Are Ortho Prescription Drug Monitoring Programs Working?

Compared to doing nothing, yes.

Prescription Drug Monitoring Programs (PDMPs – also called Prescription Monitoring Programs, PMPs) are a core strategy in the states’ and federal government’s battle to reverse the growth of the opioid abuse epidemic.

But, in the clinic and among orthopedic physicians and their patients, are they working?

Given the massive effort—every state and the District of Columbia now has one, as do the Department of Defense (DOD) and the Veterans Health Administration (VHA)—results so far are weak.

One National System or a Patchwork of State Programs?

In order for the array of PDMPs to be really effective, a single national system is probably needed. However, before that can happen, anyone advocating a national system will have to win a series of major turf battles with the states and DOD.

As of the date of this article (things are fluid), prescribers in 26 of the 51 states (including D.C.) were required to use PDMPs to check a patient’s other prescriptions to thwart “doctor-shopping” by patients seeking opioids. In 25 others, PDMP use was voluntary (the ratio changes as more states go mandatory).

Many of these state databases have been around for years (since 1939 in California, 1972 in Pennsylvania), but most were implemented between 2001 and 2012.

In Missouri, which had been the last holdout state until 2017, Gov. Eric Greitens, frustrated by the state legislature’s repeated failures to authorize a PDMP by law, created one by executive fiat. It began operating December 9, 2017.

Do Prescription Drug Monitoring Programs Work?

The logic behind PDMPs is that their increased use by physicians, and monitoring of the data by both law enforcement and federal health officials in the background, will reduce prescribing, illegal use, diversion of opioids, and both non-fatal and fatal incidents.

So how are they working?

“Extant evidence for the impact of PDMPs as an opioid risk mitigation tool remains mixed,” says a 2017 study, “Evaluating the impact of prescription drug monitoring program implementation: a scoping review.” (BMC Health Serv Res. 2017 Jun 20;17(1):420. doi: 10.1186/s12913-017-2354-5.)

That’s an oblique way of saying their impacts are few, limited, and in some cases, negative—and maybe the federal government really can’t tell.

That study didn’t take law enforcement into account. It’s likely that PDMPs are helping federal, state, and local drug cops to chase down “pill mill” physicians and pharmacies because drug cops can snoop on over-prescribing—right down to the individual physician and pharmacy.

Yet, while the total number of prescriptions is down 22% since 2012, the epidemic of opioid use disorder (OUD) and opioid deaths has worsened each year since 2012, according to CDC data. Hospital visits for drug overdoses: they’ve soared. Deaths: soared. Use of heroin: soared. Use of illegal fentanyl: soared.

The study cited above concludes that there’s a correlation between implementation of a PDMP and fewer prescriptions in some states, but not in others.

Again, No Link Between Opioid Prescriptions and Opioid Abuse (?!!)

Beyond prescribing, “Studies examining the association between PDMP implementation and opioid-related outcomes do not indicate a consistent pattern of discernible change,” it admits.

Also, not all the reduction in prescribing has been beneficial. The study mentions:

“…the “chilling effect” that PDMPs and other opioid control measures may have on providers’ opioid prescribing, leaving patients potentially under-treated for pain or seeking elsewhere for licit or illicit means to manage their pain. What happens when providers re-evaluate their opioid prescribing has proven to be a critical question, although relatively few studies have yet provided data to answer it.”… Some PHYSICIANS switched their prescriptions to hydrocondone when it was a Schedule III drug. “More troublingly, there is also evidence that patients, when faced with reduced ability to access licit opioids, may turn to illicit heroin, morphine, or fentanyl as alternatives, with studies indicating an increase in related mortality in some PDMP states.”

Why Orthopedists May NOT Sign up for Drug Monitoring

In states in which they’re not mandatory, many prescribers have resisted signing up for or using their states’ PDMPs. One reason is that they feel like coercion or government spying on prescribing practices.

The final conclusion of the study: more study is needed on the pros and cons of PDMPs. Nevertheless, Congress is pushing ahead toward requiring them.

No Data Sharing

The Department of Defense’s (DOD’s) PDMP system doesn’t share its data with states.

It’s an odd system, in which military physicians automatically receive prescription data on their patients from the DOD’s prescription management system vendor, Express Scripts. That part seems to work well. However, it’s left up to the individual physician’s judgment to act on the data and restrict the patient’s access to opioids.

The recent stir over President Trump’s embarrassing nomination of Rear Admiral Ronny Jackson—who was called the “candy man,” accused of playing fast and loose in dispensing prescription pain meds in the White House—raises the question of whether the DOD’s PDMP system is intentionally structured with loose controls, in order to keep soldiers in the field.

As for the Veterans Health Administration’s (VHA) PDMP: a law passed last December (“VA Prescription Data Accountability Act 2017,” PL 115-86) ordered the VHA to share prescription drug data with state PDMPs. So far, the VHA is falling short of fully implementing that law, according to the General Accounting Office (“Progress Made Towards Improving Opioid Safety, but Further Efforts to Assess Progress and Reduce Risk Are Needed,” GAO-18-380, May 29, 2018). The report suggests that some VA physicians are resisting using the VA PDMP now that it can share data.

Data: Garbage In, Garbage Out

There are also data and usability hurdles for the state PDMPs to overcome. One is that often, the data on filled prescriptions for a patient is incomplete because of the lag in entering it at pharmacies:

“When pharmacists dispense controlled substances to patients, they have to enter the prescription into the state PDMP. However, pharmacies submit this data to state PDMPs at varying intervals—ranging from monthly to daily or even in “real-time,” i.e., under five minutes. If there is a long interval between dispensing and submission into the state PDMP, providers and other PDMP users will not have information on patients’ most recent prescriptions.” – A CDC web page, “What States Need to Know about PDMPs.”

There are other data problems with the PDMP data and databases:

In some states, these systems show the physician a clunky,1990s-computer-era laundry list of a patient’s prescriptions. In addition, in most caregiver settings, they’re not integrated with the electronic health record (EHR), so the prescriber has to exit the patient’s health record, log into the PDMP system, do the search, log out, and log back into the EHR, according to an article in Healthcare IT News, a magazine published by the professional association of hospital and health systems IT executives.

They have other modernizing to do. State PDMPs show in-state data only. So there’s an interface system called PDM InterConnect. Most states already use it to allow a physician to check the database of neighboring states.

Integrating PDMP With EHR Systems

However, there are other, potentially very costly problems along with integrating PDMPs into the HER workflow. For example:

• integrating data from one PDMP to another
• differing definitions of what constitutes an alert threshold
• how and when is PDMP presented to the prescriber

According to work done by the Pew Charitable Trust (“Improvements to Prescription Drug Monitoring Programs Can Inform Prescribing,” 5/22/18, some states expressed worries that integrating PDMP systems could result in a loss of state control over profile features and risk indicators.

For example, the Pew discussions with users revealed that some states are leery of a modern, graphical-user-interface summary of a patient’s opioid use, on grounds that summary data doesn’t always tell a true picture, and a physician might rely on the summary and not dig down deeper into the data.

Given physicians’ busy schedules, it’s probably true that many won’t dig beyond a main summary screen. So the data in the summary has to be the right data. Problem: that concept of the right data likely differs from one state bureaucracy to the next—especially given the fact that some state PDMPs are run by law enforcement while others are run by health officials, with differing priorities.

Loss of Control

That “…loss of control…” phrase hints at a core political problem.

Every state has invested heavily in its own standards and its own computer system, created in its internal political and social climate. The federal government sat idly by, other than creating the two separate systems for DOD and VA patients. After going to the trouble of creating and implementing them, and in some instances integrating them with vendors’ electronic health records, and with their long histories of setting their own standards of medical care and licensing, and with some states preferring voluntary use, most states will understandably want to keep their own PDMPs.

Yet, in terms of a systems architecture, the best way to make the PDMP idea work nationally is a single, national system working from a single, probably cloud-based database, with one set of rules and standards, with all physicians using the PDMP within the electronic health record (or as a standalone if the caregiver lacks an EHR), and with all pharmacies reporting prescriptions filled on a timely basis.

There’s a battle looming over control.

Federal Legislation Seems to be Pointing and Nudging Toward One National System

The 2016 opioid crisis law signed by President Obama, S524, includes funding to help states create or upgrade their PDMPs and offers funding to integrate them into EHRs.

HR6, just passed by the House (but not yet acted upon by the Senate) goes beyond encouraging. Sections 5041-5042 would require physicians nationwide to check the PDMP before prescribing for a Medicaid patient. In practical effect, requiring the use of a PDMP for Medicaid means requiring it for every patient because a physician would likely be courting liability if the system were there and she/he don’t use it.

The House bill would “encourage” Medicaid providers to pay to have the PDMP system integrated into the clinical workflow. However, it’s uncertain whether Congress will fund the 2016 Obama plan to pay this expense.

The Senate hasn’t put HR6 or companion legislation on its floor calendar yet. Democrats are demanding that a bill come to the floor before the election; Majority Leader Mitch McConnell has it on the Senate Calendar (#485), but a recent Scientific American newsletter said he wants to wait until after the election. (The Senate Majority Leader’s media staff didn’t respond to a query by the deadline for this article.)