If no one reads it, what’s the purpose of a drug label?

March 29, 2018 – 10:29 pm | By Mari Serebrov | No comments yet

doctor reading ipadRobert Califf said it when he was serving as FDA commissioner. Patient advocates have said it when testifying before Congress or commenting at public meetings. And this week, experts on the FDA’s Psychopharmacologic Drug Advisory Committee (PDAC) said it again: Doctors don’t read drug labels.

Yet drug companies continue to invest millions of dollars on aspects of clinical trials that are designed to inform labeling, and FDA reviewers spend untold hours scouring the data to ferret out what should be included in the prescriber information as contraindications, warnings and cautions, boxed warnings, the mechanism of action and clinical trial findings.

All of that effort is meaningless if doctors, considered the “learned intermediaries,” don’t read the labeling. Or if they do read it, they don’t pass the pertinent information on to patients.

Doctors have a lot of excuses for not reading labels, but the only understandable one is time. After making hospital rounds, seeing an overbooked slate of patients, completing electronic health records for all those patients, going over test results, tending to prior authorization demands, keeping up with continuing medical education credits, reporting adverse events, connecting patients with clinical trials, complying with REMS requirements, and providing all the information mandated by insurance companies, Medicare, Medicaid and other programs, doctors don’t have a lot of time to keep up with journal articles and medical advances, much less to read all the small print that makes up the labeling for every new drug that’s launched.

It’s no wonder that doctors often rely on drug reps, peer word-of-mouth, industry-sponsored talks, samples and promotional materials to keep on top of things in their field.

While the FDA puts a lot of effort into scrutinizing every detail of how drug companies promote their products to patients and medical professionals, it hasn’t done much to align drug labeling with the real-world practice, and demands, of medicine in the 21st century.

The result is that patients are suffering. Big time.

A woman testifying during the public hearing at Tuesday’s PDAC meeting recounted how she almost became addicted to opioids after her surgeon put her on high doses of a potent painkiller for a month following emergency surgery to deal with a blocked kidney stone. When a second surgery to remove a slipped stent eased her pain, she stopped taking the drug. Her doctor didn’t warn her about the potential of opioid withdrawal symptoms.

Within a day or so of stopping the medication, the woman came down with what she thought was the worst case of flu she had ever experienced. She lost 12 pounds in two days and her symptoms got so bad she almost took another painkiller. Fortunately for her, she was in a graduate course on drug and alcohol addiction. The reading that week was on withdrawal symptoms. When she recognized what was happening to her, she knew she couldn’t go back on the drug.

Travis Rieder, a bioethicist at Johns Hopkins University School of Public Health, shared a similar story. He was prescribed escalating doses of opioids for an extended period of time when he underwent several surgeries following a motorcycle accident. His doctor told him to take the drug to “stay ahead of the pain.” Alarmed at the high doses prescribed, a surgeon put Rieder on an aggressive opioid tapering regimen that almost cost him his life as he struggled with the demons of withdrawal.

After several sleepless nights, Reider asked his wife to refill his prescription, but he tried one last time to sleep before giving in to the drugs. He slept. “I made it out. I was incredibly lucky,” Rieder told the committee, adding that he was sure that if he had taken one more pill, his path would have looked much different.

Regardless of the drug, the mantra today is all about a drug’s value, which is measured by the patient experience. The success of that experience is driven, to a large degree, by whether a doctor reads the label and then effectively communicates that information to the patient.

The FDA isn’t in the business of regulating how a doctor practices medicine, but it does control labeling. For the patient’s sake, it needs to rethink those lengthy, encyclopedic labels that no one has the time to read. And the health care system as a whole needs to understand that patients are best served by doctors who are given the time to read labels and keep up with the medical advances in their field.


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