ГлавнаяMy WebLinkО нас2019.11.18 WRC NYS Drug Take Back Regulations_Gottlieb1 New York State Drug Take Back Act Chapter 120, Laws of 2018 Problems with the Draft Regulations 11/18/2019 Presentation to the WRC by Ed Gottlieb 2 Initial NYS Legislation had pharmacies and consumers pay. Gov. Cuomo Vetoed. The Drug Take Back Act, an EPR law, became effective on Jan 6, 2019. To be Implemented and Administered by the Bureau of Narcotic Enforcement (“BNE”), which is part of the Department Of Health (“DOH”); in consultation with the Department of Environmental Conservation (“DEC”). Drug Take Back Act 3 Jan, 6, 2019: effective date Feb. 5, 2019 (30 days after effective date): all wholesalers that sell in or into the state must provide DOH with a list of manufacturers that produce covered drugs July 5, 2019 (180 days after effective date): manufacturers proposed drug take back programs must be submitted to DOH Sept. 3, 2019 (60 days after submission): DOH must approve or deny proposed plan, in consultation with DEC Oct. 3, 2019 (30 days after declination): If the proposed plan is not approved by DOH, a revised plan must be submitted by this date No defined date for when collection must be up and running. Drug Take Back Act -Timeline 4 An ad Hoc Stakeholders Group sent suggestions on Nov. 13, 2019 BNE delayed follow-up meeting until Oct. 3rd, 2019; the same day the proposed regulations were published. 60-day comment period (ends Dec 2nd). Regulation Review: Discovered 9 major problems and many minor ones. Drug Take Back Act – Drafting Regulations 5 Ad hoc group of stakeholders draft a comment letter. +Ulster County & Onondaga County Resource Recovery Agency _______________________________________________________________________________________________________________________________________________________________________________________________________________________________ Additional stakeholders who are now signatories: +T.C. Sheriff & Others expected. Drug Take Draft Regulation Back Act –Comments – ____________________________________________________________________________________________________________________________________________________________________________________ 6 1.Rule should specify that a Proposed Plan must include how the program Operator(s) will notify other potential authorized collectors of the opportunity to participate. 2.Distribution of mail back supplies should not be limited to authorized collectors.. 3.Annual Operator reports need to include a description of safety and security issues that arose and how they were addressed. 4.DEA registered collectors should be allowed to weigh inner liners. 5.Law enforcement officers, as well as pharmacy employees, can access inner liners. Only law enforcement can open an inner liner to retrieve an item that was accidently deposited. Drug Take Back Act Rules --Summary of Problems 7 Drug Take Back Act Rules --Summary of Problems 6.Though the DOH found it complex to create a receptacle distribution plan for the nine required, high population locations, it does not follow that setting a minimum convenience standard for the rest of the state would be too complex and not help meet the goals of the Act. 7.The draft rule enumerates the costs a pharmacy must bear to be an authorized collector. However, the Act states, “ALL COSTS OF PHARMACIES AND OTHER AUTHORIZED COLLECTORS SHALL BE PAID OR REIMBURSED BY THE MANUFACTURER”. Despite this, it may be reasonable to put some peripheral costs on pharmacies and other authorized collectors. 8.Any authorized collector who wants to participate should be included in an approved Program. The rule implies that participation is limited to required pharmacies and those who currently participate in the DEC Pilot Take Back Program. 9.The rule says the State will incur the initial administration and enforcement costs. The Act says, “MANUFACTURERS SHALL ALSO PAY COSTS INCURRED BY THE STATE IN THE ADMINISTRATION AND ENFORCEMENT OF THE DRUG TAKE BACK PROGRAM… THE STATE SHALL ONLY RECOVER ITS ACTUAL COST OF ADMINISTRATION AND ENFORCEMENT.” And, “A MANUFACTURER, INDIVIDUALLY OR JOINTLY, MUST PAY ALL ADMINISTRATIVE AND OPERATIONAL FEES ASSOCIATED WITH THE DRUG TAKE BACK PROGRAM”. Candy Medication Candy Medication 8 Comment Letter (on DOH Draft Regulations for the New York State Drug Take Back Act) Follows… See Handout (Not your proverbial “Small Type” ) 9 November 15, 2019 Mr. Joshua S. Vinciguerra Director Bureau of Narcotic Enforcement New York State Department of Health 150 Broadway Albany, NY 12204 RE: Joint Comments on the Proposed Drug Take Back Act Regulations Dear Mr. Vinciguerra: We, the undersigned coalition of environmental, product stewardship, public health, wastewater treatment, water supplier, solid waste management, and fishing organizations, thank you for the opportunity to provide comments on the New York State Department of Health’s (“the Department”) proposed regulations for implementing the requirements of Article 2-B of the Public Health Law regarding the creation of a statewide drug take back program for the safe disposal of drugs. Collectively, we offer the following recommendations to help ensure that these regulations fulfill the intent of the New York State Drug Take Back Act to provide free, convenient access to safe drug disposal for all New Yorkers: 1. Expedite the timeline for program implementation The prescription drug epidemic continues to plague New York State, with more than 2,000 New Yorkers dying annually from prescription drug abuse. Water bodies from the Great Lakes to Long Island Sound are polluted with trace amounts of pharmaceutical drugs, adversely impacting fish and the health of our ecosystem. Rolling out a robust, statewide drug take back program to provide all New Yorkers with safe, convenient drug disposal options as soon as possible will help to protect our treasured waters and protect public health. This take back program will save lives, and we cannot afford to delay. New York is already behind schedule. A number of deadlines, laid out in Chapter 120 laws for 2018, have been missed. These include a July 5, 2019 deadline for manufacturers, and/or organizations, to submit a proposal to operate a drug take back program and the deadline for the Department to then approve or deny proposals within 60 days. We urge you to move as expeditiously as possible to reach full implementation of the drug take back program. When regulations are finalized, we urge you to set a firm deadline for manufacturers/organizations to submit proposals for approval or denial by the Department in consultation with the DEC. 2. Allow all authorized collectors to participate in the program at the manufacturer’s expense. In defining the Drug Take Back Program, the statute (§ 291 (4)) states that, “A manufacturer, individually or jointly, must pay all administrative and operational fees associated with the drug take back program, including the cost of collecting, transporting and disposing of covered drugs from pharmacies and other authorized collectors and the recycling or disposal, or both, of packing collected with the covered drug.” Regrettably, the Department’s proposed regulations imply that only chain pharmacies will have their costs covered by the manufacturers. The Rural Area Flexibility Analysis in the proposed regulations states, “While not mandated under these regulations, pharmacies in rural areas that are not part of a chain may choose to operate a drug take back program and would incur any associated costs with that program.” This undermines the intent of the law and will have severe consequences on the effectiveness of the statewide take back program: ● If non-chain, authorized collectors have to pay the costs of participating in the take back program, it will be a strong disincentive to their participation. ● Non-chain pharmacies, often “Mom & Pop” operations, will be at an additional competitive disadvantage when chain pharmacies get to add this valuable public service at no cost to themselves. ● Many communities, particularly those in rural areas hard hit by the opioid crisis, will be left without convenient access to safe drug disposal options. ● Law enforcement agencies—an important partner in safe drug disposal—will have to pay program costs. Agencies with an existing program will be more likely to discontinue service if a chain pharmacy in the area offers the service (at no cost to themselves). Law enforcement agencies who want to participate will be less likely to do so if they have to pay all the costs. We recommend that the regulations be revised to explicitly state that authorized collectors that volunteer to participate in the drug take back program will have take back costs covered by the manufacturers. Costs include the collecting, transporting and disposing of covered drugs, as well as the recycling or disposal of packing left when the covered drugs were dropped off. Furthermore, the statute (§ 292 (2)) states, “All drug take back program operators shall notify other potential authorized collectors of the opportunity to serve as an authorized collector for the drug take back program.” Notifying potential authorized collectors about the opportunity to participate is paramount to ensure broad program participation from authorized collectors. They can’t participate in a program if they don’t know it exists. Regrettably, this required notification of potential authorized collectors is not explicitly required in the proposed regulations. We recommend that the regulations explicitly state that operator(s) are required to notify potential authorized collectors of the opportunity to participate, at no cost, as an authorized collector in the drug take back program. Notification efforts should be documented in the operator(s) annual report. 1. Pharmacies enrolled in the DEC Pilot Project should be rolled into the new program, unless they decline the opportunity While the regulations reference the DEC Pilot Pharmaceutical Take back Program in the section on costs (referencing potential costs to pharmacies not covered by manufacturers, such as loss of retail space or obtaining a DEA registration), it is not clear if the regulations ensure that pharmacies enrolled in the DEC pilot will be eligible to participate in the operator(s) new take back program, once they are no longer participating in the DEC pilot, with costs (collecting, transporting, disposing of collected drugs) covered by the manufacturers. This must be clarified. There are currently hundreds of independent pharmacies, geographically distributed across the state, participating in the DEC program and providing convenient access to safe drug disposal for many New Yorkers. A critical incentive for pharmacies to participate was DEC’s offer to cover the full cost of the first two years of the program. If the pharmacies currently enrolled in the DEC pilot do not have the full cost of participating in the new operator(s) take back program (save for limited exceptions, such as loss of retail space) we could potentially lose hundreds of safe disposal sites across the state. This would be a major step backwards for safe disposal of drugs in New York State. We recommend that the regulations explicitly state that all pharmacies enrolled in the DEC’s Pilot Pharmaceutical Take Back Program are eligible to participate in the operator(s) drug back program. 2. Include a statewide convenience standard While the proposed regulations require authorized drug take back programs to offer a minimum number of collection receptacles in cities and certain counties with a population of 125,000 or more, the convenience standard should also cover areas outside the nine cities and counties identified in the proposed regulations. In defining the Drug Take Back Program, the statute (§ 291 2(C)) requires that a drug take back program, “Details a collection system to provide convenient, ongoing collection services to all persons seeking to dispose of covered drugs pursuant to section two hundred ninety-two of this article that is geographically distributed in a way to ensure access in rural and underserved areas.” The law makes clear that collection services must be geographically distributed and made available to rural and underserved areas. Without a required convenience standard, we are very concerned that rural and underserved communities will not be adequately served by the take back program. Based on the experience of pharmaceutical EPR programs around the nation and the globe, it is clear that a convenience standard is necessary to provide equitable access to safe drug disposal options. 10 We recommend that DOH include a statewide convenience standard that must be met by program operator(s) requiring, at a minimum, the following: ● A collection receptacle in all “pharmacies” (i.e., chain pharmacies as defined in the Act) ● At least one collection receptacle in every village, town, city (regardless of population size), island, and unincorporated community, in every county. ● At least one additional collection receptacle for every additional ten thousand residents in a village, town, city, island, and unincorporated community. ● In locations where DOH determines that this convenience standard could not be met, for reasons beyond the control of the program operator(s), require program operator(s) to hold at least two collection events per year and distribute mail back envelopes from at least one, regularly open, public building such as a town hall. 1. Require collection receptacles (aka “kiosks” or “drop boxes”) at pharmacies and other authorized collectors participating in the program Existing take back programs have demonstrated that collection receptacles are effective at collecting large amounts of drugs at a low per pound cost. Programs with only mail back envelopes have collected only small amounts of drugs and at a higher per pound cost. While mail back is not an effective standalone option, it is a helpful supplement, providing customers who would have difficulty coming back to the pharmacy a practical disposal option. Some signatories of this letter have direct experience with take back programs on Long Island (and elsewhere), which demonstrated the overwhelming success of collection receptacles at retail pharmacies, and the ineffectiveness of a program that provided only mail back envelopes at pharmacies. A pilot project that provided only mail back envelopes at Stop and Shop pharmacies on Long Island for a two-year period—from December of 2013 to December of 2015—yielded disappointing results. That program collected less than 300 pounds and approximately 70% of distributed envelopes were never sent back with unwanted drugs. Contrarily, an ongoing project to provide collection receptacles at several King Kullen pharmacies on Long Island has demonstrated overwhelming success. As of August 2019, the nearly five-year old program has collected over 13,800 pounds of unwanted drugs. We support the requirement for collection receptacles to be used in pharmacies subject to the convenience standard the Department specified for certain counties and cities. We are concerned that, for a significant portion of New York State, the rules do not require, or even encourage, the use of collection receptacles. The overreliance on voucher mail back system will seriously reduce the effectiveness of the Act. Pilot projects conducted by the Product Stewardship Institute demonstrate the success of collection receptacle programs in rural communities in New York State. From 2016-2018, several independent and hospital pharmacies in rural NY participated in pilots that included on- site kiosks, mail back envelopes, and outreach. Based on surveys and collection data, the pilots increased residents’ knowledge about the risks associated with improper drug storage and disposal, increased their understanding of ideal safe disposal options, and increased the quantity of unwanted and expired medications collected from households in the target areas. Each kiosk collected up to 500 pounds of medication per month, and the amount collected through kiosks far outweighed that collected via mail back envelopes. We recommend that the final regulations require collection receptacles at pharmacies and other authorized collectors participating in the statewide take back program. 1. Maximize the effectiveness of mail back (as a supplement to collection receptacles) Pre-paid mail back envelopes for safe drug disposal are an important supplement to collection receptacles, especially for customers that have difficulty getting to a collection receptacle. To ensure the availability of mail back to members of the public who need it, we recommend that the regulations: ● Require operator(s) to establish and maintain a website and a toll-free phone number to provide customer service. This would allow members of the public to conveniently request a pre-paid mail back envelope. The website URL and toll-free phone number should be prominently included in the operator(s) public outreach materials. ● State that the availability of pre-paid mail back envelopes should not be limited to authorized collectors. Again, this disproportionately impacts rural areas that do not have a nearby authorized collector. Places without a convenient authorized collector nearby should have the opportunity to distribute mail back supplies through locations such as a Town Clerk’s office. ● Provide vouchers for pre-paid mail back envelopes with the distribution of every covered drug. The regulations should specify a simple, convenient process, for customers to exchange vouchers for pre-paid mail back envelopes (e.g. directly at the pharmacy from which the covered drug was purchased, along with covered drugs send via the mail system, at the town clerk’s office, at a local law enforcement agency, through a website/toll free number, etc.). 2. Make manufacturers pay the full cost of the program The regulations should be clear regarding manufacturers’ responsibility for paying for all costs. According to the Act, manufacturers must pay all administration costs. The State should not incur any costs to administer the program, including initial costs and the additional 5-10 FTE’s the Department of Health anticipates needing to hire for implementation and enforcement. That said, there may be reasonable exceptions for some costs to not be covered by the manufacturers, such as the loss of retail space at pharmacies or the cost of DEA registration. 1. Ensure transparency in the rulemaking process To ensure a transparent rulemaking process, we recommend that the DOH publish all comments, received on the proposed regulations, on its website. Thank you for your consideration of our comments. Sincerely, (groups listed in alpha order; add new categories, as needed, to first sentence.) Name Title Organization 11 After Discussion… “I Move that the WRC Approve Becoming a Signatory to the DOH Regulation Comment Letter, Just Reviewed.” Do I hear a second?Used with permission.