A conservative state policy network is urging lawmakers to make it easier for patients to get abuse-deterrent formulas of prescription opioids. But at least one Wisconsin lawmaker isn't convinced that's the way to go.
The American Legislative Exchange Council released a report this week titled "Optimizing the Abuse-deterrent Opioids Market," presented as an effort to combat prescription drug abuse and addiction.
The report calls for "neutral reform," changes that won't favor the use of abuse-deterrent formula opioids (ADFs), but will remove so-called disincentives for prescribing them. Opiates are natural drugs derived from the opium poppy while opioids are synthetic or partly synthetic drugs developed to work like opiates.
The U.S. Food and Drug Administration in 2013 released guidelines for ADFs to assist pharmaceutical companies with their development.
ADFs can work in a number of different ways, or in some combination of the following:
- They can contain an antagonist that diminishes the drug's euphoric effects.
- They can be produced in a way that prevents them from being crushed, liquidated or vaporized.
- They can be designed to have an unpleasant effect if the drug is misused or taken at a higher dosage than directed.
Wayne Winegarden, the author of the ALEC report, said Tuesday that policymakers need to balance the need to give opiates to people who need them and the need to deter abuse and addiction. Winegarden is a senior fellow in business and economics at the Pacific Research Institute and the principal of the consulting firm Capitol Economic Advisors.
"It’s very important to always think of it in terms of the balance: helping people in chronic pain versus minimizing abuse," Winegarden said on a call with reporters.
Abuse-deterrent formulas can "help strike that right balance between the cost of abuse and the cost of pain," Winegarden said.
Currently, ADFs are patented products — which means they generally cost more than non-abuse-deterrent drugs that are available in generic formulas. Examples include Opana ER (an ADF form of oxymorphone), Oxecta and OxyContin (ADF forms of oxycodone) and Exalgo (an ADF form of hydromorphone).
Abuse-deterrent doesn't mean the drugs can't be abused, it means they're harder to abuse. But they still carry that risk.
Once generic varieties of ADFs are available, the cost differential will diminish, Winegarden said. But in the meantime, he argued in favor of a few policy changes.
In some cases, when a patient gets a prescription for an ADF filled, the patient could be offered a generic non-ADF opioid for a lower cost. Winegarden and ALEC say states should require written permission from the prescribing physician before a patient would make that switch.
They're also arguing for states to add ADFs to insurance formularies for patients on Medicaid or state insurance plans.
Jennifer Malcore, an aide to state Rep. John Nygren, R-Marinette, said the lawmaker has been approached by pharmaceutical companies several times about ADF-related legislation. Most recently, Purdue Pharma approached him last year.
Purdue manufactures the abuse-deterrent formula of OxyContin, and is a corporate member of ALEC. Nygren is also a member of the policy group.
Nygren has, over the last several years, become the Wisconsin Legislature’s torchbearer for combating the state’s heroin and opiate epidemic.
Prompted by his daughter's experience with addiction and recovery, he ushered a package of bills aimed at curbing heroin abuse and deaths through the Legislature in 2014 with unanimous support. In September 2015, he introduced a second package focusing on prescription painkillers. Those bills were also passed unanimously and await Gov. Scott Walker's signature.
The bills aimed at prescription drug abuse would
- require practitioners who dispense certain prescription drugs to submit information to the prescription drug monitoring program (PDMP) within 24 hours
- require a practitioner to check a patient’s record before prescribing a monitored prescription drug for the first time, require a law enforcement officer to notify the prescribing physician and the PDMP when a prescription drug container is found near a crime scene involving a controlled-substance violation or an opioid-related overdose
- put pain management clinics within the state under the oversight of DHS
- require methadone clinics to track data and report it to DHS annually
Gov. Scott Walker also signed into law in December a measure that will allow pharmacies to sell Narcan without a prescription.
Malcore said Nygren is skeptical of pharmaceutical companies who contributed to the company's opiate abuse epidemic asking lawmakers to now pass legislation pushing their ADF drugs.
Purdue aggressively marketed OxyContin as a treatment for chronic pain in the late 1990s, and in 2007 pleaded guilty to charges it had misbranded the original drug as "abuse resistant" and misled doctors, patients and the FDA. The company replaced the original formula with an ADF version in 2010.
"That is not high on his list. He thinks there’s a lot of other things on the list that need to be fixed before we even look at that," Malcore said. "He's not really sure that’s where we need to go at this moment."
Joseph Glass, an assistant professor of social work at the University of Wisconsin-Madison who specializes in addiction and treatment, said expanding access to ADFs is not a panacea for the problem.
Research shows that ADFs reduce the rate of misuse of prescription painkillers, Glass said. However, studies also show that people who are already addicted to opiates will start using drugs like heroin when they can no longer get high on prescription opiates.
"Unfortunately, when you introduce these abuse-deterrent formulas, the people who are already addicted are going to switch to heroin, and there's a clear pattern that’s been shown," Glass said. "But the utility of them is they prevent new people from becoming inadvertently addicted."
Legislative approaches to addressing addiction should include multiple components, much like the Wisconsin Legislature has done, Glass said.
Ensuring ADFs are added to insurance formularies would help with responsible prescription, Glass said, but policymakers should be realistic about their expectations.
"It's not going to solve the current problem; it’ll prevent future problems," he said.
Wisconsin’s rate of drug-related deaths nearly doubled from 2004 to 2012, according to the state Department of Health Services. Opioid-related overdoses were the leading cause. Drug-related deaths surpassed deaths from alcohol-involved car crashes in 2004, and have remained more frequent ever since.
The proportion of drug deaths with opioids involved increased in Wisconsin by about 38 percent from 2004 to 2012, according to DHS. In the same time period, the proportion of heroin-related drug deaths jumped from 5 percent to 27 percent, and all drug-related hospitalizations increased by 15 percent. From 2008 to 2012, 56 of Wisconsin’s 72 counties saw an in increase opioid-related hospitalizations for people ages 12-25.