Public health problems often develop when the health needs of one segment of the population are in conflict with the needs or interests of others. With respect to the prescribing of opioid analgesics, or narcotic painkillers, the public health community faces two epidemics and the most obvious solutions to these epidemics appear to be incompatible. Two groups impacted by prescription narcotics - pain patients and victims of addiction and overdose –take different positions with respect to the proper legal framework for the regulation of these drugs. Meanwhile, with encouragement from the federal government, states have passed legislation creating Prescription Monitoring Programs, or PMPs, trying to address the needs of both groups.
Epidemic # 1: In the United States, an estimated 48 million people have used prescription drugs for nonmedical reasons in their lifetime.[i] The risks of misusing or abusing opioid analgesics include addiction, overdose and heightened HIV risk.[ii]
Many individuals and family members affected by opioid analgesic misuse believe that the best way to stop the epidemic of addiction and overdose is to severely limit the prescribing of these drugs. These advocates contend that doctors overprescribe narcotics, which contributes to diversion (the transfer of legally prescribed drugs into the network of illicit drug transactions), and ultimately addiction, injury or death. The advocates argue that current laws, enforced by the Drug Enforcement Agency (DEA) and the Food and Drug Administration (FDA), don’t do enough as evidenced by the rampant abuse of prescription narcotics and the related individual and societal harm.
Epidemic # 2: An estimated 40 million Americans live with chronic pain caused by disease, disorder or accident.[iii] An additional 25 million people suffer acute pain resulting from surgery or accident.
Across the table sit those with chronic pain and their healthcare providers, who believe that pain is a “silent epidemic” in the United States.[iv] Patient advocacy groups, like the American Pain Foundation, tell the story of the patient who suffers from chronic pain who loses substantial productivity and daily activity due to pain. Advocates for those who suffer chronic pain express concern over the push for rigorous restrictions limiting access to pain medication and counter that, when taken as prescribed, opioid analgesics are safe and effective - any additional restrictions on access to these medications would be “punishing” those who genuinely suffer.
Have the states found a solution? PMPs are one of the tools states have used to try find that middle ground to address both epidemics. In fact, just this year Maryland enacted legislation to establish a PMP.[v]
According to the Alliance of States with Prescription Monitoring Programs, PMPs "collect, monitor, and analyze electronically transmitted prescribing and dispensing data submitted by pharmacies and dispensing practitioners. The data are used to support states’ efforts in education, research, enforcement and abuse prevention." [vi]
The DEA states that PMPs may serve several purposes, including:
Currently, 48 states and one territory have legislation authorizing the creation and operation of a PMP. Of those, 35 states have an operational PMP. A U.S. map of PMP status by state can be found at: http://www.pmpalliance.org/pdf/pmpstatusmap2011.pdf. Specific state PMP profiles are available at: http://www.pmpalliance.org/content/state-profiles.
PMPs use surveillance and feedback mechanisms to prevent “doctor shopping,” taking a practical approach to limiting diversion while promoting appropriate medical use of controlled substances. Despite this, both groups of stakeholders feel that PMP legislation is imperfect and, to some extent, harmful.
Pain patient advocates argue that PMPs result in decreased rates of prescriptions of opioid analgesics and that there is no evidence showing a causal link between PMPs and a decrease in of diversion.[viii] These advocates fear that PMPs create negative public health outcomes by limiting availability of painkillers for legitimate medical use.
Meanwhile, many individuals and family members affected by opioid analgesic misuse continue to hold their position that the epidemic of addiction, overdose and death cannot be ended until opioid analgesics are severely limited. PMPs fall far short of this goal.
Despite a lack of consensus, states continue to try and balance the needs of both stakeholder groups with the primary goal of best serving public health—a goal that demands better pain management and reduced prescription drug misuse. PMPs are one step in that direction, but we must be mindful that PMPs do not solve either problem and we must continue to work to strike the balance between access for those in need and restrictions that effectively prevent abuse.
This information was developed by James E. Valentine, M.H.S., J.D. Candidate and intern at the Network for Public Health Law – Eastern Region. He also works at the Food and Drug Administration’s Office of Special Health Issues, and the views and opinions expressed are those of the individual and should not be attributed to the FDA.