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Drug Shortages and You

Did you know that currently if a manufacturer decides to stop making a drug, they can just stop without alerting anyone? Additionally there are no rules dictating when companies have to tell the FDA that there is an issue found in the manufacturing process.

This often leaves patients, pharmacies, and clinical providers in tight spots. Frequently, there are substitute medications available, but for some medically necessary drugs these shortages can mean the difference between life and death.

For example, over the past year we have had shortages of medically necessary drugs like dexamethasone that reduces inflammation when a breathing tube is removed and it helps reducing swelling in the brain. And there are hundreds of other prescription drugs that are currently shorted.

The American Society of Health System Pharmacists is hoping that a bill working its way through Congress will require manufacturers to notify the FDA of any discontinuance, interruption or adjustment in the manufacture of a drug that may result in a shortage. If manufacturers are required to alert the FDA of potential problems sooner or discontinuation of certain medications, then the FDA could give advance notice to other companies making the drug to ramp up.

Read more about the issue here, and take this opportunity to encourage Congress to regulate drug makers to ensure that patients always have access to the lifesaving medications they need by sending a letter to your Senator.

Lynn Eschenbacher is manager of WakeMed Raleigh Campus inpatient pharmacy and is a member of the American Society of Health System Pharmacists.


One thought to “Drug Shortages and You”

  1. When you read the report, you will notice a few things that drive the discontinuance of drugs:

    – Actual regulatory action (Such as delays placed on approving drugs by the FDA)
    – Costs placed upon drug manufacturers by regulatory actions (FDA and DEA are cited)
    – Costs placed upon drug manufacturers by out-of-control litigation

    The solution to all of this is not to regulate the drug manufaturers even more. Each regulation that is made creates an unintended consequence that must be resolved by a further regulation. This process repeats itself ad infinitum.

    Part of a real solution is to dramatically reduce the level of regulation of drug manufacturers, thus making them more responsive to the market for the multitude of drugs that are useful for treating various ailments. If there is a free market, the necessary drugs will be provided by the drug manufacturers, and with open competition, the market will settle on an “equilibrium price” that equates to the worth of each drug.

    There is a huge philosphical problem with the way that the government regulates businesses, including the drug industry. There is a suspicion of private economic activity that exists within the sort of people who go to work in regulatory agencies. They seem to feel that drug companies (and others)are worthy of a a greal deal of suspicion, as they would undoubtably hurt all concerned if it would make a quick buck. This view is not warranted by the actual circumstances that exist in this world. Any company that wishes to survive (drug companies included) must make a product that is safe and useful, else nobody will purchase it. The attitude that drug companies would intentionally or neglectfully put dangerous drugs on the market is best left for Hollywood tales featuring evil corporate executives. While there certainly have been some drugs that have been found to be dangerous, this is just because we live in a complicated world where the best efforts do ot always produce perfect results.

    The other part of the solution is to enact tort reform. This is so that drug manufacturers and others in the healthcare system are not dissuaded from practicing their healing arts or creating their healing devices and drugs. Currently, excessive, unfair, and unpredictable legals costs stifle much innovation and lead to dramatically higher prices than would exist if the lawyers were kept within due bounds. There should not be any legal liability for people or firms who are trying to medically assist others, so long as they follow reasonable standards of care. The law seems to expect that liability attaches at any time that there is not a perfect outcome, and that is not reasonable.

    So – short version: Rein in the FDA, DEA, and the trial lawyers, and we will have a much improved situation.

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