Recently, regulations governing long-term care facilities (LTCF) have undergone the biggest update in the past two decades. These changes are so vast in number and scope that they are commonly referred to as the “Mega-rule.”
They are being gradually phased in over a three-year period which began on November 28, 2016. Phase I was relatively minor in pharmacy service, but some of the Phase II changes, implanted on November 28, 2017, are far more significant.
These regulations are published by CMS as “F-Tags” and are accompanied by more detailed guidelines that are written to help State surveyors interpret and enforce the regulations.
Drug Regimen Review (DRR) must be performed at least monthly by a pharmacist.
Drug Regimen Review (DRR), performed by pharmacists, has been a requirement since 1974. This important clinical role has been shown to promote optimal drug therapy. Now, newly labeled F756 continues the mandate that DRR be performed at least monthly by a pharmacist but further clarifies that the DRR must include a review of the resident’s medical chart. This F-Tag also requires that consultant pharmacists document any drug therapy “irregularities” and report the specifics of each irregularity to the attending physician, the medical director and the director of nursing.
Addresses the concepts of “Unnecessary Drugs” and continues the requirement for gradual dosage reduction of psychotropic medications.
“Unnecessary Drugs” as well as F758 “Psychotropic medications/prn use,” both implemented in Phase 2 of the Mega-rule, will have a significant impact on medication use in LTCFs. Together, these F-Tags define and address the concept of “Unnecessary Drugs” and continue the requirement for gradual dosage reduction (GDR) of psychotropic medications that was stipulated in the former F329. However, the term “psychotropic medications” now includes antipsychotics, antidepressants, anti-anxiety agents and hypnotics as well as, ”any drug that affects brain activities associated with the mental process and behavior.”
During Drug Regimen Review (DRR), the consultant pharmacist will help identify and flag, orders for antibiotics that are not consistent with antibiotic stewardship practices.
Nursing homes must have an antibiotic stewardship program that includes antibiotic-use protocols and a system to monitor antibiotic use as part of their infection prevention and control program (IPCP), according to §483.80 (Infection Control) of the Code of Federal Regulations. The antibiotic stewardship program is another component of the Phase 2 rollout of the Reform of Requirements for Long-term Care Facilities, and surveyors will assess compliance with this new requirement of participation under F881 during the Infection Control Facility Task that is a mandatory part of the new survey process. Antibiotic Stewardship refers to a set of commitments and activities designed to optimize the treatment of infections while reducing adverse events associated with antibiotic use.
Core elements for Antibiotic Stewardship in Nursing Homes consists of:
Leadership | Accountability | Drug Expertise | Action | Tracking | Reporting | Education
During Drug Regimen Review (DRR), the consultant pharmacist will help identify and flag, orders for antibiotics that are not consistent with antibiotic stewardship practices. Pharmacy DRR – Antibiotic Stewardship UDA in Point Click Care will be utilized to create flow sheet for Action, Tracking, and Reporting of data regarding antibiotic usage in the facility. The consultant pharmacist will work with the physician, preventionist, and DON to review microbiology culture data (antibiogram) and make recommendations to the providers to help educate and guide in appropriate antibiotic selection. The consultant pharmacist shall assist the facility in developing a list of appropriate antibiotics and quantity to be kept in the Emergency Drug Kit. The consultant pharmacist shall participate in the Antibiotic Stewardship Committee meetings on a regular basis.