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150 High-Yield MCQs: Saudi Pharmacy Licence Examination (SPLE)

Saudi Laws, Regulations & Ethics - Doctor of Pharmacy

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SECTION 1: SFDA - Saudi Food and Drug Authority (Q1-20)

• A) 1999
• B) 2001
• C) 2003
• D) 2005

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• A) Pharmaceutical products
• B) Medical devices
• C) Medical education and training
• D) Cosmetics

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• A) Ministry of Health (MOH)
• B) SFDA
• C) Saudi Commission for Health Specialties (SCFHS)
• D) Saudi Drug and Narcotic Control Committee

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• A) Optional for generic drugs
• B) Only required for imported drugs
• C) Mandatory for all pharmaceutical products including generics and imports
• D) Required only for Schedule I substances

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• A) ICH CTD (Common Technical Document)
• B) FDA NDA format exclusively
• C) EMA format exclusively
• D) ICH CTD format

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• A) 1 year
• B) 3 years
• C) 5 years
• D) 10 years

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• A) DEA schedules I-V (US)
• B) SFDA's own classification based on MOH guidelines
• C) WHO essential medicines list
• D) British National Formulary classification

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• A) Permitted if approved by MOH
• B) Permitted for pharmacists only
• C) Permitted if the drug is registered with SFDA
• D) Prohibited - direct-to-consumer advertising of prescription drugs is not allowed

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• A) MOH only
• B) WHO
• C) SFDA
• D) SCFHS

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• A) MOH
• B) Saudi Customs
• C) SFDA
• D) Ministry of Commerce

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• A) English only
• B) Arabic only
• C) Both Arabic and English
• D) Any GCC official language

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• A) Only clinical data from the manufacturer
• B) GMP certificate is optional
• C) Full CTD dossier including quality, safety, and efficacy data with valid GMP certificate
• D) Only bioequivalence data

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• A) Only report deaths related to the drug
• B) Submit annual sales reports only
• C) Report all serious and unexpected adverse drug reactions to SFDA
• D) Wait until 5 years post-launch before reporting

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• A) Paracetamol tablets
• B) Antihistamines
• C) Antibiotics
• D) Narcotic and psychotropic substances

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• A) Retail pharmacies only
• B) Drug wholesale warehouses only
• C) Pharmaceutical manufacturing facilities
• D) Community pharmacies

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• A) No registration needed for herbal products
• B) Only MOH approval needed
• C) SFDA registration is required for herbal and health products
• D) Only SCFHS approval needed

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• A) Ministry of Commerce
• B) SFDA
• C) MOH
• D) SCFHS

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• A) BE studies are not required for generics
• B) Only dissolution testing is required
• C) BE studies are mandatory to demonstrate therapeutic equivalence to the reference product
• D) BE is required only for injections

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• A) Freely permitted for registered products
• B) Allowed if cheaper for patients
• C) Regulated and requires specific SFDA authorization
• D) Completely prohibited

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• A) MOH
• B) Ministry of Commerce
• C) SFDA
• D) SCFHS

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SECTION 2: Controlled Substances & Narcotic Regulations (Q21-45)

• A) Any registered healthcare professional
• B) Pharmacists with special license
• C) Licensed physicians, dentists, and veterinarians practicing in Saudi Arabia
• D) Nurses with authorization

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• A) Return it to the patient
• B) Destroy it after 30 days
• C) Send it to MOH
• D) Retain it in the pharmacy, recording the date of dispensing and register number

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• A) Any locked cabinet
• B) Refrigerator only
• C) A secure, dedicated locked safe/cabinet separate from other medications
• D) Standard shelves with restricted access

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• A) One week
• B) As determined by the physician's prescription, typically not exceeding what the prescription specifies, with quantity limits per MOH policy
• C) Three months
• D) One year

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• A) SCFHS only
• B) Ministry of Commerce
• C) MOH only
• D) Health Affairs in the region/province AND SFDA

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• A) Can be any nationality
• B) Must be a SCFHS Fellow
• C) Must be a Saudi national
• D) Must hold a PhD in pharmacy

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• A) SFDA directly
• B) Medical supply department in the region/province for review, then to SFDA
• C) Ministry of Finance
• D) SCFHS

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• A) The clinic license from MOH must be valid
• B) The clinic must have an SFDA-approved annual requirement
• C) Narcotics must be under physician supervision or a Saudi pharmacist/technician
• D) The doctor may prescribe any narcotic regardless of MOH-specified ambulatory medications

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• A) Any registered narcotic drug at the pharmacy's discretion
• B) Only narcotics registered and priced by SFDA, dispensed only with systemic prescriptions
• C) Any drug requested by the patient
• D) Narcotics available in neighboring GCC countries

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• A) Self-correct and continue
• B) Ignore minor discrepancies
• C) Ask the next pharmacist to handle it
• D) Report immediately to the supervisor and the relevant authority (MOH/SFDA)

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• A) OTC analgesic
• B) Prescription-only, non-controlled
• C) Controlled substance (psychotropic) requiring special prescription
• D) Banned substance not available in Saudi Arabia

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• A) Flushed down the drain
• B) Disposed with regular waste
• C) Sold back to the supplier
• D) Conducted under official supervision and documented per SFDA/MOH procedures

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• A) Dispense if it looks legitimate
• B) Dispense with a pharmacist annotation
• C) Dispense if the patient is a tourist
• D) Not dispense - only prescriptions from Saudi-licensed prescribers are valid for controlled substances

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• A) Declare at customs verbally
• B) No action required if within 30-day supply
• C) Carry original pharmacy label only
• D) Obtain an online clearance permit from the SFDA Controlled Drugs System (CDS) prior to arrival

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• A) Over-the-counter medications
• B) Non-controlled prescription drugs
• C) Psychotropic/controlled substances requiring a controlled substance prescription
• D) Banned substances

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• A) Electronic records alone are sufficient without a physical register
• B) Only outgoing (dispensed) quantities need recording
• C) Records can be maintained by any pharmacy staff
• D) All receipts and disbursements must be meticulously recorded with dates, quantities, and patient details

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• A) Comply as the physician is licensed
• B) Comply if the quantity is small
• C) Ask for written confirmation
• D) Refuse - narcotics may only be dispensed against individual valid patient prescriptions

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• A) Replace the missing quantity from another stock
• B) Document and wait for month-end reconciliation
• C) Inform only the pharmacy owner
• D) Immediately report to the concerned authority (MOH/SFDA/police) and document the incident

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• A) OTC drug
• B) Regular prescription drug
• C) Controlled/psychotropic substance requiring special prescription
• D) Banned drug not available in KSA

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• A) Any health professional
• B) A non-Saudi pharmacist with experience
• C) Only the pharmacy director
• D) A Saudi pharmacist or Saudi pharmacy technician designated by name

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• A) 3 days
• B) 15 days
• C) Specified by MOH regulations - typically valid for a short defined period (e.g., 7-30 days depending on the substance)
• D) 1 year like any prescription

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• A) The pharmacist's preference
• B) The principle of single dispensing - narcotic prescriptions cannot be refilled
• C) Only applicable for Schedule I drugs
• D) Only applicable in private pharmacies

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• A) Ministry of Commerce
• B) Saudi Customs alone
• C) MOH only
• D) SFDA with a valid import license

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• A) Only register the product with SFDA
• B) Obtain GMP certification only
• C) Obtain SFDA registration for the product and comply with all narcotic manufacturing regulations including annual quantity approvals
• D) Only comply with MOH standards

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• A) Any licensed physician can prescribe unlimited quantities
• B) It can be prescribed on regular prescriptions
• C) Only oncologists can prescribe morphine
• D) It requires a special controlled substance prescription with specific data fields and is subject to quantity/duration limits

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SECTION 3: Pharmacy Practice & Licensing (Q46-70)

• A) SFDA
• B) MOH only
• C) Saudi Commission for Health Specialties (SCFHS)
• D) Ministry of Commerce

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• A) Any licensed physician
• B) A pharmacy technician
• C) A licensed pharmacist
• D) A nurse with prescribing authority

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• A) SFDA alone
• B) SCFHS alone
• C) Ministry of Commerce alone
• D) MOH (Health Affairs in the region) plus meeting all regulatory requirements

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• A) Dispense and document
• B) Ask the patient to get a new prescription
• C) Dispense only if the medication is OTC
• D) Refuse to dispense and report to the appropriate authority

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• A) Without a prescription if the pharmacist deems it appropriate
• B) Based on the patient's verbal request if they claim a physician consultation
• C) Only with a valid prescription from a licensed prescriber
• D) Based on previous prescription history

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• A) Use professional judgment and dispense the closest product
• B) Ask the patient what they think it says
• C) Contact the prescribing physician for clarification before dispensing
• D) Return the prescription without dispensing

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• A) Patient's passport number
• B) Pharmacist's signature
• C) Prescriber's name, signature, date, and patient information
• D) Insurance company name

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• A) Optional at the pharmacist's discretion
• B) Only required for controlled substances
• C) The responsibility of the physician, not the pharmacist
• D) A professional and legal obligation of the pharmacist

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• A) Is freely permitted without restriction
• B) Is completely prohibited
• C) Requires patient consent only
• D) Is regulated and requires prescriber approval unless the prescription specifically allows substitution

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• A) Dispense and add a warning label
• B) Refuse to dispense without explanation
• C) Ask the patient to return later
• D) Contact the prescriber, inform the patient, and document the intervention

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• A) Therapeutic drug monitoring (TDM)
• B) Drug information services
• C) Pharmacokinetic dosing consultations
• D) Independently diagnosing and treating disease

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• A) The patient's personal notebook
• B) Any available paper
• C) The official medication administration record (MAR) and pharmacy dispensing records
• D) Only in the physician's notes

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• A) Only a verbal warning
• B) No action if the error was unintentional
• C) Civil liability only
• D) Professional disciplinary action by SCFHS, civil liability, and potentially criminal liability

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• A) Dispense it as it is OTC globally
• B) Dispense and document
• C) Refuse and explain that it requires a prescription in Saudi Arabia
• D) Refer to SFDA for guidance immediately

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• A) Diploma in pharmacy (2 years)
• B) Associate degree
• C) Bachelor of Pharmacy (B.Pharm) or Doctor of Pharmacy (PharmD)
• D) Any healthcare degree with pharmacy training

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• A) Only show their home country license
• B) Contact the Ministry of Commerce
• C) Only pass the SCFHS exam
• D) Register with SCFHS, obtain classification, pass required examinations, and obtain a work visa/iqama

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• A) Counseling patients on OTC medications
• B) Providing drug information
• C) Dispensing a prescription drug without a valid prescription
• D) Recommending generic substitution with prescriber consent

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• A) Individual employers
• B) SFDA
• C) SCFHS
• D) Saudi Pharmaceutical Society

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• A) Only dispensing medications efficiently
• B) Administering medications to patients
• C) Managing the pharmacy's finances
• D) Patient-centered practice aimed at achieving definite therapeutic outcomes and improving quality of life

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• A) Ignore it as it is not the pharmacist's problem
• B) Stop dispensing all the patient's medications
• C) Dispense all and just counsel the patient
• D) Review the medications, counsel the patient, and contact the prescribers as appropriate

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• A) Discounted and sold before disposal
• B) Returned to the supplier without documentation
• C) Mixed with current stock if the expiry is minor
• D) Immediately removed from dispensing stock, quarantined, and disposed of per SFDA/MOH procedures

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• A) Maximize pharmaceutical industry profits
• B) Import all drugs from a single country
• C) Eliminate generics from the market
• D) Ensure availability, affordability, and appropriate use of essential medicines

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• A) 24-hour pharmacy service is optional
• B) Only physician approval is needed
• C) Pharmacist presence is optional after hours
• D) Compliance with Central Board for Accreditation of Healthcare Institutions (CBAHI) or JCI standards

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• A) Increase drug sales
• B) Only report to the physician
• C) Avoid any patient interaction
• D) Conduct medication reviews and identify opportunities for deprescribing to optimize therapy

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• A) Completely prohibited
• B) Only allowed in research settings
• C) Freely permitted without any documentation
• D) Permitted when clinically justified, with proper informed consent and documentation

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SECTION 4: Professional Ethics & Conduct (Q71-95)

• A) Acceptable if the gift is small
• B) Standard industry practice
• C) Acceptable if disclosed to the employer
• D) A conflict of interest and violation of professional ethics

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• A) Information can be shared with family freely
• B) Prescription data can be shared with marketing companies
• C) Patient information is only confidential in hospitals
• D) All patient information must be kept strictly confidential unless disclosure is legally required or the patient consents

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• A) Insist the patient take the medication
• B) Tell the patient their concern is unfounded
• C) Refuse to help further
• D) Respect the patient's religious beliefs and explore alternative formulations or halal-certified products

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• A) Autonomy
• B) Justice
• C) Non-maleficence
• D) Beneficence

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• A) Beneficence
• B) Justice
• C) Autonomy
• D) Non-maleficence

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• A) Dispense but express their disapproval
• B) Never allow conscientious objection
• C) Simply refuse without any alternative
• D) Refer the patient to another pharmacist who can dispense the medication, ensuring patient access is not compromised

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• A) Signs a form before receiving any medication
• B) Must have a guardian's consent for all medications
• C) Does not need to understand; signing is sufficient
• D) Understands the medication's purpose, side effects, and alternatives before agreeing to take it

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• A) Ignore it as a personal matter
• B) Tell the patients only
• C) Confront the colleague privately and forget about it
• D) Report the colleague to the appropriate authority (SCFHS/hospital management) to protect patient safety

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• A) Reporting all crimes to the police
• B) Maximizing drug company profits
• C) Providing care only to paying patients
• D) Fair distribution of healthcare resources and treatment of all patients equitably

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• A) Is perfectly ethical as it provides education
• B) Is required for professional development
• C) Is acceptable as the company benefits too
• D) May constitute a conflict of interest and should be carefully evaluated per professional ethics guidelines

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• A) Any healthcare professional upon request
• B) Family members to ensure medication compliance
• C) Insurance companies automatically
• D) Only authorized healthcare team members directly involved in the patient's care, with patient consent

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• A) Utilitarianism exclusively
• B) Purely secular bioethics
• C) Only Western bioethical principles
• D) Islamic medical ethics (based on Sharia principles: preservation of life, health, intellect, progeny, and wealth)

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• A) Ignore herbal products as they are natural
• B) Only document in the record
• C) Tell only the physician, not the patient
• D) Counsel the patient on the interaction and communicate the concern to the prescribing physician

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• A) Dispense without comment
• B) Refuse all future prescriptions
• C) Report to the police immediately without consultation
• D) Counsel the patient, consult the prescriber, and follow appropriate protocols including possible reporting if diversion is suspected

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• A) Asking for prescription clarification
• B) Refusing to dispense a forged prescription
• C) Counseling patients on proper medication use
• D) Dispensing controlled substances without a valid prescription, fraudulent documentation, or practicing while impaired

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• A) Always provide full counseling regardless of patient preference
• B) Skip counseling completely to respect autonomy
• C) Provide counseling only if the medication is new
• D) Respect the patient's autonomy while ensuring critical safety information is communicated, and offer written materials

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• A) Implement the change without telling the physician
• B) Refuse to dispense and document only
• C) Change the prescription to the correct dose
• D) Contact the physician, communicate the concern, and document the intervention

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• A) Comply to keep their job
• B) Comply but inform patients
• C) Quit without reporting
• D) Refuse to comply, as the obligation to patient safety and professional ethics supersedes employer instructions

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• A) The pharmacist decides what is best for the patient
• B) The physician's order always overrides patient choice
• C) Family members can make all decisions for adult patients
• D) Respecting the patient's right to make informed decisions about their own healthcare

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• A) Refuse to answer any questions
• B) Provide full clinical information only via written form
• C) Report the patient to the physician for asking
• D) Provide appropriate information, ensure proper pain management coordination with the care team, and if concerned about intent, consult the palliative care team

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• A) Patient consent is not required for clinical drug trials
• B) Institutional review board (IRB) approval is optional
• C) Placebo use is always unethical
• D) Any clinical research involving patients requires IRB/ethics committee approval and informed consent

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• A) Prohibited in Saudi Arabia
• B) Only allowed for senior pharmacists
• C) Always a conflict of interest
• D) Acceptable if conducted ethically with SFDA registration and patient consent

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• A) Autonomy
• B) Beneficence
• C) Justice
• D) Accountability

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• A) Always prohibited
• B) Mandatory for CE funding
• C) Completely unrestricted
• D) Acceptable only if disclosed and the content remains independent and unbiased

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• A) Beneficence
• B) Justice
• C) Autonomy
• D) Non-maleficence

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SECTION 5: Drug Pricing, Registration & Market Authorization (Q96-110)

• A) Can be sold at the manufacturer's desired price
• B) Can be sold with a temporary pricing
• C) Can only be dispensed in hospitals
• D) Cannot be marketed until SFDA approves the price

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• A) Free market pricing
• B) Manufacturer's suggested retail price
• C) Import cost only
• D) Reference pricing compared to other countries, cost of goods, and affordability considerations

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• A) Acceptable profit margin
• B) Legitimate market pricing
• C) Standard pharmacy markup
• D) A violation of SFDA pricing regulations subject to penalties

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• A) Antidepressants
• B) Blood pressure medications
• C) Herbal supplements
• D) None of the above - all pharmaceutical and health products require SFDA registration

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• A) Import it directly for the patient
• B) Order it without registration if approved elsewhere
• C) Tell the patient to buy it abroad
• D) Not dispense unregistered products - refer to the physician who may apply for special import authorization through SFDA

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• A) Reduce the number of drugs available
• B) Increase drug prices
• C) Limit generic drug entry
• D) Streamline and accelerate drug approval processes while maintaining safety and efficacy standards

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• A) Continue dispensing if the medication looks fine
• B) Quarantine the product and wait for more information
• C) Return to supplier without notifying anyone
• D) Immediately quarantine the batch, stop dispensing, notify the supplier and relevant authorities, and follow SFDA recall procedures

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• A) Only chemical similarity to the reference biologic
• B) Lower cost compared to the originator
• C) Same brand name as the reference
• D) Biosimilarity (analytical, non-clinical, and clinical comparative studies) to a reference biologic approved by SFDA

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• A) Maximizing pharmaceutical sales
• B) Minimizing all drug expenditure regardless of outcomes
• C) Only drug acquisition costs
• D) Evaluating the clinical and economic value of drug therapies to inform formulary and reimbursement decisions

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• A) SCFHS
• B) Saudi Pharmaceutical Society
• C) SFDA exclusively
• D) MOH with guidance from multiple stakeholders including SFDA

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• A) Have the same active ingredient but different indications
• B) Contain different active ingredients with same effect
• C) Are produced by the same manufacturer
• D) Contain the same active ingredient, same dosage form, route, and strength, meeting the same pharmacopeial standards

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• A) Saudi Arabia does not recognize international drug patents
• B) Generic drugs can be marketed before patent expiry
• C) Patent protection is unlimited in Saudi Arabia
• D) Saudi Arabia recognizes drug patent protection; generics cannot be marketed until patent expiry without Bolar exemption provisions

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• A) Use any available ingredients
• B) Only compound in hospital settings
• C) Not document the compounding process
• D) Follow SFDA compounding standards, use registered ingredients, maintain documentation, and compound only against a valid prescription or specific institutional need

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• A) Post-marketing surveillance
• B) Clinical trials only
• C) Price negotiation with SFDA
• D) Stability testing conducted during drug development and registration

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• A) Manufacturer's toll-free number only
• B) Only the brand name
• C) Price tag with no additional information
• D) Registration number, expiry date, batch number, storage conditions, in both Arabic and English

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SECTION 6: MOH Policies, Hospital Pharmacy & Patient Safety (Q111-130)

• A) BID (twice daily)
• B) PO (by mouth)
• C) U (for units) - which may be misread as "0" causing 10-fold dosing errors
• D) SL (sublingual)

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• A) Make labels easier to print
• B) Increase storage capacity
• C) Label expired medications
• D) Differentiate look-alike/sound-alike (LASA) medications to prevent dispensing errors

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• A) High cost
• B) Need for refrigeration
• C) Rare adverse effects
• D) Heightened risk of causing significant patient harm when used in error

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• A) Readily available in all medication carts
• B) Stocked in every ward for convenience
• C) Dispensed in unlabeled syringes
• D) Restricted to pharmacy, never stocked on wards - must be diluted before dispensing

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• A) Improving medication safety
• B) Correct patient identification before dispensing
• C) Reducing healthcare-associated infections
• D) Maximizing pharmaceutical company revenue

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• A) Only errors resulting in patient harm
• B) Only errors made by pharmacists
• C) Prescribing errors only
• D) Any preventable event that may cause or lead to inappropriate medication use or patient harm

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• A) WHO VigiBase directly
• B) MOH hotline only
• C) SCFHS reporting portal
• D) SFDA's National Pharmacovigilance Centre (Nafdac/SFDA ADR reporting system)

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• A) Only at hospital discharge
• B) Only on admission
• C) Only when a pharmacist is available
• D) At admission, transfer between care levels, and discharge

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• A) Managing pharmacy staff salaries
• B) Handling patient complaints
• C) Overseeing drug advertising
• D) Developing and maintaining the formulary, medication use policies, and promoting rational drug use

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• A) Reduces pharmacist workload
• B) Increases the number of drugs stocked
• C) Allows nurses to prepare doses
• D) Reduces medication errors, improves dose accuracy, and facilitates patient billing

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• A) Continue the prescription as ordered
• B) Increase the dose to compensate
• C) Stop the drug unilaterally
• D) Recommend TDM to the treating team and document the clinical pharmacist intervention

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• A) Only reporting to hospital administration
• B) Disclosure only if the patient demands it
• C) No mandatory disclosure
• D) Transparent disclosure to the patient and family when a medical/medication error causes harm

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• A) Excessive caution
• B) Financial mismanagement
• C) Poor customer service
• D) Appropriate professional behavior, as inducements for prescription drug use are unethical

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• A) Annual drug inventory review
• B) Financial audit of drug spending
• C) Review of drugs near expiry
• D) Ongoing, authorized, and prospective or retrospective review of drug therapy to ensure appropriate use

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• A) Room temperature storage is acceptable for all vaccines
• B) Any refrigerator can be used for vaccine storage
• C) Vaccines can be stored with food products
• D) Dedicated pharmaceutical-grade refrigerator maintaining 2-8°C, with temperature monitoring and no food/other items

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• A) Selling antibiotics to patients
• B) Dispensing all antibiotics without restriction
• C) Only documentation of antibiotic use
• D) Reviewing antibiotic prescriptions, recommending de-escalation, IV to oral conversion, and optimal dosing based on cultures and sensitivity

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• A) A break for pharmacy staff
• B) Time limit for drug administration
• C) Delay before IV drug preparation
• D) A verification pause before administering high-risk medications to confirm right patient, drug, dose, route, and time

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• A) Reduce workload for physicians
• B) Save documentation time
• C) Allow pharmacists more autonomy
• D) Prevent errors that occur with verbal orders for high-alert oncology medications

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• A) No relevance as it is experimental
• B) Only relevant for research pharmacists
• C) Applies only to oncology medications
• D) Using genetic information to personalize drug selection and dosing for optimal therapeutic outcomes and minimal adverse effects

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• A) Right patient, right drug, right dose, right time, right cost
• B) Right drug, right dose, right form, right speed, right time
• C) Right patient, right drug, right dose, right route, right pharmacist
• D) Right patient, right drug, right dose, right route, right time

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SECTION 7: Saudi Health System, SCFHS & Professional Licensing (Q131-150)

• A) Resident
• B) Specialist
• C) Consultant
• D) Professor (academic rank, not an SCFHS clinical classification)

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• A) Automatic registration based on Arab world qualification
• B) No registration needed for Arab nationals
• C) Direct employment without examination
• D) Credential verification, SCFHS classification, and passing the Saudi Pharmacy Licensing Examination (SPLE)

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• A) Decrease the number of pharmacists
• B) Replace pharmacists with automated systems
• C) Limit pharmacy services to dispensing only
• D) Enhance pharmaceutical care quality, increase Saudi pharmacist numbers, and integrate pharmacy into healthcare teams

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• A) Reducing pharmacy education programs
• B) Eliminating private pharmacy sector
• C) Centralizing all pharmaceutical decisions
• D) Improving medication safety indicators, expanding pharmaceutical care services, and increasing pharmacist participation in clinical teams

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• A) A minor administrative issue
• B) Acceptable if renewing soon
• C) Only a financial penalty matter
• D) Illegal practice without a valid license, subject to serious legal and professional penalties

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• A) Saudi nationality
• B) Minimum 5 years of experience
• C) Recommendation from a physician
• D) Valid pharmacy degree from an accredited institution and SCFHS eligibility approval

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• A) Any licensed physician
• B) A senior administrator
• C) An MOH-appointed non-pharmacist
• D) A licensed pharmacist with relevant qualification and experience

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• A) Banning all foreign pharmacists
• B) Having no impact on pharmacy staffing
• C) Only affecting pharmacy management positions
• D) Requiring healthcare facilities to meet specified percentages of Saudi national pharmacists and technicians in their workforce

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• A) SFDA
• B) The ministry of their home country
• C) Saudi Embassies abroad
• D) SCFHS for credential evaluation and equivalency assessment

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• A) Only covering government employees
• B) Not applicable to healthcare
• C) Only covering procurement decisions
• D) Prohibiting bribery, conflict of interest, and corruption in both public and private healthcare settings

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• A) Replace pharmacists with AI dispensing
• B) Only track narcotic prescriptions
• C) Generate pharmacy revenue reports
• D) Integrate prescribing, dispensing, and patient records across the healthcare system to improve safety and efficiency

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• A) Drug pricing decisions
• B) Pharmacist licensing
• C) Drug manufacturing approval
• D) Overseeing narcotic and psychotropic substance policies, allocations, and monitoring at the national level

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• A) Pharmacists are not required in PHCs
• B) PHC pharmacists cannot provide medication counseling
• C) Prescription review is optional in PHCs
• D) Pharmacists in PHCs provide dispensing, counseling, medication management, and health promotion services

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• A) The right to choose any drug without prescription
• B) The right to refuse pharmacist counseling permanently
• C) Right to medication without informed consent
• D) The right to be fully informed about their medications, the right to refuse treatment, and confidentiality of health information

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• A) Include no clinical data
• B) Be approved by the manufacturer only
• C) Not reference SFDA registration status
• D) Be approved by SFDA, contain accurate clinical information, and not be misleading

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• A) Antibiotic stewardship
• B) Vaccine cold chain
• C) OTC drug pricing
• D) Cytotoxic drug handling, preparation safety, and SFDA special authorization requirements for oncology agents

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• A) Recommend the most potent OTC cough syrup
• B) Recommend an antibiotic syrup
• C) Recommend an adult cough syrup in a smaller dose
• D) Advise against OTC cough suppressants in children under 2, recommend honey-based preparations if appropriate, and suggest physician consultation for persistent cough

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• A) Maximizing drug prescribing
• B) Using the most expensive available drug
• C) Self-medication with prescription drugs
• D) Prescribing and dispensing the right drug, at the right dose, for the right duration, to the right patient, at the right time and cost

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• A) Defend the other pharmacist automatically
• B) Ignore the complaint as it is not their pharmacy
• C) Report the other pharmacist to SFDA
• D) Counsel the patient appropriately now, and advise them they can report concerns to SCFHS or MOH patient relations department

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• A) Expanding clinical pharmacy roles in hospitals
• B) Integrating pharmacists into multidisciplinary teams
• C) Developing telepharmacy and digital health services
• D) Restricting pharmacy practice exclusively to dispensing functions

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Quick Reference Summary of Key Saudi Pharmacy Regulatory Bodies

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• SFDA established: 2003
• Drug registration validity: 5 years
• Narcotic prescription: single use, no refills
• Labels: Arabic + English (mandatory)
• Narcotic custodian: must be Saudi national
• Traveler's personal medication: max 1-month supply with SFDA permit
• Pharmacy director: must be a licensed pharmacist

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What Those 150 MCQs Cover Well

• Saudi laws and regulations (SFDA, MOH, SCFHS)
• Controlled substances/narcotic rules
• Professional ethics
• Drug registration and pricing
• Patient safety standards

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What the Full SPLE Actually Tests

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Realistic Estimate

• The SPLE typically has 200-250 questions total across all domains
• Laws/Regulations/Ethics is roughly 10-15% of the exam (20-40 questions in the actual exam)
• You would need roughly 1,000-1,500 total MCQs across all domains to be adequately prepared

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What You Should Do Next

1. Treat those 150 as your complete laws & ethics bank - they are thorough for that domain
2. Add clinical pharmacotherapy MCQs - this is the largest and hardest domain
3. Practice pharmacokinetics and calculations - always heavily tested
4. Use NAPLEX-style question banks as a base, then adapt to Saudi-specific guidelines
5. Review Saudi-specific clinical guidelines - MOH treatment protocols for diabetes, hypertension, infections

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Bottom Line

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Saudi MOH Clinical Guidelines Review

Complete Study Reference for the Saudi Pharmacy Licensing Examination (SPLE)

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PART 1: DIABETES MELLITUS

Saudi Diabetes Clinical Practice Guidelines (SDCPG)

Screening & Diagnosis

• All adults aged ≥ 40 years
• BMI ≥ 25 kg/m² with any risk factor (family history, HTN, dyslipidemia, GDM history, PCOS)
• Annual screening for pre-diabetics

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Glycemic Targets (Saudi DCPG)

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Pharmacotherapy Algorithm (Saudi MOH)

• Metformin - first-line drug of choice for T2DM unless contraindicated
• Start at 500 mg once or twice daily with meals; titrate to 2000-2550 mg/day
• Contraindicated in eGFR < 30 mL/min/1.73m²

• If patient has established cardiovascular disease (CVD): add SGLT2 inhibitor or GLP-1 RA regardless of HbA1c
• If patient has chronic kidney disease (CKD): preferred agents = SGLT2 inhibitors (empagliflozin, dapagliflozin)
• If patient has heart failure (HF): SGLT2 inhibitors are strongly preferred
• If weight loss needed: GLP-1 RA preferred (semaglutide, liraglutide)

• Metformin + SGLT2 inhibitor (empagliflozin, dapagliflozin, canagliflozin)
• Metformin + GLP-1 RA (semaglutide, liraglutide, dulaglutide)
• Metformin + DPP-4 inhibitor (sitagliptin, saxagliptin, vildagliptin)
• Metformin + Sulfonylurea (glimepiride, gliclazide) - low-cost option
• Metformin + Insulin (basal)

• If HbA1c > 10% or symptomatic hyperglycemia: initiate insulin promptly
• Basal insulin: glargine or detemir (once daily, bedtime)
• Starting dose: 10 units/day or 0.1-0.2 units/kg/day
• Titrate by 2 units every 3 days until fasting glucose 4.4-7.2 mmol/L

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Key Drug Classes - Saudi Formulary Focus

• Mechanism: Decreases hepatic glucose production, improves insulin sensitivity
• Main side effect: GI upset (nausea, diarrhea) - take with food
• Serious: Lactic acidosis (rare) - hold before contrast media/surgery
• Dose reduction at eGFR 30-45; stop at eGFR < 30

• Mechanism: Block glucose reabsorption in proximal tubule → glycosuria
• Benefits: Reduce HbA1c, weight, BP; reduce CV events and hospitalization for HF
• Key side effects: UTI, genital mycotic infections, DKA (rare), volume depletion
• Contraindicated: eGFR < 30 (empagliflozin/canagliflozin), eGFR < 25 (dapagliflozin)
• Dapagliflozin also approved for CKD and HF with reduced ejection fraction

• Mechanism: Mimic GLP-1 → increase insulin, suppress glucagon, delay gastric emptying, reduce appetite
• Benefits: HbA1c reduction, weight loss (semaglutide most potent), CV protection (liraglutide, semaglutide)
• Side effects: Nausea, vomiting, diarrhea; pancreatitis (rare); thyroid C-cell tumors (contraindicated in MEN2 / personal/family history of MTC)
• Oral semaglutide (Rybelsus) available in Saudi Arabia

• Mechanism: Inhibit DPP-4 enzyme → increase endogenous GLP-1
• Weight neutral; low hypoglycemia risk
• Side effects: Nasopharyngitis, joint pain; rare pancreatitis
• Saxagliptin: avoid in HF (increased hospitalization)
• Dose adjustment required in renal impairment (except linagliptin - hepatic elimination)

• Mechanism: Stimulate pancreatic beta cells to release insulin
• Side effects: Hypoglycemia (most common), weight gain
• Glibenclamide (glyburide) - AVOID in elderly and renal impairment (long-acting, high hypoglycemia risk)
• Gliclazide MR preferred over glibenclamide in Saudi elderly patients

• Basal: Glargine (Lantus), Detemir (Levemir) - once daily
• Premixed: 70/30 NPH/Regular, 75/25 lispro mix
• Rapid-acting: Aspart, Lispro, Glulisine (with meals)
• Human insulin: Regular (soluble) - IV use in DKA, hyperglycemic crises

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Diabetic Complications Monitoring (Saudi MOH)

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Diabetic Emergencies

• Criteria: Blood glucose > 11 mmol/L + ketonemia/ketonuria + pH < 7.3 or HCO3 < 18
• Treatment: IV fluid (0.9% NaCl), IV regular insulin (0.1 units/kg/hr), potassium replacement
• Switch to oral insulin when: patient eating, pH > 7.3, anion gap closed
• Hold SGLT2 inhibitors (euglycemic DKA risk)

• Criteria: Blood glucose > 33 mmol/L, serum osmolality > 320, no/mild ketonemia
• Treatment: Aggressive IV hydration (0.9% NaCl), low-dose insulin, electrolyte correction

• Conscious patient: 15g fast-acting carbohydrate (glucose tablets, juice), recheck in 15 min ("15-15 rule")
• Unconscious: IV dextrose 25-50 mL of D50%, or IM/SC glucagon 1 mg

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PART 2: HYPERTENSION

Saudi Heart Association / MOH Hypertension Guidelines (2023 Update)

Classification (Saudi/International Aligned)

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Treatment Targets (Saudi HTN Guidelines)

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First-Line Antihypertensive Agents (Saudi Guidelines)

1. ACE Inhibitors (ACEi) - e.g., enalapril, ramipril, perindopril
2. Angiotensin Receptor Blockers (ARBs) - e.g., losartan, valsartan, telmisartan
3. Dihydropyridine Calcium Channel Blockers (CCBs) - e.g., amlodipine, nifedipine
4. Thiazide/Thiazide-like Diuretics - chlorthalidone, indapamide preferred over hydrochlorothiazide

• ACEi + ARB combination: avoid (dual RAAS blockade - increased renal failure, hyperkalemia risk)
• Beta-blockers: avoid as monotherapy in uncomplicated HTN unless compelling indication
• ACEi: contraindicated in pregnancy (teratogenic - fetotoxic)
• ARBs: contraindicated in pregnancy
• Aldosterone antagonist (spironolactone) + ACEi/ARB: monitor potassium closely (hyperkalemia)

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Stepwise Treatment (Saudi Guidelines)

• Add spironolactone 25-50 mg/day (preferred 4th agent)
• Alternatively: eplerenone, beta-blocker, alpha-blocker, centrally acting agent (clonidine)

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Hypertensive Emergencies (Saudi MOH)

• IV agents: labetalol IV, nicardipine IV, sodium nitroprusside, hydralazine IV
• Target: Reduce BP by 20-25% in first hour; do NOT lower rapidly (risk of ischemia)

• Oral agents, gradual BP reduction over 24-48 hours
• Restart/increase oral antihypertensives; avoid sublingual nifedipine (dangerous rapid drop)

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PART 3: DYSLIPIDEMIA

Saudi / MOH Lipid Management Guidelines

Lipid Targets by CV Risk (Saudi Guidelines)

• Triglycerides: < 150 mg/dL (1.7 mmol/L)
• HDL-C: > 40 mg/dL (men), > 50 mg/dL (women) - no specific drug target
• Non-HDL-C (very high risk): < 85 mg/dL (2.2 mmol/L)

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Pharmacotherapy for Dyslipidemia

• Highest intensity: Rosuvastatin 20-40 mg, Atorvastatin 40-80 mg
• Moderate intensity: Rosuvastatin 5-10 mg, Atorvastatin 10-20 mg, Simvastatin 20-40 mg
• Low intensity: Simvastatin 10 mg, Pravastatin 10-20 mg
• Side effects: Myopathy/rhabdomyolysis (check CK if muscle symptoms), hepatotoxicity (check LFTs)
• Contraindicated: Pregnancy, active liver disease
• Simvastatin: avoid with diltiazem, amlodipine, amiodarone (CYP3A4 - rhabdomyolysis risk)

• Ezetimibe 10 mg - inhibits intestinal cholesterol absorption; add to statin (IMPROVE-IT trial)
• PCSK9 Inhibitors (evolocumab, alirocumab) - inject SC every 2-4 weeks; for very high-risk patients not meeting targets on statin + ezetimibe; approved in Saudi Arabia

• Fibrates: Fenofibrate preferred (less interaction with statins than gemfibrozil)
• Omega-3 fatty acids: 2-4 g/day (icosapentaenoic acid / EPA)
• Avoid gemfibrozil + statin (increased myopathy/rhabdomyolysis risk)

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PART 4: INFECTIONS & ANTIMICROBIAL THERAPY

Saudi MOH / National AMR Action Plan 2022-2025

General Principles (Saudi ASP Guidelines)

• Antimicrobial Stewardship Programs (ASP) are mandatory in all Saudi hospitals
• Core elements: Physician/pharmacist ID leadership, pre-authorization, prospective audit, IV-to-oral conversion, de-escalation
• Saudi AMR Action Plan target: Reduce antimicrobial consumption by 20% by 2025

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Community-Acquired Pneumonia (CAP) - Saudi MOH

• Amoxicillin 500 mg TID x 5-7 days (first choice)
• OR Doxycycline 100 mg BID x 5-7 days (if atypical suspected)
• OR Azithromycin 500 mg day 1, then 250 mg x 4 days (if atypical suspected)

• Amoxicillin-clavulanate 875/125 mg BID + azithromycin/doxycycline
• OR Respiratory fluoroquinolone (levofloxacin 750 mg daily OR moxifloxacin 400 mg daily)

• Beta-lactam (ampicillin-sulbactam or ceftriaxone) + azithromycin
• OR Respiratory fluoroquinolone alone (levofloxacin or moxifloxacin)
• Duration: 5-7 days (if good clinical response)

• Beta-lactam (ceftriaxone or piperacillin-tazobactam) + azithromycin OR fluoroquinolone
• Add anti-MRSA coverage (vancomycin/linezolid) if MRSA risk factors present

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Urinary Tract Infections (UTI) - Saudi MOH

• Nitrofurantoin 100 mg (modified release) BID x 5 days (FIRST CHOICE)
• OR Trimethoprim-sulfamethoxazole (TMP-SMX) 160/800 mg BID x 3 days (if local resistance < 20%)
• OR Fosfomycin 3 g single dose
• Avoid fluoroquinolones for uncomplicated UTI (preserve for serious infections - Saudi ASP policy)

• Ciprofloxacin 500 mg BID x 7-14 days
• OR TMP-SMX BID x 14 days (if susceptible)

• IV ceftriaxone 1-2 g daily, then step-down to oral when clinical improvement
• If MDR suspected: piperacillin-tazobactam, carbapenem (per culture)

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Skin & Soft Tissue Infections (SSTI) - Saudi Guidelines

• Cephalexin 500 mg QID x 5-7 days (outpatient)
• IV cefazolin 1g TID (inpatient)
• Cover: Streptococcus (main pathogen)

• Incision and drainage (I&D) - primary treatment
• If systemic features: Add TMP-SMX 160/800 mg BID OR doxycycline 100 mg BID x 5-7 days (MRSA coverage)

• IV vancomycin (target trough 15-20 mcg/mL OR AUC/MIC 400-600)
• OR IV/PO linezolid 600 mg BID
• Daptomycin for bacteremia

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Surgical Site Infection (SSI) Prophylaxis (Saudi MOH)

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H. pylori Eradication (Saudi MOH)

• Bismuth quadruple therapy (14 days): PPI + bismuth subsalicylate + metronidazole + tetracycline
• OR Concomitant therapy (14 days): PPI + amoxicillin + clarithromycin + metronidazole

• Levofloxacin triple therapy: PPI + amoxicillin + levofloxacin x 14 days

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Common Organisms & Resistance Patterns in Saudi Arabia

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PART 5: ASTHMA (Saudi Initiative for Asthma - SINA 2024)

Diagnosis & Classification

SINA 2024 Severity Classification

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SINA 2024 Treatment Stepwise Approach

• SABA (salbutamol/albuterol) PRN only

• Low-dose ICS (budesonide 200-400 mcg/day OR beclomethasone 200-500 mcg/day OR fluticasone 100-250 mcg/day)
• Alternative: Leukotriene receptor antagonist (LTRA) - montelukast (less preferred)

• Low-dose ICS + LABA (budesonide/formoterol OR fluticasone/salmeterol)
• OR Medium-dose ICS alone

• Medium-high dose ICS + LABA
• Consider LTRA, theophylline as add-on

• High-dose ICS + LABA + refer to specialist
• Consider biologic therapy:
  • Omalizumab (anti-IgE) - allergic asthma with elevated IgE
  • Mepolizumab / Benralizumab (anti-IL-5) - severe eosinophilic asthma
  • Dupilumab (anti-IL-4/IL-13) - Type 2 severe asthma

• For patients on ICS-containing inhalers, as-needed budesonide/formoterol (AIR/SMART strategy) is now preferred over SABA-only reliever, even in mild asthma - reduces exacerbations

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Acute Severe Asthma / Status Asthmaticus

1. Oxygen: maintain SpO2 94-98%
2. Inhaled SABA: salbutamol 2.5-5 mg nebulized every 20 min x 3 (or MDI with spacer)
3. Ipratropium bromide 0.5 mg nebulized (add to SABA in severe attacks)
4. Systemic corticosteroids: prednisolone 40-50 mg oral OR hydrocortisone 100-200 mg IV
5. Heliox, IV magnesium sulfate 2g IV over 20 min (for life-threatening attack)
6. Mechanical ventilation if failing

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PART 6: COPD

GOLD/Saudi Guidelines for COPD

Pharmacotherapy (GOLD/Saudi)

• Influenza vaccine annually, pneumococcal vaccine (PCV13 + PPSV23)
• Smoking cessation (most important intervention)
• Pulmonary rehabilitation

• Short-acting bronchodilator PRN: SABA (salbutamol) or SAMA (ipratropium)

• Long-acting bronchodilator: LABA (formoterol, salmeterol, indacaterol) OR LAMA (tiotropium, umeclidinium)
• If persistent symptoms: LABA + LAMA combination

• LABA + LAMA (preferred dual bronchodilator)
• If blood eosinophils ≥ 300 cells/µL: Add ICS → triple therapy LABA + LAMA + ICS
• ICS monotherapy is NOT recommended in COPD

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PART 7: HYPOTHYROIDISM

Saudi / MOH Guidelines for Hypothyroidism

• Primary hypothyroidism: TSH elevated + low Free T4
• Subclinical hypothyroidism: TSH elevated + normal Free T4

• TSH goal: 0.5-2.5 mIU/L (most patients)
• Elderly: TSH 1-4 mIU/L (avoid over-treatment)
• Pregnancy: TSH < 2.5 mIU/L (first trimester), < 3 mIU/L (second/third trimester)

• Levothyroxine (T4) - drug of choice
• Starting dose: 1.6 mcg/kg/day (full replacement); 12.5-25 mcg/day in elderly/cardiac disease
• Take on empty stomach, 30-60 min before breakfast
• Recheck TSH after 6-8 weeks; adjust by 12.5-25 mcg increments
• Drugs that reduce levothyroxine absorption: calcium, iron, cholestyramine, PPIs, antacids (separate by 4 hours)
• Drugs that increase levothyroxine requirements: rifampicin, phenytoin, carbamazepine (enzyme inducers)

• IV levothyroxine 200-400 mcg loading dose, then 50-100 mcg/day
• IV hydrocortisone (give before T4 to prevent adrenal crisis)
• ICU monitoring

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PART 8: OBESITY (Saudi Guidelines 2024 Update)

Saudi Classification (WHO + Local Data)

Treatment (Saudi 2024 Obesity CPG)

• 500-750 kcal/day caloric deficit
• ≥ 150 min/week moderate-intensity aerobic activity
• Behavioral therapy

• Orlistat 120 mg TID with meals - inhibits pancreatic lipase; side effects: steatorrhea, fat-soluble vitamin deficiency; take fat-soluble vitamins 2 hours apart
• GLP-1 RA: Semaglutide 2.4 mg SC weekly (Wegovy) - approved for obesity in Saudi Arabia; liraglutide 3 mg (Saxenda)
• Phentermine-topiramate - limited use in Saudi Arabia
• Naltrexone-bupropion - limited availability

• Sleeve gastrectomy (most common in Saudi Arabia)
• Roux-en-Y gastric bypass
• Requires multidisciplinary team: surgeon, endocrinologist, nutritionist, psychiatrist, pharmacist

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PART 9: ACUTE CORONARY SYNDROME (ACS)

Saudi/ACC-AHA Aligned Protocols

• Primary PCI within 90 minutes of first medical contact (goal)
• Dual antiplatelet therapy (DAPT): Aspirin 325 mg loading + P2Y12 inhibitor (ticagrelor 180 mg OR prasugrel 60 mg; clopidogrel 600 mg if others not available)
• Anticoagulation: IV unfractionated heparin OR enoxaparin
• Thrombolysis: Alteplase or tenecteplase if PCI not available within 120 min

• Aspirin 300 mg + P2Y12 inhibitor (ticagrelor preferred over clopidogrel)
• Anticoagulation: fondaparinux preferred (lower bleeding, OASIS-5)
• Early invasive strategy within 24-48 hours

• DAPT: 12 months (aspirin + ticagrelor or clopidogrel)
• ACE inhibitor or ARB
• Beta-blocker
• High-intensity statin (atorvastatin 40-80 mg or rosuvastatin 20-40 mg)
• LDL target: < 55 mg/dL (very high risk)

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PART 10: HEART FAILURE

Saudi / ESC Aligned Heart Failure Guidelines

1. ACEi/ARB/ARNI (sacubitril-valsartan) - mortality reduction
2. Beta-blocker (carvedilol, metoprolol succinate, bisoprolol) - mortality reduction
3. MRA (spironolactone 25-50 mg or eplerenone) - mortality reduction
4. SGLT2 inhibitor (dapagliflozin or empagliflozin) - reduce HF hospitalization/CV death

• Replaces ACEi or ARB in HFrEF if tolerated
• Washout period of 36 hours required when switching from ACEi to prevent angioedema
• Do NOT combine ARNI with ACEi

• Furosemide (loop diuretic) - primary diuretic for fluid overload
• Target: euvolemia (no edema, no orthopnea)

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PART 11: COMMON INFECTIONS - QUICK REFERENCE

Antibiotic Selection Summary (Saudi Guidelines)

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PART 12: PAIN MANAGEMENT

Saudi MOH Analgesic Ladder (WHO-Based)

• Paracetamol (acetaminophen) 500-1000 mg every 4-6 hours (max 4g/day; 2g/day in liver disease)
• NSAIDs: Ibuprofen 400-600 mg TID; Naproxen 500 mg BID; Diclofenac 50 mg TID
• NSAIDs: Avoid in renal impairment, peptic ulcer, CVD, elderly; use lowest effective dose + shortest duration

• Weak opioids: Tramadol 50-100 mg every 4-6 hours (max 400 mg/day)
• Note: Tramadol is a controlled substance in Saudi Arabia
• Codeine 30-60 mg (with paracetamol)

• Strong opioids: Morphine (oral immediate-release: 5-10 mg every 4 hours)
• Oxycodone, fentanyl patch, hydromorphone
• All require controlled substance prescriptions in Saudi Arabia

• Saudi Arabia has expanded opioid availability for cancer pain (previously restrictive)
• Oral morphine: Drug of choice for moderate-severe cancer pain
• Use equianalgesic dosing when switching opioids

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KEY NUMBERS SUMMARY TABLE

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SAUDI-SPECIFIC CLINICAL PEARLS

1. Clarithromycin resistance is HIGH in Saudi Arabia - bismuth quadruple therapy preferred for H. pylori
2. Central obesity cut-offs are lower in Saudi/Arab populations (women 90 cm, men 100 cm) vs. Western guidelines (88/102 cm)
3. Fluoroquinolones are restricted in Saudi ASP programs for uncomplicated infections - preserve for serious use
4. Tramadol = controlled substance in Saudi Arabia (not treated as regular prescription)
5. SGLT2 inhibitors and GLP-1 RAs are now in Saudi MOH formulary and recommended for T2DM with CVD/CKD/HF
6. Saudization of narcotic custodians - must be Saudi national pharmacist/technician
7. ASP is mandatory in all Saudi hospitals - pharmacist role is core to the ASP team
8. Bariatric surgery (sleeve gastrectomy) is the most widely performed procedure in Saudi Arabia for obesity
9. Gestational diabetes is diagnosed at lower thresholds in Saudi Arabia due to high prevalence
10. SINA 2024 now recommends budesonide/formoterol as both controller AND reliever in mild-moderate asthma (replacing SABA-only reliever)

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