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Improving Safety in
Medication Storage
Patricia C. Kienle, RPh, MPA, FASHP
Director, Accreditation and Medication Safety
Cardinal Health Pharmacy Solutions
[email protected]
© 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved.
Common Questions
• Who says we have to control med storage?
• What departments have meds?
• Where are meds throughout the hospital?
• What can I do to make med storage safer for
patients and my co-workers?
• What areas are priorities to fix?
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© 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved.
Laws, Regulations, and Best Practice
Regulatory Bodies
Centers for Medicare and Medicaid Services (CMS)
State
Accrediting Organizations
Joint Commission
Healthcare Facilities Accreditation Program
HFAP – The American Osteopathic Association
National Integrated Accreditation for Healthcare Organizations
NIAHO – Det Norske Veritas
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© 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved.
Storage of Medications
• Secure
• Safe
• Protect the integrity of the product
• It’s all about patient safety ….
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© 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved.
Drug Security
• Before 2008
– All drugs must be locked
• Since 2008
– All drugs must be secure, and locked when
appropriate
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© 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved.
Medication Security
• CMS Hospital Conditions of Participation §482.25
• All drugs and biologicals must be kept in a secure
area, and locked when appropriate
• Controlled Drugs must be kept locked within a
secure area
• Only authorized personnel may have access to
locked areas
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© 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved.
Medication Storage in the Organization
• Drugs
• Pharmacy
• IV solutions
• Nursing Units
• Irrigation solutions
• Materials Management
• Contrast media
• Radiology
• Glucose tolerance
beverage
• OR
• Kits with local
anesthetics
• Cath Lab
• Samples
• Anesthesia
• Nuclear Medicine
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© 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved.
Security of Controlled Substances
• Must be locked
• Only those with legal access to medications
may be authorized to access controlled
substances
• Who has legal access?
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© 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved.
Controlled Substances Requirements
• Control from point of entry to administration,
wastage, or return
• Deliver directly to pharmacy
• Sign invoices
• Lock refrigerators (or containers)
• Policies for wastage
– Pharmacy
– Patient care units – fentanyl patches, infusions
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© 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved.
Emergency Medications
• All emergency containers
• Crash carts
• Malignant hyperthermia carts
• Rapid sequence intubation (RSI) kits
• Contrast reaction kits
• Transport boxes
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Secure Storage of Emergency Meds
• List on the outside
• Lock to secure
• Log to document
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© 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved.
Medication Safety
• High-alert drugs
– Insulin
– Anticoagulants
– Concentrated electrolytes
• Look- and sound-alike drugs
• Hazardous drugs
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© 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved.
Safety: High Alert Medications
• Identified by ISMP, Joint Commission, IHI and
others
• High potential for causing errors in the
medication use system
–
–
–
–
–
–
Selection
Storage
Ordering
Dispensing
Administering
Monitoring
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© 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved.
High Alert Core List
• Concentrated electrolytes
– Potassium chloride
– Potassium acetate
– Sodium chloride greater than 0.9%
• Insulin
• Anticoagulants
• Narcotics and opiates
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Additional High Alert Medications
• Chemotherapy
• Drugs used in neonates and pediatrics
• TPN
• Sterile water
– Injections greater than 10 mL
– Irrigation bags
• Others as determined by the facility
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© 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved.
Safety: LASA Medications
• Joint Commission
requires accredited
organizations to
select 10 pairs from
a list
• Special storage
requirements should
be implemented
throughout the
facility
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© 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved.
Safety: Hazardous Drugs
• First defined by
ASHP in a
document in 1990
• In 2004, further
defined by the
National Institute for
Occupational Safety
and Health (NIOSH)
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Hazardous Drugs
• Any drug that has at least one of the following
properties:
– Carcinogenicity, teratogenicity or developmental
toxicity
– Reproductive toxicity in humans
– Organ toxicity at low doses in humans or animals
– Genotoxicity
– New drugs that mimic existing hazardous drugs in
structure or toxicity
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© 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved.
List of Hazardous Drugs
• NIOSH Alert has list in Appendix A
– Draft update published in April 2009
• Intended as a starting point for a hospital’s list
– Many organizations use this list
• Includes (this is not a complete list)
–
–
–
–
–
Antineoplastic agents (“chemo”)
Antiviral agents
Hormones
Oxytocin
Finasteride (Proscar®, Propecia®)
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© 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved.
Identifying Hazardous Drugs
• Hospital-approved
list
• Suppliers should
mark the outside of
packages with a
warning
• There is no official
“hazardous drug”
symbol
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© 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved.
Medication Integrity
• Temperature
• Expiration dates
• Beyond-use dates
• Recalled medications
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© 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved.
Integrity: Temperature
• Need control and documentation for anything
outside of room temperature
– Refrigerators
– Freezers
– Warmers
• Sterile products and preparations also require
room temperature monitoring
• Must store per manufacturers’
recommendations
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© 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved.
Freezers and Warmers
• Freezers
– Vaccines
– Cervidil®
• Warmers
– Solutions in OR and Obstetrics
– Injectable contrast in Imaging
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© 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved.
Integrity: Vaccine Storage
• CDC recommendation is inspected and
surveyed as a requirement
• Temperature of vaccine storage areas must
be recorded twice a day
– 7 days a week
– All areas – Pharmacy, ED, Employee Health,
clinics, etc.
– Many state vaccine plans have additional
requirements
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© 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved.
Integrity: Expiration Dates
• The maximum time period that a
manufactured product may be used, based
on the storage requirements in the package
insert
• Inspection and accreditation standards
require you to use the manufacturers’
information
• Every manufactured medication product has
an expiration date
• Your inspection process needs to control this
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© 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved.
Integrity: Beyond Use Dates
• The date or time after which an open product
or a compounded preparation cannot be
stored or administered
• Two United States Pharmacopeia chapters
address this
– Nonsterile preparations – USP <795>
– Sterile preparations – USP <797>
• The BUD is determined from the date (or
time) compounded and the temperature at
which it is stored
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© 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved.
BUD for Non-Parenteral Agents
• Expiration date acceptable to use
unless the manufacturer requires a
shorter date
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BUD for Parenteral Agents
• Compounded sterile preparations
(CSPs) determined by the shorter of
– USP <797> sterility limits
– Stability of the drug
• Single and multiple dose vials
– FDA limit of 28 days
– Manufacturer’s information
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Maximum Storage Time for Vials
If opened and
maintained in ISO 5
air quality
Ampule
If opened outside
or taken outside of
ISO 5 air quality
Use immediately and discard remainder
Single-dose vial
6 hours
1 hour
Pharmacy bulk
package
6 hours
N/A
Multiple-dose vial
28 days
28 days
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© 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved.
Designating Beyond Use Dates
• BUDs must be
applied to multiple
dose vials that are
being stored
• This is different from
an “open date”
Use before _____________
Opened by _______ on ________
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© 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved.
Recalls
• Process to retrieve
recalled products
• Documentation
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© 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved.
Strategies to Implement
• Educate those who do medication inspections
• Control all emergency medications
• Separate insulins
• Identify LASA throughout the facility
• Check vaccine temperatures twice a day
• Mark multiple dose vials with beyond use
date
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© 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved.
It’s all about patient safety
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© 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved.
Questions?
© 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved.