CHAPTER 18 CONTROLLED SUBSTANCES - College of Pharmacy

1 CHAPTER 18 CONTROLLED SUBSTANCES Hospital CONTROLLED SUBSTANCES DEA DEA assigned to facility (vs. the Pharmacy ) Registrant is entity vs. individual Renewal every 3 years, can renew & manage registration online Director of Pharmacy responsible for oversight Large number of individuals handle CONTROLLED SUBSTANCES (CS) Sound P&P to ensure accountability, minimize opportunity for diversion ordering Schedule II-V DEA form 222 required for ordering CIIs Can request order form books on DEA website; will receive the maximum number of order form books allowed for your business activity (7 forms per book, typically max 6 books per request) Registrant may authorize power of attorney (POA) for individuals responsible for signing schedule II orders (sample form page ).

2 Must be signed by the person who signed most recent application for registration or renewal plus the individual being authorized. All executed 222 order forms must be dated on or after POA authorization date (should not have 222 orders signed by individuals that don t have an active POA on file). Maintain POA forms as part of CS records Keep POA records up to date o If renewal application signed by a different person (new DOP), must update POA files o Revoke POA when employee leaves or responsibilities change; maintain record of revoked POA in files CSOS electronic schedule II ordering (can also use for II-V ordering ) Registrant and POAs can order via CSOS once registered and digital certificate activated (registrant designates a CSOS coordinator) CSOS certificates expire when registration expires Individual enrollment; must have active POA on file prior to enrolling in CSOS Individual must enroll under each DEA license if ordering for multiple sites CSOS certificate valid for all vendors.

3 Separate set up for each No line item limit for ordering , faster than paper 222, accurate Can separate tasks of ordering and signing (added accountability) Schedule III-V - order from wholesaler or vendors ADC system interfacing tracks pars at the cabinet level and communicates to CS vault for inventory management/reordering Receiving Schedule II-V CS totes delivered directly to vault; separate from non- CONTROLLED inventory Ensure not delivered to loading docks or other general areas Best practice validate inventory received against invoices before signing for driver and taking custody of shipment (in transit loss is responsibility of supplier.)

4 After take custody, responsibility of Pharmacy and requires reconciliation with supplier and/or DEA 106 for loss) Confirm receipt of each line item on invoice for all II-V Date/initial each line on 222 form Delegate ordering and receiving to different individuals A third individual should audit receiving records to validate what was ordered to what was received and then stocked into inventory. Compare DEA 222 form (or printed CSOS) to wholesaler invoice Compare wholesaler invoice to vault receipt records Storage & Security Locked in a secure area as defined by hospital policy MM in a secure area to prevent diversion Many organizations use automated dispensing cabinets (ADC)

5 To secure CONTROLLED SUBSTANCES Require individual login Cabinet access restricted to authorized users Can restrict based on role (respiratory therapists can access cabinet and specific bins but cannot access CS or other drugs they don t administer) Maintains perpetual inventory and transaction record, provides discrepancy notifications at the cabinet and system level, maintains audit trail Accessing CS pocket requires a blind count by users (unlike non- CONTROLLED SUBSTANCES , the system doesn t tell the user what the count should be in the pocket)

6 User notified if count entered is wrong, prompted to recount or create discrepancy May choose to classify other drugs with potential for abuse or diversion as a control for tightened security, blind counts, discrepancy tracking and audit trails (propofol, sildenafil) CS only stored in lock lidded bins vs. open matrix, limited access, auditable Pharmacy vault restricted to those with CS responsibilities Users must protect passwords; Bio-ID preferred over password if possible Ensure terminated employees access to ADCs is revoked promptly Always log out of machine.

7 Auto log-off after set time period with no activity Hospitals without ADCs utilize med carts or locked cabinets on the unit, difficult to maintain security of keys when large number of nurses Emergency kits and code cart trays ideally don t contain CONTROLLED SUBSTANCES , too easy to access or transport out of unit/facility unnoticed Other considerations Securing IV CONTROLLED SUBSTANCES in patient rooms, consider lock boxes PCA and epidural pump key accountability and security Secure delivery of CS to patient care areas Waste With witness as defined by hospital policy Document all CS waste Witness login/password required at the ADC Manual (paper log, anesthesia records) requires signature of witness Reinforce witness needs to actually witness/visualize waste Reconcile waste transactions (administered + wasted = dispensed)

8 , follow up on discrepancies Consider handling of fentanyl patch waste Disposal/Destruction Reverse Distributor remove expired CS from site Schedule II transferred via DEA 222 III-V invoiced, maintain records DEA form 41 for destruction CS for immediate administration in an institutional setting remains under the control of the institution even if the substance is not fully exhausted (such as partial vial, considered pharmaceutical waste vs. requiring disposal/destruction) Destruction of CONTROLLED SUBSTANCES All Permittees (Excluding Institutional Class I Nursing Homes).

9 (1) CONTROLLED SUBSTANCES that cannot be retained as usable shall be securely stored in the Pharmacy /prescription department of the permittee Pharmacy until destroyed. (2) Permittees are required to complete a United States Drug Enforcement Administration ( ) Form DEA-41 Registrants Inventory of Drugs Surrendered (effective 8/31/2014), herein incorporated by reference, available at or This form, at the time of destruction, shall be witnessed and signed by the prescription department manager or the consultant pharmacist of record and agent, or a Department inspector.

10 This method of destruction requires that a copy of the completed and witnessed Form DEA 41 be mailed to the office in his/her area within one (1) business day after the destruction. (3) Another method of destruction shall be conducted by at least two persons: One will be the prescription department manager or the consultant pharmacist of record. The other will be one of the following: medical director or his/her physician designee, director of nursing or his/her licensed nurse designee, or a sworn law enforcement officer.