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Florida MPJE (2)
State Law Review
| Question | Answer |
|---|---|
| What should be done with unused controlled substances in class I institutions (nursing homes) and some modified class II B pharmacies? | They should not be returned to the pharmacy but securely stored until disposed of or destroyed |
| It is required that the names of what appear on scripts filled by central fill pharmacies. | Originating and central fill pharmacy |
| May a Class II Institutional Central Fill Pharmacy deliver to patients? | No |
| When may central fill pharmacies deliver to patients? | If it is not a CS, they are not by a common carrier, there is a toll free # available, pharmacist is available 40 hrs per week, and the pharmacies are under common ownership or have special agreement |
| In this type of institution, prescriptions are taken from original containers or from containers prepared by a licensed pharmacist. | Class II |
| All institutional pharmacies must have one of these employed. | Consultant Pharmacist |
| How much time is required for an institutional pharmacy to notify the board of a change of a consultant pharmacist? | 10 days |
| Must be supervised by FL licensed pharmacist employed by a “Provider Pharmacy” who need not be physically present if electronic supervision possible | Automated pharmacy systems (long term care facilities) |
| Who can restock an automated system? | Pharmacist, technician, or intern |
| What are examples of modified class II institutions? | Alcohol treatment centers, free-standing ER/ surgery center, county health programs |
| What are the three types of modified class II institutions? | A,B, & C |
| This type of modified class II institution has a formulary of not more than 15 medicinal drugs (not including emergency items) stored in bulk; CS in unit size not to exceed 100 doses; monthly inspections by CP | Type A |
| This type of modified class II institution has an expanded formulary and stores drugs both in bulk and in patient specific forms; monthly inspections by CP | Type B |
| This type of modified class II institution has an expanded formulary w/ drugs stored in patient sufficient forms only; monthly inspections by CP | Type C |
| Makes sterile products & parenteral & enteral compounding limited to sterile preps for parenteral therapy and TPN, jejunostomy feeding, & sterile irrigation, cytotoxic or antineo-plastic agents, eye drops & injectables | Sterile products/Parenteral and Enteral Compounding |
| A pharmacy that does Sterile products/Parenteral and Enteral Compounding must under the control of who? | A licensed pharmacist who is designated as pharmacy dept. mgr |
| What type of flow hoods is sterile compounding typically done under? | Type A or B Laminar flow hood |
| What references are required to be on site of a compounding pharmacy? | The Handbook on Injectable Drugs (ASHP), Practice Guidelines for Dealing with Cytotoxic Drugs, Compendia, & Florida statutes and regulations |
| These are pharmacies that compound patient- specific preparations in conjunction with an Institutional Pharmacy | Parenteral/Enteral Extended Scope Pharmacies |
| These operate under the same rules and procedures as a Parenteral/Enteral pharmacy | Parenteral/Enteral Extended Scope Pharmacies |
| These dispense to facilities where scripts are individually prepared for residents, such as nursing homes, jails, intermediate care facilities, etc. | Closed System Pharmacies |
| These pharmacies handle dialysis products and supplies that patients typically administer at home | End Stage Renal Disease (ESRD) Pharmacies |
| This has limited formulary of 16 items, including heparin, vitamin preparations, lidocaine, etc. and also must have 4 legend devices connected w/ dialysis, e.g. hemodialyzers. | End Stage Renal Disease (ESRD) Pharmacies |
| What do animal control shelters operate as? | Modified Class II Institutional Pharmacies |
| What is the sole purpose of animal control shelters? | Immobilization/euthanasia of animals |
| What examples of minor violations? | Outdated drug, failure to meet daily hours, no substitutions sign, failure to sign script log, failure to maintain references, QC program not documented, improper storage, failure to have "do not transfer" on CS, failure to ID techs, insufficient labels |
| What four violations can lead to revocation of license? | Obtaining a license or permit by misrepresentation, fraud or error of the Department, Procuring a license or permit for another by false representation, Permitting unlicensed persons to practice pharmacy, being unfit or incompetent to practice |
| Unregistered physicians can write these scripts: | Non-CS |
| These scripts written by PAs and Advanced Practice Nurses are presumed valid | Non-CS |
| What must be contained on prescriptions for medicinal drugs? | Name of prescriber, name & strength of drug, quantity, directions, date, signature of prescriber |
| How soon do you have to notify the board of a conviction? | Within 30 days |
| What can cause immediate suspension of a license? | A felony for Medicaid or common fraud or a violation of the Florida Controlled Substance Law, a misdemeanor under Medicaid law, positive drug test, or default on student loan |
| What is the treatment programs for impaired practitioners? | Professionals Resource Network (PRN) |
| What does the Florida Drug and Cosmetic Act (FLDCA) prohibit? | Making, repackaging, or selling any drug, device or cosmetic that is adulterated, misbranded, or otherwise rendered unfit for human or animal consumption, mutilating or removing any label, counterfeiting drugs, refusing inspections |
| False advertising is prohibited under this: | Florida Drug and Cosmetic Act (FLDCA) |
| Sale of HIV testing kits not approved by the FDA is prohibited under this: | Florida Drug and Cosmetic Act (FLDCA) |
| Trafficking in “contraband” drugs is a violation of what? | Florida Drug and Cosmetic Act (FLDCA) |
| Lacking pedigree papers is a violation of what? | Florida Drug and Cosmetic Act (FLDCA) |
| This may not be advertised or contain a label that contains unapproved indications | Ephedrine |
| What kind of dye does adulterated cosmetics not apply to? | Coal-tar hair dye |
| Establishments where RX drugs are kept must be free of what according to the Florida Drug and Cosmetic Act (FLDCA)? | Insects, rodents, birds & vermin |
| What must be done with outdated, damaged, adulterated drugs according to the Florida Drug and Cosmetic Act (FLDCA)? | They must be separated and quarantined |
| Are drugs that are properly compounded by a licensed pharmacist subject to mfg. standards? | No |
| How are starter packs distinguished from samples? | They are not free, they can be sold at retail, and are subject to all RX regulations |
| How does the cancer drug donation program work? | Not for donation to a specific person, they go to healthcare facilities, must be sealed, and not expired more than 6 months, and expired by a pharmacist |
| This is directed at physicians and manufacturers to give some immunity in supplying “eligible patients” with investigational drugs | Florida "Right to Try" Act |
| With this act, if patient dies, their estate is not liable for outstanding bills | Florida "Right to Try" Act |
| Who is eligible for the Florida "Right to Try" Act? | Patients with a terminal illness certified by 2 physicians with all treatment options considered, with written consent provided, and physician's certification to condition |
| Who pays the cost of drugs with the Florida "Right to Try" Act? | Patients (until they die) |
| What did Florida do with phenylalanine and ephedrine? | They made them require an RX |
| May a prescription for a controlled substance be issued on the same blank as a non-controlled substance? | No |
| A “Practitioner” for controlled substance purposed is one of the following who is properly licensed in Florida and registered w/ the DEA: | Allopathic, osteopathic physician, dentist, veterinarian, naturopath, certified optometrist, podiatrist |
| How is the quantity of a controlled substance required to be transcribed on a written prescription? | In numerical and textual form |
| How must a controlled substance prescription be dated? | In numerical, month/day/year format, or with the abbreviated month written out, or the month written out in whole |
| How many chemicals are identified as “listed precursor chemicals” which may be used in mfg. of a controlled substance? | 27 |
| How many chemicals are listed as “essential chemicals” which may be a catalyst for controlled substances? | 11 |
| A pharmacist may not dispense more than a ___ day supply of a controlled substance listed in Schedule III upon an oral prescription issued in this state | 30 |
| How soon should data be input into the Florida PMP? | Within 7 days |
| What data should be input into the Florida PMP? | Prescriber name with identifier, date of RX, method of payment, name, address, & DOB of pt, name, code, qty, strength of drug, info of pharmacy, person who dispenses the drug |
| What are exemptions to inputting PMP? | 72 hr supply, ER dispensing, dept of corrections dispensing, one time direct administration to pt, administration in a healthcare facility |
| What schedule is Rohypnol (flunitrazepam) in Florida | Schedule I (schedule IV according to DEA) |
| What schedule is buprenorphine in Florida? | Schedule V (Schedule III according to DEA) |
| Under this statute, a physician who has examined & is treating a resident pt suffering from cancer or a physical condition that chronically produces symptoms of seizures or severe/ persistent muscle spasms may order medical low-THC cannabis | Compassionate Use Statute |
| When can the Compassionate Use Statute be used? | When no other satisfactory alternative treatment options exist. |
| The term cannabis was amended so that it does not include what? | Low-THC cannabis |
| Who may serve as the administrator of a LTCF’s designee in order to witness the destruction of controlled substance medications at the facility? | Licensed physician, mid-level practitioner, nurse, sworn law enforcement officer |
| When destroying patient-specific controlled substance drugs in a Modified Institutional Class II B pharmacy, such destruction must be witnessed by who? | The consultant pharmacist, director of nursing, & the administrator or his/her designee |
| What form must be signed and sent to the DEA within one day of destruction of controlled substances by all permitees (excluding Class I - nursing homes) | DEA 41 |
| If a community pharmacy which acts as the central fill pharmacy & which notifies the Board that its pharmacy practice is limited only to such practice must it still have a designated patient consultation area? | No |
| Can a Class II institutional central fill pharmacy deliver medications to patients? | No |
| What exemptions is a community pharmacy that acts as a central fill pharmacy and that notifies the board that practice is limited to such allowed? | Doesn't require consultation area, signage requirements, or regulation of daily operating hours |
| A Special-Limited Community Permit must be obtained by a Class II Institutional Pharmacy that dispenses drugs to discharged patients of the hospital who are under a continuation of a course of therapy using multi-dose drugs. Before drugs are dispensed: | Physician must first write a specific order to authorize that the multi-dose medicinal drug is appropriate to dispense upon discharge & the patient or his/her caregiver must be educated on the administration of such drugs |
| What are examples of multi-dose drugs? | Inhalers, ocular/otic products, insulin vials/pens, bulk antibiotic suspensions, topicals, and medrol dose packs dispensed to inpts, provided in containers that may exceed a 3 ds & are meant to be continued on an outpt basis but not to be re-filled |
| Can telemedicine include the provision of health care services only through an audio only telephone, email messages, text messages, facsimile transmission, U.S. Mail or other parcel service, or any combination thereof? | No |
| Who may practice via telemedicine? | A Florida licensed physician or PA |
| May nurse practitioners practice in telemedicine? | No |
| Can a physician-patient relationship be established through telemedicine? | Yes |
| Can prescribers prescribe controlled substances via telemedicine? | No |
| RXs issued for controlled substance medications in which schedules must include both a written & numerical notation of the qty of drug prescribed? | II, III, IV |
| What if a CII-IV has a numerical quantity but not a textual quantity? | The pharmacist can dispense without verification of the prescriber if they have filled that medication previously for the patient |
| What if a CII-IV has no textual quantity and the prescriber is not available to verify the prescription? | The pharmacist may dispense the controlled substance but may insist that the person to whom the controlled substance is dispensed provide valid photographic identification |
| What is the max amount of opium that can be sold without a prescription within 48 hours? | 240 mg |
| What is the max amount of dihydrocodeine that can be sold without a prescription within 48 hours? | 60 mg |
| What is the max amount of ethyl morphine that can be sold without a prescription within 48 hours? | 30 mg |
| What is the max amount of codeine that can be sold without a prescription within 48 hours? | 120 mg |
| Does a pharmacist need to acquire a patients ID to mail CIIs? | No, they are exempt as long as they acquire the info from the patient's PBM |
| What schedule of controlled substance prescriptions can a pharmacist mail? | CII-V |
| When is oral dispensing of a CII allowed? | In a state of emergency (limited to 72 hours) |
| When is a controlled substance inventory required to take place? | Biennially, within 6 months of the biennial date |
| Drugs in this scheduled class may lead to severe psychological or physical dependence | Schedule II |
| Drugs in this scheduled class may lead to moderate or low physical dependence or high psychological dependence or, in the case of anabolic steroids, may lead to physical damage | Schedule III |
| Drugs in this scheduled class may lead to limited physical or psychological dependence | Schedule IV |
| What scheduled class of drugs is testosterone found in? | Schedule III |
| Does the PMP require the NDC to be submitted? | Yes |
| Does the PMP require the person picking up the prescriptions info be submitted? | No |
| Any pharmacist who has reason to believe that a prescriber of controlled substances is involved in the diversion of controlled substances shall report such prescriber to who? | The department of health |
| Can counterfeit-resistant prescription blanks be transferred? | No |
| Must a prescriber's DEA be pre-printed on counterfeit-resistant prescription blanks? | No |
| What happens to controlled substances seized by the authorities? | They may be weighed &/or sample-tested by the seizing agency, & any such sample and the analysis thereof shall be admissible into evidence. Agency may also use photos & video |
| According to the Florida Contraband Forfeiture Act, what may be seized & forfeited if used in the illegal sale of controlled substances? | Any vessel, property, money, negotiable instrument, etc. |
| What must appear on the face of a written CS prescription? | Patients name & address or owner's name & species (if for animal), RX number and pharmacist's initials |
| What is the max amount of fluoride a pharmacist should order for a patient and the length of time acceptable? | 264 mg - max treatment of 1 year |
| Should manufacturers change once a fluoride treatment is started? | No |
| How many days per week must a community pharmacy be open in Florida? | No specific requirement for days - just 40 hours per week |
| When may the board allow a pharmacist to serve as the prescription department manager (PDM) of more than 1 community pharmacy? | An exception to the rule can be made due to proximity of permits and limited pharmacist workload that would allow the manager to carry out all duties and responsibilities required of a prescription department manager |
| When can a licensed Florida pharmacy perform prescription drug processing for other pharmacies? | When then pharmacies are under the same common ownership, share a database, & are properly licensed in FL or another state |
| What guidelines are required for the prescription of obesity drugs? | BMI of 30 or above, BMI >27 with at least one co-morbidity factor, measurable body fat content of 25% or more in males and 30% or more in females |
| How soon after hire, must a registered pharmacy technician sign the pharmacy's policies and procedures manual? | 90 days |
| What is the difference in glove usage in compounding in FL vs USP? | Pharmacy personnel may don gloves after entry into the clean-room to avoid contamination of the gloves from the door handle or access device leading into the clean-room |
| Is the use of 2 tier containment sufficient in low volume (<40 doses/month) sufficient? | Yes |
| What is included in the agreement of the pharmacist & doctor for in-office use compounded medications? | The compounded drug may only be administered to the patient and may not be dispensed or sold, practitioner will document lot & BUD on pt records, & will provide info for pt to report adverse events to facilitate recalls |
| Can special closed system pharmacies provide medications to in-patients at hospitals? | No, they are prepared for dispensing utilizing closed delivery systems, for ultimate consumers in health care institutions including nursing homes, jails, ALF’s, Intermediate Care Facilities, etc. |
| This may be obtained by an Institutional Class II Pharmacy that dispenses medicinal drugs to employees, medical staff, emergency room patients, and other patients on continuation of a course of therapy. | Special Limited Community Permit |
| This is required to provide parenteral (IV), enteral, and cytotoxic pharmacy services to outpatients | Special Parenteral and Enteral Permit (must be assessable via phone 24 hours toll free) |
| All pharmacies performing sterile compounding must have one of these (with an exception). | Special sterile compounding permit |
| All pharmacies performing sterile compounding must have a special sterile compounding permit unless they already have this: | Special Parenteral/Enteral or Special Parenteral/Enteral Extended Scope compounding permit |
| Who must be placed in charge of all pharmacies with a special sterile compounding permit? | A prescription department manager or a consultant pharmacist |
| Who must be present for the destruction of controlled substances (excluding class I nursing homes)? | Either the prescription department manager or consultant pharmacist plus one of the following: medical director or his/her physician designee, director of nursing or his/her licensed nurse designee, or a sworn law enforcement officer |
| What can be done In lieu of destruction of controlled substances on the premises? | They may be shipped to reverse distributors for destruction in conformity with federal guidelines. |
| Is the serial number required to be on a nuclear order? | No but the calibration time is |
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