How to monitor prescription drugs

Driven by a dramatic increase in prescription drug overdoses and misuse over the past decade, state prescription monitoring programs (PMPs) have gradually rolled out in 49 states. Twenty-four of those states mandate the use of PMPs by prescribers.

The lone hold out is Missouri. But earlier this year, after years of opposition and delays, the state senate finally brought forth a compromise bill that would establish a PMP. If it passes, Missouri prescribers and pharmacists would be able to use the PMP database to more quickly identify potential prescription abuse in the state.

Initially conceived as a way to prevent diversion, PMPs have slowly evolved into a healthcare tool, leveraging data from pharmacies to help physicians identify potential prescription drug abuse among their patients. The tool can flag individuals who have filled an unusual number of prescriptions for opioids, for example.

But the transition from database to point-of-care prevention tool has not always been a smooth one.

Prescribers have historically pushed back against PMP prechecks because they consider them an administrative burden and because of logistical flaws. It can be cumbersome to access the PMP, and the data is typically not well integrated into existing workflows. Data within the PMP may also be difficult to interpret, incomplete or even provide information on multiple patients with similar names, which the prescriber has to further distill.

Programs vary

The lack of adoption has led to inconsistent monitoring.

Research firm Abt Associates analyzed 146.1 million opioid prescription records and identified a small group (0.7 percent) that purchased a disproportionate 2 percent of all such prescriptions and 4 percent of the total amount of opioid drugs, if measured by weight. On average, these outliers obtained 32 opioid prescriptions from 10 different doctors in a 10-month period. They were able to do so because physicians inconsistently checked the PMP database, and in many cases, were not able to access information from other state PMPs.

“Initially, a lot of the data was out of date because most pharmacies were only required to report twice a month or monthly, but that has changed so that the information is updated weekly or daily,” says Heather Gray, legislative director at the National Alliance for Model State Drug Laws (NAMSDL). “Access has been a challenge, but that is getting easier, and a lot of states now allow the use of delegates, so nurses can pull PMP reports for the physicians.”

More improvements could be on the way. The Centers for Disease Control and Prevention received $20 million in 2015 for its Prescription Drug Overdose Prevention for States program to target states with high levels of prescription drug overdose issues. Part of that funding will include enhancements to PMPs for states that apply for the grants. There are also efforts underway to make it easier for PMPs to share data across state lines.

PMP structures vary by state in terms of how they are accessed, how integrated the data is with healthcare systems, and how they are implemented. While nearly half of states now mandate use by prescribers, how that works at the practical level also varies quite a bit.

“In 2015, we’re seeing additional state legislatures proposing mandates now,” says Sherry Green, CEO and manager of Sherry L. Green & Associates and a consultant with the National Association of State Controlled Substances Authorities (NASCSA). “But there’s no real uniformity in terms of the circumstances of that mandate.”

For example, in New York, doctors have to check the PMP every time they prescribe a Schedule II, III or IV substance (with some specific exceptions). In New Mexico, physicians check on new patients being prescribed Schedule II, III or IV substances for more than 10 days. Generally, mandates result in more queries of the database and a reduction in opioid prescription rates.

Are PMPs worthwhile?

Mandated or not, use of PMPs can curtail doctor shopping, which is why pressure has mounted on Missouri to establish a program. Studies conducted in multiple states have shown that PMPs with active physician and pharmacy participation can reduce the overall rate of opioid prescriptions, alter physician prescribing practices, and in some instances, reduce the number of prescription opioid-related overdoses.

For example, in the first year after the inception of the PMP in Florida, the state reported that doctor shopping declined by 35 percent, while overall drug deaths fell by 6.3 percent. Deaths attributable to oxycodone overdose fell by 18 percent.

A handful of lawmakers in the Show Me State, led by state Senator (and physician) Rob Schaaf, have routinely blocked PMP legislation. Schaaf generally cites privacy concerns as the source of his opposition, along with a general disregard for those who have addictions.

“If they overdose and kill themselves, it just removes them from the gene pool,” Schaaf reportedly said during his 2012 filibuster.

Missouri’s now unique position has made it a destination for people from neighboring states hoping to fill prescriptions with no oversight. That reality has local law enforcement, pharmacists, state medical associations, and even the White House insisting that Missouri get on board with a PMP.

“Over the past 20 years, as states have begun to adopt PMPs, we can see the impact on neighboring states,” Green says. “Pharmacists in Missouri are reporting that people come from other states to get those prescriptions filled there, and there is more criminal activity on the borders with those other states.”

She also says those who want to conceal the number or the type of prescriptions they are having filled gravitate toward those areas where they know the activity isn’t monitored. Missouri happens to be bordered by eight states, the most in the country.

“If you talk to pharmacists in Missouri, they really want a program because they see all of this activity,” Gray adds.

In fact, the legislation is backed by the Missouri Prescription Drug Monitoring Program NOW, a bipartisan coalition of individuals, groups, associations and agencies that have come together to support passage of legislation to implement a statewide PMP. Members include everyone from the pharmacy and hospital associations to the state retailers’ association.

This spring, the Missouri senate finally passed a PMP bill that included improved privacy protections and penalties for misuse.

The new bill, however, has stirred up opposition among some previous supporters. The American Academy of Pain Management, for example, issued a statement that listed a number of objections, including that the PMP as described may not be technically feasible or financially viable. For example, the bill calls for the state to reimburse each dispenser for “the fees of transmitting the information required.” The bill as written may also prohibit interstate data sharing.

Law enforcement access

The type of privacy concerns that PMP opponents in Missouri have often center around the security of the databases themselves—which is improving—and close management of access by law enforcement. States have typically addressed the latter by heavily restricting police access to the information.

In order to access the PMP in most states, police need an active case number, a subpoena and/or a warrant. In fact, PMPs are generally held to a higher standard than if the police simply walked into the pharmacy and demanded a patient’s records—in many states, this doesn’t even require a warrant.

“There is a strong perception that law enforcement uses theses systems to go on fishing expeditions, but that’s not the case at all,” Gray says. “Most states don’t allow direct access to this information, and requests by law enforcement have to be approved.”

In 2013, the state of Oregon took the U.S. Drug Enforcement Agency (DEA) to court when it discovered that the agency was bypassing state law by using administrative subpoenas to access the PMP. A federal judge ruled in Oregon’s favor last year, although the DEA has appealed.

“The issue is whether or not the DEA has to have a search warrant to access the data,” Green says. “The court’s decision will be telling in terms of whether states modify their law enforcement access regulations.”

Data sharing improves

It’s now much easier for states to share PMP data, which is particularly important for practitioners that work near multiple state borders. Twenty-eight states now belong to the National Association of Boards of Pharmacy’s PMP InterConnect hub, and more plan to sign on. Most states are also now legally authorized to share data. And PMP InterConnect is now able to link up with one of the other major hubs, RxCheck.

“They can talk to each other now, so the states with those systems can share data,” Gray says. “You still have to get memoranda of understanding signed between all the states outlining the type of access they allow, and getting those bugs ironed out has taken some time.”

According to Gray, 44 states now have the authority to share across state lines. Earlier this year, U.S. Senator Mark Udall (D-N.M.) introduced the Increasing the Safety of Prescription Drug Use Act, which would expand the reach of PMPs across states, among other things.

System bugs vex docs

The bigger challenge now is getting physicians to use PMPs. According to research published in Health Affairs in March, just 53 percent of surveyed physicians reported using a PMP.

Those that do use PMPs report several obstacles that prevent wider adoption of the systems in their practices, including the fact that data were not presented in an intuitive format and system access was time-consuming.

“Providers are saying that if the delivery mechanism is not efficient, they can’t use this in a clinical context,” Green says. “The policymakers behind the mandates are not healthcare professionals, so they don’t understand the nuances of a clinical workflow.”

Many states have made registration with the PMP mandatory, which can greatly increase utilization. After Kentucky passed such a requirement, registration increased from 32 percent to 83 percent, and requests for data increased by more than 300 percent.

In Oregon, conversely, extensive outreach efforts resulted in less than 25 percent of clinicians and pharmacists acquiring PMP accounts in two years, according to an article published in The Clinical Journal of Pain in 2014. Registration increased after large pharmacy chains made participation mandatory. Major barriers identified in that research included time constraints and the inability to delegate access.

There are efforts underway to make the data easier to use. In Ohio, physicians now receive Practice Insight Reports that list their top 25 patients in terms of drugs prescribed, along with those patients ranked by opiate prescriptions. The reports also include the morphine equivalent daily dose (MED) data that doctors previously had to compile manually.

“States are trying to find ways to increase use of the PMP by prescribers so they avoid having a mandate,” Green says. “In some states, you are automatically registered when practitioners apply for a license. There are also efforts to integrate PMP data into EMR systems so the information is available at the point of care.”

Ease of access, integration, and more easily interpreted data are target areas for improvement.

“It can take some time to figure out what pieces of this information make a difference in terms of clinical decision making, and there are analytical tools being developed to help with that,” Green says.

States are also beginning to require daily data input by pharmacies, which will help eliminate the data latency that can exist among states with different reporting requirements.

If Missouri is able to launch its PMP, that will also fill in a large data gap for neighboring states. Whether that will happen before the end of the legislative session remains to be seen. The state house of representatives is now considering its own PMP bill. The compromise bill in the senate, meanwhile, is being reviewed by the Select Committee on Insurance.

Brian Albright is a freelance writer based in Columbus, Ohio.

Pros and cons of PMPs

Pros

• Databases help physicians identify and stop “doctor shoppers.”
• Physicians can proactively intervene with patients who might have dependence or addiction.
• Studies show PMPs reduce the incidence of overdose deaths.
• With the proper clearance, law enforcement can use the data to identify criminal activity.

Cons

• Not all states mandate use of PMPs, so data can be incomplete.
• States are still working to share data, so doctor shoppers still have opportunities to avoid detection.
• The databases require ongoing funding.
• Physicians find the systems cumbersome and time consuming to use.