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CHAPTER 18CONTROLLED SUBSTANCES18.1

HospitalCONTROLLED SUBSTANCESDEA 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 diversionOrdering Schedule II-V DEA form 222 required for ordering CIIs Can request order form books on DEA website; will receive the maximum number oforder form books allowed for your business activity (7 forms per book, typically max 6books per request) Registrant may authorize power of attorney (POA) for individuals responsible for signingschedule II orders (sample form page 18.9). Must be signed by the person who signedmost 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 (shouldnot 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 dateo If renewal application signed by a different person (new DOP), must update POAfileso Revoke POA when employee leaves or responsibilities change; maintain record ofrevoked 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 certificateactivated (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; 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 forinventory management/reorderingReceiving Schedule II-V CS totes delivered directly to vault; separate from non-controlled inventory18.2

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; after take custody,responsibility of pharmacy and requires reconciliation with supplier and/or DEA 106 forloss)Confirm receipt of each line item on invoice for all II-VDate/initial each line on 222 formDelegate ordering and receiving to different individualsA third individual should audit receiving records to validate what was ordered to what wasreceived and then stocked into inventory. Compare DEA 222 form (or printed CSOS) to wholesaler invoice Compare wholesaler invoice to vault receipt recordsStorage & Security Locked in a secure area as defined by hospital policy MM 03.01.01 “in a secure area to prevent diversion” Many organizations use automated dispensing cabinets (ADC) to secure controlledsubstances Require individual login Cabinet access restricted to authorized users Can restrict based on role (respiratory therapists can access cabinet and specific bins butcannot access CS or other drugs they don’t administer) Maintains perpetual inventory and transaction record, provides discrepancy notificationsat 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) 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; auto log-off after set time period with no activity Hospitals without ADCs utilize med carts or locked cabinets on the unit, difficult to maintainsecurity of keys when large number of nurses Emergency kits and code cart trays – ideally don’t contain controlled substances, too easy toaccess or transport out of unit/facility unnoticed Other considerations Securing IV controlled substances in patient rooms, consider lock boxes18.3

PCA and epidural pump key accountability and security Secure delivery of CS to patient care areasWaste With witness as defined by hospital policyDocument all CS wasteWitness login/password required at the ADCManual (paper log, anesthesia records) requires signature of witnessReinforce witness needs to actually witness/visualize wasteReconcile waste transactions (administered wasted dispensed), follow up ondiscrepancies Consider handling of fentanyl patch wasteDisposal/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 ofthe institution even if the substance is not fully exhausted (such as partial vial,considered pharmaceutical waste vs. requiring disposal/destruction)64B16-28.303 Destruction of Controlled Substances All Permittees (Excluding Institutional Class I NursingHomes).(1) Controlled substances that cannot be retained as usable shall be securely stored in thepharmacy/prescription department of the permittee pharmacy until destroyed.(2) Permittees are required to complete a United States Drug Enforcement Administration (D.E.A.) Form DEA41 “Registrants Inventory of Drugs Surrendered” (effective 8/31/2014), herein incorporated by reference,available at http://www.flrules.org/Gateway/reference.asp?No Ref-03998 orhttp://www.deadiversion.usdoj.gov/21cfr reports/surrend/. This form, at the time of destruction, shall bewitnessed and signed by the prescription department manager or the consultant pharmacist of record andD.E.A. agent, or a Department inspector. This method of destruction requires that a copy of the completedand witnessed Form DEA 41 be mailed to the D.E.A. office in his/her area within one (1) business day after thedestruction.18.4

(3) Another method of destruction shall be conducted by at least two persons: One will be the prescriptiondepartment manager or the consultant pharmacist of record. The other will be one of the following: medicaldirector or his/her physician designee, director of nursing or his/her licensed nurse designee, or a sworn lawenforcement officer. These persons shall serve as the witnesses for the Form DEA-41 and the destruction. Thismethod of destruction requires that a copy of the completed and witnessed Form DEA-41 be mailed to theD.E.A. office in the permittee’s area within one (1) business day after destruction.(4) In lieu of destruction on the premises as outlined in subsections (2) and (3) above, controlled substancesmay also be shipped to reverse distributors for destruction in conformity with federal guidelines.(5) For patient specific controlled substance prescriptions in a Modified Institutional Class II B pharmacy, thedestruction method in subsection 64B16-28.301(2), F.A.C., must be followed.Rulemaking Authority 465.005, 465.022 FS. Law Implemented 465.022, 465.018 FS. History–New 4-21-87,Formerly 21S-19.003, Amended 7-31-91, Formerly 21S-28.303, 61F10-28.303, Amended 1-30-96, Formerly 59X28.303, Amended 2-5-07, 10-27-09, 2-1-12, 4-20-14. Also refer to pages 18.12-15 FAQ: DEA Rule on Disposal of Controlled SubstancesAccountability Must be able to account for CS through entire system (closed system); maintain audit trail Outside of Pharmacy - Discrepancy monitoring by pharmacy and nursing Policies establishing expectations for surveillance (who, how often, resolution process),see sample table page 18.10 Discrepancies between expected and actual quantity on hand should be resolved in atimely manner with proper documentation of reason by person creating the discrepancyand a witness Unresolved discrepancies monitored by pharmacy and nurse manager or designee(charge nurse) Pharmacy should review discrepancy resolutions for appropriateness Establish an escalation pathway to nursing leadership for discrepancies not resolvedwithin certain time period or with inappropriate reason Empty return bins regularly, monitor for inventory discrepancies (establish who isresponsible for emptying, monitoring) Nursing should have process to ensure what dispensed is documented as administered,wasted, or returned May be on MAR, flowsheets in patient chart For CS stored in lockbox or non-automated storage location, requires manual process tovalidate logged inventory against actual, typically every shift or at least daily Patient specific dispensing of CS, ensure delivery and administration records returnedand reconciled Nursing controlled drug records One sheet lists all drugs (example page 18.11) End of shift counts (confirmation bias) Patient specific administration record - nurse records each dose administered, waste,and remaining quantity. Completed sheet and any non-administered CS returned topharmacy. Retain with CS records.18.5

Monitor anesthesia records for complete documentation, trend by user, partner withanesthesia and OR leadership If possible, incorporate data analytics software for monitoring. Otherwise, this is amanual process Trend discrepancies by unit and user level (inventory and waste transactiondiscrepancies) Compare user CS transactions to users on same unit, assess for outliers (utilizestandard deviation) Pharmacy – internal monitoring Vault blind count inventory on scheduled basis; completed by two techs Biennial inventory of all schedule II-V (every two years) Restock audit report to confirm quantity of CS dispensed from vault is received into ADCon unit (system alerts after defined period of time, giving tech time to deliver) Monitor waste documentation (used for compounding) Consider cameras or other security measures Monitor for diversion and tampering, inspect tamper seals, consider refractive index Don’t be complacent or too trusting; diverters typically don’t look the partPrescribing considerations Interns, residents, housestaff may prescribe CS under the registration of the hospital.Hospital must maintain list of internal codes for agent prescribers Example: ARNPs can write orders for CS for inpatients within their scope of practice and pursuantto medical staff protocols Florida law does not allow ARNPs to prescribe controlled substances. All prescriptions forcontrolled substances must be written and signed by a licensed physician. PAs cannot prescribe or dispense CS; however, a PA can order CS for inpatientsA supervising physician may delegate to a PA the authority to order medications for thesupervising physician’s patient during his/her care in a facility licensed under Chapter395, Florida Statutes, notwithstanding any provisions in Chapter 465 or 893, FloridaStatutes. An order is not considered a prescription in this instance.Theft or Significant Loss Notify local DEA Diversion Field Office within one business day of discovery of theft orsignificant loss Notify law enforcement (recommended but not required by federal law) Complete DEA Form 106 (available as online form; can amend)18.6