A National Registry of Unused and Expired Medications: Preliminary Data Analysis
Transcript of A National Registry of Unused and Expired Medications: Preliminary Data Analysis
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Third Annual Maine BenzodiazepineThird Annual Maine Benzodiazepine
Study GroupStudy Group
International ConferenceInternational Conference
A National Registry of Unused andA National Registry of Unused and
Expired Medications:Expired Medications:Preliminary Data AnalysisPreliminary Data Analysis
Tract BTract B
Annual Unused Medicine Return ConferenceAnnual Unused Medicine Return Conference
October 12, 2005October 12, 2005
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Copyright 2005 CRG Medical Foundation for Patient SafetyCopyright 2005 CRG Medical Foundation for Patient Safety
Matthew C. Mireles, PhD, MPHMatthew C. Mireles, PhD, MPH
Vice President and Director ofVice President and Director ofResearchResearch
CRG Medical Foundation forCRG Medical Foundation for
Patient SafetyPatient Safety
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Copyright 2005 CRG Medical Foundation for Patient SafetyCopyright 2005 CRG Medical Foundation for Patient Safety
Why a Registry?Why a Registry?
Data about unused and expired meds areData about unused and expired meds arescarce (in the US).scarce (in the US).
Data collection is haphazard andData collection is haphazard andinconsistentinconsistent Purposes of data are questionablePurposes of data are questionable Ideally, purpose and format should be setIdeally, purpose and format should be set
up a prioriup a priori
Many agencies can use same source ofMany agencies can use same source ofdata without duplication of system or extradata without duplication of system or extra
cost.cost.
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Copyright 2005 CRG Medical Foundation for Patient SafetyCopyright 2005 CRG Medical Foundation for Patient Safety
What is a Registry?What is a Registry?
A system of ongoing data collectionA system of ongoing data collection(registration) of a health-relevant condition(registration) of a health-relevant condition
in a defined populationin a defined population Examples: birth, death, cancer, injury, etc.Examples: birth, death, cancer, injury, etc.Think surveillance (safety, compliance,Think surveillance (safety, compliance,
detection of emerging health condition)detection of emerging health condition)
Standardized problem definition & dataStandardized problem definition & datacollectioncollection
Sharing of informationSharing of information
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Copyright 2005 CRG Medical Foundation for Patient SafetyCopyright 2005 CRG Medical Foundation for Patient Safety
What CRG MedicalWhat CRG MedicalFoundation Is doing in TXFoundation Is doing in TX
and US?and US? Using lessons from aviation and otherUsing lessons from aviation and other
industries to build reporting systems forindustries to build reporting systems forpatient safetypatient safety
Partnership with Texas A&M RCHI to set upPartnership with Texas A&M RCHI to set upPatientSpeaka patient safety reportingPatientSpeaka patient safety reportingsystem by patients and familiessystem by patients and families
Collaboration with Florida (FPSC) to set upCollaboration with Florida (FPSC) to set upa close call reporting system for thea close call reporting system for theStateState
Contract with NewCrop LLC (Houston)Contract with NewCrop LLC (Houston)
Phase I of Electronic Patient MedicationPhase I of Electronic Patient MedicationDatabank (ePMD)Databank (ePMD)
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Copyright 2005 CRG Medical Foundation for Patient SafetyCopyright 2005 CRG Medical Foundation for Patient Safety
What CRG MedicalWhat CRG MedicalFoundation Is doing in TXFoundation Is doing in TX
and US?and US? Clinical testing of a new, FDA-approvedClinical testing of a new, FDA-approved
device to measure hand functionalitydevice to measure hand functionality
(R21)(R21) Collaboration with Australian PatientCollaboration with Australian PatientSafety Foundation and others to evaluateSafety Foundation and others to evaluate
reporting systemsreporting systems
Master Patient Index (conceptual design)Master Patient Index (conceptual design) National Patient Safety RegistryNational Patient Safety Registry
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7/18Copyright 2005 CRG Medical Foundation for Patient SafetyCopyright 2005 CRG Medical Foundation for Patient Safety
US National Registry forUS National Registry forUnused & ExpiredUnused & Expired
MedicationsMedications Conceived in Fall 2004Conceived in Fall 2004 Designed & supported by CRG MedicalDesigned & supported by CRG Medical
Foundation (neutral party)ready to go!Foundation (neutral party)ready to go! Based in Houston, Texas; accessibleBased in Houston, Texas; accessible
anywhereanywhere
Data entry interface: online (web-based),Data entry interface: online (web-based),call-in, written formcall-in, written form
Different options for data collectionDifferent options for data collection A critical foundation for a drug returnA critical foundation for a drug return
systemsystem
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8/18Copyright 2005 CRG Medical Foundation for Patient SafetyCopyright 2005 CRG Medical Foundation for Patient Safety
US National Registry forUS National Registry forUnused & ExpiredUnused & Expired
MedicationsMedications
Discontinued175 mgClarinex04457
Death95 ml500mg/5mlChloral hydrate04412
Expired27500 mgCephalexin04457
Discontinued8410 mgBuspar04412
Discontinued910 mgBaclofen04401
Expired3025 mgAtenolol04401
WhyUnused?
QuantityStrengthBrand orGeneric Name
Zip Code
Most Simplified Version (1)Most Simplified Version (1)
(No Personal Identifier)(No Personal Identifier)
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Copyright 2005 CRG Medical Foundation for Patient SafetyCopyright 2005 CRG Medical Foundation for Patient Safety
US National Registry forUS National Registry forUnused & ExpiredUnused & Expired
MedicationsMedications
DrugType
Why was drug returned? Check box or writereason in space provided.
List drug(s) from pill bottle orpackage.
Name of Drug
From pill bottleor written prescription,write the numbers afterNDC, if available
NDC Number
L
iquid,gel,orointment
Concentration
Or Dosage
Write approx. numberof pills or capsules oramount of liquids
Quantity(e.g. approx numberof pills or capsules,
half tube, etc.) P
rescription
O
ver-the-counter
D
rugexpiredoroutdated
D
octorordered
new
drug
P
atientfeltbetter
A
dverseorallergicreaction
P
atientdiedormovedaway
D
idnotwanttotakeit
U
nknown
Other Reason
Individual Donor Version (2)Individual Donor Version (2)
(No Personal Identifiers)(No Personal Identifiers)
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Copyright 2005 CRG Medical Foundation for Patient SafetyCopyright 2005 CRG Medical Foundation for Patient Safety
US National Registry forUS National Registry forUnused & ExpiredUnused & Expired
MedicationsMedicationsBulk Donation Version (3)Bulk Donation Version (3)
(No Personal Identifiers of Individual Donors)(No Personal Identifiers of Individual Donors)
DrugType
Why was drug returned? Check box or write reasonin space provided.
List drug(s) from pill bottle or package.
Name of Drug
From pill bottleor written prescription,write the numbers afterNDC, if available
NDC NumberLiquid,gel,orointment
ConcentrationOr Dosage
Write approx. numberof pills or capsules oramount of liquids
Quantity(e.g. approx numberof pills or capsules,half tube, etc.) P
rescripti
on
Over-the-counter
Federally
Controlled
NotRegulated
Drugexpired
oroutdated
Doctororde
red
new
drug
Patientfeltbetter
Adverseorallergicreaction
Patientdiedormovedaway
Didnotwan
ttotakeit
Unknown
Other Reason
Collector or Collection Sponsor_____________________ Date________ Page ___ of _____
Contact Person_______________________ Phone Number___________________ Email___________________________________
Mailing Address__________________________ City___________________ State_____ Zip Code___________________________
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Copyright 2005 CRG Medical Foundation for Patient SafetyCopyright 2005 CRG Medical Foundation for Patient Safety
US National Registry forUS National Registry forUnused & ExpiredUnused & Expired
MedicationsMedicationsResearch Version (4)Research Version (4)(With Personal Identifiers)(With Personal Identifiers)
U.S. National Registry for Unused or Expired MedicationsResearch 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.
DONORS INFORMATION TODAYS 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: Male Female
7. Ethnic background: White, not of Hispanic origin Black, not of Hispanic origin Hispanic Asian or Pacific Islander American Indian, Aleut, or Eskimo
8. Is this your first time to use this Registry to record your unused or expired medicines? No Yes, Go To Question # 10.
9. How many times have you used this Registry before today? _______
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Copyright 2005 CRG Medical Foundation for Patient SafetyCopyright 2005 CRG Medical Foundation for Patient Safety
US National Registry forUS National Registry forUnused & ExpiredUnused & Expired
MedicationsMedicationsResearch Version (4) Electronic Web-basedResearch Version (4) Electronic Web-basedFormatFormat
(With Personal Identifiers)(With Personal Identifiers)
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Copyright 2005 CRG Medical Foundation for Patient SafetyCopyright 2005 CRG Medical Foundation for Patient Safety
Preliminary Data from NOE,Preliminary Data from NOE,
June 2005June 2005 Minimal data fields (5 variables)Minimal data fields (5 variables) Donation was anonymous (no identifier)Donation was anonymous (no identifier)
First dataset to populate RegistryFirst dataset to populate Registry Quality control (corresponding registers wasQuality control (corresponding registers wasomitted in analysis)omitted in analysis)
1 unknown drug1 unknown drug
1 wrong dose (corrected)1 wrong dose (corrected)
1 unknown returned quantity and reason for1 unknown returned quantity and reason forreturnreturn
Descriptive analysis was performedDescriptive analysis was performed
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Category and Proportion of DrugsCategory and Proportion of Drugs
AntipsychoticAntipsychotic 11.8%11.8%
AnticonvulsantAnticonvulsant 9.4%9.4%AntidepressantAntidepressant 9.4%9.4%
AnalgesicAnalgesic 8.2%8.2%
AntiarrhythmicAntiarrhythmic 8.2%8.2%AntimanicAntimanic 8.2%8.2%
OthersOthers 44.8%44.8%
Preliminary Data from NOE,Preliminary Data from NOE,
June 2005June 2005
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Preliminary Data from NOE,Preliminary Data from NOE,
June 2005June 2005
Percentage of Federally
Controlled SubstancesFederallyControlled
Substance
6%Not Federally
Controlled
94%
1 C-II, 2 C-III, 2 C-IV
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Preliminary Data from NOE,Preliminary Data from NOE,
June 2005June 2005
Prescription Drugs
Used
60%
Unused40%
Based on total count of pills and capsules
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Copyright 2005 CRG Medical Foundation for Patient SafetyCopyright 2005 CRG Medical Foundation for Patient Safety
Demographic, Social andDemographic, Social and
Economic CharacteristicsEconomic Characteristics
Based on Zip CodeBased on Zip CodeZip CodeZip Code 04401 04412 0445704401 04412 04457
Median ageMedian age 36.5 39.2 38.836.5 39.2 38.8
Average Household SizeAverage Household Size 2.22.2 2.32.3 2.52.5
Median Household Income 32,393 36,949Median Household Income 32,393 36,94931,54431,544
% 65 and older% 65 and older 13.213.2 16.7 15.316.7 15.3 % Hispanic% Hispanic 0.90.9 0.60.6 0.30.3 % HS Graduates% HS Graduates 87.787.7 90.890.8
80.980.9
% BS Graduates% BS Graduates
25.1 25.525.1 25.5
13.413.4
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Copyright 2005 CRG Medical Foundation for Patient SafetyCopyright 2005 CRG Medical Foundation for Patient Safety
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www.communityofcompetence.comwww.communityofcompetence.com
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[email protected]@crgmedical.com
[email protected]@crgmedical.com
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