Drew Plowman and Orlando Caprio of Saint Barnabas Medical Center detail their organization’s successful controlled substance diversion prevention program.

Too often, the responsibility for missing controlled substances within the hospital falls on the shoulders of the chief pharmacist. In reality, recognizing and resolving this common problem requires a hospital-wide, coordinated effort.

The first step to implementing a comprehensive controlled substances diversion prevention program is to establish standardized methods of documenting and handling controlled substances. These methods should be established through a collaborative effort involving all disciplines that work with the substances.

Saint Barnabas Medical Center in Livingston, NJ, has established an interdisciplinary group that includes members from the pharmacy, nursing, corporate security, and medical staff. Using automated dispensing machines, computer-generated reports, and diligent inventory management, Saint Barnabas has become very effective at resolving discrepancies within 72 hours, monitoring suspect diversion issues, and eliminating diversion from the pharmacy department.

The Drug Enforcement Agency and state regulations require pharmacies to demonstrate control and security over their inventories, provide documentation, and ensure the ability to verify inventory movement in a timely and retrievable manner. The DEA requires pharmacies to report significant losses in two categories:

1. A large amount of controlled substances that are unaccounted for relative to the quantity in stock. For example, the pharmacy purchases 1,000 morphine 2mg tablets per month, and 100 tablets are missing. If only five tablets were missing, it would not have to be reported the DEA, but this small loss does have to be documented and saved in case a loss pattern develops.

2. A pattern of unaccounted controlled substance loss over a period of time. For example, the pharmacy is missing five tablets of diazepam 5mg every Friday. Patterns of loss are reportable to the DEA irrespective of the quantity of medication kept in inventory.

Early signs of diversion include complaints or noticeable changes in work performance, appearance, attitude, and behavior of suspect employee. Coworkers often inadvertently enable diversion to take place by failing to recognize these warning signs.

The following are just a few of the ways employees have diverted controlled substances from patient care areas and the pharmacy department:

• Healthcare provider removes larger dose than patient receives. Patient chart demonstrates erratic pain relief.
• Healthcare provider removes drug from IV drips with the use of a tuberculin needle through the side of the bag under the pharmacy label.
• There is an unusual pattern of broken vials and ampoules.
• Narcotics are thrown in general trash. Drug is picked up later outside narcotic pharmacy area.
• There is an unusual pattern of pulverized or broken tablets.
• Healthcare provider substitutes diluent for active injectable controlled substance in IV bags.

Best practices
The use of automated dispensing machines (ADM) and computer technology from Cardinal Health to monitor, secure, and document controlled substances has proven invaluable at Saint Barnabas. The Pyxis system of hardware and software has helped the hospital close the electronic loop of controlled substance inventory, acquisition, dispensing, and administration.

To provide uniformity for access and reporting with Pyxis technologies, Saint Barnabas identifies users in the ADM system with a professional title after the user’s name. This title (RPH, RXT, RN, MD, etc.) provides a means to create different types of security access and ADM functions.

The controlled substances-vault computer generates a report based on the last three months of inventory movement in 10-day increments. The par levels are set for a 10-day resupply value (the amount of product needed to cover consumption over a period of time).

A co-signature on the documents used by the purchaser confirms the quantities received and provides accountability of the inventory purchased. A different pharmacist should distribute narcotics to patient care units than the one who receives the wholesaler inventory. The Saint Barnabas process is as follows:

1. Designated pharmacist removes the batch, blind counts, documents the batch removal, and bags by patient-care area.

2. Designated pharmacy technician delivers narcotics to ADM, signs delivery signature receipt, and staples ADM receipt to delivery signature receipt. Technician confirms that amount pulled by pharmacist matches amount refilled.

3. Delivery signature receipts and Pyxis receipts are reviewed, filed, and kept for one week.

Below are some key elements used by St. Barnabas Medical Center to ensure secure inventory movements:

• Designated pharmacist other than receiver and distributor generates a narcotic vault compare report and checks and matches send and receive transactions. Various reports are generated to resolve any inquiries or questionable transactions.
• Daily inventory of narcotic vault inventory (entire vault is inventoried within one month).
  Narcotic vault inventory confirmation is set to a blind count.
• Corporate security officer generates a proactive diversion report, a standard deviation check for Pyxis system users that exhibit atypical activity.
• Daily monitoring of unresolved controlled substances discrepancies is conducted.
• Designated pharmacist reviews discrepancy resolution report and confirms reasons for discrepancy resolutions are accurate and legitimate.
• Par levels and monitor narcotic inventory turns are set.

The goal of any effective and compassionate controlled-substance diversion program must be to help the diverter admit he/she has a problem and receive help. A majority of employees interviewed at Saint Barnabas who were confirmed diverters were post-injury or post-surgery cases. An employee assistance program should be offered for admitted diverters, helping those employees deal with their addiction and removing them from potentially endangering their patients and themselves.

Drew Plowman is pharmacy information systems pharmacist at Saint Barnabas Medical Center. Orlando Caprio is corporate security officer of Saint Barnabas Health Care System.