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Ther 201 Exam 2 > Adverse Drug Reactions > Flashcards

Adverse Drug Reactions Flashcards

1
Q

The single largest source of malpractice payouts in the US.

A

Adverse Drug Reactions

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2
Q

True or False. Despite the efforts to promote patient safety and regardless of the presence of guidelines, the fatalities from drug reaction and interaction have been going up.

A

TRUE

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3
Q

True or False. Adverse Drug Reactions occur at standard recommended doses.

A

True.

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4
Q

This characteristic of drugs together with the physiologic and pathologic changes that occur in a person’s body when that person is sick is the cause of ADRs in standard doses.

A

Drugs are XENOBIOTIC. Meaning, they are inherently toxic.

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5
Q

TRUE or FALSE. Adverse Drug Reactions are noxious and unintended responses to a drug given in wrong doses.

A

FALSE. ADRs happen when drug is given in RECOMMENDED doses. Otherwise, it’s referred to as an ADVERSE DRUG EVENT or ADE which occurs in any dose.

*OVERDOSE/TOXICITY, which may be intentional or accidental, on the other hand, goes beyond the recommended dose.

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6
Q

TRUE or FALSE. In ADRs, cause is unknown.

A

FALSE. In ADRs, causality has been determined.

  • Adverse Drug Event, on the other hand, occurs at ANY DOSE and CAUSE IS UNKNOWN.
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7
Q

TRUE or FALSE. In drug development, drugs with ADRs may be recycled because a subpopulation could benefit.

A

TRUE.

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8
Q

ADR + unknown causes + idiosyncratic causes + medication errors + treatment failure =

A

Adverse Drug Event or ADE

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9
Q

Adverse Drug Events include:

A

ADRs + Unknown Drug Reactions (Complications & Pre-clinical trials with animals) + Idiosynchratic Causes (Toxicity regardless of dose) + Medication causes (Misunderstanding handwriting & misinformation) + Treatment Failure (counterfeit drugs & quality of generics)

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10
Q

Dose-Related ADRs: Type A (Augmented);

Non-Dose-Related ADRs: ?

A

Type B (Bizarre)

Dose-Related ADRs (Type A) also:
Covers non-immune ADRs kasi primarily due to pharmacokinetic and pharmacodynamics abnormalities lang (Kaya Type A: AUGMENTED) that produce an excess of known pharmacological drug effect which can be: an Extension Effect or Side Effect

Non-Dose-Related ADRs (Type B) are mainly about Immunological Reactions (yung mga Drug Allergies at mga Hypersensitivity Reactions) and Pharmacogenetic Variations, hence B for Bizarre.

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11
Q

Predictable physiological changes caused by the drug following intended use, but beyond what is normal.

A

EXTENSION EFFECT in Dose-Related ADRs

  • > Ginagawa ng drug yung expected pharmacologic action (pero sobra)
  • > Can be managed with dose reduction or shifting to another drug.
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12
Q

Extension Effect of using Aspirin:

A

GI BLEEDING.

Normal function of aspirin is to inhibit prostaglandins so anti-inflammatory siya -> Kaso lang prostaglandins ALSO PROTECT the mucosal lining of the stomach and the small intestine. -> Ibig sabihin pag nainhibit ang prostaglandins sa stomach at small intestine …-> GI BLEEDING AND EROSIONS!

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13
Q

Predictable physiological changes caused by the drug OTHER THAN intended use.

A

SIDE EFFECT

  • only in Dose-Related ADRs
  • Inaatake ng drug yung maling target receptor rather than the one that is intended.
  • So difference between Extension Effect and Side Effect in Dose-Related ADRs, Extension = intended use + another effect consequent to intended use (ex. effect of aspirin). Side Effect = other than intended use.
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14
Q

Side effect of Beta-mimetics

A

PALPITATIONS.

They are cardiotoxic.

Beta-mimetics are the most common tocolytic medications given to women to SUPPRESS preterm labour CONTRACTIONS. The types usually used are called ‘ritodrine’ or ‘salbutamol’ (others can be ‘isoxsuprine’, ‘fenoterol’ and ‘terbutaline’).

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15
Q

Side effect of Aspirin:

A

PREVENT Thrombus Formation.

since aspirin has anti-platelet action.
From this, we can deduce na Side Effects can be GOOD or BAD and that a drug (such as aspirin) can have both EXTENSION EFFECTS and SIDE EFFECTS.

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16
Q

Variations leading to Dose-Related ADRs?

A

3P’s

PHARMACEUTICAL VARIATION - Changes in formulation, Outdated formulation, Presence of bacteria & other contaminants.
Example: carbamazepine with added flavors led to patient being stuporous.

PHARMACOKINETIC VARIATION - Variations in LADME (Liberation + ADME) & polymorphisms in Cytochrome P450

PHARMACODYNAMIC VARIATION - Actions of drugs being altered due to intrinsic factors like existence of other diseases other than the one being targeted.

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17
Q

In Pseudocholinesterase deficiency, administration of succinylcholine results to:

A

Prolonged apnea

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18
Q

Isoniazid Side Effect in Slow Acetylators

A

Peripheral Neuropathy

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19
Q

Prescribed to prevent peripheral neuropathy in slow acetylators

A

Vitamin B6 - Pyridoxine

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20
Q

TRUE or FALSE. Pharmacogenetic Variations are under Pharmacokinetic Variations

A

TRUE.

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21
Q

Liver Toxicity in Fast Acetylators is usually triggered by the use of this drug:

A

Isoniazid

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22
Q

TRUE or FALSE. Reduced clearance always results in increased adverse reactions.

A

FALSE. There might be some form of compensatory excretion

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23
Q

Reduced clearance of this drug during hepatocellular dysfunction can lead to ADRs such as hypotension and cardiac failure.

A

THEOPHYLLINE.

  • has narrow therapeutic index
  • Theophylline is used for ASTHMA & COPD
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24
Q

Reduced clearance of Phenytoin during hepatocellular dysfunction can lead to ADRs such as:

A

sedation and coma.

Basta tatlong drugs ang pwedeng itanong regarding their ADRs during hepatocellular dysfunction:

Theophylline na for ASTHMA, ADRs = Hypotension & Cardiac Failure

Phenytoin na ANTI-CONVULSANT, ADRs = sedation & coma

Warfarin na ANTI-COAGULANT, ADRs = more bleeding

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25
Q

TRUE or FALSE. When Plasma Albumin is decreased, free form of the drug is increased in circulation, leading to toxicity.

A

TRUE. Free form is active form. Abnormally low Plasma Albumin-> lesser protein-bound drugs-> increase in blood levels-> eventual toxicity

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26
Q

worsening of brain function that occurs when the liver is no longer able to remove toxic substances in the blood.

A

Hepatic Encephalopathy

27
Q

This certain drug can have an idiosyncratic reaction where it may give rise to liver toxicity even at a normal dose.

A

PARACETAMOL

28
Q

Drugs to avoid for patients with hepatic encephalopathy

A

Opiates, narcotic analgesics, barbiturates, chlorpromazine, short acting benzos, diuretics

29
Q

Anti-coagulants to avoid when patient has hepatic disease

A

PAPI

Phenylbutazone, Aspirin, Paracetamol (high dose), Indomethacin

30
Q

Drugs that exacerbate fluid retention (to avoid when there is renal disease):

A

CoCaIn Na! - i-associate mo yung Na -> sodium -> important ion in renal. Para maremember na ang pnemonic ay renal-related.

Corticosteroids, Carbenoxolone, Indomethacine, large

amounts of sodium (e.g. antacids)

31
Q

This drug increases potassium by impairment of excretion. Important for renal transplant patients.

A

Cyclosporine.

*also an immunosuppressant

32
Q

Hypokalemia and hypercalcemia in renal disease can be caused by these drugs:

A

Cardiac glycosides such as DIGOXIN.

-> Effects are potentiated, may lead to heart failure

33
Q

Drug Allergy or Hypersensitivity Reactions in Non-Dose Related ADRs are elicited by:

A

High MW proteins (vaccines), Polypeptides (insulin), Dextrans

34
Q

An anti-retroviral drug used by HIV patients for abacavir hypersensitivity reaction:

A

Human Leukocyte Antigen - HLA B57

35
Q

Identify Gell and Coombs Classification of Immunoligical Reaction:

IgE-mediated; very rapid

A

TYPE 1 Reaction. example: Anaphylaxis from beta-lactam (a member of the penicillin family)

36
Q

Identify Gell and Coombs Classification of Immunoligical Reaction:

Hemolytic anemia from penicillin

A

TYPE 2 Reaction (cytotoxic)

Basta pag cell-related ang damage, TYPE 2

37
Q

Identify Gell and Coombs Classification of Immunoligical Reaction:

Serum-sickness from anti-thymocyte globulin

A

TYPE 3 Reaction (Immune Complex)

38
Q

Identify Gell and Coombs Classification of Immunoligical Reaction:

Delayed; cell-mediated

A

TYPE 4 Reaction. Example: contact dermatitis

39
Q

Identify Gell and Coombs Classification of Immunoligical Reaction:

Morbilliform rash from Sulfonamides

A

Specific T-Cell Activation

40
Q

Identify Gell and Coombs Classification of Immunoligical Reaction:

Steven-Johnson syndrome

A

Fas/Fas-Ligand-induced

Steven-Johnson syndrome: all mucous membranes are affected, dermatological emergency, worst mucosa that can be affected are the lungs.

41
Q

Identify Gell and Coombs Classification of Immunoligical Reaction:

Toxic epidermal necrolysis

A

Fas/Fas-Ligand-induced

42
Q

TRUE or FALSE. A single type of drug can cause more than one type of Immunologic Reaction (called Cross Sensitivity or Cross Reaction).

A

TRUE. Such is the case of the penicillin family.

43
Q

Classified as ‘OTHERS’ in Gell and Coombs Classification

A

Drug-induced lupus-like syndrome; Anticonvulsant

hypersensitivity syndrome

44
Q

Binding of Fas ligand with its receptor leads to:

A

apoptosis

45
Q

This ligand/receptor interaction play an important role in the regulation of the immune system and the progression of cancer.

A

Fas ligand/receptor interactions

Fas ligand (FasL or CD95L) is a type–II transmembrane protein that belongs to the tumor necrosis factor (TNF) family. -> kaya siya anti-cancer

46
Q

Identify Gell and Coombs Classification of Immunoligical Reaction:

Reaction occurs within 1 to 3 weeks after exposure.

A

Type 3. Another example of Type 3 Immunologic Reaction: Grave’s disease and the autoimmune type of chronic idiopathic urticaria

47
Q

Identify Gell and Coombs Classification of Immunoligical Reaction:

Reaction occurs within minutes or hours

A

Type 2 Reaction

Type IIA – is the former type II – cytotoxic

Type IIB – antibody-mediated cell stimulating

48
Q

Identify Gell and Coombs Classification of Immunoligical Reaction:

Very delayed reaction; 2-7 days after cutaneous exposure and shorter when oral

A

Type 4 Reaction

Type IVA – CD4+ Th1 lymphocyte-mediated with activation of macrophages (granuloma formation and type I diabetes mellitus)

Type IVB – CD4+ Th2 lymphocyte-mediated with eosinophillic involvement (persistent asthma and allergic rhinitis)

Type IVC – Cytotoxic CD8+ T- lymphocyte with the involvement of perforin-granzyme B in apoptosis (Steven- Johnson Syndrome and toxic epidermal necrolysis)

Type IVD – T-lymphocyte-driven neutrophilic inflammation (pustular psoriasis and acute generalized exanthematous pustulosis)

49
Q

Clinical Features of Allergic Drug Reactions

A

(FAMILIARIZE =))

 Have NO CORRELATION with known properties of the drug

 Require AN INDUCTION PERIOD on PRIMARY exposure but not on re- administration

 Ciprofloxacin: Allergy will only manifest on subsequent use of drug

 Can occur with doses FAR BELOW THERAPEUTIC RANGE

 Often include a rash, angioedema, serum sickness syndrome, anaphylaxis and asthma (70% with allergic rhinitis develop bronchial asthma)

 Occur in a SMALL PROPORTION of the population

 Disappear on cessation of therapy and reappear after readministration of a small dose of the suspected drug(s) of similar structure

 Desensitization may be possible

50
Q

Most common dermatologic manifestation of drug allergy

A

Morbilliform Rash

* Most common drug causes: Beta-lactam antibiotics (penicillins, cephalosporins), antibiotic sulfonamides, allopurinol, anti-epileptic drugs and nonsteroidal anti-
inflammatory drugs (NSAID’s)
51
Q

Allergic Reaction caused by Thiol-containing and non-thiol-containing drug e.g. enalapril (anti-hypertensive) and cephalosporins and piroxicam

A

Pemphigus

52
Q

Allergic reaction from omeprazole; can occur in bronchial passages and mucosal membranes

A

Angioedema

53
Q

Fas Ligand-induced reaction where all mucous membranes are affected

A

Steven-Johnson syndrome

54
Q

TRUE or FALSE. Contact Dermatitis is a drug allergy

A

FALSE. Distribution is Localized.

55
Q

TRUE or FALSE. Viral Exanthem is a drug allergy

A

FALSE. Drug induced allergies of the skin often manifest as patches and not as small spots like the ones shown.

56
Q

Long Term Effects of ADRs

A

ADAPTIVE CHANGE
e.g. Beta-blocker: blocks Beta receptor in heart to decrease blood pressure and cardiac output. Through time, when all the receptors have been blocked, you will
develop tachyphylaxis, and eventually tolerance.

REBOUND PHENOMENA
Over time, drug gives you effects opposite to that of what was intended.
e.g. Anti-hypertensive drugs: extreme lowering, then rising up again of blood pressure

57
Q

Delayed Effects of ADRs

A

CARCINOGENESIS
E.g. Anti-cancer drugs have the predilection to produce a second cancer
E.g. Fertility drugs. Women exposed to ovulation induction drugs eventually develop ovarian cancer

EFFECTS CONNECTED WITH REPRODUCTION
Impaired Fertility
Teratogenesis
Drugs in breast milk

58
Q

Common Predisposing Factors (Both Immune and Non-Immune) for ADRs

A

Female Gender, HIV, Systemic Lupus Erythematous (SLE)

Think: Almira. Female, mukhang may HIV, tapos mapula (SLE)

59
Q

Generic Drug Reaction Risk Factors (Non-immune)

A

RALPHS

 Renal insufficiency
 Alcoholism
 Liver disease
 Polypharmacy
 Herpes infection
 Serious illness
60
Q

Hypersensitivity Drug Reaction Risk Factors (Immune)

A

PASUCA

 Previous hypersensitivity to chemically-related drug
 Asthma
 Specific genetic polymorphisms
 Use of beta-blockers
 Concomitant viral infection
 Age (adult)
61
Q

A very rare adverse drug reaction to Cefaclor.

A

Myocarditis

62
Q

Identify Gell and Coombs Classification of Immunoligical Reaction:

Vasculitis

A

Type 3 (Immune-complex-mediated)

Other clinical manifestations: Arthralgias, serum sickness, fever, lymphadenopathy, urticaria, glomerulonephritis

63
Q

Identify Gell and Coombs Classification of Immunoligical Reaction:

Hemolytic anemia,

A

Type 2 (cytotoxic). Mechanism: Specific IgG or IgM antibodies directed at drug-hapten coated cells

*Basta blood-related clinical manifestation, Type 2!

64
Q

Identify Gell and Coombs Classification of Immunoligical Reaction:

bronchospasm

A

Type 1 ((IgE-mediated))

Other clinical manifestations: Urticaria, angioedema, bronchospasm (scariest!), pruritus, vomiting, diarrhea

Ther 201 Exam 2 (3 decks)

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