Track A: Safe Drug Return The Unused and Expired Medicines UEM Registry

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Track A Safe Drug ReturnThe Unused and Expired
Medicines (UEM) Registry
Improving Patient Safety through Informed
Medication Prescribing and Disposal
Practices Fifth Annual Maine Benzodiazepine Study
Group Conference Fourth Annual Unused Drug
Return Conference
Speakers Matthew C. Mireles, Ph.D.,
M.P.H. Elizabeth A. Smith, Ph.D. Community
Medical Foundation for Patient Safety November
1, 2007
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Unused and Expired Medicines RegistryLearning
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

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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

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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

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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

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Unused and Expired Medicines Registry Why a
Registry?

• 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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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)

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Unused and Expired Medicines Registry Why a UEM
Registry?

• 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

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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

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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)

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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

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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

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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

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Unused and Expired Medicines Registry Data
Collection
DATE
ZIP CODE
SOURCE
REASON
DRUG STRENGTH
DRUG NAME
QUANTITY
SIDE EFFECTS
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Unused and Expired Medicines Registry Date
Collection

• Coding and Expanded Data Fields
• Administrative 10 Entry date, collection date
• Drug character. 16 Name, form, NDC, FCS,
  cost, unused, etc.
• Environ hazards 4 PBT index, P, B, T
• Occ exposure 6 Health effect, toxicity,
  handling
• Demographic 10 Median education level,
  income, household size, 65 and older,
  etc.

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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 (n1821), 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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Unused and Expired Medicines Registry Lessons
LearnedSo 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

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Unused and Expired Medicines Registry Your Input

• How can we make the
• UEM Registry work for you?

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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.)

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Unused and Expired Medicines Registry Project
Group

• Cheenu SrinivasanChief Info Director
• Hari AyyarResearch Intern
• Joshua ChangResearch Intern
• Matthew MirelesAdmin and Registrar
• Previous members Anita Hill, Sun Ye, Faye Wang,
  Sonali Patel, Racheal Johnson

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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