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. 2
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. 3
Speakers Rick Robinson Partner Washington, D.C. frobinson@fulbright.com +1 202 662 4534 Ron Buzzeo, RPh Chief Compliance Officer Cegedim Compliance Solutions ronald.buzzeo@cegedim.com Machelle Neal Compliance Director Cegedim Compliance Solutions machelle.neal@cegedim.com 4
Rick Robinson Head of Fulbright s Washington Health Care Practice Co-Chair of Fulbright s Life Sciences Practice Group 5
Ron Buzzeo, RPh Chief Compliance Officer, Cegedim Compliance Solutions Powered by BuzzeoPDMA Founder BuzzeoPDMA Retired Deputy Director, Drug Enforcement Administration, Office of Diversion Control 6
Machelle Neal Compliance Director, Cegedim Compliance Solutions Powered by BuzzeoPDMA State regulatory liaison 7
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.
Drug Abuse Environment 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.
Drug Abuse Environment 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
Regulatory Requirements
DEA Regulatory Requirements DEA Registration / Coincident Activities Physician PA / NP Clinic Hospital / Campus Record keeping Receiving Distribution Administration, Dispensing Prescriptions
Inventory Biennial Annual Regulatory Requirements Reporting Thefts and Significant Losses Upon discovery within one business day Disposal
Institutional and Hospital Practice Issues Impacting Practitioners
Recent DEA Actions $50 Million Regulatory Issues 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 21
Recent DEA Actions $2.75 Million Regulatory Issues Internal thefts Failure to report mail delivery losses Inventory discrepancies Fictitious DEA Registration numbers DEA will continue to aggressively inspect and monitor pharmacies. 22
Regulatory Issues Recent DEA Actions $130K 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
Improper Registrations Practice Issues 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
Thefts and Losses Practice Issues 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.
Prescriptions Practice Issues 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?
Other Regulatory Issues Practice 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 29
Practice Issues Diversion Techniques In pharmacy Falsification of records Improper refills Drugs held for disposal Theft In hospitals Falsification of records Substitution Diversion of waste Theft In Clinic and Physician s Office Falsification of records 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
Surveillance and Prevention Programs 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
Surveillance and Prevention Programs Internal Surveillance Programs Dispensing Administration Prescriptions Automated Dispensing Systems CS Variance Investigation Reports 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
Overview of DEA Programs and 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
Overview of DEA Programs and 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. 41
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