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Side Effects of the
Prescription Drug Epidemic
Health
Care Providers and the DEA’s Good
Cop/Bad Cop Role
July 25, 2012
12:00 p.m. – 1:00 p.m. Central | Web Seminar
Continuing Education Information
We have applied for one hour of California, Texas and
Virginia CLE and New York non-transitional CLE
credit. Newly admitted New York attorneys may not
receive non-transitional CLE credit. For attendees
outside of these states, we will supply a certificate of
attendance which can be used to apply for CLE credit in
the applicable bar or other accrediting agencies.
Fulbright will supply a certificate of attendance to all
participants that:
1. Participate in the web seminar by phone and via the
web.
2. Complete our online evaluation, which we will send
to later today.
©2012 Fulbright & Jaworski L.L.P.
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Administrative Information
Today’s program will be conducted in a listen-only
mode. To ask an online question at any time throughout
the program, simply click on the question mark icon
located on the tool bar. We will try to answer your
question during the session if time permits.
Everything we say today is opinion. We are not
dispensing legal advice, and listening does not establish
an attorney-client relationship. This discussion is off the
record. Anything we say cannot be quoted without our
prior express written permission.
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Speakers
Rick Robinson
Partner
Washington, D.C.
[email protected]
+1 202 662 4534
Ron Buzzeo, RPh
Chief Compliance Officer
Cegedim Compliance
Solutions
[email protected]
Machelle Neal
Compliance Director
Cegedim Compliance
Solutions
[email protected]
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Rick Robinson
Head of Fulbright’s Washington Health Care
Practice
Co-Chair of Fulbright’s Life Sciences Practice
Group
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Ron Buzzeo, RPh
Chief Compliance Officer, Cegedim Compliance
Solutions Powered by BuzzeoPDMA
Founder BuzzeoPDMA
Retired Deputy Director, Drug Enforcement
Administration, Office of Diversion Control
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Machelle Neal
Compliance Director, Cegedim Compliance
Solutions Powered by BuzzeoPDMA
State regulatory liaison
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AGENDA
Pharmaceutical Drug Diversion
Regulatory Requirements
● Registration
● Recordkeeping and Inventory Requirements
● Reporting Thefts and Significant Losses
Physician and Hospital Practice Issues
Diversion Surveillance and Prevention Programs
Regulatory Impact
Pharmaceutical Drug Abuse
in the United States
Drug Abuse Environment
Prescription Drug Abuse a major health care concern
● Report – November 2011 – Centers for Disease Control
and Prevention
More people die from prescription drug abuse than from heroin
abuse.
Fourfold increase in drug overdose deaths from prescription
drug abuse in the last decade.
HB 7095 – State of Florida – July 2011
● Multiple restrictions relating to the control and
dispensing of narcotic controlled substances
● State Health Officer Dr. Frank Farmer characterized the
dispensing of controlled substances in Florida as a
“public health emergency.”
May 2011 – DEA Administrator Michele Leonhart
in testimony before the Senate Sub-Committee on
Crime and Terrorism re: “the prescription drug
epidemic.”
2010 Monitoring the Future
● Hydrocodone is frequently abused by high school seniors
● 8% of whom reported non-medical use of prescription
drugs during the past year
● On average – 2100 12 to 17 year olds abuse a pain
medication every day.
Rates of Painkiller Sales, Deaths,
and Treatment Admissions
SOURCES: National Vital Statistics System, 1999-2008; Automation of Reports and
Consolidated Orders System (ARCOS) of the Drug Enforcement Administration (DEA),
1999-2010; Treatment Episode Data Set, 1999-2009
ARCOS Per Capita Distribution
SOURCE: Automation of Reports and Consolidated Orders System (ARCOS) of the Drug Enforcement Administration (DEA), 2010
Drug Overdose Death Rates by State
National Forensic Laboratories
System
DEA Regulatory Requirements
DEA Registration / Coincident Activities
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Physician
PA / NP
Clinic
Hospital / Campus
Record keeping
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Receiving
Distribution
Administration, Dispensing
Prescriptions
Inventory
● Biennial
● Annual
Reporting Thefts and Significant Losses
● Upon discovery within one business day
Disposal
Institutional and Hospital
Practice Issues
Impacting Practitioners
Regulatory Issues
Recent DEA Actions
$50 Million
● Dispensing CS without a prescription signed by a
practitioner
● Dispensing CS without an oral prescription called in by a
practitioner
● Prescriptions missing essential elements
● Not properly documenting partially filled prescriptions
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Regulatory Issues
Recent DEA Actions
$2.75 Million
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Internal thefts
Failure to report mail delivery losses
Inventory discrepancies
Fictitious DEA Registration numbers
DEA will continue to aggressively inspect and
monitor pharmacies.
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Regulatory Issues
Recent DEA Actions
$130K
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Internal thefts
Lack of internal surveillance and monitoring program
Inventory discrepancies
Improper recordkeeping
DEA investigation was conducted over a 5 year
period
DEA has increased enforcement and inspections of
hospital practices
Practice Issues
Improper Registrations
● “Campus” Registrations in Hospital Complexes
● Individual Physician Registrations in Hospital
Complexes
● Use of Power(s) of Attorney to sign the application for
registration and to give Power of Attorney to sign DEA
Forms 222
Practice Issues
Recordkeeping
● CSOS requirements for creating an electronic record of
receipts
● Intercompany Transfer Documents
5% Rule
Required Information
SOM implications
● Date of dispensing for “will call” prescriptions
Practice Issues
Accountability (Ability to Account for All CS)
Issues
● Hospital Procedures

Nursing stations
Electronic dispensing systems
OR and ER usage
Drug compounding
● Physician
● Clinic
● Pharmacy
Technician access to “on hand” balances
Practice Issues
Thefts and Losses
● Includes unusual or excessive loss or disappearance
● Includes in-transit loss
● Reporting must be made verbally to the local DEA
Office upon discover within one business day and
followed up with a written report within 15 days.
Practice Issues
Prescriptions
● Requirements of various practice settings
Hospital vs. institutional (Long-Term Care) vs. office-based
practice
● When is a prescription required?
Medication/administration orders vs. prescriptions
● What is required for an emergency oral prescription?
Practice Issues
Other Regulatory Issues
● DEA Biennial Inventories
“Will Call” prescription medication
Inventory format and information
Failure to include all Controlled Substances
● Security/Storage of Controlled Substances
Placement of CCTV cameras
Employee Access
Lack of security for storage
● Wasting and Disposal
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Practice Issues
Diversion Techniques
● In pharmacy

Falsification of records
Improper refills
Drugs held for disposal
Theft
● In hospitals

Substitution
Diversion of waste
Theft
● In Clinic and Physician’s Office
Substitution
Theft
Diversion Surveillance and
Prevention Programs
Surveillance and Prevention Programs
A surveillance program provides a process that monitors
controlled substance product movement and dispensing
throughout the registrant’s environment
Process provides effective controls to guard against theft and
diversion
Through the involvement of multiple departments and health
care providers, it ensures security, compliance and
accountability of controlled substance handling and
administration
Procedure is developed to monitor controlled substance
activity and to track and trend in standardized administration
and areas where pharmacy dispensing and patient
administration is not direct
Prevention Programs
● Corporate Policies
Background Investigations
Drug testing
● For cause and/or random
Training for staff
Internal Compliance Programs
● Independent
● Routine reviews/inspections
● Liaison with Diversion Officials
Accountability of selected controlled substances
Internal Surveillance Programs
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Dispensing
Administration
Prescriptions
Automated Dispensing Systems
CS Variance Investigation Reports
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Wasting
Nurse Overrides
Discrepancy Reconciliation
Specialty areas
REGULATORY IMPACT
Compliance Trends
DEA, US Attorney and State scrutiny is growing in all areas,
particularly in Manufacturing, Distribution, R & D, and Pharmacy
Companies not meeting regulatory requirements for controlled substances, prescription
drugs and List I chemicals
Inconsistent implementation of regulatory (DEA, PDMA and State) requirements
Lack of understanding of regulatory requirements
Increase inspections by DEA, States and FDA
State oversight in licensing, pedigree, gift reporting, counterfeit, outdates and damaged
Multi-Million dollar fines and penalties being levied
2008 - 2012 – $131,000,000 in fines and numerous registration actions
Several large pending cases
Pharmacy
Manufacturer
Distributor
Lack of sufficient SOM / “know your customer”
initiatives is a particular DEA hot issue
Overview of DEA Programs and
Investigations
Physician, Pharmacy, Hospital, Distributor and
Manufacturer Investigations
● Not scheduled
● The DEA will use a Notice of Inspection, an
Administrative Inspection Warrant or Subpoena
● Targeted investigations may result from ongoing
diversion or other external complaints or information
Typically result in administrative fines and/or penalties
Investigations
Investigative Techniques
● Notice of Inspection
● Administrative Inspection Warrant vs
Search Warrant
● DEA Style Accountability Investigation

Utilization Records
Rx’s
Records
Reports
● Interviews with key individuals
● Analysis of books and records
Computer and Record Seizures
Investigations
Actions and Prosecutions
● Letters of Admonition
Minor regulatory violations
● Informal (Section 510) Hearings
In person meeting/Memorandum of Understanding
● Civil Prosecution
Almost always settled out of court
● Criminal
Know the Future?
Expect continued pressure from DEA on all DEA
registrants
Expect diversion trends to continue to change
Expect volume of distributions to continue as one of
the primary factors that DEA considers when taking
action against a distributor and manufacturer
Expect DEA to obtain your SOPs, due diligence files,
emails, records, reports, etc to determine compliance
DEA reviewing entire distribution chain and health
care community
Continuing Education Information
For those attorneys requesting New York State CLE
credit for this presentation, please record the number
given during the program. You will be asked to repeat
this number on an online evaluation regarding the
program, which Fulbright will email to you later today.
If you are viewing a recording of this web seminar, most
state bar organizations will only allow you to claim selfstudy CLE credit. Please refer to your state's CLE rules.
If you have questions regarding CLE approval of this
course in your applicable bar, please contact your bar
administrator.
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