Dr.Osama (FINALS)

Question 1

Adequate evidence of an association between medicine & risk occurrence

Answer 1

Identified Risk

Question 2

some basis for suspicion for an association between medicine & risk occurrence

Answer 2

Potential risk

Question 3

Types of risk?

Answer 3

Identified, potential, missing info

Question 4

What is the difference in risk management between EU and States?

Answer 4

FDA (STATES): Determines REMS, Risk Minimization action plan (RISK MAPS) * recommended but not mandatory.
EU: Valid EU-MP is mandatory

Question 5

Risk Evaluation & Mitigation Strategies in US?

Answer 5

REMS: An operational manual that includes strategies on how to handle the risk associated with a product. Allows patients to use products under certain conditions and surveillance

Question 6

REMS includes?

Answer 6

must always include a timetable and

metrics for assessment of its effectiveness

Question 7

pharmacists utilise the
________________ as a trigger to start a dialogue
with the patient about preventing, mitigating and
reporting ADRs and MEs by providing advice and
information on how to take the medicine most
effectively and what to do in the event of a
suspected ADR or ME.

Answer 7

black triangle symbol

Question 8

a structured
evaluation of a patient‘s medicines with the
aim of optimizing medication use and
improving health outcomes.

Answer 8

medication review

Question 9

What do pharmacists use in deciding meds?

Answer 9

Patient Medication Records (PMRs) &Pharmaceutical Records

Question 10

Answer the following scenario: failure of eradication of H. pylori with a combination of
amoxicillin, clarithromycin and lansoprazole ?

Answer 10

should not be followed with a
second repeat course of the same combination, but instead a combination
of amoxicillin, lansoprazole and either metronidazole, a quinolone or a
tetracycline.

Question 11

. the pregnancy 
prevention programmes (PPPs) ?

Answer 11

desgined for for potent teratogenic

medicines such as retinoids and valproate-related substances.

Question 12

• In the US, risk minimization and management

plans are called

Answer 12

risk evaluation and mitigation

strategies (REMS).

Question 13

Involved in good pharmcy practice?

Answer 13

Pharmacists adhere to Good Pharmacy
Practices (GPPs), protocols and Standard
Operating Procedures (SOPs) as part of their
daily practice to ensure high quality delivery
of pharmaceutical services.

Question 14

_____ is seen as a first step to ‘read and

write’ access to the full eHR in the UK.

Answer 14

Pharmacy access to Summary Care Records (SCRs)