Medication Management in Assisted Living—Introduction Overview of the Assisted Living Workgroup and Medication Management Topic Group 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 living.1-6 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 management. 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 deliberated. 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” <http://www.ascp.com/public/pr/assisted/2003/alreg.pdf >. 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 residence 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 constituents. 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 <http://www.ascp.com/public/pr/assisted/mmresources/>), 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 living. 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 process. 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 http://www.ascp.com/public/pr/assisted/2003/accuracy.pdf • Prescribing and monitoring of medications in assisted living <http://www.ascp.com/public/pr/assisted/2003/monitor.pdf> • Medication-related problems in assisted living and the role of the consultant pharmacist <http://www.ascp.com/public/pr/assisted/2003/mrpprev.pdf> 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. http://www.ascp.com/public/pr/assisted/2003/accuracy.pdf A separate issue paper addresses accountability and oversight in more depth http://www.ascp.com/public/pr/assisted/2003/alreg.pdf 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 <http://www.doh.wa.gov/hsqa/uwstudy.doc > 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 management • Disclosure of ALR policies and procedures • Role of licensed and unlicensed assistive personnel in medication management • Resident assessment and service planning, with regard to medication management • 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 Programs 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 Medicare Martha Mohler, RN National Committee to Preserve Social Security and Medicare Jonathan Musher, MD American Medical Directors Association Mary Ann Outwater Massachusetts Quality Committee Doug Pace American Association of Homes and Services for the Aging Barbara Reznick, Ph.D., CRNPAmerican Geriatrics Society Karen Kauffman, PhD National Conference of Geriatric Nurse Practitioners 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 Aging 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 Recommendations 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 Role Notes: MAP = Medication Assistive Personnel; PRN = “as needed” Fourteen of the 22 recommendations achieved 2/3 consensus vote of the full Assisted Living Workgroup. References 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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