One of the key components for meeting the CMS requirements for the proper provision of pharmaceutical services is the requirement to properly store medications. First, we address the general requirements of medication storage. Second, we address the specific requirements for medication rooms and refrigerators. According to F-Tag 761, facilities must store all drugs and biologicals in locked compartments under proper temperature controls and permit only authorized personnel to have access to the keys. A facility, in coordination with a licensed pharmacist, which is generally its consultant pharmacist, must provide safe and secure storage, limited access, and mechanisms to minimize loss...
Medication Rooms and Refrigerators
Ensuring a medication room is always ready for survey requires minimal effort but requires constant vigilance. Starting with security, medication storage areas must be locked when not being accessed by an authorized person. Schedule II-controlled substances must be maintained within a separately locked permanently affixed compartment (double lock requirement). Proper labeling is also required for proper storage. Facilities must ensure medications and biologicals are properly labeled in accordance with currently accepted professional principles, including expiration dates. During the survey process, surveyors focus not only on security and the general cleanliness and organization of medication rooms and refrigerators, but also on...
Unnecessary Drugs
One of the areas often cited under Pharmaceutical Services during survey is Unnecessary Drugs, which now falls under F757 in the updated State Operations Manual (SOM). The F-Tag states that “Each resident’s drug regimen must be free from unnecessary drugs”. The term Unnecessary Drug is often misunderstood, incorrectly used and poorly applied. Upon hearing it for the first time, most assume that it refers to using a medication without an appropriate diagnosis. Although using a medication without an appropriate diagnosis would be considered unnecessary, a diagnosis alone does not justify the use of any medication or keep it from being...
Practical examples of Unnecessary Drugs
The most obvious example of a situation that could include an Unnecessary Drug is when a patient is admitted or a new medication is started and a proper diagnosis is not noted in the medical record. We encourage you to add all diagnoses to one central list, even if the diagnosis can be found in other parts of the medical record. Excessive dose happens more frequently than we realize. Although medication references list maximum daily dosages, those maximums are often different for the geriatric population and sometimes also differ based on the condition being treated. It is important to ensure...
New Clostridium Difficile Guidelines
A lot has changed in the diagnosis and treatment of Clostridium Difficile Infection (CDI) since the Infectious Disease Society of America (IDSA) and the Society for Healthcare Epidemiology of America (SHEA) last published guidelines in 2010. The new guidelines recommend the development of an antibiotic stewardship program, which should focus on reducing the frequency and duration of the use of high-risk antibiotics. Specifically, restriction of fluoroquinolones, clindamycin, and cephalosporins (except for surgical antibiotic prophylaxis) should be considered. Although probiotics are commonly seen during the treatment of CDI, the current guidelines state that there is insufficient data to support this practice...
Antibiotic Stewardship
There were two important changes that took place when Phase Two of the CMS “Mega Rule” became effective on November 28, 2017: 1) limiting PRN psychotropic medication orders to 14 days and 2) implementing an Infection Prevention and Control Program (IPCP) that includes an Antibiotic Stewardship Program. Last month we discussed specific limits on PRN psychotropics. This month we will discuss antibiotic stewardship and what you must do to be compliant. CMS requires facilities to establish an infection prevention and control program (IPCP) that must include, at a minimum, an antibiotic stewardship program. The goal of the program is to...
The “Mega Rule”
At this point everyone has heard of the so-called CMS “Mega Rule” or the nursing home Requirements for Participation, and the resulting changes. On September 28, 2016, CMS issued the Mega Rule with a three-phase implementation. Phase 1 became effective on November 28, 2016. Phase 2 became effective on November 28, 2017, and Phase 3 will become effective on November 28, 2019. During Phase 1 we talked about the need for the pharmacist to perform a drug regimen review (DRR) for each resident at least once a month and for a report to be provided to the attending physician, Director...
The OctariusRx Story
Octarius: A pint in the apothecaries’ system.
OctariusRx: The standard by which all other consultant pharmacists are measured.
My life goal has always been to help people. I didn’t always know how, but I always knew the goal: to help others.