Exercise 4 Flashcards
what is the Raid information system or Rapid Alert System?
it is a national or international information system for reporting or quality-related risk to recalls or other actions
what are some examples of the recall or other actions of the RAS?
recalls: quality defects, counterfeiting, tempered products
other actions: caution in use statements, follow-up messages
why is the RAS implemented?
to transmit urgent and serious cases to protect human an animal health
what are the criterial for a rapid alert?
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
what is the procedure of the rapid aleart system?
Coordinated by the EMA:
1. Email containing the most important details on the defects sent to a list of concerned parties
e-mail can be sent to?
human and veterinary authorities of the EEA, EC EDQM, WHO and countries that signed the Mutal recognition Agrrement
who coordinated the RAS in Germany?
Federal Institute for Drugs and Medical Devices (BfArM)
Which role does the WHO play?
on an international level, they are responsible for issuing medical product alerts for essential medicines and health products
is the report on the international level a rapid alert?
No, because, the risk will be identified and the defect validated through visual inspection or laboratory testing, fore sendimg out comment to the manufacturer
Clasification of rapid alerts is based on?
on the extent of the defect, the potential risk of harming a patient and on how the product was distributed
Class I is?
potentially life-threatening defect including
- wrong drug product i package
- different strength
- microbial contamination of sterile injectable
- chemical contamination
- -> Raid (global) alert notiication
Class II is?
Defect could casue illness or mistreament,
- insecure or seriouly defected container closure
-Missing or incorrect leaflet or insert
Rapid alert notification to affected contacts
Class III is?
defect causes no significant health hazard
- Faulty packaging or imprints
Faulty closure
examples giving in the presention for the RAS
have you looked at it?
what are the legal basis of the drug discount contracts?
Non-prescription drugs are not regulated by laws.
which law regulated the drug discount contract ?
Price ordinance, the contribution protection lw, the drug Economic law, the drug ordinance for Marketing
which drugs are part of the drug price ordinance
these are prescription only drugs, must be offered for the same price in all pharmacies in germany
what is the advantage of the uniform pricing?
that customer does not have to worry or compare prices of the drug and prevents competition within pharmacies
what does the rebate agreement between insurance companies and pharmceutical manufacturers
to ensures that insurance provides receive affordable prices for pharmaceutical
what is aim the drug economic efficienty law
to reduce the expenditure of pharmaceutical drugs which consequentlylead to changes in the social code of germany
what is the benefit of the 10 % discount on genric products?
the companies can make a contratc with the health insurance, patient is obliged to purchade the drug product
what about pharmacuetical drugs with no additional benefits?
usually follow a fixed price which is set by the federal committee
for which products are discount made?
for ready-to-use drug products
what about discounts on vaccinations?
no discounts are given for vaccinations
