1 Clinical Pharmacology Steinberg Flashcards
What types of disease are more uniquely pediatric?
Acute otitis media. Kawasaki disease. Infantile spasms, Febrile seizures, Absence epilepsy. Inborn errors of metabolism; various congenital/genetic syndroms. Hypoplastic left heart, Patent ductus arteriosus. ADHD. Neuroblastoma, Wilm’s tumor
What are some diseases that have notable differences between adults and pediatric patients?
JIA, SLE. Osteomyelitis. Heart failure. UTI, reflux nephropathy. Asthma. Drug withdrawal. Bacterial pneumonia
What is the Best Pharmaceuticals for Children Act?
Provides for voluntary pediatric drug assessments via a written request, including clinical and non-clinical studies. Reflects a public health need for pediatric studies. If a company has a product that is being used off-label in the pediatric population, FDA can require studies of that usage
What is the Pediatric Research Equity Act (PREA)?
Authorizes FDA to require a pediatric assessment of some approved drug/biologic products for certain indications
What are the 4 main points of the Best Pharmaceuticals for Children Act (BPCA)?
Studies are VOLUNTARY. Includes orphan drugs and orphan drug indications. Drugs and biologics. Studies on whole moiety (including other indications)
What are the 4 main points of the Pediatric Research Equity Act (PREA)
Studies are MANDATORY. Orphan drugs designated exempt. Drugs and biologics. Studies limited to the drug indication under review
What was the Pediatric Labeling Change for Levetiacetam (Keppra)?
Expanded indication to include pediatric patients 1 month of age
What was the Pediatric Labeling Change for Invermectin (Sklice)?
Sklice lotion is not recommended in peds patients < 6 months of age because of potential increase in systemic absorption and risk of toxicity
What was the Pediatric Labeling Change for Monteleukast?
Expanded inducation to include pediatric patients from 6-14 years old
What was the Pediatric Labeling Change for Iron Sucrose (Venofer)?
Expanded the indication from adults to pediatric patients > 2 years old
What did the FDA-approved Carvedilol labeling say for peds?
exposure appeared to be lower in pediatric subjects than adults
How does the PK/PD differ in peds patients for Carvedilol?
Twice daily dosing of Carvedilol resulted in lower trough plasma levels in children and adolescence than adults (d/t adolescence faster metabolism), suggesting that TID dosing with a higher target dose may be necessary in young children to optimize the therapeutic response
What are the majority of medication errors that occur in children?
70% of dosing errors involving calculations occurred in children
Why are there so many medication errors in Children?
Many drugs used in pediatrics are off-label, with no standard dosing (doses must be adjusted for childs weight or BSA
Why are children more prone to medication errors?
Children - especially young, small and sick children - are usually less able to physiologically tolerate a medication error d/t still developing renal immune and hepatic functions
