|§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 clinical record review and staff interview it was determined that the facility failed to ensure that the pharmacy recommendations were reviewed and acted upon by the attending physician for two of 33 sampled residents. (Resident 20, 102)
Clinical record review revealed that Resident 20 had a diagnoses that included depression, and anxiety. A pharmacy review was completed on October 7, 2019. The consultant pharmacist reported a drug irregularity regarding the consideration of a gradual dose reduction of an antidepressant medication. The recommendation was not addressed. by the physician.
Clinical record review revealed that Resident 102 had diagnoses that include dementia, anxiety and psychosis (a thought disorder in which contact is lost with external reality). Pharmacy reviews were completed March 21, 2019, through September 30, 2019, by the consultant pharmacist and during that time span there were six different recommendations by the pharmacist for dose reductions. There was no documented evidence that the physician acknowledged the recommendations made by the consultant pharmacist regarding dose reductions.
In an interview on February 6, 2020, at 1:29 p.m., the Director of Nursing confirmed that the physician had not reviewed the pharmacist recommendations.
28 Pa. Code 211.2(a)(d)(2) Physician Services.
| ||Plan of Correction - To be completed: 03/17/2020|
1. The pharmacy recommendations for Resident 20 and 102 were corrected by 2/10/2020.
2. Other residents that have the potential to be affected will have a comprehensive Pharmacy Services Audit Tool audit completed for Pharmacy recommendations for the previous 90 days, to ensure appropriate documentation and follow through of any pharmacy recommendations and physician acknowledgement.
3. The facility will take the following actions: The Quality Assurance Consultant will educate the DON and unit managers on the Medication Management Review policy. The consultant pharmacist will supply the DON with the pharmacy recommendations. The attending physicians will be notified to address the recommendations. The DON/designee will ensure the recommendations are addressed within 30 days and recommendations are signed.
4. DON/designee will conduct random audits weekly for 4 weeks in charts of residents with pharmacy recommendations with the Pharmacy Services Audit Tool to make sure these recommendations are acknowledged by the attending physician and carried out or documented as declined with rationale accordingly. Results of these audits will be taken through QAPI committee for further review and recommendation.