Abrupt decline in oxycodone-caused mortality after implementation of Florida's Prescription Drug Monitoring Program

Highlights

• A 25% drop in oxycodone-caused deaths occurred after the start of the Prescription Drug Monitoring Program (PDMP) in Florida.

• Our findings suggest that health care provider use of the PDMP played a role.

• Results have implications for national prescription drug abuse policy.

Abstract

Background

In Florida, oxycodone-caused deaths declined substantially in 2012. Multiple important law enforcement, pharmaceutical, policy, and public health actions occurred concurrently, including implementation of a statewide Prescription Drug Monitoring Program (PDMP). The effects of the PDMP on oxycodone-caused mortality in Florida were evaluated.

Methods

A time-series, quasi-experimental research design with autoregressive integrated moving average (ARIMA) statistical models, including internal and external covariates. Data included 120 repeated monthly observations. Monthly counts of oxycodone-caused deaths, obtained from the Florida Medical Examiners Commission (MEC) was the outcome variable. Models included market-entry of tamper-resistant oxycodone HC1 controlled release tablets (OxyContin^®), enforcement crackdowns (Operation Pill Nation), and regulation by FL House Bill 7095, measured by the monthly count of Florida pain management clinics closed. Two approaches were used to test the PDMP's hypothesized effect: (1) a binary indicator variable (0 = pre-implementation, 1 = post-implementation), and (2) a continuous indicator consisting of the number of PDMP queries by health care providers.

Results

Oxycodone-caused mortality abruptly declined 25% the month after implementation of Florida's PDMP (p = 0.008). The effect remained after integrating other related historical events into the model. Results indicate that for a system-wide increase of one PDMP query per health care provider, oxycodone-caused deaths declined by 0.229 persons per month (p = 0.002).

Conclusions

This is the first study to demonstrate that the PDMP had a significant effect in reducing oxycodone-caused mortality in Florida. Results have implications for national efforts to address the prescription drug epidemic.

Introduction

In the United States, deaths from prescription drug abuse, especially from pain relievers such as oxycodone, have now reached epidemic proportions (Centers for Disease Control and Prevention, 2012, Jones et al., 2013, Levy et al., 2013, Paulozzi, 2012, White House, 2011). Florida has been a focal point in the national crisis, in part due to the well-publicized, proliferation of pain management clinics (i.e., “pill mills”) and their corresponding role in the widespread distribution of oxycodone and other prescriptions and the resulting public health consequences (Johnson et al., 2014, Rigg et al., 2012, Sauber-Schatz et al., 2013, Surratt et al., 2014). From 2003 to 2009 in Florida, the rate per 100,000 population of oxycodone-caused mortality increased 265% (Goldberger et al., 2011). From 2007 to 2010, the rate per 100,000 population of oxycodone-caused deaths increased by 118.3% compared to only 16.3% for hydrocodone, −13.8% for methadone, −5.0% for fentanyl, 0.1% for morphine, −34.6% for propoxyphene, and 62.4% for hydromorphone (Lee et al., 2014). In South Florida, oxycodone was found to be a preferred prescription opioid among pill mill clients (Rigg et al., 2012). Yet, in 2014, a Centers for Disease Control and Prevention (CDC) study reported unprecedented, annual declines in oxycodone-caused mortality in Florida beginning after 2011 (Johnson et al., 2014). Declines in oxycodone deaths coincided with multiple law enforcement, pharmaceutical, and public health actions (Johnson et al., 2014).

In January, 2010, Florida required pain management clinics to register with the Florida Department of Health, which provided more regulatory oversight (Florida Department of Health, 2010). In August, 2010, a reformulated extended-release oxycodone (ERO) was introduced to the national market. In February 2011, the U.S. Drug Enforcement Agency (DEA) took action against illegitimate pain management clinics in an operation known as “Operation Pill Nation” (Alvarez, 2011) In July 2011, House Bill 7095 took effect which established or strengthened state regulation of activities by controlled substance dispensing physicians, pain management clinics, pharmacies and wholesale controlled substance distributors (Florida House Bill 7095, 2011). In October, 2011, Florida became the 37th state to implement a Prescription Drug Monitoring Program (PDMP; Alliance of States with Prescription Drug Monitoring Programs, 2013).

PDMPs are principally designed to detect abnormalities in the prescribing of controlled substances (e.g., higher-than-expected doses per unit time, questionable overlapping prescriptions, “doctor shopping” for multiple prescribers and dispensers). An effective PDMP could plausibly reduce oxycodone overdoses in the population by reducing the quantity of pills available from medical sources that could be abused (Green et al., 2011, Gugelmann and Perrone, 2011). Forty-eight states have operational PDMPs but there is an urgent need to rigorously evaluate these systems and understand the pharmaco-epidemiological consequences of implementing them (Gugelmann et al., 2012, Haffajee et al., 2015). Studies examining the effects of state PDMPs on deaths from opioids, such as oxycodone (DEA Schedule II), are limited. As of June 2014, a single study had examined the effect of PDMPs on opioid mortality and indicated no differences in states with operational PDMPs compared to those without (Davis et al., 2014, Paulozzi et al., 2011). Subsequently, researchers noted several important limitations of this work (Green et al., 2011). Recent work limited to annual mortality data lack the temporal resolution to properly examine this question (Johnson et al., 2014). Thus, the current study, using higher time resolution observations, is designed to test the hypothesis that the PDMP contributed to a reduction in oxycodone-caused mortality in Florida.