A National Registry of Unused and Expired Medications: Preliminary Data Analysis

8/14/2019 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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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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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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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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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


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


8/18Copyright 2005 CRG Medical Foundation for Patient SafetyCopyright 2005 CRG Medical Foundation for Patient Safety


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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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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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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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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MedicationsMedicationsResearch Version (4) Electronic Web-basedResearch Version (4) Electronic Web-basedFormatFormat

(With Personal Identifiers)(With Personal Identifiers)


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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%


June 2005June 2005


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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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June 2005June 2005

Prescription Drugs

Used

60%

Unused40%

Based on total count of pills and capsules


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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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A National Registry of Unused and Expired Medications: Preliminary Data Analysis