NPC BACHELOR IN PHARMACY EXAM SYALLABUS
Npc syllabus Bachelor in Pharmacy
Pharmaceutical analysis & instrumentation
·
Significant
figures, Rules for retaining significant digits, Types 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).
·
(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.
Community Pharmacy, Social Pharmacy and Public Health
Community
Pharmacy
·
Narcotics
management and record keeping.
·
Prescription
and prescription handling
·
Entrepreneurship
and business plan.
·
Good
Pharmacy practice
·
Patient
Care process in community pharmacy
·
Patient
communication and counseling.
·
New
role of community pharmacists.
·
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.
·
Descriptive
Studies (Case report, Case series and Ecological studies), Analytical Studies
(Case 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 Pharmacoepidemiology data.
·
Resources
for Drug Development
·
Input
and outcome in pharmacoeconomics
·
ECHO
model
·
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.
1.1.
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
·
Others
act relating to pharmacy practice (Consumer act, Narcotic act).
1.2. Laws relating to Industrial
Practice: Procedure for establishment of industry.
·
Procedure
for Product license.
·
Procedure
for sale and distribution of medicines.
·
Procedure
for import export of medicines.
·
Procedure
for marketing license.
·
Procedure
for advertisement.
·
Procedure
for establishment of pharmacy.
·
Procedure
for Clinical trial.
·
the
legal requirements for the sale and supply of medicines and controlled drugs
from pharmacies
·
The
implications and liability attached to the supply of licensed,
"off-label" or unlicensed medicines.
·
Label
and labeling requirements.
·
Procedure
for being a registered pharmacist
Clinical and Hospital Pharmacy
Hospital Pharmacy: Organization and Structure of hospital pharmacy
Drug and Therapeutic Committee:
·
Goals
and objectives of the DTC and 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
Manufacture of Sterile and Non-sterile Products
Handling of radioisotopes and radiopharmaceuticals.
Clinical
Pharmacy
Differentiating
minor illness from more serious disease
·
Symptoms
of conditions that require 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.
Pharmacognosy. Medicinal Chemistry and Natural Product Chemistry
1. History of Medicinal Chemistry and Drug
discovery. Physicochemical properties of drug molecules.
2. Biotransformation.
3. Prodrugs.
4. Phases of Clinical trials.
5. Introduction to QSAR and CADD.
6. Physicochemical properties, mechanism of action, structure activity relationship (SAR) of the following groups of Drugs:
6.1. Cholinergic and Anticholinergic Drugs
(Acetylcholine prototype, Carbachol, Neostigmine and similar drugs,
Organophosphate and Atropine prototype drugs.
6.2. Adrenergic and Antiadrenergics (Catechol
amines and other sympathomimetics), Alpha and Beta blockers.
6.3. Antihistaminic and Antiulcer (H1 and
H2 blockers with the examples of common drugs used in therapy.
6.4. NSAIDS (Salicylates, Pracetamol,
Ibuprofen, Diclofenac, Nimesulide, mefenamic acid).
6.5. Oxytocin, and Prostaglandins
6.6.
Steroids and other hormonal analogues: Glucocortocoides, Mineralocorticoides,
Estrogens (Estradiol, Diethylstilbestrol), Progesterone, including Oral
Contraceptives, Testesterone, Thyroid and antithyroid drugs, Insulin and Oral
Hypoglasemics.
6.7.
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 drugs: Aspirin, Dipyridamol, Streptokinase.
6.8.
Local anti-infective agents (Ethyl Alcohol, isopropyl alcohol, formaldehyde,:
phenols, cresol, hydrogen peroxide, povidone iodine, halozone, Chlorhexidine
gluconate, Gentian violet, Nitrofurazone, Merbromin. Salicylic acid and benzoic
acid).
6.9.:
Sulphonamides Sulphamethoxazole and trimethoprim, Sulphadimethoxin,
Sulfacetamide and silver sulphadiazine).
6.10.
Beta-lactam Antibiotics and Beta-lactam inhabitors
6.11.
Tétracycline and Chloramphenicol. 6.12. Aminoglycosides and macrolides
6.13.
Quinolones, Antituberculars and Antileprotics
6.14.
Antimalarials, Antiprotozaols, Antifungals, Antivirals, Antihelmentics and
Antineoplastics.
6.15.
Vitamins and enzymes
6.16.
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
1. Plant, Animal,
Microorganism and tissue culture as a source of drugs and pharmaceutical aids.
Traditional healer’s practices in Nepal.
2. Classification
of Crude drugs.
3. Role of Medicinal
& 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).
4. Adulteration of crude
drugs and their detection by organoleptic, microscopic, physical, chemical and
biological methods of evaluation. WHO guide lines of the standardization of
Herbal raw materials and finished products.
5. Plant metabolites:
primary & secondary metabolites & fundamental metabolic pathways–the
acetate, shikimate, mevalonate, and deoxyxylulose phosphate pathways.
6. ferent Plants are
containing Resins, Volatile oil, Glycoside and Alkaloid containing drugs.
7. 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. Drug Development from novel natural molecule.
8. 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.
Pharmacology and Therapeutics
Pathophysiology of Common Diseases:
1. Asthma, diabetes, rheumatoid arthritis, gout, ulcerative colitis, neoplasia, 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, Helmenthasis, Failariasis, Malaria, Polio, Kalazar and sexually transmitted diseases.
Fundamentals
of general pharmacology:
1.
Drugs acting on Peripheral Nervous System: Neurohumoral
transmission, Parasympathomimetics,Parasympatholytics, Sympathomimetics,
Adrenergic receptor and neuron blocking agents,Ganglion stimulants and blocking
agents, Neuromuscular blocking Agents, Local anesthetic Agents.
2.
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.
3.
Drugs 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-hyperlipedemic drugs, Drugs used in the therapy of
shock.
4.
Drugs acting on the Hemopoietic System: Hematinics,
Anticoagulants, Vitamin K and hemostatic agents, Fibrinolytic and anti-platelet
drugs, Blood and plasma volume expanders.
5.
Drugs acting on urinary system: Fluid and electrolyte
balance, Diuretics.
6.
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.
7.
Drugs acting on the Respiratory System: Anti-asthmatic drugs
including bronchodilators, Anti-tussives and expectorants, Respiratory
stimulants.
8.
Drugs acting on the Gastrointestinal Tract: Antacids,
Anti-secretory and Anti-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.
9.
Pharmacology of Endocrine System: Hypothalamic and pituitary
hormones, Thyroid hormones and anti-thyroid drugs, parathormone, calcitonin and
Vitamin D, Insulin, glucagons, incretins, oral hypoglycemic agents and insulin
analogs, ACTH and corticosteroids, Androgens and anabolic steroids, Estrogens,
progesterone and oral contraceptives, Drugs acting on the uterus.
10. Chemotherapy:
General Principles of Chemotherapy, Bacterial resistance; Sulfonamides and
cotrimoxazole,
11. Antibiotics- Penicillin's, 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 Anthelmintic. Chemotherapy of malignancy and immunosuppressive agents.
12. 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.
13. Basic
Concepts of Pharmacotherapy:
14. Clinical
Pharmacokinetics and individualization of Drug therapy, Drug delivery systems
and their Biopharmaceutic s & 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.
15. Important
Disorders of Organs, Systems and their Management:
16. Cardio-vascular
disorders- Hypertension, Congestive heart failure, Angina, Acute myocardial
infarction, Cardiac arrhythmias.
17. CNS
Disorders:Epilepsy, Parkinsonism, Schizophrenia, Depression.
18. Respiratory
disease-Asthma.Gastrointestinal Disorders-Peptic ulcer, Ulcerative colitis, Hepatitis,
Cirrhosis.
19. Endocrine
Disorders-Diabetes mellitus and Thyroid disorders.
20. Infectious
Diseases-Tuberculosis, Urinary tract infections, enteric infections, Upper
respiratory infections.
21. Hematopoietic
Disorders- Anemias, Joint and Connective tissue disorders- Rheumatic diseases,
Gout and Hyperuricemia.
22. Neoplastic
Diseases-Acute Leukaemias, Hodgkin's disease. Therapeutic Drug Monitoring,
Concept of Essential Drugs and Rational Drug use.
Pharmaceutical technology, biopharmaceutics & dosage form design
1.
Dehumidification and Humidity Control of an industry,
designing of dosage forms (Pre-formulation studies).
2.
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).
3.
Solubility Analysis: Stabilization and stability testing
protocol for various pharmaceutical products. ICH Guidelines for stability
testing of formulations. Ionization constant –PKa;
pH solubility profile and common ion effect –Ksp; effect of temperature;
Solubilisation; Partition Coefficient and dissolution.
4.
Stability Analysis: Stability in toxicology formulation;
Solution stability; PH rate profile ; solid state stability; bulk stability ;
compatibility studies with excipient.
5.
Study of chemical properties of drugs like hydrolysis,
oxidation, reduction, racemization, polymerization etc., and their influence on
formulation and stability of products.
6.
Manufacturing and Quality control of: Liquid Dosages Forms,
Semisolid Dosage Forms, Pharmaceutical Aerosols, Solid dosage forms, Ophthalmic
Preparations, Cosmetic Preparations, and Parenteral Products.
7.
Packaging of Pharmaceutical Products, Performance evaluation
methods of dosage forms (Dissolution, Bioavailability and Bioequivalence),
Industrial Hazards and Safety Precautions.
8.
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.
9.
GMP concept and its components, comparison of requirements of
WHO guidelines, US FDA guidelines, GLP concept and its components.
10. 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.
11. Quality
Audit (Types: 3rd Party Audit, 2nd Party Audit, 1st Party Audits, and 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.
12.
Pharmacokinetics of drug absorption (Zero
and First order kinetics), Compartment kinetics (Concepts and their importance
in the study of pharmacokinetics. One compartment 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.
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