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Controlled Substances Recordkeeping (7.5)

Controlled Substances Recordkeeping (7.5) - Policies, Clinical, UWHC Clinical, Department Specific, Pharmacy, Controlled Substances

7.5





Effective Date:

September 2002
Pharmacy Policy Manual
Chapter: Controlled
Substances

Chapter:

Policy #: 7.5


 Revision 7/15

Page 1
of 3

Title: Controlled Substances -
Recordkeeping

I. PURPOSE: To provide direction for archiving records related to controlled substance
transactions.

II. POLICY: UWHC Pharmacy Department shall satisfy the record keeping requirements for
controlled substances as outlined in the Controlled Substances Act (CSA) of 1970.

III. PROCEDURE:
A. General.
1. The Pharmacy Department shall maintain, on a current basis, complete and accurate
records of the receipt and disposition of all controlled substances.
a. Name of the controlled substance (e.g. morphine).
b. Description of each controlled substance in finished form (e.g. 10mg tablet).
c. Controlled substance received.
i. Date of receipt.
ii. Initials of person who received.
iii. Number of units or volume received.
d. Controlled substance dispensed.
i. Date dispensed.
ii. Initials of person to who dispensed.
iii. Number of units or volume dispensed.
iv. Location to which dispensed.
2. All records shall be kept for a five year period.
3. Schedule II controlled substance records shall be maintained separate from all other
records.
4. Schedule III, IV, or V records shall not be kept separate but shall be readily
retrievable.
B. Inventory.
1. A perpetual inventory shall be maintained for all controlled substances.
2. Periodic audits shall be performed to prevent diversion or where diversion is
suspected.
3. A physical inventory of all scheduled controlled substances kept in the NarcStation
shall be taken annually in conjunction with the annual pharmacy stockroom inventory.
a. Elements of the DEA required biennial inventory will be included in the audit
documentation and are as follows:
i. Name of the medication
ii. Strength and dosage form
iii. Package or bottle size
iv. Number of packages or bottles





Effective Date:

September 2002
Pharmacy Policy Manual
Chapter: Controlled
Substances

Chapter:

Policy #: 7.5


 Revision 7/15

Page 2
of 3

Title: Controlled Substances -
Recordkeeping

v. Signature and date by the Pharmacy Manager
vi. Record of when the inventory was taken
b. Documentation of each annual inventories will be kept in the following folder:
J:\Rx\RXShare\Inventory Management\FYXX\SR Inventory
c. DEA rules requires biennial Inventories for all registrants and the annual
inventory described in this section and associated documentation will fulfill this
DEA requirement.

C. Records of receipt.
1. Order form (DEA Form 222).
a. Copy 3 (blue copy) with notation of quantities and dates items received of the
order form serves the requirement of a "separate" record and shall be filed
separately.
2. Controlled Substance Ordering System (CSOS) may be used instead of DEA form
222.
a. A copy of the invoice with notation of quantities and dates items received must be
kept in lieu of the third (blue) copy of DEA Form 222.
3. Purchase orders, invoices, etc.
a. For substances in schedules III, IV or V, purchase orders, invoices, packing slips
and other business forms shall serve as records of receipt.
i. The amount listed on the packing slip must agree with the amount received.
D. Patient records.
1. Administration records.
a. The patient's medical record shall serve as the record of disposition of scheduled
controlled substances (for inpatient and clinic administered).
i. A registered physician's DEA number is not necessary for inclusion with the
order, but shall be kept on file in the medical staff office (the individual DEA
registration numbers).
ii. To facilitate retrieval, records of administration of schedule I or II controlled
substances to inpatients and clinic patients shall be kept separate from other
records or searchable using automated narcotic control system computerized
records.
E. Waste and disposal.
1. All controlled substances that are expired, refused or contaminated shall be destroyed
by a registered physician, nurse, or pharmacist and this waste must be witnessed by
another registered person.





Effective Date:

September 2002
Pharmacy Policy Manual
Chapter: Controlled
Substances

Chapter:

Policy #: 7.5


 Revision 7/15

Page 3
of 3

Title: Controlled Substances -
Recordkeeping

2. The waste can be recorded on the medication administration record (MAR), in
Acudose, or on a discrepancy report that is then forwarded to the pharmacy
department.
F. Missing Items
1. A pharmacy discrepancy report form shall be filled out for all missing controlled
substances (see Pharmacy Policy 7.4 – Controlled Substance Discrepancy Reporting).
2. Discrepancy reports will be reviewed by the Pharmacy Manager, Business Operations
and any follow up required documented on the discrepancy report.
3. Completed discrepancy reports will be kept in long term storage for 5 years (see
Pharmacy Policy 1.23 – Pharmacy Records Retention).
G. Automated Dispensing Systems (Narc Station and Acudose)
1. The department of pharmacy utilizes automated dispensing equipment to manage the
security and documentation of narcotic transactions.
2. These systems will provide the same level of documentation as outlined in this policy.

IV. REFERENCES AND RELATED POLICIES, PROCEDURES
A. Pharmacy Policy 7.4 – Controlled Substance Discrepancy Reporting
B. Pharmacy Policy 1.23 – Pharmacy Records Retention
C. DEA Pharmacist Manual

V. AUTHORED BY: Dave Musa
VI. COMMITTEE APPROVAL BY: None



Approved By: ____________________________
Director of Pharmacy Services

Date: ________________