摘要：Objectives. We sought to collect and characterize all laws governing the operation of prescription monitoring programs (PMPs), state-level databases that collect patient-specific prescription information, which have been suggested as a tool for reducing prescription drug overdose fatalities. Methods. We utilized a structured legal research protocol to systematically identify, review, and code all PMP statutes and regulations effective from 1998 through 2011. These laws were then abstracted along eleven domains, including reporting provisions, data sharing, and data access. Results. PMP characteristics vary greatly among states and across time. We observed an increase in the types and frequency of data required to be reported, the types of individuals permitted to access PMP data, and the percentage of PMPs authorized to proactively identify outlier prescribers and patients. As of 2011, 10 states required PMPs to report suspicious activity to law enforcement, while only 3 required reporting to the patient’s physician. None required linkage to drug treatment or required all prescribers to review PMP data before prescribing. Few explicitly address data retention. Conclusions. State PMP laws are heterogeneous and evolving. Future studies of PMP effectiveness should take these variations into account. Prescription opioids have proven effective in providing relief from many types of moderate to severe pain. 1–5 Opioid prescriptions in the United States increased approximately 4-fold from 1999 to 2010, largely as a result of increased awareness of and efforts to address untreated pain. 6–8 Although this increase has been beneficial for many patients, it has also contributed to a dramatic rise in fatal and nonfatal opioid overdose. 9,10 Fatal poisonings, more than 90% of which are drug overdoses, have increased nearly 6-fold in the past 3 decades to become the country’s leading cause of injury death. 11 The rate of prescription opioid-involved deaths now exceeds the rate for heroin and cocaine combined. 6,12 There has also been a rapid increase in nonfatal opioid overdose, with emergency department visits involving nonmedical use of opioid analgesics more than doubling between 2004 and 2008. 13 Although increased prescription opioid consumption is a key component of this rise, prescription opioid overdose is a complex phenomenon with a number of causal factors at both the prescriber and patient level. 14 Providers may prescribe opioids in amounts or for durations or indications that are inconsistent with evidence-based practice, and patients may seek opioids from multiple providers because their pain is being inadequately managed or they have developed addiction or dependence. 15–17 Physician error, patient nonadherence, physical health status, poorly coordinated care, comorbidities such as substance use disorders, and a number of psychosocial factors also affect overdose risk. 14,18–21 Additionally, some unscrupulous physicians have operated “pill mills” that prescribe opioids in an indiscriminate and often illegal manner. 22,23 Prescription monitoring programs (PMPs) are state-level databases that collect patient-specific prescription information at the point of dispensing. Data are generated and transmitted to a central repository where, in most states, authorized users such as medical professionals, regulatory bodies, and law enforcement agencies may access them. In theory, PMPs could help address many of the underlying causes of opioid overdose; they may make physicians more aware of the possible risks of prescribing a particular drug to a particular patient, help to coordinate care across providers, reduce overprescribing, assist in identifying patients who might benefit from screening for substance abuse treatment or referral to a pain medicine specialist, and permit law enforcement and regulatory agencies to detect patients and prescribers who may be engaging in illegal or unethical activities. Based on the assumption that PMPs can reduce opioid overdose, their implementation and utilization is recommended by the Centers for Disease Control and Prevention, and millions of dollars of federal funds have been earmarked to implement and upgrade them. 24,25 They are also a key component of the President’s Prescription Drug Abuse Prevention Plan, which sets the goal of decreasing unintentional opioid overdose deaths by 15% by 2016 and recommends that all states operate PMPs and require prescribers to be trained in their use. 26 However, no published research has shown a significant correlation between PMPs and overdose, and there is little evidence of their effect on other patient health outcomes. Existing research has largely evaluated the impact of PMPs on outcomes such as “doctor shopping,” prescribing practices, abuse and misuse, or benefits to law enforcement. 27–33 The only published analysis examining the effect of PMPs on overdose mortality found no significant difference between states with PMPs and those without them, although several limitations of that study have been noted. 34–36 This may be, in part, because nearly all studies of PMP effectiveness have used a crude binary measurement—whether the state had a PMP—as their dependent variable. This approach assumes that all PMPs can be treated homogenously regardless of their operational characteristics. This is a nontrivial assumption, which has been presented with little supporting evidence. In fact, PMPs vary greatly in ways that are likely to affect utilization and effectiveness. 37–40 There are wide variations between states and across time regarding such basic programmatic elements as the types of data required to be reported to the PMP, the frequency with which data must be sent from the dispenser to the central repository, who can access the data and in what circumstances, and where the PMP is administratively housed. At the time previous studies were conducted, no longitudinal database of the statutes and regulations (hereafter referred to collectively as “laws”) governing PMP operational characteristics existed, making it extremely difficult to factor these variations into research designs. Using public health law research methods, we have created the first in-depth, long-term longitudinal analysis of laws governing PMP operation. This compendium covers relevant laws from 1998 to 2011 across all 50 states, and can inform future research.
