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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

Susan.Mims@msj.orgKelli.Kirkpatrick@msj.org

Mission-Health.org