Board of Pharmacy Update Eric Alvarez, R.Ph., C.Ph., Pharm.D. Chair, 2006 1 Today s Objectives: Describe the purpose of the Board of Pharmacy and its relationship to state government Recognize recent changes in administrative rules affecting the practice of pharmacy Identify proposed changes Discuss requests submitted to the Board of Pharmacy for opinion 2 Florida Board of Pharmacy Department of Health/Division of MQA The Mission of the Division of Medical Quality Assurance is to protect the public through healthcare e licensure, e, enforcement e and information. 3 1

Board of Pharmacy Members Ronald Salem, Pharm. D. Chair Albert Garcia, R.Ph. Vice-Chair Eric Alvarez, Pharm.D. Gail Merrell, Pharm.D. Bob Parrado, R.Ph. Jim Powers, R.Ph. Jennifer, Lalani, R.Ph. Brigitte Goersch, Consumer Member Amy Jones, J.D. Consumer Member 4 Florida Board of Pharmacy Nine Members appointed by Governor- term expires 10/31 7 Pharmacists 2 Consumer Members 5 License Summary Pharmacists 16392 Florida 6225 Out of State Consultants 2250 Florida 138 Out of State Nuclear 141 Florida 43 Out of State Pharmacist Intern 2482 Pharmacy 7422 6 2

Complaints & Reports Received and Investigations Completed 17 Emergency Suspension Orders issued 12 Voluntary Relinquishments issued 151 fines/reprimands 99 limitations/obligations 7 ACCESSING Board of Pharmacy ON-LINE WHY? Because you can quickly access : Messages New Laws New Rules Schedules of Board and Committee Meetings Agendas and Minutes of Board and Committee Meetings 8 HOW TO ACCESS THE Board of Pharmacy ON-LINE Board of Pharmacy Web Site: www.doh.state.fl.us/mqa/pharmacy For a no-cost, automatic e-mail of every new item put on the Board website, you can subscribe by going to this web site: http://forum.doh.state.fl.us/~mqa_pharmacy 9 3

Board of Pharmacy Laws & Rules: - Chapter 465 FSS - 64B16 FAC - Chapter 456 FSS - Chapter 893 FSS - Chapter 499 FSS - 64B12 FAC 10 FINDING LAWS (STATUTES): www.leg.state.fl.us Health Care Regulation - Chapter 456 Pharmacy Practice Act - Chapter 465 HOW TO: At the web site, click STATUTES, then scroll down the right side of the screen to the Chapter you want. Each Chapter has an index of topics. 11 FINDING RULES OF THE BOARD: http:// www.flrules.org Rules are located in the Florida Administrative Code, 64B16-25 through 64B16-30. HOW TO: At the web site, search for Agencies, FAC Administrative Rules, and Florida Administrative Weekly notices. 12 4

MESSAGE FROM THE BOARD OF PHARMACY CHAIR We see too many pharmacists facing discipline because they didn t know the law or rules affecting their practice. This presentation ti will give you an easy way to find the laws and rules on- line and, most importantly, an easy-to-digest, plain English summary of 10 law and rule changes. Providing information is part of our mission so please share Dr. Salem s message with your colleagues. Ronald Salem, Pharm.D. Chair Florida Board of Pharmacy 13 10 LAWS AND RULES EVERY PHARMACIST NEEDS TO KNOW 14 # 1: You Must Update Changes To Your Profile Within 15 Days This means changes in: Mailing Address Practice location Name [section 456.035, F.S.] 15 5

# 2: PDM/CPH Change: Update Board Prescription Department Manager of Record and Consultant Pharmacist of Record must update the board office if there is a change within 10 days. [ss. 456.035, 465.018, 465.0125, F.S. 64B16-28.501, F.A.C] 16 # 3: At License Renewal, Read the Fine Print CE requirements are audited. It is your license on the line, not your corporation s or prescription department manager s. DIDN T RECEIVE YOUR RENEWAL PACKET? Call (850) 488-0595, extension #3 WANT TO SAVE TIME?-RENEW ONLINE www.doh.state.fl.us/mqaservices [section 465.008, F.S.] 17 # 4: Continuing Education Prior to your first renewal: IF license is issued less than 12 months from renewal, only 1 hour of HIV/AIDS is required. IF license is issued more than 12 months from renewal: 15 Hours of approved CE (5 must be LIVE) 12 General Hours 2 Med. Errors 1 HIV/AIDS [section 465.009, F.S. & 64B16-26.103, F.A.C.] 18 6

#5: Internet Dispensing Prescribing without a history and physical is both a standard of care violation and a violation of the Board of Medicine rule. Pharmacists have been disciplined for this with penalties ranging from revocation to suspension, reprimands and fines. [Rule 64B8-9.014, FAC] 19 #6: Physician Assistants (PA) Changes in protocols/employment must be filed with the Board of Medicine Office PAs have limited prescribing authority (no controlled substances), but must keep on file for 5 years a signed agreement with supervisor on what drugs may be prescribed [Rules 64B8-30.004 and 30.004, FAC] 20 #7: Citations New law changes how minor offenses are handled. The first citation that a licensee receives is not considered discipline. If you accept the Citation and pay the fine, it will be public but not count as discipline on your record. [section 456.077(1), F.S.] 21 7

#8: Help For Impaired Practitioners Do you know a colleague with drug, alcohol, or psychiatric problems? You can get them help without subjecting them to disciplinary action. The Board has an excellent evaluation and rehabilitation program that is a phone call away: Professionals Resource Network (PRN) 1-800-888-8776. 8776. For most practitioners, this is a confidential process that offers help to those willing to change. [section 456.076, F.S.] 22 #9: Pharmacist Reporting Out-Of-State Discipline Many of our Florida licensed pharmacists have licenses to practice in other states. If that out-of of-state license is disciplined, the Florida licensee must report that to the Board of Pharmacy. [sections 456.072 (2) and 465.016(1)(h) F.S.] 23 #10: Legible Prescription Law In effect now is a new law requiring that: written prescription must be legibly printed or typed, must contain the name of the prescribing practitioner, the name and strength of the drug prescribed, the quantity of the drug prescribed in both textual and numerical formats, and the directions for use of the drug, must be dated with the month written out in textual letters, and must be signed by the prescribing practitioner on the day when issued. [section 456.42, F.S.] 24 8

Florida Administrative Code 64B16-25 Organization and Purpose 64B16-26 Pharmacist Licensure 64B16-27 Pharmacy Practice 64B16-28 General Requirements- Permits 64B16-29 Animal Control Shelter 64B16-30 Disciplinary Guidelines 25 64B16-26.1005 Retired License Election; Renewal; Fees New rule to address retired license status Written request & $50.00 fee CE requirements/all fees Inactive status less than 5 years must pass law exam Inactive more than 5 years must pass NAPLEX 26 64B16-26.300 Consultant Pharmacist Licensure Amends rule to correct percentage of time and hour requirements. Expands the description of consultant pharmacists responsibilities Deleted (8) in order to grand-father in C.Ph. who have never completed a period of assessment and evaluation in (2)(c). Effective 11/29/06 27 9

64B16-26.402 Pharmacy Permit Application ;Community Pharmacy ;Special Pharmacies; Internet Pharmacy Repeals 64B16-28.121 Amends this section to include internet pharmacy 850 pharmacies did not renew their permits; check your permit for expiration date 2/09 28 64B16-27.100 Display of Current License This rule has been amended to eliminate the requirement of posting the wall certificate; and Requires a pharmacist and intern to be clearly identified by a means such as an identification badge or monogrammed smock showing their name and if they are a pharmacist or intern. 29 64B16-27.103 Oral Prescriptions and Copies Amends current language Removed Florida registered from the language Unless otherwise stated, t all rules imply Florida registered. 30 10

64B16-27.104 Conduct Governing Pharmacists and Pharmacy Permittees Amends current language Removed Registered from title Restated the requirements of a prescription department t manager The Board may grant an exception 31 64B16-27.220 Medicinal Drugs Which May Be Ordered By Pharmacists Oral Analgesics Keratolytics Urinary analgesics Vitamins with Fluoride Otic analgesics Medicinal drug shampoos Anti-Nausea containing lindane Antihistamines & Ophthalmics decongestants H2 Antagonists Topical Antifungal / Acne Products antibacterials Topical Antivirals Topical anti-inflammatoryinflammatory Otic Antifungal / antibacterials 32 64B16-27.410 Pharmacy Technician 1:1, 2:1, or 3:1 Ratio Proposed language from the Board Counsel due to concerns from the Joint Administrative Procedures Committee (JAPC) The board shall establish guidelines to be followed in determining circumstances under which a licensed pharmacist may supervise more than one but not more than three technicians 33 11

64B16-27.530 Duty of Pharmacists to Inform Regarding Drug Substitution There were no concerns voiced regarding the proposed changes in this rule No significant change 34 64B16-27.700 Definition of Compounding Amends current language Professional Practice Committee meeting 12/5/06 Embassy Suites, Miami Proposed language includes office use compounding 35 64B16-27.831 Standards of Practice for the Dispensing of Controlled Substances for Treatment of Pain Removed the narrative language in (1) through (3) and renumbered paragraphs Criteria SHALL cause RPH to question RX issued for legitimate medical purpose: Frequent loss of medication Only controlled substances are prescribed One person presents RX with different pt names Multiple prescribers Pays Cash and insists on brand name Required instead of should insist ID 36 12

64B16-28.141 Requirements for An Automated Pharmacy System in a Community Pharmacy Amends current language to include Patient Accessed Automated Pharmacy System RPH must be Fl licensed RPH verifying the filling and labeling is responsible if the cartridge is stocked or restocked incorrectly APS must use two methods of verification 37 64B16-28.405 Remote Medication Order Processing for Community Pharmacies Defines medication, remote prescription process General Requirements include FL licensed RPH Written agreement if not an employee Policy & Procedures Recordkeeping 38 64B16-28.450 Centralized Prescription Filling Amends current language Proposed language will allow the supplying pharmacy the opportunity to deliver the medication to the patient or patient s agent. 39 13

64B16-28.451 Pharmacy Common Database This proposed new rule creates instructions concerning pharmacies that utilize a common database and separate the processing and dispensing function of the pharmacist. 40 64B16-28.607 Automated Pharmacy System Long Term Care, Hospice, and Prison New rule in development Section 465.0235, F.S. Definitions Outlines provider pharmacy requirements Outlines PDM requirements Outlines Automated Pharmacy System Requirements Establishes Security Requirements Emergency Medications Recordkeeping Requirement Effective 4/22/07 41 64B16-30.001 Disciplinary Guidelines Range of Penalties Aggravating and Mitigating Circumstances New rule in development Changes in Chapter 456, F.S. amended disciplinary guidelines to include violation for failing to successfully complete or being terminated from an impaired practitioners treatment program Penalty range includes suspension & fine until successful completion to revocation Effective 11/29/06 42 14

On the Horizon On-line application processing On-line audio link to Board meeting Website enhancements Web Board enhancements Upcoming meetings: Tallahassee, October 16 & 17th Ramada Inn Jacksonville, December 4 & 5th 43 Questions 44 Contact Information Eric Alvarez, Pharm.D. 4052 Bald Cypress Way Bin C-04 Tallahassee, Fl 32399 (813) 361-0491 Eric072950@aol.com www.doh.state.fl.us/mqa/pharmacy 45 15