3
Over-the-Counter Products

CURRENT STATUS OF OVER-THE-COUNTER LABELS

H. Shonna Yin, M.D., M.S.

New York University School of Medicine


Inconsistency and variability in medication labeling is a source of confusion for patients and consumers, said Shonna Yin. Confusion increases risk for error. This is a significant health literacy and patient safety issue. In a first attempt to systematically look at the variability in over-the-counter (OTC) products, the study described here focuses on pediatric medications because of the prevalence of OTC medications used in children and the unique challenges of dosing liquid medications. The expectation is that the findings would likely be reflective of a wider sample of medications. Others involved in this study include Bernard P. Dreyer, Ruth M. Parker, Lee M. Sanders, and Michael S. Wolf.

There are several national initiatives focused on labeling. About the same time the Food and Drug Administration (FDA) launched its Safe Use Initiative, it also released a guidance for industry focused on dosage delivery devices for over-the-counter liquid drug products (FDA, 2009c). The Consumer Healthcare Products Association (CHPA) also released a guidance document, in cooperation with the Centers for Disease Control



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3 Over-the-Counter Products CURRENT STATUS OF OVER-THE-COUNTER LABELS H. Shonna Yin, M.D., M.S. new York University School of Medicine Inconsistency and variability in medication labeling is a source of con- fusion for patients and consumers, said Shonna Yin. Confusion increases risk for error. This is a significant health literacy and patient safety issue. In a first attempt to systematically look at the variability in over-the- counter (OTC) products, the study described here focuses on pediatric medications because of the prevalence of OTC medications used in chil- dren and the unique challenges of dosing liquid medications. The expec- tation is that the findings would likely be reflective of a wider sample of medications. Others involved in this study include Bernard P. Dreyer, Ruth M. Parker, Lee M. Sanders, and Michael S. Wolf. There are several national initiatives focused on labeling. About the same time the Food and Drug Administration (FDA) launched its Safe Use Initiative, it also released a guidance for industry focused on dosage delivery devices for over-the-counter liquid drug products (FDA, 2009c). The Consumer Healthcare Products Association (CHPA) also released a guidance document, in cooperation with the Centers for Disease Control 

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 THe SAFe USe InITIATIVe AnD HeALTH LITeRACY and Prevention’s (CDC’s) PROTECT Initiative.1 Each contains recommen- dations, but neither discusses existing levels and types of inconsistencies. The study reported in this presentation aims to quantitatively clarify the issues. The study sampled 200 top-selling OTC products that included oral liquid medications, analgesic, cough/cold, allergy, or gastrointestinal (GI) products with dosing directions for children under 12 years of age. More than half (59 percent) of the products were cough/cold remedies, fol- lowed by GI products (22 percent), analgesics (11 percent), and allergy medicines (8 percent). The study found a very high rate of inconsistency and variability in labels and devices for pediatric OTC liquid medications. Problems included • No dosage delivery device included • Inconsistency between label and dosage delivery device • Superfluous markings on the device • Missing necessary markings on the device • arkings for units of measure that do not match what is on the M label • ormat of numeric text (decimals/fractions) does not match label F text • Inconsistency across products • Nonstandard abbreviation for milliliter (not mL) • Nonstandard abbreviation for teaspoon (not tsp) • nits of measurement other than milliliter, teaspoon, and tablespoon U • Inconsistent use of numeric text (decimals/fractions) • Lack of consumer guidance on appropriate use One out of four products did not include a device for administering the medication. Almost all (99 percent) products had one or more incon- sistencies between the label and dosage delivery device. For example, 81 percent had superfluous markings on the device (Table 3-1), such as ounce or milliliter measurements when the dosing called for measurements in teaspoons. Two thirds (67 percent) used a nonstandard abbreviation for milliliter. The FDA recommended standard and the U.S. Pharmacopeia (USP) standard is lowercase m and uppercase L for mL. 1 The CHPA Board of Directors adopted a voluntary program that recommends manu - facturers take specific steps in labeling, packaging, and promotion of over-the-counter oral pediatric cough and cold medicines (http://www.chpa-info.org/scienceregulatory/ Voluntary_Codes.aspx#PediatricCoughCold).

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 oVeR-THe-CoUnTeR PRoDUCTS TABLE 3-1 Inconsistencies Between Label and Dosage Delivery Device Type of Inconsistency Percent Superfluous markings on device 81 Missing necessary markings on device 22 Markings for unit(s) of measurement do not match 89 Format of numeric text (decimals/fractions) does not 53 match SOURCE: Adapted from Yin, 2010. Two-thirds (64 percent) did not use small font size for numerals (e.g., used / instead of / which may increase the risk of administering 1 or 2 tsp, for example). Regarding consumer guidance, most products had no definitions of abbreviations, and the majority had no strategy to ensure the delivery device was used with the drug product. Two-thirds had no statement to only use the device with the specific product. Almost all (97 percent) had no mechanism to secure the device to the bottle. Based on these enormously high rates of inconsistency and variability in labels and devices for pediatric OTC liquid medications, the likelihood for confusion and mis-dosing is very high. Given the facts that one in four parents has low health literacy and that these medications are often dosed under stressful conditions (i.e., a child’s ill health), the likelihood for con - fusion and error is compounded. Therefore, efforts by the FDA and others to standardize labels and dosing devices for pediatric OTC medications are greatly needed, Yin concluded. HEALTH LITERACY TASKS FOR OVER-THE-COUNTER DRUG SAFETY Michael Wolf, Ph.D., M.P.H. Feinberg School of Medicine northwestern University Health literacy is about helping patients and families understand their health and health care, translate knowledge to recommendations, and apply problem-solving skills to new situations, especially in the con - text of OTC medications, since the consumer is making the decision to use a product, to take it home, and determine how to use it. A particular challenge occurs when the instructions for a specific medication change, because the consumer is accustomed to using the product in a particular way and probably does not check the instructions.

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 THe SAFe USe InITIATIVe AnD HeALTH LITeRACY As presented in Standardizing Medication Labels (IOM, 2008) there is a great deal of evidence of patient misunderstanding in prescription drug labeling. It was hoped that OTC labeling presented fewer challenges to consumers, but there have been limited studies to rigorously evaluate the OTC drug fact labeling. The research presented here involves investigat- ing the prevalence and root causes of misunderstandings common to OTC products. A perfect example of confusing labeling is written in a correspondence published in the new england Journal of Medicine (Parker et al., 2009). A 6-year-old girl was diagnosed with H1N1 influenza and prescribed Tami - flu oral suspension. Her mother is a master’s degree health educator and her father is an internist. Instructions called for ¾ teaspoon by mouth twice a day for 5 days. The syringe that was included in the box had 30, 45, and 60 milligram hash marks. It took the highly educated parents an hour to figure out how to appropriately dose their child because of the inconsistencies between the prescription and the dosage device. The CDC and the FDA responded within a week (Budnitz et al., 2009) and the problem was resolved; a great example of partnership between academia and industry. This example illustrates how health literacy is important for helping patients and families understand their health and health care, translate knowledge to recommended actions, apply problem-solving skills to new situations, foster ongoing health learning opportunities, and instill health promotion attitudes. Individuals must make all kinds of decisions in the use of OTCs (Box 3-1). For example, how do people approach the pharmacy aisle dedicated to analgesics and pain relievers? How do they differentiate between the array of medicines—some are combination products, some BOX 3-1 Health Literacy Tasks in OTC Drug Use • Match symptom to treatment without learned intermediary (self selection) determine personal appropriateness (pt hx) ■ • Know active ingredient • Proper dosing (of a PRN) how many pills to take at a time? ■ how long to wait before next dose? ■ when to stop (maximum daily dose) ■ SOURCE: Adapted from Wolf, 2010.

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 oVeR-THe-CoUnTeR PRoDUCTS have single-acting ingredients. Twenty-five billion doses of acetamino- phen were sold in 2008 (Woodcock, 2009). The drug surpasses viral hepa - titis as the leading cause of acute liver failure in the United States. Half to two-thirds of overdoses leading to acute liver failure are unintentional (Larson et al., 2005). How do we keep patients from unintentionally over- dosing on acetaminophen? When a doctor writes a prescription, he or she is legally responsible for communicating information on how to use the medication safely. With OTCs that safeguard does not exist. The consumer needs to recognize the active ingredient, especially with acetaminophen, to avoid unintentional overdose. Many prescription and OTC medications contain acetamino- phen. They also need proper dosing information such as how many pills to take at a time, how long to wait before they take the next dose, and the maximum daily dose. Because serious health risks have been documented with use of many OTCs, particularly analgesics, Wolf said, he and colleagues are undertak- ing four studies: a prevalence study to determine the rate of consumer misunderstanding of nonprescription analgesic medications, a follow-up study to determine why people misunderstand current labeling to inform better product language development, icon/message development to help consumers understand which products contain acetaminophen, and finally, a clinical trial testing labeling changes and whether they improve understanding. Study 1 began in June 2009. The goal is to recruit 500 consumers in Chicago and Atlanta, recruiting 125 patients from two academic settings and two community-based settings. Each patient’s functional understand- ing of OTC instructions and their knowledge of active ingredients are evaluated in interviews. Of the 300 patients recruited to date, the mean age is around 50 years of age, 52 percent are non-Hispanic white, 35 per- cent are African American, 56 percent have a college degree or higher, and 64 percent are female. Of those 300, about 1 in 5 patients have limited literacy skills. From preliminary findings, based on the 300 individuals recruited so far, respondents do relatively well determining pills per doses, with 81 to 96 percent getting the pills per dose correct; 61 to 86 percent got the dos- ing interval correct. The most significant issue was maximum daily dose: just 42 to 65 percent got that right. In the second study, participants were shown a list of several brand name products that contain acetaminophen. Fifty-nine percent thought it was okay to take Alka-Seltzer, which contains multiple ingredients, and Excedrin, which has acetaminophen, aspirin, and caffeine. Nearly 60 per- cent thought they could take Tylenol and the generic version of Tylenol, or acetaminophen. Two-thirds thought they could take the two Tylenol

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 THe SAFe USe InITIATIVe AnD HeALTH LITeRACY products together, since one was “post meridiem” and one was not. The majority of patients did not understand that these are the exact same active ingredients, and there could be a risk of overdose. Patients with lower literacy, older age, and African American race were more likely to misunderstand the medication. The task was repeated with combination products and ibuprofen, with similar, slightly higher prevalence; almost 70 percent of patients thought they could take two products with the same ingredient. The evidence sug- gests that the majority of consumers do not know the active ingredients in OTC products nor do they understand maximum daily dose. Patients do not know what is in these common products and, because they have used them for years, they do not bother to look at the packaging because they believe they know how to take it. It is important, Wolf said, to instill in patients the understanding that there are safety concerns with OTC products just as there are with prescription products. A new effort is under way in conjunction with McNeil Consumer Healthcare to develop and test new Drug Facts instructions and new icons for acetaminophen that could be used on both prescription and non- prescription packaging (see page 28). Clinical trials will take place at two locations (four sites) with a total of 1,200 participants. DISCUSSION Winston Wong of Kaiser Permanente asked whether either Yin’s or Wolf’s research included examination of directions written in Spanish to determine the extent to which similar problems exist. Wolf responded that Stacey Cooper Bailey of Northwestern University has been very interested in the language access issue. Conducting a study on the Spanish transla - tion of OTC medication instructions would be very valuable but, to date, it has not been possible to find OTC medications that have instructions in Spanish. Several participants brought up the challenges of finding labeling in Spanish. Sanders called the lack of translated labeling a “glar- ing issue,” particularly for the 1 in 10 U.S. adults with limited English proficiency. Based on a recent study conducted by Lokker and colleagues, Sanders also noted the confusion parents of young children commonly face both choosing OTC products by age and indication and dosing OTC products by age and weight. Lois Wessell, a family nurse practitioner with the Association of Clini- cians for the Underserved, asked about instruction on pediatric medica - tions based on age versus weight. In the populations she sees, mainly Latino immigrants, the obesity issue makes dosing difficult. Her Latino patients ask if the dosing is based on age or based on weight, plus they are accustomed to weighing babies in kilograms and have trouble convert-

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 oVeR-THe-CoUnTeR PRoDUCTS ing into pounds to find the correct dose. She has also seen labels listing a weight range without clarity on whether it is pounds or kilograms. Yin agreed that the issue of weight versus age-based dosing is very impor- tant for pediatric populations. As a pediatrician, she recommends dos- ing by weight. She noted, however, that many parents don’t know their child’s weight. William Ross, expressing his surprise at the amount of misinforma- tion reported by Yin and Wolf, asked if switching the United States to the metric system would ameliorate some of the problems. Isham replied that the roundtable could convene a discussion around that issue. Laura Schone, University of Rochester Medical Center, described a similar study she did with colleagues in adolescents and young adults. They found that 84 percent of adolescents, based on a combination of dosing tasks, are at risk for unintended overdose of acetaminophen. The risk for those with limited health literacy rose to 94 percent. Parents need to understand dosing, she suggested, since they teach the children—or do not teach them—how to take medications. Perhaps children could be taught in school, as part of health education, how to become safe consum- ers of health care, with a focus on OTC medicines. Isham asked the group what activities could be developed around the FDA Safe Use Initiative to address some of the issues that have been raised? What kind of coalition could be put together? Dale Slavin, with the FDA’s Safe Use Initiative, noted that the FDA has a program called Medicines in My Home2 that is a tool for teachers to use in health class to teach students how to read labels and understand medications. Isham saw a clear need for tools in the home to help people man- age their health care: charts, specific advice, e-mail addresses of caregiv - ers. He shared his family’s personal experience with complex medica - tion regimens to illustrate the need—even among people with a medical background. Cindy Brach of the Agency for Healthcare Research and Quality (AHRQ) said that agency’s pharmacy health literacy center offers sev- eral tools, including the Health Literacy Universal Precautions Toolkit, 3 released in April 2010. The toolkit offers primary care providers and their practices a way to assess their services for health literacy considerations, raise awareness of the entire staff, and work on specific areas. 2 “Medicines in My Home (MIMH) is a multimedia educational program to teach consum- ers from adolescence through adulthood how to choose over-the-counter medicines and use them safely. ‘Rooms’ of the program contain presentations, print materials, and resources that teachers, students, and adults can use online or download.” See http://www.fda. gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/Understanding Over-the-CounterMedicines/ucm092139.htm. 3 See http://www.ahrq.gov/qual/literacy/.

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 THe SAFe USe InITIATIVe AnD HeALTH LITeRACY Margaret Loveland, of Global Medical Affairs at Merck & Co., agreed that people are often confused by combination medications, especially in the cough and cold category. Very often, she said, parents will give a medicine for cough and cold, and then give Tylenol for the fever, and they are overdosing because both medicines have acetaminophen. Some patients take Excedrin Migraine for their migraine and plain Excedrin for their arthritis. People don’t realize they are taking the same medication. Problems occur for older adults who care for their grandchildren. With their aging eyesight, reading the indications on the measurement cups is very difficult, and the medicine inside the cup often obliterates the lines. Yin noted that she intends to look at the devices from that perspective. Some have etched markings, and others have printed markings. Which are easier to read? Before considering who to invite to the table, Ruth Parker suggested stepping back and asking for clarity on what the task is. Are we clear on the evidence of what it takes to safely use a product—be it a medication or a device? She and her colleagues, Scott Ratzan and Nicole Lurie, laid out a blueprint in Health Affairs (Parker et al., 2003). Isham ended the session by asking who helps the patient when there is a minor side effect when the patient is taking the medicine? How is the side effect assessed against the active ingredient? Who do they call for help? The surgeon? The internist? A nurse? The physical therapist? Mother?