Wednesday, February 15, 2012

Drug Shortages For A Different Reason

I mentioned yesterday critical shortages beginning to develop in some generic drugs because of price controls that were imposed as part of Bush's Medicare Part D law.  February 14, 2012 MSNBC reports on another cause of prescription medicine shortages: conflicting federal rules:

Mounting shortages of crucial drugs are creating a new dilemma for the nation’s hospital pharmacists, who say they find themselves caught between breaking government rules for storage and safety -- or throwing away vital and lifesaving medications.
At one hospital in Florida, officials acknowledge they’ve discarded the scarce cancer drug doxorubicin, even as patients nationwide clamor for treatment.
“I’d never want to take a chance with not following the rules,” said Alan K. Knudsen, director of pharmacy legal services for Shands HealthCare at the University of Florida in Gainesville. “I wish I didn't have to throw it out."
Surprise, surprise, FDA rules require following the inserts that come with the drugs, even when those inserts are now out of date, and the regulatory cost of updating those inserts is excessive:
Those requirements should be listed in the official prescribing information package inserts that are approved by the federal Food and Drug Administration when a drug is cleared. But the directions may be incomplete or outdated. It can be costly and time-consuming to seek new FDA label approval, so updated science often doesn't make it into the inserts.
The problem here is that at a certain point, common sense and the needs of the patients have to take precedence over slavish following of rules.  But slavish following of rules is what the federal government is creating.


  1. The FDA has also been clamping down on generic drug makers forcing them to jump through all the same hoops as if they were marketing a new untested drug. last year my daughter was prescribed a cough medicine that she had to take four times a day so she had to take it to school, but the school nurse refused to administer it because it was on a list of drugs that the FDA had issued which had not completed all of the application process yet. The pharmacy could buy it and dispense it and the doctor could prescribe it, but the school was not allowed to administer it. the profit margin on these drugs is thin enough as it is, so what is a drug manufacturer to do? figure out which drugs would still be profitable after spending the money to re-certify the production process and drop the rest.

  2. But one of the biggest problems in medicine is getting providers and patients to follow treatment regimens completely or practice necessary protocols.

    "Common sense" shortcuts can lead to disaster - or foster tolerance of sloppiness.

    Rostrom's Rule of Rules:

    Enforce a rule strictly, and unfortunate special cases will pile up screaming for mercy.

    Allow even a narrow exception, and it will be abused into a superhighway that renders the rule effectively void.

    Ya can't win.

  3. We need to completely restructure the FDA. They should be privatised, and used like Underwriter's Laboratories to provide a certain amount of testing for drugs.

    At the very least, government bureaucrats shouldn't be looking over the shoulder of all these pharmacists, doctors and drug providers, forcing them through all these hoops! Each of these individuals and institutions should be free to provide their services as they see fit, and only be held responsible when they do something wrong.

    And the FDA should not have the power to ban drugs they deem harmful. At best they should have the power to require a label, explaining that the drug does not meet FDA approval for reasons X and Y. Users of arthritis pain medication, for example, ought to have the choice to accept an increase in risk in heart attack so that they can have an immediate benefit in an increased quality of life.