the dea regulations_final

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

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.

Session Learning Objec#ves

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, 4 local agencies

•  Advisory Council: Mul)-‐stakeholder (14 members)

Global Product Stewardship Council (PSI represented on Board of Directors)

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

8

•  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.

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

N= 562 (some respondents selected mul:ple methods)

N= 926 (some respondents selected mul:ple sources)

•  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)

12

43%

26%

22%

9%

Primary Funding Mechanism of Drug Take-‐Back Programs

Self-‐funded, 43%

Sponsors, 26%

Grants, 22%

Other, 9%

53%

19%

17%

8%

3%

Collec)on Method of Drug Take-‐Back Programs

Drop-‐off (Pharmacy), 53% Drop-‐off (Police Sta#on), 19% One-‐Day Events, 17%

Other, 8%

Direct Mail Back, 3%

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:

•  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.

•  On-‐going •  Convenient •  Able to accept all drugs from

households

•  Free at the point of delivery for disposal •  Secure •  Widely promoted

13

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

What is Product Stewardship?

14

Product Stewardship

Extended Producer

Responsibility (EPR)

• Mandatory product stewardship

• Producers hold financial and managerial responsibility for post-‐consumer products and packaging

• Central tenet of product stewardship

What is Extended Producer Responsibility (EPR)?

15

Extended Producer

Responsibility (EPR)

What might EPR for Pharmaceu#cals Really Look Like?

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

Scob Cassel PSI Chief Execu#ve Officer & Founder

617-‐236-‐4822

[email protected] www.productstewardship.us

Contact

22


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)

Links-‐Website, Map, PSA’s

•  h=p://www.greatlakescleanwater.org

•  Par#cipa#ng Pharmacy Map

•  h=p://www.youtube.com/user/GreatLakesCleanWater

Contact Info

Chris Angel President, Volunteer Board of Directors Great Lakes Clean Water Organiza#on [email protected] www.greatlakescleanwater.org 989-‐736-‐8179


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 Impacts When Drugs Get Into the Wrong Hands

Easy access to prescription drugs has led to a growing number of teens whom the Partnership for a Drug-Free America refers to as “Generation Rx.”

Nationwide, 1.5 Million kids say they have abused prescription drugs. The 2010 National Survey on Drug Use and Health indicates that over 70 percent of Americans 12 and older who used pain relievers non-medically in the previous year obtained the drugs from a friend or relative.

Emergency room visits are greater for prescription drugs than marijuana and heroin COMBINED, according to the Drug 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.”


•  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.


•  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.


•  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.

the dea regulations_final

Documents

proprietary

nancial relaonships

disease control

pharmaceu

problem

drugs

services

directors