MDS Alert

Care Planning:

Try This Tool to Care Plan Boxed Warnings

Hint: Focus care plan on any aberrations staff should look out for.

One aspect of managing prescriptions for residents is understanding how different drugs interact with the body, as well as with other drugs. Prescription drugs have come under closer inspection lately by the Trump Administration’s Center for Medicare & Medicaid Services (CMS) and other governmental entities, and the use of prescription drugs in nursing homes has not escaped scrutiny.

Government agencies, including state and federal surveyors, are looking especially closely at the prescription and use of psychotropic medications in nursing home residents. Many of these mediations are labeled with boxed warnings, which are the Food and Drug Administration’s (FDA) alert that a medication carries a serious or life-threatening risk.

Of course, many residents are routinely prescribed medications in good faith, for the resident’s well-being, and some of these medications carry boxed warnings (also called black box warnings). For example, XANAX® carries a boxed warning cautioning use; the FDA says, “Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.” Care planning drugs with boxed warnings is important for staff wherewithal.

Know Why You’re Care Planning

There’s no government or surveyor or payer requirement that medications with boxed warnings be care planned but doing so is important for the resident’s well-being.

“The point is these warnings are to be taken seriously — and if the resident is taking a medication with the black box warning, it needs to be on the care plan with very specific interventions: what to watch for, how can we monitor for adverse events,” says Jane Belt, Ms, RN, RAC-MT, RAC-MTA, QCP, curriculum development specialist at American Association of Post-Acute Care Nursing (AAPACN) in Denver.

Involve colleagues in multiple medical roles when care planning for residents who are receiving medications with boxed warnings.

“There should be entries from the pharmacist and attending physician that the facility is aware of the risk associated with the medication,” she says.

With multiple medical perspectives involved in noting on the care plan exactly what staff should look out for, facility staff are better prepared.

Use This Medication Monitoring Tool for QA

If you want a thorough foundation for care planning boxed warnings, look to the Unnecessary Medications, Psychotropic Medications, and Medication Regimen Review Critical Element Pathway (CEP), also known as Form CMS 20082 (5/2017). This document is based partly on psychotropic medication usage, but the questions listed for residents, their families, medical staff, and facility staff reveal the same pertinent information that should go on a care plan.

Here are the general categories of medications and some of the serious side effects or signs that you may consider including in your care plan; this list and the descriptions are from the Medication Review Regimen CEP.

  • Opioids – assess pain, implement bowel program.
  • Anticoagulant – bleeding/bruising, pro time/international normalized ratio (PT/INR), interaction with other medications, facility must have policies around monitoring, lab work, communication of lab values, implementation of new orders in response to lab values and/or symptoms.
  • Diuretics – edema, potassium level, signs of electrolyte imbalance.
  • Insulin – monitoring of blood glucose levels, hemoglobin A1c (HbA1c), and symptoms of
  • hyper/hypoglycemia.
  • Antibiotics – interactions with other medications (for example, warfarin), adverse events (such as rash, diarrhea); prescriptions must include documentation of indication, dose, route and duration and be reviewed 2-3 days after antibiotic initiation to assess response and labs, and prescriber should reassess antibiotic selection as appropriate.
  • All psychotropics – monitor behavioral expressions or indications of distress.

Top tip: To look up specific drugs and check for boxed warnings or other pertinent information, use this FDA search tool:  www.accessdata.fda.gov/scripts/cder/daf/.

The Medication Regimen Review Critical Element Pathway lists general signs and symptoms that staff should look out for when caring for a resident who’s using certain drugs. The signs and symptoms may be physical, behavioral, psychosocial, or mental; the tool classifies them as “adverse consequences.” This Critical Element Pathway seems to be designed to probe thoroughly the usage of potentially dangerous medications, and the interview questions for the user — which are directed toward members of the interdisciplinary team, including a licensed pharmacist — offer an excellent means of scoping out the various facets of care.

Resource: Find this Medication Regimen Review in the LTC Survey Pathways folder, available in the links section here:  www.cms.gov/Medicare/Provider-Enrollment-and-Certification/GuidanceforLawsAndRegulations/Nursing-Homes.