Rx drug monitoring programs work. Why doesn't Congress mandate their use?

Topics: Providers, Prescription Drug Misuse, Politics and Policy, Federal Government

By Joe Infantino, senior staff writer

Prescription drug monitoring programs (PDMPs) have been linked to better prescribing habits and fewer overdose deaths, but Congress has fallen short of mandating their use—in part because of the burdensome nature of doing so, experts say.

President Obama on July 22 signed into law legislation to address the nation's growing opioid misuse epidemic, which HHS data show is increasingly being fueled by prescription drugs.

The law contains several noteworthy initiatives—such as facilitating access to the opioid misuse-deterrent drugs buprenorphine and naloxone—to combat the crisis. But it omits a key requirement that all prescribers use what CDC calls one of the "most promising state-level interventions" in the opioid epidemic: PDMPs.

How the databases work

PDMPs collect data on the prescribing rates of controlled substances to identify high-risk behaviors among patients and providers who prescribe such drugs.

For example, the databases can flag instances of "doctor shopping" by patients who obtain the same prescription from several providers. PDMPs also can identify when providers prescribe unusually high doses of a drug and help avoid the prescription of potentially lethal drug combinations.

Studies have shown that PDMPs also can help to:

  • Bolster clinicians' confidence in opioid prescribing;
  • Curb overall opioid prescribing rates and admissions to treatment facilities;
  • Improve providers' ability to monitor substance use disorder treatment; and
  • Reduce doctor shopping.

Most recently, a study published in Health Affairs linked PDMPs to fewer overdose deaths. According to the researchers, when a state implemented a PDMP, there was an average reduction of 1.12 opioid-related overdose deaths per 100,000 people in the year after implementation.

Lead author Stephen Patrick, an assistant professor of pediatrics and health policy at Vanderbilt University School of Medicine, told American Health Line that the findings "suggest that PDMPs are an effective public health tool to help stem the tide of the prescription opioid epidemic." He added, "I think it provides insight that these are effective investments for both state and federal policymakers."

Varying regulations

Despite the proven benefits, the implementation and use of PDMPs varies across the country. Currently, 49 states and Washington, D.C., have implemented PDMPs. Missouri is the only holdout.

According to the National Conference of State Legislatures, some state PDMPs feature more "robust characteristics," such as monitoring more drugs with misuse potential and updating data more frequently.  For example, at least 26 states require providers to check the PDMP before prescribing an opioid drug. Others mandate providers check the databases in limited circumstances, such as when there is reasonable belief of inappropriate use or if the prescription is for chronic pain. At least 15 states also require providers to recheck the PDMP within a certain time period, such as within three months, 180 days, or one year of writing the initial prescription.

The Health Affairs study found that states saw greater reductions—1.55 per 100,000—if their programs had these robust characteristics. The study estimated that if more states implemented such robust features, and if Missouri were to develop a similar program, more than 600 overdose deaths could be avoided in 2016.

Why Congress doesn't mandate PDMP use

So if PDMPs appear to be working—or at least are showing potential—why hasn't Congress mandated their use?

Gary Mendell, CEO of the advocacy group Shatterproof, told American Health Line that some stakeholders don't think a mandate is necessary because providers are going to check the databases anyway. But, he said research suggests that may not be the case.

According to a report by Shatterproof, which supports PDMP mandates, the databases are underutilized when voluntary. For example, a review of 2015 prescribing data in a sample of states where PDMP use is voluntary found prescribers checked the programs just 14 percent of the time before prescribing an opioid.

When PDMPs are being checked so infrequently, "the only alternative is to legislate it," Mendell said.

That may be easier said than done.

Mendell said the effort to mandate PDMP use faces particular resistance from two entities: drugmakers and providers.

"The basic assumption" of PDMPs is that they will reduce the number of medications being prescribed. That could rub drugmakers, who "stand to profit from the number of pills being prescribed," the wrong way, Mendell said.

Providers, meanwhile, might push back against any further regulation of the health care industry.

Patrick said, "I think [the resistance] really has to do with people's response to mandating anything more for providers to do." Physicians already are "feeling bogged down" by existing requirements, Patrick said. Another mandate could be seen as an unwanted incursion into clinical practice and workflow, he added.

A 2015 article in Health Affairs highlights other potential objections.

"Mandates also can entail substantial punitive consequences for prescribers. Penalties for failure to appropriately use PDMPs range from increased liability risk to loss of licensure or imprisonment—an extraordinary punishment for failing to access a website that may contain information of uncertain value," according to the article.

In addition, "[s]ystem imperfections, such as the lack of real-time, interstate data, and lack of full integration into clinical workflow, are important drawbacks that should be addressed. However, these limitations do not render PDMPs useless, nor should they block mandates altogether," the authors concluded.

Lessening the burden to facilitate participation   

To ease provider concerns, Patrick said, "You have to make these programs more useable in a real-life setting," and that starts with integrating them with electronic health records (EHRs).

"The chief complaint for many prescribers and pharmacists is the lack of integration of PDMPs with electronic systems used by health care providers," said Cameron McNamee, director of policy and communications at the State of Ohio Board of Pharmacy, which oversees the Ohio Automated Rx Reporting System.

Mendell agreed, "Obviously, if PDMPs were integrated into EHRs, it would make it easier for doctors. There's no question about it."

But that would require funding, Mendell and Patrick said—something the pending legislation lacks.

As it stands, the bill authorizes just $181 million in funding. Obama and other Democrats have repeatedly called for additional money—up to $1.1 billion—in the form of emergency funding, but Republicans have blocked those efforts. Instead, Republicans in a spending bill have called for $581 million for the Substance Abuse and Mental Health Services Administration.

"I think there needs to be a substantial investment in how PDMPs work," Patrick said. "If you're going to ask providers to do something additional and use a tool like a PDMP, you have to really help facilitate that and make the data useable and make it integrate into their workflow to decrease the burden."