Na#onal Rx Drug Abuse Summit Pharmaceu)cal Take-‐Back and the Proposed DEA Regula)ons Pharmacy Track – April 3, 2013 Sco= Cassel, CEO and Founder The Product Stewardship Ins#tute 1
Disclosure Statement Sco= Cassel has no has no ﬁnancial rela#onships with proprietary en##es that produce health care goods and services. Chris Angel has no ﬁnancial rela#onships with proprietary en##es that produce health care goods and services. Phil Burgess has no ﬁnancial rela#onships with proprietary en##es that produce health care goods and services. 2
Session Learning Objec#ves 1. Iden#fy the basis and eﬀects of the proposed DEA regula#ons. 2. Lay out the impact of the proposed regula#ons. 3. Construct a plan of ac#on to implement the DEA regula#ons and pill take-‐back programs in the a=endee’s community. 3
Topics I will cover today • The Problem – Improper Disposal of Pharmaceu)cals • Safety issues • Environmental concerns • The Solu)on: Pharmaceu)cal Take-‐Back programs • Support for Take-‐Back • Trends -‐ U.S. and interna#onal • Why exis#ng eﬀorts are not solving the problem • Overview of Product Stewardship and Extended Producer Responsibility (EPR) for Managing Waste Pharmaceu)cals • Legisla#ve ac#vity at local, state, and federal levels • Overview of DEA’s Proposed Regula)ons Regarding the Disposal of Controlled Substances 4
Who is the Product Stewardship Ins#tute? • Non-‐proﬁt founded in 2000 • Memberships 47 States 200+ Local governments • Partnerships (95+) Companies Organiza#ons Universi#es Non-‐US Governments • Board of Directors: 7 states, Global Product Stewardship Council 4 local agencies (PSI represented on Board of Directors) • Advisory Council: Mul)-‐ stakeholder (14 members) 5
The Problem: Drug-‐induced deaths second only to motor vehicle fatali#es (1999–2007) Source: Na#onal Center for Health Sta#s#cs, Centers for Disease Control and Preven#on. Na#onal Vital Sta#s#cs Reports Deaths: Final Data for the years 1999 to 2007 (2001 to 2010). 6
The Problem: Prescrip#on Drug Abuse Classiﬁed as an “epidemic” by the Centers for Disease Control and Preven#on 7 out of 10 prescrip#on drug abusers obtained their drugs from friends or rela#ves 7
The Problem: Accidental Poisonings • Startling facts from the Centers for Disease Control and Preven)on: • In 2009, 76% of poisoning deaths in the U.S. were uninten#onal • In 2009, 91% of all uninten#onal poisoning deaths were caused by drugs. • Among children, emergency room visits for drug poisonings (excluding misuse or abuse) are twice as common as poisonings from other household products (e.g., cleaning solu#ons) 1 • Between 2004 and 2005, an es#mated 71,000 children (<18 years of age) were seen in emergency rooms due to drug poisonings (excluding abuse and recrea#onal drug use). • Over 80% were because an unsupervised child found and consumed medica#ons. 1 1Schillie SF, Shehab, N, Thomas, KE, Budnitz DS. Medica#on overdoses leading to emergency department visits among children. Am J Prev Med 2009;37:181-‐187. 8
The Problem: Environmental Concerns • Medicines enter our waterways via a number of channels: • Agricultural run-‐oﬀ • Human excre#on • Improper disposal • Eﬀects in the environment: • Aqua#c impacts • Poten#al contamina#on of drinking water • Current wastewater treatment plants not designed to remove pharmaceu#cal compounds 9
Pharmaceu#cal Take-‐Back Programs • One-‐day “ Take-‐Back” events operated by: • Law enforcement (can accept controlled substances) • Local governments/Household Hazardous Waste collec#ons • Community organiza#ons and other NGOs • Permanent collec)ons located at: • Police departments (can accept controlled substances) • Retail pharmacies • Healthcare facili#es, community centers, etc. • Mail-‐back programs • Law enforcement • Retail pharmacies (partnering with reverse distributors) – for a fee • University pilots (e.g., University of Maine, University of Wisconsin Extension) 10
Support for Drug Take-‐Back • Drug Enforcement Administra)on (DEA) • Held 5 Na#onal Prescrip#on Drug Take-‐Back Days since 2010 next event scheduled for April 27, 2013 • Oﬃce of Na)onal Drug Control Policy (ONDCP) • Supports drug take-‐back as part of its Na#onal Drug Control Strategy • Food and Drug Administra)on (FDA) • Worked with ONDCP to develop guidelines for drug disposal recommends disposal via drug take-‐back programs • Environmental Protec)on Agency (EPA) • Encourages the public to take advantage of drug take-‐back programs • 43 states directly promote drug take-‐back • Agency websites provide informa#on either on their own state programs and/ or federal DEA Take-‐Back Days 11
Status of Pharmaceu#cal Take-‐Back Programs • Over 500 take-‐back programs currently opera#ng across the country, but the majority of Americans do not have access to a convenient take-‐back loca#on Results from Community Medical Founda:on for Pa:ent Safety’s Survey of Drug Take-‐Back and Disposal Programs (2009 , 2010) Collec)on Method of Drug Take-‐Back Primary Funding Mechanism of Drug Take-‐ Programs Back Programs 3% Drop-‐oﬀ (Pharmacy), 53% Self-‐funded, 43% 8% Drop-‐oﬀ (Police 9% Sta#on), 19% Sponsors, 26% 17% 22% 43% One-‐Day Events, 17% 53% Grants, 22% 19% Other, 8% 26% Other, 9% Direct Mail Back, 3% N= 562 (some respondents N= 926 (some respondents selected selected mul:ple methods) mul:ple sources) 12
Why aren’t exis#ng eﬀorts solving the problem? PSI developed Key Elements of Pharmaceu)cal Collec)on and Disposal Programs: A Vision for the Great Lakes Region • In order to protect public health and the environment, programs should be: • On-‐going • Free at the point of delivery for disposal • Convenient • Secure • Able to accept all drugs from • Widely promoted households • Programs should minimize impact on the environment by ensuring collected medicines are properly destroyed according to exis#ng regula#ons. • Programs must be sustainably and adequately funded. • Programs should iden#fy and address the underlying drivers that contribute to pharmaceu#cal waste. 13
What is Product Stewardship? A policy approach that… • Minimizes health, safety, environmental, and social impacts • Maximizes economic beneﬁts of a product and its packaging • Considers all lifecycle stages, from design to end-‐of-‐life • Is either voluntary or required by law 14
What is Extended Producer Responsibility (EPR)? • Mandatory product stewardship Product Stewardship • Producers hold ﬁnancial and managerial responsibility for post-‐ Extended consumer products and Producer packaging Responsibility (EPR) • Central tenet of product stewardship 15
What might EPR for Pharmaceu#cals Really Look Like? Extended Producer Responsibility (EPR) 16
Federal Pharmaceu#cal Stewardship Legisla#on Pharmaceu)cal Stewardship Act of 2011 • Introduced by Congresswoman Louise Slaughter (NY) • First federal EPR bill on any product • Would create “Na#onal Pharmaceu#cal Stewardship Organiza#on,” with Directors appointed by EPA, to implement a na#onal EPR program • Rep. Slaughter plans to re-‐introduce in 2013 17
Pharmaceu#cal Stewardship Legisla#on State Level Bills introduced: California (2013) Florida (2009) Maine (2010) Maryland (2010) Minnesota (2010) New York (2011; 2013) Oregon (2009) Pennsylvania (2012) Washington (2011) 18
Local Approach to Pharmaceu#cal Stewardship • Na#on’s ﬁrst local EPR law, ﬁrst pharmaceu#cals EPR law • Requires pharmaceu#cal manufacturers to ﬁnance and manage a take-‐back program for unused and expired medica#ons • Industry lawsuit claiming law violates the Interstate Commerce Clause pending 19
Secure and Responsible Drug Disposal Act • Passed by Congress in October 2010 to provide a framework for allowing the public (i.e., ul#mate users) to dispose of their lesover and expired controlled substances safely and securely (more ﬂexibility & less costly) • Amends the Controlled Substances Act • Drug Enforcement Administra#on (DEA) to develop regula#ons regarding the disposal of controlled substances • January 2011 – public hearing held in Washington, D.C. • December 2012 – DEA issued proposed rule [Docket No. DEA -‐316]; comment period closed February 19, 2013 20
DEA Proposed Rule Disposal of Controlled Substances DEA proposed to expand collec#on op#ons for the disposal of controlled substances to include: 1. Take-‐back events – conducted by law enforcement agencies only. 2. Permanent collec)on sites – operated by DEA-‐authorized retail pharmacies, distributors, reverse distributors, law enforcement agencies, or manufacturers. Retail pharmacies may also operate collec#on receptacles at long–term care facili#es (“LTCFs”). 3. Mail-‐back programs – operated by DEA-‐authorized manufacturers, distributors, reverse distributors, retail pharmacies, or law enforcement agencies. 21
Pharmaceu)cal Take-‐Back and the Proposed DEA Regula)ons April 2 – 4, 2013 Omni Orlando Resort at ChampionsGate
Topics I will cover today 1. Understand the importance of drug take-‐back programs and the poten#al role for pharmaceu#cal stewardship in addressing drug abuse. 2. Iden#fy the basics of DEA’s proposed rule and the implica#ons for retail pharmacies. 3. Construct a plan of ac#on to par#cipate in a drug take-‐back program in the a=endees’ community following requirements proposed by the DEA
The Problem • Flushing unwanted/unused medica#ons • Associated Press Study • US Geological Study • DEQ – Michigan Department of Environmental Quality-‐Other State Regulatory Agencies • Prescrip#on Drug Abuse • DEA –Controlled Substances
Clean Water Safe Communi#es Environmental Reasons……… Substance Abuse Preven#on Reasons…… Law Enforcement Reasons…..
Clean Water Safe Communi#es We Agree on that! Let’s Work Together! What will you do when you get home from the Rx Drug Abuse Summit? Yellow Jug Old Drugs Program working in many communi#es to provide clean water and safe communi#es
Yellow Jug Old Drugs Program Overview Non Proﬁt Model Pharmacy based Area Served Number of par#cipa#ng Pharmacies 55,000 pounds collected
Yellow Jug Old Drugs Advantages • Pharmacy based and easily recognizable • Well thought out, strict protocol • Leverage grant funds-‐Sustainable aser grants • Low opera#onal cost / Volunteers • Professional Customer Service • Free publicity – News stories, Radio and Video public service announcements (PSAs) • More a=en#on on collec#on of controlled substances in communi#es that have YJOD • New DEA Regs to allow retail pharmacies to accept controlled substances
Proposed DEA Regs allow Retail Pharmacies to collect controlled Substances • Page 8 of the proposed regula#ons “authorized registrants that choose to maintain collec:on receptacles may be enhanced by increased consumer presence at their registered loca:ons and the goodwill that develops from providing a valuable community service”” Page 86 “A pharmacy may derive tangible beneﬁts such as addi:onal revenue from increased retail traﬃc to the pharmacy”
Substance Abuse Preven#on Partners Michigan Rx Be the Solu#on Campaign NMSAS www.drugfreenorthernmichigan.com/disposal.htmlaign h=p://www.barrycountysa}.com Royal Oak Community Coali#on The Alliance of Coali#ons for Healthy Communi#es (ACHC)
Contact Info Chris Angel President, Volunteer Board of Directors Great Lakes Clean Water Organiza#on firstname.lastname@example.org www.greatlakescleanwater.org 989-‐736-‐8179
Pharmaceu)cal Take-‐Back and the Proposed DEA Regula)ons Philip P. Burgess, RPh, DPh, MBA Chairman, Illinois State Board of Pharmacy April 2 – 4, 2013 Omni Orlando Resort at ChampionsGate
Topics I will cover today • 1. Understand the importance of drug take-‐ back programs and the poten#al role for pharmaceu#cal stewardship in addressing drug abuse. • 2. Iden#fy the basics of DEA’s proposed rule and the implica#ons for retail pharmacies. • 3. Construct a plan of ac#on to par#cipate in a drug take-‐back program in the a=endees’ community following requirements proposed by the DEA.
Role of State Boards of Pharmacy • Protect the health and welfare of the ci#zens of their respec#ve state. • Ac#ve involvement in drug disposal programs by pharmacists can have signiﬁcant posi#ve impact on pa#ent safety and improve pa#ent care • Delicate “balancing act” to decrease drug diversion while improving pa#ent safety.
Unused patient medication in the U.S.• Approximately 4 billion prescriptions are filled in the United States annually with an estimated 35%, or 200 million pounds go unused.• Improper disposal of unused medications can adversely effect the environment• Improper disposal or diversion of unused medications increases the risk of accidental poisoning and drug abuse.
Societal ImpactsWhen Drugs Get Into the Wrong HandsEasy access to prescription drugs has led to a growingnumber of teens whom the Partnership for a Drug-FreeAmerica refers to as Generation Rx.Nationwide, 1.5 Million kids say they have abusedprescription drugs. The 2010 National Survey on Drug Useand Health indicates that over 70 percent of Americans 12and older who used pain relievers non-medically in theprevious year obtained the drugs from a friend or relative.Emergency room visits are greater for prescription drugsthan marijuana and heroin COMBINED, according to theDrug Abuse Warning Network.
Why Pharmacists Should be Involved Pharmacists are posi#oned to play a huge role in helping properly dispose of unused medica#ons. The most readily available health care professional in the community. It makes sense to return the drugs from where they were ini#ally purchased.
Disposal Options The Prescription Pill & Drug Disposal Program is a multi-state, collaborative effort between communities, local pharmacies, police departments, hospitals and city officials. Locations such as pharmacies and police stations can participate by setting up drop-boxes for the public to drop off their old or unused prescription drugs. www.p2d2program.org
Disposal Options Minnesota s Take it to The Box program at participating police stations. Similar grassroots efforts are popping up nation-wide.
NCPA Dispose My Meds• In 2010, National Community Pharmacy Association developed a program to promote pharmacists involvement with drug disposal.• Pilot program in conjunction with the Iowa Pharmacy Association and the Iowa Board of Pharmacy.• Participating NCPA members listed on www.disposemymeds.org• To date: – 1,400 pharmacies participating – 70,000 lbs of drugs collected for safe disposal – The Secure and Responsible Drug Disposal Act (S. 3397), legislation backed by NCPA will improve and encourage voluntary prescription drug disposal programs like the Dispose My Meds program.
Impact of Proposed DEA Regula#ons “These regula#ons propose to allow authorized manufacturers, distributors, reverse distributors and retail pharmacies to voluntarily administer mail-‐back programs and maintain collec#on receptacles. In addi#on, this proposed rule expands the authority of authorized retail pharmacies to voluntarily maintain collec#on receptacles at long term care facili#es.”
Impact of Proposed DEA Regula#ons • Allows pharmacies to par#cipate in taking back controlled substance prescrip#ons from pa#ents without the requirement of direct law enforcement involvement. • Increased access to pa#ents for the proper disposal through drop-‐oﬀ kiosks in pharmacies or use of various mail-‐back programs. • Extensive record-‐keeping requirements.
Impact of Proposed DEA Regula#ons • Although most state pharmacy regula#ons mirror DEA, there will be selected states that will require changes to either their Pharmacy Prac#ce Acts or their Rules to allow the taking back of medica#ons in the pharmacies. • Un#l those changes are enacted, the use of the mail-‐back provisions will be the only op#on in those states.
Impact of Proposed DEA Regula#ons • Con#nues to allow law enforcement agencies to voluntarily conduct take-‐back events, administer mail-‐back programs, and maintain collec#on receptacles. • NOT ADDRESSED in the regula#ons is the need to be=er educate the prescribers to minimize the quan##es that are prescribed.