Pharmacy Services are such an important element of care for nursing home residents, and understandably, the regulatory requirements are comprehensive. In our final part of CMSCG‘s Ftag of the Week series for F755 Pharmacy Services, we will review the regulatory guidance related to controlled medications and discuss the facility’s responsibility for obtaining the services of a licensed pharmacist.
Controlled Medications
F755 requires facilities to have a system in place that accounts for the receipt and disposition of controlled medications in order to enable an accurate reconciliation of these medications. The guidance for controlled medications encompasses many of the procedures for pharmaceutical services that we discussed in prior Ftag of the Week posts for F755, but with additional requirements to ensure these medications are not diverted and are appropriately destroyed, wasted or returned to the pharmacy if no longer in use.
A comprehensive system for accounting of controlled medications in a nursing homes requires multiple elements. These include:
- Record of Receipt – A process for ensuring a record of receipt of all controlled medications is in place and followed. The record must include sufficient detail to allow for reconciliation, including the resident’s name the medication was prescribed for as well as the medication name, strength, quantity and the date it was received. The Interpretive Guidance (IG) notes that the resident’s name may not be necessary if the facility is using a delivery system with single unit packaging or automated dispensing.
- Record of Personnel Access/ Usage/ Disposition – The facility must maintain records of which personnel have access to controlled medications as well as usage and disposition of these medications with enough detail for reconciliation to be performed. These records should include information regarding any destruction, wasting, return to the pharmacy or disposal of these medications (per State requirements).
- Secure and Safe Method for Disposal – In order to prevent diversion and/or accidental exposure, the facility should have a secure and safe method in place for the disposal of controlled medications. This includes following the FDA and manufacturers’ recommendations for the disposition of used fentanyl patches to avoid exposure to or ingestion of the patch.
Citation Example S/S: E – A facility was cited for failure to minimize the potential for diversion of a controlled substance when it did not ensure that a witness was present for the removal of a fentanyl patch 12 times. The facility’s narcotic record book lacked appropriate documentation to support that a second nurse had witnessed the narcotic’s disposal.
- Periodic Reconciliation – The facility is responsible for ensuring there is a periodic reconciliation of records of receipt, disposition, usage and inventory for all controlled medications. This is dependent on facility procedures and should be conducted when a loss has been identified.
- Secure and Safe Disposal – The facility needs to have in place a system to dispose of controlled substances securely and safely.
Citation Example S/S: D – A facility was cited for failure to account for one controlled medication that was found loose in the narcotic drawer of a med cart. There was an entry in the narcotic book that indicated a tablet had been popped in error and was destroyed, however, the medication had actually been popped and was unable to be found. The nurse stated that the documentation that two nurses had written stating the missing medication was destroyed was false and was not reported to a supervisor per facility policy.
Reconciliation is meant to identify loss or potential diversion of these medication more rapidly than if reconciliation did not place. The facility’s process for reconciliation should be frequent enough that any actual loss or potential diversion is detected quickly so follow-up can be conducted to identify the extent of the loss. The process must also align with State or other Federal requirements for the frequency.
- Reconciliation Discrepancies – The facility should have a process in place for if there is a discrepancy identified during reconciliation. This should include the process that the pharmacist and the facility take to develop and implement recommendations for resolving identified issues and when a referral should be made to a law enforcement agency.
- Injectable Scheduled Drug Tracking – A facility is also expected to be routinely reviewing tracking of these medications for discrepancies or unusual access patterns. CMS also expects these patterns would be investigated and whether residents should be screened for exposure to blood borne pathogens considered.
- Liquid Controlled Medications – The Interpretive Guidance (IG) states that given the packaging of liquid controlled medications, it may be more difficult to detect diversion. The general standard of practice for documentation in this case is:
- Record the starting volume from the label.
- Record each dose administered.
- Subtract the dose administered from the previously recorded volume.
- Record the remaining amount.
- If there is a discrepancy observed between what appears to be left in the container and what has been recorded, then the discrepancy should be reported per the facility’s policy.
The IG also notes that there are multiple signs of diversion for liquid controlled medications. These include:
- As mentioned above, an observable discrepancy between the written balances of the remaining medication and what is observed remaining in the bottle.
- Observed change in usual viscosity or color of the medication.
- Reports of spills
- Statements from a resident that the medication is not working.
What is interesting to note is that CMS states that the pharmacist is not required by the regulation for F755 to perform medication reconciliations. The pharmacist is expected to evaluate and determine if the facility is maintaining an accurate account of all controlled medications and is completing its reconciliation in accordance with facility procedures and consistent with State and Federal requirements.
That is not to say there is not a lot that the pharmacist is responsible for, which we will discuss in the final section of our Ftag review for F755 Pharmacy Services. We have waited until the end of this blog series to talk about the pharmacist to remind facilities that it is not just the consultant pharmacist who is responsible for ensuring accuracy and compliance.
Services of a Licensed Pharmacist
The facility is required to employ or contract the services of a licensed pharmacist to consult on all the aspects of pharmaceutical services mentioned in this blog series. The arrangement for services must be in accordance with state requirements and the agreement should include detail on how the pharmacist will collaborate with the facility to ensure effective consultation. The pharmacist is responsible for collaborating with the facility and facility Medical Director regarding pharmaceutical services procedures, as well as:
- Helping the facility to identify, evaluate and address medication issues that could impact resident care and quality of life as part of the pharmacist’s review and evaluation of the facility’s pharmaceutical services.
- Helping the facility with obtaining and maintaining timely and appropriate pharmaceutical services that meet the residents needs and goals. These services, as mentioned in prior CMSCG Blog posts, must be consistent with current standards of practice and in accordance with State and Federal regulations. Your consultant pharmacist will be in the know in these areas, but the facility is responsible for being aware as well.
- Coordinating pharmaceutical services if/when there are multiple pharmaceutical service providers being used by the facility.
- In accordance with/as permitted by State law, overseeing the contents of the emergency medication supply, including monitoring for use, replacement and disposition.
- Developing communication processes related to pharmaceutical services.
- Developing procedures for addressing and resolving identified issues
- Providing feedback regarding staff performance and practices for med administration and med errors
- Working to ensure that medications are requested, received and administered timely and in accordance with the prescribed orders.
The consultant pharmacist is expected to work with the facility and Medical Director to develop, implement evaluate, and revise, as necessary, all procedures related to the provision of pharmaceutical services. This includes procedures to support residents’ quality of life, and support safe, individualized med administration programs. If IV therapy is used in the facility, the consultant pharmacist should work with the facility to develop procedures for IV admixture and how to determine staff competency.
Other Collaborative Opportunities for the Pharmacist
Whereas the IG states the multitude of listed responsibilities of the pharmacist that we mentioned in the prior section, there is also a long list of areas where the facility may seek the input of the consultant pharmacist.
The consultant pharmacist may have recommendations for areas such as:
- The type of med delivery system/systems to be used at the facility in order to minimize med errors.
- Identifying the facility’s educational/information needs about medications.
- Procedures for automated med delivery devices/ cabinets if used in the facility.
- Procedures and related guidance regarding when a prescriber should be contacted for a med issue and/or adverse event.
- The process for receiving, transcribing and summarizing med orders.
- Recommendations for resources that can help facility staff identify meds as well as information that can be provided to practitioners, residents and families as well.
The consultant pharmacist can also interact with the facility’s Quality Assessment and Assurance Committee. In this capacity, the pharmacist could assist with the development and implementation of procedures for pharmaceutical services as well as define and monitor the corrective actions that should be taken if problems arise related to pharmacy services (i.e., med errors).
On Survey
During survey, the surveyors will be using the Medication Administration Observation and the Medication Storage and Labeling Critical Element Pathway to determine if the facility is in compliance with the requirements for F755 Pharmacy Services. There are many areas where facilities can potentially run into issues with the regulatory requirements for pharmaceutical services, so it is important to ensure that staff routinely receive education and competencies are performed, particularly around medication administration.
Don’t forget – medication errors are such an important regulatory area that in addition to the regulation for F755, there are two additional regulations for Med Errors, F759 and F760.
Don’t forget – medication errors are such an important regulatory area that in addition to the regulation for F755, there are two additional regulations for Med Errors. F759 Free of Medication Error Rates of 5% or More and F760 Residents Are Free of Significant Medication Errors which are part of the Pharmacy Services regulatory group, and also included in the surveyor tools that will be used during survey.
