National Unused and Expired Medicines Registry

Community Medical Foundation for Patient Safety
The Community of Competence™ and Foundation for Life
The Unused and Expired Medicines Project

POSITION PAPER
CMFPSDOC0017
March 9, 2009
The National Unused and Expired

Medicines Registry
AUTHORS:
Matthew C. Mireles, Ph.D., M.P.H.

Jerry A. Miller, Ph.D.
Elizabeth A. Smith, Ph.D.
Published by the Community Medical Foundation for Patient Safety

6300 West Loop South, Suite 288
Bellaire, Texas 77401
Phone 832-778-7777; Fax 281-920-1118
Email: mcmireles@communityofcompetence.com
Website: www.communityofcompetence.com
Copyright by Community Medical Foundation for Patient Safety 2009.

Duplication or reproduction of this document is strictly prohibited without written or expressed
permission of the Community Medical Foundation for Patient Safety.
The National Unused and Expired Medicines Registry

Matthew C. Mireles, Ph.D., M.P.H.
Jerry A. Miller, Ph.D.
Elizabeth A. Smith, Ph.D.
I. The Visionaries
Community Medical Foundation for Patient Safety is a nonprofit, 501(c)(3), Houston-based

organization established in December 2003. Our mission is to promote and support patient safety
through research, education, and the demonstrated practice of patient-centered healthcare. As
an active learning organization and a leader in patient safety research and education, we use
systems thinking to study and assess the roles and functions of separate parts of our complex
healthcare system and then create a unified, integrated organization that has the patient at the
center. We aim to empower and enable patients and their families to actively participate in
making informed decisions about their diagnoses, treatments, and expected outcomes. Our
educational and advocacy programs encourage people to use simple, practical ways to steadily
improve the quality and safety of their own healthcare. Ultimately, we strive for a modern
healthcare system that offers the best quality and safest medical care that is holistic,
comprehensive, and humane.
Leadership, vision, community, knowledge, innovations, compassion, values, and competency are
the essential qualities of the 21st Century healthcare system and organization. These concepts
and ideals were embedded in the concept of Community of Competence ™ (CC)1,2 and
trademarked by our Founder Elizabeth A. Smith, Ph.D., in 2005. Our philosophy is based on
recognizing and using the unique and shared competencies of individuals, groups, and
organizations to create a new synergy and communities consisting of members who are ready
and prepared to solve a given complex health problem.
In studying the healthcare system with its integrated subsystems and parts primarily to improve
quality and safety, we recognize that problems dealing with medicines and health outcomes are
complex and challenging. The present epidemic of unused and expired medicines (UEMs) in our
homes strongly indicates a deficiency in our healthcare delivery system and our pharmaceutical
management system that specifically involve monitoring of patient care, prescribing certain
medicines, and ensuring the efficacy and safety of those medicines and others that are readily
available and accessible to patients and consumers.
Our strategy for improvement and sustainable changes is to apply the framework of the CC™ to
study UEMs by bringing together expertise, input, commitment, and resources from a wide array
of disciplines. We also must adopt strategies that focus on primary prevention and other
immediate interventions to preserve health and promote wellness. Therefore, we consider and
include health determinants, such as the physical environment, community safety, education and
awareness, in our preventive strategies for long-term benefits. Our Foundation is proud to be a
leader in the discussion of UEM and in the development of solutions to address this problem.
Copyright by Community Medical Foundation for Patient Safety 2009. Page | 2

All rights reserved.
II. Rationale for a National Database on Unused and Expired Medicines
Most clinical studies about patient safety, healthcare outcome, and adherence of medicines are
confined to hospital settings where the patients can be closely observed and monitored. After
discharge from the hospital or clinic, the patient is considered outside of the ―system‖. Follow up
of patients after leaving the hospital is very poor, particularly with monitoring adherence to
medical treatment.
We believe that our modern healthcare system encompasses the delivery of medical care,
including medical treatment, at home. More healthcare services will be provided at home to
accommodate the patient’s safety, privacy, and convenience; to alleviate the overcrowding in
some hospitals and clinics, and to expand the growing market of home health care specifically
targeting the aging population.
The amount of prescribed medicines and consumption of medicines at home will significantly
increase as the ―baby boomers‖ retire and as life expectancy continue to expand. Direct
marketing to consumers and immediate access to information on the Internet play a major role
and drive the interest and demand for medicines. Patients and consumers will depend on greater
amount of medicines to maintain the quality of life which has surpassed those of the previous
generation. Medicines for our pets will follow the same trend.
At the same the time, the demand for greater number and amount of medicines to treat multiple
co-morbidities, also referred to as polypharmacy, will present a new challenge that is being
discussed and addressed presently. Stockpiling of excess medicines at home has become a
national epidemic. These medicines are often unused and have expired but kept within the
household for various reasons. They also show up at the workplace and other locations where
medicines are taken and are stored.
We listed several reasons why and how individuals accumulate medicines which eventually
become stockpiled at home and workplace1: 1) most patients do not follow instructions for
prescription medicines as directed by their doctors, and they are often non-compliant with
medical treatment and prescription regimens; 2) we tend to overuse medicines because we
believe they can cure all ailments; 3) we misuse medicines by self-medicating and sharing
prescription medicines or mixing them together; 4) for drug abusers, having excess medicines at
home is a ready supply for the addiction; 5) doctors always give abundant free samples of new
medicines and we collect them; 6) we do not adhere to expiration dates and believe that
medicines do not expire; 7) doctors overprescribe or inappropriately prescribe medicines; 8) we
want to save money and keep medicines for the next time we get sick; 9) in preparing for an
emergency or disaster, we want to have enough essential medicines for ourselves and our
families.
Having been engaged in the discussion of UEM as a national priority and studying this problem
for the past five years, we approached it from a scientific pursuit starting with a basic question
―is unused and expired medicines at home really a significant concern?‖ Our research team,
comprising of epidemiologists and other experts, immediately explored the connection between

potential harm of UEM and the impact on patient safety and public health. Others involved in the
early phases of discussion focused on pertinent issues, such as drug diversion, prescribing
patterns, drug diversion, safe and legal collection and disposal of unwanted medicines,
regulations and policies specific to collection and handling of UEM, and the environmental risk
resulting from improper disposal of UEM. Much of the leadership and direction of these
discussions came from the Maine Benzodiazepine Study Group (MBSG), a consortium of medical
professionals, governmental officials, and representatives of pharmaceutical agencies, law
enforcement, and environment protection. We were and still remain the only outside group that
advocates the inclusion of patient safety as part of the ongoing discussion and one of the high
priority aims in addressing UEM dangers.
Specifically, our primary concerns in patient safety were medication errors among seniors,
accidental poisoning among children, the growing trend of drug abuse among teen-agers (also
referred to as ―pharming‖), drug abuse and misuse in all ages, non-adherence of medical
treatment, and the long-term exposure to trace active pharmaceutical ingredients (API) in
drinking water as detected across the country. While no limits for pharmaceutical compounds in
the water supply have been set by the U.S. Environmental Protection Agency at this time and
data about UEM from homes are nonexistent, we believe that it is most prudent to adopt and
apply the precautionary principles and try to understand as much of the potential hazards
associated with UEMs as possible through rigorous research design. No federal, state or local
agency has collected any useful data on UEMs. The best data at the time was provided by
several community-based organizations that implemented take-back programs, collected UEMs,
and reported only bulk weight of the collection. While many other countries have set up
systematic programs to deal with UEM many years ahead of efforts in the U.S., no example of
remarkable data collection system was presented.
Our research team studied the UEM problem and the challenges in great details and devised a
thoughtful strategy that would satisfy all stakeholders and parties. The strategy closely followed
the framework and methodology described by Elizabeth A. Smith, Ph.D., in her concept of
Communities of Competence™. Form a CC™ for UEM by engaging experts in the areas of
concerns most relevant to the issues of UEM. Recognize, appreciate, and respect the expertise of
others. Be assertive with our concerns for patient safety in the context of public health and safety
for individuals as well as the communities. Keep the patient/consumer as the focus of our
research pursuit and conduct. The recommendations of the team that were presented and
approved by the Board of Community Medical Foundation for Patient Safety were: 1) create a
standardized way to collect data from drug take-back programs; 2) promote this data collection
as a basis for the ongoing study of UEMs; 3) design a coding protocol for UEM data based on
existing and available classification systems; and 4) compile the data into a national database or
registry for the purpose of continued research on UEMs.

III. The National Unused and Expired Medicines Registry: Genesis
With the strategy in place and approved by the Board of the CMFPS, our research team
conducted a thorough literature review on UEM with only limited success in finding scientific
papers on the topic. From a public health perspective, plenty of anecdotal information mainly
from popular press and the media were available and noted as the awareness of UEM and the
lack of systematic programs to safely and legally collect and dispose of UEMs slowly increased.
It became necessary to work closely with MBSG in order to formulate the required foundation for
a national UEM registry. Matthew Mireles was appointed principal investigator and was
sponsored by CMFPS to attend the Annual International Symposium on Pharmaceuticals in the
Home and Environment, which was organized in two separate, concurrent tracks: the Annual
Maine Benzodiazepine Study Group Conference and the Annual Unused Drug Return Conference.
The former track emphasized the clinical issues of prescribing benzodiazepines for patients, and
the latter track involved participants who were already organizing drug take-back programs and
events or were planning to organize one. The Annual International Symposium brought many
experts and interested parties to the same table. By spring 2004, CMFPS joined a national
steering committee as an independent member to examine the issues of UEM. In the fall of the
same year, CMFPS formally announced its intention to set up a national repository for UEM data.
This repository will contain and become the national database called the National Unused &
Expired Medicines Registry (National Registry).
At the 2006 Symposium, participants of Unused Drug Return Track debated several key issues
related to the required variables for a standardized data collection. The group had an immediate
consensus on the anonymity of the data—no personal identifiers of the individuals returning
drugs will be collected. After heated discussions, the remaining participants reached an
agreement for the minimal required variables that should be collected at any drug take-back
event. These variables are: 1) drug name (generic or brand/trade name), 2) the strength or
concentration of the drug, 3) the amount of drug returned (e.g. number of pills), 4) the reason
for returning the drug, and 5) zip code. Several groups in Maine have begun to collect data
based on these five variables. A uniform data collection, even with minimal number of data
fields, would allow a basic comparison of UEM by drug name, reason for return, and geographical
pattern. This standardized data collection would be the first demonstration of its kind to
characterize UEMs obtained from drug take-back events and programs.
Within a few days of an agreement for the variables, our team in Texas developed a simple one-
page, paper and pencil data collection instrument that captured the five required variables. This
instrument was distributed for review and comments. Only minor revisions were made to include
in the instrument date of the return, the source where the individual obtained the medicines, and
a column for recording any adverse side effects associated with a returned drug. Various forms
of the instrument were made available for different take-back venues, but the Individual
Anonymous Medicines Return Form (CMFFORM0019-Individual Donor Version 01-07-05)
became the most popular by request and used in its original format or slightly modified version
by several organizations with permission from CMFPS. For most organizations, the instrument

allowed for the very first time information other than cumulative weight of UEMs to be uniformly
captured.
As part of our team promoted and distributed the data collection instrument, another part
concentrated on creating the system and platform to receive, code, and store the UEM data. The
rationale for the systematic UEM data collection was presented at the 2006, 2007, and 2008
Symposium. By collecting and studying UEM data, we can better understand the problem and
challenges of UEM in our homes, workplaces, and communities. The Registry is evolving into an
indispensable data system to characterize UEM, calculate waste and cost of returned medicines,
and identify potential adverse environmental impact. Additionally, the National Registry is an
important and useful drug surveillance tool to study trends and emerging UEM-related problems
as well as an archive of vital UEM information, such as lessons learned from exemplary take-back
programs and best practices and ideas to curtail drug abuse and pharming among teens. UEM
information can be used by various law enforcement, environmental, public health, consumer
advocacy, medical, and pharmaceutical agencies for 1) monitoring and comparing UEM
collections by geographical regions and over time, 2) evaluating the efficacy of collection and
disposal programs and identifying best practices, 3) providing data for policies and legislations
based on objective analysis and scientific evidence, 4) conducting various research projects in
patient safety and public safety, and 5) detecting emerging problems with pharmaceutical
products and market (e.g., non-adherence to medical treatment due to adverse side effect or
drug interaction).
Specific to the National Registry is our educational outreach campaign Get Rid of Unused
Pharmaceuticals (GROUP) which was conceived and developed under the CMFPS’s concept of
C.A.R.E for Safe Medicines. C.A.R.E. stands for four basic educational goals and strategies of all
of our community outreach activities: 1) build the community (C) or targeted group, such as an
at-risk population; 2) create and increase the awareness (A) of a specific problem or concern for
this community; 3) delineate the important individual and collective duties and responsibilities
(R); and 4) empower (E) the members with accurate information and other resources to change
behavior and engage in a defined goal-driven, action-directed endeavor determined by the
community.
GROUP Campaign was launched in Houston on Earth Day, April 16, 2005. The acronym
purposely conveys a strong sense of ―community‖ and shared concerns. The structure and
organization of the Campaign was based on our Community of Competence™ concept. UEM is a
complex national and global problem that poses a threat to everyone. Therefore, we all belong
to this community and must work together to find solutions to a common problem or threat.
Researchers and writers at CMFPS developed and published the GROUP Manual of Procedures4 in
2006. The Manual is one of the most comprehensive how-to instructions guidelines to planning
and organizing a community-based drug take-back program. It provides in great details the
background of UEM issues, ideas for take-back event, community plan, strategies for recruitment
and training of volunteers, itemized budget, materials for promotion and publicity, checklists and
time schedule, data collection, and evaluation tools. The promotional materials included on CD
Rom that accompanies the GROUP Manual are ready to be adapted and used by any community

group. The GROUP Manual and all mentioned published materials are available in printed
hardcopy or electronic format (PDF).
Most importantly, the GROUP Manual describes the National Registry and explains step by step
how to collect good UEM data with the standardized form and how to submit the UEM dataset to
the National Registry.
To date, CMFPS presented the first standardized data collection instrument and protocol for the
classification and analysis of UEM data in the U.S. This instrument provides the important
research foundation to gather unique data never attempted before and to process the data into
the first and only National Unused and Expired Medicines Registry. To support and promote the
National Registry, we created the GROUP Campaign with a published Manual of Procedures to
assist community groups organize an effective drug take-back program and gather data about
the UEM. We encourage and invite all groups involved with drug take-back programs to use our
standardize data collection form and share their data. Presently, submitting data to the National
Registry is still voluntary. It is our hope to gather raw data and through our analysis transform
these data into new information and knowledge about UEMs so we can understand better the
impact of UEMs on our healthcare system, environment, and communities.

IV. Components and Contents of the National Registry
The National Registry is divided into five primary modules: Administrative, Drug Characteristics,
Environmental Impact, Occupational Exposure, and Demographics. The Occupational Exposure is
currently in the development phase. Each returned medicine is assigned a unique registry
identification number for tracking and cross referencing. The basic unit of analysis (and line item
counting) of the Registry is individual returned medicine (register), but the modules allow
counting by any variable or data field, such as pill count. Each returned medicine is coded and
entered into the National Registry with approximately 60 data fields. Quality control and
reliability check for data coding and entry are performed by recoding approximately 10%
subsample of the batch entries. Discrepancies are reconciled and documented in a log book.
The core of the National Registry is the identification of the myriad of pharmaceutical products,
prescription and over-the-counter (OTC). Some products may be taken off the market many
years ago. We also anticipated illicit drugs being collected and reported in the dataset.
Managing the vast amount of data of different types of returned medicines was the most
challenging task in setting up the National Registry.
After a lengthy search and comparison of existing therapeutic classification systems, including a
large number of conventional published formularies, our research team chose to standardize the
therapeutic classification, on the widely accepted and referenced Drug Abuse Warning Network
(DAWN) classification system of the U.S. Department of Health and Human Services, Substance
Abuse and Mental Health Services Administration (SAMHSA). DAWN system was determined to
be the most consistent and reliable. With more than 16,000 items, including illicit drugs by
common street (slang) names and non-conventional medicines, this classification system proved
to be highly superior compared with others in providing the most usable and convenient
therapeutic stratification. Our research team has developed our own proprietary therapeutic
classification based on DAWN but expanded to include the German Regulatory Authority’s
―Commission E‖ to classify alternative medicines and dietary supplements.
The most important and frequently requested UEM information is the Drug Characteristics data
fields which contain the codes of the specific brand/trade and generic drug names; therapeutic
class, therapeutic subclass 1 and therapeutic subclass 2: marketing status (prescription vs. OTC),
form (pill and non-pill), federal controlled substances (FCS) schedule code (II – V), National Drug
Directory number, estimated standard packsize, average wholesale price, quantity returned,
source where medicine was obtained, and reason for return.
The estimated cost of each returned medicine in the Drug Characteristics Module is coded
according to the published average wholesale price (AWP) in the Red Book 2005. On August
2008, the reference AWP coding was updated to the Red Book 2008. By a simple algorithm, the
estimated standard packsize is selected and matched with the exact drug name and strength to
obtain the AWP. The algorithm for estimating packsize has been validated in a small pilot study
conducted in Houston, TX, with a correlation coefficient (r) of 0.97 between estimated and actual
original quantities of the returned medicines.

Another frequent request for UEM information is the potential environmental hazard. With
precise drug characterization, potential environmental hazard is ascertained in the Environmental
Impact Module of the Registry. Coding of potential environmental hazard and impact is
standardized to the JANUS Classification System of Sweden (www.janusinfo.se). By generic drug
name, common returned medicines can be coded with the PBT Index. Persistence (P) is the
ability of the pharmaceutical product or its compounds to resist degradation in the aquatic
environment. Bioaccumulation (B) is the accumulation the pharmaceutical product or its
compounds in adipose tissue of aquatic organisms. Toxicity (T) is the potential the
pharmaceutical product or its compounds to poison aquatic organisms. Each index ranges from 0
to 3. Therefore, the cumulative PBT Index ranges from 0 to 9 (9 being the highest score for
potential environmental impact)
We are in the process of testing and introducing a new variable and environmental score called
the Environmental Impact Rating Score (EIRS) which incorporates the multiplicity—instead of the
addition—of PBT indices, the returned quantity, and strength of the medicine. The new EIRS will
allow researchers to quantitatively compare a more accurate relative potential harm from UEMs
in the environment.
A major limitation of any registry is the extent to which the data and findings may be generalized
or inferred. Because the data are collected only from active participants of drug take-back
programs, information in the National Registry is not considered represented of any population
due to incomplete sampling. We have no information about non-participants and the UEMs they
are still stockpiling at home. The findings derived from the National Registry can only be
generalized to that population participating in the take-back programs. Based on zip code
information, participants on the average are highly educated, older, and have above average
median household income. Supplemental surveys and interviews conducted by other
organizations indicate that participants are most concerned about the impact of UEM on the
environment. Despite the limitation, UEM data are still important and provides valuable insights
into a significant public health and patient safety problem with unwanted medicines.
For more details about the National Registry, its purpose and contents, please contact CMFPS.
PowerPoint slide presentations from Annual International Symposia on Pharmaceuticals in the
Home and Environment are available upon request. In addition, we provide a Fact Sheet on
UEMs and the National Registry and research posters illustrating the data collection and analysis.
Research posters were accepted by the Kelsey Research Foundation, 7th Annual Health Services
and Outcomes Research Conference, 2006, and the National Patient Safety Foundation, Solutions
in Healthcare Outcomes and Patient Safety, 2007.

V. Current Status of the National Registry and Use of UEM Data
Presently, the National Registry contains data on more than 20,000 items representing returned
prescription and OTC medicines that would otherwise be thrown in the trash or flushed down the
sink or toilet. Data on more than an estimated 1.2 million pills, capsules, and tablets have been
counted and entered into the Registry. To our knowledge, the National Registry has the largest
and most detailed collection of UEM data anywhere. Several credible governmental agencies that
are part of our CC™ for UEM have confirmed this fact and periodically requested access and
review of our data.
An effective use of the UEM data is to determine the proportion of wasted medicines in take-back
programs. These medicines typically would have been introduced into the water supply by
indiscriminate and improper disposal. Samples of UEM collected on the west and east coasts
have consistently shown an estimated 40% waste of prescription medicines (items and
proportion of the medicines that were never used by the patients). An example of a practical use
of the data is to determine which UEM is most frequent and develop a public education program
to reduce wasted medicines and save money. For example, if the UEM data show that antibiotics
are not used and are thrown away most often, an effective health promotion program can be
developed to remind physicians to prescribe antibiotics more judiciously and appropriately, to
inform patients about proper adherence to taking antibiotics for specific bacterial infections, and
to explain and caution the communities about indiscriminate dumping of antibiotics into the
environment promotes drug-resistance in bacteria.
The value of the National Registry depends on the quantity and quality of the UEM data gathered
across different communities. Organizers of drug take-back programs are strongly encouraged to
participate in data sharing based on the standardized data collection methods and format.
Researchers at CMFPS are available to consult with sampling design for data collection and
provide technical assistance with using the standardized data collection form and how to submit a
dataset to the National Registry. The National Registry is purposely designed to be in the public
domain with aggregated data and summary reports published on the website of CMFPS. With
sufficient funding support, UEM data will be made available to the public, researchers and policy
makers. Coding protocol and specific classification methodologies remained protected and are
considered proprietary with CMFPS.
Data analyzed by CMFPS research team are commonly used in program evaluation and as
supporting evidence for state legislations dealing with UEM issues. In most instances, our data
are the only reliable source of information used in making decisions. We have provided by
courtesy summary reports of UEMs to the State of Maine, the White House’s Office of National
Drug Control Policy (ONDCP), various medical associations, individual legislators, and
governmental and nongovernmental representatives who are leaders in addressing UEM concerns
across the country. We also provide substantial research support for a number of research
programs, including pilot studies of drug take back systems in California and Maine.
CMFPS analyzes UEM data continually with detailed comparison of UEMs to include primary
sources or locations where patients/consumers get the medicines, reasons for the UEMs, and the

estimated cost of wasted medicines is being conducted by the Foundation. Ancillary and related
studies that use data from the National Registry include a descriptive analysis of complementary
and alternative medicines that are returned to take-back programs; an examination of the direct
healthcare waste in term of estimated cost when prescription medicines are not used and thrown
away; a validation study of the method to estimate standard packsize based on only three
required variables—drug name, strength, and quantity returned; and a study of the pattern and
behavior of non-compliance or non-adherence to medical treatment (medication regimens
prescribed by physicians). Patterns of the type of medicines and medication practices based on
geographic location are now beginning to emerge from the data.
Our researchers are considering an evaluation study of the efficacy of drug take-back efforts in
the communities by comparing DAWN data to our UEM data, before and after a program is
implemented. A comparative outcome of interest may be the number of drug overdose cases in
the emergency department. Law enforcement data with number of drug-related arrests,
specifically those dealing with illegal possession, consumption, and diversion of prescription
medicines also may be used to measure the impact of a take-back program.
We also hope health educators and promoters as well as experts and advocates in community
outreach may take advantage of the vast volume of information and create programs to increase
awareness of the danger of UEMs and teach safer practices regarding the effective and prudent
use of medicines. We designed and published a series of Patient Safety Checklists, one-page list
of checkboxes to remind patients/consumers of tips to prevent medical error, increase safety,
and improve healthcare quality and outcome. As an educational and practical component of our
GROUP Campaign to increase awareness about issues concerning UEM, we have published and
routinely used the Patient Safety Checklists: Safe Medication Practice Series7 in our community
outreach presentations and workshops to demonstrate simple steps and reminders anyone may
use to ensure safety with medicines and reduce UEM at home.
With the National Directory of Drug Take-Back and Disposal Programs, one can find the closest
and most convenient location of a take-back program and take advantage of the program to
safely and legally get rid of UEMs from home. The National Directory lists two innovative take-
back programs in Maine. One is the Caribou Police Rx Prescription Return that includes a door-
to-door pick-up service by law enforcement officers. The other is a free direct mail-back program
called the Maine Safe Med Disposal, a partnership between University of Maine Center on Aging
and the U.S. Postal Service. This successful program is now expanded to the entire State of
Maine. All mailed UEMs are sent to the Maine Drug Enforcement Agency in Augusta for
processing and destruction. Data on the UEMs are sent for coding and entry into the National
Registry.
On December 23, 2008, CMFPS was recognized and designated by the U.S. Department of Health
and Human Services as Patient Safety Organization #29. Patient Safety Organizations (PSOs) in
the healthcare sector were authorized and created by the Patient Safety and Quality
Improvement Act of 2005 (Public Law 109-41, signed July 29, 2008)5,6 to systematically gather,
analyze, and compare patient safety information with uniform, federal standards and protection

for confidentiality. The purpose of this Act is to help health providers reduce the incidence of
patient safety events in order to improve patient safety and healthcare quality.
The Patient Safety Act defines the Patient Safety Work Product as any specific patient safety
information gathered by a PSO, and this information is qualified for federal protection, according
to the Final Rule. Also protected are any data generated by the PSO working with health
providers on patient safety activities that can be defined as Patient Safety Evaluation. CMFPS is
seriously exploring the idea of submitting the entire National Registry as a patient safety work
product of high significance to patient safety, particularly to reduce medication errors, accidental
poisoning, drug overdose, drug misuse and abuse, and the rate of non-adherence with
prescription medicines. Technically, the raw UEM data recorded through our standardized
collection form and sent to the National Registry is considered the patient safety work product.
The patient safety evaluation becomes the process and protocol used in coding and entering data
into the National Registry. If this endeavor is accepted by the Agency for Healthcare Research
and Quality (AHRQ) of the U.S. Department of Health and Human Services, our UEM data will be
the largest single national database to be received by AHRQ and to gain federal protection.
It is the goal of CMFPS to play the lead role in collecting and analyzing UEM data. Sound policy
decision should be made based on evidence gathered through scientific methods and design.
The National Unused and Expired Medicines Registry is a critical program to support the growing
research in UEMs and to develop solutions to eliminate or reduce UEMs through intervention and
eventually prevention at the front end of the healthcare delivery and management system that
involves providing medicines to patients and consumers.
In support of the National Unused and Expired Medicines Registry, CMFPS administers the Annual
Survey each spring to invite all organizers of drug take-back and disposal programs, including
commercial reverse distributors, to list and update description of their programs. We compile
and publish the survey results in our National Directory of Drug Take-Back and Disposal
Programs. Our National Directory is updated periodically online with the current information that
is posted at several websites. The next edition of the printed copy of the National Directory will
be published in 2010.
Last updated March 23, 2009

References
1. Smith EA. Communities of competence: New resources in the workplace. Journal of

Workplace Learning, 17 (1 /2), 7-23, 2005.
2. Smith EA. Communities of competence as catalysts for change. 2006 Pfeiffer Annual:
Consulting, John Wiley & Sons, Inc., 111-129, 2006.
3. Mireles MC, Miller JA, Smith EA. National directory of drug take-back and disposal programs,
First Edition. Community Medical Foundation for Patient Safety, 2008.
4. Mireles MC. Get rid of unused pharmaceuticals (GROUP) Manual of procedures for collection
and disposal of unused and expired medicines program. Community Medical Foundation for
Patient Safety, 2006.
5. Department of Health and Human Services. Patient safety and quality improvement, Final
Rule. Federal Register, 73(226), 70731-814. November 21, 2008. Available at
http://edocket.access.gpo.gov/2008/E8-27475.htm. Accessed April 30, 2009.
6. Department of Health and Human Services. Implementing the Patient Safety and Quality
Improvement Act of 2005, Including How to Become a Patient Safety Organization: Interim
Guidance. Available at http://www.pso.ahrq.gov/regulations/intguid.htm#Contents. Accessed
April 30, 2009.
7. Mireles MC, Miller JA, Smith EA. The patient safety checklists: Safe medication practice series.
Community Medical Foundation for Patient Safety, 2008


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Community Medical Foundation for Patient Safety

The Community of Competence™ and Foundation for Life

The Unused and Expired Medicines Project

The National Unused and Expired

Matthew C. Mireles, Ph.D., M.P.H.

Published by the Community Medical Foundation for Patient Safety

Copyright by Community Medical Foundation for Patient Safety 2009.

The National Unused and Expired Medicines Registry

Community Medical Foundation for Patient Safety is a nonprofit, 501(c)(3), Houston-based

Copyright by Community Medical Foundation for Patient Safety 2009. Page | 2

II. Rationale for a National Database on Unused and Expired Medicines

Copyright by Community Medical Foundation for Patient Safety 2009. Page | 3

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III. The National Unused and Expired Medicines Registry: Genesis

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IV. Components and Contents of the National Registry

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V. Current Status of the National Registry and Use of UEM Data

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Last updated March 23, 2009

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1. Smith EA. Communities of competence: New resources in the workplace. Journal of

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