Taking the Pain Out of Compliance with F-Tag 329: Meeting the Challenges Through Collaboration, Part I
- Mon, 10/13/08 - 12:05pm
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Dana Saffel, PharmD, CGP, and Steven Levenson, MD, CMD
Nursing facilities and physicians are still trying to interpret and address the expectations related to CMS’ December 2006 update of the Unnecessary Drug Surveyor Guidelines (F-TAG 329). Numerous medications are available, and the medication regimens of most nursing home residents are lengthy. The challenge for the practitioner is to identify a safe, effective medication regimen that minimizes the risk of having adverse consequences. In addition, both the practitioner and facility are expected to identify and address significant adverse medication consequences. This two-part article reviews several strategies for compliance, based on effective use of the care delivery process and a productive alliance between the practitioner, the consultant pharmacist, and other key facility leadership. (Annals of Long-Term Care: Clinical Care and Aging 2008;16:29-34)
This is part I of a two-part article. Part II will appear in the next issue of the Journal.
Pharmacotherapy is a vast topic with a huge literature. Numerous medications are available, and many of them have diverse uses. Most nursing home residents take many medications, which have been initiated in various settings by a variety of healthcare practitioners. Depending on a number of factors, medications can potentially improve or worsen patient outcomes and care burden.
In December 2006, the Centers for Medicare & Medicaid Services (CMS) issued updated guidance for nursing home surveyors on the topic of medications.1 This update was a comprehensive overhaul of previous guidance on the subject.
The F329 guidance emphasizes the use of medications in the proper context, to try to provide the greatest possible benefit with the least possible harm. It promotes scrutiny of the entire medication regimen, for both short-stay and long-stay residents. It directs surveyors to seek more specific information about the clinical basis for a decision to use medications, not just a diagnosis or a declaration that the patient needs it. In addition, it reinforces the intent of the original regulation to balance the risks and benefits of all medications, not just psychopharmacologic medications.
Although physicians and consultant pharmacists are the primary disciplines involved in selecting and evaluating medications, the guidance emphasizes a facility-wide responsibility for safe and effective medication use. An interdisciplinary approach is desirable because medications impact all aspects of care, and the input of various disciplines can provide additional insights into the patient’s need for and response to medications.
To these ends, the F329 guidance promotes the care process, including pertinent discussions among the staff, patients, families, and practitioner about the causes of symptoms and the potential benefits and risks of medications, and a thorough search for, and review of, the background for a medication regimen (ie, when and why a medication was initiated, added, or changed).
Part I of this article discusses managing the challenges to healthcare practitioners, reviewing and understanding the surveyor guidance, and respecting the evidence about medications. Part II will discuss the care process, including considerations related to tapering medications, and provides case examples related to improving F329 compliance.
Challenges to the Facility and Healthcare Practitioners
Some healthcare practitioners, consultant pharmacists, and nursing home staff have readily endorsed the new guidance and incorporated its clinically sound approach into medication considerations. Others agree that they should be meeting its requirements, but are concerned about how they are going to comply in the face of limited time and reimbursement. Still others dismiss the guidance as an unfounded intrusion into their current clinical practices.
For practitioners who wish to comply, additional challenges abound.
1. State operations provider certification. Centers for Medicare and Medicaid Services Website. http://www.cms.hhs.gov/transmittals/downloads/R22SOMA.pdf. Accessed June 11, 2008. 2. Gurwitz JH, Field TS, Avorn J, et al. Incidence and preventability of adverse drug events in nursing homes. Am J Med 2000;109(2):87-94. 3. Field TS, Gurwitz JH, Avorn J, et al. Risk factors for adverse drug events among nursing home residents. Arch Intern Med 2001;161(13):1629-1634. 4. Gurwitz JH, Field TS, Judge J, et al. The incidence of adverse drug events in two large academic long-term care facilities. Am J Med 2005;118(3):251-258. 5. Golomb BA, McGraw JJ, Evans MA, Dimsdale JE. Physician response to patient reports of adverse drug effects. Drug Safety 2007;30(8):669-675.