|§483.45(c) Drug Regimen Review. |
§483.45(c)(1) The drug regimen of each resident must be reviewed at least once a month by a licensed pharmacist.
§483.45(c)(2) This review must include a review of the resident's medical chart.
§483.45(c)(4) The pharmacist must report any irregularities to the attending physician and the facility's medical director and director of nursing, and these reports must be acted upon.
(i) Irregularities include, but are not limited to, any drug that meets the criteria set forth in paragraph (d) of this section for an unnecessary drug.
(ii) Any irregularities noted by the pharmacist during this review must be documented on a separate, written report that is sent to the attending physician and the facility's medical director and director of nursing and lists, at a minimum, the resident's name, the relevant drug, and the irregularity the pharmacist identified.
(iii) The attending physician must document in the resident's medical record that the identified irregularity has been reviewed and what, if any, action has been taken to address it. If there is to be no change in the medication, the attending physician should document his or her rationale in the resident's medical record.
§483.45(c)(5) The facility must develop and maintain policies and procedures for the monthly drug regimen review that include, but are not limited to, time frames for the different steps in the process and steps the pharmacist must take when he or she identifies an irregularity that requires urgent action to protect the resident.
Based on a review of clinical records and staff interview, it was determined that pharmacist failed to identify drug irregularities in the medication regimen of one resident (Resident 69) and the physician failed to document action to a pharmacist recommendation for one resident (Resident 18) out of 18 sampled.
A review of the clinical record revealed that Resident 69 was admitted to the facility on August 4, 2017, and had diagnoses that included depression, anxiety and dementia (a type of brain disease that causes a long-term and often gradual decrease in the ability to think and remember how to perform normal activities such as bathing, dressing and eating) with psychosis.
The resident had physician's order initially dated October 13, 2018, for Trazodone (antidepressant) 50 milligrams (mg) two times a day. On August 9, 2019, the dosage was increased to Trazodone 50 mg three times a day, which remained current at the time of the survey ending February 14, 2020, for depression.
The resident also had physician's order dated August 14, 2019, for Seroquel (an antipsychotic drug used to treat certain mental/mood conditions) 25 mg at bedtime. This dosage was increased on November 29, 2019, to Seroquel 25 mg in the morning and at bedtime. This dosage was again increased on December 16, 2019, remaining current at the time of the survey ending February 14, 2020, to Seroquel 50 mg two times a day for for dementia with behavioral disturbance.
A review of the monthly "Medication Regimen Reviews" conducted by the pharmacist from March 2019 through February 2020, revealed no indication that the pharmacist identified the absence of an attempt at a gradual dose reduction of the Trazodone 50 mg and the Seroquel 50 mg during the last year.
Interview with the Director of Nursing on February 13, 2020, at approximately 9:25 a.m. confirmed that there was no evidence that the pharmacist had identified the lack of a gradual dose reduction attempt in the last year and the continued use and dose of these psychoactive medications.
A review of the clinical record revealed that Resident 18 was admitted to the facility on April 6, 2018, and had diagnoses that included psychosis, anxiety and depression.
The resident had physician's order dated May 15, 2019, for Ativan (an anti-anxiety medication) 0.5 milligrams (mg) at bedtime, which was increased on October 28, 2019 to Ativan 0.5 mg twice daily. The dosage was again increased on December 9, 2019, remaining current at the time of the survey ending February 14, 2020, to Ativan 0.5 mg three times daily for anxiety.
A review of the monthly "Medication Regimen Reviews" conducted by the pharmacist from March 2019 through current at the time of the survey ending February 14, 2020, indicated that on July 23, 2019, a recommendation was made for a gradual dosage reduction of the Ativan.
There was no evidence that the physician responded to the recommendation. No dose reduction had been attempted nor physician documentation of the clinical rationale for continued administration of the current dosage to the resident.
During interview with the Director of Nursing on February 13, 2020, at approximately 9:25 a.m. the DON confirmed the lack of physician documentation of the clinical justification for the continued dosage of Ativan and rationale for the lack of attempt at a dose reduction of Ativan as the pharmacist recommended.
28 Pa. Code 211.9 (k) Pharmacy services.
28 Pa. Code 211.12 (c)(d)(3)(5) Nursing services.
Previously cited 3/29/19, 5/21/19.
28 Pa. Code 211.2(a) Physician Services
28 Pa. Code 211.5(f)(g)(h) Clinical records
| ||Plan of Correction - To be completed: 04/07/2020|
Resident 69's medication review was conducted and a recommendation of a gradual dose reduction (GDR) of trazadone and Seroquel was completed. Resident 18's physician addressed the GDR request of the Ativan.
DON/designee will complete a review of current residents to ensure residents on psychoactive medications have a recommended GDR by the pharmacist and a response documented by the physician.
NHA/designee will provide re-education to the consulting pharmacist on regulations of medication regimen reviews specifically GDR's. Physician education will be provided on responding to pharmacist recommendation. The consulting pharmacist will provide a report monthly to the NHA/Assistant NHA/DON after completion of the monthly medication regimen review.
DON/Designee will develop an audit to monitor recommendations for GDRs that are made per the regulation including documented physician response to the recommended GDR. A random 10% sampling will be completed monthly x3 and reported at the monthly QAPI.