FLORIDA PHARMACY LAW REVIEW 2012 www.doh.state.fl.us/mqa/pharmacy
FLORIDA PHARMACY LAWS • TITLE XXXII • CHAPTER 456 (HEALTH PROFESSIONS) • CHAPTER 465 (PHARMACY ACT) • TITLE XLVI (CRIMES) • CHAPTER 893 (DRUG ABUSE PREVENTION & CONTROL) FLORIDA PHARMACY REGULATIONS FLORIDA ADMINISTRATIVE CODE CHAPTER 64B16
SECTION I FLORIDA PHARMACY ACT (Chapter 465) • DEFINITIONS • Dispense • prior to delivery, pharmacist must assess for potential adverse reactions, interactions and dosage. Administration is not considered dispensing • “Medicinal drugs” • prescription drugs/legend drugs/non-proprietary • “Patent drugs” • proprietary/OTC
SECTION I . FLORIDA PHARMACY ACT (Chapter 465) cont. • DEFINITIONS • “Pharmacy department closed” • if the pharmacist is not present and on duty. Pharmacist may leave Rx department but not leave the building • “Practice of Pharmacy” • includes the administration of influenza immunizations • “Prescription” • may be transmitted by ANY means written/oral/fax/electronic) if from out-of-state must be for chronic or recurrent illness (legal?) may be scanned into computer or kept in paper form
BOARD OF PHARMACY • 9 members 7 pharmacists (1 from community pharmacy;1 from Class II hospital pharmacy) ; 2 citizen members with no connection to pharmacy; at least one member must be 60 years of age or older
RENEWAL OF LICENSE • Must renew license every two years
CONTINUING EDUCATION • 30 hours within the two years immediately prior to license renewal. Must be ACPE or Board of Pharmacy approved courses.
CONSULTANT PHARMACIST • Separate license in addition to pharmacist’s license. • Must have additional training as required by the Board including 3 hours of CE relating to laboratory and clinical testing • Responsible for maintaining all required drug records and establishing drug handling procedures • May order and evaluate laboratory or clinical tests for nursing home patients • (Consultant Rx or Doctor of Pharmacy may order & evaluate laboratory or clinical tests for patients under the care of a licensed home health care agency-Must have 3 hours of CE relating to laboratory and clinical testing.)
PHARMACY TECHNICIANS • Must be REGISTERED by the Board (A technician trainee enrolled in a technician training program does not need to be registered, but must wear ID indicating student status) • An Intern may be registered as a technician • For registration renewal must complete 20 hours of CE approved by the Board every 2 years , and 4 of those hours must be via live presentation, and 2 of those hours must be related to prevention of medication errors and pharmacy law • The technician registration certificate must be displayed in public view
PHARMACY TECHNICIANS • A pharmacist may normally supervise only 1 technician, but the Board may allow any number of technicians to be supervised by a pharmacist (See Board Regulations 27.410) • Technicians may initiate or receive telephone calls with a prescriber for refill authorization • Must be at least 17 years old and complete a technician training program approved by the Board (Exempt from the training program requirement if registered before 1/1/2011 and has worked at least 1,500 hours or is certified by a program approved by the National Commission for Certifying Agencies) • May not be a pharmacist whose license has been denied, suspended or restricted for disciplinary reasons.
REQUIRED REPORTING OF ATTEMPTS TO FRAUDULENTLY OBTAIN CONTROLLED SUBSTANCES Pharmacist must notify the sheriff within 24 hours or close of next business day if a person obtains or attempts to obtain a controlled substance by fraud or misrepresentation.
REGISTRATION OF NON-RESIDENT PHARMACIES • Any pharmacy located outside Florida that ships, mails, or delivers prescriptions into Florida must register with the Board as a non-resident pharmacy. • Must be licensed in good standing in the state where located and follow all laws/regulations of the state where located. • Must provide toll-free telephone service at least 6 days/week and 40 hours/week (Telephone number must be on label)
DISCIPLINARY ACTIONS • Violating a Florida statute or regulation relating to the practice of pharmacy; the Federal Food, Drug & Cosmetic Act or the Controlled Substances Act; another state’s law relating to the ability to practice pharmacy; or having been disciplined by another state for any offense that would violate Florida pharmacy laws or regulations • Failing to make prescription fee or price information to a patient who presents a prescription and requests such information • Placing back into stock any prescription drug which has been returned by a patient except medications for patients in hospitals, nursing homes or extended care facilities in which the medication is individually sealed in unit doses and labeled with the drug, strength, manufacturer’s control number and expiration date.
DISCIPLINARY ACTIONS • Failing to report a licensee who the pharmacist knows has violated the grounds for disciplinary action • Failing to notify the Board in writing within 20 days of the commencement or termination of practice in Florida as a result of a pending or completed disciplinary action or investigation in another jurisdiction • Dispensing a prescription when the pharmacist has reason to know that it is not based on a valid practitioner-patient relationship (Example is internet prescribing)
AUTHORITY TO INSPECT & CONFIDENTIALITY OF MEDICAL RECORDS • Agents of the Board may inspect a pharmacy at all reasonable hours • Pharmacists shall not disclose confidential prescription information except to the patient or upon the written authorization of the patient. If the patient is incapacitated, the records may be disclosed to the spouse. If no written authorization has been given by the patient, the records can only be disclosed upon a subpoena/order of a court after notice is given to the patient.
PRESCRIPTION DEPARTMENT MANAGER • No pharmacy permit will be issued unless the pharmacy has designated a prescription department manager. The pharmacy owner AND any new prescription department manager shall notify the Board within 10 days of any change in manager.
COMMUNITY PHARMACY PERMIT REQUIRED TO DISPENSE SCHEDULE II OR III CONTROLLED SUBSTANCES As of July 1, 2012 all community pharmacies that wish to dispense Schedule II or III C.S. must obtain a permit from the Board.
INSTITUTIONAL PHARMACIES • Class I institutional pharmacies (nursing home) must administer drugs from individual patient prescription containers. Prescription drugs may NOT be dispensed on the premises or from a Class I institutional pharmacy. • Class II institutional pharmacies (hospitals) employ pharmacists who provide dispensing services to patients of the institution for use on the premises of the institution. If a state of emergency is declared by the Governor, a Class II institutional pharmacy may provide dispensing and consulting services to individuals who are not patients of the institution. If a Class II institutional pharmacy dispenses prescription drugs to outpatients, it must obtain a community pharmacy permit from the Board.
INSTITUTIONAL PHARMACIES • In a Class II institution (hospital) emergency room, a physician can dispense a 24 hour supply of prescription medication, but must give the patient a prescription for such drug use after the initial 24-hour period. • All institutional pharmacies must be under the supervision of a CONSULTANT PHARMACIST, and must have a written policy and procedure manual for technician duties and functions that a registered pharmacy technician is allowed to perform.
PHARMACY PERTMITTEE DISCIPLINARY ACTIONS • The Board may revoke or suspend a pharmacy permit if the permit holder or the employees violates the Florida Pharmacy Act, the State Board Regulations, the Federal FD&C or Controlled Substances Acts, is convicted of a crime involving moral turpitude (dishonesty) or a crime which relates to the practice of pharmacy or health care fraud, or dispenses a prescription that is not based upon a valid practitioner-patient relationship. • A suspension of the permit may not exceed one year. If a permit is revoked, the permit holder may not apply for reinstatement for at least one year from the date of revocation.
AUTOMATED PHARMACY SYSTEMS IN LONG-TERM CARE FACILITIES • A pharmacy may use an automated dispensing machine that is NOT located at the pharmacy to service a long-term care facility or hospice. • The drugs in the automated system are deemed to be part of the pharmacy’s inventory • A pharmacist need not be present at the facility, and may operate the system electronically • The Board will establish rules specifying how the systems must operate, recordkeeping requirements, and labeling requirements
PROMOTION OF CONTROLLED SUBSTANCES PROHIBITED • No pharmacist may promote or advertise the use or sale of any controlled substance
GENERIC SUBSTITUTION OF DRUGS • A generic equivalent drug must be the same active ingredient in the same dosage form and in the same strength as the brand name drug ordered • Each community pharmacy in Florida must establish a formulary of generic and brand name drug products which if substituted would not pose a threat to the health and safety of patients receiving the substituted drug. This formulary must be available to the public, the Board and to physicians requesting to see it. • The Board of Pharmacy and the Board of Medicine shall establish a formulary of drugs that demonstrate in equivalence, and which would pose a threat to the health and safety of patients receiving the drug (Negative Formulary). Levothyroxine was removed from this list in 2010. If every commercially marketed equivalent of a brand name drug is “A” rated in the Orange Book, the drug shall be removed from the negative formulary list.
GENERIC SUBSTITUTION OF DRUGS • If a pharmacist receives a prescription for a brand name drug, the pharmacist shall, unless requested otherwise by the patient, substitute a less expensive generically equivalent drug from the pharmacy’s formulary unless: 1.The prescriber writes “MEDICALLY NECESSARY” in his or her own handwriting on the face of the prescription 2.On an oral prescription the prescriber expressly indicates that the brand name drug is medially necessary 3.On an electronic prescription the presriber makes an overt act indicating that the brand name drug is medically necessary 4.The drug is listed on the negative formulary of the Boards of Pharmacy and Medicine
GENERIC SUBSTITUTION OF DRUGS • If a substitution occurs, the pharmacist must notify the patient of the substitution, tell the patient the amount of the retail price difference from the brand name drug, inform the patient that the substitution may be refused, and pass on to the customer the full cost savings. The pharmacist must also make a record (on the prescription) of the substitution. • Every community pharmacy must display a sign in block letters of not less than 1 inch in height “CONSULT YOUR PHARMACIST CONCERNING THE AVAILABILITY OF A LESS EXPENSIVE GENERICALLY EQUIVALENT DRUG AND THE REQUIREMENTS OF FLORIDA LAW”
EXPIRATION DATE OF LABEL OF PRESCRIPTIONS • A pharmacist in a community pharmacy shall put an expiration date on the label of a prescription. The expiration date shall be the date provided by the manufacturer or distributor of the drug, or an earlier beyond-use date which may be up to 1 year after the date of dispensing.
TRANSFERRING OF PRESCRIPTIONS FOR FILLING OR REFILL PURPOSES • Prescription information may be transferred by any means including electronically from one pharmacy to another for the purposes of filling or refilling the prescription at the dispensing pharmacy. • The dispensing pharmacist must: 1. advise the patient and the transferring pharmacist that the prescription must be canceled at the original pharmacy 2. must verify that the prescription may be validly filled or refilled in accordance with the prescriber’s intent. 3. record all relevant information from the original prescription 4. obtain the consent of the prescriber if in the pharmacist’s professional judgment such consent is required
TRANSFERRING OF PRESCRIPTIONS FOR FILLING/REFILL PURPOSES(cont.) • The transferring pharmacist must: 1. convey all the required prescription information accurately and completely 2. record the requesting pharmacy and pharmacist’s names 3. cancel the prescription. (No further prescription information shall be given or medication dispensed on the original prescription) 4. If the requesting pharmacy is out-of-state, verify that the requesting individual is a licensed pharmacist and that the pharmacy is licensed • Prescriptions for controlled substances are limited to a one-time transfer • If the prescription is contained in a common database of a chain pharmacy, accessing the database shall not be considered a transfer if the database maintains a record of all pharmacists involved in the dispensing of a prescription
EMERGENCY PRESCRIPTION REFILLS • If a drug is necessary for the continuation of therapy in a chronic condition, is essential to the maintenance of life, or the interruption of therapy might reasonably produce undesirable health consequences or cause physical or mental discomfort, and no refill authorization exists, a pharmacist may dispense an emergency supply of the drug. • If a pharmacist is not able to obtain refill authorization from the prescriber, the pharmacist may dispense a one-time emergency refill of up to a 72-hour supply of the medication.
EMERGENCY PRESCRIPTION REFILLS • If a state of emergency has been declared by the Governor, the pharmacist may dispense up to a 30-day supply. • The pharmacist must create a written order containing all the information required on a prescription and sign the order. The pharmacist must also notify the prescriber of the emergency dispensing within a reasonable time after such dispensing.
DISPENSING PRACTITIONERS • A practitioner licensed to prescribe prescription drugs who sells such drugs for a fee or remuneration of any kind must register with his or her licensing board as a dispensing practitioner and comply with all laws and regulations applicable to pharmacists and pharmacies. • Before dispensing any such drug, the practitioner must give the patient a written prescription and advise the patient that the prescription may be filled at any pharmacy or in the practitioner’s office. • A practitioner may not dispense a Schedule II or III C.S., except for a maximum 14 day supply in connection with a surgical procedure
PHARMACIST PRESCRIBING • The Boards of Pharmacy, Medicine and Osteopathic Medicine shall create a formulary of drugs from which a pharmacist may prescribe. • The formulary shall include any drug approved for OTC sale but in a strength that requires a prescription, any antihistamine or decongestant, fluoride, lindane, and any topical anti-infective excluding eye and ear topical anti-infectives. The formulary shall NOT include a drug which is sold as an OTC product.
PHARMACIST PRESCRIBING • The pharmacist prescribing a drug under this section: 1. Must create and maintain a prescription containing all the information required by law 2. Must be the only person permitted to fill the prescription 3. May not refill the prescription 4. May not order another medicinal drug for the same condition 5. Must affix a label with all required information including the pharmacist’s name and a statement that the prescription may not be refilled
ADMINISTRATION OF INFLUENZA VIRUS IMMUNIZATIONS • Pharmacists may administer influenza virus immunizations to ADULTS under a protocol from a supervisory physician. The pharmacist must: 1. Maintain at least $200,000 of liability insurance 2. Complete training in influenza virus immunizations 3. Create and maintain patient records for a least 5 years 4. Forward immunization records to the department for inclusion in the state registry of immunization information 5. Be certified pursuant to a program approved by the Board, and the program must require at least 20 hours of CE classes approved by the Board 6. Submit a copy of the protocol to the Board
PRACTICE OF ORTHOTICS AND PEDORTHICS • The practice of ORTHOTICS and PEDORTHICS shall be within the meaning of the practice of pharmacy
SECTION II FLORIDA BOARD OF PHARMACY RULES AND REGULATIONS (Chapter 64B16)
CONTINUING EDUCATION • A pharmacist must complete at least 30 hours of approved CE within the 24 months prior to expiration of the license. All ACPE courses are “approved”, but the Board allows other ways to obtain credit: • 1. Five (5) hours of CE on risk management may be obtained by attending 8 hours of a Board meeting at which disciplinary hearings are conducted. No more than 10 hours of such credit may be obtained in any 2 year renewal period. • 2. Up to 5 hours of CE credit may be granted for volunteer services to the indigent or in underserved areas of the state. One hour of CE will be granted for every 2 hours volunteered during the 2 year renewal period. • 3. Five (5) hours of CE credit shall be given for completion of each semester hour of post professional degree programs completed within the 2 year renewal period.
CONTINUING EDUCATION(cont.) • At least 10 of the required hours must be obtained either at live seminars, live video teleconferences or through interactive computer-based applications. • By the first renewal of a pharmacist’s license, the licensee must complete 1 hour of approved CE on HIV and AIDS, including information on Florida law, testing, reporting, offering HIV testing to pregnant women and partner notification. • A pharmacist must complete at least 2 hours of approved CE on medication errors, including root cause analysis/error reduction and prevention/patient safety, during each 2 year renewal period. • A CONSULTANT PHARMACIST must complete at least 24 ADDITIONAL hours of approved CE during each 2 year renewal period (54 hours total each renewal period) • All CE records and documentation shall be maintained by the pharmacist for at least 2 years from the date of the license renewal
INFLUENZA IMMUNIZATION CERTIFICATION PROGRAM • To obtain initial certification a pharmacist must complete at least 20 hours of study on vaccines, monitoring after immunizations, immunization procedures, guidelines and schedules, informed consent, recordkeeping, reporting to state immunization registry, vaccine storage, waste disposal, physician protocols, adverse incidents, and CPR training. • The pharmacist must also pass a cognitive test to demonstrate competency.
CONSULTANT PHARMACIST LICENSURE • A pharmacist must also hold a consultant pharmacist license to serve as a consultant pharmacist. • To obtain the consultant pharmacist licensure, a pharmacist must: 1. complete a Board approved course of not less than 12 hours at an accredited college of pharmacy, and pass a cognitive test to demonstrate competency. 2. Successfully complete an assessment and evaluation under the supervision of a preceptor within 1 year of completion of the approved course of study. The assessment must include at least 40 hours of training with at least 60% of such training occurring on-site at an institution that holds a pharmacy permit, and must completed over no more than 3 consecutive months. The preceptor must be a consultant pharmacist with at least 1 year of experience and working in an institutional pharmacy which is required to have a consultant pharmacist.
CONTINUING EDUCATION TO ORDER AND EVAUATE LABORATORY TESTS • Consultant pharmacists and pharmacists holding Doctor of Pharmacy degrees that wish to order and evaluate laboratory tests must successfully complete an initial training course of at least 3 hours covering required subjects. • The certification lasts for 2 years, and for recertification the pharmacist must take at least 1 hour of CE covering required subjects. • These hours of training may also be used as CE hours to satisfy license renewal requirements.
REQUIREMENTS FOR PHARMACY TECHNICIAN REGISTRATION Must be at least 17 years of age Must complete a training program from either an approved provider or the employer. If employer based, must be approved by the Board, must have 160 hours of training during a period not to exceed 6 months. All clinical training must be supervised by a registered pharmacist .
REQUIREMENTS FOR PHARMACY TECHNICIAN REGISTRATION (Cont.) 3. If self-directed study is utilized, an exam of at least 100 questions must be given to assure participant’s knowledge 4. All program records must be kept for 3 years
DISPLAY OF CURRENT LICENSE AND IDENTIFICATION • The current license of each pharmacist and the registration of each technician shall be displayed in a conspicuous place in or near the prescription department. If working in a secondary location, each such person shall have a valid wallet license or registration as evidence of current status. • No pharmacist shall display his or her license in a pharmacy where the pharmacist is not engaged in the practice of pharmacy • A pharmacist and registered pharmacy intern shall be identified by a badge or monogrammed smock showing their name and title
PRACTICE OF PHARMACY • Only a pharmacist or registered pharmacy intern under the supervision of a pharmacist may: 1. Supervise the controlled substance inventory 2. Receive verbal prescriptions 3. Interpret and identify prescription contents 4. Engage in professional communication or consultation with a practitioner, nurse, or other health professionals 5. Advise or consult with a patient as to prescriptions and patient profiles
PRACTICE OF PHARMACY (cont.) • A pharmacist must: 1. Interpret all orders for parenteral and bulk solutions 2. Physically exam the final product or completed prescription 3. Be directly available to the patient or the patient’s agent for consultation 4. Be personally available whenever a prescription is dispensed
PRACTICE OF PHARMACY (cont.) 1. If a sign has been posted indicating the specific hours when the pharmacist may be on a meal break and assuring patients that a pharmacist is available on the premises for consultation during the meal break. 2. If the pharmacist is available for consultation regarding emergency matters 3. Only prescriptions with a final certification by the pharmacist may be delivered 4. Technicians may continue to work during the meal break, and the pharmacist must certify all prescriptions prepared by registered pharmacy technicians during the meal break.
TRANSMISSION OF PRESCRIPTION ORDERS • Prescriptions may be transmitted from a prescriber to a pharmacy by ANY means of communication (written/oral/facsimile/electronic), as limited by Federal law. • No such system of transmission shall restrict the patient’s freedom of choice • The pharmacist must ensure the validity of all prescriptions received • Only a pharmacist or registered intern under the supervision of a pharmacist may: 1. accept an oral prescription 2. Prepare a copy of a prescription. When a copy is given, a notation shall be made on the prescription that a copy has been given, the date given, and to whom given. 3. Read a prescription to any person for purposes of providing reference concerning treatment of the patient
GENERAL CONDUCT AND RULES • Advertising of drugs is limited to non-controlled substances, and must not be false or misleading • No pharmacist may pay or receive a rebate or kickback of any kind to or from a prescriber or nursing home or extended care facility for recommending the professional services of either or for the pharmacy to obtain the business of a facility. This includes entering into a percentage rental agreement with a prescriber where the rent is based on prescription volume, or providing electronic equipment or consultant pharmacist services or anything else of value at less than fair market costs to obtain or maintain the business of a facility.
GENERAL CONDUCT AND RULES • No pharmacist may place in stock any prescription drug returned by a patient after the drug has left the premises • A pharmacist or a registered intern under the supervision of a pharmacist may transfer a valid prescription from another pharmacy for the purpose of filling or refilling. Prior to the transfer, the pharmacist at the pharmacy where the prescription is on file must be notified that the former prescription must be voided after the transfer. • No prescription may be filled or refilled more than 1 year from the date of issuance. No controlled substance in Schedules III - V may be refilled more than 5 times within 6 months of the date of issuance of the prescription.