[Pharmwaste] MA's limit opoid rx & take back law

Motamedi, Saadi (DEP) saadi.motamedi at state.ma.us
Wed Mar 16 09:42:47 EDT 2016


Just to clarify:  even though some elements of the rule may address the Pharma waste management aspect, this rule is primarily intended to and is designed to fight the opioid epidemic in MA.  It may not address all of the issues but a great first step.

Thank you
_______________________________
Saadi Motamedi
Compliance and Enforcement
Bureau of Air and Waste
Western Regional Office
436 Dwight Street, Springfield, MA 01103
Phone: 413/755-2131    Fax: 413/784-1149
E-Mail: Saadi.Motamedi at state.ma.us<mailto:Saadi.Motamedi at state.ma.us>


From: Pharmwaste [mailto:pharmwaste-bounces at lists.dep.state.fl.us] On Behalf Of Heidi Sanborn
Sent: Tuesday, March 15, 2016 5:51 PM
To: Catherine Zimmer; 'Suzy Whalen'; pharmwaste at lists.dep.state.fl.us
Subject: Re: [Pharmwaste] MA's limit opoid rx & take back law

Hi Everyone:

I’ve been asked by quite a few people since this came out if it was a model so I’m going to start by saying that overall, this is great news overall and congratulations to those who worked on it for keeping this march towards EPR going forward!

However, I have to say this now before this gets copied or used as a model.  While we have not had enough time to review this 42 page bill, it does have producer responsibility components and that is wonderful!   However, we do not believe these items  should be duplicated:


1.       Definition of “covered drug” only includes to opioids and not other prescriptions or over the counter drugs (about 90% of what is out there).

2.       References on p. 20 about “in home disposal methods which could mean the usual coffee grounds and kitty litter which we are fighting against in LA and heavily promoted by the industry groups

3.       Alternative plan that could allow industry to get out of its obligations to pay.
LA County has the best ordinance draft we have seen to date as a whole, and we have board members that don’t agree with all parts of it, but it is overall incorporated the lessons learned from the ordinances that have passed and we in California believe is the best model to day informed by King County and all counties that preceded it.    http://publichealth.lacounty.gov/docs/EPR_DraftOrdinance.pdf

As LA and Chicago work towards keeping the bar high, I hope you all support them in that effort.  They are being heavily lobbied including having industry groups call seniors to ask them to send pre-fab letters against the LA ordinance.

Congratulations to all as we keep moving the ball up the hill and soon over it!

Heidi

Heidi Sanborn
Executive Director
[NSAC Final logo-01 (33%)]
1822 21st Street, Suite 200
Sacramento, CA  95811
916-706-3420
heidi at nsaction.us<mailto:nsacpres at gmail.com>
www.nsaction.us<http://www.nsaction.us/>



From: Pharmwaste [mailto:pharmwaste-bounces at lists.dep.state.fl.us] On Behalf Of Catherine Zimmer
Sent: Tuesday, March 15, 2016 9:56 AM
To: 'Suzy Whalen' <suzy at productstewardship.us<mailto:suzy at productstewardship.us>>; pharmwaste at lists.dep.state.fl.us<mailto:pharmwaste at lists.dep.state.fl.us>
Subject: [Pharmwaste] MA's limit opoid rx & take back law

Hi Suzy, Vivian and Scott of PSI  and, all,
Congratulations to PSI and MA for the shortened scrip and product stewardship of rx in MA!  Awesome!!!

As you continue to follow up w/the MA DPH, the “royal we”, ask you to incorporate source reduction, or at least bring it to the table.  No doubt pharma will want to continue to sell drugs, but possibly they will see the wisdom of source reduction when they bear at least some of the costs of the waste.

Very truly yours,

Catherine Zimmer, MS, BSMT
Executive director, HEARRT Midwest
Principal, Zimmer Environmental Improvement, LLC
Reducing and managing healthcare related waste and costs for fifteen years.
St. Paul, MN
Ph:  651.645.7509
zenllc at usfamily.net<mailto:zenllc at usfamily.net>

From: Pharmwaste [mailto:pharmwaste-bounces at lists.dep.state.fl.us] On Behalf Of Suzy Whalen
Sent: Tuesday, March 15, 2016 10:42 AM
To: pharmwaste at lists.dep.state.fl.us<mailto:pharmwaste at lists.dep.state.fl.us>
Subject: [Pharmwaste] Massachusetts Drug Abuse Prevention Law: 7-day opioid prescription limit

Good morning,

In addition to establishing a first-in-the-nation statewide drug take-back program, the MA drug abuse prevention law, signed yesterday<https://productstewardship.site-ym.com/news/279623/Governor-Signs-Massachusetts-Drug-Abuse-Prevention-Bill-First-State-to-Mandate-Drug-Take-Back.htm> by Governor Charlie Baker, also includes a 7-day opioid prescription limit. You can find more information on this provision below.


•         H. 4056<https://malegislature.gov/Document/Bill/189/House/H4056.pdf> limits first-time opioid prescriptions for adults, and all opioid prescriptions for minors, to a 7-day supply.

•         Exemptions include chronic pain and cancer treatment, and all exceptions must be documented in the patient’s medical record.

•         The 7-day limit has the support of the Massachusetts Medical and Dental societies.

The section number, summary, and full subsection language are below for context.


SECTION 24 - 7-Day Prescription Limits for adults and children


SUMMARY: Under this section, the first time a patient obtains a prescription for an opioid, the patient will be limited to receiving a 7-day supply. Minor patients are limited to 7-days for each prescription and a parent must be notified of the risks of addiction. This section provides an exception for acute conditions, chronic pain management, cancer and palliative care diagnoses with prescriber documentation of the need for medication.  This shall not apply to MAT prescriptions.


Section 19D. (a) When issuing a prescription for an opiate to an adult patient for
248 outpatient use for the first time, a practitioner shall not issue a prescription for more than a 7-day
249 supply. A practitioner shall not issue an opiate prescription to a minor for more than a 7-day
250 supply at any time and shall discuss with the parent or guardian of the minor the risks associated
251 with opiate use and the reasons why the prescription is necessary.
252 (b) Notwithstanding subsection (a), if, in the professional medical judgment of a
253 practitioner, more than a 7-day supply of an opiate is required to treat the adult or minor patient’s
254 acute medical condition or is necessary for the treatment of chronic pain management, pain
255 associated with a cancer diagnoses or for palliative care, then the practitioner may issue a
256 prescription for the quantity needed to treat such acute medical condition, chronic pain, pain
257 associated with a cancer diagnosis or pain experienced while the patient is in palliative care. The
258 condition triggering the prescription of an opiate for more than a 7-day supply shall be
259 documented in the patient’s medical record and the practitioner shall indicate that a non-opiate
260 alternative was not appropriate to address the medical condition.

Please feel free to reach out to PSI’s Vivian Futran Fuhrman<mailto:vivian at productstewardship.us> with questions at (617) 236-4771. You may also reach out to Scott Cassel<mailto:scott at productstewardship.us>, PSI’s chief executive officer, at (617) 236-4822.

Thanks,
Suzy
_____________________________________
Suzy Whalen
Outreach and Communications Coordinator
Product Stewardship Institute, Inc.
29 Stanhope St., 3rd Floor, Boston, MA 02116
P: (617) 236-8293 F: (617) 236-4766
TTY: please dial 711 or 800-439-2370; MassRelay<http://www.mass.gov/eopss/agencies/massrelay/relay-svcs/tty-relay.html>
www.productstewardship.us<http://www.productstewardship.us/>
suzy at productstewardship.us<mailto:suzy at productstewardship.us>
Follow our Facebook<http://www.facebook.com/pages/Product-Stewardship-Institute/224328115936?ref=ts>, Twitter<http://twitter.com/productsteward> and Blog<http://productstewardshipinstitute.wordpress.com/>

From: Pharmwaste [mailto:pharmwaste-bounces at lists.dep.state.fl.us] On Behalf Of Suzy Whalen
Sent: Monday, March 14, 2016 3:26 PM
To: pharmwaste at lists.dep.state.fl.us<mailto:pharmwaste at lists.dep.state.fl.us>
Subject: [Pharmwaste] PRESS RELEASE - Governor Signs Massachusetts Drug Abuse Prevention Bill, First State to Mandate Drug Take-Back Program

The following message comes from Scott Cassel, chief executive officer and founder of the Product Stewardship Institute.


Dear Colleagues:

Today, Massachusetts became the first state in the country to require drug companies to pay for and manage the safe disposal of unwanted medicine (see press release<https://productstewardship.site-ym.com/news/279623/Governor-Signs-Massachusetts-Drug-Abuse-Prevention-Bill-First-State-to-Mandate-Drug-Take-Back.htm> below). The requirement is part of a comprehensive drug abuse prevention bill that was signed this morning by Governor Charlie Baker. PSI was fortunate to have the opportunity to work with smart and dedicated legislators and their staffs to ensure that the drug take-back provision prevailed in the final bill.

With that said, there are several components to the legislation that will require articulation in the rules and regulations developed by the Department of Public Health (DPH) to ensure that the law is most effective at protecting public health and the environment. First, the law allows pharmaceutical companies to propose an “alternative plan” that could include a payment to the state in lieu of the industry managing their own safe disposal program. Second, the law allows companies to meet only two of four criteria for a program, including mail back, one-day events, in-home disposal, and kiosks. And finally, there is a sunset clause after five years.

Over the coming months, we will work to ensure that the MA DPH rules and regulations do not allow industry to offload their responsibility onto the state through inadequate payments or by requiring additional state workers to manage a program that should be implemented by the industry itself. We will also work to counter the industry’s promotion of its four-step in-home disposal process<http://myoldmeds.com/safe-storage-disposal/in-home-disposal/> of putting drugs in a plastic bag and mixing with water and then kitty litter, sawdust, or coffee grinds before disposing in the garbage. State and local government agencies around the country have rejected this approach for the past 15 years, as has the Office of National Drug Control Policy and the Drug Enforcement Administration, which spent considerable resources to change the federal Controlled Substances Act and subsequent regulations to allow collections at pharmacies and other convenient locations. They would not have spent the time or money to make sure that drugs could be conveniently collected if they thought it was safe or even feasible to mix drugs with kitty litter and put them in the garbage. Finally, no program should be sunset without a thorough evaluation.

We have a lot of work still ahead. However, at this point, I want to pause and acknowledge Vivian Futran Fuhrman and Waneta Trabert of the PSI staff for their unwavering commitment to the issue of safe pharmaceuticals disposal and to ensuring the health and safety of Massachusetts citizens. They were both tireless in the technical assistance they provided to legislative staff, and have been a key reason for this bill’s success. In addition, Suzy Whalen’s skill at communicating the nuances of the information has significantly contributed to PSI’s ability to spread the message.

This effort has also been a team effort by the wider product stewardship community, which started a decade ago when PSI identified waste pharmaceuticals as a public health and safety issue. After stakeholder meetings we held in California and Washington D.C., we developed producer responsibility models in the Great Lakes region that were further developed and implemented expertly by Alameda County, which prevailed against legal challenges by the industry all the way to the U.S. Supreme Court. The Teleosis Institute, California Product Stewardship Council, Covanta, and others have been diehard advocates of safe ways to manage the disposal of waste pharmaceuticals. As King County, Washington, and San Francisco, San Mateo, Santa Clara, Santa Cruz, and Marin counties in California know, this is a national team effort that cannot be stopped because the evidence of drug abuse deaths are as vivid as the presence of pharmaceutical compounds in our nation’s waterways.

The Massachusetts drug take-back section of the comprehensive law can certainly be improved upon. However, it is a major milestone in the history of producer responsibility, and we are honored to play a role in its development. We look forward to working with you to implement similar laws in other states and eventually at the federal level.

Scott Cassel and the PSI team


###

FOR IMMEDIATE RELEASE
March 14, 2016

Contact:
Scott Cassel, PSI - scott at productstewardship.us<mailto:scott at productstewardship.us> - (617) 236-4822
Suzy Whalen, PSI - suzy at productstewardship.us<mailto:suzy at productstewardship.us> - (617) 236-8293

Governor Signs Massachusetts Drug Abuse Prevention Bill,
First State to Mandate Drug Take-Back Program

Requires manufacturers to finance and manage safe disposal program
for leftover medications

Massachusetts - Today, Massachusetts Governor Charlie Baker signed into law a bill<https://malegislature.gov/Document/Bill/189/House/H4056.pdf> that made Massachusetts the first state in the nation to require drug companies to safely dispose of unwanted medications as part of a comprehensive drug abuse prevention strategy.

"An important goal of this comprehensive bill was to get every part of our health care system involved in reducing the misuse of opiate pills," said Senator John F. Keenan (D - Quincy), who first introduced the drug stewardship legislation, and is vice chair of a special Senate committee formed to address the state's opioid problem. "Today, for the first time, we are saying that pharmaceutical manufacturers cannot just profit from this epidemic, but must play an active role in ending it. I am very proud that Massachusetts has taken this step."

Over $1 billion<http://www.ncdoi.com/OSFM/safekids/Documents/OMCWhitePaper.pdf> in leftover drugs are thrown in the trash, flushed, or consigned to medicine cabinets each year. Drugs left in the home can get into the hands of children and potential addicts. Prescription drug abuse is the fastest growing drug problem<http://www.cdc.gov/drugoverdose/index.html> in the U.S. Last year, Massachusetts had 1,256 accidental drug-related deaths. When flushed or put in the trash, over-the-counter medications and prescription drugs can potentially contaminate waterways and the drinking water supply<http://www.productstewardship.us/?1019>.

"Our research has shown that pharmaceuticals from household wastewater end up in our waterways and ultimately our drinking water supplies," said Laurel Schaider, research scientist at the Silent Spring Institute<http://www.silentspring.org/>. "Preventing unwanted and expired medications from being thrown out or flushed down the drain will help keep pharmaceuticals out of the environment, and drug take-back programs can accomplish this goal."

"We applaud Massachusetts for recognizing that drug companies are responsible for safely managing leftover medicine and that this is a key element in reducing drug abuse," said Scott Cassel, chief executive officer of the Product Stewardship Institute<http://www.productstewardship.us/>, which has promoted drug take back nationwide for the past decade. "This law will save money for Massachusetts governments, which traditionally bear the burden of paying for proper disposal. It will also cover the cost of safe medication disposal<http://c.ymcdn.com/sites/www.productstewardship.us/resource/resmgr/Pharms_reports_factsheets/PSI_Pharms_Disposal_2014_WEB.pdf>, including at local pharmacies that are pillars of our communities."

Since 2012, seven counties on the West Coast - six in California (Alameda, San Francisco, San Mateo, Santa Clara, Santa Cruz, and Marin) and one in Washington (King) - passed laws that shift the cost burden for collecting and properly managing prescription drugs to drug makers. These laws will serve to guide the Massachusetts Department of Public Health as they develop rules and regulations to implement the new state law so that it is effective.

Learn more about the Product Stewardship Institute's work on pharmaceuticals on the website<http://www.productstewardship.us/?page=Pharmaceuticals>, or contact Vivian Futran Fuhrman<mailto:vivian at productstewardship.us> at (617) 236-4771.

###

About the Product Stewardship Institute:
The Product Stewardship Institute<http://www.productstewardship.us/> (PSI) is a national, membership-based nonprofit committed to reducing the health, safety, and environmental impacts of consumer products across their life cycle with a strong focus on sustainable end-of-life management. Headquartered in Boston, Mass., PSI takes a unique product stewardship approach to solving waste management problems by encouraging product design changes and mediating stakeholder dialogues. With 47 state environmental agency members, along with hundreds of local government members from coast-to-coast, and 110 corporate, business, academic, non-U.S. government, and organizational partners, we work to design, implement, evaluate, strengthen, and promote both legislative and voluntary product stewardship initiatives across North America. Like us on Facebook<http://www.facebook.com/productstewardship> or follow us on Twitter<http://www.twitter.com/productsteward>.
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