OTC Liquid Medications Dosing and Devices: Confusion Reigns

Abstract

Source: Yin H, Wolf M, Dreyer B, et al. Evaluation of consistency in dosing directions and measuring devices for pediatric nonprescription liquid medications. JAMA. 2010; 304(23): 2595– 2602; doi: 10.1001/jama.2010.1797Academicians from four United States medical schools studied dosing directions and measuring devices supplied with nonprescription liquid medications, determining conformity with Food and Drug Administration (FDA) guidelines published November 1, 2009.1 Guidelines were developed in response to reported unintentional drug overdoses ascribed to confusion generated by labels and measuring devices. Data reflect baseline adherence, against which the voluntary response by industry can subsequently be assessed.Utilizing an industry database (IMS Health Medicine Cabinet), medications for children younger than 12 years for the year ending on October 30, 2009 were determined. The 200 medications with the largest market share were chosen from five use categories: analgesic, cough/cold, combination analgesic and cough/cold, allergy, and gastrointestinal. Data abstracted included the presence and type of any enclosed measuring device, numeric dose amounts, exact text and abbreviations specifying units of dose measurement, format of decimals and fractions, and elements designed to guide consumers on appropriate use.Products were evaluated for differences between written dosing directions and the measuring device as well as for variability in units of measurement, abbreviations, format, and consumer guidance. Descriptive analyses were performed, including statistical association of findings with manufacturer type, medication category, and targeted age group. Products studied comprised 99% of the United States market share for nonprescription liquids. Most (74.0%) included a measuring device, usually a dosing cup (83.1%). A measuring device was supplied more frequently in products targeting infants and children exclusively (94.9% vs 60.7%) and with those supplied by large manufacturers (95.2% vs 46.3%). Provision varied by drug category: analgesics (95.5%); combination (92%); allergy (90.0%); cough/cold (71.1%); and gastrointestinal (50.0%). All associations are highly significant (P<.001). Measurement units differed between label and device in 89.0%. Devices had deficient (24.3%) or too many (81.1%) markings, and sometimes both. Some products (5.5%) used measures other than milliliters, teaspoons, or tablespoons. Many (65.0%) specified doses in multiple units. Nonstandard abbreviations were common. Dosing formats were potentially misleading and consumer guidance was rare.The authors conclude that at the time of the FDA’s new recommendations, the major pediatric OTC liquids had variable and inconsistent dosing instructions and measuring devices.Dr Ring has disclosed no financial relationship relevant to this commentary. This commentary does not contain a discussion of an unapproved/investigative use of a commercial product/device.Federal guidelines1 for dosing pediatric nonprescription liquid medications are evidenced-based, reasonable, and intuitive: provide a measuring device, with markings limited to those necessary for appropriate dosing; reconcile written dosing instructions with device markings; use only a few units (eg, milliliters, teaspoons, or tablespoons) on all packaging, labels, and devices; standardize and explain abbreviations; use only recommended formats for decimals and fractions; and provide consumers with key guidance (eg, use the device only for the product with which it is provided and clarify nonspecified doses with the prescriber). Using only metric measures2 might strengthen these recommendations. Additional factors3 need to be considered, including parental health literacy.In an accompanying editorial,2 a health communications expert considers this study in the context of the complete therapeutic encounter, emphasizing that safe and effective health care often depends on the patient (or caregiver) properly implementing treatment, especially in the outpatient setting. He opines that industry has greater responsibility for providing care related to nonprescription drugs and argues the necessity of increased research investment and more regulatory oversight.Yin and colleagues substantiate an important safety-related need4,5 for such guidelines and endorse the current federal effort. These baseline data clearly demonstrate that achieving conformity with the guidelines will require much work. Small manufacturers, cough/cold and allergy products, and products targeting broad age ranges may require particular scrutiny. Sourcing administration devices separately from the medications themselves may compound the problem. Continued focus on the drug categories and products with large market share is appropriate.The authors imply that stronger measures may be needed, including mandatory regulatory oversight in the absence of voluntary adherence by industry. Though providers are limited in how much they can influence the use of nonprescription drugs in the outpatient setting, they are nevertheless obligated to foster a culture of compliance based on clear, repetitive educational efforts. Patients and their caretakers must understand that accurate dosing and administration is important for prescription and nonprescription drugs alike. While industry and government can and should do more, limited FDA resources and increased emphasis on small government makes relying solely on industry and government insufficient.