Category Archives: Pharmaceuticals

In Response: The Drug Industry’s Triumph Over the DEA

The Product Stewardship Institute’s Scott Cassel recently submitted the following letter to the editor to the Washington Post in response to its October 15th article, The Drug Industry’s Triumph over the DEA

Dear Editor:

The October 15th investigations article, “The Drug Industry’s Triumph over the DEA,” highlights the power of the pharmaceutical industry to avoid taking responsibility for their role in the opioid epidemic, which has torn apart families and imposed unacceptable health costs on society. One billion dollars worth of leftover drugs sits in U.S. medicine cabinets and has become a gateway to addiction, abuse, and accidental poisonings.

It’s time for the U.S. pharmaceutical industry to be held accountable for the massive quantities of medicine it puts on the market. Massachusetts, Vermont, and 18 counties or cities in California, Illinois, New York, and Washington have passed laws that require pharmaceutical companies to finance and/or manage jurisdiction-wide drug take-back programs designed to provide residents with safe and convenient medication drop-off locations at pharmacies, hospitals, and law enforcement offices.

We urge the Council of the District of Columbia to amend the Safe Disposal of Pharmaceuticals Amendment Act of 2017 (B22-0228) to require the industry to take back unwanted medicine and help alleviate the raging opioid epidemic.

Sincerely,

Scott Cassel
Chief Executive Officer/Founder
Product Stewardship Institute

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In Response: “Opioid Poisonings Rise Sharply Among Toddlers and Teenagers”

The Product Stewardship Institute’s Scott Cassel and Vivian Fuhrman recently submitted the following letter to the editor to the New York Times in response to its November 4th article, Opioid Poisonings Rise Sharply Among Toddlers and Teenagers

Dear Editor:

840600_94918677_smlIn the October 31st article, “Opioid Poisonings Rise Sharply Among Toddlers and Teenagers,” you fail to mention drug take-back as the best option for families to rid their homes of the over 1 billion dollars in leftover drugs that sit in medicine cabinets and become a gateway to addiction, abuse, and accidental poisonings. Massachusetts, Vermont, and 14 counties or cities in California, Illinois, and Washington passed laws that make pharmaceutical companies responsible for financing and/or managing jurisdiction-wide drug take-back programs designed to provide residents with convenient, safe drop-off locations at pharmacies, hospitals, and law enforcement agencies. Many countries in Canada and Europe also have laws that require industry to manage the proper disposal of the medications they put into the marketplace. Unfortunately, U.S. pharmaceutical companies continue to promote garbage disposal and refuse to take responsibility for safe drug disposal. It’s time for the American pharmaceutical industry to be held accountable for the massive quantities of leftover medicines that contribute to the opioid epidemic, which has torn apart families and imposed unacceptable health costs on society.

Sincerely,

Scott Cassel, CEO/Founder
Vivian Fuhrman, Ph.D., Associate for Policy and Programs

Senator John F. Keenan: Comments on “My Old Meds” Campaign

By Senator John F. Keenan, Massachusetts Senate

On March 16, 2016, Governor Charlie Baker signed into law a comprehensive drug abuse prevention bill that made Massachusetts the first state in the nation to require drug companies to fund and manage a safe disposal program for unwanted medications. Massachusetts Senator John F. Keenan was the first to introduce the drug take-back portion of this bill to the MA legislature, and acted as an influential proponent of its inclusion in the final law. Below, Senator Keenan cautions us to stay vigilant to PhRMA’s attempts to skirt the law’s intended purpose.

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You would think that a group that helped create the opioid epidemic, which certainly has profited from it, and which is acknowledging that its products continue to fuel the epidemic, would offer more to help solve the epidemic than a catchy phrase, a website and a complete abrogation of playing any role in cleaning up the mess.

Yet, that’s what a newly formed group called “My Old Meds” has done. The sponsor of this group is the Pharmaceutical Research and Manufacturers of America (PhRMA), made up of representatives of the pharmaceutical industry. Some of these people and the firms they represent are making a lot of money from the sale of prescription painkillers, firms like Purdue Pharma, the people who brought us OxyContin and, more recently, OxyContin for kids.

“My Old Meds” recently brought their message to Massachusetts, advising that unused drugs are often diverted and become fuel for the opioid epidemic, and that old meds should therefore be disposed of at home in the trash or at government sponsored drug disposal sites.

In so advising, the sponsors of “My Old Meds” attempted to wash their hands of any responsibility for the disposal of unused medications, and place it instead on the patient and the taxpayer. Their theory: sell more pills than people need, reap the profits, then make others pay for the cleanup.

Their message was strategically timed, just as Massachusetts was considering legislation to require that pharmaceutical companies themselves become responsible for funding and operating a take-back and disposal program for unused pills. The industry was very comfortable with the arrangement of the past, watching their balance sheets grow in step with the excessive number of pills sold while communities scrambled to address the resulting opioid epidemic. That’s why they introduced their catchy phrase and website. They wanted to appear to be helpful, to convince us that no real change was necessary.

The Massachusetts Legislature was not fooled. We can be proud now of becoming the first state in the nation to require a pharmaceutical product stewardship program.

But now we must expect PhRMA’s campaign for in-home, patient and community funded disposal to continue. They will “educate” the public that they can spend their own money to buy cat litter or other carbon products that make pills “safe” for disposal, or that pills can simply be flushed into our water systems.

We must be vigilant. The new law allows the Massachusetts Department of Public Health to design an alternative stewardship plan, in which manufacturers will be allowed to participate rather than fund and operate their own programs. We must work to prevent the industry from influencing the regulatory process. We cannot let them seek regulations that set a low bar for industry responsibility, and that maximize the share of responsibility falling back onto public systems. We must work to ensure that the Department’s program is robust and effective, not a back door that lets manufacturers again step away from responsibility for safe stewardship of unused medications.

We have taken an important first step, but we must continue to fend off the message that manufacturer responsibility can be satisfied with a slogan and website.

Senator Keenan wrote a follow-up piece related to National Take-Back Day on MassLive. Learn more about Senator Keenan by visiting his website. Please feel free to contact Vivian Futran Fuhrman, PSI’s pharmaceuticals lead, with comments and questions (617-236-4771), or visit the PSI pharmaceuticals webpage for more information. 

Putting the “Green” in Walgreens

By Scott Cassel, Chief Executive Officer and Founder, Product Stewardship Institute

pharmaceutical-take-backThis week an announcement rocked the pharmaceutical take-back community. Walgreens will set up collection kiosks at 500 stores in 39 states to accept controlled and non-controlled prescription drugs.

In one instant, a decade of advocacy work was rewarded as a principal player stepped forward to help alleviate drug abuse and accidental poisonings in America. In this one move, Walgreens validated those of us who have long promoted take-back as the safest way to manage leftover drugs and remove a health risk from our homes.

It was a long road to this point. It all started for a reason we should not forget – concern over how pharmaceuticals impact water quality and aquatic organisms. The U.S. Geological Survey brought our attention to this issue in 2002 by reporting the prevalence of pharmaceutical compounds in waterways. Studies and photos of aquatic impacts – male fish with female characteristics, infertility in aquatic species, and related environmental concerns – incited our interest in finding a solution.

But it quickly became clear that the nation’s drug abuse issue would drive a solution. When King Pharmaceuticals, an opioid manufacturer, funded PSI’s pharmaceuticals take-back website, along with one of our 2008 national dialogue meetings, we knew we were on the right track. At that meeting, we reached stakeholder consensus: the federal Controlled Substances Act needed to be changed. This law limited the collection of controlled substances to locations where law enforcement staff were present – a costly, impractical, and inconvenient constraint.

In order to change the law, we needed to reach a strong agreement among government agencies, reverse distributors, and other stakeholders on two specific points: how we defined the problem and what specific language we recommended to change the law. We met with the Office of National Drug Control Policy (ONDCP), the Drug Enforcement Administration (DEA), the Department of Transportation, the U.S. Environmental Protection Agency, and the Food and Drug Administration to solidify a unified message, and wrote testimony that synthesized concerns and recommendations. In 2010, the Secure and Responsible Drug Disposal Act was enacted.

But that was only the first step. From there, PSI held multiple stakeholder calls and meetings to provide input into implementing the DEA regulations that would eventually put the new law into action. When DEA finally released its final rule in late 2014, some stakeholders remained skeptical. They questioned whether the rule went far enough, if it created unintended loopholes, and why pharmacies didn’t jump in to start collecting soon after the rule was announced. PSI, therefore, set out to find pioneering pharmacists who were collecting controlled substances under the new rule, like Monty Scheele of Four Star Drug in Nebraska, who enthusiastically explained on one of our national webinars how easy it is to collect old drugs and how beneficial it is for business.

Obviously, Walgreens was listening to pharmacists like Monty Scheele. They responded to the drum beat of requests from an ever-expanding group of take-back advocates, as well as ONDCP and DEA, who made it clear that pharmacy collection was a main goal all along when they changed the regulations.

A decade ago, King County, Washington started an epic pilot program for non-controlled substances at Bartell Drugs, a pharmacy in Seattle. Dave Galvin, one of the County’s pilot program leaders, always said: “Most people don’t go to their police station voluntarily, but they do go to the neighborhood pharmacy.”

It’s been a long journey, one that took perseverance and hope. But simple truths are hard to keep submerged. Customers are neighbors, and they will stay loyal to your pharmacy if you help alleviate a pressing community problem.

It was only a matter of time until a major initiative like this one was bound to occur. A decade isn’t so long, after all.

Learn more about PSI’s work on pharmaceuticals by visiting our website. Please feel free to contact Vivian Futran Fuhrman, PSI’s pharmaceuticals lead, with comments and questions (617-236-4771). 

What Big Pharma Can Learn From the Paint Industry

By Scott Cassel, Chief Executive Officer and Founder, Product Stewardship Institute

1028441_27922878It was one of those quiet moments of victory for environmentalists and public health advocates: In 2012, Alameda County’s Board of Supervisors unanimously adopted the nation’s first ordinance requiring pharmaceutical manufacturers to fund and manage a drug take-back program.

Millions of overprescribed, unused, and expired medications contribute to drug abuse, accidental poisonings, aquatic impacts, and water quality issues. The trash or drain is not a safe method for disposing drugs – which is why King County, Washington; San Mateo County, California; and San Francisco, California followed suit with similar ordinances.

Big Pharma, however, has spent the last three years fighting back in the courts, arguing that the Alameda law interferes with interstate commerce. After two lower court decisions cited no interstate commerce violation, Big Pharma took the case to the U.S. Supreme Court. The high court recently declined to hear the pharmaceutical industry’s case against the Alameda County Safe Drug Disposal Ordinance. Whether Big Pharma will continue to pursue its costly litigation strategy remains to be seen, but one thing is clear: if the industry instead chose to collaborate, it could help shape a long-term, cost-effective solution that protects all interests – economic, health, and environmental.

Drug take-back laws may be new, but laws requiring manufacturers to take responsibility for the safe disposal of their products are not. What’s more is that not all industries continuously push back and fight against such laws. Currently, there are 8 states (and the District of Columbia) that require the paint industry to fund and manage the recycling and safe disposal of leftover paint; all of these laws were developed in collaboration with the American Coatings Association (ACA), which represents over 95 percent of U.S. paint manufacturers.
867237_92898831First some background: Back in 2002, the Product Stewardship Institute (PSI) asked the paint industry to take responsibility for managing leftover household paint because, when poured down the drain or sent to landfills, leftover paint threatens aquatic ecosystems and wastes valuable resources. Managing paint wastes is typically the most costly part of municipal household hazardous waste programs as well. PSI estimated that it would cost paint manufacturers about $650 million each year to safely recycle or dispose of the estimated 75 million gallons of leftover paint generated yearly in the United States.

After initial reluctance, the paint industry agreed to meet with PSI and some of PSI’s state and local government members. After nearly a dozen meetings and multiple calls over four years, PSI and ACA reached an agreement in 2007 on a model state program that would be implemented nationwide. Since then, the nine aforementioned jurisdictions have used that model to adopt laws holding the paint industry responsible for collecting and properly managing all leftover paint in their area; similar bills are pending in another dozen states. As a result, 8 million gallons of paint have been diverted from disposal so far in the first five states in which the paint stewardship program has been implemented, saving local governments over $50 million in transportation and processing costs, according to paint industry estimates.

What can the pharmaceutical industry learn from this?

  1. Producer responsibility doesn’t hurt the bottom line. Since ACA’s PaintCare program was first adopted in Oregon in 2010, paint sales are still strong, retailers have the opportunity to offer a new service to their consumers, and paint recycling is on the rise. Through its PaintCare program, the paint industry has gotten out in front of the regulations, working with government to shape laws that fit with their business model. ACA representatives are regularly called upon to speak at state recycling conferences in sessions that highlight the industry’s successful demonstration of corporate sustainability and public-private collaboration. The lesson: an industry can take responsibility for its post-consumer products, and not only does it not hurt the bottom line – it often ends up benefitting them overall.
  1. Producer responsibility programs show immediate results. In just five years, the paint industry has made convenient paint take-backs available to at least 95% of residents in three states, and local governments have saved millions of dollars of taxpayer money. Unlike other recycling programs that funnel collected fees into a government fund and require significant government hours to manage (e.g., scrap tire laws), the paint stewardship program is largely run by the paint industry, alleviating the need for a large bureaucracy to handle day-to-day operations.
  1. Dialogue doesn’t mean a loss of control. It enables industry to shape policy that is effective and cost efficient. When PSI approached ACA with its request, the industry agreed to begin talks. What resulted was a national multi-stakeholder dialogue that led to joint research to answer key questions, such as “what will this program actually cost?” and “how will paint be collected and recycled?” From the beginning, ACA helped shape the program’s development; when the first bills were drafted, ACA was in the driver’s seat. The solution developed was an innovative funding model that worked for both industry and other stakeholders.

With the number of prescription drug overdoses rising annually, the risk posed by leftover medications raises the stakes, as well as the opportunity, for the pharmaceutical industry to take the lead and create convenient medicine take-back programs for U.S. residents. Such a program is within reach, and would cost the pharmaceutical industry roughly $3.51 per capita annually for the safe collection and disposal of pharmaceuticals, according to estimates from King County, WA. Similar programs have operated for years in Canada and at least a dozen European countries, taking the financial burden off of taxpayers.

This is clear: the pressure on the pharmaceutical industry isn’t going away. The path for industry-funded producer responsibility has been paved; with 88 producer responsibility laws operating in 33 states across the US for 12 different product categories, there is ample proof that take-back legislation can be implemented successfully. The pharmaceutical industry could be poised to become the next big success story – if it is willing.

A Letter to Big Pharma

PSI submitted the following letter to the Wall Street Journal last week, responding to pharma’s op-ed, “Bad Drug Trip in Alameda.” While the letter was not published, the argument still stands, further solidified by today’s Supreme Court decision in which the Court declined to hear pharma’s petition against the Alameda County Safe Drug Disposal Ordinance.* This decision means that current take-back laws in Alameda County, CA; San Francisco, CA; San Mateo, CA; and King County, WA will remain in effect.

 

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In the May 17 editorial, “Bad Drug Trip in Alameda,” the author criticizes Alameda County, California, for passing a law requiring pharmaceutical companies to provide drug take-back programs in the county, calling the law “protectionist” and based on “a speculative fear.”

Alameda’s law is necessary because pharmaceutical companies have not taken responsibility for the millions of overprescribed, unused, and outdated medications that contribute to drug abuse, accidental poisonings, aquatic impacts, and water quality concerns. The trash or drain is not a safe method for disposing drugs — which is partly why support for these kinds of laws is widespread and growing.

The White House’s Office of National Drug Control Policy, several federal agencies, and 43 state agencies all support programs to collect and safely dispose of unused medications. Four provinces in Canada and nearly a dozen countries already have pharma-funded and operated drug take-back programs. In addition to Alameda County, three other U.S. counties have adopted similar ordinances. There are 84 other state and local laws that require manufacturers to fund and safely manage the disposal of consumer products.

The US Constitution gives Congress the exclusive power to regulate interstate commerce in Article 1. Big Pharma’s challenge is primarily based on the dormant commerce clause, which maintains that states cannot burden interstate commerce. This burden is subject to a balancing test, one that calls a law illegal only if the burden on commerce is clearly excessive when compared to local benefits.

Do the local benefits – limiting drug abuse and accidental poisonings, and protecting water quality and aquatic organisms – outweigh the burden the pharmaceutical industry must incur to pay for take-back programs? We at PSI think so – and hope the Supreme Court does too

Scott Cassel
Chief Executive Officer and Founder
Product Stewardship Institute
Boston, MA

*For more information on this case, see PSI’s fact sheet exploring the implications of the decision, and another fact sheet outlining the history of this legal challenge.

4 Reasons Why EPR is the Best Solution for Safe Drug Disposal

pharmaceutical take back programsPharmaceuticals are an essential component of our healthcare system. They save lives and improve quality of life for many of us. Yet, as the number of prescriptions written increases, so too do the problems related to unwanted pharmaceuticals in the home.

Allowing unwanted pharmaceuticals to accumulate in homes increases the likelihood of accidental overdose, illegal diversion, and environmental contamination. It’s time to commit to a solution that works.

The Take Back Solution
Take-back programs provide a safe way for people to remove unwanted medications from their homes.

Existing take-back programs vary widely as to how they are organized and funded. Many happen only a couple days each year. Some local law enforcement agencies have installed permanent drop boxes in their buildings. With the recent withdrawal of federal DEA support, many programs are struggling to find funding to continue this important public service.

A new federal rule for the disposal of unwanted controlled substances allows pharmacies to run their own take-back programs, a convenient option for consumers. However, the new DEA rule does not provide any funding to make participation easier.

Both law enforcement and pharmacy-based take-back programs are severely limited by a lack of consistent funding. While voluntary take-backs are a step in the right direction, these programs simply aren’t enough.

Extended Producer Responsibility (EPR), also known as product stewardship, describes a system where the life cycle costs of a product become part of the cost of manufacturing. EPR is a proven method to sustainably fund the recycling or disposal of fluorescent lights, mercury thermostats, paint, mattresses, household batteries, and other products.

Why, then, is EPR the best solution for pharmaceuticals?

1. Proven
EPR is already being successfully implemented for pharmaceuticals in many European countries as well as some Canadian Provinces. In British Columbia (BC), for instance, 97.5% of pharmacies participate in a drug take-back program due to a solid EPR foundation. These locations collected a total of 112,888 pounds of pharmaceuticals in one year alone, equaling out to 0.02 pounds of meds collected per person. For comparison, Oregon, a state with a similar population but without an EPR program, collected only 0.004 pounds of meds per person in one year, a rate five times lower than British Columbia’s.

2. Economical
A coordinated EPR approach lowers collection and disposal costs per pound. The pharmaceutical EPR program in France, for example, collects an average of 16,237 tons per year, at a cost of just $0.0022 per box. Funded entirely by pharmaceutical manufacturers and run by the non-profit group Cyclamed, this French program is highly effective in collecting unwanted pharmaceuticals. In a recent survey, 77% of French residents claimed to have disposed of unwanted medication via these take-back sites, while 70% said they “always” dispose of pharmaceuticals in this way.

3. Stable
Unlike the current patchwork of funding used by U.S. programs, an EPR program provides secure, long-term funding. The aforementioned program in British Columbia started their mandatory Medications Return Program in 1996 with a program revamp in 2004. The pharmaceutical industry, therefore, has been funding the entire cost of the program for over 19 years.

4. Ready to Go
Momentum is growing: Alameda County, CA; King County, WA; and San Francisco, CA have all adopted EPR laws. Despite having been willing EPR partners in other countries, pharmaceutical manufacturers have challenged the Alameda law in court. Considering the narrow grounds of the appeal and improvements made to subsequent iterations of the law, other communities will soon be passing pharmaceutical EPR laws.

Please consider promoting an EPR bill in your county or state. Each new EPR law brings us one step closer to a national program.

Ed Gottlieb is the Chair of the Coalition for Safe Medication Disposal in Tompkins County, NY. Ed can be contacted at egottlieb@cityofithaca.org. 

The Faces of Despair – Something We Can Change

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I stared at the faces – perhaps one hundred individual photos, side-by-side – of all ages, sizes, and colors – cut down by the ravages of prescription drug abuse.

For the most part they were ordinary people, like you and me. A few fit the stereotype drug addict depicted on TV – disheveled, worn beyond years, tired, and glazed. But most were the epitome of success, gleaming with promise and potential.

As I gazed into their eyes in the lobby of the Omni Orlando Resort at ChampionsGate, which hosted the 2013 National Rx Drug Abuse Summit, the importance of our work on leftover pharmaceuticals solidly hit home. I can help prevent a death. I can help save a life. In fact, we can all help prevent drug abuse, and the death and destruction that appear in its wake.

I understand the over-simplicity in my statements. Every person carries historical baggage, and for some people, it may seem just too complicated, too heavy, too difficult, and too much to bear. All the support in the world might not help at times. But we can remove barriers to the chance for a healthy life, and provide needed support. One of those barriers is that too many drugs are lying around the home when they should be cleaned out and safely destroyed. I do not want to overlook the environmental and aquatic impacts of leftover medications in our waterways. But make no mistake: drug abuse drives the issue of pharmaceutical take-back.

Prescription drug abuse is the fastest growing drug problem in America and has been classified as an epidemic by the U.S. Centers for Disease Control and Prevention. Nationwide, unintentional prescription opioid overdoses kill more Americans than cocaine and heroin combined. A host of federal agencies, including the Drug Enforcement Administration, Environmental Protection Agency, and the Office of National Drug Control Policy, recommend that leftover medicine be brought to take-back programs for safe collection and disposal. So do 43 states.

We know the problem, and we know at least part of the solution. But we also need a way to pay for the means to educate people about the problem of drug abuse, make them aware of the need for safe disposal, and increase the availability of take-back programs. To date, the pharmaceutical companies that make the drugs, particularly addictive opioids like OxyContin and Percocet, have refused to take any degree of responsibility for safely disposing of leftover medications from the home. Not only is there a lack of convenient options to safely dispose of leftover medicine, there is an epidemic of over-prescription.

Two counties have stepped forward to lead a national effort to reverse this trend – Alameda County, California, and King County, Washington. PSI is supporting both of these agencies in their efforts to hold pharmaceutical companies responsible for financing and managing programs to safely collect and destroy leftover home medicines. Thousands of U.S. government agencies support this approach. Provinces in Canada and countries in Europe already successfully and cost-effectively run take-back programs financed and managed by pharmaceutical companies.

PSI is fortunate to have sensed the rise of this issue seven years ago. With the help of many of you, we began the slow, deliberate process of building national support for leftover drug take-backs, changing the federal Controlled Substances Act and associated Drug Enforcement Administration regulations (still in draft form). We are helping to implement the King County law and are setting up voluntary collection sites and raising awareness in rural counties in Washington and Oregon as pilots for national replication. We also finished a three-year project in the Great Lakes, where our coalition developed a model producer responsibility program, created a comprehensive online resource for anyone looking for more information about what to do with their leftover medications, compiled a series of “Lessons Learned” to assist communities nationwide, and created a consumer-friendly info sheet to educate people on what to do with leftover medicine. For these efforts, PSI was honored with a “A Million Thanks”  award from Covanta Energy. Personally, I find it rewarding to take part in such worthy efforts, and feel fortunate to have the opportunity.

Please help PSI do more by joining our effort. I have never solicited funds on this blog post before. But the devastating effects of drug abuse are happening right now, right before our very eyes, insidiously belying normalcy. Please consider becoming a PSI partner, making a donation*, or offering a sponsorship* to help us reverse this growing trend. Neil Young sang about every junkie being “like a setting sun.” Together, we have the power to let them see the sunrise.

*To make a donation to PSI or offer a sponsorship, contact Amanda Nicholson at 617.236.4833 or by email at amanda(at)productstewardship(dot)us.

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Recommendations on the Safe Collection, Transport, and Disposal of Controlled Substances

I wanted to share the endorsed comments I provided for the Product Stewardship Institute at the DEA’s public hearing yesterday. Thank you to the 119 endorsers for helping me to deliver the message that these considerations for the DEA’s rulemaking process are widely supported by groups concerned about the future and improvement of drug take-back programs around the country. The DEA, EPA, FDA, ONDCP, CMS, and USPS were all present. Congressman Jay Inslee from Washington opened the second day.

 

In two days of comments by both federal agencies and members of the public (including local government, state government, waste companies, reverse distributors, data companies, environmental organizations, law enforcement, pharmacies and pharmacists, drug abuse prevention groups, poison control, academic institutions, the pharmaceutical industry, and on incredibly moving grieving father), a number of themes were repeated by multiple presenters:

  • Communities need a range of options for secure disposal of controlled substances and other pharmaceutical drugs. Those mentioned included collection at pharmacy and other community locations, mail-back from the home, and HHW.
  • Take-back programs (including all methods described above) should be able to include both controlled and non-controlled substances without sorting them.
  • Take-back programs must be convenient and accessible to the public.
  • Security to prevent diversion is critical, including tracking of containers, tamper evident seals, locked containers, and other such measures.
  • Regulations should not require that individual pills/vials/etc. be counted and logged.

In addition, the question of who should pay for take-back programs was brought up many times in spite of the fact that this important question lies outside of the DEA’s responsibility under this rulemaking. There were many references to needing “public-private partnerships,” support/sponsorship from companies, and/or calling on the pharmaceutical industry to fund take-back programs. The importance of reducing drug waste was also mentioned. We look forward to seeing and commenting on the DEA’s proposed rule-making in the near future.

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PSI Recommendations for Rulemaking under CSA Amendment

I get 10 minutes in front of the Drug Enforcement Administration (DEA) next week to drive home some key points about what they can do to help make drug take-back easier and less expensive. DEA is in the process of developing regulations under the Secure and Responsible Drug Disposal Act of 2010 (see the fact sheet), which we all helped to pass.
 
Please help me to state your case by endorsing the Recommendations on the Safe Collection, Transport, and Disposal of Controlled Substances statement. This is an updated version of the one we developed in 2009 which was very effective in promoting the changed in federal law. I was told by the Office of National Drug Control Policy that having an updated document and an even longer endorsement list would be very helpful. In addition to bringing this to DEA, I will share it with this key coordinating agency.
 
We are seeking 100 endorsements by Tuesday morning at 9:30 am EASTERN. Yes, timing is tight, but we want to capture any and all of you out there who are able to turn this around quickly! To sign up as an endorser, please email me at sierra@productstewardship.us.
 
Thank you all very much! I encourage you to share this with others who are concerned with this issue. Agencies, organizations, and companies are all welcome!

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