Schedules of Controlled Substances:  Rescheduling of Hydrocodone Combination Products from Schedule III to Schedule II
2014-03-13 2014-02-28 2014-03-04 2014-03-04 2014-03-04 2014-02-28 2014-03-04 2014-03-04 2014-03-04 2014-03-05
DEA-2014-0005-0102 DEA-2014-0005-0019 DEA-2014-0005-0043 DEA-2014-0005-0039 DEA-2014-0005-0038 DEA-2014-0005-0018 DEA-2014-0005-0022 DEA-2014-0005-0033 DEA-2014-0005-0028 DEA-2014-0005-0047
04:00:00 05:00:00 05:00:00 05:00:00 05:00:00 05:00:00 05:00:00 05:00:00 05:00:00 05:00:00
https://api.regulations.gov/v4/comments/DEA-2014-0005-0102 https://api.regulations.gov/v4/comments/DEA-2014-0005-0019 https://api.regulations.gov/v4/comments/DEA-2014-0005-0043 https://api.regulations.gov/v4/comments/DEA-2014-0005-0039 https://api.regulations.gov/v4/comments/DEA-2014-0005-0038 https://api.regulations.gov/v4/comments/DEA-2014-0005-0018 https://api.regulations.gov/v4/comments/DEA-2014-0005-0022 https://api.regulations.gov/v4/comments/DEA-2014-0005-0033 https://api.regulations.gov/v4/comments/DEA-2014-0005-0028 https://api.regulations.gov/v4/comments/DEA-2014-0005-0047
William Anonymous Jennifer Anonymous Mary Anonymous Deborah Anonymous Michael Doug
Strinden md Anonymous Williams Anonymous Gurney Anonymous Anonymous Anonymous Elston Wells
The proposed rescheduling of hydrocodone will place a large time-consuming burden on physicians and will result in a larger number of pills available for diversion.   I am a  Plastic,Reconstructive,  Hand surgeon in Lufkin, a small city in rural Deep East Texas.   I am very  busy, working at least 70 hours each week.   Burns and hand  arm surgery particularly, with crush injuries from the heavy steel manufacturing and logging industry, are associated with signficant pain.   It is my general policy to initially prescribe a small number of pain pills (30) following surgery.   It is also my belief that one doesnt get any extra points for suffering, so if a patient has pain then I certainly wish to alleviate his suffering. I am presently president of the medical staff at Woodland Heights Hospital,  recent president of the County Medical Society, former president of the medical staff at Memorial Medical Center, and I sit on the bylaws committees of both hospitals.  I have been a delegate to the Texas Medical Association twenty times in my 25 year career in this same location.  That is mentioned only to emphasize that I am not a crack-pot, I am a well respected member of the medical community.    If a patient requires a refill, I can currently pick up the phone and speak to the pharmacists I know by name and quickly provide a refill.   If hydrocodone is made schedule II, then I must instead write a prescription, make it accessible to the patient to pick up and carry to the pharmacist, or I must carry it to the pharmacy and drop it off.   Forty percent of my patients live farther away from Lufkin than forty miles.   Given the increased difficulty for me to refill the prescriptions I promise you that I will make my initial prescription in all cases at least 60 tablets.   Not all of them need a re-fill, I assure you of that;   but,  a significant number do, and it would be such a hassle trying to get patients from Jasper, Newton, Onalaska, Cleveland, Shepherd, Livingston, Crockett, Grapeland, etc their prescription refills, therefore  I promise you I will provide larger numbers up front.   Unused pills sitting around are likely to be diverted.   Please do not make my life more complicated, my patients truly in pain suffer more, and especially do not create your unintended consequence of MORE pills being diverted.   Houston is not the same as Lufkin, and Washington DC is not the same as Williston, North Dakota.   Please, while sitting in your ivory tower in Washington, DC,  try to imagine how it is in rural areas of East and West Texas, Wyoming, or Western North Dakota.    Enclosed is a photo of a map in my office.  I have had at least one patient come from each dot on the map.  Some of them have come for elective surgery, many in East Texas and Louisiana because they were injured.  How in the world do you expect me to get their schedule II scripts to them at 8:00 pm at night?    On first thought, I support changing to schedule 11 as hydrocodone by itself is schedule 11.  However does this also apply to the cough syrups that have a small quantity of hydrocodone?  Just which combinations would be involved? Re:  Docket No. DEA-389I am asking you to reconsider making hydrocodone a CII drug.  I have arthritis in my cervical spine and this medication offers some relief from the terrible pain.  I have been taking this drug for 2 years and dont believe that I am a public or personal threat to myself or to others.  I am prescribed 90 tables per month, but typically dont take them all.  I take them only as needed.  I feel that me and other patients like myself who are not abusing hydrocodone and are taking it as prescribed, are being singled out and punished just because others are abusing this drug.  People will abuse any drug, if they are so inclined.  If you make this drug a CII, I will have to get a new prescription each time, meaning that I will have to see my doctor each time and pay for an office visit each time.  I am have very limited income and a high insurance deductible, so this will very difficult for me to do.  Please, consider the patients that truly need this drug and who are not abusing or diverting it to others before making this decision that will impact my medical bills.  Thank you.  I believe that hydrocodone products should be moved to C2 medications because too many people are abusing it because it is more available ,also it has big potential for abuse As a community pharmacist for 16 years and now a faculty member in a college of pharmacy teaching pharmacy law, I see several unintended consequences of moving hydrocodone combination products from CIII to CII status.  These include the following: 1.  Drug of choice prescribed will change from hydrocodone combination products to some other CIII medications like codeine codeine combination products, Suboxone and Subutex (which have off-label uses for pain) and other CIII pain medications. This really isnt solving the abuse problem -- it is just shifting the problem to another drug. 2.  This change will put increased hurdles on patients and pharmacists for those with legitimate pain and have a legitimate reason for using the medication. 3.  There are already drug shortages for other CII medications because of stop orders that wholesalers are putting on community pharmacies that are impeding those pharmacies and pharmacists abilities to take care of patients with legitimate needs.  Moving hydrocodone combination products to CII status will make this situation worse if there is no corresponding changes to this process.  4.  We are already seeing an increase in heroin and other CI substance abuse as a result of the decreased availability of oxycontin and other oxycodone containing products.  Not sure which is the lesser of the two evils.  I realize that the DEA is an enforcement agency -- I would like to know when the legitimate patient was lost in the big picture.  Instead of having health care providers and pharmacists taking care of patients as our primary roles, it seems that the DEA would rather health care providers and pharmacists have our primary role be the drug police.  That is not what I went to pharmacy school for nor do I believe this is what most health care providers went to school for. In conclusion, I realize why the DEA and FDA think that rescheduling hydrocodone combination products is a good idea.  I believe the unintended consequences of the move would actually make the situation worse.  Therefore, I respectfully ask that the DEA not reschedule hydrocodone combination products to CII.  Sincerely,Mary Gurney I am a nurse practitioner in a state that does NOT allow us to write class II narcotics.  For many patients we are their only healthcare provider.  This change will severely affect our patients ability to obtain their pain medications.  Our practice is in a very rural area where the nearest pain management provider is approximately 1 hour away making it unobtainable for many patients.    Many patients cannot make the drive due to cost of gas, cars in poor shape, or lack of family support to take them.  We also have a problem with the pain management providers not accepting all insurances, especially the Medicaid patients. I do not want to see this rule changed.  It will impact the poor, underserved patients the most. My name is Deborah. I am 42 years old and live in Alabama. I have a lower spinal birth defect, DDD, spinal stenosis  other painful health issues. For the past 6 years I have been under the care of a neurologist. In order to function I rely on Norco 10/325s, 2 pills per dose, 4 doses per day. I have been on this amount for 3 years  have worked hard to not increase this dosage.  I am uninsured.  Alabama is a state that refused the medicaid expansion funding allowed via the new National Healthcare Law. What this means to me is that I am in the gap, not enough income to buy a health plan but too much income to qualify for help through my state. I had a hearing to determine if I will be allowed my SSDI benefits 12/18/13 and am still waiting for the decision, If approved there will still be a large gap between approval  when Medicare will cover my medical expenses. I woke this morning to find that the rescheduling of my pain medicine is one step closer to becoming a reality. The impact this will have in my life is enormous so I am writing to give you a glimpse into how this will affect my family.  My doctor of 6 years, due to a sanction placed by the state medical board cannot currently write any prescriptions stronger than a schedule lll. At this point I see my doctor 4x a year for appointments. Beginning last December the visits were reduced to $100 but until that point I had paid $175/visit for 3 years and then $250/visit from that point until the recent reduction. The $250 price range is the norm for visits to comparable doctors in my area. I have also done disc decompression that I raised 3/4 of the funding for via a fundraiser. I am making payments on the balance  will be for quite some time. I also pay out of pocket for all of my medications at the cost of $200/month. If this rescheduling goes into effect I will either have to stop treatments completely or switch my care to a new doctor  pay even more for my care. New patient doctor visits cost about $300  follow up visits are in the $200-250 range. I am aware that the cost involved with obtaining a new prescription each month could run $75 for a urine screen or pick up fee to full visit cost every month. There is no way I can possibly absorb these costs  it may not even be an option to continue my care. When I first heard of these potential new regulations I made a few calls to doctors in my area and each time I mentioned that I am uninsured  require narcotics to maintain my quality of life the roadblock came up. Doctors do not want to take on an uninsured patient, apparently we are a risk whether it be fear of our diverting our medications or the potential that we may need therapy or care that we are unable to afford. I beg of you to consider the impact this rescheduling will have on myself  my family. Being unable to work I rely on family to help with these expenses and it has created a circle where they break their backs only to keep us barely above water. My children will have to watch mom suffer in agonizing pain. Now I am able to walk for short distances  leave the wheelchair for times that the walking is just more than my back  hips can tolerate. As a chronic pain patient I am very aware that some misuse this type of medication. Narcotics were not my first choice nor one I wanted but the only other medication that somewhat helped is a medication called Ultram. I tried it but it made me drunken, loopy  unable to function, I fell several times while taking it. I am at risk for having seizures if I ever take it again. I take my medication as directed  humbly give urine screens  pill counts when asked, I keep my medication under lock  key  dont even let people know I am on this medicine for fear of my safety if those who are addicted find out I am prescribed this. I cant even rally the troops so to speak via social media to encourage others to speak out for fear of those addicted knowing I have access to this narcotic  additionally, my pain contract forbids my sharing that I take this medication. It may be hard to imagine having no health insurance, if you are reading this letter you probably have it; but please try to imagine how drastically this will impact my life if it does go into effect. PLEASE, I beg of you, dont take my quality of life away. I have so much to offer to my family and children and society but I cant if I am in such pain that I cant function. My pain without intervention is so bad that I am unable to even think coherently  become severely depressed. I have cried buckets wondering how I can help myself maintain what little quality of life I have. PLEASE dont punish me and my family for actions of those who acquire these drugs illicitly  harm themselves. Ive done everything required to show I do not misuse/divert my medicine. Abusers dont care about the law  will just find another substance to abuse. I have my pride, I have never begged for anything but I BEG you. If not for me, please, for my children. I think this is a great idea.  I work with addicted adults and teenagers, and think this move will help put these drugs more out of their reach.  You will always get people who are addicted to any opioids, but the harder you make it to get them, the better. As a practicing physician, pain medications are a powerful (yet potentially dangerous) tool to assist my patients. Unfortunately those choosing to divert medications to unintended uses dilute my ability to provide safe and effective treatment to patients.I am IN FAVOR of moving hydrocodone-containing medications into Schedule II drug category to: 1) allow me to continue providing safe and effective therapy where appropriate; 2) improve surveillance on appropriate prescribing, dispensing, and utilization of these medications; 3) improve law enforcement and judiciary support to licensed prescribing physicians; 4) providing law enforcement and judiciary with enhanced mechanisms to stiffle illegal prescribing, use, and diversion of hydrocodone-containing substances.Hydrocodone medications have been Schedule III drugs and despite that level of oversight, drug diversion has demonstrably and consistently increased. Drug diversion is a HUGE public safety issue and the Federal Government is tasked with provision of measures to protect US citizens; albeit sometimes from their own misadventures.In dispatching its Public Safety mandate, the US DEA must move hydrocodone into Schedule II. As a practicing community Pharmacist for 35 years, I cannot express strongly enough the negative impacts of this proposal upon the delivery of pain controlling medication to the public.Doctors will no longer be able to quickly and efficiently call in or fax in prescriptions or refills for the mostly widely used pain medications.I practice in a rural area.  Patients often have difficulty in physically picking up handwritten Schedule-II prescriptions from their physicians.Also bear in mind that the main alternative will become Tylenol with Codeine, the age-old standard.  However, researchers tell us that approximately 30% of the population are unable to efficiently convert the inactive drug Codeine into its active metabolite Hydrocodone, in the body.  This explains why many people tell us that Codeine doesnt work for me.Although this proposal may seem warranted to stem the tide of Hydrocodone abuse, it is far too drastic.  Such a draconian measure would be akin to restricting tire sales in order to decrease automobile traffic deaths.  It makes no sense.Please err on the side of practicality and necessity.  People need fast access to powerful pain medication when necessary.  Not red tape.  Consider that your own families will most certainly be affected by this.Regards,-Doug Wells, Registered Pharmacist