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D.Pharm Year 2 Syllabus (Part II, ER-2020)

This page gives the complete second year (Part II) syllabus of the Diploma in Pharmacy as prescribed by the Pharmacy Council of India under the Education Regulations 2020 (ER-2020). Every subject of the year is covered, theory and practical, with the topic text reproduced from the official syllabus.

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ER20-21T Pharmacology - Theory

Course Code: ER20-21T

Scope

This course is designed to impart basic knowledge on pharmacology including pharmacodynamics, pharmacokinetics, classifications, mechanism of action, uses, doses and adverse effects of drugs acting on different systems of the body and various categories of drugs.

Course Objectives

This course will discuss the following:

  1. General concepts of pharmacology including pharmacodynamics, pharmacokinetics
  2. Different classifications of the commonly used drugs including the possible side effects and adverse effects
  3. Commonly used combination drugs and fixed dose combinations

Course Outcomes

Upon successful completion of this course, the students will be able to:

  1. Describe the general concepts of pharmacology including pharmacodynamics and pharmacokinetics
  2. Discuss the various types of drugs acting on nervous system, cardiovascular, respiratory, endocrine, gastrointestinal systems etc.
  3. Discuss the pharmacological uses of drugs in various therapeutic categories
  4. Describe the dosage regimen, mechanisms of action, adverse drug reactions of commonly prescribed drugs

Topics

Chapter 1: General Pharmacology: Introduction and scope of Pharmacology. Various routes of drug administration - advantages and disadvantages. Drug absorption - definition, types, importance of drug distribution and drug elimination. Bioavailability, First pass Metabolism, Excretion of drugs in urine and in bile. Pharmacodynamics: Mechanisms of drug action at macro levels. Pharmacotherapeutics: Types of drug action. Combined effects of drugs - Additive, Synergism, Antagonism. Drug interactions - beneficial interactions, adverse interactions, and pharmacokinetic drug interactions. Adverse Drug Reactions: Definitions like Toxic effects, allergic reactions, adverse drug reactions. Drugs used in pre-anaesthetic medication, General anaesthetics, Antiepileptic drugs. Drugs acting on the eye (Mydriatics, Miotics, drugs used in Glaucoma). Drugs acting on the respiratory system (bronchodilators, expectorants, anti-tussive agents, and mucolytic agents). Antiulcer drugs

Chapter 2: Drugs Acting on the Peripheral Nervous System: Steps involved in neurohumoral transmission. Definition, classification, pharmacological actions, dose, indications and contraindications of: Adrenergic drugs, Anti-adrenergic drugs, Cholinergic drugs, Anti-Cholinergic drugs, Drugs acting on Autonomic Ganglia, Skeletal muscle relaxants

Chapter 3: Drugs Acting on the Central Nervous System: Definition, classification, pharmacological actions, dose, indications and contraindications of: Hypnotics and sedatives, Anti-depressant drugs, Anti-anxiety drugs, Anti-psychotics, Nootropic agents, centrally acting analgesics, Drug Addiction and Drug abuse

Chapter 4: Drugs Acting on the Cardiovascular System: Definition, classification, pharmacological actions, dose, indications and contraindications of: Anti-hypertensive drugs, Anti-anginal drugs, Anti-arrhythmic drugs, Drugs used in atherosclerosis and congestive heart failure, Drug therapy for shock

Chapter 5: Drugs Acting on Blood and Blood Forming Organs: Definition, classification, pharmacological actions, dose, indications and contraindications of: Hematinic agents, Anti-coagulants, Anti-platelet agents, Thrombolytic agents

Chapter 6: Definition, classification, pharmacological actions, dose, indications and contraindications of: Bronchodilators, Expectorants, Anti-tussive agents, Mucolytic agents

Chapter 7: Drugs Acting on the Gastro Intestinal Tract: Anti-ulcer drugs: Proton pump inhibitors, H2 Antagonists, Antacids, Anti-emetics, Laxatives and Cathartics, Anti-diarrheal drugs

Chapter 8: Drugs Acting on Endocrine System: Drugs used in diabetes mellitus: Oral hypoglycaemic agents, Insulin preparations, Drugs used in Thyroid disorders: Thyroid supplements, Anti-Thyroid drugs. Sex hormones and related drugs including hormonal contraceptives

Chapter 9: Antibiotics and Chemotherapeutic Agents: Introduction, basic principles of chemotherapy of infections, classification, pharmacological actions, dose, indications and contraindications of: Penicillins, Cephalosporins, Aminoglycosides, Fluoroquinolones, Macrolides, Tetracyclines, Sulfonamides, Anti-tubercular drugs, Anti-fungal drugs, Anti-viral drugs, Anti-amoebic agents, Anthelmintics, Anti-malarial agents, Anti-neoplastic agents

Chapter 10: Introduction classification, pharmacological actions, dose, indications, and contraindications of: Nonsteroidal anti-inflammatory drugs (NSAIDs and anti-gout agents), Anti-rheumatic drugs, Biologicals

ER20-21P Pharmacology - Practical

Course Code: ER20-21P

Scope

This course is designed to impart basic knowledge in experimental pharmacology including identification of dosage forms, demonstrations of pharmacological experiments using software, principles of bioassay, contemporary bioassays, and Community Pharmacy / Pharmacist related contemporary pharmacology activities like drug information services, patient counseling and drug interactions.

Course Objectives

This course will provide hands-on experience in the following areas:

  1. Dosage forms and calculation of doses of commonly used drugs
  2. Simulations of pharmacological actions of common drugs
  3. Experiments related to bioassays
  4. Drug interaction studies
  5. Drug information services
  6. Patient counseling activities

Course Outcomes

Upon successful completion of this course, the students will be able to:

  1. Simulate experiments related to pre-clinical and clinical pharmacological studies
  2. Perform experiments related to bioassays of various drugs
  3. Identify the dosage forms of commonly used drugs
  4. Calculate and prepare different doses of commonly used drugs
  5. Appreciate various mechanisms of drug interactions in the body
  6. Discuss on the various drug information services
  7. Provide patient counselling services for the commonly encountered disease states

Practicals

Experiments: The following experiments are to be demonstrated in the laboratory (using videos, software and charts):

  1. Study of effect of hepatic microsomal enzyme inducers on the phenobarbitone sleeping time in mice (in-silico) / Study of stereotype and anti-catatonic activity of drugs on rats/mice
  2. Study of anti-anaesthetic activity of drugs in rats/mice
  3. Study of effect of drugs on the ciliary motility of frog oesophagus
  4. Effect of various drugs on isolated frog's heart
  5. Effect of various drugs on rabbit's eye (mydriatic and mitotic effects)

Note: Simulation experiments using software such as 'Ex Pharm' or any other suitable software may be demonstrated / performed in the laboratory

Assignments

The students shall be asked to submit written assignments on the following topics (One assignment per student per sessional period, i.e., a minimum of THREE assignments per student):

  1. Drugs used in pre-anaesthetic medication, General anaesthetics and Anti-epileptic drugs
  2. Identification of dosage forms of commonly used drugs (Tablets, Capsules, Inhalers, etc.)
  3. Drugs used in eye disorders
  4. Pre-clinical studies in new drug development
  5. Drug information services, resources and answering of queries
  6. Pre-clinical studies in new drug development
  7. Medicines and meals: Before or After food
  8. Drug information apps

ER20-22T Community Pharmacy and Management - Theory

Course Code: ER20-22T

Scope

This course is designed to impart basic knowledge on running a community pharmacy business, community pharmacy management, patient counselling and role of pharmacist in various government programs.

Course Objectives

This course will discuss about the following:

  1. Principles and functions of community pharmacy management
  2. Various types of inventory control techniques, stock management
  3. Handling of prescriptions, patient counseling and patient medication records
  4. Computer and health care applications in community pharmacy
  5. Various pharmacy business, different soft skills and communication skills needed for effective customer care services
  6. Various aspects of Good Pharmacy Practice

Course Outcomes

Upon successful completion of this course, the students will be able to:

  1. Describe the various aspects of community pharmacy business and its management
  2. Perform the inventory management process in community pharmacy
  3. Handle the prescriptions in a community pharmacy
  4. Provide effective patient counselling services
  5. Maintain patient medication records
  6. Perform effective communication process with different types of customers
  7. Use computer applications in community pharmacy

Topics

Chapter 1: Community Pharmacy Practice - Definition, history and development of community pharmacy

Chapter 2: Organization and structure of retail and wholesale drug store: types and design, Traditional and Modern stores, Legal requirements for establishment and maintenance of a drug store, drug store operations, and its management

Chapter 3: Dispensing of Drugs: Packaging and labelling of goods, dispensing process, Good dispensing practices

Chapter 4: Dispensing of proprietary medicine: handling of prescriptions with professional care

Chapter 5: Patient Counselling: Definition and benefits of patient counselling, stages of patient counselling, patient information leaflets, types of patients and methods of patient counselling

Chapter 6: Medication Adherence: Objectives, Factors contributing to non-adherence, methods to improve adherence, evaluation of medication adherence

Chapter 7: Health Screening Services in Community Pharmacy: Introduction, scope, and importance of various health screening services, for routine monitoring of patients with diabetes, hypertension, and other disorders

Chapter 9: Over The Counter (OTC) Medications - Definition, need and role of Pharmacists in OTC medication dispensing, OTC medications in Indian market: analgesic, cold preparations, anti-pyretic, hyperacidity products, OTC counselling

Chapter 10: Community Pharmacy Management: Legal requirements to set up a community pharmacy, Site selection requirements, Pharmacy designing and interiors, Vendor selection and ordering, Procurement, inventory control methods, inventory management, financial planning and management, Accountancy in community pharmacy - Day book, Cash Book, Patient medication history, Prescription records, Stock registers, and inventory registers

Chapter 11: Pharmaceutical care: Definition, principles, stages of pharmaceutical care

Chapter 12: Prescription Medication History Interview: Objectives, process of patient medication history interview, medication history form, case studies

Chapter 13: Customer Relationship Management (CRM) in community pharmacy: Various customer services, marketing strategies, sales promotional activities, customer service quality, handling of complaints and managing difficult customers

Chapter 14: Responding to symptoms of minor ailments: Basic introduction, medical aspects, product knowledge, patient management, various types of minor ailments and role of pharmacist

Chapter 15: Community pharmacy computer applications: Introduction, various business and health care applications in community pharmacy, classification and use of software

Chapter 16: Digital health: Introduction and terminologies, concept of 'Digital India' initiative, mHealth, E-Health, Health Management Information System (HMIS), Introduction to National Digital Health Mission (NDHM), National Health Authority (NHA), E-pharmacies, telemedicine guidelines, Electronic prescribing, Electronic health record, medical decision support

Note: The official syllabus prints the chapter numbers as 1 to 7 and then 9 onwards. No Chapter 8 is printed in the official document.

ER20-22P Community Pharmacy and Management - Practical

Course Code: ER20-22P

Scope

This course is designed to impart basic knowledge on handling of prescriptions, patient counselling, simulated community pharmacy experience and services in community pharmacy.

Course Objectives

This course will provide hands-on experiences in the following:

  1. Handling of prescriptions including interpretation of medical orders
  2. Providing patient counselling services
  3. Performing community pharmacy management including use of computers and software
  4. Providing health screening services

Course Outcomes

Upon successful completion of this course, the students will be able to:

  1. Interpret and handle the prescriptions appropriately
  2. Provide effective patient counselling for the disease conditions and associated medications
  3. Maintain the pharmacy premises, patient records, inventory registers, invoice formats, cash registers, stock registers and dispensing registers
  4. Use community pharmacy software for pharmacy management and billing purposes
  5. Provide health screening services

Practicals

  1. Handling of Prescriptions - Mock practice in various prescription scenarios, Clinical problems: Interpretation of Prescription and Instructional Problems
  2. Patient Counselling - Provision of patient counselling for various diseases and disorders
  3. Providing pharmaceutical care for a patient with either diabetes or any other chronic disease/disorder
  4. Simulated / Virtual store for community pharmacy management - various activities of community pharmacy including Use of Inventory ledger System, Computerised Billing and Accounts, Maintaining of Stock Registers and Patient Medication Records, Stock verification and various other community pharmacy activities
  5. Health care devices - Various health monitoring devices available in market
  6. Patient medication history interview - collection of information on the patient's past medication history, patient's current medications, allergies, drug interactions, adverse reactions, medical conditions, etc.
  7. Medication adherence - Role play, creating a reminder pill box for tracking the patient's medication adherence, educating patients about the importance of adherence
  8. Use of Community Pharmacy Software and digital health tools

Assignments

The students shall be asked to submit written assignments on the following topics (One assignment per student per sessional period, i.e., a minimum of THREE assignments per student):

  1. Requirements for establishment and maintenance of a drug store, various types of drug stores, organization and structure of retail and wholesale drug stores
  2. Dispensing of proprietary medicine: handling of controlled substances, dispensing of proprietary medicine, processing of prescriptions, ethical considerations
  3. Patient counselling process: stages of patient counselling, Patient Information Leaflet, methods of counselling
  4. Medication adherence: objectives, factors contributing to non-adherence, methods to improve adherence
  5. Health screening services in community pharmacy: introduction, scope and importance of health screening services
  6. Over the Counter (OTC) medications: definition, need and role of pharmacists in OTC medication dispensing, classification of OTC medications in India, OTC counseling
  7. Community Pharmacy Management: legal requirements to set up a community pharmacy, site selection requirements, pharmacy designing and interiors, vendor selection and ordering, procurement, inventory control methods, inventory management, financial planning and management, accountancy in community pharmacy
  8. Pharmaceutical care: definition, principles, stages of pharmaceutical care
  9. Prescription Medication History Interview: objectives, process of patient medication history interview, medication history form, case studies
  10. Community pharmacy computers: introduction, business and health care applications of computers in community pharmacy, classification and use of software
  11. Responding to symptoms of minor ailments: basic introduction, medical aspects, product knowledge, patient management, various types of minor ailments and role of pharmacist
  12. Digital health: introduction and terminologies, concept of 'Digital India' initiative, mHealth, E-Health, Health Management Information System (HMIS), Introduction to National Digital Health Mission (NDHM), National Health Authority (NHA), E-pharmacies, telemedicine guidelines, Electronic prescribing, Electronic health record, medical decision support
  13. Global Overview of Online Pharmacies
  14. Overview of health systems in different countries and the role of pharmacists in community pharmacy in India
  15. Overview of pharmacy associations in India

Field Visit

The students shall be taken to visit community pharmacies and medicine distributors in groups and observe their working, interactions with customers and patients, inventory management and supply chain logistics. Individual reports from each student on their learning experience from the field visit shall be submitted.

ER20-23T Biochemistry and Clinical Pathology - Theory

Course Code: ER20-23T

Scope

This course is designed to impart basic knowledge on biomolecules and clinically important biochemical pathways, and to learn the principles behind the clinical pathology tests and investigations related to health and diseases.

Course Objectives

This course will discuss about:

  1. Concept of biomolecules like carbohydrates, lipids, proteins, amino acids, nucleic acids, enzymes
  2. Brief knowledge of important metabolic pathways related to health and diseases
  3. Brief knowledge of clinically important laboratory parameters, pathological investigations related to health and diseases

Course Outcomes

Upon successful completion of this course, the students will be able to:

  1. Describe the functions and significance of biomolecules like carbohydrates, lipids, proteins, amino acids, nucleic acids, enzymes
  2. Summarize the metabolism of carbohydrates, lipids and proteins
  3. Describe the structure and functions of nucleic acids
  4. Discuss the laboratory investigations including collection, handling of various body fluids

Topics

Chapter 1: Introduction to Biochemistry: Scope of Biochemistry in pharmacy, Cell and its biochemical organization

Chapter 2: Carbohydrates: Definition, classification with examples, chemical properties. Monosaccharides - Structure of glucose, fructose, concept of isomerism. Disaccharide - Structure of sucrose, lactose, maltose. Polysaccharides - Chemical nature, functions, properties of starch and glycogen. Qualitative tests and biological role of carbohydrates

Chapter 3: Proteins: Definition, classification of proteins and amino acids based on chemical nature and nutritional importance. Structure and function of haemoglobin. Qualitative tests and biological role of amino acids and proteins

Chapter 4: Lipids: Definition, classification with examples. Structure and properties of triglycerides, fatty acids, phospholipids. Qualitative tests and functions of lipids

Chapter 5: Nucleic acids: Definition, classification, and biological role. Structure of purines and pyrimidines, nucleosides and nucleotides. DNA structure - Watson and Crick model. RNA structure and types

Chapter 6: Enzymes: Definition, mechanism of action, types, factors affecting enzyme action, therapeutic and pharmaceutical importance

Chapter 7: Vitamins: Coenzyme role with their physiological functions, fat soluble vitamins (A, D, E, K as per structure) Water soluble vitamins - B and C as per classification

Chapter 8: Metabolism: Carbohydrate metabolism: Glycolysis and TCA cycle, glycogenesis, glycogenolysis, gluconeogenesis, hormonal regulation of blood glucose levels. Biological oxidation: Electron transport chain and oxidative phosphorylation. Lipid metabolism: beta oxidation of fatty acids, fatty liver and obesity. Amino acid metabolism: Transamination, deamination, urea cycle, jaundice, phenylketonuria

Chapter 9: Minerals: Types, Functions, Deficiency diseases, recommended dietary requirements

Chapter 10: Water and Electrolytes: Distribution, functions of water, water turnover, electrolyte composition of body fluids. Dietary intake and output, dehydration, oral rehydration therapy (ORT)

Chapter 11: Introduction to Biotechnology

Chapter 12: Organ function tests: Kidney function tests (KFT), with brief knowledge about renal diseases. Liver function tests (LFT) with brief knowledge about hepatic diseases. Thyroid function tests (TFT)

Chapter 13: Introduction to Pathology of Blood and Urine: Lymphocytes and platelets, their role in health and disease. Erythrocytes - abnormal cells and their significance. Urine - abnormal constituents and their significance in diseases

ER20-23P Biochemistry and Clinical Pathology - Practical

Course Code: ER20-23P

Scope

This course is designed to provide training on the qualitative determination of various biomolecules, pathological investigations related to health and diseases.

Course Objectives

This course will train the students on:

  1. Basic biochemical experiments related to carbohydrates, proteins, lipids and amino acids
  2. Determination of various clinical parameters of blood and urine
  3. Collection and handling of various biological samples and their significance

Course Outcomes

Upon successful completion of this course, the students will be able to:

  1. Identify qualitatively various biomolecules like proteins, carbohydrates, lipids, amino acids
  2. Determine various clinical parameters of blood and urine
  3. Interpret the significance of abnormal findings of biomolecules in blood and urine in a diseased state

Practicals

  1. Qualitative analysis of carbohydrates
  2. Qualitative analysis of proteins and amino acids
  3. Qualitative analysis of lipids
  4. Qualitative analysis of urine for normal and abnormal constituents
  5. Determination of Blood creatinine
  6. Determination of Blood sugar
  7. Determination of Serum total cholesterol
  8. Determination of Haemoglobin content of blood
  9. Determination of Serum total protein
  10. Handling of clinical samples
  11. Study of basic haematological tests with normal values and interpretation of results: Erythrocyte Sedimentation Rate (ESR) and Packet Cell Volume (PCV), Bleeding Time (BT), Clotting Time (CT)
  12. Study of enzymatic activity of salivary amylase

Assignments

The students shall be asked to submit written assignments on the following topics (One assignment per student per sessional period, i.e., a minimum of THREE assignments per student):

  1. Biochemistry - Definition, scope, and various cell organelles with their functions
  2. Vitamins: functions, sources, deficiency diseases, daily requirements
  3. Water and Electrolytes - Functions, sources, deficiency diseases, daily requirements
  4. Organ function tests - functions of Kidney, Liver, Thyroid, their normal values
  5. Clinical Pathology - Composition of blood, urine, normal and abnormal constituents

ER20-24T Pharmacotherapeutics - Theory

Course Code: ER20-24T

Scope

This course is designed to impart basic knowledge on the common disease conditions and disabilities, etiopathogenesis, diagnosis, non-pharmacological and pharmacological management of these diseases.

Course Objectives

This course will discuss the following:

  1. Aetiology, pathophysiology, clinical presentations of commonly occurring diseases in the community
  2. Role of pharmacist in counselling of patients during dispensing of prescription in the community pharmacies

Course Outcomes

Upon successful completion of this course, the students will be able to:

  1. Describe the etiopathogenesis of selected common diseases and evidence-based pharmacotherapy
  2. Explain the importance of individualized and patient centered therapeutic approach in pharmacotherapeutics
  3. Describe the patient counselling points (pharmacological and non-pharmacological) for the selected common diseases

Note: For the following diseases, only the first line of drug therapy (name of the drug class/drug and its dose regimen) and pharmacist's role (counselling, monitoring, adherence, etc.) to be discussed at entry level and in brief.

Topics

Chapter 1: Pharmacotherapeutics - Introduction, scope, and objectives. Rational use of Medicines, Evidence Based Medicine, Essential Medicines List, Standard Treatment Guidelines (STGs)

Chapter 2: Definition, aetiopathogenesis, clinical manifestations, non-pharmacological and pharmacological management of the following diseases / conditions:

(a) Cardiovascular System: Hypertension, Angina and Myocardial infarction, Hyperlipidaemia, and Congestive Heart Failure

(b) Respiratory System: Asthma and Chronic obstructive pulmonary disease

(c) Endocrine System: Diabetes mellitus, Thyroid disorders (Hypo and Hyperthyroidism)

(d) Central Nervous System: Epilepsy, Parkinson's disease, Alzheimer's disease (Dementia), Migraine

(e) Gastrointestinal Disorders: Gastro oesophageal reflux disease, Peptic ulcer disease, Alcoholic liver disease, Inflammatory bowel disease (Crohn's disease and Ulcerative colitis)

(f) Haematological Disorders: Iron deficiency anaemia, Megaloblastic anaemia

(g) Infectious diseases: Tuberculosis, Pneumonia, Hepatitis, Herpes, Amoebiasis, Syphilis, Gonorrhoea and Urinary tract infections

(h) Musculoskeletal disorders: Rheumatoid arthritis, Osteoarthritis

(i) Dermatology: Psoriasis, Scabies, Eczema, Impetigo

(j) Psychiatric Disorders: Depression, Anxiety, Psychosis

(k) Ophthalmology: Conjunctivitis (bacterial and viral), Glaucoma

(l) Ear, Nose and Throat: Ear infections (Otitis media), Sore throat

(m) Anti-microbial Resistance

ER20-24P Pharmacotherapeutics - Practical

Course Code: ER20-24P

Scope

This course is designed to train the students and instill the skills for identifying the symptoms of major diseases and advise the non-prescription medicines, i.e., Over The Counter (OTC) drugs for minor ailments, and make referrals whenever needed.

Course Objectives

This course will train the students in the following areas:

  1. Identify the presenting symptoms and related clinical features of the minor ailments
  2. Suggest an appropriate OTC drug and if necessary, a referral to a doctor

Course Outcomes

Upon successful completion of this course, the students will be able to:

  1. Identify the major diseases based on the symptoms and clinical features
  2. Suggest the appropriate OTC drugs for the given minor ailments

Practicals

Case studies and simulated clinical skills lab: Scenario-based case studies on the following topics:

  1. Preparation of SOAP notes for the following diseases / disorders: Hypertension, Angina (Chest Pain), Myocardial Infarction, Diabetes, Peptic Ulcer, Asthma, COPD, Epilepsy, Yeast (Vaginal Candidiasis), sore throat, common cold
  2. Responding to symptoms (minor ailments) and referral cases: Headache, Nausea/Vomiting, Body pain, Generalised weakness, Cold, Fever, Cough, Diarrhoea, Allergy, Abdominal pain, Indigestion, Generalised oedema, Worm infestations, Mouth ulcers, Constipation, Insomnia, Acidity, Heart burn, Burns, Dandruff, Eye irritation, Skin rash, Muscular pain, Aches and sprains, Joint pain, Sore throat, Tooth ache

ER20-25T Hospital and Clinical Pharmacy - Theory

Course Code: ER20-25T

Scope

This course is designed to impart basic knowledge on functioning of hospital pharmacy, hospital pharmacy services, clinical pharmacy services, and patient care in hospital setting.

Course Objectives

This course will discuss the following:

  1. Hospitals, hospital pharmacy and hospital pharmacy services
  2. Pharmacy and therapeutic committee, hospital formulary, hospital drug policy
  3. Drug distribution systems, compounding and manufacturing in hospital pharmacy
  4. Clinical pharmacy, pharmaceutical care, and clinical pharmacy services
  5. Clinical laboratory tests and their interpretation
  6. Poisoning and its management
  7. Pharmacovigilance and medication errors, drug interactions

Course Outcomes

Upon successful completion of this course, the students will be able to:

  1. Describe about the hospital pharmacy, its organization, and services
  2. Discuss the various drug distribution systems in hospital pharmacy
  3. Explain the clinical pharmacy services and role of clinical pharmacist in patient care
  4. Interpret the clinical laboratory tests and their significance
  5. Describe the handling and management of poisoning cases, pharmacovigilance process / activities and drug interactions

Topics

1. Hospital Pharmacy:

2. Different Committees in the Hospital:

4. Supply Chain and Inventory Control:

5. Drug distribution:

6. Compounding in Hospitals: Bulk compounding, compounding of IV admixtures, Total parenteral nutrition

7. Radio Pharmaceuticals: Storage, dispensing and disposal of radiopharmaceuticals

8. Application of Computers in Hospital Pharmacy Practice, Electronic health records, Softwares used in hospital pharmacy

9. Clinical Pharmacy:

10. Clinical laboratory tests used in the evaluation of disease states - Significance and interpretation of test results:

11. Poisoning:

12. Pharmacovigilance:

13. Medication errors:

Note: The official syllabus prints the topic numbers as 1, 2 and then 4 onwards. No item 3 is printed in the official document.

ER20-25P Hospital and Clinical Pharmacy - Practical

Course Code: ER20-25P

Scope

This course is designed to train the students and instill the skills for identifying and reporting Adverse Drug Reactions (ADRs), and acquire practical knowledge on drug distribution systems, drug storage, purchase, dispensing, compounding in hospitals and clinical pharmacy services.

Course Objectives

This course will train the students in the following areas:

  1. Different drug distribution systems in hospitals
  2. Practical knowledge on good storage conditions, compounding, dispensing and documentation in hospital pharmacy
  3. Basics of clinical pharmacy services, identification and reporting of adverse drug reactions and drug interactions

Course Outcomes

Upon successful completion of this course, the students will be able to:

  1. Perform the functions related to drug distribution systems in hospitals
  2. Perform the good storage, dispensing and documentation practices in hospital pharmacy
  3. Identify and report adverse drug reactions

Practicals

  1. Handling of prescriptions with clinical history - case studies
  2. Drug information services - answering queries related to drugs and poisons, drug-drug interactions, checking for drug interactions in given prescriptions, safer alternatives, providing drug information to the doctors, nurses, patients
  3. Medication history interview (history taking) for real / simulated patients with different diseases
  4. Drug utilization review from the patient's medical records
  5. Identifying the prescription drugs which are available as Fixed Dose Combinations (FDCs) and discussion on rational / irrational FDCs
  6. Identifying and reporting Adverse Drug Reactions (ADRs) based on case studies / real case reports given
  7. Interpretation of clinical laboratory tests based on case studies
  8. Use of Hospital Pharmacy Software and various digital health tools

Assignments

The students shall be asked to submit written assignments on the following topics (One assignment per student per sessional period, i.e., a minimum of THREE assignments per student):

  1. Detailed study of different drug distribution systems in hospitals including Automated drug dispensing systems and devices
  2. Overview of compounding in hospitals: bulk compounding, compounding of IV admixtures, Total parenteral nutrition (TPN)
  3. Preservation and storage conditions for different types of drugs in hospitals including thermolabile drugs, controlled drugs, vaccines etc.
  4. Organization and functions of hospital pharmacy at district, taluk and village levels
  5. Computers in hospital pharmacy practice, Electronic health records, various softwares used in hospital pharmacy - overview
  6. Details on the various clinical pharmacy services offered at hospitals and the role of clinical pharmacist in patient care services
  7. Poison information centre - their services, organization, information sources and role of pharmacist
  8. Various diagnostic tools used in the hospitals - Blood pressure apparatus (sphygmomanometer), Trial lens etc., Stethoscope, Spirometer, ECG, EEG, X-ray, CT scan, MRI, 2DECHO
  9. Home Diagnostic Kits - Pregnancy Test, COVID testing etc.
  10. Measures taken in hospitals to minimize Antimicrobial Resistance
  11. Role and responsibilities of a pharmacist in public hospital in rural parts of the country
  12. Safe waste disposal of hospital waste

ER20-26T Pharmacy Law and Ethics - Theory

Course Code: ER20-26T

Note: This subject has theory only. There is no practical course for Pharmacy Law and Ethics.

Scope

This course is designed to impart basic knowledge on several important legislations related to the profession of pharmacy in India.

Course Objectives

This course will discuss the following:

  1. Legislative and ethical aspects in the practice of pharmacy profession
  2. Pharmaceutical legislations in India as per the Pharmacy Act, Drugs and Cosmetics Act, DPCO, NDPS Act and other legislations
  3. Evolving concepts of pharmacy laws in India

Course Outcomes

Upon successful completion of this course, the students will be able to:

  1. Describe the history and evolution of pharmacy law in India
  2. Interpret the act and rules regulating the profession and practice of pharmacy in India
  3. Discuss the various codes of ethics related to practice standards in pharmacy
  4. Interpret the fundamentals of patent laws from the perspectives of pharmacy

Topics

Chapter 1: General Principles of Law, History and various Acts related to Drugs and Pharmacy profession

Chapter 2: Pharmacy Act-1948 and Rules: Objectives, Definitions, Pharmacy Council of India; its constitution and functions, Education Regulations, State and Joint state pharmacy councils, Registration of Pharmacists, Offences and Penalties. Pharmacy Practice Regulations 2015

Chapter 3: Drugs and Cosmetics Act 1940 and Rules 1945 and New Amendments: Objectives, Definitions, Legal definitions of schedules to the Act and Rules. Import of drugs – Classes of drugs and cosmetics prohibited from import, Import under license or permit. Manufacture of drugs – Prohibition of manufacture and sale of certain drugs, Conditions for grant of license and conditions of license for manufacture of drugs, Manufacture of drugs for test, examination and analysis, manufacture of new drug, loan license and repacking license. Study of schedule C and C1, G, H, H1, K, P, M, N, and X. Sale of Drugs – Wholesale, Retail sale and Restricted license, Records to be kept in a pharmacy. Drugs Prohibited for manufacture and sale in India. Administration of the Act and Rules – Drugs Technical Advisory Board, Central Drugs Laboratory, Drugs Consultative Committee, Government analysts, licensing authorities, controlling authorities, Drug Inspectors

Chapter 4: Narcotic Drugs and Psychotropic Substances Act 1985 and Rules: Objectives, Definitions, Authorities and Officers, Prohibition, Control and Regulation, Offences and Penalties

Chapter 5: Drugs and Magic Remedies (Objectionable Advertisements) Act 1954: Objectives, Definitions, Prohibition of certain advertisements, Classes of Exempted advertisements, Offences and Penalties

Chapter 6: Prevention of Cruelty to Animals Act-1960: Objectives, Definitions, CPCSEA - brief overview, Institutional Animal Ethics Committee, Breeding and Stocking of Animals, Performance of Experiments, Transfer and Acquisition of animals for experiment, Records, Power to suspend or revoke registration, Offences and Penalties

Chapter 7: Poisons Act-1919: Introduction, objective, definition, possession, possession for sales and sale of any poison, import of poisons

Chapter 8: FSSAI (Food Safety and Standards Authority of India) Act and Rules: brief overview and aspects related to manufacture, storage, sale, and labelling of Food Supplements

Chapter 9: National Pharmaceutical Pricing Authority: Drugs Price Control Order (DPCO) - 2013. Objectives, Definitions, Sale prices of bulk drugs, Retail price of formulations, Retail price and ceiling price of scheduled formulations, Pharmaceutical Policy 2002, National List of Essential Medicines (NLEM)

Chapter 10: Code of Pharmaceutical Ethics: Definition, ethical principles, ethical problem solving, registration, code of ethics for Pharmacist in relation to his job, trade, medical profession and his profession, Pharmacist's oath

Chapter 11: Medical Termination of Pregnancy Act and Rules – basic understanding, salient features, and Amendments

Chapter 12: Role of all the government pharma regulator bodies – Central Drugs Standards Control Organization (CDSCO), Indian Pharmacopoeia Commission (IPC)

Chapter 13: Good Regulatory practices (documentation, licenses, renewals, e-governance) in Community Pharmacy, Hospital pharmacy, Pharma Manufacturing, Wholesale business, inspections, import, export of drugs and medical devices

Chapter 14: Introduction to BCS system of classification, Basic concepts of Clinical Trials, ANDA, NDA, New Drug development, New Drugs and Clinical Trials Rules, 2019. Brand v/s Generic, Trade name concept, Introduction to Patent Law and Intellectual Property Rights, Emergency Use Authorization

Chapter 15: Blood bank – basic requirements and functions

Chapter 16: Clinical Establishment Act and Rules – Aspects related to Pharmacy

Chapter 17: Biomedical Waste Management Rules 2016 – Basic aspects, and aspects related to pharma manufacture to disposal of pharma / medical waste at homes, pharmacies, and hospitals

Chapter 18: Bioethics - Basic concepts, history and principles. Brief overview of ICMR's National Ethical Guidelines for Biomedical and Health Research involving human participants

Chapter 19: Introduction to the Consumer Protection Act

Chapter 20: Introduction to the Disaster Management Act

Chapter 21: Medical Devices – Categorization, basic aspects related to manufacture and sale

Assignments

The students shall be asked to submit written assignments on the following topics (One assignment per student per sessional period, i.e., a minimum of THREE assignments per student):

  1. Requirements for Ayurvedic, Homeopathic manufacturing, sale, and licensing requirements
  2. Layout and contents of official websites of various agencies regulating the profession of pharmacy in India: e.g., CDSCO, SUGAM portal, PCI, etc.
  3. Licenses required, application processes (online/offline), drug regulatory office website of the respective state
  4. Case studies – actions taken on violation of any act / rule related to pharmacy
  5. Schedule H1 drugs and its implementation in India
  6. Counterfeit / Spurious medicines
  7. Drug Testing Labs in India
  8. Overview of Pharma marketing practices
  9. Generic Medicines

Official Source

Source: Pharmacy Council of India, Education Regulations 2020. Syllabus framed under Regulation 7 of the Education Regulations 2020 for the Diploma Course in Pharmacy. The topic text above is reproduced from the official syllabus of the Pharmacy Council of India.