Medicine shortages: a commentary on causes and mitigation strategies

Abstract

Shortages of medicines and vaccines have been reported in countries of all income levels in recent years. Shortages can result from one or multiple causes, including shortages of raw materials, manufacturing capacity problems, industry consolidation, marketing practices, and procurement and supply chain management. Existing approaches to mitigate shortages include advance notice systems managed through medicine regulatory authorities, special programmes that track medicines, and interventions to improve efficiency of the medicine supply chain. Redistribution of supplies at the national level can mitigate some shortages in the short term. International redistribution and exceptional regulatory approvals may be used in limited circumstances, with the understanding that such approaches are complex and may introduce cost and quality risks. If it is necessary to prioritise patients to receive a medicine that is in shortage, evidence-based practice should be used to ensure optimal allocation. Important steps in reducing medicine shortages and their impact include identifying medicines that are most at risk, developing reporting systems to share information on current and emerging shortages, and improving data from medicine supply chains.

Prospective Risk Assessment of Medicine Shortages in Europe and Israel: Findings and Implications

“…Medicine shortages have a direct impact on patient outcomes through disrupting the continuity of patient care and potentially deteriorating treatment outcomes originating from timely scarcity of drug supply and substitution with a less safe and effective alternative and the potential for medication errors (Iyengar et al, 2016;De Weerdt et al, 2017;Rinaldi et al, 2017;France Assos Santé, 2018;Phuong et al, 2019). Consequently, risk management plays an important role in healthcare settings via minimizing the likelihood of identified risk-related consequences associated with drug shortages (The Australian Council on Healthcare Standards (ACHS), 2013; Iyengar et al, 2016;American Society of Health-System Pharmacists, 2018;Root, 2018).…”

A challenge for healthcare but just another opportunity for illegitimate online sellers: Dubious market of shortage oncology drugs

“…The main difference between the U.S. and European drug supply issues is that the generic/originator ratio of drugs being in shortage is much higher in the United States comparing to the European countries [ 11 , 14 ].Causes and contributing factors of drug shortages may vary in countries and show a multidimensional nature both on the supply and demand side. Despite the variation there are similarities in the primary drivers, such as manufacturing problems, economic and health policy decisions [ 2 , 15 , 16 – 22 ] In Europe the leading cause of drug shortages can be linked to manufacturing and GMP compliance problems [ 23 ].…”

Estimation of cost-based prices for injectable medicines in the WHO Essential Medicines List

“…Pricing policies linked to manufacturer costs would also need to be used alongside policies to prevent shortages and stock-outs 24. Indeed, some of the therapeutic groups identified in this analysis as having in many cases high differences between market prices and estimated cost-based prices, such as chemotherapy medicines and antibiotics, may also be groups that are vulnerable to shortages 25 26…”