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Drug Regulatory Affairs > Exercise 4 > Flashcards

Exercise 4 Flashcards

1
Q

what is the Raid information system or Rapid Alert System?

A

it is a national or international information system for reporting or quality-related risk to recalls or other actions

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2
Q

what are some examples of the recall or other actions of the RAS?

A

recalls: quality defects, counterfeiting, tempered products

other actions: caution in use statements, follow-up messages

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3
Q

why is the RAS implemented?

A

to transmit urgent and serious cases to protect human an animal health

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4
Q

what are the criterial for a rapid alert?

A

concern requiring a change of the MA
direct concern about a medicinal product or an API such as reports or studies about unexpected and erious adverse drug reactions (change of the benefit-risk assessment

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5
Q

what is the procedure of the rapid aleart system?

A

Coordinated by the EMA:

1. Email containing the most important details on the defects sent to a list of concerned parties

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6
Q

e-mail can be sent to?

A

human and veterinary authorities of the EEA, EC EDQM, WHO and countries that signed the Mutal recognition Agrrement

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7
Q

who coordinated the RAS in Germany?

A

Federal Institute for Drugs and Medical Devices (BfArM)

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8
Q

Which role does the WHO play?

A

on an international level, they are responsible for issuing medical product alerts for essential medicines and health products

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9
Q

is the report on the international level a rapid alert?

A

No, because, the risk will be identified and the defect validated through visual inspection or laboratory testing, fore sendimg out comment to the manufacturer

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10
Q

Clasification of rapid alerts is based on?

A

on the extent of the defect, the potential risk of harming a patient and on how the product was distributed

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11
Q

Class I is?

A

potentially life-threatening defect including

  • wrong drug product i package
  • different strength
  • microbial contamination of sterile injectable
  • chemical contamination
  • -> Raid (global) alert notiication
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12
Q

Class II is?

A

Defect could casue illness or mistreament,
- insecure or seriouly defected container closure
-Missing or incorrect leaflet or insert
Rapid alert notification to affected contacts

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13
Q

Class III is?

A

defect causes no significant health hazard
- Faulty packaging or imprints
Faulty closure

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14
Q

examples giving in the presention for the RAS

A

have you looked at it?

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15
Q

what are the legal basis of the drug discount contracts?

A

Non-prescription drugs are not regulated by laws.

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16
Q

which law regulated the drug discount contract ?

A

Price ordinance, the contribution protection lw, the drug Economic law, the drug ordinance for Marketing

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17
Q

which drugs are part of the drug price ordinance

A

these are prescription only drugs, must be offered for the same price in all pharmacies in germany

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18
Q

what is the advantage of the uniform pricing?

A

that customer does not have to worry or compare prices of the drug and prevents competition within pharmacies

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19
Q

what does the rebate agreement between insurance companies and pharmceutical manufacturers

A

to ensures that insurance provides receive affordable prices for pharmaceutical

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20
Q

what is aim the drug economic efficienty law

A

to reduce the expenditure of pharmaceutical drugs which consequentlylead to changes in the social code of germany

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21
Q

what is the benefit of the 10 % discount on genric products?

A

the companies can make a contratc with the health insurance, patient is obliged to purchade the drug product

22
Q

what about pharmacuetical drugs with no additional benefits?

A

usually follow a fixed price which is set by the federal committee

23
Q

for which products are discount made?

A

for ready-to-use drug products

24
Q

what about discounts on vaccinations?

A

no discounts are given for vaccinations

25
Q

waht are some impacts of the DDCs on patient and physicians?

A

extra work for physicians/ pharmacists

26
Q

on what is the extra workload of the physicians and pharamcists based on?

A

due to the different packgae, shape, or colour–> negative impact on the confidence of the patient
substitutional product may very in the composition of excipeints and the physicians

27
Q

what are some positvey sides of the DDCs?

A

proper counselling of the patients–> better physician/pharmaceist-patient relationship

costs of the health insurance companies are hold lower with the DDCs

28
Q

purpose of the pharmacovigilance?

A

identify new information or hazrads associated with a mdeciation, here a drg susbtitution

29
Q

what is the results of the drug substituation by patient?

A

resulting in lower patient compliance and nocebo-effects

30
Q

what is the difficulties of the PV with the DDCs?

A

lack of transparency, physicians do not know, if and to what a drug is substitued
no evalution of chnages dur to substituation, nor monitoring of its impact reagrding safety issues

31
Q

why was an additional monitoring of the biologic came into forced?

A

due to the lurking risks which have not yet been identified druing CT

32
Q

why are biologics and biosimilar strickly regulated?

A

Due to the differences in their starting materials and manufacturere resulting in different characteristics

33
Q

What is the responsibility of the MAH when their product is listed on the additional monitoring list?

A

They have to include on the secondary package an inverted black triangle.
“this medicinal product is subject to additional mointoring steatment in the package leaflet annd in the SmPC

34
Q

what is the key for imporvement?

A

Post-authorisation safety studies

35
Q

aim of the PASS?

A

to identif, inspect the benefit risk profile of medicines and supports decisions of regulatory authorities

36
Q

key activites of the Eudravigilance database

A

a data processing managemnet system use for collection of Adverse effects data
ADRs are reported from MAH and member states

37
Q

What does FMD stands for and what is their aim?

A

Falsified Medicine directive

aim is to minimizing risk of counterfeit medicines entering the drug supply chain across EU

38
Q

What does SCOPE stands for and what is their aim?

A

Strengthening collaboration for operating pharmacovigilance in EU
aim: help member state develop best practice in reporting ADRs, managing signals, communicating riks, and creating a form for interaction amoung European national competent authorities

39
Q

what is a Referrals?

A

this are pharmacovigilance processes used to reolve saftey and other risk related issues linked to a medicine or group of medicine in the EU

40
Q

what is referral triggered by?

A

either by safety related issues or non-saftey related issues such as efficacy, quality and disagreements issues

41
Q

who are the actors involved in a referrla process?

A

EC, MS and MAH: capable of triggering a referral
PRAC, CHMP, CMDh: preforming the assessments
EC: final decision marker
Patient, Healthcare professionals, Academia: collaborating in the assessment

42
Q

in which parts can a referrals be divied?

A

Safteyl related or others

to the type of marketing procedure and other factors such as pediatric reason

43
Q

who is the triggering person in a safety issues reason

A

EC or MAH

44
Q

what are possible outcome?

A

Maintenance, Variation, Suspension and Revocation

45
Q

safety referral procedure

A
  1. Safety issues : EC or MS
    EC–> centralized products (article 20)
    MS and EC–> centralized antional (article 107i, Artcile 31)
  2. Assessment done by PRAC–> send out their recommendation to CHMP (centralized) or CmDh (national)
    both committee submit to EC and EC to the MS8s
46
Q

what are non-saftey issues regarding the referrals?

A

Type II variation, Efficacy, Qauality and Peadiatric issues, Harmonization issues,
Efficacy Quality issues

47
Q

procedure in the non-safety issues?

A

60 days Assessment dependen on the type of issues and respective triggering person, the assessemnt is send to the CHMP, it gives its opinion to the EC

48
Q

what is the purpose of the direct healthcare professionla communication (DHPC)

A

to support safe and effective use of medicines by informing healthcare professionals
(Suspsenion, withdrawal or revocation, a medicine supple shortage
quality problems with a medicine

49
Q

when is the information letter and the red hand letter sent out?

A

information letter: when the aim is to inform healthcare professionals
Red hand letters: sent when the healthcare professional is required to take action

50
Q

where should both letter be submitted for review?

A

to BfArm or PEI

51
Q

who sent out the red hand letter?

A

Pharmaceutical entrpreneur in consultation with the federal hiigher authorty competent for the MP

52
Q

where does the name red hand letter comes from?

A

from the distinctive picture of a red hand which is place at the top right or left hand corner of the letter

Drug Regulatory Affairs (15 decks)

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