Hospital Pharmacy – Chapter 2: Hospital Pharmacy Committees and Formulary System
Introduction
Effective hospital pharmacy practice relies on structured governance through specialized committees. These committees establish policies, ensure patient safety, promote rational drug use, and maintain quality standards. This chapter provides a comprehensive overview of three key committees: the Pharmacy and Therapeutics Committee (PTC), the Hospital Formulary System, and the Infection Control Committee (ICC). Understanding their composition, functions, and the pharmacist’s role within them is essential for every hospital pharmacist.
2.1. Pharmacy and Therapeutics Committee (PTC)
The Pharmacy and Therapeutics Committee (PTC) is a multidisciplinary group comprising physicians, pharmacists, nurses, and other healthcare professionals. Its primary purpose is to formulate policies concerning the therapeutic use of drugs within the hospital. The PTC serves as the cornerstone of medication management, ensuring that drug therapy is safe, effective, and cost-efficient.
2.1.1. Objectives of PTC
The PTC operates with dual objectives: advisory and educational.
- Advisory Objectives:
- To help formulate professional policies regarding the evaluation, selection, and therapeutic usage of drugs.
- To advise hospital administrators and medical staff on drug-related issues, especially those involving experimental or investigational drugs.
- To provide guidance to pharmacists on efficient drug distribution and control methods.
- To recommend medications that should be stored in patient care areas for emergency use.
- Educational Objectives:
- To aid in policy-making that meets the professional staff’s need for current, comprehensive drug information.
- To examine adverse drug reactions and manage the hospital formulary system.
- To coordinate training programs for healthcare professionals on rational drug use.
Dpharmguru’s exam insights:
The PTC has both advisory and educational objectives. Advisory functions focus on drug selection and policy-making, while educational functions emphasize drug information, ADR monitoring, and training. This is a frequently tested distinction in pharmacy exams!
2.1.2. Composition of PTC
The PTC is structured with a main committee and several sub-committees, each focusing on specific therapeutic categories. This ensures specialized review of drugs based on pharmacological class and clinical application.
| Sub-Committee Focus | Drug Categories Covered |
|---|---|
| Neoplastics | Anticancer agents, immunosuppressants |
| Anti-infectives | Antibiotics, antivirals, antifungals |
| Gastrointestinal & Autonomics | Laxatives, antiemetics, autonomic drugs, anti-inflammatory agents |
| Endocrinology | Hormones, thyroid agents, antidiabetic drugs |
| Cardiovascular | Cardiac glycosides, antihypertensives, vasodilators, anticoagulants, diuretics |
| CNS Agents | Analgesics, anticonvulsants, psychotherapeutics, sedatives, hypnotics, stimulants |
Each sub-committee reviews drugs within its category and makes recommendations to the main PTC for inclusion, restriction, or exclusion from the hospital formulary.
2.1.3. Functions of PTC
- Advisory Role: Acts as an advisory council to medical staff and hospital administration on therapeutic drug use.
- Formulary Development: Creates and maintains the hospital formulary of approved drugs and prescriptions.
- Policy and Procedure Development: Establishes written policies for drug selection, procurement, storage, distribution, and therapeutic use.
- Educational Programs: Develops educational initiatives for staff on rational drug therapy and new drug developments.
- Problem Resolution: Investigates drug distribution and administration issues, implementing corrective measures.
- Stock Recommendations: Advises on drugs to be stocked in wards, emergency departments, and other patient care areas.
- Distribution Oversight: Guides the pharmacy in implementing effective drug distribution and control procedures.
2.1.4. Role of PTC in Different Departments
The PTC’s influence extends across multiple domains of hospital pharmacy practice:
- In Drug Safety: The PTC ensures pharmacists are trained on narcotic and psychotropic drug regulations; maintains proper storage for dangerous drugs; verifies expired drugs; ensures GMP compliance in manufacturing; and separates external from internal preparations.
- In Adverse Drug Reaction (ADR) Reporting: The PTC develops ADR reporting forms and procedures; ensures physicians report ADRs promptly; forwards reports to regulatory agencies like the FDA; and documents ADRs in patient medical files.
- In Developing Emergency Drug List: The PTC prepares and maintains emergency drug kits with essential supplies (syringes, needles, airways) and medications (atropine, epinephrine, digoxin, heparin, calcium gluconate, etc.).
- In Drug Product Defect Reporting: The PTC investigates defective drug products, contacts manufacturers/suppliers, and escalates unresolved issues to drug regulatory authorities.
- In Drug Utilization Review (DUR): The PTC promotes rational drug use by reviewing prescribing patterns; detecting and preventing drug interactions, ADRs, IV incompatibilities, and drug-induced diseases; and ensuring safe medication practices.
Dpharmguru’s exam insights:
The PTC plays a vital role in ADR reporting and Drug Utilization Review (DUR). Remember: DUR helps detect drug interactions, ADRs, and IV incompatibilities. This is a frequently tested concept in hospital pharmacy exams!
2.1.5. Role of Pharmacist in PTC
- Ensures safe, effective, and affordable drug use through the formulary system.
- Regulates PTC activities for optimal medication management.
- Creates meeting schedules and records minutes as official documentation.
- Examines scientific, clinical, and economic data for drug evaluations.
- Conducts follow-up research when required for drug safety or efficacy.
- Communicates committee decisions to all relevant stakeholders.
2.2. Hospital Formulary
2.2.1. Definition
A hospital formulary is a continuously revised list of medications, their dosage forms, and associated clinical information, approved by the medical staff and PTC for use in the hospital. It serves as a guide for prescribing, dispensing, and administering drugs, ensuring that only safe, effective, and cost-efficient products are available.
2.2.2. Objectives of Hospital Formulary
- Drug Information: Provides comprehensive details on PTC-approved drug products and their therapeutic uses.
- Policy Information: Outlines hospital policies and procedures for drug usage, including prescribing restrictions, generic substitution rules, investigational drug policies, and emergency drug protocols.
- Operational Procedures: Details pharmacy hours, outpatient prescription policies, labelling, packaging, inpatient distribution procedures, and patient education programs.
- Special Information: Includes dosage schedules, approved abbreviations, pediatric dosing, and other clinically relevant data.
2.2.3. Guiding Principles for Use
- The medical staff appoints the PTC and defines its scope and function.
- The formulary system is sponsored by the medical staff based on PTC recommendations.
- Written policies and procedures are adopted and enforced.
- Drugs are prescribed by non-proprietary (generic) names whenever possible.
- The number of drugs stocked is limited to ensure efficiency and financial benefit.
- All staff are informed about the formulary system and any changes.
- Provision is made for non-formulary drugs when clinically necessary.
- The pharmacist is responsible for quality, quantity, and source of supply specifications.
2.2.4. Procedure for Development of Hospital Formulary
The PTC leads the formulary development, with the chief pharmacist coordinating the compilation and printing. Key decisions include:
- Publication Type: Hospital-specific formulary, drug list, or purchased formulary service.
- Evaluation Criteria: Rules for drug admission based on safety, efficacy, cost, and clinical need.
- Content Sections: Prescription writing guidelines, metric/apothecary equivalents, laboratory values, pediatric dosing, pharmacological index, and reagent information.
- Format: Size, binding (loose-leaf or bound), printing method, and indexing system.
Addition and Deletion of Drugs
- Drugs must be approved by the medical staff.
- Must be recognized by official pharmacopoeias (e.g., IP, USP).
- Manufacturer must hold a valid license under Drugs and Cosmetic Act.
- Secret composition drugs or irrational fixed-dose combinations are excluded.
- Single-ingredient preparations are preferred over multi-ingredient if therapeutic equivalence exists.
Revision of Hospital Formulary
The formulary should be revised annually. Methods include:
- Supplement sheets attached to the back covers for updates.
- Different cover colors for each edition to distinguish from previous versions.
- Regular cost-effectiveness reviews to remove obsolete or expensive products.
2.2.5. Advantages of Hospital Formulary
- Ensures access to safe, effective medications for patient care.
- Reduces drug inventory costs through streamlined procurement.
- Enhances quality assurance and facilitates dispensing accuracy.
- Promotes continuing medical education and patient education.
- Eliminates irrational drug combinations and improves ADR management.
2.2.6. Disadvantages of Hospital Formulary
- May restrict physician prescribing autonomy for specific brands.
- Pharmacist may have sole decision-making authority on brand procurement and dispensing.
2.2.7. Role of Pharmacist in Hospital Formulary
- Plays a key role in creating formulary rules and regulations.
- The chief pharmacist is primarily responsible for formulary compilation.
- Determines the quantity and source of supply for all medications, chemicals, and biologicals.
- Ensures that economic considerations do not compromise drug quality.
- Evaluates drugs per PTC recommendations and provides clinical and cost data.
2.3. Infection Control Committee (ICC)
The Infection Control Committee (ICC) is a multidisciplinary group responsible for preventing and controlling nosocomial (hospital-acquired) infections. It establishes policies, monitors infection rates, and implements educational programs to safeguard patients, staff, and visitors.
2.3.1. Objectives of ICC
- Understand the fundamentals of infection control and transmission.
- Identify causes and risk factors for nosocomial infections.
- Implement surveillance and monitoring programs.
- Reduce antibiotic resistance through antimicrobial stewardship.
- Develop local policies and standard operating procedures (SOPs) for infection prevention.
- Educate healthcare providers on infection control practices.
- Monitor compliance and programme effectiveness.
2.3.2. Composition of ICC
- Hospital Director (Chairperson).
- Chief Infection Control Officer (from Microbiology Department).
- Chiefs of Clinical Departments (Medicine, Surgery, Paediatrics, etc.).
- Chief Nursing Officer.
- Head of Maintenance and Cleaning Department.
- Director of Central Sterile Supply Department (CSSD).
2.3.3. Functions of ICC
- Data Collection: Monitors microflora in high-risk areas (OTs, ICUs, NICUs, dialysis units).
- Surveillance: Focuses on areas with high infection and antibiotic resistance rates.
- Good Infection Control Practices: Evaluates sterilization methods and disinfectant efficacy.
- Policy Development: Creates infection prevention and control policies.
- Audit and Quality Control: Reviews hand hygiene, decontamination, disinfection, and sterilization procedures.
- Training Programs: Conducts ongoing education for all staff on infection prevention.
- Visitor Management: Controls visitors in isolation settings.
- Sanitation Standards: Maintains hygiene, cleaning, and food service standards.
2.3.4. Role of Pharmacist in ICC
- Purchases, stores, and dispenses pharmaceuticals following infection control standards.
- Dispenses anti-infectives and maintains documentation on potency, incompatibility, and storage conditions.
- Ensures vaccine availability and proper storage.
- Monitors antibiotic dispensing to various departments.
- Provides summary reports on antimicrobial usage to ICC and Antimicrobial Use Committee.
- Possesses knowledge of antiseptics, disinfectants, and sterilants.
- Participates in sterilization and disinfection procedures.
- Coordinates educational programs on antimicrobial medications.
- Collaborates with microbiology lab to enhance susceptibility testing.
2.3.5. Role of Pharmacist in Preventing Antimicrobial Resistance (AMR)
- Distributes medicines safely and raises awareness about antibiotic misuse risks.
- Prevents infection transmission, reducing the need for antibiotics.
- Promotes immunisation to decrease infections.
- Guides selection and use of appropriate antibiotics, disinfectants, and sterilants.
- Organises antibiotic therapy review programmes for effectiveness.
- Generates and uses quantitative data on antimicrobial usage.
- Provides medication therapy management for optimal outcomes.
- Advises patients on responsible medication use.
- Collaborates with physicians to ensure prudent antibiotic prescribing.
Dpharmguru’s exam insights:
The ICC plays a crucial role in preventing antimicrobial resistance (AMR). Remember: Pharmacists contribute to AMR prevention through safe dispensing, promoting immunisation, and collaborating with physicians on prudent antibiotic prescribing. This is a frequently tested concept!
Comparison of Hospital Committees
| Committee | Primary Focus | Key Members | Main Output |
|---|---|---|---|
| PTC | Drug selection, formulary, safety, ADR monitoring | Physicians, Pharmacists, Nurses, Administration | Formulary, policies, drug use guidelines |
| ICC | Infection prevention, surveillance, antimicrobial stewardship | Microbiologists, Clinicians, Nurses, Pharmacists, Maintenance | Infection control policies, audit reports, training |
FAQs on Hospital Committees and Formulary
- Q: What is the main difference between PTC and ICC?
A: PTC focuses on drug therapy optimization and safety, while ICC focuses on infection prevention and control. - Q: Can a non-formulary drug be used in an emergency?
A: Yes, hospitals have procedures for non-formulary drug use, often requiring physician justification and PTC approval after the fact. - Q: How often should the formulary be updated?
A: Annually, with periodic supplements for new drug additions. - Q: What is the pharmacist’s role in ADR reporting?
A: Pharmacists assist in identifying, documenting, and reporting ADRs to the PTC and regulatory bodies. - Q: How does ICC help reduce antibiotic resistance?
A: By promoting antimicrobial stewardship, monitoring usage, and educating prescribers.
References
- American Society of Health-System Pharmacists. (2022). ASHP Guidelines on Pharmacy and Therapeutics Committee.
- World Health Organization. (2020). Practical Guidelines for Infection Control in Health Care Facilities.
- National Pharmacopoeia Commission. (2021). Hospital Formulary Development and Management.
- Centers for Disease Control and Prevention. (2023). Antimicrobial Stewardship Programs.
- D.Pharm Guru Study Materials (2024). Hospital Pharmacy Committees.
Conclusion
Hospital pharmacy practice is governed by structured committees that ensure medication safety, rational therapy, and infection control. The Pharmacy and Therapeutics Committee, Hospital Formulary System, and Infection Control Committee work synergistically to uphold quality standards. The pharmacist’s active participation in these committees is vital for achieving optimal patient outcomes and institutional compliance.
Author Attribution: Written by Dr. N. Sujith Kumar, PharmD.
Dpharmguru’s exam insights:
For students preparing for pharmacy board exams, focus on the composition and functions of PTC and ICC, the steps in formulary development, and the pharmacist’s role in drug safety and antimicrobial stewardship. Common exam questions include drug addition/deletion criteria, emergency drug list contents, ADR reporting pathways, and the differences between formulary and non-formulary drugs. Practical viva questions often ask about real-life scenarios of infection control breaches or formulary disputes, so be prepared to apply these concepts.
