Shall we play a game?

The title above comes from the 1983 movie WarGames. The plot of this movie centers around a young computer hacker that manages to access a Department of Defense computer. That computer asks the hacker, Shall we play a game? That game just happens to be Global Thermonuclear War, and as it turned out, the game was actually very real.

Sometimes, an apparently innocuous event can quickly become very dangerous, not unlike the game our hacker was playing. There are few tasks in the pharmacy world more potentially dangerous than filling controlled substance prescriptions. The risks exists on both sides of the prescription counter. Improper use by the patient can lead to significant morbidity and even death. Pharmacists face significant regulatory challenges trying to balance federal laws and DEA rules, all while assessing appropriate prescribing habits and patient outcomes.

Pharmacies and pharmacists are generally well-versed in complying with federal and laws and DEA regulations surrounding the ordering and managing of controlled substance inventory. A bigger challenge is ensuring prescriptions being filled meet all of the rules and regulations to ensure that it is valid. It is not enough to simply ensure that the prescription is not forged. To be valid, a prescription for a controlled substance must be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice.  The pharmacy has a corresponding responsibility to ensure proper prescribing of controlled substances.

Recently, the DEA has started conducting audits of pharmacies, and they are not just looking at record-keeping for inventory and ordering. Failure to fulfill the pharmacy’s corresponding responsibility to verify the prescription is valid can result in fines of up to $10,000 per violation. Let’s look at some ways to ensure your pharmacy is not subject to this type of thermonuclear attack. Below are what I consider to be best practice principles for controlled substance dispensing.

Check the PMP (Prescription Monitoring Program) and Document Findings

This should go without saying, but every controlled substance prescription you fill should be checked every time. Even if you think you know your patient, and they have only ever used your pharmacy before, be sure they have not changed their habits. Be sure to document both your search and the results.

Determine and document the indication for the medication

If the pharmacist doesn’t know what the medication is being used for, they cannot assess the appropriateness of the therapy. While a pharmacist may be able to guess the probable indication, it is important to verify and document this information every time you fill a controlled substance. Included in this is the expected duration of therapy. All of this information does not necessarily have to come from the prescription or the prescriber, it may be possible to determine parts of this simply by speaking with the patient.

Understand the accepted guidelines for treatment

In order to be able to assess the validity of a prescription, you need to be sure you understand what the standard of care is for the condition being treated. For pain medications, especially, there is a accepted progression that should be followed. Once this is in the back of your mind…

Document previous treatments used and their outcomes

Did the prescriber jump right to an controlled substance (e.g. an opioid), or did they other medications first (e.g non-steroidal medications)? Is the etiology of the condition treatable with non-pharmacologic vectors, and if so, have they been tried? What were the outcomes? In the case of pain treatments, if the pain is chronic, is the patient being followed by a pain specialist? Do they have a pain contract? Each patient is a story, and without knowing and documenting the story, assessing validity of the therapy is more difficult.

Watch Trends

Every course of treatment will have a natural progression. An acute treatment may flare and wane with time and end. Chronic treatments may slowly escalate. All of these may be normal, but it is the pharmacists job to look for potential diversion of controlled substances. By watching trends and speaking with the patient about them as they occur, you can more easily spot diversion and take appropriate actions.

The reoccurring theme in these practices is documentation. While we use a clinical documentation platform (PharmClin) to document these types of activities, the documentation can be done in a variety of other ways. Having this documentation goes a long way toward satisfying corresponding responsibility.  Be sure to take the time to protect yourself, and make every controlled substance prescription a complete story. Make every encounter count!

Published by

Michael Deninger

Mike graduated from the University of Iowa with a BS in Pharmacy in 1991 and completed his Ph.D. in 1998. He has over 20 years of practice experience, over half of which is as a pharmacy owner. Areas of expertise also include technology in practice, including integration with data sources.

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