Impact of Pediatric Labeling Changes on Cough/Cold Products
Impact of Pediatric Labeling Changes on Cough/Cold Products
Nonprescription cough and cold products are widely used by the US population, generating approximately $8 billion dollars in revenue per year. The market for these products is currently growing at a rate of 1.3% annually. While the FDA public advisory and OTC product labeling changes have been in place for several years, many parents remain unaware of the potential risks to young children with these commonly used medications. In an on-line survey of 330 parents of children less than 6 years of age conducted within 45 days of the original FDA announcement, 82.5% stated they had given one or more OTC cough and cold products to their child. When asked about efficacy of treatment, 40% of parents considered these products somewhat effective, with 18.4% rating them as slightly effective, and 2.4% as not effective. Approximately a third of parents (28.9%) were unable to identify the active ingredients in the products they used from a list of options. Of the parents who were already aware of the new FDA recommendations to avoid use in children less than 2 years of age, 32% intended to continue to give their children OTC products. Another 30% rated themselves as unsure of what to do when managing their children's cold symptoms.
A more recent national survey was conducted in January 2013 by the C.S. Mott Children's Hospital which showed little change in parental OTC medication use patterns over time. Of the 498 parents of children 0–3 years of age surveyed, 44% reported giving their children multi-symptom cough and cold products. Forty-two percent reported giving their children cough medicine and 25% gave their children decongestants. The authors found no relationship between medication use and parent gender, race, ethnicity, or household income.
In 2013, Lazarus and colleagues conducted a cross-sectional observational study of families of 65 children less than 6 years of age being seen in an urban pediatric emergency department. Fifty-two caregivers (80%) had completed 12 or more years of education. Caregivers were shown six common OTC cough and cold products and asked about how they would use these medications in their children. Fifty-three caregivers (85%) stated they would give these products to their children for a cold. Eighteen (34%) stated they would treat their child's symptoms with more than one product. Thirteen caregivers (20%) reported having received recommendations to give one or more of the products by healthcare providers, including ten physicians (6 pediatricians, 4 other), two pharmacists, and a nurse.
The authors identified a clear need for medication education. Only 46% of caregivers were aware of the warnings on the label about use in young children. Seventy percent were unaware of the potential for adverse effects with these products, and 72% were unaware of the risk for interactions with other drugs. When asked to demonstrate how they would prepare a dose for their child, 38 caregivers (72%) made errors in either determining the correct dose or in measurement of the dose. The prevalence of dose preparation errors in this study reflects a continued need to improve the labeling on pediatric OTC products.
The FDA provided specific recommendations for manufacturers regarding the content and format of labeling and the types of measuring devices to be included for oral liquids in 2011, echoing earlier guidance provided by CHPA to its members. The recommendations were categorized as top tier (having the potential to prevent three-fold or greater dosing errors) or low tier. Examples of top tier recommendations are listed below:
In the February 2014 issue of Pediatrics, Budnitz and colleagues at the Centers for Disease Control and Prevention evaluated the labeling of common OTC medications for children to assess their adherence to FDA and CHPA guidelines. Sixty-eight products were evaluated, including analgesics/antipyretics, cough and cold, and allergy products. The authors found that 91% of the dosing directions and 62% of enclosed dosing devices (droppers, oral syringes, or dosing spoons) complied with all of the top tier recommendations. Adherence with the low tier recommendations ranged from 26% to 91%. The discordance between these results and the rate of medication preparation errors in the Lazarus study highlights the difficulty in creating consumer labeling that is easily understood.
Impact on use by Families
Nonprescription cough and cold products are widely used by the US population, generating approximately $8 billion dollars in revenue per year. The market for these products is currently growing at a rate of 1.3% annually. While the FDA public advisory and OTC product labeling changes have been in place for several years, many parents remain unaware of the potential risks to young children with these commonly used medications. In an on-line survey of 330 parents of children less than 6 years of age conducted within 45 days of the original FDA announcement, 82.5% stated they had given one or more OTC cough and cold products to their child. When asked about efficacy of treatment, 40% of parents considered these products somewhat effective, with 18.4% rating them as slightly effective, and 2.4% as not effective. Approximately a third of parents (28.9%) were unable to identify the active ingredients in the products they used from a list of options. Of the parents who were already aware of the new FDA recommendations to avoid use in children less than 2 years of age, 32% intended to continue to give their children OTC products. Another 30% rated themselves as unsure of what to do when managing their children's cold symptoms.
A more recent national survey was conducted in January 2013 by the C.S. Mott Children's Hospital which showed little change in parental OTC medication use patterns over time. Of the 498 parents of children 0–3 years of age surveyed, 44% reported giving their children multi-symptom cough and cold products. Forty-two percent reported giving their children cough medicine and 25% gave their children decongestants. The authors found no relationship between medication use and parent gender, race, ethnicity, or household income.
In 2013, Lazarus and colleagues conducted a cross-sectional observational study of families of 65 children less than 6 years of age being seen in an urban pediatric emergency department. Fifty-two caregivers (80%) had completed 12 or more years of education. Caregivers were shown six common OTC cough and cold products and asked about how they would use these medications in their children. Fifty-three caregivers (85%) stated they would give these products to their children for a cold. Eighteen (34%) stated they would treat their child's symptoms with more than one product. Thirteen caregivers (20%) reported having received recommendations to give one or more of the products by healthcare providers, including ten physicians (6 pediatricians, 4 other), two pharmacists, and a nurse.
The authors identified a clear need for medication education. Only 46% of caregivers were aware of the warnings on the label about use in young children. Seventy percent were unaware of the potential for adverse effects with these products, and 72% were unaware of the risk for interactions with other drugs. When asked to demonstrate how they would prepare a dose for their child, 38 caregivers (72%) made errors in either determining the correct dose or in measurement of the dose. The prevalence of dose preparation errors in this study reflects a continued need to improve the labeling on pediatric OTC products.
The FDA provided specific recommendations for manufacturers regarding the content and format of labeling and the types of measuring devices to be included for oral liquids in 2011, echoing earlier guidance provided by CHPA to its members. The recommendations were categorized as top tier (having the potential to prevent three-fold or greater dosing errors) or low tier. Examples of top tier recommendations are listed below:
including a measuring device with clear markings for all liquids
avoiding doses on measuring devices that are more than the largest recommended dose
using standard units, such as mL, rather than nonstandard language such as dropperfuls
using small fractions (½) instead of 1/2
using leading zeros in front of all decimals
avoiding trailing zeros after decimals
avoiding use of both teaspoon and tablespoon in the labeling of a single product.
In the February 2014 issue of Pediatrics, Budnitz and colleagues at the Centers for Disease Control and Prevention evaluated the labeling of common OTC medications for children to assess their adherence to FDA and CHPA guidelines. Sixty-eight products were evaluated, including analgesics/antipyretics, cough and cold, and allergy products. The authors found that 91% of the dosing directions and 62% of enclosed dosing devices (droppers, oral syringes, or dosing spoons) complied with all of the top tier recommendations. Adherence with the low tier recommendations ranged from 26% to 91%. The discordance between these results and the rate of medication preparation errors in the Lazarus study highlights the difficulty in creating consumer labeling that is easily understood.