By now you may have heard or read that the Food and Drug Administration has endorsed rescheduling hydrocodone from a Schedule III to a Schedule II drug, as recommended by an FDA advisory panel.
Schedule II medicines are much more powerful and thought to have greater potential for addiction and death than drugs classified as Schedule III.
The FDA’s decision was based upon the large increase in opioid pain medicines that were diverted, stolen or inappropriately given to a non-patient by a patient with an opioid prescription. It is thought that this explains the huge growth in the prescribing of these pain medicines, with OxyContin as the most dangerous and reviled “painkiller.”
The new regulations will likely take effect in 2014 if approved by the Department of Health and Human Services and the Drug Enforcement Agency.
Some medical associations and pain patient groups vehemently opposed these schedule changes, saying that these life-changing and life-saving medicines would become much harder to obtain by legitimate patients seeking relief.
The recommended schedule change will result in several changes for patients, physicians and pharmacists. It would reduce from 180 to 90 days the supply of hydrocodone a patient could have without seeing his/her provider for a new prescription.
“If you are needing chronic therapy of this magnitude you should be seeing your prescriber,” FDA commissioner Janet Woodcock told The New York Times.
For many years the DEA, families of those lost to prescription drug overdoses, and groups such as Physicians for Responsible Opioid Prescribing (PROP) have been urging the FDA to make this change.
“I’m thrilled by this news,” PROP founder Dr. Andrew Kolodny told Medpage Today.
Kolodny, who is chief medical officer of Phoenix House, said it was “bittersweet” announcement for him, because of the “thousands of lives lost since the point at which the DEA first asked FDA about [rescheduling] and all of the patients who became addicted during that time.”
Inherent in Kolodny’s chortling is what is not stated, and has rarely been stated by him or the others who worked so diligently to bring about this policy change. To wit: what cataclysm might these rule changes have upon those of us living with chronic, difficult to treat pain?
I’m not suggesting that the only or even the best treatment for pain resides in the exclusive use of opioid medicines. A holistic mind-body approach that would include various modalities, including opioid medicines, could be appropriate.
However, it must be recognized that millions of us use and need opioid analgesics to provide a modicum of pain relief that other strategies fail to provide.
Instead of focusing on the haggard arguments we’ve hurled at each other over the last several years regarding the safety of opioid analgesics, I want to focus on the real world – how pain patients have faced heavy waves of disrupted treatment, followed by a tsunami of both intended and unintended deadly consequences.
This tsunami has been crashing across the country for the last several years, as state after state responds badly to the perceived epidemic.
As laws and regulations are passed, as government agencies like the FDA, the DEA, and sometimes the FBI investigate physician prescribing practices – sometimes bringing charges against law abiding doctors treating extremely difficult cases of pain — unintended consequences begin to pile up.
This, combined with government agencies bringing regulatory pressures on pharmacies, has caused the pool of physicians willing to treat us to shrink.
This has damaged patients, physicians, pharmacists and families of pain patients in state after state: Florida, Georgia, West Virginia, Kentucky, Ohio, Washington and California to name a few.
With these new rules restricting access to hydrocodone, finding physicians who will treat patients with chronic refractory pain will become even harder.
I keep getting stories from pain patients all over the country who are being fired by their physicians, even those who specialize in treating pain. I hear from those who have no success in finding doctors willing to treat them or pharmacies willing to fill their prescriptions.
Unfortunately, with these new, seemingly appropriate rules, the tsunami will sweep across more of the country, leaving untold thousands without adequate care.
Yes, the public needs protection. But as I’ve said repeatedly, the first concern should be the protection of patients whose only recourse for their ghastly pain are these medicines.
The same may be said for those patients for whom opioid treatment is a staple of a wider treatment program.
We need to monitor these changes very closely.
Mark Maginn lives in Chicago where he is a poet, writer and social justice activist. Mark suffers from chronic pain and was a longtime volunteer with the American Pain Foundation. His blog “Left Eye Blind” can be found here.
National Pain Report welcomes other opinions.
The information in this column is not intended to be considered as professional medical advice, diagnosis or treatment. Only your doctor can do that! It is for informational purposes only and represent the author’s personal experiences and opinions alone. It does not inherently or expressly reflect the views, opinions and/or positions of National Pain Report or Microcast Media.