university hospital

Introdução: O uso extensivo de medicamentos não padronizados causa aumento de custos em saúde, além de potencial redução de segurança e uso racional de medicamentos. A Comissão de Farmácia e Terapêutica orienta a prescrição de medicamentos, por meio da avaliação e seleção de medicamentos a serem incluídos no formulário de medicamentos padronizados, com base nas melhores evidências científicas disponíveis e no perfil dos pacientes locais, promovendo o uso racional de medicamentos. O objetivo deste trabalho foi analisar as solicitações de fornecimento de medicamentos não padronizados na instituição. Métodos: Trata-se de um estudo observacional e descritivo onde foram analisadas as solicitações de medicamentos não padronizados realizadas entre fevereiro de 2016 e dezembro de 2021, identificando os medicamentos envolvidos e seus respectivos custos. Resultados: Foram realizadas 203 solicitações no período, sendo 174 incluídas no estudo. Os medicamentos que tiveram mais solicitações foram o rituximabe (41), a imunoglobulina humana (31), o sucralfato (23), a nitazoxanida (12) e o eltrombopague (7). As solicitações com maior custo foram as de imunoglobulina humana (US$ 799,702.38), rituximabe (US$ 717,320.26), eltrombopague (US$ 281,062.50), ruxolitinibe (US$ 167,867.46) e bortezomibe (US$ 149,033.52). As principais clínicas que solicitaram medicamentos não padronizado foram a neurologia (47), a hematologia (30), as moléstias infecciosas e parasitárias (17), e a anestesiologia (12). As solicitações de maior custo foram realizadas pela neurologia (US$ 145,519.08), hematologia (US$ 120,980.25), transplante de medula óssea (US$ 51,635.11) e dermatologia (US$ 44,813.40). Conclusão: O estudo demonstrou que há um fluxo estruturado de solicitação de medicamentos não padronizados na instituição, sendo uma importante ferramenta de gerenciamento dessas solicitações, evitando a aquisição desnecessária de itens que não compõem o elenco terapêutico do hospital.

Introduction: Widespread use of non-formulary drugs (NFD) increases cost and may reduce safety and rational use of medicines. The Pharmacy and Therapeutics Committee provides guidance on drug prescription by evaluating and selecting medications to be included in a hospital's formulary based on best scientific evidence available and local patients' profile, promoting rational use of medicines. The objective of this study was to assess non-formulary drugs prescriptions at a tertiary hospital. Methods: This was a retrospective study. NFD prescribed and its associated costs were assessed through NFD request forms received from February 2016 to December 2021. Results: A total of 203 NFD request forms were received, from which 174 were included in this study. The most frequently prescribed NFD included rituximab (n = 41), immunoglobulin (31), sucralfate (23), nitazoxanide (12), and eltrombopag (7), with the highest costs being with immunoglobulin (US$ 799,702.38), rituximab (US$ 717,320.26), eltrombopag (US$ 281,062.50), ruxolitinib (US$ 167,867.46), and bortezomib (US$ 149,033.52). The most frequent requesting specialties were neurology (n = 47), hematology (30), infectious disease (17) and anesthesiology (12), and highest costs requests were from neurology (US$ 145,519.08), hematology (US$ 120,980.25), bone marrow transplant unit (US$ 51,635.11), and dermatology (US$ 44,813.40). Conclusion: This study showed that a structured request flow for NFD prescription is a critical procedure in order to better manage drug prescription within the hospital, promoting rational use of medicines and preventing unnecessary spending with drugs for which the clinical indication may be covered by a drug already in the hospital's formulary.

Tareas fundamentales de la obstetricia: recomendaciones para la regulación de la prescripción, uso y dispensa de medicación / El Trabajo Obstétrico en la Salud Sexual y Reproductiva / Fundamental tasks of obstetrics: recommendations for the regulation of the prescription, use and dispensing of medication / Obstetric work in sexual and reproductive health

El objetivo es presentar una descripción general de las diferentes estrategias normativas para la autorización de la prescripción, el uso y la dispensa de medicamentos por parte de obstétricas. Para ello, se ofrece un breve panorama de las recomendaciones de organismos de rectoría sanitaria y profesional para ese fin, así como de las regulaciones de diferentes países del mundo. Además, se presenta un análisis comparado de las regulaciones existentes en la Argentina, enfocando en las estrategias regulatorias y, en particular, la revisión de los vademécums obstétricos vigentes. Ello, con el fin de aportar argumentos y observaciones sobre su alcance, estructura y contenido, y para indicar las fortalezas y desafíos que cada una de estas estrategias de regulación comporta. Finalmente, aportamos algunas breves recomendaciones para la formulación de una regulación nacional y de un vademécum obstétrico nacional en el marco de la aprobación de alguno de los proyectos de ley nacional de regulación de las competencias profesionales de la obstetricia que cursan en el Congreso de la Nación actualmente.