hospital and clinical pharmacy

ACADEMIC REGULATIONS, COURSE STRUCTURE

AND DETAILED SYLLABUS

FOR

MASTER PHARMACY TWO YEAR POST GRADUATE COURSE

(Applicable for the batches admitted from 2012-2013)

ANURAG GROUP OF INSTITUTIONS

(AUTONOMOUS)

SCHOOL OF PHARMACY

Venkatapur, Ghatkesar, Hyderabad – 500088

M. Pharm (HOSPITAL AND CLINICAL PHARMACY)

2012-2013 2

Academic Regulations for M. Pharm (Regular) Degree Course (Effective for the students admitted into I year from the Academic Year 2012-2013 onwards)

The M.Pharm Degree of Jawaharlal Nehru Technological University

Hyderabad shall be conferred on candidates who are admitted to the program

and fulfill all the requirements for the award of the degree.

1.0 ELIGIBILITY FOR ADMISSIONS:

Admission to the above program shall be made subject to the eligibility,

qualifications and specialization prescribed by the university from time to

time.

Admissions shall be made on the basis of merit rank obtained by the

qualifying candidate at an Entrance Test conducted by the University or on

the basis of any other order of merit approved by the University, subject to

reservations prescribed by the university from time to time.

2.0 AWARD OF M.PHARM DEGREE:

2.1 A student shall be declared eligible for the award of the M.Pharm degree,

if he pursues a course of study and completes it successfully for not less

than two academic years and not more than four academic years.

2.2 A Student, who fails to fulfil all the academic requirements for the award

of the degree within four academic years from the year of his admission,

shall forfeit his seat in M.Pharm course.

2.3 The minimum instruction period for each semester is 90 clear instruction

days.

3.0 COURSE OF STUDY The following specializations are offered at present for the M.Pharm

Course of study.

1. Hospital and Clinical Pharmacy

2. Pharmaceutics

3. Industrial Pharmacy

4. Pharmacology

5. Pharmaceutical Analysis and Quality Assurance

4.0 ATTENDANCE:

The programs are offered on a unit basis with each subject being

considered as an unit.

4.1 A candidate shall be deemed to have eligibility to write end semester

examinations in a subject if he has put in at least 75% of attendance in the

subject.

2012-2013 3

4.2 Shortage of attendance up to 10% in any subject (i.e. 65% and above and

below 75%) may be condoned by the college Academic council on

genuine and valid reasons on representation by the candidate with

supporting evidence.

4.3 A candidate shall get minimum required attendance at least in three (3)

theory subjects in the present semester to get promoted to the next

semester. In order to qualify for the award of the M.Pharm Degree, The

candidate shall complete all the academic requirements of the subjects, as

per the course structure.

4.4 Shortage of attendance below 65% shall in no case be condoned

4.5 A stipulated fee shall be payable towards condonation of shortage of

attendance.

5.0 EVALUATION:

The performance of the candidate in each semester shall be evaluated

subject-wise, with a maximum of 100 marks for theory and 100 marks for

practical’s, on the basis of internal evaluation and End semester Examination.

For the theory subjects 60 marks shall be awarded based on the performance

in the End semester Examination, 30 marks shall be awarded based on the

internal evaluation and 10 marks for assignment.

5.1 For theory subjects, during the semester there shall be 2 midterm

examinations. Each midterm examination consists of one subjective paper

and one assignment. The subjective paper is for 30 marks with duration of 2

hours. Subjective paper of each semester shall contain 2 parts Section-A &

Section-B. Section-A comprises of five (5) short answer type of questions.

The student has to answer all the questions from section-A. Each question

carries two marks. A total of ten marks are allocated to section-A. Section-

B consists of five (5) essay type of questions from which the student has to

answer three questions. Each question carry not more than seven (7) marks.

A total of 20 marks are allocated for section-B. The questions in the first

midterm examination includes the topics of first 2.5 units while the

questions in the second midterm examination includes the topics of

remaining 2.5 units. The assignments should be submitted before the

conduct of respective midterm examinations.

The total marks secured by the student are out of 40 marks (30marks from

midterm examination and 10 marks from assignment) in an internal

examination for a subject. The average of marks secured in two midterm

examinations shall be taken as final marks. If he/she is absent for any test /

assignment, he/she are awarded zero marks for that test / assignment.

5.2 For practical subjects, 60 marks shall be awarded based on the performance

in the End Semester Examinations, 40 marks shall be awarded based on the

day-to-day performance as internal marks.

2012-2013 4

5.3 There shall be two seminar presentations during I year I semester and II

Semester. For seminar, a student under the supervision of a faculty member,

shall collect the literature on a topic and critically review the literature and

submit it to the department in a report from and shall make an oral

presentation before the departmental committee. The departmental

committee consists of Head of the department, supervisor and two other

senior faculty members of the department. For each seminar there will be

only internal evaluation of 50 marks. A candidate has to secure a minimum

of 50% to be declared successful.

5.4 There shall be a Comprehensive Viva-Voce in II year I Semester. The

comprehensive Viva-Voce will be conducted by a committee consisting of

Head of the Department and two Senior Faculty members of the

Department. The comprehensive Viva-Voce is aimed to assess the students’

understanding in various subjects he/she studies during the M.Pharm course

of study. The Comprehensive viva-voce valued for 100 marks by the

Committee. There are no internal marks for the Comprehensive viva-Voce

5.5 A candidate shall be deemed to have secured the minimum academic

requirement in a subject if he secures a minimum of 40% of marks in the

End Examination and a minimum aggregate of 50% of the total marks in

the End Semester Examination and Internal Evaluation taken together.

5.6 In case the candidate does not secure the minimum academic requirement in

any subject (as specified in 4.3) he has to reappear for the End Examination

in that subject. A candidate shall be given one chance to re-register for each

subject provided the internal marks secured by a candidate are less than

50% and he has failed in the end examination. In such case candidate must

re-register subject(s) and secure required minimum attendance. Attendance

in the re-registered subject(s) has to be calculated separately to become

eligible to write the end examination in the re-registered subject(s). The

attendance of re-registered subject(s) shall be calculated separately to

decide upon the eligibility for writing the end examination in those

subject(s). In the event of taking another chance, the internal marks and end

examination marks obtained in the previous attempt are nullified.

5.7 In case the candidate secures less than the required attendance in any

subject(s), he shall not be permitted to appear for the End Examination in

that subject(s). He shall re-register the subject when next offered.

5.8 Laboratory examination for M.Pharm courses must be conducted with two

Examiners, one of them being Laboratory Class Teacher and second

examiner shall be other Laboratory Teacher.

2012-2013 5

6.0 EVALUATION OF PROJECT /DISSERTATION WORK:

Every candidate shall be required to submit thesis or dissertation after

taking up a topic approved by the project review committee.

6.1 A Project Review Committee (PRC) shall be constituted with Principal as

chair person, Heads of all the departments which are offering the M.Pharm

programs and two other senior faculty members.

6.2 Registration of Project work: A candidate is permitted to register for the

project work after satisfying the attendance requirement of all the subjects

(theory and practical subjects).

6.3 After satisfying 6.2, a candidate has to submit, in consultation with his

project supervisor, the title, objective and plan of action of his project

work to the Departmental Committee for its approval. Only after obtaining

the approval of Departmental Committee the student can initiate the

Project work.

6.4 If a candidate wishes to change his supervisor or topic of the project he

can do so with the approval of Departmental Committee. However, the

Departmental Committee shall examine whether the change of

topic/supervisor leads to a major change of his initial plans of project

proposal. If so, his date of registration for the project work starts from the

date of change of Supervisor or topic as the case may be.

6.5 A candidate shall submit status report (in a bound-form) in two stages at

least with a gap of 3 months between them.

6.6 The work on the project shall be initiated in the beginning of the second

year and the duration of the project is for two semesters. A candidate is

permitted to submit project thesis only after successful completion of

theory and practical course with the approval of PRC not earlier than 40

weeks from the date of registration of the project work. For the approval of

PRC the candidate shall submit the draft copy of thesis to the Principal

(through Head of the Department) and shall make an oral presentation

before the PRC.

6.7 Three copies of the Project Thesis certified by the supervisor shall be

submitted to the College/School/Institute.

6.8 The thesis shall be adjudicated by one examiner selected by the Institution.

For this, Chairmen, BOS of the respective departments shall submit a

panel of 5 examiners, who are eminent in that field with the help of the

concerned guide and senior faculty of the department.

6.9 If the report of the examiner is not favourable, the candidate shall revise

and resubmit the thesis, in the time frame as prescribed by PRC. If the

report of the examiner is unfavourable again the thesis shall be summarily

rejected.

2012-2013 6

6.10 If the report of the examiner is favourable, viva-voce examination shall

be conducted by a board consisting of the supervisor, Head of the

Department and the examiner who adjudicated the Thesis.

The Board shall jointly report candidates work as:

A. EXCELLENT’

B. GOOD

C. SATISFACTORY

D. UNSATISFACTORY

Head of the Department shall coordinate and make arrangements for the

conduct of viva-voce examination. If the report of the viva-voce is

unsatisfactory, the candidate will retake the viva-voce examination after three

months. If he fails to get a satisfactory report at the second viva-voce

examination, he will not be eligible for the award of the degree.

7.0 AWARD OF DEGREE AND CLASS

After a student has satisfied the requirement prescribed for the completion of

the program and is eligible for the award of M.Pharm Degree he shall be

placed in one of the following three classes.

Classes Awarded % of marks to be secured

First Class with Distinction 70% and above

First Class Below 70% but not less than 60%

Second Class Below 60% but not less than 50%

(The marks in internal evaluation and end examination shall be shown separately in the

marks memorandum)

8.0 WITH-HOLDING OF RESULTS:

If the candidate has not paid any dues to the institution or if any case of in-

discipline is pending against him, the result of the candidate will be withheld

and he will not be allowed into next higher semester. The issue of the degree

is liable to be withheld in such cases.

9.0 TRANSITORY REGULATIONS:

Candidate who have discontinued or have been detained for want of

attendance or who have failed after having undergone the course are eligible

for admission to the same or equivalent subjects as and when subjects are

offered, subject to 5.5 and 2.0

2012-2013 7

10.0 GENERAL:

10.1 The academic regulations should be read as a whole for purpose of any

interpretation.

10.2 In case of any doubt or ambiguity in the interpretation of the above

rules, the decision of the Academic Council is final.

10.3 The institution may change or amend the academic regulations and

syllabus at any time and the changes and amendments made shall be

applicable to all the students with effect from the date notified by the

institution.

10.4 Wherever the word he, him or his occur, it will also include she, her and

hers. There shall be no transfers within the constituent colleges of Jawaharlal

Nehru Technological University.

2012-2013 8

MALPRACTICES RULES DISCIPLINARY ACTION FOR IMPROPER CONDUCT IN EXAMINATIONS

Nature of Malpractices/Improper

conduct

Punishment

If the candidate:

1. (a) Possesses or keeps accessible in

examination hall, any paper, note

book, programmable calculators,

cell phones, pager, palm,

computers or any other form of

material concerned with or related

to the subject of the examination

(theory or practical) in which he is

appearing but has not made use of

(material shall include any marks

on the body of the candidate which

can be used as an aid in the subject

of the examination)

Expulsion from the examination hall and

cancellation of the performance in that

subject only

(b) Gives assistance or guidance or

receives it from any other

candidate orally or by any other

body language methods or

communicates through cell phones

with any candidate or persons in or

outside the exam hall in respect of

any matter.



subject only of all the candidates involved.

In case of an outsider, he will be handed

over to the police and a case is registered

against him.

2. Has copied in the examination hall

from any paper, book,

programmable calculators, palm

computers or any other form of

material relevant to the subject of

the examination (theory or

practical) in which the candidate is

appearing.



subject and all other subjects the candidates

has already appeared including practical

examinations and project work and shall

not be permitted to appear for the

remaining examinations of the subjects of

that semester/year. The hall ticket of the

candidate is to be cancelled and sent to the

controller of examinations, AGI.

3. Impersonates any other candidate

in connection with the

examination.

The candidate who has impersonated shall

be expelled from examination hall. The

candidate is also debarred and forfeits the

seat. The performance of the original

candidate who has been impersonated,

shall be cancelled in all the subjects of the

examination(including practical’s and

project work) already appeared and shall

not be allowed to appear for examinations

2012-2013 9

of the remaining subjects of that

semester/year. The candidate is also

debarred for two consecutive semesters

from class work and all semester

examinations. The continuation of the

course by the candidate is subject to the

academic regulations in connection with

forfeiture of seat. If the imposter is an

outsider, he will be handed over to the

police and a case is registered against him.

4. Smuggles in the Answer book or

additional sheet or takes out or

arranges to send out the question

paper during the examination or

answer book or additional sheet,

during or after the examination.



subject and all other subjects the candidates

has already appeared including practical


not be permitted for the remaining

examinations of the subjects of that






academic regulations in connection with

forfeiture of seat.

5. Uses objectionable, abusive or

offensive language in the answer

paper or in letters to the examiners

or writes to the examiner

requesting him to award pass

marks.

Cancellation of the performance in that

subject.

6. Refuses to obey the orders of the

Chief Superintendent/Assistant-

Superintendent/ any officer on duty

or misbehaves or creates

disturbance of any kind in and

around the examination hall or

organizes a walk out or instigates

others to walk out, or threatens the

officer-in-charge or any person on

duty in or outside the examination

hall of any injury to his person or

to any office relations whether by

words, either spoken or written or

by signs or by visible

representation, assaults the officer-

in-charge, or any person on duty in

In case of students of the college, they shall

be expelled from examination halls and

cancellation of their performance in that

subjects and all other subjects the

candidate(s) has (have) already appeared

and shall not be permitted to appear for the

remaining examinations of the subjects of

that semester/year. The candidates also are

debarred and forfeit their seats. In case of

outsiders. They will be handed over to the

police and a police case is registered

against them.

2012-2013 10

or outside the examination hall or

any of his relations, or indulges in

any other act of misconduct or

mischief which result in damage to

or destruction of property in the

examination hall or any part of the

college campus or engages in any

other act which in the opinion of

the officer on duty amounts to use

of unfair means or misconduct or

has the tendency to disrupt the

orderly conduct of the examination.

7. Leaves the exam hall taking away

answer script or intentionally tears

of the script or any part thereof

inside or outside the examination

hall.


cancellation of performance in that subject

and all the other subjects the candidates has

already appeared including practical









academic regulation in connection with

forfeiture of seat.

8. Posses any lethal weapon or

firearm in the examination hall.









debarred and forfeits the seat.

9. If student of the college, who is

not a candidate for the particular

examination or any person not

connected with college indulges in

any malpractice or improper

conduct mentioned in clause 6 to 8

Student of the college’s expulsion from the

examination hall and cancellation of

performance in that subject and all the

other subjects the candidates has already

appeared including practical examinations

and project work and shall not be permitted

for the remaining examinations of the

subjects of that semester/year. The

candidate is also debarred and forfeiture the

seat.

Person(s) who do not belong to the

2012-2013 11

College will be handed over to police and,

a police case will be registered against

them.

10. Comes in a drunken condition to

the examination hall.








semester/year.

11. Copying detected on the basis of

internal evidence, such as, during

valuation or during special

scrutiny.

Cancellation of the performance in that

subject and all other subjects the candidate

has appeared including practical

examinations and project work of the

semester/year examinations.

12. If any malpractice is detected

which is not covered in the above

clauses 1 to 11 shall be reported to

the Malpractices committee, AGI

for further action to award suitable

punishment.

2012-2013 12

M. PHARM. (HOSPITAL AND CLINICAL PHARMACY)

COURSE STRUCTURE AND SYLLABUS

I YEAR I SEMESTER

Subject

Code

Group Subject L P Credits

A41001 HCPT Modern Pharmaceutical Analytical

Techniques

3 0 3

A41002 HCPT Advanced Biostatistics and

Research Methods

3 0 3

A41012 HCPT Pathophysiology and Applied

Pharmacotherapeutics - I

3 0 3

A41013 HCPT Advanced Clinical Pharmacy 3 0 3

A41014 HCPT Community Patient

Care/Community Pharmacy

3 0 3

A41210 Lab Pathophysiology and Applied

Pharmacotherapeutics – I Lab

0 3 2

A41211 Lab Advanced Clinical Pharmacy- Lab 0 3 2

A41212 Seminar - - 2

Total Credits (5 Theory + 2 Labs + Seminar) 21

II SEMESTER

Subject

Code

Group Subject L P Credits

A42001 HCPT Intellectual Property Rights & Drug

Regulatory Affairs

3 0 3

A42002 HCPT Screening methods and clinical

research

3 0 3

A42012 HCPT Clinical Pharmacokinetics and

Therapeutic Drug Monitoring

3 0 3

A42013 HCPT Pathophysiology and Applied

Pharmacotherapeutics – II

3 0 3

A42014 HCPT Hospital Pharmacy 3 0 3

A42210 Lab Pathophysiology and Applied

Pharmacotherapeutics – II Lab

0 3 2

A42211 Lab Hospital Pharmacy – Lab 0 3 2

A42212 Seminar - - 2

Total Credits (5 Theory + 2 Labs + Seminar) 21

2012-2013 13

II YEAR I SEMESTER

Subject

Code

Group Subject Name L P Credits

A43210 Comprehensive Viva - - 2

A43211 Project Seminar - I - - 2

A43212 Project Work - - 18

Total Credits 22

II YEAR II SEMESTER

Subject

Code

Group Subject Name L P Credits

A44207 Project Work 0 0 20

A44208 Project Seminar - II 0 0 2

Total Credits 22

2012-2013 14

I Year – I Sem. M.Pharmacy (HCP)

(A41001) MODERN PHARMACEUTICAL ANALYTICAL

TECHNIQUES

Unit I

a. Column Chromatography: Adsorption and partition, theory, preparation,

procedure and methods of detection

b. Thin Layer Chromatography: Theory, preparation, procedures, detection

of compounds

c. Paper Chromatography: Theory, different techniques employed, filter

papers used, qualitative and quantitative detection

d. Counter – current extraction, solid phase extraction techniques, gel

filtration

Unit II

a. Gas chromatography: Introduction, fundamentals, instrumentation,

columns: preparation and operation, detection, dramatization.

b. HPLC: Principles and instrumentation, solvents and columns used,

detection and applications

Unit III

a. UV-Visible spectroscopy: Introduction, electromagnetic spectrum,

absorbance laws and limitations, instrumentation-design and working

principle, chromophore concept, auxochromes, Wood-Fisher rules for

calculating absorption maximum, applications of UV-Visible

spectroscopy

b. IR spectroscopy: Basic principles-Molecular vibrations, vibrational

frequency, factors influencing vibrational frequencies, sampling

techniques, instrumentation, interpretation of spectra, FT-IR, theory and

applications

Unit IV

Mass spectroscopy: Theory, ionization techniques: electron impact

ionization, chemical ionization, field ionization, fast atom

bombardment, plasma desorption, fragmentation process: types of

fission, resolution, GC/MS, interpretation of spectra and applications

for identification and structure determination

2012-2013 15

Unit V

NMR: Theory, instrumentation, chemical shift, shielding and

deshielding effects, splitting of signals, spin-spin coupling, proton

exchange reactions, coupling constant(J), nuclear overhauser

effect(NOE), 13

C NMR spectra and its applications, 2D-NMR, COSY

and applications in pharmacy

Text Books:

1. Sharma BK (2007). Instrumental Methods of Chemical Analysis. 16th

ed. Delhi: Goel Publishing House.

2. Sharma YR (2011). Organic spectroscopy. 4th ed. New Delhi: S.Chand

& Co.

3. Connors KA (2010). A Text book of Pharmaceutical Analysis. 3rd ed.

India: Wiley India .

4. Vogel AI (2009). Text book of Quantitative Chemical Analysis. 6th ed.

Delhi: Pearson.

5. Beckeet AH (2002). Stenlake J.B Practical Pharmaceutical Chemistry .

4th ed. New Delhi: CBS Publication.

6. Finar IL (2009). Organic Chemistry. 6th ed. New Delhi: Pearson.

7. William Kemp (2005). Organic Spectroscopy. New York: Palgrave.

8. Grrett DC (2007). Quantitative Analysis of Drugs. 3rd ed. New Delhi:

CBS Publishers.

9. Sethi PD (2010). Quantitative Analysis of Drugs in Pharmaceutical

Formulations . 3rd ed. New Delhi: CBS Publishers.

10. Silverstein (2010). Spectrophotometric identification of Organic

Compounds . 6th ed. New Delhi: John Wiley.

11. Seth PD (1996). HPTLC: High Performance Thin Layer

Chromatography. New Delhi: CBS publishers.

12. India. Ministry of Health and Family Welfare, Indian Pharmacopoeia

Commission (2007). Indian Pharmacopoeia. Ghazibad (Raj Nagar):

Indian Pharmacopoeia Commission.

2012-2013 16


(A41002)ADVANCED BIOSTATISTICS AND RESEARCH

METHODS

Unit-I :

Developing a research question, Resources for research question,

Literature Review: Traditional Qualitative Review

Meta-Analysis—A Quantitative Review

Preparation of Research Proposal

Variables—Definition of Variable, Types of variables—Dependent and

Independent variables, Confounded variables, Measurement of variables,

Types of measurement scales and their comparison. Reliability and Validity of

Measurements.

Unit-II : Validity, Types of validity—Internal validity, Construct validity, External

validity, Threats to validity.

Control: Subject as own control (Within Subject control), Statistical control.

Unit-III:

Non-experimental Research:

Part 1—Observational, Archival and Case-Study Research: The Hermeneutic

Approach.

Observational Research: Naturalistic Observation, Participant-Observer

Research.

Archival Research: Archival Data Collection and Compilation.

Case Studies: Characteristic of Case Studies.

Non-experimental Research: Survey Research—Designing of Questionnaire,

Methods of Administration, Response Rates. Types of Samples—Haphazard

Samples, Purposive Samples, Convenience Samples and Probability Samples.

Unit-IV :

True Experiments: Single-Factor Designs, Factors, Levels, Conditions, and

Treatments. Within-Subject Designs.

True Experiments Part-2—Factorial Designs—Main Effects, Interactions, A

Mixed Factorial Design.

Unit V :

Single-Subject Experiments: Advantages and Disadvantages.

Quasi Experiments: The differences between Quasi and True Experiments.

Design without Control Groups—Interrupted Time Series Designs and

Repeated Treatment Designs.

2012-2013 17

Text Books

1. Donald H. Mc Burney -Theresa L. White (2009). Research Methods. New

Delhi: Cengage learning India Pvt. Ltd.

2. Hooda-R.P (2000). Statistics for business and economics. 3rd ed. New

Delhi: MC. Millan Business books.

3. Tiwar N.K.,Rao G.N (2008). Biostatistics & Computer applications.

Sultan Bazar, Hyderabad, AP: Pharma Med Press.

4. Lippincot Williams (2006). Remingtons Pharmaceutical Sciences. 21st ed.

Noida, India: B.I. Publications.

5. Leon Lachman, Herbert A. Lieberman (2009):The Theory and Practice

of industrial Pharmacy ,2 nd ed, New Delhi:CBS Publishers

and Distributors.

2012-2013 18


(A41012) PATHOPHYSIOLOGY AND APPLIED

PHARMACOTHERAPEUTICS – I

Pathophysiology and applied Pharmacotherapeutics of diseases associated

with following system/diseases with of special reference to the drug of choice.

Unit-I Cardiovascular

Acute Coronary Syndrome

Hypertension

Congestive Cardiac Failure

Ischaemic Heart Disease (Angina Pectoris, Myocardial

Infarction)

Arrythmias

Hyperlipidarmia

Cardiopulmonary Arrest

Shock

Cardiomyopathy

Unit-II Respiratory System

Introduction to pulmonary function tests

Asthma

Chronic Obstructive Pulmonary Disease

Drug Induced Pulmonary Diseases

Hydrogen Ion Hemostasis & Blood Gases(external and

internal respiration).

Unit-III Haematological Diseases & Nephrology

Anaemia’s

Thalassemia

Drug Induced Haematological Diseases

Venous Thromboembolism

Acute Renal Failure / Chronic Renal Failure

Renal Dialysis and Transplantation

Drug Dosing In Renal Failure / Impairment

Drug Induced Renal Diseases

End-Stage Renal Disease

Diuretic Therapy

Potassium Depletion

Hyperkaelemia

Alakalosis

2012-2013 19

Unit-IV Gastroentrology & Rheumatology

Gastro – Oesophageal Reflux Disease

Peptic Ulcer Disease

Inflammatory Bowel Disease

Hepatitis, Viral

Jaundice & Cirrhosis

Diarrhoea & Constipation

Drug Induced Liver Disease

Gout & Hyperuricemia

Rheumatoid Arthritis

Osteoarthritis

Spondylitis

NAFLD

Unit-V Endocrinology &Dermatology

Adernal Gland Disorders

Diabetic Mellitus

Thyroid Disorders

Osteoporosis

Acne Vulgaris

Psoriasis

Scabies

Eczema

Drug Induced Skin Disorders

Vetiligo

Text Books

1. JG Hardman, LE Limbard (2001). Goodman & Gilman's- The

Pharmacological Basis of Therapeutics: McGraw-Hill publications.

2. Joseph DiPiro, Robert L, Talbert, Gary Yee, Gary Matzke, Barbara

Well, Michael Posey L (2011). Pharmacotherapy: A Pathophysiologic

approach. 8th ed: McGraw-Hill publications.

3. Roger Walker Clive Edwards (2003). Clinical pharmacy and

therapeutics. 3rd ed.: Churchill Living stone publications.

4. Dennis Kasper L, Eugene Braunwald, Stephen Hauser, Dan Longo,

Larry Jameson J, Anthony Fauci S (2005). Principles of Internal

Medicine. 16th ed.: McGraw Hill Publications.

5. Dr Mary Lee (1992). Basic Skills in Interpreting Laboratory Data. 4th

ed.: American Society of Health System Pharmacists.

6. Eric Herfindal T, Joseph Hirschman L (1984). Clinical Pharmacy and

Therapeutics. 3rd ed.: Williams & Wilkins publications.

2012-2013 20

7. GK Mc Evoy (2004). American Hospital Formulary Services: American

Society of Hospital Pharmacists.

8. Graeme S Avery (1980). Drug treatment- principles and practice of

clinical pharmacology and therapeutics. 2nd ed.: Adis Press

publications.

9. Mary Anne Koda-Kimble (2008). Applied Therapeutics. 9th ed.:

Wolters Kluwer Health/Lippincott Williams & Wilkins publications.

10. Ramzi Cotran S, Vinay Kumar, Tucker Collins, Stanley Leonard

Robbins (1999). Robbins pathologic basis of disease. 6th ed. : Saunders

publications.

11. Relevant review articles from recent medical and pharmaHCPtical

Journals.

12. Russell Greene J, Norman Harris D (2008). Pathology and Therapeutics

for pharmacists - a basis for clinical pharmacy practice. 3rd ed.:

Pharmaceutical Press Chapman and Hall Publications.

13. Sir Stanley Davidson, Christopher Haslett (2002). Davidson’s

Principles and Practice of Medicine. 16th ed.: Churchill Living stone

publications.

14. Society of Hospital Pharmacists of Australia (1997). Practice Standards

and Definitions: The Society publications.

2012-2013 21


(A41013) ADVANCED CLINICAL PHARMACY

Unit-I Introduction to clinical pharmacy

Definition, Scope, History and Development of clinical

pharmacy

Unit-II Professional Activities of a Clinical Pharmacist

Ward Round Participation

Medication History Interview

Drug Therapy Monitoring (Medication Chart Review, Clinical

Review, Therapeutic Drug Monitoring & Pharmacist

Interventions)

Adverse Drug Reaction Management

Drug Information & Poison Information

Patient Counseling

PharmaHCPtical Care

Drug Utilization evaluation (DUE) & Review (DUR)

Quality Assurance of Clinical Pharmacy Services

Unit-III

A) Patient Data Analysis

The patient’s case history, its structure & use in evaluation of

drug therapy, presentation of cases.

Communication skills, including patient counseling

techniques, medication history interview, teaching skills.

Understanding common medical abbreviations &

terminologies used in clinical practices.

B) Clinical Laboratory Tests used in the evaluation of diseases states

& interpretation of test results.

Haemotological, Liver function, Renal function, Thyroid

function tests.

Medical imaging techniques

Tests associated with cardiac disorders

2012-2013 22

Fluid & Electrolyte balance

Common tests in urine, sputum, faeces, CSF.

Sensitivity screening for common pathogenic microorganisms,

its significance, resistance in disease states & selection of

appropriate anti-microbial regimens.

Pulmonary function tests.

Unit-IV

A) Drug & Poison Information

Introduction to Drug information, resources available,

Systematic approach in answering drug information serve

queries

Critical evaluation of drug information and literature

Preparation of written and verbal reports

Establishing a drug information center

Poisons information-organisation and information resources

Poisons management in drug dependence and drug abuses

(opiates, cocaine, amphetamines, alcohols, benzodiazepines,

barbiturates, tobacco). Role of emetics, anti- emetics and

respiratory stimulants.

B) Evidence Based Medicine

Formulating Clinical Questions

Searching for the best evidence

Critical Appraisal of the evidence

Applying evidence to patients

Evaluation

Unit-V A) Medication Error and Medication Adherence

Categories and causes of medication error

Performance indicators of the medication use process

Categories of medication non-adherence

Role of pharmacists at medication error and medication

adherence

B) Pharmacovigilance

Scope, Definition and Aims of Pahrmacovigilance

2012-2013 23

Adverse Drug Reactions – Classification, Mechanism,

Predisposing Factors, Causality Assessment [different scaled

used].

Reporting, evaluation, monitoring, preventing & management

of ADR’s

Role of pharmacist in management of ADR’s

Text Books

1. Hansen K N Parthasarath G (2004). A text book of clinical pharmacy

practice – Essential concepts and skills. Orient longman Publications.

2. Joseph Price Remington (1990). Remington Pharmaceutical sciences.

16th ed. Mack Pub. Co. Publications..

3. Leon Shargel Alan H Mutnick Paul F Souney Larry N Swanson

(2004).Comprehensive pharmacy review. 5th ed. Lippincott Williams &

Wilkins publications.

4. Leon Shargel Andrew Yu Susanna Wu-Pong (2012). Applied

Biopharmaceutics & Pharmacokinetics. 6th ed. McGraw Hill

Professional publications.

5. Malcolm Rowland Thomas Tozer N (1995). Clinical Pharmacokinetics-

concepts and applications. 3rd ed. Williams and Wilkins Publication.

6. Relevant review articles from recent medical and pharmaceutical

literature.

7. Scott L Traub (1996). Basic skills in interpreting laboratory data. 2nd

ed. American Society of Health System Pharmacists Inc publications.

8. Sharon Straus E (2005). Evidence Based Medicine. 3rd ed. Churchill

Livingtone publications.

9. Society of Hospital Pharmacists of Australia (1997). Practice Standards

and definitions – the Society of Hospital Pharmacists of Australia. The

society publications.

2012-2013 24


(A41014) COMMUNITY PATIENT CARE/COMMUNITY PHARMACY

Unit-I

Introduction to the concept of community pharmacy – its activities

and professional responsibilities

a) The role of community pharmacy and its relationships to other local

health care providers

b) Prescribed medication order- Interpretation and legal requirements

c) Over the counter (OTC) sales

d) OTC medication list and counseling, Rational use of common OTC

medications

(Vitamins and tonics, iron preparations, analgesics, NSAIDs, cough

mixtures, anti-diarrial preparations)

Unit-II

Health Education and Community Pharmacy: Family planning, first aid,

communicable disease prevention, smoking cessation, screening

programs.

Unit-III

a) Services to nursing homes/clinics.

b) Community Pharmacy Management: Financial, material and staff

management, infrastructure requirements, drug information resources,

computers in community pharmacy.

c) Code of ethics for community pharmacy

d) Poly pharmacy and its implications

Unit-IV

A)Communication skills – Principles and elements of communication

skills, non -verbal communication in pharmacy, barriers in

communication, listening skills, questioning skills, explaining Skills.

Patient counseling in community pharmacy

2012-2013 25

B) Education and training staff, training and continuing education for

pharmacists, pharmacy students, Medical staff and students, nursing

skills , explaining skills and ethics in communication

Unit-V

A) Public Health Policy and Health Care System – National &

International

B) Concept of Rational Use of Drugs – Importance of rational drug

use, pharmacists role, drug use indication, guidelines for rational

prescribing.

C) Code of ethics for community pharmacists

Text Books

1. William E Hassan (1986). Hospital Pharmacy. 5th ed. Lea & Febiger

publications.

2. Allwood M C Fell J T (1980). Textbook of hospital pharmacy. John

Wiley & Sons publications.


clinical pharmacology and therapeutics. 2nd ed. india: Adis Press

publications.


16th ed. india: Mack Pub. Co. Publications.

5. Relevant review articles from recent medical and pharmaHCPtical

literature

6. Sharon Straus E (2005). Evidence Based Medicine. 3rd ed. Churchill

Livingtone publications.

2012-2013 26



PHARMACOTHERAPEUTICS-I LAB

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 and do a tutorial as well as case presentation in

the following clinical conditions. The students have to make at leas 10 case

presentations covering most common diseases found in the hospital to which

the college is attached. The student should also submit a record of the cases

presented. The list of clinical cases presented should include follow-up of the

clinical cases mentioned below from the day of admission till discharge and

presented in the SOAP (Subjective, Objective, Assessment and Plan) format.

The cases may be selected from the following departments

1. Cardiology

2. Respiratory System

3. Haematological Diseases & Nephrology

4. Gastroenterology & Rheumatology

5. Endocrinology & Dermatology

Assignments

The students are required to submit a minimum of three 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 in the same.

2012-2013 27


(A41211) ADVANCED CLINICAL PHARMACY – LAB

Patient medication history interview, answering drug information

questions, patient medication counselling, participation in ward rounds.

Case studies related to laboratory investigations covering the topics dealt in

theory class.

1. Answering drug information questions (4)

(Queries related to Dosage, administration, contraindications,

adverse drug reactions, drug use in pregnancy and lactation, drug

profile, efficacy and safety)

2. Patient medication counselling – (3) Common diseases like

Diabetes, Hypertension, Asthma, COPD, Acute Renal Failure,

chronic Renal Failure.

3. Case studies related to laboratory investigations (4) – LFT,

Hematology, Thyroid, Renal, Cardiac Enzymes.

4. Patient medication history interview (2)

5. Medication order review (2)

6. Detection and assessment of adverse drug reaction and their

documentation (3)

Assignments

Drug information,

Patient medication history interview

Patient medication counseling

Problem solving in clinical Pharmacokinetics

Literature evaluation pertaining to therapeutic range used in

therapeutic monitoring of any two drugs frequently subjected for

TDM.

Critical appraisal of two recently published articles in the biomedical

literature, which deals with a drug or therapeutic issue.

2012-2013 28

I Year – II Sem. M.Pharmacy (HCP)

(A42001) INTELLECTUAL PROPERTY RIGHTS AND DRUG

REGULATORY AFFAIRS

Intellectual Property Management:

Unit I : Types of IP, definition, scope, objectives Patents, types, contents of

patent, claims and types of claims, key terminology used in patents

(Application, examiner, prior art, priority, specifications, provisional

and non-provisional applications, claims, applicant, assignee, inventor,

anticipation, obviousness, infringement and invalidation).

Unit II : Filing process, provisional and non-provisional applications, PCT

filing process, Advantages, Patentability requirement: (Novelty,

Utility, non-obviousness, enablement and best mode), Understanding

on infringement, invalidation and litigations

Unit III : Indian patent act and post 1995 amendments US and European

patent act Trademarks, copyrights, designs International

conventions, GATT, TRIPS, Paris convention, Patent cooperation

treaty.

Regulatory Affairs:

Unit IV: National drug regulatory requirements, national drug policy, Drugs

and Cosmetics Act and its amendments, over view of schedules,

details of schedule M, Schedule Y. US FDA, orange book, FDA

guidelines on IND, new drug approvals (NDA), ANDA approvals,

SUPAC changes and understanding on 505 (b) (2) applications.

Unit V : Office of generic drugs, recommendations on dissolution and bio-

equivalence requirements, types of ANDA filing (P I, II, III and

IV) PIV ANDA filing and process involved till the approval

Exclusivities (NCE, NS, NP, NDF, PED, ODE, PC exclusivity)

European regulatory agency, types of filing process (Centralized,

de-centralized, RMS countries), SPCs, SPC exclusivities, data

exclusivities, WHO, WIPO, ICH objectives and guidelines.

2012-2013 29

Text Books:

1. Guarino (2002). New drug approval process. 3rd ed. New York: Marcel

Dekker Publication.

2. Commercial Manual on Drugs and Cosmetics (2004) 2nd

edition.

3. Vijay Malik (2006). Drugs and Cosmetics act. 11th ed. Lucknow:

Publications Eastern Book.

4. S.H. Wiling (2003). Good Manufacturing Practices for Pharmaceuticals.

2nd ed. New York.: Marcel Decker.

5. P.Das and Gokul Das., Protection of Industrial Property rights.

6. S.N. Katju (2009). Hand book of Law of Drugs. 5th ed. Allahabad: Law

Publications.

7. Original Laws Published by Govt. of India

8. Hussain Laws of drugs in India,

9. R.A.Guarino, (2009). New Drug Approval Process. 4th ed. New York.:

Marcel Decker.

10. fda.org,wipo.int,patentlawlinks.com, hc-sc.gc.ca,ich.org

2012-2013 30


(A42002) PHARMACOLOGICAL SCREENING METHODS AND

CLINICAL RESEARCH

Unit I

Care Handling and breeding techniques of laboratory animals, Regulations for

laboratory animals, CPCSEA guidelines, alternatives to animal studies, Good

laboratory Practices.

Unit II

Bioassays: Basic principles of Biological standardization: Methods used in the

bio-assay of Rabbis Vaccine , Oxytocin , Tetanus Antitoxin and Diphtheria

Vaccine . Test for pyrogens.

Unit III

Toxicity tests: OECD guidelines, determination of LD50, acute, subacute and

chronic toxicity studies.

Unit IV

Organization of screening for the Pharmacological activity of new substances

with emphasis on the evaluation cardiac, psychopharmacological, anti-

inflammatory, analgesic and anti diabetic.

Unit V

Clinical evaluation of new drugs, Phases of clinical trial, protocol design,

Ethics in human research.

Pharmacovigilance: Definition, collection of data, reporting, assessment of

Post marketing surveillance, periodic safety update reports, Risk-benefit

assessment

Text Books:

1. Robert A Turner and Peter Hebborn (1979). Screening methods in

Pharmacology: . 2nd ed. New York: Academic publishers.

2. HG Vogel and WH Vogel (2010). Drug discovery and evaluation . Berlin

Heideleberg: Springerverlag.

3. SK Kulkarni (2012). Handbook of experimental pharmacology . 4th ed. Delhi:

Vallabh Prakashan.

4. David Machin, Simon Day and Sylvan green (2007). Textbook of clinical trials .

2nd ed. USA: Jhon Wiley & Sons Ltd.

5. Giovanna di ignazio, Di Giovanna and Haynes (2001). Principles of clinical

research . Hampshire: Wrightson Biomedical publishing Ltd.

6. ICH of technical requirements for registration of pharmaceuticals for human use,

ICH harmonized Tripartite guidelines - Guidelines for good clinical practice, E6

(May 1996).

7. Central drug standard control organization (2001). Good clinical practice -

Guidelines for Clinical trials on pharmaceutical products in India. New Delhi:

Minister of Health.

8. David Machin, Simon Day, Sylvan Green (2007). Textbook of clinical trials .

USA: John Wiley & Sons publications

9. Giovanna di Ignazio, Gareth Hayes (2001). Principles of clinical research.

London: Routledge publications.

10. Vogel HG., Vogel WH (2006). Drug discovery and evaluation-Pharmacological

Assays. 3rd ed. Berlin, Germany: Springer verlag publications

2012-2013 31


Advanced Pharmacology – II

(A42012) Clinical Pharmacokinetics and Therapeutic Drug Monitoring

1. Introduction to Clinical pharmacokinetics.

a. Primary pharmacokinetic parameters

b. Interrelationship between primary pharmacokinetic parameters

and their effect on plasma concentration-time profile

c. Therapeutics Dosage regimens for special populations

d. Physiologic variables Affecting drug clearance

2. Design of dosage regimens:

Nomograms and Tabulations in designing dosage regimen, Conversion

from intravenous to oral dosing, Determination of dose and dosing

intervals, Drug dosing in the elderly and pediatrics and obese patients.

3. Pharmacokinetics of Drug Interaction:

a. Pharmacokinetic drug interactions

b. Inhibition and Induction of Drug metabolism

c. Inhibition of Biliary Excretion.

4. Therapeutic Drug monitoring:

a. Introduction

b. Individualization of drug dosage regimen (Variability – Genetic,

Age and Weight , disease, Interacting drugs).

c. Indications for TDM. Protocol for TDM.

d. Pharmacokinetic/Pharmacodynamic Correlation in drug therapy.

e. TDM of drugs used in the following disease conditions:

cardiovascular disease, Seizure disorders, Psychiatric conditions,

and Organ transplantations.

5. Dosage adjustment in Renal and hepatic Disease.

a. Renal impairment

b. Pharmacokinetic considerations in renal impairment

c. General approach for dosage adjustment in Renal disease.

d. Measurement of Glomerular Filtration rate and creatinine

clearance.

e. Dosage adjustment for uremic patients.

f. Extracorporeal removal of drugs.

g. Genetic polymorphism in Drug metabolism: Cytochrome P-450

Isoenzymes.

h. Effect of Hepatic disease on pharmacokinetics.

2012-2013 32

Text Books

1. Alfonso Gennaro R (2000). Remington: The Science and Practice of

Pharmacy. 16th ed.: Lippincott Williams & Willkins publications.

2. Brahmankar DM, Jaiswal SB (1998). Bio-pharmaceutics and

Pharamcokinetics. 2nd ed.: Vallabh Prakashan publications.

3. Gilbaldi Milo (1991). Bio-Pharmaceutics and Clinical

Pharmacokinetics. 4th ed.: Lea and Febiger publications.

4. Robert Notari E (1987). Bio-Pharmaceutics and Clinical

Pharmacokinetics. 4th ed. : Marcel Dekker Inc publications.

5. John G Wagner (1971). Bio-Pharmaceutics and relevant

Pharmacokinetics: Drug Intelligence Publications.

6. Leon Shargel, Andrew Yu, Susanna Wu-Pong (1993). Applied

Biopharmaceutics & Pharmacokinetics. 6th ed.: McGraw-Hill

publications.

7. Relevant review articles from recent medical and pharmaceutical

literature

8. Rowland M, Tozer TN (1995). Clinical Pharmacokinetics – concepts

and applications. 3rd ed.: Lea & Febiger publications.

9. Scott L Traub (1996). Basic skills in interpreting laboratory data. 2nd

ed.: American Society of Health System Pharmacists Inc publications.

10. Shargel L, Yu AB (1993). Applied Bio-Pharmaceutics and

Pharmacokinetics. 2nd ed.: Appleton & Lange publications .

11. Rowland, Tozer(1996). The Society publishers Clinical

Pharmacokinetics . 2nd ed.: Williams and Wilkins Publication.

2012-2013 33



PHARMACOTHERAPEUTICS – II

Pathophysiology and applied Pharmacotherapeutics of diseases associated

with following system/diseases with of special reference to the drug of choice.

Unit-I

Neurology & Psychiatry

Epilepsy,

Parkinson’s Disease

Multiple sclerosis

Headache: Migrane & Tension Type

Pain Management

Stroke

Alzheimer’s Disease

Anxiety Disorders

Bipolar Disorders

Depressive Disorder

Schizophrenia, Psychosis

Sleep Disorders

Substance – Related Disorders

Unit-II

Oncology (Blood cancer and Solid tumors)

Basic Principles in Cancer Therapy, General Introduction To

Cancer Chemotherapy Agents

Atiangiogenic agents

Chemotherapy of Brest Cancer

Chemotherapy of Lung Cancer

Chemotherapy of Head / Neck Cancer

Leukemia

Management of Chemotherapy – Nausea/ Vomiting

Pallative Care

Colorectal Cancer

Lyphomas

Prostate Cancer

2012-2013 34

Unit-III

Infectious Diseases

Antimocrobial Regimen Selection

Central Nervous System Infections – Meningitis

Endocarditis

Fungal Infections, Invasive

Gastrointestinal Infections

HIV/AIDS

Influenza

Intraabdominal Infections

Respiratory Tract Infections – Upper & Lower

Gastroeneritis

Sepsis & Septic Shock

STD’s

Surgical Prophylasis

Tuberculosis

Urinary Tract Infections & Prostatitis

Unit-IV

Gynecologic & Obstetric Disorders / Ophthalmology/ Eye Disorders

Menopause/ Hormone Replacement Therapy In Women

Pregnancy & Lactation : Therapeutic Considerations

Contraception.

Conjunctivitis

Glaucoma

Eye infections

Unit-V

Nutritional Disorder & Immunology

Assessment & Nutritional Requirement

Enteral Nutritrion

Obesity

Total Parenteral Nutrition

Immune Disease – Pathogenesis, Mechanism of action of drugs

Orphan diseases(Sjogren's Syndrome, Paget Disease

Extramammary, progeria)

http://www.hon.ch/HONselect/RareDiseases/C05.550.114.154.774.html

http://www.hon.ch/HONselect/RareDiseases/C04.557.470.200.025.660.html



http://en.wikipedia.org/wiki/Progeria

2012-2013 35

Glucocorticoids – Anti inflammatory, Anti – allergic &

Immunosuppressive actions in tissue as well as organ

transplantation

Vaccines, Toxiods and other immunobiologics

Text Books

1. JG Hardman, LE Limbard, (2001). Goodman & Gilman's- The

Pharmacological Basis of Therapeutics: 10th edition; McGraw-Hill

publications.

2. Joseph DiPiro, Robert, L., Talbert, Gary Yee, Gary Matzke, Barbara

Wells, Michael Posey, L., (2011). Pharmacotherapy: A

Pathophysiologic approach: 8th edition; McGraw-Hill publications

3. Roger Walker, Clive Edwards, (2003). Clinical pharmacy and

therapeutics: 3rd

edition; Churchill Living stone publications

4. Dennis Kasper, L., Eugene Braunwald, Stephen Hauser, Dan Longo,

Larry Jameson, J., Anthony Fauci,S.,(2005). Principles of Internal

Medicine: 16th edition; McGraw Hill Publications.

5. Eric Herfindal, T., Joseph Hirschman, L., (1984). Clinical Pharmacy

and Therapeutics: 3rd

edition; Williams & Wilkins publications

6. GK Mc Evoy (2004). American Hospital Formulary Services: Published

by American Society of Hospital Pharmacists.

7. Graeme S. Avery (1980). Drug treatment- principles and practice of

clinical pharmacology and therapeutics: 2nd

edition; Adis Press

publications.

8. Mary Anne Koda-Kimble (2008). Applied Therapeutics: 9th edition;

Wolters Kluwer Health/Lippincott Williams & Wilkins publications.

9. Ramzi Cotran, S., Vinay Kumar, Tucker Collins, Stanley Leonard

Robbins, (1999). Robbins pathologic basis of disease: 6th edition;

Saunders publications.

10. Russell Greene, J., (2008). Norman Harris, D., Pathology and

Therapeutics for pharmacists - a basis for clinical pharmacy practice: 3rd

edition; Pharmaceutical Press Chapman and Hall Publications.

11. Sir Stanley Davidson, Christopher Haslett (2002). Davidson’s

Principles and Practice of Medicine: 19th

edition; Churchill Living stone

Publications

2012-2013 36


(A42014) HOSPITAL PHARMACY

nit-I Introduction:

The role of hospital pharmacy department and its relationship to other

hospital departments and staff.

Unit-II Hospital Drug Policy:

a) Pharmacy and therapeutic committee (PTC)

b) Hospital Formulary

c) e-Medicine

Unit-III . a)Hospital Committee

- Infection committee

- Research and ethical committee

b) Developing therapeutic guidelines

c) Hospital pharmacy communication - Newsletter.

Unit-IV Pharmacoepidemiology:

i. Definition & Scope – Origin and evaluation of

pharmacoepidemiology need for pharmacoepidemiology, aims

and applications.

ii. Measurement of outcomes in pharmacoepidemiology – outcome

measure and drug use measures, prevalence, incidence and

incidence rate, Monetary units, number of prescriptions, unit of

drugs dispensed, defined daily doses and prescribed daily doses,

medications adherence measurements.

iii. Concept of risk in pharmacoepidemiology

Measurement of risk,

Attributable risk and relative risk

Time- risk relationship and odds ratio

iv. Pharmacoepidemiological Methods – Includes theoretical aspects

of various methods and practical study of various methods with

the help of case studies for individual methods.

Drug Utilization Review

Case Reports

Case Series

2012-2013 37

Surveys of drug use

Cross-sectional studies

Cohort studies

Case Control studies

Case- Cohort studies

Meta-analysis studies,

Spontaneous Reporting

Prescription Event Monitoring &

Record Linkage system

v. Sources of data for pharmacoepidemiology studies

Ad Hoc data sources and automated data systems

vi. Selected special applications of pharmacoepidemiology

Studies of vaccine safety

Hospital pharmacoepidemiology

Pharmacoepidemiology and risk management

Drug induced birth defects

Unit-V Pharmacoeconomics

Definition, history, needs of pharmacoeconomic evaluations – Role in

formulary management decisions

Pharmacoeconomic evaluation - Outcome assessment and types of

evaluation Includes theoretical aspects of various methods and practical

study of various methods with the help of case studies for individual

methods: Case- minimization, Cost- benefit, Cost-effectiveness, Cost-

Utility, Health Insurance - Medical Insurance.

Applications of Pharmacoeconomics – Software and case studies

Text Books

1. Allwood M C Fell J T (1980). Textbook of hospital pharmacy. 3rd ed.:

John Wiley & Sons publications.

2. Brain Strom L Stephen Kimmel E Sean Hennessy

(2011).Pharmacoepidemiology. 4th ed. Wiley Interscience

publications.

3. William E Hassan (1986). Hospital Pharmacy. 5th ed. Lec and Febiger

Publications.

2012-2013 38

4. Randy Vogenber F (2000). Introduction to Applied Pharmacoeconomics

McGraw-Hill Publications.


clinical pharmacology and therapeutics. 2nd ed. Adis Press

publications.


16th ed. Mack Pub. Co. Publications.

7. Sharon E Straus (2005). Evidence Based Medicine. 3rd ed.

Elsevier/Churchill Livingstone Publication.

2012-2013 39



PHARMACOTHERAPEUTICS-II LAB

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 and do a tutorial as well as case presentation in

the following clinical conditions. The students have to make at least 10 case

presentations covering most common diseases found in the hospital to which

the college is attached. The student should also submit a record of the cases

presented. The list of clinical cases presented should include follow-up of the

clinical cases mentioned below from the day of admission till discharge and

presented in the SOAP (Subjective, Objective, Assessment and Plan) format.

The cases may be selected from the following diseases:

1. Neurology& Psychiatry

2. Oncology

3. Infectious Diseases

4. Gynecologic & Obstetric Disorders/ Ophthalmology

5. Nutritional Disorder & Immunology

Assignments

The students are required to submit a minimum of three 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 in the same.

2012-2013 40


(A42211) Hospital Pharmacy – Lab

The student is expected to perform ABC and VED analysis on the given

data on drugs used in the hospital, participate in activity session involving

issues regarding pharmacy and therapeutic committee, prepare a model

monograph for a drug formulary, critically analyse the given data on hospital

pharmacy budget, work flow patterns etc., perform patient medication

interview and counselling and present drug profiles one new drugs.

ASSIGNMENTS

The student is expected to perform the following and report.

Comparison of prescription handling in two community pharmacies.

Audit of OTC sales over a 24 hour period in a local community

pharmacy ].

Role of community pharmacists in health education, family planning,

first aid, smoking cessation screening programmes, immunisation, etc.

Code of ethics for community pharmacies.

Summary of the advice and recommendations which should be provided

to the customers at a community pharmacy.

Select a new drug, which has recently been marketed in India for the

first time.

Prepare a report for a hospital’s Drug and Therapeutic Committee, and make a

case either for or against the addition of this new drug on to the hospital’s

formulary. Issues, which you 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.

Examine and report on the drug distribution methods used in a local

hospital .

Examine and report on the purchase and inventory of drugs in a local

hospital.

hospital and clinical pharmacy

Documents