Abstract
Drug shortage is a global issue affecting low, middle, and high-income countries. Many countries have developed various strategies to overcome the problem, while the problem is accelerating, affecting the whole world. All types of drugs, such as essential life-saving drugs, oncology medicines, antimicrobial drugs, analgesics, opioids, cardiovascular drugs, radiopharmaceutical, and parenteral products, are liable to the shortage. Among all pharmaceutical dosage forms, sterile injectable products have a higher risk of shortage than other forms. The causes of shortage are multifactorial, including supply issues, demand issues, and regulatory issues. Supply issues consist of manufacturing problems, unavailability of raw materials, logistic problems, and business problems. In contrast, demand issues include just-in-time inventory, higher demand for a product, seasonal demand, and unpredictable demand. For regulatory issues, one important factor is the lack of a unified definition of drug shortage. Drug shortage affects all stakeholders from economic, clinical, and humanistic aspects. WHO established global mitigation strategies from four levels to overcome drug shortages globally. It includes a workaround to tackle the current shortage, operational improvements to reduce the shortage risk and achieve early warning, changes in governmental policies, and education and training of all health professionals about managing shortages.
Highlights
Medicines are vital elements to health-care, and access to medicines is a fundamental human right (Hogerzeil, 2006)
This review aims to evaluate the current drug shortage situation in high, middle, and low-income countries and summarize its causes, impacts, and mitigation strategies that the world can implement to overcome
There are several definitions widely used by researchers, including definitions given by the University of Utah Drug Information Service (UUDIS), the American Society of Health-System Pharmacists (ASHP) (Fox et al, 2014; Phuong et al, 2019), the United States Food and Drug (Administration US FDA, 2020), the Health Canada (Dill and Ahn, 2014), the International Society of Pharmaceutical Engineering (ISPE), the European Federation of Pharmaceutical Industries and Associations (EFPIA) (Fox and Tyler, 2013) and the International Pharmaceutical Federation (FIP)
Summary
Medicines are vital elements to health-care, and access to medicines is a fundamental human right (Hogerzeil, 2006). The prevailing drug shortage problems bring significant challenges to the health care system. The shortage of drugs remained a problem in history up to the present date. The first time of drug scarcity in the record could be traced back to the insulin shortage in the early 1920s. The drug shortage is more common worldwide (Yang et al, 2016; Walker et al, 2017; Unguru et al, 2019; Zwaida et al, 2019). In 2012, Gray and Manasse found that 21 countries were affected by drug shortages (Russell et al, 2017), and the recent data of the University of Utah Drug Information
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