21. Drug epidemiology and drug safety. Adverse drug reactions (ADRs). Classification, registration, clinical detection of ADRs. Flashcards

1
Q

what is Pharmacoepidemiology

A

clinical pharmacology and epidemiology, which studies the use of and the effects of drugs in large numbers of people.

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2
Q

what is Pharmacoepidemiology used for

A

Studies of drug safety

Studies of drug utilization

Studies of drug induced birth defects

study medication errors

improving physician prescribing

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3
Q

Methods in pharmacoepidemiology

A DOSE

A

Spontaneous reporting- (yellow card scheme), most common

Observational studies

Experimental (interventional) studies

Descriptive studies-

Analytical study-

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4
Q

what is Spontaneous reporting- (yellow card scheme),

A

used to collect information on ADRs from healthcare professionals and patients.

3 stages;
collection of data,
analysis
feedback

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5
Q

advantages of spontaneous reporting

A

cheap

collects data from large populations

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6
Q

how do observational studies differ from exp

A

difference in study groups is created experimentally and outcomes are observed.

Observational studies- the differences in the study groups are only observed and analysed NOT created experimentally.

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7
Q

examples of observ studies

A

case-control studies

cohort studies.

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8
Q

what is analysed in Analytical study

A

relationships between health status and other variables

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9
Q

Descriptive studies- describe what?

A

occurrence of a disease (ADR) in a population.

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10
Q

what is an adverse drug event

A

unwanted medical event during rx w. a ddrug but isnt directly caused by the rx

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11
Q

adr

A

oxious and unintended response to a drug which occurs at normal doses

causal relationship expected

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12
Q

Unexpected ADR

A

an ADR whose a nature or severity is not compatible with the drug information or cannot be predicted from the characteristics of the drug

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13
Q

Side-effects

A

unwanted but unavoidable pharmacodynamic effects, occurring at therapeutic doses.

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14
Q

Secondary effects

A

indirect consequences of a primary action of the drug

Eg disbacteriosis due to broad spectrum antibiotics

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15
Q

types of ADR

A

Minor ADRs: no therapy, antidote or prolongation of hospitalization is required.

Moderate ADRs: Require change in drug therapy, specific treatment or prolong hospital stay by at least 1 day.

Severe ADRs: Potentially life threatening, cause permanent damage or require intensive medical treatment.

Lethal: Directly or indirectly contributes to death of the patient.

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16
Q

ADR classification

A

type A: Augmented dose related

Type B (Bizarre)
Unrelated to dose
Type C (Chronic)
Dose and time-related
Type D (Delayed)
Delayed in time
Type E (End of treatment)
After drug discontinuation
Type F (Failure)
Unexpected failure of therapy

Type U (Unclassified)

17
Q
Type A (augmented)
Dose-related features
A

Common and predictable

Augmentations of known pharmacologic effects

can be alleviated by a dose reduction

Associated with high doses

Low mortality

Common in patients with liver and kidney failure

Minor type A reaction= side-effect

18
Q

Type A ADR examples

A

obvious ones

antihypertensive medications- orthostatic hypotension

beta blockers-
bradycardia

nitrates-
headache,
flushing
reflex tachycardia

19
Q
Type B (Bizarre)
Unrelated to dose
A

Uncommon and unpredictable

affects a small population

not related to the main pharmacologic action of the drug

high mortality

20
Q

TYPE B ADR EXAMPLES

A

immunologic reactions (allergy)

intolerance

hemolytic anemia

serum sickness

21
Q
Type C (Chronic)
Dose and time-related
A

Reactions due to long-term drug use

Related to the cumulative dose

22
Q

type c ADR examples

A

Neuroleptic-related tardive dyskinesia.

corticosteroids-(Cushing’s)

Analgesic nephropathy

23
Q
Type D (Delayed)
Delayed in time
A

occur after many years of treatment

carcinogenic, mutagenic and teratogenic effects

24
Q

Type D ADR examples

A

Tetracyclines-yellow staining of the primary or deciduous teeth

Retinoic acid or vitamin A-extremely teratogenic

anticancer drugs- carcinogenesis and may cause secondary tumors

25
Q
Type E (End of treatment)
After drug discontinuation
A

Drug withdrawal syndrome

ADRs, mostly in the form of worsening of the clinical condition for which the drug was being used

26
Q

Type E ADR examples

A

benzodiazepines w/drawal symp- insomnia, anxiety

withdrawn abruptly beta blockers- Worsening of angina pectoris or acute myocardial infarction

withdrawal of glucocorticosteroids.-Adrenocortical insufficiency

27
Q
Type F (Failure)
Unexpected failure of therapy
A

Common

Often caused by drug interactions.

28
Q

Type F examples

A

Inadequate dosage of an oral contraceptive when used with an enzyme inducer.

Resistance to antimicrobial agents

29
Q

PATIENT factors predisposing ADR

A

AGE

  • pediatric age
  • geriatric age

renal/hepatic impairment

gender

  • women> men
  • hormonal diff to met

comorbidities

genetic abnormalities
-altered met

history of ADR

30
Q

drug factors

A

higher incidence of ADRs,

high allergenicity,

31
Q

Prescriber factors

A

inappropriate drug or drug combination

inappropriate dose,

route of administration

duration of treatment.

32
Q

Criteria for causality assessment

A

Timing
- time between drug administration and reaction

Pharmacological properties of the drug, data on ADR

Investigations (clinical and lab) contributing to plausibility of ADRs

Presence or lack of other causes of the reaction

Response to drug withdrawal(dechallenge) 
and provocation (rechallenge- controlled administration of the drug))tests
33
Q

WHO criteria for the degree of causality of a drug w/ the ADR

A

Certain

Probable

Possible

Unlikely

Unclassified

34
Q

Management of ADRs

A

Drug withdrawal

decrease dose

change Route of admin
Systemic, topical or combined therapy

Hospitalization

Selection and administration of different drugs

35
Q

Pharmacovigilance

A

collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. I