One of the key priority areas in healthcare today is the access to and future of medicine – a topic stressed by major national and international organizations. Medications are an integral part of healthcare delivery, consume a significant amount of healthcare spending, and affect both developed and developing markets. Global spending on drugs was estimated to be more than $1 trillion in 2018 and is projected to reach more than $1.5 trillion by 2023.(1) The United States (US) total prescription spending alone is estimated to have reached $476 billion in 2018 – this is comparable to the full economies of some developed countries.(2)

The World Health Organization (WHO) estimates, however, that two billion people globally still lack access to essential medications.(3) These are medications that could save lives, prevent illness and suffering, and allow individuals a chance at living a better quality of life. The struggle to access medication is not exclusive to patients, as healthcare institutions (e.g., hospitals and pharmacies) are experiencing drug shortages and are having difficulties obtaining the medications they need. 

As we are experiencing shortages of personal protective equipment (PPE) during the COVID-19 pandemic, shortages of essential medications are also sounding the alarm. The universality and breadth of this crisis has impacted the global pharmaceutical supply chain.

With hundreds of medications already in short supply, global crises (like COVID-19) create additional burden on the supply chain.

Drug shortages are becoming increasingly prevalent, affecting hundreds of medications, and are considered a public health crisis across the globe – significantly impacting patient safety, drug therapy, and how we access and manage care. The Food and Drug Administration (FDA) and the American Society of Health-System Pharmacists (ASHP) both monitor and track drug shortages. They are considered a central resource for information on drug shortages in the United States. However, each has a slightly different definition of drug shortages – which ends up influencing the quantity and severity of the shortages reported. Therefore, it is common to see differences in the number of drug shortages reported by each organization.

The FDA defines a drug shortage as “A period of time when the demand or projected demand for a medically necessary drug in the United States exceeds its supply.”(4,5) Whereas, ASHP defines a drug shortage as “a supply issue that affects how the pharmacy prepares or dispenses a drug product or influences patient care when prescribers must use an alternative agent.” (4,6) The intended audience differs between these two agencies. ASHP and the University of Utah Drug Information Service (which tracks drug shortages)’s intended audience are healthcare providers, whereas the FDA is the public.(4-6) Individuals should consider checking both databases to get the latest information – as one shortage may be on one database and not the other. ASHP does note potential resupply date (when available), which manufacturer may have the product, and what specific products are available in the database. International agencies have documented the need to assess the extent and depth of this problem on a global scale. Information regarding vaccine shortages can be found at the Centers for Disease Control and Prevention (CDC) website.(7)

Drug shortages continue to remain high in volume and duration.(8) The implications of drug shortages are felt across the board – affecting all elements of health systems, patients, and their families. While the current COVID-19 crisis has caused considerable strain on the pharmaceutical supply chain, it had already been experiencing significant drug shortages and issues for years.

The impact on patient care, safety, operations, and costs caused by drug shortages are intensified during crises.

In the United States, survey data generated by numerous leading organizations in healthcare have shed light on the health system struggle to obtain medications and the impact on patient care, safety, operations, and finances. The data is staggering. The impact is seen on the micro-level (patients and health systems) as well as the macro-level (nationally and globally). It is important to note that the data available on drug shortages is predominately self-reported data by institutions and professionals surveyed. Drug shortages truly affect all elements of patient care, both within health systems and beyond.  

We have seen shortages of antibiotics, cancer treatments, surgery and cardiovascular medications – and even normal saline, to name a few.(9) The number and type of drug shortages can vary among regions, yet their impact has been felt across the globe. The presence of drug shortages has significantly threatened universal efforts to increase access to safe and quality care and has increased costs of care considerably.

There are numerous reasons for why drug shortages occur, including business decisions, manufacturing difficulties or delays, regulatory issues, recalls of products natural disasters (like the hurricane in Puerto Rico), lack of available raw or bulk materials, discontinuations, and the list goes on. While the reason a drug shortage occurs assists in identify an action plan moving forward, health facilities are often left to quickly manage unexpected shortages alone in order to ensure patients receive the care they need.

Although progress had been made to avert drug shortages over the years, they are still occurring at an alarming frequency and continue to have a significant impact. The current realities have only exacerbated the issue.