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The Lamy Initiative: Promoting Research and Awareness Of Medication Issues in Long-Term Care Facilities


PDF Versions of These Documents Can Be Downloaded Here:

Promoting Research and Awareness Of Medication Issues in Long-Term Care Facilities (PDF)
Research Prospectus March 7, 2005 (PDF)

The Peter Lamy Center on Drug Therapy and Aging at the University of Maryland School of Pharmacy has helped the Federal government develop a remarkable new national database on medication information for nursing home and assisted living facility residents as part of the Medicare Current Beneficiary Survey.  The Lamy Initiative is intended to promote research and awareness of medication issues in long-term care facilities using this new MCBS database.  The initiative has three main elements:    

  • Building a LTC Medication Research Program The Lamy Initiative will support development of significant research efforts focused on medication use in LTC facilities using the new MCBS dataset.  The Lamy Center will help researchers gain access to the data, learn its strengths and challenges, and develop fundable project ideas in partnership with Center faculty and staff.  The Center will also work with sponsors to design studies that can exploit the unique attributes of the dataset.
     
  • Facts About Medicine Use in Long-Term Care.  The second element of The Lamy Initiative is a proposed series of data profiles to promote awareness of long-term care medication issues within the health services and health policy communities.  The challenges of geriatric medication management are well known to medical directors, nurses, and consultant pharmacists in LTC facilities, but receive little attention in the mainstream medical and health policy literature.  We envisage a quarterly publication of 12 data profiles published over a three-year period.  Each 6 to 8 page profile would address a specific medication topic written in language accessible to an informed lay audience. 
     
  • National Benchmarks for Local Interventions Most studies of medication use in LTC facilities are based on small, localized samples with limited generalizability.  The Lamy Initiative will offer the opportunity for researchers, clinicians, and administrators to benchmark their findings against nationally representative samples selected to match their study subjects, thereby placing their findings in a national context.

The initiative is in mid-development and interested sponsors are still needed.  Our immediate goal is to raise $50,000 in unrestricted grants to officially launch the initiative this summer.  These funds will support production of a prototype for the Facts About Medicine Use in Long-term Care, programming data linkages to enhance the value of the LTC medication database, and to conduct pilot studies for research proposals currently in development.  Novartis Pharmaceutical Corporation has graciously agreed to kick off our fund raising effort with a check for $10,000.  Please consider helping us in this worthy endeavor! Linda Simoni-Wastila, PhD heads up The Lamy Initiative. She can be reached at (410) 706 4352 or by email at lsimoniw@rx.umaryland.edu.

 

The Lamy Initiative: Promoting Research and Awareness of Medication Issues in Long-Term Care Facilities

A Research Prospectus
March 7, 2005

            The Peter Lamy Center on Drug Therapy and Aging at the University of Maryland School of Pharmacy has helped the Federal government develop a remarkable new national database on medication information for nursing home and assisted living facility residents as part of the Medicare Current Beneficiary Survey.  The Lamy Initiative is intended to promote research and awareness of medication issues in long-term care facilities using this new MCBS database.  The initiative has three main elements:   

  • Building an LTC Medication Research Program 
  • Facts About Medicine Use in Long-Term Care  
  • National Benchmarks for Local Interventions

The Center seeks $50,000 in seed funds to launch the initiative in 2005.  We hope to raise the funds in small contributions from organizations and companies who are committed to our goal of promoting increased awareness and research on medication use in long-term care.  This prospectus describes the various elements of the project together with our specific funding needs. 

Building an LTC Medication Research ProgramThe first aim of The Lamy Initiative is to support development of significant research efforts focused on medication use in LTC facilities using the new MCBS dataset.  The Lamy Center will help researchers gain access to the data, learn its strengths and challenges, and develop fundable project ideas in partnership with Center faculty and staff.  The Center will also work with sponsors to design studies that can exploit the unique attributes of the dataset. 

Patterned after the SAGE[1] group at Brown University, The Lamy Initiative will provide a forum and resources for researchers working toward the common goal of improving medication management in long-term care facilities.  The central feature of the initiative is a unique, integrated dataset currently unavailable to other research groups.  The dataset has the following features: 

  • Nationally-representative samples of Medicare beneficiaries residing in long-term care facilities between 1997 and 2000 (2001 data should be available in late 2003).  Approximately 1,200 individuals are represented in each annual file.  Subsets of these residents can be tracked back to their community setting and forward in time for up to 3 years.
  • The samples include residents in nursing homes, assisted living facilities, and other types of long-term care institutions.
  • Complete month-by-month medication records extracted from facility medical records including all scheduled and PRN medications; all prescribed supplements, OTCs, and herbals as well as prescription-only drugs; strength, dose, and method of administration data for each medication; and the number of times the drug was administered in the month are included.  Each annual Institutional Drug Administration (IDA) file contains information on approximately 110,000 drug events with over a million administrations.
  • A planned link to MULTUM, a comprehensive up-to-date drug dictionary including drug names (brand name, generic name, and common abbreviations), therapeutic categories, manufacturer information, drug product information (ingredients, strength, route, formulation), disease names and their associated ICD-9-CM codes, drug coding systems (NDC, Medicare J-codes, MMDC), CSA schedules, orange book codes, drug prices (AWP, FUL, WAC), and product packaging information.
  • Complete Medicare Part A and B claims records for each facility resident augmented with information on specific health conditions extracted from medical records.
  • Medicaid claims data for dual-eligibles are being prepared by CMS for inclusion on the file.
  • Complete nursing facility Minimum Data System (MDS) records (1998 onward), which include ADL, IADL, and other patient functional status data.  (Note: access to the MDS is presently limited to contracts from CMS).
  • Extensive patient demographic and socioeconomic information.
  • Payment sources and cost for services other than drugs (a proposal to develop cost estimates at the drug event level has been developed).
  • Selected facility characteristics from the OSCAR files
  • Geographic location down to the county, thereby permitting links to other geographic-based dataset such as the Area Resource File.

The unprecedented depth of information available on these MCBS facility files makes them ideal for both cross-sectional and longitudinal studies of drug use in long-term care facilities, including epidemiological research, outcomes studies, drug program evaluations, and policy analysis.  In virtually every respect other than annual sample size, this dataset is superior to SAGE and other secondary data files currently available to long term care researchers.  Researchers at the Lamy Center created the Institutional Drug Administration (IDA) files under contract to CMS and ASPE.  At present we are the only research group with access to these data[2].  In the course of developing and analyzing the IDA records, we have also gained a level of familiarity with the MCBS facility file structure unmatched by other research groups. 

In the past year, Lamy Center researchers have completed three descriptive studies using the 1998 expanded MCBS facility files.  The first profiles differences in medication utilization patterns in nursing homes and assisted living and related facilities.  A copy of this report can be found on the ASPE web site at: http://aspe.hhs.gov/daltcp/reports/meduse.htm.  The second study, also for ASPE, compares cardiovascular medications used by community-dwelling and institutionalized Medicare beneficiaries with heart disease http://aspe.hhs.gov/daltcp/reports/cdmeduse.htm.  A third study, for CMS, examines use of anti-psychotic medications by institutionalized beneficiaries with and without evidence of psychosis.  (Briesacher, B., Limcangco, R., Simoni-Wastila, L., Doshi, J., Levens, S., Shea, D., Stuart, B.  (2005) “The Quality of Antipsychotic Prescribing in Nursing Homes,” Archives of Internal Medicine, in press).

 Research in progress includes a newly-awarded contract from the Assistant Secretary for Planning and Evaluation in HHS to put transaction prices on the IDA file and the study medication expenditures patterns in nursing home.  A graduate student working with the Lamy Center completed a doctoral dissertation in 2003 using the expanded MCBS facility files to examine potential under- and over-use of cardiovascular medications in the Medicare institutionalized population.  Two additional graduate students are completing dissertations using the MCBS IDA files and linked MDS records to examining pain and analgesic use in nursing home and the use of anticholinergic drugs among residents with dementia.  

This is exciting work.  But it is just a start.  Through The Lamy Initiative we intend to bring together a select group of experienced and junior researchers who are interested in working with us to exploit the potential of this unique dataset for drug use studies on long-term care populations.  The Lamy Initiative will provide members of the consortium with a forum to discuss project ideas as well as obtain detailed information about the dataset including documentation for the expanded MCBS files themselves.  As ideas coalesce into actual grant proposals, we will provide access to the files, support in proposal development, and resources to help conduct the research.  In the proposal development stage, for example, we can provide write-ups on the IDA file structure, the MCBS facility sample, and findings from our preliminary work listed above.  Consortium members can also expect opportunities for investigator roles on projects initiated by Lamy Center faculty.  Three proposals for NIH funding are in early stages of preparation.  A brief description of each is included in the appendix to this prospectus. 

Seed funds are needed to bring these proposals to fruition.  Specifically, we need programmer funding to link the MULTUM drug dictionary to the IDA file and for pilot studies to support the aims of the three proposals.  Our CMS contract utilized proprietary First DataBank (FDB) drug codes.  The licensing fee for FDB is prohibitively expensive and MULTUM is available free of charge to not-for-profit users (for proprietary uses, the MULTUM fee is $5,000 per year compared to about $40,000 for FDB).  We estimate that 3 months of programmer time will be required to achieve these tasks.  Salary, fringe and incidental expenses for this effort will cost approximately $20,000.  

Facts About Medicine Use in Long-Term Care.  The second element of The Lamy Initiative is a proposed series of data profiles to promote awareness of long-term care medication issues within the larger health services and health policy communities.  The challenges of geriatric medication management are well known to medical directors, nurses, and consultant pharmacists in LTC facilities, but receive little attention in the mainstream medical and health policy literature.  In fact, the debate over adding drug benefits to the Medicare program has virtually ignored the 2 million plus residents of nursing homes, assisted living, and related facilities—the vast majority of whom are Medicare beneficiaries.  One of the main reasons that medication issues in long-term care settings have failed to receive the attention they deserve is lack of nationally representative data.  The expanded MCBS database presents a unique opportunity to meet this need.    

            We propose to develop a Facts About Medicine Use in Long-Term Care data profile series modeled after a data profile series produced by the Georgetown University Center for an Aging Society under an RWJ funded program, “Challenges for the 21st Century: Chronic and Disabling Conditions”[3]  We envisage a quarterly publication of 12 data profiles published over a three-year period.  Each 6 to 8 page profile would address a specific medication topic written in language accessible to an informed lay audience.  The profiles would be distributed both in print form and on a dedicated website.  The intended audience would include health policy makers, researchers, providers, caregivers, the pharmaceutical industry, government agencies, and others with a stake in knowing more about medication issues in long-term care.  Candidate topics for individual profiles might include:

  • “A National Profile of Medication Use in Long-Term Care Facilities”
  • “Trends in Prescription Drug Use in Long-Term Care Facilities”
  • “The Challenge of Multiple Medication Use in Long-Term Care”
  • “Use of Supplements and Over-the-Counter Drugs in Long-Term Care Settings”
  • “Inappropriate Medication Use in Long-Term Care Facilities”
  • “The Cost of Prescription Drug Use in Long-Term Care Facilities.”

Other profiles might address treatment of specific conditions including depression, pain, dementia, osteoporosis, and incontinence.  

            Funds are needed to develop a business plan to establish, produce, and distribute the series as well as to produce a prototype profile.  The business plan would include the identification of potential partners (e.g., The American Society of Consultant Pharmacists, The Agency for Healthcare Research and Quality, The Centers for Medicare and Medicaid Services, The Gerontological Society of America, The American Geriatrics Society, associations representing various long-term care constituencies, and others) as well as potential funding sources.  We estimate that it will take approximately six months and cost $30,000 to develop the business plan and produce a prototype data profile.    

National Benchmarks for Local InterventionsThe final element of The Lamy Initiative is designed to give other researchers in long-term care medication use the opportunity to nationally benchmark their findings using the expanded MCBS dataset.  Most published studies of medication use in LTC facilities are based on small, localized samples with limited generalizability.  Lamy Center researchers are currently piloting a study of changes in functional status and medical spending among elderly stroke patients using MCBS data.  The benchmark will be used to estimate the cost-effectiveness of a locally conducted exercise intervention trial.  We have also developed proposals to use this approach to benchmark a hip fracture intervention and a medication-reduction algorithm in a local assisted living facility.  The Lamy initiative will offer the opportunity for researchers to benchmark their finding against nationally representative samples selected to match their study subjects, thereby placing their findings in a national context.  Although we have yet to develop a formal plan to market this service, it would make sense to co-develop the proposal in conjunction with the data profiles series discussed above. 


 

[1] SAGE stands for “Systematic Assessment of Geriatric Drug Use via Epidemiology.”  The SAGE dataset includes MDS records for nursing home residents in the five states (KS, ME, MS, NY, SD) that participated in the HCFA Multistate Nursing Home Case-mix and Quality Demonstration Project.  Partial medication records are available from Section U of the MDS records for these states (except NY after 1995), but only for the two weeks immediately preceding each MDS assessment.  SAGE data have been linking to Medicare Part A files, but not Part B.

[2] CMS has indicated that it would like to include the institutional drug administration files as part of the annual MCBS Cost and Use files sometime in the future.  In any event, CMS is unlikely to append the 1997-2000 IDA files to MCBS releases for these years unless researchers specifically request them.

[3] There are presently eight data profiles in the series.  They can be from the Center on an Aging Society’s website,  www.georgetown.edu/research/ihcrp/agingsociety). 



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