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.

Medicines Shortages Reporting Systems (MSRS): An exploratory review of access and sustainability.

BACKGROUND: The efficacy of medicines depends on their accessibility and availability. Dedicated medicine shortage reporting systems (MSRS) have been set up in different countries, either mandatory or voluntary, following the recommendations of the World Health Organisation to ensure these. OBJECTIVES: To explore how the Medicine Shortages Reporting System (MSRS) can tackle medicine shortages through improved access and sustainability. METHODS: Personnel directly involved in the reporting mechanisms for medicine shortages in eight (8) countries participated in semi-structured interviews. An interview protocol based on the Dynamic Capabilities View and Organisational Information Processing Theory (OIPT) was developed. It contained questions related to participant's views on the process involved in MSRS and how it was used to tackle shortages. Data were thematically analysed. RESULTS: Three core elements were identified to influence MSRS's ability to tackle shortages and ensure sustainability; (1) the ability to identify what information requirements the reporting system needs, (2) identify information processing capabilities, and (3) the ability to match requirements and information processing capabilities through a dynamic capability decision-making process. The dynamic decision-making process involves reiteratively sensing shortages by understanding and validating information received. CONCLUSION: Building MSRS to tackle shortages for accessibility and sustainability is a systemic process that entails understanding the various elements and processes of MSRS. It includes defining medicine shortages, reconfiguring resources, defining accessibility and ensuring the system's sustainability. Our study provides insights into MSRS developed for mitigating medicine shortages and provides a framework for a sustainable MSRS. The findings extend the literature on medicine shortage management by identifying the various elements required to set up an MSRS. It also provides practical implications for countries that seek to establish MSRS to mitigate medicine shortages. Further studies could extend the number of participating countries to provide a clearer picture of the MSRS and how it can reduce medicine shortages.

Blockchain technology: A potential tool for the management of pharma supply chain.

BACKGROUND: The pharma supply chain comprises various parties including distributors, manufacturers, raw material suppliers, regulators, pharmacies, hospitals, and patients. Due to the product's complexity and transaction flows, an efficient traceability system is needed in the pharma supply chain to identify the current and all previous product owners. Digitizing the track and trace process significantly improves regulatory oversight and guarantees product quality. A distributed platform for shared data that is immutable, trustworthy, accountable, and transparent in the pharmaceutical supply chain could be built using blockchain-based drug traceability. OBJECTIVE: This review aims to shed light on blockchain technology's significance and necessity for pharmaceutical supply chain management systems. METHOD: A comprehensive literature review was performed between January 2017 and September 2023. The search was conducted to elaborate on blockchain technology. Blockchain is a software-based technology that logs and records transactions using a block structure arranged chronologically. Cryptography technology links and secures these blocks on a peer-to-peer network. Blockchain is anticipated to transform the pharmaceutical supply chain by giving all participants access to a single, straightforward system that provides transparency, security, and oversight of the end-to-end delivery of goods. RESULT: In all, various literature data were included in this review. Using a supply chain powered by blockchain has many benefits. To begin with, it gives a thorough account of the entire procedure from start to finish. A single piece of software can manage the entire supply chain. Additionally, it increases communication between parties with permission. The enhanced security and traceability that blockchain offers is another important benefit. A blockchain system can track, trace, and recall products. CONCLUSION: Blockchain-based pharmaceutical supply chain management enables the tracking of medicinal drug transactions from raw materials suppliers to end consumers. The pharma blockchain has the potential to enhance the security, integrity, data provenance, and functionality of the supply chain due to its transparency, immutability, and auditability.

Portuguese Global Medicines Access Index 2021: An Indicator to Measure Access to Hospital Medicines.

OBJECTIVES: Access to innovative and effective medication is a citizen's right. The main objectives of this study were to build an indicator to measure access to medicines within hospitals, the Global Medicines Access Index, and to identify the main existing barriers. METHODS: Cross-sectional study carried out in Portuguese National Health Service hospitals. A consensus methodology (expert panel of 7 members) was used to define which dimensions should be included in the index and the weighting that each should take. The panel identified 6 dimensions: access to innovative medicines, proximity distribution, shortages, access to medicines before financing decision, value-based healthcare, and access to medication depending on cost/funding. Data were collected through an electronic questionnaire (September 2021). RESULTS: The response rate was 61.2%. Most hospitals used medicines with and without marketing authorization before the funding decision. Monitoring and generating evidence of new therapies results is still insufficient. The identified barriers were the administrative burden as the major barrier in purchasing medicines, with a relevant impact on shortages of medicines. Most respondents (87%) had a proximity distribution program, mainly implemented in the pandemic context, and the price/funding model was only identified by 10% as a barrier to access. The 2021 Global Medicines Access Index was 66%. Shortages and value-based use of medicines were the dimensions that had more influence in lowering the index value. CONCLUSIONS: The new formula used to obtain a unique and multidimensional index for access to hospital medicines seems to be more sensitive and objective and will be used to monitor access.

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.

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.