September 17 - Data Security
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For policy makers at all levels of government, battling the national opioid epidemic can feel like a deadly game of Whack-a-Mole: No matter how many times they attack a particular element of the problem, another one just pops up somewhere else. But since giving up is not an option, lawmakers continue to take a wide ranging approach in their efforts to defeat a scourge that has claimed over 300,000 lives since 2000.
Prescription opioids were developed primarily to alleviate extreme chronic pain and include a wealth of commonly used pharmaceutical drugs like oxycodone and morphine. In that regard they have been a very effective pain management tool for doctors and patients alike. But opioids can also be highly addictive, and misuse and frequent over-prescribing has helped create millions of such users. Opioids are also the main agent in illegal narcotics like heroin. Purely synthetic opioids like fentanyl can also be easily manufactured by drug traffickers, who now regularly cut supplies of heroin and cocaine intended for street sale with analogue strains of fentanyl like carfentanil, which is 100 times stronger than the standard prescription form of the drug. Not surprisingly, law enforcement officials say that influx has become a leading factor in the sharp increase in opioid-related deaths plaguing much of the nation.
Although every kind of drug is subject to abuse, opioids have become an almost overwhelming problem throughout many states. According to data released by the U.S. Centers for Disease Control and Prevention last December, 63 percent of the nation’s 52,000 fatal drug overdoses in 2015 were due to opioids. Since 2010, 30 states have experienced steady increases in opioid-related deaths, with only a handful seeing a decline (see Bird’s Eye View in this issue). And a study released last week by the Columbia University's Mailman School of Public Health showed that the number of Americans using heroin has increased five-fold over the last decade, and dependence on the drug has tripled in that time span.
Problems associated with such abuse go well beyond overdose deaths. Foster care caseloads, to name only one example, have risen dramatically in recent years, with children under age 1 the highest percentage of that increase. There is no definitive data to indicate the cause, but officials in many states believe substance abuse is a major factor.
Lawmakers have come at the problem from various angles for years. According to the National Conference of State Legislatures, 47 states and the District of Columbia – all but Montana, Wyoming and Kansas – have adopted laws since 2001 that allow greater access by first responders, family members or even friends of known opioid users to naloxone, an “opioid antagonist” drug that can counteract the effects of an overdose. Thirty seven states and D.C. now also have so-called “Good Samaritan” laws that allow someone to seek help for an overdose victim without facing criminal charges themselves, and dozens of states have acted to steer non-violent drug offenders into treatment or diversion programs rather than jail. Many have also eased mandatory minimum sentencing laws and expanded access to Medication Assisted Treatment (MAT), which combines medication and behavioral therapy to help offenders with drug habits.
All but Missouri have also adopted prescription drug monitoring programs (PDMPs), state-run electronic databases designed to monitor the dispensing of such medications. Numerous states have also started prescription drug takeback programs, which allow consumers to return unused medications in order to prevent those drugs from being taken by someone other than the person they were intended for.
Both the states and federal government are now also paying greater attention to how opioid pain relievers are being prescribed. According to the U.S. Centers for Disease Control, an estimated 20 percent of all patients seeking help from their doctor for pain have been prescribed some form of opioid. In 2012, this culminated in 259 million opioid prescriptions, enough to provide a bottle of pills to every adult in United States.
That astounding figure prompted the CDC in 2016 to issue new prescription guidelines that call on doctors to more carefully assess patients before starting them on an opioid medication. The guidelines allow greater use of nonpharmacological treatments like physical therapy or acupuncture as well as more use of non-opioid pain medications. And if a doctor does wish to start their patient on an opioid, the guidelines encourage them to first discuss in detail with that person the risks and benefits of using such a powerful and potentially addictive medication.
In March of last year, Massachusetts Gov. Charlie Baker (R) signed legislation making the Bay State the first to adopt its own restrictions on initial opioid prescriptions. That measure limits an initial opioid prescription for adults to no more than a seven-day supply, with a similar limit on all opioid prescription for minors. By the end of the year governors in seven other states - Connecticut, Maine, New Hampshire, New York, Pennsylvania, Rhode Island and Vermont – had followed suit, while Arizona Gov. Doug Ducey (R) added the Grand Canyon State to the list via executive order in October. Ducey followed that up with another EO last January that requires prisoners with a history of opioid abuse who exit jail to participate in post-release MAT and counseling.
The trend continued this year. In February, New Jersey Gov. Chris Christie (R) signed legislation that enacts a five-day supply limit and requires insurers to provide at least six months of addiction treatment coverage. Weeks later, in March, Pennsylvania Gov. Tom Wolf (D) announced the Keystone State was adopting an initial prescription limit for minors as part of a full suite of new rules intended to mitigate opioid abuse. And last Thursday, Ohio Gov. John Kasich (R) announced new prescribing rules that include the seven-day limit for adults and five days for minors.
There is good reason to believe such restrictions can help. A new CDC study shows that limiting initial prescriptions may well be a huge factor in slowing the growth of opioid abuse, particularly in young people or those who might be prone to addiction. According to that research, some patients face a significantly increased risk of opioid dependency after taking the drugs for as little as four days. The risk grows even greater after the 31st day of use or with a second prescription. Other research also indicates a strong connection between the abuse of anti-anxiety medications like Xanax and Valium, and the abuse of opioids. According to that study, concurrent use of the two drugs more than doubles the chances of an opioid user going into overdose.
But the limit laws also have detractors. A seven-day limit proposal by Maryland Gov. Larry Hogan (R) this year met strong resistance from the Old Line State medical community, which complained it didn’t give doctors enough flexibility in treating patients. Hogan and state health officials eventually worked out a compromise that requires doctors to follow best practices, including the new CDC guidelines. Maryland State Medical Society Executive Director Gene Ransom said that requirement will essentially instill the seven-day limit anyway. More than that, it puts doctors on notice that their prescribing behavior is not going unobserved.
“There is a clear message now from the General Assembly that physicians have to pay attention to what is going on with prescribing,” he told the Washington Post.
States are also continuing a wide array of other mitigation efforts. Kate Blackman, who tracks the issue for NCSL, says over 400 opioid abuse prevention bills have been introduced in the states so far this year, including 56 measures across 21 states that deal with prescribing regulations. More than 100 other bills deal with access to naloxone, though with so many states already allowing its use many of those new laws only tweak ones already in place. But even in states hit particularly hard by the epidemic, consensus can be hard to find. Last week the Oklahoma Senate Judiciary Committee killed SB 226, a bill that would have made the Sooner State the 38th to enact a Good Samaritan law. That rejection came the same week officials acknowledged that the state endured a record number of overdose deaths in 2016. Although the bulk of those were related to methamphetamine use rather than opioids, the state’s 49 opioid overdose deaths mark a 60 percent increase from 2015.
States also continue to consider other efforts, including drug buyback programs, greater opioid awareness training for health providers and the creation of state commissions and task forces. At least one state, Ohio, has adopted a requirement to provide opioid abuse training in public K-12 schools, a program that lawmakers in at least four states – Michigan, Massachusetts, Pennsylvania and South Carolina – are considering this year as well. Massachusetts and Pennsylvania have also adopted laws allowing patients to formally notify their doctors that they do not want to ever be prescribed an opioid. At least two more states – Alaska and Connecticut – are weighing similar bills.
The federal government also remains in the mix. Last week, President Donald Trump named Gov. Christie to head a commission to seek out more ways to combat opioid abuse nationwide. There may be new legislation as well: last Tuesday, Sen. Claire McCaskill (D-Missouri), the top Democrat on the Senate Homeland Security and Governmental Affairs Committee, announced that she is requesting marketing, sales, and addiction study materials from the companies that produce the nation’s top five opioid medications. Her intention is to showcase the role those manufacturers have played in the growth of the opioid epidemic.
Outside of statehouses and Congress, there is growing interest in the effort by dozens of drug makers to battle abuse by producing pills with abuse-deterrent properties that make them very difficult to crush and then snort or inject. But regulators warn that abuse-deterrent is a far cry from abuse-proof, notably because the drugs can still simply be swallowed as is. Therefore, the U.S. Food and Drug Administration says such claims should be taken with the proverbial grain of salt.
Meanwhile, some scientists believe the real answer lies in producing opioids that simply don’t give users the high that promotes abuse in the first place. Traditional opioids not only relieve pain, they send the brain a signal of euphoria. A recently released study from San Francisco-based Nektar Therapeutics showed promise for one such opioid drug. It is designed to enter the brain too slowly to produce the kind of high that entices users to overtake the medication. Nektar is only one of many pharmaceutical companies with a non-addictive opioid in development.
The question is whether these drugs will also do what current opioids do best: alleviate chronic severe pain. It is far too early to know for sure – to date testing has only been done on mice – and the answer is not likely to come soon. But with an epidemic like they’re facing now, states will take any good news they can get.