Semester 7
BP703T
Hospital & Hospital Pharmacy, Adverse Drug Reactions & Community Pharmacy
This unit introduces the foundational concepts of pharmacy practice. It covers hospital organization (classification, structure, medical staff), hospital pharmacy (functions, layout, pharmacist roles), adverse drug reactions (comprehensive classification, drug interactions types, detection methods, ADR reporting), and community pharmacy (retail/wholesale organization, legal requirements, record maintenance).
Syllabus Topics
- 1Hospital – Definition & Classification: Hospital: an institution that provides medical, surgical, and nursing care to the sick and injured. WHO definition: an integral part of social and medical organization providing complete healthcare (curative, preventive, rehabilitative). Classification by level of care: (1) Primary hospital (Primary Health Centre — PHC): basic healthcare, first level of contact. 30-80 beds. General practitioners. Basic diagnostics, minor surgeries, maternal care. Rural areas. (2) Secondary hospital (District/Sub-district hospital): specialist care — medicine, surgery, pediatrics, obstetrics. 100-500 beds. Specialist doctors. Referrals from primary level. (3) Tertiary hospital (Teaching/Medical college hospital): super-specialty care — cardiology, neurosurgery, oncology. 500-2000+ beds. Super-specialist doctors, advanced diagnostics (CT, MRI), organ transplant, research, teaching. Examples: AIIMS, PGI Chandigarh.
- 2Hospital Classification – Other Bases: Clinical basis: (1) General hospital: all specialties. (2) Specialized hospital: single specialty — cancer (Tata Memorial), eye (Shankar Netralaya), cardiac (SCTIMST), psychiatric (NIMHANS), orthopedic, infectious diseases. Non-clinical basis: (1) Government/Public: funded by central/state government — free or subsidized care. (2) Private: run by individuals, trusts, or corporates — fee-based. (3) Voluntary/Charitable: run by NGOs, religious trusts — subsidized care. (4) Teaching hospital: attached to medical colleges — dual function of patient care + medical education. Hospital organization structure: Governing body/Board → Medical Superintendent/Director → Department heads (Medicine, Surgery, Pharmacy, Nursing, Radiology, Pathology, Administration). Key departments: clinical (medicine, surgery, OBG, pediatrics), diagnostic (radiology, pathology, microbiology), support (pharmacy, nursing, dietetics, social work), administrative (HR, finance, maintenance).
- 3Hospital Pharmacy – Definition & Functions: Hospital pharmacy: department responsible for procurement, storage, compounding, dispensing, and clinical use of medications within a hospital. Functions: (1) Dispensing prescriptions (inpatient and outpatient). (2) Manufacturing/compounding (sterile and non-sterile preparations). (3) Drug procurement and inventory control. (4) Drug storage (including controlled substances, cold chain). (5) Drug information services. (6) Clinical pharmacy services (ward rounds, TDM, ADR monitoring). (7) Quality assurance of drug use. (8) Education and training (interns, nurses). (9) Research (drug use evaluation, pharmacoeconomics). (10) Pharmacy and Therapeutics Committee participation. Indian context: hospital pharmacists registered under Pharmacy Act, 1948. Pharmacist-to-bed ratio recommended: 1:50 (NABH standard).
- 4Hospital Pharmacy – Organization, Layout & Staff: Organization: Chief Pharmacist/Director of Pharmacy → Deputy Chief Pharmacist → Senior Pharmacists → Pharmacists → Pharmacy Technicians → Support staff. Location: central location in hospital — accessible to OPD, wards, and emergency. Ideally on ground floor near OPD. Layout: (1) Dispensing area (OPD counter, IP dispensing). (2) Drug storage area (general store, cold room 2-8°C, controlled substance safe). (3) Compounding/manufacturing area (sterile room for IV admixtures, non-sterile compounding). (4) Drug information center. (5) Administrative area (Chief Pharmacist office, records). (6) Receiving/loading area. Staff requirements: (1) Chief Pharmacist: M.Pharm/Pharm.D, 5+ years experience, manages entire department. (2) Clinical Pharmacist: Pharm.D/M.Pharm (Clinical Pharmacy), ward-based services. (3) Staff Pharmacists: B.Pharm, dispensing, compounding. (4) Pharmacy Technicians: D.Pharm, assist in dispensing. Responsibilities of hospital pharmacist: ensure rational drug use, drug counseling, ADR reporting, inventory management, aseptic compounding.
- 5Adverse Drug Reactions – Classification: ADR: any noxious, unintended, undesired response to a drug at doses used for prophylaxis, diagnosis, or treatment (WHO definition). Rawlins & Thompson classification: Type A (Augmented): exaggerated normal pharmacological response. Dose-dependent. Predictable. Common (80% of ADRs). Usually mild. Examples: hypotension with antihypertensives, bleeding with anticoagulants, hypoglycemia with insulin. Type B (Bizarre): not related to pharmacological action. Dose-independent. Unpredictable. Uncommon but serious. Examples: penicillin anaphylaxis, malignant hyperthermia with anesthetics, chloramphenicol aplastic anemia. Other types: Type C (Chronic/Continuous): long-term use effects (cushing’s with corticosteroids). Type D (Delayed): carcinogenicity, teratogenicity. Type E (End-of-use): withdrawal reactions (benzodiazepine withdrawal seizures). Type F (Failure): therapeutic failure (oral contraceptive failure with enzyme inducers).
- 6ADR – Specific Types: (1) Excessive pharmacological effects: drug produces stronger-than-desired therapeutic effect. Example: profound sedation with benzodiazepines, severe bradycardia with β-blockers. Risk factors: overdose, drug interactions (inhibiting metabolism), organ dysfunction (reduced clearance). (2) Secondary pharmacological effects: effects occurring secondary to the primary action. Example: dry mouth, constipation, urinary retention with anticholinergics — secondary to muscarinic blockade. Pseudomembranous colitis with antibiotics — secondary to gut flora disruption. (3) Idiosyncrasy: genetically determined abnormal susceptibility. Example: glucose-6-phosphate dehydrogenase (G6PD) deficiency → hemolytic anemia with primaquine, sulfonamides, dapsone. Slow acetylators → peripheral neuropathy with isoniazid. (4) Allergic drug reactions: immunological response. Types I-IV hypersensitivity (same as immunology). Requires prior sensitization. Type I (immediate/anaphylaxis): penicillin, sulfonamides. Type IV (delayed): contact dermatitis.
- 7Drug Interactions: Drug interaction: modification of the effect of one drug by another when administered together. Classification: (1) Beneficial interactions: intentional — used therapeutically. Levodopa + Carbidopa (↑bioavailability of levodopa). Amoxicillin + Clavulanic acid (β-lactamase inhibition). Sulfamethoxazole + Trimethoprim (sequential folate blockade). (2) Adverse interactions: unwanted — cause toxicity or therapeutic failure. Warfarin + Aspirin (↑bleeding risk). ACE inhibitor + K⁺-sparing diuretic (hyperkalemia). MAO inhibitor + tyramine-rich food (hypertensive crisis). (3) Pharmacokinetic interactions: affect ADME. Absorption: antacids ↓tetracycline absorption (chelation). Distribution: displacement from protein binding — warfarin displaced by aspirin. Metabolism: enzyme induction (rifampicin ↑CYP3A4 → ↓oral contraceptive efficacy), enzyme inhibition (ketoconazole inhibits CYP3A4 → ↑cyclosporine toxicity). Excretion: probenecid blocks renal secretion of penicillin → ↑penicillin levels.
- 8ADR Detection & Reporting: Methods for detecting drug interactions/ADRs: (1) Spontaneous case reports (Yellow Card system/MedWatch): healthcare professionals voluntarily report suspected ADRs. Simplest, cheapest, ongoing. Detects rare/severe ADRs missed in clinical trials. Limitation: under-reporting (estimated 1-10% of ADRs reported). (2) Record linkage studies: linking patient records (prescriptions, hospital admissions, lab data) in databases → identify associations between drugs and outcomes. Example: UK CPRD database, US claims databases. (3) Case-control studies: compare drug exposure between patients with ADR (cases) and without (controls). (4) Cohort studies: follow drug-exposed patients prospectively. PvPI (Pharmacovigilance Programme of India): established 2010, coordinated by IPC (Indian Pharmacopoeia Commission), Ghaziabad. ADR Monitoring Centres across India. Reports submitted through VigiFlow → WHO Uppsala Monitoring Centre (UMC). Pharmacists’ role: identify, document, report ADRs.
- 9Community Pharmacy: Community pharmacy (retail pharmacy): primary healthcare facility providing medications and pharmaceutical services directly to the public. Types: (1) Retail drug store: sells drugs to general public (requires retail license — Form 20/21 under D&C Rules). (2) Wholesale drug store: sells drugs in bulk to retailers, hospitals (requires wholesale license — Form 20B). Organization: Proprietor/Owner → Pharmacist (registered — must be present during dispensing hours) → Assistant pharmacists → Support staff. Design: (1) Dispensing counter (patient interaction area). (2) Drug storage (shelves/racks — organized alphabetically or by category). (3) Cold storage (refrigerator: 2-8°C for vaccines, insulin). (4) Controlled substance storage (locked cupboard — Schedule X drugs). (5) Record maintenance area. Legal requirements: (1) Valid drug license (retail/wholesale). (2) Registered pharmacist on premises during working hours. (3) Maintain purchase and sale registers. (4) Display license prominently. (5) Proper labeling (Schedule H/H1 warning labels). (6) Maintain controlled substance register (Schedule X).
Learning Objectives
Hospital Classification: Classify hospitals into primary, secondary, and tertiary with beds, staff, and services at each level.
Hospital Pharmacy Functions: List ten functions of a hospital pharmacy department.
ADR Types: Compare Type A and Type B adverse drug reactions with five differences and examples.
Drug Interactions: Give examples of beneficial and adverse drug interactions with their mechanisms.
Community Pharmacy: List the legal requirements for establishing and maintaining a retail drug store in India.
Exam Prep Questions
Q1. What is the difference between Type A and Type B ADRs?
Type A (Augmented): dose-DEPENDENT, PREDICTABLE, related to pharmacological action, COMMON (80% of all ADRs), usually MILD, manageable by dose reduction. Example: bleeding with warfarin.
Type B (Bizarre): dose-INDEPENDENT, UNPREDICTABLE, NOT related to pharmacological action, UNCOMMON but SERIOUS/FATAL, requires drug withdrawal. Example: anaphylaxis with penicillin.
Memory trick: A = Augmented (too much of expected effect), B = Bizarre (unexpected, unrelated to drug action).
Q2. Why must a registered pharmacist be present in a drug store?
Under the Pharmacy Act, 1948 and D&C Rules, dispensing of prescription drugs is a professional act that REQUIRES the presence of a registered pharmacist. Reasons: (1) Patient safety — pharmacist checks prescriptions for drug interactions, contraindications, correct dosing. (2) Legal requirement — Schedule H/H1 drugs can ONLY be dispensed by or under the supervision of a registered pharmacist. (3) Professional counseling — pharmacist provides usage instructions, warns about side effects, checks for allergies. (4) Controlled substances (Schedule X) — pharmacist maintains the controlled substance register. Operating without a pharmacist is a punishable offense under the D&C Act.
Q3. What is PvPI and what role does a pharmacist play?
PvPI (Pharmacovigilance Programme of India): national program for monitoring ADRs, established in 2010, coordinated by IPC Ghaziabad, under WHO’s International Drug Monitoring Programme. Over 300+ ADR Monitoring Centres (AMCs) at medical colleges and hospitals across India.
Pharmacist’s role: (1) Identify suspected ADRs in patients. (2) Document ADR details (drug, reaction, timeline, dechallenge/rechallenge). (3) Report through PvPI reporting form (can submit online through ADR reporting app). (4) Follow up on patient outcome. (5) Educate other healthcare professionals about ADR reporting. Pharmacists are crucial because they are often the FIRST to notice ADRs during dispensing and patient counseling.