Ohio MPJE 2022; 931 QUESTIONS AND ANSWERS 100% CORRECT.

Ohio MPJE QUESTIONS AND ANSWERS 100% CORRECT Ohio MPJE 2022 | 931 QUESTIONS AND ANSWERS 100% CORRECT What does "guidance" mean in law? Correct Answer: best practice; not a law What does "shall" mean in law? Correct Answer: it's required What does "should" mean in law? Correct Answer: strongly recommended What is an abandoned application? Correct Answer: occurs when an applicant for any license with the BOP fails to complete all components of the application within 30 days after notice from the board How long does a terminal distributor have to demonstrate compliance after a license application is submitted? Correct Answer: 90 days What is included in "access to drug stock"? Correct Answer: physical access and influence over the drugs (includes purchasing, inventory, etc.) What is an act of moral turpitude? Correct Answer: something that gravely violates moral sentiment/standards What is "pharmacist responsibility"? Correct Answer: the pharmacist is ultimately responsible for every prescription dispensed by a pharmacy and must do the final check What is a pharmacy? Correct Answer: any place where prescriptions are filled or where drugs are compounded, sold, offered or dispensed What is a drug? Correct Answer: something that is used to diagnose, cure, treat or prevent a disease in man or animals or intended to affect the structure/function of the body (not food); must be recognized by USP What is dispensing? Correct Answer: final association of a drug with a patient pursuant to a prescription/order; includes labeling, compounding and packaging a specific drug What is a dangerous drug? Correct Answer: a prescription drug; must have a label saying something like "Rx only" or have a statement about not dispensing without a prescription What is a drug of abuse? Correct Answer: any dangerous drug What forms can a prescription come in? Correct Answer: written, oral, faxed or electronic How are records for electronically received prescriptions stored by a pharmacy? Correct Answer: records must be kept for 3 years and there must be record of dispensing the original prescription with positive identification; if the above are met then you do not have to print out the prescriptions and save hard copies What is a prescriber? Correct Answer: anyone allowed to prescribe dangerous drugs under the Ohio Revised Code OR a pharmacist operating under a consult agreement that allows it Who can remove prescription drugs from a terminal distributor? Correct Answer: a licensed healthcare professional authorized to prescribe OR a person authorized to dispense naloxone in the cause of removing naloxone only What drugs can be removed from a terminal distributor? Correct Answer: non-controlled substance drugs, immunizations or naloxone When must drugs taken from a terminal distributor be returned? Correct Answer: 24 hours Do prescribers have to manually sign faxed prescriptions? Correct Answer: yes Do prescribers have to manually sign faxed refill authorizations? Correct Answer: yes Can an agent of the prescriber transmit a faxed prescription? Correct Answer: yes but their full name must be included in the fax What must be on a faxed prescription to be valid? Correct Answer: signature of provider, location transmitted and the date it was faxed Does the prescriber have to keep an original of a faxed prescription? Correct Answer: yes, must be kept in the patient's chart Can prescriptions be sent from a physician's computer to a pharmacy fax machine? Correct Answer: in general, no, but there are a few exceptions When are prescriptions allowed to be sent from a physician's computer to a pharmacy fax machine? Correct Answer: only if the prescription computer and fax machine are on a closed system OR there is a temporary outage of telecommunication AND the prescription is for a non-controlled substance Can an electronic drug record keeping system be used for the original order for an inpatient drug order? Correct Answer: yes, but the system must be restricted to healthcare professionals and use positive ID for ordering AND the pharmacy must have written polices about who in the pharmacy can access these orders What is the requirement for price information from a pharmacy? Correct Answer: a pharmacy must disclose pricing information for all drugs except C2 What is required when a pharmacy advertises a drug? Correct Answer: brand name generic name strength dosage form price for a specific quantity What does "readily retrievable" mean? Correct Answer: records must be produced within 3 business days What does it mean when the BOP refuses to grant or renew a license? Correct Answer: it means they denied an original or continued license for at least 24 months What is a terminal distributor? Correct Answer: a pharmacy that dispenses/sells drugs retail; includes labs What is a virtual wholesale distributor? Correct Answer: anyone who does wholesale distribution of dangerous drugs in or into Ohio; virtual indicates that the person has title of the drugs but never takes physical possession of the drugs What are the requirements to be a virtual wholesale distributor? Correct Answer: must be licensed as a wholesale distributor with a virtual classification must be registered as a business entity with local/state must operate from a zone that is for commercial use and cannot operate out of a residence/personal place What is a third party logistics provider? Correct Answer: they contract with a manufacturer or wholesaler for warehousing or distribution but they do NOT hold the title of Rx drugs and DO not have responsibility for their sale What are the requirements of a third party logistics provider? Correct Answer: must be licensed as a wholesale distributor with a third party logistics classification must be a business entity with local/state must operate from a zone that is for commercial use and cannot operate out of a residence/personal place What is wholesale sale? Correct Answer: this is a sale where the purpose is to resell whatever was purchased What is the 5% rule? Correct Answer: if a pharmacy sells more than 5% of their total cost on drugs/medical supplies to anyone besides patients they must have a wholesaler license this includes selling to providers because they are not patients What is occasional sale? Correct Answer: this means the wholesale of drugs to another pharmacy or a provider's office; limited by the 5% rule When does the 5% rule not apply? Correct Answer: sales where the pharmacies are under the same owner/control sales where the hospitals or health care entities are under the same control What does common control mean? Correct Answer: this means that one entity has power over management and policies of an organization Does dispensing have to involve a sale? Correct Answer: no, it can include giving away, disposing of, exchanging or delivering What does personal/direct supervision entail? Correct Answer: means that a pharmacist must be physically in the pharmacy to review and approve things; must be readily available to answer questions, make in-process and end-process verifications and be fully responsible for interns/techs What does federal law say are the conditions for a drug to be a prescription drug? Correct Answer: the drug is habit forming and/or unsafe to use except under the supervision of a practitioner What is a federal legend? Correct Answer: it must be on all rx drugs and state "Federal Law Prohibits Dispensing Without a Prescription" or "Rx Only" on the stock bottle What is a serial number? Correct Answer: this is the same thing as a prescription number What is meant by a business day? Correct Answer: any day other than Sat, Sun or a holiday recognized in Ohio Can a terminal distributor or wholesaler employ someone with felony convictions? Correct Answer: if they are registered with the DEA the pharmacy or wholesaler cannot employ anyone who was convicted of a felony related to controlled substances in a position with access to controlled substances; they also cannot be in these positions if they have had a DEA registration denied, revoked or surrendered for cause at any point in the past When something is done "for cause" what does that mean? Correct Answer: it means surrendering something in lieu of or as a consequence of any federal or state admin, civil or criminal action related to investigation of a person's handling of controlled substances What are the minimum requirements of a pharmacy? Correct Answer: library equipment (based on the type of pharmacy it is) drugs Rx containers physical space and fixtures POSTED pharmacy hours personnel/staff there is a catch all that states anything else necessary for specialized pharmacy practice What is the practice of pharmacy? Correct Answer: this is providing pharmacist care, which includes knowledge of biological, chemical, social, clinical and pharmaceutical sciences and the ability to make judgement and use these skills What is involves in pharmacist care? Correct Answer: interpreting prescriptions dispensing drugs and devices compounding drugs counseling and drug/device selection performing drug regimen reviews with individuals preforming drug utilization reviews with prescribers advising individuals and providers on drug therapy acting under a consult agreement administering immunizations administering drugs (long-acting injections) When can a drug be returned to pharmacy stock? Correct Answer: the drug was dispensed by not picked up or delivered and never left the pharmacy or the control of the person delivering the drug What are the requirements for returning a drug to stock? Correct Answer: must have an expiration date on the container that is the manufacturer's date or 1 year, whichever is sooner must be kept in the prescription bottle with the patient label on it, NOT returned to the stock bottle the drug must be stored properly drugs in RTS bottles must be removed during a recall unless there is a record of the lot number cannot show any signs of adulteration When can you remove the label on a RTS Rx bottle? Correct Answer: when you are adding/changing the label as long as you are not changing the drug name, dose and original expiration date OR when you are putting a new label over the original label if the drug is verified by the pharmacist; the new label must have the original expiration date OR the label was placed on the manufacturer's original sealed packaging and removing the label will still allow the lot/expiration date to be read What are the requirements for something to be returned to stock that was returned by a delivery agent? Correct Answer: drug must have not left the delivery agent's posession drug must have been dispensed in tamer-evident packaging before it left the pharmacy (either done by the pharmacy or in the manufacturer's original taper evident packaging) If you want to re-dispense the drug in a RTS bottle to a different patient, can you use a new prescription bottle? Correct Answer: yes, this is actually something you MUST do Do the laws about returning drugs to stock apply to drugs dispensed to inpatients? Correct Answer: no What are the requirements for one or more pharmacists to enter a consult agreement with one or more physicians? Correct Answer: the physician must have an ongoing relationship with the patients who are being managed the diagnosis for the patient related to drug therapy must be within the scope of practice of the physician each pharmacist must have training in the related disease state related to the drug therapy being managed What can a pharmacist do under a consult agreement? (assuming this is all written in that agreement) Correct Answer: a pharmacist can manage drug therapy for the treatment of a specific disease/diagnosis; a pharmacist can treat but NOT diagnose! What is involved in managing drug therapy and therefore can be done by a pharmacist in a consult agreement? Correct Answer: changing the duration of treatment adjusting strength, dose, dosage form, frequency, administration or ROA of a drug d/c the drug administer the drug (drug must be included in the consult agreement) add a drug to patient's regimen order blood and urine tests related to therapy NOT for diagnostic purposes (we CANT diagnose!) Who can terminate a consult agreement? Correct Answer: the pharmacist, physician, patient or person who gave consent for the patient What needs to happen if a consult agreement is terminated by a patient? Correct Answer: every pharmacist and physician involved must be notified in writing from whoever the patient tells What needs to happen if a pharmacist or physician terminates a consult agreement? Correct Answer: must notify every pharmacist, physician and patient involved in writing Where do records of terminated consult agreements need to be kept? Correct Answer: in the medical record What is a written notice? Correct Answer: this is any method that confirms delivery of written communication and includes: e-mail that confirms delivery electronic medical record that both have access to fax that confirms delivery e-prescribing system electronic pharmacy record system documented verbal communication anything else listed in the consult agreement Do consult agreements need to be in writing? Correct Answer: yes What must be included in a consult agreement? Correct Answer: the pharmacists and physicians involved diagnosis and disease being managed, including if it is primary or comorbid description of drugs or drug categories involved description of procedures a pharmacist will follow description of how pharmacist will comply with records description of blood/urine and other tests that the pharmacist can order and evaluate something that allows the physician to override anything done by the pharmacist a way to make sure that the pharmacist is only acting within the scope of the agreement the training and experience the managing pharmacist needs to have and a way to verify that they have it the effective date and the expiration date Who needs to be informed on the content of a consult agreement? Correct Answer: the patient who the agreement applies to What does a pharmacist have to do for documentation/communication under a consult agreement? Correct Answer: must record everything done and communicate with the physician at regular intervals (specified in the consult agreement); must have readily retrievable records for at least 3 years How can communication between the pharmacist and physician in a consult agreement be done? Correct Answer: e-mail that confirms delivery electronic medical record that both have access to fax that confirms delivery e-prescribing system electronic pharmacy record system documented verbal communication anything else listed in the consult agreement How long is a consult agreement good for? Correct Answer: 2 years Can a consult agreement be renewed? Correct Answer: yes, can be renewed every 2 years Can pharmacists manage therapy for any patient if they have a consult agreement? Correct Answer: no, they can only manage therapy for patients of physicians listed in the consult agreement How does liability work with a consult agreement? Correct Answer: the physician is not liable for what the pharmacist does and vice versa What does it mean that a pharmacist has training in a related disease state, meaning they can enter into the consult agreement? Correct Answer: means that they are licensed in Ohio, are in good standing and meet specific defined criteria for experience and training Does it matter if a disease managed under a consult agreement is primary or co-morbid? Correct Answer: yes, this has to be specified in the consult agreement What are the consent requirements for a consult agreement? Correct Answer: patients must be informed about participating in the consult agreement (must be communicated); this includes that a pharmacist may be involved in their care and that they can withdraw consent at any time; consent can be part of the initial consent to treatment Does consent for a consult agreement apply to inpatients? Correct Answer: no, they do not need to be made aware of a consult agreement What is a managing pharmacist? Correct Answer: they are a pharmacist managing drug therapy pursuant to a consult agreement Who can participate in a consult agreement? Correct Answer: only pharmacists and physicians licensed in Ohio; this means that PAs and APNs cannot be part of a consult agreement with a pharmacist Who actually signs the consult agreement? Correct Answer: the primary physician and either the pharmacy's responsible person OR an individual pharmacist if they are not actually working at a pharmacy; these people also must sign if any amendments are made What are roles that a pharmacist can play as long as a consult agreement says they can? Correct Answer: they can be prescribers authorized to issue new scripts or refill scripts AND/OR they can be agents of the prescriber for non-controlled substances What are the requirements for a pharmacist to be able to act as an agent of a prescriber under a consult agreement? Correct Answer: any prescriptions a pharmacist fills this way must include information required by the consult agreement the phone number of the managing pharmacist must be included with the prescription there must be positive ID for the managing pharmacist on behalf of the physician Can a pharmacist prescribe controlled substances as part of a consult agreement? Correct Answer: yes but they have to have a valid controlled substance prescriber registration from the board of pharmacy AND have a valid DEA # or be using the hospital's NOTE: this is not currently approved by the DEA What are the requirements for a pharmacist to apply for a controlled substance registration? Correct Answer: must have an Ohio license in good standing not currently be under disciplinary action or restrictions have a valid consult agreement that allows the pharmacist to prescribe controlled substances (if the consult agreement ends up void then the registration also gets voided) What must be done if a pharmacist is no longer able to prescribe controlled substances? Correct Answer: the board must be notified within 5 days, which will terminate the controlled substance registration What does a pharmacist need to do after they obtain a DEA# to prescribe controlled substances? Correct Answer: must tell the board within 30 days; also applies if any changes to the DEA license occur What are the requirements for checking OARRS in a consult agreement? Correct Answer: if a pharmacist is adding a controlled substance or changing something then they need to look at least 1 year of OARRS records Can the managing pharmacist delegate drug therapy management? Correct Answer: no! they can only delegate to another pharmacist covered by that same consult agreement Can the managing pharmacist delegate drug administration? Correct Answer: yes, this can be done by a licensed professional as long as it is within that person's scope of practice; drug administration in this case is done pursuant to an order from the pharmacist What needs to be done if the managing pharmacist is not also the one dispensing or administering a drug? Correct Answer: the pharmacist dispensing or the person administering the drug should get a copy of the consult agreement if they want proof that the pharmacist is allowed to do what they are doing Can the board of pharmacy request that a pharmacist provide the consult agreement? Correct Answer: yes, they can request the consult agreement and any policies/procedures and if they find anything they don't like they can prohibit the agreement from being in affect; things they wouldn't like would be a consult agreement that doesn't meet requirements and/or presents a danger What is involved in having a valid patient-prescriber relationship for pharmacists working under a consult agreement? Correct Answer: review patient history do an initial consultation (does not have to be in person) order and evaluate tests prescribe medications and rule out contraindications consult with the physician if needed document everything you do for the patient follow up with the patient at least on an annual basis (does not have to be in person) Can a managing pharmacist prescribe narcotics for maintenance of addiction or detoxification as part of a consult agreement? Correct Answer: yes, must include involvement from an opioid treatment program that is licensed by the state Do the requirements for a patient-provider relationship for a pharmacist under a consult agreement apply to institutional patients? Correct Answer: no What is a practitioner? Correct Answer: licensed health care professional authorized to prescribe drugs Do the laws that regulate pharmacy practice apply to providers who personally supply drugs to their patients? Correct Answer: no, but all drugs do have to be packaged/labeled according to pharmacy law and records of their purchasing and dispensing must be kept Can a pharmacist dispense/sell a prescription drug without a prescription? Correct Answer: yes under specific circumstances What are the requirements for dispensing an emergency fill (dispensing an Rx drug without a prescription)? Correct Answer: must NOT be a schedule 2 drug pharmacy has a record of the prescription and it either has no refills or the refills have expired the pharmacist cannot contact the prescriber the drug is essential for life, to continue therapy for a chronic condition or not having the drug could result in patient harm only done once per prescription How much of a drug can a pharmacist give in an emergency fill? Correct Answer: no more than a 72 hour supply OR no more than a 30 day supply for patients on consistent drug therapy on a non controlled substance OR no more than the smallest package size if the size exceeds a 30 day supply for patients on consistent drug therapy on a non controlled substance (think an inhaler) How many times can a pharmacist do an emergency dispense for a 30 day supply? Correct Answer: no more than once every 12 months; must be dispensed with no refills What do you need to do after you do an emergency dispense for a patient? Correct Answer: notify their prescriber within 72 hours of dispensing What are the record keeping requirements for an emergency dispense? Correct Answer: for at least one year the pharmacist must keep record of: name and address of the patient and whoever is getting the drug if not the patient amount dispensed original prescription number AND must create a new prescription for the emergency fill Can pharmacists look at a real time database to determine if a patient has a prescription that can be used to justify an emergency dispense? Correct Answer: yes, state law says you need to have record of the prescription but it does not say that the prescription has to be from your pharmacy What happens when copays are waved? Correct Answer: the consequences fall on the terminal distributor not the pharmacist; copay waving can occur if the plan purchaser, payer and third party administrator all agree What happens if the cash price for the drug is less than the patient's copay? Correct Answer: you must tell the patient and you cannot charge them that more expensive copay What are the requirements to be registered as a pharmacist in Ohio? Correct Answer: 18 years old good moral character obtained a degree from a pharmacy school that was board approved the year you graduated passed license exams How may attempts do you have to take the NAPLEX? Correct Answer: 5 How many attempts do you have to take the MPJE? Correct Answer: 5 If disciplinary action is taken on your license by a state board, what must you do? Correct Answer: report this to all boards for which you have a license How many members does the Ohio state board have? Correct Answer: 9 members 8 are pharmacists and 1 is a consumer who is at least 60 years old How do you become a member of the Ohio state board? Correct Answer: must be appointed by the governor How long is the term for a member of the Ohio state board and when does it start? Correct Answer: 4 year term that starts on July 1st; can be reappointed one time for an additional 4 year term What is a pharmacy internship? Correct Answer: supervised practical experience required for licensure What is a preceptor? Correct Answer: pharmacist with a license in good standing that is qualified to supervise an intern; preceptor cannot have been denied the ability to supervise interns by the board What does it mean to have a license in good standing? Correct Answer: means that the pharmacist has not had their license, registration or certificate from any public agency denied, suspended or revoked How many inters can a pharmacist be the preceptor for? Correct Answer: there is no limit to how many interns you can be the preceptor for How many interns can work if only one pharmacist is on duty? Correct Answer: only 2; one pharmacist can only supervise two interns at a time but can be a preceptor to an unlimited number of interns What is the ratio of interns to pharmacists for giving immunizations? Correct Answer: must be no more than 6 interns for every 1 pharmacist How long must a pharmacist be licensed and practicing before they can be a preceptor? Correct Answer: must have at least 1 year of experience unless employed by a school of pharmacy What are the requirements for obtaining an intern license in Ohio? Correct Answer: apply to the board provide a head and shoulder photo pay the fee document that you have at least 60 semester hours or 90 quarter hours of college credit prove that you have begun taking courses directly related to pharmacy and are actively working towards becoming licensed must prove you are enrolled in a school of pharmacy submit fingerprints for a background check What happens if you are an intern (not a graduate intern) and you are no longer enrolled in pharmacy school? Correct Answer: must notify the board and your employer within 72 hours and return the license within 10 days What are the requirements for submitting a Statement of Preceptor form? Correct Answer: must be submitted to the board within 30 days of beginning work as an intern and must be submitted whenever an intern changes preceptors or sites; you will not get credit for any work done before that 30 day mark! Is a Statement of Preceptor form needed for academic rotations through a school of pharmacy? Correct Answer: no If a pharmacist is supervising techs and interns, is there a limit? Correct Answer: the limits for techs and interns are independent from each other, so one pharmacist can supervise both 2 interns and 3 techs at the same time Can an intern sell schedule V controlled substances? Correct Answer: yes, with positive ID of the pharmacist and the intern Can an intern receive oral prescriptions? Correct Answer: yes, with positive ID of the pharmacist and the intern Can an intern transfer and receive non-controlled substance prescriptions? Correct Answer: yes, with positive ID of the pharmacist and the intern Can interns counsel? Correct Answer: yes but the pharmacist must be on site and aware of the counseling the intern is doing Can interns immunize? Correct Answer: yes, with specific requirements What immunizations can interns and pharmacists give without a prescription? Correct Answer: only those recommended by ACIP/CDC or any adopted by the board; can only be given to patients 13 or older with no prescription What immunizations can interns and pharmacists give with a prescription? Correct Answer: only those recommended by ACIP/CDC or any adopted by the board; can be given to patients aged 7-13 with a prescription only Can pharmacists and interns give flu shots? Correct Answer: yes, to anyone 7 or older Can interns participate in sterile and non-sterile compounding? Correct Answer: yes Can an intern dispense naloxone? Correct Answer: yes Can an intern send or receive e-scripts from another pharmacy? Correct Answer: yes, but the pharmacies must share a centralized database or the computers must be linked Can an intern contact a prescriber or agent to get clarification on a prescription? Correct Answer: yes as long as the clarification does not require professional judgement Can an intern perform diagnostic laboratory tests? Correct Answer: yes Can an intern request refill authorizations? Correct Answer: yes Can an intern stock automated dispensing cabinets without direct supervision of a pharmacist? Correct Answer: yes, as long as the pharmacist is able to answer any questions, conducts routine verification of the activities of the intern and is fully responsible for what the intern is doing Do interns who complete a pharmD from a school accredited by ACPE and the board need to report intern hours to the board? Correct Answer: no, but everything else about being an intern stays the same What date do intern licenses renew? Correct Answer: September 15th How many days do interns have to notify the board about a change of name? Correct Answer: 30 days How many days to interns have to notify the board about a change of address? Correct Answer: 30 days How many days to interns have to notify the board about a change of employer? Correct Answer: 30 days What are the requirements for foreign pharmacy school graduates or those not completing a pharmD? Correct Answer: must get 1750 hours of intern work in Ohio must report the hours for the previous year by March 1st must pass a spoken English test Do foreign graduates have to get all of their required hours from a pharmacy? Correct Answer: no, they can get up to 500 hours at a site that is not a licensed pharmacy; must submit a request to the board ahead of time from the intern and the supervisor and must submit a Statement of Preceptor form What conditions apply to an intern receiving an oral prescription or refill authorization? Correct Answer: pharmacist is responsible for the rx accuracy pharmacist decides if the intern is competent enough to take the oral script pharmacist must be available for questions interns must write down the prescription and give it to the pharmacist to check must have positive ID from the pharmacist and the intern Can interns do copies (transfers) for controlled substance prescriptions? Correct Answer: no; only for non-controlled substances What conditions apply to an intern sending or receiving copies? Correct Answer: pharmacist decides if the intern is competent enough to take the oral script pharmacist must be available for questions pharmacist is responsible for the rx accuracy pharmacist or intern receiving the copy must document intern must write the copy down and give it to the pharmacist to check must have positive ID of the intern and the pharmacist if an intern is doing any part of a copy, the person on the other end needs to document the full name of both the intern and the supervising pharmacist What needs to be done if a pharmacy or wholesaler changes their name, category, owner or address? Correct Answer: must submit a new application and fee to the board within 30 days How many days does a pharmacist have to notify the board of a name change? Correct Answer: 30 days How many days does a pharmacist have to notify the board of an address change? Correct Answer: 30 days How many days does a pharmacist have to notify the board of a change in employment? Correct Answer: 30 days How many days does a pharmacy have to notify the board of a change in responsible pharmacist? Correct Answer: 10 days How many days in advance do you have to notify the board if a business is discontinuing? Correct Answer: 30 days When does a terminal distributor's license renew? Correct Answer: April 1st When does a wholesaler's license renew? Correct Answer: July 1st When does a pharmacist license renew? Correct Answer: September 15th When does a laboratory terminal distributor licence renew? Correct Answer: April 1st What is corresponding responsibility? Correct Answer: a pharmacist who fills a script has a corresponding responsibility with the physician (50/50) to make sure that the prescription has been issued for a legitimate medical purpose; just because a physician wrote it does not necessary mean you can or should fill it!! What are the requirements for signing and dating a prescription? Correct Answer: the date must be the date of issuance (no post-dating!) and the prescription must be manually signed (no pre-printing!) on the day of issuance How long is an original script good for? (how long can you wait to get your first fill?) Correct Answer: 6 months How long are refills valid for a non-controlled substance? Correct Answer: 1 year from the date of issuance (NOT from the first fill date) How long are refills valid for a CV? Correct Answer: 1 year from the date of issuance (NOT from the first fill date) How long are refills valid for a CIII or CIV? Correct Answer: 6 months from the date of issuance OR max of 5 refills How long are refills good for a CII? Correct Answer: NO REFILLS ON CII!! Is a faxed prescription considered an original? Correct Answer: yes Can a physician use a pre-printed script pad? Correct Answer: yes, with some exceptions How many drugs can you select on a pre-printed script pad? Correct Answer: only one drug can be selected per pre-printed script pad Can you have a controlled substance option on a pre-printed script pad? Correct Answer: no, those are only for non-controlled substances What must be on a controlled substance prescription? Correct Answer: prescriber's DEA# (can be written on) AND days supply in both numbers and words How long must prescription records be kept under federal law? Correct Answer: 2 years How long must prescription records be kept under Ohio law? Correct Answer: 3 years How many controlled substances can you have on one prescription? Correct Answer: just one CS per script Can a controlled substance be on the same prescription as a non-controlled substance? Correct Answer: no How many non-controlled substances can be on the same prescription? Correct Answer: up to three non-CS can be on the same script What must be on a prescription for opioids? Correct Answer: at least the first four digits of the ICD-10 code; if it is from a dentist you also need the CDT code; also required for gabapentin as well as opioids What are the components needed on a prescription? Correct Answer: date issued name, title and address of the provider telephone number for the provider full name and address of the patient drug name and strength quantity appropriate directions (can't say "take as directed") number of refills and/or time period for refills trade or generic name DEA# if CS ICD-10 code if opioid or gabapentin days supply (in numbers and words) if CS Can prescriptions be "coded"? Correct Answer: no, any pharmacy should be able to fill the prescription What can the pharmacist change on a prescription after verifying with the patient/caregiver? Correct Answer: the patient's address only, NOT their name What can a pharmacist change after verifying with the provider? Correct Answer: dosage form drug strength drug quantity directions issue after date days supply ICD-10 code CDT code Do you need to contact the provider if you are selecting a generic drug or biosimilar? Correct Answer: no, as long as it is permitted by the Orange Book or the Purple Book then you do not have to contact the provider If a drug is not a controlled substance, can you make changes to the dosage form or directions without talking to the provider? Correct Answer: yes, as long as the changes are equivalent (the same API with equivalent strength, frequency and duration of therapy); you CANNOT switch from long acting to short acting without asking the provider If you are calling for clarification on a CII prescription, who do you have to talk to? Correct Answer: the provider only If you are calling for clarification on a non-CII prescription, who do you have to talk to? Correct Answer: either the provider or the provider's agent What drugs are eligible for dispensing multiple simultaneous refills? Correct Answer: not a controlled substance must be a maintenance drug for a chronic condition, a maintenance drug for disease prevention or a contraceptive total quantity does not exceed 90 days patient must have used it initially for 30 days or have previously had a 90 day supply Does the pharmacist have to ask the patient before giving multiple simultaneous refills? Correct Answer: yes, the patient needs to be told and can be told by a tech, intern or pharmacist Do physicians have to allow multiple simultaneous refills if the prescription is eligible? Correct Answer: no, a physician can prohibit this if they want If a drug is eligible for multiple simultaneous refills does the insurance company have to cover it? Correct Answer: no Can refills for one prescription be combined with refills from another prescription? Correct Answer: no What must a pharmacy do before they buy drugs from a wholesaler? Correct Answer: make sure that wholesaler is licensed by the board to sell drugs in Ohio What must a pharmacy do before they sell dangerous drugs to another pharmacy? Correct Answer: make sure that pharmacy is licensed to dispense drugs in Ohio What needs to be displayed at the pharmacy? Correct Answer: the hours of operation Can a pharmacy have a prescription pick-up station? Correct Answer: no, but delivery is ok because the delivery person is acting as an agent of the pharmacy What is an offical compendium? Correct Answer: the offical US Pharmacopoeia or National Formulary Do you have to post the terminal distributor license in the pharmacy? Correct Answer: yes, must be in a conspicuous place What is a category I terminal distributor? Correct Answer: can dispense single dose injections of IV fluids What is a category II terminal distributor? Correct Answer: can dispense any dangerous drug What is a category III terminal distributor? Correct Answer: can dispense controlled substances Are terminal distributor licenses cumulative? Correct Answer: yes, if you have a category III license you can dispense drugs in all three categories What type of compounding can registered technicians do? Correct Answer: non-sterile only; pharmacist is fully responsible and must do the final check What type of compounding can certified technicians do? Correct Answer: sterile and non-sterile; pharmacist is fully responsible and must do the final check How much continuing education do pharmacists get and how often? Correct Answer: must get 40 hours every 2 years What specific areas do pharmacists have to have CE in? Correct Answer: at least 2 hours in law (ACPE code of 03) and at least 2 hours in medication safety (ACPE code of 05) When do you have to report continuing education to the board? Correct Answer: must be reported by Sept. 15th in the year the pharmacist needs to report Do CE credits carry over from reporting cycles? Correct Answer: no, you don't get extra credit How many CEUs is 1 contact hour? Correct Answer: 1 contact hour = 0.1 CEU If a pharmacist is board cerified, can this count for their CE? Correct Answer: yes, BUT they still have to do the 2 hours of law and 2 hours of med safety every 2 years How long do you have to keep proof of CE? Correct Answer: must keep if for one year after it was required to be reported What happens if you let you pharmacist license lapse for less than 3 years? Correct Answer: must pay a fee and prove that your CE is up to date What happens if you let your pharmacist license lapse for more than 3 years? Correct Answer: must retake the NAPLEX and MPJE and complete another background check What happens if you let your pharmacist license lapse but you have been actively practicing in another state? Correct Answer: you can get your Ohio license reinstated with an application, fee and proof of CE done in the past 3 years Who is allowed to have a key to the prescription area of a pharmacy? Correct Answer: only a pharmacist Who can call their store a pharmacy or a drug store? Correct Answer: only a terminal distributor If a prescription says dispense as written, DAW, brand necessary, or anything like that, can you dispense the generic instead? Correct Answer: no; the doctor must hand-write this on the prescription themselves or indicate it on a verbal order, the nurse cannot write it for them and it cannot be typed or pre-printed on the paper script What is a generic drug? Correct Answer: has the same API as a brand drug, meets standards of quality and identity and has no known bioequivalence problems Can a patient refuse a generic drug in favor of the brand drug? Correct Answer: yes What must be on the label and bottle if a generic substitution was made? Correct Answer: the label must indicate that a generic subsitution was made and the brand name or generic manufacturer must be on the bottle and the label If you dispense a biosimilar what do you have to do? Correct Answer: must notify the prescriber within 5 business days What is the Orange Book? Correct Answer: FDA generic bio equivalence book; must check this to determine if products can be interchanged What is the Purple Book? Correct Answer: used for biosimilars Can interns do transfers for controlled substances? Correct Answer: no, this must be between two pharmacists Can transfers be faxed? Correct Answer: yes, but there must be ID of both the sending and receiving pharmacist How many times can a non-controlled substance prescription be transferred? Correct Answer: unlimited number of times How many times can a controlled substance prescription be transferred? Correct Answer: only once, unless the pharmacy has multiple locations that share the same database, then it can be transferred an unlimited number of times What must be recorded when receiving a transferred prescription? Correct Answer: original prescription number name and address of the pharmacy the script is coming from (and DEA# if controlled substance) original date first fill date date of last refill number of refills remaining full name of transferring pharmacist date that the transfer is being made the word "transfer" must be on the front of the transcribed prescription What does the pharmacist sending a transfer need to record? Correct Answer: date of the transfer name of the pharmacist making the transfer DEA # of the pharmacy if a controlled substance name and address of the pharmacy receiving the drug What needs to be done to an original controlled substance prescription if it was transferred to another pharmacy? Correct Answer: must write "void" on the prescription and record the name, address, and DEA # of the new pharmacy as well as the date it was transferred and the signature of the pharmacist who did the transfer How do you tell if a DEA# is valid? Correct Answer: add up digits 1, 3 and 5 add digits 2, 4 and 6 and multiply by 2 add the two numbers above the last digit of the added number must be the same as the last digit of the DEA number Can you enter prescriptions into the computer and not dispense them? Correct Answer: yes, must have complete info in the computer that is displayed in the patient's profile and there must be positive ID of the pharmacist who entered it Can prescriptions that were entered into the computer and not filled be transferred? Correct Answer: yes In general, what types of activities require positive ID? Correct Answer: all activities related to the practice of pharmacy Is positive ID required for entering prescription information? Correct Answer: yes Is positive ID required for a prospective DUR? Correct Answer: yes Is positive ID required for dispensing? Correct Answer: yes Is positive ID required for patient counseling? Correct Answer: yes Is positive ID required for immunization administration? Correct Answer: yes Is positive ID required for producing a written prescription from a fax or phone? Correct Answer: yes What does it mean when something requires positive ID? Correct Answer: there must be something besides a password that is a secure way of identifying someone Does a manual signature count as positive ID? Correct Answer: yes Does use of a magnetic reader, proximity badge reader or bar code reader count as positive ID? Correct Answer: yes, but must be used in conjunction with a password Does a password count as positive ID? Correct Answer: NO you must have something else besides just a password Do biometric ID methods count as positive ID? Correct Answer: yes Do randomly generated personal questions count as positive ID? Correct Answer: yes, must be board approved and be used in conjunction with a password What is a special requirement needed for internet pharmacies that regular pharmacies do not need to have? Correct Answer: must maintain accreditation as a Verified Internet Pharmacy Practice Site (VIPPS) from NABP What information needs to be on the website of an internet pharmacy? Correct Answer: full name and address that is on the license name of the responsible pharmacist on the license telephone number listing of states where they can legally sell drugs contact info for law enforcement in every state they are licensed in What are the requirements for an outpatient prescription label? Correct Answer: name and address of dispenser full name of the patient full name of the prescriber date of dispense federal caution statement Rx number drug name and strength quantity Compounded drug product label (if it applies) What are the requirements for a small container label? Correct Answer: Rx number patient name What are the requirements for an inpatient unit dose label? Correct Answer: drug name ROA if not oral strength/volume lot number expiration date manufacturer or repackager special storage conditions (if they apply) What are the requirements for an inpatient IV bag label? Correct Answer: patient name name and amount of solution name and amount of drugs added expiration date/BUD name and address of institutional pharmacy cautionary statements (if they apply) What are the requirements of an outpatient IV bag label? Correct Answer: name, address and telephone number of the pharmacy patient name prescriber name directions ROA date of dispense federal caution statement name and volume of solution name and volume of drugs quantity dispensed if appropriate expiration date storage info What is a drug sample? Correct Answer: Rx drug that has been manufactured in a container marked for sample Who can give out samples? Correct Answer: only physicians and charitable pharmacies What is a complementary supply? Correct Answer: Rx drug given to a pharmacy at no cost to help a patient get started with a therapy Is a complementary supply a sample? Correct Answer: no When can a pharmacist give out a sample? Correct Answer: ONLY if they are working at a licensed charitable pharmacy What are the requirements for a sample label when provided by a prescriber? Correct Answer: name of prescriber patient name directions for use What are the label requirements for drug products that are compounded in advance? Correct Answer: name, strength and quantity of each drug used ID of the repackager or the last 6 of the terminal distributor license number pharmacy control number expiration date/BUD "compounded drug product" Do you need to put "compounded drug product" on the label of a non-sterile manufactured medication that is being reconstituted according to the labeled instructions? Correct Answer: no Do you have to put "compounded drug product" on the label for drugs made in an institutional setting or where the patient is not the ultimate user prior to administration? Correct Answer: no Can you satisfy the requirement for the "compounded drug product" labeling by using an auxiliary label? Correct Answer: yes If there are multiple drugs in the same container, what is the maximum days supply? Correct Answer: no more than 31 days If there are multiple drugs in the same container, what is the maximum expiration date? Correct Answer: no more than 60 days What happens when there are multiple drugs in one container and one of the drugs is discontinued? Correct Answer: all of the drugs in the container are considered adulterated and may not be used What does it mean to be a practitioner? Correct Answer: means you are licensed and can prescribe Is an MD a practitioner in Ohio? Correct Answer: yes Is a DO a practitioner in Ohio? Correct Answer: yes Is a podiatrist a practitioner in Ohio? Correct Answer: yes Is a veterinarian a practitioner in Ohio? Correct Answer: yes Is a DDS a practitioner in Ohio? Correct Answer: yes (this is a dentist) Is a nurse practitioner a practitioner in Ohio? Correct Answer: yes Is an optometrist a practitioner in Ohio? Correct Answer: yes with some exceptions Are interns and residents practitioners in Ohio? Correct Answer: yes Are out of state practitioners considered practitioners in Ohio? Correct Answer: yes What are limited practitioners in Ohio? Correct Answer: means that they can only write prescriptions in the scope of their practice; includes: veterinarians optometrists dentists podiatrists What are the requirements for a patient profile that pharmacies must maintain? Correct Answer: must be immediately retrievable for at least the last 12 months and have records kept for at least 3 years What information needs to be kept in a patient profile? Correct Answer: full name address and phone number date of birth gender drug related allergies/drug reactions hx of or active disease states drug therapy record (i.e. what drugs they got dispensed) OTC drugs/devices they use pharmacist's comments on therapy What is included in the drug therapy record of a patient's profile? Correct Answer: drug name prescription number drug strength quantity dispensed date dispensed prescriber directions for use How long does a patient profile have to maintained at the pharmacy? Correct Answer: at least 1 year from the date of last entry; must either be hard copy or on the computer What are the requirements for an offer to counsel? Correct Answer: must be made by the pharmacist or pharmacist's agent for every new prescription AND every refill; note that you only have to make the offer, the patient does NOT have to actually get the counseling Who can the offer to counsel be made to? Correct Answer: the patient or the caregiver of the patient Does the pharmacist always have to offer to counsel a patient? Correct Answer: no, if the pharmacist thinks that counseling would harm the patient (ex. severe mental disorder) How to you extend the offer to counsel if the patient is not physically present in the pharmacy (i.e. mail order)? Correct Answer: must make the offer to counsel in writing or by phone and must provide a toll-free number that the patient can call to get the counseling Can an intern provide counseling? Correct Answer: yes as long as under the direct supervision of a pharmacist Can technicians counsel? Correct Answer: NO Can patient handouts, videos or other supplemental materials satisfy the required counseling if the patient requests it? Correct Answer: no, they can supplement the counseling but they do NOT substitute it What are the required components of patient counseling? Correct Answer: name and description of the drug dosage form, dose, strength, ROA and duration of use use and expected action directions for use common severe side effects, ADRs, interactions and contraindications self monitoring of therapy storage/disposal refill info what to do if you miss a dose anything else the pharmacist feels is relevant What is a DUR? Correct Answer: drug utilization review What is a prospective DUR? Correct Answer: conducted at the time a prescription is dispensed (must be done by a pharmacist before the drug can be given to the patient) What is a retrospective DUR? Correct Answer: conducted weeks or months after a prescription has been dispensed What things should a pharmacist look for when doing a prospective DUR (prospective DUR checklist)? Correct Answer: over/under utilization therapeutic duplication drug-disease contraindications drug-drug interactions incorrect dose drug-allergy interaction abuse/misuse inappropriate duration food/nutritional supplement-drug interactions Who is the responsible pharmacist? Correct Answer: the licensed pharmacist who signs the terminal distributor license for the pharmacy For how many pharmacies can one pharmacist be the responsible pharmacist for? Correct Answer: only one unless you get special permission from the board to be temporarily responsible for more than one pharmacy How are special exceptions for being the responsible pharmacist at more than one pharmacy determined? Correct Answer: can be granted by one board member, in which case the exception is only good for 60 days; can be granted by the whole board, in which case it is good for no more than 1 year How long do you have to notify the board if the responsible pharmacist changes? Correct Answer: 10 days What must happen in the pharmacy when there is a change in responsible pharmacist? Correct Answer: the new responsible pharmacist must take a full controlled substance inventory on the date the change is effective What is the requirement for physical presence of the responsible pharmacist? Correct Answer: must be physically present in the pharmacy enough that they can provide supervision and control of the drugs in the pharmacy; they do NOT have to be there any time the pharmacy is opened Can you be the responsible pharmacist if you have been denied the right to work by any professional board/licensing agency as part of an official order? Correct Answer: no Can you be the responsible pharmacist if you have committed a misdemeanor theft? Correct Answer: no Can you be the responsible pharmacist if you have committed a misdemeanor drug offence? Correct Answer: no, but you can be the responsible pharmacist if the misdemeanor drug offense was minor Can you be the responsible pharmacist if you have committed a felony? Correct Answer: no Can you be the responsible pharmacist if you have been determined eligible for intervention by a court? Correct Answer: no Can you be the responsible pharmacist if you have been granted entry into a diversion program? Correct Answer: no Can you be the responsible pharmacist if you cannot practice due to a mental or physical illness? Correct Answer: no Can you be the responsible pharmacist if you are addicted to drugs or alcohol? Correct Answer: no Can you be the responsible pharmacist if you are excluded from participating in Medicare or another state health care program? Correct Answer: no Can you be the responsible pharmacist if you have been denied a DEA license or any other license? Correct Answer: no Can you be the responsible pharmacist if you have been the subject of disciplinary action by the board, the DEA or any licensing agency? Correct Answer: no Can you be the responsible pharmacist if you have committed a misdemeanor offense that was related to professional practice? Correct Answer: no Can you be the responsible pharmacist if you committed an act of moral turpitude that was either a felony or a misdemeanor? Correct Answer: no Do all of the exclusions to being the responsible pharmacist also apply to anyone applying for a terminal distributor license? Correct Answer: yes Do all of the exclusions to being the responsible pharmacist also apply to anyone applying for a wholesaler's license? Correct Answer: yes If someone has committed acts that would prohibit them from being the pharmacist in charge or applying for a wholesaler/terminal distributor license, is there ever any way they can still get the license? Correct Answer: the board can make an exception but it is incredibly rare How long do you have to obtain pharmacy records? Correct Answer: must be retrievable within 72 hours How long do you have to sign a daily printout of prescription records? Correct Answer: within a reasonable time frame (no longer explicitly stated in the law) Who has access to pharmacy records? Correct Answer: patient prescriber licensed healthcare professional caring for the patient insurance company (doesn't matter if they are covering it or not) any agent of an Ohio licensing agency for healthcare any federal, state, county or municipal officer who is working on a specific investigation any agent who contracts with the pharmacy as a business associate anyone the patient gives written consent to (must be signed and dated) anyone who you deem necessary in an emergency What do you need to do if you give someone access to pharmacy records in the case of an emergency? Correct Answer: must write a memorandum with the patient's name, date and time of disclosure, nature of emergency and who was told Can records of pharmacy, drug administration or patient specific transaction be given over to law enforcement in the investigation of a specific case? Correct Answer: yes if it is requested What must be on the record of a prescription that is being turned over to law enforcement for a specific case? Correct Answer: prescription identification number name of the patient (if it is a medication order) drug prescribed quantity prescribed name of the prescriber date, name of and signature of the person removing the record How long do you have to keep invoices for controlled substances? Correct Answer: 3 years How do you have to store the invoices for controlled substances? Correct Answer: C3-5 must be in their own file and C2 must be in their own file (you do not put them all together and you do not put them with non-controlled records) How long does a pharmacy have to get rid of outdated drugs? Correct Answer: 1 year; need to keep them in a separate area of the pharmacy to avoid them being used How long does a wholesaler have to get rid of outdated drugs? Correct Answer: 2 years What are the requirements for keeping records outside of the pharmacy? Correct Answer: must be in an area that has a physical barrier approved by the board that is locked from unauthorized entry; must only be accessible to a pharmacist unless the board says otherwise (if a pharmacist is present, someone else can be allowed to access the records) What is included in the library requirements for a pharmacy? Correct Answer: must have access to references necessary to practice pharmacy must have the number of the nearest poison control center must have access to all current federal and stat drug laws, rules and regulations In general, how do you tell the difference between something that is adulterated and something that is misbranded? Correct Answer: adulteration is not being able to ensure the quality of the physical drug product and/or something is physically wrong with it; misbranding is mis-representing the drug in any way When is a drug considered adulterated? Correct Answer: means the physical condition of the drug is damaged and/or the manufacturing/storage environment was damaging What is a drug considered if it is past its expiration date? Correct Answer: considered adulterated if the drug is past its expiration date or its BUD if compounded What is it considered if a drug leaves the pharmacy and then is re-dispensed? Correct Answer: adulteration; you cannot guarantee the integrity of that product anymore, which is why you cannot take back drugs to re-dispense What is it considered when you dispense a dangerous drug without a prescription? Correct Answer: misbranding What is it considered when an OTC drug is not properly labeled? Correct Answer: misbranding What is it considered when refills of drugs are not appropriate? Correct Answer: misbranding What is it considered when a drug is falsely advertised? Correct Answer: misbranding What is it considered when the wrong drug is dispensed? Correct Answer: misbranding What is it considered when there is wrong information on a prescription label? Correct Answer: misbranding What is it considered when insulin or antibiotics are not batch certified? Correct Answer: misbranding What is it considered when there is not identification of a drug somewhere on the labeling/packaging? Correct Answer: misbranding If a drug expires on 1/2020, when is its actual expiration date? Correct Answer: 1/31/2020 (the last day of the month) What does it mean when a drug is past its expiration date? Correct Answer: it means that the drug has lost 10% of its potency What are the requirements for a pharmacy pick-up station? Correct Answer: must have board approval must be a licensed terminal distributor the storage and distribution of drugs must be the charge of a pharmacist must have a record keeping system for dispenses must have policies and procedures to ensure compliance What are the requirements for another site (not a pharmacy) pick-up station? Correct Answer: must be a licensed terminal distributor or exempt must have storage and distribution under the care of a licensed healthcare professional must have a record keeping system must have polices and procedures in place for compliance must have a need for a healthcare professional to have increased involvement in patient therapy and/or must be delivered to a patient who would be a danger to the public What is a central fill pharmacy? Correct Answer: licensed terminal distributor that acts as an agent under contract with an originating pharmacy to fill a prescription What is an originating pharmacy? Correct Answer: a pharmacy that uses a central fill pharmacy to fill a prescription Can a pharmacy be a central fill pharmacy and an originating pharmacy? Correct Answer: yes When can an originating pharmacy use a central fill pharmacy to fill a prescription? Correct Answer: when they have the same owner or when they have entered a written contract or agreement; must both have access to a real-time, secure online database Does an originating pharmacy need to keep records of what was filled at a central fill pharmacy? Correct Answer: yes, if the record was entered into their computer system then the originating pharmacy needs to keep records of it and make sure the patient profile meets the minimum requirements What is a special requirement for a label on a prescription that was filled at a central fill pharmacy? Correct Answer: must contain the name and address of the originating pharmacy and the name of the central fill pharmacy Do the originating pharmacy and the central fill pharmacy have to use the same Rx numbers for the same prescription refills? Correct Answer: yes What must the originating pharmacy do if the drugs filled at the central fill pharmacy are not being directly dispensed from the central fill pharmacy? Correct Answer: the originating pharmacy must have a staff member who signs the receipt of prescription delivery from the central fill pharmacy to the originating pharmacy; this record must be kept with the prescription records for at least 3 years Do central fill pharmacies need to be licensed as terminal distributors? Correct Answer: yes Do central fill pharmacies and originating pharmacies need to maintain a manual of policies and procedures? Correct Answer: yes What must be contained in the policy and procedure manual between a central fill pharmacy and an originating pharmacy? Correct Answer: responsibilities of each pharmacy name, address, phone number and license number of all pharmacies participating records of positi