FDA Struggles with Sizing Up Abuse-Deterrent Opioids
https://www.medpagetoday.com/PublicHealthPolicy/FDAGeneral/66563
During a two-day meeting convened by the FDA, experts discussed strategies for determining whether abuse-deterrent opioids are having a real-world impact on misuse, abuse, addiction, overdose, and death.
Getting a handle on the issue has been a challenge, given that the available data sources and methodologies for assessing these outcomes are imperfect, according to Judy Staffa, PhD, RPh, director of the agency’s division of epidemiology, who led the meeting.
That’s been the main reason that none of the 10 “abuse-deterrent” opioids approved by FDA to date have labeling that the drugs reduce abuse — they are only “expected” to do so.
Indeed, one such product, Opana ER, was just removed from the market because it led to an increase in injection abuse, which was tied to an outbreak of HIV and hepatitis C in Indiana, as well as cases of thrombotic thrombocytopenic purpura (TTP) across the country.
The new formulation of Opana was harder to crush, which made it more difficult to snort, but those determined to abuse it found a way to cook it down and inject it instead.
Opana ER was never officially given any abuse-deterrent labeling by FDA, but the company went to great lengths to paint it as an abuse-deterrent formulation.
Other drugmakers have also stumbled in this realm: In 2015, Purdue Pharma nixed a supplemental New Drug Application related to the ability of abuse-deterrent OxyContin to diminish abuse in the real world. It did so just 1 day before the agency was going to release its evaluation of the application.
To avoid similar problems with other abuse-deterrent formulations, the FDA invited a wide range of experts with diverse perspectives — from expertise in drug abuse and addiction treatment to those who have conducted surveillance on other public health problems — to the hearing.
While the first day focused on improving the use of existing data sources, such as poison control center data, population-based surveys, and claims data, day 2 focused on developing and using new data sources, including building on established national surveys, and designing studies that assess exposure and outcomes in the same individuals over time.
Staffa said the path forward will likely involve a “mosaic” approach that incorporates data from multiple imperfect sources.
During several public comment periods, industry representatives noted that many insurers are refusing to cover the drugs because they haven’t been shown to reduce abuse in the real world. That, in turn, is driving down the number of patients on abuse-deterrent formulations, which isn’t making it any easier to study outcomes, they argued.
Staffa noted that abuse-deterrent opioid prescriptions have fallen from 5.6 million in 2011 — the year after the first formulation was approved — to 4.3 million in 2016.
The FDA said it’s accepting comments on means of assessing real-world outcomes with abuse-deterrent drugs through Sept. 11, 2017.
FDA Commissioner Scott Gottlieb, MD, opened the first day of the meeting by announcing that the FDA will now include immediate-release opioids in its risk evaluation and mitigation strategy (REMS) for opioids. Previously, the REMS had focused on extended-release and long-acting products, but Gottlieb noted that 90% of the 200 million opioid prescriptions written each year in the U.S. are for these fast-acting products.
The education that comes with the REMS program, however, will continue to be voluntary, not mandatory. It will be expanded to include modules for nurses, pharmacists, and other practitioners who prescribe opioids, Gottlieb said.
The agency is also still considering whether to make education mandatory, he added.
An updated draft blueprint for that education expands the amount of information focused on pain management, including non-pharmacologic treatment for pain and non-opioid alternatives, and on opioid use disorders.
The agency is also initiating a study to better understand exactly how prescribers perceive the term “abuse-deterrent” and whether their perceptions “match clinical realities.”
Filed under: General Problems
This war on “opioids” is actually a war on chronic incurable diseases. A war on chronic pain disease patients who benefit from opioid medications. Medications that enable millions of Americans relief of chronic debilitating pain associated with these diseases.
The fiction, widespread hysteria and distorted truths about this “opioid epidemic”, is killing legitimate chronic pain disease patients who use their medications responsibly. We are patients.
100 million Americans have one or more chronic incurable pain Diseases. As the CDC, DEA, FDA, Medicaid and Medicare, and numerous other government agencies, are blaming Doctors for the over prescribing of opioid medication. NOBODY, is looking at or reading the statistics from chronic pain disease patients. How about NOT addressing these drugs as dangerous and addictive. When all else fails: physical therapy, exercise, over the counter medications and numerous injections etc, we chronic pain disease patients, are left with one option to help us cope, opioid pain medication. Lets address this medication as lifesaving and medically necessary for the million of Americans with chronic diseases. Chronic pain is a disease. Chronic pain disease patients are now the epidemic. The addiction rate of chronic pain disease patients is .02-.6 %. We do not misuse or abuse our medications.
No other disease medication is scrutinized. We, as patients, are being denied, dismissed, overlooked and discriminated against, by our physicians, due to all the scrutiny associated with treating chronic pain disease with opioid medications. Our Dr’s are afraid to treat us humanely and adequately. We have a disease that medication is readily accessible and beneficial to us and we are being denied. We, pain patients, are being discriminated against, due to people who abuse illegal heroin and illegal fentanyl. This is a direct hunt for Doctors who prescribe life saving medication, for pain disease patients, that benefit from them. We have our privacy invaded, we no longer are able to have doctor/patient confidentiality. We now have insurance agencies, pharmacists, and other government agencies in our physicians offices, monitoring, prosecuting and policing our physicians.
Though the statistics show a reduction in, opioid medications distributed, due to the CDC guidelines, death rates of overdoses from illegal opioids is rising.
The specific causes of deaths also needs to be closely investigated. The opioid in the person’s system needs to be specified. Was it an illegal opioid, was it opioid medication specifically for that person, was there other drugs or alcohol involved? These statistics need to come out. These Government agencies do not want that information out, due to the fact that this “opioid epidemic”, would then be debunked.
Let’s put the shoe on the other foot. Restricting or taking away our medications is like FORCING people who do not want this medication to take it. One day those against these medications will need them but they will be denied.
We have a chronic disease. We want to be able to take care of our homes, our children, our selves, as much as possible, but without access to these life saving medications, we are unable to do so. We want to live, not just exist in pain 24/7.
We need the government agencies to look at the real statistics, not the hand picked. These agencies are not physicians. They are trying to doctor us, patients, without a medical license. They are also trying to police our physicians. This is a war on a disease, medications, physicians and patients.
We chronic pain disease patients need help. All the headlines, topics and stories on how opioids are bad and how people are abusing, misusing, overdosing, becoming addicted or dying from them. We need to look at the good they do and how they help our disease of chronic pain and the million of Americans who use them for some relief.
The government needs to put the focus on illegal drugs coming into, being manufactured and distributed in this country, illegal fentanyl, illegal heroin, methamphetamine, cocaine and all other ILLEGAL DRUGS. Not the legally prescribed and medically necessary medications we patients need. We chronic pain disease patients need help, but we are helpless due to the government and government agencies. There is stigma, scrutiny and discrimination against us due to a category of medications we desperately need and benefit from, opioid medications.
WE ARE PATIENTS NOT ADDICTS! !
big picture here guys,,,thinking ahead,,if we do not get some laws on the books,,,like documenting our dead,,,those forced to use death as their only means of stopping their physical pain because their medicine was denied or taken,,,,,,THERE IS NO RECORD OF THE DEATH THE GOVERNMENT HAS CAUSED,,,,IS THERE??!!!IF WE DON’T START DOCUMENTING BY LAW,HOW MANY PEOPLE ARE NOW LIVING IN AGONY FROM TREATABLE MEDICAL CONDITIONS VIA OPIATE MEDICINE,,,,,,,THERE IS NO RECORD,LEGALLY,,,OF THE HARM,,,THE GOVERNMENT HAS DONE????!!!IF WE DONT GET IT LEGALLY DOCUMENTED HOW MANY HAVE LOST THEIR JOBS,,IE HARM,,,,THERE IS NO LEGAL RECORD,,,IS THERE????WHAT I AM SAYING,,,THE FUTURE,,,,WILL NOT HAVE 1 OUNCE OF LEGAL PROOF,,,,ANY OF THIS TORTURE AND GENOCIDE EVER HAPPEN’D,,,,,UNDERSTAND????!!!exactly how our corrupt government has planned it,,,SICKO’S!!!!!!!!!!!!!!mayrw
JMO,,,going to write these ,”comments,” and ask them why,,,the burden of proof,,,is not being applied to klondyne bullshit??!!!where has he proven,,lessening our medicines has proved to stop addiction,,or o.d’s.,,,as we all know the burden of proof,,,,proves thee opposite,,,that klondyne guidelines are killing us,,,Furthermore other alternatives their quoteing,,,SHOW ME!!!!SHOW ME WHERE IT WORKS,,, literally call me,,fly me out there and SHOW ME,, acupuncture STOP’s my physical,pain,,TALKING to some shrink,,STOPS my physical pain,,, WHY IS NO PURDEN OF PROOF,NOT BEING APPLIED,,NO-WHERE TO BE FOUND WITH THEIR ,”LAWFUL SANCTIONS” OR NEW LAWS AGAINST THE USE OF MEDICINE ,,,,,,, IS IT STOPPING PHYSICAL PAIN,, anywhere!!!!!!!!! all their new laws against our medicine is causeing more harm then good,,,,,MARYW
Mary, I faxed my Senator 12 pages the other day. It took me 3 mos, as my adhd med [12th], isn’t authentic, and my “opiate”, [7th] manufacturer has monthly alterations and side-effects. I need medical attention because of the heavy metals, serious side-effects, shock& Awes to my system for years now. I can’t take it anymore.
The FDA, INSURERS, ect are not being forth-coming because I have the blood/urine, letters…….This has been going-on for years. I need an MRI due to these non-consentual, and inauthentic frauds. Do they really think that I wouldn’t know the difference btwn a fake and what works ?