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Safety and Financial Impact of Drug Shortages on Hospitals and The Release of the 2011 ISMP Medication Safety Self Assessment


Title: Drug Shortage Author: Matt Fricker Last modified by: jtowne Created Date: 2/21/2011 8:17:55 PM Document presentation format: On-screen Show (4:3) – PowerPoint PPT presentation

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Title: Safety and Financial Impact of Drug Shortages on Hospitals and The Release of the 2011 ISMP Medication Safety Self Assessment

Safety and Financial Impact of Drug Shortages on
HospitalsandThe Release of the 2011 ISMP
Medication Safety Self Assessment
  • Allen J. Vaida, PharmD.
  • Executive Vice President
  • Institute for Safe Medication Practices

  • Allen J. Vaida, PharmD
  • Institute for Safe Medication Practices
  • Dwight Kloth, PharmD, Director of Pharmacy
  • Fox Chase Cancer Center, Philadelphia, PA
  • Joseph M. Hill Director, Federal Legislative
    AffairsAmerican Society of Health-System
  • Roslyne D. W. Schulman Director, Policy
    Development American Hospital Association

Drug Shortages
  • FDA Presents at ASHP midyear - 2000
  • First ISMP survey - 2001
  • ASHP-University of Utah partnership 2001
  • Stakeholder meeting -2002
  • 2008 2011 crisis mode

Drug Shortages a Serious and Widespread Problem
Annual New Drug ShortagesJanuary 2001 to
December 31, 2010
Tripled since 2006
University of Utah Drug Information Service
CDER Shortage Trends 2005-2010
Courtesy of CAPT. Valerie Jensen, Center for
Drug Evaluation and Research (Feb 2011)
Shortages of Critical Drugs
Courtesy of Erin Fox, Pharm.D., University of
Utah Drug Information Service (Feb 2011)
Reasons for Sterile InjectableShortages
Courtesy of CAPT. Valerie Jensen, Center for
Drug Evaluation and Research (Feb 2011)
2010 ISMP 2nd Survey on Drug Shortages
ISMP Med Saf Alert. 201015(19)1-3
What We Heard from Respondents
  • Clinical effects
  • Compromise or delay in medical treatment/procedure
  • Medication errors and adverse patient outcomes
  • Financial effects
  • Higher alternative acquisition costs
  • Reallocation and/or addition of staff
  • Management of adverse events
  • Emotional effects
  • Strained professional relationships

Near Misses, Errors, Adverse Outcomes
Most Problematic Shortages
  • Propofol
  • Succinylcholine
  • Heparin
  • Naloxone
  • Bumetanide and Furosemide
  • Emergency syringes
  • Chemotherapy medications

Top Difficulties Reported
  • No advanced warning and suggested alternatives
  • No information about cause of shortage
  • No information about duration of shortage
  • Difficulty obtaining suitable alternatives
  • Substantial resources educating practitioners on
    the use of alternatives
  • Possible loss of prior safety safeguards put in

Issues Identified with Alternative Medications
  • Enhanced risk of errors and/or adverse outcomes
  • - difficulty remembering alternative drugs
    and how to safety prescribe, dispense,
  • Ethical dilemma with rationing
  • - who gets the optimal drug especially with

Recent Survey Results from Premier
  • (3/28) Premier reported that -- surveyed 311
    pharmacy experts at hospitals and other
    facilities, such as surgery centers and long-term
    care facilities, about shortages during a
    six-month period in 2010." Investigators
    eventually discovered that "89 had experienced
    shortages that may have caused a medication
    safety issue or error in patient care."

ASHP Drug Shortages SummitNovember 5, 2010
  • Goals
  • define the scope, causes, and potential patient
    harm from drug shortages
  • discuss potential changes in public policy and
    stakeholder practices
  • Partner Organizations
  • American Society of Anesthesiologists
  • American Society of Clinical Oncology
  • Institute for Safe Medication Practices

Drug Shortages Summit
  • 50 participants, including representatives from
  • health professional organizations
  • pharmaceutical manufacturers
  • supply chain entities
  • FDA
  • CDC (Centers for Disease Control and Prevention)

Summit Outcomes
  • 21 recommendations
  • Increase sharing of information among
    stakeholders and
  • Remove barriers faced by the FDA and drug
  • Areas of focus
  • Regulatory/Legislative (13)
  • Raw Materials/Manufacturing (4)
  • Business/Market (2)
  • Distribution (2)

Available at
Business and Market Factors
  • Lack of transparency or communication about
    actual or possible product shortages
  • Lack of business incentives to enter a specific
    product market
  • Unpredictable changes in product demand
  • Reallocation of production lines
  • Consolidation of companies

Raw Materials and Manufacturing Factors
  • 80 of raw materials used come from outside the
    United States
  • Disruption to acquisition can be due
  • Political instability/Government interference
  • Natural disasters
  • Contamination during production, storage or
  • Problematic if single source Active product
    ingredients (API) or raw materials multiple
    manufacturers affected

Raw Materials and Manufacturing Factors
  • Major manufacturing difficulties identified
  • Inability to comply with current good
    manufacturing practices (cGMP) and/or voluntary
  • Limited number of production lines ? Increase
    production of one product results in shortage of
  • Complexity of manufacturing sterile injections
  • Loss of experienced personal due to business
  • Change in product formulation

Distribution Factors
  • Inventory practices by healthcare facilities and
    supply chain entities
  • Little or no inventory cushion to address
    short-term shortages or excess inventory due to
    distribution systems
  • Variability in inventory procurement capabilities
    between small and large healthcare facilities
  • Grey market

Regulatory and Legislative Factors
  • Limited FDA resources for timely inspection of
    manufacturing sites and review of NDA/ANDA
  • Lack of FDA authority to
  • Require notification from manufacturers of
    anticipated market withdrawal
  • Enforce notification requirements for medically
    necessary products

Drug Shortages Summit Next Steps
  • Workgroups begin meetings 1st week of April
  • Prioritizing and work plans
  • Not all recommendations will be implemented
  • Advocacy
  • Congressional meetings
  • Media outreach (trade and lay press)

Impact of Drug Shortages 2011Lessons from the
Front Lines
  • Dwight D. Kloth, Pharm.D., FCCP, BCOP
  • Fox Chase Cancer Center

Impact on Hospital Pharmacy Departments and other
Clinical Staff
  • Impact on the Pharmaceutical Purchaser
  • Value of the Pharmaceutical Purchaser
  • Impact on Inventory Turn Ratios and Just in Time
  • Impact on Cost of Product
  • Impact on other pharmacy personnel
  • Assistant/Associate Director of Pharmacy
  • Director of Pharmacy
  • Clinical Coordinator
  • Pharmacists
  • Technicians

Impact on Hospital Pharmacy Departments and other
Clinical Staff
  • Impact on the PT Committee
  • Impact on medical, nursing and pharmacy staff
  • Need for teamwork within the institution, vital
    need to avoid finger pointing
  • Increased risk of medication error
  • Role of PT Committee Newsletters and e-mails
    (advance warning notice weeks in advance of a
    possible out of stock condition)
  • Role of the ISMP Medication Safety Alert
    September 23, 2010

Impact on Hospital Pharmacy Departments and other
Clinical Staff
  • Impact on chemotherapy order templates or CPOE
    order sets (revisions if required to switch any
    medications, pre-meds, cytotoxics, etc)
  • Increased risk of medication error
  • inpatient
  • ambulatory infusion room
  • operating room
  • Gray Market (Black Market)- price gouging
  • Premier Healthcare Alliance analysis (March,
    2011) 200 million annual cost to US hospitals

Recent Examples Significantly Impacting Patient
  • Propofol in summer and fall of 2009
  • Hospira recall
  • Teva recall ( subsequent exit from market)
  • Baxter heparin recall
  • tainted Chinese heparin supplier 2009
  • Morphine vs. hydromorphone (e.g., errors)
  • Etoposide
  • Neuromuscular Blocking Agents

Current Severe Examples in Acute Care
  • Potassium Phosphate
  • Dear Healthcare Professional letter 3-28-2011
  • filter all lot s of the product in Pharmacy
  • In-line 0.22micron filter, impact on Nursing and
    cost of IV tubing
  • only one manufacturer in the USA at the moment-
    no alternatives
  • MVI for TPN- being rationed by CAPS
  • Calcium Gluconate injection- rationing begun
  • Norepinephrine
  • Lorazepam injection

Current Severe Examples in Oncology
  • Cytarabine
  • Thiotepa
  • Request from a major cancer center to trade with
    FCCC FCCC did not have enough to even consider
  • Bleomycin
  • Doxorubicin
  • Leucovorin (generic racemic leucovorin)
  • Request received from a 2nd opinion patient for
    FCCC to give drug supply to the patients
    hospital 70 miles away

Drug Shortages Update on ASHP Actions and
Advocacy April 7 , 2011Joe Hill Director of
Legislative Affairs
  • American Society of Health-System Pharmacists

Drug Shortages Summit Next Steps
  • Workgroups begin meetings 1st week of April
  • Prioritizing and work plans
  • Not all recommendations will be implemented
  • Advocacy
  • Congressional meetings
  • Media outreach (trade and lay press)

Impact of legislation
  • Intent of Klobuchar bill
  • Component in overall strategy
  • Short-term feasible fix
  • Early notification to FDA can prevent shortages

Drug Shortages Congressional Action
  • ASHP met with Senator Amy Klobuchar (D-Minn) late
    last year
  • Expressed their intent to introduce legislation
  • Aggressive timeline made it impossible to address
  • ASHP prioritized, identified reporting of
    manufacturing problems as the place to start

Preserving Access to Life-Saving Medications Act
  • New bill Senator Klobuchar and Senator Casey
  • Manufacturers to notify FDA of any interruption
    in production of any product 6 months in advance,
    or ASAP
  • FDA to have an enforcement mechanism fines for
    not complying
  • FDA to develop criteria for vulnerable drugs
  • Firms to develop continuity of supply plans for
    those drugs in collaboration with FDA

Shortage Bill, continued
  • FDA would track vulnerable drugs
  • Enhanced focus and monitoring by FDA drug
  • Prioritization of FDA approval procedures
  • Work with firms to resolve problems
  • No public notification of drugs vulnerable to

Other Key Issues
  • Also not included
  • Importationvery controversial
  • BiologicsASHP is working to change that
  • Public notification of pending shortages
  • No additional resources for FDA
  • May deal with that in PDUFA
  • Bill is a first step, must generate more
    discussion on the topic

What is the Plan?
  • Bill introduced February 7
  • Cosponsors include Senators Blumenthal (Conn),
    Cardin (MD)
  • Looking at a dual track approachsupport 296
    (i.e., reporting requirements, vulnerable
    products) and pursue other issues/resources
    through PDUFA reauthorization in 2012
  • Continuing to work with stakeholders, Congress

  • No easy fix.
  • Solution will require dedicated short- and
    long-term effort from all stakeholders

What can YOU do?
  • Share information and solutions with colleagues
    and clients
  • Support drug shortages advocacy initiatives
  • Contact your legislators invite them to your
  • Tell your stories
  • Emphasize the risks to public health and patient

2011 ISMP Medication Safety Self Assessment
  • Funded by the Commonwealth Fund
  • Available online
  • The self assessment will help hospitals to
  • Evaluate their safety practices
  • Identify opportunities for improvement
  • Compare their experiences over time with
    those of similar organizations

  • First assessment in 2000 followed the IOM report
    To Err is Human and was the first nationwide
    look at medication safe practices
  • All assessments are in cooperation with the
    American Hospital Association, the Health
    Research and Education Trust and funded by the
    Commonwealth Fund
  • Many prior safety items are incorporated in the
    Joint Commission safety goals and the National
    Quality Forum best practice recommendations

  • Ten elements (domains) that most significantly
    influence safe medication use
  • Twenty core distinguishing characteristics of a
    safe medication system
  • Representative self-assessment characteristics

Key Elements of the Medication System
  • Patient Information
  • Drug Information
  • computer systems
  • formulary
  • Communication
  • Labeling, Packaging and
  • Nomenclature
  • Drug Storage, Stock, and Distribution
  • Device Acquisition,
  • Use and Monitoring
  • Environmental Factors
  • Staff Competency and
  • Education
  • Patient Education
  • Quality Processes and
  • Risk Management
  • RM/QI efforts
  • Infection Control

Prior Assessments
  • 1434 hospitals submitted data in 2000 and 1623
    hospitals submitted data in 2004
  • States, individual hospitals, health systems and
    collaboratives have continued to re-assess
    themselves since 2004

2004 versus 2000 Scores (as of maximum
weighted score)
  • 2000 2004 Change
  • 43 53 23
  • 47 61 30
  • 48 59 23
  • 51 65 27
  • 53 60 13
  • Key Element I - (1)
  • Patient Information
  • Key Element III - (4)
  • Communication
  • Key Element IX - (16)
  • Patient Education
  • Key Element X - (17-20)
  • Quality Processes and Risk Management
  • Key Element II - (2,3)
  • Drug Information

2000 versus 2004
  • None Partial Full
  • 33 42 25
  • 17 42 41
  • 6 51 43
  • 1 27 72
  • 12 37 51
  • Sterile markers/labels
  • 2000
  • 2004
  • Verbal order read back
  • 2000
  • 2004
  • High alert defined

Items for the 2011 Self Assessment
  • Review of ISMP error reports and ISMP
    publications since 2004
  • Review of the safety literature including other
    sources of reports on adverse drug events
  • National Advisory Panel of a multidisciplinary
    group of practitioners

New Items for 2011
  • Expanded safe use of technology
  • Use of metrics from technology to help measure
  • Processes for the handling of drug shortages,
    maintenance of technology, and the safe
    environment for medication use
  • Elements of accountability within a Just Culture

Patient and Drug Information
  • The hospital utilizes a surgical safety checklist
    (i.e., the World Health Organization WHO
    Surgical Safety Checklist or an adaptation) prior
    to surgical procedures to verify patient
    identity, allergies, and preoperative antibiotics
    (when required).
  • Equianalgesic dosing charts for oral, parenteral,
    and transdermal (e.g., fentaNYL patches) opioids
    have been established and are easily accessible
    to all practitioners when prescribing,
    dispensing, and administering opioids.

  • General infusion pumps with SMART PUMP TECHNOLOGY
    with full functionality employed to intercept and
    prevent wrong dose/wrong infusion rate errors due
    to misprogramming the pump are in use in all
    hospital areas (including the ED, pediatrics,
    oncology, operating room).
  • The administration set used for epidural infusion
    pumps does not contain any access ports (Y
    connectors), can be distinguished from all other
    administration sets and medical tubing (e.g., a
    yellow stripe running the length of the tubing),
    and is not used for anything other than epidural

Drug Stanadization
  • IV solutions that are unavailable commercially
    are prepared in the pharmacy unless needed in
    emergent lifesaving situations.
  • Pharmacy fills all elastomeric pumps and prepares
    all IV solutions and irrigations needed in the
    operating room or procedural areas (including
    interventional radiology, cardiac catheterization
    areas), unless needed in emergent lifesaving

Infection Control
  • Pen devices that contain multiple doses of
    medication (e.g., insulin pens) are dispensed for
    individual patients and are never used as unit
    stock for multiple patients, even if the needle
    is changed between patients or the medication is
    withdrawn from the pen cartridge with a sterile
  • In patient care areas, multiple-dose vials are
    not used for saline and heparin flush solutions,
    or local anesthetics. Exception Local
    anesthetics used in the operating room that are
    restricted to a single patient procedure.

Multidisciplinary Team
  • CEO, COO, or Senior level Vice President in
    charge of Quality and Safety
  • Chief Medical Officer
  • Nurse Executive
  • Director of Pharmacy
  • Chief Information Officer
  • Front line managers

Completing the Assessment
  • Secure and anonymous password issued
  • Ability to download a pdf file and save
    information between team meetings
  • Ability to complete on-line and save information
    between team meetings
  • Immediate scoring of the assessment once the data
    is submitted
  • Comparisons to similar organizations when the
    assessment data entry period is complete

Choice Selections
  • A. There has been no activity to implement this
  • B. This item has been formally discussed and
    considered, but it has not been implemented.
  • C. This item has been partially implemented in
    some or all areas of the organization.
  • D. This item is fully implemented in some areas
    of the organization.
  • E. This item is fully implemented throughout the

Individual Items Weighted According to Impact on
  • Scale of 4 to 16 with higher weights on items
  • Target the system not workforce
  • Simplify complex processes
  • Solve several error-prone problems
  • Do not rely heavily on human memory or vigilance

Timeline and Promotion
  • Data submission through the end of August, 2011
  • Promotion by AHA, HRET, state hospital
    associations, endorsers, supporters, and
    leadership in hospitals
  • Commitments from national collaboratives

  • Association of American Medical Colleges
  • Child Health Corporation of America 
  • Federation of American Hospitals
  • Health Care Improvement Foundation
  • Health Research and Educational Trust
  • Healthcare Information and Management Systems
  • Institute for Healthcare Improvement
  • The Joint Commission
  • MedAssets
  • National Patient Safety Foundation
  • Pennsylvania Patient Safety Authority
  • Premier 
  • University HealthSystem Consortium
  • VHA
  • American Association of Colleges of Nursing
  • American Hospital Association 
  • American Nurses Association 
  • American Organization of Nurse Executives 
  • American Pharmacists Association  
  • American Society for Healthcare Risk Management
  • American Society of Health-System Pharmacists
  • American Society of Medication Safety Officers
  • Amerinet
  • Anesthesia Patient Safety Foundation