Saudi Pharmacist Licensure Examination (SPLE) Syllabus

The Saudi Pharmacist Licensure Examination is a comprehensive measure of knowledge in four major pharmacy content areas:

  • 10% – Basic Biomedical Sciences
  • 35% – Pharmaceutical Sciences
  • 20% – Social/Behavioral/Administrative Sciences
  • 35% – Clinical Sciences

1. Basic Biomedical Sciences

1.1 Physiology

1.1.1 Function of the major body systems and homeostatic impact at organ and system level

1.2 Biochemistry

1.2.1 Chemistry and utilization of bio-macromolecules including proteins, lipids, carbohydrates, nucleic acid, intermediary metabolism of energy and nutritional molecules

1.2.2 Enzymology and coenzymes and kinetics

1.2.3 Cell chemistry, signal transduction pathways

1.2.4 DNA and RNA science and protein synthesis

1.3 Microbiology Related to Human Diseases

1.3.1 Structure, function, and characteristics of microorganisms: microbe classification, structure, metabolism, genetics

1.3.2 Pathogenic microorganisms of humans: causative agents and transmission

1.4 Immunology

1.4.1 Innate and adaptive immunity

1.4.2 Principles of antibody actions

1.4.3 Hypersensitivity and types of reactions

1.4.4 Molecular genetics, genomic, proteomic, and metabolic principles that serve as a foundation for pharmacogenomics and the genetic basis of disease

2. Pharmaceutical Sciences

2.1 Medicinal Chemistry

2.1.1 Physicochemical properties of drugs in relation to drug absorption, distribution, metabolism, and excretion (ADME)

2.1.2 Chemical basis for drug action

2.1.3 Fundamental pharmacophores for drugs used to treat diseases

2.1.4 Structure-activity relationships in relation to drug-receptor interactions

2.1.5 Chemical pathways of drug metabolism

2.1.6 Applicability of structure activity relationship to make drug therapy decision

2.1.7 Drug development process

2.2 Pharmacology and Toxicology

2.2.1 Mechanisms of action of drugs of various categories including biologics

2.2.2 Pharmacodynamics and response

2.2.3 Classes of drugs, including individual agents and their approved indications

2.2.4 Adverse effects, side effects, contraindications and teratogenicity of drugs

2.2.5 Mechanisms of drug-drug interactions

2.2.6 Drug discovery and development

2.2.7 Acute and chronic toxicity, including drug and chemical overdose and antidotes

2.3 Pharmacognosy and Dietary Supplements

2.3.1 Concepts of crude drugs, semi-purified, and purified natural products

2.3.2 Classes of pharmacologically active natural products

2.3.3 Science of dietary supplements (vitamins, minerals, and herbals)

2.4 Pharmaceutics/Biopharmaceutics

2.4.1 Biopharmaceutical principles of drug delivery to the body via dosage forms: liquid, solid, semisolid, controlled release, patches, implants

2.4.2 Materials and methods used in preparation of drug dosage forms

2.4.3 Physicochemical properties relating to drug entities and dosage forms

2.4.4 Principles of drug and dosage form stability, including chemical degradation and physical instability

2.4.5 Principles of biotechnology and its application

2.4.6 Principles of drug dosage form administration

2.5 Pharmacokinetics

2.5.1 Basic principles of in-vivo drug kinetics (linear and nonlinear)

2.5.2 Principles of bioavailability and bioequivalence

2.5.3 Physiologic determinates of drug onset and duration, including disease and dietary influences on absorption, distribution, metabolism, and excretion

2.6 Sterile and Nonsterile Compounding

2.6.1 International Pharmacopeia guidelines on sterile and nonsterile compounding, hazardous drugs, and regulation of compounding.

2.6.2 Techniques and principles used to prepare dispense extemporaneous prescriptions and chemotherapy agents including labeling and dating of compounded dosage form.

2.6.3 Pharmaceutical calculations.

2.6.4 Sterile admixture techniques, including stability, clean-room requirements, sterility testing, and dating.

3. Social/Behavioral/Administrative Sciences

3.1 Health Care Delivery Systems and Public Health

3.1.1 Organization of health care delivery systems in the Kingdom of Saudi Arabia

3.1.2 Social, political, and economic factors that influence the delivery of health care in the Kingdom of Saudi Arabia

3.1.3 Public Health and Wellness: chronic disease prevention, health promotion, infectious disease control, demographics, physical, social, and environmental factors leading to disease, comparing and contrasting public health with individual medical care

3.2 Population-Based Care and Pharmacoepidemiology

3.2.1 Data sources and analytic tools that provide an estimate of the probability of beneficial or adverse effects of medication use in large populations

3.2.2 Application of epidemiological study designs to evaluate drug use and outcomes in large populations

3.2.3 Methods for continually monitoring unwanted effects and other safety-related aspects of medication use in large populations

3.2.4 Pharmacovigilance and medication safety

3.3 Pharmacoeconomics and Humanistic Outcomes of Health Care Delivery

3.3.1 Pharmacoeconomic analysis and its application to improve the allocation of limited health care resources

3.3.2 Humanistic outcomes and their application to improve the allocation of limited health care resources

3.4 Pharmacy Practice Management

3.4.1 Management principles (planning, organizing, directing, and controlling pharmacy resources) applied to various pharmacy practice setting and patient outcomes

3.4.2 Marketing of products and services: product versus service pricing, distribution, promotion

3.4.3 Accounting, budgeting and financial management

3.5 Pharmacy Law and Regulatory Affairs

3.5.1 Legal and regulatory principles applied to pharmacy practice: dispensing, professional services, drug use control

3.5.2 Administrative, civil, and criminal liability

3.5.3 Authority, responsibilities, and operation of agencies and entities that promulgate or administer laws, regulations, or guidance related to practice and prescription, controlled substances, and nonprescription medications

3.6 Biostatistics and Research Design

3.6.1 Research study designs used in medical research

3.6.2 Application and interpretation of statistical tests and data collection instruments

3.7 Ethical Decision Making

3.7.1 Principles of biomedical ethics

3.7.2 Ethical dilemmas in the delivery of patient, centered care including, conflicts of interest, end-oflife decision making, use of codes of ethics, oaths of the pharmacist

3.7.3 Research ethics

3.8 Professional Communication

3.8.1 Principles of communication abilities (appropriate verbal, nonverbal, visual, and written) with patient and caregivers, including empathetic communication and effective use of health literacy tools

3.8.2 Principles of communication abilities with other health care providers

3.8.3 Assertiveness and problem-solving techniques in relation to difficult social and professional conflicts and situations

3.8.4 Measurement and use of health literacy in pharmacy communications

3.8.5 Development of cultural competency in pharmacy personnel such that services are respectful of and responsive to the health beliefs, practices, and cultural and linguistic needs of diverse patient populations

3.9 Social and Behavioral Aspects of Pharmacy Practice

3.9.1 Application of behavior modification principles in health and illness behaviors of patients

3.9.2 Patient adherence to therapies and recommendations

3.10 Medication Dispensing and Distribution Systems

3.10.1 Systems for safe and effective preparation and dispensing of medications in all types of practice settings

3.10.2 Role of automation and technology: pharmacy informatics, information management

3.10.3 Continuous quality improvement programs or protocols in the medication-use process, including identification and prevention of medication errors, and establishment of error reduction programs

4. Clinical Sciences

4.1 Drug Information and Evidence-based Practice

4.1.1 Interpret and evaluate drug information and evidence based practice in the patient care decision-making process

4.1.2 Apply drug-information skills for the delivery of medication therapy management

4.1.3 Evaluate the reliability of various sources of information

4.1.4 Interpret guidelines as they apply in a clinical setting

4.1.5 Utilize basic science principles in the development and/or implementation of drug treatment protocols and clinical practice guidelines

4.2 Clinical Pharmacokinetics

4.2.1 Identify common drugs that require therapeutic drug monitoring and utilize appropriate monitoring pharmacokinetic parameters to avoid toxicity and maintain efficacy

4.3 Clinical pharmacogenomics

4.3.1 Utilize basic pharmacogenomics information to individualize drug therapy

4.4 Disease Prevention and Population Health

4.4.1 Recognize the proper use of non-pharmacologic therapies, including complementary and alternative medicines

4.4.2 Describe measures to promote wellness and disease prevention

4.4.3 Identify the role of immunizations in disease prevention and health promotion

4.5 Patient Assessment

4.5.1 Describe techniques for obtaining a comprehensive patient history

4.5.2 Describe how to perform patient physical assessments

4.5.3 Differentiate between normal physical assessment findings and modifications caused by common disease states and drug therapy

4.5.4 Identify and prioritize drug related problems

4.5.5 Interpret common clinical laboratory values and diagnostic tests

4.5.6 Perform calculations related to patient assessment

4.6 Clinical Pharmacology and Therapeutic Decision Making

4.6.1 Apply concepts of pathophysiology to clinical decision making

4.6.2 Make therapy recommendations based on dosage calculations, specific uses and indications of drugs and nutritional and support therapy

4.6.3 Assess pharmacotherapy considering contraindications, therapeutic duplications, dietary interactions, adverse drug reactions and interactions, and allergies

4.6.4 Triage and identify when to refer patients to other health professionals

4.6.5 Design patient-centered, culturally-relevant treatment plans

4.6.6 Apply evidence-based decision making to patient care

4.6.7 Recommend nonprescription and natural product therapies

4.6.8 Identify and manage drug side effects, toxicity, drug-induced diseases, and drug misuse or abuse

4.6.9 Monitor drug therapy for safety, effectiveness, non-adherence, misuse and/or abuse

4.6.10 Genetic Variants affecting drug action and metabolism, adverse drug reactions, and disease risk that influence the practice of personalized medicine

4.6.11 Counsel and educate patients in the different settings on all types of pharmaceutical agents to ensure safe and proper use of medications, storage and proper administration

4.6.12 Pharmacotherapy considerations in special populations such as neonates and pediatrics, pregnant women, lactating mothers and geriatrics

Note: The examination will emphasize certain parts of the outline, and no single examination will include questions on all aspects. Questions may include content that is not included in this outline.


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