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I. Prescription Drug Monitoring Program
Senate Bill 462 was signed into law by Governor Crist on Thursday, June 18, 2009.
Senate Bill 462 requires the Department of Health to establish a comprehensive electronic database system to monitor the prescribing and dispensing practices of certain controlled substances (Schedules II, III, and IV). The database will include a “patient advisory report” provided by the department to prescribers, dispensers, and pharmacists concerning the dispensing of controlled substances.
The bill requires the Department of Health to establish and design a comprehensive electronic database system. The database will be a prescription drug monitoring program that allows controlled substance prescriptions to be provided to it and that provides prescription information to a patient’s health care practitioner and pharmacist who inform the department that they wish the patient advisory report provided to them. The Department of Health must establish this database by December 1, 2010.
The information in the database for the electronic prescription drug monitoring system is not discoverable or admissible in any civil or administrative action. But, there will be criminal penalties for violating the reporting requirement or for persons using the patient information illegally. Specifically, any person who willfully and knowingly fails to report the dispensing of a controlled substance as required by the bill, commits a first degree misdemeanor.
The bill will establish that a prescriber or dispenser is not liable for good faith use of the department-approved controlled substance prescription information of a patient. For example, a prescriber or dispenser may have access to the information which relates to their own patients as needed for the purpose of reviewing the patient’s controlled drug prescription history. If a prescriber or dispenser is acting in good faith, they are immune from civil, criminal, and administrative liability that might otherwise be incurred for receiving or using information from the prescription monitoring program database.
The bill will require certain persons (new patients and persons not known to the dispenser) to present specified identification in order to obtain controlled substances. This is a similar practice already utilized in most pharmacies and clinics whereby the patients provide a driver’s license to verify their identification.
Once the database is established, it will require the pharmacy dispensing the controlled substance and any prescriber who directly dispenses controlled substances to submit to the electronic database the following:
1. the name of the prescribing practitioner, the DEA registration, and the NPI, and the date of the prescription; 2. the date the prescription was filled and the method of payment; 3. the full name, address, and the date of birth of the person for whom the prescription was written 4. the name, national drug code, quantity, and strength of the controlled substance; 5. the full name, DEA registration number, and address of pharmacy from which the controlled substance was dispensed.
Each time a controlled substance is dispensed to an individual, the controlled substance is reported to the department through the electronic system by the pharmacy, prescriber, or dispenser, but must be done within 15 days after the controlled substance is dispensed.
A pharmacy, prescriber, or dispenser will have access to information in the prescription drug monitoring database which relates to a patient of that pharmacy, prescriber, or dispenser as needed for the purpose of reviewing the patient’s controlled substance prescription history.
The rationale behind Senate Bill 462, and for stricter requirements in prescribing certain controlled substances, is to alleviate and prevent common diversion issues, theft, loose medical evaluations, internet medical evaluations, and reduce patient fraud.
The Department of Health WILL NOTIFY the dispensers and prescribers that are subject to the reporting requirements. The Department will also provide the implementation date for the reporting requirements.
II. Pain Management Clinics
All privately owned clinics which advertise for any type of pain management services, or employ a physician who is primarily engaged in the treatment of pain by prescribing or dispensing controlled substance medications, must register with the Department of Health by January 4, 2010.
A physician may not practice medicine in a pain management clinic that is required to, but has not yet registered with the department.
If the clinic is NOT registered pursuant to Florida Statutes Chapter 395 or Chapter 400, the clinic shall, upon registration, designate a physician who is responsible for complying with all requirements related to registration of the clinic. The designated physician must be licensed and shall practice at the location which the physician has assumed responsibility.
The Board of Medicine and the Board of Osteopathic Medicine will adopt rules setting forth the standards of practice for physicians practicing in privately owned pain-management clinics primarily treating pain by prescribing or dispensing controlled substances. A physician primarily engaged in the treatment of pain by prescribing or dispensing controlled substance medications is defined as those physicians with the majority of patients seen are prescribed or dispensed controlled substances for the treatment of chronic nonmalignant pain. |
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Florida Senate Bill 462 |
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Date: 07/23/2009 |
