communication, pharmacovigilance and registration

Question 1

instrumental communication

Answer 1

aimed at providing information, outcome oriented

Question 2

teach back method

Answer 2

technique to ensure that the patient understands the information being given

Question 3

affective communication

Answer 3

providing hope, reassurance, is directed towards patients emotions, process oriented

Question 4

non-medicinal medication switches

Answer 4

switching to a different medication with same function but different chemical structure

Question 5

adverse events

Answer 5

registered in clinical trials, dont necessary proved to be related to the drug

Question 6

adverse reactions

Answer 6

response to a drug that is bothering and unintended, occurs at normal doses

Question 7

type A adverse drug reaction

Answer 7

pharmacologic effect, can be predictable or less obvious. Dose related, less severe

Question 8

type B adverse drug reaction

Answer 8

bizarre, have to do with immune system, can be allergic, hypersensitivity. often serious, patient needs to stop and not restart

Question 9

seriousness

Answer 9

based on outcome of event, criteria are hospitalisation, life threatening, death, disabling

Question 10

severity

Answer 10

based on intensity of event, grading: severe, mild, etc.

Question 11

priority medicines (PRIME)

Answer 11

type of application enabling accelerated assessment

Question 12

biosimilar

Answer 12

biological medicine highly similar to another already approved biological medicine in the EU, for which marketing exclusive rights have expired

Question 13

orphan medicine

Answer 13

a medicine for rare conditions or not generating sufficient provit