On the drivers of drug shortages: empirical evidence from Germany

Abstract

PurposeDisruptions and shortages of drugs have become severe problems in recent years, which has triggered strong media and public interest in the topic. However, little is known about the factors that can be associated with the increased frequency of shortages. In this paper, the authors analyze the drivers of drug shortages using empirical data for Germany, the fourth largest pharmaceutical market.Design/methodology/approachThe authors use a dataset provided by the German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte [BfArM]) with 425 reported shortages for drug substances (DSs) in the 24-month period between May 2017 and April 2019 and enrich the data with information from additional sources. Using logistic and negative binomial regression models, the authors analyze the impact of (1) market characteristics, (2) drug substance characteristics and (3) regulatory characteristics on the likelihood of a shortage.FindingsThe authors find that factors like market concentration, patent situation, manufacturing processes or dosage form are significantly associated with the odds of a shortage. The authors discuss the implications of these findings to reduce the frequency and severity of shortages.Originality/valueThe authors contribute to the empirical research on drug shortages by analyzing the impact of market characteristics, DS characteristics and regulatory characteristics on the reported shortages. The authors’ analysis provides a starting point for better prioritizing efforts to strengthen drug supply as it is currently intensely discussed healthcare authorities.

A Returnable Transport Item to Integrate Logistics 4.0 and Circular Economy in Pharma Supply Chains

“…Recent shortages in medical supply illustrate the importance of resilient pharma logistics networks [1,2]. The pharmaceutical industry puts high requirements on its supply chains; most notably temperature monitoring and traceability of medicinal products are a priority in order to warrant product functionality or avoid distribution of counterfeit drugs, respectively [3].…”

Role of Stress Granules in the Pathogenesis of Pulmonary Hypertension Kosmas Kosmas 1,2, Fotios Spyropoulos1,2,Helen Christou 1,21Department of Pediatric Newborn Medicine, Brigham and Women’s Hospital, Boston, MA 02115, USA 2Harvard Medical School, Boston, MA 02215, USA

“…In 2019, the Food and Drug Administration (FDA) found that quality issues were the leading cause of drug shortages, accounting for 62% of shortages (U.S. Food & Drug Administration 2019). These quality issues are often a result of manufacturing problems in pharmaceutical manufacturing facilities (Francas et al 2023, Jensen et al 2002.…”

Wahlfreiheit im Gesundheitswesen – und ihre Auswirkungen auf den Wettbewerb

“…Dieser wettbewerbliche Kostendruck wird für zahlreiche Benachteiligungen und Gerechtigkeitsprobleme verantwortlich gemacht. Zuletzt wurde dies am Beispiel der Generika-Lieferengpässe im Winter 2022/2023 deutlich, die u. a. mit dem inzwischen ausgeprägten Wettbewerb der Krankenkassen um Arzneimittelrabattverträge begründet wurden [5]. Eine andere Sichtweise sieht den Wettbewerb im Gesundheitswesen als ein weitaus umfassenderes Konzept, durch das Potenziale gehoben werden, die Versorgung in allen Bereichen vor allem auch qualitativ zu verbessern.…”