Public Hearing on Ordinance Regulating Pain Management Clinics & Pharmacies

1. Public Hearing on Ordinance Regulating Pain Management Clinics & Pharmacies Board of County Commissioners June 5, 2012

2. Presentation Outline Background Substantive Recommendations of Task Force Questions and Public Hearing Requested Action

3. Background December 15, 2010 – BCC passed a moratorium on new pain management clinics June 2011 -- Mayor Jacobs created the Prescription Drug Task Force October 31, 2011 – Subcommittees present reports to TF; all recommendations of subcommittees approved

4. Background December 6, 2011 – BCC voted to extend the moratorium on new PMC’s for an additional 180 days March 6, 2012 -- BCC holds a work session on TF recommendations; authorizes staff to draft ordinances to codify all recommendations June 5, 2012 – BCC public hearing on the ordinance regulating PMCs and the second of two public hearings on associated TF zoning recommendations

5. Presentation Outline Background Substantive Recommendations of Task Force Questions and Public Hearing Requested Action

6. Recommendations Substantive Recommendations of Task Force Definitions Registration and Operational Regulations Conditions for new PMCs Other Pharmacy Regulations Prescription Drug Monitoring Program

7. Recommendations Definitions

8. Recommendations Numerous new definitions created in code Define “Pain Management Clinic” (PMC) to mean any privately owned clinic, facility or office, which has at least one of the following characteristics: Where a physician practices who issues prescriptions for a dangerous drug to more than twenty (20) patients in a single day; Holds itself out as being in business to prescribe or dispense pain medication whether for acute pain or chronic pain; Holds itself out as being in business to provide services for the treatment or management of pain (and actually dispenses dangerous drugs); or Meets the state definition of PMC

9. Recommendations PMC – Exceptions: Licensed as a hospital or other licensed facility or owned and operated by a licensed facility (ch 395, FS) Majority of physicians who provide services in the clinic primarily provide surgical or oncology services Affiliated with an accredited medical school Does not prescribe or dispense controlled substance for treatment of pain Operated for the sole purpose of serving a governmental entity

10. Recommendations Create a new term, “Dangerous Drugs” (for use with the definition of PMC) Defined as a controlled substance, specifically an opiate analgesic, listed in Schedule II and Schedule III Designed to be a very narrow subset of prescription drugs – those that have proved to be most dangerous to the community

11. Recommendations Registration and Operational Regulations

12. Recommendations Pain Management Clinics must: Register with Orange County Designate physician responsible for compliance with code Display licenses Prohibit on site sale or dispensing of controlled substances unless allowed by law Prohibit alcoholic beverages on the premises Require adequate inside waiting area

13. Recommendations Restrict operating hours to 7 am to 7 pm Monday through Friday Submit business records to County -- Number of scripts written for dangerous drugs Total number of patients seen in clinic State of residence of each person to whom dangerous drugs prescribed or dispensed Log of all attempts to access Prescription Drug Monitoring Program (PDMP)

14. Recommendations Submit employee records to County -- Name and title Home address, date of birth, phone number State or federally issued drivers license or id number Copy of current drivers license of id card List of all criminal convictions of persons hired in past calendar month

15. Recommendations Other – Must get required building and use permits May not co-locate on the same property as a pharmacy Must have 1000 ft separation from pharmacy, day care facility, day care home, religious institution Must provide adequate parking on site Must show parking demands are met on site

16. Recommendations Other Requirements

17. Recommendations Landlord Responsibility – landlord, leasing agent or owner of property where PMC operates should: Ensure that the PMC or Pharmacy is not operating in violation of County Code or other Florida laws Certification Affidavit by Applicants for Related Uses Application for Business Tax Receipt in identified categories (such as a doctors office) should: Execute an affidavit certifying registration as a PMC or stating new use will not be a PMC County Zoning Division will review the proposed use

18. Recommendations Pharmacy Regulations

19. Recommendations Identification Requirement – prior to filling or dispensing any dangerous drug, pharmacist or agent shall require and record government issued identification Verification of insurance or health plan coverage okay in lieu of identification Verification of Prescription – if the pharmacist doubts the validity of the prescription, the pharmacist or agent must personally contact the prescribing physician at the number listed in the directory to verify the prescription

20. Recommendations Records – pharmacy will keep record of all prescriptions filled for at least 2 years; records of dangerous drugs will be provided to law or code enforcement within 72 hours of the request Pharmacist Compensation – unlawful to pay any pharmacist a bonus, incentive compensation or reward solely for filling a prescription for specific dangerous drug Separation Distances – new pharmacy shall not co-locate on the same property as a preexisting PMC Applicant for a new pharmacy may request a variance from the requirements

21. Recommendations Proposed Prescription Drug Monitoring Program (PDMP) Requirement

22. Recommendations Requirement of Prescribing Physician or Agent to check PDMP Within 24 hours prior to prescribing dangerous drugs, the prescribing physician or agent shall access and review the patient’s information in the PDMP Requirement of Pharmacist or Agent to check PDMP Prior to dispensing dangerous drugs the PDMP shall be checked Verification of insurance or health plan coverage okay in lieu of PDMP check

23. Recommendations If PDMP is Not Available Compliance not required with three good-faith but unsuccessful attempts A log of dates and times of attempts must be kept

24. Recommendations Applicability And Enforcement

25. Recommendations Applicable in unincorporated and incorporated areas except not applicable within a municipality that maintains an ordinance covering this subject matter.

26. Recommendations Violations can be punished as a county ordinance violation, prosecuted in County Court as a misdemeanor *Maximum $500 fine and/or 60 days in jail Enforcement may be brought by the County

27. Suggested Revisions Page 6, line 243: after the word “an” insert the words “opiod or” Throughout document strike the number “15” and insert the number “13” Page 8, line 338; Page 11, lines 470 , 476, 482 and 499; Page 12, line 535; Page 15, line 663; Page 17, line 735

28. Suggested Revisions Page 9, line 402, and Page 10, line 432: strike the word “July” and replace with the word “August”

29. Presentation Outline Background Zoning Recommendations of Task Force Questions and Public Hearing Requested Action

30. Questions?

31. Public Hearing

32. Presentation Outline Background Zoning Recommendations of Task Force Questions and Public Hearing Requested Action

33. Requested Action Request board adopt the proposed ordinance with proposed amendments.

34. Public Hearing on Ordinance Regulating Pain Management Clinics & Pharmacies Board of County Commissioners June 5, 2012

35. MBI Suggested Revisions Page 16, beginning at line 684, strike lines 684 to 695 and insert (red language stricken): (b)  Requirement of pharmacist or pharmacist’s agent to check prescription drug monitoring program.  Prior to dispensing any dangerous drug for or to a person for whom verification of insurance or health plan coverage through a state-licensed insurance company has not been done, the dispensing pharmacy shall access the information in the Prescription Drug Monitoring Program for the purpose of reviewing the patient’s controlled drug prescription history and shall report the dangerous drug dispensed and to whom the dangerous drug will be dispensed in the Prescription Drug Monitoring Program described at Section 893.055, Florida Statutes.