Download Improving IV Medication Safety: Identifying the

Improving IV Medication Safety:
Identifying the Risk Points
Presented as a Midday Symposium at the
44 ASHP Midyear Clinical Meeting and Exhibition
th
Tuesday, December 8, 2009
Las Vegas, Nevada
Please be advised that this activity is being audio recorded for archival purposes and, in some
cases, for repurposing of the content for enduring materials.
2
Improving IV Medication Safety: Identifying the Risk Points
AGENDA
11:30 a.m. – 11:35 a.m. Welcome / Introductory Remarks
Rita Shane, Pharm.D., FASHP, FCSHP
Program Chair
11:35 a.m. – 12:10 p.m. Identifying the Risk Points: Back to the Basics
Rita Shane, Pharm.D., FASHP, FCSHP
12:10 p.m. – 12:45 p.m. Managing the Risk Points to Improve Medication Safety
Ginette A. Pepper, Ph.D., RN, FAAN
12:45 p.m. – 1:20 p.m.
Case Scenario: Evaluating a Medication Management
System and Implementing Safety Solutions
Karen Fiumara, Pharm.D., BCPS
1:20 p.m. – 1:30 p.m.
Faculty Discussion and Audience Questions
All Faculty
FACULTY
Rita Shane, Pharm.D., FASHP, FCSHP
Director of Pharmacy Services
Cedars-Sinai Medical Center
Los Angeles, California
Assistant Dean, Clinical Pharmacy Services
University of California, San Francisco, School of Pharmacy
San Francisco, California
Ginette A. Pepper, Ph.D., RN, FAAN
Professor and Associate Dean for Research
Helen Lowe Bamberger Colby Presidential Endowed Chair in Gerontological Nursing
Director, Hartford Center of Geriatric Nursing
University of Utah College of Nursing
Salt Lake City, Utah
Karen Fiumara, Pharm.D., BCPS
Patient Safety Officer
Brigham and Women’s Hospital
Adjunct Assistant Professor of Pharmacy Practice
Massachusetts College of Pharmacy and Allied Health Sciences
Boston, Massachusetts
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Improving IV Medication Safety: Identifying the Risk Points
DISCLOSURE STATEMENT
In accordance with the Accreditation Council for Continuing Medical Education’s
Standards for Commercial Support and the Accreditation Council for Pharmacy
Education’s Guidelines for Standards for Commercial Support, ASHP Advantage
requires that all individuals involved in the development of activity content disclose their
relevant financial relationships. A person has a relevant financial relationship if the
individual or his or her spouse/partner has a financial relationship (e.g., employee,
consultant, research grant recipient, speakers bureau, or stockholder) in any amount
occurring in the last 12 months with a commercial interest whose products or services
may be discussed in the educational activity content over which the individual has
control. The existence of these relationships is provided for the information of
participants and should not be assumed to have an adverse impact on presentations.
All faculty and planners for ASHP Advantage education activities are qualified and
selected by ASHP Advantage and required to disclose any relevant financial
relationships with commercial interests. ASHP Advantage identifies and resolves
conflicts of interest prior to an individual’s participation in development of content for an
educational activity.
The faculty and planners report the following relationships:
Rita Shane, Pharm.D., FASHP, FCSHP, Program Chair
Dr. Shane declares that she has served as a consultant for Abbott.
Ginette A. Pepper, Ph.D., RN, FAAN
Dr. Pepper declares that she has no relationships pertinent to this activity.
Karen Fiumara, Pharm.D., BCPS
Dr. Fiumara declares that she has no relationships pertinent to this activity.
Ron DeChant, M.S., B.S.Pharm.
Mr. DeChant declares that he has no relationships pertinent to this activity.
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Improving IV Medication Safety: Identifying the Risk Points
ACTIVITY OVERVIEW
This symposium will provide pharmacists with practical methods for minimizing potential
IV medication errors by identifying risk points in the medication management system.
Strategies for managing these risk points will be discussed as well as the sharing of
successful practices that have been demonstrated to enhance safety in various
organizations around the country. Experts will provide guidance on how a pharmacy
department can identify high-risk processes, identify errors before they reach a patient,
and develop systems that quickly mitigate the effect of any harm to a patient with
emphasis on IV medication use. An automated audience response system will be used
to facilitate active learning and application of knowledge to practice.
ACTIVITY OBJECTIVES
At the conclusion of this knowledge-based educational activity, participants should be
able to
•
Describe a process to identify medication management system risk points.
•
Identify at least one risk point within each of the six critical processes of medication
management.
•
Explain a successful medication management strategy that has been demonstrated
to enhance safety within an organization.
•
Evaluate the medication management system within an organization and implement
a strategy to enhance safety.
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Improving IV Medication Safety: Identifying the Risk Points
CONTINUING EDUCATION ACCREDITATION
The American Society of Health-System Pharmacists is accredited by
the Accreditation Council for Pharmacy Education as a provider of
continuing pharmacy education. This activity provides 2.0 hours (0.2
CEUs) of continuing pharmacy education credit (ACPE activity #204000-09-436-L01P).
Attendees must complete a Continuing Pharmacy Education Request online and may
immediately print their official statements of continuing pharmacy education credit at the
ASHP Learning Center at http://ce.ashp.org following the activity.
Complete instructions for receiving your statement of continuing pharmacy education
online are on the next page. Be sure to record the five-digit session code announced
during the activity.
Available soon at http://ashpmedia.org/symposia/IVsafety
So that this educational activity can be shared with a wider audience,
a Web-based version of it is being developed. Encourage your pharmacist
colleagues who were unable to attend the Midyear to look for this free online
continuing pharmacy education activity beginning in March 2010.
Please note that individuals who claim CPE credit for the live symposium are
ineligible to claim credit for the Web-based activity.
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Improving IV Medication Safety: Identifying the Risk Points
Instructions for Processing CPE online at http://ce.ashp.org
The ASHP Learning Center allows participants to obtain statements of continuing
pharmacy education (CPE) conveniently and immediately using any computer with an
internet connection. To obtain your CPE statements for ASHP Advantage activities,
please visit
http://ce.ashp.org
1. Log in to the ASHP Learning Center using your e-mail address and password.
If you have not logged in to the new ASHP Learning Center
(launched August 2008) and are not a member of ASHP, you will
need to set up an account by clicking on “Become a user” and
following the instructions.
2. Once logged in to the site, click on “Process Meeting CE.”
3. If you are a registered attendee at the ASHP Midyear Clinical Meeting, click on
the start button to the right of ASHP Midyear Clinical Meeting 2009.
If you are not registered to attend the ASHP Midyear Clinical Meeting, click on
the start link to the right of the activity title. If this activity title does not appear in
your meeting list, enter the 5-digit activity code in the box above the list and click
submit. The activity code for this activity is 09436. Click register again when
prompted. When you receive the “thank you for registering” message, click continue.
This step will bring you back to your meeting list. Click on the start link to the right of
the activity title.
4. Click on the click here link to view sessions associated with the day of the activity.
This activity was held on Tuesday, December 8, 2009.
5. Enter the session code, which was announced during the activity, and select the
number of hours equal to your participation in the activity. Pharmacists should only
claim credit for the amount of time they participate in an activity.
6. Click submit to receive the attestation page.
7. Confirm your participation and click submit. Your transcript page will appear.
8. Click on view/print statement of credit next to the meeting name to print your CPE
statement.
Session Code
Date of Activity
Activity Code
Tuesday, December 8
09436
(announced during the live
activity)
CPE credit
hours
2
NEED HELP? Contact ASHP Advantage at [email protected].
7
Improving IV Medication Safety: Identifying the Risk Points
8
Improving IV Medication Safety: Identifying the Risk Points
Rita Shane, Pharm.D., FASHP, FCSHP
Director of Pharmacy Services
Cedars-Sinai Medical Center
Los Angeles, California
Assistant Dean, Clinical Pharmacy Services
University of California, San Francisco, School of Pharmacy
San Francisco, California
Rita Shane, Pharm.D., FASHP, FCSHP, is Director of Pharmacy Services at CedarsSinai Medical Center, a 950-bed acute- and tertiary-care, teaching institution in Los
Angeles, CA, and Assistant Dean, Clinical Pharmacy Services at the University of
California, San Francisco (UCSF), School of Pharmacy. She is responsible for more
than 300 staff members. Dr. Shane’s goal is to ensure that wherever patients need care,
there is a demand for pharmacists to ensure optimal management of medications.
Over the years, Dr. Shane has been recognized for her passion for the profession. She
is the recipient of the 2007 California Society of Health-System Pharmacists (CSHP)
Pharmacist of the Year Award and the 2007 Distinguished Service Award from the
ASHP Section of Pharmacy Practice Managers. Dr. Shane was the 2005 recipient of the
ASHP Distinguished Leadership Award and the 1995 recipient of the John Webb Visiting
Professorship in Hospital Pharmacy for management excellence.
Dr. Shane is a co-investigator in two research studies in collaboration with the UCSF
School of Pharmacy and approved by the California State Board of Pharmacy to
demonstrate the safety and importance of allowing technicians to check technician-filled
medication cassettes in hospitals. She also worked collaboratively with CSHP to author
language in support of this regulatory change, which was approved by the State of
California effective in January 2007. Dr. Shane was co-investigator of a 2000 National
Patient Safety Foundation Research Award to study the impact of dedicated medication
nurses on the rate of medication administration errors, a randomized, controlled trial the
results of which were subsequently published in the Archives of Internal Medicine.
Dr. Shane recently served as the U.S. facilitator at the Global Conference on the Future
of Hospital Pharmacy held during the 68th Congress of the International Pharmaceutical
Federation and was responsible for reviewing the international literature on the subject
of medication administration. She also is one of the investigators in a multicenter study
of medications errors recovered by emergency department pharmacists. Throughout her
career, Dr. Shane has participated on committees and task forces at the state and
national level; she recently was a member of the American Hospital Association
Committee on Health Professions and The Joint Commission Professional Technical
Advisory Committee. She has presented at local, state, national, and international
meetings and has published a number of papers in the pharmacy literature.
9
Improving IV Medication Safety: Identifying the Risk Points
Rita Shane, Pharm.D., FASHP, FCSHP, Program Chair
PRESENTATION
Identifying the Risk Points: Back to the Basics
OVERVIEW
Intravenous (i.v.) medication therapy is characterized by complexity and has been
associated with significant morbidity and mortality. Sixty one percent of serious and life
threatening errors are associated with i.v. medications, and one study demonstrated a
73% error rate with i.v. boluses given too fast. USP MEDMARX® received 129,436
parenteral-related error reports from the years 2000 through 2006. Of these, 78.9% of
harmful errors were associated with the i.v. route of administration. Evidence
demonstrates that high risk therapies such as chemotherapy and high alert medications,
and high risk populations such as pediatrics and critical care patients, are of particular
concern. Therefore, it is essential that each element of the medication-use process is
examined to identify potential risks associated with intravenous medications.
LEARNING OBJECTIVES
At the conclusion of this knowledge-based educational activity, participants should be
able to
•
Cite evidence supporting the risks associated with intravenous (i.v.) medications.
•
Conduct a risk assessment for i.v. medications based on the elements of the
medication-use process.
•
Identify high-risk therapies and populations associated with i.v. errors.
•
Identify potential i.v. safety solutions.
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Identifying the Risk Points:
Back to the Basics
Rita Shane, Pharm.D., FASHP, FCSHP
Director, Pharmacy Services
Cedars-Sinai Medical Center, Los Angeles, CA
Assistant Dean, Clinical Pharmacy
USCF School of Pharmacy, San Francisco, CA
Objectives
• Cite evidence supporting the risks
associated with intravenous (i.v.)
medications
• Conduct a risk assessment for i.v.
medications based on the elements of
the medication-use process
• Identify high-risk therapies and
populations associated with i.v. errors
• Identify potential i.v. safety solutions
Medication-Use Process
Selection
&
Procurement
Storage
Ordering
&
Transcribing
Preparing
&
Dispensing
Administering
Monitoring
The Joint Commission: MM. 8.10: Annually identify and evaluate
risk points in the medication-use process
11
IV Errors and Harm:
The Evidence
• 61% of serious and life threatening errors
are associated with i.v. medications
• 73% error rate with i.v. boluses (i.v. push)
given too fast
• USP MEDMARX® 129,436 parenteralrelated errors reported 2000-2006
– 78.9% of harmful errors associated with i.v.
route
– 57.8% of these harmful errors occurred at
administration step
Harmful Parenteral Errors
Reported to USP
Route
%
N
IV
3,056
78.9
Subcutaneous
697
18
Epidural
74
1.9
Intravascular
48
1.2
Intrathecal
19
<1
Based on 3,873 records Categories E-I during 2002-2006
Proceedings of a summit on preventing patient harm and death from i.v. medication
errors. Am J Health-Syst Pharm. 2008; 65:2367-79.
Which parenteral route is
associated with the most harm?
A.
B.
C.
D.
Subcutaneous
Intrathecal
Intramuscular
Intravenous
12
Top 10 Drugs Most Frequently
Involved in Harmful Parenteral Errors
Drug
N
Morphine
Heparin
Hydromorphone
Insulin
270
263
195
155
Vancomycin
Fentanyl
Furosemide
Potassium Chloride
Meperidine
125
120
73
70
67
Methylprednisolone
56
Based on 3,184 reports
submitted to MEDMARX
involving parenteral routes
(Epidural, Intrathecal,
Intravascular and
Intravenous) for calendar
years 2002-2006
Which parenteral medication is
most frequently associated with
harm?
A.
B.
C.
D.
Diazepam
Natalizumab
Vincristine
Morphine
IV Errors and Harm: The Evidence
• A study using observation methodology to
evaluate the causes of errors in i.v. drug
preparation and administration
– One or more errors occurred in 49% of i.v.
doses observed doses
– Of these,1% were judged to be potentially
severe
– 29% potentially moderate errors
Taxis K, Barber N. Qual Safe Health Care. 2003; 12(5): 343-7.
13
Use of Observation Methodology
to Detect Medication Errors
Medication Errors
300
300
200
100
17
1
0
Observation
Chart Review
Incident Reports
Flynn et al. Am J Health-Syst Pharm. 2002; 59(5): 436-46.
When comparing the number of errors
detected by traditional medication error
reporting to the number of errors that will be
detected by observation, the ratio is:
A.
B.
C.
D.
300:17
17:1
300:1
400:1
IV Errors and Harm: The Evidence
• In the UK, injectable medication error events reported to
the National Reporting and Learning System are
responsible for more deaths than any other category of
events
• Causes
–
–
–
–
•
Calculation errors including dilution errors
Poor aseptic technique
Wrong route, rate and patient
Lack of information at the point of use
National Patient Safety Agency recommendations
– Conduct a risk assessment of injectable medication practices
– Provide current protocols and procedures
– Ensure the availability of information in clinical areas
Matthew L. Nurs Stand. 2007; 21(31):45-8.
14
IV Risks: Pharmaceutical
Calculations
• More than 1 in 6 medication errors involves a
calculation error
• Study demonstrated that 81% of nurses were
unable to correctly calculate medications 90% of
time
• 43.5% of test scores requiring calculations were
below 70% accuracy
• Pediatrics: 14.2% of orders from mg to ml
converted incorrectly; maximum dose deviation
of 400%
Shane R. Am J Health-Syst Pharm. 2009; 66(Suppl):542-8.
IV Risks: Wrong Route
• USP MedMARX program reported tubing
misconnections in over 300 reports
– Epidural lines connected to i.v.’s
– Oral cough syrup given i.v. push
– Tube feedings administered through
peripheral i.v.’s
• Deaths reported internationally with intrathecally
vincristine and i.v. bupivicaine
• Pediatric errors associated with oral medications
given i.v. due to lack of oral syringes
Hicks R, Becker S. J Infus Nurs 2006; 29(1): 20-7.
Harmful wrong route errors
include all but the following:
A. Oral liquid given i.v.
B. i.v. given intrathecal
C. Tube feedings
given i.v.
D. Tube feedings
given po
15
IV Medication Complexity
• USP <797>
• High-risk therapies
–
–
–
–
Chemotherapy
High-alert medications
PCA
Epidural medications
• High-risk populations
– Pediatrics
• Dose considerations
• Volume considerations
• Preservatives
– Critical Care
• TPNs
• Infusion devices,
implantable pumps,
tubing, catheters
• Quality assurance
• Pharmaceutical
calculations
• Labeling
• Compatibilities
• Expiration dating
• Rates of infusion
• Outsourcing
considerations
High-Risk Populations
Critical Care
• Nearly 2/3 of medications in the ICU are given via i.v. route
• 10.6% error rate in dosage calculation and administration
reported in a surgical ICU
– Implication: 1/10 i.v. infusions in an ICU are prepared or
administered in error
Pediatrics
• USP MedMARX®-2.5% of medication errors led to harm
• TJC Sentinel Alert re: pediatric safety
– Oral syringes in patient care areas
– Preparation of patient-specific doses
– Dose calculation sheets for emergency use and common
medications
Kane-Gill S, Weber R. Crit Care Clin. 2006; 22(2): 273-90, vi.
The Joint Commission. Preventing pediatric medication errors. online (accessed 2008 Apr 12).
High-Risk Therapies
• Chemotherapy
– Double checks at each step of the medication-use
process against the original order
– Intrathecal therapy safeguards (vinca alkaloids,
L-asparaginase)
• PCA Tool Kit Order sets
– Patient Selection
– Opioids for breakthrough pain
– Morphine/hydromorphone mix-ups
ref. 1 IV Safety/PCA Tool Kit San Diego Project.pdf
16
Risks: Lack of IV Medication
Training and Education
• Pharmacists
– IV medication therapy does not appear to be
an area of focus in pharmacy training
• Recent survey regarding the extent of instruction
on sterile preparations in U.S. pharmacy schools
revealed only 13% of schools felt that students had
“adequate training in compounding sterile
preparations”
• Technicians
– Minimal requirements in most technician
training programs
Technology to Prevent IV Errors:
Smart Pumps
• % adoption
• Study demonstrated that alerts were bypassed
25% of the time (Rothschild J et al. Crit Care Med. 2005)
• Lack of standardizations of drug names, rates,
and concentrations
– Study of 100 drug libraries used in smart pumps:
substantial variability in drug names, concentrations
and dose units within the same library
• Magnesium sulfate: mg/hr, mg/kg/hr, gm/hr, mcg/kg/hr,
meq/kg/hr and gm/hr (Bates D et al. TJC J Qual Patient Saf. 2005)
2007 ASHP Survey of U.S. Hospital and Health System Adoption & Implementation of Health Information
Technology.
IV Errors Make Headline News
Chemotherapy Overdose
–
On December 3, 1994, 39-year-old Boston Globe health
reporter Betsy Lehman died of complications of an overdose of
cyclophosphamide at the Dana-Farber Cancer Institute.
Media reported the event intensively, with 28 front-page
headlines over the next 3 years. (ref 13. AHRQ. Perspectives on safety:
organizational change in the face of highly public errors.)
•
Pharmacist sentenced to 6 months in jail
–
•
Ohio hospital pharmacist failed to recognize that technician
had made a chemotherapy solution with 23.4% NaCl leading
to death of an infant. (ref. 14 ISMP.org)
Plain D5W or hypotonic saline solutions post-op
could result in acute hyponatremia and death in
healthy children
17
IV Errors Make Headline News
• Deaths from Intravenous Colchicine Resulting from a
Compounding Pharmacy Error --- Oregon and
Washington, 2007 (MMWR Weekly Oct 12, 2007; 56(40);1050-2.)
• ‘Wrong' injection killed toddler (BBC News,
6 October, 2003)
– Patient received neuromuscular blocker instead of a sedative
• Fatal 1,000-fold overdose of zinc in TPN due to
confusion between mcg and mg (ISMP.org)
• 200 epidural blunders admitted after 3 women die.
(Oakeshoff 2006)
• Dennis Quaid's Babies Given Heparin Overdoses
Medical Malpractice Attorney Source
Types of IV Errors
According to an i.v. medication errors study, almost half of
all i.v. errors occurred in preparing or administering
medication. Common i.v. errors include, but are not
limited to:
–
–
–
–
–
–
–
Improper injection of drug
Wrong time of administration
Extra dosage or wrong dose of drug is administered
Failure to give medication through an i.v.
Faulty i.v. pumps and valves
Incompatible combination of drugs administered
Wrong drug or solution was used
http://www.medical-malpractice-attorney-source.com/medical_malpractice/hospital-malpractice/iverrors.html, (accessed 2009 Oct 10).
National Focus on IV Safety
• The Joint Commission
–
–
–
–
–
–
–
Standardized solutions
Pharmacy preparation
Labeling
Look-alikes
Pediatric Sentinel Alert - patient specific doses
Responsibility for performance of outsource vendors
Anticoagulation safety - Sentinel Alert
• USP Chapter <797>
18
National Focus on IV Safety
2008 ASHP IV Safety Summit
• Goals
– Achieve consensus on initial standard practices
– Identify barriers and means to overcome
– Prioritize recommended safe practices for immediate
implementation and for long term strategic planning
– Obtain stakeholder commitment to improve i.v. safety
• #1 Short Term Action
– Use drug information from authoritative sources to establish
national standards for i.v. use:
• Drug name
• Recommended minimum and maximum dosages, upper and
lower administration rate limits that may not be overridden,
• Standardized concentrations and dosing units, and
commercially available strengths and concentrations
Medication-Use Process
Selection
&
Procurement
Storage
Ordering
&
Transcribing
Preparing
&
Dispensing
Administering
Monitoring
The Joint Commission: MM. 8.10: Annually identify and evaluate
risk points in the medication use process
Selection and Procurement
• “Purchasing for safety”: International focus
• Does selection of new i.v. medications include an
assessment of risks associated at each step of the
medication-use process?
– Storage? Prescribing preparation? Rate of infusion? Infusion
related reactions? Monitoring?
• How are risks associated with use of vials minimized?
– Is heparin purchased in 10,000 unit/ml vials or 5,000 unit
pre-filled syringes?
– Are vial sizes of the same medication limited?
• How are drug shortages managed to minimize potential
for a medication error?
19
Storage
• What methods are used to ensure safe
storage of medications?
• How are automated cabinets filled?
• Are periodic audits conducted of
medication storage areas in pharmacies?
Patient care areas? Clinics?
• Are chemotherapy medications stored
separately from other medications?
Ordering and Transcribing
• Have guidelines/protocols been developed and
implemented for ICU titrations? For PCA orders?
• Do chemotherapy orders require an order form
or order-set with fields to ensure dosing is
displayed based on body surface area and per
dose? Total # doses? Total dose/cycle?
• (For hospitals without CPOE) Are orders on the
MAR/eMAR checked against the original order
by the nurse?
CPOE = computerized prescriber order entry
eMAR = electronic medication administration record
Preparation/Dispensing
• What methods are available to assess accuracy
of compounded products
– Is observation methodology used?
– Is validation methodology using spectroscopy?
– Is refractometry used for dextrose in TPNs?
• Are premade i.v. products purchased if
available?
• What checking processes are used for
chemotherapy? Epidurals? Pediatric/Neonatal
i.v.’s?
• Are any i.v. medications pre-checked by the
pharmacist prior to preparation?
20
Preparation/Dispensing
• Have standard concentrations been
implemented?
• How are high alert medications prepared and
dispensed?
• How is accuracy of i.v. labeling assessed?
• What is the approach to ensuring the quality of
outsourced i.v. preparations?
• If a TPN compounder is used, what safeguards
exist to prevent errors?
Administering
• Do nurses double check high-alert medications
prior to administration?
• Are there established maximum rates of
administration for i.v. medications?
• How are nurses trained in pharmaceutical
calculations?
• How are nurses trained in the use of infusion
devices?
– How are overrides of smart pump alerts managed?
Monitoring
• Are high-alert i.v. infusions checked to
verify accuracy of infusion and rate?
• Are observation studies conducted to
evaluate compliance with safe medication
practices?
• “5Rs”?
• Are Nursing and Pharmacy double
checking processes?
21
IV Safety Solutions
• Label lines to prevent wrong route due to tubing
misconnections
• Stock oral syringes on pediatric wards
• When a large number of dosage units are
ordered (e.g., more than two tablets, capsules, vials, or
ampuls) for a single patient dose, the medication
order should be questioned
• Consider pharmaceutical calculations
examinations for pharmacy and nursing staffs
IV Safety Solutions
• Standardize dosage units across all systems
– Order Sets, Information System: CPOE/Pharmacy
System/EMAR or paper MAR, Smart Pumps, Labels
• When standard drug concentrations or dosage charts
are not available, dosage calculations, flow rates, and
other mathematical calculations should be checked by a
second individual (e.g., another nurse or a pharmacist)
• New technology should be prospectively evaluated for
potential risks (FMEA = failure mode effectiveness
analysis)
• Observation methodology should be used to evaluate i.v.
medication processes
Thank You!
22
Improving IV Medication Safety: Identifying the Risk Points
SELECTED REFERENCES AND RESOURCES
1.
Agency for Healthcare Research and Quality. Perspectives on safety:
organizational change in the face of highly public errors.
http://www.webmm.ahrq.gov/perspective.aspx?perspectiveID=3 (accessed 2009
Oct 12)
2.
Bates, DW, Vanderveen T, Seger D et al. Variability in intravenous medication
practices: implications for medication safety. Jt Comm J Qual Patient Saf. 2005;
31(4): 203-10.
3.
British Broadcasting Corporation, BBC News. 2003; Oct 6.
4.
Flynn E, Barker K, Pepper G, Bates D et al. Comparison of methods for detecting
medication errors in 36 hospitals and skilled-nursing facilities. Am J Health-Syst
Pharm. 2002; 59:436-46.
5.
Hicks, RW, Becker SC. An overview of intravenous-related medication
administration errors as reported to MEDMARX, a national medication errorreporting program. J Infus Nurs. 2006; 29(1): 20-7.
6.
ISMP Medication Safety Alert. Criminal prosecution of human error will likely have
dangerous long-term consequences. 2007; 12(5):1-2.
http://www.ismp.org/Newsletters/acutecare/articles/20090423.asp (accessed 2009
Oct 12)
7.
Joint Commission (2008) Preventing pediatric medication errors.
http://www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_39.htm.,
(accessed 2008 April 12)
8.
Kane-Gill S, Weber R. Principles and practices of medication safety in the ICU. Crit
Care Clin. 2006; 22(2): 273-90.
9.
Matthew, L. Injectable medication therapy: a patient safety challenge. Nurs Stand
2007: 21(31): 45-8.
10.
Medical malpractice attorney source online. http://www.medical-malpracticeattorney-source.com/medical_malpractice/hospital-malpractice/iv-errors.html
(accessed 2009 Oct 10).
11.
Morbidity and Mortality Weekly Report. Oct 12, 2007; 56(40);1050-2.
12.
Pedersen C, Gumpper K. 2007 ASHP Survey of U.S. Hospital and Health System
Adoption & Implementation of Health Information Technology. Am J Health-Syst
Pharm. 2008; 65:2244-64.
13.
Proceedings of a summit on preventing patient harm and death from i.v.
medication errors. Am J Health-Syst Pharm. 2008; 65:2367-79.
23
Improving IV Medication Safety: Identifying the Risk Points
14.
Rothschild JM, Keohane CA, Cook EF et al. A controlled trial of smart infusion
pumps to improve medication safety in critically ill patients. Crit Care Med. 2005;
33:533-40.
15.
San Diego Patient Safety Task Force. Tool Kit: Patient Controlled Analgesia (PCA)
Guidelines of Care for the Opioid Naïve Patient. 2008;
http://www.ashp.org/DocLibrary/Policy/PatientSafety/IVSafety/PCAToolKitSanDieg
oProject.pdf, accessed 10/11/09.
16.
Shane R. Current status of administration of medications. Am J Health-Syst
Pharm. 2009; 66(Suppl):542-8.
17.
Taxis K, Barber N. Causes of intravenous medication errors: an ethnographic
study. Qual Saf Health Care. 2003; 12:343-7.
24
Improving IV Medication Safety: Identifying the Risk Points
SELF–ASSESSMENT QUESTIONS
1. Which parenteral route is associated with the most harm?
a.
b.
c.
d.
Subcutaneous.
Intrathecal.
Intramuscular.
Intravenous.
2. Which parenteral medication is most frequently associated with harm?
a.
b.
c.
d.
Diazepam.
Natalizumab.
Vincristine.
Morphine.
3. When comparing the number of errors detected by traditional medication error
reporting to the number of errors that will be detected by observation, the ratio is:
a.
b.
c.
d.
300:17.
17:1.
300:1.
400:1.
Answers
1. d
2. d
3. c
25
Improving IV Medication Safety: Identifying the Risk Points
26
Improving IV Medication Safety: Identifying the Risk Points
Ginette A. Pepper, Ph.D., RN, FAAN
Professor and Associate Dean for Research
Helen Lowe Bamberger Colby Presidential Endowed Chair in Gerontological Nursing
Director, Hartford Center of Geriatric Nursing
University of Utah College of Nursing
Salt Lake City, Utah
Ginette A. Pepper, Ph.D., RN, FAAN completed her basic education in nursing at the
University of Colorado. After serving a tour in the Army Nurse Corps, she earned her
Master of Science in Medical-Surgical Nursing from the University of Utah. On
graduation she assumed a position as the nation’s first geriatric nurse practitioner. Ginny
received her Ph.D. in Psychobiological Nursing and Pharmacology from the University of
Colorado Health Sciences Center and was a clinical nurse researcher at the Denver VA,
Swedish Medical Center, and HealthONE. She was a member of the University of
Colorado faculty beginning in 1974 through 2003. From 1990 through 2003 she held
positions as the Director of Faculty Practice, Director of the Master’s Program, and
Director of the Nursing Doctorate program. In 2007 she completed a fellowship at the
National Institutes of Health (NIH) in human genetics.
Dr. Pepper is a nationally recognized expert in medication safety, has published
extensively on the topics of medication safety and geriatric care in nursing, medical, and
pharmacy journals, and frequently speaks nationally and internationally. She has been a
member of the Safe Medication Use and the Nomenclature Expert Committees of the
United States Pharmacopeia and on the Editorial Boards of Nurse Advis-Err, the nursing
newsletter for the Institute for Safe Medication Practices (ISMP), and the Joint
Commission Journal on Quality and Safety. She has been principle investigator on two
federally funded studies on medication safety, one on medication-related falls and
imbalance in community-dwelling elderly and the other on the effects of nurses’ working
conditions on medication administration safety in hospitals. She has been co-investigator
and consultant on numerous other federally funded medication safety grants.
Since 2003, Dr. Pepper has been Professor and the Helen Bamberger Colby
Presidential Endowed Chair in Gerontological Nursing at the University of Utah College
of Nursing. She is also the Associate Dean for Research and Ph.D. Program and
Director, Hartford Center of Geriatric Nursing Excellence.
27
Improving IV Medication Safety: Identifying the Risk Points
Ginette A. Pepper, Ph.D., RN, FAAN
PRESENTATION
Managing the Risk Points to Improve Medication Safety
OVERVIEW
This presentation expands on the discussion of identifying IV risk points and medicationuse patient safety. Strategies to reduce the risk of error and ameliorate harm in all
phases of the medication-use process are discussed from the perspective of nursing.
Three factors that can help to bridge the phases of the medication-use process include
training, decision support, and work redesign. Additionally, proposed revisions to the
USP General Chapter section on injectables to enhance patient safety are reviewed.
Management of technology adoption and implications of recent research on factors
associated with the risk of medication error, high risk procedures, and nursing best
practices are presented.
LEARNING OBJECTIVES
At the conclusion of this knowledge-based educational activity, participants should be
able to
• Evaluate the role of training, decision support, and workflow redesign on
medication administration safety.
•
List three strategies to overcome issues in use of technology to promote
medication administration safety.
•
Critique new research on the risk factors and best practices for errors in
medication administration.
28
Managing the Risk Points to
Improve Medication Safety
Bridging the Nursing Perspective
Ginette A. Pepper, Ph.D., R.N., FAAN
Professor and Endowed Chair
Associate Dean for Research
Director, Hartford Center of Geriatric Nursing Excellence
University of Utah College of Nursing
Salt Lake City, Utah
Objectives
•
Evaluate the role of training, decision
support, and workflow redesign on
medication administration safety
•
List three strategies to overcome issues
in use of technology to promote
medication administration safety
•
Critique new research on the risk factors
and best practices for errors in
medication administration
Medication-Use Process
(Nursing Perspective)
Ordering
&
Transcribing
Selection
&
Preparing
Procurement
&
Dispensing
Storage
Preparing
&
Administering
Monitoring
The Joint Commission: MM. 8.10: Annually
identify and evaluate risk points in the
medication-use process
29
Medication-Use Process (MUP)
Tra
i n in
(System Perspective)
g
Selection
&
Preparing
Procurement
&
Dispensing
Storage
Ordering
&
Transcribing
Preparing
&
Administering
Monitoring
ow io
kfl icat
r
o f
W odi
M
n
on
isi ort
c
De upp
S
The Joint Commission: MM. 8.10: Annually
identify and evaluate risk points in the medication
use process
“Bridges” Across MUP
• Training
– Clinical pharmacology and therapeutics
– Rationale for changes and innovations
• What they told me about unit dosing
– Shared mental models
– GAP analysis:
• Effectiveness?
– The Denver Nurses Case
• Extra specialty practice
– A NURSE IS A NURSE IS A NURSE
– Novices
• Orientee/Agency/Pool/Float
Which of the following is accurate about
using classroom training and testing of
nurses as the central strategy in
medication safety?
A. Little evidence that it
effectively changes
behaviors
B. Those at greatest risk for
error are likely to attend
C. The same curriculum is
effective across
specialties areas.
D. It is low cost
30
“Bridges” Across MUP
• Workflow Modification
– Assess impact; adjust impact
• Communicate rationale for changes to the sharp
end
• Include representatives from the sharp end on the
planning team
• Continuous process improvement
– GAP analysis
• Expertise in human factors engineering
• Cost of nursing time
• Reality: nurses are the safety net
“Bridges” Across MUP
• Decision Support
– Nurses make decisions?
– What’s wrong with the 5 Rights?
• Right patient, time, drug, dose, route
• Goals, not procedures
• We don’t know which procedures achieve 5 Rs
– GAP analysis
• Informatics focus is not nursing
• Nurse’s capacity to articulate decisions
• Expectations paradox
Ordering & Transcribing
CPOE (computerized provider order entry)
•
•
•
•
Handwriting and Legibility
Completeness of information
Omissions (not transcribed)
Decrease slips and lapses
Issues with CPOE
•
•
•
Error is not eliminated
New types of error
Complex orders
31
Ordering & Transcribing
Issue #1: Error is not eliminated
• Ambulatory chemotherapy errors: adult
(4% CPOE vs. pediatric (1% handwritten)
Gandhi et al. Cancer. 2005; 104 (11): 2477.
• CPOE vs. handwritten orders for pediatric
infusions increased speed and satisfaction,
but not accuracy
Sowan et al. AMIA Annual Symposium Proceedings. 2006; 1105.
• CPOE system with standardized
concentrations that generates infusion chart
• 108 simulated infusions with 72 errors; 53%
handwritten detected vs. 40% CPOE (p=.07)
Ordering & Transcribing
Issue #2: New types of errors
•
Case study: Vincristine injected subcutaneously
(vs. IV “bolus”) because incorrect route entered
during protocol creation.
Garlantezec, et al. J Oncol Pharm Pract, Oct 15, 2009 (online)
–
Experienced nurse did not make the error but novice
did
– Recommendations:
• Nurses training and testing
• Pharmacists develop new ways to detect errors
Ordering & Transcribing
Issue #3: Complexity and ambiguity of orders
•
Ancillary pre-medications in chemotherapy
•
Therapeutic substitutions
•
Contingent orders: the medication administered
is dependent upon some clinical parameter
•
What does “oral” mean when there is an enteral
feeding tube in place?
Gandhi et al. (2005). Cancer, 104 (11): 2477.
32
Dispensing & Preparing
• Unit dose (a moment of silence)
– 15-20% error (stock drugs); 5-8% unit dose
Runciman et al (2003) Int J Qual Health Care, 15 (suppl), i49
• Procurement and USP revision
• Automated Dispensing Cabinets (ADC)
and other technology
• Standardized medication dispensing
– Standardized concentrations
– Manufacturer Ready-to-Use
USP General Chapter <1>
INJECTIONS: Labeling On Ferrules
and Cap Overseals
USP 32, page 34 Published PF 36 (1)
• Ferrules and overseals are reserved for critical
safety messages
– Intended to prevent imminent, life-threatening
situations, e.g., “Warning---Paralyzing Agent
– If no cautionary statement, the top surface must
remain blank
• Product that goes to the nursing unit should be
interpretable by nurses
According to the proposed revision of the
section on ferrules and overseals of
General Chapter 1 USP 34, what can be
printed on the top surface of vials for
injectables?
A. Anti-counterfeiting
logos
B. Must be diluted
C. 5 mg
D. Must be refrigerated
33
Automated Dispensing Cabinets
• 2007 ISMP (Institute for Safe Medication Practices) forum to
establish guidelines for design and use. Comments published
in Nurse Advise-Err (Apr 2009)
– Location, access, interruptions, students, poor practices
“Thank you for the opportunity to share my frustrations with
a system that was “sold” to nursing. This is another
example of departments making decisions about the use of
technology without checking out the impact on nursing
care. Most often it adds more time to our patient care,
more distance to travel and thereby increasing our
patients’ frustration with how long it takes to get their
medications to them or their treatments. Our information
technology department is commonly changing our
IT/nursing world without considering the “work arounds”
nursing will have to figure out to make the technology work
in a practical way.”
www.ismp.og/newsletter/nursing/articles/adcComments200906.asp
Other Technologies
• Barcode Medication Administration (BCMA) important technology for intercepting dispensing
and administration errors
– 73% dispensing; 28% administration
Cochran et al. (2007) Jt Comiss J Qual & Patient Safety, 33, 293.
• IV Pumps including Smart Pumps
– Dosing errors (pump programming and bypassing
safeguards)
• After FMEA, double-check was required of all high-alert
medications
• Extensive training
Adachi and Lodolce (2005). Am J Health Syst Pharm, 62, 917.
Bullock et al. (2006). Crit Care Nurs Clin N Am, 18, 515.
Which of the following approaches is
most likely to be effective in
decreasing work-arounds by nurses in
use of technology?
A. Mandatory in-service
class/module annually
B. Requiring double
checks documented in
chart
C. Including nurses in
implementation
planning and CQI
34
IV Drug Delivery Systems
Second Consensus Development Conference
– Ranked delivery systems on applicability (to special
populations), ease of use, regulatory compliance, cost,
implementation, patient safety
•
•
•
•
•
Manufacturer ready to use
Outsourced ready to use
Point of care activated*
Pharmacy compounding
Non-pharmacy compounded
(e.g., nursing unit)
*If used, need pharmacy/nursing enforcing
functions
Sanborn et al. 2009. Am J Health-Syst Pharm 15:66, 185
Standardized Concentrations
• Study of drug concentrations
– Neuroscience unit in UK
– Collected 151 syringes for insulin, midazolam,
norepinephrine, dopamine, potassium,
magnesium
– Majority exceeded concentration by more
than 10%
– Labeling quality correlated with accuracy
– Concluded: use pre-prepared syringes
Wheeler et al. 2006 Intensive Care Med., 34, 1441
Preparation & Administration
• Risk factors for errors
• Best Practices
• High risk areas
– Bolus dosing
– Tubing misconnections
35
Risk Factors for Medication
Administration Error (MAE)
• Multinational study
– 113 ICUs in 27 countries; 1328 patients
– 861 IV errors in 24 hr, 75% omission, 0.9% suffered
permanent harm
Patient factors
Unit factors
Practice factors
Organ failure
1.19
Larger units
1.01
Basic monitoring
# IV meds
1.06
Pt per nurse
1.30
Critical incident Sx 0.69
0.19
ICU interv.
1.50
Occupancy
1.03
Checks of shift
change
0.68
Monday
Unk
Pt turnover
0.73
Valentin et al., BMJ, 2009
Risk Factors for MAE
• Self-report of near-miss in Japan
– 525 person days yields 94 errors from 88 nurses
– Work load (delay due to heavy workload) and lack of
experience increased risk for error
Seki & Yamazaki. 2006. J Nurs Manage, 14, 128.
• Errors in Pediatric units
– 485 observation periods during weekdays by
pharmacy students
– Risks:
•
•
•
•
•
IV drugs (0.28)
Non-IV (4.44)
Prepared by pharmacists (1.66)
Administered by float/temp/student (1.67)
Complicated therapies (1.22)
Prot et al. 2005. J Qual Heath Care. 17, 381.
Best Practices
Unpublished study in San Francisco area that
focused on practices that improved accuracy from
85%-98%
• Compare medication to MAR (medication
administration record)
• Keep medication labeled until administration
• Check two [patient identifiers]
• Immediately record administration in chart
• Explain the medication to the patient
• Minimize distractions and disruptions during the
administration process
Olson B. Error prevention strategies: it’s not Sophie’s choice folks.
Available: http://florencedotcom.blogspot.com/2009/11/error-prevention-strategies-itsnot.html (Accessed 2009 Nov 9)
36
Which of the following is NOT one of the
best practices of medication
administration associated with accuracy
in the UCSF study?
A. Decrease distraction
and interruption
B. Take the MAR to the
bedside
C. Explain the medication
to the patient
D. Keep medications
labeled until
administration
High Risk Practice Areas
• Bolus Medications
–
–
–
–
–
Rate of administration
Many are high alert medications
Multi-step preparation
Reference/decision support at point of care.
Technology?
Taxis and Barber 2003. BMJ, 326, 1-4.
Paparella 2004. J Emerg Nurs, 30, 478.
• Tubing “Misconnections”
– Confusing enteral, parenteral, and epidural lines
– Recent reports in labor and delivery setting
Broussard B. 2009. Nursing for Women’s Health, 13, 155.
– Label lines, put different pumps on
opposite side of bed. (color coding?)
Monitoring
• The most disregarded phase of medication
safety
• Study to evaluate how many IV-ADEs (adverse
drug events) were preventable by smart pump
technology
– Pre-post design; chart review
– Of 100 preventable ADE, only 4 (2 pre; 2 post) were
preventable
– Majority were preventable by monitoring (37%) and
intervening (45%)
Nukols 2007. JGIM, 23 (Suppl 1), 41.
37
Best Bridges
• More pharmacists
• More nurses
• More
communication
Thank You!
38
Improving IV Medication Safety: Identifying the Risk Points
SELECTED REFERENCES
1.
Adachi W, Lodolce A. Use of failure mode and effects analysis in improving the
safety of i.v. drug administration. Am J Health-Syst Pharm. 2005; 62: 917-20.
2.
ADC Comments June 2009. Available
www.ismp.og/newsletter/nursing/articles/adcComments200906.asp (accessed
2009 Nov 2).
3.
U.S. Pharmacopeia. Briefing. Labeling on Ferrules and Cap Overseals Section of
Chapter <1> INJECTIONS. USP 32.
http://www.usp.org/pdf/EN/aboutUSP/theStandard2008Summer.pdf (accessed
2009 Nov 1).
4.
Broussard B. Preventing medication errors. Nursing for Women’s Health, 2009; 13:
155-8.
5.
Bullock J, Jordan D, Gawlinski A et al. Standardizing i.v. infusion medication
concentrations to reduce variability in medication errors. Crit Care Nurs Clin N Am.
2006; 18; 515-21.
6.
Cochran G, Jones K, Brockman J et al. Errors prevented by and associated with
bar-code medication administration. Jt Commission J on Quality & Pt Safety, 2007;
33: 293-301.
7.
Follow ISMP guidelines to safeguard the design and use of automated dispensing
cabinets. Nurse Advise-ERR, 2009; 7:1-4.
8.
Gandhi T, Bartel S, Shulman L et al. Medication safety in the ambulatory
chemotherapy setting. Cancer, 2003; 104: 2477-83.
9.
Le Garlantezec P, Aupee O, Almeras D, Lefewure L et al. Drug administration error
related to computerized prescribing. J. Oncol Pharm Practice, 2009; Oct 15:1-4.
(pre-pub online).
10.
Message in our mailbox: a nursing perspective on ADCs, Nurse Advise-ERR,
2009; 7 (6): 4.
11.
Nuckols T, Bower A, Paddock S et al. Programmable infusion pumps in ICUs: an
analysis of corresponding adverse drug events. JGIM, 2007; 23 (Suppl 1), 41-5.
12.
Paparella S. Avoiding disastrous outcomes with rapid intravenous push
medications. J Emerg Nurs. 2004; 30: 478-80.
13.
Prot S, Fontan J, Alberti C et al. Drug administration errors and their determinants
in pediatric in-patients. Int J Qual Health Care, 2005; 17; 381-9.
14.
Runciman W, Roughhead E, Semple S et al. Adverse drug effects and medication
errors in Australia. Int J Qual Health Care, 2003; 15 (suppl): 49-59.
39
Improving IV Medication Safety: Identifying the Risk Points
15.
Sanborn M, Moody M, Harder K, Pepper G et al. Second consensus development
conference on the safety of intravenous drug delivery systems—2008. Am J.
Health Syst Pharm, 2009; 66: 185-92.
16.
Seki Y, Yamazaki Y. Effects of working conditions on intravenous medication
errors in a Japanese hospital. J Nurs Manage. 2006; 14: 128-39.
17.
Sowan A, Gaffor M, Soeken K et al. A comparison of medication administration
errors using CPOE vs handwritten orders for continuous drug infusions. AMIA
Annual Symp Proceedings, 2006; 1105.
18.
Taxis K, Barber N. Ethnographic study of incidence and severity of intravenous
drug errors. BMJ. 2003; 326: 1-4.
19.
Valentin A, Capuzzo M, Guidet B et al. Errors in administration of parenteral drugs
in intensive care units: multinational prospective study. BMJ. 2009; 338:b814.
http://www.bmj.com/cgi/content/full/338/mar12_1/b814 (accessed 2009 Nov 1).
20.
Wheeler D, Degen B, Sehmi J et al. Variability in the concentrations of intravenous
drug infusions prepared in a critical care unit. Intensive Care Med, 2008; 34: 14417.
40
Improving IV Medication Safety: Identifying the Risk Points
SELF–ASSESSMENT QUESTIONS
1. Which substantial cause of medication administration error has been most
successfully addressed by CPOE (computerized provider order entry)?
a.
b.
c.
d.
Lack of decision support for nurses.
Complexity of medication orders.
Communication among providers.
Illegible handwriting.
2. Proposed revision of the USP General Chapter <1> section on injectables limits
printing on the top surface of vials of injectable liquids to
a.
b.
c.
d.
Statements that promotes safety.
Logos and words to prevent counterfeiting.
Cautions on imminent life-threatening situations.
Statements guiding administration technique.
3. The safety concepts underlying the proposed revision of USP General Chapter <1>
section on injectables is
a.
b.
c.
d.
Information overload and alert fatigue.
Confirmation bias and LASA.
Forcing functions and shared mental model.
Systems thinking and near miss.
Answers
1. d
2. c
3. a
41
Improving IV Medication Safety: Identifying the Risk Points
42
Improving IV Medication Safety: Identifying the Risk Points
Karen Fiumara, Pharm.D., BCPS
Patient Safety Officer
Brigham and Women’s Hospital
Adjunct Assistant Professor of Pharmacy Practice
Massachusetts College of Pharmacy and Allied Health Sciences
Boston, Massachusetts
Karen Fiumara, Pharm.D., BCPS is the Patient Safety Manager of Brigham and
Women’s Hospital (BWH), in Boston, Massachusetts. She is an Assistant Professor of
Clinical Pharmacy Practice at both Northeastern University and Massachusetts College
of Pharmacy. She received her Doctor of Pharmacy from Massachusetts College of
Pharmacy in 2002 and completed her residency program at Brigham and Women’s
Hospital in 2003.
Dr. Fiumara is a member of various professional societies, including the American
Society of Health System Pharmacists, the Massachusetts Society of Health Systems
Pharmacists and the American Pharmaceutical Association. She serves on the Brigham
and Women’s Hospital’s multidisciplinary Drug Safety Committee, which is charged with
reviewing all medication safety related issues and adverse events. She works closely
with information systems specialists as a liaison on numerous patient safety projects,
and co-chairs the Brigham and Women’s Hospital Joint Commission Anticoagulation
Task Force. She works as Clinical Pharmacy Consultant for the New England Journal of
Medicine. Dr. Fiumara has authored papers in the fields of medication safety, adverse
drug events, and anticoagulation.
43
Improving IV Medication Safety: Identifying the Risk Points
Karen Fiumara, Pharm.D., BCPS
PRESENTATION
Case Scenario: Evaluating a Medication Management System and Implementing Safety
Solutions
OVERVIEW
Many studies have been published on the risks and error rates associated with
intravenous medications. The current literature continues to highlight the high risk nature
of intravenous sterile preparations and their administration to patients. Unfortunately,
there are limited tools available to critically assess potential gaps in intravenous
medication administration and preparation. This presentation discusses common
medication errors and reviews system-based strategies for error prevention.
LEARNING OBJECTIVES
At the conclusion of this knowledge-based educational activity, participants should be
able to
•
Explain a successful medication management strategy that has been
demonstrated to enhance safety within an organization.
•
Discuss the utility of barcode technology as a system-based safety solution in
intravenous medication preparation.
•
Describe the benefits of intelligent infusion pump technology as a system-based
safety solution for administration to patients.
44
Case Scenario: Evaluating a
Medication Management System
and Implementing Safety
Solutions
Karen Fiumara, Pharm.D., BCPS
Patient Safety Manager
Brigham and Women’s Hospital
Boston, MA
Complexity of Health Care
30 years ago
Primary Care
Practitioners
(PCPs)
Hospital-based
Physicians
Today
Physician Practice
Groups
1 hour of paperwork per Administrative work was >4 hours of paperwork
day
left to administrators
per day
Practiced from privately
owned clinics
Specialists focused on
a particular system of
the body
Employed minimal
support staff
Most PCPs are part of
practice groups
Average ICU patients
require 178 daily tasks
How to manage the increasing complexity of patient care?
Plsek. BMJ. 2001; 323: 625-628.
Complexity of Other Industries
• October 30, 1935 U.S. Army held flight
competition for airplane
manufacturers
• Boeing developed long
range bomber
– 5 times as many
bombs
– Faster
– 2 times farther
• Premier flight pilot
Major Ployer Hill
45
Checklists/Reminders
• Investigation revealed nothing mechanical
had gone wrong. Crash was due to “pilot
error.”
• Aircraft was substantially more complex
–
–
–
–
Four engines
Retractable landing gear
New wing flaps
Varying air speeds
• Deemed “too much plane to fly”
• Boeing nearly went bankrupt
• Group of test pilots developed a checklist
– Pilots flew a total of 1.8 million miles without a
single accident
46
Medical Error Rates
• Two errors per day = 99% proficiency level
• If 99% was “good enough”:
– Airline industry = 2 unsafe landings per day
at Chicago O’Hare International airport
– Banking industry = 22,000 checks deducted
from the wrong account per hour
– Postal industry = 18,322 pieces of mail will
be mishandled in the next hour
• How do we transform health care into a high
reliability industry?
Leape LL. JAMA. 1994;272:1851-7.
How do we transform health
care into a high reliability industry?
A. Employ only medical
professionals with
background in banking,
airline, or auto
industries
B. Critically evaluate
systems issues that
lead to error
C. Implement and test
strategies to reduce
error
D. Both B and C
What Keeps Us Awake at Night?
• Many medication
and patient safety
officers say….
“what keeps me
awake at night is
what goes on
during the day in
the IV room!”
47
Enlarged version on page 61
Do We Have Concerns About How We Are
Preparing Sterile IV Admixtures in Hospitals?
Nearly 50% of surveyed hospitals did not have a formal
QI program for sterility and accuracy of IV Admixtures
American Journal of Health System Pharmacists, 2005 National Survey of Pharmacy
practice in hospital settings: Dispensing and Administration, Volume 63 Feb 16, 2006.
Do We Have Concerns about How We Are
Preparing Sterile IV Admixtures in Hospitals?
Enlarged version on page 62
Parshuram C et al. The Annals of Pharmacotherapy. 2006;40(5):805.
Anton C et al. Arch Intern Med. 2003;163(8):982.
Parshuram C et al. Critical Care Med. 2003;31(10):2483.
Hayes B et al. The Annals of Pharmacotherapy. 2008;42(6):766.
Enlarged version on page 63
Do We Have Concerns About How We Are
Preparing Sterile IV Admixtures in Hospitals?
Ashram C et al. CMAJ: 2008;178(1):42.
Cousins D et al. Qual Saf Health Care. 2005;14(3):190.
Veronika W et al.. Pharmacy World & Science. 2003;25(3)104.
48
Which of the following can be
considered a preparation error?
A.
B.
C.
Nurse administers
dose of cefepime to a
patient who is febrile
and neutropenic 10
hours late
Technician prepares a
TPN using insulin 500
unit vs. insulin 100 unit
vial
Pharmacist approves
an order for ampicillin
500mg with ampicillin
1000 mg
Types of IV Errors
• Improper injection of drug
• Wrong volume of drug
• Extra dosage or wrong dose of drug is
administered
• Failure to give medication through an i.v.
• Faulty i.v. pumps and valves
• Incompatible combination of drugs
administered
• Wrong drug or solution was used
Flynn EA at al. Am J Hosp Pharm 1997:54;904-12.
Patient Case
Dilution Error
• Baby LC # 1, 5 day old male
• Prematurity, 32 weeks
• Treated with beractant, TPN +
UFH 0.5 units/mL
• New PICC line inserted, flushed
with heparin/ saline
• New TPN bag at 4 PM
• Baby began to hemorrhage
from all access sites
• 7 transfusions, 10-15 mL
UFH = unfractionated heparin; TPN = total parenteral nutrition
49
Sept 17th, 2006
Enlarged version on page 64
Dec 7th, 2007
People Magazine
Enlarged version on page 65
Patient Case – Dilution Error
• Medication errors are common in the
NICU
– NICU patients are 8 times more likely to
experience a medication error with the
potential to cause harm than adults
– 54% of errors involved intravenous
medications
Kaushal et al. JAMA. 2001;285:2114-20.
50
Bar-code Technology
• An effective tool in many nonhealth care industries
– Grocery stores are more
automated than health care
• Provides a fail safe automated
identification and feedback
system in real time
• Performs the “five rights”
checking in one easy efficient
process
Can bar-code technology be useful
in the IV room?
A. Yes, but only to verify the
correct product; barcode can’t
help with verifying
concentrations, or
expiration dates
B. Yes, barcode technology can
verify correct product, expiration
dates and concentration
C. No, barcode technology is not
helpful in the IV room setting
Steps to Make a Patient Specific
Compounded Sterile Preparation (CSP)
• Prescriber orders medication via computerized
prescriber order entry (CPOE)
• Pharmacist conducts clinical review and
approves order
• Label generated in the Sterile Products Room
• Barcode scan set-up
• Prep label generated
• Compounding process under the laminar flow
hood (LFH)
• Pharmacist then checks and sends to the patient
floor
51
The Sterile Products Room
Neonatal IV Preparation
• 50 bed – neonatal intensive care unit
• Routinely requires extremely low dose
medications that are NOT commercially
available
• Example: 24 week GA male weighing 3
grams, transferred to NICU, intubated
for management of extreme prematurity,
on pressors with inadequate repose
started on hydrocortisone IV 0.5 mg/kg
(1.5 mg) Q12H
NICU – How many dilution steps are
required to prepare a 1.5mg dose
from a 100 mg/2mL solution?
A.
One dilution to a final
concentration of
100mg/mL
B.
Two dilution steps to a
final concentration of
50mg/mL
C.
Three dilution steps to
a final concentration of
1mg/mL solution
52
NICU Pharmacy System
• The commercially available product
for hydrocortisone is a 100 mg vial.
The vial is reconstituted with 2 mL
sterile water for injection for a
concentration of 50 mg/mL
• Total dose of 1.5 mg cannot be
accurately measured using a 50
mg/mL concentration
• The BWH NICU system is able to
take in consideration reconstitutions
and multiple dilutions to ensure the
correct dose is used to compound a
final product
Enlarged version on page 66
Wt: 3000 grams
Pharmacist can select the 1
mg/mL concentration for the
final product dilution which is
need to accurately measure a
dose of 1.5 mg
Enlarged version on page 67
Wt: 3000 grams
After the pharmacist selects the final
dilution concentration, the total
volume will fill in to match the final
dilution chosen.
53
Enlarged version on page 68
Enlarged version on page 69
All NICU medications
that need to be
reconstituted prior to
compounding are
listed in a
“reconstitution table.”
Enlarged version on page 70
All medications that require
further dilution are in this
“Dilution Table”.
54
Reliance on Technology
“To err is human, but to really mess
things up… you need a computer”
-Anonymous
Sterile Products Room
To prepare the Hydrocortisone:
• The final dilution that will be used to
make the final product (1.5 mg dose) is
1 mg/mL
• Four labels will generate to make this
CSP
1.
2.
3.
4.
Patient specific label
Reconstitution label
Dilution label for 10mg/ml
Dilution label for 1mg/ml
Sterile Products Room
• The system forces the user to proceed “in order”
to make the final patient product
• The system directs the user to:
– Step 1: reconstitute the vial
– Step 2: dilute the 50 mg/mL concentration to 10
mg/mL
– Step 3: dilute the 10 mg/ mL concentration to
1 mg/mL
– Step 4: manufacture CSP
• Each step is set-up, prepared, and checked by
the pharmacist
55
Enlarged version on page 71
Step 1: The system instructs the user to put 2 ml of sterile
water into the vial, which will make it 50 mg/ml concentration;
the product is manufactured and a bar-coded label for the 50
mg/mL solution is affixed to the reconstituted solution.
Enlarged version on page 72
Step 2: Once the reconstitution is completed, the dilution label for
the 10 mg/mL can be scanned. The system asks for the
reconstituted 50 mg/mL barcode to be scanned. The system
defaults the amount of medication and diluents needed to
manufacture the 10 mg/mL product. The product is manufactured
and a bar-coded label for the 10 mg/mL solution is affixed to the
diluted solution.
Enlarged version on page 73
Step 3: Once the product is diluted to a 10 mg/mL concentration, the
1 mg/mL prep label can be scanned. The system computes the
volume of medication and diluent needed to manufacture the 1
mg/mL product. The product is manufactured and a bar-code label
for the 1 mg/mL solution is affixed to the diluted solution.
56
Enlarged version on page 74
Step 4: Once the dilution of 1 mg/mL prepared; the system
prompts the user to prepare the patient specific medication.
The system requires the hydrocortisone 1 mg/mL dilution to
be scanned and computes the amount of volume need to
prepare the final CSP.
Safety Features
• The system will not allow the user to proceed if the
wrong step/drug/diluent is scanned. If you tried to make
the 1 mg/mL final patient dose with the 10 mg/mL
dilution, the system issues a hard stop.
• Bar-code labels are affixed to each product during the
prep stage. The barcode is associated with the
prepared dilution.
• There are 3 steps to every dilution:
Set-up, Preparation, and Check
• Each step requires a pharmacist double-check
Pharmacist Check
• When the first pharmacist enters his/her key, the
second pharmacist must key in right after. If one
pharmacist signs and then backs out without the
other pharmacist key, it will start the checking
process over again.
• The system cannot be bypassed. The user is
not able to proceed to the next step until two
pharmacists have entered their keys.
57
Barcodes
• All reconstitution and dilution labels have
barcodes with lot numbers and expiration
dates assigned to them.
• If the user tries to scan a dilution after the
expiration date, the system alerts the user
that the product is expired.
Administration related IV Errors
Lack of standardized dosing methods
Case report from Institute for Safe Medication Practices (ISMP):
• An 80-year-old male (80 kg) taken to an urgent care center for
treatment of urosepsis and septic shock
• Ordered dopamine in a mcg/kg/minute dose to treat persistent
hypotension
• Over the next hour, the infusion was titrated upward two
times in 5 mcg/kg increments with no response
• A critical care transport service was called to transport the
patient to a nearby hospital for admission to a critical care unit
• The transport team independently calculated the rate of
infusion
• Identified that the dopamine dose had been programmed in
mcg/kg/HOUR, not mcg/kg/MINUTE
Patient Case - Infusion Error
Error Description
• 57 YOM end stage CMP
• EF = 10%
• Heart transplant candidate
with BIVAD
• Receiving UFH 900 units
per hour (9 ml/hr)
• New order to reduce
heparin 800 units per hour
@ 10:22 PM
• Infusion pump set for 800
ml per hour
•
•
•
•
•
•
•
•
8:45 pm aPTT = 75.1
1:13 am protamine 25mg
1:28 am aPTT = >150
3:13 am aPTT = >150
3:32 am protamine 26mg
2 units PRBC
4:08 am aPTT = >150
8:21 am aPTT = 44.4
58
UFH Error Analysis: BWH
• 1 event per 1,000 patients
– 52% - Administration related
– 31% - Equipment failure, rate or dosing error
– 23% - Infusion pump
• 6% - Prolonged length of stay or significant harm
*Patient Safety Initiative: Hospital invested
$3 million in state of the art infusion pumps*
Fanikos J et al. Medication errors associated with
anticoagulation therapy in the hospital.Am J Cardiol
2004;94:532-5.
Objectives
Methods
Evaluate impact of “smart”
Programmed the drug library
infusion technology on
to alert for over-doses or
anticoagulation administration under-doses
To determine if infusion
technology equipped with
drug libraries may reduce
medication errors
Alerts where subsequently
recorded in the device’s
electronic memory along
with the user’s next action
Retrospectively reviewed all
anticoagulant alerts and the
user’s next action for all
devices from 10/2003
through 1/2005
Dosing Errors and their Magnitude
25
10 X Underdose
1
15
100 X Underdose
8
> 100 X Overdose
21
21
2
40
100 X Overdose
2
31
10 X Overdose
0
5
10
15
UFH
4
20
ARG
25
Lep
30
5
35
40
45
Bival
UFH = unfractionated heparin; ARG = argatroban; Lep = lepirudin; Bival = bivalirudin
59
Data Entry Errors Frequently Repeated with
Unfractionated Heparin (UFH)
300
286
27.2 % entry errors
User repeated the
error
Frequency
250
200
150
100
63
27
50
12
3
1
1
4
5
6
9
0
1
2
3
No. of Incorrect Device Entries
Conclusions
• Pharmacy departments should critically evaluate
risk points
• Practical use of medication-use safety strategies
such as bar-code scanning, smart infusion
devices, and standardization of medication
administration can be valuable tools in reducing
medication errors during compounding and
administering sterile products
• Error reduction strategies must include high
reliability, system-based solutions
Thank you!
60
Do We Have Concerns About How We Are
Preparing Sterile IV Admixtures in Hospitals?
Nearly 50% of surveyed hospitals did not have a formal
QI program for sterility and accuracy of IV Admixtures
American Journal of Health System Pharmacists, 2005 National Survey of Pharmacy
practice in hospital settings: Dispensing and Administration, Volume 63 Feb 16, 2006.
61
Do We Have Concerns about How We Are
Preparing Sterile IV Admixtures in Hospitals?
Parshuram C et al. The Annals of Pharmacotherapy. 2006;40(5):805.
Anton C et al. Arch Intern Med. 2003;163(8):982.
Parshuram C et al. Critical Care Med. 2003;31(10):2483.
Hayes B et al. The Annals of Pharmacotherapy. 2008;42(6):766.
62
Do We Have Concerns About How We Are
Preparing Sterile IV Admixtures in Hospitals?
Ashram C et al. CMAJ: 2008;178(1):42.
Cousins D et al. Qual Saf Health Care. 2005;14(3):190.
Veronika W et al.. Pharmacy World & Science. 2003;25(3)104.
63
Sept 17th, 2006
Dec 7th, 2007
People Magazine
64
65
Wt: 3000 grams
Pharmacist can select the 1
mg/mL concentration for the
final product dilution which is
need to accurately measure a
dose of 1.5 mg
66
Wt: 3000 grams
After the pharmacist selects the final
dilution concentration, the total
volume will fill in to match the final
dilution chosen.
67
68
All NICU medications
that need to be
reconstituted prior to
compounding are
listed in a
“reconstitution table.”
69
All medications that require
further dilution are in this
“Dilution Table”.
70
Step 1: The system instructs the user to put 2 ml of sterile
water into the vial, which will make it 50 mg/ml concentration;
the product is manufactured and a bar-coded label for the 50
mg/mL solution is affixed to the reconstituted solution.
71
Step 2: Once the reconstitution is completed, the dilution label for
the 10 mg/mL can be scanned. The system asks for the
reconstituted 50 mg/mL barcode to be scanned. The system
defaults the amount of medication and diluents needed to
manufacture the 10 mg/mL product. The product is manufactured
and a bar-coded label for the 10 mg/mL solution is affixed to the
diluted solution.
72
Step 3: Once the product is diluted to a 10 mg/mL concentration, the
1 mg/mL prep label can be scanned. The system computes the
volume of medication and diluent needed to manufacture the 1
mg/mL product. The product is manufactured and a bar-code label
for the 1 mg/mL solution is affixed to the diluted solution.
73
Step 4: Once the dilution of 1 mg/mL prepared; the system
prompts the user to prepare the patient specific medication.
The system requires the hydrocortisone 1 mg/mL dilution to
be scanned and computes the amount of volume need to
prepare the final CSP.
74
Improving IV Medication Safety: Identifying the Risk Points
SELECTED REFERENCES AND RESOURCES
1.
Anton C, Ferner R. Medication errors detected in infusions. Arch Intern Med. 2003;
163:982.
2.
Ashram C, et al. Systematic evaluation of errors occurring during the preparation of
intravenous medication. CMAJ. 2008; 178(1):42.
3.
Cousins D, Sabatier B, Begue D et al. Medication errors in intravenous drug
preparation and administration: a multicentre audit in the UK, Germany and France.
Qual Saf Health Care. 2005;14:190-5.
4.
Fanikos J, Fiumara K, Baroletti S et al. Impact of smart infusion technology on
administration of anticoagulations (unfractionated heparin, argatroban, lepirudin,
and bivalirudin). Am J Cardiol. 2007; 99:1002-5.
5.
Fanikos J, Stapinski C, Koo S et al. Medication errors associated with
anticoagulation therapy in the hospital. Am J Cardiol. 2004; 94:532-535
6.
Flynn E, Pearson R, Barker K. Observational study of accuracy in compounding IV
admixtures at five hospitals. Am J Hosp Pharm. 1997; 54:904-12.
7.
Hayes B, Klein-Schwartz W, Doyon S. Frequency of medication errors with
intravenous acetylcysteine for acetaminophen overdose. Ann of Pharmacother:
2008; 42:766-70. Epub 2008 Apr 29.
8.
Kaushal R, Bates D, Landrigan C et al. Medication errors and adverse drug events
in pediatric inpatients. JAMA 2001;285:2114-20.
9.
Leape L. Error in medicine. JAMA. 1995; 272(23):1851-7.
10.
Parshuram C, Ng G, Ho T. Discrepancies between ordered and delivered
concentrations of opiate infusions in critical care. Crit Care Med. 2003;
31(10):2483-7.
11.
Parshuram C, Dupuis L. To T et al. Occurrence and impact
of unanticipated variation in intravenous methotrexate dosing. Ann
Pharmacother. 2006; 40:805-11. Epub 2006 Apr 25.
12.
Pedersen C, Schneider P, Scheckelhoff D. ASHP national survey of pharmacy
practice in hospital settings: dispensing and administration—2005. Am J HealthSyst Pharm. 2006; 63:327-45.
13.
Veronika W et al. An observational study of intravenous medication errors in the
United Kingdom and in Germany. Pharm World & Science. 2003; 25:104.
14.
Plsek P, Greenhalgh T. Complexity science: the challenge of complexity in health
care. BMJ; 2001; 323(7313):625-8.
75
Improving IV Medication Safety: Identifying the Risk Points
SELF–ASSESSMENT QUESTIONS
1. In comparison to 30 years ago, modern health care is:
a. More complex.
b. Less complex.
c. Associated with less administrative work.
2. Quality assurance/quality insurance programs in intravenous (i.v.) sterile product
preparation suites are:
a. Routinely used.
b. Seldom used.
c. Used in approximately 50% of hospitals.
3. Which of the following can be classified as an i.v. room preparation error?
a. Technician manufactures an i.v. in the wrong base solution.
b. A nurse administers and i.v. at the wrong time.
c. A physician orders the wrong dose of methotrexate i.v.
Answers
1. a
2. c
3. a
76