Saudi Prometric Pharmacist Pharmacy Practice and Saudi Regulations

Question 1

Under Saudi Arabia's drug regulatory framework, which body is responsible for registering and regulating pharmaceutical products?

Accepted Answer

Saudi Food and Drug Authority (SFDA)

Answer

Saudi Commission for Health Specialties (SCFHS)

Answer

Ministry of Health (MOH) Pharmaceutical Care Department

Answer

Saudi Pharmacists Association (SPA)

Question 2

A pharmacist in Saudi Arabia dispenses a Schedule A controlled substance. Which documentation is mandatory?

Accepted Answer

Controlled drug register recording the patient name, prescriber, date, drug, quantity, and pharmacist signature

Answer

Standard prescription record only — no additional documentation needed

Answer

Only the prescriber's DEA/MOH number needs to be recorded

Answer

Verbal confirmation from the prescriber is sufficient documentation

Question 3

A pharmacist suspects a drug-drug interaction that has caused a serious adverse event. What is the pharmacist's obligation under Saudi SFDA pharmacovigilance regulations?

Accepted Answer

Report the adverse drug reaction (ADR) to SFDA through the national pharmacovigilance reporting system (Saudi Vigilance)

Answer

Only document in the patient's file — no external reporting required

Answer

Report only if the reaction is fatal

Answer

Report to the prescriber but not to the regulatory authority

Question 4

A pharmacist is dispensing medication to a patient. Which action is essential under Good Dispensing Practice (GDP) guidelines?

Accepted Answer

Verify the prescription, perform patient counseling, check for interactions/allergies, and accurately label the medication

Answer

Dispense as quickly as possible to minimize patient wait time

Answer

Only label the medication — counseling is optional for refills

Answer

Verify prescription only — interactions are the prescriber's responsibility

Question 5

Under Saudi pharmacy law, which category of drugs requires a valid prescription from a licensed physician before dispensing?

Accepted Answer

Prescription-only medications (POM) — classified by SFDA and include antibiotics, controlled substances, and most chronic disease medications

Answer

All medications including over-the-counter products

Answer

Only controlled substances (Schedule A and B)

Answer

Only injectable medications and Schedule A narcotics

Question 6

A patient brings a prescription for a controlled substance signed by a physician who is not licensed to practice in Saudi Arabia. What is the pharmacist's legal obligation?

Accepted Answer

Refuse to dispense — the prescription is invalid without a Saudi MOH-licensed prescriber

Answer

Dispense if the medication name is correct regardless of prescriber license

Answer

Contact the SFDA before dispensing any controlled substance prescription

Answer

Dispense once and report to MOH after dispensing