Opioid Prescribing Controversy Leads to New Legislation

Opioid Prescribing Controversy Leads to New Legislation

There's an opioid epidemic in America, and it appears that our federal lawmakers in Washington are finally taking the situation seriously. Broad bipartisan legislation has been introduced at the federal level to address the problem on various fronts. Although they're mostly still at the committee stage, at least four new acts have been tabled so far this year, and they'll all very likely make it all the way into law. Here's a quick list of the most interesting proposals from both sides of the house:
  • The FDA Accountability for Public Safety Act, would hold the FDA accountable for opioid drugs approved by the agency, say the two senators who introduced it. Senator Joe Manchin (D-WV), David Vitter (R-LA) and Senator Shelley Moore Capito (R-WV), said the legislation "ensures that experts' voices are heard when the FDA is considering new, dangerous opioid medications...and establishes procedures regarding the approval of opioid drugs by the FDA."
  • The Safe Prescribing of Controlled Substances Act, introduced by Senator Edward J. Markey (D-Mass), is a bipartisan proposal that would require prescribers of opioid pain medications and other controlled substances to undergo mandatory training on safe prescribing practices and the identification of possible substance abuse disorders.
  • The Opioid Overdose Prevention Act, also introduced by U.S. Sen. Markey and Senators Kelly Ayotte (R-NH) and Tim Kaine (D-Va) aims to exempt from civil liability people who prescribe, or are prescribed, opioid overdose-reversing drugs like Naloxone.
  • The 21st Century Cures Act is intended to speed the discovery, development, and delivery of lifesaving drugs and devices. But it also addresses the prescription drug abuse by authorizing Medicare "to use drug management programs to curb potentially harmful use of opioids and other controlled substances."
As well as these legislative proposals, there are several other activities being considered in Washington to address the licit and illicit prescription and street drug problems plaguing the nation. West Virginia's Joe Manchin, one of the originators of the proposed FDA Accountability for Public Safety Act, has been busy organizing a U.S. Senate Prescription Drug Abuse Caucus to increase awareness and gain more support for dealing with the problem. He and Caucus co-founders Tim Scott (R-SC) and Senator Capito are inviting other Senators to join and are having some success.

Opposition growing from the 'pain management' field

Not everyone is happy about the prospect of additional controls that will likely make it more difficult to prescribe opioids for pain relief where it's really needed - the estimated 100 million chronic pain patients across the U.S. Chronic pain patients consume more opioids than any other patient group. They rely on opioid painkillers to achieve "a normal quality of life", a quality that they and many doctors claim is impossible without them. And the FDA Public Safety act proposed by Manchin et al is seen as a direct threat to that quality. "That Senator Manchin is leading this isn't a surprise," said an article on the National Pain Report website. "He spoke at the National Prescription Drug Abuse Summit in Atlanta in April and claimed that West Virginia has the highest mortality rate of overdose deaths - 29 people per 100,000 - and said that ninety percent of the overdoses are really coming from prescription drugs." But the National Pain Report contributors are typical of a large and growing tide of opposition to additional controls on pain medication prescribing, which could result from new legislation including the act sponsored by Manchin and Vitter. Their concern is that people who really need help managing debilitating chronic pain are increasingly having trouble getting the drugs they need. And more legislation will make it even more difficult, they say. "Senators Manchin and Scott say that 17,000 Americans died from prescription opioid overdoses every year," the Pain Report said. "That number should be looked at in the light of 1 in 3 people in the U.S. have a chronic pain condition (100+ million people); although terrible, the number of people who died from prescription opioid overdoses represent 0.17 percent of the people living with a chronic pain condition." Daniel Bennett, MD, DABPM, is an interventional spine and pain medicine physician in Denver, CO, and also serves as CEO of the National Pain Foundation. "What pain doctors and patients worry about is whether this emphasis on one problem - prescription drug abuse - is being undertaken at the expense of millions of people who need these medications in order to combat their chronic pain, living life as normal as possible."

Persuasive arguments and more support for controls

We've written in the past about the need for prescribing physicians to be better informed about opioids and their safe use. And an important part of that is prescreening patients for signs of potential drug abuse, and paying more attention to follow-up care. These factors have been named by numerous studies as essential elements in any program aimed at reducing opioid painkiller abuse. Senator Markey's Safe Prescribing of Controlled Substances Act sets out new rules to help accomplish safer prescribing practices. Not only does it call for mandatory training on safe prescribing practices, doctors licensed under the act would be trained on best practices for pain management and alternative non-opioid therapies for pain; methods for diagnosing and treating a substance use disorder; linking patients to evidence based treatment for substance use disorders; and tools to manage adherence and diversion of controlled substances. Additionally, Markey's Opioid Overdose Prevention Act will protect people legally prescribing or using overdose-reversing drugs like Naloxone. A growing number of cities and counties already have legislated legal protection for anyone who calls 911 to report that someone is overdosing, or who brings the victim to an ER. Markey, who introduced similar legislation in 2014 that never materialized as law, said that someone attempting to save an overdose victim should be protected from prosecution. He said it will provide real world results and help reduce overdose deaths. "We cannot allow the prescription drug epidemic to spread from the emergency room to the courtroom as a result of good Samaritans administering lifesaving drugs like Naloxone to prevent overdoses," Markey said in a statement. "This legislation is an important step to help protect the first responders, volunteers, and family members who are on the front lines of preventing overdoses and working to end the scourge of prescription drug and heroin addiction in Massachusetts and across the country." And in spite of the loud cries from pain management specialists on behalf of their millions of chronic pain patients, Manchin and Capito are pressing ahead with their FDA Accountability for Public Safety Act. "With 46 people dying every day from an overdose of prescription drugs across this country, it only makes common sense for the FDA to seek the advice of its expert panel and follow its recommendations concerning the approval of dangerously addictive drugs for public use," Senator Manchin said. "Regrettably, the FDA has proven time and time again that it is willing to ignore its own experts and approve medications that harm consumers. This is deplorable and unacceptable. Too many lives have been lost, too many families have been torn apart, and too many communities have been affected by these potent painkillers. I am proud to continue fighting this growing epidemic by introducing commonsense legislation that takes another step toward making sure the drugs our government validates are safe." Here at Novus, we understand that millions of Americans need help with chronic pain, and that is a real problem. But there is also this other problem - prescription opioid abuse, and it's taking American lives every day. We believe there is a sensible solution out there that can solve both these pressing, serious problems once and for all - and to the benefit of everyone concerned. We're fully committed to such an effort, and doing our part to stem the tidal wave of prescription drug abuse across America.

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