The importance of monitoring black box prescription drug use

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Cal Cook
Cal Cook


Whether you're a nurse or the owner of a LTC center, you're certainly aware of the impact of prescription drugs on your clients. More than 3 of 4 people over the age of 50 take at least one prescription drug per day. And many seniors are taking multiple prescriptions. Most of these medications improve their health and are worth continuing, but it's also crucial for those managing their care to understand the risks, especially of “black box” drugs.

This term refers to a warning on the box of the drug. Similar to the warnings on the cover of cigarette packages, this warning references the serious health risks (usually in terms of fatal or addictive side effects) of the drug. The Food and Drug Administration, which oversees the labeling of prescription drugs, reserves black box warnings for the most grave side effects, so it's something to take seriously in an older patient population.

One major consideration in this population is the tendency towards non-compliance of doctor's medication prescriptions. Whether the cause is Alzheimer's or simply forgetfulness, the fact is that many seniors are not taking the medication they were assigned to take. The study referenced above details how 55% of the elderly are non-compliant. This would be concerning with regular pills, but with black box drugs it's even more worrying because many of these drugs can have severe side effects if use is discontinued abruptly.

Consider the drug Pradaxa, an anticoagulant that works against blood clotting in the veins. It's a black box drug that significantly increases stroke risk when the course is discontinued abruptly. There are even thousands of Pradaxa lawsuits currently outstanding due to the harmful side effects of taking this drug. If an elderly patient in a skilled nursing facility were taking this drug, it would be imperative for their care provider to be on top of their intake schedule. Not only would it be harmful for the patient's health if they were non-compliant with their intake of this drug, but it could be harmful to the financial security of the LTC center, because the patient's estate could sue if he or she died as a result of negligence.

Drugs that are black boxed aren't limited to relatively obscure products like Pradaxa. There are a host of common drugs that many patients are likely to be unaware are black-boxed. Here are a few examples:

  • Xanax -- This increasingly popular anxiety medication can cause sedation and respiratory disorders
  • Cipro -- As an antibiotic, cipro stops bacteria from reproducing in the body. It also has the unfortunate side effect of potential to cause nerve system damage from inflammation
  • Vicodin -- This drug is especially common in elderly communities after surgery. It's black boxed due not only to its highly-addictive nature but also because it increases the risk of respiratory depression

So what can you do as a care provider or a manager of a care center? First, ensure that all staff involved with the medication intake of patients are familiar with the FDA Access Data site. This is a free government resource with all of the prescription drug information. You can search by the drug a client is taking and look for black box warnings and drug interactions.

Also make sure that clients have good relationships with their pharmacist if there is not one on staff. Many patients have all of their discussions about medications with their primary care doctor, not knowing that a pharmacist is also trained to assist and answer any questions about the drugs, and often is less pressed for time than a doctor.

Hopefully these suggestions help keep your patients on black box drugs safe! If you have any additional insights please leave them in the comments.

Cal Cook investigates and writes about consumer-focused topics including finance, scams and safety for 



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