Chapter 4: Hospital Pharmacy Practice Learning Outcomes Describe differences between centralized & decentralized pharmacies List at least 2 types of services provided by hospital pharmacy departments Explain purpose of pharmacy policy and procedure manuals List at least 3 different methods of drug distribution Learning Outcomes List components of medication management process Describe role accrediting & regulatory agencies play in hospital pharmacy List 2 types of technology in hospital pharmacy Describe quality control & improvement programs List 3 organizations involved with patient safety Describe financial impact 3rd party payers Key Terms Automated medication dispensing device Centralized pharmacy Clinical pharmacy services Closed formulary Decentralized pharmacy Drug distribution services Hospital formulary Investigational drug services Key Terms Medication use evaluation (MUE) Non-formulary drug Open formulary Pharmacy satellite Quality control Quality improvement Unit dose Unit dose distribution system Historical Perspective Pharmacy services were performed from a central pharmacy often located in the basement of the hospital services were often limited Focus procurement repackaging & labeling bulk supplies delivery to patient care areas Floor Stock Was OK Bulk medications was stored on nursing stations Nurse took medication from floor stock Nurses prepared all intravenous (IV) medications Potential for medication errors was very high Mid 1960s-pharmacies assumed more accountability Organizational Structure Typically, at the top, board of directors Chief executive officer (CEO), president, or hospital director sets direction by creating vision & mission reports to the hospital's board of directors responsible for budget, personnel, & operations Second Level of Hospital Mgmt Medical staff/second level of management report directly to CEO Chief operating officer (COO) responsible for daily operations Chief financial officer (CFO) responsible for financial management Vice president of patient care services responsible for direct patient care departments (pharmacy, nursing, and respiratory therapy) Additional Levels of Mgmt Depends on size & scope of services provided financial status of facility management philosophy of CEO Patient-focused care model managers responsible for all employees & activities provided to specific patient types health care workers function as a team regardless of discipline or tasks performed Pharmacy Department Structure Director or chief of pharmacy services budget & drug expenditures medication management regulatory compliance medication safety Pharmacy Department Manager 1 coordinates: pharmacy students residency program Manager 2 coordinates: staff development, clinical pharmacy services Pharmacy technicians may supervise other technicians lead technician responsible for management functions Centralized Pharmacy Services Central location sterile preparation area (clean room) aseptic preparation of IV medications medication cart filling area outpatient prescription counter; storage area for medications and supplies advantage of centralized services: fewer staff members disadvantages : lack of face-to-face interactions with patients/providers Increased time to deliver medications to patient care areas. Decentralized Pharmacy Services provided from patient care areas Pharmacy satellites on patient care units drugs are stored, prepared, & dispensed for patients may be staffed by 1+ pharmacists & technicians Decentralized Pharmacy Advantages pharmacist interacts with patients more opportunities to discuss the plan of care, answer drug information technicians -close to medication storage used by nurses Disadvantage require additional resources personnel to staff a decentralized satellite equipment (laminar flow hoods, computers, and printers) references & second inventory of medications Clinical Practitioners Involved in all aspects of drug therapy ensure appropriate, safe, cost-effective care ensure problems requiring drug therapy are treated check appropriateness of medication check dose, dosage form, administration technique monitor effects of medication laboratory results patient-specific parameters Committee Participation Pharmacy and Therapeutics (P&T) Committee standing committee multidisciplinary makes decisions about use of medications makes decisions for the institutions' formulary Computer implementation committee example of ad hoc committee Policy & Procedure Manuals The Joint Commission requires policy & procedure manual Contains descriptions of all of pharmacy functions & services policies for operations procedures explaining how to execute policies Allows for standardized procedures method for communication & education Many policies & procedures in hospitals are multidisciplinary Drug Distribution Services Steps required to get drug to patient Methods vary in each hospital Pharmacy is responsible Sequential processes procuring, storing, preparing, delivering medications Physician orders drug Patient received drug Steps in Drug Distribution 1. Drug must be in inventory 2. Medication order must be written 3.Order reviewed & verified by pharmacist 4.Medication order must be processed 5.Drug dispensed/delivered to nursing station/cabinet 6.Drug administered to patient & documented in MAR 7.Physicians, nurses, pharmacists monitor patient Unit Dose Drug Distribution Unit dose is individually packaged medication ready to be dispensed & administered to patient labeling requirements (drug name, strength, lot number, expiration date, etc.) Two primary methods automation manual Automated Medication Dispensing Cabinets Technicians play a key role Manual Cart-Fill Process Requires use of medication carts or cassettes medication drawers labeled with patient names fill-list report is generated for specific time period-medications scheduled to be given will print technician will fill each patient's drawer from fill-list pharmacist will check the carts for accuracy tech-check-tech process in some states technician exchanges cassettes in patient care areas Emergency Crash Carts Carts or trays with medications used in emergencies defined list of medications Carts/trays are filled by techs & checked by pharmacist locked and sealed delivered to designated patient care area Clinical Services Pharmacists provide patient-focused services pharmacokinetic dosing infectious disease consultations drug information nutritional support services Pharmaceutical care Pharmacist is advocate for patient Patient is involved in decision-making process for care Role of the Technician Pharmaceutical care model allows for new roles for technician use of technicians to record laboratory results screening orders for non-formulary status identifying orders on the hospital's restricted list review & collect missing information for patient allergies height weight Investigational Drug Services Clinical trials evaluate efficacy/safety of medications Study protocol is developed, reviewed, approved by Institutional Review Board (IRB) Protocol is operating manual for clinical trial Specific requirements /procedures must be followed Clinical Trials Following protocol accurately important Patient randomized to receive study drug or placebo Results & recordkeeping may be audited by FDA Investigational medications must be stored in a separate section of the pharmacy limited access Medication Management Entire medication process involved Selection & procurement of drugs Storage Prescribing Preparation & dispensing Administration Monitoring effects Evaluation of entire system Selection & Procurement Pharmacy & Therapeutics (P&T) Committee establishes hospital formulary based on: indications for use effectiveness drug interactions potential for errors and abuse adverse effects cost Formularies Closed formulary means choice of drugs limited Drugs are admitted to formulary by process physician requests to add a drug to formulary pharmacists anticipates need drug monograph is written (by pharmacy) P&T Committee uses information in monograph to decide whether to add drug to formulary drugs removed from formulary when better drugs become available when purchasing trends show drug longer being Formulary & Non-Formulary Pharmacy technicians key role in procurement Specific procurement process Pharmacist may suggest formulary medication to replace non-formulary medication Pharmacy has procedures to allow for temporary use of non-formulary drug Storage Proper storage of medications is critical temperature light sensitivity All medications in hospital are inspected monthly inspections primarily performed by technicians referred to as unit inspections Storage of Controlled Drugs Specific storage & documentation requirements Requirements are stringent based on abuse & diversion potential Must comply with all legal & regulatory requirements Technicians need to be trained & knowledgeable about these requirements Prescribing Policies & procedures for prescribing medications Verbal orders are not recommended Procedures for verbal orders to minimize errors Helpful if indication is on medication order Prescribers can enter order electronically or write out Pharmacists must review medication orders MAR Medication order information appears on MAR MAR=Medication Administration Record Used by nursing to administer meds Pharmacist must review all orders before medication administered unless emergency situation Some hospitals outsource this function to remote sites Preparation & Dispensing Unit-ready-to-use form should be provided to nurse Pharmacy should dispense patient specific unit dose packages to nursing units because: reduction in incidence of medication errors decrease in total cost of medication-related activities more efficient use of pharmacy & nursing personnel improvement in overall drug control and drug use IV Medications Some IV medications available in unit dose form Some meds not stable in solution must be mixed by pharmacy just prior to administration Technicians: main preparers of IV medications Prep requires knowledge/skill of aseptic techniques Extemporaneous Prep Doses based on patient-specific characteristics Pediatric patients require very small doses unique doses not commercially available special dilutions made for IV solutions Extemporaneous oral solutions/suspensions compounded if patients unable to swallow tablet crush tablets-follow recipe for solution or suspension Final Prep Steps Proper labeling patient's name patient's location in hospital medication name dose route of administration expiration date special directions bar-codes Administration Procedures to ensure timely administration of meds Procedures to check 5 rights right medication right dose right patient right time right route Some hospitals add 6th right of documentation Bar Code Systems Computer systems linked so that Nurse scans the patient's wrist band & med bar code Confirms 6 rights: Right Patient Right Drug Right Dose Right Time Right Route Right Documentation-added on to original 5 rights because without documentation, dose may be given more than once in error Monitoring Monitoring effects of medications mandatory adverse effects positive outcomes important component in process Monitoring uses patient information laboratory results patient's clinical response medication profile (anti-allergic or antidote orders ) Technicians may gather info for pharmacists Evaluating Medication Process Tracking & identifying trends adverse drug events medication errors performing medication-use evaluation (MUE) MUE is commonly performed for high-use drugs high-cost drugs high-risk drugs MUE Process Data is collected for evaluation of appropriate use indications, dose, route, clinical response Data is tabulated & presented to appropriate health care providers hospital committees. Appropriate recommendations/actions might include education & training to health care providers pharmacist authority for automatic changes Regulatory Agencies Standards from best practices Regulatory and accrediting agencies make site visits meet with hospital administrators, health care providers, hospital staff review hospital's guidelines , policies & procedures The Joint Commission (TJC) Formerly known as the Joint Commission on the Accreditation of Healthcare Organizations, or JCAHO). Independent, not-for-profit organization Accredits more than 15,000 health care organizations Publishes guides to prepare for onsite inspections Pharmacy staff including technicians need to know requirements /standards Benefits of Accreditation Strengthens community confidence quality safety Competitive edge in marketplace Improves risk management & risk reduction Provides education on good practices Provides professional advice & counsel Helps staff education, recruitment, development Technology Wireless telecommunications Cellular phones Pagers Fax machines Computer networks Built-in alarms to alert health care providers Accurate record keeping (e.g., inventory control) Decreased prep of medications due to unit dose forms Automation Automated compounders Automated medication dispensing system Robotics Inventory Control Reduced diversion Data mining opportunities Surveillance of health care information Technicians play key & innovative roles Computer Systems CPOE=Computerized Physician Order Entry Prevents extra step of transcription (error prone) Pharmacist can more quickly review & verify order label will automatically print in pharmacy to be filled or nurse removes drug from automated medication cabinet Quality Programs Quality improvement aka performance improvement main initiative for institutions quality improvement departments Encouraged by Centers for Medicare and Medicaid Services (CMS) The Joint Commission Quality may be defined by what customers perceive Quality Control Process of checks and balances at critical points Requires complete written procedures training for all staff involved Quality control prevents defective products from reaching patient. Disadvantage of quality control time & resources Quality Improvement (QI) Organized approach to analyzing system performance Goal is to improve system or process make process more efficient reduce number of defects or errors Focus of QI is to apply steps/techniques to analyze problems within system, not within people QI models Six Sigma, Zero Defects, Total Quality Management (TQM), and Continuous Quality QI Methods Prospective Failure Mode and Effects Analysis (FMEA) Retrospective Root Cause Analysis (RCA) Infection Control Hospital acquired=nosocomial infections Policies & procedures related to infection control hand washing surveillance of antibiotic utilization bacteria susceptibility trends creation of formulary restrictions on broad spectrum antibiotics technician can alert the pharmacist & follow the approved procedure for this restriction Medication Safety At the heart of many decisions & processes implementing new technology or automation ordering drugs that are labeled clearly and ready to administer to patients without manipulation applying performance improvement techniques Organizations The Institute for Safe Medication Practices (ISMP) American Society of Health-System Pharmacists (ASHP) Institute for Healthcare Improvement (IHI) The Joint Commission (TJC) Institute of Medicine (IOM) Agency for Healthcare Research and Quality (AHRQ) The Leapfrog Group National Quality Forum (NQF) Centers for Medicare and Medicaid Services Financial Implications Reduce costs & improve quality of care by: developing alternative practice settings establishing reimbursement guidelines streamlining patient care services Health maintenance organizations (HMOs) focus on preventive care & wellness Hospital pharmacy department continues to play key role in cost-effective medication use Cause Mapping Problem Solving Incident Investigation Root Cause Analysis Medication Errors Angela Griffith, P.E. webinars@thinkreliability.com www.thinkreliability.com Office 281-412-7766 Houston, TX Healthcare Case Study Overview What? Medication errors are preventable events that lead to medications being used inappropriately. (Medication errors that cause harm are called adverse drug events.) So What? Adverse drug events injure hundreds of thousands of people a year in the US. Death or serious disability associated with a medication error is a \"never event\". 1 Overview (cont.) Now What? Learn about causes of medication errors Review case studies Identify possible improvements to process Then What? Implement improvements Educate your staff Pass it on! Agenda The Medication Administration Process Causes of Medication Errors Case study 1 Case study 2 Suggestions for Improvement Questions 2 Medication Delivery Process Medication Delivery Process Medication prescribed Medication prepared Medication administered to patient Pharmacist Nurse Medication transcribed Physician Process Map - Medication Prescribed/ Transcribed Patient not informed about medication Wrong dose selected Physician determines patient need for medication Physician selects medication Wrong medication selected Physician selects dose Physician writes/ enters prescription Physician explains prescription to patient Wrong medication/ dose written/ entered 3 Process Map - Medication Prepared/ Administered Wrong dose selected Pharmacist selects medication Wrong medication selected Pharmacist measures medication Wrong medication/ dose delivered Medication labeled Medication delivered to patient Wrong medication/ dose labeled Patient not monitored Medication administered to patient Patient monitored Medication given to wrong patient Medication Errors - Error Reporting 4 Case study 1: Infant Heparin Overdoses Step 1. Outline What When Problem(s) Date Time Different, unusual, unique Where Facility, site Unit, area, equipment Task being performed Adult heparin dose given to 6 newborns September 16, 2006 ? Saturday; dose 1000x higher Indianapolis, IN NICU Administration of heparin (blood thinner) Impact to the Goals Patient Safety Compliance Patient Services Labor/ Time Frequency 3 fatalities, premature newborns 3 critical condition premature newborns \"Never event\" Incorrect drug dose delivery Investigation 16,000 incorrect dosing errors between 2001-2006 Heparin Overdoses Step 2. Cause Map Heparin administered to infants AND Patient Safety Goal Impacted 3 infant fatalities, 3 critical injuries Wrong dosage heparin administered Wrong dosage removed from bottle AND Medication checks ineffective 5 Heparin Overdoses Step 2. Cause Map Risk of clogging intravenous (IV) tubes Heparin administered to infants Used to prevent blood clots AND Drugs, food, water administered via IV Heparin Overdoses Step 2. Cause Map 10 unit/10,000 unit bottles look similar Wrong dosage removed from bottle Wrong dosage removed from cabinet Wrong dosage in cabinet Wrong dosage removed from pharmacy AND Medication checks ineffective 6 Heparin Overdoses Step 2. Cause Map Medication checks ineffective Medication dose not verified Nurse accustomed to only one dose NICU stocks only one dose of heparin Heparin Overdoses Step 3. Solutions Solution: Use saline to flush IVs Heparin administered to infants Used to prevent blood clots Risk of clogging intravenous (IV) tubes AND Drugs, food, water administered via IV AND Solution: Redesign bottles Solution: Computer delivery system Wrong dosage heparin administered Wrong dosage removed from bottle Wrong dosage removed from cabinet Wrong dosage in cabinet Medication dose not verified Nurse accustomed to only one dose Wrong dosage removed from pharmacy 10 unit/10,000 unit bottles look similar AND Medication checks ineffective AND Solution: Review medication check process Medication checks ineffective NICU stocks only one dose of heparin 7 Case study 2: Mistaken Administration of Paralytic Agent Step 1. Outline What When Problem(s) Date Time Different, unusual, unique Where Facility, site Unit, area, equipment Task being performed Patient death, medication error December 1, 2014 ? Fire alarm (code red) at facility Bend, Oregon Hospital emergency room Administration of IV anti-seizure medication Impact to the Goals Patient Safety Labor/ Time Patient death 3 employees placed on administrative leave \"Never event\" Patient not monitored after IV administration Investigation Frequency First time hospital has had issue like this Employee Compliance Patient Services Paralytic Agent Administration Step 2. Cause Map Patient stopped breathing Patient Safety Goal Impacted Patient death Cardiac arrest/ brain damage Patient administered paralyzing agent via IV Evidence: Rocuronium AND Delay in treatment/ response Patient not monitored after IV administered 8 Paralytic Agent Administration Step 2. Cause Map Patient prescribed anti-seizure medication Sought treatment in ER Evidence: Fosphenytoin AND Patient administered paralyzing agent via IV Wrong medication put in IV bag Error in pharmacy AND IV bag marked for prescribed (correct) drug Paralytic Agent Administration Step 2. Cause Map Staff unavailable Patient not monitored after IV administered Fire alarm went off Evidence: For ~20 minutes, per staff AND Patient's door closed Protection from potential fire hazards 9 Paralytic Agent Administration Step 3. Solutions Patient prescribed anti-seizure medication Sought treatment in ER Evidence: Fosphenytoin Solution: Add alert stickers to paralytic agents AND Patient administered paralyzing agent via IV Wrong medication put in IV bag Solution: Update medication protocols; implement detailed checking process & safety zone for medication verification Error in pharmacy AND IV bag marked for prescribed (correct) drug Summary Now What? Causes of medication errors Similarity (names, bottles) Distraction Identify possible improvements to process Minimize distractions Add a double check Alerts/ guides for high risk Then What? Implement improvements Educate your staff Pass it on! 10 \fthis assignment will be based on answer quality, logic / organization of the paper, and language and writing skills, using the following rubric. Points: 150 Case Study 1: Statistical Thinking in Health Care Unacceptable Fair Proficient Exemplary Below 70% F 70-79% C 80-89% B 90-100% A Satisfactorily developed a process map about the prescription filling process for HMO's pharmacy, in which you specify the key problems that the HMO's pharmacy might be experiencing. Satisfactorily used the supplier, input, process steps, output, and customer (SIPOC) model to analyze the HMO pharmacy's business process. Thoroughly developed a process map about the prescription filling process for HMO's pharmacy, in which you specify the key problems that the HMO's pharmacy might be experiencing. Thoroughly used the supplier, input, process steps, output, and customer (SIPOC) model to analyze the HMO pharmacy's business process. Criteria 1. Develop a process map about the prescription filling process for HMO's pharmacy, in which you specify the key problems that the HMO's pharmacy might be experiencing. Next, use the supplier, input, process steps, output, and customer (SIPOC) model to analyze the HMO pharmacy's business process. Weight: 20% Did not submit or Partially developed a incompletely process map about developed a process the prescription filling map about the process for HMO's prescription filling pharmacy, in which process for HMO's you specify the key pharmacy, in which problems that the you specify the key HMO's pharmacy problems that the might be HMO's pharmacy experiencing. Partially might be used the supplier, experiencing. Did not input, process steps, submit or incompletely output, and customer used the supplier, (SIPOC) model to input, process steps, analyze the HMO output, and customer pharmacy's business (SIPOC) model to process. analyze the HMO pharmacy's business process. 2. Analyze the process map Did not submit or Partially analyzed the and SIPOC model to incompletely analyzed process map and identify possible main root the process map and SIPOC model to causes of the problems. SIPOC model to identify possible main Next, categorize whether identify possible main root causes of the the main root causes of the root causes of the problems. Partially problem are special causes problems. Did not categorized whether or common causes. submit or incompletely the main root causes Provide a rationale for your categorized whether of the problem are response. the main root causes special causes or Weight: 20% of the problem are common causes. special causes or Partially provided a common causes. Did rationale for your not submit or response. incompletely provided a rationale for your response. Satisfactorily analyzed Thoroughly analyzed the process map and the process map and SIPOC model to SIPOC model to identify possible main identify possible main root causes of the root causes of the problems. problems. Thoroughly Satisfactorily categorized whether categorized whether the main root causes the main root causes of the problem are of the problem are special causes or special causes or common causes. common causes. Thoroughly provided a Satisfactorily provided rationale for your a rationale for your response. response. 3. Suggest the main tools that you would use in order to analyze the business process and solve the problem. Justify your response. Satisfactorily suggested the main tools that you would use in order to analyze the business process and solve the problem. Satisfactorily justified your response. Weight: 20% 4. Propose one (1) solution to the HMO pharmacy's ongoing problem(s) and propose one (1) strategy to measure the aforementioned solution. Provide a rationale for your response. Did not submit or Partially suggested incompletely the main tools that suggested the main you would use in tools that you would order to analyze the use in order to business process and analyze the business solve the problem. process and solve the Partially justified your problem. Did not response. submit or incompletely justified your response. Did not submit or Partially proposed one Satisfactorily incompletely proposed (1) solution to the proposed one (1) one (1) solution to the HMO pharmacy's on- solution to the HMO HMO pharmacy's on- going problem(s) and pharmacy's on-going going problem(s) and proposed one (1) problem(s) and proposed one (1) strategy to measure proposed one (1) strategy to measure the aforementioned strategy to measure the aforementioned solution. Partially the aforementioned solution. Did not provided a rationale solution. Satisfactorily submit or incompletely for your response. provided a rationale provided a rationale for your response. Thoroughly suggested the main tools that you would use in order to analyze the business process and solve the problem. Thoroughly justified your response. Thoroughly proposed one (1) solution to the HMO pharmacy's ongoing problem(s) and proposed one (1) strategy to measure the aforementioned solution. Thoroughly provided a rationale Weight: 20% for your response. 5. 2 references No references provided Weight: 5% for your response. Does not meet the required number of references; some or all references poor quality choices. References are mostly References are highly relevant sources of relevant, high quality fair quality sources 6. Integration of References Sources are rarely Sources are partially Sources are mostly Sources are integrated using integrated using integrated using consistently integrated Weight: 5% effective techniques of effective techniques of effective techniques of using effective quoting, paraphrasing, quoting, paraphrasing, quoting, paraphrasing, techniques of quoting, and summarizing, or and summarizing, and summarizing, paraphrasing, and lack in-text citations. along with in-text along with in-text summarizing, along citations. citations. with in-text citations 7. Writing / Support for ideas: Weight: 5% 8. Writing / Grammar and mechanics Weight: 5% Rarely uses reasons and evidence that logically support ideas. Partially uses reasons and evidence that logically support ideas. Mostly uses reasons and evidence that logically support ideas. Consistently uses reasons and evidence that logically support ideas. Numerous errors in grammar, spelling, and punctuation. Partially free of errors Mostly free of errors in Free of errors in in grammar, spelling, grammar, spelling, grammar, spelling, and punctuation. and punctuation. and punctuation