Manufacturers have blamed other factors, including natural disasters, raw materials shortages and changes in contracts with hospitals and pharmacies, as well as medicine they discontinue. Maintaining sterility during the manufacturing of injectable drugs can be particularly difficult, industry officials said.

Officials at the Pharmaceutical Research and Manufacturers of America, or PhRMA, say they are working with the government, suppliers and providers on the issue.

"Regardless of the cause, in order to provide patients with uninterrupted access to medicines, it is important for all of us who provide life-saving medications to work collaboratively to minimize unexpected disruptions in the supply of vital medicines," said PhRMA Deputy Vice President Karl Uhlendorf in a statement.

The drug shortages mean U.S. hospitals spend at least $200 million, or 11 percent, more a year on substitutes, according to a study by the Premier Inc., an information provider and purchasing agent for hospitals. It reported that in the second half of 2010, more than 240 drugs were in short supply or unavailable and more than 400 generic drugs were on back order for five or more days.

In 2011, there could be more than 360 drugs in short supply throughout the year, Premier reports. Officials said that means hospitals will not be able to get lifesaving drugs and may postpone procedures or substitute less effective drugs. They also warned about drug-related mistakes.

A Premier report on the gray market found in a short survey of hospitals earlier this year that 18 distributors offered 1,745 drugs to 42 hospitals, all on back order or unavailable from manufacturers. The average markup was 650 percent, but some drugs were marked up as high as 4,533 percent. Cytarabine was offered at an average 3,980 percent above market.

The report says most gray market companies are legitimate, but in some cases the drugs could be counterfeit, diluted or not stored properly to maintain efficacy.

Some states, including Maryland, have pedigree laws, and report authors say buyers should also inspect the drugs and check the National Boards of Pharmacy to ensure the distributor is accredited. (Three of the five companies Cummings has requested information from do not appear on the boards' list of accredited companies.)

Maryland's law was passed in 2007, and 807 distributors are licensed in the state. They must post bonds and representatives must submit to criminal background checks, which makes the law more stringent than those of other states, according to Anna Jeffers, legislation and regulation manager for the Maryland Board of Pharmacy.

Maryland will be among the first few states to require electronic tracing of drugs in 2016.

But Frese says the prices and safety remain an issue nationwide, and she's pleased her letter writing has turned into an investigation.

Her son is currently cancer free, though he'll need to be on medications for at least two more years. She said it's scary to think that manufacturers could stop making such lifesaving drugs, that hospitals could be priced out or that some drugs may not be safe.

It's also something she said parents of kids in treatment shouldn't have to worry about.

"For my husband and me, this is personal," she said. "To think of all the families we've met, and who have touched our hearts and whose kids are in worse condition, missing the type of drugs that could save their lives is tragic. How could something like this be allowed to happen?"

meredith.cohn@baltsun.com

http://twitter.com/baltsunhealth



The letters



Cummings has alleged that these companies have excessively marked up drugs in short supply, and is requesting information from them:

Allied Medical Supply Inc., offered cytarabine, used to treat leukemia, for over $990 per vial, more than 80 times a typical contract price of about $12 per vial.

Superior Medical Supply Inc., offered paclitaxel, which is used to treat breast and ovarian cancer, for over $500 per vial, more than seven times a typical contract price of approximately $65 per vial.

Premium Health Services Inc., offered leucovorin, which is used in combination with the chemotherapy drug fluorouracil to treat advanced colon cancer, for over $270 per vial, more than 50 times a typical contract price of approximately $5 per vial.

Premium Rx National LLC, offered fluorouracil, which is used to treat colon, stomach, breast, and pancreatic cancer, for over $350 per vial, more than 23 times a typical contract price of approximately $15 per vial.

Reliance Wholesale Inc., offered magnesium sulfate, which is used to control life-threatening seizures in pregnant women and to treat magnesium deficiency in patients who receive intravenous feeding, for over $400 for 25 vials, more than 40 times a typical contract price of approximately $9 for 25 vials.

Sources: Cummings, National Boards of Pharmacy

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