§483.45 Pharmacy Services The facility must provide routine and emergency drugs and biologicals to its residents, or obtain them under an agreement described in §483.70(g). The facility may permit unlicensed personnel to administer drugs if State law permits, but only under the general supervision of a licensed nurse.
§483.45(a) Procedures. A facility must provide pharmaceutical services (including procedures that assure the accurate acquiring, receiving, dispensing, and administering of all drugs and biologicals) to meet the needs of each resident.
§483.45(b) Service Consultation. The facility must employ or obtain the services of a licensed pharmacist who-
§483.45(b)(1) Provides consultation on all aspects of the provision of pharmacy services in the facility.
§483.45(b)(2) Establishes a system of records of receipt and disposition of all controlled drugs in sufficient detail to enable an accurate reconciliation; and
§483.45(b)(3) Determines that drug records are in order and that an account of all controlled drugs is maintained and periodically reconciled.
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Observations:
Based on clinical record review and staff interview, it was determined that the facility failed to ensure the accurate acquiring, receiving, dispensing, and administering of all drugs to meet the needs of each resident for one of 12 residents reviewed (Resident 2).
Findings Include:
Review of Resident 2's clinical record revealed diagnoses that included osteoporosis (condition where bone strength weakens and is susceptible to fracture) and osteoarthritis (joint degeneration resulting in pain).
Review of Resident 2's February and May 2024 MARs (Medication Administration Records - forms used to document physician orders as well as when and how medications are administered to a resident) revealed an order for Miacalcin Nasal Solution (medication that contains calcitonin, a hormone that helps prevent bone loss in postmenopausal women) daily for osteoporosis effective February 17, 2023.
Further review of the MARs revealed that nursing staff documented that Miacalcin was not adminstered on February 22-26, 2024, and on May 16, 2024.
Review of corresponding nursing progress notes revealed the following: on February 22, 2024 - "unavailable - pharmacy called - they will send in a new bottle"; on February 23, 2024 - "called [pharmacy] again - they had sent a supply earlier this month. they need DON [Director of Nursing] approval; on February 24 and 25, 2024 - "On order"; on February 26, 2024 - "medication unavailable- awaiting pharmacy delivery"; and on May 16, 2024 - "unavailable - ordered from pharmacy."
During an interview with the Nursing Home Administrator (NHA) on May 22, 2024, at 1:45 PM she revealed that the Miacalcin was not administered to Resident 2 because the staff could not locate the medication, and when a replacement was requested from the pharmacy, the pharmacy had to request approval from the facility to fill it since it was a non-covered medication. The process took a couple of days. The NHA also revealed that she did not have any additional information regarding the missed dose on May 16, 2024.
28 Pa. Code 201.14(a) Responsibility of licensee 28 Pa. Code 201.18(b)(1)(3) Management 28 Pa. Code 211.9(a)(1) Pharmacy services 28 Pa. Code 211.12(d)(1)(3)(5) Nursing services
| | Plan of Correction - To be completed: 06/17/2024
1. Resident 2 had no adverse impact due to not receiving medication the pharmacy did not have available. 2. MAR's will be audited for medication marked unavailable in last 7 days to ensure medication has been obtained and that MD has been notified of missed medications. 3. Facility Staff will be re-educated by the Nursing Home Administer/Designee to understand the requirement of ensuring that residents receive medications ordered by the physician from the pharmacy and notification is timely for medications that are unavailable. 4. MARs will be randomly audited for 10 residents a week for four weeks than 10 residents a month for one month to ensure all medication was available as ordered and physician is notified if a medication is not available. The results of the findings will be reported monthly at the facility Quality Assurance Performance Improvements meeting.
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