Drug Monitoring Back in the News

Florida Deputy Chief Judge of Compensation Claims David Langham

Prescription Drug Monitoring Programs (PDMP) returned to the news in August, but quietly. A website for IT-related health issues, published the results of a study at Dartmouth-Hitchcock (a New Hampshire research hospital) regarding the impacts of PDMP on patient care. In a study of 1,057 patients, the researchers concluded “PDMP use negatively affects clinical efficiency,” and does not offer “much benefit as a tool for reducing opioid prescribing.”

New Hampshire is among states that have legislated the requirement for checking the PDMP prior to prescribing. Florida passed HB21 in 2018, and it became effective July 1, 2018. This increased “regulation of prescribers and dispensers,” according to the final legislative analysis. Notably, this Florida legislation also limits the duration of initial prescriptions to three or seven days, but excludes various diagnoses from such limits, including “cancer, terminal illness, palliative care, and serious traumatic injury.” Have you ever wondered what is or is not “serious” trauma?

For the first time in Florida, the law now “requires a health care practitioner to review a patient’s PDMP history before prescribing or dispensing a controlled substance.” In the interest of full disclosure, I have long advocated for PDMP use: The PDMP is Showing Progress (2013); If it’s Worth Having, Is it Worth Checking? (2015); If not, What’s the Point (2016); PDMP and Doctor Shopping (2017). Research has demonstrated that PDMP are valid tools in the reduction of “doctor shopping” and drug-seeking behavior.

Another major addition of HB21 is the foundation for establishing a broader perspective on this challenge. It authorizes the Florida Department of Health to afford PDMP access to “certain federal agencies who prescribe or dispense controlled substances,” increasing the breadth of the impact. Furthermore, the Florida Department of Health is empowered “to share and exchange PDMP data with other states if certain conditions are met.” The state limitations on data are important when patients can travel to other jurisdictions. That is perhaps more important in instances like Philadelphia, Pennsylvania and Camden, New Jersey where merely crossing a bridge might frustrate PDMP efforts. But, Florida’s “pill mill” history aptly demonstrates people are sometimes willing to travel much longer distances.

Thus, as Florida joins the mandatory PDMP jurisdictions, the New Hampshire study is of interest. That study examined an abbreviated period of “the six months before and after” New Hampshire mandated that providers check this particular hospital’s “PDMP and opioid abuse risk calculator for all patients receiving an outpatient opioid prescription for acute pain.” The data demonstrated patients that did not receive an opioid prescription following PDMP consultation. That does not mean that the PDMP data led to the absence of such a script. Thus, the researchers retrospectively consulted the PDMP for those patients to determine if each was a “high risk” such that the decision not to prescribe might be attributed to the PDMP.

Researchers complained of the burden of PDMP access at that hospital. They noted this required accessing “an external website requiring a separate login and password.” They were also seemingly critical of software features that required the providers to document the patient’s medical record regarding the PDMP inquiry. It seems a bit disingenuous to be critical of requirements that medical records are documented. Anyone that has ever reviewed a hospital chart has seen instances in which a patient’s vital signs are checked many times daily, and each time dutifully recorded in the patient’s chart. And, most of the time those recorded signs are all normal. Recording what goes on with a patient, normal or not, is simply part of what medical professionals do.

The researchers concluded that before the New Hampshire mandate, “80 percent of patients were given an opioid prescription” and that following the effective date of the law, this decreased only to 77 percent. They concluded that “The PDMP query and risk calculator did not lead to a prescription being withheld for any patient in our series.” And, the researchers concluded that the “mean number of opioid pills prescribed decreased more significantly” in the pre-mandate six months “than in the six months after the mandate was put in place.”

On these findings, the researchers concluded no benefit to the PDMP consultation in the hospital setting. They concede that PDMP “can be effective in outpatient care settings and for patients with chronic pain,” but contend that for hospital physicians the process is “unnecessarily burdensome.” The report is not clear on how the researchers reached the conclusion that PDMP is effective for outpatient, as the performed no such research. Frankly, that conclusion somewhat suggested “deflecting” as in “why don’t you regulators go pick on someone other than me.”

The researchers noted that those physicians who consulted the database invested a “median” of thirteen minutes for the PDMP and risk assessment functions. No explanation for the abandonment of mean (add all instances and divide by volume) in favor of median (the value that is in the middle of any range) in that part of the analysis. Gregg Easterbrook once said “torture the numbers and they will admit to anything,” a scathing criticism of statistical analysis. But, anytime a report focuses attention on a median or a mode, without reporting the mean also, it may raise eyebrows. That median only means that more people took 13 minutes than took any other amount of time.

This mean/median divergence in the reporting becomes more curious when the researchers return to mean in evaluating the “mean turnover time between cases at Dartmouth-Hitchcock’s outpatient surgical center,” which they assert “is 15 minutes.” To that “mean” time, the researchers add the median of “up to 13 minutes per patient” to conclude that “patient turnover time” essentially doubles and thus the PDMP requirements “inhibit clinical efficiency.” Reading the information, one might ask why the researchers measure one factor in “apples,” the second in “oranges,” and presented their ultimate conclusion in “fruit salad.”

Reading the study, I was reminded of WorkCompCentral coverage of PDMP last spring: Research on PDMPs ‘Insufficient,’ Study Claims. That provided an overview of a study that evaluated “17 past research studies” and concluded that “there is insufficient evidence to determine whether PDMPs reduce fatal or non-fatal drug overdoses.” That analysis also suggested that use of “PDMPs may have unintended consequences relating to heroin overdoses.” There is a suspicion among many that depriving people of their opioids through prescriptions may lead them to less sanitary and controlled opioid supplies on the street.

As regards the risk of other overdoses, from heroin or Fentanyl, this study concluded that a PDMP “might reasonably drive opioid-dependent persons to substitute their preferred prescription opioid with heroin or non-pharmaceutical Fentanyl.” This is perhaps incongruent. The study authors question the efficacy of PDMP, and then concede that PDMP are working in controlling access to prescription narcotics. Their criticism is seemingly not that PDMP do not work, but that they do work and therefore people seek other, illicit, alternatives. Those illicit alternatives are undoubtedly more dangerous, both in the quality of product and the risks of obtaining.

In fact, the WCC reported research substantiated that “evidence from 10 studies” out of the 17 examined, “suggested a reduction in fatal overdoses with PDMP implementation.” Furthermore, there are questions about more than overdose. One source quoted by WorkCompCentral noted that “PDMPs are intended to curtail doctors’ over prescribing of opioids.”

Thus, perhaps the PDMP process could limit access to narcotics in the first instance, reduce the development of dependency or addiction, and curtail the demand for illicit substitutes? If the demand for, and therefore use of, illicit alternatives was thus decreased, some might argue the propensity for overdose from those alternatives might similarly decrease? That decrease in narcotic prescription is substantiated in research from the Workers’ Compensation Research Institute (WCRI), the National Council on Compensation Insurance (NCCI), and others noted in the WorkCompCentral story. And, that may refute the New Hampshire assumption that hospital prescriptions are somehow unique or appropriately excluded from PDMP processes.

The WorkCompCentral story reminds us of two other critical points. First, though all states now have PDMPs, not all states require that physicians consult before prescribing. Florida has only implemented that mandatory nature this year. Furthermore, the interstate travel challenge remains nonetheless. Until PDMPs regularly and seamlessly share information, those truly dedicated to obtaining medication inappropriately may still succeed. To those with real focus may suffer nothing more from the PDMP process than some level of frustration or inconvenience.

Thus, there are critics of the PDMP process. Some physicians lament the time they must devote, others question the net effect on the singular concern of overdose. There seems a general sense that PDMP should not be perceived or advocated as either a universal or infallible solution to what is admittedly a complex issue of dependency and potentially addiction. However, the bottom line remains that too many Americans die from overdose. PDMP have been demonstrated to reduce scripts. While they may not be the “end all” solution, there seems sufficient data to support that they are “a” contribution to the solution.

Florida will look to HB21 and its changes. In the months and years to come, time will tell if the significant restrictions of this law ameliorate dependency, address drug-seeking behavior, and ultimately drug overdose. It is hoped that whether HB21 is the solution or not, that a solution is nonetheless found. Too many people are dying. That fact requires no study, it is incontrovertible. Too many.

ABOUT THE AUTHOR

David Langham is the Florida Deputy Chief Judge of Compensation Claims. He blogs weekly regarding system issues, regulations and decisions. He has published many articles and delivered more than 1,000 professional speeches.

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