Featured Product
This Week in Quality Digest Live
Health Care Features
Dirk Dusharme @ Quality Digest
ISO vs. FDA audits, Baldrige winners, and what we can learn from GE
Ryan E. Day
How BioBridge Global leverages a digital QMS in the heavily regulated world of regenerative medicines
Taran March @ Quality Digest
From digital submissions to integrated document control, the agency moves into the lean arena
Dirk Dusharme @ Quality Digest
By scaring off small medical-device companies, Canada could limit number of important and innovative products
Mike Richman
For answers to some troubling life-science questions, ask a quality professional

More Features

Health Care News
Creates adaptive system for managing product development and post-market quality for devices with software elements
Transforming a dysfunctional industry
An invite from Alcon Laboratories
Intended to harmonize domestic and international requirements
The FDA wants medical device manufactures to succeed, new technologies in supply chain managment
Neuroscientists train a deep neural network to analyze speech and music
Pharma quality teams will have performance-oriented objectives as well as regulatory compliance goals
The FDA’s RMAT designation goes live

More News

Sharona Hoffman

Health Care

Drug Shortages Pose a Public Health Crisis in the U.S.

Supply chain issues can be the difference between life and death

Published: Monday, July 2, 2018 - 11:02

On June 12, 2018, the American Medical Association announced that drug shortages pose an urgent public health crisis. This crisis should be of concern to all Americans.

The Food and Drug Administration (FDA) defines a drug shortage as a “period of time when the demand or projected demand for a medically necessary drug in the U.S. exceeds its supply.” All too often, a shortage means that doctors cannot give the right drugs to patients when needed.

Serious drug shortages are not a new phenomenon. The FDA recognized their prevalence and established a Drug Shortage Program back in 1999. The problem, however, persists.

In short supply

Currently, the United States is short on 182 drugs and medical supplies, according to the American Society of Health-System Pharmacists. The list includes IV bags, injectable morphine, and other powerful painkillers, anesthetics, antibiotics, electrolytes, cancer drugs, and many more. All of these are of critical importance to patients with serious illnesses.

Why do drug shortages occur? The AMA blames the current crisis in part on the damage caused to production facilities in Puerto Rico by hurricanes Irma and Maria in 2017. Furthermore, the government’s efforts to combat the opioid crisis by reducing the availability of opioids has hampered the ability for hospitals to obtain necessary painkillers. Production delays at manufacturing plants or delays in procuring raw materials from suppliers can also contribute to shortages.

Some companies choose to stop manufacturing a drug in order to focus on newer, more lucrative medicines. If a manufacturer is one of only a few producers or the primary producer, even a temporary stoppage can have harmful market effects. For example, only seven companies make most of the sterile injectable drugs sold in the United States. If one of these has difficulty or discontinues production, it would be very hard for the others to make up the difference.

Dangerous outcomes

Drug shortages have serious consequences. Most important, they often endanger patients’ lives. When healthcare providers cannot administer needed drugs, they cannot provide proper treatment.

The Institute for Safe Medication Practices conducted a survey of almost 300 healthcare providers in 2017. A majority of participants felt that drug shortages had affected their patients. Seven in 10 stated that shortages made them unable to provide some patients with recommended treatments. Almost half believed that, as a result, their patients received less effective therapies.

In addition, 75 percent of participants stated that they were forced to delay patient treatments because of shortages. In one case, a delay in treating sepsis with sodium bicarbonate may have contributed to a patient’s death. Other poor outcomes included more pain or discomfort during procedures because appropriate drugs were unavailable.

Drug shortages also contribute to increased healthcare costs. Medical staff must spend time managing drug shortages. They must track inventory, identify alternatives, and make decisions about rationing scarce resources.

In addition, some vendors engage in price gouging when selling drugs in short supply. The cost of this deplorable practice may reach more than $400 million a year.

Drug shortages can have other consequences for doctors and patients. Physicians face the unenviable task of explaining to patients that they cannot receive needed drugs. This can be demoralizing for patients and make them lose trust in the medical profession. Additionally, insurers may refuse to pay for a treatment that is substituted for a drug in shortage. They may insist the alternative medication is not standard therapy and therefore will not be covered.

Finally, drug shortages can adversely affect medical research. If drugs that are being studied are unavailable, research projects may have to be postponed, suspended, or canceled.

Tackling the problem

By law, manufacturers are required to report the expected duration of shortages and the reasons for them to the FDA. They must also provide notifications of production discontinuances and temporary interruptions.

The FDA states that it posts information about drug shortages on its website. However, it is not clear where on the website these data are placed. Indeed, many healthcare providers indicate that they do not consistently receive information that could help them prepare for shortages.

The FDA states that it works with manufacturers to resolve drug shortages as quickly as possible.

The ConversationFortunately, in recent years, there have been fewer drug shortages than earlier in the decade. However, the number still hovers around 200 annually. In my view, this figure remains unacceptably high and all too often compromises patient care. The drug shortage crisis must remain a priority for the government, healthcare industry, and the public at large.

This article was originally published on The Conversation. Read the original article.

Discuss

About The Author

Sharona Hoffman’s picture

Sharona Hoffman

Sharona Hoffman is a professor of health law and bioethics at Case Western Reserve University.