Example Pharmacy Policy
POLICY NAME: Controlled Substance & High Risk Medication Diversion Prevention
Define a control substance and high risk medication diversion prevention plan.
The organization shall have controls in place that meet all DEA and State Board Requirements for controlled substances and for other medications deemed to have high potential for diversion.
o Controlled Substances: Any medication defined by the DEA as a Scheduled Medication in Class I, II, III, IV, or V.
o Narcotics: All a subset of controlled substances that produce sedation or drowsiness effect.
o Medications at risk for diversion: nalbuphine, butorphanol, epoetin, darbepoetin, filgrastim, pegfilgrastim, somatropin, botulinum toxin, sildenafil, tadalafil, vardenafil.
I. Control of DEA 222 Forms and Registration Certificate
a. The Manager, Pharmacist in Charge (PIC) or designee with oversight by manager or PIC orders and signs in the DEA 222 forms into the DEA 222 Signing in Log Book.
b. DEA 222 forms are kept under perpetual inventory.
c. Two employees will sign out DEA 222 forms or forms are kept in CII safe.
II. Ordering Controlled Substances & High Risk Legend Drugs
a. The registrant of the DEA renewal is the person of record for the Power of attorney for the site. Pharmacist in Charge will determine maximum number of staff/managers who that person will grant the Power of Attorney authority to execute orders for CII drugs. The registrant will complete DEA paperwork to give these staff/managers power of attorney authority. If a pharmacist in charge changes and/or the DEA renewal registrant changes, all new power of attorney paperwork for staff/managers must be completed prior to execution of CII order forms.
b. Power of Attorney authority and paperwork are maintained on site at the pharmacy.
c. Restrict Vendors to Primary Wholesaler and other contracted vendors approved by the Director (e.g., Ameridose).
d. All invoices received will have the date when the medications are received and 2 signatures/initials on the invoice.
III. Receiving and checking in of Controlled Substances & High Risk Legend Drugs
a. Staff member, other than staff signing DEA 222 form, will initial DEA 222 Signing in Log Book for the specific DEA 222 form for which they are checking in the order.
b. Employee ordering the controlled substances and high risk legend drugs is not the sole person checking in the controlled substances or high risk drugs.
c. If there is not another employee available to check in the drugs other than the employee who ordered the drug, a double check will be completed by the next employee ASAP on their shift. All verification needs to be completed within 72 hours.
d. Reconciliation of the DEA 222 form will be completed within 24 hours.
e. Controlled substance and high risk legend drugs on back order will be written on the Backorder Log Book (DEA 222 form(s) will be kept by this log book for CII back orders). Once received, the staff will initial on the same form that the drug was received.
f. Broken controlled substances will be processed by a different staff member than the person who processed the order.
g. The quantity received and date will be filled in on all DEA 222 forms.
h. The quantity received and date and signatures will be filled in on the invoice.
IV. Stocking of Controlled Drugs & High Risk Legend Drugs in Pharmacy
a. Pharmacy staff will stock controlled substances and high risk legend drugs. The staff stocking the medications will print the report containing medications stocked and a different pharmacy staff member will compare that report with the invoice to assure accuracy between medications ordered and stocked. In cases where there is not a CII safe or the medications are controlled remotely, there will be a preliminary sign in and checked by a second person against the invoice.
b. If there is not another employee available to stock the drugs other than the employee who ordered the drug, a double check will be completed by the next employee ASAP on their shift. All verification needs to be completed within 72 hours.
c. When stocking CII mediations, pharmacy staff will fill in the DEA 222 form number for each narcotic stocked in the CII safe.
d. Discrepancies will be resolved within a maximum of 72 hours.
V. Movement of Controlled Drugs within a Hospital
a. For controlled drugs sent to patient care areas, two staff members must be involved (e.g., pharmacist orders the drug, technician sends the drug).
b. If two staff members are not available due to staffing limitation please refer to Monitoring section c.
c. All pneumatic tube transactions will be sent via secure tube transaction. For retail prescriptions, this will only include CII drugs.
d. Manual deliveries to non-Pyxis machines are co-signed by an RN or pharmacist and documentation is kept in the pharmacy.
e. A double check process is in place for drugs returned to the pharmacy that are not in Pyxis or in waste.
f. Discrepancies will be resolved within a maximum of 72 hours.
VI. Inventory of Controlled Drugs
a. Two pharmacy staff will be involved with the monthly inventory of the CII safe (due to multiple drugs per door)
b. Monthly inventory of the Pyxis Medstations can be conducted by one hospital staff member (due to single pocket and audit trail)
c. Controlled substances waiting to be destroyed must be counted in the biennial inventory. Refer to DEA regulations for details on conducting the official biennial inventory. Include all controlled substances on stock not yet administered (e.g., hospital clinics, Allina Medical Transportation (AMT), InstyMeds).
VII. Record keeping of Controlled Substances
a. Most controlled substance records need to be maintained on site for the prescribed DEA storage timelines (e.g., inventory records).
b. Financial and shipping records within the prescribed DEA storage timelines may be kept at a central location or off-site storage location, rather than at the registered location, if the registrant has notified the DEA of their intention to keep central records (and wait 14 days per DEA regulations) and have an approved variance from the MN Board of Pharmacy. Records maintained beyond the DEA storage timeline, but within the Allina retention guidelines, may be kept at a central location or at Allina off-site storage
c. Record keeping of inventories and invoices for controlled substances will be kept separate for CI & CII, CIII-CV and non-controlled drugs.
d. Pharmacy must keep a record of all records from the Reverse Distribution Company.
VIII. Waste/Destruction of Controlled Drugs
a. Wasting of controlled drugs must be incorporated into each site’s hazardous waste plan/policy.
b. Medications that are past their beyond use date and are intact are unusable and are removed from active dispensing stock. They will remain part of the site controlled substance inventory, but located in the unusable segregation area pending determination of their waste status (Schedule II can be stored separate or with Schedule III-V) until transferred out to the reverse distributor or waste hauler. Pharmacy must develop a process for segregating CII and CIII-V during the hazardous waste sort process. Each site must have a secure area (box/cabinet/room) to store items awaiting destruction.
c. Each site must maintain a log of all items stored.
d. Each site must decide appropriate method of destruction based on DEA and/or county hazardous waste restrictions.
e. Pharmacy personnel will witness the sort.
IX. Monitoring of Controlled Substances
a. Monthly Purchases of Controlled Substances - the objective is to identify all controlled substances coming into the organization and verify that all CII-V controlled substances were put into the narcotic vault or perpetual inventory stock.
· A report of all controlled substances shipped by ABC is supplied monthly by wholesaler is sent to the Pharmacy Site Lead.
§ Monthly we will get an invoice from Ameridose indicating any controlled substances purchased.
· Create a report in Pyxis CII safe (if applicable) by:
1. Select reports
2. Select inventory management
3. Select migration summary
4. Indicate dates
5. Selected scheduled medications (II-V)
6. Look at additions, received
· Compare purchases vs. what was stocked in the CII safe. Identify, resolve and document any discrepancies.
b. Vendor report – Pharmacy services will send a Lawson drug vendor report quarterly to Pharmacy Site Leads. The objective of this report is to verify that there were no controlled substances purchased outside of designated wholesaler. Any purchases by a vendor that sells/distributes controlled substance need to be investigated to verify that were not controlled substances (or in a shortage where medications had to be purchased outside designated wholesaler, verify that these were entered into the perpetual inventory).
c. Pyxis Access/HR Changes – the objective of this monthly report is to allow the site to remove Pyxis access as appropriate. Terminations or transfers listed on the HR report will be reviewed for termination of access or change in access, as appropriate
d. RxAuditor data review – the objective is to audit Pyxis activity for abnormalities associated with the dispensing of controlled substances or use of system functionality. At a minimum, the following reports will be reviewed by a pharmacy designee each month:
· Review the RxDiversion Index report. For all individuals whose activity is above a site specific designated acceptable standard deviation , the site will compare the user’s Pyxis activity on the Hot User Archive Index report to medication administration record (MAR) documentation.
The Clarity report titled “Controlled Substances Administered on Mar by Specific Employee” can be ran to identify controlled substances documented on the MAR by a specific individual for the desired time frame. This is an optional report to further clarify information in the RxDiversion Index Report.
· Review the Hot User Archive Index report: Review the “Reason Selected” field for abnormalities. This report is utilized to monitor float nurse staff whose activity may not be flagged a unit comparison report because she/he may have worked on multiple units during the report time frame. Compare Pyxis activity to MAR documentation for those with abnormal activity as outlined above.
· Review the Proactive Diversion Report from the CII Safe as an optional report to the Rx Diversion Index Report and the Hot User Archive Index Report.
· Documentation and follow up
1. Sites will maintain documentation of the individual’s name and any pertinent details for those individuals whose Pyxis activity and corresponding MAR documentation was reviewed on a potential diversion tracking form.
2. Sites will collaborate with HR and Nursing on any potential diversion or practice audits
a. Pyxis passwords should be set to expire every 90 days in Medstations and CII vault
b. Pyxis user access (if not done by manager) is periodically reviewed by manager
c. Users are granted only access needed
d. All sites will use the blind count process when controlled substances are obtained from Medstations and the CII vault.
XI. Monitoring Movement of Controlled Substances within the hospital – The object is to monitor those locations that have times of limited staffing where removal of controlled substances from the C-II safe cannot be verified at time of delivery.
· On a monthly basis a report will be run from the C-II safe and all controlled substances that were sent to patient care areas where two staff were not available in the pharmacy to verify.
· Verify delivery of these medications to the patient care units by matching C-II safe removals with RN receipt of controlled substances.
· Discrepancies will be resolved within a maximum of 72 hours.