Friday, September 14, 2018

Mandated Queries of the Florida Prescription Drug Monitoring Program: Early Experiences from a Cancer Center-based Outpatient Palliative Medicine Clinic

by Chad Kollas (@ChadDKollas)

Background and Introduction

On July 1, 2018, Florida implemented a new law requiring all licensed physicians to query the state’s prescription drug monitoring program (PDMP), known as the Electronic Florida Online Reporting of Controlled Substances Evaluation (E-FORSCE), before prescribing controlled medications, including opioid analgesics. This law evolved from a September 2017 proposal by Governor Rick Scott intended to reduce deaths from Florida’s growing number of opioid overdoses, a trend commonly known as the Opioid Crisis.

Gov. Scott’s proposal built upon two recent Florida laws, which were also proposed to combat the Opioid Crisis. The first measure created Florida’s PDMP in 2009, although the program was not funded for operation until September 2011. The second law passed in 2012 and established prescribing rules for managing chronic pain and highly regulated free-standing pain management clinics (Lenchus JD, Opioids and Controlled Substances. FMA Controlled Substance Prescribing Course, 2018). While these laws eventually resulted in the elimination of Florida’s rogue Pain Clinics, known commonly as “Pill Mills,” they unintentionally increased opioid stigma and made it more difficult for cancer patients to obtain controlled pain medications (Kollas CD, Boyer-Kollas B. J Pain Symptom Management, February 2018;55(2):663-4).

In April 2018, the Florida legislature broadened Gov. Scott’s original proposal to include almost all controlled medications (including C-II through C-IV), not just opioid analgesics, because of a political trade-off that expanded exemptions for treating chronic pain to include hospice and palliative medicine physicians. This subtle change in legislative language eluded many in the healthcare environment, until just before the planned implementation of the new law, causing anxiety for many Florida physicians and patients concerned about maintaining access to controlled medications.

In light of this anxiety about the potential impact of the new law on both patients and physicians, we initiated a quality improvement (QI) project to characterize its effects and identify opportunities to improve palliative care in the setting of implementation of the new law.

Methods

In our outpatient palliative medicine clinic (PMC), we began recording results of all E-FORSCE queries occurring after the law’s implementation of July 1, 2018. We informed each patient that the PDMP query had become mandatory in Florida, and we discussed the results of each query with each patient. Each query examined the last 12 months of the patients’ controlled medication prescriptions. This article describes our experiences in the first month of experience with the new law, although we plan to examine queries for a total of three months before closing this QI project.

For the purpose of this QI project, we have documented patients’ demographics, including each patient’s age, gender and limited identifying information, such as patient names and identification numbers; this data will be de-identified for any statistical analysis planned in the future. We also recorded patients’ main diagnosis and pain symptoms, the number of prescribers listed by the PDMP as well as the dose of the patient’s opioid analgesia, measured in average daily morphine milligram equivalents, as provided by the state database. We also noted pain ratings with and without medications, including opioids and non-opioids, as well as the difference between those ratings.

We classified the numbers of each patient’s prescribers binarily (one prescriber or more than one prescriber), and usage sage patterns were classified ordinally as medically legitimate, aberrant or medically illegitimate. Medically legitimate patterns reflected 1) cross-coverage of medication renewals, 2) evolving sites of care (such as a transitioning into oncologic care after treatment of cancer pain before establishing a cancer diagnosis), 3) prescribing of non-opioid controlled medications by primary care physicians (PCPS) and/or their cross-coverage and 4) prescribing within the policies and rules of the PMC.

We defined medically illegitimate patterns as involving 1) duplicative prescriptions (multiple prescriptions within close temporal proximity at multiple geographic site or multiple providers), 2) patterns unexplained by under-treatment and/or an inability to fill prescriptions in full quantity, or 3) behavior(s) prohibited by the policies and rules of the PMC. We used the category of aberrancy to describe situations which did not fall cleanly into the definitions of medically-legitimate or illegitimate usage.

Additionally, we classified opioid dosages ordinally, using the three planned categories for daily MME dose that will be used by the Centers for Medicare and Medicaid Services (CMS) by virtue of its opioid prescribing rules for 2019:
  • Less than 90 MME
  • 90-200 MME or
  • Greater than 200 MME
We also allowed for individualized comments regarding any unexpected or unusual findings when performing a PDMP query. The mean MME over the last 30 days was usually obtained from the PDMP, but was calculated based on prescribing instructions when not provided explicitly by that database.

Finally, we recorded patients’ self-reported pain ratings based on a 0-10/10 scale, with 0 indicating no pain and 10 indicating excruciating pain (or the most severe pain the patient had ever experienced). We recorded patients’ pain ratings with and without cancer pain medications, clarifying that we meant pain medications being prescribed medically for their cancer pain. In our clinic, the usual goal for cancer pain control is achieving a pain rating of 4-5 out of 10, not the achievement of a pain-free state, an approach that evolved from the American Pain Society’s recommendations for managing cancer pain.

Preliminary Results

Demographics

In the first month of our QI project, we queried the Florida PDMP for a total of 125 outpatients. Of these, 96% had cancer-related pain, while the rest had chronic pain related to other conditions for which they received outpatient palliative care, such as sickle cell disease (3 patients, 2.4% of total). The patients’ average age was 57.8 years old (range of 25 to 85) and 61.6% of them identified as female. Nine patients (7%) were new consultations to the PMC.

Prescribers and Usage Patterns

About 73% of the patients had more than one prescriber listed in the PDMP, while 24% had a single prescriber for controlled medications. Only two patients (1.6%) exhibited aberrancy: one had a query showing 15 prescribers, and the other was a healthcare professional who had self-prescribed renewals of anxiolytic medications (which is considered unethical, but not illegal in Florida). The patient with 15 prescribers was ultimately not found to be using opioids illegitimately, but rather was participating in the healthcare system in a fragmented way, through two, parallel sets of third-party payers (health insurance and motor vehicle insurance).

Notably, there were no patients whose prescribing pattern suggested medically-illegitimate behavior, such as “doctor shopping.” More importantly – and somewhat concerning – we uncovered four cases in which the state PDMP was demonstrably incorrect, which would reflect an error rate of 3.2% in the database. This included two cases in which prescriptions written in the PMC were attributed to non-prescribing providers at outside locations. Two other patients had filled prescriptions for controlled pain medications, but did not appear in the PDMP at all. An additional patient was not located initially, but found under her maiden name after further investigation (and not considered a PDMP error).

The mean opioid analgesic dose for all of the patients was 210 MME per day, but the median dose was 100 MME per day, with a very wide range of daily dosages (6 MME to 1300 MME; Std. Dev. = 265.2). The distribution of Daily MME is shown in Table 1 (below). Three patients had received opioid analgesics within the last year, but were no longer taking them at the time of the PDMP query.

Pain Ratings

The patients’ mean pain rating without taking any pain medications was 8.5 out of 10 (SD = 1.1, Median = 8.5). The patient’s mean pain rating when taking their prescribed cancer pain medications was 3.8 out of 10 (SD 1.5, Median = 3.5), with an average reduction in pain rating was 5.0 points (SD = 1.5, Median = 5.0). This represented an average in reduction in pain of 56.4% with usage of the prescribed regimen.

Discussion and Policy Implications

We were surprised that almost three-quarters of outpatients in a palliative medicine clinic (PMC) housed within a regional cancer center had PDMP queries that showed multiple prescribers for their controlled medications. Each patient who receives palliative care in our PMC receives written educational material describing the policies and procedures of the clinic, including a directive encouraging them to receive prescriptions for controlled pain medications from a single prescriber and use a single pharmacy to fill them. On the other hand, deeper examination of each PDMP report revealed that the vast majority of the patients were taking controlled medications in a medically legitimate way, with only two patients exhibiting medication aberrancy and no patients demonstrating medically inappropriate behavior. Florida Governor Rick Scott introduced the concept of mandatory physician queries of the PDMP to “combat opioid abuse in our state”, implying that queries might uncover inappropriate patient behavior, although the law ultimately does not advise physicians how to proceed after performing a mandated query. Additionally, some physicians have suggested that the presence as multiple prescribers in a PDMP should serve as a red flag for doctor shopping, a form of medically inappropriate patient behavior. Based on this QI project and our prior work, we are concerned that applying that using multiple prescribers as a red-flag PDMP strategy could worsen opioid stigma and difficulty filling cancer pain medications in our patient population.

We were also surprised – and disturbed – to find that our estimation of the error rate within the Florida PDMP (3.2%) exceeded the rate at which we identified medication aberrancy and medically inappropriate behaviors (1.6% and 0%, respectively) in our patient population. This calls into question the accuracy and usefulness of the PDMP as a tool to “combat opioid abuse,” at least in outpatients receiving palliative care at a regional cancer center. Of note, we took into account the lag time between when patients fill their prescriptions, at which time the pharmacy submits its record of that transaction to the PDMP, and the time that it takes for the PDMP to post the information to the database for review by prescribers, allowing for a 90-day lag in cases of missing prescriptions.

Opioid dosing varied widely in our project, with 46% of patients using doses of less than 90 MME daily and 28% using doses higher than 200 MME per day. In light of the proposed rules for opioid prescribing for 2019 by the Centers for Medicaid and Medicare Service, we anticipate that about one-quarter of patients receiving prescriptions for controlled cancer pain medications will face procedural hurdles, most likely in the form of health insurance prior authorizations (PAs) , when they attempt to fill those prescriptions beginning on January 1, 2019. It also means that pharmacists will need to contact prescribing physicians for another one-quarter of prescriptions issued to patients with cancer pain, as mandated by the CMSA Proposed Opioid Rules. Given the large number of American patients affected by cancer pain, the regulatory burden upon physicians and pharmacist should prove to be substantial. In turn, this is likely to create more difficulty for cancer patients and their families to access pain medications that many need to preserve their quality of life.

Finally, it is uncertain from our project whether Florida’s mandatory PDMP queries will lead to reduced prescribing of opioids, as has been the case in other states [see Suffoleto et al. J. of Pain, April 2018; 19(4):430-8]. What is clear, however, is that state-mandated PDMP queries have not led to reductions in opioid overdose deaths, a main goal cited by politicians when justifying their passage from legislation into law. Instead of prescription opioids, illicit fentanyl and heroin have become the drivers of opioid overdose deaths. In light of what we have learned in the QI project, this leads us to ask this critical question: Is physicians’ time best spent querying a database with a higher error rate than the rate at which it identifies medically inappropriate behavior and which might lead to worsening opioid stigma and difficulty filling prescriptions for cancer pain medications? Perhaps will be able to answer this question even more forcefully as we complete this project in the months to come.

(This QI project was reviewed and approved by the Orlando Health/UFHealth Cancer Center Joint Oncology Committee for 2018-19. - Ed.)

Dr. Kollas has provided outpatient palliative care at Orlando Health UFHealth Cancer Center for over 17 years. He first wrote about his personal experiences with chronic illness and pain in a 1997 article in the “On Being a Patient” series in Annals of Internal Medicine. You can find him on Twitter at @ChadDKollas.

Pallimed | Blogger Template adapted from Mash2 by Bloggermint