Ensuring Safe and Effective Use of Medication and Health Care: Title and subTitle BreakPerfecting the Dismount

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.¹ 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.^{2 - 5} 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.^{6 - 7} Children also may experience unnecessary pain and suffering from subtherapeutic dosing.³

Incorrect caregiver dosing is not a newly recognized problem.⁸ 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.⁹ 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 colleagues¹⁰ 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, frequently forget about transferring responsibility to patients who are not comfortable with several different types of measurements.

Yin and colleagues¹⁰ offer 3 recommendations for improving current product labeling: ensure a standardized measuring device is present with all liquid medication packaging, ensure consistency between the label dosing instructions and the markings on the measuring device, and choose standard measurement units and abbreviations. The first 2 suggestions are obvious, and it is difficult to understand how they are not already implemented. The third suggestion raises an important consideration for the FDA and the pharmaceutical industry. Can the FDA and industry agree on using 1 type of unit across all liquid medications and measurement devices? Any reference to using a teaspoon to measure volume can only increase the possibility of using an imprecise measurement tool obtained from a nearby kitchen drawer. Why not always use milliliters as the standard measurement and avoid other units? This may reduce the use of flatware, a notoriously inaccurate device for delivering liquid medication.⁸ Using milliliters would enhance standardization and accuracy of dosing instructions, a strategy consistent with quality assurance and safety research.¹¹

Perhaps the most frustrating aspect of this issue of communicating clearly to avoid mistakes is that such communication is not already an integral part of selling pharmaceuticals. The dismount for a drug company is taking the information about indications and dose and making it clear for patients. Similar to the rest of the drug development process, the industry should test the usability of dosing devices and instructions to ensure that patients of all health literacy levels can accurately use them. The cost of such testing would be minuscule compared with the outlays for research and development and marketing and would lead to greater safety and satisfaction for their customers. In fact, the guidance by the FDA⁹ and the Consumer Healthcare Products Association¹² is based on face validity and expert opinion rather than sound evidence of effectiveness in reducing errors. Although the guidance is a reasonable starting point, proceeding without evidence that demonstrates elimination of errors seems remiss.

Drug manufacturers are not the only ones who botch the dismount. As physicians, most of our time in medical education and professional development is focused on getting the diagnosis and treatment plan right. All that work is meaningless without the dismount, which, in medicine, requires enabling the patient to understand and act in ways that maximize health outcomes. Several facets of health care delivery are affected: hospital discharge (readmission), outpatient visits, filling prescriptions at the pharmacy, and selling nonprescription medications. All parts of the health care system are involved. The traditional approach has been to assume that the patient understood. That may have worked decades ago, but the past 20 years have witnessed a rapid escalation in the complexity of medical care and the requirements of the patient. At the same time, the skill base in the population has not expanded.¹³ Because of the multiple missed opportunities and consequent adverse events, accountability for patient outcomes such as hospital readmission has emerged.¹⁴ Some current leading efforts to improve transitions of care and prevention of readmission are focused on improving the dismount.¹⁵

To advance patient safety and to improve outcomes, more time and resources should be invested in practicing and perfecting the dismount. The most elegant and efficient medical therapies will fail if patients or caregivers cannot adequately and accurately administer the therapy. Everyone in research, education, and clinical care must refine and test their dismount routines with the expectation that patients will have a chance to experience the benefit of medicine's discoveries. It is time to learn to stick the landing.