1. Expectations of the Florida Board of Medicine: Prescribing
Jason J. Rosenberg, M.D., FACS
Chairman
June 29, 2012

2. Overview Who can prescribe? Prescribing laws and rules
Standards of practice
Pain Management Clinics
Penalties and violations
Case studies
Websites and contact information

3. Who Can Prescribe Medications in Florida?
Medical Doctors
Osteopathic Physicians
Dentists
Podiatrists
Advanced Registered Nurse Practitioners
Physician Assistants
Optometrists
Veterinarians (not Health Care Practitioners)

4. Who Can Prescribe Controlled Substances in Florida?
Medical Doctors
Osteopathic Physicians
Dentists
Podiatrists
Veterinarians (not Health Care Practitioners)

5. Where do I go to find laws? www.leg.state.fl.us/statutes/index.cfm
Prescribing Laws
§456.42, FS – Written prescriptions for medicinal drugs
§456.43, FS – Electronic prescribing of medicinal drugs
§456.44, FS – Controlled substance prescribing
§ , FS – Dispensing practitioner
§893.03, FS – Schedules for Controlled Substances
§893.04, FS – Pharmacist and practitioner
Where do I go to find laws?

6. Prescribing Rules Overview
Rule 64B , FAC – Standards for the Use of Controlled Substances for the Treatment of Pain
Rule 64B , FAC – Pain Management Clinics
Rule 64B-3.005, FAC – Counterfeit-resistant Prescription Blanks for Controlled Substance Prescribing
Where do I go to find rules (Florida Administrative Code)?

7. Registration Who must register?
Health care practitioners who prescribe controlled substances for the treatment of chronic non-malignant pain
Definition of Chronic Non-Malignant Pain:
Prior to June 30, 2012
Pain unrelated to cancer or rheumatoid arthritis which persists beyond the usual course of the disease or the injury that is the cause of the pain or more than 90 days after surgery
Effective July 1, 2012
Pain unrelated to cancer which persists beyond the usual course of the disease or the injury that is the cause of the pain or more than 90 days after surgery

8. Registration How to register as a controlled substance prescriber?
Log onto MQA Online Services:
Look for the “New Controlled Substance Prescriber Registration” button. Use the same user ID and password that is used for renewing your license.

9. Standards of Practice
Health Care Practitioners who prescribe controlled substances for the treatment of chronic non-malignant pain are required to follow the standards of practice
Administration – direct application of controlled substance, by injection, inhalation, ingestion, or any other means, to body of a person or animal [s (1), FS]
Prescription – order for drugs written, signed, or transmitted by word of mouth, telephone, or other means of communication by a duly licensed practitioner licensed to prescribe such drugs, issued in good faith and in the course of professional practice, intended to be filled, compounded, or dispensed by another person licensed by the laws of the state to do so [s (21), FS]
Many practitioners are confusing administering and prescribing of medications. These particular standards apply to prescribing.

10. Standards of Practice What are the requirements?
Medical history and physical examination prior to beginning treatment
Detailed medical records must be kept
Written treatment plan for assessing and monitoring risk
Controlled Substances Agreement
Regular follow up at least every 3 months
Referrals as necessary

11. Exemptions Prior to June 30, 2012 Board-certified
Anesthesiologists
Physiatrists
Neurologists
Certain board-certified physicians who have met specific criteria
Effective July 1, 2012
Board-eligible and Board-certified
Rheumatologists
Certain physicians who have met specific criteria
Physicians who prescribe medically necessary controlled substances for inpatient stay in a hospital licensed under chapter 395, FS

12. Counterfeit-Proof Prescription Pads
When are they required?
Any written controlled substance prescription
How to get them?
Order from a Department approved vendor
Where to find a list of Department approved vendors?
Risk of not using counterfeit-proof prescription?
Pharmacies reject unauthorized prescriptions
Patients are inconvenienced

13. Dispensing Practitioners
Dispensing – transferring of possession of one or more doses of a medicinal drug by a pharmacist or licensed practitioner to the ultimate consumer [s (7), FS]
Who can dispense medicinal drugs?
Pharmacists
Medical doctors, Osteopathic Physicians, Dentists, Podiatrists, ARNPs, Physician Assistants and Optometrists who have registered as dispensing practitioners with the Department of Health

14. Dispensing Practitioners
Prior to 2011:
Registered Dispensing Practitioners could dispense any medicinal drugs that they were legally permitted to prescribe
Today:
Registered Dispensing Practitioners are prohibited from dispensing Schedule II or Schedule III controlled substances

15. Exceptions
Exceptions to dispensing prohibition for Schedule II and Schedule III controlled substances:
Complimentary packages/samples
Department of Corrections
Surgical procedures
Clinical trials
Methadone facility
Hospices

16. Pain Management Clinics
What is a pain management clinic (PMC)?
Any facility:
That advertises in any medium for any type of pain management services; or
Where any month, a majority of patients are prescribed opioids, benziodiazepines, barbiturates, or carisoprodol for the treatment of chronic non-malignant pain

17. PMC Registration
2009: New law required that PMCs register with the Department of Health
2010: Laws changed to require physician ownership or AHCA registration
2011: New requirements for physicians practicing in pain management clinics and new exemptions from registration
2012: Definition of chronic non-malignant pain slightly amended and additional exemptions from registration

18. Exemptions What facilities are exempted from registration?
Licensed by AHCA as facility pursuant to Chapter 395, FS
Physicians provide surgical services
Owned by publicly held corporation
Treats pain but does not prescribe controlled substances for treatment of pain
Wholly owned and operated by board-eligible or board certified anesthesiologist, physiatrists, rheumatologists or neurologists; or certain board-certified specialists who meet specified criteria

19. PMC Physician Requirements
Physician Responsibilities:
Training requirements
Ensure a physician, PA or ARNP performs physical exam
Ensure documentation for prescribing over a 72-hour dose of controlled substance
Maintain security of prescription blanks and report lost or stolen blanks
Ensure compliance with specified facility and physical operation requirements, infection control requirements, and health and safety requirements

20. PMC Physician Requirements
Where to find requirements?
Section , FS (MDs)
Rule 64B , FAC
Section , FS (DOs)
Rule 64B , FAC

21. PMC Designated Physician Requirements
All PMC’s must have a Designated Physician.
Designated Physician responsibilities:
Ensure compliance with Quality Assurance requirements
Report adverse incidents
Comply with quarterly data reporting
Where to find requirements?
Section , FS (MDs)
Section , FS (DOs)

22. Quarterly Data Reports
Repeat and new patients
Patients discharged due to drug abuse
Patients discharged for drug diversion
Out-of-state patients

23. Penalties and Violations
Violations: May lead to Department investigation and possible discipline by the Board
Penalties: Practitioners who are found to have committed certain specified prescribing and dispensing violations face 6 months license suspensions and minimum fines of $10,000 per violation

24. Board of Medicine Prescribing Violations and Penalties
Violation of § (1)(c), FS - Being convicted or found guilty of, or entering a plea of nolo contendere to, regardless of adjudication, a crime in any jurisdiction which directly relates to the practice of medicine or to the ability to practice medicine
Disciplinary Guidelines: From probation to revocation or denial of license, administrative fine ranging from $1, to $10, (first offense)

25. Board of Medicine Prescribing Violations and Penalties
Violation of § (1)(q), FS - Prescribing, dispensing, administering, mixing, or otherwise preparing a legend drug, including any controlled substance, other than in the course of the physician’s professional practice…
Disciplinary Guidelines: From one (1) year probation to revocation or denial and administrative fine from $1, to 10, (first offense)

26. Board of Medicine Prescribing Violations and Penalties
Violation of § (1)(r), FS - Prescribing, dispensing, or administering any medicinal drug appearing on any schedule set forth in chapter 893 by the physician to himself or herself…
Disciplinary Guidelines: From one (1) year probation to revocation or denial and administrative fine from $1, to $5,000.00, and a mental and physical examination (first offense)

27. Board of Medicine Prescribing Violations and Penalties
Violation of § (1)(t), FS - …1.Committing medical malpractice as defined in s … 2. Committing gross medical malpractice. 3. Committing repeated medical malpractice …
Disciplinary Guidelines: From one (1) year probation to revocation or denial and an administrative fine from $1, to $10, (first offense)

28. Board of Medicine Prescribing Violations and Penalties
Violation of § (1)(aa), FS – Pre-signing blank prescription forms
Disciplinary Guidelines: From a reprimand to two (2) years probation, and an administrative fine from $1, to $5, (first offense)

29. Board of Medicine Prescribing Violations and Penalties
Violation of § (1)(bb), FS - Prescribing any medicinal drug appearing on Schedule II in chapter 893 by the physician for office use
Disciplinary Guidelines: From a reprimand to probation with CME in pharmacology, and an administrative fine from $1, to $5, (first offense)

30. Board of Medicine Prescribing Violations and Penalties
Violation of § (1)(pp), FS - Applicable to PMC’s designated physician:
Fraudulently registering a PMC;
Failing to comply with specified state and federal statutes and regulations;
Being convicted or found guilty of, regardless of adjudication specified state and federal offenses;
Dispensing a medicinal drug based upon a prescription not based upon a valid practitioner-patient relationship; or
Failing to timely notify the board of termination from a pain-management clinic.
Disciplinary Guidelines:
From probation to revocation, and an administrative fine ranging from $1, to $10, depending on the specific offense

31. Board of Medicine Prescribing Violations and Penalties
Violation of § (1)(qq), FS - Failing to timely notify the department of the theft of prescription blanks from a pain-management clinic or a breach of other methods for prescribing within 24 hours as required by s (2).
Disciplinary Guidelines: From a letter of concern to probation, and an administrative fine ranging from $1, to $5, (first offense)

32. Board of Medicine Prescribing Violations and Penalties
Violation of § (1)(rr), FS - Promoting or advertising through any communication media the use, sale, or dispensing of any controlled substance appearing on any schedule in Ch. 893
Disciplinary Guidelines: From a letter of concern to one (1) year suspension, to be followed by a period of probation, and an administrative fine from $1, to $5, (first offense)

33. Board of Medicine Prescribing Violations and Penalties
Violation of § (1)(ss), FS - Dispensing a controlled substance listed in Schedule II or Schedule III in violation of s
Disciplinary Guidelines: From probation to revocation and an administrative fine of $5, to $10, (first offense)

34. Board of Medicine Prescribing Violations and Penalties
Violation of § (1)(gg), FS - Engaging in a pattern of practice when prescribing medicinal drugs or controlled substances which demonstrates a lack of reasonable skill or safety to patients, a violation of any provision of this chapter or applicable practice act, or a violation of rules.
Disciplinary Guidelines: From one (1) year probation to revocation or denial and an administrative fine from $1, to $10, (first offense)

35. Case Study I Allegations of 2 combined complaints: Summary: Penalty:
§ (1)(t), FS – standard of care
§ (1)(m), FS – medical records
§ (1)(q), FS – inappropriate or excessive prescribing
§ (1)(nn), FS – violation of rules
Summary:
Practicing in several pain management clinics
Not board certified in pain medicine/management
Prescribing inappropriate and/or excessive amounts of controlled substances without justification for course of treatment in medical records, no diagnostic or lab tests, no consultations, no history taken or physicals performed (including large number of out of state patients).
Penalty:
Voluntary relinquishment of license
Jack Norden, M.D. VR
s (1)(nn), FS – Violating any provision of Chapter 458 or 456 or any rules adopted pursuant thereto.

36. Case Study II Allegations of the complaints: Summary Penalty:
§ (1)(c), FS – conviction of crime related to practice
Summary
November 2011 found guilty of of knowingly and willfully combining, conspiring, confederating and agreeing with other person to conduct and attempt to dispense controlled substances . . .
Also found guilty of knowingly and willfully combining, conspiring, confederating and agreeing with other person to conduct and attempt to conduct financial transactions affecting interstate commerce . . .
Penalty:
Revocation
Gerard Michael Dileo, M.D. – conviction
Hearing Not Involving Disputed Issues of Material Fact (Informal Hearing)
Revoked

37. Case Study III Allegations of the complaints (2): Summary: Penalty:
§ (1)(g), FS - failure to perform statutory or legal obligation
Summary:
Practicing in Pain management clinic
Registered dispensing physician
Underwent dispensing inspection of practice; inspector found Xanax and Roxicodone pills stored in containers without pill names, lot numbers or expiration dates; told by inspector not to dispense without those items; subsequently received call from manager at the practice indicating the Respondent dispensed the medications.
Penalty:
Reprimand, $2,500 fine, costs, Laws & Rules course, surrender dispensing registration and never reapply
Ida Gagliardi, M.D.
Settlement Agreement
s (1)(g), FS – failing to perform statutory or legal obligation

38. Websites DOH HB 7095 General Information:
Medical Quality Assurance (MQA) Main Page:
DOH Counterfeit-proof Pad Vendors:
Florida Board of Medicine:
Florida Board of Osteopathic Medicine:
Florida Board of Pharmacy:

39. Contact Information
Joy A. Tootle, JD
Executive Director
Board of Medicine
(850)
Anthony Jusevitch, B.A.
Board of Osteopathic Medicine
(850)
Mark Whitten, B.A.
Board of Pharmacy
(850)

40. Stay Informed
To join the Board of Medicine’s interested parties list (Mailman System) to receive periodic updates and important information from the Board about changes to laws and rules, go to:

41. QUESTIONS? Jason J. Rosenberg, M.D., FACS Chairman, Board of Medicine
Office Contact: (850)