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Therapeutics III > Pediatric Drug Safety - Block 4 > Flashcards

Pediatric Drug Safety - Block 4 Flashcards

1
Q

What is Kefauver-Harris Amendment?

A
  1. Refired consent for all human subjects
  2. ADRs reported from manufacturers to FDA
  3. Proof of efficacy and safety in new drug approvals
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2
Q

What is the Poison Prevention Packaging Act of 1970?

A

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

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3
Q

What is the definition of child-resistant?

A

80% of children cant open package, 90% adults can open

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4
Q

What is med error?

A

Any preventable event leading to inappropriate med use or patient harm related to professional, patient, or consumer or professional practice

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5
Q

What is a category I med errors?

A

Error resulting in death

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6
Q

What is a category a med error?

A

Circumstances or events that have the capacity to cause error but doesnt

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7
Q

How do you calculate pediatric BSA, BMI, and IBW?

A
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8
Q

How do you approximate pediatric dosing?

A

Clarks Rule: Adult dose x [BSA/1.73m^2]

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9
Q

Oral extemporaneous preparations include:

A
  1. Ensure correct base product used (strength) - API
  2. Vehicle selection
  3. Labels and records
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10
Q

What is the purpose for stock dilution?

A

Prevent doses of less than 0.1 mL having to be administered

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11
Q

Facotrs affecting admin and adherance?

A
  1. ADR
  2. DOsing frequency
  3. Caregiver dependence
  4. Drug formulation (paliapility)
  5. Inappropriate measurements
  6. Belief systems
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12
Q

How do we reduce risk in compounding?

A
  1. Good technique
  2. Standardize compounded concentrations
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13
Q

How do we reduce risk during verification?

A
  1. Weight based dose
  2. Double check units
  3. Double check for common errors (decimals and volumes)
  4. Don’t hesitate to call or ask questions
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14
Q

How do we reduce risk in dispensing?

A
  1. Unit dose formulations
  2. Appropriate admin tools
  3. Detailed counseling
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15
Q

What are the 5 rights of med safety?

A
  1. Right dose
  2. Right medication
  3. Right patient
  4. Right time
  5. Right route
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16
Q

What are common dosage forms for children?

A
  1. Tablet/capsule (ensure child can swallow)
  2. Liquid solution or suspension (suspension is most common)
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17
Q

What are the key considerations of selecting a PO formulation?

A
  1. Palatability
  2. Texture
  3. Uniformity
  4. Stability
  5. Excipients/preservatives
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18
Q

Benzyl alcohol

Toxicity, ADR, common products, Age restriction

A

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

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19
Q

Propylene glycol

Toxicity, ADR, common products, Age restriction

A

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

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20
Q

Ethanol

Toxicity, ADR, common products, Age restriction

A

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

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21
Q

Benzalkonium chloride

Toxicity, ADR, common products, Age restriction

A

Tox: Oxidative stess
ADR: Pulmonary decline and risk for resp support
Products: NaCl OTC nasal spray, albuterol, prednisolone ophthalmic susp
Age: Caution in <2YO

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22
Q

What are excipents that are a concern in children?

A
  1. Benzyl alcohol
  2. Propylene glycol
  3. Ethanol
  4. Benzalknoium chloride
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23
Q

What are measuring devices you shouldn’t use for medication?

A

Kitchen measuring spoons
Normal spoons

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24
Q

What are the considerations of rectal formulations?

A
  1. Absorption and expulsion
  2. Developed colon (neonates at risk for rectal tears)
  3. Size/weight and administration
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25
Q

Common pediatric suppositories?

A
  1. Bisacodyl
  2. APAP
  3. Ibuprofen
  4. Glycerin
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26
Q

Consideration for inhaled formulations?

A
  1. Delivery devices (puffer, neb, inhaler)
  2. Coordination
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27
Q

Injection use in peds?

A
  1. IM not routinely used
  2. IV may be difficult to maintain
  3. Parenteral dose volumes need to be considered as well as fluid composition
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28
Q

SubQ volumes for children?

A

<1 mL

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29
Q

Nasal and otic formulations for children?

A

Rapid absorption IN

Normally concnetrated therapy

30
Q

Ocular/Transdermal formulations for children?

A

Medications concentrate in the eye (thin membranes and less tear volume)
Systemic effects

32
Q

What is the poison control hotline?

A

1-800-222-1222

33
Q

Describe the trend of children and poisons?

A

Children are curious and mimic what they see

34
Q

What are the approaches to poisoning?

A
  1. Quick response
  2. Detailed history
  3. Stabilize airway and cadriopulmonary system
  4. GI decontamination
  5. PALS
34
Q

What is a toxidrome?

A

Combination of manifestations that help with the identification of toxins (tools for rapid detection of the suspected cause)

35
Q

What is the toxidrome for anticholinergics?

A
  1. Red as a beet
  2. Dry as a bone
  3. Blind as a bat
  4. Mad as a hatter
  5. Hot as a hare
  6. Full as a flask
36
Q

What are the cholinergic toxidromes?

A

Diarrhea, urination, miosis, bradycardia, emesis, lacrimation, salvation, sweating

37
Q

Opioid toxidrome?

A

Myosis, out of it (sedation), respiratory depression, pneumonia (aspiration), hypotention, infrequency (constipation, urinary retention), nausea, emesis

38
Q

TCA toxidrome?

A

Tachycardia, cardiac effects (QTc, arrhythmias), anticholinergic effects, sedation

39
Q

Subjective eval of poisoned child?

A
  1. Drug/substance
  2. Timing
  3. Nature of presentation
  4. Amount
40
Q

Objective eval of poisoned child?

A
  1. Oxygen saturation
  2. blood glucose
  3. Acid/base status
  4. Electrolytes
  5. Drug screens
  6. ECG
41
Q

APAP antidote?

42
Q

Anticholinesterase antidote?

A

Atrophine
Pralidoxime

43
Q

Anticholinergic antidote?

A

Physostigmine

44
Q

BZD antidote?

A

Flumazenil

45
Q

Beta blocker antidote?

46
Q

CCB antidote?

47
Q

Warfarin antidote?

48
Q

Cyanide antidote?

A

amyl nitrate, sodium nitrate, sodium thiosulfate

49
Q

cyclophosphamide antidote?

50
Q

digoxin antidote?

A

Digibind
Digoxine immune fac

51
Q

Dopamine antidote?

A

Phentolamie

52
Q

EPS antidote?

53
Q

Ethylene glycol antidote?

A

Fomepizole

54
Q

Heparin antidote?

A

Protamine sulfate

55
Q

Insulin antidote?

56
Q

Iron antidote?

A

deferoxamine

57
Q

Narcotics antidote?

58
Q

Opioid analgesic antidote?

A

Nalmefene or naloxone

59
Q

Potassium antidote?

A

Albuterol, insulin, glucose, NaHCO3, kayexalate

60
Q

TCA antidote?

A

Phyostigmine or NaHCO3

61
Q

WHat is the goal for decontamination?

A

To remove or bind the substance prior to absorption

62
Q

Main methods of decontamination?

A
  1. Syrup of Ipecac (not used)
  2. Gastric levage (not used)
  3. Activated charcoal
  4. Whole bowel irrigation
63
Q

Activated Charcoal

MOA, When to use, Dosing

A

MOA: absorption of ingested toxin via increased SA
Use: 2 hr of ingestion, powder mixed with water -> slurry
Dosing: Activated charcoal to toxin ration (10:1)
* Alt: 0.5-1.0 g/kg (max dose: 50 g)

64
Q

What is gastric lavage?

A

Stomach pumping: Large tube is inserted in the mouth/nose into the stomach and contents are aspirated

Complications: aspirationpneumonia, esophageal/gastric perforation, electrolyte imbalance, death

65
Q

What is whole bowel irrigation?

A

Induces liquid stool and mechanicall flush pills, tablets, or packets from the GIT

66
Q

Whole Bowel Irrigation

Indication, Products, Rate

A

Indication: Sustained-release/enteric coated pill ingestions
* Large ingestions not fully bound by AC
* Ingestion of illicit drug packets

Products: Golytely, Colyte, Nulytely
Rate: WBI is continued until the rectal effluent is clear
* Children 9 months to 6 years: 500 mL/hr
* Children 6 to 12 years: 1000 mL/hr
* Adolescents and adults: 1500 to 2000 mL/hr

67
Q

Syrup of Ipecac

MOA, Dosing, Counseling, ADR

A

MOA: induce vomiting via local activation of sensory receptors in the GIT and stimulation of chemoreceptor trigger zone
Dosing: 5-10 mL (6-12 months old), 15 mL (1-12 years), 30 mL (adolescents and adults)
Counseling: Patient should be upright
* Followed by 4 to 8 ounces of water immediately after administration
* Use within 4-6 hr of ingestion

ADR: Aspiration pneumonia

68
Q

Pediatric patient is unconscious with no parents, what is a quick method of determining what to give the patient?

A

Broselow tape

69
Q

WHat is PALS?

A

Pediatric Advanced Life Support

Therapeutics III (40 decks)

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