drug allergies and ADR

Question 1

ADR vs Errors

Answer 1

ADR:
effects from a drug that was admin correctly. ADRs are typically dose-related; risk increase w/ higher dose/reduced clearance

Med Error:
something wrong occurred, such as giving a med dose to a wrong pt.

Question 2

Type A vs Type B

Answer 2

type a: predictable
- dose-dependent, known pharmacological action, most common

type b: unpredictable
- not dose-dependent, unrelated to the pharmacological actions, pt-specific factors such as: allergies (immune-mediated response), pseudoallergic reaction (itching after admin of opioids, vanco infusion), idiosyncratic (SJS)

Question 3

drug allergy types

Answer 3

Type I reaction
- IgE-mediated and immediate (within 60min of drug exposure) Ex: bronchospasm, angioedema, anaphylaxis
Type II reaction
- antibody-mediated, occurring several days (5-8) days after drug exposure Ex: hemolytic anemia, thrombocytopenia
Type III reaction
- immune-complex reaction occurring >=1 weeks after drug exposure Ex: drug-induced lupus erythematosus
Type IV reactions
- cell-mediate or delayed hypersensitivity, occurring anytime from 48 hrs to several weeks after drug exposure Ex: SJS

Question 4

boxed warning

Answer 4

risk of death or permanent disability

Question 5

contra, warning and precautions

Answer 5

contra: cannon be used in pt. the risk will outweigh any possible benefit

warnings and precautions: serious reactions that can result in death, hospitalization, medical interventions, disability or teratogenicity (raloxifene warning for VTE)

Question 6

Adverse reaction

Answer 6

undesirable, uncomfortable or dangerous effects

Question 7

REMS

Answer 7

risk evaluation and mitigation strategies (REMS)
required by FDA, developed by manufacturer and approved by FDA to usner the benefits of a drug outweigh the risk
EX: clozapine REMS, isotretinoin iPLEDGE program

Question 8

Med guide

Answer 8

FDA-approved pt handouts that detail a drug’s important Adverse event in non-technical language
dispensed w/ original prescription and each refill
not necessary in hospitals

Question 9

SE, and AE and allergies should be reported to

Answer 9

FDA’s MedWatch program, which si called the FDA Adverse Event Reporting System (FAERS)

phase IV trails (post-markering safety surveillance programs)

Question 10

stomach upset/Nausea

Answer 10

should not be reported or on pt profile, do not bother w/ it because this is not an allergy. more of an intolerance. intolerance document in electronic medical record is different than allergies

Question 11

Intolerance

Answer 11

are less serious complains, such as nausea or constipation. since the drug bothers the pt it should be avoided if possilbe

Question 12

allergies e

Answer 12

immune system response and range from mild (pruritus) to severe (anaphylaxis)
present: facial swelling, bronchoconstriction, sever drop in BP, weakness, fever, severe rash

Question 13

photosensitivity

Answer 13

Use brad-spectrum sun screen both UVA and UVB
Key drugs associated w/ photosensitivity
- amiodarone
- diuretics (thiazide and loop)
- Methotrexate
- oral and topical retinoids
- quinolones
- st. john’s wort
- sulfa antibiotics
- tacrolimus
- tetracyclines
- voriconazole

Question 14

thrombotic thrombocytopenic purpura

Answer 14

blood disorder clotes form throughout the body TTP
key drugs
- oral p2y12 inhibitors (e.g. clopidogrel)
- sulfamethoxazole

Question 15

Steven johnson syndrome, toxic epidermal necrosis, drug reaction w/ eosinophilia and systemic symptoms

Answer 15

SJS, TENS, DRESS
severe skin reaction key drugs
- Abacavir
- Allopurinol
- Carbamazepine
- Ethosuximide
- Lamotrigine
- Modafinil
- Nevirapine
- Penicillins
- Phenytoin
- Sulfamethoxazole

Question 16

anaphylaxis tx

Answer 16

immediate emergency care
911 +
epi +/- diphenhydramine +/- steroids +/- IV fluids
epi is 1/1000 so 1mg/ml, in doses of .3mg (adult dose) .15mg (peds)

Question 17

EpiPen admin steps

Answer 17

• remove from carrying case and pull off the blue safety release
• keep thumb fingers and hand avey from the orange (needle) end of the device
• inject into the middle of the outer thigh at a 90 degree angle
• hold the needle firmly in place while counting to three
• remove the needle and massage the area for 10 seconds
• after the injection, the orange tip will extend to cover the needle, if needed is visible, it should not be reused

Question 18

all epi auto-injectors

Answer 18

• it is normal to see liquid remaining in the device after injecting
• call for emergency help, because additional care may be needed
• a second dose (in the opposite leg) may be given, if needed, prior to the arrival fo medical help
• refrigeration is not required
• all products can be injected through clothing
• check the device periodically to make sure the med is clear and not expired

Question 19

penicillin allergy

Answer 19

avoid at all cost on the NAPLEX, no exception!
read carefully

only situation ok is acute otitis media for peds, 2nd or 3rd generation cephalosporin in pt with a non-severe penicillin allergy.

Question 20

peanuts and soy

Answer 20

are in the same family, can have cross-reactivity

contra w/ soy allergy include clevidipine (cleviprex) and propofol (diprivan)

Question 21

eggs allergy

Answer 21

true allergy eggs, they can not use clevidipine, propofol, and yellow fever vaccine.
flublok and flucelvax quadrivalent contain no egg protein— if a severe reaction occurs regardless of the which ingredient.. pt should not receive further doses of influenza vax

Question 22

penicillin skin testing

Answer 22

true allergy in the past, but over time antibodies can wane. the test is to identify pt who are great risk of type I hypersensitivity reaction

skin test only predicates an IgE-mediate reaction. regardless of the skin test, pt should not be re-challenged w/ an agent that caused SJS or TENs

Question 23

induction of drug tolerance
desensitization

Answer 23

• recommended in prego pt w/ syphilis
• slowly, stepwise process, very small doses of medication and incrementally increased to a target dose. done in a medical setting w/ emergency care.
• if doses are missed, drug-free period allows for the immune system to re-sensitize…

desensitization does not “cure” the pt of an allergy and the reaction should not be removed form pt’s medical record.