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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
Common pediatric suppositories?
1. Bisacodyl 2. APAP 3. Ibuprofen 4. Glycerin
26
Consideration for inhaled formulations?
1. Delivery devices (puffer, neb, inhaler) 2. Coordination
27
Injection use in peds?
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
28
SubQ volumes for children?
<1 mL
29
Nasal and otic formulations for children?
Rapid absorption IN Normally concnetrated therapy
30
Ocular/Transdermal formulations for children?
Medications concentrate in the eye (thin membranes and less tear volume) Systemic effects
31
32
What is the poison control hotline?
1-800-222-1222
33
Describe the trend of children and poisons?
Children are curious and mimic what they see
34
What are the approaches to poisoning?
1. Quick response 2. Detailed history 3. Stabilize airway and cadriopulmonary system 4. GI decontamination 5. PALS
34
What is a toxidrome?
Combination of manifestations that help with the identification of toxins (tools for rapid detection of the suspected cause)
35
What is the toxidrome for anticholinergics?
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
What are the cholinergic toxidromes?
Diarrhea, urination, miosis, bradycardia, emesis, lacrimation, salvation, sweating
37
Opioid toxidrome?
Myosis, out of it (sedation), respiratory depression, pneumonia (aspiration), hypotention, infrequency (constipation, urinary retention), nausea, emesis
38
TCA toxidrome?
Tachycardia, cardiac effects (QTc, arrhythmias), anticholinergic effects, sedation
39
Subjective eval of poisoned child?
1. Drug/substance 2. Timing 3. Nature of presentation 4. Amount
40
Objective eval of poisoned child?
1. Oxygen saturation 2. blood glucose 3. Acid/base status 4. Electrolytes 5. Drug screens 6. ECG
41
APAP antidote?
NAC
42
Anticholinesterase antidote?
Atrophine Pralidoxime
43
Anticholinergic antidote?
Physostigmine
44
BZD antidote?
Flumazenil
45
Beta blocker antidote?
GLucagon
46
CCB antidote?
Glucagon
47
Warfarin antidote?
Vitamin K
48
Cyanide antidote?
amyl nitrate, sodium nitrate, sodium thiosulfate
49
cyclophosphamide antidote?
mesna
50
digoxin antidote?
Digibind Digoxine immune fac
51
Dopamine antidote?
Phentolamie
52
EPS antidote?
Benadryl
53
Ethylene glycol antidote?
Fomepizole
54
Heparin antidote?
Protamine sulfate
55
Insulin antidote?
Glucose
56
Iron antidote?
deferoxamine
57
Narcotics antidote?
Naloxone
58
Opioid analgesic antidote?
Nalmefene or naloxone
59
Potassium antidote?
Albuterol, insulin, glucose, NaHCO3, kayexalate
60
TCA antidote?
Phyostigmine or NaHCO3
61
WHat is the goal for decontamination?
To remove or bind the substance prior to absorption
62
Main methods of decontamination?
1. Syrup of Ipecac (not used) 2. Gastric levage (not used) 3. Activated charcoal 4. Whole bowel irrigation
63
Activated Charcoal | MOA, When to use, Dosing
**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
What is gastric lavage?
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
What is whole bowel irrigation?
Induces liquid stool and mechanicall flush pills, tablets, or packets from the GIT
66
Whole Bowel Irrigation | Indication, Products, Rate
**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
Syrup of Ipecac | MOA, Dosing, Counseling, ADR
**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
Pediatric patient is unconscious with no parents, what is a quick method of determining what to give the patient?
Broselow tape
69
WHat is PALS?
Pediatric Advanced Life Support

Therapeutics III (40 decks)

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