465. Florida Statutes Flashcards
In hospital, ER Prescribers may dispense drugs for outpatient use. what are the limitations?
o Smallest duration necessary or 24 hrs.
o Only if drug is warranted and community pharmacy not available
o Records must be made by prescriber and maintained by Consultant Pharmacist
o Drug must be properly labeled
Controlled Substances okay to dispense
Which of the following forms are hospitals required to obtain when they plan on using large quantities of tax free grain alcohol?
The Bureau of Alcohol, Tobacco, and Firearms controls the sale of alcohol and requires the following forms;
ATF 11: for purchase of 95% ethanol for routine compounding
ATF 1447: for purchase of tax free alcohol by large institutions.
Which of the following regarding Nuclear Pharmacy is true?
A. PDM doesn’t have to be FL licensed nuclear pharmacist.
B. Must have a secured radioactive storage and decay area (Hot lab, storage area, and compounding and dispensing area shall be a minimum of 50 square feet)
C. Must have full spectrum of supplies (syringes, gloves, protective labcoat) and equipment (hood, shield, scintillation counter, etc)
D. Registered technicians in a nuclear pharmacy may write new Rx diagnostic order from a prescriber.
C,D
B: 150sq ft
A: PDM must be FL licensed
How many days of medication can a patient in a short term detoxification treatment take home?
0
What risk ranking is this- aseptic manipulations entirely within ISO 5 or better hoods; combining 3 or less sterile products into a single bag/vial. Technically, you have 3 entries into the vial or bag - not 3 separate products. So if you need to enter the IV bag twice to place the entire dose of reconstituted drug, then you only have one more entry before you move to medium risk
Low risk
Technically, you have 3 entries into the vial or bag - not 3 separate products. So if you need to enter the IV bag twice to place the entire dose of reconstituted drug, then you only have one more entry before you move to medium risk
Can Pharmacists order fluoride treatments if patients do not have fluoride supplement in their water? what are the limitations?
Yes, Maximum one year of therapy and no more than 264mg at a time. Must not switch fluoride brands.
How many years of experience is required for a PharmD pharmacist to practice in a CDTM (collaborative drug therapy management) protocol to be able to prescribe drugs
none
Marijuana dispensing
- Cannabis is a Schedule I controlled substance per FL state law. There are not currently allowances for “medical marijuana” dispensing.
- There has (early 2014) been a law passed to allow limited use of medical marijuana. By the beginning of 2015, FL established 5 dispensaries which look unlikely to be pharmacies.
What drugs are exempt from tablet imprint requirements?
Exemptions include compounded medications, radiopharmaceuticals, investigational drugs, and any product whose size or physical characteristics make imprinting unfeasible or impossible
pharmacist tech ratio
- A pharmacist cannot supervise more than one registered pharmacy technician at a time unless otherwise permitted by the Florida Board of Pharmacy.
- Update Jan 07, 2015:
- 1:1 unless authorized by this rule which must be included in Policy and Procedures Manual:
- (3:1) Ratio: Registered pharmacy technicians assisting with delegable tasks involving sterile compounding
- (4:1) Ratio: Any pharmacist may allow a supervision ratio up to four (4) registered pharmacy technicians to one (1) pharmacist
- (4:1), as long as the delegable tasks do not involve sterile compounding.
- (6:1) Ratio: A pharmacy which does not dispense medicinal drugs may allow a supervision ratio up to six (6) registered pharmacy technicians to one (1) pharmacist (
- 6:1), as long as the delegable tasks do not involve sterile compounding
Which portion of the following federal counseling regulations is (are) a requirement for each individual state?
I. Prospective review
II. Meta analysis review
III. Retrospective review
The Omnibus Budget Reconciliation Act of 1990 (OBRA ‘90) directly impacts pharmaceutical dispensing and care; its portions for the states were included to improve understanding of medications by Medicaid beneficiaries for whom they were prescribed and dispensed. Although prospective drug utilization review (DUR) is the responsibility of the pharmacy, retrospective DUR is a requirement for each individual state.
Nonresident Pharmacy
Any Pharmacy located outside the state which ships, mail or delivers in any manner, a dispensed medicinal drug in the state. Must be registered with he board.
Who of the following must be registered by the DEA to possess controlled substances?
I. Researchers
II. Pharmacies
III. Narcotic Treatment Programs
All
The Prescription Drug Marketing Act 1987 prohibits…
The Prescription Drug Marketing Act 1987 prohibits the sale, purchase, or trade of drug samples and restricts retail pharmacies from receiving any prescription drug samples.
How many days to notify Board of any change in PIC or Consultant Pharmacist of record?
10
Durham-Humphrey Amendment
explicitly defined two specific categories for medications, legend (prescription) and over-the-counter (OTC).
The bill requires any drug that is habit-forming or potentially harmful to be dispensed under the supervision of a health practitioner as a prescription drug and must carry the statement, “Caution: Federal law prohibits dispensing without a prescription.
Until this law, there was no requirement that any drug be labeled for sale by prescription only. The amendment defined prescription drugs as those unsafe for self-medication and which should therefore be used only under a doctor’s supervision.[2]
Legend drugs must be dispensed with direct medical supervision, but over-the-counter drugs can be purchased and used without a prescription.
The law also legalized verbal transmission of prescriptions and provided for the legal right of a pharmacist to refill prescriptions as indicated in a provider’s initial prescription
Hours and contact info required of Nonresident Pharmacy
Regular hours of operation not less than 6 days per week, for a minimum of 40 hours per week, a toll-free telephone service shall be provided to facilitate communication between patients in this state and a pharmacist at the pharmacy who has access to the patient’s records. This toll-free number must be disclosed on the label affixed to each container of dispensed medicinal drugs.
Age requirement of Pharmacy Technician and Licensed Pharmacist
17 Pharm Tech
18 Pharmacist
When must the PIC notify the board of any theft or significant loss of any controlled substances after discovery of the theft or loss.
Within 1 business day
Federal Register
The Federal Register is the official daily publication for rules, proposed rules, and notices of federal agencies and organizations including changes in schedules of controlled substances.
Hospitals may apply for a Special Pharmacy - Limited Community license, what is that and whats the purpose of doing that?
Special Pharmacy - Limited Community license: allow to provide service to employees and dependents for personal use, patients of a hospital (Institutional Class II permit) under a continuation of a course of therapy, Patients in the emergency room for up to 3 day supply
dispense remaining multi-dose medications used in the hospital (topical, creams, insulin, eye drops, etc) at discharge (saves the patients money re-ordering these medications)
Patients enrolled in the Drug Addiction treatment Act (DATA) for the first 90 days may receive what maximum quantity of take home medication?
30 days
CS inventory Biennial complete and accurate inventory. Date may vary by no more than how long from the biennial date that would otherwise apply?
o Date may vary by no more than 6 months from the biennial date that would otherwise apply
FDA Modernization Act
established a fast track process for drug approval for use in serious cases
Category I: generally recognized as safe and effective for the claimed therapeutic indication;
Category II: not generally recognized as safe and effective or unacceptable indications;
Category III: insufficient data available to permit final classification
OTC Category II is the classification of OTC ingredients that are not recognized as safe and effective nor as having acceptable indications: Laxative products containing cascara sagrada are considered misbranded.???
If there are any concerns about the use/abuse/legitimacy of a CS Rx, the pharmacist SHALL:
A. Verify Rx with prescriber. If not able to verify and believes Rx to be valid should dispense full amount.
B. Require Picture ID and make copy or document ID. If no ID still must confirm identity
C. always obtain ID when dispensing CS in FL if patient is not known
D. while validating Rx, all communication with Pt is not overheard by other.
E. Pharmacist may refuse to fill Rx for CS if professional judgement determine Rx is invalid.
F. Before refusing to fill CS, pharmacist must attempt to talk to pt and prescriber. pharmacist doesn’t have to fill CS if pt refuse to cooperate. Pharmacist may use PDMP to assist legitimacy of RX.
D
A: should dispense 72 hr supply
Which of the following regarding Pedigree Papers are true?
A. Each wholesaler of Rx drugs must provide a pedigree paper to the receiver.
B. Pharmacy and Wholesaler maintain copies
C. Often wholesaler maintains pharmacy’s copies as well
D. pedigree papers is also required for veterinary drugs and drop shipments
A-C
D: paper not required for animal drugs and shipment
Medicaid / Medicare record must be maintained for how longs?
10 years
Board requirements on the use of an automated pharmacy system
(a) Recordkeeping
(b) Security requirements
(c) Labeling requirements that identifies
1. The dispensing pharmacy;
2. The prescription number;
3. The name of the patient; and
4. The name of the prescribing practitioner.
Class III institutional pharmacy policies and procedures
a. The consultant pharmacist responsible for pharmaceutical services.
b. Safe practices for the prep, dispensing, prepackaging, distribution, and transportation of medicinal drugs and prepackaged drug products.
c. Recordkeeping to monitor the movement, distribution, and transportation of medicinal drugs and prepackaged drug products.
d. Recordkeeping of pharmacy staff responsible for each step in the preparation, dispensing, prepackaging, transportation, and distribution of medicinal drugs and prepackaged drug products.
e. Medicinal drugs and prepackaged drug products that may not be safely distributed among Class III institutional pharmacies.
Modified Class II institutional pharmacies
Short-term, primary care treatment centers that meet all the requirements for a Class II permit, except space and equipment requirements.
Modified Class II A – Methadone clinic, dialysis center
*formulary limited to 15 drugs or less
Modified Class II B – Surgical Center
*no formulary limitations– drugs stored in bulk or unit dose
Modified Class II C – no drugs stored in bulk, none currently in FL
Automated pharmacy systems used by long-term care facilities, hospices, or state correctional institutions. Must be located in pharmacy??
the use of an automated pharmacy system need not be located at the same location as the pharmacy.
Requirements for automated filling system in retail pharmacy
A. Policy and procedure
B. final loading check by pharmacist
C. readily retrievable electronic record to identify all personnel involved with dispensing
D. mechanism to deal for product recalls
E. minimum dual verifications (barcode, electronic, RFID)
F. must be able to generate patient specific drug label
Special-Closed System Pharmacy
Not open to the public
Prescriptions are individually prepared for dispensing utilizing closed delivery systems to facilities where prescriptions are individually prepared for the ultimate consumer
– nursing homes, jails, ALFs etc
What rating of drug is therapeutically equivalent of a drug product?
What reference is used as to determine therapeutic equivalency?
“A” rated is therapeutically equivalent
“Approved Drug Products with Therapeutic Equivalence Evaluations” (Orange Book) published by the United States Food and Drug Administration.
USP DI: United States Pharmacopeia Dispensing Information is a set of three volumes containing a variety of information, including:
Volume I:
VolumeII:
Volume III:
Volume I: Drug Information for the Health Care Professional
Volume II: Advice for Patient
Volume III: Approved Drug Products with Therapeutic Equivalent Evaluations: it contains information from USP/NF, as well as portions of the Federal Controlled substances Act among other information.
Which of the following regarding the procedure of closing a pharmacy is true?
A. Prior to closing, must notify BOP, return permit, and advise where Rx will be transferred
B. Upon closing, must physically deliver the Rx files to a nearby pharmacy and provide a means by which to advise the public of the new location of their Rx files, receiving pharmacy must keep files separate and not commingle
C. May transfer drug to another pharmacy
D. Provide Board date of transfer, name, address, DEA# of two pharmacies, complete inventory of controlled substances
E. Close-out inventory, including controlled-substances
all are true
Immediate use in emergency (ie Code) discard in __ hour if administration has not begun (good for ___ hours once hung
discard in 1 hr and hang for 24hr if used
FL Pharmacist can order/dispense from limited formulary without a RX (Pharmacist only class of drugs, practically non-existent)
what are the limitations and requirements?
No injectables,
pregnant or nursing mothers, recommended dose and duration only (34 d max), must create a Rx
maintain patient profile for at least FOUR years including chief complaint (in patients own words).
Drugs that are prohibited to be sold in retail pharmacy are:
- Controlled substances Schedule I
- Rohypnol (flunitrazepam)
- Medical Marijuana
- Cannabis is a Schedule I controlled substance per FL state law. There are not currently allowances for “medical marijuana” dispensing.
How should sales of drug products covered by the Combat Methamphetamine Epidemic Act be recorded
Sale of drug products covered by the Combat Methamphetamine Epidemic Act (CMEA) must be recorded in a logbook that must be maintained for at least two years from the date of the last entry. This logbook can be maintained electronically but should be easily retrievable.
If a patient wants a non FDA approved drugs what requirements must be met?
A. informed consent
B. approved by MD with appropriate documentation.
C. patient has terminal illness, that is expected death within 1 year
D. for investigational use
all true
What must a pharmacist (or pharmacy intern) complete and maintain to enter into immunization protocol?
Must maintain at least $200,000 of professional liability insurance
- Must complete a certification program approved by the Board of Pharmacy in consultation with the Board of Medicine and the Board of Osteopathic Medicine.
**Program requires at least 20 hours of CE approved by the board. Must include the safe and effective administration of such vaccines & potential allergic reactions
Prescriptions must be legible and contain the following what informations?
- Date of issue (month spelled out)
- Patient’s full name (species if CS for an animal) & Patients address
- Practitioner’s name & address & manual signature
- Drug name, strength, Dosage form, Quantity (# & text), refills, Directions for use
CS in Florida, Pharmacist must
- Practitioners DEA#
- Pharmacist Initial the Rx***
- Write date filled. ****
- Rx number
Take home medication guidelines depends on time in treatment program:
Take home medication guidelines depends on time in treatment program:
• First 90 days (1-3 months): max of 1 unsupervised dose per week
• Second 90 days (4-6 months): max of 2 unsupervised doses per week
• Third 90 days (7-9 months): max of 3 unsupervised doses per week
• Remainder of year 1 (10-12 months): max of 6 unsupervised doses per week
• Etc..
What does each set of numbers on NDC means?
Manufacturer or Labeler
Drug Product
Package Size
4-4-2
5-3-2
5-4-1
Requirements of a pharmacy:
- No specific requirements other than workable and easily accessible sink, sufficient shelf/drawer/cabinet space, adequate facilities for refrigeration of drugs
- community pharmacies: provide a private consultation area in which the patient does not enter the dispensing or stock areas of the pharmacy.
- A current pharmacy reference compendium such as the United States Pharmacopoeia/National Formulary, the U.S. Dispensatory, USP DI, (United States Pharmacopoeial Drug Information), the Remington Practice of Pharmacy, Facts and Comparisons or an equivalent thereof sufficient in scope to meet the professional practice needs of that pharmacy, and a current copy of the laws and rules governing the practice of pharmacy in the State of Florida. It shall be acceptable, in lieu of an actual hard copy, to maintain these materials in a readily available electronic data format.
Requirements for a transferred rx
- The prescription order
- The name of the pharmacy where the rx was on file
- The prescription number
- The name of the drug and the original amount dispensed, the date of original dispensing, and the number of remaining authorized refills.
Requirements of pharmacist in charge of the operation of an automated pharmacy system …..
- -Need not be physically present at the site of the automated pharmacy system and may supervise the system electronically.
- -Required to develop and implement policies and procedures designed to verify that the medicinal drugs delivered by the automated dispensing system are accurate and valid and that the machine is properly restocked.
Dispensing practitioner
•
Dispensing practitioner
• A practitioner authorized by law to prescribe drugs may dispense such drugs to her or his patients in the regular course of her or his practice in compliance with sections 465.0276
• A practitioner registered under section 465.0276 may not dispense a controlled substance listed in Schedule II or Schedule III as provided in s. 893.03. This paragraph does not apply to:
1. The dispensing of complimentary packages of medicinal drugs which are labeled as a drug sample or complimentary drug as defined in s. 499.028 to the practitioner’s own patients in the regular course of her or his practice without the payment of a fee or remuneration of any kind, whether direct or indirect, as provided in subsection (5).
2. The dispensing of controlled substances in the health care system of the Department of Corrections.
3. The dispensing of a controlled substance listed in Schedule II or Schedule III in connection with the performance of a surgical procedure. Max:14-day supply and not more than 14 days after the performance of the surgical procedure.
4. The dispensing of a controlled substance listed in Schedule II or Schedule III pursuant to an approved clinical trial.
5. The dispensing of methadone in a facility licensed under s. 397.427 where medication-assisted treatment for opiate addiction is provided.
Before dispensing any drug, give the patient a written prescription and orally or in writing advise the patient that the prescription may be filled in the practitioner’s office or at any pharmacy.
What Immunizations may a pharmacist or pharmacy intern under direction of pharmacist give?
- Immunizations or vaccines listed in the Adult Immunization Schedule by the CDC
- Immunizations or vaccines recommended by the CDC for international travel
- Immunizations or vaccines approved by the board in response to a state of emergency declared by the Governor pursuant to s. 252.36.
Requirements of a pharmacy:
- No specific requirements other than workable and easily accessible sink, sufficient shelf/drawer/cabinet space, adequate facilities for refrigeration of drugs
- community pharmacies: provide a private consultation area in which the patient does not enter the dispensing or stock areas of the pharmacy.
- A current pharmacy reference compendium such as the USPNF, USP DI, , the Remington Practice of Pharmacy, Facts and Comparisons or an equivalent to meet the practice needs of that pharmacy,
- current copy of the laws and rules governing the practice of pharmacy in the State of Florida.
- It shall be acceptable, in lieu of an actual hard copy, to maintain these materials in a readily available electronic data format.
Drug product are considered bioequivalent if they have shown similar ADME when evaluated.
Bioequivalence problems arise from the following dosage form problems:
BC: Extended-release dosage forms
BE: Delayed release dosage forms
BN: Aerosol nebulizer drug delivery system
How long must prescription records be kept
4 years
compounder to become an outsourcing facility per the FDA
The Drug Quality and Security Act, signed into law on November 27, 2013, creates a new section 503B in the FDCA. Under section 503B, a compounder can become an “outsourcing facility.” The law defines an “outsourcing facility” as a facility at one geographic location or address that is engaged in the compounding of sterile drugs; has elected to register as an outsourcing facility; and complies with all of the requirements of section 503B.
An outsourcing facility can qualify for exemptions from the FDA approval requirements and the requirement to label products with adequate directions for use, but not the exemption from current good manufacturing practice (CGMP) requirements. Outsourcing facilities:
• must comply with CGMP requirements;
• will be inspected by FDA according to a risk-based schedule; and
• must meet certain other conditions, such as reporting adverse events and providing FDA with certain information about the products they compound.
o Each pharmacist dispenses/refills drugs shall verify data on hard-copy printout is correct, by dating and signing such document within how many days from the date of dispensing
7 days
USP/NF
The USP–NF is a combination of two compendia, the United States Pharmacopeia (USP) and the National Formulary (NF). It contains standards for medicines, dosage forms, drug substances, excipients, biologics, compounded preparations, medical devices, dietary supplements, and other therapeutics.
Prescription Drug Marketing Act of 1987
Prescription Drug Marketing Act of 1987 prohibits drugs from being re-imported into the United States except by the manufacturer.
It establishes legal safeguards for prescription drug distribution to ensure safe and effective pharmaceuticals and is designed to discourage the sale of counterfeit, adulterated, misbranded, subpotent, and expired prescription drugs. It was passed in response to the development of a wholesale sub-market for prescription drugs.
which of the following are true regarding nursing home (class 1 institutional pharmacy)?
A. has a pharmacy on premises thus may dispense on premises
B. Drugs are securely store and may only be accessible to license staff.
C. Must have a consultant pharmacist of record and Consultation provided (drug regimen review) at least once a month
D. may have emergency kit onsite where consultant oversees recordkeeping and inventory
E. May use automated filling systems
where Pharmacist must perform prospective drug use review prior to administration. Consultant of record responsible to maintaining a record of transaction, operation, access to the system, and maintaining policies and procedures
F. 5 controlled drugs may be included (2 doses of each for every 60 beds)
only A,F,G are not true
A. doesnt have a pharmacy on premises thus may not dispense on premises
F. 5 controlled drugs may be included (3 doses of each for every 60 beds)
G. nurse and pharmacist & other licensed personnel may inventory, replace, and reseal
If a pharmacist or technician is going to prepare high risk products - how often should media-filled tests be conducte
twice annually
Which of the following is best associated with DUR?
DUR is an acronym for drug utilization ReviewThis is done to determine if the appropriate drug is being prescribed and if it is being used appropriately. It is associated with patient counseling.
pharmacists may order medications off the FL formulary
• prescription and separate patient profiles must be maintained
•
pharmacists may order medications off the FL formulary
• prescription and separate patient profiles must be maintained
• formulary includes some: oral analgesics (mild/mod pain; up to 6d supply), antihistamines or decongestants (single active ingredient or in combo), topical anti-infectives, urinary and otic analgesics, anti-nausea medications
• days supply must not exceed 34 days
• NOT allowed for pregnant/nursing women
The formulary of a pharmacy providing services under MMA may be limited to
At least one drug from each of all therapeutic categories developed by the USP
Under the MMA all pharmacies must include drugs within all categories and classes developed by the USP
Under Cancer Drug Donation Program, Hospital pharmacy may accept donated cancer drugs and supplies from eligible donors, inspects the donated cancer drugs/supplies must be authentic and dispenses to eligible patients. Which of the following are false?
A. complete and submit a Notice of Participation form
B. May charge the recipient of the drug or supply a handling fee of 400 percent of the Medicaid dispensing fee or $25, whichever is less.
C. Drugs can be opened (not in their original sealed container)
D. can be accepted or dispensed if there is less than six months expiration date.
E. CS are also eligible for donation.
F. Eligible patients includes uninsured, do not qualify for 3rd-party insurance coverage, Medicaid, or any other gov assistance programs
B-E
o May charge the recipient of the drug or supply a handling fee of no more than 300 percent of the Medicaid dispensing fee or no more than $15, whichever is less for each cancer drug or supply dispensed
o Drugs must remain in their original sealed container or in a tamper-evident unit-dose packaging. Never in actual possession of patient
o May not be accepted or dispensed if there is less than six months remaining until the expiration date.
o Controlled substances are not eligible for donation.
Before pharmacy can be opened permit must be obtained, and Inspection must occur before a permit is issued. What do they inspected during inspections?
o written policies and procedures for preventing CS dispensing based on fraudulent representations or invalid practitioner-pt relationships.
o Permit must be issued before DEA will register
Non Medicaid Audits
(a) To be notified at least 7 calendar days before the initial onsite audit for each audit cycle.
(b) To have the onsite audit scheduled after the first 3 calendar days of a month unless the pharmacist consents otherwise.
(c) To have the audit period limited to 24 months after the date a claim is submitted to or adjudicated by the entity.
(d) To have an audit that requires clinical or professional judgment conducted by or in consultation with a pharmacist.
(e) To use the written and verifiable records of a hospital, physician, or other authorized practitioner, which are transmitted by any means of communication, to validate the pharmacy records in accordance with state and federal law.
(f) To be reimbursed for a claim that was retroactively denied for a clerical error, typographical error, scrivener’s error, or computer error if the prescription was properly and correctly dispensed, unless a pattern of such errors exists, fraudulent billing is alleged, or the error results in actual financial loss to the entity.
(g) To receive the preliminary audit report within 120 days after the conclusion of the audit.
(h) To produce documentation to address a discrepancy or audit finding within 10 business days after the preliminary audit report is delivered to the pharmacy.
(i) To receive the final audit report within 6 months after receiving the preliminary audit report.
The Controlled Substances Act identifies a “Listed Chemical” as chemicals that are:
Used in manufacturing a controlled substance
C-V
(1) Not more than 200 milligrams of codeine per 100 milliliters or per 100 grams.
(2) Not more than 100 milligrams of dihydrocodeine per 100 milliliters or per 100 grams.
(3) Not more than 100 milligrams of ethylmorphine per 100 milliliters or per 100 grams.
(4) Not more than 2.5 milligrams of diphenoxylate and not less than 25 micrograms of atropine sulfate per dosage unit.
(5) Not more than 100 milligrams of opium per 100 milliliters or per 100 grams.
For how long does the patient have to be in continuous treatment when assessed for eligibility in the medical maintenance phase of an opioid treatment program?
In the third phase of the maintenance treatment, the medical maintenance phase focuses on patients eligibility that states that the patient must be in continuous treatment for 2 years.
NDA
ANDA
NDA means New Drug Application. When the sponsor of a new drug believes that enough evidence on the drug’s safety and effectiveness has been obtained to meet the FDA’s requirements for marketing approval, the sponsor submits to the FDA a new drug application (NDA). In other words, when a pharmaceutical company creates a new drug, the company must contact the FDA and demonstrate that the new drug has a particular quality and that the drug is safe and effective.
ANDA means Abbreviated New Drug Application. An abbreviated new drug application (ANDA) contains data that, when submitted to the FDA, provides for the review and ultimate approval of a generic drug product. Generic drug applications are called “abbreviated” because they are not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, a generic applicant must scientifically demonstrate that its product is bioequivalent (i.e., performs in the same manner as the original drug).
BOP may require disciplinary coursework for misfills: what course work do they require?
Laws and Rules must be at least 12 hrs / Med Errors (QRE) must be at least 8 hrs
Beyond Use Dating:
frozen: 45 days Low risk (48hrs room temp , 14 days cold ). Medium Risk (30 hrs room temp, 9 days cold) High risk (24 hrs room temp, 3 days cold
A site can extend BUD if you have your own data to prove your technique is effective for that period of time - cannot use literature to extend date - only your own proof of effectiveness.
What risk ranking is this- non-sterile ingredients, lack effective antimicrobial preservatives, sterile surfaces. Must use ISO 5 or less
High risk
Facilities must be tested how often for sterility and air particle count?
Facilities must be tested twice a year minimum for sterility and air particle count
What risk ranking is this - combining more than three (3) commercial sterile drug products and those requiring complex manipulations and/or preparation methods. Must use ISO 5 or less - same technicality - it really is 3 entries into the IV container, not 3 separate drug products
Medium risk
Must use ISO 5 or less - same technicality - it really is 3 entries into the IV container, not 3 separate drug products
what is Modified Class II A and what are some examples of Modified Class II A?
Type “A” Modified Class II Institutional Pharmacies provide pharmacy services in a facility:
formulary not more than 15 medicinal drugs (excluding those in emergency box), and the drugs are stored in bulk.
Methadone clinic, dialysis center
Automated Storage and Distribution systems may be utilized by long term care facilities if:
a. the owner of the facility request a waiver from the appropriate agency
b. the facility employee licensed pharmacy techs
c. there is a demonstrated hardship for providing medications to the patients
d. anyone authorized to administer medication in th facility complete a course in drug administration
e. the facility maintains contracts for pharmaceutical Services with a licensed pharmacy
e
outpatient Rx must be LABELED with:
- Pharmacy name & address
- Date of dispensing, Date of initial fill if a refill
- Serial (Rx) number.
- patient Name (name of owner and the species)
- prescriber Name
- Drug Name (withhold if request by MD).
- Directions for use.
- Expiration date (uses 1 year from date filled or manufacturers expiration date if earlier)
Controlled Substances must also include:
Cautionary statement “Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed”
[CII-CIV Only]
- note what is NOT REQUIRED on the label - patient address, date Rx written, address of prescriber, quantity, dosage form, #refills remaining, formulation, telephone number of the pharmacy
Disposing of prescription drugs in a pharmacy
The department shall keep a full and complete record of all controlled substances or listed chemicals received and of all controlled substances or listed chemicals disposed of, showing:
o The exact kinds, quantities, and forms of such controlled substances or listed chemicals
o The persons from whom received and to whom delivered
o By whose authority received, delivered, and destroyed
o The dates of the receipt, disposal, or destruction
• Destruction of controlled substances:
o complete DEA Form DEA-41 signed by the PDM/consultant and a DEA agent or department inspector
o shipped to reverse distributors for destruction
• Take-back programs not for pharmacy
Authority To Inspect
Duly authorized agents and employees of the department may inspect in a lawful manner at all reasonable hours any pharmacy, hospital, clinic, wholesale establishment, manufacturer, physician’s office, or any other place in the state in which drugs and medical supplies are compounded, manufactured, packed, packaged, made, stored, sold, offered for sale, exposed for sale, or kept for sale
A cosmetic company markets an OTC topical cream claiming to treat acne. This claim may be legally challenged by which entity?
Although cosmetic manufacturers do not have to meet FDA’s Good Manufacturing Practice, the FDA has the authority to challenge an OTC product claims on the label because if proven not to treat acne it is considered misbranding.Because this cream is advertised by a cosmetic company the Federal Trade commission (FTC) controls the advertising and labeling of this product as well.
Class I Institutional Pharmacy
nursing home
- > do not dispense drugs to patients, they administer drugs
- Does not have a pharmacy on premises
- Must have a consultant pharmacist of record named
- must provide written, onsite consultation at least once a month
The USP/NF is a publication that is published by:
The United States Pharmacopeia (USP) is the official pharmacopeia of the united states published with the National formulary as the USP/NF. The USP Convention is a nonprofit organization that owns the trademark and copyright to the USP/NF and it publishes every year. - an independent organization
Substitution of Drugs… Pharmacist must
Substitute a less expensive, generically equivalent drug product unless the prescriber writes the words “MEDICALLY NECESSARY,”his own handwriting, on the face of a written prescription; the prescriber expressly indicates to the pharmacist that the brand name drug prescribed is medically necessary given orally; or for an ERX the prescriber makes an overt act when transmitting the prescription to indicate that the brand name drug prescribed is medically necessary.
FDCA (Food Drug and Cosmetic Act) of 1938 addresses what?
FDCA (Food Drug and Cosmetic Act) of 1938 addresses but not limited to all of the following
• Manufacturers should prove that their drug is safe prior to marketing
• All cosmetics, medical devices, and color additives were regulated
• Adequate directions for use on all drug products labeling
• Authority for factory inspections was granted
• A fast track approval process was established for cases of serious or life-threatening conditions.
COMPOUNDED Rx recordkeeping requirements
Date of compounding traceable control number complete formula maintained in a readily accessible format, pharmacist / technician signature or initials, manufacturer of materials used, quantity in units of finished product package size number of units prepared name of the patient
Class III institutional pharmacies
Includes central distribution facilities, affiliated with a hospital that provide the same services that are authorized by a Class II institutional pharmacy permit.
May also:
a. Dispense, distribute, compound, and fill prescriptions for medicinal drugs.
b. Prepare prepackaged drug products.
c. Conduct pharmaceutical services for the affiliated hospital and for entities under common control
d. Provide the services in sub-subparagraphs a.-c. to an entity under common control which holds an active health care clinic establishment permit as required under s. 499.01(2)(r).
There is a limited supply of which of the following drugs approved for the treatment of opioid addiction
LAAM
There is a limited supply of LAAM. LAAM use has also been restricted to patients not responsive to methadone because of the cardiac arrhythmias associated with the use of LAAM.
Filing of prescription hard copies
CII- maintained separately
CIII-CIV-CV are maintained in a record together
Non controlls are maintained in a record together
OR
CII maintained separately
All other prescriptions together, with controls marked with a red “C”
If a pharmacy has an electronic record keeping system for prescriptions which permits identification by prescription number and retrieval of original documents by prescriber’s name, patient’s name, drug dispensed, and date filled, the requirement to mark the hard copy with a red “C” is waived.
Which of the following must be completed for preliminary registration of a new pharmacy?
I. Registration with state Department of Public Safety
II. Inspection by state Board of Pharmacy
III. Complete DEA form 224
III. Complete DEA form 224
what is Modified Class II B and what are some examples of Modified Class II B?
Type “B” Modified Class II Institutional Pharmacies provide pharmacy services in a facility, drugs stored in the facility in patient specific form and in bulk form and which has an expanded drug formulary.
Surgical Center
Which act was the first to require pharmaceutical manufacturers to prove the safety of prescription drugs before marketing of the drug?
FD C Act of 1938
Who “owns” inventory of Automated Pharmacy system drugs
Medicinal drugs stored in bulk or unit of use in an automated pharmacy system servicing a long-term care facility, hospice, or correctional institution are part of the inventory of the pharmacy providing pharmacy services to that facility, hospice, or institution, and are considered to have been dispensed by that pharmacy.
C-`III
Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation containing limited quantities of any of the following narcotic drugs, or any salts thereof:
(1) Not more than 1.8 grams of codeine per 100 milliliters or not more than 90 milligrams per dosage unit, with an equal or greater quantity of an isoquinoline alkaloid of opium.
(2) Not more than 1.8 grams of codeine per 100 milliliters or not more than 90 milligrams per dosage unit, with one or more active, non-narcotic ingredients in recognized therapeutic amounts.
(3) Not more than 300 milligrams of dihydrocodeinone per 100 milliliters or not more than 15 milligrams per dosage unit, with a fourfold or greater quantity of an isoquinoline alkaloid of opium.
(4) Not more than 300 milligrams of dihydrocodeinone per 100 milliliters or not more than 15 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts.
(5) Not more than 1.8 grams of dihydrocodeine per 100 milliliters or not more than 90 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts.
(6) Not more than 300 milligrams of ethylmorphine per 100 milliliters or not more than 15 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts.
(7) Not more than 500 milligrams of opium per 100 milliliters or per 100 grams, or not more than 25 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts.
(8) Not more than 50 milligrams of morphine per 100 milliliters or per 100 grams with one or more active, nonnarcotic ingredients in recognized therapeutic amounts.
Class II Institutional Pharmacy
hospital
- Has pharmacy onsite
- Drugs must be dispensed in unit-dose packages
- Must have consultant pharmacist of record named
Florida Medicaid Audit
(a) must give at least 1 week’s prior notice of the initial audit for each audit cycle.
(b) An audit must be conducted by a pharmacist licensed in this state.
(c) Any clerical or recordkeeping error, does not constitute a willful violation and is not subject to criminal penalties without proof of intent to commit fraud.
(d) A pharmacist may use the physician’s record or other order for drugs or medicinal supplies written or transmitted by any means of communication for purposes of validating the pharmacy record with respect to orders or refills of a legend or narcotic drug.
(e) A finding of an overpayment or underpayment must be based on the actual overpayment or underpayment and may not be a projection based on the number of patients served having a similar diagnosis or on the number of similar orders or refills for similar drugs.
(f) Each pharmacy shall be audited under the same standards and parameters.
(g) A pharmacist must be allowed at least 10 days in which to produce documentation to address any discrepancy found during an audit.
(h) The period covered by an audit may not exceed 1 calendar year.
(i) An audit may not be scheduled during the first 5 days of any month due to the high volume of prescriptions filled during that time.
(j) The audit report must be delivered to the pharmacist within 90 days after conclusion of the audit. A final audit report shall be delivered to the pharmacist within 6 months after receipt of the preliminary audit report or final appeal, as provided for in subsection (2), whichever is later.
Pure Food and Drug Act
The Pure Food and Drug Act of 1906 prohibited the sale of misbranded or adulterated food and drugs in interstate commerce and laid a foundation for the nation’s first consumer protection agency, the Food and Drug Administration (FDA).
first to recognize the USP/NF as an official compendium
Prescription Drug Marketing Act
The Prescription Drug Marketing Act 1987 prohibits the sale, purchase, or trade of drug samples and restricts pharmacies from receiving any prescription drug samples.
Requirements for labeling dispensed prescriptions:
Requirements for labeling dispensed prescriptions:
• Name and address of the pharmacy.
• Date of dispensing.
• Serial number (rx #)
• Name of the patient.
• Name of the prescriber.
• Name of the drug dispensed (unless prescriber specifically requests it to be withheld).
• Directions for use.
• An Expiration Date or Beyond-Use Date.
• Controlled Substance: a warning that it is a crime to transfer the drug to another person.
