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
Primary
Ambulatory
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:
Stewardship
Financing
Human and physical resources
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:
Payers
Providers
Consumers
Health finance mobilize resources that:
support basic public health programs
provide access to basic health services
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
Access to essential medical products is equitable
Safe, effective, quality healthcare is being provided to those who need it
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:
Location (urban or rural)
Size (single building vs spread across a campus complex)
Hospital type
Hospital types:
Community
Specialized (disease, organ, patient)
Teaching
For-profit
Non-profit
Government
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:
Hospital type (community vs academic)
Institution size (large vs small)
Patient population (chronic vs. critical care)
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:
Drug-distribution-centered model
Primarily distributes drugs and processes new medication orders
Reactive role
Clinical-pharmacist-centered model
Clinical pharmacists AND distribution pharmacists
LIMITED collaboration between the two
Patient-centered-integrated model
ALL pharmacists have BOTH clinical and distribution duties
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?)
Centralized
Medications distributed from ONE LOCATION in the facility
DECentralized
Pharmacy satellites for specialty areas
Automated dispensing machines throughout the hospital
Hybrid (RUBY)
Combination of centralized and decentralized
Clinical Service Models (Where’s my Pharmacist?)
Centralized
Services provided from the central pharmacy and satellite pharmacies (order verification, telephone calls, etc.)
Decentralized (RUBY)
Integration with healthcare professionals throughout the hospital
Medical team workrooms
Rounding
Direct patient care
Hybrid
Combination of clinical and verification duties
Key Features of Pharmacy Practice
Practice and education/training will need to be interdisciplinary and team-based
Medication preparation and distribution must be made more efficient with automation, centralization, and use of trained technicians
Pharmacists’ contributions to the medication-use process are going to:
increase in direct patient care
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
Pharmacists will need to justify their value due to allocation of healthcare resources likely heavily driven by metrics
A pharmacotherapy plan should be developed for each patient and should be comprehensive, multidisciplinary, accessible, and transferable to any provider location
Pharmacists will need continuous training to practice pharmacy; credentialing and privileging of pharmacists may be requirements for practice in general and especially practice areas
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
Inpatient Care (In hospital)
Ambulatory Care (OUT of hospital)
General Role of Pharmacist in Inpatient Care
Order Verification
Medication preparation and distribution
Patient care rounds
Code response
Drug information questions (therapy initiation, dosing, etc)
Dosing protocols (PK, IV to PO, renal adjustments)
Committee Involvement (P&T, medication safety, antimicrobial stewardship)
Critical Care vs. General Care Units
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
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:
Medical reconciliation
Affordability
Discharge Counseling
Ambulatory Care
What do Ambulatory care pharmacists do?
Manage medication therapy
See patients one-on-one
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:
ED (emergency department)
Specialty Pharmacy
Home healthcare/infusion
Physician offices
Accountable care organizations
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:
Pharmacy Leadership
Pharmacists
Pharmacy Technicians
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
Dispensing Pharmacist
Responsible for medication preparation
Plays an important role in verifying that medications are prepared correctly and dispensed accurately
Clinical Pharmacists
Serve on interdisciplinary patient care teams
Interact directly with patients
Generalist vs. Specialist
Integrated practice pharmacists
Both dispensing and clinical roles
Designated time spent in each area or time split in a given day
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:
Inpatient/Central floor
Medication reconciliation
inventory/purchasers
Medication filling/discharge
Prior authorization coordinators
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
Pharmacy Automation
A unit-based dispensing cabinet
Examples
Robot
Medical Carousel
BoxPicker
Other Medication-Related Technologies
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
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
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
Ambulatory care
Cardiology
Compounded Sterile Preparations
Critical Care
Emergency Medicine
Geriatric
Infectious Disease
Nuclear
Nutrition Support
Oncology
Pediatric
Pharmacotherapy
Psychiatric
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:
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
DEA form 41
On site destruction of controlled substances
Requires TWO signatures of employees witnessing the destruction
Must be “non-retrievable” destruction
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
Ordering
CSOS
Storing
Records user/drug accessed
Dispensing
ADM (Automated Dispensing Cabinet)
Anesthesia Workstation
Returning
Requires a witness
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:
White sheet- chain of custody from the vault
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:
Acetaminophen/codeine (oral solution)
Diazepam (rectal gel, injection)
Diphenoxylate/atropine (oral solution)
Hydrocodone/Acetaminophen (oral solution)
Methadone (oral solution)
Pentobarbital (injection)
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:
Central pharmacy vault
Floor ADMs
Unsecure Controlled substances
Anesthesia Workstations
How to resolve discrepancies:
Identify medication name, strength, dosage form, and number of items
Gather additional information on the discrepancy
Cycle count the machine with the discrepancy, if able to
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:
OPIOIDS
BENZODIAZEPINES
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:
Belongings check: Security
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.
Drug Diversion Coordinator sends updated email to DDRT and documents incident.
Key points from Drug diversion:
EVERY incident (whether found/not found, diversion suspected/not suspected) MUST be documented by the Drug Diversion Coordinator
If event occurs during normal hours of service: Drug Diversion Coordinator is in charge
If event occurs OUTSIDE of normal hours of service: House Supervisor is in charge
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:
Variance Trends
Dispense patterns
Medication Trends
Action Times
User Mobility
Waste Networks
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:
Medication Preparation and Distribution
Safe Medication Practices
Controlled Substance Management
Order Review
Drug Information and Education
Improvement and Quality Assurance
Leadership and Professional Services
Financial Management
Medication Preparation and Distribution
Procurement (possession) and Preparation
Ensures appropriate storage and control
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:
Wrong dose
Wrong drug
Extra doses
Omitted dose/Failure to act
Mitigation strategies for these errors:
AVOID look-alike drugs
Use SINGLE USE vials
Stock ONLY ONE drug concentration
Standardize medication trays
INCLUDE ALERT TABS on concentrated labels or high alert medications
Management Strategies of controlled substances
Provide controlled substances in ready-to-use concentrations and volumes
Pharmacy reconciliation of all controlled substances and records
Regular review of atypical use reports
Waste content verification
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:
Dose frequency
maximum dose
Opioid hierarchy
Rescue antiemetic dose and hierarchy
Perform medication histories to avoid unintended discontinuation or alteration of chronic medications
Drug Information and Education
Ready access to electronic records
References should be current, easily accessible, and provide all pertinent drug information
Participants in journal clubs and additional education activities
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:
Understand the perioperative culture and practices
Work effectively with interdisciplinary teams
Recognize medication needs of the providers and patient
Financial Management:
Revenue and expenses
Budget development and analysis
Formulary Review and additions
Volume projections
Justification of new personnel
Desirable roles of a Perioperative Pharmacist:
Preoperative medication history/ reconciliation
Participation in PACU huddles/rounds
Care of boarded patients
Discharge prescription service
Participation in resuscitation
Education
Research
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:
Floor Stock System
Patient Prescription System
Unit Dose System
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
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
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
Order is placed by provider
Pharmacy verifies the order for safety and appropriateness
Order appears on the Medication Administration Record (MAR)
The MAR tells the nurses where the mediation is available
The nurse obtains the medication from automated dispensing machine (ADM) or floor stock or patient specific delivery
Nurse verifies medication utilizing barcode scanning
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:
LESS error rate (10% vs 88%)
LESS administration error
Benefits of utilizing Unit Dose System vs Ward Stock System
DECREASES medication errors
DECREASES cost
DECREASES inventory on units
INCREASES drug control + monitoring
INCREASES efficiency
Summary of the different Systems
Floor stock
Bulk containers
NOT patient-specific
NO pharmacy oversight
Patient Prescription System
Patient- specific
Transcription errors
LIMITED patient information
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:
Orders are computerized in order sets
Non-automated orders would be the provider placing the order
Remote verification and Automated Verification
Non-automated verification would be the pharmacist verifying the order
Dispensing can be either centralized or decentralized, IV room automation
Non-automated dispensing is when the medication is handpicked and checked by the pharmacist
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
Carousels
Handpicked by technicians
One medication at a time
Inventory control
BoxPicker
Reduced time to pull medications compared to carousels
Reduced medication errors
Decreased oversight
Pneumatic Tube System
Decreased delivery time
Decreased technician burden
CAUTION with certain items
Radio-Frequency Identification (RFID) Technology
Improves inventory management accuracy
Decreased oversight and manual burden
IV Room Automation: Product Preparation Verification, Compounding Robots
Product Preparation Verification
Cameras, gravimetric balances, and barcode scanning
REDUCES the necessity of direct pharmacist oversight in the IV room
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
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
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:
PATIENT
MEDICATION
DOSE
ROUTE
TIME
ADVANTAGES of Automation:
Reduces medication error
Reduces Pharmacy Burden
Improves security
Improves inventory accuracy
DISADVANTAGES of Automation:
Cost
Technology failure/Downtime
Possible Workflow Burdens
Training
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:
FEWER medication messages
FEWER medication redispenses
Summary: Key Takeaways
The Unit Dose System is prevalent due to its:
increase in efficiency
reduction of medication errors
Pharmacy automation and technology:
Reduces medication errors
Improves operation efficiency
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:
OPEN formulary
CLOSED formulary
Open Formulary- UNRESTRICTED list of medication available for the medication staff to prescribe to their patients
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:
SAFETY
EFFICACY
COST
Approval Communication Process:
eP&T communicates approved initiatives to local P&T committees
Local P&T chair and CMO (contract manufacturing organization) present eP&T information to local MECs (Minimum Essential Coverage)
MEC acknowledges decisions from eP&T
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
Financial analysis- cost and reimbursement
Rock paper scissor analogy
Inpatient vs. Outpatient
Reimbursement considerations for each
Base analysis on the scope of the request
Formulary efficiency
If we add a new product, can we eliminate another?
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:
Pharmacy: 45 million
Oncology: outpatient is 110 million
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
Perpetual inventory (CONTINUOUSLY tracking and updating inventory levels)
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:
Product left in a vial/container package after needed dose is administered
Manufacturer package size is GREATER than what is needed
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:
Adjusting the costs of doing business
Premixes (products that are of the right amount for one specific dose)
Changes to practice
Inventory at Ruby
Non-perpetual
Performed TWO TIMES PER YEAR
Inventory principles:
Just in Time
Pareto (80/20 rule)
PAR levels
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
Pareto (80/20 rule)
Principle that states that a small number of drugs make up a disproportionate share of usage in the hospital
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:
Inventory theft (diversion)
Product damage
Miscounting
Incorrect usage of measurements
Lost/misplaced inventory
Physical Inventory (Scope)
Pharmacy satellites
ADMs (Automated Dispensing Machines)
Central Pharmacy
Automation
Robots
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
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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
Either through wholesaler
Exs. McKesson/Cardinal/Cencora
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:
Manufacturing Problems
Supply/Demand issues
Shortage of raw material
Voluntary Recalls
Natural Disasters
Business/Economic issues
Regulatory Issues
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:
To qualify the entity must have an indigent population that it serves
Must be registered with the state and HRSA (Health Resources Service Administration)
HEAVILY REGULATED for compliance
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