Impact of Pediatric Labeling Changes on Cough/Cold Products
Within the past five years, several groups have evaluated the effect of the FDA restrictions on recommendations made by health care providers and prescriptions written for cough and cold products. In 2013, Mazer-Amirshahi and colleagues assessed the impact of the restrictions and labeling changes on use of OTC and prescription cough and cold products in young children using data from the National Hospital and Ambulatory Medical Care Surveys. The authors compared data in children 12 years of age and younger before the restrictions (2005–2006) and after (2009–2010). The authors found no change in the use of OTC cough and cold products in the Emergency Department (ED), although there was a significant decrease in the use of prescription products (6.7% versus 2.9%, p = 0.001). In ambulatory care clinics, OTC product use increased overall (6.3% versus 11.1%, p = 0.001). In children less than 2 years of age, OTC product use remained unchanged but prescription product use declined.
Sen and colleagues published a similar assessment of prescription cough and cold product use in 99,176 children less than 2 years of age in Italy and the Netherlands. Data from 2005 and 2008 were assessed to represent use before and after the change in labeling. Prescriptions for cough and cold products decreased from 83/1,000 children to 77/1,000 in Italy (p = 0.05), but increased in the Netherlands from 72/1,000 to 92/1,000. Prescriptions for both nasal sympathomimetics and opium alkaloids for cough increased in the Netherlands (p < 0.01), but there were significant reductions in the use of opium alkaloids and other cough suppressants as well as nasal sympathomimetic combination products in Italy. The authors noted that international safety warnings appear to have failed to reduce prescribing and may demonstrate a lack of prescriber recognition of the risk to benefit profile for these agents in young children.
Impact on Recommendations From Providers
Within the past five years, several groups have evaluated the effect of the FDA restrictions on recommendations made by health care providers and prescriptions written for cough and cold products. In 2013, Mazer-Amirshahi and colleagues assessed the impact of the restrictions and labeling changes on use of OTC and prescription cough and cold products in young children using data from the National Hospital and Ambulatory Medical Care Surveys. The authors compared data in children 12 years of age and younger before the restrictions (2005–2006) and after (2009–2010). The authors found no change in the use of OTC cough and cold products in the Emergency Department (ED), although there was a significant decrease in the use of prescription products (6.7% versus 2.9%, p = 0.001). In ambulatory care clinics, OTC product use increased overall (6.3% versus 11.1%, p = 0.001). In children less than 2 years of age, OTC product use remained unchanged but prescription product use declined.
Sen and colleagues published a similar assessment of prescription cough and cold product use in 99,176 children less than 2 years of age in Italy and the Netherlands. Data from 2005 and 2008 were assessed to represent use before and after the change in labeling. Prescriptions for cough and cold products decreased from 83/1,000 children to 77/1,000 in Italy (p = 0.05), but increased in the Netherlands from 72/1,000 to 92/1,000. Prescriptions for both nasal sympathomimetics and opium alkaloids for cough increased in the Netherlands (p < 0.01), but there were significant reductions in the use of opium alkaloids and other cough suppressants as well as nasal sympathomimetic combination products in Italy. The authors noted that international safety warnings appear to have failed to reduce prescribing and may demonstrate a lack of prescriber recognition of the risk to benefit profile for these agents in young children.
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