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 regulates all pharmaceutical activities: drug registration/market authorization, manufacturing facility GMP inspection, pharmacy licensing, controlled substance oversight, pharmacovigilance, drug advertising control, and enforcement of pharmaceutical regulations.

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

Saudi prescription requirements: patient full name, age/weight (pediatrics), prescriber name/license number/specialty/signature/stamp, date, drug name (generic/brand), strength, dosage form, quantity, directions for use, and number of refills if applicable.

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

Saudi pharmacists are legally obligated to report suspected ADRs to SFDA's National Pharmacovigilance Center (NPC). This includes previously unknown reactions, serious reactions, and product quality defects. Reports can be submitted through SFDA's electronic reporting system.

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

Dispensing without a valid prescription (especially controlled substances) can result in: significant financial fines, pharmacist license suspension/revocation, pharmacy license revocation, facility closure, and criminal prosecution under Saudi pharmaceutical and narcotics laws.

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

Non-maleficence requires pharmacists to verify prescriptions and intervene when potential harm exists. If a prescription contains errors (wrong dose, dangerous interaction, contraindicated drug), the pharmacist must contact the prescriber before dispensing and document the intervention.

Saudi Prometric Pharmacist Practice Test

Saudi Prometric Pharmacist Practice Test

Saudi Prometric Pharmacist Pharmacy Law and Ethics