Parenterals E1_special populations

1. drug formulations

2. infusion volumes

3. parenteral access

4. catheter and tubing sets

5. infusion devices

limitations of pediatric CSPs are assoicated with…

1. newborn/infant

2. child

3. toddler

4. adolescent

what are the categories of pediatric age groups

1. neonate

2. preterm

3. term

who is included in the newborn category/infant

neonate

infant/newborn

</=28 days old

preterm

infant/newborn

born befoer 37 weeks gestationinfa

term

infant/newborn

born between 37 and 42 weeks gestation

infant

1 month to 1 year of age

child

1 year to 11 years of age

toddler

1 year to 3 years of age

adolescent

12 to 16 years of age

gestational age

time from 1st day of last menstrual period and day of deliver

usually # weeks and #/7s (including 0/7-6/7) days

chronological age

age after birth to date of assessment

corrected age

age from expected delivery to date of assessment

day of life 0

day an infant is born

post menstrual age (PMA)

age from first day of last menstrual period to date of assessment

1. patient’s weight in kg

2. weight based dose (mg/kg/dose)

3. final calculated dose

4. route of administration

what shouldb e included in all medication orders for pediatric patients

slide 9!!

intraosseous (IO)

access point used in infants and young children in emergency situations when IV access cannot be obtained

anteromedial surface of tibia

where is IO access achieved in an infant/young child

less than 6 hours

how long is IO access intended to be used

< 1ml

this is common for infants and young pediatric patients

drug dosing and delivery is at greatest risk for errors when total volume is ____

dead space

area within IV sets, syringes, or needles in which volume of a dose can be lost

1. addition of priming volume

2. flushing line after infusion

what can be done to avoid dead space issues

small volume pumps or syringe pumps

infusion devices preferred for infusing small volumes at precise rates for infants and young children

syringe pumps

infusion device useful for delivering intermittent and continuous infusions

10 ml

continuous infusion with drugs requiring tight titration should be dispensed in syringe that is ___ or less in size

smart pumps

infusion devices that have built in software

capable of calculating and checking weight-based drug dosing for children

1. drug libraries

2. standard drug concentrations

3. max an min infusion rates

what might be built in or stored in smart pumps

in this examples a concentration of 0.1 mg/ml will be achieved from an initial drug concentration of 1 mg/ml from an ampule

1. obtain two syringes large enough to hold the needed volumes. one to draw out 9 ml the other to hold the final concentration volume of 10 ml

2. obtain a 1 ml syringe and filter needle to draw out the 1 ml of medication from the ampule

   1. attach a regular needle to either a 10 or 20 ml syringe and withdraw 9 mls of solution from the bag into the syringe take the other syringe and pull the plunger back until the final edge of the plunger piston reads 10 mls

   2. use the 1 ml syringe with a filter needle to draw out 1 ml of the med from the ampule then change needles and inject this 1 ml into the syringe filled with air where the plunger is pulled back to 10 mls. you will insert the needle of the 1 ml syringe through the hole in the tip of the 10/20 ml syringe to inject the med into the syringe

   3. next take the syringe with 9 mls of solution and add this to the syringe with 1 ml of the med

   4. total volume should be 10 ml

   5. cap and label syringe

steps of backfill method of syringe preparation

label flagging

method of labeling pediatric syringes

1. label should not obstruct graduated markings

2. label should be readable

3. must put tape on back and front of label

important points of label flagging

1. benzyl alcohol

2. chloramphenicol

3. ethanol

4. methylparaben

5. propylene glycol

6. sorbitol

7. aluminum

8. DEHP

excipients associatd with toxicity

benzyl alcohol

excipient associated with toxicity

preservative that accumulates as benzoic acid

may cause gasping baby syndrome, metabolic acidosis, respiratory and CNS depression, and death

1. gaspsing baby syndrome

2. metabolic acidosis

3. respiratory and CNS depression

4. death

signs of benzyl alochol toxicity

5 mg/kg/day

suggested acceptable daily intake of benzyl alcohol in adults

105 mg/kg/day

suggest acceptable daily intake of benzyl alcohol in neonates

chloramphenicol

excipient associated with toxicity

may cause gray baby syndrome, hypotension, cyanosis, portential death

1. gray baby syndrome

2. hypotension

3. cyanosis

4. potential death

chloramphenicol toxicity

<50 mcgml

concentration of chloramphenicol to avoid gray baby syndrome

ethanol

excipient associated with toxicity

may cause CNS depression, respiratory and cardiovascular effects

1. CNS depression

2. respiratory and cardiovascular effects

toxicities of ethanol

children <6: 0.5% v/v

children 6-12: 5% v/v

children > 12: 10% v/v

what is the max alcohol (ethanol) content allowed in OTC products for

children <6:

children 6-12:

children > 12:

methylparaben

excipient associated with toxicity

common preservative agent

displaces bilirubin from albumin with frequent exposure via flush solutions

kernicterus encephalopathy

methylparaben can increase risk of ___

kernicterus encephalopathy

a rare and serious brain condition that occurs when bilirubin levels in the blood are too high

propylene glycol

excipient associated with toxicity

alcohol solvent agent common in parenteral medications

has prolonged metabolism and renal elimination in neonates

1. CNS toxicity

2. hyperosmolality

toxicity of propylene glycol

25 mg/kg/day

acceptable daily intake of propylene glycol in adults

4555 mg/kg/day

acceptable daily intake of propylene glycol in neonates

sorbitol

excipient associated with toxicity

may cause osmotic diuresis

</=20 g/day

recommended PO intakeof sorbitol in adults

aluminum

excipient associated with toxicity

contaminant in parenteral drugs, leaches out of glass and other sources during production and packaging

1. limit to 25 mcg/L for large volume parenteral products

2. labeling of small volume parenteral products iwth max amount contained in product

FDA regulation of aluminum in parenteral products

25 mcg/L

aluminum should be limited to ____ for large volume parenteral products

4-5 mcg/kg/day

max recommended exposure to aluminum

DEHP (di(2-ethylhexyl)phthalate)

excipient associated with toxicity

plasticizer in PVC TPN bags, blood products and/or TPN additives

associated with an increased risk of cholestasis

1. reproductive

2. respiratory

3. renall

4. liver

what is effected by DEHP

20 mcg/kg/day

some specific drugs/blood products may require only 5019 mcg/kg/day of intake

acceptable daily intake of DEHP for neotates

preservative-free

preferred for immature patients

dilutions

do not have pediatric friendly formulations

geometric dilution

used to properly dilute pediatric preparations

1. aminophylline

2. amphotericin

3. clonidine

4. dexamtheasone

5. digoxin

6. famotidine

7. filgrastim

8. heparin

9. hydralazine

10. hydrocortisone

11. levothyroxine

12. methylprednisolone

13. phenobarbital

14. sodium bicarb

drugs commonly requiring dilution in infants and children

0.2 ml

commonly used as minimal dose volume for dispensing

joint commission national patient safety goals (NPSGs)

called for limitation and standardization of number of concentration of drugs for pediatric patients

medication error risks

use of standard concentrations reduced ___

weights

standard concentrations for pediatrics is limited bc of vast differences in dosing ___ of pediatric patients

1. prescribing

2. preparing

3. administering

to prevent medication erros related to CSPs, pediatric specific drug references should be readily available to all personnel involved in …