National drug shortages: Patient safety takes a backseat to profit

American Journal of Nursing [Vol. 102, No. 7, p. 11], July 1, 2002

Government intervention into the sacrosanct free market is considered anathema, but the frequency of nationwide hospital drug shortages is threatening patient care. It’s time for the federal government to intervene.

A few years ago a hospital might experience a shortage of one or two critical drugs per year. This past year the number has been closer to dozens of drugs. And the shortages can last from a few weeks to months at a time. The highest-profile drug shortage since Sept. 11 is Cipro, the antibiotic treatment for anthrax, with demand exceeding supply.

Cipro notwithstanding, the drugs typically in short supply are the injectable forms used in hospitals and outpatient surgery. In the past few years, we’ve seen shortages of Wydase, adult tetanus, Isoproterenol, Penicillin G, Fentanyl, Succinylcholine, Compazine, Narcan, Romazican, and IV Benadryl, to name a few.

There are reasons for this shortage. The hospital injectable drugs cost more to manufacture because they must be made in a sterile and bacteria-free environment, which few generic drug manufacturers have. Moreover, the pharmaceutical companies view this market as limited, with relatively few hospitalized patients compared to the millions who take pills as outpatients. And the outpatient market is far more responsive to advertising and promotions.

In my area, neonatal intensive care, since 1999 we have experienced shortages of Wydase, Fentanyl, and Penicillin G — drugs for which there is no substitute. Wydase injected into the site of serious IV infiltrates can save the infant from losing a limb. Fentanyl is preferred for pain management because of fewer respiratory and intestinal side effects. And there is no alternative for Penicillin G to treat infants with congenital syphilis.

U.S. health care is structured so that the profit-maximizing sector makes our drugs, and government protects and encourages this industry. This tight arrangement is ideal for our pharmaceutical industry to succeed in answering clinicians’ calls to find drugs to treat illness, something they’ve done very well.

In the last decade alone dramatic discoveries have led to drug therapies for horrific illnesses previously thought hopeless, for example, drug cocktails with protease inhibitors to manage AIDS, and the new generation psychotropic medications to treat severe mental illness such as schizophrenia. These drugs work and have so few side effects that patients are sticking with their drug regimens. These discoveries have saved and extended lives, improved health and restored hope.

Government protections and encouragement for this industry’s “free” market are dramatic, and arguably exceed those for any other industry. Many new drugs stem from basic research supported by the National Institutes of Health. Drug companies have low tax rates and can deduct marketing as well as research and development expenses. Most important, government provides patent protections for new drugs that are 17 years and longer, during which time the companies are free to charge whatever the market will bear.

The mergers and acquisitions of pharmaceutical companies in the 1990s profoundly shifted traditional pharmaceutical economics. With a limited number of production lines, continuing to produce the older, less profitable drugs takes up factory space that could be used for newer, more profitable drugs. Often when there’s only one maker left for a generic drug, the company grossly inflates its cost — a practice some call “price gouging.” And hospitals, under severe financial pressures, cope by keeping inventories small and bargaining aggressively for lowest drug prices.

The problem of nationwide drug shortages is serious enough that the federal government must now tighten its control over the industry. The very least that can be done is to enact the recommendation of the American Society of Health-System Pharmacists — requiring companies to notify the Food and Drug Administration (F.D.A.) and healthcare providers of anticipated shortages of any drug. After all, the notoriously tightlipped pharmaceutical companies — both the innovators and generics alike — are aware of manufacturing problems in advance of anyone else.

The inherent flaw all along in our setup of a government-protected pharmaceutical industry has been that thorny clinical problem of getting the drugs to all people who need them. The product here is not big-screen TVs. It’s drug therapy that people depend on for quality of life and even survival.

What can nurses do? The relatively new phenomenon of drug shortages can create havoc, perplexity and anger in the clinical setting. Nurses who understand (not necessarily accept) the reasons for the shortage are in a position to serve as a calming influence by offering intellectual insight to their colleagues, other clinicians and patients struggling to comprehend and deal with the shortages.

Toni Inglis, MSN, RN CNS (retired), FAAN, a lifelong Austin resident and retired neonatal intensive care nurse and editor of NursingNews, writes a monthly opinion column for the Austin American-Statesman editorial page.