Pediatric Drug Safety - Block 4 Flashcards
What is Kefauver-Harris Amendment?
- Refired consent for all human subjects
- ADRs reported from manufacturers to FDA
- Proof of efficacy and safety in new drug approvals
What is the Poison Prevention Packaging Act of 1970?
Requires child resistant (not proof) packaging for all drugs and cosmetics unless the product is:
1. Excepted products
2. One size OTC product for elderly or hadicapped
3. Prescriprion with request for noncompliant packaging
What is the definition of child-resistant?
80% of children cant open package, 90% adults can open
What is med error?
Any preventable event leading to inappropriate med use or patient harm related to professional, patient, or consumer or professional practice
What is a category I med errors?
Error resulting in death
What is a category a med error?
Circumstances or events that have the capacity to cause error but doesnt
How do you calculate pediatric BSA, BMI, and IBW?
How do you approximate pediatric dosing?
Clarks Rule: Adult dose x [BSA/1.73m^2]
Oral extemporaneous preparations include:
- Ensure correct base product used (strength) - API
- Vehicle selection
- Labels and records
What is the purpose for stock dilution?
Prevent doses of less than 0.1 mL having to be administered
Facotrs affecting admin and adherance?
- ADR
- DOsing frequency
- Caregiver dependence
- Drug formulation (paliapility)
- Inappropriate measurements
- Belief systems
How do we reduce risk in compounding?
- Good technique
- Standardize compounded concentrations
How do we reduce risk during verification?
- Weight based dose
- Double check units
- Double check for common errors (decimals and volumes)
- Don’t hesitate to call or ask questions
How do we reduce risk in dispensing?
- Unit dose formulations
- Appropriate admin tools
- Detailed counseling
What are the 5 rights of med safety?
- Right dose
- Right medication
- Right patient
- Right time
- Right route
What are common dosage forms for children?
- Tablet/capsule (ensure child can swallow)
- Liquid solution or suspension (suspension is most common)
What are the key considerations of selecting a PO formulation?
- Palatability
- Texture
- Uniformity
- Stability
- Excipients/preservatives
Benzyl alcohol
Toxicity, ADR, common products, Age restriction
Tox: Incomplete liver maturation to convert to metabolite
ADR: metabolic acidosis, respiratory depression, gasping syndrome
Products: Heparin, NS, Zyrtec and Benadryl chewables
Age: Not safe <3YO
Propylene glycol
Toxicity, ADR, common products, Age restriction
Tox: Impaired alcohol dehydrogenase enzyme systems in young children
ADR: CNS depression, sz, arrhythmias, hypotension, respiratory depression, hemolysis, AKI
Products: continuous inf of esmolol, lorazepam, phenobarbital
Age: Not safe in <6YO
Ethanol
Toxicity, ADR, common products, Age restriction
Tox: Impaired alcohol dehydrogenase enzyme systems in young children
ADR: Hypoglycemia, hypothermia, acidosis, tachycardia, seizures, loss of consciousness
Products: Dexamethasone, furosemide, and digoxin oral solutions
Age: Not safe in children <6 yo
Benzalkonium chloride
Toxicity, ADR, common products, Age restriction
Tox: Oxidative stess
ADR: Pulmonary decline and risk for resp support
Products: NaCl OTC nasal spray, albuterol, prednisolone ophthalmic susp
Age: Caution in <2YO
What are excipents that are a concern in children?
- Benzyl alcohol
- Propylene glycol
- Ethanol
- Benzalknoium chloride
What are measuring devices you shouldn’t use for medication?
Kitchen measuring spoons
Normal spoons
What are the considerations of rectal formulations?
- Absorption and expulsion
- Developed colon (neonates at risk for rectal tears)
- Size/weight and administration
Common pediatric suppositories?
- Bisacodyl
- APAP
- Ibuprofen
- Glycerin
Consideration for inhaled formulations?
- Delivery devices (puffer, neb, inhaler)
- Coordination
Injection use in peds?
- IM not routinely used
- IV may be difficult to maintain
- Parenteral dose volumes need to be considered as well as fluid composition
SubQ volumes for children?
<1 mL