ReviewInternational journal of pharmaceutics2020
New regulatory strategies to manage medicines shortages in Europe.
Review in International journal of pharmaceutics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers.
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Who cites it
24 citing papers in PubMed.
- Evolution of community pharmacy services in the European Union and beyond: a cross-country survey of 33 national pharmacy organisations.International journal of clinical pharmacy · 2026Article
- Structural drivers of drug shortages and market withdrawal: a longitudinal analysis of the Romanian pharmaceutical market.BMC health services research · 2026Article
- How to alleviate the shortage: a scoping review of prevention and management of global drug shortages.BMC public health · 2026Article
- Determinants, Models, performances, and strategies of supply chain to address medicine stockouts in primary health care: a scoping review.Journal of pharmaceutical policy and practice · 2026Review
- Medicine Shortages: An Algorithm for Evaluating the Substitution with Equivalent or Alternative Products.Healthcare (Basel, Switzerland) · 2025Article
- Impact of medicine shortages on hospital practice: role of a multidisciplinary medicine shortages team.International journal of clinical pharmacy · 2024Article
- Draft Guideline for Industry to Manage Drug Shortages in Japan.Therapeutic innovation & regulatory science · 2024Article
- Drug supply and assurance: a cross-sectional study of drug shortage monitoring varieties in China.BMC public health · 2024Article
- Impact of the pandemic on hospital care for chronic pain patients in Germany.Frontiers in medicine · 2024Article
- Article
- Digitalization enhancement in the pharmaceutical supply network using a supply chain risk management approach.Scientific reports · 2023Article
- Medicine shortages in France: a 6-year retrospective study in a university medical centre.European journal of hospital pharmacy : science and practice · 2023Article
- Reasons that lead people to buy prescription medicines on the internet: a systematic review.Frontiers in pharmacology · 2023Review
- Prevention and management of health products shortages by the French national agency (ANSM), 10 years of experience.Frontiers in public health · 2023Article
- Price increase negotiations to address drug shortages in South Korea's national health insurance.Frontiers in pharmacology · 2023Article
- International trends in prescription opioid sales among developed and developing economies, and the impact of the COVID-19 pandemic: A cross-sectional analysis of 66 countries.Pharmacoepidemiology and drug safety · 2022Article
- A 5-year look-back at the notification and management of vaccine supply shortages in Germany.Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin · 2022Article
- Supply chain resilience in a Covid-19 scenario: Mapping capabilities in a systemic framework.Sustainable production and consumption · 2022Article
- Medicine shortages: Product life cycle phases and characteristics of medicines in short supply-A register study.Frontiers in pharmacology · 2022Article
- Time-trend analysis of medicine sales and shortages during COVID-19 outbreak: Data from community pharmacies.Research in social & administrative pharmacy : RSAP · 2021Article
Corrections and comments
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Medicine shortages have been spreading in European countries. In many cases, the unavailability of medicinal products has a substantial impact on the capability of National Healthcare Systems in ensuring the continuity of care. Shortages originate from multifactorial causes. In particular, they can be due to supply-related factors (e.g., manufacturing issues, regulatory issues, logistics, distribution) and demand-related ones (e.g., fluctuating drug demand, parallel market, tendering, price and reimbursement policies). However, some extraordinary geopolitical events (e.g., Brexit) may also affect medicines' availability. The capability of European Regulatory Authorities and other stakeholders, which are involved in the pharmaceutical distribution chain and the healthcare assistance services, to define suitable problem-solving strategies has been limited for years by the fragmentation of the European regulatory framework, starting from the lack of a univocal definition of a medicine shortage. Only in 2019, the EMA and HMA joint task force released the first harmonized "shortage" definition in the European Economic Area (EEA) and guidance on public communication. This manuscript aims to review the current European regulatory framework on medicine shortages. To support the activities of regulators, manufacturers and other healthcare professionals, an algorithm was also proposed to be used as a harmonized procedure to determine the shortage/unavailability impact on public health and to rationalize the problem-solving strategies adopted in all different settings.
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