Third Annual Maine Benzodiazepine

Study Group
International Conference

A National Registry of Unused and

Expired Medications:
Preliminary Data Analysis

Tract B
Annual Unused Medicine Return Conference
October 12, 2005
Matthew C. Mireles, PhD, MPH
Vice President and Director of
Research
CRG Medical Foundation for
Patient Safety

Copyright 2005 CRG Medical Foundation for Patient Safety

 Why a Registry?
• Data about unused and expired meds are
scarce (in the US).
• Data collection is haphazard and
inconsistent
• Purposes of data are questionable
• Ideally, purpose and format should be set
up “a priori”
• Many agencies can use same source of
data without duplication of system or extra
cost. Copyright 2005 CRG Medical Foundation for Patient Safety
 What is a Registry?
• A system of ongoing data collection
(registration) of a health-relevant condition
in a defined population
• Examples: birth, death, cancer, injury, etc.
• Think surveillance (safety, compliance,
detection of emerging health condition…)
• Standardized problem definition & data
collection
• Sharing of information
Copyright 2005 CRG Medical Foundation for Patient Safety
 What CRG Medical
Foundation Is doing in TX
and US?
• Using lessons from aviation and other
industries to build reporting systems for
patient safety
• Partnership with Texas A&M RCHI to set up
“PatientSpeak”—a patient safety reporting
system by patients and families
• Collaboration with Florida (FPSC) to set up
a “close call” reporting system for the
State
• Contract with NewCrop LLC (Houston)—
Phase I of Electronic Patient Medication
Databank (ePMD)
Copyright 2005 CRG Medical Foundation for Patient Safety
 What CRG Medical
Foundation Is doing in TX
and US?
• Clinical testing of a new, FDA-approved
device to measure hand functionality
(R21)
• Collaboration with Australian Patient
Safety Foundation and others to evaluate
reporting systems
• Master Patient Index (conceptual design)
• National Patient Safety Registry

Copyright 2005 CRG Medical Foundation for Patient Safety

 US National Registry for
Unused & Expired
Medications
• Conceived in Fall 2004
• Designed & supported by CRG Medical
Foundation (neutral party)—ready to go!
• Based in Houston, Texas; accessible
anywhere
• Data entry interface: online (web-based),
call-in, written form
• Different options for data collection
• A critical foundation for a drug return
system Copyright 2005 CRG Medical Foundation for Patient Safety
 US National Registry for
Unused & Expired
Medications
Most Simplified Version (1)
(No Personal Identifier)

Zip Code Brand or Strength Quantity Why

Generic Name Unused?
04401 Atenolol 25 mg 30 Expired

04401 Baclofen 10 mg 9 Discontinued

04412 Buspar 10 mg 84 Discontinued

04457 Cephalexin 500 mg 27 Expired

04412 Chloral hydrate 500mg/5ml 95 ml Death

04457 Clarinex 5 mg 17 Discontinued

Copyright 2005 CRG Medical Foundation for Patient Safety

 US National Registry for
Unused & Expired
Medications
Individual Donor Version (2)
(No Personal Identifiers)

Drug Why was drug returned? Check box or write

Type reason in space provided.
List drug(s) from pill bottle or From pill bottle Write approx. number
Liquid, gel, or ointment

package. or written prescription, of pills or capsules or

Patient died or moved away

Adverse or allergic reaction
Doctor ordered new drug
write the numbers after amount of liquids

Drug expired or outdated

NDC, if available

Did not want to take it

Over-the-counter

Patient felt better

Prescription
Quantity

Unknown
(e.g. approx number
Concentration
Name of Drug NDC Number of pills or capsules,
Or Dosage half tube, etc.) Other Reason

Copyright 2005 CRG Medical Foundation for Patient Safety

 US National Registry for
Unused & Expired
Medications
Bulk Donation Version (3)
(No Personal Identifiers of Individual Donors)

Collector or Collection Sponsor_____________________ Date________ Page ___ of _____

Contact Person_______________________ Phone Number___________________ Email___________________________________
Mailing Address__________________________ City___________________ State_____ Zip Code___________________________

Drug Why was drug returned? Check box or write reason

Type in space provided.
List drug(s) from pill bottle or package. From pill bottle Write approx. number
Liquid, gel, or ointment

Patient diedor moved away

Adverse or lalergic reaction
Doctor ordered new drug
or written prescription, of pills or capsules or

Federally Controlled

ed or outdated
write the numbers after amount of liquids

Did not want to take it

NDC, if available

Over-the-counter

Not Regulated

Patient felt better

Prescription
Quantity

Drug expir

Unknown
(e.g. approx number
Concentration
Name of Drug NDC Number of pills or capsules,
Or Dosage half tube, etc.) Other Reason

Copyright 2005 CRG Medical Foundation for Patient Safety

 US National Registry for
Unused & Expired
Medications
Research Version (4)
(With Personal Identifiers)
U.S. National Registry for Unused or Expired Medications
Research Questionnaire for Returned Medications©
CRG Medical Foundation for Patient Safety
(CRGFORM0015-Research Version 01-07-05)

Use black or blue ink pen and print information legibly. Check boxes as appropriate. Follow skip pattern as indicated.

DONOR’S INFORMATION TODAY’S DATE: ______________

1. Name: (First)__________________ (Last)________________________ (MI) _______
2. Mailing address: ________________________________________ Apt #__________
City_____________________________________ State___________
Zip Code___________ County________________
3. Telephone number: (__ __ __)-__ __ __-__ __ __ __
4. Date of birth: Month (mm):________ Date (dd):_______ Year (yyyy):_______
5. Email address: ___________________________________
6. Gender: ‫ ٱ‬Male ‫ ٱ‬Female

7. Ethnic background: ‫ ٱ‬White, not of Hispanic origin

‫ ٱ‬Black, not of Hispanic origin
‫ٱ‬Hispanic
‫ ٱ‬Asian or Pacific Islander
‫ ٱ‬American Indian, Aleut, or Eskimo
8. Is this your first time to use this Registry to record your unused or expired medicines?
‫ ٱ‬No ‫ ٱ‬Yes, Go To Question # 10.
9. How many times have you used this Registry before today? _______
Copyright 2005 CRG Medical Foundation for Patient Safety
US National Registry for
Unused & Expired
Medications
Research Version (4) Electronic Web-based
Format
(With Personal Identifiers)

Copyright 2005 CRG Medical Foundation for Patient Safety

Preliminary Data from NOE,

June 2005
• Minimal data fields (5 variables)
• Donation was anonymous (no identifier)
• First dataset to populate Registry
• Quality control (corresponding registers was
omitted in analysis)
1 unknown drug
1 wrong dose (corrected)
1 unknown returned quantity and reason for
return
• Descriptive analysis was performed

Copyright 2005 CRG Medical Foundation for Patient Safety

Preliminary Data from NOE,

June 2005
Category and Proportion of Drugs
Antipsychotic 11.8%
Anticonvulsant 9.4%
Antidepressant 9.4%
Analgesic 8.2%
Antiarrhythmic 8.2%
Antimanic 8.2%
Others 44.8%

Copyright 2005 CRG Medical Foundation for Patient Safety

Preliminary Data from NOE,

June 2005

Percentage of Federally
Controlled Substances
Federally
Controlled
Substance
6%
Not Federally
Controlled
94%

1 C-II, 2 C-III, 2 C-IV

Copyright 2005 CRG Medical Foundation for Patient Safety
Preliminary Data from NOE,

June 2005
Prescription Drugs
Unused
40%
Used
60%

Based on total count of pills and capsules

Copyright 2005 CRG Medical Foundation for Patient Safety

 Demographic, Social and
Economic Characteristics
Based on Zip Code
Zip Code 04401 04412 04457

• Median age 36.5 39.2 38.8

• Average Household Size 2.2 2.3
2.5
• Median Household Income 32,393 36,949
31,544
• % 65 and older 13.2 16.7 15.3
• % Hispanic 0.9 0.6 0.3
• % HS Graduates 87.7 90.8
80.9
• % BS Graduates 25.1 25.5
13.4 Copyright 2005 CRG Medical Foundation for Patient Safety
 Thank you!
Please visit us
www.communityofcompetence.com
6800 West South Loop
Suite 190
Bellaire, Texas 77401
832-778-7777
esmith@crgmedical.com
matthew@crgmedical.com

Copyright 2005 CRG Medical Foundation for Patient Safety