Allan Coukell, senior director of drugs and medical devices, testified before the U.S.-China Economic and Security Review Commission on the global pharmaceutical supply chain security and the importance of the newly passed Drug Quality and Security Act.More info
A brief history of PDMPs
Through 1989, nine PDMPs had been established. Two were located in state Attorneys General offices (California, 1939 and Pennsylvania, 1972); two in Departments of Public Safety (Hawaii, 1943 and Texas, 1981); two in Departments of Health, Bureau of Narcotics Enforcement (New York, 1970 and Rhode Island, 1978); one in a Department of Substance Abuse Services (Illinois, 1961); one in a Board of Pharmacy (Idaho, 1967); and one in a Department of Consumer Affairs, Bureau of Health Professions (Michigan, 1988). All of these programs collected information about Schedule II prescriptions¹ only, and all used state-issued serialized prescription forms. The use of these multiple-page forms allowed the original prescription records to be sent to the PDMP for key-punch data entry, while the pharmacy, and in most cases the prescriber, kept a copy.
Reflecting their locations primarily in state agencies concerned with public safety and drug enforcement, these early PDMPs all provided solicited reports, and most provided unsolicited reports to law enforcement personnel and regulatory agencies or professional licensing agencies. None provided reports to prescribers or pharmacists. The reports and, where relevant, PDMP investigations focused on prescribers selling prescriptions, pharmacies selling controlled
substances illegally, and organized doctor shopping rings. For example, narcotics enforcement in New York, using PDMP data, focused on Quaalude and barbiturate prescription abuse associated with sleep clinics in the late 1970s and
early 1980s, and subsequently on stimulant prescription abuse associated with weight clinics (Eadie, 2010).
With support from the U.S. Drug Enforcement Administration (DEA), the existing PDMP administrators created the Alliance of States with Prescription Monitoring Programs in November 1990. The Alliance was founded to provide a forum for support and information exchange among PDMPs, states where efforts were under way to establish a PDMP, and states where creation of a PDMP was being considered. At this time, PDMPs expanded data collection beyond Schedule II prescriptions. In the context of computer-based information technologies, a second generation of PDMPs came into existence that collected prescription information electronically, without the use of serialized prescription forms. Examples included the Oklahoma PDMP in 1990, located in the Department of Public Safety, and the Massachusetts PDMP in 1992, located in the Department of Public Health.
The Nevada PDMP, implemented in 1997 and located in the state Board of Pharmacy, ushered in a new era of PDMPs by providing data directly to prescribers and pharmacists. Initially, Nevada proactively sent unsolicited reports to the health care practitioners who had issued and dispensed prescriptions to possible doctor shoppers — that is, individuals receiving multiple simultaneous prescriptions of commonly abused drugs. This resulted in a rapid demand for reports upon request (Prescription Drug Monitoring Program Center of Excellence [PDMP COE], Notes from the Field [NFF] 2.5). While the reports initially were sent by fax, Nevada developed in 2001 an online system that began issuing reports based upon users’ direct inquiries. Kentucky soon followed Nevada’s lead, implementing a program in 1999 and developing online capabilities within a few years. In 1994, the Alliance initiated a process to help standardize electronic formats for data collection. This resulted in the publication of the American Society for Automation in Pharmacy’s (ASAP) first version of guidelines for pharmacies to submit controlled substances prescription data to PDMPs. The standards have been updated frequently to incorporate enhancements in electronic system capabilities, and all PDMPs are
now using a version of an ASAP standard.
Early studies in New York indicated that the state’s PDMP had greatly impacted stimulant, barbiturate, and later benzodiazepine prescribing and abuse (Fisher et al., 2011). Other studies suggested that serialized prescription forms required by PDMPs had a so-called "chilling effect" on legitimate prescribing (Joranson & Dahl, 1989; Pearson et al., 2006; Fornili & Simoni-‐Wastila, 2011). In 1996, OxyContin was introduced, and sales of prescription opioids began to increase markedly. After a slow rise in 1984, the numbers of first-time illicit users of pain relievers doubled between 1994 and 1998. Unintentional drug overdose death rates, while increasing through the 1990s, began to increase more steeply in the early 2000s, largely attributed to increased prescription opioid prescribing and abuse (Hall et al., 2008; Bohnert et al., 2011).
An element of the federal response to the increasing death rate was the creation of the Harold Rogers Prescription Drug Monitoring Program Grant Program in the Department of Justice, Bureau of Justice Assistance (BJA) in federal fiscal year 2002. BJA also designated the National Association for Model State Drug Laws (NAMSDL) to assist states in developing PDMP legislation. At about the same time, Purdue Pharma, manufacturer of OxyContin, began to support the creation of new PDMPs with technical as well as monetary assistance, specifying PDMP characteristics that it deemed
desirable. In 2005, Congress passed the National All Schedules Prescription Electronic Reporting (NASPER) Act, authorizing additional federal funding for PDMPs; the Substance Abuse and Mental Health Services Administration (SAMHSA) was designated as the lead agency for NASPER. In 2008, in collaboration with the Alliance of States with Prescription Monitoring Programs and the Heller School of Social Policy and Management at Brandeis University, BJA formed the PDMP Training and Technical Assistance Center, charged with assisting PDMPs in planning, implementing, and enhancing their programs. Two years later, BJA funded the PDMP COE at the Heller School in order to provide practice-‐relevant information, evaluation, and expertise to PDMPs and their stakeholders, including the development of best practices. As the founder of these efforts and as the nation’s primary public funder of PDMPs via the Harold Rogers Grant Program, BJA has maintained a consistent focus on developing PDMP best practices and encouraging innovative applications of PDMP data. As will be noted in this paper, BJA gives priority funding consideration to states proposing to implement evidence-based practices that contribute to PDMP effectiveness.
As a result of increased public and private support and the growing recognition of PDMPs’ potential to address the prescription drug abuse epidemic, PDMPs proliferated rapidly. In 2001, 16 states had passed legislation authorizing the creation of a PDMP; by June 2012, 49 states and one territory had passed such legislation, and 41 states had an operating PDMP.
The environment in which the newer PDMPs were implemented differs technologically and politically from that of PDMPs implemented through the early 2000s, generating an array of newer PDMP practices and a great diversity of practices across all PDMPs. For example, PDMPs implemented since 2001 have typically included a secure online portal for authorized providers to access PDMP data about their patients. All older PDMPs, except one, have evolved to permit provider access, often requiring new legislation authorizing such access, and then a costly retrofitting of PDMP
operations to accommodate online and other new technology and new user demands. In contrast to the oldest PDMPs, newer PDMPs are often prohibited by law from providing unsolicited reports on patient or health care provider activity to law enforcement agencies or providers (PDMP COE survey of PDMPs, 2010). Although the wide range of practices carried out by different PDMPs suggests the possibility of evaluating the effectiveness of individual practices, the diversity of practices itself constrains the extent to which individual practices can be isolated and assessed across PDMPs, since other practices most often cannot be held constant.
Although PDMPs currently differ in their relative emphasis on improving medical care versus reducing drug diversion and abuse, they are well positioned to serve both objectives. Indeed, these objectives substantially overlap since the appropriate prescribing of controlled substances can reduce their diversion and abuse, while law enforcement efforts can protect public health by limiting diversion. This is analogous to the collaboration of public health and law enforcement
agencies in reducing automobile accidents, injuries, and fatalities. For example, criminal investigations of doctor shoppers can bring people at risk of overdose and death into drug courts, where they can be placed into drug treatment and supervised, protecting health and saving lives. Likewise, law enforcement efforts to shut down pill mills and doctor shopping rings can have substantial public health benefits by reducing the supply of prescription drugs for street
The opportunity therefore exists in establishing PDMP best practices to bring together advocates of effective medicine, drug abuse prevention, drug control, and substance abuse treatment to address common objectives using a common tool: improving the legitimate use of controlled substances and mitigating the prescription drug abuse epidemic by utilizing PDMP data in all their diverse applications. Despite differences in operations and objectives among PDMPs, the history outlined above depicts an environment in which program modification is the norm, with the identification and adoption of new concepts, technologies, and standards as constants. This suggests that development of evidence-based best practices will be welcomed by PDMPs, and their adoption can be expected.
The established value of PDMPs
Before embarking on a consideration of PDMP best practices, it should be noted that evidence suggests PDMPs are effective in improving the prescribing of controlled substances and addressing the prescription drug abuse epidemic (PDMP COE, Briefing on PDMP Effectiveness, 2012). PDMP data are unique and irreplaceable in identifying questionable activity with respect to prescription drugs, such as doctor and pharmacy shopping, prescription fraud, and problematic prescribing. No other system exists that can compile all controlled substances prescriptions, regardless of who issued the prescription, which pharmacy dispensed it, or the source of payment. According to surveys of PDMP users and a study of emergency department doctors, PDMPs are an important tool in making sound clinical decisions when prescribing or dispensing controlled substances (ASPMP, 2007; Kentucky Cabinet for Health and Family Services, 2010; Baehren, 2010). Evaluations of PDMPs generally report good user satisfaction with the utility of PDMP reports (Virginia Department of Health Professions and Virginia State Police, 2004; Lambert, 2006; Rosenblatt, 2007).
PDMP data can be used to track emerging trends in legitimate prescribing; to evaluate efforts to improve prescribing practices, such as provider education initiatives (Fisher et al., 2011a); and to reduce drug abuse and diversion, such as drug abuse prevention programs and drug control policies (Carnevale & Associates and PDMP COE, 2010; PDMP COE, NFF 3.2). PDMPs currently assist in investigations of diversion of prescription drugs into illegal use (drug diversion) (PDMP COE, NFF 2.3), medical examiner practice (PDMP COE, NFF 2.6), drug courts (PDMP COE, NFF 2.4), and direct intervention with and supervision of doctor shoppers as an alternative to criminal investigation (PDMP COE, NFF
2.1), substance abuse treatment programs (PDMP COE, NFF 2.2), and epidemiological surveillance and early warning systems (Carnevale & Associates and PDMP COE, 2010). Although questions have been raised about the effectiveness of PDMPs (Fornili & Simoni-‐Wastila, 2011), several studies suggest a connection between PDMP utilization or particular PDMP practices and positive outcomes related to improving, prescribing, and reducing prescription drug abuse (Pearson et al., 2006; Pradel et al., 2009; Reisman et al., 2009; Wang & Christo, 2009; Paulozzi & Stier, 2010; Fisher et al. 2011b;
LeMire et al., 2012; Reifler et al., 2012).
Given that PDMPs have already proven their worth in many applications, the question addressed in this white paper is what program characteristics and practices are likely to enable PDMPs to become more effective in collecting, analyzing, disseminating, and utilizing their data. See McDonald et al. (2004) for an earlier compilation of PDMP practices and recommendations for research on their effectiveness.
The effectiveness of PDMPs can be conceptualized in terms of their impact in ensuring the appropriate use of prescription-‐controlled substances, reducing their diversion and abuse, and improving health outcomes, both at the patient and community levels. This impact is maximized when prescription history data are, to the extent technologically feasible, complete and accurate; analyzed appropriately and expeditiously; made available in a proactive and timely manner; disseminated in ways and formats that best serve the purposes of end users; and applied in all relevant domains by all appropriate users. This suggests that PDMPs can be thought of as information systems with inputs, internal operations, outputs, and customers who make use of their products. An effective PDMP will optimize all system phases, expand its customer base to include all appropriate users, and make sure these customers are well trained in using the PDMP. Best practices need to be identified for each phase.
Considerable preliminary work has already been done in this regard, including in formulating the Alliance of States with Prescription Monitoring Programs’ Prescription Monitoring Program (PMP) Model Act (ASPMP, 2010), developing and continuously updating the standards for transmission of information from pharmacies to PDMPs (standards developed with ASAP), and identifying characteristics and practices of the "next generation" of PDMPs (Eadie, 2011, May and an “ideal” PDMP (Perrone & Nelson, 2012). Although the rationale for the practices mentioned in these documents in many cases seems both logical and plausible, the evidence base supporting them is often experiential and not well documented.
PDMP effectiveness can also be understood in the context of how PDMPs can best work together and in concert with other agencies, organizations, and health information technologies. Best practices will likely include data standardization and sharing among PDMPs and other agencies, as well as cooperative arrangements that maximize the value of PDMP data in their completeness, timeliness, analysis, and dissemination. To increase their effectiveness and impact, PDMPs must be integrated with other systems, including public health, health information exchanges, electronic health records,
electronic prescribing, public safety, drug abuse prevention, and drug control. This will ensure that their data are made seamlessly available to all those engaged in improving controlled substances prescribing and addressing the prescription drug abuse epidemic. An important intermediate measure of PDMP effectiveness is therefore the number and type of interorganizational linkages and information-sharing agreements between PDMPs and other agencies. Section IV of this
paper covers practices that may increase such linkages.
Toward a checklist of PDMP best practices
This paper can be considered a step toward developing an evidence-based checklist of PDMP best practices that could be used to evaluate a PDMP. Each practice would be defined operationally, and where possible and appropriate, quantitative metrics indicating success in carrying out the practice would be specified. Once parameters are established for each practice’s definition and metrics, annual or semiannual surveys of PDMPs could track their adoption. Some candidate practices considered below are sufficiently well-‐defined and arguably have enough evidential support to already warrant their inclusion in a compendium of best practices, but many need more clarification, specificity, and evidence of effectiveness to support their inclusion. For example, practices in PDMP user recruitment, enrollment, and education need to be evaluated, such as the 2012 statutes in Kentucky, New York, Tennessee, and Massachusetts mandating PDMP enrollment and use. For demonstration purposes only, a checklist of the candidate practices considered below is presented in Appendix A.
¹ - The Controlled Substances Act, passed in 1970, established the five-tiered schedule of controlled substances that
is now in effect. Drugs are assigned to one of these categories, or schedules, based on the substance’s medicinal value, harmfulness, and potential for abuse and diversion. Schedule II is the most restrictive of the schedules of legally available controlled substances.