Reducing Preventable Harm from Medications: Too Big for FDA to Do Alone

By: John J. Whyte, M.D., M.P.H.

Sometimes a drug can be used exactly as FDA approved it, taken just the way a doctor prescribed it, and a patient can still experience adverse events. When it comes to drugs, not all risks are known – even after approval.

John WhyteSadly, however, harm from medications also may come from known risks that could have been prevented. The Institute of Medicine (now called the National Academy of Medicine) estimated that at least 1.5 million preventable adverse drug events occur within our health care system each year. It’s a complex system where safety issues can arise at any turn.

Among the many challenges, prescribers and other providers often struggle with the intricacies of today’s health care system, patients can have difficulty following detailed directions, and manufacturers must carefully package and label their products to avoid confusion and misunderstanding for how they are used.

Even giving a child a dose of acetaminophen, the commonly-used over-the-counter pain reliever and fever reducer, can lead to tragic results. The product was available in a strongly concentrated form for infants so they could take a very small amount, as well as a much weaker form for older kids to swallow by the teaspoonful. Unfortunately, over the years, some parents accidentally gave their infants a full teaspoonful of the stronger concentrated form, resulting in serious liver damage and even death. The Consumer Healthcare Products Association (CHPA) worked with their members to voluntarily remove the more concentrated form from sale and market a uniform less concentrated form. Their effort was instrumental in eliminating a preventable medication error.

Safe Use blog imageReducing preventable harm from medications is a big part of FDA’s mission. It requires teamwork across all of health care and the medication manufacturing, distribution, and delivery system.

As one of many ways we facilitate that teamwork, FDA’s Center for Drug Evaluation and Research’s Professional Affairs and Stakeholder Engagement Staff is hosting a one-day public meeting on June 15, 2017, called “Safe Use Symposium: A Focus on Reducing Preventable Harm From Drugs in the Outpatient Setting.”

We’ll gather with patients, caregivers, prescribers, pharmacists, manufacturers, distributors, and others to discuss sources of preventable harm from drugs in the outpatient setting. Attendees will consider situations such as the use of inappropriate medications in certain age groups, the use of drugs that interact with one another, and unintended exposures of dangerous medications to children.

Those attending will include representatives from:

  • Federal agencies such as the Drug Enforcement Agency, the Agency for Healthcare Research and Quality, the Centers for Disease Control and Prevention, and the Centers for Medicare and Medicaid Services;
  • State regulatory bodies, including professional licensure and oversight boards;
  • Healthcare insurers; and
  • Patient advocacy organizations.

During this symposium, we want to generate ideas for specific solutions to reduce preventable harms and discuss how to evaluate the ideas’ effectiveness. These new ideas for future research can be funded by grants from FDA’s Safe Use Initiative. A variety of important research projects have been completed and FDA offers new opportunities on an ongoing basis.

There is no registration fee but early registration is recommended because seating is limited. More information about registration is available online.

We encourage all parties interested in the safe use of medications to attend. Some jobs, such as reducing the many forms of preventable harms from medication, are too big for one organization. It truly requires a communal and collaborative effort for success.

John J. Whyte, M.D., M.P.H., is Director of Professional Affairs and Stakeholder Engagement at FDA’s Center for Drug Evaluation and Research

Updated June 1, 2017

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