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An Interdisciplinary Solution to the Drug Shortage Problem
Kelli Kirkpatrick, PharmD – Mission Health, Asheville, NC
Susan Mims, M.D. – Mission Health, Asheville, NC
Got Drugs?A Trans-disciplinary Model to Medication
Shortages Susan Mims, MD, MPHKelli Kirkpatrick, PharmD
Objectives
Describe multi-disciplinary process of drug shortage management
Provide resources to facilitate effective management and communication across many disciplines
Share current challenges related to drug shortage management
Provide updated information on advocacy efforts and opportunities
Mission Hospital: Who We Are Located in Asheville, NC
Regional referral center for Western NC
Service area population: 850,000
805 acute care beds
Level II Trauma Center Surgeries/year: 40,000 Discharges/year: 40,000 Annual ED visits: 105,000 700 physicians on staff Cerner EMR Children’s Hospital
− 130 beds
Drug Shortages at Mission HospitalVolume of shortages
- Currently monitoring over 200 backordered medications
Types of medications- Sterile injectables with wide range of clinical
applications- Life-saving medications
Complexity of shortage characteristics- Classes of drugs vs one drug- Extended duration of shortage- Limited alternatives in some cases
Need for alternative supplies increased
Newly Reported Medication Shortages in US
58 74 70
129 149 166211
267
204
050
100150200250300
2004 2005 2006 2007 2008 2009 2010 2011 2012
Number of Drug Shortages
Number of Drug Shortages
Source: Fox E, Wheeler M. Drug Shortages in the US: Causes and What the FDA is Doing to Prevent New Shortages. http://www.medscape.com/viewarticle/780328_2. AccessMedicine from McGraw-Hill 2013 Data collected by the University of Utah Drug Information Service.
Active Medication Shortages in US
152 167 176 188239 246 256 273 260
211282 299
0
100
200
300
400
Q1 -10
Q2 -10
Q3 -10
Q4 -10
Q1 -11
Q2 -11
Q3 -11
Q4 -11
Q1 -12
Q2 -12
Q3 -12
Q4 -12
Active Shortages by Quarter
Active Shortages by Quarter
Source: Source: Fox E, Wheeler M. Drug Shortages in the US: Causes and What the FDA is Doing to Prevent New Shortages. http://www.medscape.com/viewarticle/780328_2. AccessMedicine from McGraw-Hill 2013 Data collected by the University of Utah Drug Information Service
Source: Source: Fox E, Wheeler M. Drug Shortages in the US: Causes and What the FDA is Doing to Prevent New Shortages. http://www.medscape.com/viewarticle/780328_2. AccessMedicine from McGraw-Hill 2013 Data collected by the University of Utah Drug Information Service
Consequences
Impacts on safety and quality of patient care
– Increased risk of medication errors– Alternative treatment options may
not be optimal
Significant time shift for staff
Increased cost Inventory
- Capital- Regulatory- Overtime
What is the Impact?University of Michigan Health System
– 2010 survey • Directors of Pharmacy in U.S.• Pharmacy, physician, and nursing input
– Evaluated• Impact of recent drug shortages• Resource utilization to manage shortages
– 253 responses (27% response rate)– 64% (n=192) community hospitals
Source: Kaakeh R, Sweet BV, Reilly C et al. Impact of drug shortages on U.S. health systems. Am J Health-Syst Pharm 2011;68:1811-9.
What is the impact?
Time Spent Managing Drug
Shortages Median (Interquartile
Range)
Annual Labor Cost≥ 400 bed hospitalMedian (Interquartile
Range)
Pharmacist 9 (5-20) 32,629 (21,753-77,494)
Pharmacy Technician
8 (3-17) 9,153 (4,225-14,786)
Physician 0.5 (0-2) 4,741 (0-18,965)
Nurse 0 (0-2) 1,697 (0-7,635)
Total 17.5 48,220 (25,977-118,880)
Source: Kaakeh R, Sweet BV, Reilly C et al. Impact of drug shortages on U.S. health systems. Am J Health-Syst Pharm 2011;68:1811-9.
Total U.S. Labor Cost $216 million annually
What is the impact?Patient Safety
– 2010 ISMP National Survey– 1800 responses
• 35% - near miss occurred within last year
• 25% - medication errors occurred within last year
• 20% - adverse patient outcomes within last year
Source: Institute for Safe Medication Practices. Drug shortages: national survey reveals high level of frustration, low levels of safety. ISMP Med Saf Alert. 2010;15 (19):1-4. http://www.ismp.org/Newsletters/acutecare/articles/20100923.asp. Accessed March 11, 2013.
What is the Impact?
Quality of Care– 2011 American Hospital Association
Survey– 820 hospital responses
• 82% hospitals reported delayed patient treatment
• 75% hospitals reports rationing or implementing restrictions for use
Source: American Hospital Association. AHA Survey on Drug Shortages. July 12, 2011. http://www.aha.org/content/11/drugshortagesurvey.pdf. Accessed March 8, 2013.
What is the impact?
December 2012
October 2012
Source: N Engl J Med 2012;267;26.; Pediatrics 2012;130;e1369;
Factors Affecting Drug ShortagesFactor DetailsRegulatory/Legislative
•Lack of FDA authority•Time to approval of submitted drug applications•Increase in FDA inspections/citations
Raw Material Supplies
•Some sole source active product ingredient (API)
Manufacturing Processes
•Good Manufacturing Practice requirements/changes•Inability to quickly adjust production volumes•Voluntary upgrades in production processes
Business Market Factors
•Firm consolidations•Product profitability
Distribution Factors
•Just-in-Time inventories
Senate Finance Committee Hearing on “Drug Shortages:Why They Happen and What They Mean”.Statement for the Record. American Society of Health System Pharmacists. December 7, 2011
What, No Vitamin K? Feb, 13th -- <1 week supply Communicated to Children’s Service
line Pulled together team
– Physicians – Pharmacists– Nurses– Educators– IT
Points for ConsiderationStock managementTherapeutic Evaluation
− Criteria for use− Alternative therapy
CPOE build/changesEducation/Communication
− Internal− Community
Drug Shortage Quality Team Purpose: Establish a proactive approach
to drug shortage management and communication
Trans-disciplinary Steering Committee– Administration– Physician Leadership– Pharmacist– Nursing– Performance Improvement– Information Technology
Requirements for Effective Management
Drug Shortage
Management
Drug Shortage Sub-Teams
Internal Logistics Physician Education Nurse Education Patient Education Clinical Decision Making and
Ethics External Logistics
Systematic Communication Plan
Drug Shortage List Color Identifiers:
Red – None in Stock
Orange – Less than 3 Day Supply
Yellow – 3 to 7 Day Supply
Purple – Chemotherapeutic agents in short supply
Blue – More than 7 Day Supply, but of great concern
• Established color scheme to define— Shortage Severity— Estimated days supply based on historical usage— Actions for each color to establish consistency
Systematic Communication PlanHospital Intranet
Updated Daily
Color Based Actions
Blue(> 7 days supply,
but of great concern)
•Add to Drug Shortage List and begin tracking inventory•Remove supplies from low use ADCs (no use in 30 days)•Initiate evidence-based literature assessment
Drug specific team– Members identified
by:• Indications for use• Electronic ordersets
Utilization data (ADCs)
Literature evaluated and summarizedADCs - Automated dispensing cabinets
Ethical Decision Making Process
Alternative acquisition sources
Substitute Meds Level of evidence
for indications
Use in PowerPlans Usage Reports Reimplementation
Medication shortage Identified
Medication shortage Identified
Designated Pharmacist:
Researches using template
Designated Pharmacist:
Researches using template
Rapid Decision Team: Review & recommend
distribution strategy
Rapid Decision Team: Review & recommend
distribution strategy
Service Line Leaders: Review & provide
feedback
Service Line Leaders: Review & provide
feedback
Implement Policy
Implement Policy• Pharmacist
• Physician• Nurse• Specialist MD• Consultants
Systematic Communication PlanPoint of Care Notification
Catalog Display
Used for drugs with 7 days supply or less (Yellow, Orange , Red)
Physician Alerts
Programmed in CPOE Primary goal – physician information at point of order– Yellow – alternative
therapies– Orange –
established criteria for use of shorted medication
– Red – supply exhausted
Color Based ActionsYellow
(3-7 day supply)
ADC stock adjustments 5 to 7 day supply - assure 2-3 day pars
in ADCs 3 to 5 day supply - unload from all ADCs
except top users “High Alert” order catalog display Physician alert
Suggested alternative therapies (use optional)
Consider addition of alternative therapies to ADCs
ADCs - Automated dispensing cabinets
Color Based Actions
Orange(less than 3 day supply)
•Centralize supplies/unload from ADCs•Optimize availability of alternative therapies in ADCs•Physician alert with criteria form
* Use restricted to patient-specific criteria
* Use of alternative therapy required if criteria not met
ADCs - Automated dispensing cabinets
Color Based Actions
Red(no supply)
•Physician alert•Suggested alternative therapies (use required)
Appeals Process
Final Decision:
Apply Policy (original or
revised)
Final Decision:
Apply Policy (original or
revised)
Yes
Provider reviews policyProvider reviews policy
Pharmacist: Explain
rationale for policy
Pharmacist: Explain
rationale for policy
P&T Chair: Review &
rule on case
P&T Chair: Review &
rule on case
Medication Shortage Ethics Committee:
Review & rule on case
Medication Shortage Ethics Committee:
Review & rule on case
Ok with decision?Ok with
decision?
Ok with decision?Ok with
decision?
Apply PolicyApply Policy
Apply Policy (original or
revised)
Apply Policy (original or
revised)
NoYes
No
Med Shortage Ethics Committee Chief of Staff designee
Physician Pharmacy and Therapeutics Member
Nurse Pharmacist Ethicist Community Member Risk Management Administrative representative Board Member
Electronic Documentation
Inventory Management
Proactive tracking system−Electronic tracking database−Supply Chain Pharmacist
Minimize waste−Unit dose preparation
• Manual draws (pharmacy tech)• RIVA robot
Challenges Resources
– Team Creation– Literature assessment– Point of Care Communications– Manual preparation of unit dose
Timing of specific drug team creation
Communication Patient/family education process
The Food and Drug Administration Safety and Innovation Act
July 9, 2012
Merits of the Act
Notification of FDA for planned production interruptions or discontinuations– 6 months required
Broadens scope of early notification to include– biologic products– drugs used in emergency care and surgery
FDA may expedite new application review Repackaging of medications for use within system
Current StatePrevented drug shortages
– 195 in 2011– 282 in 2012
FDA - Drug Shortage Task Force– Strategic plan under development
• Enhanced coordination, communication, decision-making (internal)
• Enhanced communication (external)• Evaluation of effect on research/clinical trials• Evaluation of “qualified manufacturing partner
program”Source: Federal Register. Food and Drug Administration Drug Shortages Task Force and Strategic Plan; Request for Comments. https://federalregister.gov/articles/2013/02/12/2013-03198/food-and-drug-administration. Accessed 3-9-2013.
Continued Advocacy needed! Final, structured FDA monitoring plan
Manufacturing redundancy for certain medications
More stringent consequences for manufacturers not complying with notification requirements