Let's talk causality attribution: 

Current practices and path forward.  

Presented at the World Drug Safety Europe Congress in Amsterdam (October 2023). 

Pharmaceutical supply chains have become increasingly complex due to the shift of manufacturing and critical operations to Asia. U.S. pharmaceutical dependency on foreign sole-source production of essential materials imposes vulnerability affecting the entire industry and national health systems from interruption by exposure to natural events and man-made threats, both accidental and criminal as well as political. Sector vulnerabilities stem from complex regulatory landscape, difficulties for enforcement of quality standards at foreign facilities, single-source supply chain resulting from limited sourcing options, increasing shipping distance exposure to both natural events and complicated by maritime chokepoints. Periodic and chronic shortages of many essential products across therapeutic categories have been significant for more than a decade. The Covid-19 crisis aggravated some of these long-standing issues and made the systemic vulnerabilities publicly evident. The combination of limited capacity to exercise control over essential commodities, the long-term trend of outsourcing, with the politicization of business relationships causes the entire pharmaceutical industrial sector to be internationally dependent, creating numerous potentials for systemic failure.

The workshop is designed to introduce pharmacovigilance to graduate students and working professionals interested in drug safety as a career field. After a brief introduction of publicly available data sources, each team received a case study that detailed a specific safety concern that resulted in a significant safety update of product labeling or product withdrawal. 

Innovative Approaches to Drug Safety 

(Virtual Workshop 2019). 

The current practice of pharmacovigilance is fraught with challenges and limitations, but new technologies, perspectives and concerns are shaping the way stakeholders will need to conduct this crucial activity in the coming years. You are cordially invited to join our workshop on the future of pharmacovigilance, which offers you an opportunity to participate in a robust, informative and professional discussion about the future of pharmacovigilance. We seek your perspectives on the issues before us today and how they will influence the drug safety environment in the 2020s.

Production of Real-World Evidence at the hospital level to provide accurate and timely insight into the safety and efficacy of marketed drugs.  Stakeholders in the healthcare ecosystem need accurate, comprehensive and timely medical evidence. An integrated solution to provide this evidence through analysis of real-world data can be designed and developed. Utilizing master study protocols, such a service would employ data analysis and integration platforms that would process real-world data within each contributing hospital. By producing standardized and layered medical evidence, valuable insight into the safety and efficacy of marketed drugs can be obtained and shared.

This report analyzes availability of essential medicines as defined in the WHO EML in the Czech Republic and Hungary. The report offers comprehensive information on active pharmaceutical ingredients offered locally as well as number of registrations for each API by system organ class. The WHO list contains most effective and safe medicines needed to meet the most important needs in health systems, and is frequently used by countries to create their own national lists. Without these drugs, some conditions will not be able to receive optimal therapy. Availability gap represents serious public health concern. National lists must be adjusted to reflect the need of the local population. 

Pharmaceutical supply chains are becoming more and more complex due to globalization, shift of manufacturing and business operations to Asia, and due to complex relationships between vendors and supply chain partners. Good distribution practices are an important part of the whole system of appropriate supply chain management. 

The material included in these modules serves many interests by facilitating understanding of construct, dynamics, and influences affecting regulatory policies and corporate decision-making that ultimately determine access, availability, and effectiveness of pharmaceutical products. 

Survival guide to stem cell research and therapies provides comprehensive guidance to publicly available resource materials, libraries and registries for people who are interested in understanding currently available treatment options involving human stem cells.

Edwards B, and Valdova V: “Political and religious perspectives on managing the risks and benefits of women’s medicines,” in Medicines for Women, ed. Mira Harrison-Woolrych (Springer, 2015).