SANTA BARBARA COUNTY DEPARTMENT OF Behavioral Wellness A System of Care and Recovery

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1 Section Sub-section Policy Policy# Pharmacy SANTA BARBARA COUNTY DEPARTMENT OF Behavioral Wellness A System of Care and Recovery Pyxis MedStation Controlled Substances Page 11 of 5 Programmatic Policy and Procedure Effective: 9/12/2018 Version: 1.0 Last New Policy Revised: Da~ ~2~~-z~~-1~ ~~ Pharmacist-in Charge Approval Supersedes: New policy Morgan Peterson, PharmD Date 1hte11 f' Audit 9/12/2021 Date: 1. PURPOSE/SCOPE 1.1. To provide standards and procedures for the safe inventory, management and administration of controlled substances stored in Pyxis MedStation systems at Santa Barbara County Department of Behavioral Wellness (hereafter the "Department") sites This policy applies to all Santa Barbara County Mental Health Services Pharmacy (hereafter the "Pharmacy") staff, Department program staff, and any other persons acting on behalf of the Department who utilize a Pyxis MedStation at their assigned site. 2. DEFINITIONS 2.1. Pyxis MedStation - an automated dispensing system that performs the storage, dispensing, and distribution of medications Schedule II, 111-V controlled substances - a classification of drugs as defined by the United States Controlled Substances Act that have a high potential for abuse and may lead to physical and psychological dependence. Schedules can be found online: usc/812.htm 2.3. Discrepancy - when the inventory count of a controlled substance does not match the count expected by the Pyxis MedStation. There are many causes of medication discrepancies. For example, a discrepancy could occur when a user: 1. Removes a quantity greater or less than the quantity requested. 2. Cancels the removal, but removed the medication from the Pyxis MedStation. 3. Does not remove the medication requested. 4. Makes a typographical error (for example, 11 instead of 1 ).

2 PH ARM Pyxis MedStation Controlled Substances Page J 2 of 5 5. Accesses the wrong pocket during removal, return, refilling or loading. 6. Enters incorrect quantity during re stock or reload. 7. Diverts or pilfers a medication Blind Count - when a user of the Pyxis MedStation system physically counts the inventory of that medication prior to removing that medication from the bin. In a blind count, the system does not display the count, so the user will not know whether they are witnessing a discrepancy Verified Count - in this type of count, the Pyxis MedStation system will display the expected count on the screen. Staff will then confirm this count or will make note of any discrepancy. 3. POLICY 3.1. Medications classified by the Drug Enforcement Administration (DEA) as Schedule II, 111-V controlled substances shall be subject to special management, oversight and accountability. In accordance with all relevant federal and state laws and regulations as well as standards of clinical and pharmacy practice, Department sites utilizing Pyxis MedStation systems to manage controlled substances shall enforce strict controls in the access, storage, return, record-keeping and disposal of controlled substances. 4. CONTROLLED SUBSTANCE COUNTS AND COUNT VERIFICATIONS 4.1. Before a controlled substance can be withdrawn from the Pyxis MedStation for administration to a patient, the doses must be subjected to a blind count. 1. Each time a controlled substance storage location is accessed, the user will be prompted to enter a blind count. The user will count the medication and enter the physical count they record. 2. If the user enters a quantity that is different from the count that the system expects, a discrepancy will be recorded and must be resolved by the end of the shift. Users may still administer controlled substances prior to resolving the discrepancy. 3. The respective program supervisor or manager will monitor completion of the blind counts to ensure this activity is being performed Each week, a verified count on all controlled substances will be performed. The verified count must be completed by a pharmacist and either one (1) licensed nursing staff (LNS) or one (1) other Pharmacy staff (e.g., pharmacist, pharmacy technician). The pharmacist will print a report documenting the verified count. Verified count reports will be stored onsite or at the pharmacy for a minimum of three (3) years Pharmacy staff will maintain an ongoing record of discrepancies or unusual access associated with controlled substances.

3 PHARM Pyxis Med Station Controlled Substances Page 13 of No end-of-shift count is required for controlled substances stored in the Pyxis MedStation except in the event of a system downtime period. Please see the Pyxis MedStation Downtime policy for further information. 5. NEW DISCREPANCIES 5.1. In the event of a discrepancy, an alert will appear on the Pyxis MedStation screen. During the course of the shift, the person discovering the discrepancy is responsible for resolving the discrepancy. 1. If the person who discovers the discrepancy is not an LNS at that site (for example, if they are Pharmacy staff) and they were not involved in the creation of the discrepancy, the discrepancy will be referred to the team lead or program supervisor. 2. If the Pharmacy was involved in the creation of the discrepancy, the team lead, program supervisor or responsible staff will contact the Pharmacy during regular Pharmacy hours to resolve the discrepancy. If a discrepancy is discovered after regular business hours, the Pharmacy will be notified the next business day To obtain information on the persons and medication involved in the discrepancy, staff may review either the Discrepancy Report or Activity Report Resolution of each discrepancy will be documented and witnessed by a second person who may be an LNS and/or Pharmacy staff. 6. UNRESOLVED DISCREPANCIES 6.1. The team lead or designee will check the Pyxis MedStation display for an unresolved discrepancy indicator at the end of each shift If a discrepancy remains unresolved, the user will indicate "Unresolved - follow-up required" on the Pyxis MedStation Discrepancies that cannot be resolved, and/or those discrepancies that have impacted patient care such as resulting in a delay in treatment, will be immediately reported to the on-site supervisor (or, if after hours, the on-call administrator) and an incident report 1 will be completed. 7. CONTROLLED SUBSTANCE RETURNS 7.1. Controlled substances removed from the Pyxis Med Station but not administered to the patient are returned to the bin designated specifically for returned controlled substances. A second LNS is required as a witness when returning controlled medications. 1 Please refer to the Department's "Unusual Occurrence Incident Reporting" policy for further details. For Psychiatric Health Facility (PHF) incident reports, refer to the PHF "Unusual Occurrence Reporting" policy.

4 PHARM : Pyxis MedStation Controlled Substances Page 14 of When a pharmacist verifies the accuracy of controlled substance returns when the designated return bin is emptied, a LNS or Pharmacy staff must serve as a second witness. Once the controlled substances have been verified, they can be placed back into the Pyxis MedStation inventory or sent back to the Pharmacy. 8. DOCUMENTATION AND REPORTING 8.1. All confirmed losses of controlled substances must be reported to the Department of Health Care Services (DHCS) and the California State Board of Pharmacy The Narcotic and Controlled Substances Discrepancy Resolution Report (ORR) will be generated and reviewed on a weekly basis by the Pharmacist-in-Charge or designee. 1. Discrepancy reports must be retained by the Pharmacy for a minimum of three (3) years. ASSISTANCE Morgan Peterson, PharmD, Pharmacist-in-Charge REFERENCES Pyxis Med Station TM 4000 System - Console User Guide (November 2010) California Business and Professions Code Section California Health and Safety Code Section (c)(d)(1) RELATED POLICIES Pyxis MedStation Downtime Pyxis MedStation Medication Storage, Inventory and Restocking Pyxis MedStation Medication Removal and Return Pyxis MedStation Medication Disposal Unusual Occurrence Incident Reporting PHF only- Unusual Occurrence Reporting

5 PHARM : Pyxis Med Station Controlled Substances Page 15 of 5 REVISION RECORD DATE VERSION REVISION DESCRIPTION Culturally and Linguistically Competent Policies The Department of Behavioral Wellness is committed to the tenets of cultural competency and understands that culturally and linguistically appropriate services are respectful of and responsive to the health beliefs, practices and needs of diverse individuals. All policies and procedures are intended to reflect the integration of diversity and cultural literacy throughout the Department. To the fullest extent possible, information, services and treatments will be provided (in verbal and/or written form) in the individual's preferred language or mode of communication (i.e. assistive devices for blind/deaf).