Ensuring Safe and Effective Use of Medication and Health Care

Abstract

IN GYMNASTICS, THE DISMOUNT MAY BE MORE IMPORTANT than the rest of the routine: it is the final element judges recall when evaluating the athlete. In health care, we often ignore the dismount—the handoff of responsibility from the health care system to the patient. Tremendous intellectual and capital resources are allocated toward making diagnoses, developing therapies, and designing treatment plans, but relatively few resources are spent on the transfer of care to the patient. Physicians, nurses, health systems, health plans, and pharmaceutical companies frequently botch the dismount. As a result, countless numbers of people may be injured or inadequately treated. Pharmaceutical companies spend hundreds of millions of dollars on drug development and testing with rigorous and closely monitored clinical trials to ensure efficacy and safety. Much of that work is spent determining the correct dose to keep drug levels in the therapeutic window. Although this process is not perfect, it offers some assurance that most drugs are safe if correctly used. For nonprescription medicines, physicians generally do not instruct patients on how to take them, patients have to rely on information on the label, and patients generally assume that nonprescription medications are safer than prescriptions. However, it appears that relatively few resources have been dedicated to providing clear dosing instructions to ensure safe patient use. Several studies have demonstrated that caregiver dosing of liquid medications for children is frequently inaccurate, placing children at risk for subtherapeutic dosing or toxicity. These findings apply to both prescription and nonprescription liquid medications. The cost of dosing mistakes can be high. In addition to morbidity, recent reports document that nonprescription medication dosing mistakes can result in death. Children also may experience unnecessary pain and suffering from subtherapeutic dosing. Incorrect caregiver dosing is not a newly recognized problem. Many pediatric clinicians try to provide dosing instructions when caregivers are in the office. Urging clinicians to review the correct dosing for parents is not sufficient because this approach will not reach most parents who directly access nonprescription medication, and dosing advice is usually not given at a time the parent is making dosing decisions. In 2009, the Food and Drug Administration (FDA) issued draft guidance to remind industry of its responsibility for ensuring clear and accurate instructions and concordant dosing devices for all nonprescription liquid medications. The guidance indicates that the label should use standard measurement units and accepted abbreviations, and the device also must share the same units with clear markings at the levels of the recommended doses. In this issue of JAMA, Yin and colleagues demonstrate how poorly current dosing instructions and dose delivery devices adhere to the FDA guidance. Among a sample of 200 of the top-selling analgesic, cough/cold, allergy, and gastrointestinal pediatric oral liquid over-the-counter medications evaluated, only 74% of the products included a dosing device (such as a cup, spoon, or syringe), and of those that did include a device, virtually all (98.6%) had inconsistencies between the dosing directions and the markings on the device. Not all inconsistencies were equally problematic. However, 24% of products lacked the necessary markings on the measurement device, and 89% had inconsistencies in the units of measurement between the product’s label and the enclosed device. In addition to the inconsistencies between the measurement devices and the label for a given product, there was remarkable variation across products regarding the units used to measure volume: milliliter, cubic centimeter, teaspoon, tablespoon, ounce, and dram. The researchers document a concerning state of affairs. Clinicians’ education in and familiarity with most of these measuring units may lead them to overlook the tremendous variation within and across products and opportunities for dosing errors. But that is just the point: health care providers, including pharmaceutical companies, fre-