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Drugmakers blame FDA rules for drug shortages

Hospitals across the country are running out of key drugs used in surgeries and to treat some diseases, including cancer, causing doctors to turn to older treatments.

In some cases, hospitals are paying higher prices to get their patients necessary care because wholesalers are hoarding needed medicines.

Part of the shortage is being caused by manufacturing issues and quality-control problems at a number of companies as they respond to the federal government's crackdown on drug safety. The quality issues can include toxins and "particulate matter" in medicines and workers inaccurately filling out the required paperwork to verify that the drugs, as well as the devices used to intravenously deliver the products to patients, are safe and effective.

Even after a company restarts production of a drug, it takes time to catch up to the back orders. And injectable drugs in particular, unlike pills and tablets, tend to require long lead times to produce.

About 150 drugs — triple the number just five years ago — are in short supply, according to the American Society of Health-System Pharmacists. About 60 of those are considered by federal health officials as "medically necessary," and they include prescription medicines used to treat or prevent serious diseases or other medical conditions.

Drugmakers say they are following tougher safety rules put in place by the U.S. Food and Drug Administration, which has intensified scrutiny to avoid allowing unsafe medicines on the market. The FDA came under fire for its role in monitoring the painkiller Vioxx, which was pulled off the market in 2004 by its manufacturer, Merck & Co., after the drug was linked to heart attacks and strokes.

The drug shortage is being exacerbated by consolidation in the pharmaceutical industry, which leaves fewer companies making drugs.

In addition, some drug companies have stopped making older, generic injectable drugs, which typically aren't as profitable as newer brand-name medicines. That puts additional production pressure on the remaining makers of generic treatments.

The drug shortages have attracted the attention of members of Congress. Last week, Sens. Amy Klobuchar, D-Minn., and Bob Casey, D-Pa., introduced legislation that would require drugmakers to give the FDA early notification "when a factor arises that may result in a shortage," according to a joint statement.

Hospitals are finding ways to deal with the lack of availability.

At Provena Health, which has six facilities in the Chicago suburbs and Illinois, products in short supply have had to be moved "from one hospital to another," spokeswoman Lisa Lagger said.

Other hospitals are dealing with the supply problem by turning to older medicines. While those drugs can be just as effective, the lack of familiarity among medical professionals can lead to improperly calculated dosages.

Some medical facilities have turned to secondary suppliers when their primary source for drugs has run out of needed medicines. And that has caused hospitals to pay double or more for certain drugs.

Drugmakers blame FDA rules for drug shortages 02/20/11 [Last modified: Sunday, February 20, 2011 10:57pm]
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