[Wk1: CLP & FCM] 1.5 Pharmacovigilance

Question 1

the science and activities relating to the detection, evaluation, understanding and prevention of ADR or any drug-related problems tasked to define and reduce risk and harm

Answer 1

Pharmacovigilance

Question 2

Context: No medicinal drug is entirely or absolutely safe for all people, in all places

Answer 2

Risks

Question 3

Aims of PV

Answer 3

` improve patient care and safety
` improve public health and safety
` contribute to assessment of benefit, harm, effective and risk of meds
` promote education and clincial training
` promote rational and safe use of medicines

Question 4

ADE vs. ADR

injury resulting from use of drug
> overdose
> adverse outcome w dose reduction and discontinuation of drug

Answer 4

Adverse drug effect

Question 5

ADE vs. ADR

Harm directly caused by the drug at NORMAL DOSE, DURING NORMAL USE

Answer 5

ADR

Question 6

Any new clinical xp after initiating treatment with a meds regardless of its severity or seriousness without judgment on its causality

Answer 6

AE

Question 7

requires observation of any untoward medical occurrence that may present during tx caused by a pharmaceutical product

Answer 7

Active safety medicine monitoring

Question 8

detect AE either by active follow-up after tx by asking patients directly or screening px records

Answer 8

Activate surveillance measures

Question 9

useful and validated tool which can serve as a scoring checklist to evaluate ADR probabiltiy

Answer 9

Naranjo Adverse Drug Rxn Probability Scale

Question 10

10 questions in Naranjo Adverse Drug Rxn Prob Scale

Answer 10

SCALE:
1 -> Yes
2 -> No
3 -> Do not know

1. Are there previous conclusive reports on this rxn?
   1 - 0 - 0
2. Did the AE appear after the suspected ddrug was administered?
   2 - 1 - 0
3. Did the ADR improve when the drug was discontinued or a specific antagonist was administered?
   1 - 0 - 0
4. Did the AE reappear when the drug was re-administered?
   2 - 1 - 0
5. Are there alternative causes (other than the drug) that could on their own have caused the rxn?
   (-1) - 2 - 0
6. Did the rxn reappear when a placebo was given?
   (-1) - 1 - 0
7. Was the drug detected in blood (or other fluids) in concentrations known to be toxic?
   1 - 0 - 0
8. Was the rxn more severe when the dose is increased or less severe when dose is decreased?
   1 - 0 - 0
9. Did the px have similar rxn to the same or similar drugs in any previous exposure?
   1 - 0 - 0
10. Was the AE confirmed by any objective evidence?
    1 - 0 - 0

Question 11

Naranjo Algorithm results score interpretation:

> 9

Answer 11

Highly Probable

Question 12

Naranjo Algorithm results score interpretation:

5-8

Answer 12

Probable

Question 13

Naranjo Algorithm results score interpretation:

1 - 4

Answer 13

Possible

Question 14

Naranjo Algorithm results score interpretation:

less than 0

Answer 14

Doubtful

Question 15

mishaps that occur during prescribing, transcribing, dispensing, administering, adherence, monitor of drug --> e.g. misreading or miswriting an Rx if can be stopped “near misses” or a potential ADE

Answer 15

Medication Errors (ME)

Question 16

Reasons for poor reporting

Answer 16

> Fear of repercussion or consequences

• • administrative or legal problems
• • public perception

> the sad reality of the situation is that there is really poor reporting partly due to cultural reasons and fear of repercussion

Question 17

Types of medication errors? (4)

Answer 17

() Prescribing errors wrong drug
` wrong dose

(2) Administration Errors 
` wrong drug 
` wrong dose 
` wrong time 
` improper syringe or IV prep 

(3) Transcription Error
` illegible penmanship

(4) Dispensing errors
` inc filling of Rx

Question 18

Tasks to take lead in PV activities in the PH

Answer 18

BFAD / FDA

October 1997

Question 19

Problem with herbal meds

Answer 19

studies on its LD50 or toxic dose may either be lacking or inadequate

Question 20

AE of herba medicines are attributed to wc 5 characteristics

Answer 20

1 poor product
2 improper use 
3 inadequate regulatory measure 
4 weak quality control systems 
5 uncontrolled distribution channels

Question 21

sum of all tasks required to ensure that medications are safe, effective and acceptable to the patient

Answer 21

Pharmaceutical Quality assurance

Question 22

Processes and tests that are carried out to ensure that the materials and products released for sale or supply, has been judged to be satisfactory

Answer 22

Pharmaceutical Quality Control

Question 23

part of the quality assurance activities that ensure that products are consistently produced and controlled to the quality standards appropriate to their intended use and required by the drug regulatory authorities

Answer 23

Good Manufacturing Product / GMP

Question 24

extend and rate at which a sustance or its active moiety is delivered from a pharmaceutical form and becomes available in the general circulation

Answer 24

BA

Question 25

amount of drug from a formulation that reaches the systemic circulation relative to an IV dose

Answer 25

Absolute BA

Question 26

commonly used when an IV formulation does not exist or cannot be made

Answer 26

Relative bioavailability

Question 27

measure of the extent of BA

Answer 27

AUC / Area under the concn time curve

Question 28

measure of both the rate of absorption and the extent of BA

Answer 28

Cmax / observed maximum conc of drug

Question 29

measure of the rate of absorption

Answer 29

Time after administration of a drug at which Cmax is observed

Question 30

Bioequivalence standards are applied to the PK parameters AUC and Cmax but not to ___

Answer 30

Tmax

Question 31

this means that the drugs contain the same amount of active substance in the same dosage form

Answer 31

Pharmaceutical Equivalence

Question 32

T or F

Pharmaceutical eqquivalents does not necessarily mean Therapetuic equivalence

Answer 32

TRUE

Question 33

Two drugs are therapeutically equivalent when a drug is compared to a reference drug or innovator drug and it has the same response aside from the different factors that was previously cited like having the same active ingredient and having the same effect when taken by the patient

Answer 33

Interchangeable Pharmaceutical Products

Question 34

A poor peerforming drug is very dangerous since it can cause the ff (4)

Answer 34

` lack of therapeutic effect
` toxic and adverse rxn
` waste of limited financial resources
` loss of credibility

Question 35

Main agency responsible for Medicine quality

Answer 35

FDA

Question 36

A report of a suspected adverse rxn to a medicinal product which is initiated by the consumer and without interpretation by a healthcare professional

Answer 36

Consumer report