Pill Mills, Non-Therapeutic Drug Use, and Prescription Drug Monitoring What to Look for During Investigations

Transcription

1 Pill Mills, Non-Therapeutic Drug Use, and Prescription Drug Monitoring What to Look for During Investigations ffrey J. Mesaros, PharmD, JD ice Chair Florida Board of Pharmacy ay 21, 2013

2 Learning Objectives At the conclusion of this session, participants will be able to: - Explain how prescription monitoring programs are used to detect non-therapeutic use. - Describe how prescription drug monitoring programs may be used during a pharmacy investigation. - Describe how effective prescription monitoring programs are in decreasing pill mill operations. 2

3 Questions True or False: Florida allows drug manufacturer funds to finance the state s prescription drug monitoring program? 3

4 Questions Which of the following are technologies used by the State of Florida as tools to detect cases of diversion and abuse: a. E-FORCSE b. Pedigree Requirements c. Practitioner Profile Tracking d. Counterfeit Proof Prescription Blanks e. All of the Above 4

5 Prescription Drug Monitoring Program Must report within 7 days Comply with state and federal privacy laws and regulations Requested that dispensers report retroactive data by November 30, 2011, from December 1, 2010 to August 31,

6 Prescription Drug Monitoring Program Timeline 6

7 Prescription Drug Monitoring Program 7

8 Florida s First Decline in Prescription Drug Deaths 8

9 Decrease in Oxycodone Deaths by 17.7% 9

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11 Public Health Emergency & Controlled Substance Quarantine Operation Timeline 6/3/2011 HB 7095 Signed By Governor 6/6/2011-6/29/2011 Hand-Delivery of Over 400 Letters to Dispensing Practitioners 5/26/2011 Requested ARCOS Info 6/9/2011-6/23/2011 DOH Developed List of Dispensing Practitioners Posing the Greatest Threat to Public Health 7/5/2011 Quarantine Operation 105,579.5 Dosage Units Quarantined 6/1/2011 7/1/2011 5/26/2011 7/5/2011 6/30/2011 6/6/2011 DOH/FDLE Operation 6/20/2011 5/27/2011 DOH/FDLE Operation Planning Meeting 7/1/2011 DOH Met with Planning Meeting DOH/FDLE Operation State Surgeon General Planning Meeting Declared Wholesalers Public Health Emergency 6/23/2011 Dispensing Practitioner List Given to FDLE 11

12 Public Health Emergency & Controlled Substance Quarantine Operation Criteria for Identification of Dispensing Practitioners Risk of Non-Compliance Purchase Amounts Manner of Medical Services Other Factors: Complaint history of controlled substance prescribing or dispensing violations Wholesaler reports of suspicious purchasing Law enforcement reports of suspicious behavior Dispensing practitioner inspection information 12

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14 Regional Strike Force Co-Chairs Pensacola Sheriff Frank McKeithen, Bay Chief John Van Etten, Panama City Tallahassee Sheriff Mark Hunter, Columbia Chief Dennis Jones, Tallahassee Tampa Bay Sheriff David Gee, Hillsborough Chief Chuck Harmon, St. Petersburg Jacksonville Sheriff Sadie Darnell, Alachua Chief Joel DeCoursey Jr., Alachua Orlando Sheriff Don Eslinger, Seminole Chief Brett Railey, Winter Park Fort Myers Sheriff Tom Knight, Sarasota Chief Tom Weschler, Naples Miami Sheriff Ric Bradshaw Palm Beach Chief John Brooks, Sunrise 14

15 Post-Quarantine Timeline 7/6/2011-9/22/2011 FDLE and strike force LE members have quarantined an additional 251,925.5 dosage units. 7/1/2011 State Surgeon General Declared Public Health Emergency 6/1/2011-8/25/2011 DOH Prepared for New Inspection Criteria 8/1/2011 Royal Palm Beach Dispensing Practitioner Inspection Found Schedules II and III Controlled Substances Given to FDLE for Destruction 8/30/2011 Public Health Emergency Order Expired 7/1/2011 8/1/2011 9/1/2011 6/1/2011 9/22/2011 7/28/2011 DOH & FDLE Quarantined an additional 11,390 unit dosages at Orlando location closed on the day of the operation 7/1/2011-9/12/ Dispensing Practitioner Inspections completed to Confirm Inventory & Dispensing Compliance 8/24/2011 Began Pain Management Clinic Inspections using New Criteria 15

16 Wholesale Distributors Document credentialing policies and procedures with application Report receipts and distributions of Schedules II-V controlled substances Drug Enforcement Administration (DEA) number National drug code Quantity Unit Recipient DEA number Transaction date Strength 16

17 Wholesale Distributor Controlled Substance Reporting Timeline 17

18 Dispensing Practitioners HB 7095 prohibits dispensing of Schedules II or III controlled substances by practitioners except: Complimentary Packages of Medicinal Drugs Department of Corrections Surgical Procedures Clinical Trials Methadone Facilities Hospices 18

19 Controlled Substance Prescriber Registration By January 1, 2012, practitioners who prescribe controlled substances for the treatment of chronic nonmalignant pain are required to: Register with the Department Comply with new standards of practice 19

20 Controlled Substance Prescriber Registration Timeline 20

21 Controlled Substance Prescribers Displayed on Practitioner Profile 21

22 Pain Management Clinic Registration New requirements for practicing in and registration of pain management clinics Definitions Added exemptions from registration Designated physician responsible for compliance with quality assurance requirements, data collection and reporting 22

23 Counterfeit-Proof Prescription Pad Vendors & Reporting A written prescription for controlled substances must have certain information, be on a counterfeit-proof prescription pad and be produced by an approved vendor or electronically prescribed The approved vendor must also submit monthly reports that include the number of pads printed and to whom it is provided 23

24 Counterfeit Proof Prescription Pads Timeline 24

25 Counterfeit-Proof Prescription Sample 25

26 Community Pharmacies As of July 1, 2012, community pharmacies must be permitted under new requirements to dispense controlled substances listed in Schedules II or III Requires fingerprints and background screens Requires on-site inspection within 90 days Prohibits pharmacy permit transfer Grants authority to deny or revoke a permit for prescription processing errors Establishes additional grounds for denying a permit Requires pharmacists to report to law enforcement within 24 hours any attempt to obtain a controlled substance from a pharmacy by fraud. 26

27 # of New Community Pharmacy Permits Issued & # of Community Pharmacy Permits Closed July 1, 2007 June 30, 2011 Quarterly New Permits Issued 27

28 Tool Box Report Card Complaints with HB 7095 related allegations # of complaints received # of disciplinary actions # of emergency actions Dispensing Practitioners # of new registrations issued # of new registration requests denied Community Pharmacies # of new permits issued # of applications denied # of complaints received # of disciplinary actions # of emergency actions # of reports to law enforcement for theft or fraudulent prescriptions Pain Management Clinics # of new registrations # of applications denied # closed # of complaints # of disciplinary actions # of emergency actions # of Inspections Counterfeit-Proof Prescription Pads # of orders by purchaser 28

29 Current Challenges Funding current prohibition on use of both state funds and funds from drug manufacturers to support E-FORCSE Connectivity inability to link E-FORCSE to other prescription monitoring programs Prescriber check prescriber check of the system prior to prescribing a controlled substance is not required 29

30 HB 831/SB 1192 Help on the way? Removal of the prohibition on the use of state funds to support E-FORCSE Removal of prohibition on the use of funds from drug manufacturers to support E-FORCSE Requires the prescriber to check the prescription drug monitoring program prior to prescribing a controlled substance 30

31 Questions Which of the following are technologies used by the State of Florida as tools to detect cases of diversion and abuse: a. E-FORCSE b. Pedigree Requirements c. Practitioner Profile Tracking d. Counterfeit Proof Prescription Blanks e. All of the Above 31

32 Questions True or False: Florida allows drug manufacturer funds to finance the state s prescription drug monitoring program? 32

33 Related Resources DOH HB 7095 General Information: Public Health Emergency Orders Correspondence to Licensees Frequently Asked Questions DOH Counterfeit-Proof Pad Vendors: Vendor Reporting Approved Vendor Search Vendor Applications Frequently Asked Questions Press Releases: Prescription Drug Monitoring Program (E-FORCSE): Controlled Substance Reporting System: 33

34 Questions? Mark Whitten Executive Director Florida Board of Pharmacy (850) Jeffrey J. Mesaros, PharmD, JD Vice Chair Florida Board of Pharmacy (727)