M.Pharm Pharmacy Practice Syllabus
Pharmacy Practice is the M.Pharm specialisation on clinical pharmacy, hospital pharmacy and the quality use of medicines. This page gives the complete syllabus of the branch as prescribed by the Pharmacy Council of India, subject by subject and unit by unit. This branch has no Modern Pharmaceutical Analytical Techniques subject; its Semester 1 is made of four branch subjects.
Source: Pharmacy Council of India (PCI), The Revised Regulations for the Master of Pharmacy Degree Program, Credit Based Semester System, and the M.Pharm syllabus prescribed by the Pharmacy Council of India. The syllabus below is reproduced from the PCI syllabus, unit by unit.
Semester 1
MPP101T Clinical Pharmacy Practice
Subject notes: MPP101T Clinical Pharmacy Practice notes
Unit 1: Introduction to Clinical Pharmacy and the First Clinical Pharmacy Services
Introduction to Clinical Pharmacy: definition, evolution and scope of clinical pharmacy, international and national scenario of clinical pharmacy practice, pharmaceutical care. Clinical Pharmacy Services: ward round participation, drug therapy review (drug therapy monitoring including medication order review, chart endorsement, clinical review and pharmacist interventions).
Unit 2: Clinical Pharmacy Services
Clinical Pharmacy Services: patient medication history interview, basic concept of medicine and poison information services, basic concept of pharmacovigilance, haemovigilance, materiovigilance and AEFI, patient medication counselling, drug utilisation evaluation, documentation of clinical pharmacy services, quality assurance of clinical pharmacy services.
Unit 3: Patient Data Analysis and Laboratory Data Interpretation I
Patient Data Analysis: patient's case history, its structure and significances in drug therapy management, common medical abbreviations and terminologies used in clinical practice, communication skills: verbal and non-verbal communications, its applications in patient care services. Lab Data Interpretation: haematological tests, renal function tests, liver function tests.
Unit 4: Laboratory Data Interpretation II
Lab Data Interpretation: tests associated with cardiac disorders, pulmonary function tests, thyroid function tests, fluid and electrolyte balance, microbiological culture sensitivity tests.
Unit 5: Medicines and Poison Information Services
Medicines and Poison Information Services. Medicine Information Service: definition and need for medicine information service, medicine information resources, systematic approach in answering medicine information queries, preparation of verbal and written response, establishing a drug information centre. Poison Information Service: definition, need, organization and functions of poison information centre.
MPP102T Pharmacotherapeutics-I
Subject notes: MPP102T Pharmacotherapeutics-I notes
Unit 1: Cardiovascular system
Cardiovascular system: hypertension, congestive cardiac failure, acute coronary syndrome, arrhythmias, hyperlipidemias.
Unit 2: Respiratory system and Endocrine system
Respiratory system: asthma, chronic obstructive airways disease, drug induced pulmonary diseases. Endocrine system: diabetes, thyroid diseases.
Unit 3: Gastrointestinal system, first part
Gastrointestinal system: peptic ulcer diseases, reflux esophagitis, inflammatory bowel diseases, jaundice and hepatitis.
Unit 4: Gastrointestinal system, second part, and Hematological diseases
Gastrointestinal system: cirrhosis, diarrhea and constipation, drug-induced liver disease. Hematological diseases: anemia, deep vein thrombosis, drug induced hematological disorders.
Unit 5: Bone and joint disorders, Dermatological diseases and Ophthalmology
Bone and joint disorders: rheumatoid arthritis, osteoarthritis, gout, osteoporosis. Dermatological diseases: psoriasis, eczema and scabies, impetigo, drug induced skin disorders. Ophthalmology: conjunctivitis, glaucoma.
MPP103T Hospital & Community Pharmacy
Subject notes: MPP103T Hospital & Community Pharmacy notes
Unit 1: Introduction to Hospitals, Hospital Pharmacy and Hospital Drug Policy
Introduction to Hospitals: 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, Infection Control Committee, Research & Ethics Committee, Management of Medicines as per NABH.
Unit 2: Hospital Formulary, Procurement, Inventory, Distribution, IV Admixtures and Waste
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, and Community Pharmacy Practice and Management
Education and training: 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 and responsibilities of community pharmacists, and their relationship with other health care providers. Community Pharmacy management: legal requirements to start community pharmacy, site selection, lay out and design, drug display, super drug store model, accounts and audits, good dispensing practices, different softwares and databases used in community pharmacies, entrepreneurship in community pharmacy.
Unit 4: Prescription, Minor Ailments, OTC Medicines, Counselling, Adherence and ADR Monitoring
Prescription: legal requirements and 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 counseling and use of patient information leaflets, medication adherence: definition, factors influencing adherence behavior, strategies to improve medication adherence, patient referrals to the doctors, ADR monitoring in community pharmacies.
Unit 5: Health Promotion, National Health Programs, Home Medicines Review and Research
Health Promotion: definition and health promotion activities, family planning, health screening services, first aid, prevention of communicable and non-communicable diseases, smoking cessation, child and mother care. National Health Programs: role of community pharmacist in malaria and TB control programs. Home Medicines Review program: definition, objectives, guidelines, method and outcomes. Research in community pharmacy practice.
MPP104T Clinical Research
Subject notes: MPP104T Clinical Research notes
Unit 1: Drug Development Process and Ethics in Biomedical Research
Drug development process: introduction, various approaches to drug discovery, investigational new drug application submission. Ethics in Biomedical Research: ethical issues in biomedical research, principles of ethics in biomedical research, ethical committee (institutional review board), its constitution and functions, challenges in implementation of ethical guidelines, ICH GCP guidelines and ICMR guidelines in conduct of clinical trials, drug safety reporting.
Unit 2: Types and Designs Used in Clinical Research and the Trial Team
Types and Designs used in Clinical Research: planning and execution of clinical trials, various phases of clinical trials, bioavailability and bioequivalence studies, randomization techniques (simple randomization, restricted randomization, blocking method and stratification), types of research designs based on controlling method (experimental, quasi experimental, and observational methods), time sequences (prospective and retrospective), sampling methods (cohort study, case control study and cross sectional study), health outcome measures (clinical and physiological, humanistic and economic). Clinical Trial Study team: roles and responsibilities of investigator, study coordinator, sponsor, monitor, Contract Research Organization.
Unit 3: Clinical Trial Documents and Start Up Activities
Clinical trial documents: guidelines to the preparation of protocols, investigator brochure, informed consent form, case report forms, contracts and agreements, diary cards. Clinical Trial Start up activities: site feasibility studies, site/investigator selection, pre-study visit, investigator meeting, clinical trial agreement execution, ethics committee document preparation and submission.
Unit 4: Investigational Product, Filing, Monitoring and Close Out
Investigational Product: procurement and storage of investigational product. Filing procedures: essential documents for clinical trial, Trial Master File preparation and maintenance, Investigator Site File, Pharmacy File, site initiation visit, conduct, report and follow up. Clinical Trial Monitoring and Close out: preparation and conduct of monitoring visit: review of source documents, CRF, ICF, IP storage, accountability and reconciliation, study procedure, EC communications, safety reporting, monitoring visit reporting and follow-up. Close-out visit: study related documents collection, archival requirement, investigational product reconciliation and destruction, close-out visit report.
Unit 5: Quality Assurance, Quality Control and Clinical Data Management
Quality Assurance and Quality Control in Clinical Trials: types of audits, audit criteria, audit process, responsibilities of stakeholders in audit process, audit follow-up and documentation, audit resolution and preparing for FDA inspections, fraud and misconduct management. Data Management Infrastructure and System Requirement for Data Management: electronic data capture systems, selection and implementation of new systems, system validation and test procedures, coding dictionaries, data migration and archival. Clinical Trial Data Management: Standard Operating Procedures, data management plan, CRF and database design considerations, study set-up, data entry, CRF tracking and corrections, data cleaning, managing laboratory and ADR data, data transfer and database lock, Quality Control and Quality Assurance in CDM, data mining and warehousing.
Practicals and Seminar
- MPP105P Pharmacy Practice Practical I
- Seminar/Assignment
Semester 2
MPP201T Principles of Quality Use of Medicines
Subject notes: MPP201T Principles of Quality Use of Medicines notes
Unit 1: Introduction to Quality Use of Medicines (QUM)
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.
Unit 2: Concepts in QUM
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.
Unit 3: QUM in Various Settings and in Special Populations
QUM in various settings: hospital settings, ambulatory care and 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.
Unit 4: Regulatory Aspects of QUM in India
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 5: Medication Errors and Pharmacovigilance
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.
MPP202T Pharmacotherapeutics II
Subject notes: MPP202T Pharmacotherapeutics II notes
Unit 1: Nervous system
Nervous system: epilepsy, Parkinson's disease, stroke, headache, Alzheimer's disease, neuralgias and pain pathways and pain management.
Unit 2: Psychiatric disorders and Renal system
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.
Unit 3: Infectious diseases, first part
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.
Unit 4: Infectious diseases, second part, and Gynecological disorders
Infectious diseases: meningitis, HIV and opportunistic infections, rheumatic fever, dengue fever, H1N1, helminthiasis, fungal infections. Gynecological disorders: dysmenorrhea, hormone replacement therapy.
Unit 5: Oncology
Oncology: general principles of cancer chemotherapy, pharmacotherapy of breast cancer, lung cancer, head and neck cancer, hematological malignancies, management of nausea and vomiting, palliative care.
MPP203T Clinical Pharmacokinetics and Therapeutic Drug Monitoring
Unit 1: Introduction to Clinical Pharmacokinetics, and Designing of Dosage Regimens
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.
Unit 2: Pharmacokinetics of Drug Interaction, Pharmacogenetics, and Introduction to Pharmacometrics
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.
Unit 3: Non Linear Mixed Effects Modelling
Non Linear 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.
Unit 4: Altered Pharmacokinetics
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 hepatic failure.
Unit 5: Therapeutic Drug Monitoring
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.
MPP204T Pharmacoepidemiology & Pharmacoeconomics
Unit 1: Introduction to Pharmacoepidemiology
Introduction to Pharmacoepidemiology: definition, scope, need, aims and 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, medications adherence measurements. Concept of risk: measurement of risk, attributable risk and relative risk, time-risk relationship and odds ratio.
Unit 2: Pharmacoepidemiological Methods
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 monitoring, post marketing surveillance, record linkage systems.
Unit 3: Introduction to Pharmacoeconomics
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.
Unit 4: Pharmacoeconomic evaluations
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).
Unit 5: Health related quality of life (HRQOL)
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.
Practicals and Seminar
- MPP205P Pharmacy Practice Practical II
- Seminar/Assignment
Semester 3 and 4
Semester 3 and Semester 4 are common to all M.Pharm specialisations. They cover Research Methodology and Biostatistics (MRM301T), journal club, discussion and presentation, and research work. The full common structure is given on the M.Pharm Common Semester 3 and 4 Syllabus page.