Disposal of Controlled Substances
Disposal
2013-02-28 2013-01-31 2013-02-04 2013-02-15 2013-02-20 2013-02-27 2013-02-27 2013-01-08 2013-02-20 2013-02-20
DEA-2012-0008-0137 DEA-2012-0008-0024 DEA-2012-0008-0030 DEA-2012-0008-0060 DEA-2012-0008-0067 DEA-2012-0008-0095 DEA-2012-0008-0098 DEA-2012-0008-0005 DEA-2012-0008-0068 DEA-2012-0008-0073
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 05:00:00
https://api.regulations.gov/v4/comments/DEA-2012-0008-0137 https://api.regulations.gov/v4/comments/DEA-2012-0008-0024 https://api.regulations.gov/v4/comments/DEA-2012-0008-0030 https://api.regulations.gov/v4/comments/DEA-2012-0008-0060 https://api.regulations.gov/v4/comments/DEA-2012-0008-0067 https://api.regulations.gov/v4/comments/DEA-2012-0008-0095 https://api.regulations.gov/v4/comments/DEA-2012-0008-0098 https://api.regulations.gov/v4/comments/DEA-2012-0008-0005 https://api.regulations.gov/v4/comments/DEA-2012-0008-0068 https://api.regulations.gov/v4/comments/DEA-2012-0008-0073
Chris Elizabeth Stephanie Mary Rodney William Errin R Steven Scott
Ramos Thrush Mcgrath Reissman Larson Worrell Henggeler P Brachman Wheeldon
Drug Enforcement Agency:Since 2007, the Rock County Health Department in Wisconsin, in collaboration with many, many community partners, has collected 13,279 pounds of unwanted prescription and nonprescription medication through our drug collection program. This is 13,279 pounds of drugs that have been kept out of our groundwater and out of the hands of our children. We are proud of the collaboration that has successfully and safely collected and disposed of such a large amount of medication.  If these new regulations are put in place, it will very likely result in the end of this successful program due to the additional costs and logistical challenges.  In Rock County, law enforcement retains the controlled substances and the Health Department stores non-controlled substances in a secure facility. Local pharmacists separate the controlled medications from the non-controlled medications, but this will not be allowed under the new regulations.  Last year, the Health Department stored approximately 3600 pounds of non-controlled medications.  Some law enforcement offices do not have the capacity to store this quantity of medications.  The medication that is going to be destroyed is removed from the packaging; the medication is stored in containers and the packaging is discarded. Requiring medications to be stored in the packaging, in which it was received, will result in 7 to 10 times the number of containers needed to be destroyed. This is going to add a significant cost for disposal.Our local law enforcement agencies are already stretched due to budget cuts and placing this additional cost and responsibility on them will mostly like end our successful drug collection program.  Please reconsider these changes so we can continue to get these medications out of our community. I own an independent pharmacy and it never made sense to me that we were trusted to dispense controlled medications to patients but not dispose of them if needed.  Prescription drug abuse is a huge problem and I hope this helps! It is unfair to restrict medications to cancer patients only.  Myalgic Encephalomyelitis (ME) is an extremely painful condition which has been rated to have more serious and more severe pain than that suffered by a cancer patient.  ME also can result in death.  Currently the condition is known in the states as fibromyalgia/CFS.Please do not restrict pain medication to those only with cancer when there are far worse conditions.  I beg you.  I have been disabled with this condition for years and it is not painful when undergoing treatment, but always painful, 24x7x365xLIFE.If you start restricting one medication, others will also follow suit and it will not be possible for many to tolerate their conditions.  Assisted physician suicide is not an option to patients that believe in God. Hospitals have many challenges in todays changing healthcare environment.  Disposing of waste should not be one of them.The DEA should be providing guidance and support with controlled substance disposal.  We need to have guidlines.  The DEA tells us that flushing a controlled substance, putting it into kitty liter, and putting it into hazardous waste containers for haulers to remove is not making the CS non-retrievable, therefore is unacceptable disposal.  Since all of those are not correct the DEA should be providing us an answer.I think we can agree that hospitals want to do the right thing.  They do not want to see controlled substances leave a negative effect on our environment and certainly do not want to see them abused.  Its time that our government agencies (DEA, EPA) work together and provide us with the tools we need to get a very important job accomplished. I am the Founding Dean of the School of Pharmacy at Husson University.  I am writing this letter in strong opposition to one of the stipulations of the proposed rule:the substances contained in the inner liners and mail-back packages may not be individually handled, counted, inventoried, or otherwise discerned.For the past few years I have been volunteering to assist the University of Maines Center on Aging in their Safe Medicine Disposal for ME Program.  The data collected in this mail back program was one of a kind, since it was the only mail back program that could legally accept controlled substances.  Much important information was gathered through the project.  Knowing which medications are being wasted allows for targeted educational programs to medication prescribers and/or patients.  It also helps payers get a handle on the huge amount of waste in the system and may incentivize them to implement programs to help reduce it.  By preventing the cataloging of what is being collected throughout the country is a tremendous waste of extremely valuable information resources regarding our societys medication-taking behavior.  Patient non-adherence to prescribers direction is a significant health care problem that costs our society billions.  Besides the cost of the unused medication, other related expenditures include the extra health care costs for treating patients who become sicker from a lack of appropriate therapy, subsequent lost days of work, and the loss of other contributions to society.  More importantly there is much pain, suffering and early deaths that could be prevented.   The information gathered in take-back programs could help greatly in alleviating this problem.I urge the DEA to reconsider this portion of the rule.  A very simple solution to the DEAs concern for security is to have any cataloging or counting be conducted under the supervision of law enforcement agents. Thank you for the opportunity to comment on Docket No. DEA - 316.   The proposed rules are a common sense solution to the management of unwanted drugs.  It is critical that these drugs are diverted from disposal in landfills and wastewater treatment plants. The following suggestions would lower the cost to manage this waste while at the same time provide the necessary level of security when dealing with controlled substances.  1. There are requirements for 2 authorized employees to witness the removal of the inner liner ((1317.50).  Some small retail pharmacies may not have 2 employees working at the same time.   It is important to have 2 people witness the removal, but one of the two could be the reverse distributor employee.   The way to insure that there are 2 witnesses is to have a drop box that the user places the drugs into.   The box could have 2 separate locks that would require both the pharmacist and the reverse distriibutor to  be present when the box is unlocked.   2.  There is a requirement that the waste be destroyed within 14 calendar days.  (1317.15)   Currently the San Luis Obispo County Integrated Waste Management Authority, through our hazardous waste contractor, collects sharps from 45 local pharmacies.   The collected sharps are stored at our household hazardous waste facility.  To reduce costs we have our medical waste contractor pick up the sharps from the household hazardous waste facility on a monthly basis.   If we offer a similar service for the collection of drugs, we would also like to hold the drugs for a monthly pickup.    An alternative could be that the waste be destroyed within 30 days or when more than 200 pounds are stored, whichever occurs first.  The City of Fort Collins would like to thank the DEA for publishing these proposed rules for safe medication disposal.  Overall, we are supportive of these rules and understand that DEAs primary concern is preventing illegal diversion of controlled substances.  The proposed regulatory language reads:Controlled substances collected by collectors may not be individually counted or inventoried.  The meaning of this rule is not clear.   The use of the word may leaves it open to interpretation.   If what was meant is, Controlled substances collected by collectors do not have to be individually counted or inventoried. we are very supportive.Suggestion:  Clarify the wording.   I am a PharmD student at the University of Arizona College of Pharmacy. The spirit of this rule would improve the public health of this nation. Throughout my educational career and my internships I have participated in many organized events where patients would bring in a brown bag of old and current medications where as student-pharmacists, we would counsel them on the safe and effective use of their medications. Many times patients brought in old controlled substance prescriptions that they or a recently passed away loved one no longer uses. Patients would frequently ask how to dispose of them because they did not want to flush them down the toliet nor simply throw them away and continued to hold on to them. I feel that retail pharmacies and pharmacists are in the best position to maintain a collection box and organize take back events. The major limitation in the past has been trying to have a law enforcement officer at the time when patients are able to bring in the unused scheduled drugs. Please allow pharmacists and pharmacies in good standing a simple way to be authorized and have autonomy to facilitate taking-back and mailing in the unused controlled substances. Any foreseeable negative is overwhelmingly overcome by the benefit the public health receives by reducing the number of unwanted, unused scheduled drugs from circulation.-RGPpharmacy studentUniversity of Arizona - College of Pharmacy As co-chair of the WI Pharmaceutical Waste working group and manager of the Get the Meds Out mail back program, I would like to offer the following comments:[1317.02(a)] - Allowing only full-time government employees to accept controlled substances at take-back events or mail-back services is too restrictive. Allow civilian law enforcement employees who meet the same requirements as authorized employees of other collectors, such as retail pharmacies, to handle returned materials following the agencies secure protocols. 75785 of FR 77 (246) - Our law enforcement personnel have expressed concern over new logistical challenges and cost increases; allow registered pharmacists to pre-screen controlled substances from non-controlled substances prior to placing the drugs in a collection receptacle under law enforcement oversight at take-back events.75785 of FR 77 (246)- Allowing for only law enforcement agencies or collectors with on-site destruction capabilities to operate mail-back programs will increase costs. Allow all reverse distributors to accept and temporarily store mail-back packages.75785 of FR 77 (246)- states that controlled substances collected by collectors may not be individually counted or inventoried. Allowing for research entities in collaboration with law enforcement to carry out studies to characterize and quantify the medicines returned through take-back programs.75785 of FR 77 (246)- add provision that allows authorized individuals to dispose of an incapacitated ultimate user meds.  [1317.05(a)(2), 1317.05(b)(2), 1317.05(c)(2)(iii) and 1317.05(c)(2)(iv)] - Reference the Department of Transportation or other definition being used.75802 of FR 77(246)- Allow reasonable destruction time that fits with standard practices at reverse distributors and hazardous waste incinerators, and look to those businesses to best comment on this issue.   Allow visual pre-screening for noncompliant items at take-back events and collection receptacles.  To Whom it may concern;The DEA has proposed a rule for the Disposal of Controlled Substances that includes controlled substances held in Long-Term Care Facilities.  The definition of LTCF in the proposed rule combines facilities with extremely different levels of staffing and accountability.   This proposal recommends controlled substances that remain; either after a medication is discontinued or after the resident (ultimate user) has expired, be held in approved disposal receptacles until they can be returned to an authorized registrant for disposal, without regard for a facilitys professional staffing requirements.Whereas Skilled Nursing Facility and Nursing Facility are well defined categories of LTCF with specific professional staffing requirements, but have been included in a group of LTCF, that do not, by regulation, provide full time (24 hour) licensed personnelWhereas SNFs and NFs employ professional, licensed nursing practitioners as defined in 21 CFR U.S. C. section 802, that receive, store  and administer controlled substances for the ultimate user, Whereas controlled substances are never in the possession of the ultimate user, but are received and stored on their behalf as part of an prescribed treatment plan, while residing in a SNF of NF and are not accessible to children, teenagers or the elderly for misuse, abuse or accidental ingestion,Whereas dispensing practices are changing for SNF and NF, to allow for short dispensing cycles that limit the quantities of controlled substances that are received and stored in the facilities,Whereas these controlled substances may remain due to a change in the treatment plan for the ultimate user or through the death of the ultimate user,Whereas SNF and NF are regularly inspected for compliance with federal  and state regulationsTherefore, let it be proposed that SNF and NF licensed, administrative nursing practitioners be designated as authorized agents for the ultimate user in re