Drug Safety and Risk Management Advisory Committee; Notice of Meeting
oc oc2012142 drug safety management October 29-30, 2012 hydrocodone analgesics antitussive
2013-02-12 2013-02-01 2013-02-01 2013-02-01 2013-02-01 2013-02-06 2013-02-06 2013-02-06 2013-02-06 2013-02-06
FDA-2012-N-0548-0445 FDA-2012-N-0548-0129 FDA-2012-N-0548-0131 FDA-2012-N-0548-0135 FDA-2012-N-0548-0144 FDA-2012-N-0548-0197 FDA-2012-N-0548-0206 FDA-2012-N-0548-0209 FDA-2012-N-0548-0211 FDA-2012-N-0548-0212
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https://api.regulations.gov/v4/comments/FDA-2012-N-0548-0445 https://api.regulations.gov/v4/comments/FDA-2012-N-0548-0129 https://api.regulations.gov/v4/comments/FDA-2012-N-0548-0131 https://api.regulations.gov/v4/comments/FDA-2012-N-0548-0135 https://api.regulations.gov/v4/comments/FDA-2012-N-0548-0144 https://api.regulations.gov/v4/comments/FDA-2012-N-0548-0197 https://api.regulations.gov/v4/comments/FDA-2012-N-0548-0206 https://api.regulations.gov/v4/comments/FDA-2012-N-0548-0209 https://api.regulations.gov/v4/comments/FDA-2012-N-0548-0211 https://api.regulations.gov/v4/comments/FDA-2012-N-0548-0212
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I am opposed to moving Hydrocodone substances to a Schedule 2 status.  This will impact the patients access to this medication in a timely fashion for proper pain contro as more restrictions to get proper prescription in hand of pharmacist from physician will take place.  Going about this in a different light by giving further education of physicians, better and further use of PDMPs and access, better controls and abilities for proper disposal of product with help and input of pharmacy all lend to better solutions to hinder the abuse issues surrounding the medication.  Tighter restrictions lend to higher abuse as noted by just looking at what has taken place with Oxycodone.I oppose the move to Schedule 2 status.  Believe their are better resolutions and solutions.Thank you Dear Dr. Throckmorton: I am a community pharmacist and would like to present my views on the implications for pharmacies and impact on patients surrounding the rescheduling of hydrocodone containing products. While pharmacists share concerns regarding the abuse, misuse and diversion of these prescription drugs, these concerns must be balanced with the impact on patients who legitimately need access to them. Rather than reschedule hydrocodone containing products, it is important for you to consider the following:  States Can Reschedule Controlled Substances: Under Federal law, states can act on their own to place tougher restrictions on the prescribing and dispensing of controlled substances. As a result, any state may classify these products as Schedule II without a change in Federal law, based upon the public health needs and experience of their citizens.  Products Will Be Harder to Obtain to Treat Pain: Hydrocodone in combination is one of the last non-Schedule II drugs available to treat moderate to severe pain. If these products are reclassified into Schedule II, prescribers will no longer be able to phone in prescriptions to pharmacies for their patients. Schedule II drugs can only be filled after a pharmacy receives a hard copy prescription signed by the prescriber except in an emergency. The process of calling in an emergency supply of a Schedule II medication does not allow for timely and continued access to needed medications. In most instances there is a significant lag time that will often pass before the physician can be reached to provide the required written order. This means delays in properly caring for the patients needs.  Rescheduling Would Likely Increase the Value of Illicit Hydrocodone Products and This May Lead to Increased Crimes in Pharmacies: As you are aware, the issue of pharmacy crime is very serious and unfortunately on the rise. I have serious concerns that pharmacies may become even larger targets than we  Regarding the change of hydrocodone to a class II drug: I believe we are chasing our tails in trying to regulate abuse out of out system. It cleary has not worked in the past and will not work in the future. However,  Oxycontin tablets were reformulated several years ago so that the tablets could not be crushed. This change in the tablet reduced the abuse potential of Oxycontin by 99%. My suggestion is to work in conjuction with manufactures to develope doseage forms that CAN NOT be abused.... ie smart tablets that check levels of medication and will not release any more medication after a certain level is reached. I know that this is a complicated issue but so were transdermal patches and insulin pumps 30 years ago...Lets get to work!Mike Cionci Re-scheduling Oxycodone will only make it more difficult for patients in need.  More dollars should be allocated to the DEA to enforce laws and regulations already in place.  Physicians (where the Rx starts) must be better educated and overseen as their writing habits are already accessible to the DEA.  Heavy writers of narcotics should be visited and educated. Placing the burden on wholesalers and distributors is not working because there are no guidelines and these wholesalers and distributors are being asked to come up with formulas that are skewed and not working. A persons health and needs cannot be placed in a formula.  A Pharmacist is not a detective - They are already working behind bullet proof glass or have an armed guard ($$$) on hand in their facility.Set up sensible and understandable rules and guidelines.  When I have talked to the local DEA office, they admitted they do not have the personnel, nor do they have guidelines.  They are just an enforcement arm, again without any rules or guidelines.  Its a big problem - Handle it properly, not making healthcare more difficult. February 1, 2013Douglas C. Throckmorton, M.D.Deputy Director for Regulatory ProgramsCenter for Drug Evaluation and ResearchFood and Drug Administration10903 New Hampshire Ave., Bldg. 31, rm. 2417Silver Spring, MD 20993-0002Dear Dr. Throckmorton:I am a community pharmacist and would like to present my views on the implications for pharmacies and impact on patients surrounding the rescheduling of hydrocodone containing products.While pharmacists share concerns regarding the abuse, misuse and diversion of these prescription drugs, these concerns must be balanced with the impact on patients who legitimately need access to them.Please consider: States Can Reschedule Controlled Substances: Under Federal law, states can act on theirown to place tougher restrictions on the prescribing and dispensing of controlled substances based upon the public health needs and experience of their citizens. Products Will Be Harder to Obtain to Treat Pain: Hydrocodone in combination is one of the last non-Schedule II drugs available to treat moderate to severe pain. If these products are reclassified into Schedule II, prescribers will no longer be able to phone in prescriptions to pharmacies for their patients. Schedule II drugs can only be filled after a pharmacy receives a hard copy prescription signed by the prescriber except in an emergency. The process of calling in an emergency supply of a Schedule II medication does not allow for timely and continued access to needed medications. This means delays in properly caring for the patients needs. Rescheduling Would Likely Increase the Value of Illicit Hydrocodone Products and this May lead to increased crimes in Pharmacies. I understand the concerns about diversion and abuse of these products and I share these concerns. Nevertheless, moving all of these hydrocodone products to Schedule II will result in significant barriers for patients who have a legitimate need for these products. Sincerely, Maureen Gallagher, RPh. Dear Dr. Throckmorton: I am a community pharmacist and would like to present my views on the implications for pharmacies and impact on patients surrounding the rescheduling of hydrocodone containing products. While pharmacists share concerns regarding the abuse, misuse and diversion of these prescription drugs, these concerns must be balanced with the impact on patients who legitimately need access to them. Rather than reschedule hydrocodone containing products, it is important for you to consider the following:  States Can Reschedule Controlled Substances: Under Federal law, states can act on their own to place tougher restrictions on the prescribing and dispensing of controlled substances. As a result, any state may classify these products as Schedule II without a change in Federal law, based upon the public health needs and experience of their citizens.  Products Will Be Harder to Obtain to Treat Pain: Hydrocodone in combination is one of the last non-Schedule II drugs available to treat moderate to severe pain. If these products are reclassified into Schedule II, prescribers will no longer be able to phone in prescriptions to pharmacies for their patients. Schedule II drugs can only be filled after a pharmacy receives a hard copy prescription signed by the prescriber except in an emergency. The process of calling in an emergency supply of a Schedule II medication does not allow for timely and continued access to needed medications. In most instances there is a significant lag time that will often pass before the physician can be reached to provide the required written order. This means delays in properly caring for the patients needs.  Rescheduling Would Likely Increase the Value of Illicit Hydrocodone Products and This May Lead to Increased Crimes in Pharmacies: As you are aware, the issue of pharmacy crime is very serious and unfortunately on the rise. I have serious concerns that pharmacies may become even larger targets than we  I would like for you to consider the implications of CII scheduling of hydrocodone products for all cancer and home hospice patients. We are in a very rural area with a high percentage of elderly patients. Unfortunately some of these will develop cancer, it is always easier on them to be treated at home, but if the Dr. from their oncology clinic (who is usually in a distant and larger town) cannot call these medicines in, then the patient either does without or has to travel 100 miles just to get a presciption. This just isnt feasible for most families and usually leads to  putting the patient in the hospital or nursing home (a much more expensive alternative). Thank you for your consideration. Ronny Hefner, P.D., SH Pharmacy, McCrory, AR 72101 The moving Hydrocodone products to Schedule C-II will deny many pts with acute as well as chronic pain access to this medication.. especially outside of normal docs office hours..  which will either increase the work load on ERs, increase medical expenses, or cause the acute pain pt to remain in pain or the chronic pain pt to be thrown into withdrawal.Who is going to accept responsibility for adding these unnecessary cost to a system that is already out of control.. or allowing pts to be left in pain/withdrawal... which is a form of torture. Maybe our country only finds it unacceptable to torture terrorists who wants to kill us., but not those in our society.Schedule C-II has not worked all that well to prevent diversion of Oxycodone, Opana and other C-II drugs.. Who believes that putting Hydrocodone in that schedule will alter much diversion? My name is Joshua Favre, and I am a student pharmacist in Mississippi. I have worked in the pharmacy for a little over 5 years now. I do not believe drugs containing hydrocodone should be moved to a class II. I understand the need to control the distribution of the medication, but I do not think this is the way to go about it. Hydrocodone products are given to patients whom just come out of the dentist, the hospital, or for chronic pain. It would be much simpler for the dentist or doctor to be able to call in the prescription for these patients. The chronic users would then have a limited prescription for monthly periods. I have had many elderly patients who come in once every three months to get their three month supply because it ails them to get around on a day to day basis. If the drug was moved to a Class II, I believe the problem would still persist just as it is.  January 30, 2013Douglas C. Throckmorton, M.D.Deputy Director for Regulatory ProgramsRe: FDA-2012-N-0548; Drug Safety and Risk Management Advisory Committee; Notice ofMeeting; Community pharmacy perspective regarding the public health benefits and risks ofdrugs containing hydrocodone either combined with other analgesics or as an antitussive.Dear Dr. Throckmorton:I am a community pharmacist and would like to present my views on the implications forpharmacies and impact on patients surrounding the rescheduling of hydrocodone containingproducts. While pharmacists share concerns regarding the abuse, misuse and diversion of theseprescription drugs, these concerns must be balanced with the impact on patients wholegitimately need access to them.Rather than reschedule hydrocodone containing products, it is important for you to consider the following:States Can Reschedule Controlled Substances: Under Federal law, states can act on theirown to place tougher restrictions on the prescribing and dispensing of controlled substances.As a result, any state may classify these products as Schedule II without a change in Federal law, based upon the public health needs and experience of their citizens. I prectice in the state of Florida which has had the ledgon drug carisoprodol in a higher classification for many years. Products Will Be Harder to Obtain to Treat Pain: Hydrocodone in combination is one of the last non-Schedule II drugs available to treat moderate to severe pain. If these products are reclassified into Schedule II, prescribers will no longer be able to phone inprescriptions to pharmacies for their patients. Schedule II drugs can only be filled after apharmacy receives a hard copy prescription signed by the prescriber except in an emergency. Rescheduling Would Likely I ncrease the V alue of I llicit Hydrocodone Products and This May Lead to Increased Crimes in Pharmacies: As you are aware, the issue of pharmacy crime is very serious and unfortunate.