Rational drug use

Question 1

dose

Answer 1

does the person have comorbidities that could affect the pharmacodynamics

Question 2

route of administration

Answer 2

vomiting patient, unconscious

Question 3

duration

Answer 3

prevent drug resistance with bacteria

Question 4

advice

Answer 4

how to take drugs, when to stop

Question 5

monitoring

Answer 5

making sure they benefit and not harmed

Question 6

principles of rational drug use

Answer 6

drug
dose
route of administration
duration
advice
monitoring

Question 7

define problem

Answer 7

diagnosis and severity

Question 8

set therapeutic objectives

Answer 8

what are we trying to achieve

Question 9

select therapy

Answer 9

non drug

drug therapy

Question 10

p drug

Answer 10

efficient
safe
suitable
cost effective

Question 11

patient drug

Answer 11

co-morbidities, cautions, contraindications
drug to drug interactions
convenience and compliance

Question 12

prescribing

Answer 12

information- onset of action
instructions
warnings

Question 13

monitor therapy

Answer 13

objectives being achieved?, adherent, review diagnosis

Question 14

adverse drug event

Answer 14

medical occurrence associated with the use of medicinal product but not necessarily causally related

Question 15

adverse drug reaction

Answer 15

a response to a drug which is noxious and unintended which occurs at doses normally used

Question 16

type A drug reaction

Answer 16

augmented
dose dependent
common/ predictable

Question 17

type b

Answer 17

bizarre
dose independent
rare/unpredictable

Question 18

pharmacovigilence

Answer 18

The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems.” Ultimately these activities are aimed at protecting patients and the public from drug-related harms.

Question 19

risk mitigation

Answer 19

Take a full history, including concomitant illness, medication (including OTC, CAT, SOA meds) and allergies
Heed contra-indications, cautions and warnings
Avoid unnecessary drugs
Avoid drug interactions
Use correct dose
Conduct appropriate monitoring
Report suspected ADRs

Question 20

causality assessment (WHO-UMC)

Answer 20

a- time relationship between drug use and event 
b- absence of other competing causes(meds, disease itself)
c- de-challenge
d- re-challenge
Definitely- all 4
Probably / Likely- first 3
Possibly- a only
Unlikely- no a and b
Conditional / Unclassified
Unassessable / Unclassifiable

Question 21

bradford hill criteria

Answer 21

strength of association
temporality- cause precedes outcome
consistency- same answers in different situations
specificity- specific cause for a specific effect
dose response- increased exposure leads to increased effects
biological plausibility- relationship could be explained by biological mechanisms

Question 22

Naranjo scale

Answer 22

1.
Are there previous conclusive reports on this reaction?
2. Did the adverse event appear after the suspected drug was administered?
3. Did the adverse event improve when the drug was discontinued or a specific antagonist was administered?
4. Did the adverse event reappear when the drug was re-administered?
5. Are there alternative causes that could on their own have caused the reaction?
6. Did the reaction reappear when a placebo was given?
7. Was the drug detected in blood or other fluids in concentrations known to be toxic?
8. Was the reaction more severe when the dose was increased or less severe when the dose was decreased?
9. Did the patient have a similar reaction to the same or similar drugs in any previous exposure?
10. Was the adverse event confirmed by any objective evidence?

0-doubtful
1-4 possible
5-8 probable
greater than 9- definite

Question 23

stages of drug developments

Answer 23

Identification of pharmacological target
Screening to identify molecules that interact with target
Molecules refined: chemistry, computer modelling
In vitro tests
Formulation
Toxicology
phase 1-4 clinical trials

Question 24

generic drugs

Answer 24

Generics are identical in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.

Question 25

generic drug regulations

Answer 25

meet same standard as innovator drug
bioequivalent (smiliar bioavailability, safety, efficacy, AUC, Cmax and Tmax, and the 90% confidence interval between 0.8 and 1.25) to the innovator drug
pass same quality standards as innovator drug