L7

Question 1

What do MAHs outline?

Answer 1

Specific legal responsibilities across the whole life of the product

Question 2

What are 4 requirements MAH outline?

Answer 2

Requirement to launch product
Market product (legally)
Legal responsibility in maintaining quality & safety
Legal responsibility for monitoring real-world performance & report findings

Question 3

What is pahrmacovigilance?

Answer 3

PV & post-merkaet surveillance

Question 4

What is involved in PV?

Answer 4

Series of data gathering & monitoring exercises aiming to record all new info about hazards associated with a medicine with aim of preventing harm

Question 5

What is the main focus of PV?

Answer 5

Emerging, previously unrecognized adverse effects & medical errors

Question 6

What are 3 medical errors?

Answer 6

Prescribing
Dispensing
Patient

Question 7

What is a side effect?

Answer 7

Any outcome that is not within scope of desired therapeutic/pharmalogical effect

Question 8

What is toxicity?

Answer 8

Outside therapeutic range (dose dependent)

Question 9

What is the difference between expected & unexpected side effects?

Answer 9

Expected = anything that has been noted in a trial and has made it onto patient info leaflet
Unexpected = never seen before/mentioned

Question 10

What is the rationale for PV?

Answer 10

Clinical trials are controlled and doesn’t reflect how the drug will perform in the real world

Question 11

What are 4 possible oytcomes of PV?

Answer 11

1. Withdrawal of product authorisation
2. Suspension of authorisation
3. License remains but additional restrictions are introduced
4. Updates/changes have to be communicated in labelling changes/ changes to SPC

Question 12

Define adverse effect.

Answer 12

Any untoward medical occurrence that happens during treatment but which may or may not be treatment related

Question 13

What is a serious adverse effect?

Answer 13

Life threatening, fatal cause of prolong hospital admission, cause persistent disability or concern misuse or dependence

Question 14

What is adverse drug reaction?

Answer 14

Undesirable response to a drug which is noxious & unintended & occurs at doses in the therapeutic range

Question 15

What is a serious adverse drug reaction?

Answer 15

ADR where SAE conditions of severity applies

Question 16

Whats an unexpected adverse drug reaction?

Answer 16

Adverse reaction, nature of severity of which is not consistent with MA or expected from characteristics of the drug

Question 17

What is a Signal?

Answer 17

Info reported on a possible relationship between an AE & a drug
May be unknown or incompletely documented until now

Question 18

What does the number of reports to constitute a ‘signal’ depend on?

Answer 18

Seriousness of event & quality of info

Question 19

What are Type A adverse reactions?

Answer 19

Due to pharmalogical effects
Dose related
Common
Known before marketing
eg. hypnotic effects of antihistamines

Question 20

What are Type B adverse reactions?

Answer 20

Rare & unpredictable
Little or no dose relationship
Occur in predisposed, intolerant pts
eg. penicillin allergies

Question 21

What are Type C adverse reactions?

Answer 21

Occur after long term therapy
No suggestive time relationship
Use of drug increases frequency of spontaneous diseases
eg. carcinogenesis

Question 22

What are Type D adverse reactions?

Answer 22

Presented years after a drug was used
eg. cervical cancer in women whose mothers were treated by diethylstilbestrol

Question 23

What are Type E adverse reactions?

Answer 23

Absence of drug after withdrawal - rebound
eg. corticosteriods in asthma

Question 24

What does a Causality Assessment determine?

Answer 24

Likelihood of a casual relationship between product exposure & adverse events

Question 25

What are factors in the Causality assessments?

Answer 25

Association in time/place between product use & event Medical or pharmacological plausibility Likelihood or exclusion of other causes

Question 26

Where are suspected ADRs characterized & described?

Answer 26

Case Reports

Question 27

What are 4 assessment scales for evaluating causality?

Answer 27

Karch & Lasagna scale Naranjo WHO probability Jones

Question 28

What are the Karch & Lasagna categories?

Answer 28

A - causality is highly probable B - not adequate proof of causality O - data are not adequate to assess causality

Question 29

What are 3 classifications of AE based on severity?

Answer 29

Mild Moderate Serious

Question 30

What are 3 classifications of AE based on underlying basis?

Answer 30

Intolerance Idiosyncratic Allergy Pseudoallergy

Question 31

What factors contribute to ARs?

Answer 31

Administered drug Patient

Question 32

Who reports safety data?

Answer 32

Physicians Pharamcists Pharma company Pts

Question 33

What is EudraVigulance?

Answer 33

Data processing network for reporting & evaluating suspected adverse reactions of medicinal products in EEA

Question 34

What do the WHO Monitoring Centre in Uppsala do?

Answer 34

Coordinates WHO programme for International Drug monitoring

Question 35

What is PRAC?

Answer 35

60 day safety assessment - something serious seen in data relating to a certain drug Article 31 Referral

Question 36

What do the WHO recommend for when to report (5 things)?

Answer 36

Every single problem Suspected adverse reactions Lack of efficacy & suspected quality defects Counterfeit pharmaceuticals Development of resistance

Question 37

What does SUSAR stand for?

Answer 37

Suspscted Unexpected Serious Adverse Reaction

Question 40

What are variations?

Answer 40

Amendment to the product/processes after MA

Question 41

What are minor variations?

Answer 41

Minimal or no impact on quality safety & efficacy of product - Type 1A or Type1B eg. change of manufacturer, packaging, site

Question 42

What are Major Variations?

Answer 42

Changes that may have sig. impact on quality, safety or efficacy of medicinal product Type II eg. addition of new therapeutic indication