1. No category

CLAAD
Center for Lawful Access
and Abuse Deterrence
2014 ANNUAL REPORT
About CLAAD
The not-for-profit Center for Lawful Access
and Abuse Deterrence (CLAAD) coordinates
a comprehensive national effort to prevent
prescription drug fraud, diversion, misuse,
and abuse while advancing consumer
access to high-quality health care.
CLAAD enables health professionals, law
enforcement, businesses, government
officials, and others to share resources and
work together to improve public health
and safety. We foster collaboration among
the multiple sectors of society that had
previously been working concurrently, yet
not in unison, to address the growing
national concern for prescription drug
abuse.
CLAAD gathers information and research
on prescription drug fraud, abuse, misuse,
and diversion. We also coordinate
grassroots activities among interested
organizations and make policy
recommendations on prescription drug
abuse with the goal of improving the
public health.
CLAAD’s policy positions are established
through a consensus process, in which at
least 80 percent of the participants must
represent not-for-profit organizations. This
rule of governance ensures that the public
interest drives CLAAD’s priorities, as
opposed to the interests of individual
stakeholders.
Policy Leadership. Information and
Analysis. Coalition Building.
Since 2009, the Center for Lawful Access and Abuse Deterrence (CLAAD) and its diverse
coalition of not-for-profit public health and safety and commercial organizations have
encouraged a balanced approach to the prescription drug abuse epidemic. In 2014, our
efforts resulted in progress, having witnessed the first decline in opioid-related overdose
deaths in over a decade.1 While there is still much more to do, this Annual Report
summarizes the work we did last year towards achieving our mission.
As the prescription drug abuse epidemic continues to evolve, unintended consequences
of well-intentioned policy approaches are beginning to emerge. Although efforts to
reduce the supply of opioid medications available for abuse are proving to be successful,
the pendulum has swung back, resulting in adverse effects. These include inadequate
reduction in demand; increased misuse of heroin, buprenorphine, benzodiazepines, and
stimulants; the proliferation of counterfeit and analog drugs; black market novel biologics;
and fraud and abuse in testing for substance use.
In 2015, through its National Prescription Drug Abuse Prevention Policy Meeting and
National Prescription Drug Abuse Prevention Strategy, CLAAD and its coalition will continue
to share perspectives, discuss policy, provide analysis, and build consensus, maximizing
the use of limited resources by harmonizing efforts.
Commercial coalition members that provided funding support to CLAAD in 2014 included
4Thought Products, AbbVie, Allergan, Egalet, Endo Pharmaceuticals, Grünenthal USA,
Mallinckrodt Pharmaceuticals, Millennium Health, Otsuka, Purdue Pharma, Signature
Therapeutics, Two Dreams, and Watauga Recovery Center.
[1] Donna Leinwand Leger, Painkiller deaths drop for first time since 1999, USA TODAY (Oct. 15, 2014), http://www.usatoday.com/story/news/nation/2014/10/15/painkiller-deaths-drop-for-thefirst-time-since-1999/17262383/.
Policy Leadership
•
Abuse-Deterrent Formulations (ADFs) Manuscript – Authored an
original manuscript entitled Abuse-Deterrent Formulations:
Transitioning the Pharmaceutical Market To Improve Patient and Public
Health and Safety. The article assessed the pros and cons of abusedeterrent medications to reduce the attractiveness or drug-liking
qualities of powerful controlled substances and called for the U.S. Food
and Drug Administration and Congress to implement concrete
strategies to transition the market to ADFs for all Schedule II and III
controlled substances.
•
Differential Diagnosis Policy Paper – Authored policy document that
discusses differential diagnosis of low back pain, misprescribing of an
opioid pain medication when a non-opioid would be more
appropriate, and the ensuing impact on patients. The document is
currently being reviewed and considered for publication by health
policy journals.
•
Pain Care Forum and Federal Legislative Recommendations –
Authored draft legislation consisting of 12 sections that, if enacted,
would effectively reduce prescription drug abuse. The proposal was
presented in-person to U.S. Senate Health, Education, Labor, and
Pensions Committee majority and minority staff in October.
•
Urine Drug Testing Policy Proposals – Through policy outreach to its
coalition, CLAAD formulated principles for the application of urine
drug testing to be applied to addiction treatment. CLAAD
communicated these principles to state and federal policy makers
throughout 2014:
Where We’ve Been •
Connect With CLAAD @CLAAD_Coalition http://goo.gl/qs8glP *
[email protected] •
o
Comments to Oklahoma Health Care Authority (Nov. 10)
o
Letter to CLAAD Letter to MassHealth (Dec. 16)
o
Letter to Centers for Medicare and Medicaid Services and
Palmetto GBA (Aug. 27)
o
Letter to Noridian Healthcare Solutions, LLC (Feb. 7)
Safer Prescribing Policy Proposals – CLAAD developed safer
prescribing standards in July through collaboration with its coalition
partners as well as policy analyses from states at the forefront of
addressing prescription drug abuse, such as Florida and Kentucky.
CLAAD has since proposed these safer prescribing guidelines for
certain controlled substances in multiple states:
o
Letter to Alabama Board of Medical Examiners (Sept. 3, July 16)
o
Letter to Vermont Governor Peter Shumlin (Apr. 23)
o
Letter to Delaware State Board of Pharmacy and Division of
Public Health (July 21)
State Legislation – CLAAD drafted the Overdose Death Prevention
Act (ODPA) in partnership with the Narcotics Overdose Prevention &
Education (NOPE) Task Force. The ODPA would require emergency
department staff to notify a patient’s primary care physician, the
emergency contact or the next of kin, and, if the patient is currently
undergoing addiction treatment, the treatment provider, that the
patient has suffered a life-threatening, non-fatal overdose. Language is
currently being proposed to lawmakers ahead of Florida’s 2015
Policy Leadership continued
•
Policy Outreach and Sign-On Letters
o
Letter to U.S. Senate Judiciary Committee Chairman Patrick Leahy (D-VT) and Ranking Member Charles
Grassley (R-IA) in support of White House Office of National Drug Control Policy Acting Director Michael
Botticelli’s nomination (Nov. 11)
o
Letter to U.S. Senators Orrin Hatch (R-UT) and Sheldon Whitehouse (D-RI) in support of their bill, the
Regulatory, Transparency, Patient Access, and Effective Drug Enforcement Act of 2014 (Oct. 14)
o
Letter to U.S. Department of Health and Human Services Secretary Sylvia Mathews Burwell in support of U.S.
Food and Drug Administration Commissioner Margaret Hamburg amid calls for her resignation (Oct. 8, 2014);
received reply on Oct. 21 from Center for Drug Evaluation and Research Deputy Director Douglas
Throckmorton
o
Letter to nine governors appointed to the National Governors Association Health and Human Services
Committee seeking continued focus on reducing prescription drug abuse (Sept. 19)
o
Letter to the Centers for Medicare and Medicaid Services seeking reform of the Physician Payments Sunshine
Act (Sept. 15)
o
Letter to Alabama Board of Medical Examiners regarding favorable proposed rule to indiscriminately apply
safer prescribing standards for powerful controlled substances (Sept. 8)
o
Submitted Citizen Petition and corresponding letter to the Center for Substance Abuse Treatment in support
of amending the Drug Addiction Treatment Act of 2000 (Sept. 3)
o
Letter to Health Canada regarding proposed regulations related to tamper resistance under the Controlled
Drugs and Substances Act (Aug. 26)
o
Letter to Department of Health and Human Services Secretary Sylvia Mathews Burwell urging the Obama
Administration to address limited benefits, high cost-sharing, and lack of transparency in the Health
Insurance Marketplace (“exchanges”) (July 28)
o
Letter to U.S. Representative Tom Marino (R-PA) in support of the Ensuring Patient Access and Effective Drug
Enforcement Act of 2014 (July 25)
o
Letter to U.S. Senator Jeanne Shaheen (D-NH) in support of the National All Schedules Prescription Electronic
Reporting (NASPER) Reauthorization Act to strengthen prescription monitoring programs (July 18)
o
Letter to Food and Drug Administration supporting Citizen Petition No. FDA-2014-P-0205 to impose
safety labeling changes on immediate-release opioid analgesics (Mar. 13)
Policy Leadership continued
•
Meetings and Events
o
Hosted the seventh annual National Prescription Drug Abuse
Prevention Policy Meeting in Washington, D.C. with 36
participants representing 30 not-for-profit public health and
safety organizations, private companies, and government
officials to collaborate and share the limited resources
available to reduce prescription drug abuse (Dec. 2)
o
Attended the Appropriate and Safe Use of Prescription Pain
Medication Advisory Board meeting in Chicago, Illinois
(Dec. 3-4)
o
Attended the National Association of Drug Diversion Investigators 25th Annual Conference in Cincinnati, Ohio
(Nov. 17-19)
o
Attended the U.S. Food and Drug Administration Public Meeting on the Development and Regulation of AbuseDeterrent Opioid Medications in Silver Spring, Maryland (Oct. 30-31)
o
Hosted a Policy Discussion on Protecting Consumers from Black Market Prescription Drugs in Washington, D.C.
with participants representing 17 organizations, including not-for-profit public health and safety organizations,
industry, and government officials (Oct. 21)
o
Presented “Addressing an Evolving Epidemic Through Substance Use Intervention and Treatment Policies” at the
International Nurses Society on Addictions 38th Annual Educational Conference in Washington, D.C. (Oct. 16)
o
Attended the National Consumers League Trumpeter Awards in Washington, D.C. (Oct. 8)
o
Attended Capitol Hill briefing hosted by the Alliance for Health Reform and the Pharmaceutical Care
Management Association entitled “Prescription Opioid Abuse: Fighting Back on Many Fronts” (Sept. 29)
o
Exhibited at the Partnership for Safe Medicines Interchange 2014 meeting in Washington, D.C. (Sept. 18)
o
Presented “Addressing an Evolving Epidemic Through Substance Use Intervention and Treatment Policies”
at the American Society of Pain Management Nursing 24th National Conference in Atlanta, Georgia (Sept. 17)
o
Presented “Proper Utilization of Urine Testing in Identifying and Treating Substance Use Disorders” and
“Leveraging the Equity Act and ACA To Improve Access to Treatment for Substance Use” at the 27th Annual Cape
Cod Symposium on Addictive Disorders in Hyannis, Massachusetts (Sept. 11)
o
Attended an Arthritis Foundation Capitol Hill briefing on back pain in Washington, D.C. (Sept. 5)
o
Attended the Entertainment Industries Council PRISM Awards Showcase in Washington, D.C. (Sept. 3)
o
Presented “From Campuses to Capitals: Activating the Recovery Community To Address Evolving Trends in
Substance Use” at the Generation Rx University Conference in Columbus, Ohio (Aug. 7)
o
Attended a Congressional Forum on Women and Addiction in Washington, D.C., hosted by U.S. Senators
Sheldon Whitehouse (D-RI), Rob Portman (R-OH), Amy Klobuchar (D-MN), and Kelly Ayotte (R-NH) (July 22)
o
Presented “Prescription Drug Monitoring Programs: An Exploration of Best Practices and Opportunities for
Collaboration” at the National Association of Attorneys General Summer Meeting in San Diego, California (June 4)
o
Moderated “Avoiding the Dangers of Rumor-Based Medicine” and “Integrating PDMP Data Into the Clinical
Workflow” at the National Rx Drug Abuse Summit in Atlanta, Georgia (Apr. 22)
o
Presented “Prescription Drug Abuse: Legal Strategies to Curb the Evolution of the Epidemic” at the National
Association of Attorneys General Southern Region Meeting in Point Clear, Alabama (Apr. 2)
o
Presented “Choices and Consequences: Health Policy and the Affordable Care Act” at the University of Arkansas
Law Review Symposium in Little Rock, Arkansas (Feb. 28)
o
Presented “Legal and Policy Strategies To Address and Evolving Epidemic” at the West Virginia Law Review
Symposium in Morgantown, West Virginia (Feb. 13)
o
Moderator at the Addiction Executives Industry (aXis) Summit in Naples, Florida (Feb. 9)
o
Presented “Prescription Drug Fraud, Diversion, and Abuse: Policies To Address the Evolving Epidemic” at the
National Sheriffs’ Association 2014 Winter Conference in Fort Lauderdale, Florida (Jan. 24)
Coalition Building
“I am pleased to see that
CLAAD has brought
together so many dedicated
stakeholders in putting
forward a comprehensive
plan to improve medicine,
strengthen drug education,
and ensure our children have
a bright, drug-free future.”
•
Missouri Prescription Drug Monitoring Program NOW (PDMP NOW)
Coalition – CLAAD joined the Missouri PDMP NOW Coalition with more than 30
other organizations supporting implementation of a PDMP in Missouri, the last state
without a program. Coalition members include not-for-profit public health and
safety organizations and pharmaceutical manufacturers.
•
Outreach and Awareness – Throughout 2014, CLAAD conducted outreach to
dozens of not-for-profit organizations in order to grow its footprint and raise
awareness of prescription drug abuse issues. Organizations include Trust for
America’s Health, National Governors Association, U.S. Conference of Mayors,
Pew Charitable Trusts, Clinton Foundation, Transforming Youth Recovery, Arthritis
Foundation, NCAA, The Jed Foundation, Johns Hopkins Bloomberg School of Public
Health, Legal Action Center, National Association of Counties, Network for Public
Health Law, and State Association of Addiction Services, among others.
•
Commercial Coalition Members – CLAAD secured support from multiple for-profit
organizations that share our dual mission to reduce prescription drug abuse and
optimize patient access to high quality health care.
•
Collaboration – CLAAD urged Physicians for Responsible Opioid Prescribing (PROP)
and Phoenix House to focus efforts toward collaboration among groups working to
reduce prescription drug abuse.
– HAROLD ‘HAL’ ROGERS
U.S. CONGRESSMAN (KY-05)
Non-Profits & Government at CLAAD’s Policy Meeting
Alliance for Safe Online Pharmacies
Allies in Recovery
Narcotics Overdose Prevention & Education
(NOPE) Task Force
American Pharmacists Association
National Alliance for Model State Drug Laws
American Society for Pain Management Nursing
National Association of Attorneys General
American Society of Addiction Medicine
National District Attorneys Association
American Society of Anesthesiologists
National Family Partnership
Community Anti-Drug Coalitions of America
National Governors Association
Drug Free America Foundation
National Sheriffs’ Association
Healthcare Distribution Management Association
Northeastern University
International Nurses Society on Addictions
Office of the State Attorney,
15th Judicial Circuit of Florida
Johns Hopkins Bloomberg School of Public Health
Information and Analysis
•
Collegiate Recovery Communities – Drafted blog post for Generation Rx Initiative entitled “Collegiate Recovery
Communities: Bringing Substance Use Disorders Out of the Shadows and Into the Sunlight” (Nov. 20)
•
Legislative Analysis – Monitored and analyzed federal and state legislation to provide support and feedback as it
relates to safer prescribing standards for controlled substances,
addiction treatment, abuse-deterrent medications, and other related
topics.
•
Media Exposure
•
•
o
Weighed in on a KTNV 13 ABC News of Nevada consumer
investigative report regarding hydrocodone rescheduling and
its impact on access to care for patients (Nov. 17)
o
Participated in a BioCentury TV interview about abusedeterrent medications (Nov. 10)
o
Submitted to PainDr.com an op-ed on the need for
collaboration among groups working to reduce prescription
drug abuse (Aug. 14)
o
Participated in an in-PharmaTechnologist.com report
on abuse-deterrent formulations (Aug. 6)
Commercial Support
o
Drafted opinion-editorial entitled “Let’s Convert Fear Into
Meaningful Change” about the need for balanced policies
that will reduce prescription drug abuse (June 17)
o
Participated in FDA Week story entitled “Opioid Promotion
Lawsuit Heightens FDA Painkiller Oversight Debate” (May 30)
o
Drafted op-ed about unsafe prescribing practices
entitled “Blowing the Whistle on Dirty Docs” (May 29)
o
Drafted op-ed about ACLU lawsuit exemplifying confusion
regarding therapeutic testing for substance use (May 29)
CLAAD receives funding and in-kind support from
businesses in the health care field that share
CLAAD’s mission to reduce prescription drug fraud,
diversion, misuse, and abuse while advancing
consumer access to high-quality health care.
CLAAD’s commercial supporters include
pharmaceutical companies (both abuse-deterrent
opioid manufacturers and non-opioid
manufacturers), treatment centers, and the urine
drug testing (UDT) industry.
o
Participated in Inside Health Policy story entitled “States
Should Focus Efforts On Prescribing, Dispensing Limits,
Sources Say” (Apr. 17)
Marketing and Communications – Overhaul of CLAAD website,
National Prescription Drug Abuse Prevention Policy Meeting website,
production of marketing materials, and expansion of email
distribution list to more than 1,000 supporters, partners, and other
stakeholders.
CLAAD is managed by DCBA Law & Policy (DCBA).
DCBA also provides legal and policy counsel to
professionals and businesses whose activities align
with CLAAD’s mission. To avoid conflicts of interest,
DCBA adheres to the District of Columbia Rules of
Professional Conduct §§ 1.7-1.9. Expanded Social Media Presence – Garnered attention from highprofile public figures through social media, including U.S. Senator
Amy Klobuchar (D-MN), White House Office of National Drug Control
Policy Director Michael Botticelli, Mississippi Attorney General Jim
Hood, former U.S. Representative Mary Bono (R-CA), former Rhode
Island State Representative Tom Coderre, and Emmy-winning actress
Kristen Johnston.
Treatment
2%
ADF
Opioid
39%
UDT
28%
Nonopioid
31%
Contact CLAAD
Center for Lawful Access and Abuse Deterrence
1000 Potomac Street, NW, Suite 150-A
Washington, D.C. 20007
Telephone: (202) 599-8435
Fax: (202) 459-9611
[email protected]
www.claad.org