Take as Prescribed, with Care

What you should know about adverse drug events
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Medications prescribed to treat illness do unintended harm to an alarming number of patients in the United States each year.

While advances in drug therapy have resulted in improving treatment for many diseases, nearly 700,000 patients end up in the emergency room each year as a result of overdose, medication errors, or other reactions to prescribed drugs, according to U.S. Department of Health and Human Services estimates. Adverse drug events (ADE) also account for more than 3.5 million doctor’s office visits.

The good news is there are steps that patients can take to reduce the risk. More than half of ADEs in the country are considered preventable.

Underreported, but dangerous

Opioids, antibiotics, anticoagulants and diabetes medications are the most common drugs involved in ADEs.

In August 2018, for example, the U.S. Food and Drug Administration issued a “black box warning” for Invokana (canagliflozin) and other related diabetes medications. A black box warning, the most serious warning required by the FDA, appears on the label of a prescription medication to alert patients and healthcare providers to safety concerns. Studies suggest the diabetes medications increase the risk of a rare, serious genital infection known as Fournier’s gangrene, among other problems.

Reporting of ADEs is critical to identifying such problems and shielding patients from risk. But the FDA and independent researchers have found that ADEs are significantly underreported.

A major reason is the difficulty in determining the cause of the event. Other factors include improper or poor integration of reporting systems and confusion or uncertainty about how to report ADE.

Researchers continue to study the FDA’s voluntary ADE reporting process, identifying gaps and looking for ways to improve it. In one study, for example, “scorecards” made available to doctors, pharmacists and nurses were found to raise awareness of the number of ADEs at hospitals and the underlying causes.

In the meantime, patients, their families and caregivers can help reduce the risk of ADE as well.

What consumers can do

Consumers can report adverse drug events to the FDA themselves through the MedWatch Voluntary Reporting System, which helps to build data about medications causing health issues.

Medication errors can occur throughout the medication process, from prescribing and transcribing to dispensing and administering. Some errors are the result of a lack of knowledge about a medication while some occur simply when directions aren’t properly followed. Other errors happen as a result of a patient being given the wrong amount or wrong type of medication, as well as something could have been forgotten about the medication prescribed.

Patients can take several steps to lessen their risk of experiencing adverse drug events and medication errors. For example, they can ask their physician questions about the medications they are being prescribed. They can ask their pharmacist questions about the medication when they pick it up. They can also do research online to gain background information on medications.

One of the most commonplace, preventable ADEs is accidental acetaminophen overdose,” said Katy Moncivais, medical reviewer for Con​sum​er​Safety​.org. “People don’t read their drug labels. They take Tylenol for their arthritis, cough syrup for their cold, a pain pill for their dental work, and suddenly they’ve overdosed.”

In short, patients being proactive in managing their health and understanding that they are their best health advocates can go a long way toward avoiding medication errors and adverse drug events.


Darian Carrow

Darian Carrow is a Syracuse, NY-​based writer specializing in health and medicine.

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