Dispensing in Pediatrics and Neonatal Patients. Flashcards
(30 cards)
How do pediatric medication error rates compare to adult rates?
Pediatric error rates are approximately equal to adult rates.
However, pediatric errors are 3 times more likely to be linked to potential adverse drug events (ADEs).
Which patient group has the highest medication error and potential ADE rates?
Neonatal ICU patients (newborns in intensive care).
Contributing factors: Weight-based dosing complexity, immature organ systems, and frequent medication adjustments.
In which phase do most medication errors and potential ADEs occur?
74% of errors and 79% of potential ADEs occur in the ordering phase (e.g., prescribing).
Example: Incorrect dosage, frequency, or drug selection by prescribers.
Why does a lack of pediatric formulations contribute to errors?
Adult formulations often require splitting or dilution for children.
Limited FDA-approved pediatric dosage forms (e.g., suspensions, chewables).
Example: Crushing tablets intended for adults leads to inaccurate dosing.
What are the 5 key reasons for increased pediatric medication error risk?
Pharmacokinetic variability.
Lack of pediatric formulations.
Calculation complexity.
Inconsistent measurement.
Drug delivery challenges.
What characterizes the Sensory Motor Stage (0–2 years) in terms of learning and health awareness?
Learning: Centered on sensory exploration and motor actions (e.g., touching, mouthing objects).
Health: No understanding of health connections; focus on immediate physical experiences.
How does the Pre-operational Stage (2–7 years) limit health-related reasoning?
Focuses on one aspect of a situation (e.g., “Medicine tastes bad” = all medicine is bad).
Cannot link health behaviors (e.g., handwashing) to illness prevention.
Example: A child refuses medication because it’s “yucky,” unaware of its purpose.
What cognitive leaps occur in the Concrete Operational Stage (7–12 years)?
Distinguishes internal/external worlds (e.g., germs cause illness).
Uses symbols, solves problems mentally, and considers multiple factors (e.g., diet + exercise = health).
Understands disease prevention and physiological causes.
Teaching Tip: Use concrete examples (e.g., “Germs on hands make you sick”).
How does the Formal Operations Stage (13+ years) impact health decision-making?
Capable of abstract thought (e.g., long-term consequences of smoking).
Understands personal control over health (e.g., “Exercise reduces heart disease risk”).
Example: A teenager researches vaccines to make informed choices.
How does health understanding evolve across Piaget’s stages?
Sensory Motor: No health awareness.
Pre-operational: Health = immediate sensations (e.g., pain).
Concrete Operational: Health = observable causes (e.g., germs).
Formal Operations: Health = abstract prevention and personal responsibility.
What are the clinical trial challenges limiting pediatric drug availability?
Ethical/physiological complications (e.g., vulnerability, metabolic differences).
Informed consent complexities (parental consent + child assent).
Recruitment difficulties (small populations, parental reluctance).
Age-subset stratification (neonates vs. adolescents).
Why is informed consent a barrier in pediatric trials?
Requires dual consent: Legal guardian approval + age-appropriate child assent.
Ethical dilemmas in communicating risks/benefits to children.
Example: Explaining trial procedures to a 6-year-old vs. a 15-year-old.
What solutions mitigate pediatric drug development barriers?
Policy incentives: Tax credits, grants, extended exclusivity (BPCA/PREA).
Global collaboration: Shared data across regions.
Adaptive trials: Targeting high-risk subsets to reduce costs.
Link regulatory policies to pediatric drug barriers.
PREA (Pediatric Research Equity Act): Mandates pediatric studies but increases costs.
BPCA (Best Pharmaceuticals for Children Act): Offers exclusivity extensions but limited uptake.
Example: Manufacturers may avoid PREA requirements due to financial risks.
What role does the American Academy of Pediatrics (AAP) play in pediatric drug development?
Advocates for shared responsibility to conduct pediatric research.
Supports policies ensuring rational, evidence-based drug therapy for children.
Example: Pushing for legislative reforms like PREA and BPCA.
What are the PREA (2003) and BPCA (2002, renewed 2007)?
PREA: Requires pediatric assessments for new drug applications (unless waived).
BPCA: Incentivizes pediatric studies with 6-month patent exclusivity extensions and funds orphan drug research.
What must manufacturers do under PREA?
Submit pediatric data assessments for new:
Active ingredients, indications, dosage forms, routes of administration.
Exceptions: Orphan drugs, drugs with safety concerns, or if studies are impractical.
What is the 6-month exclusivity extension under BPCA?
Grants manufacturers 6 additional months of market exclusivity for conducting pediatric studies.
Applies even if the study results are negative.
Example: A blockbuster drug’s patent expiry delayed to incentivize pediatric research.
How do PREA and BPCA complement each other?
PREA: Mandates pediatric studies (stick).
BPCA: Incentivizes studies with exclusivity/funding (carrot).
Together, they address both regulatory and financial barriers.
What are exceptions to PREA’s pediatric assessment requirement?
Drugs for orphan (rare) diseases.
Situations where studies are unethical or technically impossible.
Example: Waiving pediatric trials for a drug targeting a rare adult cancer.
How does BPCA’s orphan therapy funding reduce barriers?
Offsets R&D costs for rare pediatric conditions with limited commercial viability.
Example: Funding trials for a drug treating pediatric Batten disease (ultra-rare).
What are common dosing regimen abbreviations?
BID: Twice daily.
TID: Three times daily.
QID: Four times daily.
Q6hr: Every 6 hours (≠ QID, as Q6hr includes nighttime doses).
What are the key functions of ADCs Automated Dispensing Cabinets in medication safety?
Secure storage: Restricted access to medications (e.g., narcotics).
Inventory management: Tracks medication use in real time.
Error reduction: Requires authentication (e.g., nurse ID scan) before dispensing.
Drawback: Override options can bypass safety checks.
Example: A nurse retrieves a dose of morphine after biometric verification.
How does BPOC enhance medication administration safety?
Verification: Scans patient wristband + medication barcode to confirm the Five Rights (patient, drug, dose, route, time).
Error prevention: Alerts for mismatches (e.g., wrong drug/dose).
Benefit: Reduces wrong-patient errors by 50–80% (studies).
Example: Nurse scans a patient’s barcode and amoxicillin vial, triggering an alert for a penicillin allergy.
