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FLORIDA PHARMACY LAW REVIEW 2012 www.doh.state.fl.us/mqa/pharmacy.

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Presentation on theme: "FLORIDA PHARMACY LAW REVIEW 2012 www.doh.state.fl.us/mqa/pharmacy."— Presentation transcript:

1 FLORIDA PHARMACY LAW REVIEW 2012 www.doh.state.fl.us/mqa/pharmacy

2 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

3 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

4 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

5 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

6 RENEWAL OF LICENSE Must renew license every two years

7 CONTINUING EDUCATION 30 hours within the two years immediately prior to license renewal. Must be ACPE or Board of Pharmacy approved courses.

8 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.)

9 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

10 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.

11 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.

12 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)

13 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.

14 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)

15 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.

16 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.

17 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.

18 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.

19 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.

20 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.

21 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

22 PROMOTION OF CONTROLLED SUBSTANCES PROHIBITED No pharmacist may promote or advertise the use or sale of any controlled substance

23 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.

24 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

25 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”

26 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.

27 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

28 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

29 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.

30 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.

31 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

32 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.

33 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

34 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

35 PRACTICE OF ORTHOTICS AND PEDORTHICS The practice of ORTHOTICS and PEDORTHICS shall be within the meaning of the practice of pharmacy

36 SECTION II FLORIDA BOARD OF PHARMACY RULES AND REGULATIONS (Chapter 64B16)

37 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.

38 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

39 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.

40 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.

41 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.

42 REQUIREMENTS FOR PHARMACY TECHNICIAN REGISTRATION 1.Must be at least 17 years of age 2.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.

43 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

44 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

45 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

46 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

47 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.

48 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

49 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.

50 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.

51 PHARMACIST PRESCRIBING The following limitations and requirements apply to pharmacist prescribing: 1. Injectable products shall not be ordered 2. No oral medications may be ordered for a pregnant patient or a nursing mother 3. The quantity of drug prescribed/dispensed shall not exceed a 34-day supply 4. The dosing directions shall not exceed the manufacturer’s recommended dosage. 5. The pharmacist shall create a prescription and maintain the prescription on the prescription files of the pharmacy 6. The pharmacist shall place on the prescription label the name of the drug and the quantity dispensed in addition to all other required items.

52 PHARMACIST PRESCRIBING (cont.) 7. The pharmacist shall create and maintain for 2 years patient profiles for all patients for whom the pharmacist prescribes prescription medications, and shall initial and date all entries in the profiles 8. Only prescription drugs may be prescribed by a pharmacist. OTC drugs may not be prescribed 9. Interns and technicians may not be involved in the prescribing of drugs 10. Refer to 64B16-27.220 and 64B16-27.230 for a full list of the drugs a pharmacist may prescribe and specific limitations and requirements 11. Oral analgesics are limited to 6 day supply; urinary analgesics to a 2 day supply, and fluoride products are limited by the patient’s age and the fluoride content of the patient’s drinking water

53 CONTINUOUS QUALITY IMPROVEMENT PROGRAM Each pharmacy shall establish a Continuous Quality Improvement Program, which shall be described in the pharmacy’s policy and procedure manual. Each Quality-Related Event that occurs shall be documented in a written record or computer database created solely for that purpose.

54 RESISTERED PHARMACY TECHNICIANS Standard ratio of pharmacist to registered technicians is 1:1, but Board can approve higher ratio upon written request by the prescription department manager or consultant pharmacist. Pharmacy must have written job description, policies and procedures for registered technicians. Registered pharmacy technicians are PERMITTED to do data entry, label prescriptions, fill and compound prescriptions, initiate or receive calls for refill authorization, and initiate communications with prescribers to verify or confirm missing or illegible information including patient, medication, strength, quantity, directions, brand/generic preference, quantity, DEA number or date of last refill.

55 RESISTERED PHARMACY TECHNICIANS Registered pharmacy technicians are PROHIBITED from receiving new verbal prescriptions, performing prospective DUR, conduction final verification of prescriptions, providing patient counseling, monitoring drug usage, or overriding clinical alerts without first notifying the pharmacist. ( The Pharmacy Act requires registered pharmacy technicians to wear an identification badge with title and to identify themselves as technicians on telephone calls or other means of communication. The Act also requires 20 hours of CE within each 2 year renewal cycle, with at least 2 of the hours on medication errors and pharmacy law and 4 hours being live. Newly registered technicians also need to complete a Board approved program on HIV/AIDS prior to the end of the first renewal cycle.)

56 NEGATIVE DRUG FORMULARY AND GENERIC SUBSTITUTION Negative drug formulary established by the Boards of Pharmacy and Medicine, and contains drugs with significant biological or therapeutic inequivalence. The following drugs are on the negative drug formulary: Digitoxin, Conjugated Estrogen, Dicumarol, solid oral Chlorpromazine, controlled release Theophylline, and oral Pandcrelipase. Levothyroxine was removed from the list in 2010. Every community pharmacy must establish its own positive drug formulary, and shall include the name of the manufacturer of each generic drug. Prior to filling a prescription where a substitution may occur, the pharmacist must inform the person presenting the prescription of the right to refuse the generic substitution and the retail price savings.

57 PRESCRIPTION DRUG SAMPLES Retail pharmacies may not be in possession of prescription drug samples, except for those drugs that may be prescribed by a pharmacist. Institutional and health care entity pharmacies may possess such samples upon the written request of the prescribing practitioner.

58 COMPOUNDING OF DRUGS Allowed for dispensing to a patient pursuant to a prescription. Regulations allow compounding for administration by the prescribing practitioner and compounding of commercially available products if the patient is advised that the pharmacist will compound the product. (Both of these provisions may violate the FDA Modernization Act provisions on compounding.)

59 COMPOUNDING OF STERILE PRODUCTS Requires compliance with most provisions of the United States Pharmacopeia Section 797. Learn “High-Risk Level CSPs”, “Immediate Use CSPs”, “Low- Risk Level CSPS” and “Medium-Risk Level CSPs” depending on risk of the product becoming non-sterile Pharmacy must have a policy and procedure manual relating to sterile compounding All antineoplastic drugs shall be compounded in a vertical flow, Class II hood placed in a negative pressure room or use isolator cabinet.

60 PROSPECTIVE DRUG USE REVIEW, PATEINT COUNSELING, AND PATIENT RECORDS Similar to OBRA 90 but includes ALL prescriptions both new and refill, and private or third-party paid Prospective drug use review covers same items as OBRA 90, and must be done on new and refill Rx Counseling: – Must be offered on new and refill prescriptions both verbally and in writing, and if the Rx is delivered outside the pharmacy, a toll-free telephone number to the pharmacist must be supplied. – The items to be discussed are same as OBRA 90. – The counseling must be done by pharmacist or intern under supervision of a pharmacist – Counseling is NOT required for hospital inpatients or if patient refuses counseling

61 PROSPECTIVE DRUG USE REVIEW, PATEINT COUNSELING, AND PATIENT RECORDS Patient Records: – Must be kept for all new and refill prescriptions – Must include all drugs dispensed to the patient and all items included in OBRA 90 – Must be maintained for at least 2 years from the date of the last entry

62 DRUG THERAPY MANAGEMENT/COLLABORATIVE PRACTICE AGREEMENTS The prescriber and pharmacist enter into a “Prescriber Care Plan” under which the pharmacist may initiate or modify drug therapy, and order and interpret laboratory tests

63 STANDARDS OF PRACTICE FOR DISPENSINE OF CONTROLLED SUBSTANCES FOR TREATMENT OF PAIN A pharmacist must question a Controlled Substance prescription if any of the following occur: – frequent loss of controlled substance prescriptions by the patient – only controlled substance drugs are prescribed for the patient – one person presents prescriptions with different patient names – same or similar drugs are prescribed by 2 or more prescribers at the same time – patient always pay cash and/or insists on the brand name drug

64 If any of these occur, the pharmacist must photocopy the patient's photo ID or documents patient description on back of prescription, and verify the prescription with the prescriber. If unable to contact the prescriber, the pharmacist may dispense 72 hour supply and provide the balance after verifying with the prescriber. A pharmacist who believes that a prescriber is involved in the diversion of controlled substances SHALL report the prescriber to the Department of Health STANDARDS OF PRACTICE FOR DISPENSINE OF CONTROLLED SUBSTANCES FOR TREATMENT OF PAIN

65 INSPECTION OF PRESCRIPTION AREA Agents of the Department of Health may inspect prescription area after identifying themselves There shall be at least one inspection per year Agents may inspect invoices or any other documents pertaining to the sale or transfer of drugs from or to another pharmacy

66 PHYSICAL AND EQUIPEMENT REQUIREMENTS OF PRESCRIPTION AREA The prescription area must have adequate sink, shelves and cabinets Must have a USP/NF or USD or Remington’s or Facts and Comparisons or an equivalent AND a copy or electronic access to the pharmacy laws and rules of Florida A patient counseling area that is convenient and allows confidential conversations, and which is designated with a sign bearing “Patient Consultation Area” or similar words.

67 LABELS AND LABELING OF PRESCRIPTIONS Every prescription dispensed to a patient must have a label which includes: – name & address of pharmacy/date of dispensing (if CS would also need date of INITIAL filling) – serial number/name of patient/name of prescriber/name of drug/directions for use/expiration date/and if a CS, the transfer warning. If the drug is dispensed in a unit dose system must have label or labeling which shows: – name of resident/prescription number or other means to retrieve the order/directions for use/prescriber's name

68 LABELS AND LABELING OF PRESCRIPTIONS A “custom medication package” may be used with the CONSENT of the patient AND a label with: – name, address & telephone number of the pharmacy/serial number for the custom package AND a separate number for EACH drug dispensed/date of preparation of the custom package/patient's name/name of EACH prescriber/directions for use and cautionary statements/storage instructions/name, strength, quantity and physical description of each drug product/ a beyond use date that is not more than 60 days from the date of preparation of the custom package.

69 PRESCRIPTIION DEPARTMENT HOURS AND RULES WHEN CLOSED A community pharmacy must be open at least 40 hours and 5 days per week. A sign shall be placed at the main entrance or near the prescription department with block letters at least 1 inch high stating the hours the pharmacy department is open.

70 PRESCRIPTIION DEPARTMENT HOURS AND RULES WHEN CLOSED A pharmacy department shall be deemed closed if a pharmacist is not present and on duty. If closed, the following rules apply: 1. A sign with letters at least 2 inches high shall be prominently displayed in the prescription department stating “Prescription Department Closed”. 2. The prescription department shall be physically separated from the rest of the establishment by a partition or other means of enclosure, and locked 3. Only a pharmacist shall have the keys or other means to gain access to the department 4. No person other than a pharmacist may enter or be present in the prescription department

71 REMOVAL OF OUTDATED PHARMACEUTICALS At least every FOUR MONTHS, the prescription drug inventory must be checked, and any outdated drugs must be removed

72 REUSE OF DRUGS RETURNED FROM IN- PATIENTS AND UNCLAIMED BY PATIENTS If a prescription is unclaimed by a retail customer, the drug may be placed back into stock and reused for up to 1 year from the date of filling or until its expiration date, whichever is earlier. If a drug is dispensed in a closed delivery system for an inpatient where actual control of the drug is maintained by the facility rather than the patient, AND each dosage unit has been individually sealed or is in a manufacturer's sealed container, AND the drug is properly labeled, the drug may be returned to the pharmacy, placed back into stock, and reused.

73 MAINTENANCE OF RECORDS IN A COMMUNITY PHARMACY A community may retain required records in a data processing system All oral prescriptions shall be reduced to a hard copy All prescriptions must be retained for at least 2 years from the date of the last filling Instead of storing the actual hard copy of a prescription, an electronic imaging system may be used if it can reproduce the exact image of the prescription including the reverse side if necessary All records kept in a data processing system must be backed-up at least WEEKLY to assure no data is lost due to system failure. The system must be able to produce a daily hard-copy printout of all prescriptions filled or refilled. The printout must be produced within 72 hours of the filling or refilling of the prescription. All pharmacists who filled or refilled prescriptions shall verify that the hard-copy printout is correct by dating and signing the document.

74 CLOSING OF A PHARMACY AND TRANSFER OF PRESCRIPTION FILES AND DRUGS Prior to closing must notify the Board in writing of date of closure, and must return pharmacy permit upon closing Advise the Board what pharmacy (that is within the same locality and reasonably close to the closing pharmacy) will receive the prescription files AND deliver the files to the receiving pharmacy upon closure AND place a sign in the window advising customers of the new location of the prescription files. The receiving pharmacy must keep the transferred prescription files SEPARATE from the prescription files of the receiving pharmacy. Advise the Board what pharmacy purchased or will receive the prescription drug inventory of the closing pharmacy. Responsibility for the accuracy of the records prior to the date of transfer remains with the closing pharmacy, but custody and maintenance is with the receiving pharmacy.

75 DESTRUCTION OF CONTROLLED SUBSTANCES In community pharmacies, store the controlled substances in the prescription department until destroyed or sent to a reverse distributor. In NURSING HOMES controlled substances that have not been used by the patient shall NOT be returned to the dispensing pharmacy, and shall be stored at the facility until the drugs are destroyed. A document must be prepared listing the drug and quantity, patient's name, and Rx number, and the document shall be signed by the consultant pharmacist, the director of nursing and the administrator of the facility.

76 CENTRALIZED PRESCRIPTION FILLING Central fill pharmacies are permitted, and the prescription label shall show the name and address of the receiving pharmacy and the central fill pharmacy by name or a code. Non-controlled substances my be delivered directly to the patient by the central fill pharmacy, but controlled drug prescriptions must be returned to the receiving pharmacy for delivery to the patient. Prescriptions may be transmitted electronically from the receiving pharmacy to the central fill pharmacy, even if the drug is a controlled substance.

77 PRESCRIPTION PROCESSING FOR ANOTHER PHARMACY A Florida pharmacy may perform prescription processing (professional tasks other than the actual dispensing of the drug) for other pharmacies providing that all such pharmacies are under common ownership and utilize a common data base.

78 CLASS I INSTITUTIONAL PERMIT (NURSING HOMES) Every Class I institutional pharmacy (nursing home) must designate a consultant pharmacist. The Board must be notified within 10 days of any change in consultant pharmacist. The consultant pharmacist shall conduct Drug Regimen Reviews, inspect the facility, and monitor medication administration records and physician order sheets. The label on drug containers in nursing homes shall contain all information required for a community retail prescription AND the quantity of the drug in the container. Automated pharmacy systems may be utilized by the provider pharmacy, and such systems must be under the control of a pharmacist. All transaction records must be kept for 2 years.

79 CLASS II INSTITUTIONAL PERMIT (HOSPITALS) All Class II Institutions (hospitals) must have a consultant pharmacist. Emergency Department dispensing of prescription drugs is permitted by a licensed prescriber who must create a record of the dispensing. The record is to be maintained by the consultant pharmacist, AND the quantity dispensed must not exceed a 24-hour supply. Automated medication systems may be used in hospitals, but a pharmacist must do prospective drug use review prior to administration of the medication. Daily audits or bar coding must be used to assure correct medication selection, and those records must be prepared and kept for at least 60 days. The transaction records must be kept for 2 years.

80 SPECIAL PHARMACY PERMITS The Board may issue special pharmacy permits for: – limited community – parenteral and enteral – parenteral/enteral extended scope – closed system – non-resident (mail order) – end stage renal disease (ESRD) – assisted living facility (ALF) Hospitals must obtain a limited community permit to dispense prescriptions to employees, staff and their dependents for personal use

81 SPECIAL PHARMACY PERMITS (cont.) A pharmacy (not a hospital) preparing sterile parenteral or enteral products must obtain the parenteral and enteral limited permit. A manager shall be appointed for such pharmacies, and any change in managers must be reported to the Board within 10 days by the permit holder. Also the laminar air flow hood must be certified ANNUALLY, and cytotoxins must be prepared in a VERTICAL flow hood or mobile isolation chamber. Closed system limited permits are for pharmacies that service nursing homes, assisted living facilities, intermediate care facilities or other custodial care facilities. Prescriptions are individually prepared for the patient.

82 SPECIAL PHARMACY PERMITS (cont.) A hospital must obtain a parenteral/enteral extended permit to prepare such preparations. The hospital must have an end product testing program to ensure stability and sterility of the finished product. An assisted living facility limited pharmacy permit may be obtained by ASL facilities that use unit dose packaged drugs obtained from an outside licensed pharmacy (provider pharmacy) for individual patients. Drugs may NOT be dispensed on the premises. A consultant pharmacist must be designated, and any change in consultant pharmacists must be reported in writing to the Board within 10 days. The consultant pharmacist must inspect the facility and prepare a written report at least monthly.

83 SECTION IIIDRUG ABUSE AND PREVENTION CONTROL (Chapter 893) This law primarily covers controlled substances, and the most important sections for pharmacists are: 893.04 PHARMACIST AND PRACTITIONER 893.055 Prescription Drug Monitoring Program 893.065 Counterfeit-resistant prescription blanks for Controlled Substances in Sch. II – V 893.1495 Retail sales of Pseudoephedrine

84 DRUG ABUSE AND PREVENTION CONTROL (cont.) Prescriptions must be kept for 4 years and must contain the following information: 1. full name and address of patient 2. full name and address of prescriber and his/her DEA number 3. name of the drug, strength, quantity and directions for use 4. serial number assigned by the pharmacy 5. initials of the pharmacist filling the prescription 6. date the prescription is filled

85 DRUG ABUSE AND PREVENTION CONTROL (cont.) The label on a controlled substance prescription must contain the following information: 1. name and address of the pharmacy’s 2. date the prescription was filled 3. serial number of the prescriptions 4. name of the prescriber 5. name of patient 6. directions for use 7. a warning that it is illegal to transfer the drug to any person other than the patient

86 DRUG ABUSE AND PREVENTION CONTROL (cont.) In an EMERGENCY a Schedule II oral prescription is permitted, but the quantity is limited to a 72 hour supply. A schedule III, IV or V prescription may not be refilled more than 5 times within 6 months from the date of issuance. A written prescription for a Schedule II-IV drug must include BOTH a written AND numerical notation of the quantity prescribed on the face of the prescription, and the date with the month written out on the face of the prescription. A pharmacist may not dispense more than a 30-day supply of a Schedule III drug ordered ORALLY A prescription order for a controlled substance shall not be issued on the same blank with another order for a controlled substance which is in a DIFFERENT schedule or for any NON-CONTROLLED prescription drug.

87 DRUG ABUSE AND PREVENTION CONTROL (cont.) Florida now has a prescription drug monitoring program for drugs in Schedules II-IV – Each subject Rx must be reported to data base not more than 7 days after dispensing – A pharmacy has access to the data base for its patients Counterfeit-resistant prescription blanks must be used when ordering drugs in Schedules II-V Pseudoephedrine sales are limited to 3.6 grams in a single day, and 9 grams in any 30-day period A pharmacist must report to the sheriff within 24 hours after learning a person attempted to fraudulently obtain a C.S.

88 SECTION IVHEALTH PROFESSIONS AND OCCUPATIONS (Chapter 456) It is unlawful for any health care provider to offer or pay anything of value as a kickback for referring or soliciting patients. (Florida Pharmacy Act also prohibits such conduct) Any pharmacist convicted of Medicaid fraud will be denied licensure or renewal of a pharmacist license for 15 years from the end of the sentence or period of probation.

89 SECTION IVHEALTH PROFESSIONS AND OCCUPATIONS (Chapter 456) Any pharmacist terminated for cause from the Florida Medicaid program will be denied licensure or renewal of pharmacist license unless the pharmacist has been reinstated in the Florida Medicaid program for at least 5 years and the termination occurred at least 20 years prior to the application. A prescription issued by a practitioner must be LEGIBLY PRINTED or TYPED so as to be understandable by the pharmacist filling the prescription. If the drug is a controlled substance, the quantity must be in BOTH textual and numeric formats and the date must have the abbreviated month written out on the face of the prescription.

90 SECTION VMILITARY AFFAIRS & RELATED MATTERS (Chapter 252) If a patient lives in a county that is under a hurricane warning or where a state of emergency has been issued by the Governor, insurance companies and managed care organizations must waive time restrictions on prescription refills which include “refill too soon” edits. A patient may refill a prescription in advance in such situations for a 30 day supply regardless of when the last refill was obtained.


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