Transcript Unused and Expired Registry

Improving Patient Safety through Informed
Medication Prescribing and Disposal Practices
Fifth Annual Maine Benzodiazepine Study Group
Conference & Fourth Annual Unused Drug Return
Conference
Track A: Safe Drug Return
The Unused and Expired
Medicines (UEM) Registry
Speakers:
Matthew C. Mireles, Ph.D., M.P.H.
Elizabeth A. Smith, Ph.D.
Community Medical Foundation for Patient Safety
November 1, 2007
Unused and Expired Medicines Registry
Learning Objectives
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Fundamentals of a registry: purpose and
application of a registry
Background, description, and evolution of UEM
Registry
Participation and data collection of the UEM
Registry
Preliminary results from the UEM Registry
Future development and applications
Unused and Expired Medicines Registry
Community Medical Foundation
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Established in 2003, incorporated in Delaware,
2003; registered in Texas 2004
Philosophy based on leadership and the
Community of Competence™
A leader in research and educational programs
on patient safety and healthcare quality
Goals strongly support humanistic, patientcentered healthcare system which includes the
patients and families in all aspect of healthcare
Unused and Expired Medicines Registry
Community Medical Foundation
Patient Safety Registry and Related Projects:
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Get Rid of Unused Pharmaceuticals (GROUP)
Campaign
Unused and Expired Medicines (UEM) Registry
Joint theater trauma registry for the US military
Hand functionality Registry (CTS, FMS, TBI)
Share Our Stories (SOS): A Patient Safety
Reporting System
Unused and Expired Medicines Registry
What is a Registry?
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A system of ongoing data collection
(registration) of a health-relevant condition in a
defined population
A system of filing, record-keeping, and
archiving information
Surveillance system (safety, compliance,
detection of emerging health condition…)
Standardized problem definition & data
collection
Sharing of information
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Why a Registry?
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Why collect data? For what purpose?
Data collection should not be haphazard and
inconsistent
Different agencies can use data without
duplication of system or extra cost
Data are important to learn about a problem
and come up with ways to address the problem
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Basic Terminology
• Registry --the entire system of collecting,
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coding, entering, storing, analyzing, archiving,
retrieving, and reporting data
Register = actual document (file)
Registration = continuous process of the
activities of the registry
Registrar = one who specializes (certified) in
registration (collecting, coding, entering…)
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Why a UEM Registry?
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Data about unused and expired meds (UEM)
are scarce
Data collection is haphazard, inconsistent,
unreliable
Patterns and characterization of returned meds
can be compared
Data can lead to other research questions or
used with other existing databases or registries
Information can be used for research,
education, and policy
Many agencies can use the UEM Registry LO2
Unused and Expired Medicines Registry
Why a UEM Registry?
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Estimated $1 billion returned in unused drugs in
the US
Medication noncompliance may result in higher
overall health costs
UEM pose a patient safety problem in our homes
and a public safety in our communities
Improper drug disposal causes environmental
pollution
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Unused and Expired Medicines Registry
About the UEM Registry
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Established in Fall 2004
Designed and administered by Community
Medical Foundation for Patient Safety
Based in Houston area, Texas
Main purpose is data collection for research
Standardized data collection form and coding
procedures (basic 5 variables)
Data submission: written form, mail in, fax,
and online (web-based)
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About the UEM Registry
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The central component of the Get Rid of
Unused Pharmaceuticals (GROUP) Campaign
Classification and coding protocol based on
existing systems:
– Therapeutic class: DAWN and PDR
– Drug Characteristics: FDA NDC Directory
– Cost: Red Book
– Environmental hazard class: JANUS
– Demographic profile: US Census 2000 (zip code)
– Occupational exposure hazard: OSHA
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Purpose of the Registry
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To collect data about UEM, such as:
– Type of drugs returned
– Quantity of UEM
– Reason for return
– Percentage of FCS among UEM
To determine cost of UEM
To determine potential environmental hazards
To increase awareness of UEM and help design
better community collection programs
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Participants
of UEM Registry
• Maine Benzodiazepine Study Group (Maine)
• Northeast Occupational Exchange (Maine)
• U of Maine, Center on Aging (Maine)
• Cary Medical Center (Maine)
• Environmental Protection Agency (Maine)
• Teleosis (California)
• Community Medical Foundation for Patient
Safety
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Data Collection
DATE
ZIP CODE
SOURCE REASON
DRUG
DRUG
QUANTITY
NAME STRENGTH
SIDE
EFFECTS
Unused and Expired Medicines Registry
Date Collection
Coding and Expanded Data Fields
Administrative 10
Drug character. 16
Environ hazards 4
Occ exposure
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Demographic
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Entry date, collection date
Name, form, NDC#, FCS,
cost, % unused, etc.
PBT index, P, B, T
Health effect, toxicity,
handling
Median education level,
income, household size,
% 65 and older, etc.
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Preliminary Results
• 19 datasets received (varying sizes and
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submissions)
5,000 entries (registers) and coding by end of year
From a subsample (n=1821), 57,890 pills
Leading categories:
– CNS agents (26.4%)
– Psychotherapeutic agents (20%)
– Cardiovascular agents (13.5%)
– Respiratory agents (6.6%)
– Gastrointestinal agents (6.4%)
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Lessons Learned…So Far
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Registry is very unique and rich
Standardized data collection form is being
reviewed and adopted by more groups
Data are not representative
Participants (consumers) tend to be more
mature, educated, and knowledgeable about
some UEM issues
Participants (consumers) do not have difficulty
doing an drug inventory or filling out a return
form
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Your Input
How can we make the
UEM Registry work for you?
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Future Development &
Applications
Increase funding support and resources for the
UEM Registry
Providing services for a fee
Work with other groups to collect & share data
Make aggregated data available to the public
Generate annual or bi-annual reports
Explore other applications of data (product
sampling, educational outreach, quality control
and evaluation of collection programs, etc.)
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Project Group
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Cheenu Srinivasan—Chief Info Director
Hari Ayyar—Research Intern
Joshua Chang—Research Intern
Matthew Mireles—Admin and Registrar
Previous members: Anita Hill, Sun Ye, Faye
Wang, Sonali Patel, Racheal Johnson
Unused and Expired Medicines Registry
For More Info
Contact us at
Community Medical Foundation
For Patient Safety
6800 West South Loop, Suite 190
Bellaire, Texas 77401
832-778-7777
www.comofcom.com