Saudi Prometric Pharmacist Pharmacy Law and Ethics

Question 1

What is the SFDA's role in pharmacy regulation in Saudi Arabia?

Accepted Answer

Registering drugs, licensing pharmaceutical facilities, setting quality standards, and conducting post-marketing surveillance

Answer

SFDA has no role in pharmacy

Answer

Only inspecting pharmacies

Answer

Only regulating drug prices

Question 2

What are the legal requirements for a valid prescription in Saudi Arabia?

Accepted Answer

Patient details, prescriber information with license number, drug name/strength/quantity, directions, date, and prescriber signature/stamp

Answer

Patient name only

Answer

Only the drug name and quantity

Answer

Prescriptions are not legally required

Question 3

What is the pharmacist's legal obligation regarding adverse drug reaction (ADR) reporting?

Accepted Answer

Pharmacists are legally required to report suspected ADRs to the SFDA National Pharmacovigilance Center

Answer

ADR reporting is optional

Answer

Only physicians can report ADRs

Answer

Only severe ADRs need reporting

Question 4

What are the legal consequences of dispensing medication without a valid prescription in Saudi Arabia?

Accepted Answer

Fines, license suspension or revocation, pharmacy closure, and potential criminal charges

Answer

No consequences

Answer

A warning only

Answer

Only a small fine

Question 5

What ethical principle guides the pharmacist's decision when a prescription appears potentially harmful?

Accepted Answer

Non-maleficence (do no harm) — the pharmacist has a duty to verify and refuse to dispense if they believe the prescription could harm the patient

Answer

Always dispense what the doctor orders

Answer

Price considerations come first

Answer

Patient convenience is the only consideration

Question 6

What are the regulations regarding drug advertising to the public in Saudi Arabia?

Accepted Answer

Prescription drug advertising to the public is prohibited; OTC drug advertising must be approved by SFDA

Answer

Any drug can be advertised freely

Answer

Only hospital drugs cannot be advertised

Answer

No regulations exist for drug advertising