Abrupt decline in oxycodone-caused mortality after implementation of Florida's Prescription Drug Monitoring Program☆
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.
Section snippets
Research design
The research design was an interrupted time-series, quasi-experimental. The dependent variable consists of 120 repeated monthly counts of oxycodone-caused mortality (106 pre- and 14 post-PDMP implementation) from January, 2003 to December, 2012. A comparison time-series was included to account for the many internal (i.e., Florida-specific) and external factors (i.e., nationwide trends) that might reasonably contribute to or confound an observed effect. The quasi-experimental design with
Results
The characteristics of the population of decedents in the 14 months before and after implementation of the PDMP are shown in Table 1. A fourteen month pre-post period was chosen to provide a balanced cross-section for descriptive analysis. From 2003 to 2012, a total of 7804 oxycodone-caused deaths were reported, representing a mean rate of 65 deaths per month (range of 25 to 126 deaths per month). In 2010, the mean monthly number of oxycodone-caused deaths reached a maximum of 126 deaths with
Discussion
The implementation of Florida's Prescription Drug Monitoring Program in October, 2011 was associated with a 25% decline in oxycodone-caused mortality. The effect was significant after controlling for pre-PDMP declines associated with (1) the introduction of tamper-resistant oxycodone HC1 controlled release tablets to the market, (2) law enforcement crackdown on pill mills, which were popular for their oxycodone-alprazolam “cocktails”, and (3) the tightened rules and regulations around
Role of funding source
Nothing declared.
Contributors
CD was responsible for design, analysis, access to data, and manuscript preparation. MMM and ACW were responsible for statistical interpretation and critical revision. RLC and BAG were responsible for critical revision and data acquisition.
Conflict of interest
No conflict declared.
Acknowledgements
The authors would like to acknowledge Erika Marshall and Rebecca Poston from the Florida Prescription Drug Monitoring Program; Margaret Edwards and Danielle Santiago from the Florida Medical Examiner's Commission for their assistance in obtaining data; and Gary Reisfield of UF Health for reviewing an early draft. This study was supported in part by the Robert Wood Johnson Foundation’s Public Health Law Research Program, based at Temple University School of Law, and by the University of Florida
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Supplementary material can be found by accessing the online version of this paper at http://dx.doi.org and by entering http://dx.doi.org/10.1016/j.drugalcdep.2015.02.010.