- Email: [email protected]
Medication Management in Assisted Living
ASSISTED LIVING COLUMN Richard G. Stefanacci
Dan Haimowitz
Medication Management in Assisted Living Richard G. Stefanacci, DO, MGH, MBA, AGSF, CMD, and Dan Haimowitz, MD, FACP, CMD Perhaps nothing forces as many older adults to seek assisted living (AL) than the need for medication management. Although medication adherence is the foundation for assistance in medication management, additional opportunities exist for improved outcomes through monitoring and even recommending alternatives that may be more appropriate to AL residents and attending physicians. Medication management begins with identification of a clinical issue, which is then appropriately treated. Even in this stage of the process, AL nursing staff can play a critical role in recognizing problems and then directing their AL resident to appropriate providers. Some AL residents are able to seek out providers on their own or with help of actively involved family. However, when residents obtain care on their own outside of the AL facility, the staff has a more difficult time ensuring that the treatments ordered are carried out. To ensure that the AL staff members are able to assist their residents, they must first know what treatments have been ordered. This can occur by educating AL residents, their families, and their physicians about the important role the AL staff plays in assisting with the followthrough on treatment plans. Education of all the key stakeholders beginning at admission with continuous reinforcement on a regular basis is necessary to ensure that the AL nursing staff is fully informed. Letting outside physicians know of the valuable service the AL staff provides will go a long way to ensure the development of a partnership based on a productive flow of information. Information regarding new medication or changes to existing medication needs to be
Disclosure: Dr. Stefanacci is an investor and serves on the Board of TabSafe Health Systems.
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made known to the AL staff. It must be communicated in writing from the prescriber, and any change in directions for use of a medication for which the facility provides assistance with selfadministration must be accompanied by a written medication order issued and signed by the resident’s health care provider. Unlicensed persons cannot implement any changes without first obtaining a written order. It is important to place an “alert” label on any existing medications for which the directions for use have changed or obtain a new medication label with the new directions from the pharmacist. “Alert” labels are used to direct staff to examine the revised directions for use in the medication observation record. In addition to orders and changes, assistance needed with medication management involves ensuring that the AL resident does not run out of his or her medication. To avoid this, it is best to reorder medications from the pharmacy 7 days before running out or as directed by the facility’s policy. If medications are not received within 3 days of ordering, call the pharmacy or family member to find out where they are and how you will be able to get them before running out. When medications are received, check to make sure the correct prescription has arrived before placing it in storage. Every AL facility may have different procedures for reordering medications. Some designate a nurse to handle all health care orders, medication reordering, and disposal of medication.
Regulations Although state regulations seem to be increasing across the board in AL facilities, an especially intense area of regulation is medication management. The National Center for Assisted Living recently published a report1 covering Geriatric Nursing, Volume 33, Number 4
a state-by-state summary of AL regulations covering 21 categories, which includes medication management. Most state regulations require policies and provide direction on medication management, but there is wide variability at the level of medication management (e.g., some states require unit dose packaging). Although protecting resident rights, some states make medication management difficult. Florida, for example, states that AL facilities may not require a resident to have a physician’s order for over-the-counter (OTC) medication; this makes careful oversight to avoid potential issues with inappropriate OTC use difficult. Perhaps the biggest issue of variability and oversight is in the area of supervision of medication administration from purely self-administration to complete AL-facilitated administration (see Figure 1). With regard to this definition, Indiana takes the unique approach of describing what administration is and is not by saying that administration of medications means preparation and/or distribution of prescribed medications. Administration does not include reminders, cues, and/or opening of medication containers or assistance with eyedrops, such as steadying the resident’s hand, when requested by a resident. Kansas describes self-administration of medication as the determination by a resident of when to take a medication or biological and how to apply, inject, inhale, ingest, or take a medication or biological by any other means, without assistance from nursing staff. In addition to the definition of selfadministration versus administration, there is variability in the level of training and education required in the range of assistance. Kentucky takes the extreme approach of not permitting administration under any circumstance.
Assisted Living State Medication Regulations Alabama A resident may either manage, keep, and selfadminister his or her own medications or receive assistance with the self-administration of medication by any staff member. Medications managed and kept under the custody and control of the facility shall be unit-dose packaged. In specialty care AL facilities that care for residents with dementia, medication must be administered by a registered nurse (RN), licensed practical nurse, or an individual licensed to practice medicine or osteopathy by the Medical Licensure Commission of Alabama. Alaska If self-administration of medications is included in a resident’s AL plan, the facility may supervise the resident’s self-administration of medications. Arizona Medication administration is permitted by licensed nurses. Certified AL managers and trained caregivers may also provide medication assistance to residents and may provide medication administration with a physician order and proper training. Arkansas Level I facility staff must provide assistance to enable residents to self-administer medications. In Level II facilities, licensed nursing personnel may administer medication. California Facility staff, unless he/she is an appropriately skilled professional acting within his/her scope of practice, may not administer medications to residents but may assist them with the selfadministration of medications. Colorado
Figure 1. The “what” and “who” of medication management. Geriatric Nursing, Volume 33, Number 4
All personal medication is the property of the resident, and no resident shall be required to surrender the right to possess or self-administer any personal medication, except as otherwise specified in the care plan of a resident of a facility 304.e2
that is licensed to provide services specifically for the mentally ill, or if a physician or other authorized medical practitioner has determined that the resident lacks the decisional capacity to possess or administer such medication safely. For residents who are unable to self-administer medications, medications must be given by a qualified medication administration staff member who has completed a state-approved training and competency examination. A qualified medication aide is permitted to administer oral, inhalant, topical, vaginal, and rectal medications, but not injections. If donated by a resident or resident’s legal representative, a facility may return unused prescription medications that are not controlled substances to a pharmacist in accordance with state laws.
an unlicensed staff person to provide assistance with the self-administration of medication, he/ she must complete 4 hours of medication assisting training upon hire and then 2 hours of medication assisting training annually. This training must include specified topics and be taught by an RN, licensed pharmacist, or department staff. A licensed health care provider’s order is required when a licensed nurse provides assistance with self-administration or administration of medications, including OTC products. Assisted living facilities may not require a resident to have a physician’s order for OTC medication. In addition to core educational requirements, staff must have a minimum of 4 additional hours of training provided by an RN, licensed pharmacist, or Department of Elder Affairs staff.
Connecticut Georgia A licensed nurse may administer medications and/or pre-pour medications for clients who are able to self-administer medications. With the approval of the client or his or her representative, an assisted living aide may supervise a client’s self-administration of medications.
Facilities must comply with the Nurse Practice Act. Residents may receive assistance with selfmedication by designated care providers who have completed the “Assistance with SelfAdministration of Medication” (AWSAM) training course. Facilities must keep records on file for those who have completed the course and must complete and submit an annual AWSAM report on a form provided by the Board of Nursing. Administration of medication may only be performed by an RN or a licensed practical nurse. The facility must establish and adhere to written medication policies and procedures that address a series of issues related to obtaining, storing, and administering medication. A quarterly pharmacy review is required.
In personal care homes, all medications must be self-administered by the resident except when the resident requires administration of oral or topical medication by or under the supervision of a functionally literate staff person. There are exceptions. Staff may administer epinephrine and insulin under established medical protocols. Further, licensed nursing staff of a Specialized Memory Care Unit or Home may administer medications to residents who are incapable of self-administration of medications. Legislation and subsequent rules for the use of “proxy caregivers” in licensed facilities also allow unlicensed staffs who have been trained to perform “health maintenance activities,” including the administration of medications by a proxy caregiver. Proxy caregivers must be designated by the resident and determined to have the requisite skills necessary to administer medications. Assisted Living Community can allow the selfadministration of medications; provide assistance with self-administration using unlicensed staff, or use certified medication aides (at a minimum) to administer medications.
District of Columbia
Hawaii
Residents may store medication and facility staff may assist residents with the selfadministration of medication.
The facility must have medication management policies related to self-medication and the administration of medication.
Florida
Idaho
Unlicensed staff may provide hands-on assistance with self-administered medications. For
A licensed professional nurse is responsible for delegation of all nursing functions. Unlicensed
Delaware
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staff that successfully complete an assistancewith-medications course and have been delegated to provide assistance with medications by a licensed nurse are permitted to assist residents with self-administration of medication. A licensed professional nurse is required to check the medication regimen for residents on at least a quarterly basis. Illinois All medications must be self-administered or administered by licensed personnel. Facility staff may give medication reminders and monitor residents to make sure they follow the directions on the container. Indiana Each facility shall choose whether it administers medication and/or provides residential nursing care. These policies shall be outlined in the facility policy manual and clearly stated in the admission agreement. The administration of medications and the provision of residential nursing care shall be as ordered by the resident’s physician and shall be supervised by a licensed nurse on the premises or on call. Medication shall be administered by licensed nursing personnel or qualified medication aides. Administration of medications means preparation and/or distribution of prescribed medications. Administration does not include reminders, cues, and/or opening of medication containers or assistance with eye drops, such as steadying the resident’s hand, when requested by a resident.
Kansas Facilities can manage their residents’ medication or allow residents to engage in the selfadministration of medication. Self-administration of medication means the determination by a resident of when to take a medication or biological and how to apply, inject, inhale, ingest, or take a medication or biological by any other means, without assistance from nursing staff. A licensed nurse must perform an assessment and determine the resident can perform self-administration of medication safely. The assessment must include an evaluation of the resident’s physical, cognitive, and functional ability to safely and accurately self-administer and manage medications independently. A licensed pharmacist shall conduct a medication regimen review for each resident whose medication is managed by the facility at least quarterly and each time the resident experiences any significant change. Residents who self-administer medications must be offered a medication review conducted by a licensed pharmacist at least quarterly and each time a resident experiences a significant change in condition. Kentucky Medication administration is not permitted. The AL community provides assistance with self-administration of medication that is prepared or directed by the client, the client’s designated representative, or a licensed health care professional who is not the owner, manager, or employee of the AL community.
Iowa
Louisiana
Tenants self-administer medications or the tenant may delegate the administration to the program. The regulations defer to the Iowa Nurse Practice Act, which allows nurses to delegate medication administration to unlicensed staff. A program that administers prescription medications or provides health care professionale directed or health-related care must provide for an RN to monitor, at least every 90 days or after a significant change in condition, each tenant receiving program-administered prescription medications for adverse reactions and ensure that the medication orders are current and the medications are administered consistent with those orders.
Staff may supervise the self-administration of prescription and nonprescription medication. This assistance shall be limited to reminders, cueing, opening containers, and assistance in pouring medication. Residents may contract with an outside source for medication administration; however, facilities may not contract for this service.
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Maine Administration of medication is permitted and includes reading labels for residents; observing residents taking their medications; checking dosage; removing the prescribed dosage; and the maintenance of a medication record for each 304.e4
resident. Certain injections may be administered by trained medication aides.
assistance with self-administration of medications or administration of medications. Home care licensure statutes and rules must be followed.
Maryland The new regulations state that the AL manager and all staff who administer medications must have completed the medication administration course taught by an RN who is approved by the Board of Nursing. (The new regulations remove previous provisions related to the medication training program.) The regulations also add the requirement that an assisted living manager must arrange for a licensed pharmacist to conduct an on-site review of physician prescriptions, orders, and resident records at least every 6 months for any resident receiving 9 or more medications, including OTC and as-needed (PRN) medications. The regulation specifies what must be examined during the review and that the review must be part of the quality assurance review. There is also a requirement that all schedule II and III narcotics must be maintained under a double-lock system, and staff must count controlled drugs before the close of every shift. Massachusetts Self-administered medication management is permitted. Limited medication administration may only be provided by a family member, a practitioner as defined in state law, or a nurse registered or licensed under the provisions of state law. Nurses employed by the AL residence may administer noninjectable medications prescribed or ordered by an authorized prescriber to residents by oral or other routes (e.g., topical, inhalers, eyedrops and eardrops, medicated patches, as-necessary oxygen, or suppositories). Michigan A licensee, with a resident’s cooperation, shall follow the instructions and recommendations of a resident’s physician or other health care professional with regard to medication. The homes for the aged and adult foster care rules contain additional requirements governing administration of medications. Minnesota At a minimum, an establishment representing itself as AL must offer to provide or arrange for 304.e5
Mississippi Facilities may monitor the self-administration of medication. Only licensed personnel are allowed to administer medication. Missouri For AL facilities, a physician, pharmacist, or RN must review the medication regimen of each resident every other month. At a minimum, staff who administer medications must be a Level I Medication Aide (LIMA). Facilities are required to have a safe and effective system of medication control and use. In a level one residential care facilities (RCF), a pharmacist or RN must review the medication regimen of each resident every three months. In a level two RCF, a pharmacist or RN must review the medication regimen of each resident every other month. At a minimum, staff members who administer medications must be LIMAs. Facilities are required to have a safe and effective system of medication control and use. Montana All residents in a Category A facility must selfadminister their medication. Those residents in Category B endorsed facilities who are capable of and who wish to self-administer medications shall be encouraged to do so. Any direct care staff member who is capable of reading medication labels may provide necessary assistance to a resident in taking their medication. Category B or C residents who are unable to self-administer their medications must have the medications administered to them by a licensed health care professional or by an individual delegated the task under the Montana Nurse Practice Act. Medication management through third party services is allowed in all facility categories. Nebraska When a facility is responsible for the administration or provision of medications, it must be accomplished by the following methods: 1) selfadministration of medications by the resident, with or without supervision, when assessment determines the resident is capable of doing so; Geriatric Nursing, Volume 33, Number 4
2) by licensed health care professionals for whom medication administration is included in the scope of practice and in accordance with prevailing professional standards; or 3) by persons other than a licensed health care professional if the medication aides who provide medications are trained, have demonstrated minimum competency standards, and are appropriately directed and monitored. As of January 1, 2005, every person seeking admission to an AL facility must, upon admission and annually thereafter, provide the facility with a list of drugs, devices, biologicals, and supplements being taken or used by the person, including dosage, instructions for use, and reported use the AL facility must provide for an RN to review medication administration policies and procedures and document that review at least annually. An RN also is required to provide or oversee the training of medication aides. Nevada If a caregiver assists in the administration of medication, the caregiver must complete an initial 16-hour medication course from an approved medication training provider. The caregiver also must complete 8 hours of additional training every year and pass an approved examination. Administrators must take the same initial and refresher training as caregivers and are ultimately responsible for the medication plan and all medication errors. Facilities must have a detailed, comprehensive medication plan to help eliminate medication errors. New Hampshire In Assisted Living Residence - Supported Residential Health Care facilities, residents may selfadminister medications with or without staff supervision or self-direct medication administration, or licensed staff may administer medication. Nurse delegation of medications is also allowed. In ALR-RC facilities, residents may self-administer medications with or without staff supervision or self-direct medication administration. Licensed staff may administer medications. Nurse delegation is allowed.
lent training approved by the Department of Health and Senior Services and who have completed a medication aide course and passed a certifying exam are permitted to administer medication to residents under the delegation of an RN. Allowable injections include predrawn insulin injections as well as disposable insulin delivering mechanical devices commonly know as “pens.” New Mexico Licensed health care professionals are responsible for the administration of medications. If a resident gives written consent, trained facility staff may assist a resident with medications. New York Assistance with self-administration of medication is permitted in facilities. This includes prompting, identifying the medication for the resident, bringing the medication to the resident, opening containers, positioning the resident, disposing of used supplies, and storing the medication. North Carolina In multi-unit assisted housing with services, assistance with self-administration of medications may be provided by appropriately trained staff when delegated by a licensed nurse according to the home care agency’s established plan of care. In adult care homes, medications are required to be administered by staff whose competency is validated by an RN and who pass a written exam administered by the state. North Dakota In assisted living and in basic care facilities, unlicensed staff may administer medication except for “as needed” controlled prescription drugs. In spring 1997, a medication administration bill was passed allowing for the administration of limited medications by unlicensed personnel. This provision requires those personnel to have specific training and to be monitored by an RN.
New Jersey
Ohio
Certified nurse aides, certified home health aides, or staff members who have other equiva-
Residents must either be capable of selfadministering medications or the facility must
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provide for medication administration by a home health agency, hospice, or qualified staff person (e.g., an RN, licensed practical nurse, or physician). Trained, unlicensed staff may assist with self-administration only if the resident is mentally alert, able to participate in the medication process, and requests such assistance. Assistance includes reminders, observing, handing medications to the resident, and verifying the resident’s name on the label, etc. Ohio also is conducting a pilot program for certified medication aides in residential care facilities and nursing homes that will expand who may administer medications. Oklahoma Medication administration censed staff administering have completed a training been reviewed and approved of Health.
is permitted. Unlimedications must program that has by the Department
Oregon Medication may be administered by specially trained, unlicensed personnel over age 18. In addition, Oregon applies nurse delegation rules to these regulations. All medications administered by the facility to a resident must be reviewed every 90 days by a registered pharmacist or RN and recommendations must be documented and followed up on.
medication administration services for a resident who is assessed to need medication administration services and for a resident who chooses not to self-administer medications. Prescription medication that is not self-administered by a resident shall be administered by a licensed professional or a staff person who has completed the licensing agency’s medication administration training and has passed the performance-based competency test. Rhode Island Facilities are further classified by the degree to which they manage medications. Medication Classifications Level M1 is for a residence that has 1 or more residents who require central storage and/or administration of medications. In Level M1 facilities, licensed staff or registered medication aides are permitted to administer medications and monitor health indicators. Level M2 is for residences that have residents who require assistance with self-administration of medications (this term is defined in the regulations). Nurse review is necessary under all levels of medication licensure. South Carolina Medication administration by unlicensed staff who have been trained to perform these tasks is permitted.
Pennsylvania
South Dakota
A personal care home must provide residents with assistance, as needed, with medication prescribed for the resident’s self-administration. A home may provide medication administration services for a resident who is assessed to need medication administration services. Medications must be administered by licensed medical personnel or by a staff person who has completed a department-approved medication administration course that includes passing the department’s performance-based competency test. An assisted living residence must provide residents with assistance, as needed, with medication prescribed for the resident’s selfadministration. This assistance includes helping the resident to remember the schedule for taking the medication, storing the medication in a secure place, and offering the resident the medication at the prescribed times. A residence shall provide
Facilities that admit or retain residents who require administration of medications must employ or contract with a licensed nurse to review and document resident care and condition at least weekly. Unlicensed staff must pass an approved medication course and receive annual training for medication administration.
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Tennessee Medication must be self-administered or administered by a licensed professional. The facility may assist residents with medication, including reading labels, reminders, and observation. Texas Residents who choose not to or who cannot self-administer medication must have medication administered by a person who holds a current Geriatric Nursing, Volume 33, Number 4
license to administer medication; holds a current medication aide permit (this person must function under the direct supervision of a licensed nurse on duty or on call); or is an employee of the facility to whom the administration of medication has been delegated by an RN. Staff who are not licensed or certified may assist with self-administration of medication as allowed under the regulations. Utah Licensed staff may administer medication, and unlicensed staff may assist with selfmedication. There are 4 appropriate scenarios for medication administration: 1) the resident may self-administer; 2) the resident may selfdirect with staff assistance; 3) family members may administer but must have total responsibility for all medications; and 4) staff may administer with appropriate delegation from a licensed health care professional.
medication administration). Medication assistance may be provided by staff other than licensed nurses without nursing supervision. 2) Boarding homes have the option to provide medication administration services directly through licensed nurses or through formal nurse delegation. 3) Residents may self-administer medications, or the boarding home may permit family members to administer medications to residents. 4) Residents have the right to refuse medications. 5) Residents who have physical disabilities may accurately direct others to administer medications to them. 6) A boarding home may alter the form in which medications are administered under certain conditions. 7) Residents who are assessed as capable have the right to store their own medications. The boarding home must ensure that residents are protected from gaining access to other residents’ medications. 8) Nurses may fill medication organizers for residents under certain conditions.
Vermont If residents are unable to self-administer medications, they may receive assistance with administration of medications from trained facility staff. Staff may be trained to administer medications by delegation from an RN in accordance with regulations and Vermont’s Nurse Practice Act.
West Virginia Only licensed staff may administer or supervise the self-administration of medication by residents. As of July 1999, Approved Medication Assistive Personnel (for which specific training and testing is required) can administer medications in the facility.
Virginia Medications may be administered by licensed individuals or by medication aides who have successfully completed a Board of Nursinge approved training program, have passed a competency evaluation, and are registered with the Virginia Board of Nursing. Medication aides are permitted to act on a provisional basis when certain requirements are met. Each facility must have a written plan for medication management. A licensed health care professional must perform an annual review of all the medications of each resident assessed for residential living care, except for those who self-administer all of their medications, and a review every 6 months of all the medications of each resident assessed for assisted living care. Washington 1) All boarding homes must provide medication assistance services (differentiated from Geriatric Nursing, Volume 33, Number 4
Wisconsin Community-based residential facility: medication administration and management are performed by licensed nurses or pharmacists unless medications are packaged by unit dose. All direct-care staff and administrative personnel must complete an 8-hour approved medication administration and management course. Residential care apartment complex: medication administration and management must be performed by a nurse or as a delegated task to unlicensed staff, under the supervision of a nurse or pharmacist. Adult family home: all prescription medications must be securely stored in the original container. Before a licensee or service provider dispenses or administers medication to a resident, the licensee must obtain a written order from the prescribing physician. The order must specify who by name or position is permitted to administer the medication and under 304.e8
what circumstances the medication is to be administered. Wyoming Residents are permitted to self-medicate or receive medication assistance including, but not limited to, reminders, assistance with removal of cap or medication, and observation.
The “Right” Rx The “right” Rx involves more than ensuring the right resident takes the right medication and the right dosage, at the right time using the right route; it also involves making sure the medication is not only what was prescribed but that it is an appropriate medication for that resident. In ALs, several issues may result if the resident is not receiving the most appropriate medication. To provide direction regarding appropriate medications, ALs would be well served to follow the guidance provided in the Beers Criteria.2 The Beers Criteria is a clinical tool that is based on the originally conceived work of Dr. Mark Beers, first published in 1991. This tool was developed to assist health care providers in improving medication safety in older adults. Last year, the American Geriatric Society (AGS) undertook the task of updating the criteria. AL nurses should be familiar with this revised Beers Criteria so that they can properly assess AL residents, as well as advise them, their caregivers, and attending physicians regarding potentially dangerous medication issues. Some of those issues identified in the AGS Beers Criteria that may be common in ALs include the use of OTC agents such as the following:
Mineral oil Aspirin Nonsteroidal anti-inflammatories (NSAIDs) H2-receptor antagonists Anticholinergics Caffeine
Identifying the use of these OTCs and making recommendations based on this Beers Criteria could improve the health outcomes for AL residents. These specific recommendations include avoiding aspirin and NSAIDs, which can exacerbate existing ulcers or cause new or additional ulcers, for AL residents with a history of gastric or 304.e9
duodenal ulcers unless alternatives are not effective and the patient can take a gastroprotective agent (proton-pump inhibitor or misoprostol). Also, it is recommended that NSAIDs be avoided for AL residents with Stage IVeV chronic kidney disease because these agents may increase the risk of kidney injury. The criteria also note that aspirin should be used with caution in adults aged over 80 years because of the lack of evidence of benefit versus risk in these individuals. Mineral oil is noted in the gastrointestinal section, where it suggests that it be avoided because of the potential for aspiration and adverse effects; safer alternatives are available. H2-receptor antagonists and anticholinergic medications should be avoided in AL residents with dementia and cognitive impairment. This is recommended because of adverse central nervous system (CNS) effects associated with H2-receptor antagonists and anticholinergics. Although not often thought of as a medication, caffeine is included in the Beers Criteria. It is recommended that AL residents with insomnia avoid caffeine because of CNS stimulant effects. Beyond the Beers Criteria, ensuring that older adults are not receiving inappropriate psychotropic medications is another issue of concern. Although this has primarily focused on nursing home care, the May 2011 report from the Office of the Inspector General (OIG) has moved the Centers for Medicare and Medicaid Services (CMS) also to focus attention on ALs. The OIG found that some 14% of elderly nursing home residents had Medicare claims for atypical antipsychotic drugs and 83% of Medicare claims for atypical antipsychotic drugs for elderly nursing home residents were associated with off-label conditions. Specifically, some 88% were associated with the condition specified in the Food and Drug Administration boxed warning. Besides the clinical implications, the OIG states that 51% of Medicare atypical antipsychotic drug claims for elderly nursing home residents fall into the category of inappropriate use, and thus $116 million annually is being wasted. As a result of these findings, the OIG recommended (http://oig.hhs.gov/oei/reports/oei-07-0800150.asp) that CMS assess whether survey and certification processes offer adequate safeguards against unnecessary antipsychotic drug use in nursing homes, explore alternative methods beyond survey and certification processes to promote compliance with federal standards Geriatric Nursing, Volume 33, Number 4
regarding unnecessary drug use in nursing homes, and take appropriate action regarding the claims associated with erroneous payments. As ALs find themselves under increasing regulatory oversight, the rules currently affecting nursing homes will likely find their way into the AL setting. ALs that recognize the need to manage antipsychotic medications to ensure their appropriate use will not only be helping their residents but will be prepared to deal with the increased medication monitoring that is likely to come soon.
Taking the Medicine Many states have developed guides that cover the necessary components of “assistance with self-administration.” One such guide is available from the state of Florida.3 The American Medical Directors Association has also developed guidance regarding the taking of medications by AL residents.
The American Medical Directors Association Medication Management in Assisted Living 4 Basic Principles Minimize changes and the number of medications when possible. Understand the medication management program in AL (e.g., cycles). Avoid telephone orders; only licensed nurses can take verbal orders. Don’t shoot the messenger: the onslaught of numerous prior authorizations are mandated by payors, not the pharmacies that make the follow-up call. OTC medications often require physician orders and are as regulatory-sensitive as prescription medication. Collaborative practice with trained pharmacist can minimize the number of times that pharmacy needs to call prescribers.
Prescribing Tips Make sure you have a complete medication list before adding or change. Regarding the start date on prescription, remember that not every medication has to be delivered STAT. Geriatric Nursing, Volume 33, Number 4
Add a 365-day refill for maintenance medications; this will eliminate repeated calls for refills. Be careful to handle D/C (discontinue) orders with as much formality as new prescriptions. Minimize PRN (as needed) orders: cycled maintenance medications are much easier to manage, and caregivers often cannot exercise discretion regarding state regulations. No ambiguous “sigs” (e.g., i-ii tabs Q4-6H): caregivers often cannot understand these and will require additional calls to prescribers. Be careful regarding “look-alike or soundalike” medications. Schedule II controlled substance orders require hard copy to be delivered to the pharmacydthis is difficult to manage STAT. Consider schedule III controlled substance alternative for the first 24 to 72 hours, if appropriate. Weigh benefit of reduced dosing frequency to minimize errors and to improve adherence (e.g., daily, or QD, brand versus three-times daily, or TID, generic). Regarding the taking of one’s medication, this guide recommends a MOR medication observation record. A MOR is required to be kept for each resident who receives assistance with medications. The MOR must include the following: the name of the resident, any known allergies the resident has, the name and telephone number of the resident’s health care provider, the name of each medication prescribed and its strength and directions for use, a record of each time the medication was taken, and a record of any missed dosages, refusals to take medications as prescribed, or medication errors. Although the MOR works well to help cue the AL staff on administration times and documentation of the AL resident taking their medication, there are devices that can assist those residents who do not require direct AL staff oversight. These are particularly useful in situations in which the patient’s medications must be stored in a resident’s room (e.g., Massachusetts) or when there are self-medicating residents with complex medication regimens. Devices such as TabSafe can be filled by AL staff or the pharmacy. The pharmacy fills cartridges with a residents’ medication, and these cartridges are then loaded into the device, which prompts the AL resident to 304.e10
take his or her medication at the designated time. The device has a user-friendly Web interface that allows caregivers to check reports and make all changes to reminders remotely. The device alert calls are both proactive and nonintrusive, calling before a medication is missed while eliminating the need for repeated calls to ask, “Did you take your pills yet?” The device handles PRN meds and prevents overmedicating, provides interactive medication dose change or discontinuance when a prescription changes, maintains each medication’s inventory, automatically alerts for reorder, and digitally downloads each transaction for reports and analysis: “When released, what med, quantity, who released.” Web-accessible reports allow for the management medication regimen adherence via any Internet browsing device. Many scheduling options are available, including specific days of the week and other unique dosing patterns.
Disposal Circumstances may arise in AL facilities that require medications to be removed from the premises (e.g., medication order changes, expired medications, adulterated or contaminated medications, resident discharge, resident death). The amount and number of medications, the available options for removing them, and concerns for the environment have led AL facilities to seek guidance on how medications should be disposed of. Some facilities have asked about outside sources picking up medications for removal and how this should be handled. Many states require that a resident’s prescription medication be destroyed within 72 hours of a practitioner’s order discontinuing its use, the resident’s discharge (unless the resident needs the medication at a new location), the resident’s death, loss of medication dosage form integrity, removal of the medication from the its packaging, or medication expiration. In addition, records of all medication returned to the pharmacy for credit or destruction must be kept. Any medication not returned for credit or destruction will be destroyed in the facility, and a record of the destruction must be witnessed, signed, and dated by at least 2 of the following: the administrator or designee, an RN or a pharmacist, and 1 other employee. Controlled substances can only be in the possession of Drug Enforcement Administration 304.e11
(DEA) registrants, law enforcement, and consumers (AL residents) who have a prescription for the substance or the facility where the residents are residing. Typically, physicians, pharmacies, and hospitals are DEA registrants. Federal law currently prohibits controlled substances to be returned from a non-DEA registrant, such as a resident in an AL facility, to a DEA registrant, such as a pharmacy. Therefore, all controlled substances need to be destroyed. It is important to note that destroying medications by washing them down the drain or flushing them down the toilet and into the wastewater is highly discouraged, because wastewater treatment plants do not remove medications. Drug components can harm plants and animals that live downstream. Furthermore, it may be illegal to flush certain hazardous medications. Also, medications should not be placed in infectious waste containers. It is not appropriate (nor is it cost-effective) to put medications, empty medication bottles, or empty insulin or vaccine vials in sharps containers or biohazard waste bags. It is no longer true that most infectious waste is incinerated; typically these wastes are disinfected and put in a landfill. Although medications that are considered hazardous waste are regulated by both state and federal regulations, Wisconsin has authority to run the federal program in Wisconsin. Hazardous waste includes items that are listed by name in the regulations or that exhibit characteristics of hazardous waste. Common hazardous waste medications include epinephrine, Coumadin, vaccines preserved with thimerosal, and even certain shampoos and vitamins/minerals. An estimated 5% to 15% of medication waste may be hazardous. A reputable hazardous waste hauler can help you separate them. Needles can be detached from an intravenous delivery device in accordance with worker safety regulations; only the needle needs to be managed as infectious waste. In most cases, syringes are empty after use. Medications that are considered solid waste can generally be handled like other garbage. A potential problem with disposal via general garbage is that medications can pose safety risks to individuals who inappropriately access the garbage and expose themselves to the medications. In addition, medications that go to a landfill may leach to the groundwater system or be extracted and taken through a wastewater treatment plant. Geriatric Nursing, Volume 33, Number 4
Therefore, department of natural resources recommends that solid waste medications be routed to a licensed municipal solid waste incinerator or hazardous waste incinerator. The preferred practice is to have a waste hauler take medications to a medical waste or hazardous waste incinerator. The solid waste hauler may have appropriate containers and specific procedures for disposing of medications. If that method of disposal is not available, place the medications in a container that can be sealed. Add a small amount of water to the medication to make a slurry. Add cat litter, plaster of Paris, or some other absorbent material to the slurry. Finally, seal the container and place the container in the garbage. Remove or obliterate any labels identifying the container as containing medications.
The Future of AL Medication Management As ALs increasing take on a higher-acuity residents, including a growing number that are eligible for nursing home level of care, the need to raise the level of medication management will increase. Along with this demand is a regulatory move to provide for benefits based on patient needs rather than simply location of care. Often times referred to as “benefit following patient,” this approach calls for the benefit being based on the patient need rather than the place of care. For example, if an AL resident meets the criteria for nursing home level of care, why shouldn’t that person have access to similar benefits as if he or she were in the nursing home? With regard to medication management, the benefits provided to nursing home residents include the following: Drug regimen review by a consultant pharmacist on at least a monthly basis Specialized medication packaging provided through an institutional pharmacy provider Careful documentation of medication administration through a medication administration record (MAR) Assurance of the “right medication for the right patient at the right dose and duration”: this is especially true for psychotropic medications
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In preparation for this increased resident need and regulatory focus on medication management, AL nursing staff is advised to proactively move in this direction. Of course, like so many opportunities and challenges in ALs, this is best accomplished through an interdisciplinary team approachdin the area of medication management, this includes a consultant pharmacist, physicians, and nurse practitioners. This team would be best positioned to provide the level of care needed today and that is likely to be required in the near future. AL residents will be better assisted as a result. For additional educational opportunities on this topic, visit http://medmanagement.umaryland. edu/assisted_living.
References 1. American Health Care Associates. State assisted living regulatory/policy changes in 2011: analysis of NCAL findings. March 2012. Available at www.ahcancal.org/ ncal/resources/Documents/Summary%20-%20regulatory %20changes%20in%202011.pdf. Cited May 15, 2012. 2. The American Geriatrics Society 2012 Beers Criteria Update Expert Panel. American Geriatrics Society updated Beers Criteria for potentially inappropriate medication use in older adults. 2012. Available at www. americangeriatrics.org/files/documents/beers/2012 BeersCriteria_JAGS.pdf. Cited May 15, 2012. 3. PEGCO, Inc. Assistance with self-administered medications study guide for assisted living facility and home health staff. Available at www.pegcoinc.net/alf_ study_guide.htm. Cited July 2, 2012. 4. AMDA. Multidisciplinary medication management manual. Available at http://www.amda.com/resources/ print.cfm. RICHARD G. STEFANACCI, DO, MGH, MBA, AGSF, CMD, is an Associate Professor in Health Policy & Public Health at the University of the Sciences in Philadelphia, PA. He also serves as Chief Medical Officer of The Access Group and maintains an active clinical practice at PACEda Program of All-Inclusive Care for the Elderly in Philadelphia, PA. DANIEL HAIMOWITZ, MD, FACP, CMD, is an Internist/ Geriatrician in private practice in Levittown PA, and an Assisted Living Medical Director at Arden Courts of Yardley, PA and Brunswick at Attleboro in Langhorne, PA. 0197-4572/$ - see front matter Ó 2012 Mosby, Inc. All rights reserved. http://dx.doi.org/10.1016/j.gerinurse.2012.06.008
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Dan Haimowitz
Medication Management in Assisted Living Richard G. Stefanacci, DO, MGH, MBA, AGSF, CMD, and Dan Haimowitz, MD, FACP, CMD Perhaps nothing forces as many older adults to seek assisted living (AL) than the need for medication management. Although medication adherence is the foundation for assistance in medication management, additional opportunities exist for improved outcomes through monitoring and even recommending alternatives that may be more appropriate to AL residents and attending physicians. Medication management begins with identification of a clinical issue, which is then appropriately treated. Even in this stage of the process, AL nursing staff can play a critical role in recognizing problems and then directing their AL resident to appropriate providers. Some AL residents are able to seek out providers on their own or with help of actively involved family. However, when residents obtain care on their own outside of the AL facility, the staff has a more difficult time ensuring that the treatments ordered are carried out. To ensure that the AL staff members are able to assist their residents, they must first know what treatments have been ordered. This can occur by educating AL residents, their families, and their physicians about the important role the AL staff plays in assisting with the followthrough on treatment plans. Education of all the key stakeholders beginning at admission with continuous reinforcement on a regular basis is necessary to ensure that the AL nursing staff is fully informed. Letting outside physicians know of the valuable service the AL staff provides will go a long way to ensure the development of a partnership based on a productive flow of information. Information regarding new medication or changes to existing medication needs to be
Disclosure: Dr. Stefanacci is an investor and serves on the Board of TabSafe Health Systems.
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made known to the AL staff. It must be communicated in writing from the prescriber, and any change in directions for use of a medication for which the facility provides assistance with selfadministration must be accompanied by a written medication order issued and signed by the resident’s health care provider. Unlicensed persons cannot implement any changes without first obtaining a written order. It is important to place an “alert” label on any existing medications for which the directions for use have changed or obtain a new medication label with the new directions from the pharmacist. “Alert” labels are used to direct staff to examine the revised directions for use in the medication observation record. In addition to orders and changes, assistance needed with medication management involves ensuring that the AL resident does not run out of his or her medication. To avoid this, it is best to reorder medications from the pharmacy 7 days before running out or as directed by the facility’s policy. If medications are not received within 3 days of ordering, call the pharmacy or family member to find out where they are and how you will be able to get them before running out. When medications are received, check to make sure the correct prescription has arrived before placing it in storage. Every AL facility may have different procedures for reordering medications. Some designate a nurse to handle all health care orders, medication reordering, and disposal of medication.
Regulations Although state regulations seem to be increasing across the board in AL facilities, an especially intense area of regulation is medication management. The National Center for Assisted Living recently published a report1 covering Geriatric Nursing, Volume 33, Number 4
a state-by-state summary of AL regulations covering 21 categories, which includes medication management. Most state regulations require policies and provide direction on medication management, but there is wide variability at the level of medication management (e.g., some states require unit dose packaging). Although protecting resident rights, some states make medication management difficult. Florida, for example, states that AL facilities may not require a resident to have a physician’s order for over-the-counter (OTC) medication; this makes careful oversight to avoid potential issues with inappropriate OTC use difficult. Perhaps the biggest issue of variability and oversight is in the area of supervision of medication administration from purely self-administration to complete AL-facilitated administration (see Figure 1). With regard to this definition, Indiana takes the unique approach of describing what administration is and is not by saying that administration of medications means preparation and/or distribution of prescribed medications. Administration does not include reminders, cues, and/or opening of medication containers or assistance with eyedrops, such as steadying the resident’s hand, when requested by a resident. Kansas describes self-administration of medication as the determination by a resident of when to take a medication or biological and how to apply, inject, inhale, ingest, or take a medication or biological by any other means, without assistance from nursing staff. In addition to the definition of selfadministration versus administration, there is variability in the level of training and education required in the range of assistance. Kentucky takes the extreme approach of not permitting administration under any circumstance.
Assisted Living State Medication Regulations Alabama A resident may either manage, keep, and selfadminister his or her own medications or receive assistance with the self-administration of medication by any staff member. Medications managed and kept under the custody and control of the facility shall be unit-dose packaged. In specialty care AL facilities that care for residents with dementia, medication must be administered by a registered nurse (RN), licensed practical nurse, or an individual licensed to practice medicine or osteopathy by the Medical Licensure Commission of Alabama. Alaska If self-administration of medications is included in a resident’s AL plan, the facility may supervise the resident’s self-administration of medications. Arizona Medication administration is permitted by licensed nurses. Certified AL managers and trained caregivers may also provide medication assistance to residents and may provide medication administration with a physician order and proper training. Arkansas Level I facility staff must provide assistance to enable residents to self-administer medications. In Level II facilities, licensed nursing personnel may administer medication. California Facility staff, unless he/she is an appropriately skilled professional acting within his/her scope of practice, may not administer medications to residents but may assist them with the selfadministration of medications. Colorado
Figure 1. The “what” and “who” of medication management. Geriatric Nursing, Volume 33, Number 4
All personal medication is the property of the resident, and no resident shall be required to surrender the right to possess or self-administer any personal medication, except as otherwise specified in the care plan of a resident of a facility 304.e2
that is licensed to provide services specifically for the mentally ill, or if a physician or other authorized medical practitioner has determined that the resident lacks the decisional capacity to possess or administer such medication safely. For residents who are unable to self-administer medications, medications must be given by a qualified medication administration staff member who has completed a state-approved training and competency examination. A qualified medication aide is permitted to administer oral, inhalant, topical, vaginal, and rectal medications, but not injections. If donated by a resident or resident’s legal representative, a facility may return unused prescription medications that are not controlled substances to a pharmacist in accordance with state laws.
an unlicensed staff person to provide assistance with the self-administration of medication, he/ she must complete 4 hours of medication assisting training upon hire and then 2 hours of medication assisting training annually. This training must include specified topics and be taught by an RN, licensed pharmacist, or department staff. A licensed health care provider’s order is required when a licensed nurse provides assistance with self-administration or administration of medications, including OTC products. Assisted living facilities may not require a resident to have a physician’s order for OTC medication. In addition to core educational requirements, staff must have a minimum of 4 additional hours of training provided by an RN, licensed pharmacist, or Department of Elder Affairs staff.
Connecticut Georgia A licensed nurse may administer medications and/or pre-pour medications for clients who are able to self-administer medications. With the approval of the client or his or her representative, an assisted living aide may supervise a client’s self-administration of medications.
Facilities must comply with the Nurse Practice Act. Residents may receive assistance with selfmedication by designated care providers who have completed the “Assistance with SelfAdministration of Medication” (AWSAM) training course. Facilities must keep records on file for those who have completed the course and must complete and submit an annual AWSAM report on a form provided by the Board of Nursing. Administration of medication may only be performed by an RN or a licensed practical nurse. The facility must establish and adhere to written medication policies and procedures that address a series of issues related to obtaining, storing, and administering medication. A quarterly pharmacy review is required.
In personal care homes, all medications must be self-administered by the resident except when the resident requires administration of oral or topical medication by or under the supervision of a functionally literate staff person. There are exceptions. Staff may administer epinephrine and insulin under established medical protocols. Further, licensed nursing staff of a Specialized Memory Care Unit or Home may administer medications to residents who are incapable of self-administration of medications. Legislation and subsequent rules for the use of “proxy caregivers” in licensed facilities also allow unlicensed staffs who have been trained to perform “health maintenance activities,” including the administration of medications by a proxy caregiver. Proxy caregivers must be designated by the resident and determined to have the requisite skills necessary to administer medications. Assisted Living Community can allow the selfadministration of medications; provide assistance with self-administration using unlicensed staff, or use certified medication aides (at a minimum) to administer medications.
District of Columbia
Hawaii
Residents may store medication and facility staff may assist residents with the selfadministration of medication.
The facility must have medication management policies related to self-medication and the administration of medication.
Florida
Idaho
Unlicensed staff may provide hands-on assistance with self-administered medications. For
A licensed professional nurse is responsible for delegation of all nursing functions. Unlicensed
Delaware
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staff that successfully complete an assistancewith-medications course and have been delegated to provide assistance with medications by a licensed nurse are permitted to assist residents with self-administration of medication. A licensed professional nurse is required to check the medication regimen for residents on at least a quarterly basis. Illinois All medications must be self-administered or administered by licensed personnel. Facility staff may give medication reminders and monitor residents to make sure they follow the directions on the container. Indiana Each facility shall choose whether it administers medication and/or provides residential nursing care. These policies shall be outlined in the facility policy manual and clearly stated in the admission agreement. The administration of medications and the provision of residential nursing care shall be as ordered by the resident’s physician and shall be supervised by a licensed nurse on the premises or on call. Medication shall be administered by licensed nursing personnel or qualified medication aides. Administration of medications means preparation and/or distribution of prescribed medications. Administration does not include reminders, cues, and/or opening of medication containers or assistance with eye drops, such as steadying the resident’s hand, when requested by a resident.
Kansas Facilities can manage their residents’ medication or allow residents to engage in the selfadministration of medication. Self-administration of medication means the determination by a resident of when to take a medication or biological and how to apply, inject, inhale, ingest, or take a medication or biological by any other means, without assistance from nursing staff. A licensed nurse must perform an assessment and determine the resident can perform self-administration of medication safely. The assessment must include an evaluation of the resident’s physical, cognitive, and functional ability to safely and accurately self-administer and manage medications independently. A licensed pharmacist shall conduct a medication regimen review for each resident whose medication is managed by the facility at least quarterly and each time the resident experiences any significant change. Residents who self-administer medications must be offered a medication review conducted by a licensed pharmacist at least quarterly and each time a resident experiences a significant change in condition. Kentucky Medication administration is not permitted. The AL community provides assistance with self-administration of medication that is prepared or directed by the client, the client’s designated representative, or a licensed health care professional who is not the owner, manager, or employee of the AL community.
Iowa
Louisiana
Tenants self-administer medications or the tenant may delegate the administration to the program. The regulations defer to the Iowa Nurse Practice Act, which allows nurses to delegate medication administration to unlicensed staff. A program that administers prescription medications or provides health care professionale directed or health-related care must provide for an RN to monitor, at least every 90 days or after a significant change in condition, each tenant receiving program-administered prescription medications for adverse reactions and ensure that the medication orders are current and the medications are administered consistent with those orders.
Staff may supervise the self-administration of prescription and nonprescription medication. This assistance shall be limited to reminders, cueing, opening containers, and assistance in pouring medication. Residents may contract with an outside source for medication administration; however, facilities may not contract for this service.
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Maine Administration of medication is permitted and includes reading labels for residents; observing residents taking their medications; checking dosage; removing the prescribed dosage; and the maintenance of a medication record for each 304.e4
resident. Certain injections may be administered by trained medication aides.
assistance with self-administration of medications or administration of medications. Home care licensure statutes and rules must be followed.
Maryland The new regulations state that the AL manager and all staff who administer medications must have completed the medication administration course taught by an RN who is approved by the Board of Nursing. (The new regulations remove previous provisions related to the medication training program.) The regulations also add the requirement that an assisted living manager must arrange for a licensed pharmacist to conduct an on-site review of physician prescriptions, orders, and resident records at least every 6 months for any resident receiving 9 or more medications, including OTC and as-needed (PRN) medications. The regulation specifies what must be examined during the review and that the review must be part of the quality assurance review. There is also a requirement that all schedule II and III narcotics must be maintained under a double-lock system, and staff must count controlled drugs before the close of every shift. Massachusetts Self-administered medication management is permitted. Limited medication administration may only be provided by a family member, a practitioner as defined in state law, or a nurse registered or licensed under the provisions of state law. Nurses employed by the AL residence may administer noninjectable medications prescribed or ordered by an authorized prescriber to residents by oral or other routes (e.g., topical, inhalers, eyedrops and eardrops, medicated patches, as-necessary oxygen, or suppositories). Michigan A licensee, with a resident’s cooperation, shall follow the instructions and recommendations of a resident’s physician or other health care professional with regard to medication. The homes for the aged and adult foster care rules contain additional requirements governing administration of medications. Minnesota At a minimum, an establishment representing itself as AL must offer to provide or arrange for 304.e5
Mississippi Facilities may monitor the self-administration of medication. Only licensed personnel are allowed to administer medication. Missouri For AL facilities, a physician, pharmacist, or RN must review the medication regimen of each resident every other month. At a minimum, staff who administer medications must be a Level I Medication Aide (LIMA). Facilities are required to have a safe and effective system of medication control and use. In a level one residential care facilities (RCF), a pharmacist or RN must review the medication regimen of each resident every three months. In a level two RCF, a pharmacist or RN must review the medication regimen of each resident every other month. At a minimum, staff members who administer medications must be LIMAs. Facilities are required to have a safe and effective system of medication control and use. Montana All residents in a Category A facility must selfadminister their medication. Those residents in Category B endorsed facilities who are capable of and who wish to self-administer medications shall be encouraged to do so. Any direct care staff member who is capable of reading medication labels may provide necessary assistance to a resident in taking their medication. Category B or C residents who are unable to self-administer their medications must have the medications administered to them by a licensed health care professional or by an individual delegated the task under the Montana Nurse Practice Act. Medication management through third party services is allowed in all facility categories. Nebraska When a facility is responsible for the administration or provision of medications, it must be accomplished by the following methods: 1) selfadministration of medications by the resident, with or without supervision, when assessment determines the resident is capable of doing so; Geriatric Nursing, Volume 33, Number 4
2) by licensed health care professionals for whom medication administration is included in the scope of practice and in accordance with prevailing professional standards; or 3) by persons other than a licensed health care professional if the medication aides who provide medications are trained, have demonstrated minimum competency standards, and are appropriately directed and monitored. As of January 1, 2005, every person seeking admission to an AL facility must, upon admission and annually thereafter, provide the facility with a list of drugs, devices, biologicals, and supplements being taken or used by the person, including dosage, instructions for use, and reported use the AL facility must provide for an RN to review medication administration policies and procedures and document that review at least annually. An RN also is required to provide or oversee the training of medication aides. Nevada If a caregiver assists in the administration of medication, the caregiver must complete an initial 16-hour medication course from an approved medication training provider. The caregiver also must complete 8 hours of additional training every year and pass an approved examination. Administrators must take the same initial and refresher training as caregivers and are ultimately responsible for the medication plan and all medication errors. Facilities must have a detailed, comprehensive medication plan to help eliminate medication errors. New Hampshire In Assisted Living Residence - Supported Residential Health Care facilities, residents may selfadminister medications with or without staff supervision or self-direct medication administration, or licensed staff may administer medication. Nurse delegation of medications is also allowed. In ALR-RC facilities, residents may self-administer medications with or without staff supervision or self-direct medication administration. Licensed staff may administer medications. Nurse delegation is allowed.
lent training approved by the Department of Health and Senior Services and who have completed a medication aide course and passed a certifying exam are permitted to administer medication to residents under the delegation of an RN. Allowable injections include predrawn insulin injections as well as disposable insulin delivering mechanical devices commonly know as “pens.” New Mexico Licensed health care professionals are responsible for the administration of medications. If a resident gives written consent, trained facility staff may assist a resident with medications. New York Assistance with self-administration of medication is permitted in facilities. This includes prompting, identifying the medication for the resident, bringing the medication to the resident, opening containers, positioning the resident, disposing of used supplies, and storing the medication. North Carolina In multi-unit assisted housing with services, assistance with self-administration of medications may be provided by appropriately trained staff when delegated by a licensed nurse according to the home care agency’s established plan of care. In adult care homes, medications are required to be administered by staff whose competency is validated by an RN and who pass a written exam administered by the state. North Dakota In assisted living and in basic care facilities, unlicensed staff may administer medication except for “as needed” controlled prescription drugs. In spring 1997, a medication administration bill was passed allowing for the administration of limited medications by unlicensed personnel. This provision requires those personnel to have specific training and to be monitored by an RN.
New Jersey
Ohio
Certified nurse aides, certified home health aides, or staff members who have other equiva-
Residents must either be capable of selfadministering medications or the facility must
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provide for medication administration by a home health agency, hospice, or qualified staff person (e.g., an RN, licensed practical nurse, or physician). Trained, unlicensed staff may assist with self-administration only if the resident is mentally alert, able to participate in the medication process, and requests such assistance. Assistance includes reminders, observing, handing medications to the resident, and verifying the resident’s name on the label, etc. Ohio also is conducting a pilot program for certified medication aides in residential care facilities and nursing homes that will expand who may administer medications. Oklahoma Medication administration censed staff administering have completed a training been reviewed and approved of Health.
is permitted. Unlimedications must program that has by the Department
Oregon Medication may be administered by specially trained, unlicensed personnel over age 18. In addition, Oregon applies nurse delegation rules to these regulations. All medications administered by the facility to a resident must be reviewed every 90 days by a registered pharmacist or RN and recommendations must be documented and followed up on.
medication administration services for a resident who is assessed to need medication administration services and for a resident who chooses not to self-administer medications. Prescription medication that is not self-administered by a resident shall be administered by a licensed professional or a staff person who has completed the licensing agency’s medication administration training and has passed the performance-based competency test. Rhode Island Facilities are further classified by the degree to which they manage medications. Medication Classifications Level M1 is for a residence that has 1 or more residents who require central storage and/or administration of medications. In Level M1 facilities, licensed staff or registered medication aides are permitted to administer medications and monitor health indicators. Level M2 is for residences that have residents who require assistance with self-administration of medications (this term is defined in the regulations). Nurse review is necessary under all levels of medication licensure. South Carolina Medication administration by unlicensed staff who have been trained to perform these tasks is permitted.
Pennsylvania
South Dakota
A personal care home must provide residents with assistance, as needed, with medication prescribed for the resident’s self-administration. A home may provide medication administration services for a resident who is assessed to need medication administration services. Medications must be administered by licensed medical personnel or by a staff person who has completed a department-approved medication administration course that includes passing the department’s performance-based competency test. An assisted living residence must provide residents with assistance, as needed, with medication prescribed for the resident’s selfadministration. This assistance includes helping the resident to remember the schedule for taking the medication, storing the medication in a secure place, and offering the resident the medication at the prescribed times. A residence shall provide
Facilities that admit or retain residents who require administration of medications must employ or contract with a licensed nurse to review and document resident care and condition at least weekly. Unlicensed staff must pass an approved medication course and receive annual training for medication administration.
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Tennessee Medication must be self-administered or administered by a licensed professional. The facility may assist residents with medication, including reading labels, reminders, and observation. Texas Residents who choose not to or who cannot self-administer medication must have medication administered by a person who holds a current Geriatric Nursing, Volume 33, Number 4
license to administer medication; holds a current medication aide permit (this person must function under the direct supervision of a licensed nurse on duty or on call); or is an employee of the facility to whom the administration of medication has been delegated by an RN. Staff who are not licensed or certified may assist with self-administration of medication as allowed under the regulations. Utah Licensed staff may administer medication, and unlicensed staff may assist with selfmedication. There are 4 appropriate scenarios for medication administration: 1) the resident may self-administer; 2) the resident may selfdirect with staff assistance; 3) family members may administer but must have total responsibility for all medications; and 4) staff may administer with appropriate delegation from a licensed health care professional.
medication administration). Medication assistance may be provided by staff other than licensed nurses without nursing supervision. 2) Boarding homes have the option to provide medication administration services directly through licensed nurses or through formal nurse delegation. 3) Residents may self-administer medications, or the boarding home may permit family members to administer medications to residents. 4) Residents have the right to refuse medications. 5) Residents who have physical disabilities may accurately direct others to administer medications to them. 6) A boarding home may alter the form in which medications are administered under certain conditions. 7) Residents who are assessed as capable have the right to store their own medications. The boarding home must ensure that residents are protected from gaining access to other residents’ medications. 8) Nurses may fill medication organizers for residents under certain conditions.
Vermont If residents are unable to self-administer medications, they may receive assistance with administration of medications from trained facility staff. Staff may be trained to administer medications by delegation from an RN in accordance with regulations and Vermont’s Nurse Practice Act.
West Virginia Only licensed staff may administer or supervise the self-administration of medication by residents. As of July 1999, Approved Medication Assistive Personnel (for which specific training and testing is required) can administer medications in the facility.
Virginia Medications may be administered by licensed individuals or by medication aides who have successfully completed a Board of Nursinge approved training program, have passed a competency evaluation, and are registered with the Virginia Board of Nursing. Medication aides are permitted to act on a provisional basis when certain requirements are met. Each facility must have a written plan for medication management. A licensed health care professional must perform an annual review of all the medications of each resident assessed for residential living care, except for those who self-administer all of their medications, and a review every 6 months of all the medications of each resident assessed for assisted living care. Washington 1) All boarding homes must provide medication assistance services (differentiated from Geriatric Nursing, Volume 33, Number 4
Wisconsin Community-based residential facility: medication administration and management are performed by licensed nurses or pharmacists unless medications are packaged by unit dose. All direct-care staff and administrative personnel must complete an 8-hour approved medication administration and management course. Residential care apartment complex: medication administration and management must be performed by a nurse or as a delegated task to unlicensed staff, under the supervision of a nurse or pharmacist. Adult family home: all prescription medications must be securely stored in the original container. Before a licensee or service provider dispenses or administers medication to a resident, the licensee must obtain a written order from the prescribing physician. The order must specify who by name or position is permitted to administer the medication and under 304.e8
what circumstances the medication is to be administered. Wyoming Residents are permitted to self-medicate or receive medication assistance including, but not limited to, reminders, assistance with removal of cap or medication, and observation.
The “Right” Rx The “right” Rx involves more than ensuring the right resident takes the right medication and the right dosage, at the right time using the right route; it also involves making sure the medication is not only what was prescribed but that it is an appropriate medication for that resident. In ALs, several issues may result if the resident is not receiving the most appropriate medication. To provide direction regarding appropriate medications, ALs would be well served to follow the guidance provided in the Beers Criteria.2 The Beers Criteria is a clinical tool that is based on the originally conceived work of Dr. Mark Beers, first published in 1991. This tool was developed to assist health care providers in improving medication safety in older adults. Last year, the American Geriatric Society (AGS) undertook the task of updating the criteria. AL nurses should be familiar with this revised Beers Criteria so that they can properly assess AL residents, as well as advise them, their caregivers, and attending physicians regarding potentially dangerous medication issues. Some of those issues identified in the AGS Beers Criteria that may be common in ALs include the use of OTC agents such as the following:
Mineral oil Aspirin Nonsteroidal anti-inflammatories (NSAIDs) H2-receptor antagonists Anticholinergics Caffeine
Identifying the use of these OTCs and making recommendations based on this Beers Criteria could improve the health outcomes for AL residents. These specific recommendations include avoiding aspirin and NSAIDs, which can exacerbate existing ulcers or cause new or additional ulcers, for AL residents with a history of gastric or 304.e9
duodenal ulcers unless alternatives are not effective and the patient can take a gastroprotective agent (proton-pump inhibitor or misoprostol). Also, it is recommended that NSAIDs be avoided for AL residents with Stage IVeV chronic kidney disease because these agents may increase the risk of kidney injury. The criteria also note that aspirin should be used with caution in adults aged over 80 years because of the lack of evidence of benefit versus risk in these individuals. Mineral oil is noted in the gastrointestinal section, where it suggests that it be avoided because of the potential for aspiration and adverse effects; safer alternatives are available. H2-receptor antagonists and anticholinergic medications should be avoided in AL residents with dementia and cognitive impairment. This is recommended because of adverse central nervous system (CNS) effects associated with H2-receptor antagonists and anticholinergics. Although not often thought of as a medication, caffeine is included in the Beers Criteria. It is recommended that AL residents with insomnia avoid caffeine because of CNS stimulant effects. Beyond the Beers Criteria, ensuring that older adults are not receiving inappropriate psychotropic medications is another issue of concern. Although this has primarily focused on nursing home care, the May 2011 report from the Office of the Inspector General (OIG) has moved the Centers for Medicare and Medicaid Services (CMS) also to focus attention on ALs. The OIG found that some 14% of elderly nursing home residents had Medicare claims for atypical antipsychotic drugs and 83% of Medicare claims for atypical antipsychotic drugs for elderly nursing home residents were associated with off-label conditions. Specifically, some 88% were associated with the condition specified in the Food and Drug Administration boxed warning. Besides the clinical implications, the OIG states that 51% of Medicare atypical antipsychotic drug claims for elderly nursing home residents fall into the category of inappropriate use, and thus $116 million annually is being wasted. As a result of these findings, the OIG recommended (http://oig.hhs.gov/oei/reports/oei-07-0800150.asp) that CMS assess whether survey and certification processes offer adequate safeguards against unnecessary antipsychotic drug use in nursing homes, explore alternative methods beyond survey and certification processes to promote compliance with federal standards Geriatric Nursing, Volume 33, Number 4
regarding unnecessary drug use in nursing homes, and take appropriate action regarding the claims associated with erroneous payments. As ALs find themselves under increasing regulatory oversight, the rules currently affecting nursing homes will likely find their way into the AL setting. ALs that recognize the need to manage antipsychotic medications to ensure their appropriate use will not only be helping their residents but will be prepared to deal with the increased medication monitoring that is likely to come soon.
Taking the Medicine Many states have developed guides that cover the necessary components of “assistance with self-administration.” One such guide is available from the state of Florida.3 The American Medical Directors Association has also developed guidance regarding the taking of medications by AL residents.
The American Medical Directors Association Medication Management in Assisted Living 4 Basic Principles Minimize changes and the number of medications when possible. Understand the medication management program in AL (e.g., cycles). Avoid telephone orders; only licensed nurses can take verbal orders. Don’t shoot the messenger: the onslaught of numerous prior authorizations are mandated by payors, not the pharmacies that make the follow-up call. OTC medications often require physician orders and are as regulatory-sensitive as prescription medication. Collaborative practice with trained pharmacist can minimize the number of times that pharmacy needs to call prescribers.
Prescribing Tips Make sure you have a complete medication list before adding or change. Regarding the start date on prescription, remember that not every medication has to be delivered STAT. Geriatric Nursing, Volume 33, Number 4
Add a 365-day refill for maintenance medications; this will eliminate repeated calls for refills. Be careful to handle D/C (discontinue) orders with as much formality as new prescriptions. Minimize PRN (as needed) orders: cycled maintenance medications are much easier to manage, and caregivers often cannot exercise discretion regarding state regulations. No ambiguous “sigs” (e.g., i-ii tabs Q4-6H): caregivers often cannot understand these and will require additional calls to prescribers. Be careful regarding “look-alike or soundalike” medications. Schedule II controlled substance orders require hard copy to be delivered to the pharmacydthis is difficult to manage STAT. Consider schedule III controlled substance alternative for the first 24 to 72 hours, if appropriate. Weigh benefit of reduced dosing frequency to minimize errors and to improve adherence (e.g., daily, or QD, brand versus three-times daily, or TID, generic). Regarding the taking of one’s medication, this guide recommends a MOR medication observation record. A MOR is required to be kept for each resident who receives assistance with medications. The MOR must include the following: the name of the resident, any known allergies the resident has, the name and telephone number of the resident’s health care provider, the name of each medication prescribed and its strength and directions for use, a record of each time the medication was taken, and a record of any missed dosages, refusals to take medications as prescribed, or medication errors. Although the MOR works well to help cue the AL staff on administration times and documentation of the AL resident taking their medication, there are devices that can assist those residents who do not require direct AL staff oversight. These are particularly useful in situations in which the patient’s medications must be stored in a resident’s room (e.g., Massachusetts) or when there are self-medicating residents with complex medication regimens. Devices such as TabSafe can be filled by AL staff or the pharmacy. The pharmacy fills cartridges with a residents’ medication, and these cartridges are then loaded into the device, which prompts the AL resident to 304.e10
take his or her medication at the designated time. The device has a user-friendly Web interface that allows caregivers to check reports and make all changes to reminders remotely. The device alert calls are both proactive and nonintrusive, calling before a medication is missed while eliminating the need for repeated calls to ask, “Did you take your pills yet?” The device handles PRN meds and prevents overmedicating, provides interactive medication dose change or discontinuance when a prescription changes, maintains each medication’s inventory, automatically alerts for reorder, and digitally downloads each transaction for reports and analysis: “When released, what med, quantity, who released.” Web-accessible reports allow for the management medication regimen adherence via any Internet browsing device. Many scheduling options are available, including specific days of the week and other unique dosing patterns.
Disposal Circumstances may arise in AL facilities that require medications to be removed from the premises (e.g., medication order changes, expired medications, adulterated or contaminated medications, resident discharge, resident death). The amount and number of medications, the available options for removing them, and concerns for the environment have led AL facilities to seek guidance on how medications should be disposed of. Some facilities have asked about outside sources picking up medications for removal and how this should be handled. Many states require that a resident’s prescription medication be destroyed within 72 hours of a practitioner’s order discontinuing its use, the resident’s discharge (unless the resident needs the medication at a new location), the resident’s death, loss of medication dosage form integrity, removal of the medication from the its packaging, or medication expiration. In addition, records of all medication returned to the pharmacy for credit or destruction must be kept. Any medication not returned for credit or destruction will be destroyed in the facility, and a record of the destruction must be witnessed, signed, and dated by at least 2 of the following: the administrator or designee, an RN or a pharmacist, and 1 other employee. Controlled substances can only be in the possession of Drug Enforcement Administration 304.e11
(DEA) registrants, law enforcement, and consumers (AL residents) who have a prescription for the substance or the facility where the residents are residing. Typically, physicians, pharmacies, and hospitals are DEA registrants. Federal law currently prohibits controlled substances to be returned from a non-DEA registrant, such as a resident in an AL facility, to a DEA registrant, such as a pharmacy. Therefore, all controlled substances need to be destroyed. It is important to note that destroying medications by washing them down the drain or flushing them down the toilet and into the wastewater is highly discouraged, because wastewater treatment plants do not remove medications. Drug components can harm plants and animals that live downstream. Furthermore, it may be illegal to flush certain hazardous medications. Also, medications should not be placed in infectious waste containers. It is not appropriate (nor is it cost-effective) to put medications, empty medication bottles, or empty insulin or vaccine vials in sharps containers or biohazard waste bags. It is no longer true that most infectious waste is incinerated; typically these wastes are disinfected and put in a landfill. Although medications that are considered hazardous waste are regulated by both state and federal regulations, Wisconsin has authority to run the federal program in Wisconsin. Hazardous waste includes items that are listed by name in the regulations or that exhibit characteristics of hazardous waste. Common hazardous waste medications include epinephrine, Coumadin, vaccines preserved with thimerosal, and even certain shampoos and vitamins/minerals. An estimated 5% to 15% of medication waste may be hazardous. A reputable hazardous waste hauler can help you separate them. Needles can be detached from an intravenous delivery device in accordance with worker safety regulations; only the needle needs to be managed as infectious waste. In most cases, syringes are empty after use. Medications that are considered solid waste can generally be handled like other garbage. A potential problem with disposal via general garbage is that medications can pose safety risks to individuals who inappropriately access the garbage and expose themselves to the medications. In addition, medications that go to a landfill may leach to the groundwater system or be extracted and taken through a wastewater treatment plant. Geriatric Nursing, Volume 33, Number 4
Therefore, department of natural resources recommends that solid waste medications be routed to a licensed municipal solid waste incinerator or hazardous waste incinerator. The preferred practice is to have a waste hauler take medications to a medical waste or hazardous waste incinerator. The solid waste hauler may have appropriate containers and specific procedures for disposing of medications. If that method of disposal is not available, place the medications in a container that can be sealed. Add a small amount of water to the medication to make a slurry. Add cat litter, plaster of Paris, or some other absorbent material to the slurry. Finally, seal the container and place the container in the garbage. Remove or obliterate any labels identifying the container as containing medications.
The Future of AL Medication Management As ALs increasing take on a higher-acuity residents, including a growing number that are eligible for nursing home level of care, the need to raise the level of medication management will increase. Along with this demand is a regulatory move to provide for benefits based on patient needs rather than simply location of care. Often times referred to as “benefit following patient,” this approach calls for the benefit being based on the patient need rather than the place of care. For example, if an AL resident meets the criteria for nursing home level of care, why shouldn’t that person have access to similar benefits as if he or she were in the nursing home? With regard to medication management, the benefits provided to nursing home residents include the following: Drug regimen review by a consultant pharmacist on at least a monthly basis Specialized medication packaging provided through an institutional pharmacy provider Careful documentation of medication administration through a medication administration record (MAR) Assurance of the “right medication for the right patient at the right dose and duration”: this is especially true for psychotropic medications
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In preparation for this increased resident need and regulatory focus on medication management, AL nursing staff is advised to proactively move in this direction. Of course, like so many opportunities and challenges in ALs, this is best accomplished through an interdisciplinary team approachdin the area of medication management, this includes a consultant pharmacist, physicians, and nurse practitioners. This team would be best positioned to provide the level of care needed today and that is likely to be required in the near future. AL residents will be better assisted as a result. For additional educational opportunities on this topic, visit http://medmanagement.umaryland. edu/assisted_living.
References 1. American Health Care Associates. State assisted living regulatory/policy changes in 2011: analysis of NCAL findings. March 2012. Available at www.ahcancal.org/ ncal/resources/Documents/Summary%20-%20regulatory %20changes%20in%202011.pdf. Cited May 15, 2012. 2. The American Geriatrics Society 2012 Beers Criteria Update Expert Panel. American Geriatrics Society updated Beers Criteria for potentially inappropriate medication use in older adults. 2012. Available at www. americangeriatrics.org/files/documents/beers/2012 BeersCriteria_JAGS.pdf. Cited May 15, 2012. 3. PEGCO, Inc. Assistance with self-administered medications study guide for assisted living facility and home health staff. Available at www.pegcoinc.net/alf_ study_guide.htm. Cited July 2, 2012. 4. AMDA. Multidisciplinary medication management manual. Available at http://www.amda.com/resources/ print.cfm. RICHARD G. STEFANACCI, DO, MGH, MBA, AGSF, CMD, is an Associate Professor in Health Policy & Public Health at the University of the Sciences in Philadelphia, PA. He also serves as Chief Medical Officer of The Access Group and maintains an active clinical practice at PACEda Program of All-Inclusive Care for the Elderly in Philadelphia, PA. DANIEL HAIMOWITZ, MD, FACP, CMD, is an Internist/ Geriatrician in private practice in Levittown PA, and an Assisted Living Medical Director at Arden Courts of Yardley, PA and Brunswick at Attleboro in Langhorne, PA. 0197-4572/$ - see front matter Ó 2012 Mosby, Inc. All rights reserved. http://dx.doi.org/10.1016/j.gerinurse.2012.06.008
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