Ms. Michele M. Leonhart Administrator Drug Enforcement Administration U.S. Department of Justice 8701 Morrissette Drive Springfield, VA 22152 Re: Notice of proposed rulemaking on Disposal of Controlled Substances, pursuant to Federal Register notice published Dec, 21, 2012, Vol. 77 No. 246, Docket No. DEA-316. Dear Ms. Leonhart: On behalf of our more than 2,000 members, the Association for the Healthcare Environment (AHE), a personal membership group of the American Hospital Association appreciates the opportunity to comment on the Drug Enforcement Administration s (DEA) proposed rule implementing the Secure and Responsible Drug Disposal Act of 2010. AHE is the leader in environmental services education and training related to cleaning and surface disinfection and management of the waste streams generated during the course of medical care. AHE also provides recommended practice training on providing a clean, safe and quality care environment for patients, staff and visitors. We appreciate the time and effort DEA has invested in drafting the proposed regulation that expands available options for the collection of controlled substances from ultimate users for purposes of disposal. We also appreciate DEA s efforts to address the continuing concerns regarding disposal of controlled substances within the health care community. Our letter provides comments on the various health care sectors impacted by the changes in the proposed rule. To that effect, AHE has divided our comments into two sections, mirroring the approach taken by DEA in the proposed rule. The first section offers comments specific to the health care sector that would be impacted by the provisions in the proposed regulation. The second section offers comments and suggestions on the definitions contained in the proposed rule.
Page 2 of 8 IMPACT ON CERTAIN HEALTH CARE SECTORS LONG TERM CARE FACILITIES (LTCF) The Disposal Act authorized the U.S. Attorney General to develop regulations to permit LTCFs to dispose of controlled substances on behalf of ultimate users who reside or have resided at such facilities in a manner that provides effective controls against diversion and is consistent with public health and safety. As such, DEA proposes to allow collection receptacles to be placed at LTCFs for the disposal of controlled substances in accordance with outlined requirements. In the proposed regulation, DEA states that access to the inner liner is restricted to authorized employees of the registered retail pharmacy, and that no employees of the LTCF will have access to or influence over the contents of the collection receptacle. We are concerned about this provision because the collection receptacles may be full between medication delivery times or when the retail pharmacy is closed. We recommend that appropriate LTCF personnel (a nursing director or assistant director) should be able to remove, store and replace the liners when necessary. It also may be appropriate to permit only controlled substances in the collection receptacles. In addition, non-controlled substances should not be transferred to the retail pharmacy for secure storage and subsequently transported for disposal. LTCF personnel should be sorting the noncontrolled substances into the appropriate pharmaceutical waste receptacles for storage and disposal, consistent with current Environmental Protection Agency (EPA) requirements. Currently, only one LTCF employee delivers controlled substances. We recommend actively soliciting comments from LTCFs and organizations representing them to learn more about financial feasibility of using authorized retail pharmacy employees to pick up the liners. Comingling Substances. DEA proposes that LTCFs be permitted to dispose of controlled substances in Schedules II through V on behalf of an ultimate user who resides or has resided at the LTCF and that controlled and non-controlled substances may be comingled in the collection receptacle. Comingling increases costs; receptacles fill more quickly; and non-controlled substances may be classified as hazardous waste by EPA definition. Commingling of controlled and non-controlled substances will be problematic in states that consider senior facilities (LTCF in this instance) to be a business. All waste stream generation in such businesses are subject to EPA s Resource Conservation and Recovery Act (RCRA) hazardous waste regulations. The transfer of any pharmaceutical waste meeting the definition of hazardous would be in violation of RCRA regulations for the LTCF and the waste hauler. Waste separation enables the facility to maintain regulatory compliance within RCRA.
Page 3 of 8 HOSPITALS AND OTHER HEALTH CARE FACILITIES In the proposed rule, DEA states that a controlled substance dispensed for immediate administration pursuant to an order for medication in an institutional setting remains in the possession of that registered institution even if the substance is not fully exhausted. We urge DEA to clarify the status of used fentanyl and testosterone patches. While there will be drug remaining in the used patch, the amount is unknown and variable. Storage of these patches, which are used from DEA s perspective and out of the hospital s inventory, is impractical and could lead to additional diversion. Typically, hospitals dispose of these in the red sharps containers. Hospice facilities and LTCFs share similar challenges. Disposal of Controlled Substances by Registrants. DEA proposes to allow non-practitioners to deliver (i.e., transfer) controlled substances themselves for the purpose of disposal provided that such substances are transported directly to the destruction location and accompanied by two authorized employees. We are concerned because the destruction facility may be located hundreds or thousands of miles from the non-practitioner. Currently, some reverse distributors have received permission from the DEA Special Agent in Charge (SAC) to send the controlled substances via common carrier with witnessed inventories, both upon departure and upon receipt at the destruction facility. The SAC s also have authorized the hiring of off-duty law enforcement officers or other security personnel to witness the receipt, unloading and actual destruction by incineration of the controlled substances. The contracted security personnel then sign Form 41. Due to insurance regulations and operational policy, common carriers (whether a national or local carrier) do not normally allow employees of other companies to ride in their vehicle, and many reverse distributors do not operate their own trucking fleets. Authorized Employees. DEA proposes that an authorized employee is a person directly employed by the registrant full time. We believe this definition is problematic, specifically with respect to pharmacists and nurses, both of whom may be part-time employees. In some pharmacy departments, pharmacy staff may be employees of an outside contractor or consulting firm. With respect to nurses, many are part-time or may be contract labor from a nursing pool. We urge DEA to change the language to encompass both of these situations and define an authorized employee as someone who has been hired or contracted to perform the duties normally performed by a full-time employee of the registrant and who is duly licensed to do so. Record Requirements. DEA proposes that a registrant that destroys controlled substances or causes the destruction of controlled substances is required to maintain a record of the destruction in a form to be issued by DEA. This form will be DEA Form 41. The requirement to use a paper Form 41, especially in hospitals where automated/electronic reporting dispensing machines or automated dispensing cabinets are in use for documentation of controlled substances by two health care professionals as witnesses, is burdensome to clinicians who already have a tremendous amount of paperwork. The standard data captured by the aforementioned equipment includes the patient s name for whom the dose was removed from the machine; the name and strength of the drug; the amount of controlled substance administered; the amount of controlled
Page 4 of 8 substance wasted, ; the means of wasting (device, flushing, or returned to pharmacy for additional management); and the identity of the two health care professionals who witnessed the wasting. Additionally, some equipment can be programmed to provide prompts to the administering nurse/clinician if the wasting process is not completed and can send notifications to nursing supervisors or to the pharmacy department of any unresolved wasting discrepancies. These records are readily available for at least two years and are archived indefinitely. The records are exportable into Microsoft Excel and can also be customized through a report writer function. Returning to a paper Form 41 would not only be burdensome and take away time from bedside care, it may provide decreased functionality with respect to identifying diversion. In a large hospital, it is not unusual for 10,000 doses of controlled substances to be delivered daily, illustrating the difficulties of a manual system. We encourage DEA to seek additional information, and perhaps alternative language from the major manufacturers of automated dispensing machines. Methods of Destruction. DEA proposes a standard of destruction non-retrievable for persons that intend to destroy controlled substances. DEA is not requiring a particular method of destruction, so long as the desired result is achieved. While this statement is well-intentioned, DEA does not specify what it considers to be a non-retrievable substance. For example, do the new and available technologies such as the sequestering of left-over drug in fentanyl patches and/or the new sequestering sink system constitute acceptable methods of rending nonretrievable? Definition of Non-retrievable. DEA states that the proposed definition of non-retrievable means to permanently alter any controlled substance s physical and/or chemical state through irreversible means in order to render that controlled substance unavailable and unusable for all practical purposes. Incineration is not practical in most facilities for small amounts. LTCFs will require a grace period for the retail pharmacy provider market to install collectors. We recommend DEA authorize destruction methods as a means to remove the uncertainty as to what methods are acceptable. This uncertainty also prevents exploration and discovery of solutions that could provide mutual benefit to DEA and health care facilities. To illustrate the need for clarity, once the controlled substances are rendered non-retrievable at the health care facility by methods acceptable to DEA, is it permissible that they be transported and/or shipped as solid waste without additional documentation or monitoring with respect to the Department of Transportation s Motor Carrier Safety Assistance Program requirements? Again, we urge DEA to clarify its response what it considers to be a non-retrievable substance. In the absence of regulatory comment on new technologies, the non-specific language potentially inhibits development of innovative solution sets. In the proposed rule, DEA states that flushing does not render the drugs non-retrievable. While not an environmentally friendly option, from a practical perspective and by DEA definition, said substances could be considered non-retrievable through flushing. In many settings, including LTCFs and in smaller practices including physician, veterinary and dental, flushing may be the only option in the short term in order to maintain compliance with the regulations and to prevent diversion. However, until DEA
Page 5 of 8 renders guidance on additional methods for rendering controlled substances non-retrievable and the market provides cost-effective alternatives, flushing must remain an option. In the meantime, the industry could continue working on options for DEA review. Clarity of Reporting Requirements. DEA also proposes that the authorized registrant report all recalled controlled substance acquisition transactions pursuant to 21 CFR 1304.33. Such registrants may report either each individual receipt or a single transaction that includes all recalled controlled substances of the same name and finished form (e.g., all 10-milligram tablets or all 5-milligram concentration per fluid ounce or milliliter) received from ultimate users. It is unclear if registrants must report to DEA or if reporting to the Food and Drug Administration (FDA) is sufficient. It is our recommendation that single reporting be acceptable due to time consuming and duplicative paperwork. DEA estimates there will be 68,344 respondents (Distributors 828, Reverse Distributors 60, Manufacturers 522, Retail Pharmacies 66,934) to this information collection. The number of respondents (68,344) represents the total number of registrants in business activities that are most likely to destroy controlled substances. DEA does not list hospitals, surgery centers, physician offices, dentists or veterinarians as potential registrants that will routinely dispose of controlled substances and required to use Form 41. The concerns expressed above may apply beyond the hospital setting as automated dispensing machines become more prevalent in alternate care markets. COMMENTS ON DEFINITIONS IN PROPOSED RULE Below we offer comments on definitions contained in the proposed rule as well as language suggestions we would like to be included in future rulemaking. DISPOSALS OF CONTROLLED SUBSTANCES BY REGISTRANTS Registrant disposal. In the proposed rule s section on disposal of controlled substances by registrants, DEA says that in the event that a practitioner is required regularly to dispose of controlled substances, the Special Agent in Charge may authorize the practitioner to dispose of such substances, in accordance with subparagraph (a)(2) of this section, without prior application in each instance, on the condition that the practitioner keep records of such disposal and files periodic reports with the SAC summarizing the disposals. NOTE: Subparagraph (a)(2) Promptly deliver that controlled substance to a reverse distributor s registered location by common or contract carrier or by reverse distributor pick-up at the registrant s registered location. This language does not define practitioner and seems to indicate a blanket authorization to destroy requires the use of reverse distributors. This is not practical for the following reasons. The language limits routine destruction by nurses, pharmacists, dentists, veterinarians, etc. to reverse distributors. Only retail and hospital pharmacies currently use reverse distributors, and then primarily for outdated, unused stock. It is not economically viable for others to do so. In
Page 6 of 8 addition, small amounts of controlled substances, such as those left over in a vial, syringe, or IV bag, are not conducive to collecting, inventorying and shipping. These should be destroyed onsite, either by flushing or by an alternative method as described by DEA. If the restriction to using reverse distributors was not the intent of the regulations, the language should be modified to remove any ambiguity. DISPOSAL OF CONTROLLED SUBSTANCES BY ULTIMATE USERS AND OTHER NON- REGISTRANTS Authorization to Collect from Non-registrants. DEA says the following non-registrant persons in lawful possession of a controlled substance in Schedules II, III, IV or V may transfer that substance to the authorized persons listed in paragraph (a) of this section, and in a manner authorized by this part, for the purpose of disposal: (2) Any person lawfully entitled to dispose of a decedent s property if that decent was an ultimate user that died while in lawful possession of a controlled substance. We believe this definition should be expanded to include any parent or guardian of a minor in lawful possession of a controlled substance, and any person lawfully entitled to dispose of property for a person incapacitated and unable to dispose of their lawfully obtained controlled substance. Registrants Authorized to Collect and Authorized Collection Activities. DEA states authorized collectors may receive mail-back packages at a registered location that has an on-site method of destruction. This requirement would restrict the mail-back option to the few reverse distributors that have incinerators. Given the amount of recordkeeping required of reverse distributors, we see no reason why reverse distributors should not be able to participate in mail-back programs, just as they participate in recall and return efforts. Collector Inventory, Recordkeeping, Reporting and Order Form Requirements. DEA says for registrants authorized to collect through a mail-back program, the record shall include the following: (ii) For those unused packages provided to a third party to make available to ultimate users and other authorized non-registrants the name of the third party and physical address of the location receiving the unused packages, date sent, and the number of unused packages sent with the corresponding unique identification numbers. We are unclear if the numbers on the packages need to be reconciled with the initial inventory and if there is a time limit on the viability of the packaging. Registered Reverse Distributor and Distributor Acquisition of Controlled Substances from Law Enforcement Agencies or Authorized Collectors. DEA states that a registered reverse distributor or registered distributor that acquires controlled substances must destroy, or cause the controlled substances to be destroyed, as soon as practicable but no longer than fourteen calendar days of receipt.
Page 7 of 8 We believe this should be changed to 60 calendar days of receipt. Fourteen days does not allow enough time. Take-back Events. DEA states that each take-back event should have at least one receptacle for the collection of permitted substances. We are concerned that this will allow controlled substances to be mixed with other drugs. Using the same receptacle that is required in a retail pharmacy, etc. is not operationally practical. In addition, DEA says only ultimate users and persons entitled to dispose of an ultimate user decedent s property in lawful possession of a controlled substances in Schedule II, III, IV or V may transfer such substances to the law enforcement agency during the take-back event. No other person may handle the controlled substances at any time. We are concerned that this would eliminate the option of having pharmacists on hand to sort the controlled substances from non-controlled substances. Not only would this cause collection bins to reach capacity too quickly, it would require law enforcement to take possession of all discarded drugs, rather than the waste vendor, who could immediately transport the noncontrolled substances to an appropriate incinerator. Many law enforcement agencies would not have the facilities to store the drugs until they can be shipped to a reverse distributor or others. Collection Receptacles. DEA says for authorized collectors, a controlled substance collection receptacle shall meet design specifications, including having the outer container prominently display a sign indicating that only non-controlled drugs and Schedule II, III, IV, or V controlled substances are acceptable. The general public does not understand this language. A suggested alternative could be to include the following language in some form: ONLY prescription and over-the-counter drugs can be accepted in this container. No illegal drugs. No syringes/needles, no cosmetics, toothpaste, deodorant or other personal care materials. Ultimate user delivery and Automated Reports and Consolidated Orders System (ARCOS). We are unclear about what code a registrant should use to designate the entity from which the registrant received the recalled controlled substance. Since this information is already being captured for the FDA under a recall, what additional value does ARCOS reporting offer? Also, does it apply only to Schedule II drugs and Schedule III narcotics? Destruction Procedures. DEA says if the controlled substances are transferred to a person registered under the Act and authorized to accept the controlled substances for purposes of disposal, two authorized employees of the transferring registrant shall load and unload or observe the loading and unloading of any controlled substances until transfer is complete. This is problematic because the site of destruction may be thousands of miles away and shipments must be made frequently (30 days is the shortest amount of time recommended by
Page 8 of 8 DEA). It is cost prohibitive to fly employees to and from destruction sites this often. The receiving registrant should be responsible for documenting the accurate receipt of the transferred controlled substances as is now the case for all forward-bound controlled substances. There should be no need for the transferring registrant to have employees present for the unloading. In addition, DEA says if the controlled substances are transported by a registrant to the location of destruction, the following procedures shall be followed: Two authorized employees of the transporting registrant shall accompany the controlled substances to the destruction location; two authorized employees of the transporting registrant shall load and unload or observe the loading and unloading of the controlled substances; two authorized employees of the transporting registrant shall handle or observe the handling of any controlled substance until the substance is rendered non- retrievable; and two authorized employees of the transporting registrant shall personally witness the destruction of the controlled substances until it is rendered non-retrievable. As we noted above, the site of destruction may be thousands of miles away. The registrant would need to use a common carrier, or in the case of a RCRA hazardous waste, a hazardous waste transporter, neither of whom will allow a non-employee to accompany them. It also is cost prohibitive to fly employees to and from destruction sites this often. We recommend DEA continue to enable the hiring of responsible contractors, such as off-duty law enforcement personnel, at the site of the destruction facility to witness the unloading and destruction of the controlled substances. We further recommend DEA examine the successful practices that have been in use for the past 20 years to determine if any significant diversion has occurred and, assuming they have worked effectively, continue to utilize them. Recordkeeping Requirements. DEA states that in addition to any other recordkeeping requirements, any registered person that destroys or causes the destruction of a controlled substance shall maintain a record of destruction on a form issued by DEA. As we noted earlier in our letter, a revised DEA Form 41 will not work as well as the automated systems that are currently in use at hospitals and some other medical facilities. We urge DEA to enable the use of the current electronic reporting systems used by nurses in the automated dispensing machines, which are much more effective at identifying potential diversion. Thank you again for the opportunity to comment on this important proposed regulation. Should you have concerns or questions, please contact me at pcostello@aha.org or (312) 422-3862. Sincerely, /s/ Patti Costello Executive Director Association for the Healthcare Environment