CHAPTER 18 CONTROLLED SUBSTANCES - …

[Pages:71]CHAPTER 18 CONTROLLED SUBSTANCES

18.1

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

 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 03.01.01 "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

 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)

64B16-28.303 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 DEA41 "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

(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 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 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 18.10

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

 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

 Notify Board of Pharmacy within 1 business day after discovery of theft or loss (465.022) TJC MM.01.01.03 "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

Medicare COP standards: 42 CFR Ch. IV (10?1?11 Edition) ?482.25(a)(3) - Current and accurate records must be kept of the receipt and disposition of all scheduled drugs.

18.8

 ................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download