Hospital Pharmacy PDF

HOSPITAL PHARMACY CHAPTER 1: INTRODUCTION Introduction to Hospital Pharmacy Hospital Pharmacy, as a science, is a branch of pharmacy practice that focuses on the preparation, dispensing, and management of medications wit...

HOSPITAL PHARMACY CHAPTER 1: INTRODUCTION Introduction to Hospital Pharmacy Hospital Pharmacy, as a science, is a branch of pharmacy practice that focuses on the preparation, dispensing, and management of medications within a hospital or healthcare institution. Hospital Pharmacy is a department within a hospital or healthcare facility responsible for managing the medication needs of patients. This includes ensuring that patients receive the correct medications in the right doses at the right times. Hospital Pharmacy is the department or service in a hospital which is under the direction of a professionally competent, legally qualified pharmacist, and from which all medications are supplied to the nursing units and other services, where special prescriptions are filled for patients in the hospital, where prescriptions are filled for ambulatory patients and out-patients, where pharmaceuticals are manufactured in bulk, where narcotic and other prescribed drugs are dispensed, where injectable preparations should be prepared and sterilized, and where professional supplies are often stocked and dispensed. Evolution of Hospital Pharmacy Initially, hospital pharmacy services focused on drug supply and preparation. Over time, their role expanded to include clinical responsibilities, education, and research. The emergence of clinical pharmacy in the 1970s and 1980s marked a shift towards direct involvement in patient care, enhancing medication safety and therapeutic outcomes. Key Objectives of Hospital Pharmacy Practice 1. Optimizing Patient Care: Ensure that patients receive the correct medications, at the right dose, and at the right time. 2. Medication Safety: Minimize errors in prescribing, dispensing, and administering drugs. 3. Collaboration with Healthcare Professionals: Work closely with physicians, nurses, and other healthcare staff to provide comprehensive patient care. 4. Education and Training: Train staff on medication use, new drug therapies, and advancements in pharmacy practices. 5. Inventory Management: Ensure the availability of necessary medications while preventing overstocking or wastage. Roles of a Hospital Pharmacist Clinical Consultation: Provide advice on drug interactions, side effects, and optimal treatment plans. Drug Formulation and Compounding: Prepare specialized medications not readily available commercially. Patient Education: Inform patients about proper medication use and adherence to treatment plans. Research and Development: Participate in clinical trials and evaluate the effectiveness of new drugs. Regulatory Compliance: Ensure the pharmacy follows laws and regulations related to drug storage, handling, and dispensing. 1 HOSPITAL PHARMACY CHAPTER 1: INTRODUCTION Medication Procurement: Acquiring medications from reliable sources and ensuring their quality and safety. Importance of Hospital Pharmacy Hospital pharmacy is critical for patient safety and quality care in the healthcare system. It helps bridge the gap between theoretical pharmacology and practical patient care by applying pharmacological knowledge in a hospital setting. Pharmacists in hospitals act as a vital resource for both patients and healthcare providers, enhancing treatment outcomes. Topics Covered in Hospital Pharmacy 1. Introduction to Pharmacy Practice: Overview of hospital pharmacy as a distinct field. 2. Drug Distribution Systems: Analysis of unit dose systems, ward stock systems, and centralized pharmacy operations. 3. Sterile and Non-sterile Compounding: Preparation of intravenous (IV) fluids and customized medications. 4. Clinical Pharmacy: The role of pharmacists in direct patient care. 5. Pharmacovigilance: Monitoring and managing adverse drug reactions (ADRs). 6. Pharmacy Informatics: Use of technology in managing medication records and inventory. 7. Ethical and Legal Considerations: Understanding the responsibilities and liabilities in hospital pharmacy practice. Terminology Pharmacovigilance is a field of science focused on the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. The primary goal of pharmacovigilance is to enhance patient care and safety in relation to the use of medicines and to support public health programs by providing reliable information on the safety of medications. In-Patient Pharmacy is a specialized branch of pharmacy that operates within a hospital setting to provide medication management and pharmaceutical care to hospitalized patients. Out-Patient Pharmacy is a branch of pharmacy services that provides medication to patients who are not admitted to the hospital. These patients visit the healthcare facility for treatment and then leave, often requiring prescription medications to be filled. A formulary is a list of prescription medications that are approved for use and covered by a particular healthcare system, hospital, insurance plan, or pharmacy. Formularies are essential tools in the management of drug therapies, ensuring that patients have access to effective, safe, and affordable medications. Pharmacy Informatics is a specialized field that combines pharmacy practice with information technology to improve medication management and patient care. It involves the use of data, information systems, and technology to enhance the safety, efficiency, and effectiveness of the medication-use process. Clinical Pharmacy is a branch of pharmacy that focuses on the direct care of patients, optimizing the use of medications to promote health and prevent or treat diseases. Clinical pharmacists are integral members of the healthcare team, working closely with 2 HOSPITAL PHARMACY CHAPTER 1: INTRODUCTION doctors, nurses, and other healthcare professionals to ensure the best outcomes for patients. Medication Therapy Management (MTM) is a service provided by pharmacists and other qualified healthcare professionals aimed at optimizing therapeutic outcomes for patients. It involves a comprehensive review of a patient’s medication regimen to ensure safety, effectiveness, and adherence. References: 1. Stephens, M. (Ed.). (2011). Hospital pharmacy. Pharmaceutical Press. 2. Holdford, D. A., & Brown, T. R. (Eds.). (2010). Introduction to hospital and health-system pharmacy practice. ASHP. 3 HOSPITAL PHARMACY CHAPTER 2: HOSPITALS Hospitals and Hospital Pharmacy A hospital is a healthcare institution providing patient treatment with specialized medical and nursing staff and medical equipment. Hospitals are healthcare facilities where individuals receive medical treatment and care for various health conditions. They are designed to provide both acute and long-term medical care through a multidisciplinary approach. According to WHO the hospital is a complex organization utilizing combination of intricate, specialized scientific equipment, and functioning through a corps of trained people educated to the problem of modern medical science. These are all welded together in the common purpose of restoration and maintenance of good health. Hospitals are classified into different types and classes based on various factors such as ownership, services provided, specialization, size, and level of care. Classification of Hospitals 1. By Ownership a. Public Hospitals: Owned and operated by government entities (national, state, or local). Funded through taxes and aimed at providing affordable or free healthcare. Examples: District hospitals, government medical colleges. b. Private Hospitals: Owned by individuals, trusts, or corporations. Funded through patient fees and may include high-end facilities. Subcategories: o For-profit hospitals: Aim to generate revenue. o Non-profit hospitals: Run by charitable organizations. c. Military/Veterans’ Hospitals: Serve armed forces personnel and their families. Examples: Veterans Health Administration hospitals, military base facilities. 2. By Level of Care: a. Primary Care Hospitals: Focus on basic healthcare services. Often smaller, community-based facilities. Examples: Rural health clinics, community hospitals. b. Secondary Care Hospitals: Provide specialized medical care such as surgery, maternity, and pediatrics. 4 HOSPITAL PHARMACY CHAPTER 2: HOSPITALS Typically, these hospitals are referral centers for primary care facilities. c. Tertiary Care Hospitals: Offer highly specialized care, including advanced diagnostics and treatment. Examples: Teaching hospitals, multi-specialty hospitals. d. Quaternary Care Hospitals: Provide ultra-specialized and experimental care. Examples: Hospitals specializing in organ transplants or gene therapy. 3. By Services Provided: a. General Hospitals: Offer a wide range of services, including emergency care, surgery, and general medicine. b. Specialty Hospitals: Focus on specific medical fields or patient groups. Examples: o Cardiac Hospitals: Focus on heart-related care. o Cancer Hospitals: Specialize in oncology (e.g., Memorial Sloan Kettering). o Maternity Hospitals: Focus on childbirth and gynecological services. o Pediatric Hospitals: Specialize in care for children. 4. 4. By Size/Capacity: a. Small Hospitals: Fewer than 100 beds. Often cater to local communities. b. Medium Hospitals: Between 100 and 500 beds. Typically regional centers. c. Large Hospitals: More than 500 beds. Often tertiary or quaternary centers. 5 HOSPITAL PHARMACY CHAPTER 2: HOSPITALS 5. By Function or Teaching Role: a. Teaching Hospitals: Affiliated with medical schools. Provide training for medical students and residents alongside patient care. b. Non-teaching Hospitals: Focus exclusively on patient care without educational responsibilities. 6. By Access: a. Open-access Hospitals: Accessible to all patients, usually public hospitals. b. Restricted-access Hospitals: Serve a specific population, such as military personnel. 7. By Geographical Role: a. Urban Hospitals: Located in cities; usually larger with advanced facilities. b. Rural Hospitals: Serve remote or less populated areas, often with limited resources. c. International/Global Hospitals: Provide care to patients from various countries, often medical tourism hubs. 8. By Accreditation/Level of Quality: a. Accredited Hospitals: Certified by organizations like Joint Commission International (JCI), NABH (in India), or other regulatory bodies. b. Non-accredited Hospitals: Operate without formal recognition of standards. 6 HOSPITAL PHARMACY CHAPTER 2: HOSPITALS 9. By Category: The classification of hospitals into categories (A, B, C, etc.) varies by country but typically involves the following criteria: 1. Bed Capacity. 2. Scope of Services. 3. Accreditation or Regulation Standards. 4. Infrastructure and Equipment. 5. Patient Volume and Catchment Area. 6. Research and Education. 7. Administrative and Financial Structure. Class A Hospitals The highest-tier hospitals with the most advanced medical facilities, comprehensive services, and large capacity. Characteristics: o Advanced diagnostic and therapeutic equipment. o Tertiary and quaternary care centers. o More than 500 beds (typically). o Highly qualified and specialized medical staff (consultants, medical specialists) o Engaged in teaching and research activities. o Often located in metropolitan areas and serve as referral centers. Class B Hospitals Secondary-tier hospitals that provide a moderate range of medical services but may not have the same level of specialization or capacity as Class A hospitals. Characteristics: o Serve as secondary care centers. o Typically 100–500 beds. o Provide a mix of general and some specialized services (e.g., general surgery, obstetrics, pediatrics). o Moderate-level diagnostic and therapeutic equipment. o May or may not be affiliated with medical schools or research centers. o Commonly found in larger towns or smaller cities. Class C Hospitals Basic healthcare facilities that focus on primary and limited secondary care, often catering to smaller populations or rural areas. Characteristics: o Typically fewer than 100 beds. o Primarily offer general healthcare services (e.g., general medicine, basic surgery, maternity care). o Limited diagnostic and therapeutic equipment. o Serve as the first point of contact in the healthcare system. o May refer patients to higher-level facilities (Class A or B) for specialized care. o Found in rural or underserved areas. 7 HOSPITAL PHARMACY CHAPTER 2: HOSPITALS Class D Hospitals (if applicable in some systems) Smaller healthcare centers, often community-based or outpatient clinics, providing only basic care and stabilization before referral. Characteristics: o Fewer than 50 beds (if any). o Focus on preventive care, outpatient services, and minor medical emergencies. o Minimal diagnostic and therapeutic facilities. o Staffed by general practitioners or nurses. o Located in remote or underserved communities. Table 1. Hospital Classification Standards Country Classification System Details Philippines Class A, Class B, Class C Class A: Large tertiary hospitals with the highest level of specialization, research, and training capabilities. Class B: Secondary care hospitals with some specialized services and equipment. Class C: Basic hospitals offering primary care and limited secondary services. China Tier 3, Tier 2, Tier 1 (with sub- Tier 3A: Top hospitals in grades A, B, C) urban areas with advanced care, research, and education. Tier 2B: Smaller city hospitals with moderate specialization. Tier 1C: Community-level hospitals focusing on primary care. India Class A, Class B, Class C Class A: Multi-specialty and super-specialty hospitals with tertiary care. Class B: Medium hospitals offering secondary care. Class C: Primary health centers or rural hospitals. 8 HOSPITAL PHARMACY CHAPTER 2: HOSPITALS Standards for Hospital Pharmacy The standards for hospital pharmacies are designed to ensure safe, effective, and efficient medication management within healthcare facilities. These standards encompass structural, operational, and professional requirements. Standards may vary by country and accrediting organizations. The following are general principles for hospital pharmacy standards: 1. Infrastructure and Design Physical Space: o Separate areas for storage, preparation, compounding, dispensing, and record-keeping. o Clean, well-lit, and ventilated workspaces to maintain drug quality and ensure staff safety. Storage Conditions: o Adequate refrigeration for temperature-sensitive medications. o Controlled storage for narcotics and high-risk drugs, including secure locking systems. o Proper shelving to avoid contamination or mix-ups. Compounding Facilities: o Sterile compounding areas (e.g., cleanrooms) for preparing intravenous (IV) medications. o Non-sterile compounding areas for other preparations like ointments or oral suspensions. 2. Medication Management Procurement: o Purchase medications from approved and licensed vendors. o Ensure the availability of essential drugs and emergency medications. Storage: o Adhere to Good Storage Practices (GSP) to maintain drug potency and safety. o Use First-Expire-First-Out (FEFO) or First-In-First-Out (FIFO) methods. Dispensing: o Dispense medications only with valid prescriptions. o Double-check doses, patient information, and allergies before dispensing. Inventory Management: o Regular stock audits to prevent shortages or overstocking. o Maintain an accurate database of medications in inventory. 3. Sterile and Non-Sterile Compounding Compliance with Guidelines: o Follow USP for sterile compounding and USP for non-sterile compounding (in the U.S.). o Adhere to aseptic techniques to prevent contamination. Personal Protective Equipment (PPE): Staff must use gloves, masks, gowns, and other protective gear during compounding. Hazardous Drugs: Handle hazardous medications (e.g., chemotherapy drugs) in compliance with USP or equivalent standards. 9 HOSPITAL PHARMACY CHAPTER 2: HOSPITALS 4. Clinical Services Pharmacist Roles: o Participate in clinical rounds to provide insights on drug interactions, dosages, and alternatives. o Monitor patient medication therapy to improve outcomes and minimize adverse effects. Medication Reconciliation: Verify patient medication history during admission, transfer, and discharge. Education and Counseling: Educate patients and staff on proper drug use, potential side effects, and storage. Drug Utilization Review (DUR): Regularly review medication use to identify trends, improve practices, and prevent errors. 5. Quality Assurance and Safety Policies and Procedures: Develop and regularly update Standard Operating Procedures (SOPs) for all pharmacy operations. Error Prevention: Implement systems to prevent medication errors, such as barcoding or automated dispensing cabinets. Adverse Drug Reaction (ADR) Monitoring: Maintain a system for reporting, analyzing, and addressing ADRs and medication errors. Compliance with Laws and Regulations: Follow local and international guidelines, such as FDA, WHO, or EMA standards. 6. Technology and Automation Electronic Health Records (EHRs): Integrate pharmacy systems with hospital EHRs for better coordination and tracking. Automated Dispensing Systems: Use robotics or automated systems to improve efficiency and reduce errors. Inventory Management Software: Leverage technology for real-time stock updates and predictive analytics. 7. Staff Competency and Training Qualification: Pharmacists must hold relevant degrees (e.g., PharmD or equivalent) and licenses. Continuing Education: Regular training programs on new drugs, regulations, and technologies. Certification: Encourage certifications like BCPS (Board Certified Pharmacotherapy Specialist) or other specializations. Teamwork: Encourage collaboration with physicians, nurses, and other healthcare professionals. 8. Accreditation and Guidelines Hospital pharmacies are often assessed for compliance with accreditation and regulatory standards. Examples include: Joint Commission International (JCI): Focus on patient safety and high-quality care. National Accreditation Board for Hospitals and Healthcare Providers (NABH, India): Sets specific standards for pharmacy operations. 10 HOSPITAL PHARMACY CHAPTER 2: HOSPITALS World Health Organization (WHO): Guidelines for Good Pharmacy Practices (GPP). American Society of Health-System Pharmacists (ASHP): Standards for hospital and health- system pharmacy services. 9. Emergency Preparedness Critical Medications: Maintain stock of emergency drugs for cardiac arrest, anaphylaxis, and other critical conditions. Disaster Management: Establish protocols for medication management during natural disasters or pandemics. 10. Ethical and Legal Compliance Controlled Substances: Strict adherence to regulations for handling and dispensing narcotics or psychotropics. Patient Confidentiality: Maintain confidentiality of patient records and prescriptions. Waste Management: Dispose of expired or unused drugs in an environmentally safe manner. 11. Hospital Pharmacy Administration The pharmaceutical service shall be directed by a professionally competent, legally qualified pharmacist. He or she must be on the same level within the institution's administrative structure as directors of other clinical services. The director of pharmaceutical services is responsible for: (1) Setting the long- and short-range goals of the pharmacy based on developments and trends in health care and institutional pharmacy practice and the specific needs of the institution. (2) Developing a plan and schedule for achieving these goals. (3) Supervising the implementation of the plan and the day-to-day activities associated with it. (4) Determining if the goals and schedule are being met and instituting corrective actions where necessary. References: 1. Stephens, M. (Ed.). (2011). Hospital pharmacy. Pharmaceutical Press. 2. Holdford, D. A., & Brown, T. R. (Eds.). (2010). Introduction to hospital and health-system pharmacy practice. ASHP. 11 HOSPITAL PHARMACY CHAPTER 3: Therapeutics Committee Pharmacy and Therapeutics Committee Roles of Hospital Pharmacists Hospital pharmacists play a critical role in healthcare by ensuring the safe and effective use of medications within hospital settings. Their responsibilities include the following: 1. Medication Management Prescription Review: Verify and review prescriptions for accuracy, appropriateness, and safety. Compounding and Dispensing: Prepare, compound, and dispense medications, including sterile preparations. Formulary Management: Maintain and manage the hospital's drug formulary in collaboration with the Pharmacy and Therapeutics Committee. 2. Patient Care and Counseling Medication Counseling: Educate patients about the correct use of their medications, potential side effects, and interactions. Therapeutic Drug Monitoring: Adjust medication doses based on individual patient needs (e.g., renal function, weight, or age). Clinical Rounds: Participate in multidisciplinary ward rounds to offer advice on drug therapy. 3. Ensuring Medication Safety Error Prevention: Monitor for and prevent medication errors and adverse drug events. Pharmacovigilance: Report and assess adverse drug reactions (ADRs) and implement strategies to minimize them. Drug Interactions: Identify and manage potential drug-drug or drug-food interactions. 4. Research and Education Clinical Trials: Collaborate in clinical research and trials involving investigational drugs. Training: Train pharmacy students, residents, and other healthcare staff in pharmacotherapy. Education: Provide drug-related education to healthcare providers and patients. 5. Inventory and Supply Chain Management Stock Management: Order, store, and monitor inventory of medications, ensuring quality and expiration management. Controlled Substances: Handle and track narcotics and controlled substances to comply with legal and regulatory standards. 6. Specialized Roles Oncology Pharmacy: Prepare and manage chemotherapy drugs. Nutrition Support: Collaborate in the formulation and management of total parenteral nutrition (TPN). Radiopharmacy: Prepare and dispense radiopharmaceuticals for diagnostic and therapeutic use. 16 HOSPITAL PHARMACY CHAPTER 3: Therapeutics Committee 7. Policy and Administration Drug Policy Development: Develop policies for medication use within the hospital. Antimicrobial Stewardship: Promote the rational use of antibiotics to combat resistance. Compliance: Ensure adherence to hospital, state, and national pharmacy regulations. 8. Emergency and Critical Care Support Code Blue Situations: Provide immediate drug support during medical emergencies (e.g., cardiac arrest). ICU Pharmacy: Assist with the complex medication needs of critically ill patients. Role of Pharmacy Technicians in Pharmaceutical Services Pharmacists and pharmacy technicians are integral members of the healthcare team, each playing a distinct role in ensuring safe and effective medication use. While pharmacists focus on proper drug dispensing and direct patient care, pharmacy technicians assist by managing tasks that do not require a pharmacist's professional judgment. This collaboration allows pharmacists to dedicate more time to patient counseling and healthcare interventions. Definition and Scope A pharmacy technician is a trained individual who works under the supervision of a licensed pharmacist, performing various tasks related to drug distribution. The scope of their responsibilities may vary depending on the country’s laws and regulations. Key Responsibilities Pharmacy technicians are involved in various aspects of medication preparation and distribution, including: 1. Prescription Handling: o Receiving written prescriptions or refill requests from patients or caregivers. o Verifying that prescriptions are complete and accurate. 2. Medication Preparation: o Counting, weighing, measuring, and mixing medications. o Preparing prescription labels and selecting appropriate containers. 3. Patient Profiles: o Establishing and maintaining accurate patient profiles. 4. Inventory Management: o Ordering and stocking prescription and over-the-counter medications. 5. Supportive Roles: o Assisting with clinical drug studies. o Taking prescriptions over the telephone and transferring prescriptions between pharmacies. 6. Error Management: o Tracking and reporting medication errors. 7. “Tech Check Tech” Duties: o Preparing and verifying medication carts for accuracy. Pharmacy technicians contribute significantly to the efficiency of pharmaceutical services, ensuring that pharmacists can focus on delivering expert patient care while maintaining high standards of safety and accuracy in drug distribution. 17 HOSPITAL PHARMACY CHAPTER 3: Therapeutics Committee Pharmacy and Therapeutics Committee The multiplicity of drugs available and the complexities surrounding their safe and effective use make it necessary for hospitals to have an organized, sound program for maximizing rational drug use. The pharmacy and therapeutics committee, or its equivalent, is the organizational keystone of the program. The pharmacy and therapeutics committee is an advisory group of the medical staff and serves as the organizational line of communication between the medical staff and pharmacy department. This committee is composed of physicians, pharmacists, and other health professionals selected with the guidance of the medical staff. It is a policy-recommending body to the medical staff and the administration of the hospital on matters related to the therapeutic use of drugs. Roles or Purposes 1. Advisory Role: o Recommends and formulates policies related to drug evaluation, selection, and therapeutic use. 2. Educational Role: o Develops programs to provide the hospital’s professional staff with current drug-related knowledge. Organization and Operation While the composition and operation of the pharmacy and therapeutics committee might vary from hospital to hospital, the following generally will apply: 1. Composition: o At least three physicians, one pharmacist, one nurse, and one administrator. o Members are appointed or elected by the medical staff’s governing body. 2. Leadership: o A physician serves as the chairman, and a pharmacist is typically the secretary. 3. Meetings: o Conducted at least six times per year or more as needed. o Specialists may be invited for specific topics. 4. Documentation: o Secretary prepares and circulates the agenda, minutes, and supplementary materials before meetings. o Meeting minutes are permanently archived. 5. Recommendations: o Submitted to the medical staff or relevant committees for action. 6. Liaison: o Maintains collaboration with other committees like infection control and medical audit. Functions and Scope 1. Advisory Role: o Guides the medical staff and hospital administration on all drug-related matters, including investigational drugs. 2. Formulary Development: o Develops and maintains a drug formulary based on therapeutic merit, safety, and cost- effectiveness. o Reduces unnecessary drug duplications. 3. Cost-Effective Therapy: o Establishes programs to ensure economical drug use. 18 HOSPITAL PHARMACY CHAPTER 3: Therapeutics Committee 4. Educational Programs: o Plans staff education on drug use and therapy. 5. Quality Assurance: o Oversees quality-related activities like drug distribution, administration, and usage. o Reviews adverse drug reactions within the hospital. 6. Drug-Use Review: o Conducts and analyzes drug-use studies and reviews. 7. Drug Control: o Advises on efficient drug distribution and control systems. 8. Stock Recommendations: o Recommends medications for stocking in patient-care areas.. References: 1. Stephens, M. (Ed.). (2011). Hospital pharmacy. Pharmaceutical Press. 2. Holdford, D. A., & Brown, T. R. (Eds.). (2010). Introduction to hospital and health-system pharmacy practice. ASHP. 19