Aopha Slides(8 21)

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Pharmacy DEA Compliance

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  • Controlled Substances Act
    The Drug Enforcement Administration (“DEA”) has published advance notice of proposed rulemaking that solicits comments on the disposal of controlled substances by non-registrants.  This proposal for the first time could authorize DEA registrants to accept controlled substances back from patients for disposal.  It could also place additional burdens on registrants, particularly pharmacies, who may be inundated with requests to dispose of unused controlled substances. 
    Under the Controlled Substances Act (“CSA”) and its regulations, controlled substances may be transferred only between DEA registrants, including manufacturers, distributors, pharmacies and practitioners.  Patients for obvious reasons, are exempt from DEA registration.  Long term care facilities such as nursing homes, retirement facilities and other institutions that provide extended health care to resident patients are also exempt because they hold prescribed controlled substances in a custodial capacity for their patient-residents.   
    Because DEA registrants may not receive controlled substances from non-registrants, patients and long term care facilities cannot transfer unused or unwanted controlled substances to a DEA registrant.  For example, current law prohibits patients and long term care facilities from returning controlled substances to the dispensing pharmacies or transferring the drugs to reverse distributors, the registrants specifically authorized to receive and dispose of controlled substances.  Such prohibition would seem to contradict DEA’s mission to prevent the diversion of legitimate controlled substances because it could lead to non-registrants stockpiling unwanted drugs.
    Under current law, patients and long term care facilities who wish to dispose or destroy controlled substances and do not want to just throw them away or flush them down the drain must submit a letter to the local DEA office for authorization.  The authorization may include transfer of the drugs to a registrant, delivery to a DEA agent or local DEA office, or destruction in the presence of a DEA agent.  Few consumers are aware of this regulation and the requirement can present a burden on long term care facilities who may need to dispose of controlled substances on a frequent basis.
    On a case-by-case basis, DEA recently granted temporary permission to law enforcement agencies who have requested authorization to accept unwanted controlled substances from patients for disposal. 
    The advanced notice of proposed rulemaking recognizes that there may be additional appropriate methods for disposing unwanted controlled substances held by non-registrants and DEA is requesting public comments on disposal options that minimize the risk of diversion, are consistent with the CSA and its regulations and which are environmentally sound.
    Comments should be submitted to DEA on or before March 23, 2009.
  • Controlled Substances Act
    The Drug Enforcement Administration (“DEA”) has published advance notice of proposed rulemaking that solicits comments on the disposal of controlled substances by non-registrants.  This proposal for the first time could authorize DEA registrants to accept controlled substances back from patients for disposal.  It could also place additional burdens on registrants, particularly pharmacies, who may be inundated with requests to dispose of unused controlled substances. 
    Under the Controlled Substances Act (“CSA”) and its regulations, controlled substances may be transferred only between DEA registrants, including manufacturers, distributors, pharmacies and practitioners.  Patients for obvious reasons, are exempt from DEA registration.  Long term care facilities such as nursing homes, retirement facilities and other institutions that provide extended health care to resident patients are also exempt because they hold prescribed controlled substances in a custodial capacity for their patient-residents.   
    Because DEA registrants may not receive controlled substances from non-registrants, patients and long term care facilities cannot transfer unused or unwanted controlled substances to a DEA registrant.  For example, current law prohibits patients and long term care facilities from returning controlled substances to the dispensing pharmacies or transferring the drugs to reverse distributors, the registrants specifically authorized to receive and dispose of controlled substances.  Such prohibition would seem to contradict DEA’s mission to prevent the diversion of legitimate controlled substances because it could lead to non-registrants stockpiling unwanted drugs.
    Under current law, patients and long term care facilities who wish to dispose or destroy controlled substances and do not want to just throw them away or flush them down the drain must submit a letter to the local DEA office for authorization.  The authorization may include transfer of the drugs to a registrant, delivery to a DEA agent or local DEA office, or destruction in the presence of a DEA agent.  Few consumers are aware of this regulation and the requirement can present a burden on long term care facilities who may need to dispose of controlled substances on a frequent basis.
    On a case-by-case basis, DEA recently granted temporary permission to law enforcement agencies who have requested authorization to accept unwanted controlled substances from patients for disposal. 
    The advanced notice of proposed rulemaking recognizes that there may be additional appropriate methods for disposing unwanted controlled substances held by non-registrants and DEA is requesting public comments on disposal options that minimize the risk of diversion, are consistent with the CSA and its regulations and which are environmentally sound.
    Comments should be submitted to DEA on or before March 23, 2009.
  • Aopha Slides(8 21)

    1. 1. ChangingChanging LivesLives AANNUALNNUAL CCONFERENCE ANDONFERENCE AND TTRADERADE SSHOWHOW August 25th, 26August 25th, 26thth & 27& 27thth , 2009, 2009
    2. 2. ChangingChanging LivesLives How Pharmacy ComplianceHow Pharmacy Compliance with the DEAwith the DEA Affects your Bottom LineAffects your Bottom Line Session 15G Wednesday, August 26, 2009 9:45 -11:15 a.m.
    3. 3. 6175 Hi-Tek Court Mason, Ohio 45040 www.skilledcare.com
    4. 4. Larry Galluzzo, RPh Larry Galluzzo has been the President/Owner of Skilled Care Pharmacy since 1980. He was the co-founder of Net-Rx, a purchasing group comprised of owners of privately-held pharmacies, as well as the co- founder of Excel CSO, a group service organization serving the Long Term Care market. He is a member of the American Society of Consultant Pharmacists and the Ohio Pharmacist Association, and an active participant in the Ohio Health Care Association, The Ohio Academy of Nursing Homes, Kentucky Association of Health Care Facilities, Association of Ohio Philanthropic Homes and Housing for the Aging, The American College of Nursing Home Administrators, and the Assisted Living Association of America.
    5. 5. Tracy Overton CII Compliance Supervisor Tracy Overton has served as a pharmacy technician in the long-term care industry for the past seven years assuming positions in both staff and supervisory roles. At Skilled Care, Tracy is exclusively responsible for pharmacy and physician compliance with the controlled substance (CII) prescription process per the Drug Enforcement Agency regulatory expectations. Recently, she participated in the successful realignment of the CII process within the pharmacy for which she gained great knowledge and expertise in procedural accountability and facility/physician buy-in.
    6. 6. Angela Sagraves, RPh Senior Pharmacy Manager Angela Sagraves has served in a pharmacist capacity for 15 years in the long-term care industry. She has assumed positions in multiple settings as staff pharmacist and consultant pharmacist as well as 10 years in institutional pharmacy management. Her responsibilities at Skilled Care include oversight of the order entry, controlled substances, dispensing, prescription verification, and intravenous pharmacy processes encompassing over 100,000 prescriptions per month. Most recently, in conjunction with her operational duties, she was actively involved in the development and implementation of procedural changes relative to the management of controlled substance prescription acquisition and medication dispensing.
    7. 7. 28601 Chagrin Boulevard Eton Tower, Suite 500 Beachwood, Ohio 44122 Phone 216.831-0042 Fax 216.831.0542 www.meyersroman.com Winner 2006 & 2007
    8. 8. Mary Louisa L’Hommedieu is experienced in a wide variety of corporate health care, commercial, and employment matters. She has litigated numerous cases in state and federal courts and before administrative bodies. Mary Louisa devotes a substantial portion of her practice to the resolution of business and regulatory disputes in the health care, long-term care and pharmacy industries. She also handles a broad range of other commercial litigation, and has authored and presented seminars on health care, employment and real estate topics. Prior to joining the firm, Mary Louisa’s practice was focused in health care, commercial litigation and employment law . She also served as a judicial attorney for the Honorable William B. Hoffman of the Fifth District Court of Appeals, and as judicial attorney for the Honorable Patricia A. Cosgrove of the Summit County Court of Common Pleas. She graduated cum laude from the University of Akron School of Law in 1996, where she was a member and an Associate Editor of the Akron Law Review. Mary Louisa is a member of the Cleveland and Ohio Bar Associations, as well as a member of the American Health Lawyers Association, OHCA (where she serves on the Facility Standards Committee) , and AOPHA. She has served as an Executive Board Member of the Youngstown Chapter of Habitat for Humanity, and is a member of the Hudson Chamber of Commerce. Look for her article, “Never Events and the Advent of Value Based Purchasing in Long Term Care” in the September, 2009 edition of Health Lawyer’s News. She lives in Hudson, Ohio with her husband and two children. Mary Louisa L’Hommedieu
    9. 9. Mark P. McGrievy focuses his practice on business services, real estate, finance (representing both borrowers and lenders) and health care transactions and regulatory issues. Mark is a partner in the firm and serves as Chair of its Health Care Practice Group. He counsels clients on organizational structure; mergers, acquisitions and divestitures; financing; debtor/creditor workouts; licensure; Medicare and Medicaid certification, compliance and regulatory issues. Mr. McGrievy represents a number of health care providers, including; Nursing Homes, Residential Care and Assisted Living facilities, Physicians, Home Health Care and Senior Services companies, Medical Billing companies, Device Manufactures, Oxygen, Ambulance and Therapy companies and other Ancillary Providers, as well as Real Estate companies, Lending Institutions and closely held businesses in a variety of business sectors. Mr. McGrievy graduated in 1988 from Cleveland-Marshall College of Law and began his legal career as a law clerk to the Honorable Thomas R. Rumana, JSC, Passaic County N.J. Superior Court. He is admitted to practice in Ohio and New Jersey. Before joining a downtown Cleveland law firm in 1995, he served as Chief Financial Officer and General Counsel for a Nursing Home Management company from 1990 to 1995. Mark is a member of the Cleveland and Ohio Bar Associations, as well as a member of the American Health Lawyers Association, Ohio Health Care Association, and Ohio Academy of Nursing Homes. He served as President of the Allied Healthcare Professionals Association, and is involved in several Community organizations; IPMC Treasurer (2002 to present), Fraternal Order of Eagles, and March of Dimes. Mark P. McGrievy Chair, Healthcare Group
    10. 10. ChangingChanging LivesLives AGENDA Introduction & BackgroundIntroduction & Background
    11. 11. ChangingChanging LivLives AGENDA Introduction & Background Controlled Substances Act & DEA RegulationsControlled Substances Act & DEA Regulations
    12. 12. ChangingChanging LivesLives AGENDA Introduction & Background Controlled Substances Act & DEA Regulations CII Dispensing RulesCII Dispensing Rules
    13. 13. ChangingChanging LivesLives AGENDA Introduction & Background Controlled Substances Act & DEA Regulations CII Dispensing Rules CIII through C-V DispensingCIII through C-V Dispensing
    14. 14. ChangingChanging LivesLives AGENDA Introduction & Background Controlled Substances Act & DEA Regulations CII Dispensing Rules CIII through C-V Dispensing ““Agent” of the Practitioner IssuesAgent” of the Practitioner Issues
    15. 15. ChangingChanging LivesLives AGENDA Introduction & Background Controlled Substances Act & DEA Regulations CII Dispensing Rules CIII through C-V Dispensing “Agent” of the Practitioner Issues Is your Facility at Risk?Is your Facility at Risk?
    16. 16. ChangingChanging LivesLives AGENDA Introduction & Background Controlled Substances Act & DEA Regulations CII Dispensing Rules CIII through C-V Dispensing “Agent” of the Practitioner Issues Is your Facility at Risk? Penalties, Fines and other RepercussionsPenalties, Fines and other Repercussions
    17. 17. ChangingChanging LivesLives AGENDA Introduction & Background Controlled Substances Act & DEA Regulations CII Dispensing Rules CIII through C-V Dispensing “Agent” of the Practitioner Issues Is your Facility at Risk? Penalties, Fines and other Repercussions Facility & Pharmacy challenges and how to work togetherFacility & Pharmacy challenges and how to work together
    18. 18. ChangingChanging LivesLives AGENDA Introduction & Background Controlled Substances Act & DEA Regulations CII Dispensing Rules CIII through C-V Dispensing “Agent” of the Practitioner Issues Is your Facility at Risk? Penalties, Fines and other Repercussions Facility & Pharmacy challenges and how to work together Compliance challenges and Cost of Non-complianceCompliance challenges and Cost of Non-compliance
    19. 19. ChangingChanging LivesLives AGENDA Introduction & Background Controlled Substances Act & DEA Regulations CII Dispensing Rules CIII through C-V Dispensing “Agent” of the Practitioner Issues Is your Facility at Risk? Penalties, Fines and other Repercussions Facility & Pharmacy challenges and how to work together Compliance challenges and Cost of Non-compliance Question & Answer SessionQuestion & Answer Session
    20. 20. ChangingChanging LivesLives AGENDA Introduction & Background Controlled Substances Act & DEA Regulations CII Dispensing Rules CIII through C-V Dispensing “Agent” of the Practitioner Issues Is your Facility at Risk? Penalties, Fines and other Repercussions Facility & Pharmacy challenges and how to work together Compliance challenges and Cost of Non-compliance Question & Answer Session
    21. 21. ChangingChanging LivesLives WARNINGWARNING DEA currently has ACTIVE investigations in Ohio, Michigan, New York , Wisconsin, West Virginia and Pennsylvania.
    22. 22. ChangingChanging LivesLives WARNINGWARNING DEA currently has ACTIVE investigations in Ohio, Michigan, New York , Wisconsin, West Virginia and Pennsylvania. Please do not discuss or raisePlease do not discuss or raise questions regarding particularquestions regarding particular Facility or Pharmacy issuesFacility or Pharmacy issues
    23. 23. ChangingChanging LivesLives Introduction & BackgroundIntroduction & Background In the last five years, prescription drug abuse hasprescription drug abuse has risen more than two-thirds nationwiderisen more than two-thirds nationwide. It is the DEA’s responsibility to work with our law enforcement partners to monitor prescriptions and ensure that legitimate pharmaceuticals are not diverted for illegitimate abuse. -Special Agent in Charge John P. Gilbride, commenting on a recent case reported on DEA website. 3/22/07
    24. 24. ChangingChanging LivesLives Introduction & BackgroundIntroduction & Background Nearly 7 million Americans are abusing prescription drugs7 million Americans are abusing prescription drugs*—more than the number who are abusing Cocaine, Heroin, Hallucinogens, Ecstasy, and Inhalants, combined. That 7 million was just 3.8 million in 2000, an 80 percent increase in just 6 years80 percent increase in just 6 years.
    25. 25. ChangingChanging LivesLives Introduction & BackgroundIntroduction & Background Methods of acquiring prescription drugs for abuseMethods of acquiring prescription drugs for abuse include “doctor- shopping”, traditional drug-dealing, theft from pharmacies or homes, illicitly acquiring prescription drugs via the Internet, and from friends or relatives.
    26. 26. ChangingChanging LivesLives Introduction & BackgroundIntroduction & Background Misuse of painkillers represents three-fourths of the overallMisuse of painkillers represents three-fourths of the overall problemproblem of prescription drug abuse; Hydrocodone is the most commonly diverted and abused controlled pharmaceutical in the U.S. From DEA Drug Fact Sheet, on DEA website: http://www.usdoj.gov/dea/concern/prescription_drug_fact_sheet.html
    27. 27. ChangingChanging LivesLives Introduction & BackgroundIntroduction & Background Pharmacies investigated for common practices generally are regulated by State Boards, but now DEA investigations are on the rise.
    28. 28. ChangingChanging LivesLives Introduction & BackgroundIntroduction & Background Nursing Home, Residential Care and Assisted Living facilities have experienced increased investigations and should expect heightened scrutiny! Pharmacies investigated for common practices generally are regulated by State Boards, but now DEA investigations are on the rise.
    29. 29. ChangingChanging LivesLives Controlled Substances Act & DEA RegulationsControlled Substances Act & DEA Regulations Controlled Substances Act  Legal foundation of the Federal government’s authority over controlled substances and listed chemicals.
    30. 30. ChangingChanging LivesLives Controlled Substances Act & DEA RegulationsControlled Substances Act & DEA Regulations Controlled Substances Act  Legal foundation of the Federal government’s authority over controlled substances and listed chemicals.  Consolidates more than 50 laws regulating controlled substances and listed chemicals.
    31. 31. ChangingChanging LivesLives Controlled Substances Act & DEA RegulationsControlled Substances Act & DEA Regulations Controlled Substances Act  Legal foundation of the Federal government’s authority over controlled substances and listed chemicals.  Consolidates more than 50 laws regulating controlled substances and listed chemicals.  System of U.S. compliance with international treaties. Implemented in DEA Regulations: Title 21 CFR 1300 to End
    32. 32. ChangingChanging LiLives Controlled Substances Act & DEA RegulationsControlled Substances Act & DEA Regulations Controlled Substances Act  “Closed system” of distribution.
    33. 33. ChangingChanging LivesLives Controlled Substances Act & DEA RegulationsControlled Substances Act & DEA Regulations Controlled Substances Act  “Closed system” of distribution.  Five “schedules” of controlled substances. C-I through C-V
    34. 34. ChangingChanging LivesLives Controlled Substances Act & DEA RegulationsControlled Substances Act & DEA Regulations Controlled Substances Act  “Closed system” of distribution.  Five “schedules” of controlled substances. C-1 through C-V  Created the Compliance Program (1971) to monitor the legitimate manufacture and distribution of controlled substances.
    35. 35. ChangingChanging LivesLives Controlled Substances Act & DEA RegulationsControlled Substances Act & DEA Regulations Closed System of Distribution:  Registrants must maintain DEA registration
    36. 36. ChangingChanging LivesLives Controlled Substances Act & DEA RegulationsControlled Substances Act & DEA Regulations Closed System of Distribution:  Registrants must maintain DEA registration  Each registrant involved in a transaction must verify the other registrant’s DEA registration
    37. 37. ChangingChanging LivesLives Controlled Substances Act & DEA RegulationsControlled Substances Act & DEA Regulations Closed System of Distribution:  Registrants must maintain DEA registration  Each registrant involved in a transaction must verify the other registrant’s DEA registration  Transfer by the end user to any other person is illegal distribution
    38. 38. ChangingChanging LivesLives Controlled Substances Act & DEA RegulationsControlled Substances Act & DEA Regulations Closed System of Distribution:  DEA Registrants (Handlers of Controlled Substances)
    39. 39. ChangingChanging LivesLives Controlled Substances Act & DEA RegulationsControlled Substances Act & DEA Regulations Closed System of Distribution:  DEA Registrants (Handlers of Controlled Substances)  Importers, Manufacturers
    40. 40. ChangingChanging LivesLives Controlled Substances Act & DEA RegulationsControlled Substances Act & DEA Regulations Closed System of Distribution:  DEA Registrants (Handlers of Controlled Substances)  Importers, Manufacturers  Distributors (Wholesalers), Exporters
    41. 41. ChangingChanging LivesLives Controlled Substances Act & DEA RegulationsControlled Substances Act & DEA Regulations Closed System of Distribution:  DEA Registrants (Handlers of Controlled Substances)  Importers, Manufacturers  Distributors (Wholesalers), Exporters  Pharmacies
    42. 42. ChangingChanging LivesLives Controlled Substances Act & DEA RegulationsControlled Substances Act & DEA Regulations Closed System of Distribution:  DEA Registrants (Handlers of Controlled Substances)  Importers, Manufacturers  Distributors (Wholesalers), Exporters  Pharmacies  Narcotic Treatment Programs (NTPs)
    43. 43. ChangingChanging LivesLives Controlled Substances Act & DEA RegulationsControlled Substances Act & DEA Regulations Closed System of Distribution:  DEA Registrants (Handlers of Controlled Substances)  Importers, Manufacturers  Distributors (Wholesalers), Exporters  Pharmacies  Narcotic Treatment Programs (NTPs)  Practitioners (MD, DO, DDS, DVM)”
    44. 44. ChangingChanging LivesLives Controlled Substances Act & DEA RegulationsControlled Substances Act & DEA Regulations Closed System of Distribution:  DEA Registrants (Handlers of Controlled Substances)  Importers, Manufacturers  Distributors (Wholesalers), Exporters  Pharmacies  Narcotic Treatment Programs (NTPs)  Practitioners (MD, DO, DDS, DVM)  Mid-Level Practitioners (PA, ARNP)
    45. 45. ChangingChanging LivesLives Controlled Substances Act & DEA RegulationsControlled Substances Act & DEA Regulations Closed System of Distribution:  DEA Registrants (Handlers of Controlled Substances)  Importers, Manufacturers  Distributors (Wholesalers), Exporters  Pharmacies  Narcotic Treatment Programs (NTPs)  Practitioners (MD, DO, DDS, DVM)  Mid-Level Practitioners (PA, ARNP)  Researchers, Analytical Labs
    46. 46. ChangingChanging LivesLives Controlled Substances Act & DEA RegulationsControlled Substances Act & DEA Regulations Closed System of Distribution:  DEA Registrants (Handlers of Controlled Substances)  Importers, Manufacturers  Distributors (Wholesalers), Exporters  Pharmacies  Narcotic Treatment Programs (NTPs)  Practitioners (MD, DO, DDS, DVM)  Mid-Level Practitioners (PA, ARNP)  Researchers, Analytical Labs  “Reverse Distributors”
    47. 47. ChangingChanging LivesLives Controlled Substances Act & DEA RegulationsControlled Substances Act & DEA Regulations Closed System of Distribution: Disposition of Unwanted Controlled Substances:  Return to supplier
    48. 48. ChangingChanging LivesLives Controlled Substances Act & DEA RegulationsControlled Substances Act & DEA Regulations Closed System of Distribution: Disposition of Unwanted Controlled Substances:  Return to supplier  Send to “Reverse Distributor”
    49. 49. ChangingChanging LivesLives Controlled Substances Act & DEA Regulations Closed System of Distribution: Disposition of Unwanted Controlled Substances:  Return to supplier  Send to “Reverse Distributor”  Receive permission from DEA to destroy
    50. 50. ChangingChanging LivesLives Controlled Substances Act & DEA RegulationsControlled Substances Act & DEA Regulations Long term care facilities such as nursing homes, assisted living facilities, and other institutions providing extended health care to resident patients are exempt from the Registration requirement because they hold prescribed controlled substances in a custodial capacity for their residents.
    51. 51. ChangingChanging LivesLives Controlled Substances Act & DEA RegulationsControlled Substances Act & DEA Regulations Some DEA offices have advised that flushing or pouring down the drain are not acceptable methods of destruction. Under current law long term care facilities who wish to dispose or destroy controlled substances and do not want to just throw them away or flush them down the drain, must submit a letter to the local DEA office for authorization.
    52. 52. ChangingChanging LivesLives Controlled Substances Act & DEA RegulationsControlled Substances Act & DEA Regulations Schedule I – No current medical use in the United States, with a Very High potential for abuse: Heroin MDMA (Ecstasy) LSD Marijuana Scheduled Substances: http://www.usdoj.gov/dea/pubs/scheduling.html
    53. 53. ChangingChanging LivesLives Controlled Substances Act & DEA RegulationsControlled Substances Act & DEA Regulations Schedule II - Legitimate medical use, but with High potential for abuse:  Methamphetamine  Dilaudid  Cocaine  Morphine  Ritalin  Percocet  Adderall  Oxycontin
    54. 54. ChangingChanging LivesLives Controlled Substances Act & DEA RegulationsControlled Substances Act & DEA Regulations Schedule III - Legitimate medical use, but with lesser potential for abuse including Narcotic (III), and Non-narcotic (IIIN): Examples:  Vicodin, Lortab (Hydrocodone) (III)  Tylenol with Codeine (III)  Buprenorphine (Suboxone) (III)  Butorphanol (Stadol) (III)  Anabolic Steroids, Ketamine (IIIN)
    55. 55. Changing Lives Controlled Substances Act & DEA RegulationsControlled Substances Act & DEA Regulations Schedule IV - Low potential for abuse:  Valium  Xanax  Darvocet  Diet Drugs
    56. 56. ChangingChanging LivesLives Controlled Substances Act & DEA RegulationsControlled Substances Act & DEA Regulations Schedule V - Lowest potential for abuse  Cough syrups  Lyrica  Lomotil
    57. 57. ChangingChanging LivesLives Controlled Substances Act & DEA RegulationsControlled Substances Act & DEA Regulations DEA Regulations:  The Controlled Substances Act of 1970 is the foundation for the body of regulations that governs the production, transfer, and disposal of controlled substances.
    58. 58. ChangingChanging LivesLives Controlled Substances Act & DEA RegulationsControlled Substances Act & DEA Regulations DEA Regulations:  The Controlled Substances Act of 1970 is the foundation for the body of regulations that governs the production, transfer, and disposal of controlled substances.  Current federal requirements can be found under 21 CFR 1300, et seq.
    59. 59. ChangingChanging LivesLives Controlled Substances Act & DEA RegulationsControlled Substances Act & DEA Regulations DEA Regulations:  The Controlled Substances Act of 1970 is the foundation for the body of regulations that governs the production, transfer, and disposal of controlled substances.  Current federal requirements can be found under 21 CFR 1300, et seq.  Controlled substances are also regulated at the state level (usually under the State Department of Health)
    60. 60. ChangingChanging LivesLives Controlled Substances Act & DEA RegulationsControlled Substances Act & DEA Regulations Federal and State Regulations  Healthcare professionals must comply with both federal and state laws and regulations.
    61. 61. ChangingChanging LivesLives Controlled Substances Act & DEA RegulationsControlled Substances Act & DEA Regulations Federal and State Regulations  Healthcare professionals must comply with both federal and state laws and regulations.  When federal laws or regulations differ from state laws or regulations, the more stringent law applies.
    62. 62. ChangingChanging LivesLives Controlled Substances Act & DEA RegulationsControlled Substances Act & DEA Regulations http://www.usdoj.gov/dea/pubs/csa.html DEA Website lists text of law, with links to regulations:
    63. 63. ChangingChanging LivesLives Controlled Substances Act & DEA RegulationsControlled Substances Act & DEA Regulations DEA Diversion Web Site: www.deadiversion.usdoj.gov
    64. 64. ChangingChanging LivesLives CII Dispensing RulesCII Dispensing Rules  A prescription for a controlled substance (CII-CV) must be issued for a legitimate medical purpose by an individual medical practitioner “acting in the usual course of his or her professional practice.”
    65. 65. ChangingChanging LivesLives CII Dispensing RulesCII Dispensing Rules  A prescription for a controlled substance (CII-CV) must be issued for a legitimate medical purpose by an individual medical practitioner “acting in the usual course of his or her professional practice.”  Responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner.
    66. 66. ChangingChanging LivesLives CII Dispensing RulesCII Dispensing Rules  A prescription for a controlled substance (CII-CV) must be issued for a legitimate medical purpose by an individual medical practitioner “acting in the usual course of his or her professional practice.”  Responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner.  A “corresponding responsibility rests with the pharmacist who fills the prescription.” 21 CFR 1306.04(a). 21 CFR 1306.03.
    67. 67. ChangingChanging LivesLives CII Dispensing RulesCII Dispensing Rules  All prescriptions for controlled substances must be:  dated as of, and signed on the day issued, .
    68. 68. ChangingChanging LivesLives CII Dispensing RulesCII Dispensing Rules  All prescriptions for controlled substances must be:  dated as of, and signed on the day issued,  must bear the full name and address of the patient .
    69. 69. ChangingChanging LivesLives CII Dispensing RulesCII Dispensing Rules  All prescriptions for controlled substances must be:  dated as of, and signed on the day issued,  must bear the full name and address of the patient  the drug name .
    70. 70. ChangingChanging LivesLives CII Dispensing RulesCII Dispensing Rules  All prescriptions for controlled substances must be:  dated as of, and signed on the day issued,  must bear the full name and address of the patient  the drug name  strength .
    71. 71. ChangingChanging LivesLives CII Dispensing RulesCII Dispensing Rules  All prescriptions for controlled substances must be:  dated as of, and signed on the day issued,  must bear the full name and address of the patient  the drug name  strength  dosage form .
    72. 72. ChangingChanging LivesLives CII Dispensing RulesCII Dispensing Rules  All prescriptions for controlled substances must be:  dated as of, and signed on the day issued,  must bear the full name and address of the patient  the drug name  strength  dosage form  quantity prescribed .
    73. 73. ChangingChanging LivesLives CII Dispensing RulesCII Dispensing Rules  All prescriptions for controlled substances must be:  dated as of, and signed on the day issued,  must bear the full name and address of the patient  the drug name  strength  dosage form  quantity prescribed  directions for use and .
    74. 74. ChangingChanging LivesLives CII Dispensing RulesCII Dispensing Rules  All prescriptions for controlled substances must be:  dated as of, and signed on the day issued,  must bear the full name and address of the patient  the drug name  strength  dosage form  quantity prescribed  directions for use and the name, address and registration number of the practitioner. 21 CFR 1306.05 .
    75. 75. ChangingChanging LivesLives CII Dispensing Rules  Prescriptions must be written with ink or indelible pencil or typewriter .
    76. 76. ChangingChanging LivesLives CII Dispensing Rules  Prescriptions must be written with ink or indelible pencil or typewriter  Manually signed .
    77. 77. ChangingChanging LivesLives CII Dispensing Rules  Prescriptions must be written with ink or indelible pencil or typewriter  Manually signed  Prepared by the secretary or agent .
    78. 78. ChangingChanging LivesLives CII Dispensing Rules  Prescriptions must be written with ink or indelible pencil or typewriter  Manually signed  Prepared by the secretary or agent  Pharmacy may not fill any prescription without all required elements. 21 CFR 1306.05.
    79. 79. ChangingChanging LivesLives CII Dispensing Rules Proper Prescriptions for Schedule II Controlled Substances:  Written prescription signed by the practitioner  Original written, signed prescription must be presented to the pharmacist for review prior to the actual dispensing These general rules have specific, limited exceptions. 21 CFR 1306.11(a) .
    80. 80. ChangingChanging LivesLives CII Dispensing Rules Proper Prescriptions for Schedule II Controlled Substances Exception 1: Faxed CII prescriptions sufficient when:  Long term care facility (“LTCF”) resident  Hospice Patient  Compounded for certain direct administration In each of these cases, the facsimile serves as the original written prescription. 21 CFR 1306.11.
    81. 81. ChangingChanging LivesLives CII Dispensing Rules Exception 2: Oral authorization permitted in Emergency Situation: (1) The quantity limited to the emergency period; (&) .
    82. 82. ChangingChanging LivesLives CII Dispensing Rules Exception 2: Oral authorization permitted in Emergency Situation: (1) The quantity limited to the emergency period; (&) (2) Immediate reduction to writing; (&) .
    83. 83. ChangingChanging LivesLives CII Dispensing RulesCII Dispensing Rules Exception 2: Oral authorization permitted in Emergency Situation (cont). (1) The quantity limited to the emergency period; (&) (2) Immediate reduction to writing; (&) (3) Validation; (&) .
    84. 84. ChangingChanging LivesLives CII Dispensing RulesCII Dispensing Rules Exception 2: Oral authorization permitted in Emergency Situation (cont). (1) The quantity limited to the emergency period; (&) (2) Immediate reduction to writing; (&) (3) Validation; (&) (4) Obtain written prescription within 7 days.
    85. 85. Changing Lives CII Dispensing RulesCII Dispensing Rules Exception 2: Oral authorization permitted in Emergency Situation (cont). Pharmacist must notify DEA of Doctor’s failure to deliver or face loss of license. 21 CFR 1306 .
    86. 86. ChangingChanging LivesLives CII Dispensing RulesCII Dispensing Rules Exception 2: Emergency Situations (cont). Oral authorization in Emergency Situations:  Immediate administration is necessary .
    87. 87. ChangingChanging LivesLives CII Dispensing RulesCII Dispensing Rules Exception 2: Emergency Situations (cont). Oral authorization in Emergency Situations:  Immediate administration is necessary  No appropriate alternative treatment is available, including administration of N-CII drug .
    88. 88. ChangingChanging LivesLives CII Dispensing RulesCII Dispensing Rules Exception 2: Emergency Situations (cont). Oral authorization in Emergency Situations:  Immediate administration is necessary  No appropriate alternative treatment is available, including administration of N-CII drug  Not reasonably possible for the physician to provide a written prescription prior to the dispensing. 21 CFR 1306.11 and § 290.10.
    89. 89. ChangingChanging LivesLives CII Dispensing RulesCII Dispensing Rules Refilling and Multiple Prescriptions of CIIs: Prohibited, except:  Where pharmacist is unable to supply the full quantity  Partial fills for LTC residents or terminally ill 21 CFR 1306.12 .
    90. 90. ChangingChanging LivesLives CIII, IV & V Dispensing RulesCIII, IV & V Dispensing Rules SCHEDULE III, IV AND V SUBSTANCES Prescriptions. Generally, a written prescription is required before dispensing a Schedule III, IV or V controlled substance and may be dispensed only with:  a written prescription signed by a practitioner; or  a facsimile of a written, signed prescription; or  an oral prescription made by an individual practitioner and promptly reduced to writing by the pharmacist containing all information required in Sec. 1306.05, except for the signature of the practitioner. 21 CFR 1306.21
    91. 91. ChangingChanging LivesLives CIII, IV & V Dispensing RulesCIII, IV & V Dispensing Rules SCHEDULE III, IV AND V SUBSTANCES Refilling of prescriptions for controlled substances listed in Schedule III and IV.  No more than six months after the issue date.  No more than five times. 21 CFR 1306.22 & 21
    92. 92. ChangingChanging LivesLives Dispensing RulesDispensing Rules Robert J. Compliant, M.D. 123 Holly Lane Date: 5/01/09 Hudson, Ohio 44236 Reg. No.: ________ _________________________________________ Patient’s name: ___________________________ Address: ________________________________ Drug: ___________________________________ Disp: #______# (write out quantity) Sig: __________________________ Signature of Individual Medical Practitioner
    93. 93. Is this Correct? 93
    94. 94. Is this Correct? 94
    95. 95. Is this Correct? 95
    96. 96. Is this Correct? 96
    97. 97. Is this Correct? 97
    98. 98. ChangingChanging LivesLives “Agent” of the Practitioner Issues Who is the “Agent,” and why is this causing such a controversy?
    99. 99. ChangingChanging LivesLives Is your Facility at RiskIs your Facility at Risk??  Just a Pharmacy issue?
    100. 100. ChangingChanging LivesLives Is your Facility at RiskIs your Facility at Risk??  Just a Pharmacy issue?  Patient Care
    101. 101. ChangingChanging LivesLives Is your Facility at RiskIs your Facility at Risk??  Just a Pharmacy issue?  Patient Care  Nursing Home Resident’s Bill of Rights
    102. 102. ChangingChanging LivesLives Is your Facility at RiskIs your Facility at Risk??  Just a Pharmacy issue?  Patient Care  Nursing Home Resident’s Bill of Rights  Fraud & Abuse issues
    103. 103. ChangingChanging LivesLives Is your Facility at RiskIs your Facility at Risk??  Just a Pharmacy issue?  Patient Care  Nursing Home Resident’s Bill of Rights  Fraud & Abuse issues  False Claims Act
    104. 104. ChangingChanging LivesLives Is your Facility at RiskIs your Facility at Risk??  Just a Pharmacy issue?  Patient Care  Nursing Home Resident’s Bill of Rights  Fraud & Abuse issues  False Claims Act  DEA Investigations, audits, fines
    105. 105. ChangingChanging LivesLives Is your Facility at RiskIs your Facility at Risk??  Just a Pharmacy issue?  Patient Care  Nursing Home Resident’s Bill of Rights  Fraud & Abuse issues  False Claims Act  DEA Investigations, audits, fines  Potential Criminal and Civil liability
    106. 106. ChangingChanging LivesLives Is your Facility at RiskIs your Facility at Risk?? WHAT SHOULD YOU BE DOING?  Contact your Pharmacy to discuss issue
    107. 107. ChangingChanging LivesLives Is your Facility at RiskIs your Facility at Risk?? WHAT SHOULD YOU BE DOING?  Contact your Pharmacy to discuss issue  Set protocols with your Pharmacy
    108. 108. ChangingChanging LivesLives Is your Facility at RiskIs your Facility at Risk?? WHAT SHOULD YOU BE DOING?  Contact your Pharmacy to discuss issue  Set protocols with your Pharmacy  Assist Pharmacy in dealing with the Resident’s Physicians
    109. 109. ChangingChanging LivesLives Is your Facility at RiskIs your Facility at Risk?? WHAT SHOULD YOU BE DOING?  Contact your Pharmacy to discuss issue  Set protocols with your Pharmacy  Assist Pharmacy in dealing with the Resident’s Physicians  Audit medication requests for compliance
    110. 110. ChangingChanging LivesLives Penalties, Fines and other RepercussionsPenalties, Fines and other Repercussions  Civil Fines and Criminal Penalties
    111. 111. ChangingChanging LivesLives Penalties, Fines and other RepercussionsPenalties, Fines and other Repercussions  Civil Fines and Criminal Penalties  Litigation & Defense Costs
    112. 112. ChangingChanging LivesLives Penalties, Fines and other RepercussionsPenalties, Fines and other Repercussions  Civil Fines and Criminal Penalties  Litigation & Defense Costs  False Claims Act
    113. 113. ChangingChanging LivesLives Penalties, Fines and other RepercussionsPenalties, Fines and other Repercussions  Civil Fines and Criminal Penalties  Litigation & Defense Costs  False Claims Act  Fraud & Abuse
    114. 114. ChangingChanging LivesLives Penalties, Fines and other RepercussionsPenalties, Fines and other Repercussions  Civil Fines and Criminal Penalties  Litigation & Defense Costs  False Claims Act  Fraud & Abuse  Loss of Provider Agreements
    115. 115. ChangingChanging LivesLives Penalties, Fines and other RepercussionsPenalties, Fines and other Repercussions  Civil Fines and Criminal Penalties  Litigation & Defense Costs  False Claims Act  Fraud & Abuse  Loss of Provider Agreements  Five Star Ranking
    116. 116. ChangingChanging LivesLives Facility & Pharmacy challenges and how to work togetherFacility & Pharmacy challenges and how to work together  Recognize potential problems
    117. 117. ChangingChanging LivesLives Facility & Pharmacy challenges and how to work togetherFacility & Pharmacy challenges and how to work together  Recognize potential problems  Appoint Liaison
    118. 118. ChangingChanging LivesLives Facility & Pharmacy challenges and how to work togetherFacility & Pharmacy challenges and how to work together  Recognize potential problems  Appoint Liaison  Recordkeeping
    119. 119. ChangingChanging LivesLives Compliance ChallengesCompliance Challenges  Disruption to Facility
    120. 120. ChangingChanging LivesLives Compliance ChallengesCompliance Challenges  Disruption to Facility  Cost of Compliance
    121. 121. ChangingChanging LivesLives Compliance ChallengesCompliance Challenges  Disruption to Facility  Cost of Compliance  Cooperation between all Parties involved
    122. 122. ChangingChanging LivesLives Question & Answer SessionQuestion & Answer Session ? ? Ask Away
    123. 123. THANK YOUTHANK YOU

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