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29 Cards in this Set

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What age ranges fall under pediatric compounding?
Neonates - Newborn <4 weeks old
Infants - Birth to 12 months
Toddlers - 12 to 36 months
Children <12 years
Consequences of "Off-label" use
1) Under-treatment
2) Over-treatment
3) Inappropriate dose
4) Drug safety
5) Toxicity
What are pediatric considerations for compounding?
1) Difficulty swallowing tablets
2) NPO
3) Poor GI absorption
4) Need to discharge
5) IV access
6) Flavor/taste
What are some changes which occur in children that affect drug disposition and action?
1) Metabolism changes
2) Body composition
3) Receptor expression and function
4) Growth rate
5) Organ functional capacity
What are examples of increased toxicity in pediatrics?
1) Chloramphenicol in newborns
2) Tetracyclines in infants and children
3) Benzyl alcohol containing IV fluids in premies/neonates
Why should children and teenagers avoid aspirin?
Aspirin use has been associated with Reye syndrome, a rare but serious condition that can cause death
Why must caution be exercised when using sorbitol or propylene glycol in pediatric compounding?
Sorbitol - Diarrhea

Propylene Glycol - Hyperosmolality
What makes up the flavor experience?
1) Taste
2) Smell
3) Texture
4) Appearance
5) Temperature
What do patients desire in flavoring?
1) Immediate flavor identity
2) Rapid full flavor development
3) Acceptable feel to mouth
4) Brief after taste
5) No undesirable sensations
What is the most common device used to measure liquid medications in a household?
Household teaspoons (75%)
What are the four common dosing instruments
1) Syringes
2) Droppers
3) Cylindrical dosing spoons
4) Dosage Cups
What is the maximum ethanol concentration in pediatric compounding?
1996 OTC Guidelines - 0.5%

1984 Guidelines - 25 mg per 100 mL

Toxicity neuronal dysfunction can occur between 1mg/100ml to 100mg/ml
At what ages should physicians monitor while using products containing alcohol?
Children < 6 years old
What are six tips for poison proofing your home?
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
What is the FDA's definition of compounding?
~ 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
When does a patient need a compounded medication?
1) Patient is allergic to ingredient of approved drug
2) Not commercially available
3) Cancer treatment
4) Pediatric patients
5) Pain management
What are the main risks with compounded medications?
1) Safety and efficacy unknown
2) Quality problems
When is manufacturing disguised as compounding?
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
What special product labeling for children is required for the drug midazolam?
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
What special product labeling for children is required for the drug etodolac?
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
What special product labeling for children is required for the drug gabapentin?
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
What special product labeling for children is required for the drug propofol?
Increased mortality when used for pediatric ICU sedation; concomitant administration with fentanyl may result in serious slowing of the heart rate
What special product labeling for children is required for the drug sevoflurane?
Precaution about the potential of the product to cause seizures in children without a previous history of such
What special product labeling for children is required for the drug buspirone?
Efficacy not established at the dose studied in pediatric clinical trials
What are concerns pertaining to Over-The-Counter drugs?
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
What are the limits for children and cough and cold products?
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
Why is the a concern over measuring devices for administering medications to children?
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
What does the term "Off-Label" use mean in regards to medication for children?
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
What is the Best Pharmaceuticals for Children Act?
2002: An act to amend the Federal Food, Drug and Cosmetic Act to improve the safety and efficacy of pharmaceuticals for children