In 2016, the Centers for Medicare & Medicaid Services (CMS) introduced the Final Rule, a set of new regulations that significantly impact LTC pharmacy services. The most taxing phase of the Final Rule, Phase 2, went into effect in November 2017. While Phase 1 introduced a number of important medication-related changes that affect LTC pharmacy and residents, Phase 2 is far more complex. It involves several pertinent medication-related topics. Before the implementation of Phase 2, we explored the implications of some of the coming medication-related changes. In particular, we examined topics concerning psychotropic medications. But to ensure you’re prepared, we wanted offer an updated, in-depth review of some of the most fundamental medication-related changes. Let’s take a look.
Final Rule Phase 2’s Impact on LTC Pharmacy Services: New Regulations Regarding Crushed and Enteral Tube Medication Administration
The administration of crushed and enteral tube medications has been a hot topic. One cannot combine and administer crushed medications all at one time, either orally or via feeding tube. As such, the advanced copy of Appendix PP and Surveyor Guidance indicates that SNF staff members are to administer each crushed oral medication separately. So each deliver each medication for residents, for example, in a separate applesauce or pudding supply.
While CMS believes this practice to be the standard, many in the industry hold that CMS’ approach may not be ideal for all residents. Because of this, failing to administer these medications separately will not be considered a medication error. That is, unless one does not follow specific instructions about crushing and administering the medication.
Compliance With New Regulations
To stay in compliance with the new regulations, it’s important for Skilled Nursing Facilities to keep the following updates top-of-mind:
- Oral medications— As part of Phase 2 changes, administering crushed medications orally is more person-centered. No medication error results if one administers medications together. However, appropriately documenting residents’ desires related to medication administration is advisable.
- Enteral tube medications— Enteral tube administration requires flushing between each medication. If not, a medication error counts for each medication without a flush in between.
With that in mind, a facility is not required to flush between medications. There could be a physician’s order specifying a different flush schedule due to fluid restriction. It could also specify the amount of water needed for flushing due to fluid regulation.
A prescriber could order crushed medication but the manufacturer states that they should not crush the medicine. Then, the prescriber or pharmacist must explain in the resident’s clinical record why crushing it will not adversely affect the resident. Moreover, the pharmacist should inform the facility staff to observe the resident for adverse effects. The Medication Regimen Review process addresses this, which we’ll cover momentarily.
The new standards for the administration of these medications are to ensure the safety of the resident. Also, they are to prevent adverse effects from combining multiple medications. These updates focus on providing person-centered care. So it’s encouraged, when possible, to separate crushed medications to provide the best resident care.
Final Rule Phase 2’s Impact on LTC Pharmacy Services: Medication Regimen Review Changes and Recommendations Follow-up
Many long-term care residents have multiple disease states that require numerous medications. This leads to medication regimens that are complex and have the potential to increase residents’ risk for adverse reactions. One way to potentially minimize these adverse reactions is to use a Medication Regimen Review, provided by a consultant pharmacist. These reviews may help prevent drug interactions as well as help identify omissions, duplications of therapy, and miscommunication between care providers.There are two key focus points of Phase 2 changes to the Medication Regimen Review requirement:
- Helping residents maintain their highest level of function
- Preventing or minimizing adverse consequences related to medication therapy
To be compliant with these integral changes, facilities will need to provide the following:
A licensed pharmacist’s review of each resident’s medication regimen at least once a month
- The consultant pharmacist’s review will include a review of the resident’s complete medical record/chart.
Consulting pharmacists will review all admissions, including residents not expected to be in the facility. Any findings for new admissions or re-admissions will be sent to the Director of Nursing within seven business days of admission.
More frequent reviews of medication regimens
- A consultant pharmacist will review the medication regimen of a specific resident. Any member of the interdisciplinary team will do this upon request. This is based upon a change in resident status and/or the presence of an adverse consequence.
Request acute status change reviews by completing and faxing the Medication Regimen Review Request Form to the pharmacy. Results of the review will be provided to the facility within three business days of the request.
Reports of irregularities
- The consultant pharmacist will identify irregularities through a variety of resources and review specific resident information using any medical information available for the resident.
Document any irregularities and/or clinically significant risks from medications in the resident’s medical record. Address recommendations related to the irregularity to the resident’s attending physician, the nursing staff, or the pharmacy. A separate report detailing all irregularities identified during the consultant pharmacist’s reviews for the month will be provided to the resident’s attending physician, the facility Medical Director, and the Director of Nursing each month.
Proof of action taken
- Physicians may either accept and act upon the suggestions, or reject the suggestions and provide an explanation for disagreeing. All recommendations must be reviewed and responded to.
Final Rule Phase 2’s Impact on LTC Pharmacy Services
A psychotropic medication is any medication that affects brain activities associated with mental processes and behavior. Antipsychotics, antidepressants, anxiolytics, sedatives, and hypnotics are some examples of the different categories that psychotropic medications can fall under. Until recently, CMS’ focus has primarily been centered around antipsychotic medications. However, with the new regulations in place, the focus will now shift to all psychotropic medication classes.
The required provisions of the CMS Final Rule Phase 2 aim to reduce or eliminate the need for psychotropic medications, if not clinically contraindicated, to safeguard residents’ health. National prevalence of antipsychotic use for long-term care residents has fallen, but for providers that still have a high rate of use, CMS has identified a new goal of a 15-percent reduction in antipsychotic use by 2019.
Guidelines for Psychotropic Medications
With this new focus on reducing antipsychotic medication rates, those in the industry will notice a marked shift toward the use of nonpharmacologic approaches and person-centered care practices. As such, according to the Final Rule, when prescribing psychotropic medications based on a comprehensive assessment of a resident, the facility must ensure that:
- All residents who have not previously been prescribed psychotropic medications must have a specific condition requiring the use of the medication and have that condition or diagnosis documented in the resident’s clinical records.
- Residents already taking psychotropic medications should receive gradual dose reductions and nonpharmacologic interventions, unless clinically inappropriate, with the goal being to eventually discontinue the medication.
- Residents who require psychotropic medications on an as-needed (PRN) basis must have documentation in their clinical record of the specific condition that requires the use of the medication.
- PRN psychotropic medications are limited to 14 days. If extended therapy beyond 14 days is required, the prescriber must document the reasoning in the resident’s clinical record and indicate the new duration of use.
- All PRN antipsychotic medications are limited to 14 days. If there is a clinical reason to continue the order, the prescriber must evaluate the resident for appropriateness and write a new order that will be limited to another 14 days. This process must be repeated with each subsequent order.
The Grane Rx team works hard to stay in-the-know on regulatory and guideline changes as they relate to LTC pharmacy services, and put that information into action. Could your SNF benefit from our services? Call (866) 824-MEDS (6337) to find out more. ]]>