2014 Legislative Session. Disclosure. Florida Pharmacy Laws(Statutes) Objectives (1) Pharmacy Technician. FL Pharmacy Law Update May 24, 2014

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1 2014 Legislative Session FL Pharmacy Law Update May 24, 2014 Norman Tomaka, MS, BS Pharm, FAPhA Board of Directors, FSHP HB 323/SB 278 HB 7077/SB 662 HB 859/SB 962 SB 7016 HQS1 Relating to Pharmacy Technicians Relating to Nonresident Pharmacies Relating to Medical Use of Cannabis Relating to Prescription Drug Monitoring Relating to Sterile Compounding 4 Disclosure I do not have a vested interest in or affiliation with any corporate organization offering financial support or grant monies for this continuing education activity, or any affiliation with an organization whose philosophy could potentially bias my presentation Florida Pharmacy Laws(Statutes) Chapter 465 Florida Pharmacy Act Chapter 893 Florida Comprehensive Drug Abuse Prevention and Control Act Chapter 120 Administrative Procedures Act Chapter 499 Florida Drug, Device and Cosmetics Act Chapter 456 Health Professions and Occupations 2 5 Objectives The participant will become familiar with issues centered on patient safety involved with recently enacted FL legislation related to the Chapter 465 of the Florida Statues (Pharmacy Practice Act). The attendee will review FL Board of Pharmacy revised rules pertaining to initial training program, FL registration, background screening and continuing education requirements. The participant will become familiar with key bills related to pharmacy technicians as presented for consideration to the FL House and Senate during the 2014 legislative session (1) Pharmacy Technician A person other than a licensed pharmacist or pharmacy intern may not engage in the practice of the profession of pharmacy, except that a licensed pharmacist may delegate to pharmacy technicians who are registered pursuant to this section those duties, tasks, and functions that do not fall within the purview of s (13) The attendee will become familiar with evolving practice regulations related to sterile compounding as per the FL Board of Pharmacy

2 Pharmacy Technician (Continued) All such delegated acts shall be performed under the direct supervision of a licensed pharmacist who shall be responsible for all such acts performed by persons under his or her supervision (2) Pharmacy Technician The board shall register each applicant who has: remitted a registration fee set by the board, not to exceed $50 biennially has completed the application form and remitted a nonrefundable application fee set by the board, not to exceed $50 is at least 17 years of age; and has completed a pharmacy technician training program approved by the FL Board of Pharmacy Pharmacy Technician (Continued) A pharmacy registered technician, under the supervision of a pharmacist, may initiate or receive communications with a practitioner or his or her agent, on behalf of a patient, regarding refill authorization requests (6) Pharmacy Technician As a condition of registration renewal, a registered pharmacy technician shall complete 20 hours biennially of continuing education courses approved by the board or the Accreditation Council for Pharmacy Education 4 hours must be via live presentation (interactive) 2 hours must be related to the prevention of medication errors and pharmacy law CS/HB 323 Pharmacy Technician Bill A licensed pharmacist may not supervise more than one registered pharmacy technician unless otherwise permitted by the guidelines adopted by the board. A pathway was made for increases in the technician ratio above 3:1, but only on a case by case basis pursuant to Board of Pharmacy guidelines and approval (7) Pharmacy Technician The number of actively practicing institutional pharmacists and community pharmacists which must be appointed to the Board of Pharmacy was increased from one of each to two of each providing the necessary expertise to review applications for increases in the technician ratio and other matters

3 (8) Pharmacy Technician The BOP may enter an order imposing any of the penalties specified in s (2) against the applicant or registrant If the applicant for registration or registered pharmacy technician has committed an act that constitutes grounds for discipline as set forth in s (1) Committed an act that constitutes grounds for denial of a license or disciplinary action as set forth in this chapter, including an act that constitutes a substantial violation of s (1) or a violation of this chapter which occurred before the applicant or registrant was registered as a pharmacy technician Florida Pharmacy Regulations(Rules) Chapter 64B 16 Board of Pharmacy Florida Administrative Code Chapter 61N 1 Drugs, Devices and Cosmetics Program 61N (e f) Wholesale distribution of prescription drugs Exceptions and Specific Distribution Authorized Chapter 64K 1 Prescription Drug Monitoring Program CS/HB 323 Pharmacy Technician Also authorizes pharmacists to administer meningococcal vaccine under a physician protocol Removes requirement for a Rx from a physician to administer shingles/zoster vaccine (Zostavax ) Amended to allow the date on a controlled substance Rx for to be numeric month/day/year format or the whole month name to be legibly written. Removes requirement that the date and quantity must be written on the face of the prescription. Board of Pharmacy Regulations 64B Practice of Pharmacy 64B Display of Current License 64B Cont. Education Credits; Renewal 64B Exemptions for Members of the Armed Forces 64B Subject Matter for Registered Pharmacy Technician Continuing Education 64B Standards for Approval of Courses and Providers BOP Regulations (continued) I am a Law, Now What? Regulations!!! 64B Tripartite Continuing Education Committee 64B Guidelines for Board Ordered Disciplinary Continuing Education Courses 64B Continuing Education Records Requirements 64B Standards for Approval of Registered Pharmacy Technician Training Programs 64B Requirements for Pharmacy Technician Registration

4 BOP Regulations (continued) 64B Registered Pharmacy Technician to Pharmacist Ratio 64B Registered Pharmacy Technician Responsibilities 64B Responsibilities of the Pharmacist 64B Policies and Procedures Registered Pharmacy Technician Continuing Education Information Registration renewal 20 hours C.E. 4 hours of 20 must be LIVE (interactive) 1 hour FL approved HIV/AIDS course for the first time renewal only CE must be approved by the FLBOP or ACPE All courses must be appropriate for pharmacy technicians (objectives) What occurs if FL technician registration renewal is late? 20 Technician renewal must be completed by December 31, 2014! 23 Registered Pharmacy Technician Continuing Education Information FLBOP uses the CE Broker database to determine a registrant s compliance with the requirements for continuing education. Two method of entering CE hours: FLBOP approved CE providers (FSHP) auto Self reporting (instruction on CE Broker website) NOTE: It is the registrant s responsibility to provide proof of compliance with CE requirements (not the employer or pharmacy manager) SB662/HB7077 Sterile Compounding Require out of state pharmacies that compound medications to obtain a sterile compounding permit if they wish to ship sterile compounds into the State of Florida. Insure that non resident pharmacies meet or exceed the standards for sterile compounding required of Florida pharmacies. Enforcement of FL rules by authorizing inspection of the nonresident pharmacies by Florida inspectors (co$t) Subject non resident pharmacies to the same disciplinary standards as FL resident pharmacies

5 USP 797 Standard of safe sterile compounding practice that applies to pharmacists, physicians, nurses, and ALL allied health team members since 2004 Non governmental, non profit organization Primary activities of USP are: Creation of standards Foster patient safety Provide healthcare information Verification of product quality SB702 Pharmacy Audit Bill of Rights Florida s pharmacies support the right of a pharmacy benefit manager (PBM) to conduct audits to prevent fraud and abuse. Adopted industry established uniform audit standards to govern the auditing process Bill of Rights established in SB 702 do not apply to audits in which suspected fraudulent activity or other intentional or willful misrepresentation is evidenced by a physical review, review of claims data or statements or other investigative methods Sterile Compounding What is sterile compounding? Sterile compounding is the preparation of custom medications for patients in a sterile environment to prevent contamination and maintain patient safety. Pharmacies that offer this service are known as compounding pharmacies. A compounding pharmacy may use pharmacists or technicians to prepare medications. In both cases, they work in a sterile environment. SB702 Pharmacy Audit Bill of Rights (a) To be notified at least 7 calendar days before the an initial on site audit for each audit cycle (b) To have the on site audit scheduled after the first 3 calendar days of a month unless the pharmacist consents otherwise (c) To have the audit period limited to 24 months after the date a claim is submitted to or adjudicated by the entity (d) Audits that require clinical or professional judgment must be conducted by or in consultation with a pharmacist Sterile Compounding Permit The Florida Board of Pharmacy published notice that USP <797> and associated chapters have been officially adopted as the rules for sterile compounding in Florida FLBOP defined exceptions pertaining to facility design and workplace cleaning All pharmacies engaged in sterile compounding had to apply for and received the Special Sterile Compounding Permit by March 21, 2014 SB702 Pharmacy Audit Bill of Rights (e) To use the written and verifiable records of a hospital, physician, or other authorized practitioner, which are transmitted by any means of communication, to validate the pharmacy records in accordance with state and federal law (f) Audits can NOT deny reimbursement for claim retroactively where there is a clerical error, typographical error, scrivener s error, or computer error if the prescription was properly and correctly dispensed, unless a pattern of such errors exists, fraudulent billing is alleged, or the error results in actual financial loss to the entity

6 SB702 Pharmacy Audit Bill of Rights (g) Receive the preliminary audit report within 120 days after the conclusion of the audit (h) Allow pharmacy to produce documentation that will address a discrepancy or audit finding within 10 business days after the preliminary audit report is delivered to the pharmacy (i) Receive the final audit report within 6 months after receiving the preliminary audit report (j) To have recoupment or penalties based on actual overpayments and not according to the accounting practice of extrapolation SB1030 Medical Marijuana FL Licensed Physicians will be able to prescribe a specially grown marijuana extract for treatment of severe seizures and other conditions. authorizes the use of a "non euphoric" marijuana extract known as cannabidiol or CBD which is low in tetra hydrocannabinol (THC), the drug that produces euphoria dispensing will NOT occur via pharmacies, but by five approved dispensing organizations Prescription Drug Monitoring Program (PDMP) The Legislature has favored non state funding of the program. Finding sources has been difficult While the legislation containing this funding did not pass, a new $ source has been found FSHP and the Florida Pharmacy Association worked this session to secure funding of the PDMP from surplus money in the Pharmacy Account of the FL Medical Quality Assurance Trust Fund SB1030 Medical Marijuana Testimony during FL legislative hearings that CBD has been effective in treating children with frequent epileptic seizures when FDA approved medications were ineffective FL House amended the bill to also allow physicians to administer CBD for cancer related treatments Prescription Drug Monitoring Program (PDMP) FL Attorney General announced that she will be using $2 million from a past settlement with Caremark to fund the Prescription Drug Monitoring Program for four years The PDMP is considered by many an important tool in the battle against prescription drug abuse, and will now have viable funding for four years through 2018 FAILED! SB1646/HB7113 Telehealth Legislative that attempted to allow a process for health care via telecommunication technology to reach underserved communities in Florida. It was part of the omnibus health care bill from the FL House (Committee Substitute for HB 7113) FAILED as the Senate removed the telemedicine provisions from the bill and sent it back to the House in the final hours of the Session. The House declined to take the bill up again before final adjournment

7 References Florida Board of Pharmacy website Florida Statutes, Chapters 120, 456, 465, 499 and Florida Administrative Code 64B16 HARMACY%20PRACTICE&ID=64B16 CE Broker 37 FL Pharmacy Law Update May 24, 2014 Norman Tomaka, MS, BS Pharm, FAPhA Board of Directors, FSHP 7