10/4/12. Controlled Substances Dispensing Issues and Solutions. Objectives. Financial Disclosure

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1 Controlled Substances Dispensing Issues and Solutions Ronald W. Buzzeo, R.Ph. Chief Compliance Officer November 7, 2012 CE Code: Financial Disclosure I have no actual or potentially relevant financial relationship to disclose and no conflict of interest in relation to this activity 2 Objectives Identify and prevent regulatory violations that impact the dispensing of controlled substances Develop solutions for implementing the regulatory requirements for controlled substances, including the receiving of prescriptions and dispensing Identify the requirements for disposal of controlled substances, utilizing automatic dispensing systems and the role of the authorized agent Address the basic rules for dispensing controlled substances in all Schedules and answer questions that have been most frequency raised by prescribers, pharmacists and nurses 3 1

2 Agenda! Compliance Trends and the Changing Landscape! Pharmaceutical Drugs of Abuse! Regulatory Issues! Regulatory Actions!! Role of an Authorized Agent! Solutions! Assessment Questions 4 Controlled substance abuse is a major public health and law enforcement problem domestically. The federal agency charged with regulating these drugs is the Drug Enforcement Administration (DEA). Understanding DEA's requirements and enforcement efforts is important to preventing regulatory violations. We will discuss developments in regulatory investigations, compliance trends, dispensing and other regulatory issues, regulatory actions and solutions while reducing the risk of regulatory violations. 5 COMPLIANCE TRENDS AND THE CHANGING LANDSCAPE 6 2

3 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 Increased 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 : $175,000,000 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 7 The Changing Landscape Drug Enforcement Administration! Developments in regulatory controls! Diversion and abuse of US manufactured Controlled Substances! Internet Pharmacy! Pain Clinics! Prescriptions! Record keeping, prescription and reporting violations! List I Chemicals! Controlled Substances! Suspicious Order Monitoring (SOM)! Sept / 06 Letter! Feb / 07 Letter! Dec / 08 Letter! Suspension and/or civil fines 8 DEA Congressional Testimony! Discussion of closed system of distribution and regulatory controls! Two-pronged Reorganization/Restructuring in 2008! Expansion of Tactical Diversion Squads! As of 6/1/2012 there were 48 operational TDS units! 286 Authorized task force officer positions! Enhanced Regulatory Oversight! Distributor, manufacturer and health care community initiatives! Warning signs! Increase in frequency of scheduled inspections! Additional dedicated Diversion Investigators.! FY 2011 budget requested 60 investigator positions! FY 2012 budget requested 50 DI positions! All Diversion Investigators have completed training 9 3

4 The Changing Landscape Recent DEA Actions! $50 Million! Dispensing CS without a prescription signed by a practitioner! Dispensing CS without an oral prescription called in by practitioner! Prescriptions missing essential elements! Not properly documenting partially filled prescriptions! $2.75 Million! Internal thefts! Failure to report mail delivery losses! Inventory discrepancies! Fictitious DEA registration numbers 10 The Changing Landscape Recent DEA Actions (Continued)! Immediate suspension of two Florida Distribution Center s registrations! Revocation of a Florida DC registration for 2 years! Revocation of the registrations of 2 chain pharmacies in Florida 11 Know the Future! Expect continued pressure from the DEA against DEA registrants! Expect diversion trends to continue to change! Expect volume to continue as one of the factors that DEA considers when taking action against a distributor, manufacturer and pharmacy! Expect DEA to obtain your SOPs, due diligence files, training file, s about compliance, etc during an investigation! DEA reviewing entire distribution chain and health care community 12 4

5 Pharmaceutical Drug Abuse in the United States 13 Drug Abuse Environment! Annual 2010 National Survey on Drug Use and Health! Hydrocodone is most frequently abused by high school seniors! 7 million individuals reported non-medical use of prescription drugs during the past year! 3.2% of 12 to 17 year olds reported non-medical use of pain relievers! Annual 2011 National Survey on Drug Use and Health! Hydrocodone is most frequently abused by high school seniors! 6.1 million individuals reported non-medical use of prescription drugs during the past year! 2.3% of 12 to 17 year olds reported non-medical use of pain relievers Attributed to increased law enforcement and education 14 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 15 5

6 Rates of Painkiller Sales, Deaths, and Treatment Admissions SOURCES: National Vital Statistics System, ; Automation of Reports and Consolidated Orders System (ARCOS) of the Drug Enforcement Administration (DEA), ; Treatment Episode Data Set, ARCOS Per Capita Distribution SOURCE: Automation of Reports and Consolidated Orders System (ARCOS) of the Drug Enforcement Administration (DEA), Drug Overdose Death Rates by State 18 6

7 National Forensic Laboratories System 19 REGULATORY ISSUES 20 Regulatory Issues! Lack of receiving and return records or records that lack required information! Lack name, address and/or DEA registration number of the supplier or customer! Lack of actual date of receipt or return! Prescriptions! Schedule III, IV and V prescriptions that lack required information! Unsigned Schedule II prescriptions! Failure to notify the DEA! Utilizing emergency prescriptions for routine dispensing! Consistent quantity dispensed 21 7

8 Regulatory Issues! Prescriptions (Continued)! Prescriptions that are not readily retrievable! Transmission by a non-authorized agent! LTCF employee making medical determination! Utilization of chart orders Lack required info! Back-up pharmacy! Transfer of prescriptions! Billing 22 Regulatory Issues! Inventories! Did not include all controlled substances! E-Kits, ADS! Held for disposal, return, 7 day dispensing! Lack required information! ADS / Emergency Kits! Registration! Inventory! Starter dose (routine dispensing)! Lack of authority Authorized Agent! Employee thefts! Lack of Security 23 Regulatory Issues! Reporting! Failure to report thefts and/or significant losses! Accountability discrepancies! Selected controlled substances! Disposal / wasting 24 8

9 REGULATORY ACTIONS 25 Controlled Substances Actions! Penalties and Fines! Administrative sanctions;! Letter of Admonition! Administrative Hearing! Immediate Suspension/Loss of Registration! DOJ Civil Prosecution. Consent Decree. Fines! DOJ Criminal Prosecution. Fine. Jail. Forfeiture! Board of Pharmacy Action. Licensure. 26 REGULATORY REGUIREMENTS 27 9

10 ! 21 CFR 1300 to the End! To prevent the diversion of controlled substances, establish a control system and ensure that a sufficient amount of controlled substances are made available for legitimate medical requirements! Controlled Substances! Import, export, manufacturing, distribution, dispensing, instruction, research, chemical analysis, narcotic treatment programs 28! 21 CFR 1301 Registration! Separate locations! Who can sign! Retail Pharmacy! ADS! 21 CFR and 76! Security! Securely locked, substantially constructed cabinet! Dispersed! Employment Waiver! Reporting thefts and significant losses DEA ! 21 CFR ! Distribution/transfer to another DEA registrant (pharmacy, physician)! Registration verification! SOM! 5 % rule! Shipment security 30 10

11 ! 21 CFR 1304 Records, Reports, Inventories! Records Schedule II! Separate from all other records! Separate prescription file! Records Schedule III, IV and V! Separate from all other records! Readily retrievable! Prescriptions! Separate prescription file! Readily retrievable! Central Fill (CF)! Common owner, or! Contractual relationship! Retail pharmacy (RP) - keep a record of CFs! CF - keep a record of RPs 31! 21 CFR 1304! Inventories! All CS! Schedule II - exact count or measure! Schedule III, IV and V! Estimated! Exact count / 1000! Recommendation exact count or measure! Opening or close of business! Schedule II separate from Schedule III, IV and V! Drug name, dosage form, strength, quantity and number of commercial containers 32! 21 CFR 1304! Records! Receiving / Including returns (Schedule II, III, IV and V)! Name, address and DEA registration number of the supplier! Date of receipt! Drug name, dosage form, strength, quantity and number of commercial containers! Distribution / Including returns! Name, address and DEA registration number of the customer! Date of distribution! Drug name, dosage form, strength, quantity and number of commercial containers! 21 CFR DEA Forms 222! Who can sign! POA Who can issue! CSOS 33 11

12 ! 21 CFR , 1304, 1306 Definitions, Records, Reports, Inventories. Prescriptions! Central Fill (CF)! Common owner, or! Contractual relationship! Retail pharmacy (RP) - keep a record of CFs! CF - keep a record of RPs 34! 21 CFR 1306 Prescriptions! May not be used for supplying a practitioner for general dispensing! Issuance of a prescription! Signed and dated on the day of issue! Full name and address of the patient! Drug name, strength, dosage form, quantity prescribed, directions for use! Name, address and registration number of the practitioner! Authorized number of refills / Schedule III, IV and V! Multiple prescriptions! Written instructions on each Rx! No undue risk! Permissible under state law! Meets all requirements 35! Schedule II Prescriptions (continued)! A Schedule II drug may only be dispensed pursuant to a valid written prescription, signed by the practitioner and must list:! The full name and address of the patient! Drug name, strength, dosage form, quantity prescribed and directions for use! Name, address and registration number of the practitioner! Practitioner s signature 36 12

13 10/4/12! Schedule II Prescriptions (continued)! Facsimile! Only for residents in long-term care or in a Medicare hospice program! Fax must meet all of the requirements of a valid, written prescription order (including the signature of the practitioner).! For hospice patients, prescription must state hospice patient.! May be transmitted only by practitioner or the practitioner s agent 37! Schedule II Prescriptions (continued)! Emergency (FDA Definition of Emergency Situation)! Immediate administration of the controlled drug is necessary for proper treatment of the intended ultimate user! No appropriate alternative treatment is available, including administration of a drug which is not a controlled substance! It is not reasonably possible for the prescribing practitioner to provide a written prescription to be presented to the person dispensing the controlled substance prior to dispensing 38! Schedule II Prescriptions (continued)! Verbal! ONLY in emergency situations! Quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period! Pharmacist must reduce prescription to writing immediately with all required information except the physician s signature! If the practitioner is not known to the pharmacist, the pharmacist must make reasonable efforts to determine that authorization came from a registered individual practitioner 39 13

14 ! Schedule II Prescriptions (continued)! Seven Day Rule! For all emergency verbal orders, the prescriber must deliver a valid written prescription to the dispensing pharmacist within seven (7) days! Prescription must state on its face, the date of the oral order and Authorization for Emergency Dispensing! If delivery by mail, it must be postmarked within seven (7) days! Upon receipt, pharmacist must attach it to the oral emergency authorization 40! Schedule II Prescriptions (continued)! Partial Fills! Only for LTCF or terminally ill patients! Pharmacist must record on the prescription that patient is LTCF Patient or terminally ill! For each partial fill, dispensing pharmacist must record the date of the partial filling, quantity dispensed, remaining quantity authorized to be dispensed and ID of dispensing pharmacist! Total quantity dispensed cannot exceed quantity prescribed! Prescription is only valid for 60 days 41! Controlled Substance Prescriptions (continued)! Emergency Kits! Must have valid written Rx unless the Emergency Rule applies! E-Kits should never be used routinely to dispense drugs that should have been reordered! E-Kits are not starter doses! E-Kits should only be used for unanticipated emergencies 42 14

15 ! Schedule III, IV and V Prescriptions (continued)! Can be dispensed only pursuant to:! A valid written prescription signed by the practitioner,! A facsimile of a written, signed prescription transmitted to the pharmacy by the practitioner or the practitioner s agent, or! Pursuant to an oral prescription made by an individual practitioner and promptly reduced to writing by the pharmacist containing all information required for a valid prescription, such as authorized refills, quantity, except for the signature of the practitioner 43! Central Fill Schedule II, III, IV and V (continued)! Retail! Rx or electronic! Central Fill on original Rx! Refills dispensed / refills remaining! Maintain original Rx 2 years from date of last refill! Receipt for filled Rx with method of delivery, date, employee accepting! Central Fill! Copy of Rx or electronic, including name, address and DEA registration of the retail pharmacy! Record of date of receipt, name of pharmacist filling, dates of filling or refilling! Record of the date delivered with method of delivery to the Retail! 5 % rule does not apply 44! Transfer Schedule III, IV and V Prescriptions (continued)! Refills only! One time basis only! Transfer is communicated directly between two licensed pharmacists! Void on Rx! Record on reverse side invalidated Rx! Name, address and DEA registration of the pharmacy transferred! Name of pharmacist receiving! Date of the transfer and the name of the pharmacists transferring 45 15

16 10/4/12! Transfer Schedule III, IV and V Prescriptions (continued)! Pharmacist receiving! Transfer on the face of the Rx! Provide all Rx information, date of issuance of original, original number of refills, date of original dispensing, number of refills remaining, and dates and locations of previous refills! Name, address, DEA registration, and Rx number from which transferred! Name of pharmacist who transferred! Name, address, DEA registration, and Rx number from which originally filled! Maintain for 2 years from date of last fill! Electronically accessing the same Rx record must satisfy all requirements of a manual transfer 46 ROLE OF AN AUTHORIZED AGENT 47! Communicating Prescriptions! Only an individual practitioner can issue! But once prepared, a valid prescription may be communicated to a pharmacist by:! An authorized agent of the practitioner 48 16

17 ! Agent means: an authorized person who acts on behalf of or at the direction of a manufacturer, distributor, or dispenser; except that such term does not include a common or contract carrier, public warehouseman, or employee or the carrier or warehouseman, when acting in the usual and lawful course of the carrier s or warehouseman s business. 49 Role of Authorized Agents! Medical determinations to prescribe controlled substances (CS) only by a practitioner! Practitioner must determine that a Rx for a CS is for a legitimate medical purpose May not be delegated! Authorized agent does not have the authority to make medical determinations! Agent may not legally perform duties that must be personally performed by the practitioner! Valid prescription must have the required elements! An agent is an authorized person who acts on behalf of the practitioner! Agent could communicate the prescription, depending on Schedule! Hand delivery, facsimile, phone call or electronic transmission 50! Role of Authorized Agents (continued)! Schedule III, IV and V! Authorized agent could transmit to the pharmacy via facsimile! Authorized agent could transmit orally to the pharmacist! Reason to believe! Duty to inquire into the legitimacy! Schedule II! The prescription may be transmitted by facsimile by the authorized agent from the LTCF! Emergency oral communication may not be delegated to an authorized agent! Practitioner must personally communicate the emergency oral prescription to the pharmacist! An agent may not call in an oral prescription for Schedule II even in an emergency 51 17

18 ! Role of Authorized Agents (continued)! Summary of the Acts that an agent may take! May prepare a written prescription for the signature of the practitioner, if the practitioner has determined there is a legitimate medical need! Where a practitioner has conveyed all the required prescription information to the practitioner s authorized agent, that agent may telephone the pharmacy and convey that prescription information to the pharmacist (Schedule III, IV and V)! Valid written prescription and the regulations permit the facsimile to the pharmacy - the practitioner s agent may transmit! Who is an agent of an individual practitioner! Practitioner has taken steps to establish a valid agency relationship for those aspects of the CSA that may be executed by an authorized agent 52! Role of Authorized Agents (continued)! Who is an agent of an individual practitioner (continued)! Written authorization! Practitioner may designate one or more persons at one or more locations! An individual may act as an authorized agent for multiple practitioners! The authorization is not subject to further delegation! Practitioner is responsible for making all medical determinations! Agent has no authority! Practitioner must call in an emergency order! Original agreement kept by practitioner, copy by agent and pharmacy 53 SOLUTIONS 54 18

19 Solutions! Training for pharmacy and LTCF staff and physicians on regulatory requirements! Discontinue use of back-up pharmacies! On-going meetings with LTCF Administrator and physicians! Discontinue routine use of Schedule II emergency prescriptions! FDA Definition of Emergency Situation! Obtain signed prescriptions for Schedule II emergency orders 55 Solutions! Coordinate with physician to ensure there are valid signed agreements with authorized agents! Implement ADS! To decrease employee thefts, upgrade security by storing and dispensing from a secure enclosure and limit access! Develop a SLT to determine if a loss is significant! Report thefts and significant losses within one business day of discovery! Do not utilize E-Kits and ADS for routine dispensing and implement requirements for use 56 Solutions! Do not use chart orders in lieu of prescriptions! Work with Administrator of LTC facility to revise chart orders to meet Schedule III, IV and V prescription requirements! Ensure receiving records from supplier meet the regulatory requirements! Ensure records for the transfer of controlled substances to another DEA registrant meet the regulatory requirements! Legislation! Registration 57 19

20 ASSESSMENT QUESTIONS 58 Assessment Questions Identify and prevent regulatory violations that impact the dispensing of controlled substances! Prescription violations may include the following:! Failure to list the address of the patient. T or F! Prescription transferred to the pharmacy by a non-authorized agent. T or F! Unsigned Schedule II prescriptions. T or F! Obtain POA to sign a DEA Form 222 from the corporate officer that signed the DEA application for registration. T or F! Discontinuing use of a pharmacist prepared Schedule II prescription for signature of the physician will eliminate a prescription violation? T or F 59 Assessment Questions Develop solutions for implementing the regulatory requirements for controlled substances, including the receiving of prescriptions and dispensing! To decrease the opportunities for employee theft maintain and dispense controlled substances within a substantially constructed enclosure. T or F! Educate physicians and LTCF staff on the requirements for use of the emergency requirements for Schedule II controlled substances. T or F! To prevent incomplete prescriptions, revise chart orders so that they meet the requirements for a Schedule III, IV and V prescriptions. T or F! Training staff in the regulatory requirements and implementing the authorized agent procedures may prevent some prescription violations, such as the transfer of prescriptions from the LTCF to the pharmacy? T or F 60 20

21 Assessment Questions Understanding the requirements for disposal of controlled substances, utilizing automatic dispensing systems and the role of the authorized agent! Practitioner must determine that a Rx for a CS is for a legitimate medical purpose May not be delegated. T or F! Authorized agent does not have the authority to make medical determinations. T or F! A pharmacy, prior to disposing of controlled substances must have written approval from the DEA or approval from the appropriate state agency. T or F! Utilization of an automatic dispensing system within a LTCF requires an additional DEA pharmacy registration. T or F 61 Assessment Questions Addressing basic rules for dispensing controlled substances in all Schedules and answer questions that have been most frequency raised by prescribers, pharmacists and nurses! The following data elements are required on a prescription:! Name and address of the patient! The drug name, strength, dosage form, quantity prescribed and directions for use! Refills if a Schedule III, IV and V and authorized by the physician or PA! Name, address and DEA registration number of the physician or PA! An employee of a LTCF may authorized a controlled substance for a patient. T or F! May a pharmacist authorize a back-up pharmacy to dispense the initial dose for a prescription. T or F 62 Thank You for Your Attention Ronald W. Buzzeo, R.Ph. ronald.buzzeo@cegedim.com