M Pharm Syllabus Clinical 2017 Revission

Purbanchal University, Syllabus in M Pharm in Clinical Pharmacy, First Revision January 2017
1. Mission Statement
Purbanchal University mission is to contribute to the nation for providing graduate trained
pharmaceutical manpower through prescribed training program of M.Pharm, with Professional
Pharmaceutical education and effective competency to undertake the national task of meeting
social and pharmaceutical needs in clinical Pharmacy, Industrial Pharmacy, Patient Care,
Pharmaceutical Education and Research.
2. Aim and Objective
To produce a competent pharmacist professionals Research pharmacists with background
knowledge of various specializations of Pharmaceutical Science.
Master of Pharmacy in Clinical Pharmacy
Upon completion of the course, the candidate shall have Knowledge and understanding of the
practice of Clinical & Hospital Pharmacy to provide the pharmaceutical services to the patient
and community.
3. Admission
1. All the applicants for the Master of Pharmacy course must have passed the
Bachelor of pharmacy degree from a recognized university and with minimum of CGPA/ SGPA
2.5 or 50 % in aggregate with one year of Pharmacy practice experience ((for example work
experience in hospital or, community or industry, analytical lab, academia etc. ) and must pass the
entrance examination. The candidates will be admitted strictly in accordance with the merit
secured at the Entrance examination.
2. No admission/ readmission/ promotions to be made after two weeks of the
commencement of the classes in the semester.
2. A candidate admitted into Master of Pharmacy Post-Graduate Degree course in Purbanchal
University, shall submit the prescribed application form for registration duly filled along with
prescribed tuition fee.
The course structure and code numbers are revised as following table no. 3.3.
3.3.: Branch – C: Master of Pharmacy in Clinical Pharmacy

Credits Marks Allocated Total
Theory Practical
First Semester Interna Final Inter Final
l nal
MPHAR 614 - Biopharmaceutics and 3 +1= 4 20 80 25 25 150
Pharmacokinetics
MPHAR 616 : Pathophysiology 3 +1= 4 20 80 25 25 150
MPHAR 617: Principles of Pharmacology and 3 50 100 ---- ---- 150
Toxicology
MPHAR 618: Clinical Pharmacy I 3 +1= 4 20 80 25 25 150
MPHAR-619: Hospital Pharmacy I 3 +1= 4 20 80 25 25 150
19 Credits
Seminar as part of MPHAR 617/618/619 750
practical
Second Semester
MPHAR 620: Novel Drug Delivery System 2 10 40 25 25 100
and Pharmaceutical products
MPHAR 621: Pharmacotherapeutics - I 3 +1= 4 20 80 25 25 150
MPHAR 622: Biostatistics and Clinical 3 20 80 25 25 150
Research
MPHAR 623: Clinical Pharmacy II 3 +1= 4 20 80 25 25 150
MPHAR 624 : Hospital and Community 3+1= 4 20 80 25 25 150
Pharmacy
MPHAR 625: Pharmaceutical Jurisprudence 2 10 40 50
practical
19 Credits
Clinical clerkship (practical for MPHAR
621/623/624 ( 3 credits )
Third Semester
MPHAR 630: Pharmacotherapeutics - II 3 +1= 4 20 80 25 25 150
MPHAR 631: Clinical Pharmacy III 3 +1= 4 20 80 25 25 150
MPHAR 632- Dissertation Synopsis 2 - - 50 50 100
MPHR 633: Pharmacoepidemiology and 2 10 40 -- -- 50
Pharmacoeconomics
12 Credits 450
Clinical clerkship (practical for MPHAR 630,
MPHAR 631) ( 2 credits)
Fourth semester
MPHAR 640A : Project Dissertation 8 - - 300 - 300
MPHAR 640B : Article writing 2 - - 50 50
MPHAR 640C: Defense (Viva-voice) 2 - - - 50 50
12 Credits 400
Total Credits hours 62 credits 2350
4. Seminars
The candidate for Master of Pharmacy course will have to give seminar in each semester.
 First Semester: Seminar topics to be selected from the papers of specialization (Clinical
Pharmacy, Pharmacotherapeutics) as 25 % practical examination.
 Second Semester: Seminar topics to be selected from the papers of specialization (Clinical
Pharmacy, Pharmacotherapeutics) as 25% practical examination. .
 Third Semester: Seminar on the introduction of dissertation (Thesis Synopsis 2 credits).
 Fourth Semester: Seminar will be on entire work of dissertation.
The candidate will have to give seminar with the help of audio visual aids. In case of first and
second semester’s seminar, 25 % of the internal practical marks will be allocated for seminar.
The evaluation of seminar will be based 50% on scientific content and 50% on presentation skill.
1. Nature, Duration and Structure of the Courses
The normal duration of the course is 2 years (4 semesters). In each of the first two semesters,
there shall be course work comprising minimum of 15 weeks of instruction and examination
preparation leave of one week. The part of the third semester will be allocated for instruction &
fourth semester shall be exclusively dedicated for dissertation. The maximum duration of the
course shall be double the normal duration i.e. 4 years in special circumstances.
Each academic year consists of two semesters as mentioned above. Each specialization of the
Master of Pharmacy program will have a curriculum and course content (syllabi) for the subjects
recommended by the subject committee and approved by the Academic Council of the
Purbanchal University as mentioned in the scheme of instruction below. The course content of
the individual subjects, theory and practical, is expressed in terms of a specified number of
credits. The number of credits assigned to a subject depends on the number of contact hours
(lectures) per week. In general, credits are assigned to the subjects based on the contact hours
per week per semester. One credit of theory is equivalent to fifteen lecture hours. One credit of
practical or hospital internship is equivalent to minimum of 45 hours. The medium of instruction
(including examinations and project reports) shall be English. The assessment of the student’s
performance in each course will be based on continuous internal evaluation and semester-end
examinations. The allocation of marks for each of the component of assessment is indicated in
Table: 3.3.
2. Writing a Review Paper

The candidate for M. Pharm. course will have to write a review paper (in each semester (First,
second and Third)) related to the core course (as per below table) during first and second
semester. Students have to review the papers published in reputed international Journals using
“HINARI” or other data base. The papers will be evaluated by subject teacher as 25 % of end
semester practical examination of the respective subjects.
Semester M Pharm in Clinical Pharmacy

First Semester MPHAR 617 or MPHAR 618 or MPHAR 619
Second Semester MPHAR 621 or MPHAR 623 or MPHAR 624
3. Attendance, Assessment and Final Examination

The students must attend every lecture, seminar and practical classes. However, to accommodate
for sickness and other contingencies, the attendance requirement shall be a minimum of 75% of
the classes in any particular subject, otherwise s/he shall not be allowed to take the final
examination in that subject. In addition, to be eligible for final examinations, student must
compulsorily pass the internal assessments. Internal tests include the MCQs as well as long
answer and short answer questions. University conducts final examination at the end of each
semester. The procedure of final examination conduction will be as per the examination rules of
the university. The end-semester question model is in accordance with the model attached in
annex: I.
8. Dissertation
The topics for the dissertation shall be assigned by the Supervisor, a recognized Post-graduate
Teacher and/or visiting faculty, within two weeks of the beginning of third semester. Every
candidate presenting himself/herself for the M. Pharm. fourth semester examination is required
to submit two type written copies of the dissertation duly certified by the Supervisor. The
dissertation shall be sent to external examiner for evaluation. The candidate defense the
dissertation and he suggested corrections and suggestions of external examiner’s have to be
incorporated and final four copies has to be submitted to the University/college not later than
seven days of defense. The dissertation also needs to be certified by the Principal of the college
or HOD of Department of Pharmacy. The dissertation is to be submitted not before 23 months
from the date of commencement of first semester of M. Pharm Course. If candidate fails to
submit his/her dissertation within 27 months, he/she will have to submit dissertation in
subsequent semester. In case of affiliated colleges, the Principal of the concerned
College/Institute will forward the dissertation to the PUCMAS office.
So every candidate pursuing M. Pharm course is required to carry out work on a selected
research project under the guidance of a recognized postgraduate teacher and/or visiting faculty.
The results of such a work shall be submitted in the form of a dissertation. The dissertation is
aimed to train a postgraduate student in research methods and techniques. It includes
identification of the problem, formulation of a hypothesis, review of literature, getting
acquainted with recent advances, designing of a research study, experimental work and/or
collection of data, critical analysis, and comparison of results and drawing conclusions.
The dissertation should be written under the following headings:
1. Introduction 2. Aims or Objectives of study 3. Review of literature 4. Material and
Methods 5. Results 6. Discussion 7. Conclusion 8. Recommendation 9. References 10. Tables
11. Annexure.
The written text of dissertation shall be not less than 50 pages and shall not exceed 150 pages
excluding references, tables, questionnaires and other annexure. It should be neatly typed with
double line spacing on one side of the white paper (A4 size, 8.27" x 11.69") and bound properly
with black color cover. Spiral binding should be avoided. The dissertation shall be certified by
the supervisor and co-supervisor if any, Head of the Department and Head of the Institution. The
dissertation shall be submitted at least one month before the end of fourth semester.
Three copies of the dissertation duly recommended by the Guide supervisor, to the Head of the
Department for evaluation by the external examiner nominated by Purbanchal University, one
month before the final defense notified.
The evaluation scheme will be as shown in tablet 6 and evaluation sheet is attached in Annex-
IV.
9. Viva-voce Examination
The Viva-Voce examination shall aim at assessing the depth of knowledge, logical reasoning,
confidence and oral communication skills. The Viva-Voce examination shall be held
immediately after the defense of the dissertation. If any candidate fails to submit the dissertation
on or before the date prescribed, his/her Viva-Voce shall be conducted during the subsequent
examination, which shall not be earlier than six months from the date fixed in the first instance.
10. Examiners
There shall be at least two examiners, out of them one shall be external examiner and the other one
shall be the internal examiner. The internal examiner ordinarily is the supervisor.
11. Award of Class
Class 
Grading System
Percent of marks Letter grades Grade
value
90 and above A+ 4.00
80 and Below 90 A 3.75
70 and Below 80 B+ 3.50
60 and Below 70 B 3.00
50 and Below 60 C 2.50
40 and Below 50 D 1.75
Below 40 F
CGPA (Cumulative Grade Point Average) at the end of the degree defines the division which will be one of the
followings: CGPA definitions
CGPA Division
3.75-4.00 Excellence
3.50-Below 3.75 Distinctions
3.00- Below 3.50 First Divisions
2.5-Below 3.00 Second Division
2.0-Below 2.5 Pass
The CGPA of student must remain 2 or above throughout the duration of studies. A student who has
not obtained the minimum CGPA by the completion of all semester exams shall be allowed to take
betterment examination having lowest grade i.e. 'C' grade according to proposed grading system to
improve grade to make up the minimum CGPA.
The student will be allowed to sit for betterment exam after completion of all semester exams, according
to
The betterment examination application submitted by student and approval from the office of
examination management. The maximum duration for completion of the undergraduate program for a
student shall be three years more for three or four years
Course and two years more for two year course plus the duration of concerned academic program. It
shall be
counted from the last date of completing final exam of final semester/yearly exam. The student must
clear
all the course requirements, including all the provisions of evaluation scheme within this period.

First Semester Intern Final Internal Final

al
MPHAR 616: Pathophysiology 3 +1= 4 20 80 25 25 150
MPHAR 617:Basic Principles of 4 50 100 - - 150
Pharmacology and Toxicology
MPHAR 614 - Biopharmaceutics and 3 +1= 4 20 80 25 25 150
Pharmacokinetics
MPHAR 618: Clinical Pharmacy I 3 +1= 4 20 80 25 25 150
MPHAR-619: Hospital Pharmacy I 3 +1= 4 20 80 25 25 150
20 Credits 750
Seminar as part of MPHAR 617/618/619
practical
MPHAR 616T: Pathophysiology [45 hrs]

Scope
This course is designed to impart knowledge on the area of Pathophysiology.
Objectives
Upon completion of the course student shall be able to
 Understand the basic pathophysiology of different systems.
 Understand the causes and mechanisms of disease of different diseases.
 Understand the basic diagnostic tests.
Unit-1: Membrane Physiology, Nerve and Muscle (4 hrs)
Physicochemical properties of cell membrane, permeability & transport. Genesis of resting
membrane potential. Action potential. Contraction of skeletal and smooth muscles.
Unit-2: CNS and ANS (3 hrs)
General Introduction to neurophysiology. Neurohumoral transmission in CNS and ANS.
Pathophysiology of depression and Parkinsonism.
Unit-3: Blood (8 hrs)
Principles of hemopoiesis. Erythropoiesis. Fate of RBC‟s. Regulation of WBC production.

Functions of WBC. Immune system. Blood groups. Hemostasis and blood coagulation.
Pathophysiology of Jaundice and Anemia.
Unit-4: Cardiovascular System (7 hrs)
Properties of cardiac muscle. Action potential and spread of impulse in the heart. ECG. Cardiac
cycle. Neural regulation of cardiac activity. Cardiac output: measurement and regulation. Neural
control of circulation. Pathophysiology of Hypertension, Arrhythmia, Angina pectoris and
Cardiac failure.
Unit-5: Respiratory System (5 hrs)
Lung volumes and capacities. Mechanics of respiration. Exchange of gases in the lungs. O 2 CO2
carriage, dissociation curve. Neural regulation of respiration. Chemical regulation of respiration.
Pathophysiology of Pneumonia, Asthma, Hypoxia, Cyanosis and Dyspnoea.
Unit-6: Gastrointestinal System (8 hrs)
General Organization of G.I. tract. Motility, Nervous Control and Blood Circulation. Gastric
secretion, Biliary and pancreatic secretions. Digestion and Absorption. Pathophysiology of
Peptic Ulcer, Constipation and Diarrhea.
Unit-7: Endocrine System (4 hrs)
Various endocrine glands and their related disorders (Diabetes, Pituitary disorders, Thyroid and
parathyroid disorders, Adrenocorticotropic disorders).
Unit-8: Reproduction (4 hrs)

Male reproductive physiology. Female reproductive physiology. Hypothalamic – pituitary –
gonadal axis. Puberty. Pregnancy. Parturition and lactation.
Unit-9: Etiology and diagnosis of neoplastic diseases: (2 hrs)
Classification of tumors, Etiologic factors, Diagnosis of tumors and Treatment modalities.
MPHAR 616P: Pathophysiology practical

1. Demonstration of pathological slides of different diseases discussed in theory.
2. Discuss the common laboratory and diagnostic tests of above systems discussed in
Theory
3. Obtain a basic understanding of the need for various laboratory and diagnostic tests in the
diagnosis and treatment of disease.
References:
4. Robbins and Cotran Pathologic Basis of Disease –Kumar, Abbas, Fausto W.B. Saunders,
8th ed., 2010.
5. Harrison’s Principles of Internal Medicine, McGraw-Hill, latest Edition.
6. Textbook of Medical Physiology by A.C. Guyton, Saundersco. Londo
7. Text Book of Pathology by Harsh Mohan. Jaypee Brothers, New Delhi
8. Text Book of pathology. BN Dutta. Jaypee Brothers, New Delhi
9. Gould, B. E. Pathophysiology for the Health Professions 3rd ed., Philadelphia, PA,
Saunders Publishers, 2006.
MPHAR 617T: Basic Principles of Pharmacology and Toxicology [60 hrs]

Scope
This course is designed to impart knowledge on the area of Basic Pharmacology and Toxicology.
Objectives
Upon completion of the course student shall be able to
 Understand ADME.
 Understand the theories of Drug action.
 Understand the basic principles of Toxicology.
Unit-1: Drug Absorption (8 hrs)
Drug absorption: Gastrointestinal, Percutaneous and rectal kinetics and factors affecting drug
absorption from GIT, skin permeation and bioavailability
Unit-2: Drug distribution (4 hrs)
Plasma protein binding, Factors affecting plasma protein binding, Tissue binding, transfer of
drugs through biological barriers and their therapeutic implication in drug action.
Unit-3: Biotransformation (12 hrs)
Biotransformation of drugs, phase I and phase II metabolic reactions. Microsomal and non-
microsomal (enzymes). Example reactions.
Drug metabolism in liver, kidney, intestine and placenta. Drug metabolism in fetus and new
born. In-vitro and In-vivo studies in drug metabolism. Factors influencing drug metabolism:
Stereo-chemical and physico-chemical factors; Physiological factors (species difference, stain
difference, sex, age and environmental factors); Pathological states; Genetic factors.
Unit-4: Excretion of drugs (6 hrs)

Various organs for drug excretion, Mechanism of drug excretion from kidney, Factors affecting
renal excretion of drug. Elimination of drugs: Concept of hepatic and renal clearance of drugs,
biological half-life.
.Unit-5: Pharmacodynamics (20 hrs)

Theories of Drug action: Principles of drug action, ion channels, enzymes, Drug receptor theory:
Types of receptors: G-Proteins, Second messengers and gene therapy, Principle of drug design,
structure activity relationship of selected groups like opioid drugs, catecolamines, penicillin,
barbiturates, benzodiazepines.
Unit-6: General principles of toxicology (10 hrs)
History and scope of toxicology, Definition of poison, Mechanisms of toxicology, Risk
Assessment, Management of poisoning with particular reference to barbiturates, opioids, organ
phosphorous and atropine poisoning, heavy metals and heavy metal antagonists.
Reference
1. Biological standardization by J.H. Burn D.J. Finney and I.G. Goodwin
2. Indian Pharmacopeia and other Pharmacopeias
3. Screening methods in Pharmacology by Robert Turner. A
4. Evaluation of drugs activities by Laurence and Bachrach
5. Methods in Pharmacology by Arnold Schwartz.
6. Selected topics on the experimental pharmacology by Usha G.Karnal Dadkar, N.K and
Seth, U.K
7. Fundamentals of experimental Pharmacology by M.N.Ghosh
8. Pharmacological experiment on intact preparations by Churchill Livingstone

9. Drug discovery and Evaluation by Vogel H.G.
10. Animal models in toxicology by Shyane Cox Gad and Christopher .P Chengellis.
11. The UFAW hand book on the care and management of laboratory animals by UFAW.
12. Principles and methods of toxicology by Hayes.
13. CRC Hand book of toxicology by Derelanko and Holinger.
14. Intellectual Property rights, The WTO Intellectual property Rights and their Knowledge
Economy by Keith. E. Maskus.
Journals
1. Indian Journal of Pharmacology. 3. Indian Journal of Experimental Biology.
2. Indian Journal of Physiology and Pharmacology 4. Pharmacological research.
MPHAR 614 T- Biopharmaceutics and Pharmacokinetics [45 hours]

Scope
This course is designed to impart knowledge on the area of stability of drug products.
Objectives
Upon completion of the course student shall be able to:
 Understand the Bioavailability and Bioequivalence of Drug products.
 Understand the method development, validation and procedure to conduct the BA/BE
study.
 Understand the techniques of Interpretation of the BA/BE Data
Unit-1: Introduction (8 hrs).

Definition of Bioavailability, bioequivalence, generic drugs, types of BA, methods to
determine BA, Hatch max-man act 1971. Formulation factors affecting bioavailability of
drugs in dosage forms of tablets, capsules, parenterals, liquid orals and topical dosage forms.
DDA Regulations about BA/BE.
Unit-2: Application of Biopharmaceutics in BA/BE (15 hrs).
Biopharmaceutical aspects of absorption, distribution, metabolism and elimination, factors
influencing bioavailability of dosage forms, methods to determine BA/BE. Bioavailability of
highly variable drugs, narrow therapeutic index drugs and poorly soluble drugs. Methods for
enhancement of BA. Drug product selection, concept of orange book, need of BE studies,
generic drug product selection, study submission and drug review process
3. Ethical Issues involved in BA/BE studies Designing of protocol, rationale of the research,
selection of subjects. Construction, role and responsibilities of IRB/IEC. Helsinki
declaration.
Unit-3: Conduct of Study (5 hrs)
Design of the study, inclusion and exclusion criteria, sampling point, sampling volume,
treatment groups, Approaches to determine bioequivalence (21 CFR 320.24)
Unit-4: Interpretation of the Data (7 hrs)
Statistical methods used for the treatment of the data, Statistical software to treat the data
obtained from analysis, presentation of results and determination of conclusions.
Unit-5: Bioanalytical method development and validation for BA/BA studies. (10 hrs)
Introduction, sample preparation, column, method validation with ICH guidelines, upgraded
technologies like GC-MS, LC-MS. Application of RIA.
MPHAR 614P - Advanced Biopharmaceutics and Pharmacokinetics Practical

1. Dissolution studies of 3 marketed formulations (immediate, sustain release)
determination of drug release kinetics.
2. Measurement of bioavailability based on urinary data of commonly used 3 drugs in
clinic.
3. Practical’s based on biopharmaceutical aspects of drug formulations
(pharmacotechnical variables)
4. Preparation of model study protocol for BA/BE
5. Determination of similarity and dissimilarity factor Development of bioanalytical
method and validation of the same.
Reference
1. Milo Gibaldi & Donald Perrier. Pharmacokinetics, 1992, Marcel Dekker, New
York.
2. D.M. Brahmankar, S.B. Jaiswal. 1997, Biopharmaceutics & Pharmacokinetics - A
treatise. CBS Publications, New Delhi.
3. P.L. Madan. Biopharmaceutics & Pharmacokinetics, 2000, Jaypee publications,
New Delhi.
4. Gibaldi & Pancot. Handbook of clinical pharmacokinetics. 1992, Marcel Dekker.
5. Swarbrik. Biopharmaceutics. 1987, Lea & Febiger book publication. U. K
6. Dr. Tapan Kumar Pal, M. Ganeshan. Bioavailability and Bioequivalence in
Pharmaceutical Technology. CBS Publishers and Distributors.
7. Llyod r. Snyder, J. J. Kirkland, J. L. Glajch. Practical HPLC method development.
John Wiley & Sons
8. Peter G. Welling, Francis L. S. Tse, Shrikant V. Dighe. Pharmaceutical
Bioequivalence. Marcel Dekker Inc.
9. Jerry L. Hamelink, Peter F. Landrum, Harold L. Bergman, William H. Benson.
Bioavailability. Physical, chemical, and biological interactions. Lewis publishers.
10. DDA Regulations, MOHP, Government of Nepal.
11. Helsinki Declaration. World Medical Association.
12. The Analysis of Drugs in Biological Fluids, Joseph Chamberlain, CRC Press.
13. EMEA for Bioanalytical method validation.
14. Industrial guidelines for Bioanalytical method validation.
15. BA-BE guidelines for BA-BE studies as per USFDA (CFR).
16. Milo Gibaldi & Donald Perrier. Pharmacokinetics, 1992, Marcel Dekker, New
York.
17. D.M. Brahmankar, S.B. Jaiswal. 1997, Biopharmaceutics & Pharmacokinetics - A
treatise. CBS Publications, New Delhi.
18. Yadav A.V, Yadav V.B, Shete A.S, Experimental biopharmaceutics and
pharmacokinetics
19. www.fda.gov/cder/guidance/3618 , 8www.fda.gov/cder/guidance/2070DFT
20. www.iuphar.org/pdf/hum_55.pdf
21. www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-Id/bio/bio-
a_c
MPHAR 618T: Clinical Pharmacy I [45 hours]
Scope
This course is designed to impart knowledge on the area of Clinical Pharmacy.
Objectives
 Understand the Clinical Pharmacokinetics.
 Understand the Clinical Evaluation of New Drugs
 Understand the use of Clinical Laboratory Tests.
 Understand the Clinical Evaluation of New Drugs
 Understand the contrast media used in diagnostic purpose.
 Understand the Drugs in Special Patient groups.
 Understand the techniques of Drug Therapy Monitoring and Patient Data Analysis.
 Understand the principles involved in the management of poisoning by different agents.
 Critically apprize the clinical biomedical literature
Unit-1: Introduction (1 hr)
Definition, development and scope of Clinical Pharmacy
Unit-2: Clinical Pharmacokinetics and Pharmacodynamics (7 hrs)
Volume of distribution, Clearance, Plasma protein binding, concentration dependent clearance,
flow dependent clearance, multi compartment models, physiologic model, pharmacodynamic
models, time course of drug action, cumulative effects of drugs, steep concentration effect
curves.
1. Hysteresis 2. Prosteresis, 3. Target Concentration Strategy. 4. Variability and control
strategies in quantitative therapeutics Bioavailability, Drug Biotransformation,
1. Pharmacokinetic variability; Body weight & size, obesity, age. Drug metabolism, Plasma
protein binding and renal excretion in newborn & children. Sex, pregnancy and genetic
factors. Polymorphic acetylation and oxidation
2. Effect of disease states on drug disposition, therapeutic drug monitoring and dosage
prediction of digoxin, gentamycin and anticonvulsants. Hypothesis of individualization &
optimization of drug therapy.
Unit-3: Clinical Evaluation of New Drugs (3 hrs)
Clinical trials, various phases of clinical trials, design and execution of trials in different clinical
settings.
Unit-4: Clinical Laboratory Tests (6 hrs)
Used in the evaluation of disease states, and interpretation of test results. Hematological, liver
function, renal function tests, tests associated with cardiac disorders, fluid and electrolyte
balance, common tests in urine, sputum, feces. Sensitivity screening for common pathogenic
micro-organisms, its significance, resistance in disease states and selection of appropriate anti-
microbial regimens.
Unit-5: Studies of Imaging Pharmaceuticals (contrast media) - (5 hrs)

Introduction, parenteral injection methods, types of contrast media, characteristics of iodinated

contrast media, pharmacodynamics, and pharmacokinetics of contrast media and clinical
applications), preventive care and emergency, response to contrast media, patient education and
assessment. Patient preparations, pre-medication, types of contrast medium reactions.
Unit-6: Drugs in Special Patient Groups (Pregnancy and Nursing, Neonates and Children,
Elderly). (2 hrs)
Unit-7: Clinical Importance of Genetics in Drugs effects. (1 hr)
Unit-8: Drug Therapy Monitoring (6 hrs)
Medication chart view, clinical review, TDM Pharmacist interventions, and therapeutic drug
monitoring and dosage prediction of digoxin, gentamycin and anticonvulsants. Hypothesis of
individualization & optimization of drug therapy. Ward round participation. Adverse drug
reaction management. Medication history and patient counseling. Drug utilization evaluation
(DUE) and review (DUR), quality assurances of clinical pharmacy services. Patient data
analysis. Introduction of information sources available.
Unit-9: Patient Data Analysis (3 hrs)
The patient’s case history. its structure and use in evaluation of drug therapy. Patient medication
history review, presentation of cases, teaching skills. Understanding common medical
abbreviations and terminology used in clinical practices.
Unit- 10: Clinical Toxicology (7 hrs)
General principles involved in the management of poisoning. Antidotes and their clinical
applications. Supportive care in clinical toxicology. Gut decontamination. Elimination
enhancement. Toxicokinetics. Clinical symptoms and management of acute poisoning with the
following agents: Pesticide poisoning: organophosphorus compounds, carbamates,
organochlorines, pyrethroids Opiate overdose, Antidepressants, Barbiturates and
benzodiazepines, Alcohol: ethanol, methanol, Paracetamol and salicylates, Non steroidal anti-
inflammatory drugs, Radiation poisoning.
5 Clinical symptoms and management of chronic poisoning with the following agents: Heavy
metals: Arsenic, lead, mercury, iron, copper. Food Poisoning.
Unit- 11: Clinical Literature Evaluation (4 hrs)
Objective, primary, secondary and tertiary literature, Evaluation Techniques and steps. Study design,
Statistical tests and Bias. Introduction to systematic review and meta analysis.
Use HINARI or other Data Bases

Examples: Fowkes, F. G. R., & Fulton, P. M. (1991). Critical appraisal of published research:
Introductory guidelines. BMJ, 302, 1136-1140. Retrieved
from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1669795/
Kissling, L. S., & Davis, J.M. (2009). How to read and understand and use systematic reviews and
meta-analyses. Acta Psychiatrica Scandinavica, 119, 443-450. doi:10.1111/j.1600-
0447.2009.01388.x [PMID: 19469725]
Young, J. M., & Solomon, M. J. (2009). How to critically appraise an article. Nature Clinical
Practice Gastroenterology & Hepatology, 6(2), 82-91. doi:10.1038/ncpgasthep1331 [PMID:
19153565]
Brenda R. Motheral. Pharmaceutical Step-Therapy Interventions: A Critical Review of th e

Literature. J Manag Care Spec Pharm, 2011 Mar; 17(2):143-155. Volume 17 Issue (2)
DOI: http://dx.doi.org/10.18553/jmcp.2011.17.2.143
MPHAR 618P: Clinical Pharmacy I Practical
Students are posted to the hospital.

One SOP note has to be submitted every day (Internal Assessment)
Detail report has to be submitted covering all learning objectives. Report will be evaluated by
external examiner with viva. (Final Examination).
Reference
1. Malcolm Rowland & Thomasn Tozer. Clinical Pharmacokinetics & Concepts and
Applications Lippincott Williams & Wilkins 1995
2. Ellenhorns Medical Toxicology – Diagnosis and treatment of poisoning. Mathew J.
Ellenhorn.. Williams and Willkins publication, London. Second Edition
3. Hospital Pharmacy by William E. Hassan
4. Brian L. Strom, Stephen E. Kimmel. Textbook of Pharmacoepidemiology. Wiley
5. Drug Interactions. Stockley I.H. (1996). The Pharmaceutical Press
6. Toxicology - The basic science of poisons, international edition, Curtis D.Klaassen, 6th
edition
7. Toxicology – Principles and Applications, Raymond J.M.Niesink, John de.Vries,
Mannfred A. Hollinger
8. Drug Interaction Facts, 2003. David S. Tatro.
9. Toxicology - The basic science of poisons, international edition, Curtis D.Klaassen, 6thedition
10. Toxicology – Principles and Applications, Raymond J.M.Niesink, John de.Vries,Mannfred
A. Hollinger
11. Basic skills in interpreting laboratory data-Scott LT. American-society of health system
pharmacists Inc.
12. Practice, Standards & Definitions — The Society of hospital Pharmacist of Australia.
13. Clinical Pharmacokinetics-Rowland and Tozer, Williams and Wilkins publication.
14. Biopharmaceutics & Applied Pharmacokinetics-Leon Shargel, Prentice Hall publication.
15. Relevant review articles from recent medical and pharmaceutical journals.
MPHAR-619 T: Hospital Pharmacy [45 hrs]

Scope
This course is designed to impart knowledge on the area of Hospital Pharmacy.
Objectives:
 Understand the health care delivery system in Nepal.
 Understand the regulatory requirements of health institution in Nepal.
 Organize the hospital Pharmacy Department.
 Understand and deliver the pharmaceutical Services in a hospital.
Unit -1: Introduction to Hospital Pharmacy (10 hrs)
Brief introduction to health care delivery system in Nepal (ancient time to modern health care;
Nepal health policy 1991, MOH, Millennium development goal, DDA regulations about hospital
pharmacy and Hospital Pharmacy Nirdeshika 2070.) (4hrs)
Hospital pharmacy (History, functions, objectives, guidelines, regulatory bodies,
interrelationship to other depts.) (2 hrs)
Hospital drug policy, Drug and Therapeutic Committee (DTC, Infection Prevention Control
Committee (IPCC), Hospital Formulary development. New molecule for clinical use). (4 hrs)
Unit-2: Hospital pharmacy management (35 hrs)

2.1 Good Pharmacy Practice guidelines (GPP): Staff (professional and non-professional),
Materials (drugs, non-drugs, consumables), Financial (drug budget, cost centers, sources of
revenue, revenue collection), Policy and planning, Infrastructure requirements (building,
furniture and fittings, specialized equipment, maintenance and repairs), Workload statistics). (5
hrs)
2.2 Organization (Charting) of hospital pharmacy services
2.2.1. Drug distribution (12 hrs)
a)Policy and procedure for drug distribution and administration (prescribing, labeling,
administration, medication procedure, inspection of nursing cabinets).
b)Distribution system to Ambulatory patients (Receive and validate prescription or verbal
request, Understand and interpret prescription, Prepare items for issue, Recording,
documentation and reporting, Issue drugs to patient with clear instructions and advice).
c) Distribution system to In-patients: wards/CCU/ICU/OT (floor stock system, individual
prescription order, unit dose distribution system)
d)Distribution system to emergency Department
e)Distribution system of controlled drugs (classification, comprehensive drug abuse prevention
and control act, labeling, inventory, control, guideline, policy)
f) Automated dispensing systems (types, devices with advantages and disadvantages, records,
role of pharmacists)
2.2.2 Procurement and inventory control (purchasing procedure, inventory procedure, expiry date
control, recycling of drugs, stocktaking, drug recalls) (4 hrs)
2.2.3 Drug store management (medical store management, stock arrangement, special storage
conditions, cold chain, vaccine transportation) (4 hrs)
2.2.4 Drug information (Drug information centers in Nepal, DINoN, DIB, classification) (3hrs)
2.2.5 Patients counseling (guidelines, infrastructures, procedure) (2 hrs)

2.2.6 Nuclear Pharmacy (Radioisotopes, indications, manufacturing and dispensing in hospital
premises, precautions) (5 hrs)
MPHAR-619P: Hospital Pharmacy I Practical
1. Establish a drug information center in a 300 bed teaching hospital. Prepare a written report for
the hospital’s administration summarizing the resources you will need to do this, including a
budget for both initial and ongoing expenditure. Provision and Evaluation of Drug Information
Services.
2. Select a new drug, which has recently been marketed in Nepal for the first time.
Prepare a report for a hospital’s Drug and Therapeutics Committee, and make a case either for or
against the addition of this new drug on to the hospital’s formulary. Issues, which may need to
cover, include the drug’s pharmacology, its clinical use, the opinions of relevant hospital
consultants and a cost comparison with existing therapies for the same condition for which the
new drug is indicated.
3. Write a Report: Describe and evaluate the layout and workflow patterns in the dispensary of a
local hospital. Include in the report any improvements, which you would recommend to achieve
more efficient work practices.
4. Examine and report on the drug distribution methods used in the practicing hospital.
5. Prepare one Inventory for the following: Drugs and Surgical, based on ABC and VED
Analysis.
a) Injection AntiSnake Venom b) Injection Adrenaline c) Injection Hydrocortisone Acetate and
Injection Hydrocortisone succinated) Bandage cloth, e) Disposable Syringes f) Antacid tablets g)
Antibactericals) Vitamin B-Complex tablets i) Pethadine Inj j) Inj. Atropine K) Benzathine
Penicillin. .l) Inj Fentanil
6. Study the Store Management in Teaching/ District/ local hospitals for the following aspects.
a) Receipt of Stores b) Storage c) Issue d) Documentation.
7. Patient Counseling and development of patient information leaflets
8) Management of Drugs provided by MOHP (DHO). 9) Management of Life Saving Drugs.
10)prepare a model monograph for a drug formulary
M Pharm 2nd Semester
Second Semester
MPHAR 620: Novel Drug Delivery System 2 10 40 25 25 100
and Pharmaceutical products
MPHAR 621: Pharmacotherapeutics - I 3 +1= 4 20 80 25 25 150
MPHAR 622: Biostatistics and Clinical 3 20 80 25 25 150
Research
MPHAR 623: Clinical Pharmacy II 3 +1= 4 20 80 25 25 150
MPHAR 624 : Hospital and Community 3+1= 4 20 80 25 25 150
Pharmacy
MPHAR 625: Pharmaceutical Jurisprudence 2 10 40 50
practical
19 Credits
Clinical clerkship (practical for MPHAR
621/623/624 ( 3 credits )
MPHAR 620 T: Novel Drug Delivery System and Other Pharmaceutical products [30 hours]
Scope
This course is designed to impart knowledge on the area of Hospital Scale manufacturing and
Quality Control.
Objectives:
 Understand the advantage and applications of Novel Drug Delivery Systems.
 Understand the Hospital Scale manufacturing process.
 Understand the stability and quality control of extemporal preparation.
 Demonstrate principles and procedures of sterile technique in preparing injectable drugs
and IV solutions.
 Prepare TPN
 Understand the components of Nutraceuticals
 Understand the process of Biological products preparation and quality control
Unit-1: Introduction to Novel Drug Delivery Systems 8 hrs
 Diffusional systems, Reservoir system, Lag time, Burst effect, Matrix system, Effect of
porosity and tortuosity dissolution controlled system, Diffusion layer controlled
dissolution, Bioerodible and combination of diffusion and dissolution systems.
Pharmakokinetic variability and clinical significance of controlled released formulations.
 Topical Drug Delivery Systems: advantages and limitation of hydrogel, organogel,
insitugel, gel using thixotropic behavior.
 Colloidal and supramolecular delivery systems: Applications of specialized liposomes
and pharmaceutical, applications. Of niosomes. Nanoparticles, microspheres,
 Targeted drug delivery: History, concept, types and key elements

Unit-2- Extemporaneous Compounding (3 hrs)
Purpose and reason for compounding prescriptions. Assurance of Quality and Safety. Challenges
and Limitations of Extemporal Preparations. Stabilities and Incompatibilities of extemporal
preparations. Repackaging: Selection of Packaging materials, Primary and secondary packaging.
Unit-3: Aseptic Procedures for Sterile Pharmaceuticals (6 hrs)

Describe the proper aseptic technique for hand-washing, for preparing sterile pharmaceuticals
using ampoules, and vials, cleaning and use of laminar air flow, HEPA filters, use of IPA and
other fumigating agents in sterile section, describe the logic of each of the steps of sterile
technique. Discuss the USP chapter 797 regulations.
Unit-4: Total Parenteral Nutrition Service- TPN (6 hrs)
IV additive program (TPN). Preparation of IV admixture, main components of a TPN and
preparations with minimum five examples. Environmental condition and precaution of IV
additives preparation.
Unit -5: Nutraceuticals (2 hrs)

Defination, Properties and functions of various Nutraceuticals: Glucosamine, Octacosanol,
Lycopene,. Alpha-lipoic acid, Omega 3 and Omega 6 fatty acids, Flavanones, Beta carotene,
Probiotics, lignans, flaxseed oil as Nutraceuticals. Discussion about the availability of
Nutraceuticals in the market.
Unit – 6: Biological products (4 hrs)
Production of Human insulin (Humulin), Interferons, somatotropin, human growth hormone
(Humatrop), somatostatin., vaccines, Monoclonal Antibody Based Pharmaceuticals,
Recombinant Human Deoxyribonuclease, activase , Hepatitis –B Vaccine, proteases and other
biotechnology products. Quality control, Storage and handling of biotechnology products.
Economic considerations in Medical Biotechnology.
Unit-7: Application of novel approaches in cosmetic formulations (4 hrs)

Surfactants in cosmetic suspensions: Wetting property, Flocculation and deflocculation of
suspensions, Surface treatment of particles and Evaluation of suspensions and suspending agents.
Emulsion–Surfactant Technology in Cosmetics. Concepts of micro emulsions, liposomes,
niosomes, nanoparticles, iontophoresis, to enhance functional attributes & delivery of
cosmeceuticals.
References
1. J.R. Robinson & V.H.L. Lee (Eds), Controlled Drug Delivery, Fundamentals and
applications, Vol. 29&Vol. 31, 2nd Edition, Marcel Dekker, N.Y. 1987
2. Y.W. Chien (Ed.), Transdermal Controlled Systemic Medications, Marcel Dekker, N.Y.
1987.
3. N.K. Jain, Advances In Controlled And Novel Drug Delivery, CBS publication New
Delhi.
4. S.D. Bruck, Controlled Drug Delivery, Vol.1 (Basic Concepts) CRC Press. Florida, 1983
5. S.D. Bruck, Controlled Drug Delivery, Vol. II (Clinical Applications) CRC Press.
Florida, 1983.
6. L.F. Prescot and W.S. Nimmo, Novel Drug and its Therapeutic Applications, John Willy
and Sons, Chichester (1990).
7. N.K. Jain, Controlled and novel drug delivery, 1997, CBs, New Delhi. 7. N.K. Jain,
Advances in Controlled and novel drug delivery, 2001, CBS, New Delhi.
8. Remington Practice of Pharmaceutical Sciences
9. David J Woods Extemporaneous formulations of Oral Liquids; A Guide
10. Rita K. Jew, Winson and Sarah C. Erush, Extemporaneous Formulations for Pediatric,
Geriatric, and Special Needs Patients, 2nd Edition
11. Christopher A. Langley, Dawn Belcher, Pharmaceutical Compounding and Dispensing.
Pharmaceutical Press, 2012.
12. Judith E. Thompson, Lawrence W. Davidow.A Practical Guide to Contemporary
Pharmacy Practice. Lippincott Williams & Wilkins, 2004.
13. Mark Jackson, Andrew Lowey. Handbook of Extemporaneous Preparation: A Guide to
Pharmaceutical Compounding. Pharmaceutical Press, 2010.
14. The ASHP Discussion Guide for Compounding Sterile Preparations.
MPHAR 621T: Pharmacotherapeutics I [45 hrs]

Scope: Upon completion of this Pharmacotherapeutics I, the student will be expected to
competently recognize and apply knowledge to compare, differentiate and evaluate the diseases
of the different anatomical system.
Objectives:
Upon completion of the course, it is expected that students will be able to:
 Recognize and resolve preventable drug-related problems.

 Design, implement, monitor, evaluate, document, and modify or recommend
modifications in pharmacotherapy to insure effective, safe and economical
pharmaceutical care.
 Effectively communicate and educate both patients and other health care professionals in
order to optimize pharmacotherapy and prevent future health problems
 Critically evaluate new advances in pharmacotherapy or systems of care and effectively
utilize this new knowledge in patient care
 Describe and explain the rationale for drug therapy
 Summarize the therapeutic approach for management of these diseases including
reference to the latest available evidence
 Discuss the controversies in drug therapy and evidence based medicine
 Discuss the preparation of individualized therapeutic plans based on diagnosis
 Identify the patient specific parameters relevant in initiating drug therapy, and monitoring
therapy (including alternatives, time- course of clinical and laboratory indices of
therapeutic response and adverse effect/s)
Discussion of the following diseases under different anatomical systems with example of
cases:
Unit-1: Clinical Pharmacokinetics (13 hrs)
Application of principles of pharmacokinetics and pharmacodynamics in special circumstances
in pharmacology: children, geriatrics, pregnancy, lactation, pharmacogenetics, renal disease and
hepatic disease. Analysis of concentration/time data with example. Use pharmacokinetic
concepts to determine rational drug dosing regimen. Use pharmacokinetic concepts to determine
paediatric drug dosing regimens. Prediction of the pharmacology and possible effects of a drug
group from an understanding of its mechanism of action, Analysis concentration-effect data.
Assessing the pharmacodynamic variation over time and how this impacts on clinical decisions?
Unit-2: Cardiovascular system (8 hrs)

Hypertension, Congestive cardiac failure, Ischaemic heart disease (Angina, Myocardial
infarction), Arrhythmias, Hyperlipidaemias, Thromboembolic disorders, Cardiac arrest –
resuscitation.
Unit-3: Respiratory system (4 hrs)
Pulmonary function tests, Asthma, Allergic Rhinitis, Chronic obstructive airways disease, Drug
induced pulmonary diseases. Hydrogen ion hemostasis and blood gases.
Unit-4: Renal system (4 hrs)
Diuretic therapy, Potassium depletion, Hyperkaelemia, Alkalosis, Nephritic Syndrome, Acute
renal failure, chronic renal failure, Dialysis, Renal replacement therapy, End-stage renal disease,
Drug induced renal diseases.
Unit-5: Hematological diseases (4 hrs)
Blood and body fluids, Complications of blood transfusion and blood substitutes, Anemia, Drug
induced hematological disorders.
Unit-6:. Immunology (4 hrs)
Immune disease – pathogenesis, mechanism of action of drugs, Glucocorticoids – anti-
inflammatory, anti-allergic and immunosuppressive actions in tissue as well as organ
transplantation, Vaccines – management of primary immunodeficiency.
Unit-7: Endocrine system (4 hrs)
Diabetes, Thyroid diseases, Oral contraceptives, Hormone replacement therapy, Osteoporosis.
Unit-8: Nervous system (4 hrs)

Epilepsy, Parkinson’s disease, Dementia, Stroke and transient ischemic attacks, Headache,
Migraine.
MPHAR 621P: Pharmacotherapeutics I Practical
The students are required to be posted to various clinical wards for their exposure with
therapeutic management and other clinical aspects. They are expected to have experience to do a
case presentation in the clinical conditions covered in theory. The students have to make one
SOP note every day and at least 10 cases presentations covering most common diseases found
in the deputed hospital. Student should also submit a record of the cases presented in the
prescribed format.
.Practical Assignments: The students are required to submit a minimum of two written
assignments (1500 to 2000 words) selected from the topics on different disease conditions given
to them. The students are required to discuss both the clinical and therapeutic aspects of the
same.
Reference
1. Clinical Pharmacy and therapeutics- Roger and Walker, Churchill Livingstone
publication.
2. Pharmacotherapy: A Patho-physiological approach- Joseph T. Dipiro et al. Appleton and
Lange.
3. Goodman’s and Gillman’s Pharmacological Basis of Therapeutics.
4. Pathologic basis of diseases-Robins SL, W.B.Saunders publication.
5. Pathology and therapeutics for pharmacists: a basis for clinical Pharmacy Practice. Green
and Harris, Chapman and Hall Publication.
6. Clinical Pharmacy and therapeutics- Eric T Herfindal, Williams and Wilkins Publication.
7. Applied Therapeutics: the clinical use of drugs. Lloyd Young and Koda-Kimble MA
[ISBN 0-333-65881-7].
8. Avery’s drug treatment, latest edition, Adis international limited.
9. Relevant review articles from recent medical and pharmaceutical literature.
MPHAR 622 T- Biostatistics and Clinical Research [45 hrs]
Scope
The course is designed to impart knowledge for postgraduate students regarding various
concepts about research methodology and biostatistics to enable them to design a research
protocol with an appropriate methodology and suitable statistics for evaluation of the results.
Objectives
After the completion of the course, students are able to:
 Understand and apply suitable statistics to evaluate the research findings.

 Understand and appreciate research question/s
 Know the different methods of research design and their application.

 Understand about the measurement of research outcomes
Unit -1: Biostatics (8hrs)
1.1. Introduction
Simple Definitions of Observation, Random Variable, Quantitative Variables, Qualitative

Variables, Discrete Random Variable, Continuous Random Variable, dependant and independent
variables. Population, Sample and Random Sample and Parameter.
1.2. Different tests and their application in research (8 hrs)
Types of Errors: Basic Logic of Tests o Z-Test o t-Test o F-test 6 Measures of Association (Chi-
Square Test, Cochran Mantel Haenszel Test, Fisher’s Exact Test, Correlation and Regression:
ANOVA.
1.3. Biostatistics in Epidemiology (7 hrs)
Incidence, Incidence rate, Prevalence, Prevalence rate, Absolute risk, Relative Risk , Odds and
Odds Ratio, Absolute risk reduction, Relative risk reduction, Attributable risk, Odd ratio,
Confidence interval of odd ratio, Sensitivity and Specificity. Introduction to statistical software:
SPSS, Epi Info, SAS.
Factorial Experiments – Principles and applications; Probit analysis: Dose – effect relationships,
calculation of LD50, ED50.
Unit -2: Research Question and study subject and sampling (7 hrs)
Origins of a research question, Characteristics of a good research question • Developing the

research question and study plan
Choosing Study Subjects: Basic terms and concepts, Selection criteria, Sampling and
Recruitment of study subjects.
Sampling techniques. Sample size determination and calculation. Sample size determination for
descriptive, analytical and experimental studies. Other considerations and special issues for
Sample size determination. Strategies for minimizing and maximizing sample size,
Unit -3: Research Studies (15 hrs)
Introduction to Research studies, Observational Study: Cohort Studies (Prospective cohort

studies, Retrospective cohort studies, Nested Case-Control and Case-Cohort studies, Multiple-
cohort studies and External Controls and planning a cohort study).
Observational Study, Control Studies (Cross sectional studies, Case control studies). Experiment:
Experimental and Quasi experimental designs.
Clinical Trials: Selecting the participants, Measuring Baseline variables, Applying the
interventions, Follow-up and adherence to the protocol, measuring the outcomes, analyzing the
results, Alternatives to the randomized blinded trials.
Randomization in Clinical Trials: Definition, Types of bias in randomization, Selection bias,

Accidental bias, Fixed allocation randomization, Simple randomization, Block randomization,
Stratified randomization, Adaptive randomization, Biased coin method, Baseline adaptive
(minimization) , Black box design for ayurvedic products.
Clinical Trial Documents: NHRC guidelines, Guidelines to the preparation of documents,

Preparation of synopsis and protocols, Preparation of Investigator Brochure, Preparation of
Informed Consent Document, Preparation of case report forms , Preparation of clinical study
reports and summaries, Preparation of RCT protocol.
Reference
1. Bio-statistics by Dr. K Balaji and AVS Raghavaiah. IK International Publishing House
Bangalore. 2010
2. Biostatistics‟ by KS Negi AITB Publishers, Delhi. 2002
3. Fundamentals of Biostatistics‟ by Irfan Alikhan Ukaaz Publications 2nd edition, 1994
4. Biostatistics for Pharmacy‟ by Khan and Khanum Ukaaz Publications vol:16, 2 nd
edition ill, Chapman & Hall / CRC 2006
5. Statistics and Pharmaceutical applications‟ by J.E, Demuth Mercel & Dekker vol: 16 6.
Applied statistics by S.C.Gupta & V.K.Kapoor S.Chand, 3 rd edition, 1996.
6. Handbook of clinical research. Julia Lloyd and Ann Raven Ed. Churchill Livingstone c.
2.
7. Principles of Clinical Research edited by Giovanna di Ignazio, Di Giovanna and Haynes.
8. 3. Central Drugs Standard Control Organization. Good Clinical Practices-Guidelines for
Clinical Trials on Pharmaceutical Products in India. New Delhi: Ministry of Health;
2001.
9. International Conference on Harmonization of Technical requirements for registration of
Pharmaceuticals for human use. ICH Harmonized Tripartite Guideline. Guideline for
Good Clinical Practice.E6; May 1996.
10. Ethical Guidelines for Biomedical Research on Human Subjects 2000. Indian Council of
Medical Research, New Delhi.
11. NHRC guidelines
MPHAR 623T: Clinical Pharmacy II [45 hrs]

Scope: This course is design to impart the knowledge of Clinical Pharmacy in advance
Level.
Objectives:
Upon completion of the subject student shall be able to:
 Monitor drug therapy of patient through medication chart review and clinical review;
 Obtain medication history interview and counsel the patients;
 Identify and resolve drug related problems;
 Address the drug information queries
 Detect, assess and monitor adverse drug reaction;
 Interpret selected laboratory results (as monitoring parameters in therapeutics) of specific
disease states;
 Retrieve, analyze, interpret and formulate drug or medicine information.
 Understand the Concepts in Quality Use of Medicine
Unit-1: Introduction to daily activities of a clinical pharmacist (3 hrs)
Drug therapy monitoring (medication chart review, clinical review, Lab results, patient history,
pharmacist interventions), Ward round participation, Adverse drug reaction and adverse event
management, Medication history, Patient counseling, Quality assurance of clinical pharmacy
services and Pharmaceutical care.
Unit-2: Medication errors (3 hrs)
Definition of medication error, common causes of medication errors, Medication Dispensing
and Distribution Systems ( identification and prevention of medication errors, issues of
distribution systems associated with all types of practice, settings role of automation and
technology in workload efficiency and patient, safety assurance of safety in the medication-use
process, medication error reduction programs, continuous quality improvement programs and
consequences of medication errors) strategies to prevent medication errors, pharmacy leadership
in medication safety.
Unit-3: Communication skills (3 hrs)
Patient counseling techniques, medication history interview, presentation of cases. Professional
Communication (effective verbal and written interpersonal communication, health literacy,
communicating with diverse patients, families, pharmacists, and other health professionals in a
variety of settings, both individually and as a member of a team active listening and empathy,
assertiveness and problem-solving techniques, strategies for handling difficult situations)
Unit-4: Drug Utilization Evaluation (DUE) and Drug Utilization Review (DUR) (3 hrs)
Definition and Cycle, prospective, concurrent and retrospective, steps in conducting DUE,
Unit-5: Concepts in Quality Use of Medicine (QUM) and Evidence based medicine (6 hrs)
Definition, concept of evidence based medicine, Approach and practice of evidence based
medicine in clinical settings Essential drugs: Definition, need, concept of essential drug, National
essential drug policy and list Rational drug use: Definition, concept and need for rational drug
use, Rational drug prescribing, Role of pharmacist in rational drug use
QUM in various settings: Hospital settings, Ambulatory care/Residential care, Role of health
care professionals in promoting the QUM, Strategies to promote the QUM, Impact of QUM on
E-health, integrative medicine and multidisciplinary care. QUM in special population: Pediatric
prescribing, Geriatric prescribing, prescribing in pregnancy and lactation, Prescribing in immune
compromised and organ failure patients 12 Hrs 4. Regulatory aspects of QUM in India:
Regulation including scheduling, Regulation of complementary medicines, Regulation of OTC
medicines, Professional responsibility of pharmacist, Role of industry in QUM in medicine
development.
Unit-6: Drug & Poison information (4 hrs)

Introduction to drug information resources available, Systematic approach in answering DI
queries,
Critical evaluation of drug information and literature, Preparation of written and verbal reports,
Establishing a Drug Information Centre and Poisons information- organization & information
resources
Unit-7: Pharmacovigilance (4 hrs)
Scope, definition and aims of pharmacovigilance, Basics of Adverse Drug Reactions (ADRs):
Definition, classification, mechanism, predisposing factors, Assessment of ADRs (Causality,
Preventability, Predictability, Severity), Reporting, evaluation, monitoring, preventing &
management of ADRs, Role of pharmacist in management of ADR and Spontaneous Reporting
System,
National Pharmacovigilance program of Nepal: Structure, Operational Modality and functions,
Unit-8: Critical evaluation of biomedical literature (3 hrs)

Unit-9: Prescribing in special group of patient ( 3 hrs)
Prescribing for eldery , Prescribing for children, Prescribing in hepatic impairment, Prescribing
in renal impairment, Prescribing in pregnancy, Prescribing in breast-feeding, Prescribing in
palliative care, Prescribing in dental practice (Ref: BNF 2015).
Unit- 10: Pharmaceutical care of critical patients (15 hrs)

1. Evaluation of all drug therapy for appropriate indications, dosage, drug interactions, and
drug allergies; monitors the ICU patient’s pharmacotherapeutic regimen for effectiveness
and ADEs; and carry out intervention as needed.
2. Total Parenteral Nutrition (TPN) Service- process and monitoring of the service by
pharmacist.
3. Provision of drug information to ICU team and assist nursing staff on the IV
compatibility of various IV medications.
4. Quality assurance programs to enhance pharmaceutical care in the ICU.
5. Applying pharmacoeconomic tools to minimize drug cost in ICU department through
appropriate use of drugs in the ICU and through implementation of cost-containment
measures.
6. Providing pharmaceutical care support to sepsis patient, burnt patient and patient under
anticoagulant, amino glycosides, gentamicin, vancomycin and other treatment requiring
close monitoring.
MPHAR 623P: Clinical Pharmacy II Practical

Students are expected to perform 10 practical in the following areas covering the topics dealt in
theory class.
1. Answering drug information questions (1 )
2. Patient medication counseling (2 )
3. Case studies related to laboratory investigations (3 )
4. Patient’s past medical history and medication history, analysis of relevance and
interview (1 )
5. Prescribing in special group of patient (3)
Assignment of practical:
Students are expected to submit THREE written assignments (1500 – 2000 words) on the topics
given to them covering the following areas dealt in theory class.
Drug information, Patient medication history interview, Patient medication counseling, Critical
appraisal of recently published articles in the biomedical literature which deals with a drug or
therapeutic issue.
Reference
1. Basic skills in interpreting laboratory data - Scott LT, American Society of Health
System Pharmacists Inc. c. Biopharmaceutics and Applied Pharmacokinetics - Leon
Shargel, Prentice Hall publication.
2. A text book of Clinical Pharmacy Practice; Essential concepts and skills,
Dr.G.Parthasarathi et al, Orient Langram Pvt.Ltd. ISSBN8125026.
3. Drugs.com Staff. (2010) Total Parenteral Nutrition. Drugs.com. Diabetes Care January
2009 32:S1-S2; doi: 10.2337/dc09-S006. Last retrieved on 10/2010 from
Infusion Nursing Society. (2004) Core Curriculum for Infusion Nursing Lippincott
Williams and Wilkins, 3rd edition..
4. F.A.Davis, 4th edition, 2005. Phillips, Lynn Diane Manual of Therapeutics.
5. Practice Standards and Definitions - The Society of Hospital Pharmacists of Australia.
System Pharmacists Inc.
7. Biopharmaceutics and Applied Pharmacokinetics - Leon Shargel, Prentice Hall
publication.
8. BNF 2015. Pharmaceutical Press London.
Dr.G.Parthasarathi etal, Orient (Langram Pvt.Ltd. ISSBN8125026)
10. Australian drug information -Procedure manual. The Society of Hospital Pharmacists of
Australia.
11. Clinical Pharmacokinetics - Rowland and Tozer, Williams and Wilkins Publication.
MPHAR 624 T: Hospital and Community Pharmacy [45 hrs]
Scope: This course is designed to impart basic knowledge and skills that are required to practice
pharmacy in both hospital and community settings.
Objectives: Upon completion of this course it is expected that students shall be able to:
 Understand the organizational structure of hospital pharmacy

 Understand drug policy and drug committees
 Know about procurement & drug distribution practices
 Know the admixtures of radiopharmaceuticals
 Understand the community pharmacy management
 Know about value added services in community pharmacies
 Understand the different approaches of health promotion
 Understand and apply the computer in pharmaceutical care
Unit - 1: Introduction to Hospitals (8 hrs)
Definition, classification, organizational structure Hospital Pharmacy: Definition, Relationship

of hospital pharmacy department with other departments, Organizational structure, legal
requirements, work load statistics, Infrastructural requirements, Hospital Pharmacy Budget and
Hospital Pharmacy management Hospital Drug Policy: Pharmacy & Therapeutics Committee,
and other Committees in the hospital.
Unit – 2: Hospital Formulary (6 hrs)
Hospital Formulary Guidelines and its development, Developing Therapeutic guidelines, Drug
procurement process, and methods of Inventory control, Methods of Drug distribution,
Intravenous admixtures, Hospital Waste Management
Unit – 3: Education and training (10 hrs)
Training of technical staff, Training and continuing education for pharmacists, Pharmacy
students, Medical staff and students, Nursing staff and students, Formal and informal meetings
and lectures, Drug and therapeutics newsletter. Community Pharmacy Practice: Definition, roles
& responsibilities of community pharmacists, relationship of community pharmacists with other
health care providers Community Pharmacy management: Legal requirements to start
community pharmacy, site selection, lay out & design, drug display, super drug store model,
accounts
Unit – 4. Prescription (6 hrs)
Patient medication adherence, Essential drugs concept and rational drug therapy. Factors
affecting medication adherence, role of pharmacist in improving the adherence. Legal
requirements & interpretation, prescription related problems responding to symptoms of minor

ailments: Head ache, pyrexia, menstrual pains, food and drug allergy, OTC medication: Rational
use of over the counter medications Medication adherence and Patient referrals to the doctors
ADR monitoring in community pharmacies.
Unit – 5. Health Promotion (7 hrs)

Definition and health promotion activities, family planning, Health screening services, first aid,
prevention of communicable and noncommunicable diseases, smoking cessation, Child &
mother care Home Medicines review program – Definition, objectives, Guidelines, method and
outcomes. Code of ethics for community pharmacists and Research in community pharmacy.
Unit – 6: Computer applications in pharmacy (8 hrs)

Computer System in Hospital Pharmacy: Patterns of Computer use in Hospital Pharmacy –
Patient record database management, Medication order entry – Drug labels and list – Intravenous
solution and admixture, patient medication profiles, Inventory control, Management report &
Statistics.
Computer in Community Pharmacy: Computerizing the Prescription Dispensing process.
Use of Computers for Pharmaceutical Care in community pharmacy. Accounting and General
ledger system. Drug Information Retrieval & Storage: Introduction – Advantages of
Computerized Literature Retrieval.
MPHAR 624 P: Hospital and Community Pharmacy Practical
Preparation of an outline for hospital formulary

Preparation of content of a medicine, with proper justification, for the inclusion in the hospital
formulary (one)
Formulation and dispensing of a given IV admixtures
Preparation of a patient information leaflet (at least three)
Preparation of a plan for opening a community pharmacy outlet
Reference
1. Hospital Pharmacy - Hassan WE. Lec and Febiger publication.
2. Textbook of hospital pharmacy - Allwood MC and Blackwell.
3. Avery’s Drug Treatment, Latest edition, Adis International Limited.
4. Remington Pharmaceutical Sciences. 5. Relevant review articles from recent medical and
pharmaceutical literature
5. A Textbook of Clinical Pharmacy Practice – Essential concepts and skills – Parthasarathi
G, Karin Nyfort-Hansen and Milap Nahata (Latest edition)
6. J.T.Fell, Textbook of Hospital Pharmacy - Allwood MC, Blackwell Scientific
Publications: (1980) .
7. Nepal Health Policy, Department of Health Service, Ministry of Health, Government of
Nepal.
8. Nepal Drug Policy, DDA, Ministry of Health, Government of Nepal.
9. WHO: Guidelines for DTC
10. Drug Bulletin of Nepal, different numbers, DDA, Ministry of Health

11. R. Lewelyn Davies and HMC Macaulay, Hospital Planning and Administration (Jaypee
Brothers Medical Publishers P. Ltd., New Delhi)
12. C.M. Francis and et al., Hospital Administration (Jaypee Brothers Medical Publishers
Pvt. Ltd., New Delhi)
MPHAR 625: Pharmaceutical Jurisprudence [30 hrs]
Scope: This course is designed to impart basic knowledge and skills that are required to practice
in regulatory settings.
Objectives: Upon completion of this course it is expected that students shall be able to:
 Understand the basic concepts of drug regulation

 Understand drug related laws and their application
 Understand the drug regulation in Nepal and other countries
Unit -1: History of Pharmacy in Nepal (2 hrs)

Evolution and development of Pharmacy profession in Nepal and History of Pharmaceutical sector in
Nepal (Pharmaceutical regulation, Pharmaceutical education, medicine manufacturing, hospital pharmacy
and retail pharmacy).
Unit -2: Drug Act 2035 and its amendments (8 hrs)
Basic principles of drug regulatory legislation. Highlight of the drug act 2035 and sections and schedules
there in.
Unit -3: Highlights of the Different Rules and Regulations under Drug Act 2035 (1976) (5 hrs)
1. Regulations on constitution of Drug Consultative Council & Drug Advisory Committee 2037 BS
(1979).
2. The Drugs Registration Regulation, 2038(1981 and Medicine Registration Guidance 2073.
3. Code for Manufacture of Drugs. 2041 BS (1986).
4. Code for Sale and Distribution of Drugs.
5. Code for Advertisement of Drugs.
Unit -4: Highlights of the other laws affecting pharmacy profession (4 hrs)
1. Nepal Health Services Act, 2053 BS

2. Consumer Protection Act, 2054 BS
3. Narcotic Drugs (Control) Act, 2033 (1976) and Drug Abuse Control Act, 2033 BS (1976
4. Black Marketing & Other Social Offences Act, 2032 BS (1975)
Unit -5: Introduction to the National Drug Policy 1995. (1 hr)
Unit -6: WHO guidelines: (3 hrs)
About medicines policy, intellectual property rights, financing & supply management, quality & safety,
selection & rational use of medicines, technical co-operation and traditional medicines.
Unit -6: Drug laws of the different countries (7 hrs)
Introduction to: Drug & Cosmetic law of India (including Schedule M and Schedule T), Pharmacy Act
1948, Regulations of European Medicines Agency (EMEA), US FDA and TGA regarding Hospital and
Clinical pharmacy. Introduction to International Conference on Harmonization (ICH) activities.
Reference
1. History of Pharmacy: Medication and healing by Dr Dharma Prasad Khanal and Sarita
Khanal, MMIHS 2013.
2. Drug Act-2035(1976), Government of nepal
3. Health Related Legislation of Nepal (Nepal’s Quest for Health: ANNEXURE I).
4. Nepalese Pharmaceutical Guide, 1993.
5. Nepal Niyam Sangraha, Khanda 8(ka), 2040, Ministry of Law & Justice, HMG/N,
Kathmandu.
6. Collection of Health Related Acts and Regulations, 3rd Edition, 2060 BS. Makalu Books
and Stationers, Kathmandu.
7. Clinical research regulation in India-history, development, initiatives, challenges and
controversies: Still long way to go. J Pharm Bioallied Sci. 2013 Jan-Mar; 5(1): 2–9.
8. Drug & Cosmetic Act of India,
9. Pharmacy Act 1948 (India)
10. Regulations of WHO, ICH, EMEA, US FDA and TGA.
Third Semester
MPHAR 630: Pharmacotherapeutics - II 3 +1= 4 20 80 25 25 150
MPHAR 631: Clinical Pharmacy III 3 +1= 4 20 80 25 25 150
MPHAR 632- Dissertation Synopsis 2 - - 50 50 100
MPHR: 633: Pharmacoepidemiology and 2 10 40 -- -- 50
Pharmacoeconomics
12 Credits 500
Clinical clerkship (practical for MPHAR 630,
MPHAR 631) ( 2 credits)
MPHAR 630 T: Pharmacotherapeutics II [45 hrs]

Scope: Upon completion of this Pharmacotherapeutics I, the student will be expected to
competently recognize and apply knowledge to compare, differentiate and evaluate the the
diseases of the different anatomical system.
 Describe and explain the rationale for drug therapy
 Summarize the therapeutic approach for management of these diseases including
reference to the latest available evidence
 Discuss the controversies in drug therapy and evidence based medicine
 Discuss the preparation of individualized therapeutic plans based on diagnosis
 Identify the patient specific parameters relevant in initiating drug therapy, and monitoring
therapy (including alternatives, time- course of clinical and laboratory indices of
therapeutic response and adverse effect/s)
Discussion of the following diseases under different anatomical systems with example of
cases:
1. Psychiatric disorders (4 hrs)
Schizophrenia, Depression, Anxiety disorders, Sleep disorders.
2. Gastrointestinal system (8 hrs)
Ulcer diseases, Congenital anomalies of intestine, Malabsorption syndromes &
Enterocolitits, inflammatory bowel diseases, Diarrhoea and Constipation, General
features of liver disease (patterns of hepatic injury, jaundice, portal hypertension, hepatic
failure, liver function tests), Alcoholic liver disease, cirrhosis, metabolic liver disease.
Gallbladder – cholecystitis, choleithiasis.
3. Bone and joint Disorders (4 hrs)
Osteoporosis, rheumatoid arthritis, osteoarthritis, gout, Paget’s disease of bones.
4. Infectious diseases (10 hrs)

Meningitis, Respiratory tract infections, Gastroenteritis, Pneumonia, Bacterial
endocarditis, Septicaemia, Otitis media, Urinary tract infections, Tuberculosis, Leprosy,
Protozoal infections including malaria and helmenthiasis, HIV and opportunistic
infections, Fungal infections including Onychomycosis.
5. Skin and sexually transmitted diseases (5 hrs)
6. Psoriasis, Eczema and scabies, Syphilis, Chancroid, Gonorrhoea, Allopecia, Systemic
Lupus Erythematosus, Polyarteritis nodosa, Urticaria.
7. Oncology (7 hrs)
Cell cycle, General principles of cancer chemotherapy, Commonly used cytotoxic drugs,
Chemotherapy of lung cancer, breast cancer, head and neck cancer, prostate cancer,
Cervical cancer, colorectal cancer, haematological malignancies. Leukaemia –actue
leukaemias - Chronic leukaemias, , other chronic myelo-proliferative disorders including
myelofibrosis.
8. . Ophthalmology: Glaucoma, Eye infections. (1 hr)
9. Pain management (4 hrs)
Pathophysiology of inflammation and repair, Pain pathways, Analgesics and NSAIDs,
Opiates, Local anesthetics, Neuralgia, Muscle relaxants.
10. General Prescribing Guidelines for: - (2 hrs)
Pediatric patients. Geriatric patients. Pregnancy & Breast feeding. Antibiotics & parenterals.
MPHAR 630P: Pharmacotherapeutics I Practical
The students are required to be posted to various clinical wards for their exposure with
therapeutic management and other clinical aspects. They are expected to have experience to do a
case presentation in the clinical conditions covered in theory. The students have to make one
SOP note every day and at least 10 case presentations covering most common diseases found in
the hospital deputation. The student should also submit a record of the cases presented in the
prescribed format.
Practical Assignments: The students are required to submit a minimum of two written
assignments (1500 to 2000 words) selected from the topics on different disease conditions given
to them. The students are required to discuss both the clinical and therapeutic aspects of the
same.
Reference
1. Clinical Pharmacy and therapeutics- Roger and Walker, Churchill Livingstone publication.
2. Pharmacotherapy: A Patho-physiological approach- Joseph T. Dipiro et al. Appleton and Lange.
3. Goodman’s and Gillman’s Pharmacological Basis of Therapeutics.
4. Pathologic basis of diseases-Robins SL, W.B.Saunders publication.
5. Pathology and therapeutics for pharmacists: a basis for clinical Pharmacy Practice. Green and
Harris, Chapman and Hall Publication.
6. Clinical Pharmacy and therapeutics- Eric T Herfindal, Williams and Wilkins Publication.
7. Applied Therapeutics: the clinical use of drugs. Lloyd Young and Koda-Kimble MA [ISBN 0-
333-65881-7].
8. Avery’s drug treatment, latest edition, Adis international limited.
9. Relevant review articles from recent medical and pharmaceutical literature.
MPHAR 631 T: Clinical Pharmacy III [45 hrs]

Scope: This course is design to impart the knowledge the knowledge of Clinical Pharmacy
in advance Level.
Objectives:
 Able to understand the normal and pathological condition of different lab test data
 Discuss and understand the TPN
 Understand the importance of nutraceuticals
 Understand the use and importance of Immunotherapeutic agents
 Understand and able to use the clinical lab data in clinical practice
 Understand and interpret the Evidence-based Medicine
Unit-1: Explain and discuss the normal and pathological condition of the following lab test
data as well as their clinical significance: (23 hrs)
 Complete hematology analysis, electrolyte analysis including PT/INR.

 Role and alterations of acid-base balance and blood gases in the body.
 Uric acid analysis and importance of an ammonia assay (BUN).
 Blood glucose and glycosylated hemoglobin ( HbA1c (%)) monitoring (Differentiate

different aspects of the normal physiology of glucose (test F as well as PP), compare and
contrast the pathophysiology of types 1 and 2 diabetes. Use of glycosylated hemoglobin
data in the management of diabetes)
 Test of cholesterol, triglycerides, HDL, LDL and lipoprotein.
 Tests data of LFT (Liver), RFT (Renal), TFT(Thyroid) and their clinical significance
 Data of routine test of urine and stool
 Idea of a routine examination of cerebrospinal fluid, and clinical conditions, including
gross examination, cell counts, morphologic examination, and common chemical tests
 Blood culture, Urine culture, stool culture, antimicrobial susceptibility testing and their
led time and clinical significance.
 Introduce the antigen and antibody testing. Describe the clinical application of antibody
titer.
 Testing for rheumatoid factor (RF). prostate specific antigen (PSA),
 Pancreatic function, testing, disorders
 Endocrinology, testing, disorders
 Cardiac troponin test, C-reactive protein (CRP) and other protein markers like
Apolipoprotein A1 and B, clotting factors Factor II / Factor V, Vitamin A and Vitamin D
tests.
Unit-2: Total Parentral Nutrition (TPN) (5 hrs)

Discuss principles of parenteral nutrition. Describe practical aspects of parenteral nutrition in the
intensive care unit setting. Describe TPN including its indications and goals of therapy. Discuss
parenteral nutrition issues during major organ dysfunction. Identify basic components of and
supplies for TPN therapy. Discuss the purpose of total parenteral nutrition and dosage and
monitoring considerations and complications. Describe the special role of pharmacists in
parenteral nutrition support. Guidance on intravenous infusions (as per BNF 2015).
Unit-3: Nutraceutical (5 hrs)

Definition, Relation of functional foods & Nutraceutical (FFN) to foods & drugs. Nutraceuticals
bridging the gap between food and drug, Nutraceuticals in treatment for cognitive decline,
Nutraceutical remedies for common disorders like Arthritis, Bronchitis, circulatory problems,
hypoglycemia, Nephrological disorders, Liver disorders, Osteoporosis, Psoriasis and Ulcers etc.
Applications of herbs to functional foods, Concept of free radicals and antioxidants; Nutritive
and Non-nutritive food components with potential health effects, Brief idea about some
Nutraceutical rich supplements e.g. Bee pollen, Caffeine, Green tea, Lecithin.
Unit-4: Immunotherapeutic agents (7 hrs)
Vaccines and sera (typhoid vaccine, hepatitis A, B vaccine, rabies vaccine, varicella vaccine,
pooled normal human immunoglobulin, Antisnake venom and other vaccines included in
National Vaccination Schedule. Introduction to Monoclonal antibodies (Murine, Chimeric) and
Humanized Fusion proteins (chimeric polypeptide). Soluble cytokine receptors (tumor necrosis
factor (TNF)-α, Soluble IL receptors). Recombinant cytokines (Colony-stimulating factors

(CSF), such as erythropoietin, granulocyte CSF (G-CSF), and granulocyte-macrophage CSF
(GM-CSF), Interferon-α (IFN-α) and IFN-γ ). Small-molecule mimetics (erythropoietin,
thrombopoietin, and G-CSF). Cellular therapies (cytotoxic T cells). Vaccination requirements for
health care workers and international travel. Introduction and application of Radioimmunoassay
(RIA).
Unit-7: Evidence Based Medicine (5 hours)
Introduction to Evidence-based Medicine. Posing questions and running searches in HINARI and
other Data Bases. Describe: random allocation, concealed allocation, “blinding” and “intention to
treat analysis” in studies assessing interventions Apply guidelines for assessing the validity of a
clinical research study that has evaluated the efficacy and safety of a preventive or therapeutic
intervention.
MPHAR 631P: Clinical Pharmacy Practical III
Students are expected to perform minimum 10 practical in the following areas covering the
topics dealt in theory class.
1. Complete lab data analysis(Two)
2. TPN related problem (Three)
3. Work related to Nutraceuticals (One)
4. Work related to Immunotherapeutic agents including the reporting of National
Vaccination Schedule (two )
5. Critical appraisal of clinical literature and evidence medicine base practice (Two)
Assignment practical
Students are expected to submit THREE written assignments (1500 – 2000 words) on the
topics given to them covering the following areas dealt in theory class.
Reference
1. Drug Information: A Guide for Pharmacists 4th edition by Patrick M. Malone, Karen L.
Kier, and John E. Stanovich 2012 McGraw-Hill Companies (ISBN 978-0-07-162495-4).
2. Practice Standards and Definitions - The Society of Hospital Pharmacists of Australia.
3. BNF 2015. Pharmaceutical Press London.
4. HANDBOOK OF CLINICAL DRUG DATA, 10TH EDITION , 2002 by The McGraw-Hill Companies
System Pharmacists Inc. c. Biopharmaceutics and Applied Pharmacokinetics - Leon
Shargel, Prentice Hall publication.
Dr.G.Parthasarathi etal, Orient Orient Langram Pvt.Ltd. ISSBN8125026.
7. Drugs.com Staff. (2010) Total Parenteral Nutrition. Drugs.com. Diabetes Care January
2009 32:S1-S2; doi:10.2337/dc09-S006. Last retrieved on 10/2010 from
8. Infusion Nursing Society. (2004) Core Curriculum for Infusion Nursing Lippincott
Williams and Wilkins, 3rd edition..
9. F.A.Davis, 4th edition, 2005. Phillips, Lynn Diane Manual of IV Therapeutics.
10. Clinical Pharmacy and therapeutics- by Roger Walker & cate whittels, Churchill
Livingstone 4 th edition publication. 2011
11. Pharmacotherapy : A Patho-physiological approach- by Joseph T. Dipiro et al. 6 th
edition McGraw hill Publication. 2011
12. Pathology and therapeutics for pharmacists: a basis for clinical Pharmacy Practice.
Russell Russell, 3rd edition, Pharmaceutical Press, 2008.
13. Clinical Pharmacy and therapeutics- Eric Herfindal, Williams and Wilkins Publication. 5
th edition, 1992.
14. Applied Therapeutics: the clinical use of drugs. Lloyd Young and Koda-Kimble MA
[ISBN 0 333-65881-7]. 3 rd edition, 1983.
MPHR: 632T: Pharamcoepidemiology and Pharmacoeconomics [ 30 hrs]

Scope
This course enables students to understand various pharmacoepidemiological methods and their
clinical applications. Also, it aims to impart knowledge on basic concepts, assumptions,
terminology, and methods associated with pharmacoeconomics and health related outcomes, and
when should be appropriate pharmacoeconomic model should be applied for a health care
regimen.
Objectives Upon completion of this course it is expected that students shall be able to:
 Understand the various epidemiological methods and their applications

 Understand the fundamental principles of pharmacoeconomics.
 Identify and determine relevant cost and consequences associated with pharmacy
 products and services. Perform the key pharmacoeconomics analysis methods
 Understand the pharmacoeconomic decision analysis methods and its applications.
 Describe current pharmacoeconomic methods and issues.
 Understand the applications of pharmacoeconomics to various pharmacy settings.
Unit- 1: Introduction to Pharmacoepidemiology (8 hrs)
Definition, Scope, Need, Aims & Applications; Outcome measurement: Outcome measures,
Drug use measures: Monetary units, Number of prescriptions, units of drug dispensed, defined
daily doses, prescribed daily doses, Diagnosis and Therapy surveys, Prevalence, Incidence rate,
Monetary units, number of prescriptions, unit of drugs dispensed, defined daily doses and
prescribed daily doses, medications adherence measurements. Concept of risk: Measurement of
risk, Attributable risk and relative risk, Time- risk relationship and odds ratio
Unit- 2: Pharmacoepidemiological Methods (6 hrs)
Qualitative models: Drug Utilization Review; Quantitative models: case reports, case series,
Cross sectional studies, Cohort and case control studies, Calculation of Odds ratio, Meta analysis
models, Drug effects study in populations: Spontaneous reporting, Prescription event monitoring,
Post marketing surveillance, Record linkage systems, Applications of pharmacoepidemiology.
Unit- 3: Introduction to Pharmacoeconomics (8 hrs)
Definition, history of pharmacoeconomics, Need of Pharmacoeconomic studies in Nepalese

healthcare system. Cost categorization and resources for cost estimation: Direct costs. Indirect
costs. Intangible costs. Outcomes and Measurements of Pharmacoeconomics: Types of
outcomes: Clinical outcome, Economic outcomes, Humanistic outcomes; Quality Adjusted Life
Years, Disability Adjusted Life Years Incremental Cost Effective Ratio, Average Cost Effective
Ratio. Person Time, Willingness to Pay, Time Trade Off and Discounting.
Unit- 4: Pharmacoeconomic evaluations (4 hrs)
Definition, Steps involved, Applications, Advantages and disadvantages of the following

Pharmacoeconomic models: Cost Minimization Analysis (CMA), Cost Benefit Analysis (CBA),
Cost Effective Analysis (CEA), Cost Utility Analysis (CUA), Cost of Illness (COI), and Cost
Consequences Analysis (COA).
Unit- 5: Definition, Steps involved, Applications, Advantages and disadvantages of the

following: (4 hrs)
Health related quality of life (HRQOL): Definition, Need for measurement of HRQOL, Common
HRQOL measures. Definition, Steps involved, Applications of the following: Decision Analysis
and Decision tree, Sensitivity analysis, Markov Modeling, Software used in pharmacoeconomic
analysis, Applications of Pharmacoeconomics.
Unit-6: Health Insurance (4 hrs)

Introduction, Health insurance policy of government of Nepal. Implementation of health
insurance. Health Insurance, Market Failure and Risks Concept of Health Insurance, Types,
origin, evolution and importance: Private Health Insurance for profit Private. Community Health
Insurance (CHI), Employer Based Insurance and Reinsurance Public Health Insurance: National
Health Insurance, Social Health Insurance and premium payment. Fundamental difference
among various Health Insurance Schemes. Health Insurance in global perspective.
Reference
1. Rascati K L. Essentials of Pharmacoeconomics, 2nd ed. Philadelphia: Woulters Kluwer
Lippincott Williams & Wilkins, 2013.
2. Andrew Briggs, Karl Claxton, Mark Sculpher. Decision Modeling for Health Economic
Evaluation, Published by the Oxford University Press 2006.
3. Michael Drummond, Mark Sculpher, George Torrence, Bernie O'Brien and Greg
Stoddart. Methods for the Economic Evaluation of Health Care Programmes Oxford
University Press (Third Edition) – 2005.
4. George E Mackinnon III. Understanding health outcomes and pharmacoeconomics, 2013.

5. Brian L. Strom, Stephen E. Kimmel, Sean Henness, Pharmacoepidemiology.
6. Eisenberg. "Clinical Economics: a Guide to the Economic Analysis Of Clinical
Practices."
7. Grauer D, Lee J, Odom T, Osterhaus J, Sanchez L, Touchette D. Pharmacoeconomics
and Outcomes: Applications for Patient Care, 2nd ed. 2003, American College of Clinical
Pharmacy, Kansas City, MO.
8. Gold MR, Siegel JE, Russell LB, Weinstein MC. Cost Effectiveness in Health and
Medicine. Oxford University Press, 1996 Briggs
9. Health Insurance Policy of Government of Nepal
10. L.M. Harpster and M.S. Veach, Risk Management Handbook for Healthcare Facilities
(American Hospital Association, USA, 1990) References
11. Hand Book on Health Insurance- Department of Economics (Autonomous), University of
Mumbai and Insurance Institute of India, Mumbai.
12. Health Insurance in India. Insurance Institute of India
Fourth semester
MPHAR 640A : Project Dissertation 8 - - 300 - 300
MPHAR 640B : Article writing 2 - - 50 50
MPHAR 640C: Defense (Viva-voice) 2 - - - 50 50
12 Credits 400
62 credits
Annex- I: End Semester Evaluation question structure

Final Examination Pattern: (Theory, Time: 3 hrs = 70 marks)
1. MCQs=20 (1×20=20)
2. Problem Based Learning (PBL)=1 (1×10=10): 1 Question Compulsory
3. LAQs= 4 Questions out of 5 questions (4×8=32)
4. SAQs= 4 Questions out of 5 questions (4×2=8)
PBL= Problem Based Learning.
Annex – II: Topics for Seminars (Examples only: not limited to the list)
1. Characteristics of Clinical Pharmacy as a discipline, the aim, basic terminology.
2. Drug use as a part of medical care process.
3. Social aspects of drug use.
4. Prescribing behaviour and its influencing factors for therapeutic outcome.
5. Drug Distribution systems./Drug life cycle.
6. Different ways of ranking drug expenditure in Nepal.
7. Cultural aspects and traditions as influencing factors of drug use.
8. Traditional Medicine in the Health care system of Nepal
9. Economic aspects of drug use.
10. Health insurance in Nepal and in other countries.
11. Factors affecting drug consumption.
12. Drug utilization studies, measurement of drug consumption.
13. Types of Drug Utilization Study./ Quantification of Drug Use.

14. Studies of prescriptions and prescribing patterns.
15. Studies of patient compliance.
16. Drug utilization and the health professions.
17. Monitoring the Quality of Drug Treatment.
18. Transferability of Drug Utilization Studies.
19. Descriptive tools for analyses in drug utilisation studies.
20. Types of Economic Evaluation.
21. Pharmacovigilance in Nepal.
22. Cost Models and Cost Effectiveness Analysis.
23. Health need, Health care systems and structures.
24. Drug policy and its tools to regulate drug movements.
25. Drug registration (authorization).
26. Factors affecting the drug consumption.
27. Per capita spent on drugs and quality of health care in Nepal
28. Drug pricing –market competition and role of government
Annex – III: Basic Equipment and instruments for M Pharm Clinical Pharmacy
specializations
1. High Performance Liquid Chromatograph
2. Double Beam Spectrophotometer
3. 6/8 Basket Dissolution Machine
4. Pan Balance -1/ Dispensing Balance – 1
5. Motor and Pastel – sufficient and Marble Slab and Spatula – sufficient
6. API, Reagents and Glass ware sufficient.
7. Primary packaging containers different size – sufficient.
8. Hot Water Bath – 2/ Portable Autoclave - 1
9. SS vessels – 1 liters/2 liters – sufficient
10. Solution filtration (vacuum filter) – 2 sets
11. Plastic sealing machine-1
12. Emulsifier for 5 kg stirring capacity
13. Hot plate – 2 and other necessary equipments to conduct the practical in PUCMAS lab.
Annex -IV: Dissertation Evaluation Sheet
Purbanchal University Biratnagar Nepal

Institute of Medical and Allied health Sciences (PUCMAS)
Program: Master of Pharmacy. Date:
Dissertation Evaluation Sheet
Criteria Marks Evaluation by examiners Total full Total marks Obtained
marks
Internal External HOD
Literature review and 50 √ ´ ´ 50
reference
Experimental Work 60 √ ´ ´ 60
Scientific contents 40 ´ √ ´ 40
Research writing 20 ´ √ ´ 20
Result & 25 + 25 √ √ ´ 50
Conclusion writing
Experimental Work 15 +15 √ √ ´ 30
Scientific contents 15 ´ √ ´ 15
reporting
Conclusion Reporting 10 ´ √ ´ 10
Head of the Department 25 ´ ´ 25 25
Total 300 150 125 300
Article writing 50 √ ´ ´ 50
Defense and Viva
Presentation skills & 10 + 10 √ √ ´ 20
Communication
Question and Answer 30 ´ √ 30
Grand Total 400
If the supervisor and HOD is same in that case all internal examiners’ evaluation
also has to be done by HOD.
Marks in words:
NB: Range of evaluation- Internal Examiner (126 to 180). External Examiner (81 to 122) and HOD (15 to
22.50). For Defense Viva: (Range External: 24-36, internal: 6 to 9).
Explanation(if out of range):
Signature of External Examiner Signature of Internal Examiner
Name: Name:
Signature of HOD:
Date:
Annex – V: List of Resource Persons for Syllabus Preparation in 2014

Pharmacy Subject Committee, Purbanchal University
1. Dr. Dharma Prasad Khanal M Pharm, PhD. Chairman
2. Mr. Nanda Kishor Bhatta M Pharm Member
3. MS Renu Shrestha M Pharm Member
4. MS Nisha Shrestha M Pharm Member
5. Mr. Nirmal Choudhary M Pharm Member
6. Mr. Sarad Pudasaini M Pharm Member
7. Mr. Roshan Poudel M Pharm Member
8. Mr. Suraj Shakya M Pharm Member
9. Mr. Raj Kumar Thapa M Pharm Member
Other Resource Persons
1. Dr. Uttam Budathoki M Pharm PhD, (Postdoc Fellow , Eppelheim, Germany)
2. Dr. Bijaya Aryal M Pharm PhD, (Chitwan Medical College, Nepal)
3. Dr. Sarmila Shrestha Amatya M Pharm PhD, (Busan, South Korea)
4. Dr. Kadir Alam M Pharm PhD, (Manipal Hospital, Pokhara Nepal)
5. Mr. Kiran Sundar Bajracharya M Pharm Faculty, MMIHS
6. Mr. Sumit Chandra Shrestha M Pharm GM Technical, OHAM Pharmaceuticals Pvt. Ltd
[
Annex – V: Resource Persons involved for this revision January 2017
1. Dr. Siddartha Koirala MBBS, MD, Dean PUCMAS

Pharmacy Subject Committee, Purbanchal University
1. Dr. Dharma Prasad Khanal M Pharm, PhD. Chairman
2. Mr. Nanda Kishor Bhatta M Pharm Member
3. Ms Renu Shrestha M Pharm Member
4. Mr. Sarad Pudasaini M Pharm Member
5. Dr Sachit Kumar Neupane M Pharm, Pharm D Member
6. Mr. Kshit Gartowla M Pharm Member
Invited Experts
7. Ms Meena Bhatta (Karnali College) B Pharm, Pharm D Faculty
8. Dr. Bijaya Aryal (Gandaki Medical College) M Pharm PhD Faculty
9. Mr. Raj Kumar Thapa (Patan Hospital) M Pharm In charge, Hospital Pharmacy
10. Mr. Chain Bajrachrya (Model Hospital) M Pharm In charge, Hospital Pharmacy
11. Mr. Kiran Sundar Bajrachrya M Pharm Pharmacist officer, DDA
12. Ms Mijala Bajrachrya M Pharm Faculty, MMIHS
13. Dr. Kaji Ram Adhakari M Pharm PhD Associate Professor, PUCMAS
14. Dr. Prashana Dhal Pharm D Visiting faculty, PUCMAS
15. Mr. Madan Ghimire M Pharm Faculty, MMIHS
Invited experts
16. Dr. Shiva Bdr Karki M Pharm PhD Professor CIST College
17. Mr. Santosh KC M Pharm Senior Pharmacist Officer DDA
We appreciate and acknowledge the detail suggestions provided by Nepal Pharmacy Council for this
revision.

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Purbanchal University, Syllabus in M Pharm in Clinical Pharmacy, First Revision January 2017

3.3.: Branch – C: Master of Pharmacy in Clinical Pharmacy

2. Writing a Review Paper

Semester M Pharm in Clinical Pharmacy

3. Attendance, Assessment and Final Examination

First Semester Intern Final Internal Final

MPHAR 616T: Pathophysiology [45 hrs]

Principles of hemopoiesis. Erythropoiesis. Fate of RBC‟s. Regulation of WBC production.

Unit-8: Reproduction (4 hrs)

Classification of tumors, Etiologic factors, Diagnosis of tumors and Treatment modalities.

MPHAR 616P: Pathophysiology practical

MPHAR 617T: Basic Principles of Pharmacology and Toxicology [60 hrs]

Unit-4: Excretion of drugs (6 hrs)

.Unit-5: Pharmacodynamics (20 hrs)

8. Pharmacological experiment on intact preparations by Churchill Livingstone

MPHAR 614 T- Biopharmaceutics and Pharmacokinetics [45 hours]

Unit-1: Introduction (8 hrs).

MPHAR 614P - Advanced Biopharmaceutics and Pharmacokinetics Practical

Unit-5: Studies of Imaging Pharmaceuticals (contrast media) - (5 hrs)

Introduction, parenteral injection methods, types of contrast media, characteristics of iodinated

Use HINARI or other Data Bases

Brenda R. Motheral. Pharmaceutical Step-Therapy Interventions: A Critical Review of th e

MPHAR 618P: Clinical Pharmacy I Practical

Students are posted to the hospital.

MPHAR-619 T: Hospital Pharmacy [45 hrs]

Unit-2: Hospital pharmacy management (35 hrs)

2.2.5 Patients counseling (guidelines, infrastructures, procedure) (2 hrs)

MPHAR-619P: Hospital Pharmacy I Practical

M Pharm 2nd Semester

 Targeted drug delivery: History, concept, types and key elements

Unit-3: Aseptic Procedures for Sterile Pharmaceuticals (6 hrs)

Unit -5: Nutraceuticals (2 hrs)

Unit-7: Application of novel approaches in cosmetic formulations (4 hrs)

MPHAR 621T: Pharmacotherapeutics I [45 hrs]

 Recognize and resolve preventable drug-related problems.

Unit-2: Cardiovascular system (8 hrs)

Unit-8: Nervous system (4 hrs)

After the completion of the course, students are able to:

 Understand and apply suitable statistics to evaluate the research findings.

 Know the different methods of research design and their application.

Unit -1: Biostatics (8hrs)

Simple Definitions of Observation, Random Variable, Quantitative Variables, Qualitative

1.2. Different tests and their application in research (8 hrs)

1.3. Biostatistics in Epidemiology (7 hrs)

Origins of a research question, Characteristics of a good research question • Developing the

Unit -3: Research Studies (15 hrs)

Introduction to Research studies, Observational Study: Cohort Studies (Prospective cohort

Randomization in Clinical Trials: Definition, Types of bias in randomization, Selection bias,

Clinical Trial Documents: NHRC guidelines, Guidelines to the preparation of documents,

MPHAR 623T: Clinical Pharmacy II [45 hrs]

Unit-6: Drug & Poison information (4 hrs)

Unit-8: Critical evaluation of biomedical literature (3 hrs)

Unit- 10: Pharmaceutical care of critical patients (15 hrs)

MPHAR 623P: Clinical Pharmacy II Practical

MPHAR 624 T: Hospital and Community Pharmacy [45 hrs]

 Understand the organizational structure of hospital pharmacy

Unit - 1: Introduction to Hospitals (8 hrs)

Definition, classification, organizational structure Hospital Pharmacy: Definition, Relationship

Unit – 2: Hospital Formulary (6 hrs)

Unit – 3: Education and training (10 hrs)