Facilities can foster a holistic, resident-centered approach to medication management by heeding updated federal guidelines

       Editor’s note: This is the fifth in a series of articles related to topics presented at the 2007 Symposium on Regulatory Issues for Management in Long-Term Care (SORIM LTC). For more information, visit www.SORIMLTC.com.

M

edications and pharmacy services are a critical part of the care provided to residents in nursing homes. Throughout the years, the focus has been on medications that may be inappropriate for nursing home residents through the utilization of the Beers criteria. Now the paradigm of care has shifted, moving to the appropriate use of medications. This is a much more complicated process in that it requires the coupling of knowledge surrounding the medication and each individual resident. This process needs to be incorporated into the existing care provided at the facility. This article will highlight to the reader what updates have been made regarding the federal tags (F-Tags) related to pharmacy within the Centers for Medicare & Medicaid Services (CMS) State Operations Manual (SOM) and what implications it may have at the facility level.

The Changes: Where and How?

       Numerous changes have been made in various sections of the SOM regarding pharmacy issues. The first change is within Appendix P, Survey Protocol for Long-Term Care Facilities, which now couples F329 (Unnecessary Medications) and F428 (Medication Regimen Review). The second change is at Task 5—especially 5E, which now evaluates not only the medication pass but pharmacy services (F425), including storage, labeling,

Table 1

and controlled medications (F431). The other change is at Appendix PP, Interpretive Guidelines for Nursing Home Surveyors, at F329, F425, F428, and F431. It is important to stress that the regulations categorized by F-Tags have not changed, but they have been combined (see Table 1).
       The process by which these changes have been made is very involved. The first document, which was developed by stakeholders (eg, the American Health Care Association, American Society of Consultant Pharmacists, and American Medical Directors Association), was released for public comment on October 2004. The comments were collected, and the expert panels reconvened in April 2005. Due to the significant number of comments received during the first comment period and subsequent revisions, a second draft was released in September 2005. The expert panels reconvened again in December 2005 and January 2006, and the final documents were released in September 15, 2006. The effective date of implementation was December 18, 2006. It is important to note that there have been numerous opportunities to provide feedback along the way. To follow is a look at changes to the specific F-Tag guidance to surveyors.

F329: Unnecessary Medications

       The regulations at F329 state that each resident’s medication regimen must be free from unnecessary medications. An unnecessary medication is any medication used: in excessive doses (including duplicate therapy); for excessive duration; without adequate monitoring; without adequate indications for its use; in the presence of adverse consequences, which indicate that the dose should be reduced or discontinued; or any combinations of the reasons above.
       In addition, the regulations state that the facility must ensure that residents who have not used antipsychotic drugs are not given these drugs unless antipsychotic drug therapy is necessary to treat a specific condition as diagnosed and documented in the clinical record, and that those who use antipsychotic drugs receive gradual dose reductions and behavioral interventions (unless clinically contraindicated) in an effort to discontinue these drugs.

Table 2

       The guidance moves the surveyor away from looking at a list of inappropriate medications based on the Beers criteria to a more comprehensive evaluation of the resident based on the care process. When we look at medication management within the care process, it includes but is not limited to: recognition or identification of the problem or medical condition; assessment; defining the etiology of the problem; management and treatment; and monitoring and then revising interventions. Within the guidance, the process was further defined by breaking down each of the medication management considerations (see Table 2).
       The medication management domain that has received the most attention is gradual dose reduction and tapering. This is a complicated topic in that it truly requires the team approach to clearly define the continued need of all medications. Due to the regulations,

Table 3a

facilities as well as surveyors have historically focused on antipsychotics. Yet with the updated guidance at F329, there are tables highlighting medications that may be problematic for residents in nursing homes depending on their medical and medication history. (See tables 3a and 3b for changes that have been made to the guidance regarding gradual dose reduction and tapering.)

Table 3b

       There are numerous opportunities during the care of a resident to evaluate all medications for appropriateness, such as during the pharmacist’s review of the medication regimen, the physician’s visit or signing of orders, or the quarterly Minimum Data Set (MDS) review. It is important to evaluate the resident’s target symptoms and the effect of the medication on symptoms (eg, severity, frequency), changes in the resident’s function during the previous quarter, and whether he or she experienced any medication-related adverse consequences during the previous quarter.
       Let us consider a case example. R.M. is a 79-year-old woman who has been at your facility for the last three months. She has a five-year history of dementia as well as recurring urinary tract infections (UTI). The staff notes that she is more confused over the last two days and combative with her roommate. This is a not a new behavior for her, but it has become worse, and the staff is concerned about the safety of the other resident. R.M. was started on a low dose of haloperidol to calm her agitation after the nurse on duty reported the behavioral change to the attending physician. Her other medications consist of donepezil for dementia, nitrofurantion for UTI prophylaxis, risperidone for agitation, and baby aspirin for prevention. Since the addition of the haloperidol, she is more lethargic and confused and has fallen twice.
       This may seem like an obvious case, but it illustrates the importance of looking at the resident and medications in a systematic way. First, the initiation of haloperidol in this resident may be considered unnecessary due to the fact that reversible causes (eg, a new UTI) have not been ruled out and because the resident is already on one antipsychotic for the same behavior (ie, duplicative therapy). Coupled with the presence of the adverse consequences of lethargy and confusion, it stresses the importance of the facility staff reassessing the continued need of this medication. This case leads nicely into the guidance at F428, which discusses the medication regimen review (MRR).

F428: Medication Regimen Review

       The regulation at F428 states that the drug regimen of each resident must be reviewed at least once a month by a licensed pharmacist, that the pharmacist must report any irregularities to the attending physician and the Director of Nursing (DON), and that these reports must be acted upon. It is important to first define what a medication regimen is. The guidance document states it is a “thorough evaluation of the medication regimen of a resident, with the goal of promoting positive outcomes and minimizing adverse consequences associated with medications. The review includes preventing, identifying, reporting, and resolving medication-related problems (MRPs), medication errors, or other irregularities and collaborating with others members of the interdisciplinary team.” Given this definition, it is important to note that the document also states: “This guidance is not intended to imply that all adverse consequences related to medications are preventable, but rather to specify that a system exists to assure that medication usage is evaluated on an ongoing basis.”
       The MRR needs to be done monthly or more frequently, depending on the resident’s condition and risks for adverse consequences related to his or her current medications. The MRR is usually done within the facility because important information may be attainable only by talking to staff, reviewing the paper chart, and observing and/or speaking with the resident. However, new technology (eg, electronic health records [EHR]) may permit the pharmacist to conduct some components of the review outside of the facility. It is important to note that the pharmacist is expected to document either that no irregularity was identified or the nature of any that were identified. If there were no irregularities, the pharmacist would include a signed and dated statement to that effect.
       The timeliness of the notification depends on the significance of the irregularities. The pharmacist should collaborate with the facility to identify the most effective means of notification and documentation, which may be done electronically. These finding are part of the clinical record and must be available for other healthcare professionals to utilize. The physician must either accept the recommendation and act or reject the recommendation and provide a brief explanation (eg, in a dated progress note).
       States the guidance: “It is not acceptable for a physician to document only that he/she disagrees with the report without providing some basis for disagreeing.” Also, direct care issues that do not require physician intervention can be addressed by the DON or designated nurse.

F425: Pharmaceutical Services

       The regulations at F425 note that the facility must: provide routine and emergency medications and biologicals to its residents or obtain them under an agreement; provide pharmaceutical services, including procedures that assure the accurate acquiring, receiving, dispensing, and administering of all medications and biologicals to meet the needs of each resident; and employ or obtain the services of a licensed pharmacist who provides consultation on all aspects of the provision of pharmacy services in the facility. In addition, the facility may permit unlicensed personnel to administer medications if state law permits, but only under the general supervision of a licensed nurse.
       With the implementation of Medicare Part D as well as the numerous avenues in which residents can receive their medications, F425 is important guidance for facilities to look at to ensure appropriate pharmaceutical services are provided. In providing quality care, the facility needs to ensure through discussions and collaboration with the pharmacy provider(s) that issues (eg, a lack of pain medication for a new admission who is in severe pain or a delay in treating an infection due to an inability to get the antibiotics) do not arise.
       The pharmacist is integral in developing procedures with the facility that may address: coordination of pharmaceutical services if multiple providers (eg, multiple pharmacies, hospice) are utilized; the inventory in the emergency supply kits; and the effectiveness of the medication pass as well as the MRR. The pharmacist is an important part of the team when it comes to improving medication management and pharmacy services in your facility.

F431: Storage, Labeling, and Controlled Medications

       The regulations at F431 note the facility must employ or obtain the services of a licensed pharmacist who establishes a system of records of receipt and disposition of all controlled medications in sufficient detail to enable an accurate reconciliation and determines that medication records are in order and that an account of all controlled medications is maintained and periodically reconciled. The regulations go on to discuss that medications and biologicals used in the facility must be labeled in accordance with currently accepted professional principles. They also include the appropriate accessory and cautionary instructions and expiration date when applicable. In addition, medications and biologicals must be stored in accordance with state and federal laws/requirements, and the facility must store all in locked compartments under proper temperature controls and permit only authorized personnel to have access. Specifically for controlled medications, the facility must provide separately locked, permanently affixed compartments for storage except when the facility uses single-unit package medication distribution systems in which the quantity stored is minimal and a missing dose can be readily detected.
       Key points to consider when reviewing this guidance include: how your facility labels medications that are administered multiple times (eg, an inhaler, eye drops); who has access to the medications; and whether your medications are being stored and handled according to manufacturer specifications, state requirements, and standards of practice (eg, the United States Pharmacopiea [USP]). These types of issues will now be evaluated during the medication pass, which is part of the revised survey protocol in Appendix P, Task 5.

Conclusion

       As discussed throughout this article, the regulations themselves have not changed—only the guidance to the surveyors as well as the investigative protocols have. All in all, these updated guidelines take a holistic approach to medication management that stresses the importance of incorporating medications into the resident-centered care process. The changes have increased the awareness of the impact of medications on the resident. This is the time to update and utilize your policies and procedures regarding pharmacy services. Pay attention to the impact medications have both positively as well as negatively on your resident, and read the changes in the SOM at www.cms.hhs.gov/manuals/downloads/som107_Appendicestoc.pdf. To stay current, periodically check the Survey and Certification (S&C) Memos to States/Regions online at www.cms.hhs.gov/SurveyCertificationGenInfo/PMSR/.