Improving Patient Safety through Informed Medication Prescribing and Disposal Practices

Fifth Annual Maine Benzodiazepine Study Group Conference & Fourth Annual Unused Drug Return

ConferenceTrack A: Safe Drug Return

The Unused and Expired Medicines

(UEM) RegistrySpeakers:

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

• 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

• 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, patient-centered 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:

• 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?

• 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 LO1

• 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

Unused and Expired Medicines Registry Why a Registry?

LO1

Unused and Expired Medicines Registry Basic Terminology

• Registry --the entire system of collecting, 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…)

LO1

• 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

Unused and Expired Medicines Registry Why a UEM Registry?

LO2

Unused and Expired Medicines Registry Why a UEM Registry?

• 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

LO2

Unused and Expired Medicines Registry About the UEM Registry

• 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)

LO2

Unused and Expired Medicines Registry About the UEM Registry

• 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

LO2

Unused and Expired Medicines Registry Purpose of the Registry

• 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

LO2

Unused and Expired Medicines Registry 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

LO3

Unused and Expired Medicines Registry Data Collection

ZIP CODE

DRUG NAME

DRUG STRENGT

H

QUANTITY

SOURCE REASON

DATE

SIDE EFFECTS

Unused and Expired Medicines Registry Date Collection

Coding and Expanded Data FieldsAdministrative 10 Entry date, collection

dateDrug character. 16 Name, form, NDC#,

FCS, cost, % unused, etc.Environ hazards 4 PBT index, P, B, TOcc exposure 6 Health effect, toxicity,

handlingDemographic 10 Median education level,

income, household size, % 65 and older, etc.

LO3

Unused and Expired Medicines Registry Preliminary Results

• 19 datasets received (varying sizes and 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%)

LO4

Unused and Expired Medicines Registry Lessons Learned…So Far

• 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

LO4

Unused and Expired Medicines Registry Your Input

How can we make the UEM Registry work for you?

LO4

Unused and Expired Medicines Registry 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.) LO5

Unused and Expired Medicines Registry Project Group

• 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 FoundationFor Patient Safety

6800 West South Loop, Suite 190Bellaire, Texas 77401

832-778-7777www.comofcom.com