[{"id": "FDA-2018-P-0673", "title": "Requests that the FDA produce a study on control of alprazolam products in relation to the overall effect on the Opioid crisis in the USA.", "context": "2021-02-17T17:40:12Z", "purpose": "Nonrulemaking", "keywords": ["Citizen Petition", "CDER", "Justice for Jake", "produce a study on control of", "alprazolam products in relation to the overall", "effect on the Opioid crisis in the USA", "OPEN"], "comments": [{"text": "If someone is poisoned by lacing punch, gummie bears or whatever, it is not the drugs fault, it is the person delberately tampering with the food, beverage committing murder. Does the date rape drug take the rap when someone puts it in another persons drink? Is it guilty of the crime?
Despite what ignorant individuals are stating, the only people suffering from the opioid crisis are the people that need the medication to live. The lives of people with horrible medical conditions have been destroyed. The lives of the elderly have been destroyed. The correct od stats are 17k. People do not take the time to fact check the current 'fad." Govt quietly corrects data while continuing to disseminate erroneous data,
MILLIONS OF PEOPLE WITH ILLNESSES WHO PREVIOUSLY WERE ABLE TO FUNCTION, CONTRIBUTE TO SOCIETY ARE NOW INCAPACITARED AND IN EXRUCIATING PAIN. YOU HAVE DESTROYED THEIR LIVES AND THEIR FAMILIES AND WE BY FAR OUTNUMBER THE POOR LITTLE ADDICTS WHO COULD CARE LESS ABOUT ANYTHING OTHER THAN GETTING THEIR ILLEGAL FIX ON THE STREET.
THE SICK ARE NOW COMMITTING SUICIDE DUE TO NONSTOP PAIN.
STOP PICKING ON PEOPLE WITH ILLNESSES OF ANY KIND.
THERE SHOULD NOT BE A SIGN IN A CANCER DOCTORS OFFICE STATING THEY CANNOT GIVE YOU THE MEDICATION YOU NEED FOLLOWING CHEMO AND RADIATION.
THE DEA LIES ABOUT DRUG SHORTAGES FOR THE SICK, WHILE THE FDA WEBSITE LISTS THEM AS SHORT.
IGNORANT AMERICANS YET TO BE AFFECTED BY THE FACT THAT PAIN KILLS CONTINUE TO PREACH WITHOUT KNOWING THE CORRECT STATS OR THE TRUTH.
PERSECUTION OF PEOPLE IN PAIN OR ANY ILLNESS NEEDS TO STOP.
MAKING IT HARDER FOR SOMEONE THAT MEDICALLY NEEDS OPIOIDS OR XANAX IS IRRESPONSIBLE.
Figures Lie and Liars Figure Why the Demographics of the So-Called Prescription Opioid Crisis Dont Work, Richard Lawhern, National Pain Report, 11/17/17
http://nationalpainreport.com/figures-lie-and-liars-figure-why-the-demographics-of-the-so-called-prescription-opioid-crisis-dont-work-8834839.html
CDC Researchers State Overdose Death Rates From Prescription Opioids Are Inaccurately High, CATO INSTITUTE, JEFFREY A. SINGER, 3/22/18
https://www.cato.org/blog/cdc-researchers-state-overdose-death-rates-prescription-opioids-are-inaccurately-high
Are Prescription Opioids Driving the Opioid Crisis? Assumptions vs Facts. Rose ME1.
Pain Med. 2018 Apr 1;19(4):793-807. doi: 10.1093/pm/pnx048.
https://www.ncbi.nlm.nih.gov/pubmed/28402482
B.C. doctors cant limit opioids or discriminate against pain patients
CAMILLE BAINS, VANCOUVER THE CANADIAN PRESS, 6/6/18
https://www.theglobeandmail.com/canada/article-bc-doctors-cant-limit-opioids-or-discriminate-against-pain-patients-2/
The Opioid Epidemic In 6 Charts Designed To Deceive You, ACSH, Josh Bloom, 10/12/17
https://www.acsh.org/news/2017/10/12/opioid-epidemic-6-charts-designed-deceive-you-11935
The truth about the US opioid crisis prescriptions arent the problem
Marc Lewis is a neuroscientist/author on addiction, The Guardian
https://www.theguardian.com/commentisfree/2017/nov/07/truth-us-opioid-crisis-too-easy-blame-doctors-not-prescriptions
Fentanyl & Heroin Deaths Lead Soaring Overdose Rate, 12/21/17, PNN
https://www.painnewsnetwork.org/stories/2017/12/21/fentanyl-heroin-deaths-exceed-overdoses-from-pain-meds
Why Untreated Chronic Pain is a Medical Emergency
1/28/18 by Pharmaciststeve http://www.pharmaciststeve.com/?p=23988
Untreated Chronic Pain can Kill! 6/20/17 Suzanne Stewart, NPR
http://nationalpainreport.com/untreated-chronic-pain-can-kill-8833859.html
CDC Report Ignores Suicides of Pain Patients, June 07, 2018, Pat Anson, PNN
https://www.painnewsnetwork.org/stories/2018/6/7/cdc-report-ignores-suicides-by-pain-patients
Jeffrey M Geurin, Staff Sergeant, United States Air Force 1997-2008
https://www.regulations.gov/document?D=FDA-2018-N-1621-1264
Why Living In Pain Will Eventually Kill You, By Kristin Hayes, RN, 7/27/17
https://www.verywell.com/why-living-in-pain-will-eventually-kill-you-3972227
Response to: FDA-2017-N-5608
by: Stefan G. Kertesz, MD, MSc and Ajay Manhapra, MD
U Alabama at Birmingham School of Medicine & Yale School of Medicine
https://www.regulations.gov/contentStreamer?documentId=FDA-2017-N-5608-0938&attachmentNumber=1&contentType=pdf
Time: Report: Chronic, Undertreated Pain Affects 116 Million Americans
By Maia Szalavitz 6/29/11
http://healthland.time.com/2011/06/29/report-chronic-undertreated-pain-affects-116-million-americans/
10 Myths About the Opioid Crisis, Pnn
https://www.painnewsnetwork.org/stories/2017/12/24/10-myths-about-the-opioid-crisis
The other opioid crisis: hospitals are running short of powerful painkillers
PAULINE BARTOLONE, KAISER HEALTH NEWS
http://www.latimes.com/business/la-fi-opioid-painkiller-hospitals-20180316-story.html#
In the midst of a massive opioid crisis, hospitals are experiencing an opioid shortage
Aaron Schachter, 5/14/18
https://www.marketplace.org/2018/05/14/health-care/midst-massive-opioid-crisis-hospitals-are-experiencing-opioid-shortage", "comment_id": "FDA-2018-P-0673-0007", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-P-0673-0007", "comment_date": "2018-08-10T04:00:00Z", "comment_title": "Comment from Anonymous", "commenter_fname": null, "commenter_lname": null, "comment_length": 5323}, {"text": "We highly object. Making it difficult for people who legitimately need medication is not the way to stop overdoses from illegal street drugs which are many times laced with heroin. The majority of deaths are due to ILLEGAL drugs bought on the street. By restricting opioids and in this case xanax, you are only driving up the black market for these illicit drugs. People who actually need these medications are being denied access and in some cases are probably now desperate enough to try impure illegal drugs in order to manage medical conditions. Who benefits? The drug cartels which now have even more people to sell to as restricting access has now driven up demand. Since the crackdown on opioids began, we now have even more ER overdose cases. Guess what, they aren't from legitimate prescriptions, but street laced "copies" especially fentanyl. And for the record, someone could just as easily kill them-self with alcohol (a central nervous system depressant) tobacco, tylenol, aspirin, antihistamines...To combat illegal drugs, you should be looking to the DEA to crack down on drug cartels, pill mills and hey how about looking into those drug and alcohol Rave parties. Children and teens need to be properly educated by their parents. It is time for people to start taking responsibility for themselves and to stop blaming drugs. This is like blaming steak knives for every stabbing death and banning them. What about butter knives? They can kill as well. And knives don't just get up off the table and stab someone, just like drugs don't just jump out of their bottle into people's mouths or up their noses. There will always be something illegal on the street that entices some people to get high. Targeting legitimate prescriptions only creates additional suffering and hardship for those that need the medication, while those abusing it still have access to their illegal supply.", "comment_id": "FDA-2018-P-0673-0004", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-P-0673-0004", "comment_date": "2018-03-19T04:00:00Z", "comment_title": "Comment from Anonymous", "commenter_fname": null, "commenter_lname": null, "comment_length": 1926}, {"text": "In order to ensure that Alprazolam (Trade Name Xanax) be more strongly controlled in distribution and use I support moving it from Schedule 4 to Schedule 2.
In the United States the drug continues to show up in overdose cases implicating it as a contributor to overdose situations which lead to hospital visits, temporary or permanent debilitation and death.
I find this petition to be in good order becamse Alprazolam has an actual and growing potential for abuse not only of the drug by itself but in combination with other drugs such as both the natural and synthetic opioids.
Scientific evidence of its pharmacological effect continues to indicate it is a serious mood, mind and body altering drug which must be distributed in only rare cases.
The state of current scientific knowledge regarding the drug's interactions with other drugs, such and natural and synthetic opioids as well as the psychiatric states it can trigger have been recorded in studies that the manufacturers continue to marginalize.
Over the course of its (relatively) brief history a pattern of abuse has arisen for the drug itself and it is now being used in combination with other drugs to create specific life endangering effects.
The scope, duration, and significance of abuse is increasing at a high rate over time. The control of the current supply has clearly been lost.
The risk there is to the public health continues to be loss of mental ability, physical ability and life. The debilitating effects of the drug lead to the curtailing of economic activities by family members which damage growing children, other family members and the entire community in which these tragedies occur. Death is also expensive.
The psychic and physiological dependence liability is clear and warned about. It is hard to manage with an individual of general intelligence and strength let alone someone suffering from the very symptoms this drug is supposed to alleviate.
", "comment_id": "FDA-2018-P-0673-0005", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-P-0673-0005", "comment_date": "2018-07-25T04:00:00Z", "comment_title": "Comment from Alfred Brock", "commenter_fname": null, "commenter_lname": null, "comment_length": 2027}, {"text": "I am a 55 year old female and disabled since MVA in 2005. I am a RN and worked as a nurse for 35 yrs. I have had multiple surgeries due to the accident and also was diagnosed with Hep C that was contracted in the late 80s from a blood transfusion. I was infected for more than 20 years before being aware and it quietly destroyed my liver. I was blessed to bedcover a perfect match at the very last moment and I have been cured of the Hepc now. However I continue with severe chronic pain and my new liver has complicated my options for pain relief. My doctors had found the best medication for me wS Fentanyl patch. It worked well for me for many years. My life and activities were greatly improved. My liver health had been great for 5 years. Since the opioid rules I have lost two of my PCP because they could not prescribe to me. My liver enzymes have been spiking since they took the patch away. My BP has been extremely high at times. I have allergies to a few pain medications and many I simply cant have for reason of causing harm to my liver. Now being sent your in paon management clinics that insist on painful injections that I was told by my doctors I could not have. I pay huge copays and family must run me to appointments that last for hours. They never put hands involved me nor read my piles of records. They send me for repeated Scans MRIs and such for proof that I already have in my records. I am now on oxycodone pills that they previously took me off due to allergy. I continue to have pinching in my liver and my daily pain is 9-10. I never sleep through the night due to constant pain. I need more oregano surgeries but due to my health now I worry about the risks. My life now is very difficult I am depressed and tearful most days. I have 5 sons and 4 grandchildren and fur to my pain I rarely can participate with them and depression again.Before all of this Opioid crisis my quality of life was good. Pain was minimal and I enjoyed my family had normal relations with my husband. I even thought I could possibly work a few hours a week sitting at a desk. I very much miss my job as a nurse. Even if u could not go back to work at least I felt a timed I could be purposeful. Its no longer the case.all I can do now is happily retire and spend days enjoying life and my grandchildren Burbank thats option is gone. I have to have pain control and the proper medication that does not harm me. Like it or not Fentanyl worked well and I had complications. I seem to put that small percentage that. Policy and lawmakers has not considered. I refuse to have my life taken away after all I have been through. I want my PCP back and not be told he will risk losing his license to care for medical ", "comment_id": "FDA-2018-P-0673-0006", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-P-0673-0006", "comment_date": "2018-07-25T04:00:00Z", "comment_title": "Comment from Denise R Niemi", "commenter_fname": null, "commenter_lname": null, "comment_length": 2717}, {"text": "I am a 41 year old disabled women. This is ridiculous on how Congress want to restrict the people who really need pain meds even more. I had to get 3 spinal surgeries and still have pain, muscle spasms, permanent nerve damage and pain. It is hard doing everyday activities. In my spine I have 15 titanium rods, 4 cages and 2 spacers. My back is permanently damaged. I have depression and anxiety disorder. It is a hassle to see the doctor and they consumed with the fear of prescribing pain meds. What are the people with real pain going to do? You guys are going at this wrong. Us economically disproportionate patients will suffer. The people with money will have access. I am tired of the lack of care. The state of Florida medical is worse. I am always compliant, get drug tested and go to my appointments. Why do I have to suffer?", "comment_id": "FDA-2018-P-0673-0008", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-P-0673-0008", "comment_date": "2018-08-10T04:00:00Z", "comment_title": "Comment from Anonymous", "commenter_fname": null, "commenter_lname": null, "comment_length": 836}, {"text": "I object to this matter.
I have been on alprazolam for 4 years. Obtaining this medication was not simple. I had multiple breathing attacks during the day, I've had my left side go numb, and multiple physical symptoms due to severe anxiety. The stigma already surrounding mental health is a hindrance to individuals who seek care. Why make this more complicated thus increasing the likelihood of self medicating a mental issue? This issue would been seen heavier on other sides such as alcohol as patients self treat anxiety in ways not helpful. Stop hindering the accessibility to mental health, and medications used appropriately are far less likely to be abused, because when someone needs it, they don't feel it. I don't "feel" Xanax. I begin to have a normal heart rate and other symptoms gone. Yes counseling helped give me tools to help, but xanax is also a necessary tool. We deserve a quality of life. We did not choose this. ", "comment_id": "FDA-2018-P-0673-0010", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2018-P-0673-0010", "comment_date": "2018-08-14T04:00:00Z", "comment_title": "Comment from Anonymous", "commenter_fname": null, "commenter_lname": null, "comment_length": 966}]}, {"id": "FDA-2022-D-1847", "title": "Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency", "context": "2022-11-03T13:44:18Z", "purpose": "Nonrulemaking", "keywords": ["CDER", "2022-329", "Exemption and Exclusion", "from Certain Requirements", "of the Drug Supply Chain Security Act", "for the Distribution", "of FDA-Approved Naloxone Products", "During the Opioid Public Health Emergency", "Open"], "comments": [{"text": "My son died September 11th, 2019 from an accidental overdose. He had overdosed twice before he died and it was only because of Narcan was he able to live another day. I have been talking to pharmacist, doctors, and the public in general and it is unbelievable how little they know about this lifesaving drug. I implore the FDA to please invest in a campaign of awareness concerning Narcan so that we can Save Just One. Someone dies every 5 minutes from an overdose or poisoning in this country. We are losing an entire generation.", "comment_id": "FDA-2022-D-1847-0004", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-D-1847-0004", "comment_date": "2022-11-03T04:00:00Z", "comment_title": "Comment from LeAnne Burdette", "commenter_fname": null, "commenter_lname": null, "comment_length": 530}, {"text": "We are talking about lives here! The lives of the person who tried pot for the first time and it was laced with Fentanyl. The addict who couldn't no more and his overdose was a suicide attempt. We should have vending machines at every corner with Naloxone!. I understand regulations are necessary to keep individuals safe, but the individuals that need Naloxone are those not following regulations. I thank you for absolutely taking the initiative to lift regulations temporarily while we can get these numbers down. We should not limit a lifesaving medication by restricting it to prescription. Have not only harm reduction organizations carry it but recovery community organizations, rehabs, schools, libraries. Make it AVAILABLE! Easily accessible. ", "comment_id": "FDA-2022-D-1847-0003", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2022-D-1847-0003", "comment_date": "2022-09-29T04:00:00Z", "comment_title": "Comment from Alex Grimes", "commenter_fname": null, "commenter_lname": null, "comment_length": 756}]}, {"id": "HHS-OS-2009-0007", "title": "Proposed Rule on Buprenorpine Dispensing In Opioid Treatment Programs", "context": "2019-01-11T01:04:12Z", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "Comment 4", "comment_id": "HHS-OS-2009-0007-0006", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2009-0007-0006", "comment_date": "2009-08-17T04:00:00Z", "comment_title": "Comment on FR Doc # fr_doc_num", "commenter_fname": "Ronald", "commenter_lname": "Pike", "comment_length": 9}, {"text": "see attatched file", "comment_id": "HHS-OS-2009-0007-0008", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2009-0007-0008", "comment_date": "2009-08-17T04:00:00Z", "comment_title": "Comment on FR Doc # E9-14286", "commenter_fname": "Elizabeth", "commenter_lname": "Stanton MD", "comment_length": 18}, {"text": "please see attached comments from the Cleveland Clinic", "comment_id": "HHS-OS-2009-0007-0003", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2009-0007-0003", "comment_date": "2009-07-20T04:00:00Z", "comment_title": "Comment on FR Doc # E9-14286", "commenter_fname": "blair", "commenter_lname": "barnhart", "comment_length": 54}, {"text": "Comment from Robert Newman, M.D.", "comment_id": "HHS-OS-2009-0007-0010", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2009-0007-0010", "comment_date": "2009-08-17T04:00:00Z", "comment_title": "Comment on FR Doc # E9-14286", "commenter_fname": "Robert", "commenter_lname": "Newman", "comment_length": 32}, {"text": "Please see the attached PDF file", "comment_id": "HHS-OS-2009-0007-0014", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2009-0007-0014", "comment_date": "2009-08-18T04:00:00Z", "comment_title": "Comment on FR Doc # E9-14286", "commenter_fname": "Thomas", "commenter_lname": "Merrill", "comment_length": 32}, {"text": "See attached.", "comment_id": "HHS-OS-2009-0007-0012", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2009-0007-0012", "comment_date": "2009-08-18T04:00:00Z", "comment_title": "Comment on FR Doc # E9-14286", "commenter_fname": "Elinore", "commenter_lname": "Mccance-Katz, M.D.", "comment_length": 13}, {"text": "August 17, 2009
Re: Dockett No. CSAT 001, Proposed Rule Change for Buprenorphine Take Homes for Opioid Treatment Programs (OTPs)
At Texas Clinic, we started utilizing buprenorphine, specifically Suboxone, soon after it was approved for usage in our OTP. We have had great success with this medication, as it seems to have reached a new population of individuals addicted to opiates.
Our main problem from the very beginning in giving buprenorphine to our patients has been the cumbersome take home restrictions identical to those placed on methadone dispensing. We are constantly having to get exception requests for take homes while our colleagues in private practice were simply able to prescribe or dispense Suboxone with no such restrictions.
The take home restrictions have definitely been a deterrent to successful treatment. Over the years, we have had patients drop out of treatment while waiting for their take homes to be processed for approval or simply switch to a private practice (which actually cost them more) because they had freedom to work, go to school, or manage their household more easily.
We would strongly be in favor of lifting any take home restrictions on buprenorphine in OTPs and, therefore, amending the Federal OTP regulations as soon as possible. In this vain, we would further propose that an emergency order be issued, lifting such restrictions immediately, to avoid the possibility of any other patients leaving treatment, relapsing, and going back to a life of abusing opioids.
Thank you for allowing us to comment on this proposed rule change.
Sincerely,
Farrukh Shamsi, MBA
Executive Director
Texas Clinic Fulton
6311 Fulton St.
Houston, TX 77022
(713) 694-8100", "comment_id": "HHS-OS-2009-0007-0009", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2009-0007-0009", "comment_date": "2009-08-17T04:00:00Z", "comment_title": "Comment on FR Doc # E9-14286", "commenter_fname": "Farrouk", "commenter_lname": "Shamsi", "comment_length": 1798}, {"text": "Please find comments by the American Society of Addiction Medicine, regarding the approval of take-home buprenorphine within OTPs, attached. (Docket No. CSAT 001) Thank you.", "comment_id": "HHS-OS-2009-0007-0007", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2009-0007-0007", "comment_date": "2009-08-17T04:00:00Z", "comment_title": "Comment on FR Doc # E9-14286", "commenter_fname": "Alexis", "commenter_lname": "Geier-Horan", "comment_length": 175}, {"text": "See Attached", "comment_id": "HHS-OS-2009-0007-0011", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2009-0007-0011", "comment_date": "2009-08-18T04:00:00Z", "comment_title": "Comment on FR Doc # E9-14286", "commenter_fname": "Charles", "commenter_lname": "O'Keefe", "comment_length": 12}, {"text": "See Attached.", "comment_id": "HHS-OS-2009-0007-0013", "comment_url": "https://api.regulations.gov/v4/comments/HHS-OS-2009-0007-0013", "comment_date": "2009-08-18T04:00:00Z", "comment_title": "Comment on FR Doc # E9-14286", "commenter_fname": "Doug", "commenter_lname": "Kramer", "comment_length": 13}]}, {"id": "FDA-2011-N-0802", "title": "Role of Naloxone in Opioid Overdose Fatality Prevention; Public Workshop; Request for Comments", "context": "2015-09-11T10:39:47Z", "purpose": "Nonrulemaking", "keywords": ["cder2011177", "CDER", "Naloxone", "Public Meeting", "Request for Comments", "2015-376", "open", "Exploring", "Uptake and Use"], "comments": [{"text": "Please see the attached letter from the American Association of Nurse Anesthetists.", "comment_id": "FDA-2011-N-0802-0045", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-N-0802-0045", "comment_date": "2015-09-11T04:00:00Z", "comment_title": "Comment from American Association of Nurse Anesthetists (AANA)", "commenter_fname": null, "commenter_lname": null, "comment_length": 83}, {"text": "Please see the attached PDF document for comments submitted by the Drug Policy Alliance in reference to Docket No. FDA-2014-N-0998. Thank you.", "comment_id": "FDA-2011-N-0802-0047", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-N-0802-0047", "comment_date": "2015-09-11T04:00:00Z", "comment_title": "Comment from Drug Policy Alliance", "commenter_fname": null, "commenter_lname": null, "comment_length": 142}, {"text": "I stongly support the increase availability of Naloxone in the prevention of Opioid Overdose. Making naloxone availalble saves lives! I work as a nurse on a adult detox center at the University of Minnesota, Fairivew and we have noticed an alarming upward trend of 18 y o to 28 y o heroin addicts. Most started with abuse of narcotics then switched to heroin. Many are motivated to come to treatment because a friend overdosed and died. Recently I cared for a young male who came in because he himself nearly died of an overdose but a friend did rescue breathing and got him to an ER. Unfortunetly this friend overdosed the next day and died. We just had a high school student overdose on heroin and alcohol and died. As a mother and a nurse I request you make naloxone and needles available to the public. One idea would be to have public health and/ or pharmacy's distribute the medication/syringes after a person views an informational adminstartion/safety video on an i-pad.
As a community in the Twin Cities we organized a multi -agencyOpioid coaltion to fight this horrific trend of young opioid abusers. Availability of Naxolone is one layer of a solution to this problem. Additonal prevention and public education measures are urgently needed for this nation wide epidemic.
Thank you,
Mary Kay Borgstrom RN
Opioid Coalition Prevention Leader
www.opioidcoalition.org", "comment_id": "FDA-2011-N-0802-0006", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-N-0802-0006", "comment_date": "2012-04-12T04:00:00Z", "comment_title": "Mary Kay Borgstrom - Comment", "commenter_fname": null, "commenter_lname": null, "comment_length": 1403}, {"text": "See attached file(s)", "comment_id": "FDA-2011-N-0802-0044", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-N-0802-0044", "comment_date": "2015-09-11T04:00:00Z", "comment_title": "Comment from CVS Health", "commenter_fname": null, "commenter_lname": null, "comment_length": 20}, {"text": "Working in Massachusetts on the opioid overdose prevention initiative has been one of the most fulfilling times of my professional life. Teaching a parent or loved one of an opioid addict, who is consumed with the fear of losing their loved one to overdose, how to reverse an overdose with nasal naloxone is unparalleled. Most people are amazed at how easy it is to save someone's life with this medication. There is so much misinformation around naloxone that it is crucial to educate the public on its use and importance in our society. None of us can change the fact that presently we are literally fighting for peoples' lives when we talk about opioid abuse, but we can save people from dying from an overdose. An overdose often opens the door for people to reevaluate their situation and look at treatment as a viable option. I did a focus group a few weeks ago and this came from a participant: "I don’t use drugs, but I have been here a lot, I’m an alcoholic. I have had alcohol poisoning and I was lucky to survive. So when I took your class I thought it was important to get Narcan, because you never know. I left here and went to a sober house. My first day in the house, a young kid overdosed on heroin. I used that Narcan and saved his life. I called 911, they came, they took him to the hospital, no issues. I need to get more Narcan. It’s important that alcoholics know that it does apply to them, it applies to everyone if you can save someone’s life. "", "comment_id": "FDA-2011-N-0802-0004", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-N-0802-0004", "comment_date": "2012-04-12T04:00:00Z", "comment_title": "Hillary Dubois - Comment", "commenter_fname": null, "commenter_lname": null, "comment_length": 1521}, {"text": "Please see the attached PDF for our comments submitted in collaboration with the American Pharmacists Association. Also, the National Alliance of State Pharmacy Associations would like to again express our appreciation for the opportunity to participate in and serve as a panelist at the FDA meeting: Exploring Naloxone Uptake and Use. Thank you.", "comment_id": "FDA-2011-N-0802-0046", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-N-0802-0046", "comment_date": "2015-09-11T04:00:00Z", "comment_title": "Comment from National Alliance of State Pharmacy Associations and American Pharmacists Association", "commenter_fname": null, "commenter_lname": null, "comment_length": 346}, {"text": "Many news and research articles have been decrying escalating trends in overdoses and deaths from opioid analgesics and heroin. Yet, rarely is mention made of the fact that there is an effective and safe antidote for such tragedies — naloxone. Isn’t it time to stop the complaining, and conducting pilot studies, and to start using naloxone on a broad scale to finally address and ameliorate the problems?
Evidence-based comments by Stewart B. Leavitt, MA, PhD, executive director of the Pain Treatment Topics and Opioids911-Safety education projects are in an attached MS Word document.", "comment_id": "FDA-2011-N-0802-0003", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-N-0802-0003", "comment_date": "2012-04-12T04:00:00Z", "comment_title": "Pain Treatment Topics (Pain-Topics.org) - Comment", "commenter_fname": null, "commenter_lname": null, "comment_length": 608}, {"text": "Hello,
The United States is a leader in preventing overdose deaths with the use of naloxone.
People from all over the world utilize the resources that have been produced in the US about naloxone. The US has the experience, research, and expertise to respond to this preventable epidemic; leading the way for so many other places.
Having naloxone empowers all parties to engage in meaningful and educational dialogue about the risks associated with substances.
", "comment_id": "FDA-2011-N-0802-0016", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-N-0802-0016", "comment_date": "2012-06-13T04:00:00Z", "comment_title": "Erin K Gibson - Comment", "commenter_fname": null, "commenter_lname": null, "comment_length": 500}, {"text": "Naloxone use by VA Police in a first responder role outside the VA Hospital on VA grounds or City property requires
regulations to outline clear authority for use.
The Minneapolis VA has extended the naloxone rescue kits to providers to prescribe to patients, in addition, seek to
enable our VA police officers to be trained and have clear authority to administer a potential life saving medication for
opioid overdose.
I have been unable to establish authority for VA Police to administer naloxone (prescription medicine) under a
standing order because a standing order for naloxone is for an unknown patient.
I have asked our VA Legal counsel but no information is available.
The VA Police Chief here in Minneapolis wants naloxone rescue kits available in the medical kits used by the VA officers.
Clinical staff want this as well.
VA Police officers are first responders to off-site areas(not in the hospital) that include apartments on this campus
and must call 911 for city ambulance response if needed. Naloxone could be useful.
Past history does include a drug overdose at VA run apartments, sadly naloxone would not have helped in that case.
The Chief anticipates need. Pharmacy Service will commit to training the officers in opioid overdose avoidance, recognition
and response.
", "comment_id": "FDA-2011-N-0802-0040", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-N-0802-0040", "comment_date": "2015-09-11T04:00:00Z", "comment_title": "Comment from Gary Zielke", "commenter_fname": null, "commenter_lname": null, "comment_length": 1372}, {"text": "The FDA should act swiftly to make naloxone available over-the-counter. Increased access to naloxone will help save the lives of opioid users who often do not receive professional medical help because of the fear of police involvement. The majority of studies that compare different reasons for delaying or foregoing a call for assistance find that fear of police involvement is the most commonly cited reason. I attached an additional file which contains more details on the relevant empirical research. These findings make a compelling case for expanding the availability of naloxone. Even if fear of police prevents the seeking of professional medical assistance, the administration of naloxone by a witness can still save a life. And since it is unlikely that the fear of police will be completely eliminated in the near future, naloxone must be a critical part of comprehensive overdose prevention plans. As of April 11, 2012, only six states grant help-seekers and victims limited immunity from prosecution for possession of controlled opioids. Even in states that have enacted these 911 Good Samaritan protections, awareness of the law may remain low. For example, a year after Washington passed their 911 Good Samaritan law, only one of out of six of Seattle police had heard of it and only one out of three opioid users had heard of it. Furthermore, no state has extended Good Samaritan immunity to distribution offenses, despite the fact that most nonmedical opioid users obtain these drugs from friends or relatives who share or sell them. In this context, naloxone must be available to ensure that fear of punishment does not inadvertently condemn overdose victims to a death sentence.", "comment_id": "FDA-2011-N-0802-0007", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2011-N-0802-0007", "comment_date": "2012-04-12T04:00:00Z", "comment_title": "Jeffrey Joseph Cece - Comment", "commenter_fname": null, "commenter_lname": null, "comment_length": 1706}]}, {"id": "CMS-2019-0111", "title": "Revisions to Payment Policies under the Medicare Physician Fee Schedule, Quality Payment Program and Other Revisions to Part B for CY 2020 (CMS-1715-P)", "context": "2020-10-16T21:14:52Z", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "Sept 12, 2019
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS1715P
P.O. Box 8016
Baltimore, MD 212448016
RE: Medicare Program; CY 2020 Revisions to Payment Policies under the Physician Fee Schedule and
Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Medicaid
Promoting Interoperability Program Requirements for Eligible Professionals; Establishment of an
Ambulance Data Collection System; Updates to the Quality Payment Program; Medicare Enrollment of
Opioid Treatment Programs and Enhancements to Provider Enrollment Regulations Concerning Improper
Prescribing and Patient Harm; and Amendments to Physician Self-Referral Law Advisory Opinion
Regulations [CMS-1715-P]
Dear Administrator Verma:
I am writing in response to the request for comments on the Centers for Medicare and Medicaid Services
(CMS) Calendar Year (CY) 2020 Revisions to Payment Policies under the Physician Fee Schedule (PFS)
and Other Revisions to Medicare Part B proposed rule.
I am a physical therapist assistant and am concerned about this potential regulation change. Physical therapy and occupational therapy services are critically important for improving patient function in order to return home or maintain their highest level of independence and quality of life.
I appreciate the opportunity to provide feedback to CMS on the proposed rule. Specifically, I am writing
in response to CMS proposed application of the CQ/CO modifier when outpatient physical therapy and
occupational therapy services are furnished in whole or in part by a physical therapist assistant (PTA) or
occupational therapy assistant (OTA).
I understand that Section 53107 of the Bipartisan Budget Act of 2018 (BBA), enacted on February 9,
2018, included the assistant adjustment as a pay-for provision related to the repeal of the Medicare Part B
payment cap for therapy services. However, if finalized as proposed, this policy will negatively affect
Medicare beneficiary access and add administrative burden. Further, if the application of the modifiers is
finalized as proposed, the access to and safety of vital outpatient physical and occupational therapy
services for the most vulnerable physically impaired beneficiaries will be compromised.
I ask the Secretary to not finalize these policies as proposed. Instead, I am requesting that CMS, in
finalizing the therapy assistant adjustment provisions of Section 1834 of the BBA, implement the
following policy:
1. When a therapist and assistant are jointly furnishing services to a patient at the same time as a
team, and the therapist is fully engaged in the service during that time, the service during that
time period should be identified as a therapists services and be allocated to the therapist.
2. That CMS define in whole or in part to mean skilled therapy service furnished by a PTA or an
OTA that is furnished under the supervision of a therapist, but independent of any time the
therapist is furnishing the service.
3. That only those units of services provided in whole or in part by the assistant should be subject
to the 10% de minimis standard, the CQ/CO modifier, and subsequently the 15% payment
adjustment, not all units of the entire therapy service.
4. That no new burdensome documentation requirements be added. At a maximum, sub regulatory
guidance could revised to include a statement such as The provider should have a mechanism in
place to provide evidence whether a specific service was furnished independently by a therapist
or an assistant, or was furnished in part by an assistant in sufficient detail to permit the
determination of whether the de minimis threshold was met.
Thank you for the opportunity to comment on the CY 2020 Medicare Physician Fee Schedule and
proposed rule.
Sincerely,
Alvin Fall
PTA", "comment_id": "CMS-2019-0111-6442", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2019-0111-6442", "comment_date": "2019-09-17T04:00:00Z", "comment_title": "Comment on CMS-2019-0111-0092", "commenter_fname": null, "commenter_lname": null, "comment_length": 4096}, {"text": "I am writing in strong support of CMS' efforts to eliminate unnecessary administrative barriers by simplifying current documentation requirements for evaluation and management (E/M) services. Currently, CMS only allows E/M documentation provided by medical students to be verified, rather than re-performed, by teaching physicians for billing purposes. This places a significant burden on physician, PA, and NP preceptors of PA and NP students and restricts the ability of preceptors to train the future health workforce. I therefore applaud CMS' recognition of this issue and its proposed changes, which would allow all preceptors to verify the documentation provided by medical, PA, and NP students. This will allow preceptors more time to train students and provide patient care.
The proposed rule clearly intends to allow NPs, PAs, and other preceptors to verify, rather than re-perform, documentation provided by students in the medical record. Therefore, I urge CMS to specifically name PAs and NPs as clinicians eligible to verify documentation, rather than including them as "other members of the medical team," which may lead to unnecessary confusion. Rather than stating that the documentation of "students" can be verified, the term "medical, PA, and NP students" should be utilized. By explicitly naming the types of clinicians and students for which documentation can be reviewed and verified, misinterpretation on the part of health systems, providers, and educators can be eliminated - thus improving both clinical training opportunities and, ultimately, patient care.
I further encourage CMS to reexamine the current physical presence requirement that results in significant burden for preceptors when students are participating in patient care. While physical presence in the clinic is critical for safe patient care, presence in the examination room during documentation is onerous and unnecessary."
", "comment_id": "CMS-2019-0111-6412", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2019-0111-6412", "comment_date": "2019-09-17T04:00:00Z", "comment_title": "Comment on CMS-2019-0111-0092", "commenter_fname": null, "commenter_lname": null, "comment_length": 1988}, {"text": "I am writing in strong support of CMS' efforts to eliminate unnecessary administrative barriers by simplifying current documentation requirements for evaluation and management (E/M) services. Currently, CMS only allows E/M documentation provided by medical students to be verified, rather than re-performed, by teaching physicians for billing purposes. This places a significant burden on physician, PA, and NP preceptors of PA and NP students and restricts the ability of preceptors to train the future health workforce. I therefore applaud CMS' recognition of this issue and its proposed changes, which would allow all preceptors to verify the documentation provided by medical, PA, and NP students. This will allow preceptors more time to train students and provide patient care.
The proposed rule clearly intends to allow NPs, PAs, and other preceptors to verify, rather than re-perform, documentation provided by students in the medical record. Therefore, I urge CMS to specifically name PAs and NPs as clinicians eligible to verify documentation, rather than including them as "other members of the medical team," which may lead to unnecessary confusion. Rather than stating that the documentation of "students" can be verified, the term "medical, PA, and NP students" should be utilized. By explicitly naming the types of clinicians and students for which documentation can be reviewed and verified, misinterpretation on the part of health systems, providers, and educators can be eliminated - thus improving both clinical training opportunities and, ultimately, patient care.
I further encourage CMS to reexamine the current physical presence requirement that results in significant burden for preceptors when students are participating in patient care. While physical presence in the clinic is critical for safe patient care, presence in the examination room during documentation is onerous and unnecessary.", "comment_id": "CMS-2019-0111-6590", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2019-0111-6590", "comment_date": "2019-09-17T04:00:00Z", "comment_title": "Comment on CMS-2019-0111-0092", "commenter_fname": null, "commenter_lname": null, "comment_length": 1972}, {"text": "Thank you for recognizing and addressing the disparity between student documentation requirements for teaching physicians and their students and those for advanced practice nurses (APRNs) and physician assistants (PAs) preceptors and their students. Currently, CMS allows teaching physicians to review and verify any student documentation of the components of E/M services in the medical record, rather than re-document the work. However, this burden reduction policy was not applied to APRN/PA preceptors and their students. Excluding APRN/PA preceptors and their students from this policy had the unintended effect of heightening the challenge of securing preceptors for APRN/PA students when teaching clinicians are in short supply. The revision contained in the Medicare Physician Fee Schedule proposed rule will authorize all APRNs /PAs and physicians to review and verify rather than re-document work for all E/M services by all members of the medical care team (including APRN/PA students). This will remove the disparity and lead to parity among providers and burden reduction for all clinicians. Therefore, we support the inclusion of APRN/PAs in the proposed rule.
For additional information, please contact the AANP Government Affairs Office at 703/740-2529 or governmentaffairs@aanp.org.", "comment_id": "CMS-2019-0111-6713", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2019-0111-6713", "comment_date": "2019-09-17T04:00:00Z", "comment_title": "Comment on CMS-2019-0111-0092", "commenter_fname": null, "commenter_lname": null, "comment_length": 1348}, {"text": "As a physical therapist and employer of 5 Physical Therapists assistants, I urge the payment policy be reviewed and deemed not beneficial for patient care. The use of physical therapists assistants in the healthcare world is vital for efficiency and quality. The proposed decrease in reimbursement will negatively impact employment and likely lead to additional shortages of rehab professionals through the country. I fully understand the need for cost containment however strongly disagree with this methodology. I urge your committee or group to reconsider the payment reduction.
Sincerely, Joe Walters PT
Owner, Physical Therapy One
Portage, MI 49024 ", "comment_id": "CMS-2019-0111-6706", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2019-0111-6706", "comment_date": "2019-09-17T04:00:00Z", "comment_title": "Comment on CMS-2019-0111-0092", "commenter_fname": null, "commenter_lname": null, "comment_length": 671}, {"text": "I am writing in strong support of CMS' efforts to eliminate unnecessary administrative barriers by simplifying current documentation requirements for evaluation and management (E/M) services. Currently, CMS only allows E/M documentation provided by medical students to be verified, rather than re-performed, by teaching physicians for billing purposes. This places a significant burden on physician, PA, and NP preceptors of PA and NP students and restricts the ability of preceptors to train the future health workforce. I therefore applaud CMS' recognition of this issue and its proposed changes, which would allow all preceptors to verify the documentation provided by medical, PA, and NP students. This will allow preceptors more time to train students and provide patient care.
The proposed rule clearly intends to allow NPs, PAs, and other preceptors to verify, rather than re-perform, documentation provided by students in the medical record. Therefore, I urge CMS to specifically name PAs and NPs as clinicians eligible to verify documentation, rather than including them as "other members of the medical team," which may lead to unnecessary confusion. Rather than stating that the documentation of "students" can be verified, the term "medical, PA, and NP students" should be utilized. By explicitly naming the types of clinicians and students for which documentation can be reviewed and verified, misinterpretation on the part of health systems, providers, and educators can be eliminated - thus improving both clinical training opportunities and, ultimately, patient care.
I further encourage CMS to reexamine the current physical presence requirement that results in significant burden for preceptors when students are participating in patient care. While physical presence in the clinic is critical for safe patient care, presence in the examination room during documentation is onerous and unnecessary.", "comment_id": "CMS-2019-0111-6705", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2019-0111-6705", "comment_date": "2019-09-17T04:00:00Z", "comment_title": "Comment on CMS-2019-0111-0092", "commenter_fname": null, "commenter_lname": null, "comment_length": 1972}, {"text": "CMS,
I strongly disagree with the CY 2020 Medicare Physician Fee Schedule Proposed Rule update to certain CPT codes for cardiac PET Imaging (CPT codes 78491, 78492, 78x31, 78x32). I disagree with this policy as it is based off of incorrect data and observation. It appears that inaccurate overhead data, a lack of thorough survey inputs and non-"real world" assumptions have caused Medicare and the RUC to recommend changes to the work inputs associated with Direct Expense and Practice Expense values, that combined with an inaccurate utilization rate resulted in a proposed reimbursement decline that is significant enough to make it impossible for facilities to continue to offer cardiac PET services after January 1, 2020.
The RUC and Medicare relied on market survey data to provide inputs for calculating the technical component (TC) reimbursement. These flawed surveys provided incorrect data or incomplete data regarding equipment direct expense, utilization rate, and practice expense inputs. In addition, the surveys failed to assess the true cost of starting, operating, and maintaining a cardiac PET lab, omitting input allowances for numerous high cost requirements. Therefore, based on this flawed survey data, both the RUC and Medicare recommended a reimbursement value well below what is necessary for the technical operation of a cardiac PET laboratory. I request that CMS NOT commence with the proposed reimbursement in 2020 and instead allow reimbursement to continue at current levels.
", "comment_id": "CMS-2019-0111-6759", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2019-0111-6759", "comment_date": "2019-09-17T04:00:00Z", "comment_title": "Comment on CMS-2019-0111-0092", "commenter_fname": null, "commenter_lname": null, "comment_length": 1543}, {"text": "Dear Administrator Verma,
RE: CMS-2019-0111-0092
I am writing today to comment on the CY 2020 Revisions to Payment Policies under the Physician Fee Schedule (CMS-1715-P). Specifically, I strongly support the proposal to allow Certified Registered Nurse Anesthetists (CRNAs) to provide the pre-anesthetic assessment in Ambulatory Surgical Centers (ASCs) as part of the Conditions for Coverage (CfC).
This change would relieve ASC regulatory burden associated with operating the Medicare program, reduce healthcare costs, and ensure patient safety. CRNAs are highly educated anesthesia experts who are fully qualified to provide the pre-anesthesia assessment. In fact, performing the pre-anesthetic assessment and evaluation of the risk of anesthesia is within the scope of practice of a CRNA.
This proposal would align the anesthetic risk and pre-surgery evaluation standard with the post-anesthetic evaluation standard and would promote continuity of care for the patient by allowing "the patient's anesthesia professional to have familiarity with the patient's health characteristics and medical history."
In many facilities, CRNAs may be the only anesthesia providers, and, therefore, the only healthcare professionals possessing the expertise and training to perform the pre-anesthetic evaluation. Modification of this requirement would promote efficiency and flexibility in ASCs and will reduce administrative burden.
This is the right proposal for patients and for the healthcare system, and I urge you to ensure that it is included in the final rule. Thank you for taking the time to review these comments.
Sincerely,
Pamela Thurman
726 Marina Village Dr
Grand Rivers, KY 42045-9010
", "comment_id": "CMS-2019-0111-6644", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2019-0111-6644", "comment_date": "2019-09-17T04:00:00Z", "comment_title": "Comment on CMS-2019-0111-0092", "commenter_fname": null, "commenter_lname": null, "comment_length": 1838}, {"text": "Dear Administrator Verma,
RE: CMS-2019-0111-0092
I am writing today to comment on the CY 2020 Revisions to Payment Policies under the Physician Fee Schedule (CMS-1715-P). Specifically, I strongly support the proposal to allow Certified Registered Nurse Anesthetists (CRNAs) to provide the pre-anesthetic assessment in Ambulatory Surgical Centers (ASCs) as part of the Conditions for Coverage (CfC).
This change would relieve ASC regulatory burden associated with operating the Medicare program, reduce healthcare costs, and ensure patient safety. CRNAs are highly educated anesthesia experts who are fully qualified to provide the pre-anesthesia assessment. In fact, performing the pre-anesthetic assessment and evaluation of the risk of anesthesia is within the scope of practice of a CRNA.
This proposal would align the anesthetic risk and pre-surgery evaluation standard with the post-anesthetic evaluation standard and would promote continuity of care for the patient by allowing "the patient's anesthesia professional to have familiarity with the patient's health characteristics and medical history."
In many facilities, CRNAs may be the only anesthesia providers, and, therefore, the only healthcare professionals possessing the expertise and training to perform the pre-anesthetic evaluation. Modification of this requirement would promote efficiency and flexibility in ASCs and will reduce administrative burden.
This is the right proposal for patients and for the healthcare system, and I urge you to ensure that it is included in the final rule.
Sincerely,
Ursula Waller
128 Marshall Rd
Buckhead, GA 30625-2906
", "comment_id": "CMS-2019-0111-6631", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2019-0111-6631", "comment_date": "2019-09-17T04:00:00Z", "comment_title": "Comment on CMS-2019-0111-0092", "commenter_fname": null, "commenter_lname": null, "comment_length": 1770}, {"text": "Dear Administrator Verma,
RE: CMS-2019-0111-0092
I am writing today to comment on the CY 2020 Revisions to Payment Policies under the Physician Fee Schedule (CMS-1715-P). Specifically, I strongly support the proposal to allow Certified Registered Nurse Anesthetists (CRNAs) to provide the pre-anesthetic assessment in Ambulatory Surgical Centers (ASCs) as part of the Conditions for Coverage (CfC).
This change would relieve ASC regulatory burden associated with operating the Medicare program, reduce healthcare costs, and ensure patient safety. CRNAs are highly educated anesthesia experts who are fully qualified to provide the pre-anesthesia assessment. In fact, performing the pre-anesthetic assessment and evaluation of the risk of anesthesia is within the scope of practice of a CRNA.
This proposal would align the anesthetic risk and pre-surgery evaluation standard with the post-anesthetic evaluation standard and would promote continuity of care for the patient by allowing "the patient's anesthesia professional to have familiarity with the patient's health characteristics and medical history."
In many facilities, CRNAs may be the only anesthesia providers, and, therefore, the only healthcare professionals possessing the expertise and training to perform the pre-anesthetic evaluation. Modification of this requirement would promote efficiency and flexibility in ASCs and will reduce administrative burden.
This is the right proposal for patients and for the healthcare system, and I urge you to ensure that it is included in the final rule.
Sincerely,
Jaclyn Taylor
108 S Elmhurst Ave
Mount Prospect, IL 60056-3125
", "comment_id": "CMS-2019-0111-6629", "comment_url": "https://api.regulations.gov/v4/comments/CMS-2019-0111-6629", "comment_date": "2019-09-17T04:00:00Z", "comment_title": "Comment on CMS-2019-0111-0092", "commenter_fname": null, "commenter_lname": null, "comment_length": 1779}]}, {"id": "DOD-2013-HA-0085", "title": "Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)/\r\nTRICARE: Pilot Program for Refills of Maintenance Medications for TRICARE For Life Beneficiaries through the TRICARE Mail Order Program", "context": "2020-10-22T01:33:13Z", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "i BELIEVE THE EFFECTIVE DATE OF THE RULE FOR OPTING OUT SHOULD BE EARLY IN 2013 AS MANY OF US BEGIN USING MAIL ORDER AT THAT TIME IN ACCORDANCE WITH THE LAW.....NOW YOU BACK IT OFF UNTIL February 14, 2014. IT WAS NOT THE BENEFICIARY FAULT THAT THE PHARMACY BENEFIT MANAGER WAS NOT READY TO IMPLEMENT THE LAW....ITS A FIVE YEAR PROGRAM AND SOME OF US PLAYED BY THE RULES AND NOW FIND WE ARE PENALIZED. AFTER WELL OVER A YEAR IN THE PROGRAM, THE MAJOR PROBLEM IS THE LACK OF ABILITY TO COMMUNICATE WITH EXPRESS SCRIPTS....IN WELL OVER A YEAR, WE HAVE NOT COMMUNICATED WITH A PHARMACIST OR EVEN A TECHNICIAN. WE HAVE NO IDEA THE QUALIFICATION OF THE SO CALLED ADVOCATES IN PHARMACOLOGY. THE RULES FOR OPTING OUT AND FOR A WAIVER SHOULD BE MUCH MORE SPECIFIC. EXPRESS SCRIPTS WORKS HARD ON KEEPING THE MEDICATIONS ON TIME....BUT GOD FORBID IF THE PHYSICIAN CHANGES THE mg OR THE DRUG....IMPOSSIBLE TO COMMUNICATE THE ISSUE WITH THEM IN TIME TO MEET THE DEMANDS OF THE MEDICATION. I ALSO QUESTION YOUR SAVINGS FROM THE PROGRAM...IN A RECENT DOD/IG REPORT THEY SAY THE PROGRAM IS A WASTE OF MONEY......WHEN AND WHERE WILL THE LIST OF SELECTED MEDICATION FOR MAIL ORDER BE POSTED? .THANK YOU FOR LETTING ME COMMENT. ", "comment_id": "DOD-2013-HA-0085-0002", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2013-HA-0085-0002", "comment_date": "2014-01-17T05:00:00Z", "comment_title": "Comment on DOD-2013-HA-0085-0001", "commenter_fname": null, "commenter_lname": null, "comment_length": 1211}, {"text": "See attached file(s)", "comment_id": "DOD-2013-HA-0085-0004", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2013-HA-0085-0004", "comment_date": "2014-02-18T05:00:00Z", "comment_title": "Comment on DOD-2013-HA-0085-0001", "commenter_fname": null, "commenter_lname": null, "comment_length": 20}, {"text": "Please see attached comments of the National Association of Chain Drug Stores.", "comment_id": "DOD-2013-HA-0085-0003", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2013-HA-0085-0003", "comment_date": "2014-02-10T05:00:00Z", "comment_title": "Comment on DOD-2013-HA-0085-0001", "commenter_fname": null, "commenter_lname": null, "comment_length": 78}, {"text": "Please see attached comments from the Iowa Pharmacy Association.", "comment_id": "DOD-2013-HA-0085-0005", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2013-HA-0085-0005", "comment_date": "2014-02-18T05:00:00Z", "comment_title": "Comment on DOD-2013-HA-0085-0001", "commenter_fname": null, "commenter_lname": null, "comment_length": 64}, {"text": "See attached file(s)", "comment_id": "DOD-2013-HA-0085-0007", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2013-HA-0085-0007", "comment_date": "2014-02-18T05:00:00Z", "comment_title": "Comment on DOD-2013-HA-0085-0001", "commenter_fname": null, "commenter_lname": null, "comment_length": 20}, {"text": "Please see attached comments from the Pharmaceutical Care Management Association.", "comment_id": "DOD-2013-HA-0085-0006", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2013-HA-0085-0006", "comment_date": "2014-02-18T05:00:00Z", "comment_title": "Comment on DOD-2013-HA-0085-0001", "commenter_fname": null, "commenter_lname": null, "comment_length": 81}]}, {"id": "DEA-2020-0002", "title": "Schedules of Controlled Substances: Placement of cyclopentyl fentanyl, isobutyryl fentanyl, para-chloroisobutyryl fentanyl, para-methoxybutyryl fentanyl, and valeryl fentanyl into Schedule I", "context": "2021-12-02T01:00:58Z", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "In light of growing number of opioid overdose deaths in America (more than 70,000 people died of opioid overdose in 2017 according to the CDC), I support the permanent addition of cyclopentyl fentanyl, isobutyryl fentanyl, para-chloroisobutyryl fentanyl, para-methoxybutyryl fentanyl, and valeryl fentanyl to list of Schedule 1 drugs. These drugs are structurally similar to the opioid fentanyl but are not FDA-approved drug products. As a result, users of these drugs are not protected by the FDA's quality standards. According to the CDC, abusing unregulated opioids of unknown quality and potency represents a significant risk of opioid overdose to users. Opioid overdose has been estimated to cost the United States more than 400 billion dollars annually (according the White House Council of Economic Advisors). Additionally, I argue that the social and emotional damage done to American communities caused by the opioid overdose epidemic cannot be presented solely financial terms. In an effort to minimize the presence of unregulated opioid substances of unknown quality and potency in illicit drug markets, I support the listing of these subtances as Schedule 1 drugs, as they meet the DEA's requirements for Schedule 1 subtances. ", "comment_id": "DEA-2020-0002-0011", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0002-0011", "comment_date": "2020-03-04T05:00:00Z", "comment_title": "Comment on FR Doc # 2020-01681", "commenter_fname": "Brian", "commenter_lname": "Rogers", "comment_length": 1287}, {"text": "Why don't you get a chemist to make a list of all the chemical pictures that cause drug addicts who are using fentanyl to feel satisfied so that we don't do this stupid add five chemicals and China imports four hundred variants. The solution is to list every fentanyl variant as schedule 1.", "comment_id": "DEA-2020-0002-0009", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0002-0009", "comment_date": "2020-03-04T05:00:00Z", "comment_title": "Comment on FR Doc # 2020-01681", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 298}, {"text": "The proposal to reschedule fentanyl to schedule one under the Controlled Substances Act though honorable in intent, may potentially do more harm than good. A large portion of our population relies on controlled substances, such has fentanyl, to relieve their chronic pain. While these drugs were never meant to be a long-term solution, that has become the reality we must deal with. Rendering fentanyl illegal would leave many patients in a lurch, unable to access the care they were previously receiving. These patients would no doubt either receive a prescription for a different opioid or worse, obtain illicit substances to fill the void they are now left with. While prescription drugs make up a great portion of the opioid epidemic and I agree that alternative therapies need to be established, it would be foolish to forget the schedule one substances that are already contributing to this nation-wide crisis. The majority of fentanyl related deaths are due to its mixture with other substances that are already classified as schedule one. Creating more illegal substances will not solve the issue, rather add fuel to the fire that is the illegal drugs trade. ", "comment_id": "DEA-2020-0002-0006", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0002-0006", "comment_date": "2020-03-04T05:00:00Z", "comment_title": "Comment on FR Doc # 2020-01681", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1167}, {"text": "Here's a article reported by CNN's Madeline Holcombe which explains everything we need to know about the fentanyl crisis that we are dealing with here in central Ohio: "This Ohio county (Franklin) may need a second morgue to handle the number of fentanyl overdoses." [1]
In her article, Holcome discusses the opioid scourge that is heavily affecting my home state. The article stated that [Franklin] county has seen 23 overdose deaths from January 31 to February 7, Dr. Anahi Ortiz, the county's coroner, said in a statement on her Facebook page. The next day, the county had five more. Dr. Ortiz also stated that [fentanyl] is the deadliest drug in the US, according to the Centers for Disease Control. It is up to 100 times more powerful than morphine, and just .025 milligrams can be deadly.While Franklin County usually has one or two overdose deaths in a day, Ortiz said on Facebook, one 26-hour period in September 2019 saw 10 people dying of overdoses.That year, overdose deaths in the county were up 15% from the year before, and 90% were opiate related.
Fentanyl is a drug that affects everyone and is not limited to race, income, social class, age, education level, etc. It is a killer and can be fatal on someone's first dose because of its potency and the chemicals it is mixed with for the purpose of "cutting" it for sale on the street and larger profits for the dealers.
I have never had a friend or relative killed or had their lives destroyed by it, but I believe that I am in the minority. Almost everyone has been impacted by these drugs. We have all watched the news reports, watched documentaries, seen the impacts of the drugs in TV shows or movies... everyone knows it is a problem which needs a solution ASAP! We need to make it a schedule 1 narcotic and take every legal step to eliminate fentanyl from our streets, or neighborhoods, our schools, and our homes. Fortunately we are in the process of closing/controlling entry on our southern border where most of this lethal drug is being smuggled in from central and southern America. There is no simple, single solution to combating this fentanyl plague, all possible solutions need to be taken, and reclassifying fentanyl to a schedule 1 drug is a necessary step to take.
[1] Madeline Holcombe, This Ohio county may need a second morgue to handle the number of fentanyl overdoses, CNN, (February 13, 2020), https://www.cnn.com/2020/02/13/us/ohio-fentanyl-overdose-second-morgue/index.html.
Thank you for considering my comments and concerns.
Respectfully,
James E. Yerian
", "comment_id": "DEA-2020-0002-0008", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0002-0008", "comment_date": "2020-03-04T05:00:00Z", "comment_title": "Comment on FR Doc # 2020-01681", "commenter_fname": "James", "commenter_lname": "Yerian", "comment_length": 2663}, {"text": "This is a drug I think is abused by people by age and it is terrible to see it get worse year by year. I am glad that people will be punished at a higher degree of law if they are using these drugs to ruins the lives of others by providing a source for this drug. I hope that this reclassification will prevent further deaths and addiction.", "comment_id": "DEA-2020-0002-0010", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0002-0010", "comment_date": "2020-03-04T05:00:00Z", "comment_title": "Comment on FR Doc # 2020-01681", "commenter_fname": "Jose", "commenter_lname": "Vargas", "comment_length": 340}, {"text": "Yes, this is good because the drug dealers are the words and much worse than the users.", "comment_id": "DEA-2020-0002-0007", "comment_url": "https://api.regulations.gov/v4/comments/DEA-2020-0002-0007", "comment_date": "2020-03-04T05:00:00Z", "comment_title": "Comment on FR Doc # 2020-01681", "commenter_fname": "Lily", "commenter_lname": "Grant", "comment_length": 87}]}, {"id": "SAMHSA-2022-0001", "title": "Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid (OFMG) (Revised)", "context": "2022-06-14T14:14:08Z", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "This is completely absurd and unjust! It is time to move past these destructive policies. If a person's physician believes it is in one's best interest to use a medicine, then the federal government should not be able to hold this against the person due to a failed test. This is very un-American! Cannabis is a very safe, and effective medicine. We should embrace it as such.", "comment_id": "SAMHSA-2022-0001-0007", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0001-0007", "comment_date": "2022-04-13T04:00:00Z", "comment_title": "Comment from Richard Rousseau", "commenter_fname": "Richard", "commenter_lname": "Rousseau", "comment_length": 384}, {"text": "Although I believe Oral Fluid testing is a good thing for quick non dot testing, I think it is offering many opportunities for Cheating for DOT testing. There will be more and more companies that will begin to do their own testing with their Employees which leaves the opportunity for friends and colleagues testing each other and promotes collaboration between Staff and Employee", "comment_id": "SAMHSA-2022-0001-0023", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0001-0023", "comment_date": "2022-04-26T04:00:00Z", "comment_title": "Comment on FR Doc # N/A", "commenter_fname": "Bill", "commenter_lname": "Kincaid", "comment_length": 381}, {"text": "I believe that medical cannabis users should be exempt from fedral drug screen failures.", "comment_id": "SAMHSA-2022-0001-0022", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0001-0022", "comment_date": "2022-04-19T04:00:00Z", "comment_title": "Comment on FR Doc # 2022-06886", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 88}, {"text": "his is slightly insane but a logical outcome of the federal government’s continued refusal to change its outdated, disproven, and harmful categorization of cannabis as a Schedule I drug.", "comment_id": "SAMHSA-2022-0001-0019", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0001-0019", "comment_date": "2022-04-19T04:00:00Z", "comment_title": "Comment on FR Doc # 2022-06886", "commenter_fname": "Alexi", "commenter_lname": "Martinez", "comment_length": 192}, {"text": "This rule is founded on completely archaic ideas about cannabis and how it affects an individual. There is no science backing up the non-legitimacy of medical use cases for cannabis where in many circumstances, actually improves the life of the person who uses it. Personally I have suffered from high anxiety/depression and PTSD and using cannabis before bed helps me immensely to calm down and get good rest. Without it I typically have night sweats/terrors that severely affects my performance the next day. Using cannabis before bed however allows me to function fully the next day and show up to work and other responsibilities with a clear and balanced mind. The harmless nature of this drug truthfully should allow it to be legal federally. Even for non medical patients, it is far safer to be taken recreationally than something like alcohol. Having cannabis be a schedule 1 drug is completely erroneous but while states have laws allowing it to be used medically, we should honor that and not move retroactively. Progress needs to be made here to establish facts about cannabis instead of digging in our heels based off assumptions made by politicians from decades ago. More and more research is coming out showing the benefits of cannabis and how truly harmless it can be. We need to be a country that creates rules based off these facts in order to maintain the sense of freedom that we cherish here. ", "comment_id": "SAMHSA-2022-0001-0021", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0001-0021", "comment_date": "2022-04-19T04:00:00Z", "comment_title": "Comment from Eric Florence", "commenter_fname": "Eric", "commenter_lname": "Florence", "comment_length": 1412}, {"text": "SAMHSA 2022-0001 is a throwback to a relic of reefer-madness legislature. All of this is the politically neurotic outcome of the federal government’s continued refusal to change its outdated, targeted, and medically harmful categorization of cannabis as a Schedule I drug. Please look yourself in the mirror and explain this, “a physician’s authorization or medical recommendation for a Schedule I substance is not an acceptable medical explanation for a positive drug test.” I'll help, it's a back asswards loophole to apply to try to regulate an innoxious substance. It's also funny how the most addictive substances known to man are considered safe enough to assign to Schedule II; live with yourself knowing that you helped fuel a crisis that ruins lives and kills people because of a nonsensical mindset of ignorance, greed, and fear. You won't read it but here's to you, cheers; https://www.npr.org/2022/02/25/1082901958/opioid-settlement-johnson-26-billion, https://www.newsnationnow.com/health/where-do-us-opioid-trials-settlements-stand/.", "comment_id": "SAMHSA-2022-0001-0011", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0001-0011", "comment_date": "2022-04-19T04:00:00Z", "comment_title": "Comment on FR Doc # 2022-06886", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 1091}, {"text": "As a qualified SAP from 05 to present I am in support for Oral Fluid Testing but with the following caveats: 1) ONLY Urine Testing should be used for the RTD Return to Duty test. 2) There should be no change to the SAP being the sole author of any employee's mandatory Follow up Testing Plan. The SAP is the one in the entire RTD process who is spending up to hours of time providing a clinical assessment and applying diagnostic criteria with backend recommendations for education or treatment or both. Thus, upon any employee compliance the SAP should be the only Service Agent type deciding the amount of Follow-up Tests but also if they recommend ORAL or URINE for Follow-up tests. I would advise that all Follow up Tests are URINE TESTS only. The Oral Test appear from what I read to be the way to go for Pre-employment Test, Random's, Reasonable Suspicion, Post Accident etc but the RTD and Follow up Test should ALWAYS be Urine based. If there is a choice on either for Oral and Urine testing for RTD and Follow-up Testing this call should ONLY be for the contracted SAP to make and never the employer or 3rd party TPA. ", "comment_id": "SAMHSA-2022-0001-0027", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0001-0027", "comment_date": "2022-05-05T04:00:00Z", "comment_title": "Comment on FR Doc # N/A", "commenter_fname": null, "commenter_lname": null, "comment_length": 1135}, {"text": "Comment on SAMHSA 2022-06884
I am an operations manager at a public transit authority and think adding the ability to conduct drug testing using oral fluids will be a benefit felt across the board. Our organization would certify staff to be able to self administer oral fluid testing as well as use a clinic. Drivers would still have to go to a clinic for BAC testing, so we would not self administer that test. It takes a lot of planning and resources to pull drivers off route for random testing, send them to the clinic, wait at the clinic, then coordinate getting them back on route. Being able to self administer random testing will simplify the process and make it more convenient to test at all times of service.
Our practice would be to use urine tests for pre-employment, return to duty, and follow up. In the cases of shy bladders or the inability to produce a large enough specimen, we would be open to transitioning from urine to oral fluids before exhausting the time limit. We prefer pre, return, and follow-up to be more structured through a clinic and to use urine, especially for return and follow-up.
In response to the question of whether or not to allow opposite gender techs to observe urine collection, our team was split. The male point of view was it makes no difference. The human resources and female recommendation was to have it observed by the same gender. Past experiences show female staff were already stressed about being observed. To have the collection observed by a male would further exacerbate the situation. Just because someone is going through the follow up process doesn't mean they should lose their dignity. We understand in smaller communities it may be harder to find same gender techs to observe urine collections, but we don't have the issue in our area.
In response to the question of whether or not refusing an opposite gender observer constitutes a refusal to test, we assumed that the regulation wouldn't require same gender observers. We would recommend calling that a refusal to test. If your test requires observing, you must have already tested positive. We cannot give someone the ability to cheat the system if they know there aren't many same gender techs.
In summary, let's get oral fluid testing up and running and relieve some of the burden placed on organizations to maintain compliance with drug testing. A separate soap box issue I would like to see movement on is THC levels testing to remove the current zero tolerance policy that can last for up to 60 days after last contact/consumption. Safety sensitive industries need a better answer than zero tolerance when cannabis products and marijuana use are rising as fast as they are now. Zero tolerance is hurting staff retention and recruiting. ", "comment_id": "SAMHSA-2022-0001-0030", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0001-0030", "comment_date": "2022-05-05T04:00:00Z", "comment_title": "Comment on FR Doc # N/A", "commenter_fname": null, "commenter_lname": null, "comment_length": 2811}, {"text": "Comments of Airlines for America attached.", "comment_id": "SAMHSA-2022-0001-0040", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0001-0040", "comment_date": "2022-06-07T04:00:00Z", "comment_title": "Comment on FR Doc # N/A", "commenter_fname": null, "commenter_lname": null, "comment_length": 42}, {"text": "Official comment from OraSure Technologies, Inc. is attached.", "comment_id": "SAMHSA-2022-0001-0038", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2022-0001-0038", "comment_date": "2022-06-07T04:00:00Z", "comment_title": "Comment on FR Doc # N/A", "commenter_fname": null, "commenter_lname": null, "comment_length": 61}]}, {"id": "SAMHSA-2023-0001", "title": "Medications for the Treatment of Opioid Use Disorder", "context": "2023-05-08T13:37:08Z", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "I think it would benefit greatly if Telemed appointments were permanently available for inductions/first visits.", "comment_id": "SAMHSA-2023-0001-0007", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2023-0001-0007", "comment_date": "2023-05-05T04:00:00Z", "comment_title": "Comment from Powell, Kennedy, HHS_FRDOC_0001, HHS_FRDOC_0001-0876, 2022-27193", "commenter_fname": "Kennedy", "commenter_lname": "Powell", "comment_length": 112}, {"text": "As a public health professional, I strongly urge SAMSHA to adopt the proposed changes to medications for opioid use disorder (MOUD) regulations to increase access to these lifesaving medications and enable people with substance use disorder (SUD) to successfully discontinue illicit drug use and reclaim their lives. I currently serve as deputy director of Virginia Harm Reduction Coalition, a 501(c)(3) nonprofit providing harm reduction services to people who use drugs (PWUD) in Southwest Virginia. I have witnessed firsthand the struggles our clients face in accessing MOUD, including not being able to afford to take time off work for appointments and facing stigma at work when they do, difficulties with getting childcare to facilitate appointments, and difficulties obtaining transportation to access appointments. I have witnessed clients struggle mightily to remain in treatment only to finally succumb to the weight of these barriers and relapse. The closest Medicaid-accepting methadone clinic to Roanoke, Virginia, is located 50 miles away in Martinsville. Methadone is much more effective for many of our clients than buprenorphine (especially since Virginia law makes obtaining buprenorphine without a naloxone component impossible for most patients). The availability of telehealth appointments for methadone patients and the ability of patients to receive up to 4 weeks’ worth of medication enables many more of our clients to enter and remain compliant with treatment. It is an absolute game changer. ", "comment_id": "SAMHSA-2023-0001-0014", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2023-0001-0014", "comment_date": "2023-05-05T04:00:00Z", "comment_title": "Comment from Zabielski, Barbie, HHS_FRDOC_0001, HHS_FRDOC_0001-0876, 2022-27193", "commenter_fname": "Barbie", "commenter_lname": "Zabielski", "comment_length": 1526}, {"text": "While I absolutely believe addiction and addiction issues are a significant problem, I wanted to make sure that my understanding (and my doctor’s understanding is correct as it was told to me, a pain patient). The proposal’s wording leaves no choice for someone taking opioids to NOT be dependent either physically or mentally. Meaning, it is appropriate to code all patient’s claims who use opioids as at least “opioid dependence” diagnosis. They have no choice to do this even if their doctors have zero dependency concerns documented in the medical chart. Even if the patient has no dependency issues with the opioid(s) being taken. And I am assuming there will be some sort of protections for the patients to ensure that there will be no denial of organ transplants, should they ever be needed in the future because of this coding. Because again, the patient and doctor had no choice.", "comment_id": "SAMHSA-2023-0001-0017", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2023-0001-0017", "comment_date": "2023-05-05T04:00:00Z", "comment_title": "Comment on HHS_FRDOC_0001, HHS_FRDOC_0001-0876, 2022-27193", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 918}, {"text": "Anything to make buprenorphine more easily accessible. It is by far the safest opioid. It's use to treat pain and opioid overdose should be studied and encouraged. It is safe enough to be dispensed over the counter to competent adults.
H B Edwards, MD
Addiction Psychiatrist
BehaveNet, LLC", "comment_id": "SAMHSA-2023-0001-0019", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2023-0001-0019", "comment_date": "2023-05-05T04:00:00Z", "comment_title": "Comment on FR Doc # 2022-27193", "commenter_fname": "HOWARD", "commenter_lname": "EDWARDS", "comment_length": 306}, {"text": "I am an OTP methadone patient. I've watched as federal and state laws have provided easier access to treatment. However, this means nothing if the OTP or Methadone clinic does not adopt these rules. I have 14 years 100% compliant in my treatment but my clinic will not allow me to have more than 6 take home doses. According to Samhsa and my state law I should be getting up to 27 doses. People at other clinics with less time clean can get more takehomes than me. But because you make these changes and do not require these opioid treatment programs to follow, nothing will change. It's a shame. You just let people suffer and die and do nothing about it. I am told by the people who run the clinic that they get paid more when we have to show up in person more. So it's become about these companies money and bottom lines and not peoples lives and treatment. You all should be quite ashamed of yourselves.", "comment_id": "SAMHSA-2023-0001-0020", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2023-0001-0020", "comment_date": "2023-05-05T04:00:00Z", "comment_title": "Comment on FR Doc # 2022-27193", "commenter_fname": "Anonymous", "commenter_lname": "Anonymous", "comment_length": 919}, {"text": "January 24th, 2023
Substance Abuse and Mental Health Services Administration,
Department of Health and Human Services
Re: Notice of Proposed Rulemaking on Medications for the Treatment of Opioid Use Disorder
Dear Sir or Madam,
I am submitting a comment in response to SAMHSA’s proposed rulemaking “Medications for the Treatment of Opioid Use Disorder” published in the Federal Register on December 16th, 2022.
I am a 4th year medical student with a little more than 3 months left before graduation. I recently completed my addiction psychiatry rotation and I hope to practice as a Family Medicine Physician with a strong MOUD patient panel. I strongly support the rulemaking regarding the removal of stigmatizing language and inclusion of principles of harm reduction and patient centered perspectives. However, I would like to draw your attention to a few areas where you can better realize those ideals.
While the proposed change to methadone provision rules is an improvement to the pre-COVID days, it leaves many harmful practices in place. I would like to draw from the attached article by Frank et. al. published in the Harm Reduction Journal. Here, the authors affirm the importance of take-home doses, but note that the take-home dosing guidelines are the ‘ceiling’, not the ‘floor’, as “individual clinics can adopt stricter policies if they choose”. These policies can take many different forms, many of which are not addressed by the proposed rulemaking. I have also attached the “Methadone Manifesto”, published in the American Journal of Public Health. While the whole article is worth reading, Box A details some recommended additions/changes to the rule. Notably, the elimination of negative drug tests as a requirement for take home dosing, elimination of burdensome bottle return or lock box requirements, and prohibition of accelerated tapering schedules/financial detox (often insufficient for adequate withdrawal).
It is my belief that federal policy truly rooted in patient centered perspectives and harm reduction would include these provisions. I recommend reading both attached articles to push the proposed rule to be as patient-centered as possible. The MOUD policies should be as empowering and non-stigmatizing as the proposed language changes suggest. Thank you for the opportunity to submit a comment.
Sincerely,
Jay Mainthia
", "comment_id": "SAMHSA-2023-0001-0034", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2023-0001-0034", "comment_date": "2023-05-05T04:00:00Z", "comment_title": "Comment on FR Doc # 2022-27193", "commenter_fname": "Jay", "commenter_lname": "Mainthia", "comment_length": 2510}, {"text": "My name is Jeffrey A. Singer, MD and I am a senior fellow at the Cato Institute, in the Department of Health Policy Studies. Please see my attached comment on the Proposed Rule.", "comment_id": "SAMHSA-2023-0001-0015", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2023-0001-0015", "comment_date": "2023-05-05T04:00:00Z", "comment_title": "Comment from Singer, Jeffrey, HHS_FRDOC_0001, HHS_FRDOC_0001-0876, 2022-27193", "commenter_fname": "Jeffrey", "commenter_lname": "Singer", "comment_length": 177}, {"text": "I am totally NOT in favor of SAMHSA adopting the Proposed Rule as is, in its entirety because it will create a huge financial hardship on the agencies that receive funding based on being CARF accredited if given one year or a non-accreditation outcome for more than a few recommendations that could be resolved within 60-90-days. Without a lot of details regarding why SAMHSA is moving into this direction, it is very difficult to really assess the pros and cons. However, one thing that I know is that agencies work hard to comply with CARF standards as well as overall service delivery to consumers and to put these stricter expectations as well as time restraints on these agencies appears to be a setup for failure. No agency is perfect and to say an agency can only have a hand full of recommendation is not reality because of the overall diversity within all agencies. It is not a one size fit all type of situation. The reason why agencies have chosen to comply with CARF standards as initially written is because we were want to provide a high level of care to our consumer based on surveyors' overall feedback within a reasonable amount of time to correct issues, etc. This is not a agency at large friendly proposal. ", "comment_id": "SAMHSA-2023-0001-0042", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2023-0001-0042", "comment_date": "2023-05-05T04:00:00Z", "comment_title": "Comment on FR Doc # 2022-27193", "commenter_fname": null, "commenter_lname": null, "comment_length": 1238}, {"text": "I wanted to say that I think this is a good thing for MH & addicted patients, also think that MH patient for some if not most should not be taken away our rights to certain anxiety and panic attacks meds such as benzodiazepines. When I came to South Carolina from California I had to quit on my own wt benzodiazepines because no doctor here would refill it.I would like to suggest for more groups & resources for MH patients as is almost non existent here in SC. I don’t think MH or addiction should be stigmatized anymore.!!! Thank you ", "comment_id": "SAMHSA-2023-0001-0027", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2023-0001-0027", "comment_date": "2023-05-05T04:00:00Z", "comment_title": "Comment on FR Doc # 2022-27193", "commenter_fname": "Rose", "commenter_lname": "Muniz", "comment_length": 551}, {"text": "To expect a treatment center to not have a singular standard (out of 1900) out of conformance seems like an unrealistic expectation. If a surveyor finds one treatment plan out of all the charts that they look at and that treatment plan was completed a week after its due date. Then that would be the one singular out of conformance that they are allowed to have for their entire survey (now they know they are only going to get a one year and they are stuck in compliance nightmares all year for every clinic they have). This regulation would force surveyors to decide if they should make any recommendations to the clinic to help them improve or decide that it is crucial for the clinic to stay open to treat patients so they must ignore any issues and just issue a perfect 100% survey at every location to ensure access to treatment for patients. It defeats the purpose of professional consultation and makes the survey process punitive.", "comment_id": "SAMHSA-2023-0001-0040", "comment_url": "https://api.regulations.gov/v4/comments/SAMHSA-2023-0001-0040", "comment_date": "2023-05-05T04:00:00Z", "comment_title": "Comment on FR Doc # 2022-27193", "commenter_fname": "Scott", "commenter_lname": "N", "comment_length": 943}]}, {"id": "DOD-2011-HA-0085", "title": "TRICARE; Removal of the Prohibition to Use Addictive Drugs in the Maintenance Treatment of Substance Dependence in TRICARE Beneficiaries", "context": "2020-10-22T01:28:06Z", "purpose": "Rulemaking", "keywords": null, "comments": [{"text": "See attached", "comment_id": "DOD-2011-HA-0085-0035", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2011-HA-0085-0035", "comment_date": "2012-03-01T05:00:00Z", "comment_title": "NAABT Comment", "commenter_fname": null, "commenter_lname": null, "comment_length": 12}, {"text": "Dear Sir/Ma'am,
Please note my strong support FOR the proposed rule change.
The exclusion of maintenance therapies for addiction treatment because they are "addictive" ignores best practices in the medical treatment of substance use disorders, ties the hands of service providers, and makes recovery from chemical dependence harder for patients to achieve.
The proposed rule change would increase the effectiveness of treatment for this life-threatening and widespread illness.
Thank you,
William Aprill
LCSW-BACS, LAC, CCGC", "comment_id": "DOD-2011-HA-0085-0002", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2011-HA-0085-0002", "comment_date": "2012-01-03T05:00:00Z", "comment_title": "Comment on DOD_FRDOC_0001-3051", "commenter_fname": null, "commenter_lname": null, "comment_length": 565}, {"text": "Patients enrolled in a methadone clinic accept a high level of supervision and demonstrate a commitment to their recovery.", "comment_id": "DOD-2011-HA-0085-0017", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2011-HA-0085-0017", "comment_date": "2012-02-14T05:00:00Z", "comment_title": "Comment on DOD-2011-HA-0085-0001", "commenter_fname": null, "commenter_lname": null, "comment_length": 122}, {"text": "I have submitted the comment below on letterhead using the file upload function. Here is the text.
As a researcher and clinician in the addiction field, I am writing to express my strong support for the proposed inclusion in TRICARE of coverage for methadone and buprenorphine maintenance for drug dependent individuals. Extensive research – much of it conducted with former military personnel receiving care in the Veterans Health Administration – indicates that opiate substitution therapies sharply reduce illicit drug use and risk of fatal overdose. These therapies have also been proven highly cost-effective.
At a time when a growing number of U.S. military personnel are reporting problems with prescription and non-prescription opioids, the addition of this benefit to TRICARE is critically important. For the regulatory change to be maximally beneficial to the health of our military personnel and their families, it should be coupled with extensive outreach to TRICARE providers to make them aware of the new insurance benefit.
Thank you for proposing this major step forward for the TRICARE program.
", "comment_id": "DOD-2011-HA-0085-0003", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2011-HA-0085-0003", "comment_date": "2012-01-03T05:00:00Z", "comment_title": "Comment on DOD_FRDOC_0001-3051", "commenter_fname": null, "commenter_lname": null, "comment_length": 1284}, {"text": "The use of opioid maintenance therapy on a long term basis has not been proven to improve functionality or reduce mortality or relapse. Most tests of the efficacy of opioid treatment therapy have been conducted on a short term basis. Research has shown that on a short term basis, those given methadone or buprenorphine reduce their use of other opioids, but only for as long as they are on the drugs. Many continue to use other substances such as alcohol, and continue to be at risk of overdose. Methadone overdoses have increased 400% from 2004-2008. Harm reduction philosophy (upon which use of an addictive substance is sanctioned to treat dependence on another substance) is an enabling philosophy that continues addiction, rather than treat it. As long as the person remains dependent on an abusable substance, he or she can never realize his/her potential as a whole, infinite spiritual being. It is a disrespectful and demeaning approach to the plight of the addict and keeps him/her shackled to the progression of this dangerous mental disorder and foreshortens his/her life. The use of chronic opioid therapy for chronic noncancer pain has created this epidemic of opioid dependent persons and yet so little is being done to stop the production of opioid dependent persons and much is being propagated about the "evidence-based" need for the use of more opioids to treat the problem. This is insane!", "comment_id": "DOD-2011-HA-0085-0004", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2011-HA-0085-0004", "comment_date": "2012-01-03T05:00:00Z", "comment_title": "Comment on DOD_FRDOC_0001-3051", "commenter_fname": null, "commenter_lname": null, "comment_length": 1419}, {"text": "The proposed change reflects the best evidence-based practice in the treatment of opioid dependence. I fully support this change in the applicable regulation.
I speak from the experience of prescribing buprenorphine (Suboxone/Subutex) since 2004 in the treatment of opioid dependence in the context of a comprehensive treatment program by our agency of which I am the medical director. I also support Opioid Treatment Programs that prescribe methadone in the treatment of opioid dependence along with counseling.
I am Board-certified in Internal Medicine and Addiction Medicine and have been working in the field of addiction medicine since 1989.", "comment_id": "DOD-2011-HA-0085-0007", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2011-HA-0085-0007", "comment_date": "2012-01-10T05:00:00Z", "comment_title": "Comment on DOD-2011-HA-0085-0001", "commenter_fname": null, "commenter_lname": null, "comment_length": 666}, {"text": "Dear Sir or Madam,
On behalf of the Ohio Department of Alcohol and Drug Addiction Services (ODADAS) Clinical Roundtable Committee, I am pleased to submit the following comments on the proposed rule related to TRICARE benefits, “Removal of the Prohibition to Use Addictive Drugs in the Maintenance Treatment of Substance Dependence in TRICARE Beneficiaries (Document ID DOD-2011-HA-0085-0001).”
The Clinical Roundtable -- comprised of six senior clinicians and supervisors with established expertise in the clinical treatment of addictive disorders, drawn from ODADAS-certified treatment agencies from across the state -- strongly supports extending the benefit so that maintenance regimens of Medicated-Assisted Treatment (MAT) will be covered by TriCare. Scientific literature supports provision of MAT on an ongoing basis as being far more efficacious than alternative approaches, including detoxification-only or short-term utilization of MAT. Furthermore, several Roundtable members are familiar with the use of opioid replacement therapies (MAT) on an ongoing basis in their own agencies and have found it to be effective and practical.
The Clinical Roundtable also recommends addressing barriers that limit access to other clinical services (counseling, case management) within the TRICARE system. MAT is considerably more likely to be effective when combined with counseling and case management services; however, community agencies with the highest level of expertise in providing such services have found that they cannot receive reimbursement through TRICARE. While the Clinical Roundtable fully supports and recommends immediate action on the MAT proposal, there is a strong consensus that further access to addiction-related services needs to be addressed as well.
Thank you for this opportunity to provide comment. Please do not hesitate to call or email if I can be of additional assistance.
Sincerely,
Orman Hall, Director
ODADAS
", "comment_id": "DOD-2011-HA-0085-0026", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2011-HA-0085-0026", "comment_date": "2012-02-27T05:00:00Z", "comment_title": "Comment on DOD-2011-HA-0085-0001", "commenter_fname": null, "commenter_lname": null, "comment_length": 2019}, {"text": "See attached file(s)", "comment_id": "DOD-2011-HA-0085-0020", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2011-HA-0085-0020", "comment_date": "2012-02-23T05:00:00Z", "comment_title": "Comment on DOD-2011-HA-0085-0001", "commenter_fname": null, "commenter_lname": null, "comment_length": 20}, {"text": "See attached.", "comment_id": "DOD-2011-HA-0085-0033", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2011-HA-0085-0033", "comment_date": "2012-02-28T05:00:00Z", "comment_title": "CSAC Comment", "commenter_fname": null, "commenter_lname": null, "comment_length": 13}, {"text": "On behalf of NAADAC, the Association for Addiction Professionals, which represents the professional interests of more than 75,000 addiction counselors, educators and other addiction-focused health care professionals in the United States, Canada and abroad, we thank you for this opportunity to submit comments to the Department of Defense regarding the TRICARE: Removal of the Prohibition to Use Addictive Drugs in the Maintenance Treatment of Substance Dependence in TRICARE Beneficiaries (RIN 0720–AB54).
NAADAC applauds the proposed change in TRICARE policy regarding the use of therapeutic drugs in maintenance treatments for substance dependence. There is a wealth of medical evidence available that supports the belief that medication-assisted treatments are safe and highly effective. The extension of benefits to include these treatments increases the quality of treatment options available to TRICARE beneficiaries.
The use of medication-assisted treatments is not for everyone. Thus, we would recommend that included in the rule is a requirement that all individuals undergo an assessment prior to starting any medication-assisted treatment to ensure that they are receiving the appropriate care. We also recommend that there be a requirement that anyone receiving medication-assisted treatments also take part in a comprehensive psychosocial treatment program to be administered concurrently. We believe these added components will serve to prevent further dependence by assisting counselors in obtaining an ongoing assessment of the treatment.
While NAADAC does not have an official written statement outlining support for medicated assisted treatment for individuals with addiction problems, since 2005 we have been active in the development of training experiences surrounding this topic for addiction treatment professionals. Through a training program entitled “NAADAC’s Life Long Learning Series” five different training experiences have been developed and trained to ", "comment_id": "DOD-2011-HA-0085-0015", "comment_url": "https://api.regulations.gov/v4/comments/DOD-2011-HA-0085-0015", "comment_date": "2012-02-14T05:00:00Z", "comment_title": "Comment on DOD-2011-HA-0085-0001", "commenter_fname": null, "commenter_lname": null, "comment_length": 2048}]}, {"id": "FDA-2017-P-6307", "title": "Request that the FDA designate Morphine Sulfate Extended Release Tablets, 100 mg from Rhodes pharmaceuticals LP (ANDA# A074769) as reference standard (RS) for the subject drug product to conduct in vivo bioequivalence studies.", "context": "2019-03-14T16:22:32Z", "purpose": "Nonrulemaking", "keywords": ["CITIZEN PETITION", "CDER", "Aurolife Pharma LLC", "Reference listed drug (MSCONTIN", "NDA # 019516)", "Purdue Pharma LP", "discontinued", "MS CONTIN", "Referencing Approved Drug Products in ANDA", "Morphine Sulfate Extended Release Tablets", "100 mg", "Rhodes Pharmaceuticals LP (ANDA# A074769)"], "comments": [{"text": "Goals for Chronic Pain Patients to receive adequate pain relief;
* For correct misinformation online and in Media about chronic pain patients and opioid therapy be amended and corrected!
* * institute a Chronic Pain Patients "Bill Of Rights".
-We all have a right to relief from our debilitating pain and discomfort.
* United Nations policy states PAIN MANAGEMENT IS A FUNDAMENTAL HUMAN RIGHT, under treatment or not treating is a crime against humanity and considered torture! That is what is being done to chronic pain patients all over this country right now! I being one of them as I am experiencing abandonment of care from my doctor. who has refused to treat me. Thus, I am in a very precarious state right now! I looking for a doctor. However, all pain management specialist are booked for at least a four month window! My pain is chronic 24/7, 365 days a year. I can't wait that four months. I do not want to end up as a statistic on the suicide list!
Since the narrative of the "opioid epidemic" has taken hold, some/ many doctors are refusing pain relief, in fear of retribution, imprisonment or loss of livelihood!
Many hospitals are implementing after surgery a spinal block and Tylenol, many patients are dying attributing it to cardiac arrest which is not the case!
#2 Collateral damage Because of the innumerable, severe, and long lasting effects of constant pain, I believe that treatment for chronic pain is a human right.
It impairs every part of a persons entire life, career, family, mind, body, spirit and soul. From financial hardships due to being unable to work and the family issues as we cannot be the parents, grandparents partners that we would have and should be.
Many chronic pain patients are hypo metabolizers or hyper-metabolizer ... I suffer with malabsorption I had a surgically inserted port in my chest.
I had tpn pumped into to my body for 12 to 24 hours a day for 8 + years.
I could not absorb the proteins in my food this is the way I sustained my life. It makes sense since food did not absorb either did my medication that is why I had to have higher doses For it to work.
We are not a one-size-fits-all society.
This creates, a lot of collateral damage to the family because we are not able to function in a fashion that our family needs us to ! It also starts to deteriorate our children's mindset as they are continually worried as to our health, expectancy of life/ longevity of life !
I know this first-hand has changed who my four children could have been ! It put too much weight on them while trying to go through school and life in general !
Because of all the family issues in addition to other health issues like brain and organ damage from lack of sleep, medications, and the rewiring of your brain from constant stress. Air condition, heating our sensory capabilities are all screwed up we need to help chronic pain patients get better treatment, education of the public on the complexities of chronic pain, lobby the government to make changes that will benefit chronic pain patients, and to foster a better understanding of chronic pain patients struggles day in Day Out with daily life.
After reading so many frustrating stories of chronic pain patients dealings with the healthcare industry, I decided to create a foundation that would serve the needs of chronic pain patients everywhere. By first educating the public on what chronic pain really is, how it affects us and our families, and what is missing in our treatment. Then I would like to focus on changing how government views chronic pain patients and writes guidelines and legislation that affects them.
For those of us who suffer day in and day out 24/7, 365 days a year Relentless, cruel, aching, affliction, agony, burn, catch, convulsive, cramping, crick, discomfort, distressing, fever, gripping, hurting, illness, injury, irritation, laceration, malady, misery, pang, paroxysm, prickling, sickness, smarting, soreness, spasm, stinging, stitching, straining, tenderness, thro, tingling , tormentous, torturous, troubling, twinging, wounding always present, horrendous, debilitating pain sharp, exacerbating,
There is a need in the chronic pain community and it is not being addressed, please we need to reduce the suffering as much as possible, of people suffering from chronic pain.
Suicidedue2pain
Malabsorbtion -TPN
Music therapy
Massage
Behavior therapy
Physical therapy
Biofeedback
Acupuncture etc
Three options - reform of opioid guidelines
3. Campaign/Organizational Goal and Key Objectives
Educating the public about chronic pain and how it affects chronic pain patients.
-Fight preconceived notions on pain medication and those who need it.
-What is missing from treatment of chronic pain?
-Changing governmental views
-Get new guidelines on pain medication created for chronic pain sufferers.
-Explain how the war on opioids is killing chronic pain sufferers!", "comment_id": "FDA-2017-P-6307-0006", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-P-6307-0006", "comment_date": "2018-05-01T04:00:00Z", "comment_title": "Comment from CATHY KEAN", "commenter_fname": null, "commenter_lname": null, "comment_length": 5172}, {"text": "Dear Readers,
I am not certain how to write this letter, but I feel I must respond and comment on these regulations and have a voice in federal making of decisions.
I have been in chronic pain since 1984. In all these years since a respiratory infection ended with widespread body pain, I have not had one day without pain. The original disease has increased from musculoskeletal to inflammatory and degenerative arthritis throughout all my joints. Every X-ray is filled with arthritis and bone spurs, even bone in locations bone should not be. An MRI of my spine sent me to a neurosurgeon who said the only surgery that might work would never permit me to bend over again.
I take both diazepam and hydrocodone, in addition to medications you might not consider opioids or narcotics. These two are not high dosage, but they have worked and allowed me an active life. Daily I take care of horses, my own home, animals, and I work. I work as a writer and have had 16 books published while taking these medications. My main publisher has been WW Norton in NY. And for poetry, I have used a smaller, independent press. I also travel frequently to read my work, do workshops, and lecture on a variety of topics.
This is with my medications.
Without them, I am unable to get out of bed. I have had screams that are involuntary. I cannot bend or do any movement or work. My hands do not work, will not type, nor can I walk without severe pain. Without these medications, I will have no life, or
at least not one worth living.
The Dr. has changed. Even he has fear. He does not wish to prescribe medications like the ones I take, swears they would kill anyone else, all the exact same stories as the numerous other pain patients say they have heard. I feel sorry for those of us in pain, but I also feel sorry for those in the medical profession who are unable to really help their patients.
Many pain patients have been committing suicide rather than living a life suffering. These deaths are worse than the ones of addicts who are shooting up because they are created by the government's regulations and fear tactics. They are going after the wrong people.
Most of us are taking our meds at the right times, not asking for larger doses, and are responsible with our meds. We do not misuse our medicines. For us they are not addictive drugs, but healing agents that allow us to live full lives.
Please consider this in your Regulations. We do want to live. We do not overdose. We are not the criminals. We want to be free from pain, as anyone else also would.
Sincerely,
Linda Hogan
Professor Emerita
U of Colorado, Boulder
www.lindahoganwriter.com
", "comment_id": "FDA-2017-P-6307-0003", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-P-6307-0003", "comment_date": "2018-03-28T04:00:00Z", "comment_title": "Comment from Linda Hogan", "commenter_fname": null, "commenter_lname": null, "comment_length": 2763}, {"text": "I'd like to start out by saying I'm a 39 yr old mother of 6. And have had chronic pain for over half my life.
I was 11 yrs old when I first started having back pain and then went on to knee pain. I was cative throughout school I was involved in track n field, volleyball, cheerleading & basketball. I had to wear 2 knee braces and was on a very high does of anti-inflammatory prescription from my knee doctor at age 12. After giving birth to my 3rd child at age 20 I had my 1st knee surgery, every year after that 1st surgery i had knee surgery after another for 5 years... I had been sent to neurologist's and physical therapy chiropractor and differant doctor's ect.
Finally at age 28 i found my dr and he referred me to a spine specialist and he diagnosed me with Schumann's disease which is very painful my spine was 69% curved on top and 69% curved on the bottom. They did surgery October15th 2010 and it was a very long recovery.
I've been on Percocet for 7 yrs and don't abuse it. I can't even get out of bed, walk or do basic self care without it. I've seen what drug addiction has done to our community and people i love.
But dont punish us that need our medication to live our basic daily lives.", "comment_id": "FDA-2017-P-6307-0005", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2017-P-6307-0005", "comment_date": "2018-04-17T04:00:00Z", "comment_title": "Comment from Miranda MuellerMcClure", "commenter_fname": null, "commenter_lname": null, "comment_length": 1261}]}, {"id": "FDA-2021-P-0514", "title": "Requests that the FDA declare that Naloxone HC1 Nasal Spray, 8 mg/Spray, is suitable for submission as an ANDA and to introduce a new 8 mg/Spray metered spray strength for prescription use", "context": "2022-04-25T11:42:15Z", "purpose": "Nonrulemaking", "keywords": ["Suitability Petition", "CDER", "HYMAN, PHELPS & MCNAMARA, P.C.", "for prescription use", "metered spray strength", "introduce a new 8 mg/Spray", "Approved Drug Products with", "Orange Book", "Therapeutic Equivalence Evaluations", "Reference Listed Drug (RLD)", "as an ANDA", "Abbreviated New Drug Application (ANDA)", "is suitable for submission", "8 mg/Spray", "declare that Naloxone HCl Nasal Spray", "OPEN"], "comments": [{"text": "N/A", "comment_id": "FDA-2021-P-0514-0007", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2021-P-0514-0007", "comment_date": "2022-04-25T04:00:00Z", "comment_title": "Comment from Foley & Lardner, LLP", "commenter_fname": null, "commenter_lname": null, "comment_length": 3}, {"text": "On behalf of Hikma Pharmaceuticals USA, Inc. (“Hikma”), the undersigned submits the following comments pursuant to 21 C.F.R. § 10.30(d) opposing the above-referenced suitability petition.", "comment_id": "FDA-2021-P-0514-0006", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2021-P-0514-0006", "comment_date": "2021-08-20T04:00:00Z", "comment_title": "Comment from Lassman Law+Policy", "commenter_fname": null, "commenter_lname": null, "comment_length": 204}]}, {"id": "FDA-2005-P-0191", "title": "For patient safety and public health considerations, recommending scheduling tramadol under the Controlled Substances Act", "context": "2021-09-01T01:01:17Z", "purpose": "Nonrulemaking", "keywords": ["substances", "controlled", "tramadol", "fda", "scheduling", "drugs", "food", "CDER"], "comments": [{"text": "See attachment", "comment_id": "FDA-2005-P-0191-0005", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2005-P-0191-0005", "comment_date": "2016-03-22T04:00:00Z", "comment_title": "Comment from Ortho-McNeil, Inc. (Hyman, Phelps & McNamara)", "commenter_fname": null, "commenter_lname": null, "comment_length": 14}]}, {"id": "FDA-2016-D-0785", "title": "General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drugs Products", "context": "2017-11-22T10:26:14Z", "purpose": "Nonrulemaking", "keywords": ["2015-181", "General Principles for Evaluating", "Abuse Deterrence of Generic Solid Oral", "Opioid Drugs Products", "2016-932"], "comments": [{"text": "
My name is Jennifer Ford, and I have fibromyalgia. Including chronic pain, chronic fatigue, depression, anxiety, degenerative disc disease, COPD, just to name a few. I am able to barely maintain some level of a normal life with pain levels of a 5-6 on a good day. This is with the use of three hydrocodone a day. No more, no less. I receive a prescription of 90 per month. That's 3 a day, for 30 days. Take that away from me, and I have no idea what I'll do. Please leave chronic pain patients alone. We are patients, not addicts.
13", "comment_id": "FDA-2016-D-0785-0008", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-D-0785-0008", "comment_date": "2016-05-09T04:00:00Z", "comment_title": "Comment from Jennifer Ford", "commenter_fname": null, "commenter_lname": null, "comment_length": 556}, {"text": "No more opioid guidelines that hurt the Chronic Pain community. My doctors are refusing medications they themselves put me on. We matter, the quality of our lives matter and our voices need to be listened to. Addiction within our community is very rare. ", "comment_id": "FDA-2016-D-0785-0016", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-D-0785-0016", "comment_date": "2016-05-26T04:00:00Z", "comment_title": "Comment from C, Hope For The Hopeless Chronic Pain Issue's and Awareness", "commenter_fname": null, "commenter_lname": null, "comment_length": 254}, {"text": "I have taken opioids on and off for 30 years responsibly and safely. I have adhesive arachnoiditis. Without these meds many chronic pain patients will have no quality of life. What the government is doing is outrageous. You can buy codeine over the counter in Canada. It is not a gateway drug to heroin. Although the money grubbing addiction industry would like you to think so. The problem is heroin coming into the country from Mexico and China. If you want to fix the drug problem fix that. A new study shows that opioid overdoses peaked in 2012. Even if you take opioids off the market you will still have addicts acquiring it on the streets. You are throwing the baby out with the bath water. Patients who suffer everyday with excruciating pain rely on these medications to bring the pain down to a tolerable level. We take our medications responsibly. Any physician who says to take oxycodone off the market has no compassion. There is a place for opioids in medicine when the are prescribed responsibly. Pain patients are just getting warmed up! If you think we're going to tolerate this treatment you are wrong! ", "comment_id": "FDA-2016-D-0785-0025", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-D-0785-0025", "comment_date": "2016-06-06T04:00:00Z", "comment_title": "Comment from Katherine Owen", "commenter_fname": null, "commenter_lname": null, "comment_length": 1124}, {"text": "I my name is James I have a chronic pain disease called rsd or crps. I use some of these drugs to control my pain and help me get through my day. There are many of us in the same position as I am. If you put uncentsable regulations on this we are going to be the ones that suffer from this for others stupidity pleases stop and think about the people that need this to get though our days and nights and to be able to spend time with our families. There are other ways to weed out the people that are abouseing theses drugs. I know we as the people of this country don't really matter to you people on any of these maters, but maybe just maybe for once in your time in office you will do the right thing and help the people that put you there. If you all had to spend one day in any of our shose you would understand where we are coming from. PLEASE PLEASE STOP AND THINK BEFORE YOU TAKE ANY ACTION ON THIS. If you were one of use you would be doing all you can't to take a different position on any of this.", "comment_id": "FDA-2016-D-0785-0043", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-D-0785-0043", "comment_date": "2016-06-08T04:00:00Z", "comment_title": "Comment from James Boles", "commenter_fname": null, "commenter_lname": null, "comment_length": 1016}, {"text": "Dr. Glapinski, I am a chronic pain sufferer and one who is DEPENDENT on oxycodone for a QUALITY OF LIFE. In reading your comment, you are aware that chronic pain pts depend on opiods and are in agreement, and then you turn around and say ban oxycodone. Just because you are against it for what ever reason, there are MANY LEGITIMATE chronic pain pts who retain a QUALITY OF LIFE by taking oxycodone. I have tried nearly all of them over the course of ten years. Opiods were my last resort, first came years of physical therapy, massage, chiro, accupuncture, epidurals, discographies, OTC AND NSAIDS that tore my stomach and liver up, facet injections, trigger point injections, nerve blocks, steriods, nerves burned, TENS, and two FAILED spinal fusions that left me with severe nerve damage. Oxycodone happens to be the one medication that agrees with me and takes my unbearable pain to a tolerable level, when I was on the right dose. Because of all these INHUMANE restrictions by the CDC, FDA, DEA and the government, Legitimate pain ots are having their once stable dose lowered to INEFFECTIVE DOSES or totally stripped of them, leaving many in agony and severe withdrawal. Shame on any of you doctors who abandon their patients. We are suffering from incurable conditions that cause severe pain, I beg God to take me daily. Would you do that to your Mom? Could you sit back and watch your loved one be at war with their body, stabbing, burning, crushing, piercing, pains, the emotional and mental toll it takes on a person, If your loved one got relief by taking opiods, would you want them to have some QUALITY OF LIFE and enjoy what they can or strip them of the only treatment they gave them some relief, force them to remain bedridden, shut off from society, many are turning to suicide to escape the pain. You doctors took an oath to do no harm. I get the DEA is targeting all our drs, there is way more harm being done to the chronically ill, we are being FORCED to suffer, to exist in hell, All the doctors thruout this country who believe in helping the suffering, especially when we've tried the alternative therapies OUR BODIES could take, it's physically, mentally and emotionally exhausting fighting this battle, then the stigma that is thrown on our backs, shame on all of you dra for not standing alongside the suffering. Perhaps if you treated each person as if you would your mom, maybe there would be compassion and empathy brought back into the dr/patient relationship. I see and hear nothing but NEGLECT, ABUSE, DEGRADING, DISCRIMINATION AGAINST LEGITIMATE PAIN PTS. Another fact is there is no opiod epidemic. The CDC used false data, even admitted to MISCLASSIFYING MANY heroin and fentanyl deaths, doubling and tripling one persons death, legit pain pts who committed suicide were listed an overdose, if alcohol or any other illicit drugs played a part the CDC looked the other way, they created mass hysteria that the media and government took off with, constantly demonizing a chronic pain pts LIFE SAVING MEDICATIONS. The CDC created FALSIFIED STATISTICS MADE TO FIT THE GOVERNMENTS ADDICTION DRIVEN AGENDA. Chronic pain pts are LAW ABIDING citizens who have DEBILITATING INCURABLE CONDITIONS, who have tried whatever was put in front of us by the medical community to get relief. We dont BREAK THE LAW, WE DONT ABUSE, SELL, SHARE, SNORT, OR ANYTHING ELSE TO OUR LIFE SAVING MEDS. WE ARE SICK FOR GOD SAKE. We are treated HORRIBLY by the medical community, treated like everyone is a pill seeking junkie, addict, and criminals. I am so fed up with paying the high price with my health and overall well being because of those who CHOOSE TO ABUSE, people who CHOOSE TO BREAK THE LAW, WHO CHOOSE TO POP DRUGS, OR GET DRUNK OFF ALCOHOL, PEOPLE WHO CHOOSE TO DESTROY THEIR BODIES, Addicts are given all kinds of opportunities to get help, all kinds of doors open for them, hell even the government passes out clean needles to shoot their drug of choice up with and safe houses to go get high and shoot up. When an addict, someone who CHOOSES TO ABUSE , fails a drug test during treatment they are given chance after chance, they aren't kicked out and turned away, A LEGITIMATE chronic intractable pain pts are turned away, judged and labeled as addicts, pts who have been with their drs for years and were on the same stable dose that worked for them are having meds reduced or taken away thru no fault of our own, for following the rules, getting drug tested monthly, shamed at the pharmacy, if you even find a pharmacy to fill your LEGAL lifesaving medication. Nearly all chronic pain pts have suffered for years and have years of medical records documenting their DEBILITATING INCURABLE conditions, usually has had many MRI's scans, tests, etc.These debilitating conditions only continue to worsen over time, so why are we decreasing legit pain pts meds when the doses really should be increased. How would it make you feel if your own mother were so poorly neglected!?", "comment_id": "FDA-2016-D-0785-0056", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-D-0785-0056", "comment_date": "2016-06-08T04:00:00Z", "comment_title": "Comment from Pam Molnar", "commenter_fname": null, "commenter_lname": null, "comment_length": 5013}, {"text": "1.Although the theme of the guidance seems, as expected, to proof that tested generic formulation (T) is not inferior to an approved AD reference formulation (R) and some studies were designed to test T against R directly, e.g. syringeability, introducing the control formulation (C) in some studies, e.g. extractability, created some confusion between qualifying an original brand name AD formulation (R) and a generic. We believe that, for generics, T should be tested directly against R, with no need for a third formulation (control), unless one route of abuse was not considered/listed on the R label.
2.There is no clarity if in-vitro testing need to be done or at least verified by a third party laboratory to avoid manufacturer's bias which we have noticed as a third party lab.
3.The draft guidance, as well as the previously approved AD guidance, focus on opioids but we believe that it should cover, also, non-opioids of potential abuse, e.g. amphetamines or molecules that can be precursor for recreational drugs, e.g. pseudoephedrine.
4.Smoking simulation study listed 233C as a definite temperature for heating but from our experience, this temp was not good to volatilize morphine or oxycodone and for which we needed to optimize the heating conditions. Not sure why the paper ignition temperature was used to set up this figure noting that different heating techniques including direct heating a drug on a piece of aluminum foil or putting a drug directly on ignited charcoal, e.g. "hookah", have been used. We believe that, smoking simulation studies should be optimized first using pure compounds and select the most effective heating condition/temp to test an AD formulation.
5.The guidance did not mention core separation as a part of physical manipulation for formulations with API is enclosed in a core within a hard shell.
6.The guidance did not mention saline solution for extractability or syringeability where it's a potential solvent that can be easily obtained by a drug abuser and safely injected. In this regard, for generics, we believe that all or representative solvents which were used to qualify an R should be used for T.
7.For particle size distribution following physical manipulation, 500 micron was used as a cut-off; does this mean no particle size characterization is needed below 500 micron?
8.Free base isolation; 233C for 2-15 minutes was listed to dry up a precipitated base without a rationale. From our experience, different temperatures and/or different heating times can be needed and noting that 233C was already suggested for smoking simulation, heating some compounds at this temp for 15 minutes may cause significant loss.
9.Liquid-liquid extraction was not listed but from our experience, after proper optimization, it was an efficient tool to isolate some opioids.
10.The guidance did not handle AD formulation which depend on conjugation of an active moiety to a pharmacologically inert side chain which needs to be cleaved inside the human body for slow release of the active molecule.
11.The guidance suggest 28 to 18 for syringeability and we suggest to consider either 28 or 27 as the latter is common and such small bore size should not make a difference compared to 28.
", "comment_id": "FDA-2016-D-0785-0003", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-D-0785-0003", "comment_date": "2016-04-29T04:00:00Z", "comment_title": "Comment from Abdel Halim", "commenter_fname": null, "commenter_lname": null, "comment_length": 3791}, {"text": "I don't understand why you think that going after physicians & their patients, specifically chronic pain patients is going to somehow make this heroin epidemic lessen or disappear. I am a woman who was born with severe JRA at 15 months old, have had several surgeries, & other diagnoses along the way........Fibromyalgia, CFS, seemingly untreatable bi-lateral hip bursitis, constant back spasms, & the list goes on. I have for over 10 years been under the care of my wonderful rheumatologist & have ALWAYS listened to her, followed all directions, & more importantly NEVER, EVER given her reason to think I was doing anything otherwise. I am a perfect patient. My pain meds make my life liveable & when I say that....I mean my kind of liveable. I am permanently disabled so nothing is perfect, BUT being able to make dinner for my family at night & do some light housekeeping is only because of my pain meds. And now you want to make it harder? For what? Why? To eliminate what you think is the reason for heroin? Look around, do some more research. We have above pharmacy grade opiates coming across our borders & drug dealers are selling it to addicts. That's NOT us. Under 5% of the chronic pain community become addicts. Do we depend on our meds? Yes, but for living, for function, & so we are not bedridden. We aren't getting "high", we are getting some relief. There's a HUGE difference between physical dependence & psychological dependence. We are not in the latter group. Diabetics rely on their insulin, we rely on pain management. There is really no difference. Every medication comes with risks. You overdose on an over the counter medication too. It's called personal responsibility & because some don't practice that, you make ALL pay? You have already made getting our meds tougher with changing the scheduling class, breathing down the necks of our doctors, making them so scared to actually treat their patients now, pain contracts, random urine tests, pill counts, etc, etc...... What else do you want?? After all those things were implemented NOTHING changed with the addicts. In fact in one city next to me the drug use & overdoses have actually doubled since then! Seems like you are barking up the wrong tree. I get my meds, keep them in a fire safe locked box & practice good medication safety, but now I feel that at any moment my rheumatologist could pull the rug out from under me because of fear, or because you come up with some other crazy rule/regulation. She has already stated that it is out of her hands & she actually told me she will not longer prescribe pain meds to new patients, only the ones that are already on them. Really? Find another way to control this epidemic, because last I checked drug addicts don't hang out at rheumatologist, neurologist, or oncologists offices. Go after the drug dealers & the border. Please leave those of us that do nothing wrong alone. Will you release the suicide rates in the chronic pain community when they go off the charts? Because I have already read of SO many, & in many cases it happened because a physician got scared & just stopped their meds cold turkey, which is incredibly dangerous & in my opinion medically unethical. Those people end up in the ER & are treated like subhuman beings. Wow, that's really good medical care. Let the rheumatologists, neurologists, oncologists, & pain clinic physicians do their job. None of us want to be on these meds, but we have come to them because we have tried everything else. I have done physical therapy several times & got cortisone shots every 3 months for over 4 years. Give me a break! Until the scientists & researchers come out with some other medication and/or treatment that works as good as opiates, leave us alone. There are also so many of us that cannot take the conventional medications for our diseases because we have really horrible side effects, & opiates end up being our safest most effective treatment. Why punish the innocent people just trying to live a semi-normal life? When are you going to stop punishing the wrong group of people? Why should we pay for others bad decisions? I am disgusted & I don't deserve to be treated like this. The way pharmacists look at us, treat us, & even lie about how they "cannot" fill our prescriptions is beyond ridiculous. Thankfully I have a wonderful pharmacy. I ran a chronic pain support group on line for over 4 years & I heard the horror stories. They have been so bad I was forced to stop running the group.....between the stress & my own illness, well.....I just felt I had nothing left to give my members. Everything looks dim for them, & that's a sad state of affairs for people that have no choice, who were born with horribly painful diseases & illnesses. They aren't addicts, they are patients. Shame on the medical community, the government, the DEA, & the CDC. You aren't doing your job, you are just creating another problem. Looks good on paper maybe? Horrible!", "comment_id": "FDA-2016-D-0785-0023", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-D-0785-0023", "comment_date": "2016-06-06T04:00:00Z", "comment_title": "Comment from Anonymous", "commenter_fname": null, "commenter_lname": null, "comment_length": 5186}, {"text": "We are real chronic pain patients with real pain...........not drug addicts!", "comment_id": "FDA-2016-D-0785-0071", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-D-0785-0071", "comment_date": "2016-06-08T04:00:00Z", "comment_title": "Comment from Anonymous", "commenter_fname": null, "commenter_lname": null, "comment_length": 76}, {"text": "The regulations against opiate pain medicine has been devastating to my family, to people I care about and to myself personally. I am not a pain patient or user of opiates but my husband who has been disabled for 20 years is a chronic pain patient. These regulations put him through on-going trauma, and pain. Our basic human rights are violated. We are not allowed to live where we want to, or in the state we want to, because we are prisoners to proximity to a doctor who will prescribe the essential medicine. To get this medicine he must submit to urine tests which violate his 5th amendment rights. Law enforcement doesn't belong in doctor's offices and hospitals! Basic human rights are disregarded in this failed "War on Drugs" created by Nixon for racist and evil objectives. Stop restricting medicines! Stop your "war" against the American people! Leave pain patients alone. Stop blaming suicides on pain medicine and look at the patients in chronic pain who are told that their only source of relief has been outlawed! Stop criminalizing self-medication. You are not supposed to control other people's choices with their own bodies. Citizens of the United States are back to having to reclaim their rights to self ownership.", "comment_id": "FDA-2016-D-0785-0078", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-D-0785-0078", "comment_date": "2016-07-07T04:00:00Z", "comment_title": "Comment from Heather Martin", "commenter_fname": null, "commenter_lname": null, "comment_length": 1267}, {"text": "Why are you not going after other patients medications? Start taking medications for those suffering from all other conditions too! SMH!! ", "comment_id": "FDA-2016-D-0785-0033", "comment_url": "https://api.regulations.gov/v4/comments/FDA-2016-D-0785-0033", "comment_date": "2016-06-08T04:00:00Z", "comment_title": "Comment from Anonymous", "commenter_fname": null, "commenter_lname": null, "comment_length": 141}]}]