According to the CDC, the number of opioids prescribed in the U.S. has quadrupled in the past 15 years, even though there's been no change in the amount of pain American patients report. In 2013, health care providers wrote enough opioid prescriptions for every adult American to have their own bottle of pills.1
Through properly regulated prescribing practices, we can reverse the current opioid overdose epidemic and save countless lives. The federal government has three main routes to achieving this goal: prescribing guidelines, prescriber education, and the full utilization of state-run Prescription Drug Monitoring Programs. Shatterproof is actively advocating for all three.
Improving the way opioids are prescribed through clinical practice guidelines can ensure that patients have access to safer, more effective chronic pain treatment, while reducing the number of people who misuse these drugs, or overdose.
On March 15, 2016 the CDC published the CDC Guideline for Prescribing Opioids for Chronic Pain (also called the CDC Prescribing Guideline) to provide recommendations for the prescribing of opioid pain medication for patients 18 and older in primary care settings. The recommendations focus on the use of opioids in treating chronic pain (that is, pain lasting longer than 3 months or past the time of normal tissue healing) outside of active cancer treatment, palliative care, and end-of-life care.
The CDC Prescribing Guideline and its twelve recommendations are voluntary. So it's critical that states take the initiative to ensure providers adopt these guidelines as a standard of care.
There are a variety of ways to ensure implementation of these prescribing guidelines. One way the federal government can take action is to condition grants to states on the adoption of the CDC Prescribing Guideline. Shatterproof is also exploring private and public health insurance reimbursements being conditioned upon the utilization of prescribing guidelines.
Shatterproof recommends that the Drug Enforcement Administration (DEA) require education and additional training for medical practitioners who prescribe opioid painkillers. This education and training should be a part of initial and subsequent registration under the Controlled Substances Act of 1970.
Shatterproof’s recommendation is consistent with the recommendation of an advisory panel to the U.S. Food and Drug Administration (FDA), stating that physicians who prescribe opioid painkillers should receive training on the risks of overusing immediate release, extended-release, and long-acting formulations of pain medications. The committee made this endorsement following a hearing held in May 2016.
The advisory panel noted the following:
- FDA’s current opioid REMS program, which has been in effect since 2012, was unsuccessful. The program asked clinicians to voluntarily complete continuing medical education courses to learn about the risks associated with long-acting opioids. As the voluntary training has only been able to reach about 20% of opioid prescribers, most committee members felt that the only way to accelerate the process was to make the training mandatory. In addition, the current program doesn’t provide enough education on short-acting opioids or pain management.
- Some panel members suggested that clinicians be trained in best practices of pain management, that training be tied to the recently released CDC Guideline for Prescribing Opioids for Chronic Pain, and that it involve mental health and suicide screening.
- One panel member noted, “There needs to be education around safe prescribing methods, because, over the past decade, many physicians have become used to writing prescription refills without realizing the consequences of some patients becoming dependent on medications. By giving physicians information regarding alternatives to opioid medications, they will have other options for treating patients who are in pain after having surgical procedures. It is incumbent upon healthcare professionals to learn how to screen patients so that they can prescribe a safe number of painkillers. Most people who die of an unintentional opioid or heroin overdose get medications from a friend or relative. These friends and relatives usually receive their medications from one doctor.”
- The FDA could implement a mandatory REMS program or consider other options, such as working with the U.S. Drug Enforcement Administration to enforce it or making continuing medical education a requirement to renew a medical license. The FDA could also suggest that individual states impose the mandate through medical licensing boards.
- One member recommended that FDA-mandated training be modeled after a program adopted by the New Mexico state legislature in 2012. Initially, it required clinicians to take five hours of training in pain management and screening for addictions within 18 months. Then, whenever a healthcare provider renews his or her medical license, they must complete another five hours of opioid education. According to a 2014 study of its results, the bill resulted in a 16% reduction in opioid dispensing, especially high-dose opioids, and a 13% reduction in benzodiazepine dispensing. During the two years following the training, the number of deaths caused by opioid overdoses decreased—only in 2014 did an increase in total drug overdose deaths occur, and the majority of these deaths were due to methamphetamine abuse, not opioids.
If we pay attention to these recommendations, we can give doctors the education they need to understand the risks and safe use of prescription opioids.
Full utilization of Prescription Drug Monitoring Programs
A growing body of recent scientific evidence suggests that mandatory provider use of Prescription Drug Monitoring Programs (PDMPs) will change prescribing practices that increase overdose risk.2 PDMPs are state-based electronic databases that collect data on controlled prescription drugs dispensed by pharmacies and, in some states, by dispensing physicians. They contain information about patients’ controlled substance prescription history that doctors can review prior to writing a prescription to help them identify risk factors for opioid-related fatal overdose, such as dangerous combinations of medications, receipt of opioids from multiple sources and total prescribed opioid dosage. According to the CDC, PDMPs are among the most important state-level interventions to improve painkiller prescribing, inform clinical practice, and protect patients at risk.
One way the federal government can increase PDMP usage is to condition grants to states on the effective use of PDMPs.
One bill that does this is The Prescription Drug Monitoring Act of 2016, S. 3209.3 This bill, recently introduced in the U.S. Senate, would save countless lives by incentivizing states to more effectively use their PDMPs. Introduced by Senator Amy Klobuchar (D-MN) and co-sponsored by Senators Joe Manchin (D-WV) and Angus King (I-ME), the bill provides the following to come into effect within two years after enactment:
- Each prescribing practitioner must consult their state’s PDMP before initiating treatment with a prescription for a controlled substance listed in Schedule II, III or IV of the Controlled Substance Act, and every 3 months thereafter as long as the treatment continues.
- The PDMP must provide proactive notification to a practitioner when patterns indicative of controlled substance misuse, including opioid misuse, are detected.
- Each dispenser (i.e., pharmacy, drugstore, etc.) must report to the PDMP within 24 hours for each prescription for a controlled substance that it dispenses to the patient.
- The PDMP must make available a quarterly de-identified data set and an annual report for public and private use.
- The state shall make the data contained in the PDMP available to other states through data-sharing technology.
The bill would also give the Justice Department, in coordination with HHS, the authority to award a grant to an eligible entity to establish and maintain an inter-state data-sharing hub. The aim of this technology is to make it easy for states to share PMDP data, and for practitioners to access this data. The bill proposes the appropriation of $2 million dollars for fiscal years 2017 through 2020 to develop this technology.
To ensure patient privacy, the bill would also require regulatory protections, while simultaneously promoting research and easy access to the technology. It would also allow states to retain ownership of the data submitted by their health care practitioners, and would prohibit the distribution, in whole or in part, of any PDMP data without the express written consent of the PDMP state authority.
To maximize research potential, the technology must provide a source of de-identified data that can be used for statistical, research, or educational purposes. State authorized users would be permitted to access data from a PDMP of a covered state without having to pay a user fee. Finally, the data would have to conform to the standards of the Prescription Monitoring Information Exchange.
All these specific and well-thought-out details add up to one thing: a comprehensive, easy-to-use tool that will reduce opioid overprescribing and save lives.