541 - Drug Delivery Systems Lab I - Exam III - Pediatric Compounding & FDA's View of Compounding

Neonates - Newborn <4 weeks old
Infants - Birth to 12 months
Toddlers - 12 to 36 months
Children <12 years

1) Under-treatment
2) Over-treatment
3) Inappropriate dose
4) Drug safety
5) Toxicity

1) Difficulty swallowing tablets
2) NPO
3) Poor GI absorption
4) Need to discharge
5) IV access
6) Flavor/taste

1) Metabolism changes
2) Body composition
3) Receptor expression and function
4) Growth rate
5) Organ functional capacity

1) Chloramphenicol in newborns
2) Tetracyclines in infants and children
3) Benzyl alcohol containing IV fluids in premies/neonates

Aspirin use has been associated with Reye syndrome, a rare but serious condition that can cause death

Sorbitol - Diarrhea

Propylene Glycol - Hyperosmolality

1) Taste
2) Smell
3) Texture
4) Appearance
5) Temperature

1) Immediate flavor identity
2) Rapid full flavor development
3) Acceptable feel to mouth
4) Brief after taste
5) No undesirable sensations

Household teaspoons (75%)

1) Syringes
2) Droppers
3) Cylindrical dosing spoons
4) Dosage Cups

1996 OTC Guidelines - 0.5%

1984 Guidelines - 25 mg per 100 mL

Toxicity neuronal dysfunction can occur between 1mg/100ml to 100mg/ml

Children < 6 years old

1) Always close the container
2) Properly secure child-resistant packaging, placing out of reach
3) Keep in original container
4) Keep iron, and all, medications always out of reach and sight of children
5) Never keep medicines on a counter top or bedside table
6) Follow medicine label directions carefully to avoid overdoses

~ Combing, mixing or altering ingredients to create a customized drug

~Requires a licensed physician, writing a prescription for a patient with needs a FDA approved drug could not meet

1) Patient is allergic to ingredient of approved drug
2) Not commercially available
3) Cancer treatment
4) Pediatric patients
5) Pain management

1) Safety and efficacy unknown
2) Quality problems

1) When drugs are compounded in advance of prescriptions
2) Compounding for resale by third parties
3) Compounding copies of FDA approved drugs
4) Compounding products withdrawn from the market

Higher risk of serious life-threatening situations in children with congenital heart disease and pulmonary hypertension who need lower doses than predicted to prevent respiratory compromise

Recognition of a need for a dose 2 to 3 times (in mg/kg) the dose used in adults for effective treatment of childhood arthritis

Need to use higher doses in children less than five years of age in order to control seizures and new adverse events such as hostility and aggression identified in children less than 12 years

Increased mortality when used for pediatric ICU sedation; concomitant administration with fentanyl may result in serious slowing of the heart rate

Precaution about the potential of the product to cause seizures in children without a previous history of such

Efficacy not established at the dose studied in pediatric clinical trials

1) How much to give?
2) How often to give it?
3) What is in the medication?
4) Warnings about the drug?
5) If the drug is safe for children?
6) How much should I give?
7) If the medication has alcohol in it

1) Do not use under 2 years of age unless directed by a provider
2) Do not use any medication that is packaged and made for adults

People often use inaccurate household measuring devices which may deliver an incorrect amount of the drug. They should either use the prepackaged measuring device or purchase one from the pharmacy

1) Most drugs prescribed for children have not been studied in children
2) Only 20-30% of drugs approved by FDA are indicated for pediatric use
3) Often prescribers give medications to children that have not been studied

2002: An act to amend the Federal Food, Drug and Cosmetic Act to improve the safety and efficacy of pharmaceuticals for children