Wellness Without Borders

Definition

A shortage is defined by a period of time when a country’s demand for a device surpasses the supply. However, the FDA has acknowledged that there are circumstances of regional supply delays, even if the demand does not exceed the supply (FDA).

Legal

Laws, policy regulation Section 506J of the FD&C Act. On March 27, 2020, the CARES Act was enacted, adding Section 506J to the Federal Food, Drug, and Cosmetic Act (FD&C Act). This new section mandates that manufacturers inform the FDA about any permanent halt or significant interruption in the production of certain devices that could substantially impact the domestic supply.

According to the law, the requirement for "506J notifications" is only in effect during or in anticipation of a declared public health emergency. Since the COVID-19 public health emergency ended on May 11, 2023, the FDA no longer expects manufacturers to submit these notifications for devices deemed critical during that period. However, the FDA accepts and encourages device manufacturers to voluntarily report any interruptions or discontinuances in manufacturing, even outside of declared public health emergencies, as this information is crucial for preventing and managing disruptions in the supply of essential devices (FDA).

Management/Production

Cost cutting, manufacturing and quality problems, geopolitical issues.

Emergency Preparedness

Natural disasters, delays, public health emergencies, and discontinuations (COVID). The recent shortages of small volume parenteral (SVP) IV fluids were driven by the manufacturing disruption from Hurricane Maria superimposed on reduced supply due to manufacturer quality issues. The reduced supply of SVP products, including normal saline, led to widespread disruption in the delivery of healthcare in the US and globally as these products are used for hydration and preparation of numerous additional widely used medications.

Until 2017, all 0.9% Sodium Chloride IV bags, also known as Saline Bags, which are required for all patients admitted into the emergency rooms were produced in Puerto Rico. However, in 2014, the U.S. experienced a nationwide shortage of IV solutions, specifically saline large volume intravenous solutions. Manufacturers blamed supply disruptions on plant shutdowns for routine inspection and upgrades. The main manufacturer, Baxter International, went south.

Effects

The shortage crisis has affected multiple countries, including Mexico, the United Kingdom, and rural areas of China and Australia. It has also impacted various products such as saline bags/infusion pumps.

Products Affected

Saline Bags/Infusion Pumps

To help alleviate the 2014 shortage, the FDA announced that it was working with the three U.S. manufacturers, Baxter Healthcare, B. Braun Medical, and Hospira, to increase supply. The agency also approved Fresenius Kabi USA to temporarily import its European sodium chloride 0.9% Freeflex Injection Solution for Intravenous Infusion into the U.S. market in late 2014. Then, in May 2015, the FDA approved Baxter’s Sabinanigo, Spain facility as a manufacturing site for 0.9% sodium chloride injection, USP, for the U.S. market. Even with these interventions, the American Society of Health-System Pharmacists (ASHP) reported shortages of 0.9% sodium chloride irrigation and 0.45% sodium chloride injection bags throughout 2016 across multiple manufacturers, including B. Braun, Baxter, Hospira, and Pfizer.

N95 Masks

When COVID-19 surged in 2020, the resulting shortage of N95 respirator face masks in the U.S. highlighted the complexities of global medical product supply chains, as well as the need for serious modifications to ensure public health and safety. The COVID-19 pandemic has disrupted supply chains, resulting in a critical shortage of high-demand PPE, including N95 respirators, worldwide. In many countries, healthcare workers have little choice but to use substandard PPE and respirators, even homemade ones. Similar situations have also occurred during past pandemics and epidemics. National, local, regional, and hospital administrative authorities should have the oversight to monitor the demand for PPE and prioritize the needs of the frontline healthcare workers who are at the highest risks of exposure to the virus.

Impact on Patient Care

According to a survey, 60% of respondents reported shortages of more than 20 drugs, single-use supplies, or other medical devices in the six months leading up to the survey. The shortage crisis has permeated multiple medical specialties, with 74% of respondents citing compromised care in surgery and anesthetics, 64% in emergency care, 52% in pain management, 45% in cardiology, 44% in hematology and oncology, 39% in infectious diseases, and 37% in obstetrics and gynecology.

Disruptions in the medical product supply chain have been an ongoing issue for decades. Although shortages of drugs and medical devices can be life-threatening for some individuals, they also have broader systemic impacts. These shortages put additional strain on manufacturers and suppliers to handle unexpected spikes in demand, ultimately affecting the entire U.S. healthcare system and resulting in costs amounting to millions of dollars annually (National Academies).

Mission Statement: Empowering communities globally to provide funding for healthcare inequality through education, advocacy and collaborative action.