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To assess the likely impact of the Food and Drug Administration (FDA) advisory not to use over-the-counter (OTC) cough and cold products for children < 2 years old on care provided by pediatricians and parents
One-hundred and five community pediatricians completed a mailed survey (53% response rate), and 1,265 parents with children < 12 years old completed a self-administered survey while waiting for an office visit.
All physicians were aware of the advisory; 75% agreed with it. Fifty-nine percent did not recommend OTC cough and cold products for children < 2 years old before the advisory and 35% were less likely to do so afterwards.
Seventy-three percent of parents were aware of the advisory, 70% believed these products relieved symptoms, 68% did not believe they were dangerous, and 74% had them at home. After the advisory, 21% of parents were more likely to request an antibiotic from the doctor. 225 parents only had children < 2 years old and 695 only had children 2–11 years old. Among these parental groups respectively, 53% and 10% of parents did not use these products before the advisory, an additional 33% and 28% were less likely to do so afterwards, and 15% and 61% would continue use them.
Pediatricians must be prepared for requests from parents for antibiotics and other remedies for symptom relief for their children with colds. As no effective alternatives are available maybe non-treatment should be promoted.
The potential for adverse effects in children from commonly used over the counter (OTC) cough and cold medications (including decongestants, anti-histamines, and cough expectorants and suppressants) has concerned many pediatricians for years.1–4 In March 2007, the cumulative morbidity and mortality associated with use of these drugs prompted a group of pediatric experts to petition the United States Food and Drug Administration (FDA) to advise that these medications not be used by children less than sixyears old.1, 5 During the FDA review process, many pharmaceutical manufacturers voluntarily withdrew OTC cough and cold products that were being sold for infants and children less than 2 years old.3 In January 2008, the FDA issued a nationwide Public Health Advisory “recommending that over-the-counter cough and cold medicines not be used to treat infants and children less than two years of age because serious and potentially life-threatening side effects can occur.” 6 For older children, the FDA recommends that parents and caregivers “understand that these products are just for symptom relief, and will not treat the cause of the symptoms or shorten illness duration.” 6
Our objective was to assess the likely impact of the FDA advisory and warnings on parent and pediatrician attitudes towards and use of these products.
We developed and implemented two surveys, one of community pediatricians and one of parents. As no standardized tools were available, both surveys were developed by the authors. Survey items were based on the literature and the author’s experience in primary care and were refined after pilot testing. The reading level of the parent questionnaire was 6.4 (Flesch-Kincaid). Each survey took about five minutes to complete. The study was approved by Washington University Human Research Protection Office.
Eligible physician subjects were community pediatricians affiliated with St. Louis Children’s Hospital (SLCH). All these physicians were mailed a written invitation to participate in the survey, together with the 27-item self-administered questionnaire. As the questionnaire was anonymous, physicians indicated their participation (yes or no) by returning a postcard separate from the questionnaire. Up to two additional mailings were sent to those who did not return the postcard.7
Questions assessed the physician’s usual practice regarding recommending OTC cough and cold products, their knowledge of and agreement with the FDA advisory, and its likely impact on future patient care. In addition, physicians selected from a list of anticipated barriers to implementation of the advisory and provided demographic information.
All pediatricians who received the physician survey were asked if they would allow an on-site research assistant (RA) to recruit subjects for the parent survey. At sites who agreed, parents who brought their child for an office visit were approached by the RA in the waiting room and invited to “complete a brief survey about OTC cough and cold medicines.” At each site, the majority of potentially eligible parents were approached during the time the RA was on site. Parents were not approached if they were immediately called to see the physician or if the RA was already busy with one parent. Unaccompanied minors or grandparents were not approached. Subjects completed the anonymous, 30-item, self-administered paper survey prior to seeing the physician. Parents were excluded from the study if they did not have at least one child who was < 12 years old.
Questions assessed parents’ attitudes towards and behaviors regarding use of OTC cough and cold products, their knowledge of the FDA Advisory, and its likely impact on the care they would provide for their children with an upper respiratory infection (URI). In addition, demographic data were recorded.
For both the physician and parent surveys, respondents used a five-point categorical scale to report their agreement with attitudinal statements about characteristics of OTC cough and cold medications (strongly disagree, disagree, neither disagree or agree [unsure], agree, strongly agree). Respondents used a four-point scale to indicate their likely future behaviors regarding use of these and other products for symptom relief following the advisory (no change, do not do this; no change, usually do this; more likely to do this; less likely to do this).
For both populations, continuous variables are reported as mean (standard deviation, SD) or median (range), and categorical data as proportions. Responses of agree and strongly agree and disagree and stronly disagree were combined and reported as agreed and disagreed respectively. We conducted subgroup analyses to compare responses from parents with children in different age groups (< 2 years, and 2–11 years). For clarity, parents with children in both age groups were excluded from these subgroup analyses; generally, their responses were the same as those from parents of older children. Other subgroup analyses used the whole study population to explore if race (black vs. other), insurance (Medicaid vs. other), parent education (college graduate vs. other) and family structure (single parent vs. other) were associated with an increased likelihood to request an antibiotic or symptomatic treatment following the advisory (sum of “would continue to do so” and “more likely to do so”). For these analyses, differences in the univariable analyses were compared using the chi-squared test. Logistic regression was used for the multivariable analyses. A probability of p < 0.05 (two-tailed) was used to establish statistical significance. All statistical analyses were done using STATA 9.0 (Stata Corp.2001. Stata Statistical Software: Release 9.0 College Station, TX: Stata Corporation).
Between March 24 and May 1, 2008 physician surveys were mailed to 197 community pediatricians from 88 practices. One hundred and five (53%) pediatricians completed the survey (Table 1). Participants were similar with respect to gender, practice type, and practice location to those who returned a postcard to indicate they would not participate.
These pediatricians stated that they were commonly asked for, and provided advice about the use of OTC cough and cold products. Of the last 10 children diagnosed with a URI, on average 6.8 parents requested advice about these products (SD 2.7), and physicians provided advice for 7.9 parents (SD 2.6).
Respondents selected one of three statements to best represent their usual advice to parents about the use of OTC cough and cold medicines for children < 2 years old: “OTC cough and cold medicines may make your child more comfortable” (selected by 6%); “I don’t recommend OTC cough or cold medicines because they are not effective” (31%); “Do not use OTC cough and cold medicines because they are not effective and they may cause serious and potentially life-threatening side effects” (63%).
All physician respondents were aware of the FDA advisory; 75% agreed with this recommendation (13% disagreed, 12% were unsure). Most physicians identified the non-medical media (87%) as a source of this information, but others identified medical newspapers (59%), physician colleagues (38%), peer-reviewed medical journals (28%), and patients/parents (13%) (participants could select > 1 source).
Forty-six percent of physicians believed there were no barriers to implementing the advisory. Others selected parental demand for treatment (48%), obtaining consensus among practice partners (15%), lack of educational materials for parents (14%), education of office staff (10%), lack of agreement with the advisory (9%), and feeling the need to recommend something (4%) as barriers (participants could select > 1 barrier).
The likely impact of the advisory on care for children with URIs reported by physicians is presented in Table 2. Six percent reported they would continue to recommend these products for infants and children < 2 years old, while 29% would do so for older children.
Twenty of 88 (23%) offices allowed in-office recruitment for the parent survey during the four month study period (March 25, to July 29, 2008). Participating sites did not differ from nonparticipating sites for type of practice or location (most were group practices located in the suburbs). We were able to track recruitment in nine offices. In these offices, 582 of 725 attendees were approached, 26 (4%) declined to participate, and 143 were not approached. Assuming all those who were not approached were eligible, the overall participation rate in these nine practices was 77% (median office participation rate was 74%, range 47% to 91%, only one site was <67%). Unfortunately, we do not have data to determine the accuracy of this estimate for the participation rate across the sample. Practice characteristics for the nine sites that provided these recruitment data were similar to the other 11 sites except they had fewer African American attendees (5% vs. 29%, p<0.001). When < 95% of parents responded to a question, the number of respondents is provided.
Thirteen hundred and eighty six parent interviews were completed, but 121 were excluded as the parent did not have a child < 12 years old; 1,265 parent interviews were included in the analysis (median eligible interviews/office 59.5, range 6–126). Forty-six percent of respondents had at least a college degree and 19% used Medicaid insurance for their children (Table 1).
Forty-four percent of parents reported they usually used OTC cough and cold medications for a child with a URI (18% < 2 years, 53% 2–11 years, p<0.001) and 74% (686/926) reported they had OTC cough and cold products in their home (55% < 2 years, 79% 2–11 years, p<0.001).
Parental attitudes towards these products are presented in Table 3. Seventy percent of parents believed that these OTC products would make their child more comfortable (54% < 2 years, 76% 2–11 years, p<0.001), and 32% agreed that “these products can cause serious and potentially life-threatening side-effects in infants and young children.” (36% <2 years, 30% 2–11 years, p=0.3)
Nine-hundred and fifty-one (73%) parents were aware of the FDA advisory (79% <2 years, 67% 2–11 years, p=0.001). Seventy percent of these respondents learned about the advisory from the media, 32% from their physician or nurse, 14% from friends or relatives, and 5% learned about it from their pharmacist (Participants could select > 1 source).
(Percentages do not sum to 100% because of rounding). After the advisory, only 15% of parents of children < 2 years old reported they would continue to use OTC cough and cold products for their child (53% did not use these products before the advisory and an additional 33% would not use them afterwards). By contrast, 61% of parents of children 2–11 years old would continue to use these products for their child (10% did not use them beforehand and an additional 28% would not do so afterwards). Seventy-four percent of all parents would continue to use these products for themselves (13% did not use them before the advisory and an additional 13% would not use them afterwards), with no difference by their child’s age group.
In Table 4 we present parents reported intention to seek other treatments to relieve their children’s symptoms. Twenty-one percent were more likely to request an antibiotic (27% <2 years, 19% 2–11 years, p=0.001), and 40% were more likely to request alternative symptomatic treatment.
The results of the univariable analyses are presented in Table 5. In the multivariable analyses, parents were more likely to request an antibiotic if their child was black (OR 1.59, 95% CI 1.26 to 2.00) and less likely to do so if they had at least a college degree (OR 0.54, 95%CI 0.42 to 0.70). They were more likely to ask for another symptomatic remedy if their child had Medicaid insurance (OR 1.57, 95%CI 1.09 to 2.26) and less likely to do so if they were a college graduate (OR 0.67, 95%CI 0.52 to 0.86).
In the wake of widespread dissemination of an FDA advisory and warnings that OTC cough and cold medications are dangerous for infants and children under two years of age, many pediatricians and parents reported they were less likely to use these products. However, our data suggest that parents were not convinced that these products are dangerous. While fewer than twenty percent of parents of children under two years old articulated that they will continue to use these products, parent’s confidence in their safety and efficacy together with their continued availability in the home suggest more widespread use is likely. These findings are similar to those from a national survey conducted in the fall of 2008, prior to the advisory,8suggesting that the FDA advisory may have relatively little impact on parent behavior.
Pediatricians are parents most trusted source of information about drug safety and effectiveness.8 As no effective, safe treatments are available to provide symptomatic relief for children with coughs and colds, maybe it is time for physicians to recommend “non-treatment” -- avoidance of remedies that are unlikely to offer benefit, while ensuring adequate hydration and the treatment of fever when necessary. One dose of buckwheat honey at bedtime may reduce nocturnal cough frequency and improve sleep, 9 but honey is not recommended for infants less than one year old because of the risk of botulism.10 Echinacea,11, 12 zinc, 13 high dose vitamin C 14 and herbal medicines15 have not been shown to offer benefit. Prevention of URIs through breastfeeding16 and frequent hand-washing17 could also be promoted.
We were surprised that one in five parents reported they were more likely to request an antibiotic for symptom relief after the advisory. It is possible that parent’s interpreted the phrase “request an antibiotic” to mean “make sure an antibiotic is not required.” Pediatricians identified the lack of parent education materials as a potential barrier to implementation of the FDA advisory, but resources to support avoidance of antibiotic treatment for a URI are available free of charge at http://www.cdc.gov. Although controversial, watchful waiting is recommended for some children with uncomplicated acute otitis media and acute sinusitis,18–20 is common practice in some European countries,21, 22 and is an acceptable approach for many U.S. parents.23 Providing information about judicious antibiotic use during well child visits may lessen expectations for antibiotic treatment when a URI occurs.
Our data suggest that the voluntary recall of products marketed for infants and children under two years old is unlikely to reduce the availability of products at home. Similarly, the recent action by members of the Consumer Healthcare Products Association (CHPA) to re-label products as “do not use” in children under four years old is unlikely to reduce availability.24 Accidental ingestion is the most common cause of emergency department visits for adverse drug events related to OTC cough and cold medications,1and it is worrisome that products continue to be available in most homes. A recommendation by the FDA to avoid use of these products in older children and adults would likely reduce availability in the home, but introduction of child-resistant packaging proposed by CHPA manufacturers may be a more effective strategy to reduce accidental ingestion.1
There are several limitations to this study. While our response rate of 53% for the physician survey was comparable to other physician surveys, and our estimate of the response rate for the parent survey is robust (~ 77%), it is possible that non-response bias may have affected our results. Similarly, although our sample of parents was large, the study population was primarily suburban, caucasian and non-medicaid and our findings may not be generalizable to other populations. As the physician survey was anonymous, we cannot assess how many of the pediatricians at the participating offices had completed the physician survey, nor can we link the physician and parent responses. Relying on self-reported data may have resulted in an overestimate of perceived desired behaviors such as reducing the use of OTC cough and cold medications, but other FDA warnings to avoid drugs because of safety concerns have decreased use in the targeted population.25 Only 73% of parents answered the question about having OTC in the home, which may reduce the accuracy of this estimate.
Physicians and parents are aware of the recent FDA warnings and advisory about avoidance of OTC cough and cold medications for infants and children under two years of age. Although most parents intend to avoid these products for their very young children, few agree they are dangerous, and many continue to believe they provide symptom relief and keep them at home. To avoid use of these and other alternative treatments that offer no benefit and incur cost, physicians should consider promoting “non-treatment” of children with URIs except for management of fever and dehydration as necessary.
We thank all the physicians and parents who completed the surveys, and the pediatricians at Blue Fish Pediatrics, Children’s Clinic, Esse Health-Watson, Esse Health-Creve Coeur, Esse Health-Florissant, Heartland Pediatrics, Forest Park Pediatrics, Northwest Pediatrics, Pediatric Healthcare Unlimited, Primary Care Pediatrics and Tots thru Teens Pediatrics who allowed us to enroll patients in their offices. We also thank Shannon McBride for her careful review of the manuscript.
Funding: This publication was made possible by Grant Number UL1 RR024992 from the National Center for Research Resources (NCRR), a component of the National Institutes of Health (NIH), and NIH Roadmap for Medical Research. Its contents are solely the responsibility of the author and do not necessarily represent the official view of NCRR or NIH.
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