POCP Blog

By Connie Sinclair, Director, Regulatory Resource Center

Until recently, Missouri was the only state without a Prescription Drug Monitoring Program (PDMP).  Growing evidence suggests that use of these state-run databases of controlled substance prescriptions are proving to be effective in reducing opioid prescriptions. Missouri, like other states, has been hard hit by the opioid crisis. As a result, pressure has been put on Missouri officials to put a PDMP in place. The legislature resisted, so Governor Eric Greitens finally took matters into his own hands. On July 17, he signed Executive Order 17-18, which creates a unique PDMP program.

What Missouri’s PDMP looks like? The PDMPs in other states and in many specific counties in Missouri (led by St. Louis) allow prescribers and dispensers to electronically check the database and see entries before a prescription is written and/or dispensed, depending on state law. Missouri’s state-wide PDMP solution will be a multi-stage effort that is radically different.

In the first phase, the state’s Department of Health and Senior Services (DHSS) must enter into contracts with all pharmacy organizations to analyze prescriber and pharmacy prescriptions and dispensing data for schedule II-IV controlled substances.

The second phase requires dispensers to submit their controlled substance prescription and dispensing information to DHSS to be looked over to identify any instances of controlled substances being inappropriately given out or prescribed.

The final step requires DHSS to work with private companies and government entities to purchase the tools and technology to properly monitor the prescription information that is sent to DHSS or its designee as part of the PDMP. The work of running the program apparently could be contracted out because the Executive Order mentions state officials or a “designee.”

All information gathered and shared throughout the multi-phase process will be kept confidential. Prescribers and dispensers will not be given access to the patient history data at the point of care.

The impacts. Missouri’s PDMP has been met with a lot of criticism. According to news reports, the legislature was peeved that the Governor went around the legislative process. Concerns remain among many that the new process is still fraught with privacy concerns, which was one of the main reasons that numerous legislative attempts to establish a PDMP failed in the last couple of years. It’s not beyond the realm of possibility that the next legislative session will take some actions to address the Executive Order and create a real PDMP, or work to undermine the one established under the Executive Order.

The Missouri PDMP seems to be designed as a retroactive law enforcement tool, rather than a clinician tool. As the patient’s controlled substance history will not be accessible to prescribers and pharmacists, there is no prevention of over-prescribing before the patient becomes addicted. The overwhelming challenge of treating and reversing addiction is well-known, so the more effective tools will be those who can prevent it in the first place.

It also is unclear what happens to the county-level PDMP efforts that were beginning to spring up. In the absence of a state-wide PDMP, a handful of counties followed St. Louis’ lead by creating their own PDMP more along the lines of what’s operational in other states. Many contracted to be part of the St. Louis County program. The new Executive Order apparently does not cancel these programs. It therefore begs the question whether these programs will forge ahead or tread water to see if the new program established under the Executive Order has legs or is cancelled.

Finally, there has been a lot of skepticism about the workings of the new program. Providers and pharmacists appear to be cut out of the decision making, which does not sit well with the medical and pharmacy communities. The program emphasizes retroactively identifying bad actors, while providing nothing in terms of prospective decision support for those prescribing and dispensing controlled substances.

Then there are process issues. So far, details are lacking about the program’s go-live date and how, how often and when opioid prescription information will be provided to prescribers. It is unclear how and when the prescription information will be provided to the state officials or their “designee” and what infrastructure will be used to run the program. There is no definition of inappropriate prescribing behavior, so it is unknown what criteria or methods will be used to examine prescribing data and then determine what prescribing behavior is in and out of bounds. Because doctors and pharmacists can’t query a database about an individual patient or see prescription data, there are concerns that the new program will not be useful in addressing doctor shopping and drug seeking behavior. Some have charged that the new program is basically another tool for law enforcement. And there is no way to interoperability share information with other states.

Point-of-Care Partners is watching this one closely to see what happens next. We will also keep abreast of developments related to PDMPs in other states. Our ePrescribing State Law Review and ePrescribing State Law On-Demand were created to keep companies current with federal and state regulatory changes so they can proactively identify opportunities and modifications that may be needed. Subscribers receive ongoing, in-depth analyses of relevant prescribing rules and have access to POCP regulatory experts.

To lean more, visit our Regulatory Resource Center or contact me at connie.sinclair@pocp.com.

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