Upload
opunite
View
244
Download
1
Tags:
Embed Size (px)
DESCRIPTION
Citation preview
Clinical Track Panel Discussion: Avoiding the Dangers of Rumor-‐Based Medicine
Panelists:
Stacey Worthy, JD, Associate A6orney, DCBA Law and Policy
Dr. Seddon Savage, MD, MS, Chronic Pain and Recovery Center, Silver Hospital
Joseph T. Rannazzisi, JD, RPh, Office of Diversion Control, United States Drug Enforcement AdministraLon
Moderator: Michael C. Barnes, JD, Center for Lawful Access and Abuse Deterrence
Disclosures
• Stacey Worthy has no financial rela3onship with proprietary en33es that produce health care goods and services.
• Seddon Savage has no financial rela3onship with proprietary en33es that produce health care goods and services.
• Joseph T. Rannazzisi has no financial rela3onships to disclose and will not discuss off-‐label use and/or inves3ga3onal drug use in his presenta3on.
Learning Objec3ves
1. Describe factors health care providers must consider on a case-‐by-‐case basis before prescribing controlled substances.
2. Iden3fy reasonable efforts controlled substance prescribers may make to spot signs of medica3on diversion, misuse, or abuse.
3. Explain steps a prescriber may take to reduce the likelihood of liability without abandoning a pa3ent with a substance use disorder.
Avoiding the Dangers of Rumor-‐Based Medicine
Stacey Worthy has no financial rela3onship with proprietary en33es that produce health care
goods and services.
Preview
• Standards of care • Civil and criminal ac3ons
• Trends • Recent cases • How to avoid liability • Conclusion
Standards of Care
• Physicians have a legal duty to abide by the medical standard of care
• What happens if they don’t? – Professional Sanc3ons, Civil Liability, & Criminal Liability
• No universally accepted defini3on – Common: medical customs; reasonable, prudent physician; CSA
• Test encompassing all standards: – Legi3mate medical purpose – Within the usual course of medical prac3ce – Took reasonable steps to prevent harm
Civil & Criminal Ac3ons
• Medical Malprac3ce / Negligence (monetary) • Involuntary manslaughter (max. 4 years)
– High-‐risk ac3vity without due cau3on • Second-‐degree murder (min. 15 years)
– Conscious disregard for life • First-‐degree murder (typically life)
– Premedita3on – Felony-‐murder (death while commi`ng a felony, irrespec3ve of malice)
Trends
• Aggressive prosecu3on: professional sanc3ons & civil suits inadequate for par3cularly egregious offenders
• Tradi3onal defenses are no longer reliable – Contributory negligence (blaming the pa3ent)
– Good faith / trus3ng the pa3ent – Lack of foreseeability / willful ignorance – Calculated risk
Recent Cases
• People v. Murray (Los Angeles, 2011) – Convicted of involuntary manslaughter; 4 years – Administered lethal dosages of benzodiazepines and propofol – Ct. rejected pa3ent-‐blaming defense – Medical board revoked license post-‐sentencing in 2012
• Chua v. State (Georgia 2011) – Medical board suspended license; civil suit for malprac3ce
sedled – Convicted of felony-‐murder for death of pa3ent; life in prison – Prescribed oxycodone & distributed methadone; pa3ent’s
medical records showed padern of abuse; ignored warning signs – Defense of willful ignorance didn’t work
Recent Cases
• People v. Rodriguez (Florida 2013) – Pleaded guilty to manslaughter for deaths of 4 pa3ents; 27
years – Medical board revoked license and fined him $40K – Operated a “pill mill”; prescribed oxycodone, methadone, and
alprazolam without examining his pa3ents – Ct. rejected pa3ent-‐blaming defense
• People v. Klein (Florida 2012) (ongoing) – Charged with first-‐degree murder – Prescribed single prescrip3on for over 200 pills without
determining legi3mate medical need; pa3ent died the next day – Adempted to blame the pa3ent
Recent Cases
• People v. Tseng (Los Angeles 2012) (ongoing) – “Dr. Feelgood”; charged with second-‐degree murder – Responsible for 8 pa3ents’ deaths; prescribed without proper exam
– “If a pa3ent decides to take a month’s supply in a day, then there’s nothing I can do about that” (pa3ent-‐blaming / lack of foreseeability / willful ignorance)
– Voluntarily surrendered license; sedled civil case • William Mar3n Valuck (Oklahoma, 2013) (ongoing)
– Charged with first-‐degree murder for deaths of 9 pa3ent – Each had been prescribed between 250 and 600 pills – Surrendered license; civil suit pending
How to avoid liability
• Prescriber educa3on • Follow best prac3ces to meet the standard of care (Dr. Savage to elaborate)
Conclusion
• Michael C. Barnes & Stacey L. Sklaver, Ac=ve Verifica=on and Vigilance: A Method To Avoid Civil and Criminal Liability When Prescribing Controlled Substances, 15 DEPAUL J. HEALTH CARE L. 93(2013).
• LinkedIn.com/in/staceyworthy
• Thank you
A Clinician’s View of Professional Responsibilities
with Respect to Opioids
Seddon R. Savage MD, MS
Silver Hill Hospital Chronic Pain & Recovery Center and
Geisel School of Medicine at Dartmouth
Enduring Responsibilities
• To heal when possible &
to comfort always
• Above all else do no harm Hippocrates
AMA Code of Ethics A physician shall
• Provide competent care with compassion & respect for human dignity & rights
• Uphold standards of professionalism, be honest in professional interac3ons, & report physicians deficient in character or competence, or engaging in fraud
• Respect the rights of pa3ents, colleagues, & other health professionals & safeguard pa3ent confidences & privacy within constraints of the law
• Study, apply, & advance scien3fic knowledge, provide relevant informa3on to pa3ents, colleagues, & the public, obtain consulta3on, & refer when indicated
• Except in emergencies, be free to choose whom to serve, with whom to associate, & the environment in which to prac3ce
• Par3cipate in ac3vi3es to improve the community & beder the public health
• While caring for a pa3ent, regard responsibility to the pa3ent as paramount
• Support access to medical care for all people
(Paraphrased to shorten)
Accountability Systems for Physician Practice
• Professional – Peer review – Credentialing
• Regulatory – Boards of Medicine
• Meeting professional standards of care • Complying with AMA Code of Ethics (some states) • Compliance with state regulations, including State CSAs (+/- with AGs)
– DEA • CS registration & administrative compliance
• Civil – Malpractice liability
Accountability Systems for Physician Practice
• Criminal – Federal & State justice systems with respect to practice
related criminal behavior • Financial fraud • Some HIPAA violations • Credentialing fraud • Assaults • Other
– DEA with respect to CSA breach of providing CS • For no legitimate medical purpose • Outside the course of usual medical practice
• And then there is the Media…
Opioids are Unique
• Potent in healing. Potent in harm with misuse.
• Require practice strategies not required of other medications
• Relate to subjective patient domains that cannot be objectively measured – Pain
– Reward
Professional Standards with Respect to Opioids
• Continuously evolving
• Differ between states and communities
• Reasonable to consider FSMB guidelines as a practice standard – Informed by diverse professional perspectives
– Inform many state standards
– Detailed and proscriptive
Model Guideline on Opioids in Treatment of Chronic Pain, 2013
• Legitimate medical practice – Sound clinical judgment – Current best clinical practices – Appropriately documented – Of demonstrable benefit to the patient
• Usual course of practice – A legitimate physician-patient relationship exists – Medications are appropriate to the diagnosis – Care includes careful follow-up monitoring of
• Patient’s response to treatment • Safe use of the prescribed medication
– Therapy adjusted as indicated
Model Guideline on Opioids in Treatment of Chronic Pain, 2013
• Comprehensive pain assessment & indication for opioids
• Screen for risk (interview/screening tool, records, PDMP)
• Multidimensional treatment plan, adjusted to risk
• Clear goals of treatment & initiate opioids as a trial
• Written informed consent & treatment plan
• Monitor regularly & adjust plan
• Periodic drug screens & address findings
• Consultation & referral when appropriate
• Discontinue opioids if indicated, but not care http://www.fsmb.org/pdf/pain_policy_july2013.pdf
Systems Challenges with Respect to Opioids
• Ethically must have systems capacity to prescribe opioids when indicated – In a manner that addresses pain and deters harm
• Meeting practice standards requires a prepared office system – Challenging for small practices but doable – Opioid clinics or specialists within practice systems may
be helpful
Special Clinical Challenges with Respect to Opioids
• Perceived tension between “comfort always” & “do no harm”
• Hijacked (addicted) brain may result in conflict – Patient seeking care in their best interest
– Patient seeking drugs to satisfy the beast
• Profiteers may exploit compassionate physicians
• Experts manage complex high risk patients
Questions
• Should a physician prescribing opioids in the course of usual practice for a legitimate medical purpose, acting with due diligence within the standards of practice be subject to criminal prosecution due to a patients actions? Eg (overdose or sale of opioids)
• When do violations of professional standards become criminal acts?
Opioid Medications
Harm Healing
Joseph Rannazzisi Deputy Assistant Administrator Office of Diversion Control
I have no financial rela3onships to disclose and
I will not discuss off-‐label use and/or inves3ga3onal drug use in my presenta3on
Disclosure Statement
U.S. Drug Enforcement Administra3on Office of Diversion Control
Factors to be considered prior to prescribing a controlled substance
Discuss legal obliga3ons of the DEA registrant Discuss poten3al Red Flags and the process of
reconciling
Iden3fy methods of pharmaceu3cal diversion and discuss how a health care prac33oner can prevent diversion
Goals and Objectives
U.S. Drug Enforcement Administra3on Office of Diversion Control
Inadequate Pain Control
U.S. Drug Enforcement Administra3on Office of Diversion Control
We conclude that despite widespread use of narco3c drugs in hospitals, the development of addic3on is rare in medical pa3ents with no
history of addic3on.
U.S. Drug Enforcement Administra3on Office of Diversion Control
U.S. Drug Overdose Deaths by Major Drug Type, 1999-2010
Source: CDC/NCHS, NVSS U.S. Drug Enforcement Administra3on Office of Diversion Control
Source: 2004, 2007, 2008, 2009, 2010, 2011, 2012 National Survey on Drug Use and Health U.S. Drug Enforcement Administra3on
Office of Diversion Control
Drug Overdose Mortality Rates per 100,000 People 1999
Source: Trust for America’s Health, www.healthyamericans.org. “Prescription Drug Abuse: Strategies to Stop the Epidemic (2013)”
U.S. Drug Enforcement Administra3on Office of Diversion Control
Source: Trust for America’s Health, www.healthyamericans.org. “Prescription Drug Abuse: Strategies to Stop the Epidemic (2013)”
Drug Overdose Mortality Rates per 100,000 People 2010
U.S. Drug Enforcement Administra3on Office of Diversion Control
The Trinity
C-‐IV as of 1/11/2012
Hydrocodone
U.S. Drug Enforcement Administra3on Office of Diversion Control
The Controlled Substances Act
U.S. Drug Enforcement Administra3on Office of Diversion Control
CSA Registrant Population
March 20, 2014
Provisional registraEons in effect at the Eme CSA was passed (relaEve to the Harrison NarcoEcs Act of 1914)
U.S. Drug Enforcement Administra3on Office of Diversion Control
Foreign Mfr Importer Manufacturer
Distri-butor
Practitioner Pharmacy Hospital Clinic
Patient
?
Law: 21 USC 822 (a) (1) Persons Required to Register: “Every person who manufactures or distributes any Controlled Substance or List I Chemical or who proposes to engage in ..”
Law: 21 USC 822 (a) (2) Persons Required to Register: “Every person who dispenses, or who proposes to dispense any controlled substance ...”
Cyclic Investigations
Security Requirements
Recordkeeping Requirements
ARCOS Reporting
Established Quotas
Registration
Established Schedules
U.S. Drug Enforcement Administra3on Office of Diversion Control
Closed System of Distribution
U.S. Drug Enforcement Administra3on Office of Diversion Control
U.S. Drug Enforcement Administra3on Office of Diversion Control
The Controlled Substances Act
U.S. Drug Enforcement Administra3on Office of Diversion Control
The Flow of Pharmaceuticals
PATIENTS
Hospitals NTPs
21 CFR 1306.04
Physicians (Rx and drugs)
Pharmacies
QUOTAS Raw Material
Importers Imp - Manufacturers 21 USC 823(c)(1) 21 USC 823(d)(1) 21 CFR 1301.71 Dosage Form
Manufacturers
Manufacturers
Dosage Form Manufacturers
21 USC 823(b)(1) 21 USC 823(e)(1) 21 CFR 1301.71 21 CFR 1301.74 (Suspicious Orders) Wholesalers - Distributors Smaller Distributors
U.S. Drug Enforcement Administra3on Office of Diversion Control
Diversion via the Internet
U.S. Drug Enforcement Administra3on Office of Diversion Control
WA
OR ID
WY
ND
SD
MN
NE
WI MI
CO KS MO
IL IN UT
NV
CA
AZ NM OK
AR
LA
TN
KY
MS AL GA
SC
NC
OH
VA
PA
NY
ME
VT N
H
CT
DE WV
RI
MD
MA
Domestic ‘Rx’ Flow
MT MT
FL TX TX
2. Request goes through Website Server in San Antonio, TX
WS FL
IA IA NJ
1. Consumer in Montana orders hydrocodone on the Internet
C
3. Web Company (located in Miami, FL) adds request to queue for Physician approval
WC
4. Order is approved by Physician in New Jersey and returned to Web Company Dr.
S
6. Pharmacy in Iowa fills order and ships to Consumer via Shipper
Rx
5. Approved order then sent by Web Company to an affiliated Pharmacy
Purchases of hydrocodone by Known and Suspected Rogue Internet Pharmacies
January 1, 2006 – December 31, 2006
Date Prepared: 03/07/2007 Source: ARCOS
98,566,711
New Felony Offense Internet Trafficking - 10/15/2008
21 USC 841(h)(1): It shall be unlawful for any person to knowingly or intentionally:
(A) deliver, distribute, or dispense a controlled substance by means of the Internet, except as authorized by this title; or
(B) aid or abet any violation in (A)
U.S. Drug Enforcement Administra3on Office of Diversion Control
What has been the reaction????
Per Se Violations
No in-person medical evaluation by prescribing practitioner
Online pharmacy not properly registered with modified registration.
Website fails to display required information
U.S. Drug Enforcement Administra3on Office of Diversion Control
Problem Solved, Right?
Wrong!!!!!
The Emergence of Rogue Pain Clinics…
U.S. Drug Enforcement Administra3on Office of Diversion Control
Pain Clinics
U.S. Drug Enforcement Administra3on Office of Diversion Control
Explosion of South Florida Pain Clinics
As of June 4, 2010, Florida has received 1,118 applica3ons and has approved 1026 *As of May 14, 2010, Broward 142; Miami-‐Dade 79; Palm Beach 111 U.S. Drug Enforcement Administra3on
Office of Diversion Control
U.S. Drug Enforcement Administra3on Office of Diversion Control
Hydrocodone Oxycodone
2002 9,376 8,288
2003 12,130 9,715
2004 16,401 13,492
2005 21,190 14,643
2006 24,984 17,927
2007 30,637 22,425
2008 33,731 28,756
2009 38,084 38,332
2010 39,444 48,210
2011 37,483 46,906
2012 35,140 42,869
2013* 26,844 31,897
NFLIS – Federal, State, and local cases reported
U.S. Drug Enforcement Administra3on Office of Diversion Control NFLIS Query Date: 02/24/14
Medical Care ?
Many of these clinics are prescrip3on/dispensing mills
Minimal prac33oner/pa3ent interac3on
U.S. Drug Enforcement Administra3on Office of Diversion Control
Checks and Balances of the CSA and the Regulatory Scheme
Distributors of controlled substances
“The registrant shall design and operate a system to disclose to the registrant suspicious orders of controlled substances…Suspicious orders include orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency.” (21 CFR §1301.74)
U.S. Drug Enforcement Administra3on Office of Diversion Control
DEA Distributor IniEaEve Purpose and format:
Educate and inform distributors/manufacturers of their due diligence responsibilities under the CSA by discussing their Suspicious Order Monitoring System, reviewing their ARCOS data for sales and purchases of Schedules II and III controlled substances, and discussing national trends involving the abuse of prescription controlled substances
August 2005 – Present:
Briefings to 83 firms with 276 locations
Examples of civil action against distributors:
Cardinal Health , $34 million civil fine McKesson, $13.25 million civil fine Harvard, $6 million civil fine
Examples of suspension, surrender or revocation of DEA registration
Keysource, loss of DEA registration Sunrise, loss of DEA registration U.S. Drug Enforcement Administra3on
Office of Diversion Control
Source: www.kuow.org , 01/30/2014
John Gray, president and CEO of Healthcare Distribution Management Association, said suppliers used to have a more cooperative and collaborative relationship with the Drug Enforcement Agency. But things have changed, he said. “It’s all been dumped in our laps as wholesalers to make what I would consider to be law enforcement decisions as to whether or not a particular customer or account is or is not over what the DEA, in their own mind, thinks is a viable limit for Schedule II drugs they ought to be dispensing,” Gray said.
U.S. Drug Enforcement Administra3on Office of Diversion Control
Checks and Balances Under the CSA
• Practitioners
“A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice.” (21 CFR §1306.04(a))
United States v Moore 423 US 122 (1975)
U.S. Drug Enforcement Administra3on Office of Diversion Control
U.S. Drug Enforcement Administra3on Office of Diversion Control
Perfunctory ini3al physical exam…return visits no exam
Physical exam included needle mark checks…some were simulated
Pa3ent received quan3ty of drugs requested…were charged based on quan3ty
Unsupervised urinalysis – results did not mader
Accurate records not kept – quan3ty dispensed not recorded
Prac33oner not authorized to conduct methadone maintenance;
Pa3ent directed prescribing; U.S. Drug Enforcement Administra3on
Office of Diversion Control
Rosen was a 68 yo physician who had a prac3ce that was focused on obesity. He dispensed large quan33es of s3mulants to undercover officers outside the scope and not for a legi3mate purpose.
The 5th circuit had to address whether the medica3on was dispensed “for a legi3mate medical purpose and in the course of the doctors professional prac3ce.” In its analysis, the court stated, “We are however, able to glean from reported cases, certain recurring concomitance of condemned behavior, examples of which include the following:
An inordinately large quan3ty of controlled substances prescribed
Large numbers of prescrip3on were issued
No physical exam given
The physician warned the pa3ent to fill prescrip3ons at different drug stores U.S. Drug Enforcement Administra3on
Office of Diversion Control
Customers coming into the pharmacy in groups, each with the same prescrip3ons issued by the same physician; and
Customers with prescrip3ons for controlled substances wriden by physicians not associated with pain management (i.e., pediatricians, gynecologists, ophthalmologists, etc.).
Overwhelming propor3on of prescrip3ons filled by pharmacy are controlled substances
Pharmacist did not reach out to other pharmacists to determine why they were not filling a par3cular doctors prescrip3on
Verifica3on of legi3macy not sa3sfied by a call to the doctors office
U.S. Drug Enforcement Administra3on Office of Diversion Control
The physician issued prescrip3ons to a pa3ent known to be delivering the drugs to others
The physician prescribed controlled drugs at intervals inconsistent with legi3mate medical treatment
The physician involved used street slang rather than medical terminology for the drugs prescribed
There was no logical rela3onship between the drug prescribed and treatment of the condi3on allegedly exis3ng
The physician wrote more than one prescrip3on on occasions in order to spread them out
U.S. Drug Enforcement Administra3on Office of Diversion Control
Pa3ents receiving the same combina3on of prescrip3ons; cocktail
Pa3ents receiving the same strength of controlled substances; no individualized dosing: mul3ple prescrip3ons for the strongest dose
Majority of pa3ents paying cash for their prescrip3ons
Pa3ent asking for drugs in street slang
Pa3ent directed prescribing
Early refills
No specialized training in pain management;
Individuals driving long distances to visit physicians and/or to fill prescrip3ons
No records/pa3ent contracts/ urinalysis U.S. Drug Enforcement Administra3on Office of Diversion Control
The Controlled Substances Act Illegal Distribution
21 U.S.C. § 841 (a) Unlawful acts:
Except as authorized by this subchapter, it shall be unlawful for any person to knowingly or intentionally
(1) to manufacture, distribute or dispense, or possess with intent to manufacture, distribute or dispense, a controlled substance; or
U.S. Drug Enforcement Administra3on Office of Diversion Control
Checks and Balances Under the CSA
Pharmacists – The Last Line of Defense
“The responsibility for the proper prescribing and dispensing of controlled substances is upon the practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription.” (21 CFR §1306.04(a))
U.S v. Hayes 595 F. 2d 258 (5th Cir 1979) U.S. v. Leal 75 F. 3d 219 (6th Cir 1996) U.S. v. Birbragher 603 F. 3d 478 (8th Cir 2010) East Main Street Pharmacy 75 Fed. Reg. 66149 (Oct. 27, 2010)
U.S. Drug Enforcement Administra3on Office of Diversion Control
Checks and Balances Under the CSA
Pharmacists – The Last Line of Defense
“An order purporting to be a prescription issued not in the course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of section 309 of the act (21 USC 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.” (21 CFR §1306.04(a))
U.S v. Hayes 595 F. 2d 258 (5th Cir 1979) U.S. v. Leal 75 F. 3d 219 (6th Cir 1996) U.S. v. Birbragher 603 F. 3d 478 (8th Cir 2010) East Main Street Pharmacy 75 Fed. Reg. 66149 (Oct. 27, 2010)
U.S. Drug Enforcement Administra3on Office of Diversion Control
The Last Line of Defense
U.S. Drug Enforcement Administra3on Office of Diversion Control
THE PHARMACIST
The $80 million settlement is the largest fine related to DEA’s strategy of cracking down on rampant prescription drug abuse by targeting large corporations
Walgreen “negligently allowed” prescription painkillers to be diverted for illegal black market sales
The license of a Florida facility used by Walgreen to distributed controlled substances was revoked for two years
U.S. Drug Enforcement Administra3on Office of Diversion Control
The $80 million settlement is the
largest fine paid by a pharmacy chain as related to DEA’s
strategy of cracking down on rampant prescription drug
abuse U.S. Drug Enforcement Administra3on
Office of Diversion Control
Inquiries by pharmacists with doctors regarding the ra3onale behind prescrip3ons, diagnoses and treatment plans are inappropriate,
according to a new resolu3on by the American Medical Associa3on.
The AMA adopted the resolu3on at its 2013 annual mee3ng, calling such inquiries “an interference with the prac3ce of medicine and
unwarranted”.
Red Flag?
What happens next?
You adempt to resolve…
U.S. Drug Enforcement Administra3on Office of Diversion Control
Many customers receiving the same combina3on of prescrip3ons; cocktail
Many customers receiving the same strength of controlled substances; no individualized dosing: mul3ple prescrip3ons for the strongest dose
Many customers paying cash for their prescrip3ons
Early refills
Many customers with the same diagnosis codes wriden on their prescrip3ons;
Individuals driving long distances to visit physicians and/or to fill prescrip3ons;
U.S. Drug Enforcement Administra3on Office of Diversion Control
Customers coming into the pharmacy in groups, each with the same prescrip3ons issued by the same physician; and
Customers with prescrip3ons for controlled substances wriden by physicians not associated with pain management (i.e., pediatricians, gynecologists, ophthalmologists, etc.).
Overwhelming propor3on of prescrip3ons filled by pharmacy are controlled substances
Pharmacist did not reach out to other pharmacists to determine why they were not filling a par3cular doctors prescrip3on
Verifica3on of legi3macy not sa3sfied by a call to the doctors office
U.S. Drug Enforcement Administra3on Office of Diversion Control
U.S. Drug Enforcement Administra3on Office of Diversion Control
Purchases of Oxycodone 30mg
In 2009, 44% of all oxycodone 30mg products were distributed to Florida
In 2010, 43% of all oxycodone 30mg products were distributed to Florida
U.S. Drug Enforcement Administra3on Office of Diversion Control
Remaining States 593,625,290 dosage units Florida
94,923,484 dosage units
Source: ARCOS Date Prepared: 01/30/2014 U.S. Drug Enforcement Administra3on
Office of Diversion Control
Florida 94,923,484 dosage units
New York 50,658,100 dosage
units
Remaining States 486,977,390 dosage units
California 55,989,800 dosage
units
Source: ARCOS Date Prepared: 01/30/2014 U.S. Drug Enforcement Administra3on
Office of Diversion Control
Paul Volkman, Chicago Doctor, Gets 4 Life Terms In Drug Overdose Case
ANDREW WELSH-‐HUGGINS 02/14/12 06:45 PM ET Associated Press COLUMBUS, Ohio — A Chicago doctor who prosecutors say dispensed more of the powerful painkiller oxycodone from 2003 to 2005 than any other physician in the country was sentenced Tuesday to four life terms in the overdose deaths of four pa3ents. Dr. Paul Volkman made weekly trips from Chicago to three loca3ons in Portsmouth in southern Ohio and one in Chillicothe in central Ohio before federal inves3gators shut down the opera3ons in 2006, prosecutors said. He was sentenced in federal court in Cincinna3. "This criminal conduct had devasta3ng consequences to the community Volkman was supposed to serve," Assistant U.S. Adorneys Adam Wright and Tim Oakley said in a court filing ahead of Tuesday's hearing. "Volkman's ac3ons created and prolonged debilita3ng addic3ons; distributed countless drugs to be sold on the street; and took the lives of numerous individuals who died just days azer visi3ng him," they said. The 64-‐year-‐old Volkman fired his adorneys earlier this month and said he acted at all 3mes as a doctor, not a drug dealer. "The typical drug dealer does not care how much drugs a client buys, how ozen he buys, or what he does with his drugs," Volkman said in a 28-‐page handwriden court filing Monday, maintaining that he did all those things and more for his pa3ents.
U.S. Drug Enforcement Administra3on Office of Diversion Control
Violations?
What happens next…..
U.S. Drug Enforcement Administra3on Office of Diversion Control
DEA Legal Recourse Administra3ve Immediate Suspension Order (ISO)
Memorandum of Agreement (MOA)
Order to Show Cause (OTSC)
Civil Fines
Criminal
Tac3cal Diversion Squads U.S. Drug Enforcement Administra3on
Office of Diversion Control
How Do You Lose Your Registration?
The Order to Show Cause Process 21 USC § 824
a) Grounds – 1. Falsifica3on of Applica3on 2. Felony Convic3on 3. State License or Registra3on suspended, revoked or denied –
no longer authorized by State law 4. Inconsistent with Public Interest 5. Excluded from par3cipa3on in Title 42 USC § 1320a-‐7(a)
program
b) AG discre3on, may suspend any registra3on simultaneously with Order to Show Cause upon a finding of Imminent Danger to Public Health and Safety
* FY2014 as of February 27, 2014
Administrative Actions Initiated by DEA FY2007 thru 2014*
U.S. Drug Enforcement Administra3on Office of Diversion Control
Thank You!
U.S. Drug Enforcement Administra3on Office of Diversion Control