rgpv syllabus MPharm PCI Grading System 2nd Semester Microsoft Word

<<<<<<< HEAD rgpv syllabus MPharm PCI Grading System 2nd Semester Microsoft Word - M Pharm PCI Syllabus all branches

PRINCIPLES OF QUALITY USE OF MEDICINES (MPP 201T)

Scope:

This course is designed to impart basic knowledge and skills that are required to practice quality use of medicines (QUM) in different healthcare settings and also to promote quality use of medicines, in clinical practice, through evidence-based medicine approach.

Objectives:

Upon completion of this course it is expected that students shall be able to:

 Understand the principles of quality use of medicines

 Know the benefits and risks associated with use of medicines

 Understand regulatory aspects of quality use of medicines

 Identify and resolve medication related problems

 Promote quality use of medicines

 Practice evidence-based medicines

THEORY 60 Hrs

1. Introduction to Quality use of medicines (QUM): Definition and Principles of QUM, Key partners and responsibilities of the partners, Building blocks in QMC, Evaluation process in QMC, Communication in QUM, Cost effective prescribing.

Concepts in QUM
Evidence based medicine: 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

12
Hrs

12
Hrs
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.
Medication errors: Definition, categorization and causes of medication errors, Detection and prevention of medication errors, Role of pharmacist in monitoring and management of medication errors
Pharmacovigilance: Definition, aims and need for
pharmacovigilance, Types, predisposing factors and mechanism of adverse drug reactions (ADRs), Detection, reporting and monitoring of ADRs, Causality assessment of ADRs, Management of ADRs, Role of pharmacist in pharmacovigilance.
12
Hrs

12
Hrs

REFERENCES:
1. A Textbook of Clinical Pharmacy Practice – Essential concepts and skills – Parthasarathi G, Karin Nyfort-Hansen and Milap Nahata
2. Andrews EB, Moore N. Mann’s Pharmacovigilance
3. Dipiro JT, Talbert RL, Yee GC. Pharmacotherapy: A Pathophysiologic Approach
4. Straus SE, Richardson WS, Glasziou P, Haynes RB. Evidence-Based Medicine: How to practice and teach it
5. Cohen MR. Medication Errors
6. Online:
   http://medicinesaustralia.com.au/files/2012/05/MA_QUM_External_Red uced.pdf
   http://curriculum.racgp.org.au/statements/quality-use-of-medicines/
   http://www.rug.nl/research/portal/files/14051541/Chapter_2.pdf
7. Relevant review articles from recent medical and pharmaceutical literature.

PHARMACOTHERAPEUTICS II (MPP 202T)

Scope

This course aims to enable the students to understand the different treatment approaches in managing various disease conditions. Also, it imparts knowledge and skills in optimizing drug therapy of a patient by individualizing the treatment plan through evidence-based medicines.

Objectives

Upon completion of this course it is expected that students shall be able to:

 Describe and explain the rationale for drug therapy

 Summarize the therapeutic approach for management of various disease conditions including reference to the latest available evidence

 Discuss the clinical controversies in drug therapy and evidence based medicine

 Prepare 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)

THEORY 60 Hrs

1. Nervous system: Epilepsy, Parkinson's disease, Stroke, Headache, Alzheimer’s disease, Neuralgias and Pain pathways and Pain management.

Psychiatric disorders: Schizophrenia, Depression, Anxiety disorders, Sleep disorders, Drug induced psychiatric disorders Renal system: Acute renal failure, Chronic renal failure, Renal dialysis, Drug induced renal disease
Infectious diseases: General guidelines for the rational use of antibiotics and surgical prophylaxis, Urinary tract infections, Respiratory tract infections, Gastroenteritis, Tuberculosis, Malaria, Bacterial endocarditis, Septicemia.
Infectious diseases: Meningitis, HIV and opportunistic infections, Rheumatic fever, Dengue fever, H1N1, Helmenthiasis, Fungal infections
Gynecological disorders: Dysmenorrhea, Hormone
replacement therapy.
12
Hrs

12
Hrs

12
Hrs

12
Hrs
Oncology: General principles of cancer chemotherapy, pharmacotherapy of breast cancer, lung cancer, head & neck cancer, hematological malignancies, Management of nausea and vomiting, Palliative care
12
Hrs

REFERENCES
1. Roger and Walker. Clinical Pharmacy and Therapeutics - Churchill Livingstone publication.
2. Joseph T. Dipiro et al. Pharmacotherapy: A Pathophysiologic Approach- Appleton & Lange
3. Robins SL. Pathologic basis of disease -W.B. Saunders publication
4. Eric T. Herfindal. Clinical Pharmacy and Therapeutics- Williams and Wilkins Publication
5. Lloyd Young and Koda-Kimble MA Applied Therapeutics: The clinical Use of Drugs- Lippincott Williams and Wilkins
6. Chisholm- Burns Wells Schwinghammer Malone and Joseph P Dipiro. Pharmacotherapy Principles and practice-– McGraw Hill Publication
7. Carol Mattson Porth. Principles of Pathophysiology- Lippincott Williams and Wilkins
8. Harrison's. Principles of Internal Medicine - McGraw Hill
9. Relevant review articles from recent medical and pharmaceutical literature

CLINICAL PHARMACOKINETICS AND THERAPEUTIC DRUG MONITORING

(MPP 203T)

Scope

This course is designed to enable students to understand the basics principles and applications of pharmacokinetics in designing the individualized dosage regimen, to interpret the plasma drug concentration profile in altered pharmacokinetics, drug interactions and in therapeutic drug monitoring processes to optimize the drug dosage regimen. Also, it enables students to understand the basic concepts of pharmacogenetics, pharmacometrics for modeling and simulation of pharmacokinetic data.

Objectives

Upon completion of this course it is expected that students shall be able to:

 Design the drug dosage regimen for individual patients

 Interpret and correlate the plasma drug concentrations with patients' therapeutic outcomes

 Recommend dosage adjustment for patients with renal/ hepatic impairment

 Recommend dosage adjustment for paediatrics and geriatrics

 Manage pharmacokinetic drug interactions

 Apply pharmacokinetic parameters in clinical settings

 Interpret the impact of genetic polymorphisms of individuals on pharmacokinetics and or pharmacodynamics of drugs

 Do pharmacokinetic modeling for the given data using the principles of pharmacometrics

THEORY 60 Hrs

1. Introduction to Clinical pharmacokinetics: Compartmental and Non compartmental models, Renal and non-renal clearance, Organ extraction and models of hepatic clearance, Estimation and determinants of bioavailability, Multiple dosing, Calculation of loading and maintenance doses

Designing of dosage regimens: Determination of dose and

dosing intervals, Conversion from intravenous to oral dosing, Nomograms and Tabulations in designing dosage regimen.

Hrs

Pharmacokinetics of Drug Interaction: Pharmacokinetic drug interactions, Inhibition and Induction of Drug metabolism, Inhibition of Biliary Excretion
Pharmacogenetics: Genetic polymorphism in Drug metabolism:
Cytochrome P-450 Isoenzymes, Genetic Polymorphism in Drug Transport and Drug Targets, Pharmacogenetics and Pharmacokinetic / Pharmacodynamic considerations
Introduction to Pharmacometrics: Introduction to Bayesian Theory, Adaptive method or Dosing with feedback, Analysis of Population pharmacokinetic Data.
Non Linier Mixed Effects Modelling: The Structural or Base Model, Modeling Random Effects, Modeling Covariate Relationships, Mixture Model, Estimation Methods, Model Building Techniques, Covariate Screening Methods, Testing the model assumptions, Precision of the parameter estimates and confidence intervals, Model misspecification and violation of the model assumptions, Model Validation, Simulation of dosing regimens and dosing recommendations, Pharmacometrics software.
Altered Pharmacokinetics: Drug dosing in the elderly, Drug dosing in the paediatrics, Drug dosing in the obese patients, Drug dosing in the pregnancy and lactation, Drug dosing in the renal failure and extracorporeal removal of drugs, Drug dosing in the in hepatic failure.
Therapeutic Drug monitoring: Introduction, Individualization of drug dosage regimen (Variability – Genetic, age, weight, disease and Interacting drugs), Indications for TDM, Protocol for TDM, Pharmacokinetic/Pharmacodynamic Correlation in drug therapy, TDM of drugs used in the following conditions: Cardiovascular disease: Digoxin, Lidocaine, Amiodarone; Seizure disorders: Phenytoin, Carbamazepine, Sodium Valproate; Psychiatric conditions: Lithium, Fluoxetine, Amitriptyline; Organ transplantations: Cyclosporine; Cytotoxic Agents: Methotrexate, 5- FU, Cisplatin; Antibiotics: Vancomycin, Gentamicin, Meropenem.
12
Hrs

12
Hrs

12
Hrs

12
Hrs
REFERENCES
1. Leon Shargel, Susanna Wu-Pong, Andrew Yu. Applied Biopharmaceutics & Pharmacokinetics. New York: Mc Graw Hill.
2. Peter L. Bonate. Pharmacokinetic - Pharmacodynamic Modeling and Simulation. Springer Publications.
3. Michael E. Burton, Leslie M. Shaw, Jerome J. Schentag, William E.Evans. Applied Pharmacokinetics & Pharmacodynamics: Principles of Therapeutic Drug Monitoring. Iippincott Williams & Wilkins.
4. Steven How-Yan Wong, Irving Sunshine. Handbook of Analytical Therapeutic Drug Monitoring and Toxicology. CRC Press, USA.
5. Soraya Dhillon, Andrzej Kostrzewski. Clinical pharmacokinetics. 1st edition. London: Pharmaceutical Press.
6. Joseph T.Dipiro, William J.Spruill, William E.Wade, Robert A.Blouin and Jane M.Pruemer .Concepts in Clinical Pharmacokinetics. American Society of Health-System Pharmacists, USA.
7. Malcolm Rowland, Thomas N. Tozer .Clinical Pharmacokinetics and pharmacodynamics: concepts and applications. Iippincott Williams & Wilkins, USA.
8. Evans, Schentag, Jusko. Applied pharmacokinetics. American Society of Health system Pharmacists, USA.
9. Michael E. Winter. Basic Clinical Pharmacokinetics. Iippincott Williams & Wilkins, USA.
10. Milo Gibaldi. Biopharmaceutics and Clinical Pharmacokinetics. Pharma Book Syndicate, USA.
11. Dhillon and Kostrzewski. Clinical pharmacokinetics. Pharmaceutical Press, London.
12. John E .Murphy. Clinical Pharmacokinetics. 5th edition. US: American Society of Health- System Pharmacist, USA.
13. Relevant review articles from recent medical and pharmaceutical literature

PHARMACOEPIDEMIOLOGY & PHARMACOECONOMICS (MPP 204T)

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.

THEORY 60 Hrs

1. Introduction to Pharmacoepidemiology: 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

Pharmacoepidemiological Methods: 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
12
Hrs

12
Hrs
monitoring, Post marketing surveillance, Record linkage systems, Applications of Pharmacoepidemiology
Introduction to Pharmacoeconomics: Definition, history of Pharmacoeconomics, Need of Pharmacoeconomic studies in Indian 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.
Pharmacoeconomic evaluations: 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), Cost Consequences Analysis (COA).
Definition, Steps involved, Applications, Advantages and disadvantages of the following:
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.

REFERENCES
12
Hrs

12
Hrs

12
Hrs
1. Rascati K L. Essentials of Pharmacoeconomics, Woulters Kluwer Lippincott Williams & Wilkins, Philadelphia.
2. Thomas E Getzen. Health economics. Fundamentals and Flow of Funds. John Wiley & Sons, USA.
3. Andrew Briggs, Karl Claxton, Mark Sculpher. Decision Modelling for Health Economic Evaluation, Oxford University Press, London.
4. Michael Drummond, Mark Sculpher, George Torrence, Bernie O'Brien and Greg Stoddart. Methods for the Economic Evaluation of Health Care Programmes Oxford University Press, London.
5. George E Mackinnon III. Understanding health outcomes and pharmacoeconomics.
6. Graker, Dennis. Pharmacoeconomics and outcomes.
7. Walley, Pharmacoeconomics.
8. Pharmacoeconomic – ed. by Nowakowska – University of Medical Sciences, Poznan.
9. Relevant review articles from recent medical and pharmaceutical literature

PHARMACY PRACTICE PRACTICAL - II (MPP 205P)

Pharmacy Practice practical component includes experiments covering important topics of the courses Principles of Quality Use of Medicines, Pharmacotherapeutics-II, Clinical Pharmacokinetics & Therapeutic Drug Monitoring and Pharmacoepidemiology and Pharmacoeconomics.

List of Experiments (24)

Causality assessment of adverse drug reactions (three)
Detection and management of medication errors (three)
Rational use of medicines in special population (three)
Presentation of clinical cases of various disease conditions adopting Pharmaceutical Care Plan Model (eight)
Calculation of Bioavailability and Bioequivalence from the given data (two)
Interpretation of Therapeutic Drug Monitoring reports of a given patient (three)
Calculation of various Pharmacoeconomic outcome analysis for the given data (two)

======= rgpv syllabus MPharm PCI Grading System 2nd Semester Microsoft Word - M Pharm PCI Syllabus all branches

PRINCIPLES OF QUALITY USE OF MEDICINES (MPP 201T)

Scope:

Objectives:

Upon completion of this course it is expected that students shall be able to:

 Understand the principles of quality use of medicines

 Know the benefits and risks associated with use of medicines

 Understand regulatory aspects of quality use of medicines

 Identify and resolve medication related problems

 Promote quality use of medicines

 Practice evidence-based medicines

THEORY 60 Hrs

Concepts in QUM
Evidence based medicine: 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

12
Hrs

12
Hrs
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.
Medication errors: Definition, categorization and causes of medication errors, Detection and prevention of medication errors, Role of pharmacist in monitoring and management of medication errors
Pharmacovigilance: Definition, aims and need for
pharmacovigilance, Types, predisposing factors and mechanism of adverse drug reactions (ADRs), Detection, reporting and monitoring of ADRs, Causality assessment of ADRs, Management of ADRs, Role of pharmacist in pharmacovigilance.
12
Hrs

12
Hrs

REFERENCES:
1. A Textbook of Clinical Pharmacy Practice – Essential concepts and skills – Parthasarathi G, Karin Nyfort-Hansen and Milap Nahata
2. Andrews EB, Moore N. Mann’s Pharmacovigilance
3. Dipiro JT, Talbert RL, Yee GC. Pharmacotherapy: A Pathophysiologic Approach
4. Straus SE, Richardson WS, Glasziou P, Haynes RB. Evidence-Based Medicine: How to practice and teach it
5. Cohen MR. Medication Errors
6. Online:
   http://medicinesaustralia.com.au/files/2012/05/MA_QUM_External_Red uced.pdf
   http://curriculum.racgp.org.au/statements/quality-use-of-medicines/
   http://www.rug.nl/research/portal/files/14051541/Chapter_2.pdf
7. Relevant review articles from recent medical and pharmaceutical literature.

PHARMACOTHERAPEUTICS II (MPP 202T)

Scope

Objectives

Upon completion of this course it is expected that students shall be able to:

 Describe and explain the rationale for drug therapy

 Summarize the therapeutic approach for management of various disease conditions including reference to the latest available evidence

 Discuss the clinical controversies in drug therapy and evidence based medicine

 Prepare individualized therapeutic plans based on diagnosis

THEORY 60 Hrs

1. Nervous system: Epilepsy, Parkinson's disease, Stroke, Headache, Alzheimer’s disease, Neuralgias and Pain pathways and Pain management.

Psychiatric disorders: Schizophrenia, Depression, Anxiety disorders, Sleep disorders, Drug induced psychiatric disorders Renal system: Acute renal failure, Chronic renal failure, Renal dialysis, Drug induced renal disease
Infectious diseases: General guidelines for the rational use of antibiotics and surgical prophylaxis, Urinary tract infections, Respiratory tract infections, Gastroenteritis, Tuberculosis, Malaria, Bacterial endocarditis, Septicemia.
Infectious diseases: Meningitis, HIV and opportunistic infections, Rheumatic fever, Dengue fever, H1N1, Helmenthiasis, Fungal infections
Gynecological disorders: Dysmenorrhea, Hormone
replacement therapy.
12
Hrs

12
Hrs

12
Hrs

12
Hrs
Oncology: General principles of cancer chemotherapy, pharmacotherapy of breast cancer, lung cancer, head & neck cancer, hematological malignancies, Management of nausea and vomiting, Palliative care
12
Hrs

REFERENCES
1. Roger and Walker. Clinical Pharmacy and Therapeutics - Churchill Livingstone publication.
2. Joseph T. Dipiro et al. Pharmacotherapy: A Pathophysiologic Approach- Appleton & Lange
3. Robins SL. Pathologic basis of disease -W.B. Saunders publication
4. Eric T. Herfindal. Clinical Pharmacy and Therapeutics- Williams and Wilkins Publication
5. Lloyd Young and Koda-Kimble MA Applied Therapeutics: The clinical Use of Drugs- Lippincott Williams and Wilkins
6. Chisholm- Burns Wells Schwinghammer Malone and Joseph P Dipiro. Pharmacotherapy Principles and practice-– McGraw Hill Publication
7. Carol Mattson Porth. Principles of Pathophysiology- Lippincott Williams and Wilkins
8. Harrison's. Principles of Internal Medicine - McGraw Hill
9. Relevant review articles from recent medical and pharmaceutical literature

CLINICAL PHARMACOKINETICS AND THERAPEUTIC DRUG MONITORING

(MPP 203T)

Scope

Objectives

Upon completion of this course it is expected that students shall be able to:

 Design the drug dosage regimen for individual patients

 Interpret and correlate the plasma drug concentrations with patients' therapeutic outcomes

 Recommend dosage adjustment for patients with renal/ hepatic impairment

 Recommend dosage adjustment for paediatrics and geriatrics

 Manage pharmacokinetic drug interactions

 Apply pharmacokinetic parameters in clinical settings

 Interpret the impact of genetic polymorphisms of individuals on pharmacokinetics and or pharmacodynamics of drugs

 Do pharmacokinetic modeling for the given data using the principles of pharmacometrics

THEORY 60 Hrs

Designing of dosage regimens: Determination of dose and

dosing intervals, Conversion from intravenous to oral dosing, Nomograms and Tabulations in designing dosage regimen.

Hrs

Pharmacokinetics of Drug Interaction: Pharmacokinetic drug interactions, Inhibition and Induction of Drug metabolism, Inhibition of Biliary Excretion
Pharmacogenetics: Genetic polymorphism in Drug metabolism:
Cytochrome P-450 Isoenzymes, Genetic Polymorphism in Drug Transport and Drug Targets, Pharmacogenetics and Pharmacokinetic / Pharmacodynamic considerations
Introduction to Pharmacometrics: Introduction to Bayesian Theory, Adaptive method or Dosing with feedback, Analysis of Population pharmacokinetic Data.
Non Linier Mixed Effects Modelling: The Structural or Base Model, Modeling Random Effects, Modeling Covariate Relationships, Mixture Model, Estimation Methods, Model Building Techniques, Covariate Screening Methods, Testing the model assumptions, Precision of the parameter estimates and confidence intervals, Model misspecification and violation of the model assumptions, Model Validation, Simulation of dosing regimens and dosing recommendations, Pharmacometrics software.
Altered Pharmacokinetics: Drug dosing in the elderly, Drug dosing in the paediatrics, Drug dosing in the obese patients, Drug dosing in the pregnancy and lactation, Drug dosing in the renal failure and extracorporeal removal of drugs, Drug dosing in the in hepatic failure.
Therapeutic Drug monitoring: Introduction, Individualization of drug dosage regimen (Variability – Genetic, age, weight, disease and Interacting drugs), Indications for TDM, Protocol for TDM, Pharmacokinetic/Pharmacodynamic Correlation in drug therapy, TDM of drugs used in the following conditions: Cardiovascular disease: Digoxin, Lidocaine, Amiodarone; Seizure disorders: Phenytoin, Carbamazepine, Sodium Valproate; Psychiatric conditions: Lithium, Fluoxetine, Amitriptyline; Organ transplantations: Cyclosporine; Cytotoxic Agents: Methotrexate, 5- FU, Cisplatin; Antibiotics: Vancomycin, Gentamicin, Meropenem.
12
Hrs

12
Hrs

12
Hrs

12
Hrs
REFERENCES
1. Leon Shargel, Susanna Wu-Pong, Andrew Yu. Applied Biopharmaceutics & Pharmacokinetics. New York: Mc Graw Hill.
2. Peter L. Bonate. Pharmacokinetic - Pharmacodynamic Modeling and Simulation. Springer Publications.
3. Michael E. Burton, Leslie M. Shaw, Jerome J. Schentag, William E.Evans. Applied Pharmacokinetics & Pharmacodynamics: Principles of Therapeutic Drug Monitoring. Iippincott Williams & Wilkins.
4. Steven How-Yan Wong, Irving Sunshine. Handbook of Analytical Therapeutic Drug Monitoring and Toxicology. CRC Press, USA.
5. Soraya Dhillon, Andrzej Kostrzewski. Clinical pharmacokinetics. 1st edition. London: Pharmaceutical Press.
6. Joseph T.Dipiro, William J.Spruill, William E.Wade, Robert A.Blouin and Jane M.Pruemer .Concepts in Clinical Pharmacokinetics. American Society of Health-System Pharmacists, USA.
7. Malcolm Rowland, Thomas N. Tozer .Clinical Pharmacokinetics and pharmacodynamics: concepts and applications. Iippincott Williams & Wilkins, USA.
8. Evans, Schentag, Jusko. Applied pharmacokinetics. American Society of Health system Pharmacists, USA.
9. Michael E. Winter. Basic Clinical Pharmacokinetics. Iippincott Williams & Wilkins, USA.
10. Milo Gibaldi. Biopharmaceutics and Clinical Pharmacokinetics. Pharma Book Syndicate, USA.
11. Dhillon and Kostrzewski. Clinical pharmacokinetics. Pharmaceutical Press, London.
12. John E .Murphy. Clinical Pharmacokinetics. 5th edition. US: American Society of Health- System Pharmacist, USA.
13. Relevant review articles from recent medical and pharmaceutical literature

PHARMACOEPIDEMIOLOGY & PHARMACOECONOMICS (MPP 204T)

Scope

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.

THEORY 60 Hrs

Pharmacoepidemiological Methods: 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
12
Hrs

12
Hrs
monitoring, Post marketing surveillance, Record linkage systems, Applications of Pharmacoepidemiology
Introduction to Pharmacoeconomics: Definition, history of Pharmacoeconomics, Need of Pharmacoeconomic studies in Indian 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.
Pharmacoeconomic evaluations: 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), Cost Consequences Analysis (COA).
Definition, Steps involved, Applications, Advantages and disadvantages of the following:
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.

REFERENCES
12
Hrs

12
Hrs

12
Hrs
1. Rascati K L. Essentials of Pharmacoeconomics, Woulters Kluwer Lippincott Williams & Wilkins, Philadelphia.
2. Thomas E Getzen. Health economics. Fundamentals and Flow of Funds. John Wiley & Sons, USA.
3. Andrew Briggs, Karl Claxton, Mark Sculpher. Decision Modelling for Health Economic Evaluation, Oxford University Press, London.
4. Michael Drummond, Mark Sculpher, George Torrence, Bernie O'Brien and Greg Stoddart. Methods for the Economic Evaluation of Health Care Programmes Oxford University Press, London.
5. George E Mackinnon III. Understanding health outcomes and pharmacoeconomics.
6. Graker, Dennis. Pharmacoeconomics and outcomes.
7. Walley, Pharmacoeconomics.
8. Pharmacoeconomic – ed. by Nowakowska – University of Medical Sciences, Poznan.
9. Relevant review articles from recent medical and pharmaceutical literature

PHARMACY PRACTICE PRACTICAL - II (MPP 205P)

List of Experiments (24)

Causality assessment of adverse drug reactions (three)
Detection and management of medication errors (three)
Rational use of medicines in special population (three)
Presentation of clinical cases of various disease conditions adopting Pharmaceutical Care Plan Model (eight)
Calculation of Bioavailability and Bioequivalence from the given data (two)
Interpretation of Therapeutic Drug Monitoring reports of a given patient (three)
Calculation of various Pharmacoeconomic outcome analysis for the given data (two)

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