Guest Column

Substance diversion can and will happen

By Christopher M. Dembny, RPh
President
Dembny Pharmacy Consultants
Richardson, TX

Controlled substance diversion is one of those things that every administrator thinks "could never happen to me. I don't have any thieves or drug abusers working here." In my 20 years of being a pharmacist consultant for surgery centers, I've heard that more times than I can count.

We know that the national average is that 10% of the population has a problem with some type of substance abuse, and that the incidence is higher among those who have easy access. If you're in the healthcare industry long enough, you will have an experience with a person diverting controlled substances.

There is no way that we can completely prevent diversion. People who want drugs badly enough will find a way to steal them. It is our job to put systems in place to discourage this and to detect it as quickly as possible when it happens. The little secret that few people know is that drug abusers will often target ambulatory surgery centers BECAUSE their systems to prevent diversion are not as well-designed and maintained as larger hospitals. Surgery centers rarely have automation (Pyxis, Omnicell, etc.) and have fewer people involved in the oversight of controlled substances. For someone who has a desire to steal controlled substances, this situation can make the drugs at a surgery center "low-hanging fruit."

That being said, every outpatient surgery program center should put as many safeguards and checks and balances in place to make it harder to steal and easier to detect. A good thief will always look for the easiest point of access. Some of these thieves have a lot more experience finding weak spots than we do at preventing and identifying them. Because of this, we need to make sure to close the holes in any areas that involve the movement of controlled substances:

  • ordering and receiving drugs from wholesalers;
  • daily administration to patients and wastage;
  • transfer of drugs to another registrant;
  • reverse management of drugs sent for destruction.

The area with the best potential for large scale diversion is the ordering and receiving drugs from wholesalers. Abusers can obtain large quantities of controlled substances by intercepting drugs in this first step of their journey through the facility.

Safeguards that should be put in place in this area include:

  • A different person should receive the drugs than the person who ordered them.
  • Someone other than those two people (preferably a consultant pharmacist) should validate that every controlled substance that is received is added to the continual inventory. This step is done by reviewing the controlled substance invoices and checking off, line by line, that every controlled substance that is invoiced has a matching entry that it was added to the continual inventory. This step shouldn't be very difficult because invoices for Schedule II drugs (CII) under the Controlled Substances Act for the United States are required by the Drug Enforcement Administration (DEA) to be maintained separately. Also, invoices for drugs in schedules CIII-V must be maintained in a separate file.
  • Many facilities will keep a log of all the DEA 222 forms received and when they are used to order controlled substances. This step will prevent someone from stealing a DEA 222 form and using it to procure CII drugs. With the advent of the controlled substance ordering system (CSOS), the need for this step will diminish as people order CII's online through this system.
  • At the end of each month or quarter, someone should review the documentation from the wholesaler to ensure that there are invoices present for all controlled substances shipped from the wholesaler to the surgery center. These are the invoices mentioned above that a third person has validated have been added to inventory. This step is accomplished either by a summary of controlled substances shipped from the wholesaler (generated by the wholesaler) or a review of the invoices paid by accounts payable (AP). Note that we want the ones from AP. Someone could steal drugs by destroying the pharmacy copy of the invoice, but they still have to send one on to be paid or it sends up a red flag from the supplier.

In summary, we should be able to validate that every controlled substance shipped to the surgery center has been added to the continual inventory. Nothing should be able to be removed from the supply chain as it moved toward the center.

  • The volume of controlled substances that move through the system by daily administration to the patients also creates movement of drugs that can be falsified and drugs removed from the system. Controlled substance policies should be in place and be followed for the day-to-day tracking and administration of controlled substances, AND they should be followed. (See more information, below..)
  • Any transfer of controlled substances to another registrant (borrowing by another surgery center, hospital, or physician) is carefully documented and validated. This should happen rarely, but when it does, it needs to be documented correctly, including a DEA 222 form if schedule II drugs are involved.
  • Another way drugs leave the facility is through reverse management channels for expired medications.

A log should be maintained of drugs that are removed from inventory because they are expired. These drugs should be signed out of the regular inventory and into the expired inventory when they are removed from regular stock. The expired drug log also should contain space for information to document the return and/or destruction by a wholesaler or reverse management company. In this way, there is a reproducible audit trail that can be followed from

— removal of drugs from current stock;

— addition to expired drug inventory;

— transfer from expired drug inventory to reverse management company;

— documentation of destruction by reverse management company.

In summary, people WILL steal controlled substances. If you haven't experienced it yet, you will. Anyone who has been in healthcare very long knows of instances of this happening. We need to do all we can to make sure that our facility doesn't fall victim to theft of controlled substances.

The potential problems caused by this theft are many. A lawsuit because of poor patient care delivered by an impaired caregiver is one of many potential consequences. Scrutiny from the DEA is another. We need to remain vigilant and put systems in place that will deter and detect controlled substance diversion. (Editor's note: Dembny is a consultant pharmacist who has been consulting for ASCs for 20 years. He is consulting for 75 ASCs. He can be reached at cdembny@tx.rr.com.)

Ensure these steps for controlled substances

By Christopher M. Dembny, RPh
President
Dembny Pharmacy Consultants
Richardson, TX

Controlled substance policies should be in place and be followed for the day-to-day tracking and administration of controlled substances. Here are my recommended steps:

  • Two people should count controlled substances at the beginning and end of each shift (often each day in the ambulatory surgery center environment).
  • There must be a reproducible audit trail for all drugs that leave the inventory of the facility and are administered to the patient/wasted.
  • For each controlled substance that is administered/wasted, the Drug Enforcement Administration (DEA) requires documentation of:

— date and time of administration;

— name of patient;

— drug and dosage form administered;

— dose administered;

— amount of drug wasted (if any);

— signature or electronic signature of the person administering the controlled substance;

— signature or electronic signature of the person witnessing waste of controlled substance (if      any);

— name of the practitioner who ordered the controlled substance.

These records must be maintained separately from patient charts and must be readily retrievable. Someone should go back and validate these entries with an eye for diversion. This retrospective review is done in many states by the consultant pharmacist. (See signs of potential diversion, below.)

There should be a reproducible audit trail that anyone can follow. The time to see if this trail is easy to follow is not when the DEA or other regulatory agency comes to visit. Managers need to know that they can track all controlled substances leaving their inventory. This process can be labor intensive, but it the best way to ensure that drugs are not just walking out the door with staff. Drugs also can be diverted as they are transferred out of the facility.


Potentials Signs of Diversion

  • Messy paperwork that is hard to follow
  • Altered entries in the documentation
  • Late entries. Example: controlled substance documentation for the 10 a.m. case that wasn't entered until 3 p.m.
  • One person's signature that appears on the paperwork more times than everyone else's
  • A significant amount of controlled substance wastage
  • Unusually large doses
  • Controlled substances administered to patients who didn't have painful procedures
  • The same person always doing the beginning and/or ending count
  • Audit trail not complete and reproducible. For example, if 12 fentanyl 2 ml amps left the inventory on a given day, there should be documentation that 12 amps were administered/wasted. Without this validation, drugs can just disappear, and no one will notice it. Surgery centers often administer a large amount of controlled substances. Someone patient enough to steal just a few dosage units per day can get away with it for a while.

Source: Christopher M. Dembny, RPh, President, Dembny Pharmacy Consultants, Richardson, TX.