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									     Medication Management in Assisted Living—Introduction

Overview of the Assisted Living Workgroup and Medication Management Topic

The Assisted Living Workgroup (ALW), a coalition of approximately fifty
national organizations, was formed in August 2001 in response to concerns
expressed by the United States Senate Special Committee on Aging. In the
absence of national laws or regulations to govern the assisted living industry, a
wide variety of laws and regulations developed by the various states had been
implemented at that time. Considerable variation existed from state to state with
regard to the extent and enforcement of laws and regulations for the industry. A
number of government and news media reports had documented serious
problems in a number of states with regard to quality of care issues in assisted

The goal of the coalition was to involve a wide variety of stakeholders to develop
recommendations and guidelines relating to the operation and oversight of the
assisted living industry. Consumer organizations, assisted living provider
organizations, health professional organizations, and regulatory organizations
participated in this broad coalition.

Early in the organizational process, the ALW formed six topic groups to explore
various aspects of assisted living. One of the topic groups was Medication
Management, because of widespread concern about errors in medication
prescribing, administration, and monitoring in assisted living. This topic group
included representatives from a number of perspectives, including nurses,
pharmacists, and physicians with expertise in medication management. See
Table 1 for a list of participants. Over the course of approximately 18 months,
the Medication Management Topic Group developed and presented to the full
ALW a total of 22 recommendations on various aspects of medication

Assisted Living Workgroup—Key Issues

Some fundamental philosophical issues were faced by the ALW early in the
process of deliberation, and not all of these were satisfactorily resolved. Some of
these divisions created obstacles to achieving consensus on many of the
recommendations considered by the various topic groups. Some of these key
issues are described below.

1.      Definition of assisted living
        How can assisted living be differentiated from the traditional nursing
facility, or from the newer models of nursing facility care, such as the Eden
Alternative? What is the minimum number of beds that an organization should
have to be considered assisted living? Should private rooms be a requirement
for all assisted living facilities, and incorporated into the definition?
2.      Hospitality model versus “medical” model
        In the early days of assisted living, many providers emphasized the
hospitality aspects of assisted living and denied involvement in health care
aspects of care for the aging. Today, few can deny that assisted living does have
responsibility for some health care needs of its residents, but defining the scope
of that involvement is challenging. ALW participants were at different points
along this continuum, and health care responsibilities of AL providers were often
3.      Aging in place
        Should assisted living be a place where residents can check in and expect
to remain as their health conditions decline? Or should AL providers have
specific boundaries of care, beyond which residents should be discharged to a
nursing facility or other setting?
4.      Levels of care
        Along the same lines as #3 above, should some assisted living providers
be limited to “light care” while others are enabled to provide heavier care similar
to what a nursing facility resident might require? In some states, waiver
programs require that a person be nursing home eligible before federal funds can
be used for their care in alternative settings, such as assisted living.
5.      Safety versus autonomy
        While assisted living generally emphasizes the right of the resident to
exercise free choice, some choices may increase risk of harm to the resident.
Some ALW participants tended to emphasize the responsibility of the AL
provider to ensure a safe environment, while others emphasized the right of the
resident to exercise choice even if the choice is risky.
6.      Regulation—Process versus outcomes
        In developing recommendations from the ALW, a few participants
wanted a minimalist approach focused on outcomes rather than processes of
care. Most, however, saw a need for a mixture of process and outcome oriented
recommendations. For example, it is not enough just to say that AL residences
should not experience any resident injuries from fires. Certain process measures
must be in place to help ensure that these serious adverse outcomes are
prevented. For a more thorough discussion of this issue, see “Regulation of
Assisted Living—Process versus Outcome Measures”
< >.
7.      Cost
        Finally, cost was a frequent topic of discussion as various issues were
deliberated. ALW participants were keenly aware that many of the
recommendations could be costly to implement, and wanted to keep assisted
living affordable for as many people as possible. It was when a recommendation
could involve significant costs that philosophical differences were much more
difficult to reconcile. Indeed, many of the recommendations brought some of
these sharp contrasts into play, where a middle ground of compromise was
difficult to find.

Medication Management in Assisted Living—What does quality look like?

Modern medicine has come to depend upon medications for managing chronic
conditions. When properly used, medications also can improve or maintain
functional status and quality of life for older persons. For example, pain
medications can permit persons with arthritis to continue to dress themselves,
and medications can slow the progress of cognitive decline in persons with
Alzheimer’s Disease.

Yet medications can be hazardous as well. Medications can cause toxicity,
adverse drug reactions, drug interactions, and other adverse consequences such
as falls, mental confusion, and urinary incontinence. Careful prescribing and
monitoring are needed to ensure optimal outcomes are achieved and residents
are protected from possible adverse consequences.

In the assisted living environment, the following objectives should be achieved
when a quality medication management program is in place:
    • Residents are prescribed appropriate medications in an appropriate dose
    • Residents are protected from harmful drug interactions and preventable
       adverse drug reactions
    • Residents receive the correct medications in the right dose and dosage
       form at the right time, with the correct documentation
    • Adverse drug reactions and medication errors are detected promptly and
       interventions are implemented to prevent harm to the resident
    • The medication management program is continually reviewed and
       improved through the continuous quality improvement process of the

Final Status of Medication Management Topic Group Recommendations

Of the 22 recommendations developed by the Medication Management Topic
Group (MMTG), 14 were accepted by the full ALW with at least 2/3 consensus
vote. See Table 2 for a list of all the recommendations and their disposition.

The reasons for individual organizations choosing to vote against particular
recommendations were quite varied. Examples of concerns that resulted in a
negative vote included:
   • Disagreement over implementation of the recommendation (Guideline for
      Operations versus Guideline for State Regulation)
   • Disagreement over one sentence or small part of the recommendation,
      resulting in a vote against the entire recommendation. For example, one
      group voted against all the definitions (M.15) because of concern about a
      single definition.
   • Concern that a particular recommendation was either “too weak” or “too
      strong.” For example, some organizations thought that a consultant
      pharmacist should be a requirement, whereas others thought this should
      be just a recommendation. Efforts to achieve agreement on compromise
      language in the presence of fundamental philosophical disagreements
      were often unsuccessful.
   • Concern about cost of implementation of recommendations. All
      organizations involved were seeking to prevent the cost of assisted living
      from becoming a greater barrier to access by consumers, but different
       groups placed different priorities on where increasing costs were
       acceptable to achieve desired results.
   •   Political considerations. Each vote by an organization reflected the
       consensus of key constituents within that organization. In some cases, a
       negative vote might result from concerns from one or more of those key

Despite the failure of some recommendations to achieve the necessary 2/3
consensus vote of the full ALW, all of the recommendations were developed
by a multidisciplinary panel of experts in medication use in assisted living.
Deliberations and decisions were guided by a review of available literature on
this subject (see Resources
<>), and the collective
experience and expertise of the Topic Group members. Although not every
Topic Group member agreed with the final version of every recommendation
developed, the recommendations as a whole were developed by a consensus of
the group. As such, all of these recommendations should be considered as
useful resources in providing guidance to assisted living operators, states, and
other stakeholders with an interest in medication management in assisted

Framework for Medication Management in Assisted Living

Because of the complexity of the medication management issue, and the diversity
of state approaches, the Medication Management Topic Group recognized at the
outset that it would not be possible to craft recommendations that would be
consistent with every state’s laws and regulations. Therefore, the decision was
made to develop a medication management model from the ground up. The
proposed model is designed to be internally consistent and incorporates key
principles for which consensus could be achieved through this deliberative

One challenge faced by the group is the serious lack of research to guide policy
decisions in this area. The lack of research may be one of the reasons for the
great diversity in approaches to this subject in the various states. The lack of
research on which to base recommendations also meant that many individuals
and organizations were filtering the recommendations through their own
experiences and perspectives, which were quite diverse. This sometimes
presented a challenge in achieving consensus.

Medication management in assisted living can be divided broadly into two
issues. One issue is the challenge of accurate administration of medications to
residents—giving the right medication to the right resident at the right time in
the right dose and dosage form, with accurate documentation. The second
challenge relates to the broader issue of prescribing and monitoring of
medications—preventing and identifying adverse drug reactions and other types
of medication-related problems. The MMTG developed recommendations that
relate to all these issues.

Included in this report are three issue papers that provide more in-depth
information about each of these key issues:
    • Assuring accuracy of medication administration
    • Prescribing and monitoring of medications in assisted living
    • Medication-related problems in assisted living and the role of the
      consultant pharmacist

The MMTG developed the recommendations on medication management
around four key elements that are integral to effective medication management
in assisted living:
• A structured medication use system
• Competent staff
• A continuous quality improvement process
• Accountability and oversight

              These elements are discussed in more depth in the issue paper on
       accurate medication administration.
A separate issue paper addresses accountability and oversight in more depth This paper explores
the advantages and disadvantages of structure, process, and outcome measures
in evaluating and ensuring quality in assisted living.

Key Issues Addressed by the Medication Management Topic Group

The medication management model proposed here involves an effort to balance
priorities and perspectives that were often in sharp conflict. In some cases, for
example, maximizing safety for the resident might result in diminished choices
or autonomy for the resident. Some of these issues are highlighted below.

Should residents who desire to self-administer medications be permitted to do so?

Since autonomy and freedom of choice are highly valued in assisted living,
residents should generally be given control of their lives to the maximum extent
possible. Yet older adults often overestimate their own capacity to manage what
are often complex medication regimens. When cognitive impairment is present,
the resident’s perceptions may also be altered. Since an error in managing
medications can have disastrous consequences, the group consensus was that
residents should have an objective assessment by a qualified health professional
to evaluate capacity for safe self-administration of medications.

Should a nurse always be directly involved in medication administration, or can
medicines be safely administered by trained personnel who are not nurses?
From the safety perspective, most participants preferred to have a nurse
administering medicines to residents. Yet, the practical barriers of high cost and
a shortage of nurses could have raised the cost of assisted living and/or reduced
the availability. This would have meant that assisted living would be an option
only for a privileged few. As a result, most participants embraced a model that
would permit administration of medications by trained non-licensed personnel,
but with specific requirements and safeguards to minimize the potential for
harm from medication errors.

There is little research comparing medication administration by nurses with non-
nurses, but what evidence is available indicates that non-nurses can administer
medications safely with proper safeguards in place. A study in Washington
state, for example (see web site
< > for the full report), studied
medication administration by non-nurses, through a model involving delegation
by a nurse. This study did not identify any medication errors resulting in
hospitalization in settings where nurse delegation was implemented. There was
also no evidence of significant harm or adverse outcomes to patients among
those receiving medications through nurse delegation.

Without health professionals present on a daily basis, who will detect adverse drug
reactions or other problems resulting from medication use?

Since most assisted living residents take multiple medications and often see
several prescribers, the risk for adverse drug reactions or other medication-
related problems is high. To provide safeguards in this area, the Topic Group
provides recommendations about involvement of registered nurses in an
oversight role for the Medication Assistive Personnel (unlicensed staff who
administer medications). See recommendation M.16. Recommendations also
address the role of the consultant pharmacist in reviewing drug regimens,
educating assisted living staff, and implementing other strategies to help prevent
harm from medications (M.22). Finally, a Quality Improvement Committee with
health professional involvement is considered a key element in safe medication
management in assisted living (M.21).

Shouldn’t assisted living residents be free to obtain their medicines from any pharmacy
they choose?

Assisted living residents, and their family members, prefer to have the flexibility
and freedom to obtain medicines from the pharmacy of their choice. Saving
money is often the primary concern in selecting a pharmacy provider. Yet when
facility staff are responsible for storage, security, and administration of the
resident’s medicines, the assisted living residence values other priorities, such as
timely delivery of needed medicines and use of specialized packaging. This
specialized packaging is especially important because it facilitates accountability
of medicines (especially controlled drugs such as morphine) and fosters
efficiency and accuracy in medication administration.
One of the key principles of quality improvement is to reduce process variation.7
Efficiency and safety are maximized when all medications administered by the
residence are packaged in the same way, such as unit dose or bingo card
packaging systems. Yet many older adults do not have a pharmacy benefit that
includes a provision to pay for needed specialized medication packaging. The
Topic Group did develop two recommendations on this subject (M.11 & M.12),
and the full ALW strongly supported implementation of changes in pharmacy
benefits to support the need for specialized packaging for older adults.

A wide variety of issues needed to be addressed to develop recommendations for
the assisted living residence. The Medication Management Topic Group
addressed the following areas:

   •   Development of policies and procedures regarding medication
   •   Disclosure of ALR policies and procedures
   •   Role of licensed and unlicensed assistive personnel in medication
   •   Resident assessment and service planning, with regard to medication
   •   Medication orders, storage and documentation
   •   Role of the consultant pharmacist
   •   Quality improvement

The Medication Management Topic Group developed these recommendations to
states and assisted living residences to provide guidance and suggestions for
improving the use and oversight of medications in assisted living. The full text
of the ALW Medication Management Topic Group recommendations can be
found here: <MM.pdf>.
                                   Table 1

                   Assisted Living Workgroup
         Medication Management Topic Group Participants

Josh Allen, RN*             American Assisted Living Nurses Association
Jan Brickley, RPh           American Society of Consultant Pharmacists
Tom Clark, RPh, MHS         American Society of Consultant Pharmacists
Diane Crutchfield, PharmD   American Society of Consultant Pharmacists
Peggy Daley, RN             Consumer Consortium on Assisted Living
Sandi Flores, RN            American Assisted Living Nurses Association
Kathleen Frampton, RN       American Medical Directors Association
Genevieve Gipson, RN        National Network of Career Nursing Assistants
Brian Lindberg              National Association of State Ombudsman
Willie Long                 Assisted Living Federation of America
Jane Mayfield, RN           Senior Residential Care Advisors
Ethel Mitty, EdD, RN        National Committee to Preserve Social Security and
Martha Mohler, RN           National Committee to Preserve Social Security and
Jonathan Musher, MD         American Medical Directors Association
Mary Ann Outwater           Massachusetts Quality Committee
Doug Pace                   American Association of Homes and Services for the
Barbara Reznick, Ph.D., CRNPAmerican Geriatrics Society
Karen Kauffman, PhD         National Conference of Geriatric Nurse
Carol Robinson, RN          American College of Health Care Administrators
Shelly Sabo                 National Center for Assisted Living
Bradley Schurman            American Association of Homes and Services for the
Ed Sheehy*                  Assisted Living Federation of America
Bill West, RN               Assisted Living Federation of America

* Topic Group Co-Chairs
                                   Table 2

Final Disposition of Medication Management Topic Group

Subject                   Number(s)                  Consensus Achieved?
Definitions               M.15                       No
Policies & Procedures     M.01 & M.02                Yes
Resident Assessment &     M.03, M.04, & M.05         Yes
Medication Management
Med Admin. by MAP         M.06                       Yes
Supervision of MAP        M.16                       No
MAP Job Description       M.07                       Yes
MAP Training Program      M.08                       Yes
Ongoing MAP Training      M.09                       Yes
MAP Activities            M.10                       Yes
Permitted in Med Admin
MAP Administration of     M.17                       No
PRN Medication
MAP Admin of Insulin      M.18                       No
MAP Admin of Meds via     M.19                       No
Enteral Tube
Medication Packaging      M.11 & M.12                Yes
Medication Storage        M.13                       Yes
Medication Records        M.14                       Yes
Telephone Orders          M.20                       No
Quality Improvement       M.21                       No
Consultant Pharmacist     M.22                       No

Notes: MAP = Medication Assistive Personnel; PRN = “as needed”

Fourteen of the 22 recommendations achieved 2/3 consensus vote of the full
Assisted Living Workgroup.

   1. GAO Report: Consumer Protection and Quality-of-Care Issues in Assisted
      Living. May 1997. GAO/HEHS-97-93.
   2. Meier, Barry. States see problems of quality of care at centers for aged.
      New York Times, November 26, 2000.
   3. Steinhauer, Jennifer. As assisted living centers boom, calls for regulation
      are growing. New York Times, February 12, 2001.
   4. Meier, Barry. Experiment in assisted living exposes regulatory confusion.
      New York Times, February 28, 2001.
   5. Goldstein, Amy, Assisted living: helping hand may not be enough.
      Washington Post, February 19, 2001.
   6. Goldstein, Amy. Assisted living: paying the price. Washington Post,
      February 20, 2001.
   7. Crossing the Quality Chasm: A New Health System for the 21st Century.
      Committee on Quality Health Care in America, Institute of Medicine.
      Washington DC: National Academy Press, 2001.

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