The Problems of Opioids

During roughly the past two decades there have been significant increases in the prescription of opioid analgesics for helping millions of patients with pain disorders. At the same time, the United States is in the midst of an epidemic of misuse of these drugs and related abuse, addiction, overdose, and deaths.

For example, the prescribing of opioid analgesics has more than doubled since the 1990s. At the same time, sales of opioids quadrupled and there was a 6-fold increase in admissions to substance abuse treatment programs. Most importantly, opioid-related deaths have more than tripled, with unintentional deaths due opioid overdose exceeding those of heroin and cocaine combined.

As one tool for addressing the problems associated with opioid analgesics, prescription drug monitoring programs (PDMPs) have been developed over the years. These programs are intended to medically benefit patient care, and also as a tool for law enforcement and other agencies concerned with stemming the tide of opioid-related threats to the public health.

PDMPs: Simple in Concept, Complex in Execution

Fundamentally, a PDMP is a central repository of prescribing and dispensing records pertaining to medications classified as scheduled, controlled substances by the U.S. Drug Enforcement Administration, but a PDMP may include any drug/substance of interest or determined to have abuse potential. These days, the information is stored in online electronic databases allowing easy access to authorized individuals or agencies, such as law enforcement and drug control agencies, practitioner licensure boards, medical examiners, drug courts and criminal diversion programs, addiction treatment programs, public and private third-party payers, medication dispensers (e.g., pharmacies) and prescribers, and other healthcare providers. States vary widely in which categories of users are permitted to request and receive prescription history reports and under what conditions.

Individual state PDMPs also differ as to required prescribing information — such as, drugs of interest, dose/quantity, date dispensed, and dispenser, prescriber, and patient information, etc. — and time of entry into the database. Only one state, Oklahoma, collects data in real time — that is, at the same time that a prescription is filled — whereas, most states allow up to a week or longer for submission of data to the PDMP.

In using the data, PDMPs may be categorized as being a) reactive, b) proactive, or c) a combination of the two. A reactive approach passively relies on inquiries (solicitations) from authorized agencies or individuals before generating reports; for example, a physician might query the PDMP database prior to prescribing an opioid for a patient. Or, PDMPs may be more proactively designed to watch for patterns of prescribing or dispensing that raise red flags and then provide unsolicited reports to authorized agencies or individuals for further action. In some cases, state PDMPs use a combination of both approaches.

A Long Evolution of PDMPs

According to research conducted for the Pew Charitable Trusts, PDMPs are not a new concept. In fact, as of 1990 there had been 9 PDMPs developed, dating from the earliest in California in 1939. Most of the programs were initiated by law enforcement and/or regulatory agencies and all of them only collected data on Schedule II prescriptions (i.e., opioids) using multi-page, serialized prescription forms requiring manual data entry at the PDMP. There was an emphasis on controlling illicit channels of opioid purchase or distribution and these early PDMPs provided reports on request (solicited) as well as unsolicited reports to law enforcement personnel, regulatory agencies, or professional licensing agencies; no reports were provided to prescribers or pharmacists.

Beyond 1990, and with support from the U.S. Drug Enforcement Administration (DEA), PDMP administrators formed an alliance for mutual support and information exchange, and to help promote expansion of PDMPs to other states. At this time, PDMPs also started to extend data collection beyond Schedule II drugs; although, each state was free to select the drugs included. This also marked a new generation of PDMPs using electronic technology for prescription information collection, largely abandoning the need for serialized prescription forms. Initially, reports were transmitted by fax, but online systems soon allowed more expedient inquiries.

Continued interest at the federal level, and focusing on reducing opioid-related problems, resulted in various economic support programs; e.g., Harold Rogers Prescription Drug Monitoring Program Grants and the National All Schedules Prescription Electronic Reporting (NASPER) Act. The U.S. Bureau of Justice Assistance helped to form PDMP assistance and training programs with a special emphasis on evidence-based practices. Through the years, other government agencies (e.g., ONDCP, CDC, etc.) and private industry (Purdue Pharma) provided additional assistance and support for program development.

According to the most current information, by the end of 2014 all 50 states and the District of Columbia (Washington DC) had or were nearing realization of a PDMP; Washington DC enacted legislation but did not have an operational program and Missouri was nearing legislative authorization of a PDMP. Still, there are many inconsistencies across state programs, for example:

• Many, but not all, programs allow sharing of their information with other state PDMPs; however, in many cases there are problems with data formatting and transmission that are barriers to such sharing.
• In 5 states, PDMPs are still housed in law enforcement agencies.
• When it comes to proactively sending unsolicited reports, there are many differences in who is contacted, whether it be prescribers, pharmacists, law enforcement, or licensing entities.
• Less than a quarter of states (12) require that patients are notified when or if their prescription information might be accessed.

As a newly added concern, the recent hacking of online, electronic databases threatens the integrity of PDMP programs and the security of confidential patient information. According to news reports, hacker attacks in Oregon and South Carolina exposed social security numbers and other personal information housed in state databases. Last August, a collective of activist hackers known as “Anonymous” brought the Missouri state database servers to a halt temporarily, which may threaten passage of PDMP legislation in the state.

Serving Multiple Roles

The early and ongoing development of PDMPs has been principally driven by concerns about opioid-related problems — e.g., diversion, abuse, deaths — so the programs were designed foremost to serve regulatory and law enforcement agencies. For example, the database can be used at the individual-patient level to identify those obtaining prescriptions for drugs of concern from multiple prescribers and/or pharmacies during a brief timeframe (known as “Doctor Shoppers”); in response, the prescribers can be proactively alerted. On a larger scale, PDMP records can help to identify medical practices or clinics that appear to over-prescribe controlled substances of concern (“Pill Mills”), which may trigger investigations leading to regulatory or law enforcement actions. In other cases, PDMP records may be used to identify insurance fraud in billing for certain drugs and possible drug diversion within a particular locale.

Of greatest interest currently is having medical professionals use PDMPs as a tool for reducing the abuse, addiction, and diversion of opioid analgesics and other prescription drugs. For example, prescribers are urged to proactively use the database to detect alleged “Dr. Shoppers” so such behavior can be deterred at the point-of-care. Another potential benefit of PDMPs is the improved patient care and safety afforded by prescribers knowing of all controlled substances patients are being prescribed by all healthcare providers, since patients may not report complete information in their health history. Ideally, PDMP reports would include data on all prescription medications, beyond just CII opioids, but most PDMPs are not designed to capture such extensive information.

Although PDMPs have significant potential to improve public health and patient care outcomes, they remain a substantially underutilized resource. Reasons for this include differences in the data individual state PDMPs collect, whether and how data quality is ensured, the kinds of data analyses and reports that are produced, and to which users and under what conditions data are made available. Furthermore, while it is claimed that PDMPs do not infringe on the legitimate prescribing of controlled substances and simply make it possible to spot potential problems in patients deserving a closer look, an end result often has been a “chilling effect” on the prescribing of opioids overall.

Evidence Lacking to Support PDMPs

Early PDMPs in the pre-electronic era had limited effects due to the lag time inherent in reporting information via paper documentation, the minimal data collected, the need for manual data entry, the absence of off-hours access to data, and the voluntary nature of reporting. Since 2001, with the advent of newer and improved PDMPs, there still have been no federally-mandated rules to enforce consistency and compatibility among those programs, which makes doing research across programs more challenging.

Several dozen published and unpublished empirical studies on PDMP effectiveness have been summarized in the Pew report, which more than anything points to the difficulties of such investigations. At best, studies have been observational in nature, but most have been case reports of select aspects of PDMPs (e.g., increases in user satisfaction); the vast majority of studies reported favorable outcomes related to PDMP applications and practices. It is important to note, however, that none of the studies were of high quality and none examined improvements in patient care or health outcomes as a result of PDMP implementation and use.

The few broader-scope comparisons of all states with versus states without PDMP programs did not show outcomes favoring PDMPs. For example, an observational study by Paulozzi, Jones, et al. (2011) of early program effectiveness, spanning 1999 through 2005, found that states with PDMPs demonstrated unfavorably increased trends in drug overdoses and mortality, along with significantly greater consumption of hydrocodone. Interestingly, the only states showing improvements in overdose deaths and opioid consumption at the time included 3 states with PDMPs still using special prescription forms rather than newer electronic approaches. This suggested there were many challenges still to be overcome in developing electronic PDMPs and, while it cannot be stated that PDMPs themselves caused negative outcomes, the researchers concluded that, “…it can be said unequivocally that PDMP states did not do any better than the non-PDMP states in controlling the rise in drug overdose mortality.”

Further studies are needed to assess individual state programs as well as PDMPs grouped on a regional and nationwide basis. Along with that, however, many potentially confounding factors must be considered. For example, several government agencies have been developing and promoting educational and regulatory programs that impact some of the same outcome variables measured for PDMP programs. For example, reductions in opioid-related overdoses and deaths during recent years might be attributed to successes of the FDA’s REMS (Risk Evaluation and Mitigation Strategies) programs for opioid analgesics.

Prescriber Dilemmas

Prescribers have not widely embraced the use of PDMPs, even though there could be some advantages of PDMPs for patient care. For example, a comprehensive and accurate history of pharmacotherapy-management is essential for clinical evaluation of a new patient with chronic pain. While reliance on the patient’s self-reported history is generally considered acceptable, it may lead to dangerous misprescribing. A PDMP might help to identify patients who are receiving multiple legitimate prescriptions for opioids or benzodiazepines, from different healthcare providers, and are at risk for complications from polypharmacy — but only if the PDMP tracks more than class CII opioids.

Online electronic PDMPs help to solve many of the problems that restrained earlier, paper-based systems, but they also raise new concerns. In one survey of prescribers, the respondents cited time restraints and access difficulty issues as barriers to using PDMPs. A newly-reported nationwide survey, by researchers at the Johns Hopkins Bloomberg School of Public Health, found that among the 420 randomly-selected eligible physicians questioned more than one-fifth (22%) were not aware of their state’s PDMP and only 53% had actually used the program.

The researchers suggest that usage might be improved if more states allow physicians to appoint a proxy such as a staff member who can do the work of accessing the database. Another problem noted is that, in some state databases, the information is not clearly presented, making it difficult to interpret. Furthermore, only 21 states presently require prescribers to register with their PDMP and only 16 states require that prescribers use PDMP information.

In that regard, a cross-sectional study of 33 PDMP programs found that only slightly more than half of clinicians on average within the states were registered to use the PDMP, with many who did register using it infrequently. In states with PDMPs administered by law enforcement agencies, usage by healthcare providers was lower than in states with PDMPs managed by health or pharmacy boards.

In a recent survey of PDMP users in Oregon, almost all (95%) reported accessing the database when they suspected drug abuse or diversion in a patient, but fewer than half checked it routinely for every new patient or every time they prescribed a controlled drug. Clinicians also reported a variety of problems that arose when a PDMP report included “worrisome” information: patients often reacted with anger or denial (at least 88% reacted this way sometimes); nearly three-quarters of clinicians (73%) said that those patients sometimes did not return; less than a quarter (22%) reported that the confronted patients asked for help with drug addiction or dependence problems.

Overall, the data at hand suggest that prescribers generally do not perceive PDMPs as an essential tool for improving patient care in their practices, and the detriments may overshadow advantages. While most practitioners believe that they can detect “problem patients” on their own, research has shown this to be untrue. Additionally, accessing PDMPs incurs extra time in busy healthcare practices, whether by the clinician or a proxy staff member, without added compensation. Plus, the uncovering of “worrisome” data opens a proverbial “can of worms,” requiring further uncompensated time with patients to discuss information that may not be accurate, that may be upsetting to patients and damaging to practitioner-patient relationships, and that the clinician may be uneducated to manage.

Many Challenges Ahead

There still seem to be questions about whether PDMPs successfully serve the interests of public health (e.g. to stem opioid abuse, drug trafficking, deaths) or better patient care (e.g., to avoid harmful drug interactions and help guide opioid prescribing) or both objectives. Clinicians are facing the challenge of caring for an increasing number of patients with chronic pain who may benefit from opioid therapy. At the same time, increased opioid prescribing has correlated with soaring rates of abuse, diversion, addiction, overdose and deaths. PDMPs are no panacea for addressing the problems.

There are realistic concerns that PDMPs can be burdensome for prescribers and dispensers, and a “chilling effect” of these programs may inappropriately reduce the amount of opioid analgesics prescribed as an unintended consequence. Many clinicians are still unaware of the PDMPs in their states and those who are aware also realize that their prescribing practices are being monitored by law enforcement, regulatory, and licensing agencies. Concerns about punitive action for falsely-perceived misprescribing or overprescribing practices may foster apprehensions among prescribers and medical boards to adopt and use PDMPs. This, in itself, may alter prescribing habits in ways that adversely affect patient care.

Online database security and patient confidentiality also are of concern, particularly when PDMP databases expand to include multiple state programs or are consolidated nationally and inadvertently become appealing targets for hackers. The costs of implementing secure PDMPs are significant and, beyond infrastructure and administrative costs, the time and effort required to use PDMPs effectively must be considered.

Research examining outcome effects of PDMPs has been hampered by the variations in individual state’s program designs. As states develop, expand, or retool their PDMPs, the most successful characteristics of existing programs must be identified and applied to enhance the future impact and effectiveness of all PDMPs. Along with that, there must be a common goal of facilitating the legitimate prescription of controlled substances for patient well-being while mitigating the prescription drug abuse epidemic and associated public health problems via appropriate uses of PDMPs and their data.

References

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