Congress: stand up to the paper lobby and abolish outdated paper labeling for clinicians

There’s no place in health care for practices that fail to serve the best interests of patients and their clinicians. One such obsolete and harmful practice is providing outdated and wasteful paper prescribing information to pharmacists and prescribers when they can — and do — obtain the most up-to-date prescribing information online.

FDA-approved information for prescribers includes detailed technical information about a drug’s molecular structure, along with its approved uses, dosing, expected side effects, warnings, contraindications, and precautions. The prescribing information is different than patient labeling, which is written in non-technical language and contains practical information about how to take a drug and what side effects to watch out for.

The FDA requires prescribing information to be provided on or within each package of prescription medication from which the drug is to be dispensed. For example, it is included in the large bottles provided to pharmacies from which they dispense smaller quantities of pills to patients, and in the cartons of medications dispensed directly to patients in original packaging. The prescribing information is also compiled into compendia by third parties.

As a veteran of the Food and Drug Administration, where I spent years working to develop innovative policies for the regulation of pharmaceuticals, I’m irritated when I’m reminded that the agency has been prevented from eliminating paper prescribing labels. These labels, which are intended to help practitioners provide the best care, have been available online for 15 years, which is how the majority of practitioners have been accessing the most up-to-date prescribing information.

Clinicians who rely on paper labeling can put patients at risk. Printed prescribing information accompanies a medication only while it is in its original packaging, and most practitioners never see the actual paper labeling. If a practitioner does obtain an actual paper package insert, he or she must unfold what might be a huge piece of paper that contains information printed in type so small that it requires a magnifying glass to read.

What’s more, because paper prescribing information is often out of date, by months if not years, it may lack the most recent warnings or contraindications necessary for safe use of the drug. Prescribers may look at the paper labeling unaware that the information has been updated electronically after the paper label was printed and could prescribe or administer the drug to patients for whom the drug would be dangerous.

Paper labeling also causes environmental harm. Printed labeling can range from a few pages to more than 100 pages, meaning that each year a vast amount of paper used to print these documents is produced from our forests and then discarded, having served no useful purpose. The elimination of paper labeling would save millions of trees a year and contribute to long-term targets for reduction of carbon emissions, water use, and paper waste.

Decades ago, when the FDA began to require prescribing information on all prescription drugs, printed paper labels were the only option. But digital alternatives have been widely available and used for almost two decades. In 2005, the FDA began to provide electronic prescribing information to the National Institutes of Health for posting on the National Library of Medicine’s DailyMed website. There, prescribing labels can be updated within days of a labeling change, as opposed to a delay of months — or years — until the same change reaches the paper label.

DailyMed should have made the practice of printing paper labels obsolete. So why does the FDA still require companies to provide paper labeling, given that this information is of little use to patients and ignored by health care providers?

The answer lies with Congress which, at the behest of the paper industry and companies that specialize in printing and folding label inserts, has perennially blocked the FDA from following through with a proposed 2014 rule to eliminate the paper requirement and require electronic distribution of prescribing information. In every appropriations bill since 2015, Congress has forbidden the FDA from using any funds to allow or require prescribing information to be distributed in electronic form instead of paper, and these provisions prevent the FDA from proposing to bring prescribing information into the modern digital era.

Opponents of eliminating paper labeling — who are mostly those who produce the paper and paper inserts — continue to advance the argument that paper must be available for pharmacists and physicians who practice in rural areas and who may lack online access. This argument has no merit, as it is easily resolved by providing paper prescribing information to practitioners who request it.

For far too long, the FDA has been needlessly prevented from implementing a sensible policy of providing practitioners with prescribing information electronically. It is time for Congress to step aside and let the FDA take the actions necessary to best serve practitioners, patients, and the environment.

Jane A. Axelrad is a former associate director for policy at the FDA’s Center for Drug Evaluation and Research, where she worked to abolish paper labeling. As the principal of Axelrad Solutions, LLC, her continued work on this issue could benefit some of the company’s clients.