Prescription Drug Shortages Threaten Patient Care

 

For Immediate Release 
Sept. 13, 2011

 

Contact: Pam Udall
phone: (512) 370-1382
cell: (512) 413-6807

Brent Annear
phone: (512) 370-1381
cell: (512) 656-7320

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Broken bones lie ahead for premature babies because their doctors can’t give them the drugs they need, a leading Texas physician says. 

A record shortage of prescription medications threatens patients with complications and even death if they receive a less-effective alternative medication or the wrong dosage of a substitute drug, or have to go without the drug altogether. 

The U.S. Food and Drug Administration (FDA) listed 246 drugs in short supply as of June, according to a story in the October issue of Texas Medicine magazine, published by the Texas Medical Association (TMA). Some of these are anesthesia medicines, treatment for severe allergic reactions, and diuretics (calcium gluconate, neostigmine, propofol, epinephrine, furosemide, several sterile injectables, and antibiotics, to name a few).

TMA physicians are concerned about the impact the shortage can have on patient safety. Michael Speer, MD, TMA’s president-elect, says drug shortages frustrate physicians because “the best medication for the patient’s condition is no longer available,” forcing physicians to substitute drugs that may not be in the patient’s best interest. But sometimes it’s that or nothing.

For example, Dr. Speer, a neonatologist, describes his fragile newborn patients at Houston’s Texas Children’s Hospital. They need proper nutrients to survive and grow. One of the drugs on the shortage list, calcium gluconate, provides valuable minerals those newborns in neonatal intensive care need.

“Right now we don’t have drugs that allow us to provide babies with nutrition through an IV. Because of the shortage, babies, particularly the smaller, more vulnerable ones, are at increased risk of fractures,” Dr. Speer, who also is a faculty member in the neonatology section of Baylor College of Medicine, told Texas Medicine.

Houston’s hospital district reported more than 75 drugs were in short supply or on backorder this summer.

Why do shortages occur? The FDA, physicians, and others say there could be several causes:  

  • Consolidation of the drug industry so when the only company producing a generic medication ceases production, there is no drug;  
  • Scarcity of raw materials;  
  • Manufacturing problems;  
  • Unexpected demand for a given drug; and  
  • Business decisions within the pharmaceutical industry. For example, manufacturers might cut back on producing low-cost generic drugs in favor of more profitable brand-name drugs. The FDA adds that as more versions of a drug become available, its price can decrease; if their profit shrinks below the drug’s cost, companies may stop making it.  

Physicians often get little warning about what drugs are available. Dr. Speer says, “It would be helpful if FDA could give physicians, pharmacists, and health care facilities advanced warning of impending drug shortages.”

Remedies are few. The FDA can’t force a manufacturer to produce a drug or impose a penalty if a manufacturer doesn’t notify the agency of a discontinuation. Law does not require manufacturers to report that they’re discontinuing a drug unless they are the sole manufacturers of a drug that is life-supporting, life-sustaining, or intended for use in the prevention of a debilitating disease or condition.

The FDA may encourage drug makers to increase supply, or expedite the review of new manufacturers wanting to make a drug. In rare cases, the FDA can temporarily import drugs from other countries, especially if the drugs are approved in other countries and comparable to the product used in the United States.

TMA is working to alleviate the problem. The association created new policy to work with the American Medical Association (AMA) and the federal government to closely monitor for potential drug shortages, and alert physicians sooner — and suggest alternatives.

“It’s incumbent on the FDA and the government to [understand] that physicians and patients are vulnerable to shortages and the decisions of pharmaceutical companies. Physicians need to have some advance warning shortages are coming to give us enough time to look at alternative medications,” says TMA Foundation President Russell Kridel, MD, FACS, a member of an AMA committee working to mitigate the problem.

TMA is the largest state medical society in the nation, representing more than 45,000 physician and medical student members. It is located in Austin and has 120 component county medical societies around the state. TMA’s key objective since 1853 is to improve the health of all Texans.

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