Safety and Financial Impact of Drug
Shortages on Hospitals
and
The Release of the 2011 ISMP
Medication Safety Self Assessment®
Allen J. Vaida, PharmD.
Executive Vice President
Institute for Safe Medication Practices
avaida@ismp.org
Speakers
• 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 Affairs
American Society of Health-System Pharmacists
• 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 Shortages
January 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 Injectable
Shortages
*Courtesy of CAPT. Valerie Jensen, Center for Drug Evaluation and Research (Feb 2011)
2010 ISMP 2nd Survey on
Drug Shortages
ISMP Med Saf Alert. 2010;15(19):1-3
What We Heard from Respondents
• Clinical effects
– Compromise or delay in medical treatment/procedures
– 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
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Propofol
Succinylcholine
Heparin
Naloxone
Bumetanide and Furosemide
Emergency syringes
Chemotherapy medications
Top Difficulties Reported
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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 place
Issues Identified with Alternative
Medications
• Enhanced risk of errors and/or adverse outcomes
- difficulty remembering alternative drugs and how to safety
prescribe, dispense, administer
• Ethical dilemma with rationing
- who gets the optimal drug – especially with oncology
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 Summit
November 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:
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health professional organizations
pharmaceutical manufacturers
supply chain entities
FDA
CDC (Centers for Disease Control and Prevention)
Summit Outcomes
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21 recommendations
– Increase sharing of information among
stakeholders and
– Remove barriers faced by the FDA and drug
manufacturers
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Areas of focus
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Regulatory/Legislative (13)
Raw Materials/Manufacturing (4)
Business/Market (2)
Distribution (2)
Available at: www.ashp.org/drugshortages/summitreport
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 transport
• 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 recall
– Limited number of production lines Increase production
of one product results in shortage of another
– Complexity of manufacturing sterile injections
– Loss of experienced personal due to business decisions
– 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
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Workgroups begin meetings 1st week of
April
Prioritizing and work plans
– Not all recommendations will be implemented
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Advocacy
– Congressional meetings
– Media outreach (trade and lay press)
Impact of Drug Shortages 2011
Lessons 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 Ordering”
• Impact on Cost of Product
• Impact on other pharmacy personnel
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Assistant/Associate Director of Pharmacy
Director of Pharmacy
Clinical Coordinator
Pharmacists
Technicians
Impact on Hospital Pharmacy
Departments and other Clinical Staff
• Impact on the P&T 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 P&T 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 Care
• 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
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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 patient’s hospital 70 miles
away
Drug Shortages: Update on ASHP
Actions and Advocacy
April 7 , 2011
Joe 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
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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 everything
• ASHP prioritized, identified reporting of
manufacturing problems as the place to start
Preserving Access to Life-Saving
Medications Act S.296
• 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 availability
– Prioritization of FDA approval procedures
– Work with firms to resolve problems
• No public notification of drugs “vulnerable” to
shortage
Other Key Issues
• Also not included:
– Importation—very controversial
– Biologics—ASHP 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 approach—support 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 hospital
Tell your stories
Emphasize the risks to public health and patient safety
CONTINUE TO REPORT DRUG SHORTAGES
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
Background
• 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
Content
• 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)
• 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
43%
2004
53%
% Change
23%
47%
61%
30%
48%
59%
23%
51%
65%
27%
53%
60%
13%
2000 versus 2004
• Sterile markers/labels
2000
2004
• Verbal order read back
2000
2004
• High alert defined
None
Partial
33%
17%
42%
42%
Full
25%
41%
6%
1%
51%
27%
43%
72%
12%
37%
51%
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
improvement
• 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.
Technology/Devices
• 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 infusions.
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 situations.
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 syringe.
• 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
item.
• 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
organization.
Individual Items Weighted According
to Impact on System
• Scale of 4 to 16 with higher weights on items that:
 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
Endorsers
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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
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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 Society
Institute for Healthcare Improvement
The Joint Commission
MedAssets
National Patient Safety Foundation
Pennsylvania Patient Safety Authority
Premier
University HealthSystem Consortium
VHA
Questions