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

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

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

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

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 §465.0276, FS – Dispensing practitioner §893.03, FS – Schedules for Controlled Substances §893.04, FS – Pharmacist and practitioner Where do I go to find laws? www.leg.state.fl.us/statutes/index.cfm

Prescribing Rules Overview Rule 64B8-9.013, FAC – Standards for the Use of Controlled Substances for the Treatment of Pain Rule 64B8-9.013, 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)? www.flrules.org/

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

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

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. 893.02(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. 893.02(21), FS] Many practitioners are confusing administering and prescribing of medications. These particular standards apply to prescribing.

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

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

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? www.floridashealth.com/mqa/counterfeit-proof.html Risk of not using counterfeit-proof prescription? Pharmacies reject unauthorized prescriptions Patients are inconvenienced

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. 893.02(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

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

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

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

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

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

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

PMC Physician Requirements Where to find requirements? Section 458.3265, FS (MDs) Rule 64B8-9.0131, FAC Section 459.0137, FS (DOs) Rule 64B15-14.0051, FAC

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 458.3265, FS (MDs) Section 459.0137, FS (DOs)

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

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

Board of Medicine Prescribing Violations and Penalties Violation of §458.331(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 $1,000.00 to $10,000.00 (first offense)

Board of Medicine Prescribing Violations and Penalties Violation of §458.331(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 $1,000.00 to 10,000.00 (first offense)

Board of Medicine Prescribing Violations and Penalties Violation of §458.331(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 $1,000.00 to $5,000.00, and a mental and physical examination (first offense)

Board of Medicine Prescribing Violations and Penalties Violation of §458.331(1)(t), FS - …1.Committing medical malpractice as defined in s. 456.50… 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 $1,000.00 to $10,000.00 (first offense)

Board of Medicine Prescribing Violations and Penalties Violation of §458.331(1)(aa), FS – Pre-signing blank prescription forms Disciplinary Guidelines: From a reprimand to two (2) years probation, and an administrative fine from $1,000.00 to $5,000.00 (first offense)

Board of Medicine Prescribing Violations and Penalties Violation of §458.331(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 $1,000.00 to $5,000.00 (first offense)

Board of Medicine Prescribing Violations and Penalties Violation of §458.331(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 $1,000.00 to $10,000.00 depending on the specific offense

Board of Medicine Prescribing Violations and Penalties Violation of §458.331(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. 458.3265(2). Disciplinary Guidelines: From a letter of concern to probation, and an administrative fine ranging from $1,000.00 to $5,000.00 (first offense)

Board of Medicine Prescribing Violations and Penalties Violation of §458.331(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 $1,000.00 to $5,000.00 (first offense)

Board of Medicine Prescribing Violations and Penalties Violation of §458.331(1)(ss), FS - Dispensing a controlled substance listed in Schedule II or Schedule III in violation of s. 465.0276 Disciplinary Guidelines: From probation to revocation and an administrative fine of $5,000.00 to $10,000.00 (first offense)

Board of Medicine Prescribing Violations and Penalties Violation of §456.072(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 $1,000.00 to $10,000.00 (first offense)

Case Study I Allegations of 2 combined complaints: Summary: Penalty: § 458.331(1)(t), FS – standard of care § 458.331(1)(m), FS – medical records § 458.331(1)(q), FS – inappropriate or excessive prescribing § 458.331(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. 458.331(1)(nn), FS – Violating any provision of Chapter 458 or 456 or any rules adopted pursuant thereto.

Case Study II Allegations of the complaints: Summary Penalty: § 458.331(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

Case Study III Allegations of the complaints (2): Summary: Penalty: § 458.331(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. 458.331(1)(g), FS – failing to perform statutory or legal obligation

Websites DOH HB 7095 General Information: www.floridashealth.com/mqa/HB7095.html Medical Quality Assurance (MQA) Main Page: www.doh.state.fl.us/mqa/ DOH Counterfeit-proof Pad Vendors: www.floridashealth.com/mqa/counterfeit-proof.html Florida Board of Medicine: www.doh.state.fl.us/mqa/medical/ Florida Board of Osteopathic Medicine: www.doh.state.fl.us/mqa/osteopath/ Florida Board of Pharmacy: www.doh.state.fl.us/mqa/pharmacy/

Contact Information Joy A. Tootle, JD Executive Director Board of Medicine (850) 245-4131 Joy_Tootle@doh.state.fl.us MQA_Medicine@doh.state.fl.us Anthony Jusevitch, B.A. Board of Osteopathic Medicine (850) 245-4162 Anthony_Jusevitch@doh.state.fl.us MQA_Osteopath@doh.state.fl.us Mark Whitten, B.A. Board of Pharmacy (850) 245-4197 Mark_Whitten@doh.state.fl.us MQA_Pharmacy@doh.state.fl.us

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: www.doh.state.fl.us/mqa/medical/me_mailman.html

QUESTIONS? Jason J. Rosenberg, M.D., FACS Chairman, Board of Medicine Office Contact: (850)245-4131