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Track A: Safe Drug Return The 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. Track A: Safe Drug Return The Unused and Expired Medicines (UEM) Registry. Speakers:

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

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

  2. 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

  3. Unused and Expired Medicines RegistryCommunity 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

  4. Unused and Expired Medicines RegistryCommunity 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

  5. Unused and Expired Medicines RegistryWhat 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

  6. Unused and Expired Medicines RegistryWhy 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 LO1

  7. Unused and Expired Medicines RegistryBasic 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

  8. Unused and Expired Medicines RegistryWhy 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 LO2

  9. Unused and Expired Medicines RegistryWhy 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

  10. Unused and Expired Medicines RegistryAbout 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

  11. Unused and Expired Medicines RegistryAbout 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

  12. Unused and Expired Medicines RegistryPurpose 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

  13. Unused and Expired Medicines RegistryParticipants 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

  14. Unused and Expired Medicines RegistryData Collection DATE ZIP CODE SOURCE REASON DRUG STRENGTH DRUG NAME QUANTITY SIDE EFFECTS

  15. Unused and Expired Medicines RegistryDate 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. LO3

  16. Unused and Expired Medicines RegistryPreliminary 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

  17. Unused and Expired Medicines RegistryLessons 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

  18. Unused and Expired Medicines RegistryYour Input How can we make the UEM Registry work for you? LO4

  19. Unused and Expired Medicines RegistryFuture 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

  20. Unused and Expired Medicines RegistryProject 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

  21. Unused and Expired Medicines RegistryFor 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

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