[Pharmwaste] NYS DEC Releases Report on Pharmaceutical Stewardship

Ed Gottlieb EGottlieb at cityofithaca.org
Mon Jun 4 11:44:26 EDT 2018

Dear Pretreatment Coordinators, Pharmwaste Listserv, & Others,

NYS Governor Cuomo's December veto, of a weak pharmaceutical extended producer responsibility (EPR) bill, directed the New York State Department of Environmental Conservation (DEC) to meet with stakeholders and investigate the feasibility of creating and implementing a statewide pharmaceutical stewardship program "provided by manufacturers, at no cost to consumers"

I recommend reading the DEC report, issued on June 1, available at:  www.dontflushyourdrugs.net<http://www.dontflushyourdrugs.net> &


Reducing environmental impacts is given almost as much emphasis as combating the opioid epidemic.

The DEC report and Press Release (bottom) include this quote from DEC Commissioner Seggos:

“An accessible, statewide program ensuring the safe disposal of expired and unused pharmaceuticals would protect communities already burdened by the opioid crisis while also safeguarding our waterways from contamination. New York is taking every possible step to combat this addiction crisis and protect our waters from drug waste. A safe and convenient way to get rid of expired and unwanted drugs will help both reduce the risk of new Yorkers misusing pharmaceuticals and protect our environment by preventing these medications from being irresponsibly flushed or tossed in the trash.”

The DEC, in consultation with the DOH, issued recommendations that are stronger than I expected, requiring all pharmacies to participate.  Note: they define "authorized collector" as, "businesses and facilities allowed to collect pharmaceuticals pursuant to DEA regulations."  It is my understanding that this includes law enforcement agencies.  Report excerpt:

A. Collection [pg. 26]

DEC and DOH recommend that all pharmacies be required to house a permanent collection receptacle in accordance with federal requirements as part of a manufacturer-run program, unless they fall into an exception as described below. In addition, any other authorized collector who wishes to participate as a collection location should be allowed to join the manufacturer-run program. Collection at all locations should be fully funded by the manufacturers.

For those counties where there is no pharmacy, or other authorized collector, the pharmaceutical stewardship organization would need to provide a minimum of two authorized collection events per year.

Prepaid, pre-addressed, nondescript mail-back envelopes should be available from all pharmacies and authorized collection locations, provided by the stewardship organization free of charge to the collection locations and to consumers. In addition, consumers should be able to request prepaid, pre-addressed mail-back envelopes directly from the pharmaceutical stewardship organization via the public education website.

The program must include a mechanism to waive the collection receptacle requirement for pharmacies where hosting a collection receptacle would pose an undue hardship. If a waiver is granted, these locations would not be required to host a collection receptacle, but should be required to provide pharmaceutical stewardship program information and offer prepaid, pre-addressed mail-back envelopes.

Mail-order and online pharmacies are also major distributors of pharmaceuticals and should be required to participate in a manufacturer-run stewardship program. We recommend that all mail-order and online pharmacies that fill prescriptions for delivery in New York be required offer a mail-back envelope, at the time of sale, for each sale for delivery in the state.

A pharmaceutical EPR bill is currently under consideration by the State Senate and Assembly (A 9576<http://r20.rs6.net/tn.jsp?f=001yqYqpny2RTPIOGop1Ij0-l-NYb92weKZ0kid0wRpaZ8tnAP8XpEDfn5p3bZrudCthyvl3fVgHYpF2i1nFzztGmYYtdB7Lz3wA9Vd8FBtAOIX7Z1X7MeRaslEd9Sli-ara0w-ezlUk3sckhXhynetRAqHNGMJmKofqB9hrbbI0FwBwdKzpKeShxpj-A2h1sT4JRq0jiX2ZtASpws0AdSVy-W3kUSHx2SnCOuM8K2MD_47Zp7juc1V9vsxqO-dDMRbZ2Go24jGoBF7Ls_uIN5clOzDMQVQyn9NWlVogsfk7-E=&c=PW6HKlNbqwkOsJx7hZiw2qsGoAQ2aEtbosFaCrSs4YpXw0S07fIqZg==&ch=1bBSbvMPG4Qu4meIau_X2h9yJAY0d3XvTIgJQazCVIWOr_NLUcdTlA==> & S 7354<http://r20.rs6.net/tn.jsp?f=001yqYqpny2RTPIOGop1Ij0-l-NYb92weKZ0kid0wRpaZ8tnAP8XpEDfn5p3bZrudCt568JHrSfhpIcyaxKF-tN8R6TqPpfXN9__O4NukeFfXL02yHVUu9CfcFuNkrYnhBdZyGylsdlmA1CzBFsbT61maoL0rZPTAlt2bHBHz8DhL_jtRVUoS_h2HcyP9odfePER5Pi1SJ9kGUoTA1zXfyRNOemsLDVpU4Y&c=PW6HKlNbqwkOsJx7hZiw2qsGoAQ2aEtbosFaCrSs4YpXw0S07fIqZg==&ch=1bBSbvMPG4Qu4meIau_X2h9yJAY0d3XvTIgJQazCVIWOr_NLUcdTlA==>).  Though not as strong as the just released DEC recommendations, many organizations support passage.  With the legislative session ending soon, passage of this bill is up in the air.

This DEC report gives me hope that if the current bill does not pass, an even stronger state bill will pass next session.

Ed Gottlieb
Chair, Tompkins County Coalition for Safe Medication Disposal
Board Member, New York Product Stewardship Council
Member, National Association of Clean Water Agencies Pretreatment & Pollution Prevention Committee
Member, Product Stewardship Institute Pharmaceuticals’ Policy & Coordination Work Group
Member, New York Water Environment Association Government Affairs Committee
Industrial Pretreatment Coordinator
Ithaca Area Wastewater Treatment Facility
525 3rd Street
Ithaca, NY  14850
(607) 273-8381<tel:(607)%20273-8381>
fax: (607) 273-8433<tel:(607)%20273-8433>

Subject: DEC Releases Report on Pharmaceutical Stewardship

Please distribute to appropriate staff.


For Immediate Release: 06/01/2018

Contact: Erica Ringewald | (518) 402-8000

Press Office | PressOffice at dec.ny.gov<mailto:PressOffice at dec.ny.gov>


Report Identifies Need for Accessible, No-Cost Statewide Program for Consumers to Safely Dispose of Waste Pharmaceuticals

 Convenient Disposal of Expired and Unused Drugs would Protect Communities and Environment

New York State Department of Environmental Conservation (DEC) Commissioner Basil Seggos today announced the release of the agency’s report on pharmaceutical stewardship developed in consultation with the New York State Department of Health. Report recommendations include establishing an independent pharmaceutical stewardship organization to provide oversight of a statewide program funded by pharmaceutical manufacturers rather than consumers or taxpayers. The report is the result of a comprehensive assessment of existing programs in New York and across the country, as well as meetings with key stakeholders about the proper management and disposal of unused, expired, and unwanted pharmaceuticals.

            Commissioner Seggos said, “An accessible, statewide program ensuring the safe disposal of expired and unused pharmaceuticals would protect communities already burdened by the opioid crisis while also safeguarding our waterways from contamination. New York is taking every possible step to combat this addiction crisis and protect our waters from drug waste. A safe and convenient way to get rid of expired and unwanted drugs will help both reduce the risk of new Yorkers misusing pharmaceuticals and protect our environment by preventing these medications from being irresponsibly flushed or tossed in the trash.”

            In the report, DEC, in consultation with DOH, recommends establishing an independent pharmaceutical stewardship organization to oversee a statewide program that is funded by pharmaceutical manufacturers rather than burdening consumers or pharmacies. In addition, the report recommends that all New York pharmacies be required to maintain a pharmaceutical waste collection receptacle and offer pre-paid mail-back envelopes. Recommendations also include education and outreach with information about accepted materials; safe disposal methods approved by DEC under federal regulations; and regular reports on the efficacy of the program provided by the proposed pharmaceutical stewardship organization.

            New York State Department of Health Commissioner Dr. Howard Zucker said, "When used properly prescription drugs can provide great medical benefits to those who need them.  But when unused medications are disposed of improperly they can create critical public safety and public health concerns.  Under Governor Cuomo’s leadership we’re safeguarding New Yorkers from misuse of medications and decreasing the risk of addictions, accidental poisonings and overdoses.”

Governor Andrew M. Cuomo directed DEC to undertake the report to ensure New York consumers and pharmacies would not be disproportionately burdened with the costs associated with take-back and disposal, as proposed in legislation passed by the State Assembly and Senate in 2017. DEC worked closely with DOH to develop the report, which includes an assessment of current programs across the country. Across the country, 18 counties, including Rockland County in New York, four cities, and three states have adopted pharmaceutical stewardship laws that establish take-back programs to help ensure consumers’ unwanted, expired, and excess drugs are disposed of safely. Many of these stewardship programs are operated and financed differently.

            In addition, in 2018, DEC met with stakeholders representing New York’s local governments and municipalities, retailers, manufacturers, waste management industry representatives, and environmental advocacy groups to discuss the proper management and disposition of unused, expired, and unwanted pharmaceuticals.

During the course of its review of current programs and after meeting with stakeholders, DEC and DOH identified elements critical to a comprehensive pharmaceutical stewardship program: identification of entities required to participate and their respective roles; requirements for collection, disposal, and reporting; public education and outreach; funding and cost allocation; uniform statewide application; compliance, enforcement, and penalties; and an implementation schedule.

            Rates of prescription drug abuse in the U.S. are disturbingly high, as are the number of accidental poisonings and overdoses due to these drugs. Studies show that most abused prescription drugs are obtained from family and friends, including from the home medicine cabinet. In addition, there are concerns about unused pharmaceuticals getting into the wrong hands. The Centers for Disease Control and Prevention reports that one U.S. citizen dies every 16 minutes from a drug overdose and has declared this public health threat an epidemic. Americans are now advised that their usual methods for disposing of unused medicines –throwing them in the trash or flushing them down the toilet—pose potential health, safety and environmental hazards.

With technological advances in analytical techniques, it is now possible to detect low levels of drugs in surface water and groundwater. Some drugs pass largely unaltered through wastewater treatment plants and enter rivers and other waterways. Flushed medications have been found in New York lakes, rivers and streams and can negatively affect the waterways. A national study conducted in 1999 and 2000 by the U.S. Geological Survey found low levels of drugs such as antibiotics, hormones, contraceptives and steroids in 80 percent of rivers and streams tested. Medications adversely affect fish and other aquatic wildlife and increase the development of drug-resistant bacteria.

DOH currently operates the Medication Drop Box Program, which allows law enforcement agencies to operate an on-site drop box for pharmaceuticals. The box is available to members of the public, during hours of operation, who may drop off any unwanted pharmaceuticals. All costs associated with destruction of surrendered pharmaceuticals must be borne by the participating locations and a law enforcement officer must be involved in the transport and destruction. Currently, according to DOH, 41 counties have at least one drop box through DOH’s program.

The report’s recommendations complement DEC’s current $2 million pilot Pharmaceutical Take-Back Program. To date, the pilot program has distributed 87 collection boxes to participating retail pharmacies, hospitals, and long-term care facilities across the state. The pilot program to safely collect unused and expired waste medication was launched by DEC in December 2017, and a total of 246 facilities have agreed to participate.

            The pilot is funded with $2 million from the state’s Environmental Protection Fund, which covers the full cost of purchasing U.S. Drug Enforcement Administration-compliant medication drop boxes, as well as the cost of up to 50 inner liners, pick up, transport and destruction of collected waste pharmaceuticals for a period of two years. At the end of the pilot program participants are required to continue the program, at their own expense, for six additional months. As proposed by the Governor, the Enacted Budget for 2018-19 includes an additional $1 million to support the expansion of this pilot program.

The report is available at www.dontflushyourdrugs.net<http://www.dontflushyourdrugs.net>.

New Yorkers are encouraged to use existing medication collection box locations, which can be found by visiting www.dontflushyourdrugs.net<http://www.dontflushyourdrugs.net> and clicking on NYS Medication Drop Box Locations link or the DOH website https://www.health.ny.gov/professionals/narcotic/medication_drop_boxes/<https://www.health.ny.gov/professionals/narcotic/medication_drop_boxes/>.


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