CHAPTER 18 CONTROLLED SUBSTANCES

Transcription

1 CHAPTER 18 CONTROLLED SUBSTANCES 18.1

2 CONTROLLED SUBSTANCES Hospital 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 18.9). 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; 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 18.2

3 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 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) 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) 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 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 18.3

4 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), 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) 64B Destruction of Controlled Substances All Permittees (Excluding Institutional Class I Nursing Homes). (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 (D.E.A.) 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 D.E.A. agent, or a Department inspector. This method of destruction requires that a copy of the completed and witnessed Form DEA 41 be mailed to the D.E.A. office in his/her area within one (1) business day after the destruction. 18.4

5 (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. These persons shall serve as the witnesses for the Form DEA-41 and the destruction. This method of destruction requires that a copy of the completed and witnessed Form DEA-41 be mailed to the D.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 substances may 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, the destruction method in subsection 64B (2), F.A.C., must be followed. Rulemaking Authority , FS. Law Implemented , FS. History New , Formerly 21S , Amended , Formerly 21S , 61F , Amended , Formerly 59X , Amended , , , Also refer to pages FAQ: DEA Rule on Disposal of Controlled Substances Accountability 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 Discrepancies between expected and actual quantity on hand should be resolved in a timely manner with proper documentation of reason by person creating the discrepancy and 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 resolved within certain time period or with inappropriate reason Empty return bins regularly, monitor for inventory discrepancies (establish who is responsible 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 to validate logged inventory against actual, typically every shift or at least daily Patient specific dispensing of CS, ensure delivery and administration records returned and 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 to pharmacy. Retain with CS records. 18.5

6 Monitor anesthesia records for complete documentation, trend by user, partner with anesthesia and OR leadership If possible, incorporate data analytics software for monitoring. Otherwise, this is a manual process Trend discrepancies by unit and user level (inventory and waste transaction discrepancies) Compare user CS transactions to users on same unit, assess for outliers (utilize standard 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 ADC on 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 part Prescribing 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 pursuant to medical staff protocols Florida law does not allow ARNPs to prescribe controlled substances. All prescriptions for controlled substances must be written and signed by a licensed physician. PAs cannot prescribe or dispense CS; however, a PA can order CS for inpatients A supervising physician may delegate to a PA the authority to order medications for the supervising physician s patient during his/her care in a facility licensed under Chapter 395, Florida Statutes, notwithstanding any provisions in Chapter 465 or 893, Florida Statutes. 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 or significant loss Notify law enforcement (recommended but not required by federal law) Complete DEA Form 106 (available as online form; can amend) 18.6

7 Notify Board of Pharmacy within 1 business day after discovery of theft or loss ( ) TJC MM abuses and losses are reported to the Director of Pharmacy and the Chief Executive Officer Collaborate with HR and Occupational Health. Be familiar with HR policies related to drug free workplace, for cause drug testing, management of suspected diversion, coordination with PRN (Professionals Resource Network), etc. Collaborate with nursing and anesthesia recognition of impaired professional Policies and Procedures Consider policies for: Inventory management including ordering and receiving, tracking, scheduling of inventory counts Scope of services (especially if multiple DEA licenses, offsite offices, EDs or ambulatory surgery centers who is responsible for what?) Access levels of personnel Surveillance and monitoring Discrepancy resolution Handling and documentation of waste Disposal and destruction Recordkeeping All records including purchasing, receiving, storage, distribution, dispensing, disposal CS records must be maintained for 4 years Schedule II separate from III-V Executed 222 forms separate from other documents (although can attach to matched invoice) Records to be maintained DEA 222 (executed and unexecuted forms) or CSOS Power of Attorney authorization to sign forms Receipts and invoices for schedule III, IV and V controlled substances All inventory records including the initial and biennial inventories, dated as of beginning or close of business Records of controlled substances distributed or dispensed DEA 106 Inventory of Drugs Surrendered for disposal (DEA form-41 or Reverse Distributor) Records of transfers of controlled substances between pharmacies DEA registration certificate Other issues Updated record of doctor DEA numbers Prescription pad control 18.7

8 Medicare COP standards: 42 CFR Ch. IV ( Edition) (a)(3) - Current and accurate records must be kept of the receipt and disposition of all scheduled drugs. 18.8

9 SAMPLE POWER OF ATTORNEY FORM Power of Attorney for DEA Forms 222 and Electronic Orders (Name of registrant) (Address of registrant) (DEA registration number) I, (name of person granting power), the undersigned, who am authorized to sign the current application for registration of the above-named registrant under the Controlled Substances Act or Controlled Substances Import and Export Act, have made, constituted, and appointed, and by these presents, do make, constitute, and appoint (name of attorney-in-fact), my true and lawful attorney for me in my name, place, and stead, to execute applications for Forms 222 and to sign orders for Schedule I and II controlled substances, whether these orders be on Form 222 or electronic, in accordance with 21 U.S.C. 828 and Part 1305 of Title 21 of the Code of Federal Regulations. I hereby ratify and confirm all that said attorney must lawfully do or cause to be done by virtue hereof. (Signature of person granting power) I, (name of attorney-in-fact), hereby affirm that I am the person named herein as attorney-in-fact and that the signature affixed hereto is my signature. (signature of attorney-in-fact) Witnesses: Signed and dated on the day of, (year), at. Notice of Revocation The foregoing power of attorney is hereby revoked by the undersigned, who is authorized to sign the current application for registration of the above-named registrant under the Controlled Substances Act or the Controlled Substances Import and Export Act. Written notice of this revocation has been given to the attorney-in-fact this same day. (Signature of person revoking power) Witnesses: Signed and dated on the day of, (year), at. 18.9

10 SAMPLE SURVEILLANCE TABLE REPORT NAME FREQUENCY REVIEWER SCOPE UNRESOLVED DISCREPANCIES DAILY CONTROLLED SUBSTANCE PHARMACY TECHNICIAN (CST) This report identifies any discrepancies noted by nursing that have not been resolved. Discrepancies that have not been resolved within 24 hours of their inception will be communicated to the appropriate nurse manager. The Controlled Substance Technician will run additional Omnicell reports, gather the necessary information, and discuss the resolution of the discrepancy with the Pharmacy manager for the Vault area. When needed the Assistant Director, IP Pharmacy Operations will arrange to discuss unresolved discrepancies with the appropriate nursing manager. Discrepancies that have not been resolved will be recorded by the Controlled Substance Technician. A monthly report by nursing area will be generated and distributed to the nursing and pharmacy managers. RESOLVED DISCREPANCIES DAILY CST This report is used to monitor the resolution of controlled substance discrepancies. The analysis should include appropriateness of resolution reason and the identification of patterns related to individual users. Acceptable resolutions will be filed. Unacceptable resolutions will investigated jointly by nursing and pharmacy management and corrective VAULT INVENTORY DAILY CST Blind, manual count of all items involved in any Secure Vault transaction since previous End of Cycle Report VAULT INVENTORY WEEKLY CST Blind, manual count of ALL Secure Vault inventory items. DISPENSE/RETURN/WASTE DAILY AS NEEDED DEA requirement to document transactions for all scheduled medications. Report generated automatically and stored electronically, available as reference if needed. RESTOCK AUDIT DAILY CST DESTOCK/RESTOCK matching: identify discrepancies between controlled substances ISSUED from Secure Vault and RESTOCKED at the designated cabinet. NON-VAULT SUPPLEMENTAL RESTOCK DAILY CST Two-Fold purpose: 1. Evaluate cabinet inventory (pars and reorder points) 2. DESTOCK/RESTOCK matching for off hours dispensing. EXPIRED MED REPORT DAILY CST Monitor expired controlled substances stocked in ADCs. Report looks for past one year and 14 days in advance. EMPTY DRAWER RETURN WEEKLY CST AND AUTOMATION TECHS END OF CYCLE DAILY CST CABINET CYCLE COUNT QUARTERLY CST AND AUTOMATION TECHS The cycle count assignments will be rotated to ensure no single person counts the same cabinet twice in 2 consecutive months

11 SAMPLE FORM Controlled Drug Record Proof of Use Form NOTE: Top of box is the transaction amount. ORAL CONTROLLED DRUGS Bottom of box is the final count. Date BALANCE from previous Signature #1 Unit sheet verified by: Signature #2 Page of Time Patient Name Medication GIVEN Dosage WASTED Nurse Signature Alprazolam 0.25 MG tab Alprazolam 0.5 MG tab Clonazepam 0.5 MG tab Clonazepam 1MG tab Diazepam 5 MG tab Hydrocodone/Acet 10/500 MG tab Hydrocodone/APAP 2.5/500 MG tab Hydrocodone/Acet 5/500MG tab Hydrocodone/Acet MG tab Hydromorphone 2 MG tab Lorazepam 0.5 MG tab Lorazepam 1 MG tab Methadone 10 MG tab RECORD ALL WASTE WITH SIGNATURE ON BACK OF FORM 18.11

12 18.12

13 18.13

14 18.14

15 18.15

16 18.16

17 18.17

18 NURSING HOME Controlled Drugs in the Nursing Home I. Regulatory Overview 1. Board of Pharmacy Regulations 64BB Destruction of Controlled Substances Class I (Institutional Pharmacies Nursing Homes) 2. Controlled Substances Act 10D Nursing Home Regulations 59A Pharmacy Services (1) The consultant pharmacist shall establish a system to accurately record the receipt and disposition of all controlled drugs in sufficient detail to enable an accurate reconciliation. (2) The pharmacist shall determine that drug records are in order and that an account of all controlled drugs is maintained and periodically reconciled. (3) All controlled substances shall be disposed of in accordance with State and federal laws. All non-controlled substances may be destroyed in accordance with the facility s policies and procedures. Records of the disposition of all substances shall be maintained in sufficient detail to enable an accurate reconciliation. 4. Federal Survey Manual F431 MEDICATION STORAGE, LABELING, AND CONTROLLED SUBSTANCES GUIDANCE (Excerpts) INTENT (F431) 42 CFR (b)(2)(3)(d)(e) The intent of this requirement is that the facility has in place a functioning medication system that includes the services of a licensed pharmacist and provides for: Safe and secure storage (including proper temperature controls and limited access) and safe handling (including disposition) of all medication; Accurate labeling to facilitate consideration of precautions and safe administration of medications; Accurate and timely medication records and periodic reconciliation and accounting of all controlled substances; and Prompt identification of loss or diversion of controlled substances so as to minimize the time between actual loss or diversion and the detection and determination of the extent of loss or diversion. CONTROLLED SUBSTANCES The facility should have a system to account for the receipt and disposition of all controlled substances. This system includes, but is not limited to: Record of receipt of all Schedule II medications specifying the name and strength of the medication, the quantity received, and designating the name of the resident or the emergency medication supply (consistent with state law); NOTE: The facility may store some controlled medications in an emergency medication supply in accordance with state law. The system must address the reconciliation and monitoring of this supply as well as the supply for individual residents. Documentation of usage, which may include for example, the medication administration record, proof-ofuse sheets, or declining inventory sheets; Documentation of disposition including destruction, wastage, return to the pharmacy/manufacturer, or disposal in accordance with applicable state law, and Periodic reconciliation of the records (generally, at least monthly or more frequently as defined by facility procedures)

19 The pharmacist is not required by these regulations to complete the reconciliation, but rather to determine that there is an effective system to do so and that the facility has completed the reconciliation according to its procedures and/or state laws and regulations. Although this regulation does not set a time frame for reconciliation, this system should identify how often, how, when, and by whom the reconciliation will be done. The system should be capable of readily identifying loss or diversion of controlled substances so as to minimize the time frame between the actual loss or diversion and the time of detection and follow-up to determine the extent of loss. Because diversion can occur at any time, the reconciliation should be done often enough to identify problems. (Some state or other federal laws or regulations may specify the frequency of reconciliation, which may be reflected in the facility s procedure and practices.) If the systems have not been effective in preventing or identifying diversion or abuse, the pharmacist and the facility should review and revise the monitoring procedures, as necessary, such as increasing the frequency of reconciliation efforts. II. Tamper Proof Prescriptions and E-Forcse in Long Term Care (Florida Statute ) 1) Schedule III V prescriptions can still be faxed from the prescriber to the pharmacy without the use of a tamper proof prescription 2) Verbal prescriptions for Schedule III V can still be called in from the prescriber s office to the long term care pharmacy without a follow-up hard copy 3) Schedule II prescriptions can still be faxed from the prescriber to the pharmacy for a nursing home resident. In an ALF, DEA regulations do not allow a faxed prescription to serve as an original prescription. Therefore, A tamper proof prescription blank should be used. 4) A verbal emergency prescription can still be called in from the prescriber to the LTC pharmacy for Schedule II drugs. 5) All controlled substance prescriptions in Schedules II IV need to be reported to E-Forsce within 7 days of dispensing. 6) Closed door pharmacies are not required to re-register for dispensing of controlled substances by July 2012 as required for retail pharmacies. III. DEA s view of the facility nurse as an agent of the prescriber (Page ) In most LTC facilities the nurse will accept a verbal order from the prescriber, prepare a telephone order and fax that order to the vendor pharmacy. While a nursing home nurse is generally considered an agent of the prescriber by state Boards of Pharmacy, the DEA requires a written agreement between the nurse and prescriber in order to act as an agent for Schedule III V controlled substances. CII Emergency prescriptions MUST be verbally communicated between the prescriber and the pharmacist. IV. Chart Order vs Prescription Order DEA a drug order written on a patient s chart in a long term care facility is not an effective controlled substances prescription, unless it contains all necessary information as described in Manner of Issuance of Prescriptions in the DEA code. This includes: a. Date b. Patient Name c. Patient Address (not facility name) d. Drug Name, Strength and Dosage Form e. Quantity to be dispensed f. Prescriber s Signature g. Prescriber s Address h. DEA Number i. Directions for use 18.19

20 V. Proper Procedures for Obtaining a Hard Copy Prescription a. DEA Opinion Letter ( see page & ) b. Appropriate Form Use for Obtaining CII Hard Copy RX s (see page 18.36) VI. Audit Trail - Security, Accountability, Disposal a. Drugs received into the facility 1) By patient 2) By pharmacy 3) Name, date, quantity received b. Drugs administered to the resident 1) Medication administration record (MAR) 2) Proof of use sheets - required for Schedule II, desirable for the rest c. Drugs not administered to the resident 1) Wastage, contamination (witness) 2) Pilferage 3) Sent home with the resident 4) Destroyed in the facility VII. Change of Shift Inventory Count (see Page 18.33) a. Date, hour, signature of on-coming and off-going nurses b. Discrepancy c. Monitoring VIII. The Process for removing Controlled Substances from the floor a. End of shift b. When the D.O.N. is not available (ex. Weekends) IX. Reconciliation of Controls in the Facility Once this system is established, the consultant can determine that reconciliation is done by either: 1. Reviewing internal audits done by the facility 2. Spot checking documentation at the nursing station 3. Monitoring shift counts 4. Doing a complete audit of all controlled substances records in the facility. This option may be reserved for those cases when the facility identifies multiple discrepancies or suspected diversion

21 X. Destruction of Controlled Substances (by Facility Type) 1. Class I Institutional Pharmacy (Nursing Homes & ICF-DD s) Option One - Facility may destroy drugs on the premises Witnessed by the consultant pharmacist, the director of nursing, and the administrator or designee. Option Two - A Pharmacy licensed as a "Collector" with DEA may place a collection receptacle with an inner liner within the facility (in a secure area). Both controls and non-controls can be collected. When the liner is full it is sealed and transferred off site for destruction (sent to a reverse distributor). Once the inner liner is removed it must be sent within 3 days for destruction 64B Destruction of Controlled Substances Institutional Class I Pharmacies (Nursing Homes). (1) Controlled substances that have been dispensed and not used by the patient shall not be returned to the pharmacy and shall be securely stored by the nursing home until destroyed. (2) A document must be completed showing the name and quantity of the drug, strength and dosage form, patient s name, prescription number and name of the institution. This documentation, at the time of destruction, shall be witnessed and signed by the consultant pharmacist, director of nursing, and the administrator or his/her designee, which may include a licensed physician, mid-level practitioner, nurse, another pharmacist, or a sworn law enforcement officer. Rulemaking Authority , FS. Law Implemented , FS. History New , Formerly 21S , Amended , Formerly 21S , 61F , Amended , Formerly 59X , Amended , Class II Institutional Pharmacy including Modified IIA, B and C A. FOR CONTROLED SUBSTANCES UNDER THE DEA PERMIT Option One - The Controlled Substances may be sent to an approved reverse distributor. Option Two - Send a completed DEA Form 41 (Registrants Inventory of Drugs Surrendered) Signed by the consultant pharmacist or Pharmacy Manager, a DEA agent or a Dept Inspector witnessing the destruction. The completed DEA Form 41 must be mailed to the local DEA office within ONE day of destruction Option Three - The destruction must be completed by 2 people including the Prescription Department Manager or Consultant Pharmacist. The other could be the Medical Director (or a Physician designee), the D.O.N (or a licensed nurse designee) or a sworn law Enforcement Officer. The completed DEA Form 41 must be mailed to the local DEA office within ONE day of destruction B. FOR PATIENT SPECIFIC CONTROLLED SUBSTANCES A document must be completed showing the name and quantity of the drug, strength and dosage form, patient s name, prescription number and name of the institution. This documentation, at the time of destruction, shall be witnessed and signed by the consultant pharmacist, director of nursing, and the administrator or his/her designee, which may include a licensed physician, mid-level practitioner, nurse, another pharmacist, or a sworn law enforcement officer. 64B Destruction of Controlled Substances All Permittees (Excluding Institutional Class I Nursing Homes). (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 (D.E.A.) Form DEA-41 Registrants Inventory of Drugs Surrendered (effective 8/31/2014), herein incorporated by reference, available at 18.21

22 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 D.E.A. agent, or a Department inspector. This method of destruction requires that a copy of the completed and witnessed Form DEA 41 be mailed to the D.E.A. 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. These persons shall serve as the witnesses for the Form DEA-41 and the destruction. This method of destruction requires that a copy of the completed and witnessed Form DEA-41 be mailed to the D.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 substances may 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, the destruction method in subsection 64B (2), F.A.C., must be followed. Rulemaking Authority , FS. Law Implemented , FS. History New , Formerly 21S , Amended , Formerly 21S , 61F , Amended , Formerly 59X , Amended , , , Florida ALF s WITH PHARMACY PERMIT Follow the same procedures spelled out for Modified II permits WITHOUT PHARMACY PERMIT The facility may destroy on-site without the assistance of a consultant pharmacist. This type of destruction should always be documented on a form of some type and witnessed by a minimum of two people 18.22

23 DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR PARTS 1300, 1301, 1304, 1305, 1307, and 1317 [Docket No. DEA-316] RIN 1117-AB18 Disposal of Controlled Substances FACILITIES OTHER THAN NURSING HOMES (page ) Issue: Commenters asked the DEA to clarify how hospitals, schools, summer camps, or other entities may dispose of controlled substances that unintentionally end up in their possession (e.g., when persons abandon controlled substances and return is not possible). Also, several commenters asked the DEA to explain how controlled substances may be disposed of when the ultimate user or other authorized person is unable to dispose of them due to death or incapacitation. Response: The DEA has limited authority regarding who may deliver pharmaceutical controlled substances for the purpose of disposal. Pursuant to the Disposal Act, Congress granted the DEA authority to authorize three groups of people to deliver controlled substances for the purpose of disposal. First, an ultimate user who has lawfully obtained a pharmaceutical controlled substance may deliver the substance to another person who is authorized to accept it for the purpose of disposal. The CSA defines ultimate user as a person who has lawfully obtained, and who possesses, a controlled substance for his own use or for the use of a member of his household or for an animal owned by him or by a member of his household. 21 U.S.C. 802(27). Second, if a person dies while lawfully in possession of a pharmaceutical controlled substance, any person lawfully entitled to dispose of the decedent s property may deliver the substance to another person for the purpose of disposal. 21 CFR Third, LTCFs may dispose of pharmaceutical controlled substances on behalf of ultimate users who reside or have resided at such facilities. 21 U.S.C. 822(g). The DEA has no authority to expand the types of individuals and entities lawfully permitted to deliver pharmaceutical controlled substances for the purpose of disposal. The DEA has carefully considered its statutory authority, diversion risks, public safety, convenience for ultimate users, and the interests of the public. The DEA believes that this rule provides safe and convenient disposal options for ultimate users and other authorized persons. The DEA understands that there may be circumstances where there is no authorized person to dispose of the controlled substances, such as when controlled substances are abandoned at a school or summer camp, and return to the ultimate user is not feasible. In such instances, the affected entities should contact local law enforcement or their local DEA office for guidance on proper disposal procedures

24 DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR PARTS 1300, 1301, 1304, 1305, 1307, and 1317 [Docket No. DEA-316] RIN 1117-AB18 Disposal of Controlled Substances CONTROL SUBSTANCE DESTRUCTION - FINAL RULE NON-RETRIEVABLE STANDARD (Page 10) Existing DEA regulations do not specify a standard to which controlled substances must be destroyed. With this final rule, the DEA is implementing a standard of destruction nonretrievable for registrants that destroy controlled substances, and procedures for the destruction of controlled substances. 21 CFR ( non-retrievable ), , and The DEA is not requiring a particular method of destruction, so long as the desired result is achieved. This standard is intended to allow public and private entities to develop a variety of destruction methods that are secure, convenient, and responsible, consistent with preventing the diversion of such substances. Destruction of controlled substances must also meet all other applicable Federal, State, tribal, and local laws and regulations. Once a controlled substance is rendered non-retrievable, it is no longer subject to the requirements of the DEA regulations. Page 106 the DEA indicated that incineration and chemical digestion are some examples of current technology that may be utilized to achieve the non-retrievable standard. The preamble of the NPRM states that sewering (disposal by flushing down a toilet or sink) and landfill disposal (mixing controlled substances with undesirable items such as kitty litter or coffee grounds and depositing in a garbage collection) are examples of current methods of disposal that do not meet the non-retrievable standard

25 18.25

26 18.26

27 XI. PHARMACY OPERATIONAL ISSUES 1. Emergency CII orders must get original within 7 days 2. Faxed C-II medications as original II in the LTCF and Hospice. The term Long Term Care Facility (LTCF) means a nursing home, retirement care, mental care or other facility or institution which provides extended health care to resident patients. 3. Partial Fills of a CII may be partially filled for up to 60 days Requirements: 1) Patient must be a resident of a Long Term Care Facility OR a terminally ill patient 2) The Pharmacist must record on the original prescription either LTCF patient or terminally ill 3) For each partial filling, the dispensing pharmacist: Must record on the back of the prescription or on another appropriate record, uniformly maintained, and readily retrievable (1) The date of the partial filling (2) Quantity dispensed (3) remaining quantity (4) identification of the dispensing pharmacist XII. Theft or Diversion 1. Report to administrator and director of nursing 2. If substantiated: a. Submit DEA form 106 (available at or may be submitted on line on an electronic version of Form 106 b. Report to AHCA c. Report to local police 3. Types of Diversion in the nursing home a. Removal of controlled substances and documentation b. Reordering Controls when not needed c. Ordering new Controls without a valid order d. Diverting discontinued controls e. Documenting Administration for orders not administered f. Diversion from the Emergency Kit g. Tampering with the dosage form ( ex. removing the contents of a capsule) h. Diversion of used dosage Forms (used Duragesic patches) XIII. Biennial Inventories 1. Facilities that are DEA registrants must do a complete inventory at least every other year even if they maintain perpetual inventories 2. Nursing Homes are not required to do Biennial inventories since they are not DEA registrants 3. The vendor Pharmacy is required to do biennial inventories and must include any controlled substances in the Emergency Kits 18.27

28 XIII. Summary of Consultant Responsibilities 1. Oversight of the audit trail to ensure that controls can not diverted without the system identifying the loss. 2. Ensure that reconciliation is occurring in the facility 3. Review of shift count procedures at each nursing unit 4. Review of security of Controlled Substances in the Emergency Kits Suggestions: 1. Destroy discontinued controls frequently to prevent large supplies being stored in the facility 2. Destroy controls prior to any change in D.O.N. or consultant 18.28

29 NURSING HOME SAMPLE POLICY & METHODS DISPOSITION OF CONTROL DRUGS POLICY: METHOD: It is the policy of this facility to dispose of control drugs in accordance with all state and federal laws. All control drugs which have been discontinued or control drugs not being sent home with discharged patients will be returned to the drug enforcement agency for destruction. When control drugs are to be removed from the nursing unit, the nurse in charge will prepare a disposal of medication form, indicating the name of the patient, prescription number, name of the drug, quantity of drug, and signature of the nurse in charge. This form along with the medication and the proof of use sheet will be returned promptly to the director of nursing office. The director of nursing and the consultant pharmacist will certify as to the accuracy of the disposal of medication form and both will sign this form if correct. This form and the proof of use sheet will be maintained in the patient medical record or as a separate file. The consultant pharmacist with the other two witnesses will prepare DEA Form 41. Each entry will indicate the patient name, RX number, name of the control drug, strength, and the quantity. The DEA Form 41 will be mailed to DEA within one day f the destruction

30 NURSING HOME SAMPLE POLICY & METHODS PROOF OF USE FORMS POLICY: METHODS: It is the policy of this facility that the administration of all control substances shall be properly recorded on a proof of use form and retained in the patient records as required by law. 1. When receiving a control substance (II through V), a proof of use form shall be properly completed listing the name of the patient, the name, strength, and quantity of the drug. 2. When administering a control drug this proof of use form will be properly completed listing the drug given, the time of administration, and the signature of the licensed person administering the drug. 3. If any control drug is wasted for any reason, an explanation shall be promptly recorded on the back of this form and witnessed by another licensed person. 4. When this form is completed is shall be retained on the patients chart

31 18.31

32 CONTROLLED SUBSTANCES AUDIT FACILITY: Resident's Name Drug & Strength Control Log Count DATE: Doses on MAR/PRN Notes 18.32

33 NARCOTIC SHIFT COUNT UNIT: MONTH YEAR DATE E.D.K. LOCK * G or Y NURSE OFFGOING 7AM NURSE ONCOMING 7AM E.D.K. LOCK * G or Y NURSE OFFGOING 3PM NURSE ONCOMING 3PM E.D.K. LOCK * G or Y NURSE OFFGOING 11PM NURSE ONCOMING 11PM * G = Green Lock L= Yellow Lock Nursing: If Yellow lock Present, please Document lock Number And contact Pharmacy To replace kit 18.33

34 18.34

35 18.35

36 18.36

37 IIB14: TRANSDERMAL DRUG DELIVERY SYSTEM (PATCH) APPLICATION Purpose To administer medication through the skin for continuous absorption while the patch is in place, through proper placement of the patch and care of the application sites. Equipment Required 1. Medication patch 2. Alcohol wipes 3. Medication Administration Record (MAR) Procedures A. Identify the location on the body for patch placement. B. Remove old patch from body. C. Cleanse area of old patch with alcohol wipe. D. Remove new patch from package and envelope. E. Label patch with date and nurse s initials. F. Apply new patch firmly against skin. G. Wash your hands. H. Document placement site on MAR as follows: SITE Left upper arm Right upper arm Left upper thigh Right upper thigh Left chest Right chest Left upper back Right upper back CODE LA RA LT RT LC RC LB RB For transdermal scopolamine: Behind left ear LE Behind right ear RE I. Fentanyl patches maintain up to 84% of the Fentanyl when replaced. To prevent diversion each used patch should be documented on a Fentanyl Destruction Log and destroyed by flushing. The destruction should be witnessed by a second nurse with both signatures appearing on the Destruction Log

38 FENTANYL PATCH DESTRUCTION LOG {affix pharmacy label here} MONTH: DAY OF MONTH TIME OF REMOVAL SIGNATURE OF NURSE DESTROYING PATCH SIGNATURE OF NURSE WITNESS 18.38

39 18.39

40 18.40

41 18.41

42 18.42

43 18.43

44 Designating Agent of Practitioner For Communicating Controlled Substance Prescriptions to Pharmacies (Name of registered individual practitioner) (Address as it appears on certificate of registration) (DEA registration number) I, (name of registrant), the undersigned, who is authorized to dispense (including prescribe) controlled substances in Schedules II, III, IV, and V under the Controlled Substances Act, hereby authorize (name of agent), to act as my agent only for the following limited purposes: 1. To prepare, for my signature, written prescriptions for controlled substances in those instances where I have expressly directed the agent to do so and where I have specified to the agent the required elements of the prescription (set forth in 21 CFR ). 2. To convey to a pharmacist by telephone oral prescriptions for controlled substances in Schedules III, IV, and V in those instances where I have expressly directed the agent to do so and where I have specified to the agent the required elements of the prescription (set forth in 21 CFR ). 3. To transmit by facsimile to a pharmacy prescriptions for controlled substances in those instances where I have expressly directed the agent to do so and where I have specified to the agent the required elements of the prescription (set forth in 21 CFR ) and I have signed the prescription. This authorization is not subject to further delegation to other persons. Both the undersigned DEA-registered individual practitioner and the undersigned agent understand and agree that the practitioner is solely responsible for making all medical determinations relating to prescriptions for controlled substances communicated by the agent pursuant to this agreement, and for ensuring that all such prescriptions conform in all other essential respects to the law and regulations. The undersigned agent understands he or she does not have authority to make any medical determinations. The undersigned DEA-registered prescribing practitioner further understands that the prescribing practitioner must personally communicate all Schedule II emergency oral prescriptions to the pharmacist. Both the undersigned practitioner and agent understand that the agent may not call in an emergency oral prescription for a Schedule II controlled substance on behalf of the practitioner. This agency agreement shall be terminated immediately if and when any of the following occur: 1. The undersigned practitioner no longer possesses the active DEA registration specified in this agreement. 2. The undersigned agent is no longer employed in the manner described in this agreement. 3. The practitioner or the agent revokes this agency agreement by completing the revocation section at the end of this document or by executing a written document that is substantially similar to the revocation section at the end of this document. (Signature of practitioner) 18.44

45 AGENT I, (name of agent), hereby affirm that I am the person named herein as agent and that the signature affixed hereto is my signature. I further affirm that I am a (title), licensed in the State of Florida, and (if applicable) am employed by/under contract with (name of employer or contracting entity). I agree to abide by all the terms of this agreement and to comply with all applicable laws and regulations relating to controlled substances. (Signature of agent) (State license number of agent where applicable) (Name of employer/contracting entity where applicable) (Address of employer/contracting entity where applicable) Witnesses: Signed and dated on the day of (month), (year), at. Revocation The foregoing agency agreement is hereby revoked by the undersigned. The agent is no longer authorized to communicate Schedule III, IV and V controlled substance prescriptions to a pharmacy on my behalf. A copy of this revocation has been given to the agent this same day. (Signature of registered practitioner revoking power) Witnesses: Signed and dated on the day of (month) (year), at. Note: DEA recommends that the original signed agency agreement be kept by the practitioner during the term of the agency relationship and for a reasonable period after termination or revocation. Suggested retention policy is 2 years

46 PREPARING FOR FACILITY NURSES ACTING AS PRESCRIBER AGENTS ACTION STEPS: 1. Contact prescribers to see if they are willing to use facility nurses as agents 2. Identify which nurses will act as prescriber agents 3. Complete DEA written agreements between willing prescribers and facility nurses 4. Facility will need to maintain a database of these agreements so that staff changes are carried through. This includes revoking agreements for employees that leave, adding new nurses and new prescribers 5. Prepare procedures which need to be incorporated into the pharmacy P&P manual 6. Train nursing staff on necessary elements for a controlled prescription NOTES: 1. This agreement does not affect Schedule II drugs. These must still be handled by the prescriber. 2. A controlled substance prescription must include: 1) patient name 2) patient address (must be address of facility not facility name) 3) drug name and strength 4) quantity 5) refill instructions 6) Doctor s address 7) Doctor s DEA number 3. I would suggest that the nurse document Agent next to his/her name on the telephone order to reflect a current agreement with the prescriber

47 U. S. Department of Justice Drug Enforcement Administration 8701 Morrisette Drive Springfield, Virginia OCT Dear Colleague: On November 19, 2007, the Drug Enforcement Administration (DEA) published in the Federal Register (FR) the Final Rule entitled Issuance of Multiple Prescriptions for Schedule 11 Controlled Substances (72 FR 64921). In the preamble to that Rule, DEA stated that "the essential elements of the [schedule 11] prescription written by the practitioner (such as the name of the controlled substance, strength, dosage form, and quantity prescribed).,. may not be modified orally." The instructions contained in the Rule's preamble are in opposition to policy posted on the DEA Diversion website regarding changes a pharmacist may make to a schedule II prescription after oral consultation with the prescriber, In a Question and Answer section, the website instructed that a "pharmacist may change or add the dosage form, drug strength, drug quantity, directions for use, or issue date only after consultation with and agreement of the prescribing practitioner." DEA recognizes the resultant confusion regarding this conflict and plans to resolve this matter through a future rulemaking. Until that time, pharmacists are instructed to adhere to state regulations or policy regarding those changes that a pharmacist may make to a schedule II prescription after oral consultation with the prescriber. Questions regarding this correspondence may be directed to the Liaison and Policy Section, Office of Diversion Control, DEA at (202)

48 18.48

49 18.49