Pediatric Compounding. Erika Fallon, PharmD/RPh

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1 Pediatric Compounding Erika Fallon, PharmD/RPh

2 Disclosure I, Erika Fallon, declare no conflicts of interest, real or apparent, and no financial interests in any company, product, or service mentioned in this program, including grants, employment, gifts, stock holdings, and honoraria.

3 Learning Objectives Identify and describe pediatric patients Explain the importance of standardizing pediatric compounded injection and oral medication formulations Discuss formulation opportunities for different dosage forms

4 The Pediatric Population Definition A branch of medicine dealing with the development, care, and diseases of infants, children, and adolescents The American Academy of Pediatrics recommends people be under pediatric care up to the age of 21. (In some cases longer) Physiological and size differences Children are not simply "little adults

5 The Pediatric Population Breakdown of ages Neonates: birth to 28 days of life (the first 4 weeks) Infants: 29 days to 12 months Children: 1 to 12 years Adolescents: 13 to 17 years Young adults: 18 to 24 years Dynamic w/respect to drug disposition Changes in: body comp, drug metabolism, organ function

6 Pediatric Dosing Break it down by patient weight mg/kg/dose, mg/kg/day Consider maximum adult doses when making this calculation (ex. APAP) Maintenance fluid rate Typically, older than 1 month, use the rule. This calculation is 4 ml for the first 0 to 10 kg, plus 2 ml for 11 to 20kg, plus 1 ml for 21+ kg. For example, a 25kg kid would get 65 m/hr Starting boluses usually 10 to 20 ml/kg for normal saline and 5 ml/kg dextrose boluses.

7 Pediatric Dosing Pharmacokinetics Children usually metabolize faster; can vary widely, always check Ex. Vanco dosing starts at q6h for a 4y/o Practical issues Controlled release formulation Palatability; swallowing pills Parent/guardian issues Significant dilution of parenteral dosage forms

8 High potency meds w/ potential for dilution intoxication (Injection) An extra amount in delivered with flush, delivering doses 115% to over 200% the desired dose Atropine, Diazepam, Digoxin, Epinephrine, Hydralazine, Insulin, Morphine, Phenytoin Example: Morphine available as 8mg/mL, wanting to deliver 0.1mg (0.013mL); dose delivered with flush is 0.22mg 220%

9 Recommended Formulations Oral liquid preparations Solutions/suspensions potential issues: toxic excipients, nonuniform dispersion, palatability (taste AND texture) Other formulations RDTs, suppository, sprinkles/sachets (erratic absorbtion), transdermal, implantable reservoirs, chewable tabs

10 Standardizing formulations Improves medication safety Inpatient to outpatient care Significant variation in concentrations compounded, volumes of products to be administered, can lead to potentially serious medication errors References

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14 Commercially Available Pediatric Meds Always preferred Epaned enalapril 1mg/mL Diuril chlorothiazide 50mg/mL syrup Diastat rectal gel Revatio - Sildenafil powder for reconstitution 10mg/mL Furosemide 10mg/mL solution Doxycycline suspension and powder for reconstitution

15 Commonly requested Non-sterile Ursodiol suspension, tacrolimus suspension Spironolactone* suspension, HCTZ suspension LDN transdermal, mefloquine capsules, diaper rash ointments Sterile CH3B12, OHB12 TPNs (hospital)

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23 Resources for standardized concentrations AND formulas (w/evidence based BUDs) formulas w/ evidence based BUDs **Pediatric & Neonatal Dosage Handbook by Lexicomp new edition annually** dose checking, PK/PD, extemporaneous preps, comm avail -Centers for Disease Control and Prevention and World Health Organization growth charts. cdc.gov/growthcharts/clinical_charts.htm -NeoFax (a subset of Micromedex) -Pediatric Injectable Drugs: The Teddy Bear Book, (ASHP, 2013)

24 Future of Pediatric compounding Compounding kits Omeprazole, lansoprazole, metronidazole, baclofen 3D printing