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Midy-term

Phar 830 Midterm


A Health system is an organization that includes at least one hospital and at least one group of physicians that provides comprehensive care who are connected with each other through common ownership and health management. 


Comprehensive care of a Health system includes

  1. Primary 

  2. Ambulatory 

  3. Specialty 


The primary focus of a Healthcare system is to positively impact health outcomes. 


Components of a Healthcare System include:  

  • Inpatient/acute care

  • Primary care/outpatient care

  • Long-term care

  • Home care 

  • Accountable care organizations 

  • Insurance 


The World Health Report 2000 (WHO 200) identifies the four key functions of a Healthcare System: 


  1. Stewardship 

  2. Financing 

  3. Human and physical resources

  4. Organization and management of service delivery 



Stewardship- the careful and responsible management of something entrusted to one’s care

  • The LEADERSHIP of any system 

  • People entrust both their lives and their resources to the healthcare system 


Example of a Stewardship: The Government and WVU medicine has a board that acts as a steward for the enterprise 


Health Financing 

  • Health Financing consists of:

  1. Payers

  2. Providers

  3. Consumers 

Health finance mobilize resources that: 

  1. support basic public health programs

  2. provide access to basic health services

  3. Configure health service delivery systems 


Health finance pay providers based on EFFICACY and QUALITY 



Human and Physical Resources


  • Recruitment, training, deployment, and retention of qualified personnel 

  • Procurement, allocation, and distribution of essential medications and supplies 

  • Investment in physical healthcare infrastructure (facilities, equipment, etc)



Organization and Management of Service and Delivery


Need to ensure 

  1. Access to essential medical products is equitable 

  2. Safe, effective, quality healthcare is being provided to those who need it 

  3. When and where healthcare is needed with a minimal waste of resources 


Quality assurance- quality improvements are closely linked to improved health outcomes 


Examples of quality assurance:

  • Standard treatment guidelines 

  • Training standards 

  • Medical record audits 

  • Facility inspections 


The largest component of health-system practice: Hospitals 

Hospitals are differentiated based on: 

  1. Location (urban or rural)

  2. Size (single building vs spread across a campus complex)

  3. Hospital type


Hospital types: 

  1. Community

  2. Specialized (disease, organ, patient)

  3. Teaching 

  4. For-profit 

  5. Non-profit

  6. Government 

  7. Multihospital System 

Healthcare system Pharmacy Practice- Provision of distributional and clinical pharmacy services at a broad range of health system settings 



Practice Models 


Pharmacy Practice models- describes how pharmacists, pharmacy technicians, and automation interrelate to provide pharmacy practice services 


Pharmacy practice models vary based on: 

  1. Hospital type (community vs academic)

  2. Institution size (large vs small)

  3. Patient population (chronic vs. critical care)

  4. Philosophy of how pharmacy services should be delivered 


WVU Health Service Pharmacy Mission

  • WVU Medicine Pharmacy will provide safe, high quality, affordable patient-centered care to IMPROVE THE HEALTH of West Virginians and all we serve

WVU Health Service Pharmacy Vision

  • WVU Medicine Pharmacy will be the most employee focused pharmacy delivering THE BEST patient care 


Pharmacy Practice Model Types: 

  1. Drug-distribution-centered model 

  • Primarily distributes drugs and processes new medication orders

  • Reactive role 

  1. Clinical-pharmacist-centered model

  • Clinical pharmacists AND distribution pharmacists 

  • LIMITED collaboration between the two 

  1. Patient-centered-integrated model

  • ALL pharmacists have BOTH clinical and distribution duties 

  1. Comprehensive model

  • Pharmacists spend time on BOTH clinical and distributive functions with clinical specialists assigned to specific locations of disease states


Distributive Services (Where’s my drug?)

  1. Centralized 

  • Medications distributed from ONE LOCATION in the facility 

  1. DECentralized

  • Pharmacy satellites for specialty areas 

  • Automated dispensing machines throughout the hospital 

  1. Hybrid (RUBY)

  • Combination of centralized and decentralized 

Clinical Service Models (Where’s my Pharmacist?)


  1. Centralized 

  • Services provided from the central pharmacy and satellite pharmacies (order verification, telephone calls, etc.)

  1. Decentralized (RUBY)

  • Integration with healthcare professionals throughout the hospital 

  • Medical team workrooms 

  • Rounding 

  • Direct patient care 

  1. Hybrid 

  • Combination of clinical and verification duties 


Key Features of Pharmacy Practice 


  1. Practice and education/training will need to be interdisciplinary and team-based

  2. Medication preparation and distribution must be made more efficient with automation, centralization, and use of trained technicians 

  3. Pharmacists’ contributions to the medication-use process are going to:

  1.  increase in direct patient care 

  2.  decrease in medication distribution 

      4.  Health information technology will give pharmacists greater ability to positively                                                                                                                 influence the medication-use process 


Key Features of Pharmacy Practice INDEPENDENT of the Model


  1. Pharmacists will need to justify their value due to allocation of healthcare resources likely heavily driven by metrics 

  2. A pharmacotherapy plan should be developed for each patient and should be comprehensive, multidisciplinary, accessible, and transferable to any provider location

  3. Pharmacists will need continuous training to practice pharmacy; credentialing and privileging of pharmacists may be requirements for practice in general and especially practice areas 

  4. Pharmacists in health systems will need to collaborate better with community pharmacists to coordinate care as patients transition from one practice setting to the next. 


Patient Care settings 


  1. Inpatient Care (In hospital) 

  2. Ambulatory Care (OUT of hospital) 



General Role of Pharmacist in Inpatient Care 

  1. Order Verification

  2. Medication preparation and distribution

  3. Patient care rounds

  4. Code response 

  5. Drug information questions (therapy initiation, dosing, etc)

  6. Dosing protocols (PK, IV to PO, renal adjustments)

  7. Committee Involvement (P&T, medication safety, antimicrobial stewardship) 


Critical Care vs. General Care Units 


  1. Critical Care Units

  • Surgical, Medical, Neurosurgery, Pediatrics, Cardiovascular, Neonatal, Burn units 

  • HIGHER ACUITY LEVEL (sicker patients requiring specialized care)

  • Mainly IV medications 

  • Declining organ function affects dosing 

  • Pharmacists must ensure compatibility, appropriate route, etc


  1. General Care Unit

  • Medical, Surgical, Pediatrics, Cardiology, Orthopedics, Post-Partum, Obstetrics and Gynecology, Oncology units 

  • Drug therapy more likely to be STABLE 

  • Combination of ORAL and IV medications 

  • Pharmacists have a continuity of care role in: 

  1. Medical reconciliation

  2. Affordability 

  3. Discharge Counseling


Ambulatory Care


What do Ambulatory care pharmacists do? 

  1. Manage medication therapy

  2. See patients one-on-one

  3. Collaborate with other healthcare professionals 


Clinical Examples:

  • Primary care/medication adherence

  • Anticoagulation

  • Palliative care

  •  Oncology

  • Cardiology/Heart Failure 

  • Transitions of care 


Other settings of Ambulatory care include:

  1. ED (emergency department)

  2. Specialty Pharmacy 

  3. Home healthcare/infusion

  4. Physician offices

  5. Accountable care organizations 

  6. Insurance organizations 


WVU Medicine Pharmacy Services: Inpatient

  • Central pharmacy 

  • Decentralized pharmacists 

  • Children’s Hospital pharmacy 

  • Cancer Center/ Infusion center Pharmacy

  • OR satellite

  • Chestnut Ridge Pharmacy 


WVU Medicine Pharmacy Services: Ambulatory 

  • Med Center Pharmacy 

  • Discharge Pharmacy 

  • Specialty Pharmacy 

  • Ambulatory Care 

  • Clinics (GI, Weight Management, HF, diabetes, COPD, Endocrinology, Rheumatology)



Pharmacy Roles 


Key Contributors to the Pharmacy Department: 

  1. Pharmacy Leadership 

  2. Pharmacists

  3. Pharmacy Technicians 

  4. Automation and Technology 


Interdisciplinary Patient Care Team: 

  • Pharmacists

  • Physicians

  • NP (nurse practitioner), PA (physician assistant)

  • Nurses 

  • Respiratory therapists

  • Social Workers

  • Dieticians 




Different pharmacists and their roles in a hospital 


  1. Dispensing Pharmacist

  • Responsible for medication preparation

  • Plays an important role in verifying that medications are prepared correctly and dispensed accurately 


  1. Clinical Pharmacists 

  • Serve on interdisciplinary patient care teams 

  • Interact directly with patients 

  • Generalist vs. Specialist 


  1. Integrated practice pharmacists

  • Both dispensing and clinical roles 

  • Designated time spent in each area or time split in a given day 


  1. Managed/Administration Pharmacist 

-Examples: Operations Manager, Pharmacy Director 


Pharmacy Technicians 

  • Perform duties under pharmacist supervision 

  • Scope of role depends on expertise and training (determines their responsibilities)

  • Training standards allow greater responsibility to be transferred to pharmacy technicians 

Greater technician responsibility= more direct patient care opportunities for pharmacists 


Pharmacy Technician roles:

  1. Inpatient/Central floor

  2. Medication reconciliation 

  3. inventory/purchasers

  4. Medication filling/discharge 

  5. Prior authorization coordinators 

  6. Informatics 


Automation and Technology

  • Increase dispensing efficacy and accuracy 

  • Improves safety 

  • Redirects staff away from routine technical tasks and toward direct patient care activities 

  • Cannot replace a pharmacist role due to the clinical services that cannot be provided without one 




  1. Pharmacy Automation 

  • A unit-based dispensing cabinet 

Examples 

  1. Robot 

  2. Medical Carousel 

  3. BoxPicker   


Other Medication-Related Technologies 

  1. Bar-coded medication administration (BMCA)

  • Requires pharmacy involvement in ensuring that drug packages have appropriate readable barcodes and that information systems capture and document information 

  1. Computerized provider order entry (CPOE)

  • Requires an interface or integration with pharmacy information systems so that medication ordering information is able to transfer between the prescriber and the pharmacy 

  1. Smart Pumps 

  • Predefined minimum and maximum rates 

  • Ensures limits are clinically appropriate 



Health System Regulation 


Hospitals and Healthcare Systems are highly regulated organizations that can be subjected to voluntary accreditation and are always subjected to regulatory oversight 


Accreditation- a voluntary process by which an outside accrediting body assesses the quality of hospital-provided care on a routine basis

  • The primary purpose of accreditation is to assess and improve the quality of patient care 

  • NO authority to impose fines or bring legal action 

Example: the Joint Commision 


Regulatory Bodies- law enforcement bodies 

  • The primary purpose of regulatory bodies is public protection

  • CAN impose fines and take legal action 

Examples: US Food and Drug Administration (FDA), Centers for Medicare and Medicaid (CMS), Drug Enforcement Administration (DEA), state and local departments of health, Board of Pharmacy (BOP)






Practice Standards/Practice Guidelines 


  • Practices that a profession develops and imposes on itself 

  • Should be based on scientific evidence, and should strive to surpass minimum requirements established by law or regulation 

  • Elements of a practice standard may be adopted or adapted into law regulation but, unlike laws and regulations, they are voluntary 

Examples: ASHP Best Practices 


Post-Graduate Opportunities 


PGY1- Well-rounded experience, exposure to a variety of disease states, builds upon knowledge, skills, and abilities gained from pharmacy school 

PGY2: Focused on a SPECIFIC area of practice 

  • Allows for more career opportunities in clinical pharmacy 


Post-Graduate Board Certification 

  • Voluntary 

  • Requires continuing education 


BPS Specialty Certifications

  1. Ambulatory care 

  2. Cardiology

  3. Compounded Sterile Preparations

  4. Critical Care

  5.  Emergency Medicine 

  6. Geriatric 

  7. Infectious Disease 

  8. Nuclear

  9. Nutrition Support

  10. Oncology

  11. Pediatric 

  12. Pharmacotherapy 

  13. Psychiatric 

  14. Solid Organ Transplantation 


Summary (take home messages) 

  • The practice of pharmacy in healthcare-system settings is unique and diverse; it requires pharmacists to have skills and expertise beyond those generally gained through pharmacy education

  • Pharmacists in Healthcare-system settings are integrated members of the healthcare team as the medication therapy and medication-use system experts 

  • The practice model in pharmacy continues to evolve 


Controlled Substance Distribution, Diversion, Prevention, and Perioperative services 


The Controlled Substance Act (CSA) 

  • Defined controlled substances 

  • Established the five schedules 

  • Established the Drug Enforcement Agency (DEA)

  • Mandated CLOSED-system distribution 

  • All individuals dispensing, prescribing, and handling controlled substances are to be licensed 

  • Accurate and complete inventory and transaction records 


Controlled Substances Schedule (Five classes)

CV= LOWEST abuse potential 

CI= HIGHEST abuse potential 



DEA forms: 


  1. DEA form 222

  • Single copy DEA form 

  • Contains 20 order lines 

  • The purchaser filling out the form MUST make a copy

  • MUST be kept for a minimum of 2 years 

  1. DEA form 41

  • On site destruction of controlled substances 

  • Requires TWO signatures of employees witnessing the destruction 

  • Must be “non-retrievable” destruction 


  1. DEA form 106

  • Reporting theft or significant loss 





Controlled Substance Ordering System (CSOS) 


  • Electronic Ordering system 

  • Requires registration with the DEA


Advantages of CSOS: 

  • No item limits 

  • CI-CV and non-controlled 

  • Quicker turnaround time 


Disadvantages of CSOS:

  • Requires dedicated hardware/software 

  • Downtime 

  • Difficult to obtain access 


Automation

  1. Ordering 

  • CSOS

 

  1. Storing 

  • Records user/drug accessed

  1. Dispensing

  • ADM (Automated Dispensing Cabinet)

  • Anesthesia Workstation

  1. Returning 

  • Requires a witness 

  1. Wasting 

  • Loops

  • Requires a witness



Controlled Medication Storage 

  • ALL controlled medications are locked, inventoried, and monitored 


Central pharmacy: must have a narcotic vault 


Distributed ADM (Automated Dispensing Cabinet)

  • Located on patient floors

  • Requires count for removal and witness for wasting 


Distributed: Anesthesia Workstation

  • Located on operation rooms 

  • Barcode scanning and waste documentation, but no blind count or witness wasting 

  • Combination of automatic and manual locking drawers


Dispensing controlled medications: 

  1. White sheet- chain of custody from the vault 

  2. ADM (Automated Dispensing Cabinets)- Loaded into ADM with a loop





Patient Owned Medications (POMs)

  • Patient owned medications are assigned to a pocket in the ADM

  • The POMs are then locked, inventoried, and monitored like other controlled medications 

  • POMs are always tracked with patient documentation between patient, central pharmacy, and RN


Controlled Substance Wasting 

  • Waste witnesses MUST observe the actual waste process 

  • Best practice: wasting at the time of removal of the medication 

  • Post Administration wasting: RN should administer and chart the medication in MAR (medication administration record) prior to wasting 


Disposal of Controlled Medications 

  • Waste MUST BE placed in the controlled substance containers 


For regular controlled substances (99% of controlled substances waste)- waste container 


For HAZARDOUS/regulated controlled substances- HAZARDOUS labeled controlled substance waste container 

  • Only use for a few medications by specific dosage forms 

  • These medications are identified on the MAR (Medication Administration Record) with a link to the waste table and within ADMs when the product is removed 

  • There’s a posted list of the drugs above each container 


HAZARDOUS/REGULATED CONTROLLED Substances list: 

  1. Acetaminophen/codeine (oral solution)

  2. Diazepam (rectal gel, injection)

  3. Diphenoxylate/atropine (oral solution)

  4. Hydrocodone/Acetaminophen (oral solution)

  5. Methadone (oral solution)

  6. Pentobarbital (injection)

  7. Phenobarbital (Oral elixer, injection)



Controlled Substance Discrepancies 


A discrepancy is created if there are any missing or extra controlled substances 


Discrepancies can occur in various locations: 

  1. Central pharmacy vault 

  2. Floor ADMs

  3. Unsecure Controlled substances 

  4. Anesthesia Workstations 

How to resolve discrepancies: 

  1. Identify medication name, strength, dosage form, and number of items 

  2. Gather additional information on the discrepancy 

  3. Cycle count the machine with the discrepancy, if able to 

  4. Escalation of discrepancies is based on the hospitals’ policies 


Drug Diversion 

Drug diversion-  the transfer of prescription or controlled substance to an individual to whom it was NOT PRESCRIBED to regardless of intended usage 

  • Estimated cost of controlled prescription drug diversion, abuse to public, and private medical insurers is $72.5 billion per year 


The MOST diverted medications: 

  1. OPIOIDS 

  2. BENZODIAZEPINES 

  3. STIMULANTS


For MISSING controlled substances: 

  • Contact house supervisor IMMEDIATELY. The house supervisor notifies the pharmacy and security. 

  • RN in charge/unit leader will check the med room, unit, WOWs (trash can for products or wrappers), House supervisor can also assist in searching if needed. 

  • Pharmacy will run and review usage reports \

  • Pharmacy Drug Diversion team will run diversion detection software reports (during normal business hours)


If the product is FOUND: 

  • Drug Diversion coordinator (runs during normal business hours) or House Supervisor  (runs outside normal business hours) notifies security, and Direct Supervisor/Manager of the area of the finding. 

  • Drug Diversion Coordinator documents incident 


If THEFT is suspect: IT MUST BE REPORTED TO DEA WITHIN 24 HOURS BY PHARMACY!


If the product is NOT found:

  • Normal business hours: Drug Diversion Coordinator activates live drug response team via live Live Process/TEAMs meeting 

  • Outside normal business hours: the House supervisor follows HS drug diversion Process document along with the hospital administrator on call to determine if live process notification/TEAMs meeting is warranted 


  • DDRT, unit manager or night shift supervisor (if after hours), employer’s manager/supervisor, and HR meet to review data and identify next steps 

  • Hospital Admin on call is invited to the meeting if the event occurs outside normal business hours. 

  • Previously determined parties and employee meet to discuss. The WVUH Reasonable Suspicion Checklist is used along with any other questions identified by the group meeting 


Following the meeting, If DIVERSION IS NOT SUSPECTED: 

  • Drug Diversion Coordinator sends email update to DDRT and documents incident 


Following the meeting, if DIVERSION IS SUSPECTED: 

  1. Belongings check: Security 

  2. FFD testing: Manager or designee escorts employee to Employee Health. Employee health sings consent form.

  • Employee Health Clinician or House Supervisor (if after hours) conducts drug and alcohol testing and informs employee to EAP or FSAP resources. 

  1. Drug Diversion Coordinator sends updated email to DDRT and documents incident. 


Key points from Drug diversion: 

  1. EVERY incident (whether found/not found, diversion suspected/not suspected) MUST be documented by the Drug Diversion Coordinator 

  2. If event occurs during normal hours of service: Drug Diversion Coordinator is in charge 

  3. If event occurs OUTSIDE of normal hours of service: House Supervisor is in charge

  4. Suspected THEFT MUST BE REPORTED TO THE DEA WITHIN 24 HOURS! 


DEA form 106 (THEFT)

  • Submitted via the Theft Loss Reporting (TLR) system 

    • TLRs automatically determine which forms need to be generated and submitted.

      -    Completed for ANY theft or loss of controlled substances, mail-back packages, or inner liners 


Theft: requires background information about the incident

Controlled substances: requires NDC and quantity of the controlled substances being reported








BlueSight and ControlCheck


Individual Risk Identification Score (IRIS) 

  • Artificial intelligence can calculate the “IRIS score” to allow the use of this data to predict employees who may be at higher diversion risk 

IRIS (Individual Risk Identification Score) Components: 

  1. Variance Trends

  2. Dispense patterns 

  3. Medication Trends 

  4. Action Times

  5. User Mobility 

  6. Waste Networks 

  7. Full package waste 


IRIS (Individual Risk Identification Score) in Drug Diversion

  • Generates graphs and reports for easier visualization of data. 

  • Allows comparison of IRIS within site and floors to determine if behavior is unusual

  • Identifies possible diversion risk, but requires human oversight to determine what should be acted on. 


Pharmacists Role in Perioperative Services 


Perioperative Services-  The care the patient receives before (Preoperative Care), during (Intraoperative care) , and after surgery (Postoperative care) 


Essential roles of Perioperative Pharmacists: 

  1. Medication Preparation and Distribution

  2. Safe Medication Practices

  3. Controlled Substance Management 

  4. Order Review 

  5. Drug Information and Education 

  6. Improvement and Quality Assurance 

  7. Leadership and Professional Services 

  8. Financial Management 










  1. Medication Preparation and Distribution 


  1. Procurement (possession) and Preparation

  • Ensures appropriate storage and control

  1. Drug Shortages

  • Pharmacy-based strategies: 

    • Centralization of stock 

    • Preparation of unit doses

      C.     Distribution 

  • Automated Dispensing Cabinets 

  • Manual Dispensing Cabinets 

  • Combination of Manual and Automated dispensing cabinets 

 



Safe Medication Practice: 


The most common General Anesthesia medication errors:

  1. Wrong dose  

  2. Wrong drug 

  3. Extra doses 

  4. Omitted dose/Failure to act 


Mitigation strategies for these errors:

  1. AVOID look-alike drugs 

  2. Use SINGLE USE vials 

  3. Stock ONLY ONE drug concentration 

  4. Standardize medication trays 

  5. INCLUDE ALERT TABS on concentrated labels or high alert medications 


Management Strategies of controlled substances 

  1. Provide controlled substances in ready-to-use concentrations and volumes 

  2. Pharmacy reconciliation of all controlled substances and records 

  3. Regular review of atypical use reports 

  4. Waste content verification

  5. Staff education 









Order Review


Main goal of order review: prospective order review of ALL PACU (Post-Anesthetic Care Unit) ORDERS by a pharmacist. 

  • Pharmacists should be involved in developing or reviewing PACU order sets: 

  1. Dose frequency

  2. maximum dose

  3. Opioid hierarchy 

  4. Rescue antiemetic dose and hierarchy 


  • Perform medication histories to avoid unintended discontinuation or alteration of chronic medications 


Drug Information and Education

  1. Ready access to electronic records 

  2. References should be current, easily accessible, and provide all pertinent drug information

  3. Participants in journal clubs and additional education activities 

  4. Pharmacists should be educated in all services for appropriate cross-coverage when needed 


Improvement and Quality Assurance

  • Interdisciplinary Committees 

  • Medication-use guidelines 

  • Waste Reduction 

  • Culture 


Leadership and Professional services 

  • The perioperative pharmacist may be tasked with the role to lead and oversee the delivery of services by the perioperative pharmacy. 


Qualifications of perioperative pharmacy leadership:

  1. Understand the perioperative culture and practices 

  2. Work effectively with interdisciplinary teams 

  3. Recognize medication needs of the providers and patient 


Financial Management: 

  1. Revenue and expenses

  2. Budget development and analysis 

  3. Formulary Review and additions 

  4. Volume projections 

  5. Justification of new personnel 



Desirable roles of a Perioperative Pharmacist: 

  1. Preoperative medication history/ reconciliation 

  2. Participation in PACU huddles/rounds 

  3. Care of boarded patients 

  4. Discharge prescription service 

  5. Participation in resuscitation 

  6. Education

  7. Research 

  8. Therapeutics (P&T) Committee 


Summary (Take Home messages) 

  • Narcotic Distribution is a CLOSED system that is CLOSELY monitored and inventoried

  • Controlled substance wasting and discrepancy resolution follow STRICT department specific protocol

  • Drug diversion is an issue in the healthcare setting that pharmacists can play a role in monitoring and resolving 

  • Pharmacists contribute to the perioperative settings greatly to ensure safe medication delivery and dispensing 



Medication Distribution Systems and Pharmacy Automation 


History of the unit dose system: 


Floor stock → Patient prescription → Unit dose 


THREE SYSTEMS of medication distribution: 

  1. Floor Stock System 

  2. Patient Prescription System 

  3. Unit Dose System


  1. Floor stock System: 

  • Medications are kept in an individual storage area on each nursing unit and are BOTH prepared and administered BY NURSES 


BENEFITS of Floor Stock System

  • Medication availability


CHALLENGES of Floor Stock System

  • Medication errors

  • Nursing burden 

  • Inefficiency 







  1. Patient Prescription System:  

  • Nurses transcribe medication orders that are filled by pharmacy in patient specific containers 


BENEFITS of Patient Prescription System: 

  • Pharmacy oversight 


CHALLENGES of Patient Prescription System: 

  • Medication errors 

  • Workflow inefficiency 

  • Limited patient information 



  1. Unit Dose System 

  • PHARMACY-COORDINATED method where medications are dispensed in SINGLE-UNITS, ready-to-administer packaging 

  • Generally, NO more than a 24-hour supply is available 


BENEFITS of Unit Dose System

  • Pharmacy oversight 

  • Inventory Control 

  • Decreased Cost 

  • Reduced Medication errors 


CHALLENGES of Unit Dose System 

  • Keeping up with stock 


Unit Dose System workflow

  1. Order is placed by provider

  2. Pharmacy verifies the order for safety and appropriateness

  3. Order appears on the Medication Administration Record (MAR)

  4. The MAR tells the nurses where the mediation is available 

  5. The nurse obtains the medication from automated dispensing machine (ADM) or floor stock or patient specific delivery 

  6. Nurse verifies medication utilizing barcode scanning

  7. Nurse records medication administration on the MAR and the patient is billed accordingly 



Unit Dose System vs. Ward Stock System 


Ward Stock Distribution System (WSDS)- HAND-WRITTEN prescriptions

Unit Dose Drug Distribution System (UDDDS)- COMPUTERIZED prescription


Unit Drug Dose Distribution System is the PREFERRED system due to:

  1.  LESS error rate (10% vs 88%)

  2. LESS administration error 


Benefits of utilizing Unit Dose System vs Ward Stock System 

  1. DECREASES medication errors

  2. DECREASES cost 

  3. DECREASES inventory on units 

  4. INCREASES drug control + monitoring 

  5. INCREASES efficiency 



Summary of the different Systems 


  1. Floor stock 

  • Bulk containers 

  • NOT patient-specific 

  • NO pharmacy oversight 


  1. Patient Prescription System 

  • Patient- specific

  • Transcription errors 

  • LIMITED patient information 


  1. Unit Dose System

  • Pharmacy oversight 

  • Ready-to-administer 

  • Reduced Supply 












Pharmacy Technology and Automation


Pharmacy Automation- machine technology linked by a computer to complete pharmacy related tasks


With automation: 

  1. Orders are computerized in order sets 

  • Non-automated orders would be the provider placing the order 

  1. Remote verification and Automated Verification 

  • Non-automated verification would be the pharmacist verifying the order 

  1. Dispensing can be either centralized or decentralized, IV room automation

  • Non-automated dispensing is when the medication is handpicked and checked by the pharmacist 

  1. Administration via barcode scanning, electronic MAR

  • Non-automated administration is when the medication is delivered to the floor for administration 


Centralized Automation: Carousels, BoxPicker, Pneumatic Tube System, Radio-Frequency Identification (RFID) Technology 

  1. Carousels

  • Handpicked by technicians 

  • One medication at a time 

  • Inventory control 

  1. BoxPicker

  • Reduced time to pull medications compared to carousels 

  • Reduced medication errors 

  • Decreased oversight 

  1. Pneumatic Tube System

  • Decreased delivery time 

  • Decreased technician burden 

  • CAUTION with certain items 

  1. Radio-Frequency Identification (RFID) Technology

  • Improves inventory management accuracy 

  • Decreased oversight and manual burden



IV Room Automation: Product Preparation Verification, Compounding Robots


  1. Product Preparation Verification

  • Cameras, gravimetric balances, and barcode scanning 

  • REDUCES the necessity of direct pharmacist oversight in the IV room 

  1. Compounding Robots 

  • Improves speed and accuracy while reducing the need for direct oversight

  • Can improve employee safety 

BENEFITS of IV Room Automation

  • REDUCES medication error 

  • REDUCES pharmacist oversight 


CHALLENGES of IV Room Automation 

  • Can take up alot of space 

  • Expensive 

  • Technology failure









Decentralized  Automation: Automated Dispensing Machines (ADMS), Barcode Scanning


  1. Automated Dispensing Machines (ADMs)

  • Located on EACH unit for nursing ease of access

  • House medications in locked compartments that can only be opened when a medication is selected (protects home medications)

  • Links to central pharmacy automation for inventory control 

  • REDUCES DIVERSION


  1. Barcode Scanning 

  • Used in many areas of the pharmacy including inventory management, medication distribution, medication administration, etc. 

  • REDUCES medication error


****Barcode Scanning Accounts for the FIVE RIGHTS OF MEDICATION ADMINISTRATION, which are:

  1. PATIENT 

  2. MEDICATION

  3. DOSE

  4. ROUTE

  5. TIME 


ADVANTAGES of Automation: 

  1. Reduces medication error

  2. Reduces Pharmacy Burden 

  3. Improves security 

  4. Improves inventory accuracy 



DISADVANTAGES of Automation:

  1. Cost 

  2. Technology failure/Downtime 

  3. Possible Workflow Burdens 

  4. Training 

  5. Limited Capacity 


Summary of Automation

  • Pharmacy automation can REDUCE MEDICATION ERRORS AND LABOR BURDEN

  • A DISADVANTAGE with pharmacy automation can be SIGNIFICANT FINANCIAL BURDEN

  • Automation allows pharmacists to FOCUS ON CLINICAL TASKS (not worrying about medication errors and labor burden)



Models of Delivery 

CENTRALIZED and DECENTRALIZED 


CENTRALIZED Model: 

  • Central pharmacy 

  • Cartfill 

  • Medication Dispensing 

  • Drug Repackaging 

  • Order Processing 


CENTRALIZED MODEL

  • DECREASES interaction with patient and providers 

  • INCREASES medication delivery time 

  • MINIMIZES drug inventory 

Think about it: it’s all in ONE AREA so the pharmacist has to move which can take time!!!! 













DECENTRALIZED Model: 

  • Central pharmacy 

  • Satellite pharmacies 

  • ADM utilization 

  • Specialized Services 

  • Pharmacist Accessibility


DECENTRALIZED MODEL: 

  • INCREASED clinical service provided 

  • DECREASED medication delivery time (don’t have to go to one remote place)

  • INCREASED INVENTORY throughout hospital  



Batch Fill/ADM restock 


ADM: 

If medication falls below “minimum level” the ADM will trigger a fill alert to the pharmacy


Central Pharmacy: 

Central Pharmacy will fill medications to par level +/ pharmacist check 


Technician:

Delivers and restocks medications in ADM



Hybrid Model 

  • A MIX between centralized and decentralized


Centralized models INCREASE TECHNICIAN BURDEN 

Decentralized models INCREASE NURSING BURDEN and COST MORE 



Future of Pharmacy: Technician Role Expansion 

  • Inventory management

  • Tech-Check-tech

  • Compounding 

  • Diversion

  • Medication histories 

  • Distribution


Electronic Health Record-Integrated Mobile Dispense Tracking 

REDUCES TECHNICIAN BURDEN AND DRUG COSTS BY: 

  1. FEWER medication messages 

  2. FEWER medication redispenses 

Summary: Key Takeaways

  • The Unit Dose System is prevalent due to its:

  1.  increase in efficiency 

  2.  reduction of medication errors

  • Pharmacy automation and technology: 

  1. Reduces medication errors 

  2. Improves operation efficiency 

  3. Enhances inventory management 

  • Hybrid distribution models COMBINE aspects of BOTH CENTRALIZED and DECENTRALIZED models




Health System Finance 


Team/Responsibilities of WVUH Pharmacy Supply Chain Team


Lead Technician: Drug Shortage Specialist 


3 Technician Buyers: 

  • Inpatient 

  • Children’s 

  • Consignment/Blood factors


4 Technician Receivers 


Formulary- an official list giving details of medicines that may be prescribed 

TWO TYPES: 

  1. OPEN formulary 

  2. CLOSED formulary 


  1. Open Formulary- UNRESTRICTED list of medication available for the medication staff to prescribe to their patients 



  1. Closed Formulary- The medical and pharmacy staffs of hospitals compose a list of the medications that the hospital pharmacy stocks, along with information about each medication. 

  • The committee that compiles the hospital formulary typically meets MONTHLY to make changes as necessary 

  • This Group is called the Pharmacy and  Therapeutics committee (P&T committee)


***Pharmacy and Therapeutics (P&T) Committee- committee that meets MONTHLY to make changes in a CLOSED hospital formulary as necessary****


Pharmacist and Therapeutic (P&T) committee considerations: 

  1. SAFETY 

  2. EFFICACY 

  3. COST



Approval Communication Process: 

  1. eP&T communicates approved initiatives to local P&T committees

  2. Local P&T chair and CMO (contract manufacturing organization) present eP&T information to local MECs (Minimum Essential Coverage)

  3. MEC acknowledges decisions from eP&T

  4. Local P&T implements policy under direction of Director of Pharmacy and local P&T chair


Larger percentage of drugs APPROVED by P&T committee 


Most common specialized area spent on formulary: Oncology 


P&T Monograph Considerations


  1. Financial analysis- cost and reimbursement 

  • Rock paper scissor analogy 

  1. Inpatient vs. Outpatient

  • Reimbursement considerations for each 

  1. Base analysis on the scope of the request

  2. Formulary efficiency 

  • If we add a new product, can we eliminate another?

  1. Non-Financial Benefits 

  • Some savings are difficult to quantify (ex: fixed costs, time)


*Trials ARE NOT a short-cut to formulary addition

*Allow TIME to complete thorough analysis 



Budget


Fiscal year- a 12-month period used by organizations for accounting, budgeting, and financial reporting

  • JANUARY-DECEMBER 

Budget evaluation can be either monthly or yearly- but justification is required of being over or under the time frame

Three accounts of budgeting at Ruby:

  1. Pharmacy: 45 million

  2. Oncology: outpatient is 110 million

  3. Provider-based clinics: 17 million 


Other considerations: 

System budgeting is about 200 million 

340B Oversight is about 94 million



Budget Considerations- Low hanging fruit for reducing costs (means achieve reducing costs)


Shrink- when the actual amount of inventory is less than what’s recorded

  • Expired medications 

  • IV wastes 


Inventory can be 

  1. Perpetual inventory (CONTINUOUSLY tracking and updating inventory levels)

  2. Non Perpetual Inventory (PERIODICALLY tracking and updating inventory levels)



The cost of medications on average we expire each year is 4.4 million 

  • WVUH- 1.2 M 


The cost of IV preparations we waste each year is $385,000  




Drug waste examples: 

  1. Product left in a vial/container package after needed dose is administered

  • Manufacturer package size is GREATER than what is needed

  1. Prepared products that are no longer needed (ex. IV bags) and reasons include:

  • Discharge

  • Patient expired

  • Therapy changed 

  • Product is no longer stable 



Expired Medications/IV Waste is a common issue but we can fix it by: 

  1. Adjusting the costs of doing business

  2. Premixes (products that are of the right amount for one specific dose)

  3. Changes to practice 


Inventory at Ruby

  • Non-perpetual 

  • Performed TWO TIMES PER YEAR 


Inventory principles: 

  1. Just in Time 

  2. Pareto (80/20 rule)

  3. PAR levels 


  1. Just in Time Inventory

  • Products are ordered and delivered when they are needed for patient care 

  • The goal is to decrease and extra process steps 


  1. Pareto (80/20 rule)

  • Principle that states that a small number of drugs make up a disproportionate share of usage in the hospital 


  1.  PAR Level System (Periodic Automatic Replenishment)

  • Principle that inventory drugs fall in a predictable usage level 

  • Minimum and maximum orders are set 


***Inventory orders are placed based off the PAR Level System***


Perpetual Inventory- a record of inventory items that is CONSTANTLY updated when items are added or subtracted from inventory.


Stock Rotation- Process of placing products nearest to the expirations at the FRONT of the shelf so they will be used first (LIFO- Last in, First out)


Fixed costs- a cost that DOES NOT CHANGE with an increase or decrease in the amount of goods or services produced or sold 


Variable costs- a cost that VARIES in relation to changes in the volume of activity 


Shrinkage 

Inventory Shrinkage- the excess amount of inventory listed in the accounting records, but which no longer exist in the ACTUAL inventory


EXCESS shrinkage levels can be a PROBLEM and causes are: 

  1. Inventory theft (diversion)

  2. Product damage

  3. Miscounting 

  4. Incorrect usage of measurements 

  5. Lost/misplaced inventory

Physical Inventory (Scope)

  1. Pharmacy satellites 

  2. ADMs (Automated Dispensing Machines)

  3. Central Pharmacy 

  • Automation

  1. Robots

  2. Carousels


4. Sterile product area (IV Room)

5. Narcotic Rooms 

6. Refrigerated items 

7. General Stock 

  • Clinics



Inventory turns- refers to how many times we completely use our on-hand inventory in one year 


Textbook defines inventory turns as :    Actual Drug Spent 

                                                                  __________________

        Average inventory



WVUH defines inventory turns as :     Actual Drug Spent

    __________________

      PHYSICAL inventory 


Example: What is the yearly turns if  (MEMORIZE EQUATION)

  • 20 M spent yearly 

  • Inventory on hand is 2 M


20M/2M= 10 inventory turns 


Purchasing 

  1. Either through wholesaler 

Exs. McKesson/Cardinal/Cencora

  1. OR through various accounts 

Exs. GPO (Group Purchasing Organization), WAC (Weighted Average Cost), 340B, Provider Clinics (UTC/Cheat Lake/POC), Chestnut Ridge, Cancer Center, WVU Medicine Children’s, Fairmont 





Purchasing and Receiving Agents generally occur through use of technology

  • Computerized ordering and receiving 

  • Bar Code Technology

  • Handheld Scanners

  • Reporting/Analytics 



The Basics of Group Purchasing Organizations (GPOs)


Group Purchasing Organizations (GPOs)- negotiate contracts that hospitals can use when making their own purchases 

  • Price and terms and conditions 

  • Suppliers, distributors, and other


GPO contracts account for 73% of non-labor purchases in hospitals 

  • About 98% of hospitals use a GPO 


  • Providers are free to make non-GPO contracted purchases within the limits of the agreement


GPOs are financed through administrative fees paid by suppliers. After expenses, these fees are generally distributed to members/stakeholders


GPOs DO NOT purchase or take possession of any products 


Independent Contracts 

  • Contract terms 

  • Product offering (Cost)

  • Market share or other committees 

  • Contract Length 















Drug Shortages: definitions differ across regulatory bodies 


FDA’s definition of  Drug shortages- if ONE manufacturer says they can provide a drug.. it is NOT considered a short  


ASHP’s definition of  Drug shortages- if the drug IS NOT AVAILABLE TO BUY… it’s short


Reasons for Drug Shortages: 

  1. Manufacturing Problems 

  2. Supply/Demand issues 

  3. Shortage of raw material

  4. Voluntary Recalls 

  5. Natural Disasters

  6. Business/Economic issues

  7. Regulatory Issues 

  8. Government Appropriation  


Worst drug shortage year: 2010 (idk why)


Most National drug shortages are UNKNOWN or reason would not be provided


  • Drug shortages are currently monitoring 95 active drug shortages, 30 additional “watch list”

  • Additional spend due to drug shortage is $500-$750 k/year 


Work groups meet weekly due to drug shortages 

  • Clinical Representation key 

  • Listings posted in the Pharmacy and e-mailed to staff weekly 


Natural Disaster drug shortage: Hurricane Helene (Sept. 29th 2023)

  • Baxter 

  • Icumedical

  • B I Braun


Natural Disaster Drug Shortage: Hurricane Maria -Ripple effect 

  • LVF - small volume parenteral

  • Limited empty bags

  • Limited mini bags 

  • Decrease in premixed products and allocations from other manufacturers






The pharmacy maintains a borrow-loan system for acquisition of drugs during a shortage or outage of a prescribed medication or disaster/emergency 

  • Borrowed medication are LIMITED to commercially available products 

  • The pharmacy department policy and procedure outlines the borrow/loan process to include reconciliation



DSCSA (Drug Supply Chain Security Act) Compliance- beginning in 2015, trading partners (defined a manufacturers, wholesale distributors, and dispensers) are REQUIRED to provide the subsequent purchaser with product tracing information when engaging in transactions involving certain prescription drugs. 


  • Trading partners are also required to capture the product tracing information and maintain that data for no less than SIX YEARS after the transaction occurs 


  • FDA does not Intend action against any trading partner NOT compliant with certain aspects of DSCSA prior to March 1 2016 




340B Background- designed to provide affordable drug access to at-risk populations via Qualified Entities (QE)


Qualified Entities of 340B- Low income/indigent families and individuals 


  • Allows QE’s to receive drugs at heavily discounted prices (51% average wholesale prices)

  • Applies to drugs purchased for qualified outpatient visits 


340 B Includes Disproportionate Share Hospitals (DSH), Critical Access Hospitals (CAH), Federally Qualified Health Centers (FQHC)


  • Goal of 340 B was to provide discounts to patients in need, while delivering more comprehensive services and systems 

  • To drive more efficient business practices, quality assurance and outcomes-driven pharmacy services 

340B was created in 1912


340 B Business Purpose: 

  1. To qualify the entity must have an indigent population that it serves 

  2. Must be registered with the state and HRSA (Health Resources Service Administration)

  3. HEAVILY REGULATED for compliance 

  4. Under continual Government scrutiny

Specialty Drugs have continued to grow in revenues over the past years (nearly ½ of pharmacy industry revenues currently)

  

Some random thing I typed: A diagnosis resource group (DRG)  provides optimal Quality and efficient- based care 








 





 




 


  









 


 





 

 




 












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