Availability of Safe and Effective Therapeutic Options to Pregnant and Lactating Individuals Following the United States Food and Drug Administration Pregnancy and Lactation Labeling Rule.

OBJECTIVE: To explore the extent and type of pregnancy and lactation data of newly approved prescription drugs and assess whether the presented recommendations are data-driven, as required by the US Food and Drug Administration Pregnancy and Lactation Labeling Rule implemented in 2015. STUDY DESIGN: In this descriptive analysis, we reviewed pregnancy and lactation data of all new molecular entities approved between 2001 and 2020 in their most updated labeling. Information was collected regarding the pregnancy and lactation risk statements, the source of pregnancy and lactation data, and the design and methods of pregnancy and lactation studies in the labeling. RESULTS: Of the 422 new molecular entities, the key advisory statement for use of 133 (32%) drugs in pregnancy and 194 (46%) drugs in lactation were classified as "against use." Less than 2% of all drugs had a key advisory statement that supported their use during pregnancy or lactation. The sources of data regarding use in pregnancy were studies in human and animals in 46 (11%) and 348 (82%) drugs, respectively. For use during lactation, data included studies in human and animals in 23 (5%) and 251 (59%) drugs, respectively. The key advisory recommendation was consistent with the available human information in 4 (8%) drugs in pregnancy and 3 (13%) drugs in lactation. Prescription drug labeling contains limited data to support informed decision-making for the use of prescription drugs during pregnancy/lactation. Close collaboration among stakeholders is required to enhance the availability of data in this population.

Prescription Drug Shortages: Implications for Ambulatory Pediatrics.

OBJECTIVE: To describe contemporary drug shortages affecting general ambulatory pediatrics. STUDY DESIGN: Data from January 2001 to December 2015 were obtained from the University of Utah Drug Information Service. Two pediatricians reviewed drug shortages and identified agents used in ambulatory pediatrics. Shortage data were analyzed by the type of drug, formulation, reason for shortage, duration, marketing status, if a pediatric friendly-formulation was available, or if it was a single-source product. The availability of an alternative, and whether that alternative was affected by a shortage, also was noted. RESULTS: Of 1883 products in shortage during the study period, 314 were determined to be used in ambulatory pediatrics. The annual number of new pediatric shortages decreased initially but then increased to a high of 38 in 2011. Of the 314 pediatric shortages, 3.8% were unresolved at the end of the study. The median duration of resolved shortages was 7.6 months. The longest shortage was for ciprofloxacin 500-mg tablets. The most common class involved was infectious disease drugs. Pediatric-friendly dosage forms were affected in 19.1% of shortages. An alternative agent was available for 86% drugs; however, 29% of these also were affected. The most common reason for shortage was manufacturing problems. CONCLUSIONS: Drug shortages affected a substantial number of agents used in general ambulatory pediatrics. Shortages for single-source products are a concern if a suitable alternative is unavailable. Providers working in the ambulatory setting must be aware of current shortages and implement mitigation strategies to optimize patient care.

The impact of pediatric labeling changes on prescribing patterns of cough and cold medications.

OBJECTIVE: To evaluate the impact of initiatives created by the pharmaceutical industry and the Food and Drug Administration to limit the use of over-the-counter (OTC) cough and cold medications (CCMs) in young children in emergency departments (EDs) and ambulatory clinics. STUDY DESIGN: Analysis of the National Hospital Ambulatory Medical Care Survey and National Ambulatory Medical Care Survey was performed comparing 2005-2006 and 2009-2010 in children aged ≤ 12 years with a reason for visit consistent with cough or cold-related symptoms. Data were stratified by age (<2 years, 2-6 years, and 6-12 years). Descriptive frequencies and survey-weighted χ(2) tests were used to assess OTC and prescription CCM prescription rates in ED and ambulatory clinic settings. RESULTS: Comparing 2005-2006 and 2009-2010 revealed no changes in ED use of OTC CCMs; however, the use of prescription CCMs decreased, from 6.7% to 2.9% (P = .001). In ambulatory clinics, the overall rate of OTC CCM use increased from 6.3% to 11.1% (P = .001); however, use by children aged <2 years was unchanged. Prescription CCM use in EDs declined in all age groups, but in ambulatory clinics, decreases were significant only in patients aged <2 years. CONCLUSION: Implementation of pharmaceutical industry and Food and Drug Administration initiatives did not decrease the use of OTC CCMs in children aged <2 years in EDs or ambulatory clinics. The use of prescription CCMs was decreased in both settings, however.

The impact of race on analgesia use among pediatric emergency department patients.

We studied the effect of race on analgesia use in potentially pain-related pediatric emergency department visits using the National Hospital Ambulatory Medical Care Survey (2005-2010). There were independent patient- and hospital-level racial disparities when it came to the type of analgesia used, suggesting black children are treated differently even within hospitals with high numbers of black patients.

Effect of cough and cold medication restriction and label changes on pediatric ingestions reported to United States poison centers.

OBJECTIVE: To determine the impact of industry and Food and Drug Administration initiatives implemented to limit the use of over-the-counter (OTC) cough and cold medications in children younger than 6 years of age. STUDY DESIGN: This is a retrospective database study of OTC cough and cold medication ingestions reported to US poison centers between 2000 and 2010. Data analyzed from the National Poison Data System included the month and year of ingestion, reason for ingestion, health care utilization, and medical outcome. Ingestion frequencies were stratified by age and reason. Data were divided into pre- and postintervention periods for comparative analysis. RESULTS: Unintentional ingestions of OTC cough and cold medications decreased 33.4% and therapeutic errors by 46.0%. Health care facility referral declined for unintentional ingestions (28.9% <2 years of age, 19.9% 2-5 years of age, P < .0001) and therapeutic errors in children younger than 2 years of age (59.2%, P < .0001). Moderate and severe adverse outcomes decreased for unintentional ingestions in children younger than 2 years of age by 32.4% and by 21.3% in 2- to 5-year olds, P < .0001. CONCLUSIONS: The restriction of OTC cough and cold medications has led to a decline in unintentional ingestions, therapeutic errors, health care facility referral, and serious medical outcomes in children younger than 2 years of age. There has also been a decline in ingestions in 2- to 5-year-old children.