Globally, there are dozens of definitions of what constitutes a drug shortage. According to the most important national drug regulation authority worldwide, the U.S. Food and Drug Administration (FDA), a drug shortage is "a period of time when the demand or projected demand for a drug (within the U.S.) exceeds its supply." Although one could think that drug shortages are probably an issue of poorer and developing countries, they are also a substantial, and quite common, problem in developed countries. Drug shortages can have serious repercussions. First, for patients, for example through changes in treatment, inferior treatment, delayed treatment as well as denied treatment, prolonged hospital stays, and even death can occur as a worst-case scenario. Furthermore, drug shortages mostly result in additional costs for various stakeholders, but again especially for patients.
What are the major causes?
There are three major causes for drug shortages: supply-related issues, demand-related issues, and regulatory issues. All reasons for drug shortages can be allocated to one of these groups. Supply issues can include, for example, manufacturing issues and unavailability of raw materials. In the U.S., manufacturing issues were responsible for more than one fifth of all drug shortages in 2021. In Canada, disruption in manufacturing was named as major reason for more than half of all drug shortages. On the other hand, a sudden increase in demand can also lead to drug shortages. Typically, unexpected increase in demand can be caused by outbreaks, epidemics and pandemics, and disasters. Regulatory issues can be caused by the long process for authorities to review existing and new drugs for their qualifications. When authorities decide to make a product available to new age groups (children, for example), demand for a drug can also jump immediately and significantly. However, it should be mentioned that in many cases the real reason for a drug shortage remains unknown.
What patients and drugs are under higher risk?
Recent data shows that more than 60 percent of adult Americans are current users of one or more prescription drug. In most European countries, the share of prescription drug users lies between 40 and 60 percent. It’s obvious that large parts of populations in developed countries consume prescription drugs. Among the most used drugs are in general those used for the treatment of high-prevalent chronic conditions like hypertension, high cholesterol, diabetes, mental illness, respiratory diseases, etc. Across Europe, cardiovascular drugs, nervous system medicines, and respiratory medication are the three drug classes most affected by shortages. In the U.S., drugs for the treatment of the central nervous system showed the highest risk for shortages. Thus, drug shortages can potentially affect many people. Canadian data shows that generic, non-patented drugs have a higher risk of shortage. Interestingly, the more manufacturers of a molecule, the higher the share of drugs in shortage.
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