Example Pharmacy Policy
POLICY NAME:
Controlled Substance & High Risk Medication Diversion Prevention
PURPOSE:
Define a control substance and high risk medication diversion prevention plan.
POLICY STATEMENT:
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.
DEFINITIONS:
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.
PROCESS:
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
X.
XI.
Pyxis
a.
b.
c.
d.
Pyxis passwords should be set to expire every 90 days in Medstations and CII vault
Pyxis user access (if not done by manager) is periodically reviewed by manager
Users are granted only access needed
All sites will use the blind count process when controlled substances are obtained from
Medstations and the CII vault.
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.