Transcript DRUG ABUSE AND PREVENTION CONTROL (cont.)

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 antiinfectives. 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
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 .
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.
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.
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
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.
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.
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.)
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.
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.
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.)
COMPOUNDING OF STERILE PRODUCTS
• Requires compliance with most provisions of the United
States Pharmacopeia Section 797.
• Learn “High-Risk Level CSPs”, “Immediate Use CSPs”, “LowRisk 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.
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
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
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
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
STANDARDS OF PRACTICE FOR DISPENSINE OF
CONTROLLED SUBSTANCES FOR TREATMENT OF PAIN
• 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
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
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.
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
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.
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.
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
REMOVAL OF OUTDATED
PHARMACEUTICALS
• At least every FOUR MONTHS, the prescription drug inventory
must be checked, and any outdated drugs must be removed
REUSE OF DRUGS RETURNED FROM INPATIENTS 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.
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.
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.
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.
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.
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.
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.
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.
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
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.
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.
SECTION III DRUG 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
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
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
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.
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.
SECTION IV HEALTH 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.
SECTION IV HEALTH 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.
SECTION V MILITARY 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.