• Shuffle
    Toggle On
    Toggle Off
  • Alphabetize
    Toggle On
    Toggle Off
  • Front First
    Toggle On
    Toggle Off
  • Both Sides
    Toggle On
    Toggle Off
  • Read
    Toggle On
    Toggle Off
Reading...
Front

Card Range To Study

through

image

Play button

image

Play button

image

Progress

1/237

Click to flip

Use LEFT and RIGHT arrow keys to navigate between flashcards;

Use UP and DOWN arrow keys to flip the card;

H to show hint;

A reads text to speech;

237 Cards in this Set

  • Front
  • Back
Definition of Administration
Obtain and give a single dose of medical by legally authorized person

Is not the same as dispensing
Definition of Board
Board of Pharmacy
Defintion of Consultant Pharmacy
Pharmacist licensed and certified as a consultant pharmacist
Definition of Data communication device
electronic device that receives electronic information from one source or routes it to another (eg bridge, router, switch, gateway)
Definition of Departement
Department of Health
Definition of dispense
Transfer of possession of one or MORE doses of medicinal drug by pharmacist to the consumer or his/her agent

Pharmacist will verfiy rx prior to and offer counseling
Definition of institutional formulary system
medical staff evaluates/appraisal/selects medicinal drug which staff using clinical judgment of most useful in patient care and available in Class 2 institutional pharmacy
Definition of medicinal drugs or drugs
substances or preparations commonly known as prescription or legend drugs which require prescription

does not include proprietary or patent preparations
Definition of Patent or Proprietary preparation
medicine in its unbroken, original package which is sold to the public under the authority of the manufacturer or primary distributor
Definition of Pharmacist
person licensed to parctice pharmacy
Definition of pharmacy
includes community pharmacy, nuclear pharmacy, institutional pharmacy, special pharmacy and internet pharmacy
Definition of community pharmacy
every location where medicinal drugs are compounded, dispensed, stored or sold; or where prescriptions are filled and dispensed on outpatient basis
Definition of insitutional pharmacy
every location in a hospital, clinic, nursing home, dispensary, sanitarium, extended care facility or other facility (health care institutions) where medicinal durgs are compounded, dispensed, stored or sold
Definition of nuclear pharmacy
every location where radioactive drugs and chemicals (within classification of medicinal drugs) are compounded, stored, dispensed or sold

does NOT include hospitals which have nuclear medicine facilities
Definition of special pharmacy
every location where medicinal drugs are compounded, dispensed, stored or sold if such locations are not already defined.....

Snowcone Sudafed cart
Definition of Internet pharmacy
locations that are not otherwise licensed or issued a permit within or outside the state, which use internet to communicate with or obtain information from consumer in Florida and use such communication or information to fill or refill presciptions or to dispense, distribute, or practice pharmacy in this state
When is the pharmacy department considered closed?
when the pharmacist is 'not present and not on duty'
When does pharmacist 'not present and not on duty' not apply?
Pharmacist is counseling or providing assistance to customers, attending to personal hygeine needs, or performing other expected pharmacy activities (eg giving a flu shot)
Definition of pharmacy intern
us

person currently in or graduated from duly accredited pharmacy program, and is registered with Department
Definition of practice of the profession of pharmacy
Anything taught in pharmacy school

Compounding, dispensing, consulting, therapeutic values, uses of drugs, counseling

other pharmaceutical services (MTM), medication review, flu vaccine administration, any other act/research/ service/operation that involves pharmacy
Definition of prescription
any order for drugs or medicinal supplies that can be modified through communication from prescriber to pharmacist
Definition of nuclear pharmacist
Licensed and certified as nuclear pharmacist
Definition of centralized prescription filling
prescription filling by one pharmacy upon request by another pharmacy, to fill or refill the presciption

includes the performance by one pharmacy for another pharmacy of other pharmacy duties: drug utilization review, therapeutic drug utilization review, claims adjudication and the obtaining of refill authorizations
Definition of automated system
mechanical system that delivers prescription drugs received froma Florida licensed pharmacy and maintains related transaction information
Explain who is on the Board of pharmacy
Seven members must be licensed pharmacists are Florida residents and practiced pharmacy for at least 4 yrs (represent different pharmacy settings)

One pharmacist must be community pharmacy, one pharmacist must be institutional pharmacy, the remaining 5 pharmacists can be in any practice setting

The last 2 members of the board are not connected in any way to pharmacy, and have never practiced pharmacy
What is the board of pharmacy?
Created within the department of health

Will consist of 9 members appointed by the Governor and confirmed by the Senate. Terms for members are for 4 years and members will continue to serve until successors are appointed
Who is allowed to inspect the pharmacy and when are they allowed to do so?
1) Duly authorized agents and employees of the department

2) at reasonable hours to determine if pharmacy has violated any law, obtain samples/specimens, secure evidence for prosecution
When can the pharmacy hand over patient records?
1) Request by patient/legal representative
2) Request by department
3) patient's spouse (with written authorization)
4) Subpoena, in which case you will also notify the patient
What must a graduate of a foreign pharmacy school do to become licensed?
Complete TOEFL or TSE
Pass the Foreign pharmacy graduate equivalency exam and complete minimum of 500 hrs in supervised work activity program under supervision of a Fl pharmacist approved by the Board
What must a graduate of an accredited US COP do to become licensed?
Send application + fee
Pay fee for exam
Be > 18 YO
Submit proof of internship program
What is licensure by endorsement and how does that work?
Complete application + fee,
Be > 18 YO,
Completed internship,
Passing score on exam,
Evidence of pharmacy practice in 2 of last 5 yrs OR completed internship requirements in prev 2 yrs,
if prev license in another state-has 30 hrs CE,
Not in trouble with another Board
How many hrs of CE are required?
30 biennially
May be reduced on initial licensure
What do you have to do to reactivate you license, in terms of CE and fees?
Complete the initial 30 hrs CE from last active licensure, and complete 15 hrs CE per inactive yr,
Will also pay inactive license fee, delinquency fee, and reactivation fee
What is the process for Consultant pharmacy license renewal?
Submit renewal application,
Pay renewal fee
Must complete additional training
What are the responsibilities of the consultant pharmacist?
Maintain drug records, establish safe drug handling and storage procedures, may be responsible for orderine & evluating lab/clinical tests (provided traned and complete additional 3 hrs CE)
What is the process for nuclear pharmacist renewal?
Submit renenwal application, Pay fee, Must complete additional training
What are the responsibilities for nuclear pharmacists?
Responsible for compounding and dispensing nuclear pharmaceuticals, Maintaining drug records
As of Jan 1, 2010: Pharmacy technicians must do what?
Apply for registration with the Board and pay fee, be in a program or completed tech program, Be > 17 YO, complete 20 hrs CE biennially (with 4 hrs live and 2 hrs on medication error & pharmacy law)
These violations result in a 1st degree misdemeanor
1) own/operate/etc an unregistred pharmacy, act as a pharmacist when not licensed as such or intern who acts without supervision

2) Misrepresent as a pharmacist, pharmacy
These violations result in a 3rd degree felony
1)Make a false statement to the Board via affadavit, interview, etc.
2) Dispense medications without a licensed pharmacist
3) Dispense Rx meds without a Rx
4) Sell samples
How do non-resident pharmacies become licensed in Florida?
1) Have valid licnese at current location (an follow laws there)
2) Let the board know about those involved (notify in 30 days of any changes), druge records of dispensed drugs, have set # of hrs for 6 days/wk as well as 24-hr phone #
3) Registration + biennial fee
4) Do NOT advertise in FL unless registered here 1st
5) Pharmacy and pharmacist (manager) must be licensed in FL
How can I lose my license?
1) fradulantly getting license to begin with
2) Having unlicensed person do a licensed pharmacist work
3) Being unfit or incompetent
4) Violation of FDCA
5) Crime conviction, incl nolo contendre
6) Filing false reports
7) Not giving medication price
8) Violating Board or Dept rules from disciplinary hearign
9) Not reporting law breakers
10) Not telling the Board you're quitting within 20 days
11) Releasing pt records inappropriately
What is the difference between a Class I instiutional pharmacy and a Class II institutional pharmacy?
Class 1 pharmacy can only administer medication, NOT dispense
Class 2 pharmacy can dispense medication
What does a Class II institutional pharmacy do?
Dispense and consult to patients in institution

If Governor declared state of emergency, then can dispense and counsel outside of institution
What is a modified class II pharmacy, and how does it differ from a class II institutional pharmacy?
Differs from class II in terms of space and equipment

Can be a short-term care or ambulatory care, clinic pharmacy
What types of pharmacies are required to hace technician manuals?
Institutional and special pharmacies
What types of pharmacies need to notify the board of changed in the pharmacy dept managers within 10 days/
Community, nuclear, and special pharmacies
What are the requirements to obtain an internet pharmacy permit?
1) Apply to dept
2) Designate a pharmacy manager--licensed pharmacist will be responsible for drug records
3) Notify Dept in 30 days of any changes
4) Written policy for techs (duties, etc.)
What are the general requirements for a pharmacy license?
1) Must be > 18 YO or corporation officers are > 18 YO
2) File application with Board
3) Board will check out the application to decide whether to issue license
Where can a pharmacy provide automated pharmacy systems?
Long-term care facility or hospice or state correction institution
What is necessary to operate an automated pharmacy system?
Must be under the supervision of FL-licnesed pharmacist (but does not need to be physically present)
THe Pharmacist will develop & implement policy/procedures to verify accuracy and validity or dispensing and that it is restocked properly
What are drugs that pharmacies are NOT allowed to promote?
Controlled substances may not be advertised because that is not in the best interest of the public

All other medicianl drugs may be advertised as long as they are not false, misleading or deceptive
What is the information disclosure rule?
Every pharmacy needs to have link to performance and financial data on its' website (to be published by AHCA)
What must be on a prescription for the pharmacist not to substitute?
Medically necessary
What must the pharmacist tell the patient when he/she picks up medication, in regards to medication substitution?
1) Med was substituted
2) Price difference
3) Can refuse substitution
Are prescribers liable if patient has bad reaction to substituted medication?
No, unless the original drug was incorrectly prescribed
What are the requirements for manufacturers in regards to expiration dates?
Must display expiration date of each drug in a conspicuous and bold fashion on the container and on its packaging
What are the requirements for community pharmacists in regards to expiration dates?
Needs to display on outside of the container or in written form the expiration date provided by manufacturer -OR- container must be dated for a year as soon as its opened (as long as date on the bottle does not come first)
Who is liable when medication lose effectiveness PRIOR to labeled expiration date?
Pharmacist and prescribers
How can a pharmacist avoid liability in regards to expiration or storage problems of a drug?
Tell the patient how to store medication appropriately....then it becomes the patient's fault
Who is responsible for verifying that the person or entity ( in another state)involved int he transfer of a prescription is actually licensed?
the Pharmacist and/or pharmacy located in FL
Can a controlled substance prescription be transferred?
Schedule II- NO!
Schedule III, IV, and V can be transferred ONCE
In centralized prescription filling process, pharmacies involved must have....
1) Same owner, -OR-
2) written contract which specifies services, responsibilities, and manners of cooperation with state & federal law.

Each pharmacy must also maintain a policy and procedures manual
In order to use a common database, all pharmacies must...
1) Be under same ownership and utilize same common database
2) Maintain policy and procedures manual (owner of database must)
3) Be licensed
In general, policy and procedure manuals should outline what?
1) Best practices model for compliance with state, federal laws and regulations
2) Procedure for record maintenance
3) Provision for adequate security to protect confidentiality and integrity of patient information
4) Qualtiy assurance program
When can an emergency prescription refill occur?
1) Prescriber cannot be reached, but must notify prescriber of emergency dispensing in reasonable time
2) Governor proclaims a state-of-emergency
3) Medication must be essential to maintenance of life or chronic therapy
What are the limitations of emergency prescription refills?
1) Only 72 hr supply if not state of emergency
2) Drug cannot be Schedule II
Prescription via facsimile can occur when?
1) Rx issued by authorized prescriber
2) Original Rx on hand at time of drug delivery
3) Recipient must sign log with name & address of recipeint and patient
Can a facsimile prescription be used for Schedule-II?
Yes, but ONLY for narcotic infusion therapy, narcotic in patient in hospice acare or any Schedule-II drug for a resident in a LTCF
What is the penalty for a pharmacist teaming up with a physician/surgeon/org/etc for rebates and/or commissions?
Penalties include disciplinary action, fine not to exceed $1,000 and possible recommendation by dept to appropriate regulatory agency that disciplinary action be taken
Who/What establishes the formulary of drug products and dispensing procedure?
*NOTE: not hospital formulary*
Committe with 2 members from the Board of Medicine, 1 member from Board of Osteopathic Medicine, 3 members of the BOard of PHarmacy and 1 person with background in health cre or pharmacology chose by committee
What can the formulary include?
*NOTE: not hospital formulary*
1) Any drug of single or multiple active ingredient in any strength that is approved for OTC by FDCA
2) Any drug recommended by US FDA Panel for transfer to OTC status pending approval of FDA
3) Any drug containing antihistamine or decongestant as single or combo active ingredient
4) Fluoride in any strength
5) Lindane in any strength
6) Any OTC proprietary drug under fed law that is approved for reimbursement by FL Medicaid
7) Any topical anti-infectives excluding eye and ear topical
8) Any OTC proprietary drug under fed law is not included in formulary
What is the penalty for a pharmacist violating the rule which outline what a pharmacist may order and dispense?
1st degree misdemeanor
What are the labelling requirements for pharmacist order and dispensing of medication?
1) Pharmacist name
2) Name and address of pharmacy
3) Dispensing date
4) Ordre #
5) Patient name
6) Directions for use
7) Statement that order may not be refilled
What is the procedure for a Medicaid audit?
1) Agency doing audit gives 1 week notice prior to initial audit for each audit cycle
2) Audit conducted by RPh and physican record
3) RPh is given 10 days to produce documentation to address any discrpancy
4) Audit covers period < 1 yr
5) Audit will not occur within first 5 days of the month
6) Audit reports will be delivered within 90 days and fianl report within 6 months
What must a pharmacist do to be allowed to give a flu vaccine?
1) Complete certification program with at least 20 hrs of class time
2) Must have $200,000 of professional liability infurance and completion of training
3) Supervisingphysicain must have notice of certification
4) Follow written protocol
Controlled substances prescriptions, according to state law, must contain what?
1) Name and address of patient
2) Practitioner's name, address and DEA
3) If animal: species
4) Name, strength, quantity, and directions for substance
5) Rx #
6) Date filled and RPh intials
Which controlled substances can the pharmacist dispense without a Rx?
1) Schedule-V drugs
2a) Any depressant or stimulant (except Schedule II amphetamine) --OR--
2b) Sympathomimetic or Schedule IV (no CNS activity)
In order to get a controlled substance without a prescripton, the patient must be....?
1) > 18 YO; if under 18 need Rx and must maintain volume record
2) Quantity must be: <240 mg opium, <120 mg codeine, <60 mg dihydrocodeine and < 30 mg ethylmorphine
Who, in FL, can prescribe medications, but not controlled substances?
ARNP and PA
(456.0392)
If a prescriber is not elgible for a DEA #, what needs to be on the Rx?
Prescriber name and professional license #
(456.0392)
If a pharmacist notifies a patient of an adverse event that may cause harm, is the pharmacist liable?
Notifications of adverse effects do not constitute liability admission, and cannot be introduced as evidence (456.0575)
What is complementary or alternative healthcare treatment?
any treatment designed to provide patients with an effective option to the prevailing or conventional treatment methods associated with the service provided by a healthcare practitioner; it may also be preovided in addition or inplace of other treatment options (456.41)
If complementary or alternative therapy is an option, what must the practitioner do, in terms of communication?
1) Offer complementary/alternative healthcare treatments that area associated with same rqmt, etc of conventional treatment
2) Inform patient of nature of treatment (risks, benefits, etc)
3) Inform patient of education level , experience, credentials,etc
4) Must record that requirements for communication of treatment alternatives was met (456.41)
What is the penalty for an internet pharmacy that is not licensed in FL, but dispenses to FL residents?
2nd degree felony (456.0161)
If a patient has an adverse event from a medication, is the practitioner required by law to tell the patient, and if he/she does so is practitioner liable?
Yes required by law under 'dut to notify patient, but are NOT liable (456.0575)
What does Florida law require to be on a prescription?
*for general medications
1) Need to be legibly printed or typed
2) Name of prescriber
3) Name and strength of drug
4) Quantity
5) Directions for use
6) Date
7) Signed by practioner on date
(456.42)
What does Florida law require to be on a prescription for a controlled substance?
1) Must be legibly written or typed
2) Prescriber name
3) Name and strength of drug
4) Quantity of drug (in TEXT and NUMERIC format)
5) Directions for use
6) Date: month can NOT be abbreviated
(456.42)
7) Prescriber signature on date
8)
T/F An electronically generated prescription must have the quantity in numeric and textual format, and must be signed & dated by the prescribing practitioner.
False, quantity need only ve in numeric format (456.42)
Definition of prescribing decision
Means a prescriber's decision to prescribe a certain pharmaceutical (456.42)
What are the rules and regulations regarding electronic prescribing?
1) Can not interfere with patient's freedom to choose a pharmacy
2) Should not be influenced by advertising, instant messaging, economic incentive, etc. the prescribing decision
3) Means of prescribing should not be in response to prescribing a certain pharmaceutical or to certain pharmacy
3) May show info regardind payor's formulary (456.43)
Definition of point of care
Time that a prescribing practitioner or his/her agent is in the act of prescribing a certain pharmaceutical (456.43)
What are the conditions that a prescription may be filled under emergency conditions?
1) Not Schedule-II
2) Essential for life or maintenance of life
3) Interruption of therapy may lead to undesirable health consequences
4) Pharmacist should create a writtne order with alll Rx info and sign it
5) Notify prescriber of emergency dispensing
(465.0275)
What are the storage requirements for prescription drugs?
1) Suitable size
2) Adequate lighting, ventilation, temperature, sanitation, humidity, space, equipments
3) Clean and orderly conditon
4) No infectation of bugs
5) Store at appropriate temp and conditions as on label(499.0121)
What are the security requirements for storage of prescription drugs?
1) Be secure from unauthroixed entry
2) Well-lit perimeter
3) An alarm system to detect entry after hrs
4) Any vehicle with Rx drugs must be secure
(499.0121)
T/F Donated cancer drugs or supplies may be donated to a specific cancer patient.
False
(499.029)
In order to donate cancer drugs what conditions must be met?
1) Can not be billed to Medicard
2) Must be in original, unopened, sealed container (or in tamper-evident unit-dose packageing
3) Expiration date is >6 months of donation date
4) Inspected by pharmacist
(499.029)
What fees may cancer donation center charge?
1) can NOT submit claim for reimbursement
2) can charge handling fee sufficient to cover the cost of preparation and dispensing of cancer drugs or supplies under the program
(499.029)
Who is elgible to participate in cancer donation program?
1) Insurance benefits are exhausted
2) Those who have coverage through privagte or federal coverage are INELGIBLE
(499.029)
When can phenylalanine be dispensed?
Only upon prescription of authorized prescriber (499.032)
What ephedrine products, in general, do NOT require a prescription?
*Not specific formulations
1) Sold legally as OTC
2) Manufactured and distributed for legitimate medicinal use
(499.033)
What solid dosage forms of ephedrine do not require a prescription?
1) Theophylline (100-130mg), ephedrine (12.5-24mg).
2) Theophylline (60-100mg), ephedrine (12.5-24mg), guaifenesin (200-400mg).
3) Ephedrine (12.5-25mg), guaifenesin (200-400mg).
4) Phenobarbital (not greater than 8mg) in combination with the ingredients.
(499.033)
What liquid ephedrine dosage forms are exempt from requiring prescription?
Per 5 mL
1) Theophylline (< 45mg), ephedrine (< 36mg), guaifenesin (< 100mg), phenobarbital (< 12mg).
2) Phenylephrine (< 5mg), ephedrine (< 5mg), chlorpheniramine (< 2mg), dextromethorphan (<10mg), ammonium chloride (<40mg), ipecac fluid extract (<0.005ml).
(499.0033)
What anorectal preparations with ephedrine are exempt from requiring a prescription?
those which contain <5% ephedrine (499.033)
What are the procedures for putting a license on retired status?
a. To place license on retired status at the time of renewal, the licensee must submit a written request to the Board with a $50 retired status fee and an unlicensed activity fee. If it’s not the renewal time, submit all the above with a $25 change of status fee.
(64B16-26.1005)
What are the procedures for reactivating the license from retired status?
b. To reactivate a retired license, you must meet the CE requirements and pay renewal fees imposed on active status licensee for all biennial licensure periods, plus current unlicensed activity fee during which the licensee was on retired status
Must retake jurisprudence exam, and must retake NAPLEX if its greater than 5 yrs retirement (64B16-26.1005)
What are the conditions where the Board determines that a license is delinquent?
If it goes past midnight of expiration date
(64B16-26.1021)
How do you reinstate a delinquent license?
1) Delinquent consultant RPh licenses can be reinstated to active or inactive status by submitting delinquent fee of $25 plus current fee for active or inactive status
2) Delinquent licenses not renewed before midnight of the expiration date of current licensure cycle are null and the licensee will have to apply for a new license
(64B16-26.1021)
What are the specific CE requirements?
1) 1 hr CE HIV/AIDS or end of life ( unless completed in previous biennial)
2) 2 hrs on ACPE on med errors
3) 5 hrs on risk management
obtained by by attending 1 full day or8 hrs of disciplinare hearings
4) 5 hrs of CE of volunteer services to indigent or underserved populations
5) 10 CE hrs must be live
6) Consultant and nuclear pharmacists must complete an additional 24 hrs
(64B16-26.103)
How many CE hrs of HIV/AIDS, med errors and reisk management are required?
1) 1 hrs HIV/AIDS if not completed in last biennial
2) 2 hrs med errors
3) 5 hrs risk management
(64B16-26.103)
Alternative sources for CE include seminars and lectures, what are these possibilties?
1) attending full day or 8h of a board meeting w/ discipline hearings( max 10hrs; 5hrs per meeting for risk management)
2) doing volunteer service to indigent people or to underserved populations or in areas of critical need (max 5hrs)
3) 1hr credit given per 2 hrs volunteered
4) completing post professional degree program
(5hrs per semester hr)
5) providing expert witness opinions for cases reviewed by Dept of Health (max 10hrs; 5hrs in risk management per case)
(64B16-26.103)
What CE is required to give flu vaccine?
1) Need 20 hrs
2) CE needs to cover: MOA/CI/DDI and monitoring of vaccines, vaccine schedules, protocols, adverse effects, reimbursement, administration, CPR
(64B16-26.1031)
How does the license renewal work with armed forces and their spouses?
Members of the armed forces are exempt as long as they are on active duty, OR are within 6 months after being on active duty AND not practicing pharmacy in private sector.

Spouses who are required to be away from the state of Florida, due to their spouse being on active duty, are also exempt.
(64B16-26.104)
What exams must we pass to become licensed?
1) NAPLEX – North American Pharmacist Licensure Examination
2) MPJE – Multistate Pharmacy Jurisprudence Examination
(64B16-26.200)
What is an internship program required to have?
1) Current license or permit
2) Operated by a pharmacist
3) Sufficient diversity in prescription filling or compounding
4) Clean record in regards to the law
5) Not more than one intern at a time
(64B16-26.2032)
What should consultant licensure training include?
1) Minimum 40 hrs in max of 3 months
2) Be able to do a regimen review, documentation and communication
3) Be evaluated bby faculty review
3) Facility review
3) Committee and reportsL quarterly quality of care (pharmacist prepare dreport)
4) Policy and procedures
5) Interact with facility administration and staff
(64B16-26.300)
What CE is involved in consultant pharmacist license renewal?
1) Need additional 24 hrs
2) Required CE (at least 12 hrs with 3 hr block in any subject): drug therapy, administrative responsibilities, consultant pharmcy facility responsibilities,
What are the training requirements for nuclear pharmacist?
1) Submit course outline from accredited COP
2) Certificate of training for 200 hrs min
3) Training will include: radiation physics and instrumentation (85 hrs), radiation protection (45 hrs), mathematics related to use and measurement of radioactivity (20hrs), radiation biology (20 hrs), and radiopharmaceutical chemistry (30hrs)
4) Minimum on-the-job training of 500 hrs (under supervision
5) If the didactic and experiential training required in this section have not been completed within the last seven (7) years, the applicant must have been engaged in the lawful practice of nuclear pharmacy in another jurisdiction at least 1080 hours during the last seven (7) years.
(64B16-26.303)
What is the recommended CE subject matter for nuclear pharmacist?
1) Application of radiopharmaceutical theory
2) Effective communication skills
3) Application of the most rigorous and up-to-date principles of radiation safety and quality assurance
4) Management of a nucelar pharmary
5) Advances in drug, radiopharmaceutical or related technology
(64B-16-26.304)
What CE is required to order and evaluate lab tests?
1) at least 3 hrs for initial certification and at least 1 hr for recertification
2) A consultant pharmacist may apply the three (3) hour initial certification course and the one (1) hour recertification course toward the continuing education requirement for renewal of a consultant pharmacist., or may apply such continuing education hours toward the continuing education requirement for renewal of a pharmacist license., but may not use the same continuing education hours to satisfy both requirements. A Doctor of Pharmacy who is not a consultant pharmacist may apply the three (3) hour initial certification course and the one (1) hour recertification course toward the continuing education requirement for renewal of a pharmacist license
(64B16-26.320)
What are the requirements for registration and employment as a pharmacy intern?
1) Enrolled or graduation from accredited COP
2) Needs to be supervised by licensed person
(64B16-26.400)
What are the duties of the Tripartite CE Committee?
Their duties are to become a board approved continuing education provider, oversee the approval of individual programs or courses submitted by providers, and perform auditing and monitoring activities.
(64B16-26.600)
How are members for the tripartite CE committee selected?
1) The tripartite CE committee is composed of equal representation from the Board of Pharmacy, each College and School of Pharmacy in the State, and practicing pharmacists within the State.
2) Selected by the Board and serve 2 yrs
(64B16-26.600)
What standards must CE courses meet for approval?
1) Education content development
2) Methods of delivery: want active participation
3) Program facult qualifications
4) Facilities
5) Evaluation: must be able to evaluate what was learned
6) Contact hr criteria: provider of CE will determine
7) Record keeping: must keep for inspection by the Board (form min 3 yrs)
(64B16-26.601)
What documentation is required for CE fro license renewal?
Documentation consists of statements for credit for lecture attendance, certification forms from the instructors or course completion slips from corresponcence courses (64B16-26.603)
How long can the pharmacist take a break, and the pharmacy still be considered open?
not to exceed 30 min, provided that:
1) as long as lunch break is posted on sign, such that pharmacist still available for consult
2) Activities of the techs are still under the direct and immediate personnal superciosn of a pharmacist
(64B16-27.1001)
Can the pharmacy intern make the final check on a prescription?
No, only the licensed pharmacist can
(64B-1627.1001)
Who can accept verbal prescriptions and prepare copies of prescriptions?
Only the pharmacist or intern (who is under supervision) may accept oral prescription, and prepare a copy of prescrption

When copy is give, a notation shall be made upon the prescription tha copy has been given , the date and who it was given to
(64B16-27.103)
Can a pharmacist offer supplies and/or equipment at no charge or below market value?
No, these are not integral elements of the med distribution system
(64B16-27.1042)
What are the limitations of pharmacist ordering and dispensing medicinal drugs?
1) can not be injectable
2) can not be oral meds for pregnant or nursing
3) amount can not exceed 34 days or standard course (unless advise pt to see dr)
4) OTC meds are exempt and can be recmommended as OTC products
5) Interns and techs may not be involved in ordering of meds
(64B16-27.210)
What must be put in patient's record if pharmacist orders meds?
1) Patient compliant (in patient's words)
2) Patient medical history
3) Patients current complaint
4) Med ordered & dispensed
5) RPh intial
6) Rx#
(64B16-27.210)
What medications can the pharmacist order?
1) Magnesium salicylate/phenyltoloxamine citrate, Acetylsalicylic acid (Zero order release, long acting tablets), Choline salicylate and magnesium salicylate, Naproxen sodium, Naproxen, Ibuprofen.
(2) Urinary analgesics. Phenazopyridine, not exceeding a two (2) day supply.
(3) Otic analgesics. Antipyrine 5.4%, benzocaine 1.4%, glycerin
(4) Anti-nausea preparations: Meclizine up to 25 mg, scopolamine not exceeding 1.5 mg. per dermal patc
(a) Antihistamines: Diphenhydramine, Carbinoxamine, Pyrilamine, Dexchlorpheniramine, Brompheniramine.
(b) Decongestants: Phenylephrine, Azatadine.
(6) Topical antifungal/antibacterials: Iodochlorhydroxyquin with 0.5% Hydrocortisone (not exceeding 20 grams).
(b) Haloprogin 1%.
(c) Clotrimazole topical cream and lotion.
(d) Erythromycin topical.
(7) Topical anti-inflammatory. Preparations containing hydrocortisone <2.5%.
(8) Otic antifungal/antibacterial. Acetic acid 2% in aluminum acetate solution
(9) Keratolytics. Salicylic acid 16.7% and lactic acid 16.7% in flexible collodion
(10) Vitamins with fluoride. (This does not include vitamins with folic acid in excess of 0.9 mg.)
(11) Medicinal drug shampoos containing Lindane.( <4 oz; head lice only)
(12) Ophthalmics. Naphazoline 0.1%
(13) Histamine H2 antagonists: Cimetidine, Famotidine, Ranitidine HC1.
(14) Acne products: Benzoyl Peroxide.
(15) Topical Antiviral: Acyclovir ointment, Penciclovir.
(64B16-27.220)
When can the pharmacist order fluoride-containing medicinal products?
1) Oral fluoride products can be ordered when the patient does not have fluoride in their drinking water
(64B16-27.230)
If fluoride content is <0.5ppm, what is the dosing schedule for supplementation for 0-6 months, 6 months-3 yrs, 3-6 yrs, 6-16 yrs?
1) 0-6 months: do not supplement
2) 6 months-3 yrs: <0.3 ppm, supplement with 0.25 mg F/day
3) 3-6 yrs: 0.3-0.6 ppm, supplement with 0.25 mg F/day; <0.3 ppm, supplement with 0.5 mg F/day
4) 6-16 yrs: 0.3-0.6 ppm, supplement with 0.5 mg/day; <0.3 ppm, supplement with 1.00 mg F/day
(64B16-27.230)
What is the max amount of fluoride which can be dispensed at any one time to a patient?
264 mg
(64B16-27.230)
DEA numbers that start with:
P or R are for?
M are for?
A, B or F are for?
1) Manufacturers
2) Mid-level practitioner
3) Practioner
If you want to put your license on inactvie license, then you have to do what?
1) send leter notifying Board of change of status
2) Send $ (which you will continue to pay every 2 yrs to stay on inactive)
Can a non-resident pharmacy deliver medication to a FL resident if not licensed?
yes, can make one-time delivery of a dispensed medicinal drug
(64B16-28.840)
What are the legal ways to destroy controlled substances?
1) Complete DEA form 41, witnessed and signed by pharmacy dept manager, DEA agent or a Dept inspector...does not require prior approval from DEA
2) Contact DEA, fill out form41; destroy meds with pharmacy dept manager, pharmacist, sworn law officer
3) Reverse distributor (222)
(64B16-28.303)
There are 2 types of Board-ordered disciplinary courses:
__ hrs of Law and Rules, and __ hrs of Quality related events.
Law = 12 hrs
QRE = 8 hrs
Which of the following licensees can put their license on inactive status:
a. community pharmacist
b. consultant pharmacist
c. nuclera pharmacist
d. pharmacy technician
e. all of the above
All of the above
(64B16-26.1004)
What is considered a quality related event?
1) Inappropriate dispensing or administration of a prescribed med
2) A variation from prescriber;s Rx order: incorrect drug/dose/strength/patient/packaging/labeling or directions
3) Faillure to identiy and manage: over or under utilization, terhapeurtic duplication, drug-disease CI, DDI, incorrect drgu dosagr oduration, drug alleryg, clincal abuse/misuse
(64B16-27.300)
What is the continuous quality improvement program and what is its purpose?
1) System of standards and proceduresto identify and evaluate quality-related events and improve patient care
(64B16-27.300)
What are the minimum requirements for continuous quality improvement program?
1) Each pharmacy must establish a CQIP
2) Will be described in pharmacy's policy and procedure manual
3) Manual will contain provisions fro CQI manager, preovisions of record to ensure QI review at least every 3 months, planned process to record/measure/assess and improve patient care, and procedure for reviewing QRE
(64B16-27.300)
When must a QRE be recorded?
ON the same day of its having been described to the pharmacist
(64B16-27.300)
How long must the pharmacist keep a QRE on file?
At least until the event has been considered by the committee and incorporate in the summary (analysis of remedial measures undertaken following a QRE)
T/F QRE records are considred peer-review documents and are confidential; however, records are subject to discovery in civil litigation or administrative actions
False, NOT subject to discovery
(64B16-27.300)
How long must summarization for CQI be maintained?
2 yrs (64B16-27.300)
What is the approved tech: pharmacist ratio?
1) Permitted ration is 1:1
2) If want 2:1 or 3:1, must get approval from the Board
(64B16-27.410)
What are the functions that tech can engage in to help the pharmacist?
1) Assist in performing professional services
2) Prepackage and labelling of unit and multi-dose packages
3)Assist in the preapration of the presciption
4) Issue supplies and other products from an institutional pharmacy to physicians, nursing homes and other depts in institution
5) Initiate communication witih prescriber for refills or Rx clarification
(64B16-27.410)
What are the responsibilities of the pharmacist, according to the Board?
1) Delegation of duties nad tasks
2) Coninued review and ultimate supervision
3) Supervise acitivity of 1 pharmacist to one tech (for continuity)
4) Retain professional and personal responsibility for those in his/her employ and supervision
(64B16-27.430)
What medications are on the negative formulary?
1) Digitoxin
2) Conjugated estrogen
3) Dicumarol
4) Chlorpromazine (solid dosage form)
5) Theophylline CR
6) Levothyroxine sodium
7) Pancrealipase (PO dosage form)
(64B16-27.500)
Why is a medication put on the negative formulary?
Substitution could result in:
1) Adverse clinical effects
2) Could otherwise pose a threat to the health and safety of patients receiving such Rx meds
Who/What determines what goes on the negative formulary?
Boards of medicine and pharmacy
(64B16-27.500)
T/F Pharmacies must establish a formulary, which will include brand and generic name products. The generic products have to specify the manufacturer.
True (64B16-27.510)
What parties must agree for a generic substitution to occur in FL?
1) Prescriber must issue prescription ina way that dose not forbid substitution
2) Pharmacist must believe that there's an available generic substitute
3) Person presenting with Rx
(64B16-27.520)
When can a pharmacy possess samples of medicinal drugs?
1) Medicinal drugs that may be ordered by the pharmacist
2) Institutional pharmacies-on written request of prescriber
3) Community pharmacies that are health care entity pharmacies, on request of prescriber

Note if not one of the above exceptions: pharmacy must returen samples to company of origin
(64B16-27.615)
What is compounding?
A professional act by a pharmacist which incorporates ingredients to create a finished product for dispensing toa patient or for administration by a practitioner or his/her agent

Differs from manufacturing in that compounding is for one patient
(64B16-27.700)
What is office use compounding?
Provision and administration of a compounded drug to a patient by a practioner in a practitioner's office

Amount can not exceed the amount practioner anticipates using prior to expiration date
(64B16-27.700)
What is the anteroom?
Area where personnel perform hand hygeine, garbing procedures, order entry, CSP labeling and other high particle activities
(64B16-27.797)
A Class 100 environment means...?
an atmospheric environment which contains no more than 100 particles of 0.5 microns in diameter or larger percubic foot of air

Equivalent to ISO Class 5
(64B16-27.797)
How should high-risk sterile products be rendered sterile?
Heat sterilization, gas sterilization or filtration sterilization
(64B16-27.797)
How quickly should immediate-use CSPs be administered?
Administration should be within 1 hour of preparation
(64B16-27.797)
What are the standards of practice for compounding sterile products?
1) Pharmaceutical care
2) Preparation, labeling and distibution of sterile pharmaceuticals
3) Product quality and characteristics
(64B16-27.797)
What is the buffer area?
Area where activities of CSP take place

It will not contain sinks or drains; and for high-risk CSP it, must be a separate room.

ISO Class 7 level of particulate contamination
(64B16-27.797)
What is beyond-use-dating?
Date after-which a compounded prescription should not be used and is determined from the date the preparation was compounded
(64B16-27.797)
What are high-risk CSPs?
Products compounded under conditions that are either non-sterile or at high risk to become non-sterile with infectionus stuff
1) Non-sterile ingredients/device for sterile parenteral administration
2) Sterile contents which lact effective antimicrobial preservatives
3) Non-sterile procedures in the process of compounding
(64B16-27.797)
What are the quality assurance practices for high-risk CSPs?
1) Same as those for low-risk CSPs
2) Each person authorized to compound high-risk levels CSP must demonstrate competency with media-filled test that represents high-level compounding semiannually
(64B16-27.797)
What are medium-risk CSPs?
When CSPs are compounded aseptically under low-risk conditons, but one or more of the following occur:
1) >3 commercial sterile drug products
2) Multiple doses are combine or pooled to prepare CSP for multi administration (diff patients or same patient multiple times)
3) Long duration of compounding process
(64B16-27.797)
What are low-risk CSPs?
1)<3 ingredients
2) Aseptic manipulations in ISO class 5
3) Manipulations are limited to just opening container and
(64B16-27.797)
What are the low-risk CSP wuality assurance practices?
1) Routine disinfection and air quality testing, maintain ISO class 5 air quality
2) Visual confirmation that wearing protective garments
3) Review all orders and packages of ingredients
4) Visual inspection of CSPs...that they look right
(63B16-27.797)
What is required on the label for bulk compounded products?
1) Contents
2) Beyond-use-date
3) Storage requirements
(64B16-27.797)
What are the practice guidelines for preparation of cytotoxic drugs?
1) Vertical flow, Class II hood
2) Biological safety cabinent placed in negative pressure room, unless using barrier isolators
3) Gloves, and tight cuff gowns
3) Appropriate safety and containment techniques
4) Proper disposal of waste
5) Written procedures for handiling spills
6) Prepared doses shall be dispensed, labeled (with precautions) and shupped in manner to minimize risk of accidental rupture
(64B16-27.797)
What are the requirements for obtaining patient records?
1) Pharmacist will make reasonable effort to obtain:
full name and address of patient, telephone #, DOB, gender, list of all new &refill medications (for last 2 yrs) and pharmacist comments on therapy
2) Provides immediate retirval of information necessar yfor dispensing
(64B16-27.800)
In reviewing the patient record, the pharmacist will analyze what?
1) Over or under utilization
2) Therapeutic duplication
3) Drug-disease CI
4) DDI
5) Incorrect drug dose or duration
6) Drug-allergy interactions
7) Clinical abuse or misuse
Pharmacist will take appropriate steps to avoid or resolve above issues
(64B16-27.810)
T/F Pharmacist needs to only verbally offer counseling.
False, need verbal AND printed offer of counseling
(64B16-27.820)
If the prescription is delivered, how can the pharmacist ensure that the offer of counseling is made?
Have written offer of counseling with toll-free telephone #
(64B16-27.820)
What are appropriate elements of patient counseling?
1) Name and description of drug
2) Dosage form
3) Route of administration
4) Duration of therapy
5) Intended use
6) Expected action of the drug
7) Special instruction or precautions
8) Commone side effects
9) Techniques for self-monitoring
10) Proper storage
11) Refill information
12) Action to be taken if missed dose
13) Any other relevant information
(64B16-27.820)
When is patient counseling not required?
1) when patient or his/her agent refuses offer of counseling
2) when patient is an inpatient at a hospital or institution where health care practitioners are authorized to administer drug
(64B16-27.820)
When would you be suspicious of whether a controlled substances prescription is for a legitimate medical purpose?
1) frequent loss of controlled substance meds
2) Patient only gets controlled substances Rx
3) Oner person present controlled substances Rx with different patient anmes
4) Same or similar controlled substance medication is prescribed by >2 prescribers @ same time
5) Patient always parys cash and insists on brand name
What is the dept allowed to inspect?
1) Rs dept where Rs filled/processed/acceted/etc.should be viewable and available forinspection at reasonable time
2) Minimum of 1 yr inspection expected by Board
3) Dept agents can inspect invoices, shipping tickets, or other documents pertaining to the transfer of drugs or drug preparations
(64B16-28.101)
What equipment is required for ALL pharmacies?
1) Sink with running water
2) Sufficient shelf, drawer or cabinet space for pharmaceutical storage
3) Refregerator
4) Adequate sanitation
5)Current pharmacy referece and current cooy of the laws and rules governing the practice of pharmacy in Florida (electronic or hard copy)
(64B16-28.102)
The outer label of radiopharmaceutical container must have....?
1) Name and address of pharmacy
2) Name or prescriber
3) Date of original dispensing
4) Radiation symbol
5) Procedure name
6) Rx order #
7) Radionuclide and chemical formula
8) expiration date and time
9) Quantity: liquid-volume, solid-# of items or weight, gas-# of ampules or vials
10) Molybdenum 99 content to USP limits
11) Name of patient or 'Physicain use only'
(64B16-28.108)
What are the labeling requirements for the inner label of radiopharmaceuticals?
1) Name of pharmacy (do not need address)
2) Standard radiation symbol
3) Radionuclide & chemical form
4) Name of procedure
5) Rx order #
(64B16-28.108)
What is required on the label for Extended Scope Renal dialysis (ESRD) pharmacy?
1) 'Use as directed'
2) Name and address of the person receiving delivered products
3) Prescriber name
4) Name and address of ESRD pharmacy location (from where shipped)
5) Rx #
6) Special instructions regading delivery dates orlocations
7) Beyond-use-date or manufacturer's expiration date (if unopened)
(64B16-28.108)
What are the minimum hrs and days per week that the pharmacy is required to be open?
1) 40 hrs
2) 5 days/wk
(64B16-28.1081)
What holidays are pharmacies allowed to be closed?
1) New Year's Day
2) Memorial Day
3) Fourth of July
4) Labor Day
5) Veteran'd Day
6) Thanksgiving
7) Christmas
8) Any religious holiday provided notice of such closing is given (1 in lettering sign)
(64B16-28.1081)
When the pharmacy is closed, who is allowed to enter or remain in the pharmacy?
Only the pharmacist
(64B16-28.109)
Who is allowed to have a key to the pharmacy?
Only the pharmacist
(64B16-28.109)
If the pharmacy is closed what must occur?
1) Pharmacy will be closed off from other section and will be securely locked
2) only the pharmacist will be allowed to remain in the pharmacy
3) 2' font sign stating: Prescription Department Closed' will be displayed in prominent place in pharmacy
(64B16-28.109)
How oftern must pharmaceutical stock be checked for outdates?
Every 4 months; Expired drugs must be discarded and NEVER be dispensed
(64B16-28.110)
What is a closed delivery system?
A system in which the actual control of the unit dose or customized patient medication package is maintained by the facility rather than by the individual patient
(64B16-28.118)
How long can a prescription go unclaimed and stil be re-used?
Up to 1 yr, provided the medicaiton does not expire
and is not recalled (64B16-28.1191)
What is the definition of a single location?
1) Contiguous area under control of the permit holder
2) An area <0.5 miles from the central location of the permit
(64B16-28.113)
Can the Board issue one permit for more than one location?
No, only possible exception is if other location is within 0.5 miles of permit location (so still fits single location definition)
(64B16-28.113)
What are the requirements for drug storage at a Class I pharmacy?
1) Bea dministered from individual containers to individual patient
2) Be prohibited unless proper prescription and properly labeled
(64B16-28.120)
What are the requirements for drug storage in Class II institutional pharmacy?
Be stored in confines of pharmacy (exception: drugs for treatment procedures )
(64B16-28.120)
How long soudl original prescription be retained?
At least 2 yrs from date of last filling
(64B16-28.140)
What other forms can prescriptions be stored as?
1) Reduce prescription to a hard copy for verbal orders
2) In lieu of actual original presciptions, can use electronic recordkeeping system, which can capture/store and reproduce exact image of prescription
(64B16-28.140)
What are the requirements for back-up system?
1) Pharmacy must maintain a back-up copy of information and update it weekly
2) Data processing systems shall produce an audit trail for presceding 2 yrs
3) Change or data processing system: records must be transferred to new system or purge to printout (for 2 yrs)
(64B16-28.140)
How long does the pharmacy manager have to report significant loss of information from data processing system to the Board?
10 days from discovery
(64B16-28.140)
The dispensing pharmacist shall verify a hard copy within __ days from dispensing date.
7
(64B16-28.140)
What is the alternative to producing a daily hard-copy printout (for records)?
Pharmacy can maintain a log book where each individual pharmacist shall sign a statement attesting to the fact that the info enetered data processing system that day has been reviewed by hi,/her and is correct as entered (must be keptfor 2 yrs)
(64B16-28.140)
What is the requirements for compounding records?
Need a written record maintained for each batch of compounded products

Record must include:
1) Date of compounding
2) Control #
3) Complete formula, including methodology and necessary equipment
4) Initials of person performing compounding
5) Initialsof pharmacist responsible
6) Names of manufacturer for raw materials used
7) Quantity of finished prpoduct
8) Package size and # of units prepared
9) Patient name
(64B16-28.140)
What are the requirements for an automated pharmacy system?
1) Policy and procedure manual: name of system, security features of system, process for stocking, identification method of pharmacists & techs, CQI compliance, patient confidentiality and ability to change access
2) Properly dispenses
3) Readily retireves electronic records to identify those dispensing drugs
4) Ability to comply with product recalls
(64B16-28.141)
Who can restock an automated pharmacy system?
Florida licensed pharmacist, unless system uses removable cartridges/containers so that it can be loaded by personnel designated by the pharmacist
(64B16-28.141)
What needs to be on the records of transactions with patient-accessed automated pharmacy system for Department?
1) Patient name
2) Name, strength and dosage form of dispensed drug
3) Quantity of drug
4) Name of provider pharmacy
5) Rx #
6) Name of prescriber
7) Pharmacis twho approved Rx/order
8) Person to whom the drug was released
(64B16-28.141)
Definition of 'prescription files'
drug dispensing records of a pharmacy which shall include all orders for drugs or medicinal supplies, dispensing records for medicinal drugs issued by practitioner
(64B15-28.202)
Definition of 'closing of a pharmacy'
Cessation or termination of professional and business activities within a pharmacy
(64B16-28.202)
What is the process for closing a pharmacy?
1) must notify the Board (in writing) prior to closure date
2) Arrange with Board to return permit to Board
3) Advise Board which permitee will receive prescription files
4) Physically deliver files to nearby pharmacy
5) Display sign advising public of new location of prescription files
6) Pharmacy receiving prescription files sall maintain delivered Rx in separate files, so they don't get mixed up
(64B16-28.202)
Can a pharmacy permit be transferred?
No. At sale of pharmacy, a new application must be filed for a permit.
(64B16-28.2021)
Does a change in the company/person who leases the building for the permit constitute a change in ownership?
No
(64B16-28.2021)
If a large corporation has the permit, but then transfers all stock of the corporation to another person or entity, does that constitute a change in ownership?
It depends.
It does not constitute a change in ownership as long as the initial corporation continues to exist
(64B16-28.2021)
What information must transferor pharmacy provide to Board upon change of ownership?
1) Name, address, permit # and DEA # of transferor pharmacy
2) Name, address, permt#, DEA# and authorized business activity of transferee
3) Date of transfer
4) Complete inventory of medicinal drugs
5) Exact count of C-II (need 222 to transfer), and estimates of C-III to C-V (unless in bottles >1000, then exact count)
6)Both pharmacies will have a copy of the inventory for records
(64B16-28.203)
What are the duties of consultant pharmacist at an institutional pharmacy?
1) To ensure compliance with laws and rules governing permit
2) Drug use review, inspect facility and do written report for class I, modified class II or Special ALF (min monthly)
3) Monitor facility system monthly for MARs and physician order sheets to ensure that the most current record of meds are available for review
(64B16-28.501)
What needs to be on the label for drug containers of inpatients in Class I institutional facilities?
1) Name and address of pharmacy
2) Prescriber name
3) Patient name
4) Fill date
5) Rx#
6) Directions for use
7) Name of medicinal drug (unless prescriber wants it witheld)
(64B16-28.502)
Definition of a vendor pharmacy
Pharmacy contracted to dispense drugs to a patient in a Class I or Modified Class II institution.
(64B16-28.503)
Definition of starter dose pharmacy
Pharmacy that dispense a starter dose to patient served by a vendor pharmacy (64B16-28.503)
When can a starter dose pharmacy dispense a starter dose?
1) When has written contract with vendor pharmacy
2) Maintains a record of each starter dose prescription
3) Maintains a policy and procedure manual that includes a starter dose prescription
4) record for each starter dose prescription shall be readily retrievable for 2 yrs
(64B16-28.503)
What are the dispensing requirements in a Class II institutional pharmacy?
1) can only be taken from original container and prepared by registered pharmacist
2) Only single doses shalle be removed from container once prescribed and recorded
3) A single dose of a prescription may also be obtained and administered under the suprevision of a nurse in charge
(64B16-28.602)
What are the requirements for Class II institutional pharmacy to contract with Special patenteral//enteral extended scope pharmacies?
1) Policy and procedure manual (sort out duties and responsibilities)
2) Institutional pharmacy should make sure that Special pharmacy is licensed
3) Provisions: institutional pharmacy must maintain appropriate records, inspect & log all drugs provided and pharmacists for institutionshall provide DUR and revies eash RX prior to transmission
(64B16-28.602)
What do licensed individuals have to do to dispense from the ER?
1) Need Class II permit
2) Meet dispensing and labeling requirements
3) Maintain records: patient name & address, drug, stregth, quantity, directions, prescriber, DEA, and reason why community pharmacy not accessible
(64B16-28.6021)
What are the activities which consititute remote medical order processing (RMOP) in Class II institutional pharmacy?
1) Receiving, interpreting or clarifying medication orders
2) Entering/transferring medication order data
3) Prospective DUR
4) Obtaining substitution authorizations
5) Interpreting and acting on clinnical data
6) Performing terapuetic interventions
7) Providing drug information
8) Authroizing release of a medication for administration
(64B16-28.606)
What are the general requirements of remote order processing for a CLass II institutional pharmacy from a remote location?
1) Pharmacists have to licensed in FL
2) Need sufficient patient info for: prosepctive DUR< approval of med orders.
3) Written contract with pharmacist or entity employing pharmacist (if not an employee of institutional pharamcy)
(64B16-28.606)
In Florida, are pharmacists explicitly protected from liability by conscience clause?
Yes/No. We are the other person, in: The provisions of this section shall not be interpreted so as to prevent a physician or other person from refusing to furnish any contraceptive or family planning service, supplies, or information for medical or religious reasons; and the physician or other person shall not be held liable for such refusal
What are some examples of a Modified Class I intstutional pharmacy?
They are institutional pharmacies which provide specialized pharmacy service restricted in scope or practice and designed to provide certian helath care pharmacy services that are generally not obtainanable from other pharmacies.
Primar alcoholism treatment center, free-standing emergency rooms, rapid in/out surgical centers, certain county health programs and correctional institutions
What is a type A modified Class II pharmacy?
Type “A” Modified Class II Institutional Pharmacies provide pharmacy services in a facility which has a formulary of not more than 15 medicinal drugs, excluding those medicinal drugs contained in an emergency box, and in which the medicinal drugs are stored in bulk and in which the consultant pharmacist shall provide on-site consultations not less than once every month, unless otherwise directed by the Board after review of the policy and procedure manual.
What is a type C Modified CLass II institutional pharmacy?
Type “C” Modified Class II Institutional Pharmacies provide pharmacy services in a facility in which medicinal drugs are stored in the facility in patient specific form and which has an expanded drug formulary, and in which the consultant pharmacist shall provide on-site consultations not less than once per month, unless otherwise directed by the Board after review of the policy and procedure manual.
What are the requiremendt for the policy and procedures manual for Modified Class II institutional pharmacies?
1) Specific drugs and strengths sotred
2) Committtee that meets once a yr
3) Emergency box can be used and logs for recordkeepign
4) Security
5) Proof of use forms for all drugs
6) Diagram of facilit, storage and security
7) Maintain records (2 yrs)
8) if type c: provisions for a MAR
Why would someone get a limited-commmunity permit?
To dispense meds to:
1) Empolyees/staff/etc for personal use
2) Patients in hospital (For <3 day supply)
2) Patients in ER
(64B16-28.810)
Who/What can you dispense to if you obtaina a closed system pharmacy permit?
1) Consumer
2) Nursing Homes
3) Correctional facility
4) Adult congregate living facility
5) Immediate care for mentally disabled
(64B16-28.830)
What must you do to obtain a special pharmacy permit?
1) Application to Department
2) Pay Fee
3) Have policy and procedure manual that will outline type of services provided
4) Be subject to inspection
(64B16-28.800)
What are the general requirements for sterile products and partenteral/enteral compounding pharmacies?
1) Supercision of a pharmacist
2) Provide special handling of patenteral products
3) Profile for each patient
4) Poilcy and procedure manual
5) Certified laminar flow hood
6) Protective garb
7) Asepic procedures
8) Proper disposal
(64B16-28.820)
What are the minimum equipment requirements for sterile and pareteral/enteral pharmacy?
1) space: clean and enough
2) equipment: laminar hood (horzontal and vertical), refrdigerator, freezer, sink and wach area, and appropriate waste containers
3) Supplies: gloves, masks, gowns, needles, syringes, disinfectants, clean towels, handwashing stuff, vacuum containers, and spiil kits
What are the provisions for a special-closed system pharamcy permit?
1) Policy and procedure manual
2) Provide 24 hr emergency and on-call service
3) Supervision of rx dept manager (responsible for drug records, security and other rules)
4) Use of interns and technicians
(64B16-28.830)
What are the requirements for a special- non-resident pharmacy?
1) Rx dept manager: must be licensed in state of location
2) Changes of location, officers and dept managers must be reported to the board
3) Regular hrs of operation: 6 days/kw, min 40 hrs
4) Toll-free telephone # for patients
5) Can make a one-time delivery without a permit to a patient in FL
(64B16-28.840)
What medications can be delivered and distributed by ESRD pharmacies?
1) Saline solutions
2) Heparin: porcine and beef
3) Dextrose solutions
4) Doxercalciferol
5) Epoietin alfa
6) NaCl injection 50mEq/20mL
7) Levocarnitine
8) Lidocaine
9) Vitamin preparations (dialysate only)
10)Paricalcitrol
11) Peritoneal dialysate solutions
12) Protamine sulfate
13) Potassium 20mEq/10mL
14) Sodium ferric gluconate complex
15) Sterile water for injection
16) Hemodialysis solutions
17) Bloodlines and associated connectology
18) Peritoneal dialysis tubing and connectology
(64B16-28.850)