Schedules of Controlled Substances:  Placement of Tramadol into Schedule IV
2013-12-02 2013-12-12 2013-11-22 2013-11-18 2014-01-06 2013-11-26 2013-11-25 2013-11-26 2014-01-06 2013-12-09
DEA-2013-0010-0012 DEA-2013-0010-0020 DEA-2013-0010-0007 DEA-2013-0010-0006 DEA-2013-0010-0024 DEA-2013-0010-0010 DEA-2013-0010-0008 DEA-2013-0010-0009 DEA-2013-0010-0022 DEA-2013-0010-0015
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https://api.regulations.gov/v4/comments/DEA-2013-0010-0012 https://api.regulations.gov/v4/comments/DEA-2013-0010-0020 https://api.regulations.gov/v4/comments/DEA-2013-0010-0007 https://api.regulations.gov/v4/comments/DEA-2013-0010-0006 https://api.regulations.gov/v4/comments/DEA-2013-0010-0024 https://api.regulations.gov/v4/comments/DEA-2013-0010-0010 https://api.regulations.gov/v4/comments/DEA-2013-0010-0008 https://api.regulations.gov/v4/comments/DEA-2013-0010-0009 https://api.regulations.gov/v4/comments/DEA-2013-0010-0022 https://api.regulations.gov/v4/comments/DEA-2013-0010-0015
Daniel Thomas Robert Roneet Deborah Anonymous M James Bryan Melissa
Anonymous Thompson Brassell jr (c07673494) Lev Anonymous Anonymous Williams Mone' Soukup Almeida
The reason this drug is being prescribed more is because the doctors dont fear the DEA breathing down their neck with a non scheduled prescription. I suffer chronic pain and this drug works for me. I cant imagine it having any abuse potential as you dont get High on it as you would taking the traditional schedule II and III narcotics. It doesnt even compare to pentazocine (Talwin) Sch IV. There is too much regulation of useful drugs in this country. I dont need my doctors scared to prescribe tramadol for me. I have been on it in excess of 7 years. My dose has remained the same for those seven years, 2 50mg tabs tid. Its not like the other narcotics and Ive been on them all in the past at one time or another. If people want to try to get high off something they will. Something else will just fill in that gap. There seems to be a never ending story of scheduling drugs to what end. I live in Washington State, legal pot is available to me if I want it. I cant use marijuana as it makes me sick and I dont think it would help anyhow. Tramadol does help though,  I do not want to see any scheduling decisions that scare my doctors off from prescribing a perfectly safe, effective, non escalating dose, necessary drug that I need to function . I have AIDS and severe peripheral neuropathy I have been on every drug from hydrocodone, morphine, and fentanyl and more not to mention all the amitrytylines and neurontins that dont work and cause bad side effects such as ticks, metallic taste, etc. This is the first one I have landed on that did not carry any of those drugs problems. All of those in Schedule II and III caused problems and the doses had to be escalated to keep my pain under control not to mention the addiction from them. I have finally found a non scheduled opiod where I dont have to escalate the dose that works for my pain (Ive been on it over 7 years). Tramadol needs to remain  unscheduled. This is not the first time this has been proposed and it needs to be overturned again.   Docket No. DEA-351The Drug Enforcement Administration (DEA) proposes to place the substance 2-((dimethylamino)methyl)-1-(3-methoxyphenyl)cyclohexanol, its salts, isomers, salts of isomers, and all isomeric configurations of possible forms including tramadol (the term isomers includes the optical and geometric isomers) into Schedule IV of the Controlled Substances Act (CSA).Ok, for the United States of America to meet  or help meet the standards of Our treaty obligations under The Psychotropic Substances Act of 1978 as amended by the Controlled Substances Act proper regulation of the substance 2-((dimethylamino)methyl)-1-(3-methoxyphenyl)cyclohexanol, its salts, isomers, salts of isomers, and all isomeric configurations of possible forms including Tramadol (the term isomers includes the optical and geometric isomers) must be placed  into Schedule IV of the Controlled Substances Act (CSA) or subjected to certain defined uses only. Current research shows the above named substance aka Tramadol to affect Public Health in the United States; the substance Tramadol has from research caused Death, Sickness along with affecting Commerce by not being regulated enough to prevent Serotonin syndrome along with other symptoms. I find it troubling that proper action has not already reflected a change in the regulation of Tramadol, however now is the time. So the question proposed is to place Tramadol into either Schedule IV or III of the CSA. If Tramadol was to be placed into Schedule III of the CSA then what could occur is non use of the substance, now since there are reports of the drug working for some for Restless leg syndrome placement into Schedule IV should be considered. Further it would also be unethical not to a placement into the CSA. This substance is nothing compared to substances listed in Schedule III of the CSA so I believe action to place the substance into Schedule IV or V is warranted. I must note that there are similar substances that can be used that are much safer than Tramadol and those other substances have listings in Schedule IV and Schedules III along with Schedule II of the CSA.Tramadol and its similar substances of this listings remind myself of Libby Zion. I believe that to prevent Death along with illness caused by Tramadol we must accept previous similar occurrences and only allow combinations of Tramadol so in effect Schedule III placement could occur. Further notation should be noted that Death and Illnesses from using Tramadol are very different than substances listed in Schedule III of the CSA. We cannot compare Tramadol to Hydrocodone. Hydrocodone is an Opioid and Tramadol is Psychotropic in nature and very similar if not the same as a SNRI.  CodificationSection was enacted as a part of the Psychotropic Substances Act of 1978, and not as a part of the Controlled Substances Act which comprises this subchapter.Change of NameSecretary of Health and Human Services substituted for Secretary of Health, Education, and Welfare in par. (3) pursuant to section 509(b) ofPub. L. 9688, which is classified to section 3508 (b) of Title 20, Education.Effective DateSection 112 of title I of Pub. L. 95633provided that: This title [enacting this section and section 852 of this title, amending sections 352, 802, 811, 812, 823, 827, 872, 952, and 953 of this title and section 242a of Title 42, The Public Health and Welfare, and enacting provisions set out as notes under sections 801 and 812 of this title] and the amendments made by this title shall take effect on the date the Convention on Psychotropic Substances, signed at Vienna, Austria on February 21, 1971, enters into force in respect to the United States. [The Convention entered into force in respect to the United States on July 15, 1980.] Speaking and acting within ALL, ALL INCLUSIVE, his capacities, ALL INCLUSIVE, INCLUDING AND ESPECIALLY as the respective SOLE, PRO BONO Estate Administrator (abbreviated as SOLE Est. Adm.) of the Delois Albert Brassell Estate (D-U-N-S Number 831823948 and active CAGE Code 5PAZ8) AND Robert James Brassell Estate (D-U-N-S Number 962019514 and active CAGE Code 64WJ9), ALL INCLUSIVE: I WANT MY OFFICIAL, FULLY-UPDATED, FULLY-AUTHENTICATED, FULLY-AUTHORIZED, FULLY-EMPOWERED ET AL., ALL INCLUSIVE, U.S. ET AL., ALL INCLUSIVE, DOD, USCG, NOAA (i.e., National Oceanic and Atmospheric Administration), CIA (i.e., United States Central Intelligence Agency), USDOJ (i.e., United States Department of Justice), HHS (i.e., United States Department of Health and Human Services), ODNI (i.e., Office of the United States Director of National Intelligence) ET AL., ALL INCLUSIVE, COMMON ACCESS CARDS (respectively one set for the aforementioned Delois Albert Brassell Estate and the other set for the aforementioned Robert James Brassell Estate, for now, for more sets WILL BE TIMELY AND CORRECTLY forthcoming) NOW, INCLUSIVE. Ever since I acquired the respective EINs (between Winter 2002 and Winter/Spring 2004) for the respective Delois Albert Brassell Estate (D-U-N-S Number 831823948 and active CAGE Code 5PAZ8) and Robert James Brassell Estate (D-U-N-S Number 962019514 and active CAGE Code 64WJ9), INCLUSIVE, among many various other Estates, INCLUSIVE, I was LEGALLY REQUIRED AND ENTITLED to be FORMALLY, CORRECTLY, TIMELY AND OTHERWISE ON-THE-RECORD informed of the precursors to ALL, ALL INCLUSIVE, such all-in-one smart cards, INCLUSIVE, so as to continue the work et al., ALL INCLUSIVE, said respective decedents were conducting, had established et al., ALL INCLUSIVE, among many various other affirmative-to-and-for-me matters, concerns et al., ALL INCLUSIVE. These, ALONG WITH MANY VARIOUS OTHER MATTERS, CONCERNS ET AL., ALL INCLUSIVE, WERE NOT FORTHCOMING, INCLUSIVE, i.e., IT DID NOT OCCUR, ALL INCLUSIVE. Said all-in-one smart cards, i.e., Common Access Cards, were, upon my additionally and correctly acquiring the respective New York State Surrogate Court (Suffolk County)-issued Certificates of Letters of Administration (a/k/a Certificates of Appointment) respectively for said Delois Albert Brassell Estate (Court Index Number 176A2004 (original court certificate number 17268), respective Certificate of Letters of Administration granted on and permanently valid from (i.e., respective date of estate administration appointment on) Friday, March 26, 2004 onward) and said Robert James Brassell Estate (Court Index Number 177A2004 (original court certificate number 17269), respective Certificate of Letters of Administration granted on and permanently valid from (i.e., respective date of estate administration appointment on) Thursday, March 18, 2004 onward), acquiring the respective D-U-N-S Numbers for each said and respective Estate AND FINALLY THE RESPECTIVE AND LONG-OVERDUE CAGE CODES (said Delois Albert Brassell Estates respective CAGE Code actively issued on Tuesday, September 8, 2009 and said Robert James Brassell Estates respective CAGE Code actively issued on Tuesday, September 10, 2010), ALL INCLUSIVE, REQUIRED TO BE TIMELY, OFFICIALLY, CORRECTLY, ON-THE-RECORD ET AL., ALL INCLUSIVE, TURNED OVER TO ME FIRST AND FOREMOST AS THE SOLE EST. ADM. OF THE RESPECTIVE REGISTERED ENTITIES SAID ESTATES, ALL INCLUSIVE. SAID COMMON ACCESS CARDS AND THEIR RESPECTIVE PRIVILEGES ET AL., ALL INCLUSIVE, WERE ILLEGALLY AND WITHOUT ANY OFFICIAL NOTICE-MAILED-TO-ME-AT-MY-OFFICIAL-BUSINESS-MAILING-ADDRESS-AT-THE-UNITED-STATES-POSTAL-SERVICE-JAMES-A.-FARLEY-BUILDING WITHHELD FROM ME WITHOUT ANY CAUSE ET AL., ALL INCLUSIVE, FROM THE HIGHEST LEVELS, ESPECIALLY FROM WITHOUT DOD, CIA, NOAA AND THE REST OF USDOC (i.e., United States Department of Commerce), USCG AND THE REST OF USDHS, ODNI ET AL., ALL INCLUSIVE, resulting in me, among numerous various other actions, INCLUSIVE, manually (via the USPS First-Class Mail) using my authority to purge virtually all independent contractors and subcontractors (including Charles Ellis Schumer (New York State Office of Court Administration currently-registered Attorney Registration Number 1923804 (since 1976) and William Gerard Asher (New York State Office of Court Administration currently-registered Attorney Registration Number 1209329 (since 1966))) associated with and within said respective Estates except for several respective independent contractors and subcontractors. The purge is OVERDUE AND NECESSARY, ALL INCLUSIVE, despite the metaphorical ET AL., ALL INCLUSIVE, foot dragging ET AL., ALL INCLUSIVE, from the President (i.e., POTUS), the rest of the White House Office/EOP, the United States National Security Council (U.S. NSC), the United States Homeland Security Council (U.S. HSC) ET AL., ALL INCLUSIVE. I WANT ALL, ALL INCLUSIVE, MY COMMON ACCESS CARDS NOW, ALL INCLUSIVE. Thank you. On behalf of the Prescription Drug Abuse Medical Task force of San Diego, California we would like to strongly supportthe proposed Docket No. DEA regulation 351 to move Tramadol to a schedule IV medication. Tramadol is currently a loop hole drug which is addictive, abused, and diverted, yet many patient and prescriber do not realize this because it is not a controlled substance. Tramadol cannot currently be tracked in our state Prescription Drug Monitoring Program because it is not a scheduled medication.The morphine equivalents of the typical Tramadol dose of 50 mg contains 10 morphine equivalents compared to Hydrocodone 5mg which contains 5 Morphine equivalents and Oxycodone 5 mg which contain 7.5 morphine equivalents. This regulation is an important step in combating the prescription drug abuse epidemic.Roneet Lev, MD FACEPChair, Prescription Drug Abuse Medical Task ForceSan Diego, California Society might not be as inept as believed to be by those in power. Leave the people alone. Let us decide what we ingest for pain or anxiety.Many of us elderly persons know by nowThat too many doctors turn away From pain treatment even though we Patients have read about our right to pain relief.IGNORE THE STIGMASOMEONE HAS BEEN CRYING AND WRITHING ATHOME, BED-RIDDEN FOR 3 WEEKS... RECLUSE..IN PAIN.. TRULY WISHING FOR DEATH, whenJust a block away, medicine sits guarded by our laws..Nurses and pharmacy assistants laugh us off And the whole of society sits judging without pity Or empathy. Control, control, and kill. Just wait until itHappens to your loved one. Its coming for you, and you areNot fighting hard enough for our liberty.Stop badgering Doctors. They want to help, but dare they?BUT THE DOCTOR SAYS IM FINE FINE? ID BE BETTER OFF DEAD.Its disgusting to witness someone hopeless, in pain  My girlfriend was in horrible pain for along time barely able to get off the couch. She had surgery her stomach muscle was torn from hip bone. Ins paid for half. Now both sides are torn and she has no insurance, being able to take the tramadol does not take all of her pain away but it helps to lead a some what normal life. It brakes my heart to think  of  her going back to that miserable women on the couch. Before the injury she was a work horse even worked side by side with her husband to build their own house. I realize there are addicts that abuse things but they always find some thing to get high on, Robatussin  spray paint cans or whatever sick thing they find. The people that really need it and dont abuse it are the ones that will suffer. There not going to stop selling Robatussen or spray paint are they? I support the proposed Docket No. DEA-351, Schedules of Controlled Substances: Placement of Tramadol into Schedule IV.  As a Certified Pharmacy Technician I see on a daily basis the abuse that Tramadol gets from patients.  It is a controlled substance in Mississippi and the stricter laws have seemed to lessen the abuse.  Since it is a controlled substance in this state, patients are only allowed to get this prescription at the max, two days early and a max of five refills per prescription.   Mississippi is one of the more stricter states when it comes to controlled substances and medications in general.  We are one of two states that has made pseudoephedrine a scheduled drug and we are also a state in which controlled medications cannot be transferred, even within the same state or even to the same chain pharmacy.  Tramadols opioid like actions makes it just as addicting as other opioids.  The known abuse of its pharmacology is a potential harm to patients and society.  Since becoming a controlled substance in Mississippi it has cut down on many issues that comes with dispensing addictive but non-controlled medications.  Instead of just refusing to fill it we can now go back to the state laws and their regulations regarding controlled substances.  This proposed docket would also make the penalties for illegal manufacturing, dispensing, distribution, export, import or any other illegal activity harsher in punishment.  Tramadol is the only non-opiate analgesic that has any effect at all on my pain, caused by trigeminal neuralgia.  My doc will give me hundreds of oxy or hydro-codone, but these have activity only at high doses that most docs are reticent to prescribe.  If tramadol becomes unavailable, Ill be forced to go back to the streets to get effective pain killers.  With opiates, docs refuse to entertain the phenomenon of tolerance, requiring, on occasion, more than is prescribed.  Those of us with severe chronic pain that is refractory to most analgesics are once again, out on our own to find drugs on the street just to get enough pain relief to act like a living person.  This sucks.  This will make thousands of legitimate users out in the cold, again.  Oh well, back to the street corners with pockets full of cash.  Yall should be ashamed of yourselves when pain relief takes a back set to maybe catching a buzz.  Screw all of you. December 30, 2013Michele Leonhart, AdministratorDrug Enforcement Agency (DEA)8701 Morrissette DriveSpringfield, Virginia 22152Attn: DEA Federal Register Representative/ODL RE: Docket No. DEA-351: Opposition to Upscheduling Tramadol Dear Administrator Leonhart: Thank you for the opportunity to provide input in consideration of the Drug Enforcement Administrations (DEA) November 4, 2013 proposal to schedule substance 2-((dimethylamino)methyl)-1-(3-methoxyphenyl) cyclohexanol, its salts, isomers, salts of isomers, and all isomeric configurations of possible forms including tramadol (tramadol) into Schedule IV of the Controlled Substances Act (CSA). The American Society of Consultant Pharmacists (ASCP) appreciates the opportunity to assist DEA with the development of reasonable and practical regulations to impede the abuse and diversion of prescription medications while avoiding access issues for sick and injured patients who legitimately need these drugs for valid pain-related purposes.  Tramadol is a frequently dispensed medication in the long-term care (LTC) setting because it is indicated for moderate to moderately severe pain, including bone and cancer pain.  Making it a controlled substance would serve to limit access to needed pain medications for the frail and elderly patient population. Therefore, ASCP opposes the proposed upscheduling until a workable solution to ensure timely access for patients in LTC facilities can be reached. Prescribers who care for elderly patients in LTC facilities often are not full-time employees of the facility. Because the prescriber may not be on-site, he or she may not be able to examine a patient in-person as soon as the need for controlled pain medications arises.  This problem is exacerbated because controlled substances require an actual prescription from the prescriber. In the LTC setting, when a patient needs a new, non-controlled substance prescription a nurse can call-in or fax a chart order containing the prescribers recommendation for the needed drug directly to the pharmacy. This is a quick and seamless process for patients in nursing homes and other LTC facilities. However, this procedure is not possible when dealing with controlled substances. In LTC facilities, the prescriber must call, hand deliver, or fax the prescription. This involves LTC employees tracking down the non-employee prescriber no matter the day or time.This practice can severely impede the delivery of prescription medications to elderly patients in LTCs. For example, if a patient is discharged from a hospital on a Friday evening and requires unanticipated intensive pain management upon admission to the nursing home, that patients prescriber must be located and must write or call-in a controlled substance prescription. The patient may endure prolonged periods of pain and discomfort because LTC personnel must locate the off-site prescriber, a task that could take an extended period of time. In considering this hardship for patients, it cannot be forgotten that most patients who use tramadol do so legally. Further, this medication is a common component to many patients pain management regimens and overall health.  Access barriers create serious medical difficulties, and any program to prevent drug abuse should be narrowly tailored to protect legitimate users.  Accordingly, there are more appropriate options for handling prescription drug abuse that will avoid these access issues, like electronic prescription drug monitoring programs (PDMPs). PDMPs maintain statewide electronic databanks of prescriptions for controlled substance and facilitate the identification, tracking and investigation of potential abuse. The government should focus resources on practical programs, like PDMPs, instead of harmful and taxing regulations that will only serve to create barriers for those who legitimately need these medications for pain management. ASCP believes a more comprehensive and long-lasting solution is needed to ensure that patients have swift, responsible access to medically necessary pain medications. We would value the opportunity to work with DEA on finding a solution to the issue of the prescriber-agent status in long-term care facilities. Wed like to offer our assistance, experience, and knowledge in crafting an enduring resolution for this problem.  The American Society of Consultant Pharmacists shares DEAs concerns regarding the abuse of tramadol and other pain medication; however, upscheduling this drug will not adequately address this problem and will create serious obstacles for patients. ASCP members are committed to working with you and other stakeholders to develop viable preventative measures to discourage abuse and diversion and to ensure public safety. Sincerely,Bryan J. SoukupBryan J. Soukup, Esq. - Manager of Government AffairsAmerican Society of Consultant Pharmacists  My 25-year old daughter has Lupus and Fibromyalgia. Doctors started giving her Tramadol and kept increasing the dose. My daughter became addicted, as did her husband, and they have lost their jobs, their home, all of their belongings, and custody of their 4 1/2 year old daughter. Theyve stolen from family and friends,  went doctor and hospital shopping to get this pill, and even pretended to be me at a hospital so that she could be written more. Ive seen people addicted to Meth, and Heroin, and theyve done the EXACT same things to get their drugs. My daughter recently decided to attempt to take her own life.....all while on Tramadol. I HATE THIS DRUG. It shouldve been controlled long ago. Ive done my research: people have died on it...and continue to do so. Ive prayed this drug would be made to be a controlled substance. PLEASE DO BEFORE ANYONE ELSE DIES. THIS PILL HAS DESTROYED OUR FAMILY.