Pharmacist License Exam Syllabus Nepal Pharmacy Council

Nepal Pharmacy Council License Exam Syllabus Pharmacist

Objective of the Name Registration Examination

The registration examination is designed to check the prerequisite knowledge and understanding required for effective professional practice of graduate pharmacist. In the examination he/she will be required to demonstrate the minimum knowledge and understanding of theoretical part as well as practical part by analyzing and evaluating practice-based problems.

The examination covers the following:

The examinable knowledge elements about the source, property, design and quality of medication used in pharmacy practice.
The examinable knowledge elements about the tools and equipment’s used for the quality control of medicines.
The examinable knowledge elements underpinning the clinical and pharmaceutical aspects of pharmacy practice.
The examinable knowledge elements underpinning the legal and professional practice of pharmacy in Nepal.

Pharmacology and Therapeutics

Pathophysiology of Common Disease:

Asthma, diabetes, rheumatoid arthritis, gout, ulcerative colitis, neoplasia (Leukemia, Breast Carcinoma, Cervical cancer), psychosis, depression, mania, epilepsy, acute and chronic renal failure, hypertension, angina, congestive heart failure, myocardial infarction, congestive heart failure, peptic ulcer, anemia, hepatic disorders, tuberculosis, urinary tract infections, Helmenthiasis, Filariasis, Malaria, Polio, Kalazar and sexually transmitted diseases.

Fundamentals of general pharmacology:

Drugs acting on Peripheral Nervous System: Neurohumoral transmission, Parasympathomimetic, Parasympatholytics, Sympathomimetics, Adrenergic receptor and Neuron blocking agents, Ganglion stimulants and blocking agents, Neuromuscular blocking Agents, Local anesthetic Agents.

Drugs acting on Central Nervous System: Neurohumoral transmission in the C.N.S., General Anesthetics, Alcohols and disulfiram, Sedatives, Hypnotics, Anti-anxiety agents and Centrally acting muscle relaxants,

Psychopharmacological agents: (anti-psychotics, Antidepressants, Anti-epileptics drugs, Anti-Parkinsonian drugs, Analgesics, Antipyretics, Narcotic analgesics and antagonists, C.N.S. stimulants, Drug Addiction and Drug Abuse.

Drug acting on Cardiovascular System: Drugs for congestive cardiac failure, Antihypertensive drugs, Anti-anginal and Vasodilator drugs, including calcium channel blockers and beta adrenergic antagonists, Antiarrhythmic drugs, Anti-hyperlipidemic drugs, Drugs used in the therapy of shock.

Drugs Acting on the Hemopoietic System: Hematinic, Anticoagulants, Vitamin K and hemostatic agents, Fibrinolytic and anti-platelet drugs, Blood and plasma volume expanders.

Drugs acting on urinary system: Fluid and electrolyte balance, Diuretics.

Autacoids: Histamine, Antihistaminic drugs, 5-HT- its agonists and antagonists, Prostaglandins, thromboxanes and leukotrienes, Angiotensin, Bradykinin and Substance P and other vasoactive peptides, nonsteroidal anti-inflammatory and anti-gout agents.

Drugs Acting on the Respiratory System: Anti-asthmatic drugs including bronchodilators, Anti-tussives and expectorants, Respiratory stimulants.

Drugs acting on the Gastrointestinal-Tract: Antacids; Anti-secretory and And-ulcer drugs, Laxatives and anti-diarrhoeal drugs, Appetite Stimulants and Suppressants, Emetics and anti-emetics, Miscellaneous: Carminatives, demulcents, protectives,adsorbents, astringents, digestants, enzymes and mucolytics.

Pharmacology of Endocrine System: Hypothalamic and pituitary hormones, Thyroid hormones and anti-thyroid drugs, parathormone, calcitonin and Vitamin D, Insulin, glucagons, Panncreatins, oral hypoglycemic agents and insulin analogs, ACTH and corticosteroids, Androgens and anabolic steroids, Estrogens, progesterone and oral contraceptives, Drugs acting on the uterus.

Chemotherapy: General Principles of Chemotherapy, Bacterial resistance; Sulfonamides and cotrimoxazole, Antibiotics- Penicillins, Cephalosporins, Aminoglycosides, Chloramphenicol, Macrolides, Tetracyclines, Quinolones, fluoroquinolones and miscellaneous antibiotics; Chemotherapy of tuberculosis, leprosy, fungal diseases, viral diseases, HIV and AIDS, urinary tract infections and sexually transmitted diseases, malaria, amoebiasis and other protozoal infections and Anthelmentics. Chemotherapy of malignancy and immunosuppressive agents.

Principles of Toxicology: Definition of poison, general principles of treatment of poisoning with particular reference to barbiturates, opioids, organophosphorous and atropine poisoning, Heavy metals and heavy metal antagonists.

Basic Concepts of Pharmacotherapy: Clinical Pharmacokinetics and individualization of Drug therapy, Drug delivery systems and their Biopharmaceutics & Therapeutic considerations, Drugs used during infancy and in the elderly persons (Pediatrics & Geriatrics), Drugs used during pregnancy, Drug induced diseases, The basics of drug interactions, General principles of clinical toxicology, Common clinical laboratory tests and their interpretation.

Important Disorders of Organs, Systems and their Management:

Cardio-vascular disorders: Hypertension, Congestive heart failure, Angina, Acute myocardial infarction, Cardiac arrhythmias.

CNS Disorders: Epilepsy, Parkinsonism, Schizophrenia, Depression.

Respiratory disease: Asthma.

Gastrointestinal Disorders: Peptic ulcer, Ulcerative colitis, Hepatitis, Cirrhosis.

Endocrine Disorders: Diabetes mellitus and Thyroid disorders.

Infectious Diseases: Tuberculosis, Urinary tract infections, Enteric infections, Upper respiratory infections.

Hematopoietic Disorders: Anemias

Joint and Connective tissue disorders: Rheumatic diseases,

Gout and Hyperuricemia.

Neoplastic Diseases: Acute Leukaemias, Hodgkin’s disease. Therapeutic Drug Monitoring

Concept of Essential Drugs and Rational Drug use.

Pharmacognosy, Medicinal Chemistry and Natural Product Chemistry

History of Medicinal Chemistry and Drug discovery. Physicochemical properties of drug molecules, Biotransformation, Prodrugs, Phases of Clinical trials, Introduction to QSAR and CADD, Physicochemical properties, mechanism of action, structure activity relationship (SAR) f the following groups of Drugs:

Cholinergic and Anticholinergic Drugs (Acetylcholine prototype, Carbachol, Neostigmine and similar drugs, Organophosphate and Atropine prototype drugs.

Adrenergic and Antiadrenergics (Catechol amines and other sympathomimetics), Alpha and Beta blockers.

Antihistaminic and Antiulcer (H1, and H2 blockers with the examples of common drugs used in therapy.

NSAIDs(Salicylates,Paracetamol,Ibuprofen, Diclofenac, Nimesulide, mefenamic acid). Oxytocin, and Prostaglandins

Steroids and other hormonal analogues:

Glucocortocoides, Mineralocorticoides, Estrogens (Estradiol, Diethylstilbestrol), Progesterone, including Oral Contraceptives, Testesterone, Thyroid and antithyroid drugs, Insulin and Oral Hypoglasemics.

Cardiovascular Agents: Cardiac glycosides (Digoxin), Glyceryl nitrate, Propranolol. Antihypertensive agents: Reserpine, Prazosin, Terazosin, Clonidine, Hydralazine, Sodium Nitroprusside, Minoxidil, Captopril, Enalapril, Losartan, Nifedipine.

Diuretics: Acetazolamide, Hydrochlorothiazide, Frusemide, Spironolactone and Mannintol.

Anticoagulants: Heparin and Warfarin

Antiplatelate: Aspirin, Dipyridamol, Streptokinase.

Local anti-infective agents (Ethyl Alcohol, isopropyl alcohol, formaldehyde,: phenols, cresol, hydrogen peroxide, povidone iodine, halogen, Chlorhexidine gluconate, Gentian violet, Nitrofurazone, Merbromine, Salicylic acid and benzoic acid). Sulphonamides Sulphamethoxazole and trimethoprim Sulphadimethoxin, Sulfacetamide and silver sulphadiazine). Beta-lactam Antibiotics and Beta-lactam inhibitors.

Tetracycline and Chloramphenicol.

Aminoglycosides and macrolides

Quinolones, Antituberculars and Antileprotics

Antimalarials, Antiprotozaols, Antifungals, Antivirals, Antihelmentics and Antineoplastics.

Vitamins and enzymes

Importance of inorganic compounds in pharmacy and medicine (Acidifying agents, Antacids, Protective and Adsorbents, Cathartics;), Intra- and Extra-cellular Electrolytes, Essential and Trace Elements, Topical Agents (Protective, Astringents and Anti-infectives).

Pharmacognosy and Natural Product Chemistry

Plant, Animal, Microorganism and tissue culture as a source of drugs and pharmaceutical aids. Traditional healer’s practices in Nepal.

Classification of Crude drugs.

Role of Medicinal and aromatic plants in National Economy. Medicinal plants occurring in various climatic zones of Nepal. Method of medicinal plant collection, preparation of herbarium and their storage. Complementary and Alternative system of medicine practices in Nepal (Ayurvedic, homeopathic, traditional Chinese, siddha system, unani system and Amchi system).

Adulteration of crude drugs and their detection by organoleptic, microscopic, physical, chemical and biological methods of evaluation. WHO guidelines of the standardization of Herbal raw materials and finished products.

Plant metabolites: primary & secondary metabolites & fundamental metabolic pathways-the acetate, shikimate, mevalonate, and deoxyxylulose phosphate pathways.

Different Plants containing Resins, Volatile oil, Glycoside and Alkaloid.

General methods associated with the phytochemical investigation of herbal drugs- Authentication of plant materials, various methods of extraction, general ideas of isolation, purification of the chemical constituents and characterization of isolated compounds.

Drugs Development from novel natural molecule.

Utilization and production of phytoconstituents such as Taxene, Resin, Alkaloids, Sennosides, Digitalis glycosides, Volatile oil and Polyphenolic compounds. Chemistry of Alkaloids and Glycosides.

Herb collection centers around Nepal.

Pharmaceutical analysis & instrumentation

Different techniques of pharmaceutical analysis, Preliminaries and definitions:

Type of errors, Mean deviation, Standard deviation, Statistical treatment of small data sets, Selection of sample, Precision and accuracy.

Fundamentals of volumetric analysis: Methods of expressing concentration, primary and secondary standards, Acid Base Titrations, Oxidation Reduction Titrations, Precipitation Titrations, Gravimetric Analysis, Non-aqueous titrations, Complexometric titrations, Diazotization titrations, Kjeldahl method of nitrogen estimation, Karl-Fischer aquametry, Chromatography (TLC, HPLC, GC, GC/MS, LC/MS).

The Theoretical Aspects, Basic Instrumentation, Elements of Interpretation of Spectra, and Applications (quantitative and qualitative) of the following analytical techniques:

(Ultraviolet and visible spectrophotometry, Fluorimetry, Infrared spectrophotometry, Nuclear Magnetic Resonance spectroscopy [proton technique only], Mass Spectrometry, Flame Photometry, Atomic Absorption Spectroscopy).

GLP, ISO 9000, ISO 17025, TQM, Quality Review and Quality documentation, Regulatory control, regulatory drug analysis, interpretation of analytical data, Validation, quality audit: validation of equipment, validation of analytical procedures.

Pharmaceutical technology, biopharmaceutics & dosage form design

Dehumidification and Humidity Control of an industry, designing of dosage forms (Pre-formulation studies).

Bulk characterization: Crystallinity and polymorphism, hygroscopicity, Fine particle characterization, Bulk density and study of powder flow properties (Carr’s index, Hausner index, Angle of Repose).

Solubility Analysis: Stabilization and stability testing protocol for various pharmaceutical products. ICH Guidelines for stability testing of formulations. Ionization constant – pKa; pH solu bility profile and common ion effect: Ksp; effect of temperature; Solubilisation; Partition Coefficient and dissolution.

Stability Analysis: Stability in toxicology formulation; Solution stability, pH rate profile; solid state stability; bulk stability; compatibility studies with excipients.

Study of chemical properties of drugs like hydrolysis, oxidation, reduction, recemization, polymerization and their influence on formulation and stability of products. Formulation development Liquid Dosages Forms, Semisolid Dosage Forms, Pharmaceutical Aerosols, Solid dosage forms, Ophthalmic Preparations, Cosmetic Preparations, and parenteral Products.

Manufacturing and Quality control of: Liquid Dosage Forms, Semisolid Dosage Forms, Pharmaceutical Aerosols, Solid dosage forms, Ophthalmic Preparations, Cosmetic Preparations, and Parenteral Products.

Packaging of Pharmaceutical Products, Performance evaluation methods of dosage forms (Dissolution, Bioavailability and Bioequivalence), Industrial Hazards and Safety Precautions.

GMP: Introduction, Relationship among Quality Elements (Quality Assurance, Good Manufacturing Practices (GMP) for Drugs and Quality control). Short description of Premises, Personnel and equipments. GMP regulation in Nepal including “Ausadi Utpadan Samhita”. Quality Assurance: Concept, function and organizational Approach.

GMP concept and its components, comparison of requirements of WHO guidelines, USFDA guidelines, GLP concept and its components.

Concept of ISO, difference of GMP guidelines with ISO. Concept of TQM, Quality Review and Quality Documentation. Validation, validation of equipment, validation of analytical procedures.

Quality Audit (Types: 3rd Party Audit, 2nd Party Audit, 1st Party Audits, Audit Categories: System Audit, Conformance Audit, Compliance Audit, Process Audit, Product Audit and Department Audit. Benefits of audit). Site Master File, GMP certification: Audit of Hardware, software and Practice.

Pharmacokinetics of drug absorption (Zero and First order kinetics), Compartment kinetics (Concepts and their importance in the study of pharmacokinetics. One component open model. Assessment of pharmacokinetic parameters from plasma and urine data after i. v. bolus, i. v. infusion, i. v. injection with loading dose and oral administration. Percent absorbed time plot and determination of absorption rates based on one compartment model. Introduction to ‘Two compartment model) ; Clinical Pharmacokinetics.

Clinical and Hospital Pharmacy: Test the knowledge elements underpinning the clinical and pharmaceutical aspects of pharmacy practice.

Hospital Pharmacy: Organization and Structure of hospital pharmacy

Drug and Therapeutic Committee

Goals and objectives of the DTC
Functions of DTC
Structure and organization of DTC

Managing Formulary Process

Formulary List/Essential Medicine List
Formulary Manual
Standard Treatment Schedule
Criteria in Medicine Selection

Drug Information Services

Assessing New Medicines
Primary/Secondary/Tertiary

Drug Store Management and Inventory Control

Drug Management Cycle
ABC analysis, Therapeutic Category analysis, VED analysis
Daily Defined Dose (DDD)
WHO/INRUD Drug use indicators

Drug distribution Systems in Hospitals

Inpatient and outpatient Application of computers in Pharmacy. Central Sterile Supply Unit and their Management

Clinical Pharmacy

Differentiating minor illness from more serious disease

Symptoms of conditions that required referral to a medical or other healthcare practitioner
Conditions not requiring referral and how they may appropriately be treated by non-prescription medicines, by short-term action that does not involve medication or by lifestyle change.

Non-prescription remedies

Actions and licensed uses of medicinal products available without prescription that are commonly used to treat minor ailments.

Pharmacovigilance, Adverse effects and drug interactions

Type of ADR and Drug Interactions
Causality and severity assessments
Drug-drug interactions, Drug-food interactions
The correct actions to take in response to a client reporting an adverse drug reaction, including the national reporting scheme in Nepal.

Interpretation of common test results

The normal ranges for blood pressure and key blood components

The normal ranges for key parameters of bodily function
The normal ranges for therapeutic blood levels of commonly used drugs with a narrow therapeutic index
The implications of figures outside these ranges
Selection of appropriate diagnostic or physiological testing techniques to inform clinical decision making

Patient data collection, data analysis and prescribing guidelines. Prescribing in Special Populations

Paediatric, Geriatric, Pregnant, breast feeding, Renal and Hepatic failure patients.

Requirements for the establishment of retail and whole sale drug store.

Community Pharmacy, Social Pharmacy and Public Health Community Pharmacy

1. Narcotics management and record keeping.
2. Prescription and prescription handling
3. Entrepreneurship and business plan.
4. Good Pharmacy practice
5. Patient Care process in community pharmacy
6. Patient communication and counseling
7. New role of community pharmacists.

Primary Healthcare

Healthcare management models
Healthcare delivery system in Nepal.
Elements, Principles, Implementation of PHC (in terms of WHO and government of Nepal).
Role of pharmacists in primary healthcare.

Research for Pharmaceutical sciences

Descriptive Studies (Case report, Case series and Ecological studies), Analytical Studies (Care control studies, Cohort studies), Experimental Studies (True experimental studies, Quasi experimental studies). Methods of quantifying drug interactions/ADR and adherence to drug therapy in pharmacoepidemiology).

Sources of Pharmacoepidemiological data.

Pharmacoeconomics

Pharmacoeconomics and Drug Development
Input and outcome in pharmacoeconomics
Cost (Direct, Indirect and Intangible)
Equity, Efficacy and effectiveness
Cost of Illness (COI), Cost Benefit Analysis (CBA), Cost Effectiveness Analysis (CEA), Cost Minimization Analysis (CMA), Cost Utility Analysis (CUA).
Discounting and sensitivity analysis.
Health Technology Assessments

Forensic Pharmacy (Pharmacy Law and Ethics)

Test the knowledge underpinning the legal and professional practice of Pharmacy.

Acts and Regulations Governing Pharmacy Practice in Nepal. Drug Act 2035
Drug Consultative Council and Drug Advisory Committee Regulation 2038
Drug Registration Regulation 2037
Drug Inquiry and Inspection Regulation 2040
Drug Standard Regulation 2043
Drug Manufacturing Code 2041
Nepal Pharmacy Council act 2057
WHO GMP
Other act relating to pharmacy practice (Consumer act, Narcotic act.)
Laws relating to Industrial Practice: Procedure for establishment of industry.