Department of Pharmacy Policies & Procedures
Number: 6:07
Effective Date: May, 1984
Revisions: 9/98 ; 8/99
Approval: October, 1999
Subject: CONTROLLED SUBSTANCES
A. POLICY
Bulk inventories of controlled substances are stored in the pharmacy vault. A perpetual inventory of all controlled substances is maintained and verified routinely in the in-patient pharmacy.
B. INVENTORY CONTROL
1. When controlled substances are sent to a patient care area or used to fill a prescription, they are removed from the pharmacy inventory.2. Monthly an inventory of all controlled substances is done and reconciled with the perpetual electronic inventory in the inpatient pharmacy.
3. Annually a comprehensive inventory is performed, witnessed and certified. The inventory is performed during the fiscal year inventory in June. A letter stating this intent is on record with the DEA. The inventory is kept on file in the Quality Assurance files.
C. PROCEDURE FOR THE ANNUAL INVENTORY - INPATIENT
1. No controlled substance is distributed or accepted for return during the four morning hours of 8:00 A.M. and 12:00 noon on the day of the annual inventory. Supplies in the IV Preparation room are counted first so that the supply may be used.
2. The quality assurance pharmacist or designee will count all controlled substances with another pharmacist assigned by the Director of Pharmacy and any auditor who may be assigned from the controller’s office.
3. All discrepancies between the count and the electronic inventory must be reconciled to the satisfaction of both pharmacists. The resolution must be documented electronically.
4. Distribution of controlled substances can occur after the counts are reconciled.
5. The completed verified count is printed and certified by both parties performing the inventory.
D. PROCEDURE FOR ANNUAL INVENTORY – OUTPATIENT1. Non-schedule II, controlled substances are counted during business hours.
2. Schedule II drugs are inventoried after the out-patient pharmacy closes.
3. The schedule II inventory is conducted by the out-patient supervisor. It is signed and stored in controlled substances inventory records in the Schedule II cabinet.
E. REPORTING CONTROLLED SUBSTANCES LOSSES
Significant losses of controlled substances must be reported to the Drug Enforcement Agency with copies sent to the Arkansas Department of Health and the Arkansas Board of Pharmacy.
Reportable losses are defined as follows:
1. Disappearance of controlled substances between the receiving area and the pharmacy.
2. Receipt of controlled substances in a damaged condition.
3. Robbery of the pharmacy or patient care area.
4. Burglary of the pharmacy of patient care area
5. Consistent and identifiable disappearance of drugs from the pharmacy or patient care area.
Note: Small, non-recurring discrepancies in the controlled substance inventories will be documented by the parties discovering the problem. This documentation will be filed in the pharmacy quality assurance files for future reference.
F. DESTRUCTION OF WASTE
1. Quarterly, before the comprehensive inventory, or more often if quantities dictate, any controlled substances which have been deemed unfit for use are counted, itemized and boxed.2. A "Report of Drugs Surrendered" form is prepared, listing all the drugs and the amount of each. This form is furnished by the State Health Department - Pharmacy Division.
3. The box of drugs and the prepared form(s) is hand carried to the State Health Department for destruction. Mailing of the drugs is allowed.
4. Drugs may qualify as unfit for use if,
a. They are out of date and are ineligible for return to the supplier for credit.
b. The package has been damaged.
c. The label has been obscured
d. The drugs are part of a patient prescription.
e. The drug appears to be deteriorated or is suspected of being contaminated.
G. PURCHASING CONTROLLED SUBSTANCES
1. Controlled substances in Class III, IV and V may be ordered by the normal ordering process from the vendor who has the pharmacy DEA number on record.2. Controlled substances in Class II are ordered on the DEA Form 222. This form is provided by the DEA. The form must be signed by the person to whom the DEA permit is issued or to other individuals with Power of Attorney to sign for the permit holder.
3. The first and second copy of the form are forwarded with the purchase order to the vendor.
4. The third copy of the form (blue) is kept on file until the order is received. The receipt of the drug is recorded on this form and the copy is kept on file in the quality assurance files for a minimum of two years.
5. In an emergency, class III, IV, and V drugs can be borrowed from a local hospital with whom we have an informal borrowing agreement. Repayment is made in kind. Class II drugs can be obtained from a local hospital by presenting them with a completed DEA Form 222.