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

The Saudi Food and Drug Authority (SFDA) is the national regulatory body responsible for drug registration, marketing authorization, post-market surveillance, pharmacovigilance, and setting standards for pharmaceuticals in Saudi Arabia. The MOH handles healthcare delivery; SCFHS handles professional licensing.

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

Saudi Arabia requires controlled drug registers for Schedule A narcotics and psychotropics, documenting: date, prescription number, patient name, prescriber name and license number, drug name, dose, quantity dispensed, and dispensing pharmacist signature. These registers must be retained for 5 years and available for inspection.

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

Saudi SFDA requires mandatory reporting of serious and unexpected adverse drug reactions through the Saudi Vigilance system (online, mobile app, or paper form). All healthcare professionals are obligated to report. The national pharmacovigilance system collects data to identify signals and update drug safety information.

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

Good Dispensing Practice includes: prescription verification (validity, completeness), drug utilization review (interactions, contraindications, allergies), accurate dispensing, proper labeling, and patient counseling. All elements are mandatory for every dispensing event, not optional components.

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

Saudi SFDA classifies medications as POM (prescription-only) or OTC. POMs include antibiotics, antihypertensives, hypoglycemics, psychiatric medications, and controlled substances. Dispensing POMs without a valid prescription is a legal violation. Saudi Arabia has been strengthening antibiotic POM enforcement.

Saudi Prometric Pharmacist Practice Test

Saudi Prometric Pharmacist Practice Test

Saudi Prometric Pharmacist Pharmacy Practice and Saudi Regulations