1. Controlled Substances
Nursing Training Module

2. Learning Objectives Upon completion of this module, you will
Understand your responsibilities when handling controlled substances
Identify the proper procedure for receiving administering substances in the pharmacy
Identify the steps for proper dispensing of controlled substances
Understand how controlled substances are wasted/returned.
Understand how to document/report a controlled substance discrepancy

3. Controlled Substance Policy
The Department of Pharmacy will maintain a perpetual inventory system for all scheduled drugs. The Department of Pharmacy will maintain all controlled substances in accordance with all applicable state and federal laws. These records will be available for inspection by all state and federal regulators
All employees must strictly adhere to all laws, regulations and hospital policies and procedures with regard to procurement, distribution, storage, administration, documentation and destruction of prescription drugs and controlled substances.

4. Storage
Controlled Substances kept at the nursing station will be secured in the Omnicell.
The Pharmacy will perform monthly inspections to ensure security of controlled substances.
Controlled Substances should be removed from the Omnicell just prior to administration.

5. Dispensing
Controlled substances will be dispensed from the Pharmacy to the nursing units through the Omnicell.
In the event that a controlled substance cannot be stocked in an Omnicell, such items will be supplied to the nursing station as individual patient doses and must be sent secured.
Controlled substances will be delivered by Pharmacy personnel to the nursing unit and stocked in the Omnicell.
The amount being added to the stock will be verified by a witness who has access to the Omnicell.
Personnel authorized to witness include: Pharmacy Technicians, Pharmacists, Physicians, Anesthesiologists and licensed Nurses.
Individual doses of controlled substances dispensed by the Pharmacy may be delivered by authorized Pharmacy personnel to the patient care unit. The licensed Nurse receiving the dose will sign the delivery form.

6. Discrepancies
Any discrepancies in controlled substance count will be investigated and documented as follows
Staff Responsibilities:
When notified by the Omnicell of a controlled substance discrepancy, the user will initiate an investigation as soon as possible. The user should review the Omnicell printout. The user should review the discrepancy with the previous operator indicated on the printout.
The user and the previous operator should document/resolve the discrepancy by entering the findings/reasons for the discrepancy in the "document discrepancy area" of the Omnicell and give the printed receipt to the Charge Nurse or designee for review (if the previous operator is not available, documentation/resolution may be completed with another nurse).
To reduce the potential for unresolved and inappropriate resolutions, a print out of all documented discrepancies must be turned in to the charge nurse by the end of each shift.
Charge Nurse Responsibilities:
The Charge Nurse or designee will review all unresolved discrepancies on the Nursing unit prior to the end of his or her shift.
The Charge Nurse should immediately follow-up with the user and previous operator on those undocumented discrepancies or where the resolution is unclear or inconsistent and resolve. The patient care unit manager will follow-up and review discrepancies in question by the next business day. Any undocumented discrepancies or discrepancies with questionable documentation will be reported (same day) to Pharmacy Management immediately and report to the Pharmacy Manager or Director.

7. Administration
At the time the dose is needed for administration, the administering Nurse will remove the medication from the ADM. The administering Nurse MUST document each dose of controlled substances administered on the Medication Administration Record or as otherwise appropriate in the medical record.

8. Monitoring
The Pharmacy Director or designee will monitor, review and evaluate controlled substance usage patterns, individual activity reports, statistical usage reports and discrepancies. The Nursing Manager will receive anomalous usage reports to review for unusual usage patterns. Further assessment of high users will be confirmed by criteria based review. A monthly report of all purchases of controlled substances from all vendors will be compared to the report of the controlled substances stocked in the pharmacy vault. Any discrepancies will be reconciled.

9. Returning and Wasting
Unused and unopened controlled substances may be returned to the Omnicell with a witness. The returned item and the printed receipt will be placed in the Omnicell secure, external return bin.
The user will select the patient for whom the medication was issued then initiate the return process.
The user will select the medication and the quantity being returned.
The user will place the return item in the Omnicell return box with the printed receipt.
Individually dispensed doses of controlled substances, if not stocked in an Omnicell, may be returned by contacting the Pharmacy.
Whenever a portion of a dose is unused, it must be wasted by licensed personnel in the presence of a second licensed person who serves as a witness.

10. Wasting (cont)
The wastage will be recorded through the Omnicell, including:
Patient name
Drug being wasted
Dose given
Amount unused/wasted
The wasted medication is to be documented at the time the medication is wasted.
A controlled substance is not considered wasted until the waste is documented and the medication has been destroyed.
A report of un-reconciled waste will sent, as necessary, to the unit manager for investigation.

11. Diversion
No prescription drug or controlled substance may be sold, transferred, or otherwise distributed, except as allowed by law, and as authorized by written policy or by the appropriate individual charged with such responsibility.
All employees must strictly adhere to all laws, regulations, and hospital policies & procedures with regard to procurement, distribution, storage, administration, documentation and destruction of prescription drugs and controlled substances.
The hospital has a responsibility to investigate and intervene when there is a report and/or suspicion of drug diversion. The hospital has a multidisciplinary process to respond to reported or suspected diversions.
All employees are expected to report knowledge/suspicion of drug diversion. Employees should report any known or suspected drug diversion incidents to their manager/director. Department Managers/ Directors will notify the Director of Pharmacy or designee for further follow up.
The Pharmacy Director and Nurse Manager will monitor, review and evaluate controlled substance usage patterns, individual activity reports, statistical usage reports and discrepancies
An employee suspected of drug diversion may be placed on administrative suspension while the investigation is in process.

12. Thank You - Please complete your test