Florida MPJE 2022
KNOW ALL OF THESE!!: Terms and conditions to be followed by a pharmacist when ordering and dispensing from pharmacist formulary
"34 pregnant directors in FL advised for 4 injected prescriptions in pt profiles" - this makes no sense but it encompassess all of the requirements so pls remember it <3 - NO injectable drugs - NO drugs for pregnant or nursing mothers - Max Qty 34-day supply or standard course of treatment - Advise pts to seek advice of appropriate provider if their condition does not improve upon completion of regimen - Directions for use CANNOT EXCEED manufacturer's recommended dosage - Can only be performed in a FL permitted pharmacy - Pharmacist MUST create an Rx - Pharmacist MUST maintain a pt profile separate from rx order, and date & initial all profile entries ----> Such profiles shall be maintained for 4 years ----> Required information to be in patient profile includes: medical history, current complaint, drug ordered, etc.
NEED TO KNOW: What should the valid prescription that the prescriber provides the pharmacy with following an emergency telephone C2 rx be marked with?
"Authorization for Emergency Dispensing"
Manufacturer label requirement for animal prescription drug product
"Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian"
When can you not fill out the PSE logbook?
"Convenience" packaging of less than 60 mg of PSE
USP 800 requires that each entity have a ______ to be responsible for developing and implementing HD handling procedures.
"Designated Person" - not required to be a pharmacist by USP - not required to be a manager - May have responsibility for >1 location
Kefauver-Harris Amendment of 1962
"Drug Efficacy Amendment" New drugs must be SAFE AND EFFICACIOUS Established GMPs FDA oversees prescription drug advertising
Controlled substance dispenser registrations start with what letters?
"FAB" F A B - or G for department of defense contractors
OTC Drugs for Minor Sore Throat warning statement
"For temporary relief of minor sore throat" "Warning- Severe or persistent sore throat or sore throat accompanied by fever, headache, nausea, and vomiting may be serious. Consult physician promptly. Do not use more than 2 days or administer to children under the age of 3 unless directed by a physician"
KNOW THIS: HAS BEEN ASKED ON OTHERS' EXAMS: Non-prescription drugs that require child-resistant containers under the PPPA of 1970
"Little MANIC MILKMAID Died from the Flu" - Lidocaine - if containing >5mg in a single package (ALL dosage forms, NOT just oral like the others) - Methyl salicylate (oil of wintergreen) - liquid containing >5% by weight of this ingredient unless packaged in pressurized spray containers - ASA - Naproxen - if containing >250mg in a single package - Iron-containing drugs - except animal feeds used as vehicles for drug administration, noninjectable animal and human drugs providing iron for therapeutic or ppx purposes, which contain total amount of 250mg elemental iron - Dietary supplements containing iron - w/ exception of ones where iron present solely as colorant, dietary supplements containing 250mg or more of elemental iron in a single package - Controlled drugs - Methyl alcohol (methanol) - liquid containing >4% by weight of this ingredient unless packaged in pressurized spray containers - Ibuprofen - if containing >1g in a single package - Loperamide - if containing >0.045 mg in a single package - Ketoprofen - if containing >50mg in a single package - Minoxidil - if containing >14mg in a single package (including topical) - APAP - if containing >1g of APAP in a single package; see diff slide for exemptions - Imidazolines - if containing >0.08 mg in a single package (these include tetrahydrozoline, naphazoline, oxymetazoline, xylometazoline - all often found in ophthalmic and nasal products) - Diphenhydramine HCl - >66mg of diphenhydramine base in a single package - Dibucaine - if containing >0.5 mg in a single package (ALL dosage forms) - Fluoride - if containing >50 mg elemental fluoride and >0.5% fluoride in a single package - and ANY drug switched from Rx to OTC status
What must be written on a written prescription by a prescriber to prohibit generic substitution of a drug?
"MEDICALLY NECESSARY"
What must be written on a prescription to dispense brand only?
"Medically necessary" May also be verbal or electronic
What schedule is phendimetrazine?
"Phen-di-met" = 3 syllables before last part = C3 C-III
Aspartame warning statement
"Phenylketonurics: Contains phenylalanine ___ mg per dosage unit"
What sign must be placed when the prescription department is closed?
"Prescription Department Closed" At least 2 inches width/height Bold In a prominent place
OTC spermicides with nonoxynol 9 and vaginal contraceptive warning statement
"STD Alert: This product does not protect against HIV/AIDS or other STDs and may increase risk of getting HIV from an infected partner"
KNOW THIS!!!! Which drugs are on the negative formulary?
"Theo Digs Diced Pancakes Containing Chlorine" 1. Theophylline (controlled release) 2. Digitoxin 3. Dicumarol 4. Pancrelipase (oral dosage form) 5. Conjugated Estrogens 6. Chlorpromazine (solid oral dosage forms)
Drug Supply Chain Security Act (DSCSA)
"Track and Trace Amendment" - Uniform national framework for an electronic track-and-trace system for rx drugs as they move through the supply chain & sets national standards for states to license drug wholesaler distributors - Applies to Rx drugs for human use in finished dosage form - Does NOT apply to blood/blood components, radioactive drugs, imaging drugs, some IV products for fluid replacements, dialysis solutions, medical gases, compounded drugs, medical convenience kits containing drugs, certain combination products, sterile water, and products for irrigation - Manufacturers have to provide transaction data for each product sold
OTC products containing which ingredients require special labeling requirements under federal regulations and in the FDCA?
"WIMPY ASSASSIN PAIN" - youre a wimpy assassin in pain if you take any of these OTC ingredients and dont read the label - Wintergreen Oil - Isoproterenol inhalation preparations - Mineral oil - Potassium Salt preparations for oral ingestions - FD&C Yellow No. 5 (tartrazine) and No. 6 - Aspartame - Sulfites - Sodium Phosphates - Alcohol Warning - Salicylates - OTC Drugs for Minor Sore Throats - Ipecac Syrup - OTC drugs for vaginal contraceptive and spermicide use containing nonoxynol 9 as the active ingredient - Phenacetin (acetophenetidin) - OTC products containing iron in solid oral dosage form - OTC pain relievers (APAP & NSAIDs)
What is required on the Drug Facts Panel on OTC drugs?
"Walruses Question People's AUDIO" - im aware this makes no sense Active ingredients Purpose Use(s) - indications Warnings Directions Other necessary information Inactive ingredients (alphabetical order) Questions? (Optional) followed w/ telephone number
A "qualifying practitioner" authorized to prescribe under DATA can apply for a DATA 2000 waiver which will provide the practitioner with an identification or _____ code that must be included with their DEA number.
"X"
What schedule is phenmetrazine?
"phen-met" = 2 syllables before last part = C2 C-II
FD&C Yellow No. 5 (tartrazine) warning statement
"precautions" for allergic reactions in susceptible persons
A pharmacist may not enter into an immunization protocol with a physician unless he or she maintains at least _________ of professional liability insurance.
$200,000 - not required for interns working under a pharmacist
Certified optometrists topical ocular pharmaceutical formulary
*Pg 118-121 of book* Cycloplegic and Mydriatics: - Atropine sulfate 1% (soln & ointment) - Phenylephrine HCl 2.5% - Cyclopentolate HCl 1% - Scopolamine hydrobromide 0.25% - Homatropine hydrobromide 5% - Tropicamide 1% - Hydroxyamphetamine hydrobromide 1% (in combination) Local Anesthetics - Tetracaine 0.5% - Proparacaine HCl 0.5% - Benoxinate HCl 0.4% (w/ fluorescein) - Lidocaine HCl ophthalmic gel or soln 4% Diagnostic Products - Fluorescein paper strips - 9mg/strip - Lissamine Green - 1.5mg/strip - Rose bengal - 1.3mg/strip - Phenol red thread - Schirmer test strips - Hypromellose ophthalmic demulcent soln 2.5% Antibacterial - Erythromycin 0.5% - Bacitracin 500 U/g (ointment alone & in combination) - Polymyxin 10,000 U/g (only in combo) - Neomycin 3.5 mg/g (only in combo) - honestly... this list is way to effing long sorry not sorry im not doing it NSAIDS Antihistamines, mast cell stabilizers, and anti-allergy agents Antiviral agents Antiglaucoma agents Misc drugs
What must the supplier fill out on DEA Form 222?
- # of containers furnished for each ordered item - Date the products are shipped to purchaser - DEA number of supplier, only if purchaser left it off of the form
What must the purchaser record on DEA Form 222 when the product has been received?
- # of containers received - Date received for each item on the copy of the DEA Form 222 they made when ordering the product
What items need to be included on the DEA Form 222?
- # of lines completed - Name & Address of supplier from whom the controlled substances are being ordered - Signature (written or electronic) by the registrant (individual, partner, or officer) or by the person authorized to execute the form (via POA)
KNOW: With pressure gradients, the buffer room (where the hood is placed) must be _____ more positive than the anteroom, which must be _____ more positive than the general area it opens into.
- 0.020" for both
What is required in order for a pharmacist to serve as a consultant pharmacist preceptor?
- 1 year of experience as a consultant pharmacist - Must be a consultant pharmacist of record at a institutional pharmacy - Can not precept more than 2 applicants
Renewal requirements to order lab tests under physician authorization
- 1hr CE
The second letter of dispenser registration prefixes will normally be ______ for individual practitioners, or _______ for pharmacies or hospitals.
- 1st letter of practitioner's LAST name - 1st letter of pharmacy or hospital's name
KNOW!!! Additional licensure requirements for nuclear pharmacists
- 200h didactic training from accredited college of pharmacy or other recognized program on specified radiopharmaceutical topics - 500h of radiopharmacy internship - If above requirements were not completed within last 7 years, the applicant must have been engaged in practice of nuclear pharmacy in another jurisdiction for at least 1080h in the last 7 years
Pseudoephedrine retail sales limits
- 3.6g/day - 9g/30 days
Pharmacist requirements to order lab tests by physician authorization
- 3hr CE course - Physician authorization
How long must records be maintained for all automated medication systems?
- 60 days for daily audits and transactions for all non-controlled substances - 4 years for any report or analysis that is part of the quality assurance program; any report or database related to access to the system or any change in access to the system, or medication in the system, and transaction records for all controlled substances
What is a positive formulary in a community pharmacy?
- A formulary of generic and brand name drugs that if substituted would NOT pose a threat to the health and safety of patients - Shall be made available to the public, BOP, or any physician requesting it
Animal Control Shelter Permit
- A modified Class II Institutional permit, but a consultant pharmacist is NOT required - Must have DEA registration - May only stock sodium pentobarbital and sodium pentobarbital w/ lidocaine, tiletamine HCl alone or in combo w/ zolazepam, zylazine, ketamine, acepromazine maleate, acetylpromazine or in combo w/ etorphine, and yohimbine HCl alone or in combo w/ atipamezole, for euthanization or chemical immobilization of animals within their lawful possession Yellow = also human drugs, the rest are vet drugs hence why ive never seen them before in my life
OTC Products Containing Iron in Solid Oral Dosage Form warning statement
- Accidental overdose is leading cause of fatal poisoning in children <6, keep out of reach of children - Warning also applies to iron-containing dietary supplements
What are some drugs that require medication guides?
- Accutane (isotretinoin) - Antidepressants in children & teenagers - Coumadin (warfarin sodium) - Epogen (epoetin alfa) - Forteo (teriparatide, rDNA origin) - Lindane shampoo and lotion - Lotronex (alosetron hydrochloride) - Nolvadex (tamoxifen) - NSAIDs - Remicade (infliximab) - Trizivar (abacavir sulfate/lamivudine/zidovudine) - Opioid analgesics and cough products - BZDs
Who is exempt from reporting to the PDMP?
- All acts of administration - Dispensing of controlled substance in healthcare system of the Department of Corrections - Dispensing to pt <16 yo - Pharmacies and registered dispensing practitioners that don't dispense controlled drugs in or into this state
What are the requirements for patient records in florida?
- All pharmacies must have a patient record system that provides for immediate retrieval of information necessary for the dispensing pharmacist to identify previously dispensed drug - Pharmacist must make a reasonable effort to obtain, record, and maintain the following info: (a) Name of pt (b) Address & Phone # of pt (c) Age OR DOB of pt (d) Gender (e) List of new and refill rx's obtained by pt at pharmacy during previous 4 years (f) Pharmacist's comments relevant to the pt's drug therapy - Pharmacist shall ensure that a reasonable effort is made to obtain allergies, drug rxns, idiosyncrasies, and chronic conditions/disease states and identity of any other drugs (including OTC drugs/devices) used by pt - must also record these - Records shall be maintained for 4 years from date of last entry
Function of a PCP for DTM
- Any act or service by a pharmacist in compliance w/ orders in a Prescriber Care Plan (PCP) - May include individualized assessment and orders for specific drugs, lab tests, and other pharmaceutical services, interpreting lab values ordered for a pt, executing drug therapy orders for a pt, and notifying the prescriber
What can designated agents do in regards to calling in controlled prescriptions?
- Are employees or nonemployees of prescriber - Can communicate an Rx for a C3-5 drug but CANNOT authorize or prescribe - Prescriber must formally write an appointment of the designated agent if they are not an employee of the physician (i.e., nursing home nurse calling in rx on behalf of Dr)
KNOW: What are the space and equipment requirements for nuclear pharmacies?
- Area for storage, compounding, distribution, and disposal of radiopharmaceuticals shall be adequate to completely separate such radioactive pharmaceuticals from non-radioactive drugs - The hot lab, storage area, and compounding and dispensing area must be a minimum of 150 sqft - Must have specified equipment (specified in the rule)
KNOW: What chronic health conditions can be treated under a CPPA?
- Arthritis - Asthma - COPD - T2DM - HIV/AIDS - Obesity And any other chronic health condition adopted in rule by the BOP, which include: - Hyperlipidemia - HTN - Anticoagulation management - Smoking cessation/ Nicotine dependence - Opioid use disorder
What requirements must be met for a pharmacist to serve as a consultant pharmacist preceptor?
- Be a consultant pharmacist of record at an institutional pharmacy - Have 1+ years experience as a consultant pharmacist of record - Only precept a max of 2 applicants at a time
KNOW: How often must PEC surfaces be cleaned?
- Beginning of each shift - Before each batch - Q30 mins DURING compounding - After spills - When surface contamination is known or suspected
NEED TO KNOW: Components of counterfeit Rx pad
- Blue or green background that resists reproduction - Must be printed on artificial water-marked paper - Must resist erasures and alterations - The word "void" or "illegal" must appear on any photocopy or other reproduction of the pad or blank - Rx must contain specific info, including a unique tracking ID number for each order on the front of the counterfeit-proof rx pad or blank
What may psychiatric nurses prescribe?
- CII psychiatric meds for >7 day supply - Controlled psychiatric meds for <18 yo
Renewal requirements for chronic care management under a CPA
- CPA certification - 8hr CE per license cycle
NEED TO KNOW: What can the pharmacist do if the person picking up a controlled Rx does not have any form of ID with them?
- Call prescriber or their agent to verify validity of rx and identity of pt - Verify health plan eligibility through real-time inquiry or adjudication system
Test & Treat Protocol Functions
- Can test & treat minor "nonchronic" health conditions - Test or screen for & treat minor using drug formulary (per FBOP) and outlined in TTP - No controlled substances - CLIA waived and other safely performed tests - Provide written notice to pt to seek follow-up care from PCP
KNOW! What are the laws for the sales of dextromethorphan?
- Can't sell to anyone <18 (if no Rx for the drug, if Rx can sell to any age) - If selling any quantity of this drug OTC, must obtain proof of age from purchaser prior to sale, unless they look to be >25 years old
The NIOSH list comprises drugs that are hazardous to healthcare workers which include
- Carcinogens - Genotoxins - Teratogens - Reproductive toxins - Cause organ toxicity at low doses *DIFFERENT FROM Environmental Protection Agency (EPA) LIST (which are hazardous materials to the environment)*
Pharmacist requirements to enter into a Test & Treat Protocol (TTP)
- Certification - 20h CE Course for Test & Treat
Pharmacist requirements to enter into a CPA for chronic care management
- Certification - 20hr CPA CE course
Documentation of pharmacy technicians having received training in all required areas must be one of the following
- Certification of the supervising licensee (i.e., pharmacist) - Certification by an instructor, trainer, or other similar person - Training attendance logs or completion certificates accompanied by an outline of the material addressed - Exam or written questionnaires
KNOW: What is the ONLY exception to the rule that drugs cannot be returned to stock after being dispensed to a patient? What type of drugs does this apply to?
- Closed drug delivery systems - Non-controlled drugs only
Compounding isolator examples
- Compounding aseptic isolators (CAIs) - Compounding aseptic containment isolators (CACIs)
Pharmacist requirements to enter into a Collaborative Practice Agreement
- Consultant pharmacist (CP) Licensure - 20hr CE course - $200k liability insurance
Rules for Authorized Collectors (only some bc too many)
- Controlled can be mixed w/ non-controlled - Only patients are permitted to place the controlled substance into the receptacle, nobody else can handle it - LTCF staff can dispose of a pt's controlled med into an authorized collection receptacle within 3 business days after D/C of the med by the patient - Collection receptacles must be in immediate proximity (where they can be seen) of where controlled substances are stored (the pharmacy) - Collection receptacles must be securely fastened to a permanent structure, locked, and securely constructed w/ a permanent outer container and removable inner liner - Inner liner must be: waterproof, tamper-evident, removable, sealable immediately upon removal w/ no emptying or touching of contents or ability to see them; must also have permanent unique identification # that allows tracking - Inner liner must be removed by or under supervision of at least 2 employees of the authorized collector - Collectors can destroy the meds in any of the other ways we talked about a few slides ago or by contacting the DEA special agent in charge for assistance; ---> if doing DEA Form 41, would fill out section 2 as this is for collected substances and it requires the unique identification # of the inner liner from the receptacle or the mail-back package
KNOW: What does the Probable Cause Panel receive from the Department?
- Copy of the Department's complete investigative file - Any expert opinions obtained by the Department - Subject's response to the complaint (if submitted)
KNOW: What is required to be in the prescription department of each pharmacy?
- Current pharmacy reference compendium (ex: USP/NF, USD, USPDI, Remington's Science and PRactice of Pharmacy, Facts and Comparisons, or equivalent) - Current copy of the laws and rules governing the practice of pharmacy - The library requirements (from 1st bullet) may be maintained in a readily available electronic format
What is required to be documented in the compounding recordbook?
- Date of compounding - Control number for each batch - Complete formula of compounded product - Signature/Initials of compounder and person who checked it - Manufacturers of ingredients - Quantity of ingredients - Package size and number of units prepared - Name of patient who received the product
Which OTC products do not require tamper-evident packaging?
- Dermatological drugs - Dentifrice - Insulin - Lozenge products
For centralized prescription filling between an originating pharmacy and a central pharmacy, what information must be included in the policy and procedure manual for each pharmacy?
- Description of how each pharmacy will comply with federal and state laws, rules, adn regulations - Procedure for maintaining appropriate records to identify the pharmacist responsible for dispensing the rx and counseling the pt - Procedures for tracking the Rx during each stage of filling and dispensing - Procedure for identifying on the rx label all pharmacies involved in filling and dispensing the rx - Policies and procedures for providing adequate security to protect the confidentiality and integrity of patient information - Procedure for implementing and operating a quality assurance program - Types of meds that may and may not be filled by the central pharmacy - Procedures for securely transporting the filled rx's from the central fill pharmacy to the originating pharmacy - Specific services provided and duties and responsibilities of each pharmacy this is so boring i want to DIE
KNOW: Labeling of CSPs must include
- Drug name - Drug strength/ concentration - Total volume - BUD - Route of administration - Storage conditions
KNOW: What is the Cancer Drug Donation Program that is under the FFDCA?
- Established to facilitate donation of cancer drugs and supplied to eligible pts - Includes drugs to treat cancer + its side effects, but does NOT include any controlled substances
Orders for which two drugs must contain DEA 222 forms with only orders for those drugs?
- Etorphine hydrochloride - Diprenorphine
NEED TO KNOW: What records are not permitted to be kept with central records?
- Executed (completed) DEA order forms (Copy 3 of DEA Form 222 or the copy made by pharmacy of a single copy DEA Form 222) - Prescriptions - Inventories all of these must be kept AT PHARMACY
Federal agencies that promulgate USP
- FDA - Centers for Medicare and Medicaid Services (CMS)
When is remote medication order processing permitted?
- FL licensed pharmacist - Pharmacist must have access to sufficient patient information necessary to perform prospective drug use review and approval of med orders
NEED TO KNOW: What requirements must be met of the 2 "consumer members" to be considered for a position on the FBOP?
- FL resident - Never a licensed pharmacist - No connection to pharmacy at all - No connection to drug manufacturers or wholesalers
NEED TO KNOW: What requirements must be met as a pharmacist to be considered for a position on the Florida Board of Pharmacy?
- FL residents - Practicing pharmacy in FL for at least 4 years
KNOW: Who determines the contents of an Emergency Medication Kit in nursing homes?
- Facility's medical director AND - Director of nursing AND - Consultant pharmacist
Under the automated distribution and packaging rule, under what circumstances does a pharmacist NOT have to perform prospective drug use review and approve EACH medication order prior to administration?
- For an override medication - For a low-risk override medication - For a physician-controlled medication
Modified Class II Institutional Pharmacy Permit
- For institutional pharmacies in short-term, primary care tx centers that meet all the requirements for a Class II permit, except space and equipment requirements - Typically don't have a full-time pharmacist on duty & drugs are administered to pts on the premises; no outpatient dispensing is permitted - Required to have a consultant pharmacist provide on-site consultations at least once monthly - Must have policy/procedure manual w/ specific required info (definitive info on drugs and strengths to be stocked) - May contract w/ special parenteral/enteral extended scope pharmacy for services - Must have a Pharmacy Services Committee that meets at least annually Examples: - Primary alcoholism treatment centers - Free-standing ERs - Rapid in/out surgical centers - Certain county health programs - Correctional institutions
What is a negative formulary in a community pharmacy?
- Formulary developed by BOP and BOM that demonstrates clinically significant biological or therapeutic inequivalence which may NOT be substituted
KNOW: For licensure by examination, if the individual is not a recipient of a degree from an accredited school or college of pharmacy in the US, what requirements must they meet in its place?
- Graduated from a school or college of pharmacy outside the US - Passed TOEFL, TSE, & FPGEE - Have 500 hours of supervised work activity program
Locations that collaborative practice agreements (CPA) are permitted
- Healthcare facility - Hospice inpatient - Ambulatory care center
KNOW: What requirements must a pharmacist meet in order to become certified under a CPPA?
- Hold active and unencumbered pharmacy license in this state - Have earned PharmD or completed 5 years of experience as RPh - Have completed initial 20h course approved by BOP in consultation w/ BOM, that include instruction on the following: (1) Performance of patient assessments (2) Ordering, performing, and interpreting clinical laboratory tests related to collaborative pharmacy practice (3) Evaluating and managing diseases and health conditions in collaboration w/ other healthcare practitioners (4) Any other area required by the board, including: (i) Applicable laws and rules (ii) Writing and entering into a CPA (iii) >/= 8h of course must be LIVE (iv) Pharmacists who successfully complete certification are awarded 20h of general CE credits (v) Course may be provided by a provider accredited by ACPE, a program provider accredited to provide educational activities designated for the American Medical Association Physician's Recognition Award Category I credit, or approved by AOA to offer medical CE credits - Maintain at least $250,000 of professional liability insurance coverage - File an application for Pharmacist Collaborative Practice Certification available on the Board's website - Have an established system to maintain records of all pts receiving services under a CPPA for a period of 5 years from each pt's most recent provision of service
KNOW: Requirements for a pharmacist to test and treat under the test/treat legislation
- Hold an active and unencumbered license to practice pharmacy in this state - Hold a certification issued by the board to test and screen for and treat minor, nonchronic health conditions in accordance w/ requirements established by the board in rule in consultation w/ BOM/BoM (can apply on board's website) (1) Requires one-time 20h CE (2) Must address pt assessments, POC testing procedures, safe/effective tx for such conditions, and identification of contraindications (3) Additionally, must include: (i) Applicable laws and rules (ii) Writing/entering into a written protocol (iii) >/= 8h of course must be LIVE (iv) Completion of course awards 20h of general CE (v) Provided by accredited ppl in ACPE or AOA - Maintain at least $250,000 of liability coverage
KNOW THIS: PECs must meet specific criteria, including maintenance of an ISO ____ classification, have _____directional airflow, and meet other requirements listed in USP 797.
- ISO 5 - Unidirectional
When must the BOP and BOM remove a drug from the negative formulary?
- If every commercially marketed equivalent of the drug has an "A" rating in the FDA Orange Book
KNOW: When can a pharmacist provide DTM under a prescriber care plan?
- Incidental to dispensing - As part of consulting on therapeutic values of drugs - As part of managing/monitoring a pt's drug therapy
KNOW: What conditions are included in the Test and Treat legislation for minor, nonchronic health conditions?
- Influenza - Streptococcus - Lice - Skin condition, such as ringworm and athlete's foot - Minor, uncomplicated infections
Per USP 800, surface wipe sampling should be done routinely to ensure that cleaning procedures are effective in removing remaining HD residues after handling or compounding. The sampling should include...
- Inside surface of the C-PEC & any equipment contained in it - Pass-through chambers - Staging surfaces - Areas adjacent to the C-PEC - Areas immediately outside the buffer room or C-SEC - Patient administration areas
Traditional types of PECs
- Laminar airflow workbenches (LAFWs) - Biological safety cabinets (BSCs)
KNOW: What is inactive status and how can this be reactivated?
- Licensees can request to be placed on inactive status at time of renewal but must still pay an inactive license renewal fee - Reactivate by meeting required CE hours and paying a reactivation fee
Under Florida law, who can legally prescribe controlled substances with a valid DEA registration number?
- MD/DOs - Dentists - Podiatrists - Veterinarians - Certified optometrists (limited to only 2: tramadol and apap/codeine no3) - PA's (w/ certain circumstances) - APRNs (w/ certain circumstances) - Psychiatric nurses
All community pharmacies must have a prescription department manager (PDM) who is responsible for what?
- Maintaining all drug records - Providing for the security of the prescription department - Ensuring the pharmacy's compliance w/ all statutes and rules
Which activities require separate DEA registrations?
- Manufacturing (CI-CV) - Distributing (CI-CV) - Reverse distributing (CI-CV) - Dispensing (CII-CV) - includes prescribing and administering by practitioners and dispensing by pharmacies - Conducting research (CI) - Conducting research (CII-CV) - Conducting narcotic treatment program (CII-CV) - Conducting chemical analysis (CI-CV) - Importing (CI-CV) - Exporting (CI-CV)
What are additional requirements listed under FL law for emergency refills?
- May be provided if the interruption of therapy might reasonably produce undesirable health consequences or may cause physical or mental discomfort (in the pharmacist's professional judgment) - Dispensing pharmacist creates a written order containing all the information required on an rx and signs that order - The dispensing pharmacist notifies the prescriber of the emergency dispensing within a reasonable time after such dispensing
Licensure by endorsement requirements
- Meet age, internship, and education requirements - Passing NAPLEX & FL MPJE scores ----> successful MPJE scores may be used upon reapplication only if completed within 3 years of reapplying - Evidence of: ---> being licensed and practicing pharmacy in another jurisdiction for at least 2 of the immediately preceding 5 years, or ---> submit evidence of successful completion of board-approved post-grad training or board-approved clinical competency examination within the year preceding application, or ---> have completed internship requirements within the preceding 2 years - If licensed in diff state for >2 years, submit proof of 30 hrs of CE for the 2 years preceding application - Can't be under investigation in any state or have had a license suspended or revoked in any state or currently be subject to discipline in any state
NEED TO KNOW: What are some requirements of written controlled substance prescriptions?
- Must be manually signed by practitioner and dated on the date issued - Must be written on a counterfeit-proof rx pad obtained from a vendor approved by the Florida DOH - May NOT be issued on same rx blank w/ an Rx for a non-controlled substance or a controlled in a different schedule - Must contain all required information (see diff slide)
What are USP 800 requirements for chemotherapy gowns?
- Must close in back - Must be disposable - Must resist permeability to HDs - Must be changed per manufacturer's info for permeation of the gown, or every 2-3 hrs if not specified - Must be changed immediately after a splash or spill - If worn in HD handling areas, may not be worn in other areas of a facility
What are consultant pharmacist of record rules for all institutional pharmacies?
- Must have a licensed pharmacist designated as consultant pharmacist of record - BOP must be notified of a change in this person within 10 days of change - This person must conduct Drug Regiment Review, inspect the facility, and prepare a written report to be filed at the facility at least MONTHLY - This person may access a facility or the pharmacy's electronic database remotely
KNOW: Requirements for community pharmacies for patient counseling
- Must have a private consultation area designated w/ a sign - Must provide a verbal AND printed offer to counsel for every new or refill rx - If rx delivered outside of pharmacy, offer to counsel shall be in WRITING and shall provide for toll-free telephone access to pharmacist - If pt does NOT refuse counseling, pharmacist shall review pt's record and discuss matters that will enhance or optimize drug therapy - not required for inpatients or institutions where licensed healthcare practitioners are authorized to administer drugs (nursing homes, etc) - Not required when pt or pt's agent refuses consultation
Unit dose labeling requirements
- Name - Strength - Dosage form - Manufacturer - Expiration
What must be included on DEA Form 41?
- Name of drug - NDC number - Strength - Dosage form - Package size - Quantity being destroyed - Method by which drugs were destroyed - Signature of 2 employees who witnessed the destruction
NEED TO KNOW: What must be written in the pseudoephedrine logbook for recordkeeping?
- Name of product - Qty sold - Name & Address of purchaser - Date & Time of sale
What are the label requirements for compounded drugs?
- Name, address, and phone number of the pharmacy - Name and strength of compound - Active ingredients with strength - Lot number - BUD - Quantity/amount - Ancillary instructions (Storage, hazards, warnings, etc.) - "For Office Use Only" if not patient specific - "Compounded Drug" if from a vet
KNOW!!: What should be included on the prescription label for centralized prescription filling between an originating and central fill pharmacy?
- Names of both central fill + originating pharmacy - Name & address of originating pharmacy - Identification code of central fill pharmacy
KNOW THIS: Under what circumstances can a central fill pharmacy deliver prescriptions directly to a patient?
- Non-controlled substances - Both pharmacies have pharmacist available 40h/wk (in person or via two-way communication technology like phone or whatever) - Toll-free number to provide counseling
When are pharmacists allowed to dispense naloxone?
- Non-patient-specific standing order for an auto-injection delivery system or intranasal application delivery system - Can dispense to emergency responders - Need separate standing order from Dr to dispense to pts, caregivers, or others
KNOW: PPE required for nonsterile or sterile antineoplastic compounding under USP 800
- Nonpermeable gowns - Head & hair covers - Shoe covers - 2 pairs of powderless chemo gloves
What information must be communicated to the patient prior to delivery of a generically substituted drug?
- Notification of any generic substitution - Amount of the price difference - Patient's right to refuse the substitution Must be communicated at a meaningful time to allow pt to make an informed choice regarding substitution Method of communication may be determined by the pharmacist Pharmacist must also inform pt if their cost-sharing obligation (copay) exceeds the retail price of the prescription if they paid cash
KNOW: What are the requirements prior to closing a pharmacy?
- Notify the BOP in writing of date of closure & which permittee will be receiving the Rx files
What are the pharmacist's professional responsibilities under the standards of practice for Orthotics and Pedorthics?
- Ongoing consultation w/ the prescribing physician - Orthotic and/or pedorthic evaluation of the patient - Identification and documentation of precautions, special problems, or contraindications - Development, implementation of, and periodic review of a treatment plan - Collaboration w/ other members of the healthcare team - Advising the patient of the nature of the purpose and nature of the services to be rendered and the techniques for use and care of the devices - Determination of the appropriateness of proper fit and function of the devices
Function of ordering lab tests under physician authorization
- Ordering and evaluating any lab or clinical testing
What are the prescription drug requirements for side effects statements?
- Outpatient pharmacies must distribute a side effect statement for all new and refill prescriptions - Must read "Call your Dr for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088" - Statement can be distributed on a sticker attached to container, on a preprinted rx vial cap, on a separate sheet of paper, or found within consumer medication information (CMI) or med guides
KNOW: If a community pharmacy acts ONLY as a central fill pharmacy and notifies the Board, which requirements can they be exempt from?
- Patient counseling area - Signage requirements - Operating hours
Who must the Power of Attorney (POA) be signed by in order for a registrant to authorize an individual to execute DEA 222 Forms?
- Person granting the power - Person receiving the power (the "attorney-in-fact") - Two witnesses
Who may restock decentralized automated medicaiton systems?
- Pharmacist - Pharmacy intern - Pharmacy tech
KNOW: What additional restrictions are in place for a pharmacist in a CPPA?
- Pharmacist cannot modify or d/c drugs prescribed by a diff prescriber that they're not in a CPPA with - Cannot enter into a CPPA while acting as an employee w/o the written approval of the owner of the pharmacy - Physician cannot delegate the authority to the pharmacist to initiate/prescribe a controlled substance
KNOW: What are the requirements on the day of closing the pharmacy?
- Physically deliver rx files to a pharmacy within reasonable proximity of the pharmacy that is closing - Affix a sign on front entrance of pharmacy advising the public of the new location of the rx files or otherwise provide a means to advise the public of the new location
Functions of chronic care management under CPA
- Physician collaboration on patient care services for all chronic conditions as defined by the CPA - Assessments ,ordering, performing, interpreting labs, evaluation, and managing health conditions - No controlled substances
KNOW: If the institutional pharmacy is closed because there is not a licensed pharmacist present and on duty, who may enter the pharmacy and under what circumstances?
- Physician or charge nurse - Only to obtain a SINGLE DOSE
In addition to a CQI committee that reviews QREs quarterly, what other components must be in the pharmacy's CQI policy/procedure manual?
- Planned process to record, measure, assess, and improve quality of pt care - Procedure reviewing quality-related events
Schedule V Drugs
- Pregabalin - Antitussive products w/ codeine - Antidiarrheal products w/ opium
What must a purchaser do if a completed DEA Form 222 is lost or stolen?
- Prepare another DEA Form 222, PLUS - A statement containing the serial number and date of the lost form, stating that the goods covered by the first order were not received because the form was lost
KNOW: When transferring medicinal drugs and/or changing ownership of a pharmacy (all permit types), what must be done?
- Provide transfer information to BOP - Complete inventory of all controls - Transfer C2 drugs with a DEA 222 form
When can a pharmacy disclose PHI without patient authorization?
- Provide treatment - Normal healthcare operations - Public health activities/gov need - State drug monitoring programs - Law enforcement - Face-face communication with patient - Refill reminders
Only times controlled substances can be prescribed via telehealth
- Psychiatric disorder - Inpatient tx - Hospice - Nursing home pt
USP 800 requires that there be designated areas for
- Receiving and unpacking HDs - Storing HDs - Compounding of nonsterile and sterile preparations
Non-delegable tasks
- Receiving new verbal prescriptions - Receiving any verbal change in med, strength, or directions of an existing prescription - Interpreting an rx or med order for therapeutic acceptability and appropriateness - Conducting the final verification of dosage and directions - Engaging in prospective drug review - Monitoring rx usage - Overriding clinical alerts - Transferring a prescription - Preparing a copy of an rx or reading an rx to any person for purpose of providing reference concerning treatment of the person or animal for whom the rx is written - Patient counseling - Receiving therapy or blood product procedures in a permitted nuclear pharmacy - Engaging in any other act that requires the exercise of a pharmacist's professional judgement
KNOW: What does it mean to elect for your license to be placed on retired status? How can it be reactivated?
- Request the board to go on on retired status and pay the retired status fee and an unlicensed activity fee - Prior to reactivating, must meet all CE requirements for all 2-year periods when the license was retired
What are institutional special pharmacy permits?
- Required for any location where drugs are compounded, dispensed, stored, or sold, but is NOT a community pharmacy, institutional pharmacy, nuclear pharmacy, or internet pharmacy; they provide misc specialized pharmacy services - Won't be issued unless the special pharmacy has a designated licensed pharmacist to undertake supervision of compounding and dispensing of all drugs - Applicants must provide BOP w/ policy/procedure manual that sets forth a detailed description of the type of pharmacy services to be provided
Nonresident Sterile Compounding Outsourcing Facility Permit
- Required for outsourcing facilities located outside of FL to ship, mail, or deliver a sterile compounded product into FL for office use - May also ship/mail/deliver/ dispense a pt-specific compounded sterile product into FL
Nonresident Sterile Compounding Permit
- Required for pharmacies located outside of FL that ship, mail, deliver, or dispense, in any manner, a pt-specific compounded sterile product into FL - All applicants must have a current and satisfactory inspection report
KNOW: Nonresident Pharmacy Permit
- Required for pharmacies located outside of FL that ship, mail, or deliver in any manner, a dispensed medicinal drug into florida - Doesn't allow shipping/mailing/delivering/ dispensing of compounded sterile products into FL - Does NOT have to obtain a permit if it limits dispensing to one time per calendar year in an isolated transaction, which is defined as to a single, identifiable patient in FL
NEED TO KNOW: What CV prescriptions are available over the counter?
- Robitussin AC (small amounts of codeine) - Antidiarrheals containing small amounts of opium
KNOW: For medications dispensed by nuclear pharmacies, the immediate INNER CONTAINER must be labeled with:
- Rx number - Standard radiation symbol - "Caution: Radioactive Material" - Radionuclide + Chemical formula
What is a medguide?
- Similar to PPI but w/ amended requirements for institutionalized pts - Required for all new and refill Rx's dispensed in community setting when: ---> Labeling could prevent serious adverse effects ---> Product has serious risks relative to benefits ---> Patient adherence to directions is crucial - Must be written in a standard format/language suitable for patients - Manufacturers must obtain FDA approval before distributing these & are responsible for ensuring sufficient #s are provided to pharmacies - Over 1,000 products that require medication guides; if a med requires it and it is not provided, med is misbranded
KNOW: What must be included in a written test and treat protocol?
- Specific categories of pts who the pharmacist is authorized to test or screen for and treat such conditions - Physician's instructions for obtaining relevant pt medical hx for the purpose of identifying disqualifying health conditions, adverse rxns, and CIs to the approved course of tx - Physician's instructions for tx of such conditions based on age, symptoms, and test results, including negative results - A process & schedule for the physician to review the pharmacist's actions under the protocol - A process and schedule for the pharmacist to notify the physician of the pt's condition, tests administered, test results, and course of tx
State agencies that promulgate USP
- State boards of pharmacy & health
KNOW: Biological Safety Cabinets (BSCs) and Compounding Aseptic Containment Isolators (CACIs) are used for ______ preparations and must maintain ISO ___ air cleanliness and have ______ airflow.
- Sterile - ISO 5 - Unidirectional
What drugs does DATA 2000 authorize qualifying practitioners to prescribe?
- Subutex (buprenorphine) - Suboxone (buprenorphine/naloxone) (both C3 drugs)
Requirements for renewal of Test & Treat Protocol (TTP)
- T&T certification - 3h CE per license cycle
What nonviable elements must be monitored daily by compounding personnel?
- Temp of compounding areas (should be 20C or lower) - Pressure gradients between rooms (see next slide) - Airflow: combined ante/buffer rooms must have a displacement airflow of at least 40 ft/min over the line of demarcation from the buffer area to the ante-area
Accreditation organizations that promulgate USP
- The Joint Commission - The Pharmacy Compounding Accreditation Board (PCAB)
KNOW: Initial compounding training requirements
- Theoretical principles - Practical skills including aseptic work practices, observation of expert compounders, and return demonstrations - Written competencies - Hand & hygiene competencies - Garbing - Gloved fingertip test w/o any contamination - Media fill tests
What controlled substances can certified optometrists prescribe?
- Tramadol - APAP/Codeine No3
KNOW: What requirements must a pharmacy have in order for DTM to be provided?
- Transferable pt care record including Prescriber Care Plan which includes a section of "orders" from a prescriber for each pt and progress notes - A private, distinct, and partitioned area in the pharmacy designated for patient care - CQI program including standards and procedures to identify, evaluate, and improve DTM services
Telehealth providers can only prescribe control substances in what situations?
- Treatment of a psychiatric disorder - Inpatient treatment at a hospital - Treatment of a patient receiving hospice services - Treatment of a resident of a nursing home facility
What are the only two things that pharmacy interns CANNOT do under the direct supervision of a pharmacist?
- Verify orders - Immunize influenza vaccines to pts <7 yo
When compounding, sterility of critical sites must be maintained. What are considered critical sites?
- Vial septa - Ports - Needle hubs - Other surfaces at highest risk of exposure to contamination
NEED TO KNOW: C3-5 drugs may be filled from what type of prescriptions?
- Written - Verbal - Facsimile - Electronic
KNOW: Requalifying compounding training
- Written test - Media fill test - Gloved fingertip tests
What is the 5% rule?
-Manufacturer 5% rule— if the total # of dosage units of all Rx drugs compounded in any consecutive 12mo period is more than 5% of total # of dosage units of Rx drugs prepared by the pharmacy during the 12mo period, that pharmacy must obtain a manufacturer's license -Wholesaler 5% rule—if the total # of dosage units of all Rx drugs distributed in a consecutive 12mo period is more than 5% of total # of dosage units of Rx drugs distributed and dispensed by the pharmacy during the 12mo period, then the pharmacy must obtain a wholesaler's license. -Controlled Substance (CS) 5% rule—if the total # of dosage units distributed in a 12mo period exceeds 5% of the total # of dosage units of all CS distributed and dispensed during the 12mo period, the dispenser shall obtain a license to distribute CS. ----> CS one is for transferring CS between registrants
KNOW: How many CE hours is equivalent to each ACPE CE unit (CEU)?
0.1 CEU = 1h
KNOW: ISO class is determined by the number of particles larger than _____ microns in a volume of air.
0.5
How many pharmacies can one pharmacist serve as the PDM for?
1
KNOW: How many CE hours can be claimed by pharmacists presenting a live seminar, live video conference, or an interactive computer-based application?
1 CE per hour presented *CAN ONLY CLAIM THIS ONCE PER PRESENTATION* so if you present same thing twice you will only get CE hours for the first time
A theft or significant loss of controlled substances must be reported in writing to DEA within _______ of discovery of the theft or significant loss.
1 business day
Florida law requires the completed DEA Form 41 to be sent to the closest DEA office within _____ of destruction.
1 business day
Time limit to report significant loss or theft of controlled substances
1 business day/24h to DEA, county sheriff and FLBOP
BUD for immediate use CSP
1 hour
CE hours for HIV
1 hour upon first renewal
CE hours for human trafficking
1 hour upon first renewal
If the 2-file storage system is used, controlled substance prescriptions in the 2nd file must be stamped with red ink in the lower right corner of the prescription with a "C", not less than ____ height, to be readily retrievable from non-controlled substances.
1 inch
At the time a pharmacy commences operations, a sign in block letters not less than _____ in height, stating _______, must be placed at the _______ of the establishment.
1 inch Hours the rx dept is open each day At main entrance of establishment or near the place where rx's are dispensed
KNOW: How many patients does a Prescriber Care Plan/Drug Therapy Management agreement cover?
1 patient - 1 agreement per patient for an individualized assessment of patients
How long do you have from date of issuance to fill a non-controlled prescription?
1 year
If an OTC product is prescribed and filled as a prescription, what is its beyond use date?
1 year
When applying for licensure by examination in FL, all requirements must be met within ____ of receipt of application, or else have to be reapplied.
1 year
What is the general rule for beyond use date for repackaged or unit-dosed medications?
1 year OR original exp date (whichever is first)
Method for verifying a DEA registration number
1. (1st + 3rd + 5th) 2. (2nd + 4th + 6th) X 2 3. (Step 1) + (Step 2) - Last digit of the sum should correspond to the last digit of the DEA number
What are the storage options for the hard copies of all written or verbal controlled substance prescriptions that were reduced to writing?
1. 3-File Storage System: - File 1 = CII only - File 2 = CIII-CV - File 3 = Non-controlled 2. 2-File Storage System: - File 1 = CII only - File 2 = CIII-CV AND non-controlled substances THESE ONLY APPLY TO HARD COPY RXs, NOT ELECTRONIC ONES
NEED TO KNOW: What are the three rules for partial filling a C2 prescription?
1. 72-hr rule - pharmacist must provide remaining qty within 72h of partial quantity dispensed 2. 30-day rule - Under CARA 2016, can partially fill C2's for up to 30 days if requested by patient OR physician - assuming this is if pt cant afford whole quantity? 3. 60-day rule - Can partially fill C2s as many times as needed within 60 days for LTCF & terminally ill pts - partial fillings must be recorded on rx or maintained in pharmacy's computer system
KNOW: Consultant pharmacist license requirements:
1. Active pharmacist license in good standing 2. Completion of consultant pharmacist course >/= 20h sponsored by an accredited college of pharmacy and approved by the Tripartite Committee. 3. Course must include subject matter in Rule 64B16-26.301 and a cognitive test that the applicant must pass
What are selected violations under the FFDCA?
1. Adulteration and misbranding of a drug 2. Refusal to allow the DBPR to: - enter or inspect an establishment in which drugs, devices, or cosmetics are manufactured, processed, repackaged, sold, brokered, or held - inspect any record of that establishment - enter and inspect any vehicle that is being used to transport drugs, devices, or cosmetics - take samples of any drug, device, or cosmetic 3. Purchase/receipt of rx drug from person not authorized to distribute rx drugs to that purchaser/recipient 4. Sale/transfer of a rx drug to person not authorized under law of jurisdiction where person receives the drug to purchase/possess rx drugs from the person selling/transferring the rx drug 5. Obtaining/attempting to obtain an rx drug or device by fraud, deceit, misrepresentation, or subterfuge, or engaging in misrepresentation or fraud in the distribution of a drug or device 6. Charging a dispensing fee for dispensing/ administering/ distributing an rx drug sample 7. Removing a pharmacy's dispensing label from a dispensed rx drug w/ the intent to further distribute the rx drug 8. Distributing an rx drug that was previously dispensed by a licensed pharmacy, unless such distribution is authorized in the FL pharmacy act or rules 9. Failure to acquire or deliver a transaction hx, transaction info, or transaction statement as required 10. Selling a product containing dextromethorphan to an individual <18 yo
Prior to a transfer of a prescription, what must the pharmacist either verbally or electronically do?
1. Advise the patient that the Rx on file at the other pharmacy must be cancelled 2. Determine that the Rx is valid and may be filled or refilled 3. Notify the pharmacist or pharmacy where the prescription is on file that the prescription must me cancelled 4. Record in writing or electronically the: (a) Name of pharmacy transferred FROM (b) Rx number (c) Name of drug (d) Original AMOUNT dispensed (e) Date of original dispensing (f) Number of remaining authorized refills 5. Obtain the consent of the prescriber when the pharmacist deems it necessary using his or her professional judgment
Who does NOT have to register with the DEA?
1. Agents or employees of any registered manufacturer, distributor, or dispenser if acting in teh usual course of business or employment - Ex: pharmacists working in a pharmacy, nurses working in a hospital or physician's office 2. Common or contract carrier or warehouseman or employee whose possession is in the usual course of business or employment 3. An ultimate user (patient) who possesses such substance for a lawful purpose 4. Officials of US armed services, public health service, or bureau of prisons acting in the course of their official duties
KNOW THIS: What ORAL drugs can certified optometrists prescribe
1. Analgesics: Max 72h supply - Tramadol HCl - APAP 300 mg + No.3 codeine phosphate 30 mg 2. Antibiotics "DEAD MAK" - Minocycline - Amoxicillin w/ or w/o clavulanic acid - Keflex - Dicloxacillin - Erythromycin - Azithromycin - Doxycycline/Tetracycline 3. Antivirals "FAV" - Famciclovir - Acyclovir - Valacyclovir 4. Oral Anti-Glaucoma Agents: Max 72h supply - Acetazolamide - Methazolamide
KNOW: What license renewal exemptions exist for pharmacist or pharmacy technicians that are members of the armed forces and spouses?
1. Anyone on active duty w/ armed forces in US, who at the time of becoming a member of Armed Forces was in good standing w/ BOP, is exempt from all license renewal provisions so long as the license is on active duty and for 6 months after discharge 2. Pharmacists or technicians who are spouses of a member of Armed Forces of US and were caused to be absent from the state of FL b/c of spouse's duties shall also be exempt from all license renewal provisions (which includes renewing licenses or registrations, meeting CE requirements, and paying renewal fees)
What are the criteria for a PA to be able to prescribe controlled substances?
1. Authority must be delegated by supervising MD/DO 2. C-II limited to 7-day supply 3. Cannot prescribe controls in pain management clinics 4. Cannot prescribe psychiatric mental health controls for <18 yo
What are the criteria for an APRN to be able to prescribe controlled substances?
1. Authority must be delegated by supervising MD/DO 2. C-II limited to 7-day supply (except for psychiatric nurses) 3. Cannot prescribe controls in pain management clinics 4. Cannot prescribe psychiatric mental health controls for <18 yo (except psychiatric nurses)
C-SECs must be used for compounding both nonsterile and sterile preparations and must meet what requirements?
1. Be a room w/ fixed walls that is separate from nonhazardous storage or compounding 2. Have a negative pressure gradient of 0.010-0.030" of water column w/ respect to adjacent areas 3. Have appropriate air exchange (ACPH) 4. Be vented to the EXTERIOR of the facility
NEED TO KNOW: Under what three circumstances is a facsimile prescription able to serve as the original written prescription for C-II drugs?
1. C2 narcotic for home infusion/IV pain therapy 2. C2 (any) for LTCF patients 3. C2 narcotic for hospice pts narcotic only is for the 2 H's
What are PA's not allowed to prescribe?
1. C2 psychiatric meds to ppl <18 yo 2. General, spinal, or epidural anesthetics 3. Radiographic contrast materials
Types of CSOS Certificates
1. CSOS Administrative Certificates - digitally sign communications w/ DEA & other participants in the CSOS community; issued only to CSOS Coordinators; are not valid for electronic ordering 2. CSOS Signing Certificates - digitally sign controlled substance orders; issued to approved registrant and POA applicants
NEED TO KNOW: Acute pain does NOT include pain related to
1. Cancer 2. Terminal conditions 3. Palliative care to provide relief of symptoms related to an incurable, progressive illness or injury 4. Traumatic injury with an Injury Severity Score of >/=9
KNOW: What are the 2 types of SECs?
1. Cleanroom Suite: - Positive pressure anteroom + at least 1 buffer room - Anteroom must be positive pressure and must be at least ISO 7 if it opens into any negative pressure buffer room, or at least ISO 8 if it opens only into positive pressure buffer rooms - The buffer room must be at least ISO 7 2. Segregated Compounding Area (SCA): - Area designated for use for sterile compounding - Does NOT have to be a separate room - A more complex containment segregated compounding area (C-SCA) is used for hazardous drug compounding
What are the three types of containment engineering controls?
1. Containment Primary Engineering Control (C-PEC) 2. Containment Secondary Engineering Control (C-SEC) 3. Containment Supplemental Engineering Controls
KNOW: If the Department's investigator issues a Notice of Deficiencies for a minor violation, what shall the licensees do?
1. Correct the violation 2. Respond to the investigator on forms provided by the DOH & w/ other evidence of compliance within 30 days - Failure to do this shall subject the licensee to further proceedings
KNOW: Under FL law, a written record shall be maintained for each batch/sub-batch of a compounded product, which shall include:
1. Date of compounding 2. Control # for each batch/sub-batch of a compounded product (a) manufacturer's lot # or new # assigned by pharmacist (b) If assigned by pharmacist, they shall also record original manufacturer's lot # and exp date (c) If original #s and expiration dates are NOT known, pharmacy shall record the source & acquisition date of the component 3. Complete formula for the compounded product maintained in a readily retrievable form (including methodology & necessary equipment) 4. Signature or initials of the pharmacist or pharmacy tech performing the compounding 5. Signature or initials of supervising pharmacist 6. Name of manufacturer(s) of the raw materials used 7. Qty in units of finished products or grams of raw materials 8. Package size & # of units prepared 9. Name of pt who received the product
KNOW: If a practitioner NOT registered as a dispensing practitioner is dispensing complimentary drugs, what are the requirements they must follow for dispensing?
1. Dispense in manufacturer's labeled package OR 2. Dispense in a container w/ the following info: (a) Practitioner's name (b) Patient's name (c) Date dispensed (d) Name & strength of drug (e) Directions for use
KNOW: Order of donning garb and performing hand hygiene
1. Don head & hair covers, masks, and shoe covers upon entry to the anteroom or SCA 2. Perform hand hygiene (wash hands and arms up to elbows for 30 seconds) 3. In an anteroom, step over into the clean side of the room 4. Don gown 5. Apply alcohol-based hand rub to hands and allow to dry 6. Don sterile gloves
What are the rules for using automated pharmacy systems in long term care, hospice, and correctional facilities?
1. Drugs stored in system at such facilities shall be owned by the provider pharmacy 2. Drugs in system at facilities are part of the inventory of the provider pharmacy, NOT part of the inventory of any other pharmacy permit for the facility 3. Provider pharmacy must have policies & procedures to ensure adequate secrity 4. Drugs may only be removed w/ a valid prescription order (EXCEPT IF USED AS AN EMERGENCY MED KIT) 5. Pharmacist at provider pharmacy shall control all operations of automated system and approve release of initial dose of a rx or order; subsequent doses may be released W/O additional approval 6. Stocking must be done by pharmacist or other licensed personnel unless system uses removable pockets/drawers that can be filled at provider pharmacy and uses bar code verification, electronic verification, or similar verification to assure that the cartridge or drawer is accurately loaded into the system 7. Must have a DEA registration if the system stores controlled substances
Under the institutional formularies and therapeutic substitution in nursing homes legislation, what must the nursing home do?
1. Establish a committee to develop the institutional formulary and written guidelines or procedures for such, which must consist of all 3 of these individuals: (a) facility's medical director (b) Facility's director of nursing services (c) Consultant pharmacist 2. Establish methods & criteria for selecting and objectively evaluating all available pharmaceutical products that may be used as therapeutic substitutes 3. Establish policies and procedures for developing and maintaining the institutional formulary and for approving, disseminating, and notifying prescribers of the institutional formulary 4. Perform quarterly monitoring to ensure compliance w/ the policies and procedures and monitor the clinical outcomes in circumstances in which therapeutic substitution has occurred
KNOW: Who must be included in the committee that develops the institutional formulary for a nursing home and written guidelines or procedures for such?
1. Facility's medical director 2. Facility's director of nursing services 3. Consultant pharmacist
NEED TO KNOW: What must be included on a written controlled substance prescription?
1. Full name & address of patient 2. Drug name, strength, & dosage form 3. Quantity prescribed (both numerically & textually - for written ONLY) 4. Directions for use 5. # refills authorized, if any 6. Name, address, & DEA# of practitioner 7. If C2 to be filled at a later date, write the earliest date the pharmacy may fill the rx on the prescription
KNOW: What are considered aggravating circumstances that serve to increase the penalty imposed?
1. Hx of previous violations of the practice act and rules 2. In case of negligent acts, the magnitude and scope of damage or potential damage inflicted upon the pt or the public 3. Evidence of violation of professional practice acts in other jurisdictions where the licensee has been disciplined by the appropriate regulatory authority 4. Harm that occurred
KNOW: What are considered mitigating circumstances that serve to decrease the penalty imposed?
1. In case of negligent acts, the minor nature of the damage or potential damage to the pt or public 2. Lack of previous disciplinary hx in FL or any other jurisdiction 3. Restitution of any monetary damage suffered by the pt 4. The licensee's professional standing among his or her peers 5. Steps already taken by the licensee to ensure the non-occurrence of similar violations in the future (ex: PRN network involvement) 6. Degree of financial hardship incurred by the imposition of fines or suspension
The Tripartite Committee approves CE courses from approved providers or individuals who are non-approved providers for general CE courses and also specific Florida CE that may be required. What are some of the examples of these?
1. Initial Consultant Pharmacist Certification 2. Consultant Pharmacist Recertification 3. Nuclear Pharmacist Recertification 4. Medication Errors 5. HIV/AIDS 6. Laboratory Tests 7. Laws and Rules (required Board-ordered CE in disciplinary cases) 8. Quality Related Events 9. Validation of Prescriptions or Controlled Substances
Which two drugs have some of the most extensive REMS programs?
1. Isotretinoin (Accutane) iPLEDGE Program 2. Thalomid (thalidomide) REMS both require negative pregnancy tests monthly and Rx's must be filled within 7 days of most recent negative pregnancy test for females and within 30 days from date issued for males
Major topics on the consultant pharmacist course cognitive test include
1. Jurisprudence (laws/regulations) 2. Policies & procedures 3. Administrative responsibilities 4. Professional responsibilities 5. The institutional environment 6. Nuclear pharmacy
KNOW: Under the automated distribution and packaging rule, what is the consultant pharmacist of record responsible for?
1. Maintaining a record of each transaction or operation 2. Controlling access to the system 3. Maintaining policies and procedures for operation, training, etc 4. Security 5. Assuring that a patient received the pharmacy services in a timely manner 6. Assuring that the system maintains the integrity of information and protects patient confidentiality 7. Establishing a comprehensive quality assurance program 8. Establishing a procedure for stocking or restocking the system 9. Ensuring compliance with all packaging and labeling requirements
If a pharmacist chooses to print the daily hard copy from the computer system recordkeeping, what requirements must be met?
1. Must be printed w/in 72h of date drugs were dispensed 2. Each individual pharmacist who dispenses or refills an Rx shall verify that the data is correct by dating and signing (no initials) the daily hard copy within 7 days
KNOW: Requirements of nuclear pharmacies
1. Must have PDM 2. Must be secured from access by unauthorized personnel 3. Must have a secured radioactive storage and decay area 4. Must maintain accurate records of acquisition, inventory, distribution, and disposal of all radiopharmaceuticals 5. Name of pt must be obtained prior to dispensing if order is for therapeutic or blood product radiopharmaceuticals (as opposed to diagnostic radiopharmaceuticals) 6. Diagnostic radiopharmaceuticals may be labeled "Physician's Use Only" if name of pt is readily retrievable from physician upon demand 7. Must meet all label , space and equipment requirements (See next 3 slides)
Federal Hazardous Substances Act label requirements on the immediate package of hazardous products
1. Name & business address of manufacturer/ packer/ distributor/ seller 2. Common/ usual/ chemical name of each hazardous ingredient 3. "Danger" for products that are corrosive, extremely flammable, or highly toxic 4. "Caution" or "Warning" for all other hazardous products 5. Statement of the principal hazard(s) that the product presents (e.g., Flammable, Harmful if Swallowed, Causes Burns, Vapor Harmful, etc) 6. Precautionary statements regarding what to do/not to do to protect themselves 7. First aid instructions if injured (where appropriate) 8. "Poison" if highly toxic, in addition to "Danger" 9. Instructions for handling/storage if product requires special care in order to protect themselves 10. "Keep Out of the Reach of Children"
Elements of counseling are up to professional judgment of pharmacist, but may include what components?
1. Name and description of drug 2. Dosage form, dose, route of admin, duration of therapy 3. Intended use of drug and expected action 4. Special directions and precautions for preparation, administration, and use 5. Common severe side effects or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur 6. Techniques for self-monitoring drug therapy 7. Proper storage 8. Prescription refill information 9. Action to be taken in the event of a missed dose 10. Pharmacist comments relevant to drug therapy
KNOW: What does a CPPA specify?
1. Name of collaborating physician's pt or pts for whom a pharmacist may provide services 2. Each chronic health condition to be collaboratively managed 3. Specific medicinal drug or drugs to be managed by the pharmacist for each pt 4. Circumstances under which the pharmacist may order or perform and evaluate laboratory or clinical tests 5. Conditions and events upon which the pharmacist must notify the collaborating physician and the manner and time frame in which such notification must occur 6. Beginning and ending dates for the CPPA and termination procedures, including procedures for pt notification and medical record transfers 7. A statement that the CPPA may be terminated, in writing, by either party at any time
The invoice provided by the wholesaler or manufacturer when ordering CIII-CV drugs must contain
1. Name of controlled substance 2. Dosage form and strength 3. # of units per container (e.g., 100-tablet bottle) 4. Quantity received (containers) 5. Date of receipt 6. Name, address, and DEA # of registrant from where the controlled substance was received Pg. 72
NEED TO KNOW: What items CANNOT be changed on a written C2 prescription even after calling the prescriber?
1. Name of patient 2. Name of drug 3. Name or signature of the prescribing physician
NEED TO KNOW: What information must be reported by a pharmacy to the PDMP?
1. Name, DEA#, and NPI# of prescriber 2. Date Rx issued 3. Date Rx filled 4. Method of payment 5. Name, address, phone #, DOB of patient 6. Name, NDC#, Qty, & strength of controlled substance dispensed 7. Name, DEA#, pharmacy permit #, and address of pharmacy 8. Whether Rx was initial or refill, and # of refills ordered 9. Name of person picking up the Rx and type of ID provided
KNOW: Upon receiving a compliant, what steps are followed by the Department?
1. Notify subject of the complaint 2. Provide subject an opportunity to submit a response 3. Conduct a thorough investigation 4. Forward complaint to prosecution services unit where an attorney reviews the file and recommends either dismissal or the filing of an administrative complaint
General laws for compounding ingredients
1. Obtain from reliable sources 2. Store appropriately (not on floor) 3. Applicable Safety Data Sheets (SDSs) & other documentation must be available for APIs for compounders 4. APIs that aren't USP or NF grade must be accompanied by a lot=specific Certificate of Analysis (COA) 5. Can't use ingredients that were withdrawn from the market for safety purposes
KNOW - EVERYBODY HAS BEEN ASKED THESE QUESTIONS ON EXAM: What are grounds for denial of a license or disciplinary action?
1. Obtaining license by misrepresentation or fraud or through an error of the Board or Department 2. Procuring or attempting to procure a license for another person 3. Permitting someone not licensed as a pharmacist in this state or not registered as an intern in this state, or permitting a registered intern who is NOT acting under the direct and immediate supervision of a licensed pharmacist to fill, compound, or dispense any Rx in a pharmacy owned or operated by such pharmacist or in a pharmacy where such pharmacist is employed or on duty 4. Being unfit or incompetent to practice pharmacy by reason of: (a) Habitual intoxication (b) Misuse or abuse of any controlled substance; or (c) Abnormal physical or mental condition which threatens the public safety 5. Violating the Federal Food, Drug, and Cosmetic Act (FDCA) or Federal Controlled Substances Act 6. Having been convicted or found guilty, regardless of adjudication, of a crime which directly relates to the ability to practice pharmacy. A plea of nolo contendere (no contest) constitutes a conviction for purposes of this section. 7. Using, in the compounding or dispensing of a prescription, an ingredient or article different in any matter from the ingredient or article prescribed (except as authorized for generic substitution or a formulary system) 8. Having been disciplined by a regulatory authority in another state for any offense that would be a violation of the pharmacy act. 9. Compounding, dispensing, or distributing legend drugs or controlled substances other than in the course of the professional practice of pharmacy. 10. Making or filing a report or record known to be false, intentionally or negligently failing to file a report or record required by state or federal law, or willfully impeding or obstructing such filing or inducing another person to do so 11. Failing to make prescription fee or price information readily available upon request 12. Placing in the stock of any pharmacy any part of an Rx that has been returned by a patient (exception for unit-dose meds in hospitals, nursing homes, etc) 13. Being unable to practice pharmacy w/ reasonable skill and safety by reason of illness, use of drugs, narcotics, chemicals, or any other type of material or as a result of any mental or physical condition 14. Violating a rule of the Board or Department or violating an order previously entered in a disciplinary hearing 15. Failing to report to the DOH a physician who the pharmacist knows has violated the grounds for disciplinary action set out in the law under which that person is licensed and who provides healthcare services in a facility licensed under Ch 395 (hospitals and other licensed facilities) or a health maintenance organization (HMO) in which the pharmacist also provides service. ----> Exception: if a person who the licensee knows is unable to practice medicine or osteopathic medicine by reason of illness or use of alcohol, drugs, narcotics, chemicals, or any other type of material etc, or as a result of a mental or physical condition, may be reported to a consultant operating an impaired practitioner (PRN) program rather than to the department 16. Failing to notify the Board in writing within 20 days of the commencement or cessation of practice when such commencement or cessation of practice was a result of a pending or completed disciplinary action or investigation in another jurisdiction 17. Using or releasing a patient's records except as authorized 18. Violating any provisions of Ch 456 or 465 and any rules adopted pursuant thereto 19. Dispensing any medicinal drug based upon a communication that purports to be an Rx when the pharmacist knows or has reason to believe that the purported Rx is not based upon a valid practitioner-patient relationship 20. Committing an error or omission during the performance of a specific function of Rx drug processing, which includes stuff in next slide
Collaborative Practice Agreement Functions
1. Order & evaluate any lab or clinical tests 2. Conduct pt assessments as appropriate to evaluate and monitor drug therapy 3. Modify or D/C medicinal drugs, via a pt-specific order or preapproved treatment protocol 4. Administer medicinal drugs
KNOW: Written collaborative practice agreements for consultant pharmacists must outline the circumstances under which the consultant pharmacist may:
1. Order and evaluate an lab or clinical tests to promote and evaluate patient health and wellness adn monitor drug therapy and tx outcomes 2. Conduct pt assessments as appropriate to evaluate and monitor drug tx 3. Modify or d/c medicinal drugs as outlined in the agreed-upon pt-specific order or pre-approved tx protocol under the direction of a physician - but can't modify or d/c any of the pt's meds that were prescribed by someone NOT in a written collaborative practice agreement w/ the pharmacist 4. Administer medicinal drugs
KNOW: What are considered minor violations for an initial offence?
1. Outdated pharmaceuticals 2. Failure to meet regulation of daily operating hours 3. Generic substitution sign not displayed 4. Info required on controlled substance Rxs: - Practitioner's address - Practitioner's DEA # - Patient's address 5. Failure by dispensing pharmacist to certify the daily hard-copy printout or daily log 6. Failure to have pharmacy minimally equipped (i.e., references, compounding equipment, and a current copy of laws and rules governing the practice of pharmacy in the State of FL) 7. Failure to properly identify technicians 8. Results of P&E quality assurance program not documented or available for inspection 9. Improper storage of legend drugs 10. Improper documentation of destruction of controlled substances 11. Consultant pharmacist's monthly reports not current or available for inspection 12. Controlled substance Rx labels lack transfer crime warning labeling 13. Failure to maintain proof of licensure, display licenses/registrations or notices, or to properly identify pharmacy staff 14. Failure to have a continuously designated PDM or Consultant Pharmacist of Record, if the gap between designations is less than 15 business days
KNOW THIS: For prospective drug use reviews, a pharmacist shall review the patient record and each new and refill rx presented for dispensing in order to promote therapeutic appropriateness by identifying what information?
1. Overutilization or underutilization 2. Therapeutic duplication 3. Drug-disease contraindications 4. Drug-drug interactions 5. Incorrect drug dosage or duration of treatment 6. Drug-allergy interactions 7. Clinical abuse/misuse *upon recognizing any of these, pharmacist shall take appropriate steps to avoid or resolve the potential problems which shall include consultation with the prescriber if necessary*
Florida BOP requires that pharmacies (except for Institutional Class I- nursing homes) using a DEA Form 41 for destruction have the following sign the form as a witness:
1. PDM or consultant pharmacist of record AND a DEA agent or Department of Health inspector OR 2. PDM or consultant pharmacist of record AND A) medical director or his or her physician designee; OR B) director of nursing or his or her licensed nurse designee; OR C) a sworn law enforcement officer
KNOW: If a pharmacist has been on retired status for 5 years or more, what must they do to reactivate their license?
1. Pass the FL MPJE if they have been actively practicing for at least part of those 5 years in another jurisdiction, or 2. Pass both MPJE and NAPLEX if they have NOT been actively practicing in another jurisdiction for 5+ years
General Pharmacy Permit Requirements
1. Person/business entity must file a sworn application, including fingerprints from each person with >/= 5% ownership, along w/ those overseeing operation of the applicant, including officers and members of board of directors if a corporation 2. For corporations w/ >$100 million of assets in the state, only PDM or consultant pharmacist of record is required to submit fingerprints 3. Pharmacy permit application must include written policies/procedures for preventing controlled substance dispensing based on fraudulent representations or invalid practitioner-patient relationships 4. Pass an on-site inspection prior to initial permit issuance, for change of ownership, change of address, or change of location 5. Permit only valid for a specific entity under a specific name and single physical location listed on permit 6. A single physical address may cover a broader area if it is a contiguous area under the control of the permit holder and is <0.5 miles from the central location of the permit --> similar to campus registration for DEA; pharmacists at large facilities need to make sure both their state and permit and DEA registration cover the entire campus 7. Permit is NOT TRANSFERABLE; if pharmacy is sold, a new application must be filed and a new permit obtained
What are additional rules that must be followed when restocking automated medication systems?
1. Pharmacist must conduct a daily audit of meds placed or to be placed in the system using random sampling, OR 2. System may use bar code verification, electronic verification, or similar verification processes to assure correct selection of meds placed or to be placed into an automated med system
KNOW: What are considered citation violations?
1. Practicing pharmacy w/ an inactive license 2. Operating a pharmacy w/ an inactive permit 3. 1st time failure to complete the required CE requirements during biennial license period 4. Failure to timely pay a fine or costs incurred by a Board order 5. Failure to display any sign, license, or permit required by statute or rule 6. Failure to have any reference material required by statute or rule available 7. Failure to notify the Board of a change in PDM or consultant pharmacist 8. Using, in the compounding of an Rx, or furnishing upon an Rx, any ingredient or article different in any manner from the ingredient or article prescribed or dispensing a med w/ dosage form instructions different in any way than prescribed, provided that the med was not used or ingested 9. Tendering a check payable to the BOP or DOH that is dishonored 10. Failure to comply w/ the educational course requirements for HIV/AIDS 11. Failure to correct minor violations 12. 1st time failure to report controlled substance dispensing info to the PDMP 13. 1st time failure to consult the PDMP prior to dispensing a controlled substance 14. Failure to request a photo or other verification of identity prior to dispensing a controlled substance to a person not known 15. Failure to inform customers of a less expensive drug when cost-sharing obligation to customer exceeds retail price 16. Failure to comply w/ pharmacist to registered pharmacy technician ratio for activities not involving sterile compounding w/ no injury to patient 17. Failure to remove from active stock and properly quarantine outdated Rx drugs
Under which circumstances does the mandatory electronic prescriptions for controlled substances NOT apply?
1. Practitioner and dispenser are same entity 2. Rx can't be transmitted electronically under most recently implemented version of the National Council for Prescription Drug Programs SCRIPT Standard 3. Practitioner was issued a waiver by the department, not to exceed 1 year, due to demonstrated economic hardship/technology limitations not in control of the practitioner 4. Practitioner determines it impractical for pt to obtain medicinal drug prescribed by electronic rx in a timely manner and such delay would adversely impact the pt's medical condition 5. Practitioner is prescribing a drug under a research protocol 6. Rx is for a drug that the FDA requires the Rx to contain elements that may not be included in electronic prescribing 7. Rx is issued to an individual receiving hospice care or who is a resident of a nursing home facility 8. Practitioner determines it's in best interest of pt, or pt determines its in their best interest, to compare rx prices among pharmacies - must be documented by practitioner in pt's medical record
KNOW: Under FL law, the definition of compounding includes
1. Preparation of drugs or devices in anticipation of rx's based on routine, regularly observed prescribing patterns 2. Preparation, pursuant to an Rx, of drugs or devices that are not commercially available 3. Preparation of commercially available products from bulk when prescribing practitioner has prescribed the compounded product on a per-Rx basis, and the pt has been made aware that the compounded product will be prepared by the pharmacist (the reconstitution of commercially available products pursuant to the manufacturer's guidelines is permissible WITHOUT notice to the practitioner) *The preparation of drugs or devices for sale or transfer to pharmacies or practitioners, or to entities for purposes of dispensing or distribution, is NOT compounding*
NEED TO KNOW: Per DEA regulations, a pharmacy's electronic system must have the capability of printing out any refill data, which the pharmacy must maintain under the CSA. The printout must include what components?
1. Prescribing practitioner's name 2. Patient's name & address 3. Qty and date dispensed on each refill 4. Name or identification code of the dispensing pharmacist 5. Original Rx number
NEED TO KNOW: Requirements for OTC sales of CV drugs
1. Pt must be >/= 18 yo and show photo ID 2. Bound record book must be maintained containing: - Name and address of purchaser - Name & qty of controlled substance purchased - Date of purchase - Name/initials of dispensing pharmacist
KNOW: What records of prescribing and dispensing must be created by the prescriber/dispenser and maintained by the consultant pharmacist of record for the facility if a prescription is dispensed by an institutional pharmacy to a patient of the ED?
1. Pt name & address 2. Drug & strength prescribed/dispensed 3. QTY prescribed/dispensed 4. Directions 5. Name of prescriber/dispenser 6. Prescriber DEA # if applicable 7. Reason community pharmacy services were not readily accessible *Container must also meet all labeling requirements*
KNOW: Who can be a "donor" for the Cancer Drug Donation Program?
1. Pt or pt representative who donates cancer drugs or supplies needed to administer cancer drugs that have been maintained w/in a closed drug delivery system 2. Healthcare facilities, nursing homes, hospices, hospitals w/ closed drug delivery systems 3. Pharmacies, drug manufacturers, medical device manufacturers or suppliers, or wholesalers of drugs or supplies 4. Physician who receives cancer drugs or supplies directly from a drug manufacturer, wholesale distributor, or pharmacy
Under what circumstances is consulting the PDMP not required?
1. Pts <16 yo 2. Prescribing or dispensing controlled substance to hospice patient 3. Non-narcotic CV's - Pregabalin (Lyrica) - Brivaracetam (Brivact) - Lacosamide (Vimpat) - Ezogabine (Potiga) Also not required if: - System is nonoperational as determined by the FDOH - System cannot be accessed b/c of temporary technological/electrical failure
KNOW: A pharmacist may dispense and deliver a quantity of a compounded drug to a practitioner for office use, provided that what criteria are met?
1. QTY of compounded drug doesn't exceed amount a practitioner anticipated may be used in their office before the expiration date of the drug 2. QTY of compounded drug is reasonable considering the intended use of the compounded drug and the nature of the practitioner's practice 3. QTY of compounded drug for any practitioner and all practitioners as a whole is not greater than the amount the pharmacy is capable of compounding in compliance w/ pharmaceutical standards for identity, strength, quality, and purity of the compounded drug that are consistent w/ USP guidelines and accreditation practices 4. Pharmacy and practitioner enter into a written agreement w/ specific provisions 5. Adequate, retrieval records of all compounded drugs ordered by practitioners for office use are maintained as required by rule 6. The label affixed to any compounded drug for office use includes all necessary information (see next slide)
KNOW: Committing an error or omission of what information during the performance of a specific function of prescription drug processing can be considered grounds for denial of a license or disciplinary action?
1. Receiving, interpreting, or clarifying an Rx 2. Entering Rx data into the pharmacy's record 3. Verifying or validating an Rx 4. Performing pharmaceutical calculations 5. Performing prospective drug review as defined by the Board 6. Obtaining refill and substitution authorizations 7. Interpreting or acting on clinical data 8. Performing therapeutic interventions 9. Providing drug information concerning a patient's prescription 10. Providing patient counseling
What is considered remote medication order processing?
1. Receiving, interpreting, or clarifying med orders 2. Entering or transferring med order data 3. Performing prospective DUR 4. Obtaining substitution authorizations 5. Interpreting and acting on clinical data 6. Performing therapeutic interventions 7. Providing drug info 8. Authorizing release of med for administration
Requirements for Pharmacy Technician Registration
1. Register w/ BOP and pay registration fee 2. Be >/= 17 yo 3. Have completed a pharmacy technician training program approved by the board, including: - Preapproved pharmacy technician training programs - Federal Armed Services programs - Other non-employer based programs - Employer-sponsored training programs ---> Note: PTCB or NHA are NOT approved 4. Has not previously had their license to practice pharmacy denied, suspended, or restricted for disciplinary reasons
KNOW: What must a practitioner who dispenses medicinal drugs for human consumption for a fee or remuneration of any kind (whether direct or indirect) do?
1. Register w/ their professional licensing board as a dispensing practitioner and pay a fee at the time of registration and upon each renewal of their license 2. Comply w/ and be subject to all laws and rules applicable to pharmacists and pharmacies 3. Before dispensing any drug, give the pt a written Rx and orally or in writing advise the pt that the Rx may be filled in the practitioner's office or at any pharmacy
KNOW THIS: What must a pharmacy owner, manager, or proprietor do if a pharmacy permit is revoked or suspended?
1. Remove all signs/symbols identifying the premises as a pharmacy 2. BOP will decide how long suspension will be, but it will not exceed 1 year 3. If revoked, the owner/operator of establishment CANNOT apply for a permit to operate a pharmacy for at least 1 year from date of revocation 4. Upon date of revocation, permittee must advise BOP of the disposition of medicinal drugs located on the premises
Exemptions to PPPA of 1970
1. Request of patient OR physician 2. Bulk containers not intended for household use 3. Drugs distributed to institutionalized patients 4. Rx drugs packaged for residents of LTCFs and other institutional settings if the facility personnel will administer the meds to the pts 5. One package size of OTC drugs designed for the elderly 6. Specific Rx and non-Rx exemptions - see next slide
What permits are under the Florida Food Drug and Cosmetic Act (FFDCA)?
1. Retail Pharmacy Wholesale Distributor - Required for community pharmacy engaging in wholesale distribution of rx drugs, which does not exceed 30% of the total annual purchases of Rx drugs - If wholesale distribution activity is >30% maximum, the pharmacy must obtain a rx drug wholesale distributor permit - The transfer (i.e., distribution) must be between a retail pharmacy and another retail pharmacy, or a modified class II institutional pharmacy, or a healthcare practitioner licensed in this state and authorized by law to dispense or prescribe rx drugs 2. Complimentary Drug Distributor - Required for anyone engaging in distribution of complimentary drugs (i.e., prescription drug samples) - Rx drug sample requirements are similar to those under the PDMA - All expired rx samples must be returned to manufacturer or distributor who provided the sample 3. Medical Oxygen Retailer - Required for an entity located in FL that sells or delivers medical O2 directly to pts in FL - Sale/delivery must be based on an rx/order from a Dr authorized by law to prescribe - May not possess, purchase, sell, or trade a medical gas other than medical O2 - Not required if already licensed under Ch. 465 - one of the VERY Few examples where an rx drug may be dispensed by an entity other than a pharmacy 4. Veterinary Prescription Drug Retailer - Required for anyone that sells veterinary rx drugs to the public but does not include a pharmacy licensed under Ch. 465 - Sale to public must be based on a valid written order from a vet licensed in FL who has a valid client-vet relationship w/ purchaser's animal - Vet rx drugs may not be sold in excess of the amount clearly indicated on the order or beyond the date indicated on the order - Order not valid for >1yr - Vet rx drug retail establishment may not purchase, sell, trade, or possess human rx drugs or any controlled substance ----> doesn't mean vets cant prescribe human rx drugs or wholesaler, just means they cant store or sell those drugs if the have this permit - Must sell a vet rx drug in original, sealed manufacturer's container w/ all labeling intact and legible 5. Healthcare Clinic Establishment Registration - required for purchase of a rx drug by a place of business at one general physical location that provides healthcare or vet services, which is owned and operated by a business entity that has been issued a federal employer tax identification number - Individual practitioners w/ authority to prescribe may purchase rx drugs under their license to be used in their office, but this permit allows a business (such as a clinic) to purchase rx drugs that may be used by multiple providers at the clinic - must have a qualifying practitioner who is responsible for complying w/ all legal and regulatory requirements related to purchase, recordkeeping, storage, and handling of rx drugs - qualifying practitioner shall be practitioner whose name, establishment address, and license # is used on all distribution documents for rx drugs purchased or returned by the healthcare clinic establishment
Under what circumstances may controlled substanced be mailed to patients?
1. Rx container must be labeled in compliance w/ Rx labeling rules 2. Outer wrapper or container that Rx is placed in must be free of markings that would indicate the nature of its contents (including name of pharmacy as return address) 3. No markings on package to indicate nature of contents
KNOW: Computer systems must have the capability of producing a daily hard-copy printout of all prescriptions filled or refilled containing what information?
1. Rx number 2. Date of dispensing 3. Patient name 4. Prescriber's name 5. Name & strength of drug dispensed (manufacturer if generic) 6. Quantity dispensed 7. Initials or ID of dispensing pharmacist 8. Only if not immediately retrievable by computer screen, must ALSO include: Pt's address, prescriber's address, prescriber's DEA number if for controlled substance, QTY prescribed if diff from QTY dispensed, date of issuance of rx if diff from date of dispensing, and total # of refills dispensed to date
NEED TO KNOW: Under FL law, what must all written controlled substance prescriptions that are filled include?
1. Rx number 2. Initials of filling pharmacist 3. Date filled
KNOW: What components must the prescription department of each pharmacy have?
1. Sink w/ running water accessible to rx counter 2. Sufficient shelf, drawer, or cabinet space for storage of everything u need to fulfill your duties 3. Sufficient walking space and work counter space to allow employees to fulfill their duties 4. Adequate sanitation 5. Other equipment as necessary to meet the needs of the professional practice of pharmacy
KNOW: 8 Types of Institutional Special Pharmacy Permits
1. Special Limited Community Permit - required for any Class II pharmacy that dispenses to employees, medical staff and their dependents, pts of ER, and discharged pts of the hospital, NOT TO EXCEED A 3-day supply (exceptions apply for drugs in multi-dose packages like inhalers, ocular or otic products, insulin vials/pens, bulk abx suspensions, topical agents, and methylprednisolone dose packs) 2. Special Sterile Products and Special Parenteral/Enteral Compounding - Required for any pharmacy providing parenteral (IV), enteral, and cytotoxic pharmacy services to outpatients (a) may be a stand-alone permit or used in conjunction w/ a community pharmacy permit (b) required to have a PDM (c) required to maintain a pt profile (d) required to have policy/procedure manual including quality assurance program (e) must meet specific requirements for space and all compounding requirements 3. Special Parenteral/Enteral Extended Scope Permit - Required for pharmacies to compound and dispense pt-specific parenteral/enteral drugs in conjunction w/ an institutional permit - essentially allows a pharmacy to prepare pt-specific sterile products for pts in a hospital or other institutional facility 4. Special Sterile Compounding Permit (SSCP) - Required for any pharmacy or outsourcing facility compounding sterile products (a) required for all outsourcing facilities; if it also engages in pt-specific compounding, must also have either community pharmacy or institutional permit depending on practice setting (b) an ADDITIONAL permit for pharmacies compounding sterile products (c) not required for a special parenteral/enteral or extended scope pharmacy if they hold no other permit and are not registered as an outsourcing facility (d) not required for a modified type B class II institutional pharmacy if they only compound low-risk-level sterile products for immediate use 5. Special Closed System Pharmacy Permit - required for any pharmacy that dispenses to facilities where rx's are individually prepared for ultimate consumer - includes nursing homes, jails, adult congregate living facilities, intermediate care facilities for individuals w/ intellectual disabilities (ICF-IIDs), or other custodial care facilities - must have 24-hr on-call service 6. Special ESRD Permit - Provides dialysis products and supplies to persons w/ CKD for self administration at their home or specified address 7. Special ALF Permit - optional license for ALFs using drugs in unit-dose packaging - Drugs cannot be dispensed on the premises - Allows medicinal drugs (not controlled) to be returned to the dispensing pharmacy 8. Special Internet Pharmacy Permit - Required for any location not otherwise issued a permit, within or outside the state, that uses the internet to communicate w/ or obtain information from consumers and uses this information to fill or refill rx's or to dispense, distribute, or otherwise engage in the practice of pharmacy in FL
All pharmacies must establish and maintain a policy and procedure manual regarding the number of registered pharmacy technician positions that must include the following topics
1. Supervision by a pharmacist 2. Minimum qualifications of registered pharmacy technicians 3. In-service education or ongoing training and demonstration of competency 4. General duties and responsibilities 5. All functions related to prescription processing 6. All functions related to prescription drug and controlled substance ordering and inventory control, documentation, and recordkeeping 7. All functions related to retrieval of prescription files, patient files, patient profile information, and other records 8. All delegable tasks and non-delegable tasks per 64B16 whatever 9. Confidentiality and privacy laws and rules 10. Rx refill and renewal authorizations 11. Functions related to automated pharmacy systems 12. Continuous quality improvement program
What are the Centers for Medicare and Medicaid Services (CMS) Requirements
1. Tamper-resistant prescriptions - requires that all written Rx's meet certain tamper-resistant requirements to prevent unauthorized copying and counterfeiting - Must include: ---> 1 or more feature to prevent copying of a completed or blank rx form ---> 1 or more feature to prevent erasure or modification of info on Rx pad ---> 1 or more feature to prevent use of counterfeit Rx forms 2. Pharmacy Services at LTCFs - Med regimen reviews by consultant pharmacist Q30 days - Resident's therapy must be free from unnecessary drugs - PRN psychotropic drugs limited to 14 days unless documented by provider - max 14-day supply of Rx's can be dispensed at a time to these residents - Routine + emergency meds must be provided in timely manner
Under what circumstances is advertising of prescription drug prices exempt from FDA advertising regulations?
1. The only purpose of the advertising is to provide information on price, NOT on drug's safety, efficacy, or indications for use 2. The advertising contains the proprietary name of the drug (if any), generic name, strength, dosage form, and price charged for a specific quantity of the drug 3. Advertising may include other info such as availability of professional or other types of services, as long as it is not misleading 4. The price stated in the advertising shall include all charges to the consumer; but mailing & delivery fees (if any) may be stated separately
What must a pharmacist do when RECEIVING a transfer request?
1. Transfer the information required in #4 of previous slide 2. Record on Rx or electronically record the: (a) Name of REQUESTING pharmacy (b) Name of pharmacist (c) Date of request 3. Cancel the Rx electronically or by writing the word "VOID" on the Rx record
What are the only exceptions to having a distribution license and passing transaction data?
1. When the distribution is between two entities that are affiliated or under common ownership 2. When a dispenser is providing product to another dispenser on a patient-specific basis 3. When a dispenser is distributing under emergency medical reasons 4. When a dispenser is distributing "minimal quantities" to a licensed practitioner for office use
Codeine C-III concentration limit
1.8g/100 mL and 90 mg/dosage unit *anything ABOVE this limit = C-II* Way to remember: 9X the limit of C-V (200 X 9 = 1800) and 90 mg/dosage unit
Dihydrocodeine C-III concentration limit
1.8g/100 mL and 90 mg/dosage unit - same as w/ codeine!
The triplicate (3-copy) DEA Form 222 contained _____ lines, whereas the new single DEA Form 222 contains _____ lines.
10 20
How long after change of a PDM must the board be notified? Who should notify them?
10 days max Pharmacy permittee AND newly designated PDM must notify the board of change and identity of the new PDM - new PDM must comply w/ fingerprint requirements
Time limit to report a change in consultant pharmacist record
10 days to the FLBOP
Time limit to report change in prescription department manager
10 days to the FLBOP
How many hours of CE must be from live seminars?
10 hours
KNOW: The compounder is responsible for preparing CSPs that are accurately mixed, within ______% of labeled strength/potency (unless otherwise listed), and prepared w/ appropriate technique in proper facilities.
10%
What is the allowable percent error for compounding?
10%
What do the different digits of NDC numbers represent?
10-character number that identifies a particular drug by manufacturer or packager (labeler), product, and package size 1. First 4-5 digits = labeler code 2. Next 3-4 digits = specific drug, strength, dosage form 3. Last 1-2 digits = package size
Dihydrocodeine C-V concentration limit
100 mg/100 mL - half of codeine max
Opium C-V concentration limit
100 mg/100 mL - same as dihydrocodeine!
What DEA form must be completed for theft or significant loss of controlled substances?
106
KNOWWWW: What are the size requirements for the mandatory human trafficking sign that must be displayed in all pharmacies in a conspicuous place accessible to all employees?
11 X 15 in 32-point font Must say in English.& Spanish: "If you or someone you know is being forced to engage in an activity and cannot leave, whether it is prostitution, housework, farm work, factory work, retail work, restaurant work, or any other activity, call the National Human Trafficking Resource Center at 888-373-7888 or text INFO or HELP to 233-733 to access help and services. Victims of slavery and human trafficking are protected under United States and Florida law."
KNOW!! The room for storage of NISOH Table 1 antineoplastic HDs that will be compounded and HD-APIs must be vented to the exterior of the facility and must have at least ______ air changes per hour (ACPH).
12
KNOW: CE courses on Laws and Rules shall be at least _______ in length and must cover specific topics as outlined in the rule.
12 hours
BUD for low risk CSP in an SCA
12 hours room temp or fridge
KNOW: USP 800 requires any entity that stores, compounds, prepares, transports, or administers HDs to maintain a list of HDs used in the entity and to review the list at least every ______, and update whenever a new agent or dosage form is used.
12 months
BUD for customized med pack
120 days
BUD for Low-risk drugs made in an SCA at room temperature
12h
BUD for Low-risk drugs made in an SCA when refrigerated
12h
BUD for Low-risk drugs when refrigerated
14 days
For pharmacies wishing to maintain shipping and financial records at a central location other than the registered location, they must notify the nearest DEA Diversion Field Office and are permitted to begin maintaining central records ______ after notifying the DEA.
14 days
If a pharmacist delivers a controlled substance to a DATA-waived practitioner to administer the medication by injection or implantation for purposes of maintenance or detoxification, how long after delivery does the prescriber have to administer the drug to the patient?
14 days
PRN orders for psychotropic drugs must be limited to...
14 days Rationale must be documented for >14 days
If a community pharmacy chooses to delay the commencement of operations, how long do they have to notify the board?
14 days IN WRITING
Time limit to report a delay in commencement of operations in a community pharmacy
14 days to the FLBOP
Days supply for dispensing of a CIII drug by a dispensing practitioner
14-day supply
A written report of loss/theft of listed chemicals must be provided to the DEA within _____ of discovery and must include a description of the circumstances of the loss (in-transit, theft from premises, etc).
15 days
KNOW THIS!!! CE requirements for initial renewal >12 months after initial licensure date
15 hours total CE - 5h must be LIVE - 2h med errors - 2h controlled substances - 1h HIV/AIDS (since initial renewal)
KNOW: Per USP 797, if an area has an ISO Class 5 recirculating device, a minimum of ____ ACPHs through the area supplying HEPA filters is adequate, provided the combined ACPH is not less than _____.
15, 30
What is the minimum age to become a pharmacist? Technician?
18 17
Age limit for DXM
18 or older
What are the requirements for selling PSE?
18 or older Photo ID with DOB No more than 3 packages (regardless of weight) Must be logged in NPLEx before completing sale Cannot complete sale if NPLex "Stop Sale" alert is present
Under FL law, how old must a purchaser be to buy pseudoephedrine?
18 yo
Foreign pharmacy graduate interns must be supervised at a ___:___ ratio of pharmacist:intern.
1:1
Maximum ratio of interns:pharmacists
1:1 ONLY IF: - Performing immunizations - If a foreign pharmacy graduate otherwise no limit
What is the pharmacist:intern ratio?
1:1 for vaccines and if the intern is a foreign graduate Otherwise, there is no limit/specific ratio
What is the pharmacist:technician ratio for sterile compounding?
1:3
What is the pharmacist:technician ratio when NOT involved in sterile compounding?
1:6
What is the pharmacist:technician ratio in a dispensing pharmacy when in an area that is separate from the dispensing area?
1:8
What is the pharmacist:technician ratio in non-dispensing pharmacies, as long as they are not sterile compounding?
1:8
What CE course is specifically required for initial renewal of a pharmacist license?
1h HIV/AIDS CE
BUD for immediate use drugs at room temperature
1hr
Failure of a pharmacy to notify the county sheriff within 24h of discovery of theft or significant loss of controlled substances is considered a
1st degree misdemeanor
How many FLBOP members reside on the Probable Cause Panel
2
NEED TO KNOW: What kind of pharmacists make up the FBOP? How many of each?
2 community 2 institutional (Class II, modified class II, or class III) 3 from any practice setting
How many maximum terms can board members serve on the FBOP?
2 full terms - If a member's term expires, they can remain on board until a new appointment is made by the govna
CE hours for med errors
2 hours
For pharmacies and registered dispensing practitioners that don't dispense controlled drugs in or into this state, they must submit a "Notification of Exemption From Reporting" to the PDMP, and must renew the exemption every _____ when renewing their pharmacy permit.
2 years
How long must records of controlled substances be maintained?
2 years
When a purchaser receives an unaccepted electronic order from the supplier, the original statement must be retained for
2 years
How long must a pharmacy keep controlled substance related information?
2 years ie. DEA 222 or 106, prescriptions, invoices, etc. REMEMBER: All prescriptions in FL must be kept for at least 4 years
Pharmacist licenses are renewed every ____ on ______.
2 years (biennially) September 30th of odd-number years
What mandatory continuing education is required for dispensing controlled substances?
2-hour CE on validation and counseling of prescriptions for Controlled Substances and Opioids, which must include: 1. Ensuring access to CS for all pts w/ a valid rx 2. Use of PDMP 3. Assessment of rx for appropriate therapeutic value 4. Detection of Rx's not based on a legitimate medical purpose 5. Laws and rules related to prescribing and dispensing of CS 6. Proper pt storage and disposal of CS 7. Protocols for addressing and resolving problems recognized during the drug utilization review 8. Education on the provision of FL statute on emergency treatment for suspected opioid overdoses and on the state surgeon general's statewide standing order for Naloxone for as long as the order is valid and effective 9. Pharmacist-initiated counseling of patients with opioid prescriptions, and 10. Available tx resources for opioid physical dependence, addiction, misuse, or abuse
What coding system is used for therapeutic equivalence in the FDA orange book?
2-letter coding system with the first letter being the key: 1. A = both pharmaceutically equivalent AND therapeutically equivalent 2. B = NOT pharmaceutically equivalent and therapeutically equivalent
Time limit to notify of commencement of cessation of practice as a result of pending or completed disciplinary action in another jurisdiction
20 days to the FLBOP
Sterile compounding area must have a temperature under
20 degrees C
Max concentration for pharmacists to compound narcotics
20%
Pharmacies may compound narcotic controlled substances pursuant to a prescription as long as the concentration is not > _____.
20% - applies to aqueous or oleaginous solutions or solid oral dosage forms
Codeine C-V concentration limit
200 mg/100 mL - Robitussin AC and Cheracol contain the max amount of codeine allowed for C-V; even if 1mg was added to these products, they'd then be C-III
How many intern hours are required?
2080
KNOW: Pharmacy technician requirements for renewal of registration
20h approved CE - 2h med error - 4h must be LIVE - 1h HIV/AIDS - 1st renewal only
Minimum hours a community pharmacy must remain open
20h per week
If probable cause is found and a complaint is officially filed, how long does the subject have to respond?
21 days
KNOW: If probable cause is found, a complaint is filed and the subject has _____ to respond.
21 days
Time to respond to a complaint
21 days to FLBOP
Which DEA form is required for ordering C-II drugs?
222 - required for each sale or transfer of C-II drugs, except when dispensing to ultimate user
DEA registration form for controlled substance dispensers (pharmacies & practitioners)
224
DEA renewal form for controlled substance dispensers (pharmacies & practitioners)
224a
Days supply limit for drugs dispensed by a practitioner from an Emergency Room?
24 hour supply or minimal dispensing quantity
BUD for high risk CSP
24 hours room temp 3 days fridge 45 days freezer
Time limit to report that someone is trying to obtain controlled substances without a prescription
24 hours to county sheriff
Time limit to report illegitimate products
24 hours to trading partners
CE hours for consultant pharmacist
24 on top of required 30 for regular pharmacist license renewal
BUD for high-risk drugs at room temperature
24h
Pharmacists have a duty to report fraudulent controlled prescriptions within _____ after learning of the fraud or attempted fraud, OR at the close of the next business day, whichever is ______.
24h Later
KNOW: What are the CE requirements for renewal of a consultant pharmacist license?
24h of consultant pharmacist CE, including: - drug therapy - administrative responsibilities - consultant pharmacist facility requirements - compounding sterile or nonsterile drugs
KNOW!! Additional CE requirements for nuclear pharmacists
24h of nuclear pharmacy topics in addition to regular CE requirements
KNOW: High-risk CSPs (except those for inhalation or ophthalmic administration) that are made in groups of > ______ must also pass a bacterial endotoxin (pyrogen) test.
25 units
CIII Opium
25mg / dosage unit and 500 mg/100 mL
Expiration for multi-dose vial
28 days in/out of ISO 5
KNOW: How often is a pharmacy inspected during 1st year of operation?
2x/year
NEED TO KNOW: If a prescriber or dispenser does not consult the PDMP due to either a nonoperational system or system failure, they shall document the reason and shall not prescribe or dispense greater than a _____ supply of a controlled substance to the patient.
3 day
Days supply available when unable to check the PDMP because of a technology or power failure
3 day supply
Days supply for C2 opioids for acute pain
3 day supply
Days supply for drugs dispensed by a hospital under a Special Limited Community pharmacy permit
3 day supply
NEED TO KNOW: Days supply for schedule II opioids for acute pain
3 day supply
Days supply for prescriptions from Certified Optometrists for oral analgesics and anti-glaucoma agent on approved formulary
3 day supply, unless optometrist consult with a licensed physcician
BUD for high-risk drugs when refrigerated
3 days
For collectors conducting mail-back programs, they may only accept packages that they made available. If they receive one that they did NOT, the collectors must notify the DEA within ______ of receipt.
3 days
NEED TO KNOW: How long can a physician who is NOT part of a narcotic treatment program administer (not prescribe) narcotic drugs to an addicted individual until the patient can be enrolled in a narcotic treatment program?
3 days
Time to report the administration of narcotics to an addicted individual by a practitioner or hospital
3 days
CE hours for ordering/evaluating lab tests
3 hours (optional)
KNOW: Every pharmacy must have an established CQI program with a CQI committee that reviews quality-related events at least every ______.
3 months
CSOS allows electronic orders based on digital certificates issued by the DEA Certification Authority that are valid until the expiration of the DEA registration for the facility, which is _____.
3 years
Controlled substance dispensers (pharmacies & practitioners) register every ______ with the DEA.
3 years
DEA registration for dispensers is valid for...
3 years
Registration for controlled substance dispensers is valid for
3 years
PSE daily limit
3.6 g 146 tabs of 30 mg 73 of 60 mg 36 of 120 mg
KNOW: Per USP 797, an ISO Class 7 buffer area and ant-area supplied with HEPA-filtered air shall receive an ACPH of not less than _____.
30
KNOW THIS: Pharmacist renewal CE requirements - general
30 CE hours during 24 months before expiration All count towards 30h: - 2h medication error course - 2h controlled substances rx course - 10h total must be LIVE - 3h vaccine administration/epi auto-injection for those certified
NEED TO KNOW: Verbal prescriptions for C3 drugs are limited to a ____ supply.
30 day
Days supply for a verbal CIII prescription
30 day supply
Days supply for an emergency refill during a Governor declared Emergency
30 day supply
All healthcare licensees, including pharmacists, must report to their respective Board any conviction or pleas of nolo contendere to any crime in writing within _____.
30 days
Short term detox limit
30 days
Time limit to dispense the remaining quantity of a partially filled CII if the patient or prescriber makes the request
30 days
Pharmacies must comply with a patient's request to obtain a copy of their PHI within
30 days - but may extend time by no more than 30 additional days if they notify the pt/individual of the reason for the delay
Time limit to notify of termination of enrollment in an intern program or registration or attendance to a college of pharmacy
30 days to the FLBOP
Time limit for internet pharmacies to notify of change in PDM?
30 days, to the FLBOP
BUD for medium risk CSP
30 hours room temp 9 days fridge 45 days freezer
NEED TO KNOW: Pseudoephedrine HCL 3.6g daily limit equivalents by product
30 mg Tablets: - 146 tabs 60 mg Tablets: - 73 tabs 120 mg Tablets: - 36 tabs
NEED TO KNOW: Under FL law, how much may a pharmacist dispense for a schedule III controlled substance from a verbal prescription?
30-day supply - UNIQUE TO FL LAW- KNOW THIS
BUD for medium-risk drugs at room temperature
30h
Long term detox limit
31-180 days
Days supply for a pharmacist order for medicinal drugs
34 day supply
How to maintain immunization certification
3h CE every 2 years
How long must patient profiles be kept from the date of the last fill?
4 years
How many years must prescription records be kept?
4 years
KNOW: For records maintained in a data processing (computer) system, they must be able to produce an audit trail of drug usage for the preceding ______.
4 years
How long are FBOP board member terms?
4 years - but if a board member's term ends, they can continue to serve until a new board member has been appointed
KNOW: Per FL law, how long must all original prescriptions be retained?
4 years from date of last filling
Under Florida law, how long must records of original prescriptions (both controlled and non-controlled) be maintained?
4 years from the date of last dispensing
Term length and limit for FLBOP members
4 years, maximum 2 full terms
Combined ante-buffer rooms must have a displacement airflow of ______ over the line of demarcation from the buffer area to the ante area.
40 ft/min
Which form must be completed for on-site destruction of controlled substances in a pharmacy?
41
BUD for Low-risk drugs when frozen
45 days
BUD for high-risk drugs when frozen
45 days
BUD for medium-risk drugs when frozen
45 days
Days supply for drugs dispensed by a hospital pharmacy to an inpatient or ER patient on discharge
48 hour supply OR amount until next business day (whichever is greater)
Once requested, time to provide print out hard copy of all prescriptions dispensed
48 hours from time of request
BUD for low risk CSP in ISO
48 hours room temp 14 days fridge 45 days freezer
BUD for Low-risk drugs at room temperature
48h
KNOW: PECs must be ISO ____ or cleaner.
5
How many hours of CE can pharmacy technicians obtain in the subject of Risk Management by attending one full day of a Board meeting at which disciplinary hearings are conducted? What is the maximum allowable CE by this method?
5 CE hours/day Max: 10 hours
KNOW: Under the test & treat legislature, how long does a pharmacist have to send records to a designated healthcare practitioner on the patient's request?
5 days
Time limit to notify of entering a CPA
5 days to the FLBOP
KNOW: If attending a board meeting for one full day, how many hours of CE can you get in the subject matter of Risk Management? What is the maximum amount of hours you can obtain by this method?
5 hours Max: 10 hours
KNOW: If a pharmacist volunteers as an expert witness providing expert opinions for cases being reviewed by the DOH, how many CE hours can be claimed in the subject matter of Risk Management? What is the maximum amount of CE hours that can be claimed by this method?
5 hours Max: 10 hours (same as when u attend a board meeting for a full day!)
KNOW: For pharmacists completing post-professional degree programs from accredited colleges or schools of pharmacy, how many hours of CE can be claimed for courses completed during the renewal period?
5 hours per semester hour
KNOW: How many hours of CE can be obtained through volunteering for indigent or underserved populations in areas of critical need within the state?
5 hours total - 2h volunteering = 1h CE
How long must you keep immunization records?
5 years
KNOW!!: How long must patient records be maintained under a CPPA?
5 years from most recent visit/service
Pharmacists licensed for ____ years or more are exempt from payment of renewal or delinquent fee and are given a lifetime license.
50
Morphine C-III concentration limit
50 mg/100 mL - the most stringent C-III limit!!
503A vs 503B facilities
503A: - Compounding pharmacies that supply patient-specific drugs - Regulated by state - Follow USP - Can only compound pursuant to prescription 503B: - Outsourcing facilities which supply non-patient-specific drugs - Regulated by FDA - Follow cGMP - Can compound w/o Rx outsourcing facilities - Exempt from new drug provisions, adequate directions, and track-and-trace
What is the minimum time per week that internet pharmacies must be open?
6 days a week for a minimum of 40 hours per week
Expiration for a single dose vial
6 hours in ISO 5 1 hour outside of ISO 5
Any pharmacy that fails to commence operations within ________ of the date of receipt of the FL pharmacy permit shall provide a written statement to the Board office, which shall include the reasons(s) the pharmacy has not yet commenced operations, the efforts they have made to commence operations, and the date the pharmacy expects to commence operations.
6 months
KNOW: After the Department makes a final decision on a complaint, they must make their final recommendation to a Probable Cause Panel on the compliant within ______ of its receipt.
6 months
PECs and SECs must be certified every ______ by a qualified certification technician.
6 months
Time limit to provide written notice of failure to commence operations of a community pharmacy
6 months
When must the Probable Cause Panel receive its final recommendation after receipt of a complaint?
6 months
What is the time limit to fill a CIII-CV from date of issuance?
6 months and no more than 5 refills within those 6 months
How long must transaction data be maintained by each supply chain partner?
6 years
At least ONE member of the FBOP (either pharmacist or consumer) must be >/= ______ years of age.
60
Time limit to notify an affected individual of a breach of unsecured PHI
60 calendar days
Time limit to dispense the remaining quantity of a partially filled CII prescription if it is for an LTCF or hospice patient
60 days
Pharmacies must comply with a patient's request to amend or request for an accounting of PHI disclosure within
60 days - But may extend it by no more than 30 additional days if they notify the individual of the reason for the delay
No DEA Form 222 is valid for more than ______ after its execution by the purchaser.
60 days - Exception: certain department of defense orders
Relative humidity for sterile compounding area should be under
60%
KNOW: Anterooms that open into a negative pressure room and buffer rooms must be ISO ____ or cleaner.
7
Days supply for opioid for acute pain with "ACUTE PAIN EXCEPTION" on Rx
7 day supply
How often must pharmacists sign the daily hard copy prescription printouts?
7 days
If the prescriber chooses to mail the pharmacy the valid prescription following an emergency telephone C2 rx, it must be post-marked within _____.
7 days
NEED TO KNOW: When an emergency C2 prescription is called in, a pharmacist must immediately reduce the order to writing. Within ______ after authorizing an emergency telephone rx, the prescriber must provide the pharmacist with a signed or valid electronic rx for the controlled substance prescribed.
7 days
Time to obtain written or electronic prescription from a practitioner after dispensing an emergency verbal CII prescription
7 days
NEED TO KNOW: Days supply for prescription C-II opioids for acute pain with "Acute Pain Exception" on the prescription
7-day supply
Days supply for CII's from APRNs
7-day supply ***Additional restrictions for opioids for acute pain
Days supply for CII's from PA's
7-day supply ***Additional restrictions for opioids for acute pain
Mail order PSE limit
7.5 g in 30 day period
Federal mail-service pharmacy pseudoephedrine limit
7.5g per 30 days
Mobile retail vendors ("flea markets") sales of pseudoephedrine are limited to no more than
7.5g per customer per 30 days
Pharmacies that sell less than ____ gm of PSE in 30 days and lack the technology e-record keep may seek exemption from reporting to the state.
72 gm
Days supply for an emergency refill (Not Governor-declared emergency)
72 hour supply
Days supply for emergency verbal C2 Rx
72 hour supply
Days supply limit for an emergency verbal schedule II prescription
72 hour supply
KNOW: How long does a pharmacy have to produce a "summary record" of controlled substances dispensed in the past 60 days by a prescriber or patient?
72 hours
Time limit to dispense remaining quantity of a partially filled CII prescription if the pharmacist is unable to supply full quantity
72 hours
Time limit to print out the daily hard copy computer record of all prescriptions dispensed
72 hours - most pharmacies don't do this and use logbook instead
Once requested, time to provide print out hard copy of all controlled substance prescriptions dispensed
72 hours from time of request
Max days supply for an emergency NON-CONTROLLED without a prescriber's authorization
72 hours or up to one vial of insulin
NEED TO KNOW: What is the supply limit for an emergency CII prescription?
72h supply
USP ______ outlines compounding standards for nonsterile compounding.
795
USP nonsterile compounding chapter
795
USP ______ outlines compounding standards for sterile compounding.
797
USP sterile compounding chapter
797
If hazardous drugs are compounded, what USP chapters apply?
797 & 800
KNOW: Anterooms that open only into positive pressure buffer rooms must be ISO _____ or cleaner.
8
KNOW: CE courses on Quality Related Events shall be at least _______ in length and must cover specific topics as outlined in the rule.
8 hours - often required after a dispensing error
USP hazardous drugs chapter
800 - has not been adopted by FL but still need to know
USP radiopharmaceuticals chapter
825 - has not been adopted by FL
KNOW: Endotoxin testing shall be established for every lyophilized product, and it shall be performed in accordance with USP Chapter _____ and confirmed to fall within the set limits.
85
KNOW: What additional CE is required with each biennial licensure renewal for pharmacists under a CPPA?
8h in ADDITION to required general CE
BUD for medium-risk drugs when refrigerated
9 days
PSE 30 day limit
9 g
How many members on FLBOP?
9 total 7 pharmacists (FL residents, practice for >4 years) 2 non-pharmacists/community members At least one member must be >60 years old
NEED TO KNOW: # of members in florida BOP and how many of each profession?
9 total - 7 pharmacists - 2 consumer members *AT LEAST 1 MEMBER HAS TO BE >/=60 YO*
Days supply for multiple CII prescriptions issued on the same day
90 day supply
KNOW: All fines imposed by the Board for any disciplinary action must be paid within ______ from the date of the final order unless that time limitation has been modified by the board for good cause in order to prevent an undue hardship.
90 days
Technicians must sign documentation acknowledging that they reviewed the policy and procedure manual within ___ from hire date, and pharmacies must maintain this documentation.
90 days
Time limit on the payment of fines to the department of health
90 days
KNOW: In lieu of potency testing for lyophilized products, weight-based verification may occur based on formula verification, which will be based on _________% theoretical yield.
90-110% - Potency testing shall be based on USP monograph if one is available, but if not, it shall also be based on 90-110% theoretical yield
NEED TO KNOW: The DEA permits prescribers to issue multiple C2 prescriptions, provided the patient does not receive more than a _____ supply of a C2 controlled substance.
90-day - so basically 3 separate rx's for 30-day supply each is how this normally goes - Instructions indicating the earliest fill date for which each rx can be filled must be present on each rx
NEED TO KNOW: What is the quantity limit when a practitioner issues multiple C-II prescriptions on the same day?
90-day supply
What is FL law for sale of syringes and needles?
<18 yo: - Rx needed >18 yo: - No Rx needed
KNOW: A cancer drug may not be accepted or dispensed under the Cancer Drug Donation Program if it bears an expiration date that is less than ______ after the date the drug was donated, OR if the drug appears to have been tampered with or mislabeled.
<6 months
Action levels for air sample of ISO 5 (PECs)
>1 CFU per 1,000 liters of air
Action levels for air sample of ISO 7 (buffer rooms and anteroom opening into a NEGATIVE pressure room)
>10 CFUs per 1,000 liters of air
Action levels for air sample of ISO 8 (anteroom opening only into POSITIVE pressure buffer room)
>100 CFUs per 1,000 liters of air
Action levels for surface sample of ISO 8 (anteroom opening only into POSITIVE pressure buffer room)
>100 CFUs per plate
Action levels for surface sample of ISO 5 (PECs)
>3 CFUs per plate
Action levels for surface sample of ISO 7 (buffer rooms and anteroom opening into a NEGATIVE pressure room)
>5 CFUs per plate
What is a "vendor pharmacy"?
A community pharmacy or Special Closed Door Pharmacy which has a contract to dispense drugs to a patient in a facility holding a Class I Institutional Pharmacy or Modified Class IIB permit
Which pharmacists may enter into a Collaborative Practice Agreement (CPA)?
A consultant pharmacist
KNOW: What medications may a pharmacist prescribe under the test and treat law?
A formulary adopted by the board including drugs approved by the FDA indicated for tx of such conditions; NO CONTROLLED SUBSTANCES Drugs include all FDA approved medicinal (rx) drugs and all compounded drugs that utilize only active pharmaceutical ingredients approved by the FDA
What is a summary record?
A hard-copy printout summary of controlled substances dispensed in the previous 60-day period - Shall be made available within 72h of request by any authorized law enforcement personnel
KNOW: What must every pharmacy have included on their website?
A hyperlink to the health information from the Agency for HealthCare Administration - provides a consumer-friendly internet-based platform that allows consumers to research the cost of healthcare services and procedures and allows for price comparison https://pricing.floridahealthfinder.gov
KNOW: The Probable Cause Panel determines whether a complaint should be closed or an administrative complaint is filed, and a decision to either find probable cause on a complaint or to dismiss it must be made made by
A majority vote of the Probable Cause Panel
What is a low-risk override medication?
A med determined to have low risk of the following: - Drug allergy - Drug interaction - Dosing error - Adverse pt outcome
What is a physician-controlled medication?
A med distributed in an environment where a practitioner controls the order, preparation, and administration of the medication ex: ERs, ORs, recovery rooms, cath labs, etc
What is permitted for an emergency prescription refill when a pharmacist is unable to readily obtain refill authorization from the prescriber?
A onetime emergency refill of: - Up to a 72h supply of the prescribed medication - One vial of insulin
Who may charge a handling fee sufficient to cover the cost of preparation and dispensing of cancer drugs or supplies under the Cancer Drug Donation Program?
A participant facility that voluntarily takes part in the program - the fee shall be established in rules adopted by the department
KNOW: What must be done prior to dispensing drugs donated through the Cancer Drug Donation Program to an eligible patient?
A pharmacist must inspect the cancer drug or supplies to determine that they have not been tampered with or mislabeled
What suppliers are not required to report transactions to ARCOS? What must they submit instead?
A pharmacy or practitioner acting as a supplier under the 5% rule - in this case, they must submit a copy of the original DEA Form 222 to DEA either by mail or by email to [email protected] when acting as a supplier
What is a "starter dose pharmacy"?
A pharmacy that dispenses a medicinal drug pursuant to a starter dose prescription for a patient served by the vendor pharmacy
What is a "starter dose prescription"?
A prescription transmitted by a vendor pharmacy to a starter dose pharmacy for the purpose of initiating drug therapy for a patient in a facility served by the vendor pharmacy
KNOW: Cleaning is done with
A properly diluted detergent
KNOW: Decontamination is done with
A properly diluted oxidizer or other agent intended to eliminate HDs
What is required for ALL automated medication systems?
A quality assurance program
What must a pharmacist perform for override medications from an automated dispensing system?
A retrospective drug use review
What is an override medicaiton?
A single dose of a medication that may be removed from a decentralized automated medication system prior to pharmacist review bc a practitioner has determined that the clinical status of the patient would be significantly compromised by delay
What is essentially the minimum cleanroom requirement permitted under USP 797?
A single room w/ an ante-area and a buffer area A line dividing the two areas must be used to demonstrate airflow of 40 feet per minute from the buffer to ante-area The design is not recommended and is unlikely to be allowed in the future
NEED TO KNOW: What are narcotic treatment programs?
A specific type of DEA registration that permits the administration and dispensing of methadone, but NOT PRESCRIBING
KNOW: What is a closed drug delivery system?
A system in which the actual control of unit-dose or customized patient medication packages are maintained by the facility (Class I, Class II, modified Class II, or Special ALF facilities) and NOT by the individual patient
Dispenser registration numbers start with...
A, B, or F G = government
Goal for nonsterile-to-sterile compounding is to
ACHIEVE sterility
USP 797 applies to
ALL healthcare professionals who compound CNSPs and applies in ALL healthcare settings
What council approves CE's for pharmacists?
Accredidation Council for Pharmacy Education (ACPE)
What is the Infectious Disease Elimination Act (IDEA)?
Act passed into law in FL in 2019 Allows counties to set up needle and syringe exchange programs
What are the requirements for pharmacists to furnish naloxone?
Active/current pharmacist license Permit to dispense naloxone to emergency responders Copy of naloxone standing order SAMHSA Emergency Toolkit for first responders must be followed
NEED TO KNOW: The 3 and 7 day limits to C-II opioids only applies to the treatment of
Acute pain
For controlled substance transfers between registrants, they can only be made to which address?
Address listed on the DEA registration - applies to CII-CV
Federal Hazardous Substances Act of 1966
Administered by CPSC to protect consumers from Hazardous and toxic substances
Poison Prevention Packaging Act of 1970 (PPPA)
Administered by Consumer product safety commission (CPSC) Requires use of child-resistant containers for ALL prescription and certain nonprescription drugs (containers must be manufactured such that 80% of kids <5 yo CAN'T open them, but 90% of adults CAN) Pt must request easy open caps; otherwise all Rx's dispensed with child-proof caps
Adulterated or Misbranded: A pharmacist counts a medication on a tray that has residue from another medication
Adulterated
Adulterated or Misbranded: A pharmacist stores a specific product incorrectly, such as stocking a medication on a pharmacy shelf instead of in the refrigerator as required
Adulterated
Adulterated or Misbranded: A pharmacist stores inventory in a room or refrigerator where the temperature is not adequately controlled
Adulterated
Adulterated or Misbranded: An expired drug product in a manufacturer's bottle
Adulterated - b/c after the expiration date, the strength cannot be assured - if pharmacist filled a Rx with an expired drug but labeled the expiration date to be later than what the manufacturer said, then it would also be misbranded
Where may pharmacies NOT store all controlled substances?
All cannot be stored on one unsecured shelf (as in every controlled substance in the pharmacy can't be on the same unsecured shelf; either in a secure safe/cabinet or dispersed throughout pharmacy w/ non-controlled substances)
Other than prescriptions for medicaid patients, what prescriptions require tamper resistant security forms?
All controlled substances unless otherwise asked for by the patient
Who can access the PDMP?
All dispensers and prescribers of controlled substances
Which pharmacy employees must be identified by means of an identification badge?
All of them! pharmacists, interns, and techs
Locations that Test & Treat Protocol (TTP) is permitted
All settings
Where can DTM under a PCP be utilized
All settings - must be under auspices of a pharmacy permit providing a transferable patient care record, a private area for pharmaceutical care, and a CQI plan
In what settings can physicians authorize PharmD's to order and interpret laboratory tests?
All settings serviced by a Home Health Agency
Under USP 800, how should PPE be disposed?
All worn PPE should be placed in an appropriate waste container and disposed of properly PPE used in compounding HDs should be discarded in proper containers before leaving the C-SEC
KNOW: What is the Test and Treat legislation?
Allows certified pharmacists to test or screen for and treat minor, nonchronic health conditions w/in the framework of an established written protocol w/ a supervising physician (DO or MD)
NEED TO KNOW: What does the Drug Addiction Treatment Act of 2000 (DATA 2000) do?
Allows office-based, specially trained practitioners to prescribe certain narcotic C3-5 drugs to treat opiate dependence through a risk management program outside of a narcotic treatment facility
What is the Drug Therapy Management law?
Allows pharmacists to provide DTM services in compliance w/ orders in a "Prescriber Care Plan" written by an MD/DO, PA, dentist, or podiatrist ---> APRNs not included, but PA's are!!
NEED TO KNOW: When are controlled substances valid as electronic prescriptions?
Always if both the prescriber's and pharmacy's computer meet all DEA requirements
Drug Quality and Security Act of 2013 (DQSA)
Amendments (DCQA & DSCSA) to the FDCA that addressed two primary topics: 1. Large-scale compounding by pharmacies 2. Establishment of a framework for a uniform track-and-trace system for Rx drugs throughout the supply chain to prevent counterfeit drugs
Chemotherapy gloves must meet the ______ standard and should be worn when handling any HD.
American Society of Testing Materials (ASTM) standard D6978
What is a psychiatric nurse?
An APRN with the following qualifications: - A master's or doctoral degree in psychiatric nursing - Nationally certified as a psychiatric mental health APRN - Has 2 years of post-master's clinical experience under supervision of MD/DO
What is the Hazard Communication Standard
An OSHA standard that requires employers to inform employees about hazardous substances in the workplace and to educate and train them in safe and proper handling. The standard is commonly known as the "Right to Know Law". - drugs in solid, final dosage form for administration are exempt
KNOW: Antineoplastic HDs in NIOSH Table 1 that will be compounded to make the final preparation and Active Pharmaceutical Ingredients (API) of any NIOSH HDs must be stored in
An area away from non-HDs to prevent contamination or personnel exposure
Who runs the FBOP?
An executive director who is an employee of the - is NOT one of the 9 board members - does NOT have to be a pharmacist
What is a prescriber care plan?
An individualized assessment of a patient and orders for specific drugs, lab tests, and other pharmaceutical services intended to be dispensed or executed by a pharmacist Specifies the conditions under which the pharmacist can order lab tests, interpret values, execute drug therapy orders for a pt, and notify the prescriber
KNOW: Any entity handling HDs must maintain Standard Operating Procedures (SOPs) for safe handling of HDs at all stages and locations where HDs are found in the facility, and these SOPs must be reviewed at least ______ and should include a hazard communication program, occupational safety program, designation of HD areas, and items discussed in the slide before this.
Annually
KNOW: Facilities using hazardous drugs must perform an assessment of risk at least ________ to determine if new or alternate containment strategies need to be employed to mitigate risks for exposure from HDs.
Annually
KNOW: How often is a pharmacy inspected if they fail to pass an inspection or are disciplined during the two-year inspection cycle?
Annually - until it achieves passing inspections and no discipline for the most current 3-year period
Pressure gradient between anteroom that opens into general area of pharmacy
Anteroom >0.020 positive than general area
Minimum pressure gradient required between anteroom to adjacent general area
Anteroom must be at least 0.020" MORE POSITIVE than general area
In general, what are institutional pharmacy permits required for?
Any location in any healthcare institution where medicinal drugs are compounded, dispensed, stored, or sold
How may CE courses being taken as part of a disciplinary order be conducted (unless otherwise ordered by the Board)?
Any method (live, correspondence, distance education, etc)
Wintergreen Oil warning statement
Any more than 5% methyl salicylate (often used as a flavoring agent) must include warning that it can be deadly to children and must be kept out of reach of children
KNOW: What are the library requirements in a pharmacy?
Any of these or equivalent: - US Pharmacopeia/National Formulary - US Dispensatory - US Pharmacopeia Drug Information - Remington's Science and Practice of Pharmacy - Facts and Comparisons
Duly authorized agents and employees of the DOH may inspect what pharmacies under the Authority to Inspect law?
Any pharmacy, hospital, clinic, wholesale establishment, manufacturer, physician's office, or anywhere else in the state where drugs and medical supplies are compounded, manufactured, packed, packaged, made, stored, sold, offered for sale, exposed for sale, or kept for sale for the purpose of: - Determining if any provision of this chapter or any rule adopted under its authority is being violated - Securing samples or specimens of any drug or medical supply after paying or offering to pay for such sample or specimen; or - Securing such other evidence as may be needed for prosecution under this chapter May inspect the following pursuant to this section: - Registered nonresident pharmacy - International export pharmacy permittee - Registered nonresident sterile compounding permittee
How should losses of listed chemicals be reported?
Any unusual or excessive loss or disappearance (including theft) of a listed chemical should be reported to the DEA at the earliest practicable opportunity
In a hospital setting, what are PA's allowed to write orders for?
Anything
DEA registration applications must be signed (or electronically signed) by ______ if it's for an individual, by a ______ if it is for a partnership, or by a ______ if it's for a corporation.
Applicant Partner Officer
KNOW: What is a "delinquent license" and who does this apply to?
Applies to pharmacist, consultant pharmacist, nuclear pharmacist, and pharmacy technician registrations - If a license or registration is not renewed in time, it automatically reverts to delinquent status
Therapeutic equivalent definition
Approved drug products that are pharmaceutical equivalents for which bioequivalence has been demonstrated, and they can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling
What is the Tripartite Continuing Education Committee and who is it comprised of?
Approves CE providers and courses submitted by providers Comprised of Equal Representation from: - FBOP - Each College/School of Pharmacy in the State - Practicing pharmacists
Per the 2008 version of USP 797, Master Formulation Records and Compounding Records (are/are not) required.
Are NOT - in any case, appropriate records should be developed and maintained
NEED TO KNOW: What is the only way methadone can be legally dispensed from a pharmacy?
As an analgesic (for pain tx)
Compounding technique requires ______ technique as a core practice that must be mastered.
Aseptic
When must PPE be worn for HDs?
At all stages of the handling of HDs, from receiving to waste disposal
Time limit that a licensee may reapply for licensure after revocation
At least 1 year
KNOW: Who is the Probable Cause Panel composed of?
At least 2 board members
Destruction of controlled substances in an Institutional Class I (Nursing Home) Pharmacy must be witnessed by
At least 2 of the following: 1. Consultant pharmacist 2. Director of nursing 3. Facility administrator (diff than other witnesses for normal pharmacies) 4. A licensed physician, mid-level practitioner, nurse, or another pharmacist employed by or under contract w/ the facility 5. A sworn law enforcement officer
How often must information stored in a computer be backed up?
At least weekly
KNOW: Where must the inventory for the contents of Emergency Medication Kits in nursing homes be places and what must it include?
Attach to OUTSIDE of kit Include earliest expiration date of kit drugs *If seal is broken, kit must be RESTOCKED and RESEALED the next business day after use*
What does the Institutional Formularies and Therapeutic Substitution in Nursing Homes legislation allow?
Authorizes nursing homes to implement an institutional formulary and for a pharmacist to therapeutically substitute medicinal drugs under the established formulary
Which pharmacist does the remote medication order processing rule apply to?
Automated dispensing systems Special pharmacy permits servicing class I, class II, modified class II, class III, and special ALF permitted facilities
Most suppliers (e.g., wholesalers) are required to report the acquisition and disposition of C-II and certain C-III and C-IV controlled substances to the DEA's _______.
Automation of Reports and Consolidated Orders System (ARCOS)
How to remember FDA drug and device recall classifications
B/C in CLASS we would CALL (sing) this: 1st is the worst, 2nd is the best, 3rd is the one w the treasure chest
Sign requirements for prescription department closed
BOLD LETTERS not less than 2 inches in height, stating "Prescription Department Closed"
Do you have to wear two gloves or two shoe covers when compounding HDs?
BOTH
What requirements must a drug meet in order to be considered generically equivalent?
BOTH of the following: 1. Pharmaceutically equivalent to the reference drug 2. Therapeutically equivalent to the reference drug
Ipecac warning statement
BOXED AND IN RED LETTERS "For emergency use to cause vomiting in poisoning. Before using, call physician, the poison prevention center, or hospital ER for emergency advice" "Warning: Keep out of reach of children. Do not use in unconscious persons" Dosage must appear - usually 1 tbsp (15 mL) in persons above 1 year May only be sold in 1 oz (30 mL) containers
KNOW: Facilities that mix only low and medium-risk level CSPs must test for ______.
Bacteria
KNOW: Facilities that mis high-risk level CSPs must test for ______
Bacteria AND fungus
USP 85
Bacterial endotoxin test(adopted by florida law)
USP Chapter 85
Bacterial endotoxin tests Used for lyophilized CSPs
FDA medical device classifications
Based on risk associated with the device - OPPOSITE OF THE RECALL CLASSIFICATIONS 1st = low risk 2nd = moderate risk 3rd = highest risk
Why is the DEA Form 41 not required for destruction by a Class I Institutional Pharmacy?
Because these drugs have already been dispensed to the patients and are accounted for in the dispensing records of the pharmacy servicing that nursing home
Why aren't Laminar airflow workbenches or Compounding Aseptic Isolators (CAIs) acceptable for compounding antineoplastic HDs?
Because they are positive pressure devices
Under USP 800, when must a second pair of shoe covers be donned?
Before entering the C-SEC - must be removed before leaving the HD handling areas and entering other areas of the facility
The Combat Methamphetamine Epidemic Act of 2005 requires all products containing "listed chemicals" (pseudoephedrine, ephedrine, phenylpropanolamine) to be stored
Behind a counter (not necessarily a pharmacy counter) or in a locked cabinet, if located on the selling floor
How often are controlled substance inventories required?
Biennially (every 2 years) - initial inventory is done on the 1st day a pharmacy is open for business
How often is renewal?
Biennially, September of odd years
FDA Purple Book
Biologic interchangeability book
Florida allows emergency refills for which drugs?
Both non-controlled and C3-5 drugs
Adulterated or Misbranded: A misfilled prescription involves the wrong strength of the drug prescribed
Both! - wrong drug, strength, or directions on label = misbranded - wrong strength of prescribed drug = adulterated
Pressure gradient between nonhazardous buffer room and anteroom
Buffer >0.020 more positive than anteroom
Pressure gradient between hazardous buffer room and anteroom
Buffer room between 0.010 and 0.030 negative to anteroom
Minimum pressure gradient required between nonhazardous buffer room to anteroom
Buffer room must be at least 0.020" MORE POSITIVE than anteroom
Minimum pressure gradient required between hazardous buffer room to anteroom
Buffer room must be between 0.010 and 0.030" NEGATIVE to anteroom
When _______ are used, those active pharmaceutical ingredients (APIs) must comply with the standards in a USP monograph and the applicable USP compounding standards.
Bulk drug substances
How may a prescriber prohibit generic substitution on a verbal prescription?
By expressly indicating to the pharmacist that the brand name drug prescribed is medically necessary
How may a prescriber prohibit generic substitution on an electronic prescription?
By making an overt act to indicate that the brand name drug prescribed is medically necessary
KNOW: How is sterilization of a high-risk CSP achieved?
By using terminal sterilization such as an autoclave, or by filtration - both require quality control measures to ensure they have performed as intended
Any prescription for a narcotic that is not mixed with another drug, regardless of concentration, will always be in Schedule ____.
C-II - Ex: if codeine or opium is only mixed w/ water or simple syrup rather than with a non-narcotic therapeutic agent
A compounded narcotic prescription will never be a schedule ____.
C-IV
A C-SEC is the room in which the _____ is located.
C-PEC
KNOW: Engineering control requirements for nonsterile HD compounding for C-PEC and C-SEC
C-PEC: - Externally vented (preferred) or redundant-HEPA filtered w/ HEPA filters in series C-SEC: - Room separate from non-HD activities - Negative pressure (0.010-0.030-inch water column) relative to adjacent areas - Externally vented - 12 ACPH
KNOW: For Unclassified C-SCAs for sterile HD compounding, what are the C-PEC and C-SEC requirements?
C-PEC: - Vented externally (ex: Class 2 BSC or CACI) C-SEC: - Room separate from non-HD activites - Vented externally - 12 ACPH - Negative pressure
KNOW: For ISO Class 7 buffer rooms w/ ISO Class 7 anterooms for sterile HD compounding, what are the C-PEC and C-SEC requirements?
C-PEC: - Vented externally (ex: Class 2 BSC or CACI) C-SEC: - Room separate from non-HD activities - Vented externally - 30 ACPH - Positive pressure anteroom - Negative pressure buffer room
Minimum pressure gradient required between Containment Segregated Compounding Area (C-SCA) to adjacent general area
C-SCA must be between 0.010 to 0.030" NEGATIVE to adjacent area
KNOW: In general, a dispensing practitioner may NOT dispense a controlled substance listed in what schedules?
C2 or C3
NEED TO KNOW: What controlled substances are valid when issued as verbal prescriptions?
C3-5 Emergency ONLY: - C2
NEED TO KNOW: What controlled substances are valid when issued as faxed prescriptions?
C3-5 with prescriber's original signature (NOT electronic!!) Special Circumstances ONLY: - C2; see in a few slides
KNOW: What immunizations or vaccines are pharmacists AND interns authorized to give to adults?
CDC Immunization Schedule Vaccines: (13 total) - Influenza (pharmacists only can do kids 7+) - Tetanus, Diphtheria, Pertussis (Td/Tdap) - Human papillomavirus (HPV) - Zoster recombinant (RZV) - Measles, mumps, rubella (MMR) - Pneumococcal 13-valent conjugate (PCV13) - Pneumococcal polysaccharide (PPSV23) - Meningococcal A, C, W, Y (MenACWY) - Meningococcal B (MenB) - Hepatitis A (HepA) - Hepatitis B (HepB) - Haemophilus influenzae type b (Hib) - Varicella (VAR) - Immunizations recommended by CDC for international travel - Immunizations licensed for use in US or for emergency use by FDA - Immunizations approved by board in response to state of emergency declared by the Governor
What electronic tracking system is used by all healthcare providers licensed by the FDOH to track their CE hours?
CE Broker
The FDOH will not allow you to renew your license if you do not have the required CE hours reported in _______.
CE broker
What schedule drugs can animal shelters have?
CII and CII? (Pentobarb and pentobarb with lidocaine for euthanasia)
What schedule drugs can PA's prescribe?
CII-CV
What schedule drugs can NP's prescribe?
CII-CV under physician supervision
What schedule drugs can optometrists prescribe?
CIII and CIV (APAP with codeine and tramadol)
Requirements for renewal of Collaborative Practice Agreement
CP license renewal (24h CE per license cycle)
All ACPE-approved providers report CE hours to _______.
CPE Monitor (online CE tracker through NABP)
What task is not delegable?
Calling in emergency C2 rx's
Where must final dosage forms of NIOSH Table 1 HDs and other HDs be stored?
Can be stored w/ non-HD inventory if permitted by entity policy in the Assessment of Risk
What are the different types of institutional pharmacy permits?
Class I - Nursing homes Class II - Hospitals Modified Class II - Primary alcoholism treatment centers - Free-standing ERs - Rapid in/out surgical centers - Certain county health programs - Correctional institutions Class III - Institutional pharmacies, including central distribution facilities, affiliated with a hospital that provide the same services issued with a Class II permit - Intended for big facilities w multiple locations so the central fill facilities can distribute meds to all their locations Special Pharmacy Permits - 8 different types - will cover later
KNOW! What type of central fill pharmacy is restricted to only delivering medications to the originating pharmacy?
Class II Institutional Central Fill (hospital)
Which institutional pharmacy classes may do limited outpatient dispensing, but must obtain a Special-Limited Community Pharmacy Permit to do so?
Class II and III
KNOW: The smaller the ISO number, the _______ the air.
Cleaner
Time limit to report dispensing of a controlled substance
Close of next business day to the PDMP
What must be used for administration of Table 1 NIOSH antineoplastics and for compounding?
Closed system drug-transfer devices (CTSDs)
What form is used to inspect/assess pharmacies in Florida?
Community inspection form by the Florida Department of Health
Only ______ ______ can dispense Schedule II or III controlled substance prescriptions.
Community pharmacies - NOT physicians
How to obtain immunization certification
Complete 20h of CE for safe & effective vaccine administration, including CPR training
If transferring a Controlled Substance (II) to another registrant, what must be done by the receiving pharmacist?
Complete a DEA Form 222 to be sent to the supplier/seller
KNOW: Requalification glove fingertip test requirements
Compounder must complete 1 set (2 plates), and the # of CFUs cannot exceed 3 on both plates
KNOW: Initial glove fingertip test requirements
Compounder must complete 3 sets (6 plates) with no growth
In Institutional Class I (Nursing Home) Pharmacies, the _____ must review all controlled substance destruction documentation every _______ to ensure compliance.
Consultant pharmacist Month
The separate room and negative pressure work to ______ the hazard, whereas external ventilation and air changes per hour work to _____ the hazard.
Contain, Remove
Negative pressure rooms assist in
Containing hazards - so are used for hazardous ("chemo") buffer rooms
What is a CQI
Continuous quality improvement program which is a system of standards and procedures to identify and evaluate quality-related events and improve patient care
Florida law prohibits pharmacies from advertising the sale of...
Controlled Substances
DEA allows electronic ordering of C-II drugs through the
Controlled Substances Ordering System (CSOS)
Under all pharmacy permits, promoting sale of what drugs is prohibited?
Controlled substances
When a purchaser is filling out a single copy DEA Form 222, a copy (paper or electric) must be made for ______ and the original form must be submitted to ______.
Copy = purchaser records Original = supplier
Durham-Humphrey Amendment of 1951
Created OTC vs. Legend drugs Verbal prescriptions Prescription refills
What are pharmacies not allowed to advertise?
DMSO: Must state "Warning. May be Unsafe. Not approved for human use." Any false advertisement about a drug/device/cosmetic Controlled substance sales
KNOW: How often must floors, counters, and other easily cleanable surfaces be cleaned?
Daily
Beyond use date definition
Date beyond which a CSP must not be used Established by compounders for their preparations (diff from expiration date which is provided by manufacturers for their products)
Per USP 800, the cleaning process for hazardous drugs must start with ______, then _____.
Deactivating the drug (when possible) Decontaminating the surfaces that HDs have touched
KNOW: What does the automated distribution and packaging rule for institutional pharmacies apply to?
Decentralized automated distribution systems such as Pyxis machines or package medications for final distribution by a pharmacist (centralized automated distribution systems)
How are controlled substances destroyed in an Institutional Class I (Nursing Home) Pharmacy?
Destroy w/ documentation of: - Name of drug - Quantity - Strength - Dosage form - Patient's name - Rx number - Name of institution (no DEA Form 41 needed)
The person in charge of compounding needs to establish and maintain adequate policies and procedures to ensure safe & reproducible CNSPs. The standard operating procedures (SOPs) should include
Details concerning: - Facilities - Equipment - Personnel - Receipt - Storage - Compounding - Other elements
PECs and SECs are cleaned with a ________, followed by application of _______.
Detergent ---> sterile 70% isopropyl alcohol
KNOW: Which drugs CANNOT be generically substituted?
Digitoxin Conjugated estrogen Dicumarol Chlorpromazine (solid oral dosage form) Theophylline (controlled release) Pancrelipase (oral dosage form)
NEED TO KNOW: What is short-term detoxification through narcotic treatment facilities?
Dispensing of a narcotic drug in decreasing doses for a person not to exceed 30 days
NEED TO KNOW: What is long-term detoxification through narcotic treatment facilities?
Dispensing of a narcotic drug to a narcotic-dependent person in decreasing doses for 31-180 days
What does the 2013 Drug Quality and Security Act (DQSA) do?
Distinguishes 503A entities from 503B entities in terms of USP's authority over compounding
When registrants authorize other individuals to execute the DEA Form 222, where should the Power of Attorney (POA) be sent?
Does NOT need to be sent to DEA Just maintained in the pharmacy
KNOW: Under what conditions may a cancer drug be accepted or dispensed in the Cancer Drug Donation Program?
Drug is in its original, unopened, sealed container, or in a tamper-evident unit-dose packaging - except a cancer drug packaged in single-unit doses may be accepted and dispensed if the outside packaging is opened but the single-unit-dose packaging is unopened w/ tamper-resistant packaging intact
Pharmaceutical equivalent definition
Drug products with identical - dosage forms - route(s) of administration - amounts of the active drug ingredient
Middle 3 to 4 digits of NDC
Drug, strength, dosage form
Food, Drug, and Cosmetic Act (FDCA) of 1938
Due to sulfanilamide elixir deaths New drugs must be SAFE before marketing Established the FDA
What is the name of Florida's PDMP?
E-FORCSE Includes all CII-CV
Under USP 800, when unpacking HDs not contained in plastic, personnel should wear what?
Elastomeric half-face masks which have been fit-tested w/ /a P100 filter and a multi-gas cartridge
Florida law requires ALL prescriptions to be transmitted _______ unless certain exceptions are met.
Electronically - know exceptions!! on a previous slide somewhere or pg 123 of book
What must the purchaser do when they receive an unaccepted electronic order from the supplier?
Electronically link the statement of nonacceptance to the original order
What is one of the rare exceptions where DEA allows non-dispensed (or bulk) controlled substances to be stored at a location that does NOT have a DEA registration?
Emergency Medication Kits in nursing homes
A pharmacist, acting in good faith and exercising reasonable care, is NOT subject to discipline or other adverse action under any professional licensure statute or rule and is immune from any civil or criminal liability as a result of dispensing a(n) _______.
Emergency opioid antagonist
KNOW: In the event that an institutional pharmacy dispenses a medication to a patient of the ED, what is the days supply limit?
Enough to last for 48h or until the end of the NEXT business day,whichever is GREATER If governor-declared emergency, can dispense a 72h supply
USP General Chapters contains what information?
Established procedures, methods, and practices ex: USP 795, 797, and 800
An (exact/estimated) count is required for CIII-CV drugs, unless the container holds >1,000 tablets or capsules.
Estimated
Orders for _______ and ________ with DEA Form 222 must contain ONLY orders for these substances.
Etorphine hydrochloride Diprenorphine
KNOW: How often is a pharmacy inspected that has had passing inspections for the last 3 years with no discipline in that time frame?
Every 2 years
Medication regimen reviews must occur...
Every 30 days
How often to change chemo gloves?
Every 30 minutes
How often must PECs and SECs be certified?
Every 6 months
How often must electronic air sampling be performed in places that make CSPs?
Every 6 months
When to media fill/glove test for high risk CSP?
Every 6 months
An (exact/estimated) count is required for all C-II drugs.
Exact
Difference between expiration date and beyond use date
Exp date: - Manufacturer exp date BUD: - 1yr from dispensing
T/F: A prescription that was shipped to a patient but NOT delivered is still considered to be dispensed by the BOP.
FALSE - NOT considered to be dispensed by BOP and therefore may legally be returned to stock, but should only be done based on pharmacist's professional judgment
T/F: CBD containing no more than 0.1% THC is a schedule V drug.
FALSE - no longer controlled as of 2020
Prescription drug advertising is regulated by _____.
FDA
What FDA book contains approved drug products with therapeutic equivalence evaluations?
FDA Orange Book
KNOW: The _____ mandates the use of USP standards for compounding.
FDCA
Pharmacist requirements to enter into a PCP for DTM
FL pharmacist license
What act recognizes USP standards?
Federal Food, Drug, and Cosmetic Act (FDCA)
OTC advertising is regulated by _____.
Federal Trade Commission (FTC)
Opium C-III concentration limit for FEDERAL and FLORIDA law
Federal: - 500 mg/100 mL and 25 mg/dosage unit - 5x its C-V limit Florida: - None listed - This means that in FL, any compounded opium product > 100 mg/100 mL goes from C-V straight to C-II
Which controlled substances are required to have the federal transfer warning on the label when dispensed to the patient?
Federal: - CII-CIV Florida: - ALL CONTROLS - CII-CV Exception: - If CS is dispensed in a blinded clinical study
An applicant for DEA registration can authorize another individual to sign the application and renewals by
Filling out a Power of Attorney - grants that individual the authority and filing that Power of Attorney with the DEA Registration Unit - helpful if a company/corporation wants a pharmacist to be responsible for applying and renewing the DEA registration but the pharmacist is not an officer of the corporation
Which drug is in different schedules federally?
Fioricet: CIII (Like Fiorinal)
What is the second letter of the DEA registration number?
First letter of last name
_______ -approved CE providers will automatically report your hours to CE broker, but they may have to be reported manually from ______ providers.
Florida National (ACPE)
NEED TO KNOW: What recordkeeping system is required to be used in FL for pseudoephedrine sales?
Florida Department of Law Enforcement electronic recordkeeping system
NEED TO KNOW: What is the total maximum quantity of codeine that may be sold OTC to any one purchaser within a 48-hr time period?
Florida: 120 mg Federal: 120 cc (4 oz)
NEED TO KNOW: What is the total maximum quantity of opium that may be sold OTC to any one purchaser within a 48-hr time period?
Florida: 240 mg Federal: 240 cc (8 oz)
NEED TO KNOW: What is the total maximum quantity of ethyl morphine that may be sold OTC to any one purchaser within a 48-hr time period?
Florida: 30 mg Federal: 120 cc (4 oz)
NEED TO KNOW: What is the total maximum quantity of dihydrocodeine that may be sold OTC to any one purchaser within a 48-hr time period?
Florida: 60 mg Federal: 120 cc (4 oz)
NEED TO KNOW: What is a pharmacist permitted to do if they are unable to fill the entire quantity on a C2 prescription?
Follow the 72-hr Rule: - provide a partial quantity so long as the remaining quantity is provided within 72 hours - If the remaining quantity cannot be provided, the pharmacist must notify the prescriber
When may extensions of time to report PDMP data be granted?
For no more than 30 days Upon request to the program if: - Unable to submit data by electronic means - Mechanical or electronic failure is preventing reporting - The system is unable to receive submissions
What are the laws for placement of C-PECs for sterile and nonsterile compounding under USP 800?
For places that compound both sterile & nonsterile HDs, the C-PECs must be located in separate rooms, unless the C-PECs used for nonsterile compounding can effectively maintain ISO 7 air quality in the room If C-PECs for nonsterile and sterile compounding are located in the same room, they must be placed at least 1 meter apart If the C-PECs are in the same room, any nonsterile compounding that generates particulate matter may not be performed when sterile compounding is being performed
Under what circumstances may a pharmacist leave the prescription department?
For purposes of consulting or providing assistance to patients, attending to personal hygiene needs, taking a meal break, or providing other functions for which the pharmacist is responsible for
NEED TO KNOW: In what circumstances are quantity limits enforced for schedule II prescriptions?
For schedule II opioid products used for acute pain - 7-day supply
NEED TO KNOW: In which situation must a prescriber issuing an rx for a C-II opioid concurrently prescribe an emergency opioid antagonist?
For treatment of NON-ACUTE pain related to a traumatic injury with an Injury Severity Score of >/=9
What is done if the complaint is not considered a minor violation or one that can be resolved with a citation?
Formal disciplinary action may be taken
Modified Class II A Institutions
Formulary limited to 15 drugs Must not have large stock bottles of controlled substances (>100 dosages) <10% of registrations Ex. Methadone Clinics. Dialysis Center
FDA Orange Book
Generic equivalency book, A is interchangeable
FBOP members are appointed by the ______ and confirmed by the ______.
Governor FL Senate
Tripartite Continuing Education Committee
Has the authority to approve CE providers and approval of courses submitted by providers Made up of equal representation from the FLBOP, each College of Pharmacy and practicing pharmacist
What are requirements for outsourcing facilities?
Have a licensed pharmacist Register as an outsourcing facility Report to the Secretary of HHS on registering and every 6 months Be inspected by the FDA Report serious adverse events within 15 days Label products with identifying statement as compounded products Only compound bulk drugs that have a clinical need and/or on shortage - NOT EXEMPT FROM cGMP
USP 800
Hazardous Drugs - Compounding in Healthcare Settings NOT OFFICIALLY ADOPTED IN FLORIDA
HITECH Act
Health Information Technology for Economic and Clinical Health Act Amended HIPAA to strengthen its provisions; added a breach notification requirement that requires: 1. Covered entities to notify ppl of a breach of their "unsecured" PHI w/in 60 calendar days after breach is discovered 2. Business Associates (BAs) must report any breaches to the covered entity and provide identities of each affected person 3. Breach = unauthorized acquisition, access, use, or disclosure of PHI that comprises its security or privacy 4. Breaches affecting <500 ppl --> covered entities must maintain a log and notify HHS of the breaches annually 5. Breaches affecting >500 ppl --> Secretary of HHS and local media must be notified in addition to affected individuals within 60 days of discovery of the breach
What level risk is mixing an alum irrigation from an Active Pharmaceutical Ingredient (API)?
High
KNOW!! The media fill tests and requalifying glove fingertip tests must be done at least every _____ if high-risk CSPs are mixed, or at least every _____ if only low- and medium-risk CSPs are mixed.
High: - 6 months Med-Low: - 12 months
Class II medical devices + example
Higher risk and require greater regulatory controls than Class I Ex: Syringes
Class III medical devices + example
Highest risk devices & subject to highest level of regulatory control; Those that pose a significant risk of illness or injury require premarket approval by FDA Ex: Replacement heart valves REMEMBER: if u have 3 of your 4 heart valves replaced you are at HIGH risk for everything; so class 3 = worst!!!!
What are primary engineering controls (PECs)?
Hoods - Devices in which CSPs are mixed
Class III Institutional Pharmacy Permit
Hospital pharmacies including central distribution facilities, affiliated w/ a hospital, that provide the same services authorized by a Class II institutional pharmacy Allows Pharmacy To: 1. Dispense, distribute, compound, and fill rx's 2. Prepare prepackaged drugs 3. Conduct other pharmaceutical services for the affiliated hospital and for entities under common control that each are permitted to possess medicinal drugs Facilities can have Class III alone or have it in conjunction w/ another permit
Class II Institutional Pharmacy Permit
Hospitals - encompasses pharmacists that provide dispensing and consulting services on the premises to pts of that institution, for use on the premises of that institution
NEED TO KNOW: Sales of methadone 40mg from manufacturers are restricted to
Hospitals and narcotic treatment clinics ONLY - no retail pharmacies
What must internet pharmacies have on their container label?
Hours Toll-free number
Compounded sterile products prepared for lyophilization shall be maintained in an ISO _____, ____directional laminar flow air throughout sterilization, filling, and transport from the PEC into the lyophilizer.
ISO 5 unidirectional laminar flow
ISO classification for a negative pressure buffer room
ISO 7
ISO classification for a positive pressure buffer room
ISO 7
ISO classification for an anteroom that opens into negative pressure rooms
ISO 7
ISO classification for an anteroom that opens into positive pressure buffer rooms
ISO 8
KNOW: For PECs used in the compounding of sterile non-HD preparations AND for C-PECs, what is the ISO air quality requirement?
ISO Class 5
Per USP 797, when closed-system vial-transfer devices (CSTDs) are used, they shall be used within an ISO Class ____ environment of a ______.
ISO Class 5 BSC or CACI
What are secondary engineering controls (SECs)?
IV room or IV lab - Rooms in which the PEC is placed
What is adulteration?
If a drug: - contains any filthy, putrid, decomposed substance - prepped or stored in unsanitary conditions - does not meet gmp's - is manufactured, processed, packed, or held in any establishment where the owner denies/refuses inspection - composed of any poisonous or deleterious substance which may contaminate it - includes unsafe color additive - product claims to meet USP standards and its strength or quality does not meet those standards -contains drug recognized in or not official compendia, but its strength, purity, or quality is lower than the official standards - mixed or packed w/ any substance that reduces its strength or quality, or drug has been substituted in whole or in part
When is a pharmacy permitted to reuse a glass container for a prescription?
If a new safety cap is provided with each fill
When may a pharmacist fill a prescription from out-of-state prescribers?
If determined that the order is valid and necessary for the treatment of a chronic or recurring condition (including controls)
When are products considered interchangeable?
If it has been shown to be biosimilar to the reference product and can be expected to produce the same clinical result as the reference product in any given patient - MUST be designated "interchangeable" in order to be substituted for the original reference product by a pharmacist; if biosimilar without "interchangeable" designation, would need prescriber intervention to substitute
NEED TO KNOW: What is the only way that methadone or any other drug can be dispensed for the maintenance or detoxification of addicts?
If it is provided through a registered narcotic treatment center
NEED TO KNOW: Which pharmacy is able to request an exemption from utilizing the electronic recordkeeping system for pseudoephedrine sales?
If it maintains a sales volume of <72g of base product in a 30-day period
KNOW: What are the requirements for separate DEA registrations for automated pharmacy systems at nursing homes?
If nursing home is using the system to dispense routine meds OR using it as an emergency med kit, a separate DEA registration for the automated pharmacy system at the facility is required in the name of the provider pharmacy
KNOW: When may the Board refer pharmacists to the PRN program?
If the Board receives a complaint regarding impairment under certain circumstances
When may a pharmacist dispense a substitute biological product?
If the FDA has determined that the product is biosimilar and interchangeable for the prescribed biological product - can be found in FDA Purple Book - the BOP is required to maintain a list of current biological products that the FDA has determined are biosimilar and interchangeable
KNOW: Under what conditions may a telehealth provider prescribe controlled substances in Florida?
If the controlled substance is prescribed for any of the following: 1. Tx of a psychiatric disorder 2. Inpatient tx at a hospital 3. Tx of pt receiving hospice services 4. Tx of a resident of a nursing home facility
When may a C-PEC not be required?
If the entity compounds only nonsterile, non-HD drugs, or if they are not manipulating HDs in any form except handling the final dosage forms
NEED TO KNOW: Under FL law, what is a major exception to requiring ID from a patient picking up a controlled prescription?
If the med was adjudicated (billed) through the health plan
Under what circumstances may a community central fill pharmacy deliver non-controlled medications for an originating pharmacy DIRECTLY to a patient?
If the pharmacies have a pharmacist available 40 hours/week, either in person or via two-way communication technology (telephone, etc), and a toll-free number to provide counseling
NEED TO KNOW: When may a pharmacist change items such as drug strength, dosage form, quantity, or directions for use on a C2 prescription?
If the pharmacist: 1. Contacts the prescriber and receives verbal permission for the change 2. Documents on rx that the change was authorized, the name/initials of the individual granting authorization, and the pharmacist's initials
KNOW: When may a pharmacist administer a long-acting antipsychotic medication approved by the FDA by injection to a patient?
If the pharmacist: - Is authorized by & acting w/in the framework of an established protocol w/ the prescribing physician - Practices at a facility that accommodates privacy for non-deltoid injections and conforms w/ state rules and regulations regarding the appropriate and safe disposal of medication and medical waste - Has completed the 8hr CE course that concerns the safe and effective administration of behavioral health and antipsychotic meds by injection, including, but not limited to, potential allergic rxns to such meds ----> Can count towards the required 30h of pharmacist CE for license renewal
Under what circumstance would the requirement to mark the hard-copy controlled substance prescription with a red "C" be waived?
If the pharmacy maintains records in a computer system that allows for identification by Rx number and retrieval of original documents by: - Prescriber's name - Patient's name - Drug dispensed - Date filled
When may the pharmacist therapeutically substitute medicinal drugs in accordance with an institutional formulary established for the resident of a nursing home facility?
If the prescriber has agreed to the use of such institutional formulary for the patient and if rx does not include "no therapeutic substitution" or prescriber did not overtly indicate that it is prohibited
NEED TO KNOW: What is an exception to the law that states C3-5 prescriptions may only be transferred as refills after the original prescription has been filled at least once?
If the rx is an original electronic prescription for a controlled substance (EPCS) and both pharmacies transferring the rx have the capability to forward and receive the EPCS using an electronic sharing platform, they are legally allowed to transfer original prescriptions for even C2 drugs!
Under what circumstances may a vendor pharmacy transmit a starter dose prescription (excluding controlled substances) to a starter dose pharmacy?
If the vendor pharmacy: 1. Has written authorization from the facility to use a starter dose pharmacy 2. Has written authorization from the prescriber, directly or via facility agreement, to act as the prescriber's agent to transmit the starter dose prescription 3. Has a valid rx from the prescriber prior to transmitting the starter dose rx 4. Maintains a record of each starter dose rx 5. Maintains a policy and procedure manual that references starter dose rx *This allows a pharmacy serving a facility such as a nursing home to get a new rx to a patient QUICKLY utilizing a closer, local pharmacy to provide the initial dose or doses*
When shall the department or board deny an application for a pharmacy permit?
If they have done any of the 20 things listed in the slide a few cards ago, or any of the following: 1. Has been terminated for cause from the Florida Medicaid program unless the applicant has been in good standing w/ the FL Medicaid program for the most recent 5-year period 2. Has been terminated for cause from any other state Medicaid program, unless the applicant has been in good standing w/ the FL Medicaid program for the most recent 5-year period and the termination occurred at least 20 yrs before the date of application 3. Is currently listed on the US DOH and Human Services Office of Inspector General's List of Excluded Individuals and Entities
How often is a pharmacy inspected?
If they have passing scores over the past 3 years, they must be inspected every 2 years thereafter. They will be inspected annually if they receive a failing score
NEED TO KNOW: Under what circumstance when receiving a controlled substance prescription does the pharmacist have a duty to report to the Florida Department of Health?
If they have reason to believe that a prescriber is involved in the diversion of controlled substances
KNOW: When is a pharmacy permitted to perform centralized prescription filling for another pharmacy?
If they have the same owner OR have a contract w/ the other pharmacy
When would an individual practitioner need to have an additional DEA registration?
If they maintain a supply of controlled substances at a second site or if the 2nd site is in another state
KNOW: When will a pharmacist with impairment NOT be referred to the Board for discipline?
If they voluntarily enter into a contract for treatment with PRN, as long as they acknowledge the impairment and successfully complete the program
NEED TO KNOW: Under what circumstances may a hospital that is not part of a narcotic treatment program administer narcotics to a drug-dependent person for either detoxification or maintenance therapy?
If they're being treated in the hospital for a condition other than addiction
The DOH or Board may revoke or suspend the permit of any pharmacy permittee, and may fine, place on probation, or otherwise discipline any pharmacy permittee if the permittee, or any affiliated person, partner, officer, director, or agent of the permittee, including a person fingerprinted under 465.022, has:
If they've done any of these: 1. Fraudulently obtained a permit 2. Fraudulently got a permit or attempted to get one for someone else 3. Violated any of the rules from the FDCA or the Comprehensive Drug Abuse Prevention and Control Act 4. Convicted or found guilty of any felony or other crime involving moral turpitude in any adjudication 5. Convicted/disciplined by a regulatory agent of the government or of another state for any offense that would constitute a violation of this chapter 6. Convicted of or entered a plea of nolo contendere to a crime relating to the practice of pharmacy or to healthcare fraud in any jurisdiction 7. Dispensed a drug when they knew there wasn't a valid practitioner-patient relationship
When must the C-PEC be operated continuously?
If used for sterile compounding OR if it supplies some or all of the negative pressure for the room
KNOW: When may a licensee or registrant with a delinquent license request reinstatement of the license?
If: - All CE requirements are met - Reactivation fee is paid - Is done prior to the next renewal (i.e., within 2yrs since license became delinquent)
KNOW: When are dispensing practitioners authorized to dispense C2 or C3 controlled substances?
If: 1. Dispensing of complimentary packages of medicinal drugs which are labeled as a drug sample or complimentary drug to a practitioner's own patients in the regular course of their practice w/o the payment of a fee or remuneration of any kind, whether direct or indirect 2. Dispensing of controls in the healthcare system of the Department of Corrections 3. Dispensing of controls in C2 or 3 in connection w/ the performance of a surgical procedure under the following conditions: (a) C2 opioid for tx of acute pain, the 3 or 7-day limits apply (b) Tx of pain other than acute pain, they must indicate "NONACUTE PAIN" on an Rx (c) Tx of pain related to traumatic injury w/ Injury Severity Score of 9 or greater, they must concurrently prescribe an emergency opioid antagonist (d) For C3 drugs, amount dispensed cannot exceed a 14-day supply 4. Dispensing of controls in C2 or C3 pursuant to an approved clinical trial 5. Dispensing of methadone in a facility licensed under 397.427 where med-assisted tx for opiate addiction is provided 7. Dispensing of C2 or C3 to a pt of a hospice facility 8. Dispensing of C2 or C3 that have been approved by FDA for purpose of treating opiate addictions, including buprenorphine & buprenorphine combo products, by an authorized practitioner authorized to the practitioner's own patients for the med-assisted tx of opiate addiction
Under what circumstances may a pharmacist distribute patient-specific medications within a facility from a centralized automated medication system WITHOUT checking each individual medication selected or packaged by the system?
If: 1. Initial med order has been reviewed & approved by a pharmacist 2. Med is distributed for subsequent administration 3. Bar code verification, electronic verification, or similar verification process is utilized to assure correct selection of medication placed or to be placed into the automated medication system
When is the technician:pharmacist ratio 8:1?
In a non-dispensing pharmacy, or If a dispensing pharmacy, in any area physically separate (by a permanent wall or barrier) from the area where drugs are dispensed and there is NO sterile compounding taking place
In what circumstances is it acceptable to use two tiers of containment (e.g., CSTD within a BSC or CACI that is located in a non-negative pressure room)?
In facilities that prepare a low volume of hazardous drugs (<40 doses/month)
What is a biosimilar product?
In reference to a biological product that is highly similar, with minor differences in inactive ingredients and no clinically meaningful differences between the two in terms of safety, purity, and potency
What do "Quality Related Events" include?
Inappropriate dispensing or administration of a prescribed medication, including: A) A variation from prescriber's rx order, including but not limited to: - Incorrect drug - Incorrect drug strength - Incorrect dosage form - Incorrect patient - Inadequate or incorrect packaging, labeling, or directions B) A failure to identify and manage: - Overutilization or underutilization - Therapeutic duplication - Drug-disease contraindications - Drug-drug interactions - Incorrect drug dosage or duration of treatment - Drug allergy interactions - Clinical abuse/misuse
Nuclear pharmacy definition
Includes every location where radioactive drugs & chemicals within the classification of medicinal drugs are compounded, dispensed, stored, or sold - does NOT include hospitals or nuclear med facilities of such hospitals
Medical devices definition
Includes instruments, apparatuses, machines, implants, or other related articles intended to treat or prevent disease, but, unlike drugs, does not achieve its primary purpose through chemical action within or on the body and does not depend on being metabolized
What can a physician do to prevent a therapeutic substitution in a nursing home of a specific prescription?
Indicate "NO THERAPEUTIC SUBSTITUTION" on the Rx - if verbal Rx, prescriber must make an overt action to opt out of therapeutic substitution
NEED TO KNOW: What is an exception to the logbook requirement for pseudoephedrine sales?
Individual sales of a single "convenience" package of <60mg of pseudoephedrine
USP General Notices provide what information?
Info for use of the standards, such as description of dosage forms, temperature requirements, and other info
What must a summary record include?
Information to be able to determine the: - Volume (quantity) & Identity of CS being dispensed under the rx of a specific prescriber - Volume (quantity) and identity of CS being dispensed to a specific patient
NEED TO KNOW: How must obesity drugs be prescribed to comply with the FL BOM?
Initial prescriptions or orders must be written - cannot be called in - rule is old so says nothing about electronic rx's
KNOW: What additional CE is required for consultant pharmacists who order and evaluate laboratory tests under collaborative practice agreements?
Initial: - 3h CE Renewal: - 1h CE - may apply to the 24h of consultant pharmacist CE required to renew a consultant pharmacist license
KNOW: What kind of institutional pharmacy can elect to participate in the Cancer Drug Donation Program as a "participant facility" and accept donated cancer drugs and supplies?
Institutional Class II (hospital)
Hospitals must assign a specific ______ ______ for each practitioner authorized to use the hospital's DEA number.
Internal code - Suffix to the hospital's DEA number (Ex: AP1234563-10 or AP1234563-A12)
KNOW: Disinfection is done with
Isopropyl alcohol - MUST be sterile for use in C-PECs used for sterile compounding
NEED TO KNOW: C3-5 drugs may be refilled as indicated on the original prescription up to 5 times in the 6-month period from the date the prescription was _____.
Issued
KNOW: What is the timeline for reactivating an inactive license?
It can be kept inactive indefinitely, so long as the licensee continues to pay the renewal fee
What is an emergency medication kit in nursing homes?
It contains a limited supply of meds for use during an emergency that are NOT labeled for a specific patient No specific types or QTY of drugs are specified under FL law for these kits
When does an intern license expire?
It doesn't
What is the requirement for a decentralized medication system that contains controlled substances?
It shall NOT allow simultaneous access to multiple drugs, drug strengths, or dosage forms of controlled meds
What is required on pharmacy staff ID badges?
Job title Monogrammed smock with ID badge or monogram Must state name and title in electronic or written communication
What is misbranding?
Label is defaced/false or misleading Labeling is missing any of the required information (for both Rx and OTC) It is a drug is liable to deterioration unless packaged or labeled accordingly Container is made, formed, or filled to be misleading Drug is exact imitation of another drug or offered for sale under name of another drug It is dangerous to health when used in the dosage or manner suggested in the labeling It is packaged or labeled in violation of the Poison Prevention Packaging Act
KNOW: What is a Collaborative Pharmacy Practice Agreement (CPPA)?
Legislation that permits a certified pharmacist to enter into a collaborative practice agreement w/ a physician (DO or MD) for certain chronic health conditions
Who does the dispensing practitioner law NOT apply to??
Licensed veterinarians administering compounded drugs to a patient or dispensing a compounded drug to the patient's owner or caretaker
Sodium phosphates warning statement
Limits the amount of sodium phosphate oral solution to not more than 90 mL per OTC container.
What is the FDA Purple Book?
Lists biological products that are considered biosimilars and provides interchangeability evaluations for these products "Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations"
USP Chapter 731
Loss on Drying
USP 731
Loss on drying(adopted by florida law)
What level risk is reconstituting a vial of cefazolin and placing it in a piggyback IV bag?
Low
Class I medical devices + example
Low risk Ex: Dental floss
DEA registration numbers for midlevels start with...
M
Mid-level practitioners' DEA registrations begin with what letter?
M
The goal for sterile-to-sterile compounding is to
MAINTAIN sterility
KNOW: Who can write a Prescriber Care Plan/Drug Therapy Management agreement?
MD, DO, PA, DPM, DDS
Drug exemptions to the PPPA of 1970 (KNOW THIS)
Made new quizlet just for these - OCs, conjugated estrogens, norethindrone acetate in manufacturer's dispenser package - Medroxyprogesterone acetate tablets - Sublingual nitroglycerin and sublingual and chewable isosorbide dinitrate of 10 mg or less - ASA and APAP in effervescent tablets or granules - Potassium supplements in unit-dose packaging - Sodium fluoride containing not more than 264 mg of sodium fluoride per package - Anhydrous cholestyramine and colestipol packets - Erythromycin ethylsuccinate granules for oral suspension and oral suspensions in packages containing </= 8g of erythromycin - Erythromycin ethylsuccinate tabs in packages containing </= 16g of erythromycin - Prednisone tabs containing </= 105 mg per package - Methylprednisolone tabs containing </= 84 mg per package - Mebendazole tabs containing </= 600 mg per package - Betamethasone tabs containing </= 12.6 mg per package - Preparations in aerosol containers intended for inhalation - Pancrelipase preparations - Sucrose preparations in a solution of glycerol and water - Hormone replacement therapy products that rely solely upon the activity of one or more progestogen or estrogen substances
What may pharmacies do instead of printing the daily hardcopy from the computer system recordkeeping?
Maintain a logbook in which each individual pharmacist signs a statement each day attesting that the info entered into the computer is correct
What are the emergency kit requirements for LTCF's?
Maintained by the facility Limited emergency med supply, determined by Medical director, Nursing director, and pharmacist Readily available Sealed Items properly labeled Maintain a log with meds and exp dates If the seal is broken, it must be replaced and restocked by the end of the next business day
Drug Compounding Quality Act (DCQA)
Maintains traditional compounding regulations but establishes new section to FDCA that allows facilities that are compounding sterile pharmaceuticals to register with FDA as outsourcing facility (503B) These facilities are exempt from new drug provisions, adequate directions for use, and drug track/trace provisions - passed in response to fungal meningitis outbreak in 2012 due to contaminated injectable steroids
Patient Package Insert (PPI)
Manufacturer's patient product information included with the product package Indicated for a layperson Required for OC's and estrogen containing products Hospitalized pts= PPI on first admin and every 30 days Failure to give a PPI = Misbranded
KNOW: What is the rule for unused unit-dosed medications in a closed drug delivery system?
May be returned to pharmacy for re-dispensing if each individual package is individually sealed and is clearly labeled w/ the: - Name of the drug - Dosage strength - Manufacturer's control number - Expiration date THIS IS THE ONLY EXCEPTION TO THE RULE THAT DRUGS CANNOT BE RETURNED ONCE DISPENSED TO PATIENTS!!! CLOSED DRUG DELIVERY SYSTEMS ARE THE ONLY EXCEPTION AND IT IS ONLY FOR NON-CCONTROLLED DRUGS
What are pharmacists permitted to do with a prescription that was faxed by the PATIENT?
May fill, but may NOT dispense until ORIGINAL written Rx is received
KNOW!!!!! Pharmacist Formulary Drugs
May only be dispensed by ordering pharmacist and shall NOT be refilled, nor shall another drug be ordered for the same condition unless consistent w/ dispensing procedures - OTC drugs - Drugs recommended by FDA for transfer to OTC status pending FDA approval - Drugs w/ antihistamine or decongestants as active ingredients - Meds containing fluoride in any strength - Meds containing lindane in any strength - Topical anti-infectives excluding eye and ear - Any OTC proprietary drug approved for reimbursement by FL Medicaid program
KNOW: What options does the subject of an administrative complaint have for a hearing?
May request: - A formal administrative hearing before an Administrative Law Judge, OR - An informal hearing before the Board
What level risk is making a batch of 10 antibiotic syringes?
Medium
Adulterated or Misbranded: A pharamacist fails to dispense a medication in a child-resistant container when required
Misbranded
Adulterated or Misbranded: Misfilling a Rx with the wrong drug, strength, or directions for use
Misbranded
Adulterated or Misbranded: The advertising or promotion of a compounded drug that is false or misleading
Misbranded
Adulterated or Misbranded: A drug has a REMS program and is prescribed or dispensed without meeting the requirements of the REMS
Misbranded - b/c the REMS program is part of the official labeling of the drug
Adulteration or Misbranding: A pharmacist that does not comply with the PPPA
Misbranding
KNOW: Medium-risk CSPs
Mixed in USP 797 compliant area as a batch for multiple patients or for one patient on multiple occasions, or more complex mixtures such as TPNs
Low risk csp
Mixed in USP 797 compliant area as a single dose for a patient ex: Reconstituting a vial of cefazolin and putting in an IV piggyback
KNOW: High-risk CSPs
Mixed in USP 797 compliant cleanroom suite w/ a nonsterile starting ingredient, or any risk level if mixed without complete garb as required
KNOW: Low-risk CSPs
Mixed in USP 797-compliant area as a single dose for one patient
KNOW: Immediate Use CSPs
Mixed outside of compounding facilities when the urgency does not permit mixing in a cleanroom suite or segregated compounding area (SCA) - Limited to simple transfer of not more than 3 sterile manufactured ingredients and not more than 2 entries into any one container
KNOW: Order of USP components in terms of specificity
Monographs > General Chapters > General Notices
KNOW: How often must storage, shelving, walls, and ceilings be cleaned?
Monthly
Medium risk CSP
Multiple individual or small doses of sterile products combined, more complex manipulation, with medium risk storage Ex: batching syringes and TPN
Acetaminophen warning statement
Must have "Acetaminophen" displayed prominently Warn about liver toxicity Must warn to not use with other APAP combo products and/or Warfarin
NSAIDs warning statement
Must include "NSAID" prominently on label Warning for "stomach bleeding"
Sulfites warning statement
Must state that preservatives are used
BUD for Low-risk drugs made in an SCA when frozen
N/A
BUD for immediate use drugs frozen
N/A
BUD for immediate use drugs refrigerated
N/A
Renewal requirements for a pharmacist practicing under a PCP for DTM
N/A
KNOW: Drugs provided through the pharmacist formulary must include what information on the label?
NAME: - Pharmacist (acting as prescriber) - Pharmacy - Patient ADDRESS: - Pharmacy PRESCRIPTION: - Rx Number - Date of dispensing - Directions for use - Trade name or generic name - Quantity dispensed ADDITIONAL: - Clear statement that order CANNOT BE REFILLED
KNOW: What are the label requirements for compounded drugs for office use?
NAME: - Pharmacy - Drug ADDRESS: - Pharmacy PRESCRIPTION: - Strength - Active ingredient list w/ strengths - Beyond use date - QTY - Ancillary instructions (storage, cautionary statements, HD warnings if needed) OTHER: - Pharmacy's lot # - "For Institutional or Office Use Only - Not for Resale", or if provided to a veterinarian, "Compounded Drug"
KNOW: For medications dispensed by nuclear pharmacies, the immediate OUTSIDE CONTAINER must be labeled with:
NAME: - Pharmacy - Prescriber - Patient or "Physicians Use Only" - Procedure (if diagnostic med) - Radionuclide - Dispensing pharmacist's initials ADDRESS: - Pharmacy PRESCRIPTION: - Chemical form of radionuclide - Date of original filling - Rx number - Expiration date and TIME - Liquid: Volume - Solid: # of items or weight - Gas: # of ampules or vials OTHER: - Standard radiation symbol - The words: "Caution: Radioactive Material" - Amount of radioactivity and the calibration date AND time - If for a Tc 99m product, the molybdenum 00 content to USP limits
KNOW: Labeling requirements for repackaged or unit-dose drugs in institutional settings
NAME: - Manufacturer - Drug (brand or generic) PRESCRIPTION: - Strength - Dosage form - Expiration date - Lot number (manufacturer's or pharmacy's)
KNOW THIS PLS: Label requirements for customized medication packages
NAME: "PPPD" - Pharmacy - Patient - Prescriber(s) - for each drug - Drug - each one ADDRESS: - Pharmacy TELEPHONE: - Pharmacy PRESCRIPTION: "Never Quit Buying Dad Super Soft Dachshund Puppies" - Prescription Number (1 for whole package and 1 for each drug dispensed) - Quantity - BUD = 120 days from preparation, unless one of the drugs expires before then - Directions for use for each - Storage instructions - Strength - Date of preparation - Physical description
KNOW!!! Labeling requirements of drugs for inpatient nursing home
NAME:(of everything!) - Pharmacy - Prescriber - Pt - Drug ADDRESS: - Pharmacy PRESCRIPTION: - Date of original filling or refill - Rx number - Directions for use - Quantity - Transfer warning if controlled substance
Can central fill pharmacies (including a community central fill pharmacy) deliver controlled substances directly to a patient?
NO
Can prescribers ask for a blanket waiver for tamper resistant packaging?
NO
KNOW: Do DOH inspectors need a warrant?
NO
When a central fill pharmacy delivers a filled prescription (non-controlled) directly to a patient, is this considered dispensing?
NO - treated more like the central fill pharmacy is the uber eats driver from the originating pharmacy
Are places other than pharmacies allowed to call themselves such? or by any other name?
NO Cannot reference: Rx, Apothecary, drug, pharmacy, prescription drug, etc.
Can pharmacists furnish emergency contraception?
NO However, Plan B and Next Choice can be purchased without a prescription at any age
KNOW: Can consultant pharmacists apply their 24 hours of consultant pharmacist CE towards the general 30 hour CE requirements for a pharmacist license?
NO!
KNOW: Are patient names required to be included on repackaged or unit-dosed drugs in institutional settings?
NO, as long as the unit-dose system clearly indicates the name of the pt or resident, rx number, or other means of identifying the med order, directions for use, and name of prescriber
Can pharmacies dispense methadone for treatment of addiction?
NO, just for pain Methadone for addiction can only be given at a DEA registered narcotic treatment center
Does an automated dispensing pharmacy system need to be located at the same location as the community pharmacist?
NO, only if: - Automated system is under supervision and control of the community pharmacy - Automated system is housed in an indoor environment are and in a location to increase patients' access to their Rx's, including, but not limited to medical facilities or places of business where essential goods and commodities are sold or large employer workplaces or locations where access to a community pharmacy is limited - Community pharmacy providing services through the automated system notifies the board of location of automated pharmacy system and any changes in such location - Automated system has a mechanism to provide live, real-time pt counseling by a pharmacist licensed in FL before dispensing any medicinal drug - Automated system does NOT contain or dispense any controlled substance - Community pharmacy maintains a record of the medicinal drugs dispensed, including the identity of the pharmacist responsible for verifying the accuracy of the dosage and directions and providing pt counseling - Automated system ensures confidentiality of PHI
KNOW: What is the minimum ISO classification for segregated compounding areas (SCAs) and containment segregated compounding areas (C-SCAs)?
NONE - not required to be ISO classified
When is the technician:pharmacist ratio 6:1?
NOT engaging in sterile compounding
KNOW: Labeling requirements for patient-specific medications dispensed from an Institutional Class II, Modified Class II Type B, or Class III Permit
NOTE: this is applicable only to compounded IV solutions, except for very last section DRUG: - Name of active ingredients - Amounts or concentrations of active ingredients - BUD and time - Storage requirements (if applicable) - Identification of responsible compounding personnel AND/OR dispensing pharmacist ADDITIONAL REQUIREMENTS FOR LABELS FOR BATCH-PREPARED COMPOUNDED STERILE PRODUCTS: - Control or lot # - Auxiliary labeling (including precautions) - Device-specific instructions ADDITIONAL REQUIREMENTS FOR LABELS FOR PT-SPECIFIC MEDS: - Pt's name - Location that med is being delivered to - Directions for use and applicable accessory and cautionary instructions
What must be in a patient profile?
Name Address Phone number Age/DOB Gender All meds for the past 4 years Pharmacist comments relevant to drug therapy Allergies Drug reactions Chronic conditions Idiosyncrasies Devices
What information must be on a prescription drug's manufacturer's labeling?
Name and address of manufacturer, packer, or distributor Brand and/or generic of drug Net quantity (weight, qty, or dosage units) Weight of active ingredients per dose Federal "Rx Only" for legend drugs Route of administration (unless taken orally) Any special storage requirements Manufacturer's control # (lot #) Expiration date Adequate info/directions for use (package insert for Rx) - Pink = unique to RX REQUIREMENTS ONLY
What does Florida require to be on a prescription container LABEL?
Name and address of pharmacy Date of dispensing Serial number Patient/pet name Prescriber Name of the drug (Unless otherwise stated by the prescriber) Directions for use Expiration/BUD For controls: crime to transfer statement FEDERAL: Florida covers all federal requirements
For remote medication order processing, records must be maintained that identify what information?
Name, initials, or ID code of each person who performed a processing function for every med order
Schedule IV Drugs
Narcotics: - Dextropropoxyphene - Products w/ </=1 mg of difenoxin and >/=25 mcgs atropine sulfate per dosage unit Depressants: - Alprazolam - Chloral hydrate - Diazepam - Lorazepam - Phenobarbital Stimulants: - Diethylpropion - Phentermine Others: - Carisoprodol - Tramadol - Pentazocine - Butorphanol
Schedule III Drugs
Narcotics: - Narcotic schedule II drugs in combination w/ ASA or APAP Non-narcotic Suppositories: - Amobarbital - Secobarbital - Pentobarbital Stimulants: - Chlorphentermine - Phendimetrazine - Benzphetamine Anabolic Steroids: - Testosterone - Ketamine - Paregoric - Fiorinal (butalbital/ASA/ caffeine) - NOT FIORICET
What is NIOSH?
National Institute for Occupational Safety and Health part of CDC that is responsible for conducting research relating to work-related illness. Makes recommendations to OSHA
The _____ maintains a list of hazardous drugs (HDs) used in healthcare, which is updated approximately every _____.
National Institute of Occupational Safety and Health (NIOSH) Q2 years
A pharmacist may NOT substitute a generic drug for a prescribed brand name drug if it is listed on the _______.
Negative formulary
When receiving HDs, USP 800 requires that all hazardous drugs and active pharmaceutical ingredients (HD-APIs) be removed from shipping containers in an area that is _____ or ______ pressure relative to the surrounding areas.
Negative or Neutral - General receiving areas are ok as long as they aren't positive pressure areas - Also shipping cartons containing HDs and/or HD-APIs must not be opened in sterile compounding or positive pressure areas
KNOW: What are the requirements for C-PECs ONLY used for nonsterile HD compounding?
Negative pressure No ISO requirement No unidirectional airflow requirement
KNOW: Pressure gradient requirement for hazardous drug ("chemo") buffer rooms and C-SCAs
Negative pressure requirement
USP 800 requires that certain areas have a ______ pressure gradient with respect to surrounding areas of the facilities to reduce the risk of contaminating areas where non-HD-authorized individuals work.
Negative-pressure gradient - these should have uninterrupted power source in the event of loss of power to facility
When may a pharmacist fill a prescription from out-of-country prescribers?
Never! they have no DEA number
DEA Form 224
New application for Retail pharmacy, hospital, practitioner, teaching institution, mid level practitioner
The FDA exempts compounding from what requirements?
New drug application - provided that the compound is made by a licensed pharmacist or physician and complies w/ USP chapters on pharmacy compounding
Are any laws in place preventing physicians or pharmacists from prescribing or filling drugs for off-label use?
No
Are preceptors required to register with the state board?
No
Can pharmacists who are required to attend a board meeting still claim 5 hours of CE for a full day?
No
Can technicians take oral prescriptions down from the voice-mail or if a physician calls a prescription in?
No
Do interns need a background check for licensure?
No
Do pharmacies have to put licenses in public view?
No
Is a Notice of Deficiencies considered disciplinary action?
No
Is there a limit on the number of syringes that may be purchased without a prescription?
No
KNOW: Are dispensers of donated cancer drugs or supplies able to submit a claim/seek reimbursement from any public or private third-party payor for the donated cancer drugs or supplies dispensed to any patient under the Cancer Drug Donation Program?
No
KNOW: Does a PCP/DTM agreement specify what conditions may be treated by the pharmacist?
No
Is a DEA Form 41 required when transferring controlled substances to an authorized reverse distributor for destruction?
No - CIII-CV: document w/ invoice - CII: Complete DEA Form 222
Can pharmacists dispense a prescription "for office use"?
No - medicinal drugs can only be dispensed based on a pt-specific rx (w/ exception of naloxone and compounded rx's for office use) - Pharmacists can sell an original manufacturer's bottle of an rx drug to a practitioner for use in their office, but cannot dispense drugs pursuant to a prescription for "office use"
If a practitioner only dispenses complimentary packages of medicinal drugs without any sort of reimbursement, do theys till need to register as a dispensing practitioner?
No - must dispense in manufacturer's labeled package though or follow the rules on next slide
NEED TO KNOW: Can pharmacies provide PDMP information to a law enforcement officer?
No - they'd need to directly contact the PDMP program at the DOH, and are ONLY allowed to do this for an active investigation *remember, it's controlled substances that they can request w/ no permit to see what was dispensed in the last 60 days from a specific dr or to a specific pt*
KNOW! When a central fill pharmacy delivers a filled prescription directly to a patient, is this considered dispensing?
No - originating pharmacy dispensed, central delivers
Modified Class II B Institutions
No formulary limitations Drugs stored in bulk or unit-dose >90% of registrations Ex. Surgical Center
Modified Class II C Institutions
No formulary limitations Medications stored is patient-specific form
When is the latest a controlled substance can be reported through the PDMP after being dispensed?
No later than the close of the next business day - unless an extension is granted
What is the limit for partial fills for C3-5 prescriptions?
No limit! as long as you dont exceed the total prescribed dosage units and it is done within a 6 month period
Maximum number of refills for non-controlled?
No limit, but cannot exceed what is written on the script or >1 year
Minimum pressure gradient required between segregated compounding areas (SCAs)
No requirement
KNOW: Pressure gradient requirement for segregated compounding areas (SCAs)
No requirements
When must DEA Form 106 be filled out following theft or significant loss of controlled substances?
No set time, but if investigation by pharmacy is ongoing prior to filling out the form and the investigation lasts longer than 2 months (60 days), the pharmacy needs to provide an update to DEA
Can records and inventories of all controlled substances be kept together?
No, CIIs must be kept separately or be "readily retrievable"
KNOW: Does a PCP/DTM agreement require filing of the agreement with the BOP?
No, but consultant pharmacist & collaborating practitioner have to keep record of the written agreement and make it available if the Board requests
KNOW: Does a PCP/DTM agreement require certification with BOP?
No, but consultant pharmacists may enter into these so they'd have to get their consultant license
Do you have to submit a CPA to the board?
No, but it must be available upon inspection
Are there limits to prescribing any meds to oneself or family members?
No, controlled or non-controlled
Are suppliers permitted to fill orders from a copy of DEA Form 222?
No, may fill from original ONLY
Are there different levels of technicians based on training?
No, not in Florida
KNOW: Are institutional pharmacies allowed to dispense drugs to outpatients?
No, not unless they obtain a community pharmacy permit
ID required for non-controlled or controlled?
No, only if the person is not known to the pharmacist
Does USP enforce their standards?
No, they are recommendations. The states and other governing boards do the actual enforcing. ie the FDCA mandates following USP guidelines
Are schedule III-V drugs required to be ordered through CSOS?
No, they can be ordered through normal ordering processes from a wholesaler or manufacturer, but must be documented by a pharmacy with the invoice provided by the wholesaler or manufacturer
Does a pharmacy have to display the license of each pharmacy employee (pharmacist, intern, and technicians)?
No, they can choose to display a notice that licenses are available for viewing upon request
Can suppliers ship products if the DEA Form 222 is faxed?
No, they can only prepare the order when faxed but cannot ship products until the original DEA Form 222 is received and verified
Can a practitioner that works at a Narcotic Treatment Program automatically prescribe medication assisted treatment (MAT) drugs for opioid dependence?
No, they need to fill out a DATA waiver in order to prescribe MAT drugs to be filled at a pharmacy
Can a PDM be registered through the board as the manager of more than one pharmacy?
No, unless they grant an exception upon application by the pharmacy and the PDM showing circumstances, such as: - proximity of pharmacies and - limited pharmacist workload that would allow the manager to carry out all of the duties and responsibilities required of a PDM
Who can correct a defective CSOS order?
Nobody - purchaser must issue a new order for it to be filled
Which CV's are exempt from PDMP reporting?
Non-narcotic CV's Lyrica Briviact Vimpat Potiga (ezogabine)
USP 795
Non-sterile compounding NOT OFFICIALLY ADOPTED IN FLORIDA
Morphine C-V concentration limit
None listed - ALL morphine products are either C-II or C-III
What quantity limits on schedule II prescriptions exist under FL law?
None!
What is the limit for number of prescriptions on a form?
None, but must be legible
Containment Ventilated Enclosures (CVEs, often called powder containment hoods) are devices used only for ______ preparations.
Nonsterile
High-risk CSPs are mixed using ______ starting ingredients.
Nonsterile
KNOW: The Florida law for office use allows office use compounding for what products?
Nonsterile products that are NOT patient-specific - in contrast to federal law which only allows non-patient-specific sterile compounding through outsourcing facilities
Certification involves a qualified technician checking and ensuring that _____ parameters listed in USP 797 are within manufacturer's and industry specifications.
Nonviable
Environmental monitoring for compounding consists of what two elements?
Nonviable elements - Temp - Pressure gradients - Airflow Viable elements - Microbial contamination
Are pharmacists providers for the reason of reimbursement?
Nope
Is the 1h human trafficking CE required for every 2 year licensure renewal?
Nope, it was a one time thing to be completed by Jan 2021
Can controlled and non-controlled be on the same script?
Not addressed in FL law
Is a citation considered disciplinary action?
Not for the 1st offense
Class III FDA recall
Not likely to cause adverse health consequences
CIII Codeine amount
Not more than 1.8g codeine/100mL or not more than 90mg per dosage unit
CV Opium amount
Not more than 100mg/100mL
CV Codeine amount
Not more than 200mg/100mL
KNOW: Does a PCP/DTM agreement expire?
Not specified in law
Time limit that the BOP can suspend a license
Not to exceed 1 year
KNOW: For minor violations which do NOT endanger the public health, safety, and welfare and which do NOT demonstrate a serious inability to practice the profession, the Board may issue a
Notice of Noncompliance (Notice of Deficiencies)
KNOW: What are the rules for closing a pharmacy per the FL BOP?
Notify BOP as soon as possible of anticipated closing date IN WRITING w/ the following information: 1. Date of closing 2. Names & addresses of persons who shall have custody of rx files AND the controlled drug inventory records of the pharmacy to be closed 3. Names & addresses of any persons who will acquire any of the legend drugs from the pharmacy to be closed No later than 10 days after closing, the pharmacy permit must be returned to BOP office, and the permittee shall file a WRITTEN report w/ the board office containing the following info: 1. Confirmation that a SIGN has been posted outside of closed establishment indicating name and address of pharmacy where rx files have been transferred 2. Confirmation that all legend drugs have been transferred to an authorized person OR destroyed; if transferred, all names of persons whom received them must be provided 3. If controlled drugs were transferred, report must indicate all names AND addresses of persons who received them 4. Confirmation that DEA registration and all blank DEA 222 (order forms) were returned to DEA Miami Regional Office
NEED TO KNOW: What must a pharmacist do if the prescriber fails to deliver a written or electronic rx following an emergency telephone C2 rx?
Notify the DEA
In addition to reporting theft or significant loss to the DEA, what is also required by Florida law?
Notify the county sheriff within 24h of discovery
What are the requirements for generic substitution?
Notify the patient of price difference Tell them they may refuse Any savings from switching from the brand must be told to the consumer Prescriber must write "medically necessary" to dispense brand only. The patient may also request brand only without this message.
If the CSOS order cannot be filled for any reason, the supplier must
Notify the purchaser and provide a statement as to the reason - they can refuse to accept any order for any reason
Class I institutional pharmacy permit
Nursing homes - All medicinal drugs are administered from individual Rx containers to the individual pt and in which medicinal drugs are not dispensed on the premises (w/ exception of medicinal O2) *Unique to FL b/c we require them to get a pharmacy permit despite them receiving everything from a sourcing facility and not dispensing anything themselves*
KNOW: Per FL law, who is permitted to dispense C2 or C3 drugs?
ONLY Community pharmacies (including limited community pharmacy permits) - done to limit physician dispensing - some exceptions in medial practice acct
KNOW: Under what circumstances may an institutional pharmacy dispense drugs to outpatients?
ONLY if they obtain a community pharmacy permit EXCEPTION: - Class II or Class III institutional pharmacy may dispense to a pt of the hospital's ED or a hospital inpatient upon D/C if prescriber determines that the drug is warranted and that community pharmacy services are not readily accessible, geographically or otherwise, to the patient
FDA drug and device recall classifications
OPPOSITE OF THE MEDICAL DEVICE ONES - if you RECALL, back in CLASS in elementary school we'd say: 1st is worst 2nd is best 3rd is one w/ treasure chest
What are the requirements for out of state compounding pharmacies to dispense/mail to Florida?
Obtain a "Non-resident Sterile Compounding Permit" before shipping, mailing, delivering, or dispensing their product
What is OSHA?
Occupational safety and health administration Makes rules concerning occupational toxicity levels of hazardous materials Responsible to Health Services Administration
What records are maintained for the receipt of CII drugs?
Old DEA Form 222: - Copy 3 New DEA Form 222: - Copy of the original single page w/ #s of containers and date received filled in
How can the prescriber request for a medication to be dispensed in a non-child-resistant container?
On an individual prescription basis - NOT for all future Rx's! - Request NOT required to be in writing!
When must newly scheduled drugs or drugs moved from one schedule to another be inventoried?
On the day scheduled or moved to a new schedule
How many times can you transfer a CIII-CV?
Once However, if the pharmacies share a real-time database, they can transfer up to as many refills left on the prescription An original script CANNOT be transferred unless it is an EPCS
How many C-II items can be ordered per line on Form 222?
One item per numbered line
What are the required elements for tamper resistant prescription forms?
One or more features to prevent copying One or more features to prevent erasure or modifying One or more features to prevent counterfeit forms
Who may clean the PECs?
Only compounding personnel - some organizations allow others w/ documented competency to clean floors, walls, and ceilings
Under what circumstances may suppliers provide a partial quantity for the requested amount by DEA Form 222?
Only if the remaining quantity is sent within 60 days or the order becomes void
Who can access drugs stored in treatment areas in institutions?
Only licensed staff in accordance w/ their license, practice act, or to other personnel specifically authorized by the institution
What can a pharmacist change on a CII-CV prescription?
Only quantity and date Everything else is ILLEGAL federally
Mineral Oil warning statement
Only take at bedtime and do NOT use in infants unless under advice of a physician - label also CANNOT encourage use during pregnancy
Schedule I Drugs
Opiates & Derivatives: - Heroin - Dihydromorphine Hallucinogens: - Marijuana - Lysergic acid diethylamide (LSD) - Peyote - Mescaline Depressants: - Methaqualone
Schedule II Drugs
Opium & Other Narcotics: - Morphine - Codeine - Dihydrocodeine - Oxycodone - APAP + Hydrocodone (Vicodin) - Methadone - Meperidine - Hydromorphone - Fentanyl - Cocaine Stimulants: - Amphetamine - Methamphetamine - Phenmetrazine - Methylphenidate Depressants: - Pentobarbital - Secobarbital - Amobarbital - Glutethimide - Phencyclidine
CE hours for Vaccines
Optional, but is 3 hours
KNOW PLS: List of pharmacist formulary drugs
Oral Analgesics for mild-mod pain and menstrual cramps for pts w/ no hx of PUD (limited to 6-day supply) "MANNIC" - Magnesium salicylate/phenyltoloxamine citrate - Acetylsalicylic acid (zero order release, long-acting tabs) - Naproxen sodium - Naproxen - Ibuprofen - Choline salicylate and magnesium salicylate Urinary Analgesics - Phenazopyridine (max 2-day supply) Otic Analgesics - Antipyrene 5.4%, Benzocaine 1.4%, glycerin Anti-Nausea Preparations "MS" for motion sick - Meclizine up to 25mg (except for pts taking CNS depressant) - Scopolamine up to 1.5mg/patch Antihistamines (>/=6 yo) "Dexter's Brother Carl Died Painfully" - sorry this is morbid - Dexchlorpheniramine - Brompheniramine - Carbinoxamine - Diphenhydramine - Pyrilamine Decongestants (>/= 6 yo) "PA" - Phenylephrine - Azatadine Topical Antifungals/Antibacterials "Hal's ICE" - Haloprogin 1% - Iodochlorhydroxyquin w/ 0.5% hydrocortisone (max 20g) - Clotrimazole topical cream and lotion - Erythromycin topical Topical anti-inflammatory Preparations - Hydrocortisone max 2.5% Otic Antifungal/Antibacterial - Acetic acid 2% in aluminum acetate solution Keratolytics "Sal Likes to Flirt w/ Linda" - Salicylic acid 16.7% and lactic acid 16.7% to be applied to warts except for pts <2 yo and those w/ DM or impaired circulation - Vitamins w/ fluoride (not including vitamins w/ folic acid >0.9mg) - Medicinal drug shampoos containing lindane (max 4oz) Ophthalmics - Naphazoline 0.1% Histamine H2 Antagonists - Cimetidine - Famotidine - Ranitidine Topical Antivirals "PA" - Penciclovir - Acyclovir ointment for HSV on lips Acne Product - Benzoyl peroxide
Which drugs currently require a PPI?
Oral contraceptives Estrogen containing products
What can pharmacists do under a CPA?
Order and evaluate labs (3 hour CE required) Conduct patient assessments Administer vaccines and antipsychotics Initiate, modify, or discontinue drugs
DEA Form 222
Ordering controlled substances
If action levels are exceeded or if trends are noted, when must organisms be identified versus immediately remedied?
Organisms exceeding action level should be identified at least to genus level Highly pathogenic organisms (GNRs, coag positive staph, molds, yeasts) must be immediately remedied even if they do NOT exceed action level
All C-PECs used for the purpose of compounding sterile hazardous drugs must be vented to the
Outside
KNOW: Eyewash stations and a sink must be readily available, however, all water sources and drains must be located
Outside the buffer room and at least one meter from the C-PEC or entrance to any negative pressure room
A community pharmacy permit may not be issued unless a licensed pharmacist is designated as the ____.
PDM (called PIC in other states)
What additional requirements are enforced by the FPA statute for reporting any theft or significant loss of any controlled substances in Florida?
PDM must notify Florida BOP within one business day after discovery of theft or loss - in an institutional pharmacy, the consultant pharmacist of record would be the one notifying the BOP
KNOW: Who is responsible for ensuring that a pharmacy has an operating CQI program and that all CQI activities are documented?
PDM or the consultant pharmacist of record
International Pharmacy Permit
PENDING FEDERAL APPROVAL FL BOP will establish 2 programs to safely import FDA-approved drugs into florida: 1. Canadian drug importation program 2. International drug importation program department of business and professional regulation is responsible for managing the program
What organization operates the impaired pharmacist recovery program?
PRN (Professional Development Network)
Last 1-2 digits of NDC
Package size
What is a customized medication package?
Packages prepared by a pharmacist for a specific patient that is a series of containers containing two or more solid oral dosage forms
Who can provide a blanket request for all future prescriptions to be dispensed in a non-child-resistant container?
Patient ONLY
KNOW: A community pharmacy that acts ONLY as a central fill pharmacy AND notifies the board is exempt from what requirements?
Patient counseling area requirement, signage requirements, and operating hours
What does OBRA'90 outline rules for?
Patient records, DUR, and counseling
What activities can interns not perform?
Perform final check /verification of prescriptions
Initially and after any change to the cleaning process or agents, what must a pharmacy do to validate a high-level disinfection process for the lyophilizer?
Perform validation studies with the 5 aerobic bacterial and fungal ATCC organisms referenced in USP 71 - May be done by an external vendor or internal laboratory - If done internally, lab must be separated from the compounding area and work area to prevent contamination - documentation of validation shall be readily available for inspection
Filtration is checked by
Performing a bubble point test of the used filter to ensure its integrity
What are the Federal Tax-Free Alcohol Regulations
Pharmacies sometimes use 95% ethanol (190 proof) for compounding purposes If used for scientific/ medicinal/ mechanical purposes/ to treat patients, such alcohol is considered "Tax-Free" Regulated by: - The Alcohol and Tobacco Tax and Trade Bureau (TTB) Enforced by: - The Federal Bureau of Alcohol, Tobacco, Firearms, adn Explosives (ATFE)
What pharmacies are permitted to transfer up to the maximum number of refills permitted by law and the prescriber's authorization for C3-5 drugs?
Pharmacies that share an electronic, real-time, online database of rx's
When the prescription department is closed, it shall be separated from the remainder of the establishment by a partition or other means of enclosure to prevent access and shall be securely locked, with only the ______ having means to gain access to the prescription department
Pharmacist - and no person other than a pharmacist may enter the department when it is closed
Who can dispense OTC schedule V drugs?
Pharmacist ONLY - after they've dispensed and done recordkeeping, a non-pharmacist can do the actual sale and delivery
What is the pharmacist permitted to do in regards to emergency refill requests if the governor issues an emergency order or proclamation of a state of emergency?
Pharmacist may dispense a 30-day supply in area/counties affected by the order or proclamation, provided that: - Rx is NOT for a C2 - Med is essential to maintenance of life or to continuation of tx in a chronic condition
NEED TO KNOW: Minimum standards before refusing to fill a prescription
Pharmacist must attempt to: 1. Initiate communication w/ the patient to acquire relevant information 2. Initiate communication w/ the prescriber to acquire relevant information 3. In lieu of (1) or (2), but not both, the pharmacist may elect to access the PDMP to acquire relevant information
Who can provide the offer to counsel?
Pharmacist or intern, NOT technician
Who does the retired license election apply to?
Pharmacists' licenses only (no technicians)
KNOW: A certified pharmacist or certified registered intern may administer vaccines to adults under a written protocol with a supervising _______.
Physician - note: this is between PHARMACIST and physician, not pharmaCY!!!
How many patients may a DATA-waived physician, APRN, or PA treat?
Physician: - 30, 100, or 275 depending on their authorization APRN or PA: - Initially: 30 patients - After 1 year: can apply to treat up to 100 patients
Phenacetin warning statement
Possible kidney damage when taken in large amounts for long periods of time
For any community pharmacy not open 40 hours per week, what must they do?
Post the days and hours the pharmacy is open and information for after-hours access and shall also have a written policy and procedure for transferring a prescription or receiving an emergency dose pursuant to 465.0275
Who is considered a mid-level practitioner?
Practitioners other than: - Physicians - Dentists - Veterinarians - Podiatrists who are licensed, registered, or otherwise authorized under state law to dispense/prescribe controlled substances in the course of professional practice
Which practitioners may apply for a DATA waiver without having to meet certain DEA certification requirements related to training, counseling, and other ancillary services (i.e., psychosocial) that are normally required?
Practitioners who limit their treatment to no more than 30 patients
A nursing home facility must notify the prescriber before each therapeutic substitution using a method of communication designated by the _______. A nursing home facility must document the therapeutic substitution in the resident's medical records.
Prescriber
Drug therapy management (DTM) is done under a
Prescriber Care Plan (PCP)
A nursing home facility must obtain the _______ approval for any subsequent change made to a nursing home facility's institutional formulary.
Prescriber's
KNOW: According to USP 800, HDs must be stored in areas that can accomplish what?
Prevent or contain spillage or breakage of container if it falls - CAN'T BE STORED ON FLOOR
Positive pressure rooms assist in
Preventing contamination entering the room - so are used for anterooms and nonhazardous buffer rooms
Prescription Drug Marketing Act of 1987
Prevents re-importation of a drug into US Prohibited hospital and healthcare entities from reselling their pharmaceuticals Bans sale, trade, or purchase of prescription drug samples Mandates the storage, handling, and record-keeping requirements for prescription drug samples - *A community pharmacy that is NOT affiliated w/ a healthcare entity may NOT be in possession of prescription drug samples* Prohibits re-sale of prescription drugs purchased from hospitals or healthcare facilities - done to prevent diversion of drugs due to price diversion since hospitals receive lower prices for drugs than community pharmacies
What information must be on a OTC drug's manufacturer's labeling?
Principal display panel with statement of identity of the product Name and address of manufacturer, packer, or distributor Net quantity Cautions and warnings for the user Adequate directions for safe and effective use Drug Facts panel (w/ proper content & format) - Blue = unique to OTC REQUIREMENTS ONLY
Pharmacies must designate a _______ who is responsible for development and implementation of HIPAA-related policies, procedures, and compliance.
Privacy Official - this person may also be the designated contact person to receive complaints
KNOW: The computer system recordkeeping must be able to print a hard copy on demand by an authorized agent of the Department of Health. What should be done if no printer is on site?
Produce a hard-copy printout within 48h or it is considered a failure to keep and maintain records
What does the Federal Hazardous Substances Act of 1966 apply to
Products sold in a pharmacy that are NOT regulated by the FDA such as bleach, cleaning fluids, antifreeze, etc
KNOW: Despite the provisions for discipline for pharmacists/practitioners with impairment due to alcohol, drugs, or mental or physical issues, most cases do not result in discipline due to what program?
Professionals Resource Network (PRN) - Impaired practitioner program
Office use definition
Provision and administration of a compounded drug to a patient by a practitioner in the practitioner's office or in a healthcare facility or treatment setting, including a hospital, ambulatory surgical center, or pharmacy
What is considered a listed chemical?
Pseudoephedrine products
Under USP 800, how often should chemo gloves be changed unless recommended differently by the manufacturer?
Q30 mins
KNOW: A professional certifier must assess the primary and secondary engineering controls every ______.
Q6 months
KNOW: Electronic air sampling must be checked at least _______, and surface sampling must be checked _______.
Q6 months Periodically
KNOW: How often must SECs be certified?
Q6 months OR when changes are made in the room that could affect the airflow
KNOW: How often must PECs be certified?
Q6 months and after servicing
What CV's can be dispensed without a prescription?
Quantity given in 48 hours cannot exceed... 120 mg of codeine 60 mg of dihydrocodeine 30 mg of ethyl morphine 240 mg opium
KNOW: How often must monitoring of nursing home formulary policies/procedures be done?
Quarterly
USP 825
Radiopharmaceutical NOT OFFICIALLY ADOPTED IN FLORIDA
Class I FDA recall
Reasonable probability will cause serious AE or death
What are technicians NOT allowed to do?
Receive new non-written prescription or receive any change in the medication, strength or directions of an existing script Interpret for therapeutic acceptability Final verification Prospective new drug review Monitor prescription usage Transfer Rx Patient counseling Override clinical alerts Prepare a copy of a prescription or read a prescription for the purpose of providing a reference Receive therapy or blood product procedures in a permitted nuclear pharmacy Anything that requires a pharmacist's clinical judgment
How can out-of-state providers utilize telehealth services for patients in Florida?
Register w/ FDOH
Are technicians licensed or reigistered?
Registered, but they must also complete a Board certified training program
The advertising of prescription drug pricing is considered _______ advertising under FDA regulations.
Reminder
KNOW: A community pharmacy must maintain written policies and procedures to ensure proper, safe, and secure functioning of the automated pharmacy system, and must review the policies/procedures ________ and maintain records for a minimum of _______.
Review: - Annually Maintain: - 4 years *things that must be included are on pg 200-201 but there is too much to write*
Salicylates warning statement
Reye's syndrome in pediatric patients
What is REMS?
Risk Evaluation and Mitigation Strategy Helps to manage a known or potential serious risk associated with a drug or biological product
NEED TO KNOW: When must a prescriber write "Non-acute Pain" on the prescription?
Rx for a C-II opioid for treatment of pain other than acute pain
What is the only biosimilar product the FDA has indicated is interchangeable? What is it interchangeable with?
Semglee (Insulin Glargine-yfgn) Lantus
As of July 2021, what insulin was FDA approved as interchangeable for its reference product, Lantus?
Semglee (insulin glargine-yfgn)
A successful media test is one that
Shows no growth or cloudiness over the time period of the test
What sign must be posted by a pharmacy that has delayed commencement of operations?
Sign in block letters not less than 1 inch in height at main entrance of establishment, stating that the pharmacy has not yet commenced operations and that medicinal drugs may not be sold nor prescriptions filled or dispensed
What are the sign requirements for generic substitution?
Sign in block letters not less than 1 inch in height, which reads: "CONSULT YOUR PHARMACIST CONCERNING THE AVAILABILITY OF A LESS EXPENSIVE GENERICALLY EQUIVALENT DRUG AND THE REQUIREMENTS OF FLORIDA LAW" Must be displayed in a prominent place w/ a clear and unobstructed view, AT or NEAR the place where prescriptions are dispensed
What are the space/equipment requirements for pharmacies?
Sink with running water Sufficient shelf, drawer, and cabinet space Adequate facilities for storage and refrigeration Adequate sanitation Current pharmacy reference compendia
What is done to demonstrate that transport from the PEC to the lyophilizer can be accomplished while maintaining ISO 5 laminar flow air at all times?
Smoke studies
KNOW: When information in USP conflicts, the more ______ document applies.
Specific
USP Monographs contain what?
Specific info about a formulation or compound USP compendium contains almost 200 different compounding monographs
503a pharmacies are governed by.... 503b pharmacies are governed by....
State BOP, USP standards FDA and cGMP standards
Florida pharmacists are required to report ALL vaccinations to the
State Health Online Tracking System (SHOTS) program
Who enforces USP standards?
States and accreditation organizations that incorporate the standards into their requirements - USP themselves do not enforce these
USP 797
Sterile preparations
USP Chapter 71
Sterility Tests
KNOW: Finished product testing requirements for lyophilized compounded drugs
Sterility testing methods described in USP 71, or equivalent ones - Diluents for reconstituting the vials for testing must be preservative free - Lyophilized products released w/ BUDs within USP 797 shall, in lieu of sterility testing, conduct viable air, surface, and personnel (glove & sleeves) sampling for EACH BATCH
USP 71
Sterility tests(adopted by florida law)
What records are maintained for the receipt of CIII-CV drugs?
Supplier's invoice
What is a CQI program?
System of standards to identify and evaluate quality-related events and improve patient care
KNOW THIS PLS FOR THE LOVE OF GOD: Label requirements for drugs dispensed to a patient
THIS IS FOR A LABEL NOT FOR AN RX!!!!! NAME: "PPPD" - Patient or owner + species - Pharmacy - Prescriber - Drug ADDRESS: - Pharmacy PRESCRIPTION: "NEDD" - Rx Number - Expiration or BUD - Directions - Date dispensed - IF ALSO CONTROLLED: Federal transfer warning
T/F: Any prescription for a narcotic that is not mixed with another drug will always be a CII?
TRUE
T/F: Pharmacies must have a sign about human trafficking on the premise
TRUE
T/F: Electronic transfers of prescriptions are permitted REGARDLESS of whether the transferor or transferee pharmacy is open for business.
TRUE - REMEMBER: DEA only allows transfer of REFILLS (not original Rx) for controlled substances, although by policy, they allow original Rx's to be transferred if they are electronic Rx's for controlled substances
Can you fill scripts from out of the country?
Technically yes, but controls would not have a DEA so technically wouldn't be a valid prescription
Class II FDA recall
Temporary or medically reversible adverse health problem, or there is a remote chance that the device will cause serious health problems
For the drugs that pharmacists are authorized to issue a prescription for, who must dispense the medication?
That same pharmacist
Who may add, delete, or reschedule substances under the FLCSA?
The Florida Attorney General
Who enforces the Florida Food Drug and Cosmetic Act (FFDCA)?
The Florida Department of Business and Professional Regulation (DBPR) - NOT the BOP
HIPAA and HITECH are enforced by
The Office of Civil Rights
Who is the only person who may grant a POA for signing DEA Form 222?
The actual registrant (individual, partner, or officer)
Biosimilar definition
The biological product is highly similar to the reference product, notwithstanding minor differences in clinically inactive components, and there are no clinically meaningful differences between the biological product and the reference product in terms of safety, purity, and potency of the product
All prepackaging of medications must be done in accordance with procedures set up by
The consultant pharmacist of record
A DEA Form 41 is only required for destruction of controlled substances when
The destruction of controlled substances is done on the premises of the pharmacy (except nursing homes) - if transferred elsewhere for destruction, follow the transfer between registrants rule (invoice for C3-5, 222 for C2)
A prescription department is considered closed whenever
The establishment is open and a pharmacist is not present and on duty
What is the law for informed consent for the nursing home formulary legislation?
The facility must obtain informed consent from pt/representative to use the institutional formulary for the resident. Must clearly inform resident/designee of right to refuse to participate in use of institutional formulary and may NOT take any adverse action against the resident who refuses to participate in the use of the institutional formulary
KNOW THIS!!! CE requirements for initial renewal <12 months after initial licensure date
The following CE's only - 2h med errors - 2h controlled substances - 1h HIV/AIDS (since initial renewal)
When selling a pharmacy, under what circumstances does the DEA permit the new owner to continue the business of the pharmacy under the previous owner's registration?
The following requirements must be met: 1. New owner must expeditiously apply for an appropriate DEA registration and state licensure 2. Previous owner grants Power of Attorney to the new owner that provides for the following: - Previous owner agrees to allow controlled substance activities of the pharmacy to be carried out under their DEA registration - Previous owner agrees to allow new owner to carry out the controlled substance activities of the pharmacy, including the ordering of controlled substances, as an agent of the previous owner - Previous owner acknowledges, as the registrant, that he or she will be held accountable for any violations of controlled substance laws that may occur, and - Previous owner agrees that controlled substance activities of the pharmacy may be carried out under their DEA registration and shall remain in effect for no more than 45 days after purchase date
KNOW: If a delinquent license is NOT reactivated within 2 years, what happens?
The license is void
What are action levels for a gloved fingertip test?
The maximum # of CFUs allowed
KNOW: If the seal is broken in an emergency medication kit for a nursing home, when must the kit must be restocked and resealed?
The next business day after use
What shall be done if a transferred prescription is not dispensed within a reasonable time?
The pharmacist shall notify the transferring pharmacy, which serves to revalidate the cancelled prescription
KNOW: Who bears the cost of DOH inspections?
The pharmacy or permittee
What is the definition of therapeutic substitution in nursing homes?
The practice of replacing a nursing home facility resident's prescribed medicinal drug with another chemically different medicinal drug that is expected to have the same clinical effect - often done in hospitals, but this law permits the practice in nursing homes
What is a dwell time?
The time the solution (for cleaning a clean-room) must be wet and in contact with the surface in order to achieve its intended result (i.e., decontamination, cleaning, disinfection).
To be interchangeable, a drug must be...
Therapeutically and pharmaceutically equivalent
KNOW!! What is the policy/rule for transfer of prescriptions in pharmacies that are under common ownership or utilize a common database?
They may dispense a prescription in the common database and such a dispensing is NOT considered a transfer - KNOW TRANSFER VS DISPENSING FROM COMMON DATABASE
What must a pharmacist do if a drug is prescribed that is on the Negative Formulary, but no brand name is specified?
They must dispense a product that has an approved New Drug Application or Abbreviated New Drug Application to market the drug - In this case, whichever brand is dispensed should ALSO be used for any refills
KNOW: Regardless of the type of hearing requested by the subject, how else can a complaint be settled?
Through a consent decree OR stipulation which is submitted to the Board for approval
What is the goal of the FFDCA?
To prevent fraud, adulteration, misbranding, or false advertising in the preparation, manufacture, repackaging, or distribution of drugs, devices, and cosmetics - Applies primarily to drug manufacturers, drug repackagers, drug wholesalers, medical gas/oxygen manufacturers and distributors, and others involved in distribution (NOT dispensing) of drugs
FDA Form 3911
Track and trace form to report illegitimate products to the FDA ***Must also notify trading partners within 24 hours***
What is the preferred method of destruction of controlled substance inventory in a pharmacy?
Transfer to an Authorized (Registered) Reverse Distributor - simply transferring from one DEA registrant (the pharmacy) to another (the reverse distributor)
T/F: A pharmacist may take up to a 30-minute meal break but cannot leave the premises. The pharmacy is NOT considered closed during this time, nd registered pharmacy technicians may remain in the pharmacy.
True
T/F: A pharmacy intern may be employed as a pharmacy technician without paying a registration fee or filing an application as a pharmacy technician.
True
T/F: A pharmacy receiving custody of prescription files from another pharmacy shall maintain the delivered Rx files separately.
True
T/F: A prescriber may opt out of the nursing home facility's institutional formulary w/ respect to a medicinal drug or class of medicinal drugs for any resident.
True
T/F: A prescriber must authorize use of the institutional formulary in a nursing home for each patient.
True
T/F: An individual practitioner who is registered at one location but practices at other locations in the same state is NOT required to register at those other locations if they only prescribe controlled substances at those locations.
True
T/F: Any Board member who participated on the Probable Cause Panel for a complaint may NOT vote on the final disciplinary decision for that complaint.
True
T/F: If initial CPPA is addended, pharmacist must maintain a copy of both the addendum AND initial agreement.
True
T/F: The pharmacist is considered directly and immediately available to patients during a meal break if patients are informed that they may request a pharmacist contact them at their earliest convenience after the meal break and if the pharmacist is available for consultation for emergency matters.
True
T/F: An impaired pharmacist who voluntarily enters into a contract for treatment with PRN will not be referred to the FLBOP for discipline.
True ***As long as they acknowledge the impairment and successfully complete the program
T/F: It is unlawful for any person other than a pharmacist licensed under this chapter to use the title "pharmacist" or "druggist" or otherwise lead the public to believe that she or he is engaged in the practice of pharmacy.
True - same concept for ppl placing signs or advertising that they dispense or compound medicinal drugs other than the person owning the pharmacy (owner does not have to be a pharmacist)
T/F: Compounding for practitioners to resale or distribute is not allowed, but compounding for administration in a practitioner's office is permitted.
True!! - considered office use compounding
T/F: The FLBOP may refer a pharmacist to treatment with PRN if they receive a complaint.
True, but only under certain circumstances
How often must a new pharmacy be inspected?
Twice during the first year of operation
KNOW: Modified Class II Pharmacy Permit Subcategories
Type A - Max 15 drugs on formulary (excluding emergency kit), not stored in bulk - Controlled substances must be </= 100 dosage units (unless an exception is granted by BOP) - Ex: Alcoholism treatment center Type B - Expanded formulary w/ meds stored in bulk AND pt-specific form - Ex: Urgent care centers, outpatient surgery centers, correctional institutions Type C - Expanded formulary, drugs stored in pt-specific form, no bulk drugs allowed - Ex: Jail w/ small inmate population in which drugs are self-administered under supervision
How does FL law for donning of gloves differ from USP requirements?
USP requires donning of gloves prior to entering clean room FL allows donning to be done after entry into the clean room to avoid contamination of the gloves from the door handle
What is the unclaimed prescription rule?
Unclaimed rx's may be retained by pharmacy and reused for 1yr from date of filling, unless it has an earlier expiration date
Laws and rules for collaborative practice by consultant pharmacists
Under collaborative practice agreement, they may provide med management services in a healthcare facility within framework of a written CPA between facility med director or a physician, a podiatric physician, or a dentist
What do medical devices have instead of NDC numbers?
Unique Device Identifiers (UDIs)
In-use time for a single-dose vial when opened OUTSIDE of or REMOVED from ISO 5
Up to 1 hour
In-use time for a multiple-dose vial when opened AND maintained in ISO 5
Up to 28 days (unless manufacturer's instructions differ)
In-use time for a multiple-dose vial when opened OUTSIDE of or REMOVED from ISO 5
Up to 28 days (unless manufacturer's instructions differ)
In-use time for a single-dose vial when opened AND maintained in ISO 5
Up to 6 hours
When may the Board deviate from the disciplinary guidelines?
Upon a showing of aggravating or mitigating circumstances by clear and convincing evidence
What may pharmacists do instead of keeping original paper prescriptions?
Use an electronic imaging recordkeeping system as long as it is capable of capturing, storing, and reproducing the exact image of the rx (front and back if necessary) for 4 years from date of last filling
In-use time for ampule when opened OUTSIDE of or REMOVED from ISO 5
Use and discard remainder
In-use time for an ampule when opened in AND maintained in ISO 5
Use and discard remainder
Expiration for an opened ampule
Use and discard remainder regardless of ISO class
High risk CSP
Use of a non-sterile product, product without preservatives or exposure to environment for over 1 hour, non-sterile water or bulk products, with high risk storage Ex: Not garbing to make something or starting with a non-sterile API
KNOW: Per USP 797, terminal sterilization is described only as
Use of an autoclave (steam under pressure) or dry heat - Filtration is NOT considered terminal sterilization under USP!!!
Alcohol warning statement on medications
Used on NSAIDs and other internal analgesics/pyretics Warning for ppl drinking more than 3 alcoholic beverages a day to consult Dr before taking
How should media fills be conducted for sterile compounded products prepared using a process that includes lyophilization?
Using maximum batch sizes - shall demonstrate the filling, transportation to the lyophilizer, loading, and stoppering operations - media shall NOT BE FROZEN as part of the media fill, as freezing of the media could reduce the ability of the media to support growth
Can you fill a prescription for a patient if the doctor has died or retired?
Varies state to state, but not addressed in FL law According to DEA, the DEA number expires once the prescriber has died.
Who is exempt from using a counterfeit prescription pad for written controlled substance prescribing?
Veterinarians
How can a prescriber's DATA waiver be verified by a pharmacist?
Via the SAMHSA website's Buprenorphine Pharmacy Lookup
What are citation violations?
Violations for which there is no substantial threat to the public health, safety, and welfare or no violation of standard of care involving injury to a patient - may include a penalty (fine) and payment of the costs of investigation
How often must pharmacies back up their computer systems?
Weekly
KNOW: For records maintained in a data processing (computer) system, information stored must be backed up at least ______.
Weekly
When is an institutional pharmacy considered closed?
When a FL licensed pharmacist is not present and on duty - no other person than a FL licensed pharmacist shall enter except as permitted by FPA 465.019 and Rule 64B16-28.602
KNOW: Other than when compounding antineoplastic HDs, when are 2 pairs of powderless chemo gloves required?
When administering injectable antineoplastic HDs
When do OTC labeling products not have to be followed?
When an OTC product is prescribed and filled as a prescription - Rx drug labeling requirements would apply and would include the prescriber's directions for use
When is the technician:pharmacist ratio 3:1?
When engaging in sterile compounding
When is the only time a prescription drug product is exempt from the manufacturer's labeling requirements?
When it is dispensed pursuant to a valid prescription - therefore, if a pharmacist dispenses a Rx without authorization, the drug becomes "misbranded" even if it is labeled correctly - pharmacists must have an rx in order to dispense the prescription product or it will be misbranded
KNOW: When are only one pair of powderless chemo gloves required to be worn?
When receiving NIOSH Table 1 antineoplastic HDs
Under what conditions is a pharmacy exempt from having to caulk the inlaid ceiling tiles to the perimeter of the support frame?
When the following conditions are met: 1. Ceiling tiles are specifically manufactured to be utilized in a facility that must meet and maintain an airborne particulate cleanliness of ISO Class 7 or better 2 .Core of the ceiling tiles are sealed on the front, back, and all edges to render them impervious and hydrophobic, so they can be properly maintained and cleaned as required by this rule 3. Ceiling tiles are inlaid or installed using gasket grid sealing system, which is manufactured for use in facilities that must meet and maintain an airborne particulate cleanliness of ISO Class 7 or better. The sealing system must create and maintain a positive seal between the ceiling tiles and the support frame, and the seal between the ceiling tiles and support frame shall be secured w/ retention clips. this is so boring i could die
Under USP 800, when is it advised to wear face and eye protection?
When there is a risk of spills or splashes of HDs - safety eyeglasses w/ side shields do NOT provide adequate protection
When is a supplier NOT required to send a copy of the original DEA Form 222 to the DEA?
When they report transactions to ARCOS, bc this info has already been reported
NEED TO KNOW: In which circumstances is the "X" number NOT required for a prescription for a buprenorphine product?
When they're used for pain or "off-label" use
Who is required to present a valid photo ID before being dispensed any controlled substance (C2-5)?
Whoever is purchasing, receiving, or otherwise acquiring the med
What license must pharmacies that are "distributing" have?
Wholesale distribution license
If transferring a Controlled Substance (III-V) to another registrant, what must be done by the transferring pharmacist?
Will need to provide an invoice (since the pharmacy would be considered the supplier in the case of transferring) including all the stuff in that previous slide
How often should glove fingertip sampling be done for sterile compounded products prepared using a process that includes lyophilization?
With each batch after the fill and transport of the vials
KNOW: How is viable monitoring accomplished?
With electronic air sampling and surface sampling
NEED TO KNOW: Under FL law, how long after being issued by a prescriber must a C-II Rx be filled?
Within 1 year
How soon after commencement of operations (following a delay in commencement) shall the pharmacy notify the board of the date of commencement?
Within 2 days
Time to notify BOP of commencement of operations for a community pharmacy
Within 2 days of commencement of operations
If a product is illegitimate, when must pharmacies notify trading partners?
Within 24 hours
How soon after termination of enrollment in an intern program (college of pharmacy), or withdrawal of registration or attendance in an accredited school or college of pharmacy, should all interns report such change in enrollment, registration, or attendance to the board?
Within 30 days
Time to send a DEA form 41 for Destruction of Drugs once it has been completed and witnessed
Within one business day of destruction to DEA
How can CII prescriptions be issued?
Written or electronic ONLY - unless emergency, then verbal
DEA letter of DATA waived prescriber
X Authorizes dispensing and prescribing of buprenorphine and buprenorphine/naloxone outside of a narcotic treatment center
Does FL have a standing order for naloxone?
YES
T/F: An FDA approved drug must have an NDC
YES But, not all drugs have an NDC; ie unapproved drugs
When to media fill/glove test for medium CSP?
Yearly
KNOW: What travel vaccine requires additional qualification in order for pharmacists to administer the immunization?
Yellow Fever
Are syringe exchange programs allowed?
Yes
Can emergency medication kits in nursing homes include controlled substances?
Yes
Do prescribers need to write "Non-acute Pain" on a prescription for a C-II opioid if the quantity is >7 days?
Yes
Is central fill allowed in Florida?
Yes
Under florida law, are pharmacists permitted to remotely supervise pharamacy technicians, including the technicians working at home or at other locations?
Yes
Can a pharmacy technician accept verbal authorization to refill a prescription if no changes are made?
Yes - if changes were made, no - if new verbal rx, no
Can pharmacists administer long acting injectable psych meds?
Yes Must complete an 8 hour CE (can count towards 30 required for renewal) Be in a CPA with a physician Follow all safety and privacy guidelines for administration of other injections
Are CQI programs required?
Yes Must have a committee that meets every 3 months
Can any healthcare professional enroll in Florida's impaired pharmacist recovery program?
Yes They can be court ordered or self-enroll
KNOW: Is the pharmacist required to submit the CPPA to the board of pharmacy?
Yes - prior to initiating or immediately after renewal
If an rx is provided electronically w/ a note to the pharmacist indicating "Acute Pain Exception" or "Non-acute Pain", will that meet the requirements of the law?
Yes since it was transmitted w/ or is a part of the rx
If a pharmacy intern in training is currently enrolled in a board-approved technician training program, can they be in a pharmacy to obtain practical training or is this not allowed until training is complete?
Yes they can be in a pharmacy to obtain practical training while still enrolled in program
KNOW: What if a pharmacist earns general CE in a different state that is NOT ACPE approved, but it IS approved by the BOP in the other state? Will this still be applied to their FL CE requirements?
Yes!
Can pharmacists, prescribers, and dispensers appoint a designee to access the PDMP to request and receive information?
Yes! - the designee has to complete a form and be linked to the account by the person designating them - if they dont access E-FORSCE within 6 months they get deactivated and will have to reapply
Are pharmacist allowed to annotate an Rx if the prescriber forgets to write "Acute Pain Exception" or "Non-acute Pain"?
Yes, after contacting provider to verify rx
KNOW THIS: Can MD/DOs prescribe drugs outside their specialty?
Yes, but it is illegal to fill it - ex: Oncologist prescribing HTN med
Can you get needles without a prescription?
Yes, but must be over the age of 18 This is also determined by certain cities and counties. It is LEGAL statewide, but may be stricter within various places in the state.
Can physicians self-prescribe non-controlled medications or prescribe for family members?
Yes, but per the definition of a "legal prescription", it requires a valid practitioner-patient relationship and the rx must be issued in the usual course of professional practice, so physicians can be disciplined by the board of medicine for this - pharmacists can also be disciplined for dispensing such meds if they know or have reason to believe that the rx isn't based on a valid practitioner-patient relationship
Can you fax prescriptions?
Yes, but they may not be dispensed until after the original copy has been received - not sure if this is correct so dont memorize this pls
Can pharmacists take lunch breaks without closing the pharmacy?
Yes, for 30 minutes Must have a sign that states the pharmacist is available upon request A sign must also be posted that the pharmacist is not on duty Technicians can perform normal duties during this time
Is offer to counsel required for all prescriptions?
Yes, for all new and refill prescriptions, either verbal statement or in writing
NEED TO KNOW: Are pharmacists allowed to add a practitioner's DEA number to a C2 prescription or correct the patient's name/address?
Yes, if determined to be appropriate per the pharmacist's professional judgement
Are medical ID cards required for marijuana use?
Yes, only given for certain indications including... Cancer, epilepsy, chronic pain, PTSD, HIV, AIDS, glaucoma, MS, Parkinson's, ALS, and many other chronic/terminal conditions
Must pharmacies have a PDM?
Yes, or consultant pharmacist of record if inpatient
KNOW: Can pharmacists that prescribe off the pharmacist formulary get reimbursement for their services?
Yes, they are eligible for reimbursement by third-party plans when so provided by contract
It is unlawful for a person, firm or corporation that is NOT licensed or registered under this chapter to:
a. Use in a trade name, sign, letter, or advertisement any term, including "drug," "pharmacy," "prescription drugs," "Rx," or "apothecary," which implies that the person, firm, or corporation is licensed or registered to practice pharmacy in this state b. Hold himself or herself out to others as a person, firm, or corporation licensed or registered to practice pharmacy in this state --> same w/ pharmacy technicians
Immediate use CSP
are compounded in emergency situations or where immediate patient administration is mandated to avoid harm that may result from delays in treatment
Autoclaving is monitored using
biological indicators
HDs must be transported in containers that minimize the risk of
breakage and leakage
NEED TO KNOW: FL law requires ALL institutional pharmacies (including hospitals) to be under the direction of a
consultant pharmacist
An institutional pharmacy permit may not be issued unless a licensed pharmacist is designated as the ____.
consultant pharmacist of record
Any pharmacies registered as outsourcing facilities must meet/comply with the
current Good Manufacturing Practices (cGMPs) of the FDA
first 4-5 digits of NDC
labeler code
Community pharmacy permits are required for every location where
medicinal drugs are compounded, dispensed, stored, or sold or where rx's are filled or dispensed on an outpatient basis
Donations of cancer drugs or supplies under the Cancer Drug Donation Program shall only be made at a
participant facility - they may decline to accept a donation
Per FL law, pharmacists must substitute a generic equivalent, unless otherwise requested by the purchaser, if the drug is on the pharmacy's ________.
positive formulary
KNOW: Complaints against pharmacies, pharmacists, registered pharmacy technicians, and registered pharmacy interns made to the BOP are investigated by
the Medical Quality Assurance Division of the Florida DOH
The BUD for any compounded drug cannot be longer than
the expiration date of any of its components
What is a 503A pharmacy?
traditional pharmacy that compounds for specific patients pursuant to prescriptions (no cGMP required) ****Follow USP 797*** Interstate distribution of compounded drugs is limited to 5% of the total prescription orders dispensed or distributed by such pharmacy (effective 10/22/22 in FL)
What schedule is phentermine?
used 4 weight loss - get it.. C4 C-IV
If a portion of the dispensing information is incorrectly entered or omitted in the PDMP, how long does the reporting dispenser have to correct it and resubmit?
within 1 business day of notification of the error/omission
KNOW: How long after entering into a written Test & Treat protocol with a physician must the pharmacist submit a copy of the written agreement to the BOP?
within 5 days
BEGINNING OF CH. 5 WOO
yeehaw
How do you verify a DEA number?
• add the 1st, 3rd and 5th number • then and the 2nd, 4th, and 6th number and multiply the result by 2 • take the ans. from both equation and add them together • the sencond digit in the ans should match the last digit of the DEA number ** the fist letter of the DEA number represents the type of practice or institution the DEA number is issued to and the second letter represents the first letter of the practitioners last name**
