Preparation, Clinical Pharmacy & OTC Sales
This unit covers three important areas of pharmacy practice. Budget preparation and implementation for the pharmacy department. Clinical Pharmacy — the concept, functions, and responsibilities of clinical pharmacists including medication chart review, clinical review, pharmacist intervention, ward round participation, medication history, and pharmaceutical care. Also covers dosing based on pharmacokinetics and disease patterns. Over-the-Counter (OTC) medications — introduction to OTC sales and rational use of common non-prescription drugs.
Syllabus & Topics
- 1Budget Preparation: Budget: financial plan that estimates income and expenditures for a specific period (typically fiscal year). Pharmacy department budget: one of the LARGEST hospital budgets (drugs account for 30-40% of total hospital expenditure). Types of budgets: (1) Operating budget: day-to-day expenses — drug purchases, salaries, supplies, maintenance. (2) Capital budget: major equipment purchases — automated dispensing machines, IV hood, cold storage units. Budget preparation steps: (1) Review previous year’s actual expenditure. (2) Analyze drug consumption patterns (ABC/VED analysis data). (3) Factor in: new drugs added to formulary, price inflation (~5-10% annual), new services planned, patient volume changes. (4) Prepare line-item budget (each expense category listed separately). (5) Submit to hospital finance committee. (6) Justify each line item. (7) Negotiate and finalize.
- 2Budget Implementation & Monitoring: Budget implementation: converting the approved budget into action. Strategies: (1) Monthly allocation: divide annual budget into monthly portions (seasonal adjustments). (2) Purchase authorization: all purchases within budgeted amounts → department head approval. Exceeding budget → higher authority approval. (3) Variance monitoring: compare ACTUAL spending vs BUDGETED amounts monthly. Positive variance (underspent): may indicate unmet needs. Negative variance (overspent): investigate — price increases? New formulations? Unexpected demand? (4) Cost containment measures: generic substitution (30-80% cost savings), therapeutic interchange (PTC-approved), bulk purchasing/rate contracts, reduction of drug wastage (review floor stocks, near-expiry management), proper inventory control (avoid overstocking). (5) Revenue generation: pharmacy can generate revenue through outpatient drug sales, clinical pharmacy services (in private hospitals). Reports: monthly expenditure reports, quarterly variance analysis, annual budget performance review — presented to hospital administration.
- 3Clinical Pharmacy – Introduction: Clinical pharmacy: discipline concerned with the application of pharmaceutical expertise to help maximize drug efficacy and minimize drug toxicity in individual patients. Concept: shift from product-oriented (preparing and dispensing drugs) to patient-oriented (optimizing drug therapy outcomes). Clinical pharmacist = pharmacist who works directly with the healthcare team and patients on the ward. Evolution: originated in USA (1960s), now established globally. India: growing — Pharm.D program (6-year professional degree) produces clinical pharmacists. Functions: (1) Drug therapy monitoring. (2) Medication chart review. (3) Clinical review. (4) Pharmacist intervention. (5) Ward round participation. (6) Medication history taking. (7) Patient education/counseling. (8) ADR monitoring and reporting. (9) Pharmacokinetic dosing. (10) Pharmacoeconomic evaluation.
- 4Medication Chart Review & Clinical Review: Medication chart review: systematic review of each patient’s medication chart (medication administration record — MAR) by the clinical pharmacist. Check for: (1) Correct drug (indication appropriate, formulary drug). (2) Correct dose (age, weight, renal/hepatic function adjusted). (3) Correct route and frequency. (4) Drug interactions (screen all concurrent medications). (5) Drug allergies (cross-reference with patient allergy history). (6) Duplicate therapy (two drugs from same class). (7) Therapeutic appropriateness (is the drug necessary?). (8) IV-to-oral switch opportunity (↓cost, ↓infection risk). (9) Proper monitoring (lab tests ordered for drugs requiring monitoring). Clinical review: deeper evaluation — reviewing clinical parameters (lab results, vital signs, clinical progress) in context of drug therapy. Assess if drug therapy is achieving intended outcomes. Identify drug-related problems: untreated indication, unnecessary drug therapy, wrong drug, dose too high/low, ADR, non-adherence, drug interaction.
- 5Pharmacist Intervention & Ward Rounds: Pharmacist intervention: recommendation made by clinical pharmacist to optimize drug therapy. Types: (1) Dose adjustment (renal impairment → aminoglycoside dose reduction). (2) Drug discontinuation (unnecessary drug identified). (3) Drug substitution (more effective/safer/cheaper alternative). (4) Additional drug recommended (untreated indication). (5) Route change (IV → oral step-down). (6) Monitoring recommendation (drug level, lab test). (7) ADR management. Documentation: intervention recorded — drug, recommendation, rationale, outcome (accepted/rejected by prescriber), clinical impact. Acceptance rate typically 70-90%. Ward round participation: clinical pharmacist joins physician team during daily ward rounds. Role: (1) Provide drug information on the spot. (2) Alert team to potential interactions when new drugs discussed. (3) Recommend evidence-based therapy. (4) Answer drug-related questions. (5) Ensure pharmacy perspective in treatment decisions. This is the MOST VISIBLE clinical pharmacy activity.
- 6Pharmaceutical Care: Pharmaceutical care (Hepler & Strand, 1990): the responsible provision of drug therapy for the purpose of achieving definite outcomes that improve a patient’s quality of life. Core concept: pharmacist takes RESPONSIBILITY for patient’s drug therapy outcomes — not just dispensing correctly, but ensuring the drug WORKS and doesn’t cause harm. Elements: (1) Establish therapeutic relationship with patient. (2) Collect patient-specific information (medication history, labs, clinical status). (3) Identify drug-related problems (DRPs): unnecessary drug therapy, untreated condition, wrong drug, dose too low/high, ADR, non-adherence, drug interaction. (4) Develop care plan for each DRP. (5) Implement care plan (recommendation to prescriber, patient education). (6) Follow up and monitor outcomes. (7) Document everything. Pharmaceutical care ≠ clinical pharmacy (broader): clinical pharmacy is the PRACTICE; pharmaceutical care is the PHILOSOPHY/GOAL. All drug therapy decisions judged by: Does this improve the patient’s quality of life?
- 7Dosing Patterns & Disease-Based Therapy: Dosing based on pharmacokinetics: (1) Loading dose = (Vd × Css) / F → achieve therapeutic levels quickly (important in critical care). (2) Maintenance dose = (Cl × Css × τ) / F → maintain steady state. (3) Dose adjustment in renal impairment: Cockcroft-Gault → estimate CrCl → adjust dose. Drugs requiring adjustment: aminoglycosides, vancomycin, digoxin, lithium, methotrexate. (4) Dose adjustment in hepatic impairment: Child-Pugh score → guide dose reduction for hepatically metabolized drugs. (5) Pediatric dosing: weight-based (mg/kg), body surface area-based (mg/m²). Disease-specific dosing considerations: (1) Renal failure: ↓clearance → ↓dose or ↑interval. (2) Hepatic failure: ↓metabolism → ↓dose of hepatically cleared drugs. (3) Heart failure: ↓cardiac output → ↓organ perfusion → altered PK. (4) Obesity: use ideal body weight for some drugs, actual for others. (5) Burns: ↑Vd, ↑clearance for some drugs → ↑dose may be needed.
- 8Over-the-Counter (OTC) Medications: OTC drugs: medications that can be purchased WITHOUT a prescription — considered safe for self-medication when used as directed. India: drugs NOT listed in Schedule H, H1, or X are available OTC. However, India doesn’t have a formal OTC category like FDA. Common OTC categories: (1) Analgesics/antipyretics: paracetamol, ibuprofen, aspirin. (2) Antacids: aluminum hydroxide, magnesium hydroxide, ranitidine (now withdrawn). (3) Cough/cold: dextromethorphan, chlorpheniramine, pseudoephedrine. (4) Antiallergics: cetirizine, loratadine. (5) Antidiarrheal: ORS, loperamide. (6) Topical: antiseptics (povidone-iodine), antifungals (clotrimazole), analgesic balms (diclofenac gel). (7) Vitamins/supplements: multivitamins, calcium, iron. Rational use: pharmacist must counsel on — correct dosage, duration (short-term only), contraindications, drug interactions, when to see a doctor. Irrational OTC use problems: masking serious symptoms, drug interactions with prescription drugs, overuse (paracetamol hepatotoxicity), misuse (cough syrups containing codeine).
Learning Objectives
Exam Prep Questions
Q1. What is the difference between clinical pharmacy and pharmaceutical care?
Clinical pharmacy is the PRACTICE/DISCIPLINE — it encompasses all patient-oriented activities performed by pharmacists (chart review, ward rounds, TDM, counseling, drug information). Pharmaceutical care is the PHILOSOPHY/GOAL — it’s the concept that the pharmacist takes RESPONSIBILITY for the patient’s drug therapy outcomes, not just performing tasks. Think of it this way: clinical pharmacy is WHAT you do; pharmaceutical care is WHY you do it. A clinical pharmacist provides pharmaceutical care. The term was coined by Hepler & Strand (1990) to shift pharmacy from product-focused to outcome-focused.
Q2. What are drug-related problems?
Drug-Related Problems (DRPs) are any undesirable events involving drug therapy that actually or potentially interfere with patient outcomes. The seven categories: (1) Unnecessary drug therapy (no indication, duplicate therapy). (2) Untreated condition (indication needs drug, but not prescribed). (3) Wrong drug (more effective alternative available, contraindicated). (4) Dose too LOW (subtherapeutic). (5) Dose too HIGH (toxicity risk). (6) Adverse drug reaction. (7) Non-adherence (patient not taking as prescribed). The clinical pharmacist systematically screens for ALL seven categories during medication review.
Q3. What is the pharmacist’s role in OTC sales?
The pharmacist is the GATEKEEPER of OTC medication use: (1) ASK: determine the symptom — severity, duration, associated symptoms (red flags → refer to doctor). (2) ASSESS: appropriate OTC treatment? Any contraindications (pregnancy, chronic disease, other medications)? (3) ADVISE: recommend the most appropriate OTC product — correct drug, dose, duration. Counsel on side effects and when to seek medical attention. (4) MONITOR: if patient returns repeatedly for same OTC → underlying condition needs medical evaluation. The pharmacist should PREVENT self-medication with OTC drugs when symptoms suggest a serious condition (chest pain, persistent fever, blood in stool, severe headache).