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CT MPJE QUESTIONS AND ANSWERS GRADED A
How soon must loss, theft, or unauthorized destruction of controlled substances be reported? - correct answer CT: 72 hours (to Commissioner of Consumer Pro... [Show More] tection/DCP) Federal: 24 hours (DEA Form 106) Who is the "commissioner" - correct answer Commissioner of Consumer Protection How many members are on the Commission of Pharmacy, and who are they? - correct answer 7 members: 5 full-time pharmacists and 2 members of the public (at least 2 pharmacists from retail: 1 from independent and 1 from chain; at least 1 pharmacist from hospital) How often does the Commission of Pharmacy meet? - correct answer at least 6 times per calendar year at the office of commission, and at other times when a chairperson or a majority of the commission deems necessary the commission should keep a record of its proceedings How often should the commissioner inspect each retail pharmacy? - correct answer not less than once every 4 years What are the 5 requirements for a pharmacist LICENSE? - correct answer 1) submitted a written application on a form approved by the department 2) graduated from a school of pharmacy approved by the commission 3) has professional experience as a pharmacy intern 4) successfully passed any examinations required by the commissioner 5) eighteen years of age or older The Department of Consumer Protection shall issue a temporary permit to practice pharmacy to an individual who: - correct answer -practices under the direct supervision of a licensed pharmacist -has an application for reciprocity on file with the commission -is a licensed pharmacist in good standing in a state from which the state's board of pharmacy grants similar reciprocal privileges to pharmacists -has no actions pending against their license When will a TEMPORARY permit to practice pharmacy expire? - correct answer at the time the individual with the temporary permit is licensed as a pharmacist in this state, or not later than three months from the date of issuance of the temporary permit, whichever occurs first (the commission may authorize one three-month extension of the temporary permit) What is the fee for issuance of a pharmacist license? When does a license to practice pharmacy expire? How do you renew your pharmacist license? - correct answer $200 biennially (biannually) completion of an application payment of $120 completion of CE credits Pharmacies are to be supervised and managed by a pharmacist. What are the requirements of the pharmacy manager? - correct answer -must be licensed in CT full-time -must be full-time at the store where acting as pharmacist manager -may not manage more than 1 pharmacy at a time -may be, but does not have to be the supervising pharmacist -name should be displayed for public viewing -if there is a change in position, the DCP must be notified of the change and immediately enroll a new manager -pharmacy must report the absence of a pharmacist manager if: >16 days (must be reported to the commission within 5 days) >42 days (they are deemed ceased to be pharmacy manager; immediately enroll new pharmacy manager) -new first-time manager must conduct an interview with the commission first -($90 fee for change in pharmacy management; $50 late fee added if late) What is a "continuing education unit" (CEU)? - correct answer ten contact hours of participation in accredited CE What is a "contact hour" (CE)? - correct answer 50-60 minutes of participation in accredited continuing professional education What are the pharmacist continuing education requirements? - correct answer -at least 15 CE credits per year -at least 5 annual CE credits have to be live -at least 1 annual CE credit has to be on drug law What is the fee for filing notice of a chance in name, ownership, or management of a pharmacy? What is the late fee for failing to give such notice? - correct answer $90 $50 plus the fee for notice What is the fee for issuance of a pharmacy license? When do pharmacy licenses expire? What is the fee for renewal? - correct answer $750 annually $190 What is the fee for registration as a pharmacy intern? - correct answer $60 What is the fee for application for registration as a pharmacy technician? What is the fee for renewal of registration as a pharmacy technician? - correct answer $100 $50 Three requirements/descriptions of pharmacy technicians - correct answer 1) must be registered or certified with DCP to work as a pharmacy technician 2) does not include persons not engaged in dispensing/compounding of medications (i.e. store clerks) 3) must wear name tag that clearly identifies their roles No legend drug may be dispensed or sold at retail except: - correct answer -in a pharmacy -by a hospital to an employee of the hospital when prescribed by a practitioner for the employee or for the employee's spouse or dependent children -by a hospital to a retiree of such hospital or the retiree's spouse Tech DO's in CT (10): - correct answer 1) type Rx label 2) enter Rx into computer 3) enter information into patient file 4) retrieve medications from stock 5) place medications in container 6) place label on container 7) prepare nursing home medication cards 8) reconstitute oral liquids 9) obtain REFILL authorization for non-controlled drug 10) compound medications for dispensing Tech DON'Ts in CT (7): - correct answer 1) accept oral order for new prescription 2) consult with patient/practitioner about prescription or medical record 3) identify, evaluate, interpret, or clarify a prescription 4) interpret clinical data 5) perform professional consultation 6) verify a prescription order 7) determine generically or therapeutically equivalent drugs Tech ratio in community retail pharmacy - correct answer 2:1 3:1 if one tech is certified (pharmacist can refuse to supervise 3 techs, but refusal must be in writing given to the manager) Tech ratio in COMMUNITY IV, unit dose, or bulk compounding/dispensing pharmacy - correct answer 3:1 (pharmacists can't refuse to supervise 3 techs in this setting) Tech ratio in institutional outpatient pharmacy - correct answer 2:1 (can be up to 3:1 with demonstrated need + petition) Tech ratio in institutional inpatient pharmacy - correct answer 3:1 (can be up to 5:1 with demonstrated need + petition) Tech ratio in institutional satellite pharmacy - correct answer 3:1 (can be up to 5:1 with demonstrated need + petition) Documentation of pharmacy tech training must include: - correct answer -NAME of the person receiving training -DATES of training -general description of TOPICS -SIGNATURES of both technician and pharmacy manager -(change in pharmacy manager? new manager must review and sign documentation of tech training) Dispensing of legend drug or devices pursuant to Rx only: - correct answer -gives authority to pharmacist (and intern under supervision) to dispense based on a prescription -allows technician (under direct supervision) to assist in dispensing -prevents a pharmacist whose license is suspended or revoked from being a technician -does not prevent a prescriber from dispensing drugs to his/her own patients if within scope of practice T/F A prescriber can DISPENSE drugs to his/her own patients - correct answer True (if within scope of practice) What is an emergency "kit"? Under what circumstances can an emergency kit be used? - correct answer An emergency kit allows non-pharmacist (i.e. nursing supervisor or physician) in an institution to dispense drugs when a pharmacist is not available MUST be: 1) an emergency 2) reviewed by nursing supervisor or physician prior to administration 3) recorded by RPh (CT Pure Food and Drug Act addresses labeling requirements) Emergency stock at a SNF is technically distributed to whom? - correct answer medical director who has valid DEA & Connecticut controlled substances registration Two ways to order CIIs - correct answer 222 (triplicate order form) CSOS (electronic order system) Where is the Power of Attorney application kept? - correct answer - on record in the pharmacy - (it does NOT go to the DEA) What to do if an UNFILLED (written on but not received) 222 order form is lost - correct answer -must complete second (new) form -must prepare STATEMENT that includes first order form's serial number & date, and verify that original order was never received -attach the statement to the second order form and keep a copy of statement with Copy #3 of the first and second order forms What to do if an UNUSED (not written on) 222 form is lost or stolen - correct answer -immediately report to DEA/CT Drug Control -give serial numbers of lost/stolen forms -if found later, notify DEA/CT drug control T/F A starter pack given to a retail pharmacy is considered a sample - correct answer F (starter packs given to retail are NOT samples) What is a prescription drug sample? - correct answer a unit of drug intended not to be sold but rather to promote the sale of the drug Requirements of prescription drug samples (5) - correct answer 1) samples may be distributed ONLY to practitioners licensed to prescribe or to pharmacies of hospitals or health care entities -this does NOT include retail pharmacies 2) samples must be requested by the practitioner, in writing, on a form that includes the necessary information by law 3) the practitioner must make the request EACH time (no standing orders) 4) recipient must execute a written receipt for the delivery of the samples 5) the receipt must be returned to the manufacturer or wholesaler 6 requirements a Dispenser must do (wholesaler stuff): - correct answer 1) use licensed/registered Trading Partner to purchase prescription drugs 2) quarantine & investigate "suspect" products 3) keep investigation records for suspect drug 6 years 4) identify & remove "illegitimate" products 5) notify FDA and Trading Partners within 24 hours 6) keep records of product identified as illegitimate for 6 years What does "suspect" drug product mean? - correct answer there is REASON TO BELIEVE the product is counterfeit, diverted, or unsafe What does "illegitimate" drug product mean? - correct answer CREDIBLE EVIDENCE shows that the product is counterfeit, diverted, or unsafe What are the Dispenser accept/transfer/regulator requirements? ("pedigree" requirements of Prescription Drug Marketing Act of 1987; Drug Supply Chain Act of 2013; Title II of Drug Quality and Security Act) - correct answer Accept: dispensers must accept ONLY rx drugs that have transaction information, transaction history, and transaction statement ("pedigree" information) Transfer: provide the transaction information, transaction history, and transaction statement (this is for transferring back to wholesaler; this history INCLUDES information received from upstream Trading Partners) Regulators: for recalls & investigations of suspect products, provide transaction information, transaction history, and transaction statements to regulators Requirements for pharmacy-to-pharmacy distribution of controlled substances (CT law) - correct answer retail or hospital pharmacy *may distribute "small quantities"* of CS to another pharmacy if: - C-III through C-V only (no C-II) - for "immediate needs of patient" - ≤1 ounce powder/ointment - ≤16 ounces liquid - ≤100 tablets/capsules, suppositories, or injectables Who may a pharmacy (acting as distributor without being registered as a distributor) distribute controlled substances to? (what 2 parties) - correct answer - another pharmacy - a registered practitioner for the purpose of general dispensing by the practitioner to patients 4 requirements for pharmacy to act as a distributor (to another pharmacy/registered practitioner) - correct answer 1) the pharmacy/practitioner receiving controlled substances is registered with the DEA to dispense 2) the distribution and receipt are recorded on both ends 3) if it is for CII: the distributing pharmacy documents transfer on DEA Form 222 (or CSOS) 4) *the total number of dosage units for all controlled substances distributed does not exceed 5% of all controlled substances dispensed in a calendar year* (if >5%, must register as a distributer) Controlled substances may be mailed if either - correct answer the mailer or the addressee is a DEA registrant the mailer or the addressee is exempt from DEA registration 3 packaging requirements for mailing a *controlled substance* - correct answer 1) the inner container is marked and sealed and placed in a plain outer container or securely wrapped in plain paper 2) if the mail consists of prescription medicines, the inner container is also labeled to show the *name and address* of pharmacy/practitioner/or other person dispensing the prescription 3) the outside wrapper or container is free of markings that would indicate the nature of the contents The Prescription Drug Marketing Act of 1987 prohibits the sale, purchase, or trade of prescription drugs purchased by HOSPITALS except: - correct answer - own use (the hospital's patients) - sales or purchases to Nonprofit Affiliates and those of common control - sales or purchases for Emergency Medical Reasons - dispensing prescription drugs pursuant to prescriptions for employees, spouses/children of employees, and retirees Reimportation of prescription drugs is illegal EXCEPT for: - correct answer manufacturers importing in small quantities, if they are not approved in the US and are needed to treat serious illnesses in the US an individual patient may reimport, on their person, an FDA approved drug from Canada in a quantity NOT TO EXCEED a 90-day supply, in its original container CSA allows for 50 dosage unit limit to be personally transported, in original container, and declared at customs 1 unit of a controlled substance medication is: - correct answer 100 units or capsules 1 pint of liquid (16 oz) 1/8 oz of powder, crystal, flake, or granule 1 multi-dose vial 10 single-dose vials, tubexes, or other single-dose package form 10 suppositories Schedule I Controlled Substances - correct answer highest abuse potential no currently accepted medical use in the US lack safety information heroin, marijuana (federal), methaqualone, MDMA, LSD, mescaline, psilocybin Schedule II Controlled Substances - correct answer high abuse potential with severe psychological or physical dependence liability; have accepted medical use narcotics: morphine, codeine, hydrocodone, opium, hydromorphone, methadone, meperidine, oxycodone, fentanyl stimulants: amphetamine, methamphetamine, methylphenidate other: cocaine, amobarbital, secobarbital, pentobarbital, glutethimide, immediate precursor to fentanyl marijuana (in CT) phencyclidine (PCP) Required records that must be maintained by a pharmacy (11) - correct answer DEA Form 222 or CSOS (executed and unexecuted) DEA Form 106 (reports of theft or significant loss) DEA Form 41 (inventory of drugs surrendered for disposal) Power of Attorney authorization to sign order forms receipts and/or invoices for schedules III, IV, and V controlled substances ALL inventory records of controlled substances, including initial and biennial inventories, dated as of beginning or close of business records of controlled substances distributed (to other registrants, returns to vendors, to reverse distributors) records of controlled substances dispensed records of transfers of controlled substances between pharmacies DEA registration certificate self-certification certificate and logbook (as required under the Combat Methamphetamine Epidemic Act) 4 standards for approved safe - correct answer - minimum of a B Burglary Rate - equipped with a relocking device - weight of 750 pounds or more or rendered immobile by being securely anchored to a permanent structure of the building - adequate interior space to store all controlled substances required to be kept within the safe Manufacturer, wholesaler, distributor, importer, exporter *SECURE* storage of controlled substances (CII-CV, various quantities) - correct answer CII <250 units in an approved safe CII ≥250 units in a vault CIII-CV in an approved vault *know 4 standards for approved safe* (separate question) Retail licensed pharmacy *SECURE* storage of controlled substances (CII-CV, various quantities) - correct answer CII <150 units in a completely enclosed locked wood or metal cabinet *pharmacies that are new or relocated after 1/1/1975 should store ALL CII in approved safe* CII ≥150 units in approved safe CIII-CV stored in approved safe, locked wood or metal cabinet, or dispersed throughout stock (not bunched together) *know 4 standards for approved safe* (separate question) Practitioner (MDs, dentists, veterinarians, osteopaths, podiatrists) *SECURE* storage of controlled substances (CII-CV, various quantities) - correct answer CII *AND* CIII ≤15 units in a wood or steel cabinet CII *AND* CIII >15 units in an approved safe *Veterinarians*: CII *AND* CIII ≤40 units in a steel or wood cabinet (for barbituate-type used solely for animal anesthesia or animal euthenasia) CIV-CV stored in a steel or wood cabinet *OR* in a securely safeguarded location Laboratory (*other than hospital clinical laboratory*) secure storage of controlled substances (CI-CV, various quantities) - correct answer *CI-CII* stock stored in an approved safe ^except CII barbituates ≤10 units used *solely* for sedative or anesthetic effect on animals stored in an approved safe *OR* separate secured locked location CIII-CV in an approved safe *OR* separate secured locked location Hospital pharmacy *SECURE* storage of controlled substances (CII-CV, various quantities) - correct answer CII *AND* CIII <150 units in a locked wood or metal cabinet CII *AND* CIII ≥150 units but <1000 units in an approved safe CII *AND* CIII ≥1000 units in an enclosed masonry room with a vault-type steel door; must be equipped with a "day gate" *completely enclosed masonry rooms contructed after 1/1/1975 must be equipped with an electrical alarm system* CIV-CV stock stored in a secure location within the pharmacy prescription compounding area or drug room *Hospital Clinical Laboratories*: CII-CIII in approved safe *Hospital Clinical Laboratories*: CIV-CV kept in a separate secure locked location *know 4 standards for approved safe* (separate question) [Show Less]
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PHARMACY LAW MPJE EXAM WITH WELL EXPLAINED ANSWERS FEDERAL LAW
What did the Federal Controlled Substances Act do? Why was it implemented? - correct answer Legislators very concerned in the 1960s about legal and illegal... [Show More] drugs being abused They were given the opportunity to design an act/law Created the DEA to promulgate and enforce the law Created a closed system between: manufacturer, distributors, prescriber, dispenser, and patient. What did the Pure Food and Drug Act of 1906 do? - correct answer Prohibited the adulteration and misbranding of foods and drugs in interstate commerce; DID NOT have to be proven safe or effective; did not require the label to list ingredients, directions for use, or provide warnings What did the Food, Drug, and Cosmetic Act do? (started in 1938) - correct answer Provides for the comprehensive regulation of all drugs introduced into interstate (and most intrastate) commerce Under this act no new drug may be marketed and sold unless it has been proved SAFE ONLY for its intended use and approved by the FDA Labels must contain adequate directions for use and warnings about habit-forming properties of certain drugs Describe the FDCA - correct answer The purpose of the FDCA is to protect consumers from adulterated or misbranded foods, drugs, cosmetics, or devices; provided that no new drug could be marketed until proven safe for use under the conditions described on the label and approved by the FDA; also started the labeling requirements; applies to devices as well; all drugs before 1938 are exempt from the requirement that new drugs be proven safe If you get in trouble with the board of pharmacy can you get in trouble with the government too? What about the a lawsuit with a patient? - correct answer Yes, you can have an administrative lawsuit, a civil lawsuit, and a criminal lawsuit separately for the same offense What did the Durham-Humphrey Amendment of 1951 do? - correct answer Established 2 classes of drugs; prescription and OTC Allows refills on prescriptions and oral prescriptions Per the Durham-Humphrey Amendment; what must be labeled on a prescription medication - correct answer Caution: federal law prohibits dispensing without a Rx; they do not need adequate directions for use like OTC (talking about the MANUFACTURERS label here; there is no take this medication x amount of times daily on the manufacturer labeling) What did the Kefauver-Harris Amendment of 1962 do? - correct answer Required all drugs to not only be proven safe but also EFFECTIVE Transferred the regulation of drug advertising from the FTC to the FDA The efficacy requirement made by the Kefauver-Harris Amendment included all drugs marketed during what time period - correct answer 1938-1962; drugs produced before 1938 were just grandfathered in and did not have to prove their efficacy What did the Orphan Drug Act of 1983 do? - correct answer Provided tax and exclusive licensing incentives for manufacturers to develop agents for the treatment of rare disease or conditions (those conditions that affect < 200,000 Americans) What did the Drug Price Competition and Patent Term Restoration Act of 1984 do? - correct answer Made generic drugs more readily available to the public and at the same time provided incentives for manufacturers to develop new drugs Eliminated the need for generic to prove safety and efficacy thus allowing new generics to get approved more easily What did the Prescription Drug Marketing Act of 1987 do? - correct answer Established sales restrictions and recordkeeping requirements for prescription drug samples Prohibits hospitals and other healthcare entities from selling drugs to other businesses (because the hospitals were getting the drugs for a discount then reselling them) Requires state licensing of wholesalers Prohibits ANY SAMPLES for any reason in a retail pharmacy Bans importation of prescription drugs except by manufacturers and for emergency use Mandates record keeping requirements for drug samples for 3 years What is the Prescription Drug User Fee Act of 1992 - correct answer Drug companies volunteered to pay tax and the money was used to hire more FDA scientist in hopes to speed up NDA reviews; however the price of drugs just went up to cover the fee being paid by the drug manufacturers What did the Dietary Supplement Health and Education Act (DSHEA) of 1994 do? - correct answer Provided laws on the regulation of dietary supplements; forced the FDA to treat these products more as food than drugs Define dietary supplement per the law - correct answer A product that is intended for *ORAL* ingestion, intended to supplement the diet, and contains any one or more of the following: a vitamin, mineral, herb or other botanical, an amino acid, dietary substance or use by humans to supplement the diet by increasing the total dietary intake and a concentrate, metabolite, constituent, extract or combination of the previous. All dietary supplements must be claimed as - correct answer A dietary supplement; they CANNOT say they are drugs or anything else on the labeling Dietary supplement manufacturers may not make these claims - correct answer Disease Claims Dietary supplement manufacturers may only make these types of claims - correct answer Structure / Function The label can't say that it will cure or prevent but it can say "will support or maintain" Dietary Supplements must have this on the labeling - correct answer "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease." Who enforces drug advertising? - correct answer FDA Who enforces dietary supplement advertising - correct answer FTC Do dietary supplements have to be safe and/or effective? - correct answer No How does a dietary supplement get pulled off the market? - correct answer The FDA cannot act until the dietary supplement is proven to be dangerous; the products should not be adulterated or misbranded (passed in 2007); however since little to no testing is conducted on these products it would be difficult to tell if they are adulterated or misbranded Can you put a bunch of publications regarding how awesome a dietary supplement is on the self with the dietary supplement to get people to purchase the product? - correct answer No; here are the rules: Dietary supplement publications must be reprinted in their ENTIRETY You cannot have any information that is FALSE or MISLEADING Must be present with other publications, if available, to present a balanced view All publications must be PHYSICALLY SEPARATE from the product What did the Food and Drug Modernization Act of 1997 do? - correct answer 1) Renewed the Prescription Drug User Fee Act 2) Compounding by pharmacists was finally clarified 3) Manufacturer only has to do 1 clinical trial to supplement their NDA 4) Established inactive OTC ingredients requirement 5) Pharmacists can do nuclear compounding 6) Fast track approval process for drugs used for serious or life-threatening diseases (initial drugs for this were HIV/AIDS medications) What organization is the primary enforcer of the FDCA? - correct answer FDA The FDA is a component of what organization? - correct answer DHHS Is the USP a government agency? - correct answer No, it is an independent agency that sets purity standards A drug recognized in the USP/NF must meet all standards or it will be considered - correct answer Misbranded or adulterated What are the 2 major offenses of the FDCA? - correct answer 1) Adulteration 2) Misbranding These violations are of "strict liability nature", what does that mean? - correct answer Adulteration or misbranding results in violation of the FDCA regardless of the person's knowledge or intentions Describe a Class I Recall - correct answer Most serious; issued when there is reasonable probability that the product will cause serious, adverse health consequences or death; must contact patients Describe a Class II Recall - correct answer May result in temporary or medically reversible adverse effects; probability is remote Describe a Class III Recall - correct answer Not going to hurt anyone; usually technical violations What are Current Good Manufacturing Practices? - correct answer A set of regulations that establishes minimum requirements for the methods, facilities, or controls used in the manufacture, processing, packaging, or holding of a drug product. APPLIES TO MANUFACTURERS ONLY. Do manufacturers have to register with the FDA? - correct answer Yes How often does the FDA inspect manufacturers? - correct answer Typically every 2 years Per the FDCA, define the following, starting with "New Drug" - correct answer Any new drug (except animal drug or feed with animal drug) composition of which is such drug, as a result of investigations to determine its safety and effectiveness for use under such conditions has become so recognized but which has not otherwise than in such investigations been used to a material extent or for a material time under such conditions (if change is from QID to BID for same thing, it has to be a new drug. Same with new indication. New drug also applies to patient population) What is adulteration - correct answer Adulteration: prepared, packed or held in conditions where it may have been contaminated; exposed to a container that may have contaminated it; or manufactured under conditions that do not conform to current GMP (deals with a drug's strength, purity, and quality) What are adequate DIRECTIONS for use? - correct answer Directions that the layperson must be able to understand; pertains to OTC drugs What are adequate INFORMATION for use? - correct answer Prescription medications; adequate INFORMATION for use is designed for healthcare professionals; the package insert The labeling must include the medical indication, effects, and dosage; the route, method, frequency, and duration, of administration; any relevant hazards, contraindications, side effects, and precautions. What is a New Drug Application (NDA) - correct answer The New Drug Application (NDA) is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The goals of the NDA are to provide enough information to permit FDA reviewer to reach the following: Is the drug is safe and effective in its proposed use(s), and do the benefits of the drug outweigh the risks? Is the drug's proposed labeling (package insert) appropriate, and what should contain? Are the methods used in manufacturing (Good Manufacturing Practice,GMP) the drug and the controls used to maintain the drug's quality adequate to preserve the drug's identity, strength, quality, and purity? The documentation required in an NDA is supposed to tell the drug's whole story, including what happened during the clinical tests, what the ingredients of the drug are, the results of the animal studies, how the drug behaves in the body, and how it is manufactured, processed and packaged. Once approval of an NDA is obtain What is an INDA (Investigational New Drug Application) - correct answer The Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved. The FDA reviews the IND for safety to assure that research subjects will not be subjected to unreasonable risk. A clinical study also requires an IND if it is intended to support a: New indication, Change in the approved route of administration or dosage level, Change in the approved patient population (pediatric) or a population at greater or increase of risk (elderly, HIV positive, immunocompromised) ,Significant change in the promotion of an approved drug. What is an Abbreviated New Drug Application (ANDA) - correct answer An Abbreviated New Drug Application (ANDA) is an application for a US generic drug approval for an existing licensed medication or approved drug. The ANDA contains data which when submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public. What is a compassionate use INDA? - correct answer Permission from the FDA to use a drug on a patient, after all other measures have been exhausted, that has not yet been approved and released to the market. Patient is not registered in a drug study. What is an Orphan Drug? - correct answer Drugs used for diseases with <200,000 occurrences in the U.S. Incentives are offered to companies to develop medications in class (7 years of exclusive marketing and tax credits). What is an Approved Drug? - correct answer A new drug for which the NDA has been approved by the FDA and is still valid OR as a drug in use prior to effective date of the 1938 FDCA therefore is not subject to the NDA requirements, provided and distributed promoted in accordance with labeling and established use as then existed. What is an unapproved drug? - correct answer A drug not approved by the FDA or an NDA not approved by the FDA What is approved use? - correct answer The prescribing and administering of a drug within the limits of the required dosage and route of administration, therapeutic indications, precautions, warnings, and contraindications. What is another word for unapproved use? - correct answer Off Label What is a prescription drug - correct answer Drug intended for use by man which, because of its toxicity or potential for harmful effect or the method of use or the collateral measures necessary to its use is not safe for use except under the supervision of a practitioner licensed by law to administer such a drug. It is limited by an approval to use under professional supervision of a practitioner licensed by law to administer such drug. Must have a written prescription, oral prescription, faxed prescription, or refill to dispense such medications. Dispensing contrary to these provisions is deemed MISBRANDING. What is an OTC drug? - correct answer Drugs recognized as among experts to be safe and effective for use. Must be manufactured under the FDA's good manufacturing standards and be labeled with directions for the layperson that indicate their safe and effective use. Compounding vs Manufacturing - correct answer Compounding / Manufacturing 1) Compounding on a particular basis (if compounding ahead of time in large quantities or without prescriptions would be manufacturing) 2) Being compounded for an individual patient prescription (compounding large quantities for office use or other uses would be manufacturing) 3) The geographic area of distribution (large area would be manufacturing) 4) Whether any advertising is being used (may not advertise for compounding) 5) The % of gross income from sales of particular compounded drugs (large % gross income would be more of a manufacturer than a pharmacy) 6) Whether drugs are being offered at wholesale prices 7) If they do not manufacturer, prepare, propagate, compound, or process drugs or devices for sale other that in the regular course of their business dispensing or selling devices at retail would be deemed manufacturing. Misbranding is the same thing as - correct answer Mislabeling What is the definition per the FDCA of adulterated drug? - correct answer Filthy, putrid, decomposed product; Packed/held in unsanitary conditions; methods to produce/package do not follow good manufacturing practice; does not meet compounding standards; container is at all exposed to poisonous or deleterious substance; contains unsafe coloring; new animal drug unsafe within the meaning; animal feed with unsafe drug. What is strict liability / liability without fault? - correct answer The FD&C Act imposes strict liability (liability without fault) on all who are affected by its provisions. (The specific prohibited acts include misbranding and adulteration of drugs.) Criminal intention is not necessary to violate the Act. It is not a defense to claim lack of knowledge or lack of intent to violate the law. (The Act would be unenforceable if these pleas were acceptable.) What is the safe harbor provision? - correct answer If pharmacies have a guarantee from the supplier that the drug has not been misbranded or adulterated then the pharmacist will not be responsible for a sealed medication bottle. Per the FDCA, define dietary supplements? - correct answer 1) Product other than tobacco intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, mineral, herb or other botanical, amino acid, a dietary substance for use by man to metabolite, constituent, extract, or combination of any ingredient above. 2) A product intended for INGESTION in tablet, capsule, powder, softgel, gelcap, or liquid form; or if not intended for ingestion in such a form is not represented as conventional food and is not represented for use as a sole item of a meal or of the diet. Who decides if a drug has a black box warning? - correct answer FDA Who decides if a drug is a REMS drug? - correct answer FDA What are the 5 pregnancy warnings? - correct answer A, B, C, D, and X Does the presence of a NDC on a label indicated that a drug has been approved by the FDA - correct answer No, the FDA assigns NDC numbers simply for identification purposes Name 7 instances when a drug would be approved as a new drug - correct answer 1) The drug contains new substance 2) There is a new combination of approved drugs 3) The proportion of ingredients in combination is changed 4) There is a new intended use for the drug 5) The dosage, method, or duration of administration or application is changed 6) New packing materials 7) A new patient population Describe the process for filing for an INDA - correct answer 1) File for INDA after animal testing for safety 2) If the FDA does not REJECT the INDA within 30 days then you may being human clinical testing What is the purpose of Phase 1 Clinical Trials? - correct answer To detect adverse events; not determine efficacy Who is enrolled in Phase 1 Clinical Trials? - correct answer Healthy patients; need written informed consent [Show Less]
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FLORIDA JURISPRUDENCE EXAMINATION WELL EXPLAINED 100%
The Laws and Rules Examination has 40 scored questions and the content and approximate weights are: - correct answer 1. Legislative Intent and Definitions ... [Show More] 25% 2. Board Powers and Duties 5% 3. Licensure and Examination 7.5% 4. Patient Care 35% 5. Disciplinary Action and Unlawful Practice 15% 6. Consumer Advocacy 12.5% 1.1 Legislative intent: the sole purpose in chapter - correct answer ensure every PT/PTA in state meets min requirements for safe practice. If PT/PTA fall below min competency or present a danger to the public be prohibited from practicing in this state. 1.1 Legislative intent: requirements: - correct answer (1) INTENT: if a person wants to be a PT/PTA, they are entitled to if qualified 1.1 Legislative intent: requirements: why regulated? - correct answer preservation of the health, safety, and welfare of the public under the POLICE powers of the state 1.1 Legislative intent: requirements: when regulated? - correct answer - practice can harm or endanger the health, safety, and welfare of the public - public not effectively protected by other means, (other state statutes, local ordinances, or federal legislation). - Less restrictive means of regulation are not available. 1.1 Legislative intent: requirements: restrictions - correct answer - Neither the department nor any board may take any action that tends to create or maintain an economic condition that unreasonably restricts competition - Neither the department nor any board may create a regulation that has an unreasonable effect on job creation or job retention in the state or that places unreasonable restrictions on the ability of individuals who seek to practice or who are practicing a profession or occupation to find employment. - all expenditures are made in the most cost-effective manner to maximize competition, minimize licensure costs, and maximize public access to meetings 1.2 "Physical therapy" or "physiotherapy," - correct answer deemed identical and interchangeable with each other, means a health care profession. 1.2 "Practice of physical therapy" - correct answer - assessments - treatment or prevention of any disability, injury, disease, or other health condition of human beings - physical, chemical, and other properties of air - electricity - exercise - massage; - acupuncture (only with compliance) when no penetration of the skin occurs - radiant energy, including ultraviolet, visible, and infrared rays - ultrasound; - water - apparatus and equipment - performance of tests of neuromuscular functions (to aid diagnosis or treatment) of any human condition - electromyography (aid in diagnosis of human condition - with compliance) - implement a plan of treatment for a patient if outside the scope of PT: - correct answer PT will refer the patient to or consult with a health care practitioner licensed under chapter 458, 459, 460, 461, or chapter 466, how long can PT treat without a referral? - correct answer 21 days the PT will obtain a practitioner of record who will review and sign the plan (licensed under chapter 458, 459, 460, 461, or chapter 466 and engaged in active practice) if longer than 21 days. May a PT use roentgen rays and radium for diagnostic and therapeutic purposes? - correct answer NO - outside the scope of PT. May a PT use electricity for surgical purposes, including cauterization? - correct answer NO - outside the scope of PT May a PT practice chiropractic medicine, including specific spinal manipulation? - correct answer NO - For specific chiropractic spinal manipulation, a PT will refer the patient to a health care practitioner licensed under chapter 460. Nothing in this subsection authorizes a physical therapist to implement a plan of treatment for a patient currently being treated in a facility licensed pursuant to chapter 395. - correct answer Chapter 395 = Hospital 1.3 "Physical Therapist" - correct answer licensed and who practices physical therapy in accordance with the provisions of this chapter. 1.3 "Physical Therapist Assistant" - correct answer - licensed in accordance with the provisions of this chapter to perform patient-related activities, including: physical agents - license in good standing - activities performed under the direction of a physical therapist Type of supervision for PTA for a board-certified orthopedic physician or physiatrist licensed chapter 458 (physician), 459 (osteopathic), or practitioner under chapter 460 (chiropractor) - correct answer general supervision of a physical therapist, but shall not require onsite supervision by a physical therapist. Type of supervision for PTA for Patient-related activities performed for all other health care practitioners licensed under chapter 458 (physician), 459 (osteopathic), or chapter 461 (Podiatric - foot & ankle), or chapter 466 (dentistry) - correct answer onsite supervision of a physical therapist. "Direct supervision" - correct answer requires the physical presence of the licensed PT for consultation and direction of the actions ( Except in a case of emergency) 1.3 "Physical therapy practitioner" - correct answer PT or PTA who is licensed and who practices physical therapy in accordance with the provisions of this chapter. 1.4 "License" - correct answer document of authorization granted by the board and issued by the department for a person to engage in the practice of physical therapy. 1.4 Reactivation of an Inactive or Retired License. - correct answer FEES ( - biennial renewal fee for inactive $50. 64B17-2.005(1), F.A.C.; - unlicensed activity fee $75 64B17-2.001(5) - reactivation fee $50 64B17-2.005(6) - change of status fee $50 64B17-2.001(7) CON ED - 64B17-9.001 - Prevention of medical errors - 10 hours per year license was inactive - including 2 hours on prevention of medical errors - No more than 6 hours may be completed by home study per year of inactive status - 2 hours on Florida Physical Therapy Laws and Rules within the 12 months immediately preceding DOCUMENTATION - applicant is licensed and in good standing in another state and has actively engaged in the practice for 4 years immediately preceding application (> 400 hours per year) - successful passage of the NPTE including payment of all associated fees application fee for licensure (national examination or endorsement) - correct answer $100 initial licensure fee - correct answer $75 biennial renewal fee for an active license - correct answer $75 biennial renewal fee for an inactive license - correct answer $50 retired status fee - correct answer $50 delinquency fee - correct answer $55 fee for reactivation - correct answer $50 change of status fee - correct answer $40 duplicate license fee - correct answer $25 Con ed contact hours defined - correct answer 1 contact hour = 50 clock minutes 1/2 contact hour =25 clock minutes 1 CEU = 10 contact hours. Exemption of Spouses of Members of Armed Forces from Licensure Renewal Provisions - correct answer - spouse of Armed Forces: for any period of time which the licensee is absent from the State of Florida due to the spouse's duties with the Armed Forces. - must document the absence and the spouse's military status to the Board - notify change in status within 6 months of the licensee's return to the State of Florida or the spouse's discharge from active duty - If the change of status within the second half of the biennium, the licensee is exempt from the continuing education requirement for that biennium Continuing education requirements - correct answer - 24 hours biennially. - courses sponsored by accredited college or university with PT/PTA curriculum - accredited agency: APTA, FPTA - home study (up to 12 contact hours) -Con ed Course instructors (up to 6 hours) - instructors for normal course instruction (0 hours) - Clinical Instructors credentialed through APTA (1 contact hour for every 160 hours of clinical internship limited to a maximum of 6 contact hours Instruction on HIV & AIDS - correct answer - at least 1 clock hour (Board approved course) - by first biennial renewal of licensure - Board will accept PT school coursework no more than 5 years preceding initial licensure date. - courses will be at least one hour and include the following subject areas: (a) Modes of transmission; (b) Infection control procedures; (c) Clinical management; (d) Prevention; (e) Florida law on AIDS and the impact on testing, confidentiality, and treatment. A home study course shall be permitted to fulfill this aspect of the HIV/AIDS education. Prevention of Medical Errors Education - correct answer - 2 contact hours - include a study of root-cause analysis, error reduction and prevention, and patient safety, which shall encompass: (a) Medical documentation and communication; (b) Contraindications and indications for physical therapy management; and (c) Pharmacological components of physical therapy and patient management. - Applicants for initial licensure must have completed at least 2 contact hours of medical error education - will accept coursework from accredited schools of physical therapy provided such coursework was completed after January 1, 2002. - If the course is being offered by a facility licensed pursuant to Chapter 395, F.S., the Board may apply up to one hour of the two-hour course if specifically related to error reduction and prevention methods used in that facility. - The course may be used as part of the home study continuing education hours. Continuing Education acceptable subject area - correct answer professional ethics clinical education clinical practice clinical research clinical management clinical science Florida law relating to physical therapy basic sciences risk management (no more than 5 contact hours) HIV/AIDS. (up to 3 hours) prevention of medical errors education (up to 3 hours) PT: renewal, inactive status, reactivation of license; fees.— - correct answer renewal $200 biennial fees: application, renewal, delinquency, reactivation not to exceed $200 inactive renewal: con ed 10 hours per year inactive OR evidence actively practice PT in another state for 4 years preceding OR application & passes examination Address of Licensee. - correct answer current address for any notice of law to be served provide board of address change within 60 days in writing Requirements for Reactivation of an Inactive or Retired License. - correct answer An inactive or retired license shall be reactivated upon receipt by the Board office of the following: (1) Payment of all applicable fees, including: (a) The biennial renewal fee as specified by subsection 64B17-2.005(1), F.A.C.; (b) The unlicensed activity fee as specified by subsection 64B17-2.001(5), F.A.C.; (c) The reactivation fee as specified by subsection 64B17-2.005(6), F.A.C.; (d) The change of status fee as specified by subsection 64B17-2.001(7), F.A.C.; (2) Documentation of compliance with all continuing education requirements as provided in Rule 64B17-9.001, F.A.C., including prevention of medical errors, for the biennium during which the licensee last held an active license; and, (3)(a) Documentation of completion of ten (10) hours of continuing education for each year the license was inactive, including two (2) hours on the prevention of medical errors. No more than six (6) hours of continuing education may be completed by home study per year of inactive status. In additi False representation of licensure, or willful misrepresentation or fraudulent representation to obtain license, unlawful.— - correct answer (1)(a) It is unlawful for any person who is not licensed under this chapter as a physical therapist, or whose license has been suspended or revoked, to use in connection with her or his name or place of business the words "physical therapist," "physiotherapist," "physical therapy," "physiotherapy," "registered physical therapist," or "licensed physical therapist"; or the letters "P.T.," "Ph.T.," "R.P.T.," or "L.P.T."; or any other words, letters, abbreviations, or insignia indicating or implying that she or he is a physical therapist or to represent herself or himself as a physical therapist in any other way, orally, in writing, in print, or by sign, directly or by implication, unless physical therapy services are provided or supplied by a physical therapist licensed in accordance with this chapter. (b) It is unlawful for any person who is not licensed under this chapter as a physical therapist assistant, or whose license has been suspended or revoked, to use in connection with her or 64B17-6.006 Administration of Topical Medications - correct answer Pursuant to a physician's prescription for the patient, a physical therapist may retain custody of that patient's non-scheduled legend topical medications and administer those medications to that patient. All prescription medication used in physical therapy treatment shall be properly dispensed by a Florida licensed pharmacist and administered only to the patient for whom the prescription was authorized. 64B17-6.007 Delegation to Unlicensed Personnel by the Physical Therapist. - correct answer (1) Unlicensed personnel may be utilized to assist in the delivery of patient care treatment by the physical therapist, with 28 direct supervision by the physical therapist or the physical therapist assistant. (2) It is the sole responsibility of the physical therapist to consider the task delegated, select the appropriately trained personnel to perform the task, communicate the task or activity desired of the unlicensed personnel, verify the understanding by the unlicensed personnel chosen for the task or activity, and establish procedures for the monitoring of the tasks or activities delegated. (3) The physical therapist shall retain ultimate responsibility for the patient's physical therapy treatment. Any delegation of treatment to supportive personnel shall be done with consideration of the education, training, and experience of the support personnel. It is the sole responsibility of the physical therapist to define and delineate the education, training, and experience required to 64B17.6.005 Costs of Duplicating Medical Records. - correct answer (1) Any person licensed pursuant to Chapter 486, F.S., required to release copies of reports or patient medical records, or make reports or records available for digital scanning, may condition such release upon payment by the requesting party of no more than the reasonable costs of reproducing the records, including reasonable staff time. (2) Reasonable costs of reproducing copies of written or typed documents or reports shall not be more than the following: (a) For the first 25 pages, the cost shall be $1.00 per page. (b) For each page in excess of 25 pages, the cost shall be $.25 per page. (3) Reasonable costs of reproducing x-rays and such other kinds of records shall be the actual costs. "Actual costs" means the cost of the material and supplies used to duplicate the record and the labor and overhead costs associated with the duplication. The Board approves for continuing education credit: courses or attendance sponsored at: - correct answer - college/university PT program that is accredited 1 credit hour = 1 contact hour - APTA - FPTA - Florida Board meetings attendance where disciplinary cases are being heard (licensee is not on the agenda or appearing for another purpose) - Former Board members on the Board's Probable Cause Panel 5 contact hours of risk management per biennium - file DOH form #DH-MQA 1144, "Application Materials For The Florida Laws and Rules Examination,"and exam passed 2 hours of con ed credit not awarded if taken as result of discpline or board ordered (licensure) CON ED exceptions: including waiver of all or a portion of these requirements or the granting of an extension of time - correct answer - finding of good cause by majority vote of the Board at a public meeting - following receipt of a written request for exception based upon emergency or hardship. Emergency or hardship cases are those: (1) long term illness (personal, close relative, care giving responsible) (2) required course(s) are not reasonably available; and (3) other demonstrated economic, technological or legal hardships that substantially relate to the ability to perform or complete the continuing education requirements. CON ED: must keep records for how long? - correct answer 4 years 456.036 Licenses; active and inactive status; delinquency - correct answer (1) A licensee may practice a profession only if the licensee has an active status license. A licensee who practices a profession with an inactive status license, a retired status license, or a delinquent license is in violation of this section and s. 456.072, and the board, or the department if there is no board, may impose discipline on the licensee. (2) Each board, or the department if there is no board, shall permit a licensee to choose, at the time of licensure renewal, an active, inactive, or retired status. 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QUESTIONS AND ANSWERS 100- CORRECT OHIO MPJE EXAM SET
Medical marijuana can be used for the following conditions? - correct answer (a) Acquired immune deficiency syndrome (b) Alzheimer's disease (c) Amyotrop... [Show More] hic lateral sclerosis (d) Cancer (e) Chronic traumatic encephalopathy (f) Crohn's disease (g) Epilepsy or another seizure disorder (h) Fibromyalgia (i) Glaucoma (j) Hepatitis C (k) Inflammatory bowel disease (l) Multiple sclerosis (m) Pain that is either chronic and severe or intractable (n) Parkinson's disease (o) Positive status for HIV (p) Post-traumatic stress disorder (q) Sickle cell anemia (r) Spinal cord disease or injury (s) Tourette's syndrome (t) Traumatic brain injury (u) Ulcerative colitis Define guidance - correct answer best practice not a law, although the FDA can take action based on its guidance What does shall and should mean in terms of laws? - correct answer shall - it is required should - strongly recommended Define abandoned application - correct answer an application for any license with the Board of Pharmacy is considered abandoned if the application fails to complete all application components within 30 days after being notified by the board of an incomplete application *a terminal distributor or wholesaler has 90 days to demonstrate compliance of all laws once a complete application is submitted define access to drug stock - correct answer this includes not only physical access but also influence over the handling of prescription drugs including purchases, inventories, issuance of medical orders, etc. it does not include maintenance, janitorial, IT, or other staff that may need limited, supervised access Define pharmacist responsibility - correct answer a pharmacist is ultimately responsible for every prescription dispensed by a pharmacy. It is up to the pharmacist to conduct the final check for accuracy and DUR on every prescription dispensed Define pharmacy - correct answer any area or room where prescriptions are filled or where drugs dangerous drugs, or poisons are compounded, sold, offered, or dispensed What is a drug? - correct answer an article USP recognized for use in diagnosis, cure, treatment, or prevention of disease in man or animals, Also, any article, other than food, intended to affect the structure or any function of the body of humans or animals Define dispense - correct answer the final association of a drug with a particular patient pursuant to a prescription, drug order, or other lawful order of a prescriber. It also means the professional judgement and responsibility for interpreting, labeling, preparing, compounding, and packaging a specific drug What is a dangerous drug? - correct answer -A drug that is required to have "Rx only" or any similar language -Can only be dispensed with an Rx -Contains CV substance (except Robitussin AC) -Drug intended to be administered by injection into the human body other than thru a natural orifice What is a drug of abuse? - correct answer any dangerous drug What is a prescription? - correct answer written, oral, fax, or electronic (if board approved) --pharmacies are no longer required to print out electronic prescriptions but still must be maintained for 3 years Define prescriber - correct answer a person authorized by the ORC to prescribe dangerous drugs as part of their professional practice or a pharmacist authorized to manage drug therapy pursuant to a consult agreement but only if authorized in the agreement and only to the extent specified in the consult agreement Can drugs be removed from a terminal distributor? - correct answer 1) a licensed health professional authorized to prescribe may temp remove drug from the terminal distributor to treat current or prospective patients - must be returned within 24 hours 2) a person authorized to furnish or dispense naloxone must return in it within 24 hours 3) a licensed health professional may temp remove non-controlled drug or immunizations from the terminal distributor to treat current or prospective patients - must be returned within 24 hours What must faxed prescription contain? - correct answer -Includes full name of prescriber or agent that transmitted Rx -the original prescription or the refill authorization must be manually signed by the prescriber -Include header info to identify origin of Rx -the original prescription should be placed in the pts file Can a fax be sent from a computer? - correct answer No they become illegal except: 1. the fax prescription operates within a closed system 2. can be accepted during a temporary outage What is required if electronically prescribing in an inpatient facility? - correct answer positive identification of a licensed health care professional What price information must be available for those that ask? - correct answer -pharmacists must disclose price information for all drugs EXCEPT those schedule II drugs What must be included if a pharmacy advertises a price of a medication? - correct answer -brand name -generic name -strength -dosage form -price for specific quantity What is considered to be "readily retrievable"? - correct answer -records must be able to be produced for review within 3 business days What does it mean to refuse to grant or renew a license? - correct answer -to deny original or continued licensure for a period of at least 24 months What is a terminal distributor? - correct answer -pharmacy that dispenses drugs at a retail price -this includes laboratories What is a virtual wholesale distributor? - correct answer -any person engaged in wholesale distribution of dangerous drugs in or into OHIO -the wholesaler has title to the drugs but does not take physical possession of the drugs When can drugs be removed from a terminal distributor? - correct answer -a licensed health professional authorized to prescribe may temporarily remove prescription drugs from the terminal distributors to treat current or prospective patients but these must be returned within 24 hours -a person authorized to furnish or dispense naloxone must return it within 24 hours to a terminal distributor -a licensed health professional may temporarily remove non-controlled substance prescription drugs or immunizations from the terminal distributor to treat current or prospective patients but these must be returned within 24 hours What must be on a faxed prescription to ensure that it is valid? - correct answer -it must be manually signed by the prescriber -if an "agent" of the physician is transmitting the faxed prescription, his/her full name must be included -it must have a header with location transmitted and date it was faxed -the original prescription at the physician's office will be placed in the patient's chart What is a third party logistics provider? - correct answer -contracts with a manufacturer or wholesaler to provide or coordinate warehousing, distribution, or other services on their behalf but does not take title of prescription drugs or have responsibility for their sale or disposition -must have a license as a wholesale distributor, registered as a business What is a wholesale sale? - correct answer -means any sale in while the purpose of the purchaser is to resell the article purchased or received What is the 5% rule? - correct answer -if a pharmacy has >5% of sales due to selling medications to people other than patients, they must receive a wholesaler's license When does the 5% rule not apply? - correct answer -inter-company sales between pharmacies that are under common ownership -among hospitals or health care entities under common control What is an occasional sale? - correct answer -a wholesale sale of a commercially available prescription drug to another terminal distributor or person exempted from being a terminal distributor such as vets, dentists, docs What 2 conditions cause a medication to be considered a prescription drug? - correct answer -habit forming -unsafe for use except under the supervision of a practitioner define dispense - correct answer sell, leave with, dispose of, change, barter, give away, or deliver define personal supervision - correct answer pharmacist must be in the prescription department in full and actual charge What is a federal legend? - correct answer -all prescription drugs must have "Rx only" or a variation of this on the stock bottle What is a serial number? - correct answer -prescription number What is considered to be a business day? - correct answer -any day other than Saturday, Sunday or holiday recognized by the state of Ohio What is the minimum standard of a pharmacy? - correct answer -Drug library (laws and references) -Poison Control Center # -Equipment necessary to conduct pharmacy -Drugs and Rx containers -Well-lighted, well-ventilated, clean and sanitary -Adequate physical security -Posted pharmacy hours -appropriately staffed -Staff in contact with patients, must have name tag with job title Define pharmacy practice - correct answer 1. managing drug therapy 2.dispensing and compounding drugs 3. dispensing devices 4. counseling pts 5. review of drug regiments 6. review of drug utilization 7. drug therapy advice How far in advanced can drugs be compounded based on routine, regularly observed dispensing patterns? - correct answer 30 days What conditions must be met for drugs that are returned to stock in a pharmacy? - correct answer -an expiration date must be placed on the container -the drugs returned to stock must be kept in the prescription bottle it was dispensed in with the original patient label on it -when dispensing the product to a new patient, a new container must be used -if there is a drug recall, all medication on the shelf must be removed if the exact lot number is not known -if the medication wished to be returned was with a delivery agent, the medication either needs to have been in the stock bottle still or there is a way to show that it had not be tampered with -none of these apply to medications that are dispensed inpatient How far in advanced can drugs be compounded based on routine, regularly observed dispensing patterns? - correct answer What can a pharmacist do under a consult agreement? - correct answer -changing the duration of treatment of current therapy -adjusting the strength, dose, dosage form, frequency, administration, or route of administration -discontinue the use of a drug -administer a drug, if the drug is included in the consult agreement -add a drug to the patient's drug therapy -order blood and urine tests and if specified within the practice protocols that are part of the consult agreement, evaluate the results related to drug therapy being managed --HOWEVER, these tests do NOT authorize the pharmacist to make a diagnosis Who can terminate consent for a consult agreement? What must happen after that? - correct answer -The pharmacist, physician, or patient can terminate it -if pt terminates - pharmacist and physician must be notified in writing -if the pharmacist or physician terminates - provide written notification to all other parties involved and record in medical record When can a pharmacist enter into a consult agreement with one or more physicians? - correct answer -each physician has an ongoing physician-patient relationship with each patient whose drug therapy is being managed -the diagnosis for which each patient has been prescribed drug therapy is within the scope of practice of each physicians practice -each pharmacist has training and experience related to the particular diagnosis for which drug therapy is prescribed What must be included on the written consult agreement? - correct answer -the diagnoses and disease being managed under the consult agreement including whether each disease is primary or comorbid -a description of the drugs or drug categories the agreement involves -a description of the procedures, decision criteria, and plan the pharmacist is to follow in acting under the consult agreement -a description of the how the pharmacist is to comply with the records of each action taken and at what regular intervals this will take place What patients can be managed under a consult agreement? - correct answer only pts of physicians listed in the consult agreement How long is a consult agreement good for? - correct answer 2 years What is a comorbid disease? - correct answer -an additional disease that co-occurs with a primary disease What is a primary disease? - correct answer -a disease that arises spontaneously and is not associated with or caused by a previous disease, but may lead to a co-morbid disease What is included in the consent that must be received from the patient that will be involved in a consult agreement? - correct answer -a pharmacist may be utilized in the management of the patient's care -the patient has the right to participate or withdraw from the consult agreement this consent may be part of the patient's initial consent to treatment What is a managing pharmacist? - correct answer -a pharmacist managing a patient's drug therapy pursuant to a consult agreement What forms of communication can occur in a consult agreement between the pharmacist and physician? - correct answer -electronic mail that confirms delivery -interoperable electronic medical records system -fax that confirms delivery -electronic prescribing system -electronic pharmacy record system -documented verbal communication -any other method of documented notification as outlined in a consult agreement What can be considered a written notice? - correct answer -electronic mail -interoperable electronic medical records system -fax -electronic prescribing system -electronic pharmacy record system -any other method in writing that provides notice in a timely manner How long must pharmacists maintain record of each action taken for each patient under a consult agreement with positive identification? - correct answer 3 years What needs to be done if a pharmacist wants to be authorized to prescribe a non controlled substances as per a consult agreement? - correct answer -the rx should include the required info of the consulted physician -Phone # where the pharmacists can be reached -positive id (including manual signature) on the prescription of the pharmacist What needs to be done if a pharmacist wants to be authorized to prescribe controlled substances as per a consult agreement? - correct answer -have a valid controlled substance prescriber registration issued by the Ohio State Board of Pharmacy -must submit an application and valid consult agreement -must obtain and keep current a valid DEA registration from the federal government -the DEA registration must be submitted to the board within 30 days -if the consult agreement is not valid the license is void Who can participate in a consult agreement? - correct answer -only Ohio licensed pharmacists and physicians -NO PA's or nurse practitioners When should the pharmacist review OARRS if prescribing a controlled substance? - correct answer -when adding a controlled substance -adjusting a controlled substance (i.e. changing strength, dose, dosage form, route, or frequency) What should be done if a pharmacist is no longer authorized to prescribe controlled substances per the consult agreement? - correct answer -the Board must be notified within 5 business days What conditions must be met for a pharmacist to be able to dispense a dangerous drug other than a CII without a written or oral prescription from a licensed health care professional authorized to prescribe drugs? - correct answer -pharmacy has a record of a prescription for the drug in the name of the patient who is requesting it and the prescription has no refills or the refills have expired (they have to have record of the rx but this does not mean that pharmacy has specifically filled the rx before, could use a database or PMR) -R. Ph is unable to contact the prescriber for refill authorization -in the pharmacist's judgment, the drug is essential to sustain life, continues therapy for a chronic condition, or failure to dispense the drug could result in harm to the health of the patient What is a practitioner? - correct answer -licensed health care professional authorized to prescribe drugs How much medication can be given to the pt? - correct answer -the amount of drug cannot exceed a 72 hour supply -if the pt is on a consistent drug therapy the amount of drug cannot exceed a 30 day supply or the smallest standard unit. Only on non controlled rxs and only once in a 12 month period If copayments or deductibles are waived who is at fault? - correct answer the terminal distributor not the individual pharmacist How many attempts do you have to pass the NAPLEX and MPJE? - correct answer 5 How does the pharmacist fill an emergency fill? - correct answer -the pharmacist must create a new rx and document it as an emergency fill -for 1 years after the sale the pharmacist must keep record of: --the name and address of the pt --name and address of the individual receiving the drug (if different than pt) --amount dispensed --original rx number definition of a preceptor - correct answer -pharmacist whose license is in good standing, of good moral character, and is qualified to direct the practical experience of an intern -a pharmacist can be a preceptor for an unlimited number of pharmacy interns but no more than 2 interns can be working with each pharmacist on duty -unless employed by a school of pharmacy a preceptor must have at least one year of practice experience as a licensed pharmacist to receive an intern license what must the student do? - correct answer -apply to the board for a license -provide a head to shoulders photograph -pay a fee -must have completed 60 semester hours or 90 quarter hours of college already [Show Less]
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OHIO MPJE SULLIVAN EXAM SET (444 QUESTIONS) WITH COMPLETE SOLUTION
1) A prescription is written for atenolol 50 mg and dated August 15, 2017. The patient brings the prescription in to be filled on March 1, 2018. Can you le... [Show More] gally fill this prescription? a) Yes b) No - correct answer b (March 1, 2018 is past 6 months) 2) Prescription records must be kept for ___________________ under federal law, and ____________________ under Ohio law. a) 3 years, 3 years b) 2 years, 2 years c) 2 years, 3 years d) 2 years, 5 years e) none of the above - correct answer c 3) Records for poisons must be kept 5 years a) True b) False - correct answer a 4) It is legal for a physician to write prescriptions for Crestor 10 mg and alprazolam 0.5 mg on the same prescription form. a) True b) False - correct answer b 5) A pharmacy with a category III terminal distributor's license may dispense controlled substances, dangerous drugs, and IV solutions a) True b) False - correct answer a 6) The labels of both inpatient and outpatient IV (intravenous medications) must have an expiration on it. a) True b) False - correct answer a 7) A prescription container (like a bottle Timpotic XE) too small to bear a complete label must have at least the following information on it. Select all that apply. a) Rx number b) patient name c) directions for use d) prescriber name e) refills - correct answer a and b 8) A pharmacist comes to work one day early in the morning and notices that all of the Adderall XR hsa been stolen. The pharmacy must notify..... a) Board of Pharmacy b) Local Law Enforcement c) DEA d) a and c only e) a, b, and c - correct answer e 9) Which of the following is false regarding multiple drugs in the same container? Select all that apply. a) Only a maximum of 31 days supply of medication can be dispensed b) The expiration date of the container cannot be for more than 31 days c) When one drug is discontinued, everything in the package is adulterated d) There must be regular outpatient labels for each drug in the container e) The number of drugs cannot exceed the capacity of the container - correct answer b 10) A doctor licensed in Florida writes a prescription in Florida for a patient on vacation. The patient brings that prescription back to Ohio. Can you fill it? a) Yes b) No - correct answer a 11) The definition of a poison is a chemical deleterious to an adult's life in quantities of six grams or less. a) True b) False - correct answer b (in quantities of four grams or less) 12) When a patient requests their medical records from a pharmacy, HIPPAA states that they have access to all patient notes and comments the pharmacist has entered into the computer as well. a) True b) False - correct answer a 13) Under Ohio law, atorvastatin 20 mg is considered a drug of abuse. a) True b) False - correct answer a (Any prescription drug is considered a drug of abuse) 14) Pharmacists have _____________ hours to verify and sign the daily printout of prescriptions for the day. a) Within a reasonable amount of time b) 48 hours c) 96 hours d) 1 week e) 24 hours - correct answer a 15) Insurance companies have access to only those patient prescription records for medications they paid for. a) True b) False - correct answer a 16) Controlled substances can be mailed using the United States Postal Service. a) True b) False - correct answer a 17) __________________ drugs are those drugs required to meet the therapeutic needs of patients when a pharmacist is unavailable. ___________________ drugs are those drugs required to meet immediate needs to save or sustain life. a) emergency; contingency b) crash cart; contingency c) contingency; emergency d) crash cart; floor stock e) emergency; floor stock - correct answer c 18) Pharmacists must have the phone number of the nearest poison control center available as part of the library requirement. a) True b) False - correct answer a 19) A lab technician and a doctor may legally enter the pharmacy to obtain medications when the pharmacy is closed. a) True b) False - correct answer a (2 people must enter, one must be a licensed health care professional authorized to administer drugs) 20) All of the following are considered hospital orders. Select all that apply. a) a faxed order from the physician b) an order written order c) an oral order from a physician, but the order must be verified by the physician - correct answer a, b, c 21) Refills for schedule III and IV controlled substances are good for ______________ from the date the prescription was written or a maximum of __________________ total refills. a) 1 year; 5 b) 6 months; 4 c) 1 year; 4 d) 6 months; 5 e) none of the above - correct answer d 22) Which of the following are a schedule IV drug? Select all that apply. a) chlordiazepoxide b) midazolam c) dihydrocodeine d) ketamine e) clorazepate - correct answer a, b, and e 23) Cancer drugs (anti-neoplastics) can be compounded in horizontal flow hood with annual certification. a) True b) False - correct answer b (Must be compounded in a vertical flow hood and certified every 6 months) 24) Invoices of C-II's, C-III's, C-IV's, and C-V's (all controlled substances purchased) must be kept together in one file. a) True b) False - correct answer b (Invoices for C-IIs must be in one file and C-III's, C-IV's, and C-V in another file) 25) A dog breeder comes into your pharmacy and wants to buy some syringes to give his puppies immunizations. Can you sell him the syringes? a) Yes b) No - correct answer a 26) You must be __________ years old to buy a C-V as an OTC and at least ______________ years old to buy a poison. a) 18; 18 b) 16; 16 c) 18; 16 d) 16; 18 e) 18; 21 - correct answer c 27) If pharmacies sell more than 5% of what they purchase at wholesale (example: selling injectable medications they buy to doctor's offices), they need a wholesale's license. a) True b) False - correct answer a 28) Technician can help a pharmacist compound as long as the pharmacist inspects and approves the final product and the technician makes no professional judgements. a) True b) False - correct answer a 29) Under Ohio law, outdated drugs are: a) misbranded b) adulterated c) both adulterated and misbranded - correct answer b 30) Mrs. Smith leaves the pharmacy building with her prescription. Two hours later she brings it back. She said she never opened the Rx vial. Can you redispense the medication in the bottle? a) Yes b) No - correct answer b (Once it leaves the pharmacy it cannot be re-dispensed) 31) If you dispense Paxil without a prescription, the bottle it is dispensed in is: a) adulterated b) misbranded and adulterated c) misbranded - correct answer c 32) A prescription is brought to your pharmacy for 100 Zohydro ER (scheduled II controlled substance). You only have 30 in stock. How long do you have to fill the remaining 70 capsules? a) 24 hours b) 48 hours c) 7 days e) 60 days - correct answer c 33) If you make a mistake on DEA Form 222 when ordering schedule II's, you can erase the mistake and correct it. a) True b) False - correct answer b 34) In which of the following cases can a doctor fax a schedule II (C-II) prescription for a patient? Select all that apply. a) a patient in an assisted living facility b) a prescription for Dilaudid 2 mg for a hospice patient c) a home IV prescription for morphine for a cancer patient d) a patient who resides in a nursing home e) a prescription for Adderall XR 20 mg for a child homebound in a wheelchair - correct answer b, c, and d 35) Which of the following are considered to be professional duties of an intern under Ohio Law? Assume the intern is being supervised by a pharmacist. Select all that apply. a) Patient counseling b) Transferring controlled substance prescriptions c) Selling schedule V cough syrups as an OTC d) Receive an oral prescription for a controlled substance e) Give a flu vaccine to a 6 year old child - correct answer a, c, and d (Interns cannot transfer controlled substances & cannot give flu shots to child under 7) 36) Which of the following are schedule III drugs. Select all that apply. a) promethazine with codeine cough syrup b) zalpelon c) perampanel d) glutethimide e) sodium oxybate (Xyrem) - correct answer c and e 37) If a prescription drug has an NDC number, then it must be FDA approved and can be sold. a) True b) False - correct answer b 38) A medical device that requires pre-marketing approval, and must demonstrate safety and effectiveness is a ________________ device. a) Class I b) Class II c) Class III - correct answer c 39) A patient is discharged from Surfside Plastic Surgery Hospital. She gets her prescriptions filled at the inpatient pharmacy before she's discharged. A month later she needs a refill. Can she have he prescription filled at the outpatient pharmacy across the street in Surfside Hospital Medical Building Pharmacy? a) Yes b) No - correct answer a (Yes, they can have it refilled at the outpatient pharmacy but not the inpatient pharmacy) 40) Pharmaceutical sales representatives must do an inventory of their samples every two years pharmacies. a) True b) False - correct answer b (It must be done annually) 41) A pharmacist can give travel vaccines. a) True b) False - correct answer a 42) Pharmacists and interns can give immunization recommended by the Advisory Committee on Immunization Practice (ACIP) of the Center for Diseases Control (CDC) and any immunization specified in the rules adopted by the Board to individuals 12 years and older without a prescription. a) True b) False - correct answer b (Individuals must be 13 years and older) 43) Pharmacists and interns can give immunization recommended by the Advisory Committee on Immunization Practice of the Centers for Disease Control and any immunization specified the rules adopted by the Board to individuals between the ages of 7 and 13 years of age with a prescription. a) True b) False - correct answer a 44) Which if the following are true regarding immunizations? a) Pharmacists and interns can give flu shots to patients 7 years of age and older b) You must receive & document consent from the parent or guardian of any patient under the age of 18. c) Pharmacists and interns can give an MMR immunization to a 10 year old child with a prescription from a physician d) a and b are true e) a, b, and c are true - correct answer 45) An intern wants to give immunizations at a flu shot clinic. The intern is immunization certified. There are three licensed nurses at the flu shot clinic. Can the intern give flu shots at the clinic? a) Yes b) No - correct answer b 46) An intern wants to give immunizations at a flu shot clinic. The intern is immunization certified. The pharmacists supervising the intern is not immunization certified. Can the intern give flu shots at the clinic? a) Yes b) No - correct answer b 47) A pharmacist has been seeing a lot of prescriptions from Dr. Acne, a dermatologist from down the street, for a specific compound containing several ingredients. It takes the pharmacist about 30 minutes to make each one. Under federal law, how much can the pharmacist make up in advance and have ready for her patients? a) 7 days supply b) 10 days supply c) 30 days supply d) 60 days supply e) There is no limit - correct answer c (Federal law says you can have a 30 day supply on hand for anticipatory compounded products) 48) Under Ohio law, to practice pharmacy means. Select all that apply. a) give drug therapy advice b) counsel patients c) dispense and compound drugs d) enter prescription data into the computer e) review drug regiments - correct answer a, b, c, and e 49) An "oral" DAW from a physician is legally considered the same as written "DAW" in Ohio. a) True b) False - correct answer a 50) Can a dentist write a prescription for hypertension medication? a) Yes b) No - correct answer b 51) How many C.E.U.'s of continuing education does a pharmacist have to complete every three years? a) 45 b) 6.0 c) 0.1 d) 30 e) 60 - correct answer b 52) Pharmacist Lauren Smith is getting married on September 10, 2018. Once she becomes married, she has 30 days to notify the Board of Pharmacy of her change of name. a) True b) False - correct answer a (Law changed as of March 2017) 53) The date for renewing a terminal distributors license is: a) January 1st b) July 1st c) September 15th d) April 1st e) None of the above - correct answer d 54) Which of the following conditions can medical marijuana be used to treat? Select all that apply. a) AIDS b) Alzheimer's disease c) Crohn's disease d) Epilepsy e) Parkinson's disease - correct answer a, b, c, d, and e 55) Which of the following cannot write prescriptions under Ohio law? Select all that apply. a) dentists b) MDs c) chiropractors d) psychologists e) podiatrists - correct answer c and d 56) Theft or loss of prescription blanks or documents must be reported to the Board of Pharmacy. a) True b) False - correct answer a 57) Fred Thomas, a physician, has decided that he is tired of practicing medicine. He decides he wants to be a pharmacist again and has taken a job with CVS Pharmacy. His license has lapsed for two years. Does he have to retake the pharmacy board exams? a) Yes, he has to retake the board exams b) No, he does not have to retake the board exams - correct answer b (If your license has lapsed for more than 3 years, you must retake the Boards.) 58) The maximum number of times a pharmacy graduate can take the NAPLEX in Ohio is.... a) 2 b) 3 c) 5 d) 7 e) An unlimited number of tim - correct answer c 59) Warren Buffet's investments have been performing poorly. Therefore, Mr. Buffett decides he's going to start buying pharmacies. Can Mr. Buffett have the keys to the prescription department? a) Yes b) No - correct answer b 60) Dr. Jack Johnson writes a prescription for a controlled substance. He gives you the following DEA number: BJ 7980457. Is this a valid DEA number? a) Yes b) No - correct answer a 61) John Perry is in the hospital for gall bladder surgery. John is mad at the nurses because they are slow to give him his medications. He wants the nurse to start leaving his unit-dose labeled medications for the entire day at his bedside so he can self medicate. Is this legal? a) Yes b) No - correct answer b (Patients who self-medicate in a hospital must have outpatient labels on their medications) 62) Phil Mickelson comes into your pharmacy with a prescription for Protonix 40mg. The doctor has typed on the prescription "DAW". Phil wants the generic no matter what his doctor says. Can you dispense the generic? a) Yes b) No - correct answer a (If the MD has hand-written DAW, brand necessary, no substitution or any other similar words, the pharmacist must dispense the generic) changed in spring 2017 63) The definition of generic drug is a drug that contains identical active and inactive ingredients of the brand name product. a) True b) False - correct answer b (Generic drugs only have identical "active" ingredients) 64) Regarding multiple drugs in the same container (nursing homes), the maximum amount of drug that can be dispensed is __________ supply and cannot have an expiration date of not more than __________. a) 60 days; 31 days b) 7 days; 45 days c) 31 days; 31 days d) 31 days; 60 days e) 45 days; 45 days - correct answer d 65) Which of the following are a schedule II drug? Select all that apply. a) ecstasy b) levorphanol c) secobarbital d) Remoxy e) methaprylon - correct answer b, c and d 66) Dr. Stephens writes a prescription for atorvastatin 10 mg for Mr. Mike Jones. The prescription is written on September 1st, 2017, but is not filled for the first time till October 30th, 2017. The prescription has one year's worth of refills. When do the refills expire? a) The refills never expire. b) The refills expire on October 30th, 2018. c) The refills expire on September 1st, 2018. d) The refills expire on March 1st, 2018. e) The refills expire on April 30th, 2018. - correct answer c 67) Dr. Stone likes to use prescription blanks with 25 pre-printed drugs on them. He chooses two drugs on one pre-printed blank he wishes to prescribe for Ken Karson. Neither of these drugs are controlled substances. Is this a legal prescription? a) Yes b) No - correct answer b (A physician can only select one drug per form on a pre-printed Rx form with several drugs on it) 68) If a pharmacy has a Category II terminal distributor's license, it can sell (dispense) drugs in categories I and II. a) True b) False - correct answer a 69) Pharmacist Jack Frost is closing the prescription department (pharmacy) early so he can makeit to the ball park on time. Even though the prescription department is closed, the rest of the store is open. Can he leave a patient's prescription with the cashier up front for her to pick up after the prescription department is closed? a) Yes b) No - correct answer b 70) Which of the following are misbranded? Select all that apply. a) An OTC without proper labeling b) A stock bottle of lisinopril 20mg whose label gets destroyed c) A stock bottle of lisinopril 20mg whose contents have smoke damage from a fire d) A stock bottle of lisinopril 20mg whose content gets wet during a fire (sprinklers get it wet) e) A prescription botle missing the directions for use - correct answer a, b, and e 71) If a MedGuide is required to be given with a prescription, it must be given with both new and refilled prescriptions. a) Yes b) No - correct answer a 72) Under Ohio law, a prescriber's professional redentials (MD, DO, etc.) must be on every prescription. a) True b) False - correct answer a 73) If a physician calls in an emergency oral prescription for hydromorphone (schedule II), he has ________________ to get the written original prescription to the pharmacy. a) 24 hours b) 72 hours c) 7 days d) 30 days e) 60 days - correct answer c 74) Jim Carey has taken up a new hobby, sculpture. He is building a 10-foot sculpture out of pop cans. He wants to buy some syringes from the pharmacist to inject rubber cement between the cans as an adhesive. Can a pharmacist legally sell him syringes for this purpose? a) Yes b) No - correct answer a 75) If a wholesaler does not have enough of a schedule II drug (Adderall XR 10mg) in stock, they have _____________ to fill the remainder of the prescription. a) 7 days b) 60 days c) 30 days d) 48 hours e) 72 hours - correct answer b 76) Pharmacists order schedule II medications on which form? a) DEA 221 form b) DEA 223 form c) DEA 41 form d) DEA 222 form e) Pharmacists don't need a special form to order schedule II controlled substances - correct answer d 77) Pharmacists have ________________ to dispose of outdated drugs and wholesalers have __________________. a) 1 year; 1 year b) 2 years; 2 years c) 1 year; 2 years d) 2 years; 1 year e) 1 year; 3 years - correct answer c 78) Can Dr. Tommy Timmons (a psychiatrist) legally write a prescription for birth control for a patient? a) Yes b) No - correct answer a (In some cases, this is appropriate because all MDs went to medical school, just different specialties) 79) Under Ohio law, a podiatrist can write a prescription for lisinopril 10mg for blood pressure. a) True b) False - correct answer b (A podiatrist is considered a limited presriber and can only prescribe within scope of practice) 80) Which of the following controlled substances does the pharmacist have to do an exact count: I. an opened 100 tablet bottle of mepiridine (schedule II. an opened 1000 tablet bottle of zolpidem (schedule IV) III. an opened 2000 tablet bottle of diazepam (schedule IV) IV. an opened 500 tablet bottle of Tylenol 4 (schedule III) a) I, II, III b) I, II, III, and IV c) II and III d) II, III and IV e) I and III - correct answer e 81) A pharmacist goes on medical leave for 2 weeks. She can still be the responsible pharmacist. a) True b) False - correct answer a (She can still be the "responsible pharmacist" as long as she is comfortable with that situation.) 82) Can a physician write a prescription for the controlled substance Dexedrine (schedule II) for weight loss? a) Yes b) No - correct answer b (Scheduled II controlled substances cannot be prescribed for weight loss) 83) A patient brings you a prescription for the controlled substance Adipex #30, one daily for weight loss. The prescription has 1 refill. Can you dispense the refill? a) Yes b) No - correct answer a (Yes, but you must call the MD and verify they were seen by the MD before dispensing the refill.) 84) Ohio law authorizes the Board to waive the 2:1 pharmacist to intern ratio for the operation of immunization clinics or other special circumstances? a) True b) False - correct answer a 85) For terminally ill patients, prescriptions for schedule II's can be split (partially dispensed) for up to ________________ as long as the tablets dispensed don't exceed the total written on the prescription. a) 15 days b) 30 days c) 60 days d) 90 days e) none of the above, schedule II's cannot be partially dispensed under any circumstances - correct answer c 86) A controlled substances inventory must be taken every two years within the calendar year the inventory is due. a) True b) False - correct answer b (A controlled substance inventory must be taken every year as of 1/1/15) 87) The definition of a prescription drug under federal law is a) any drug that is habit forming b) any drug unsafe for use except under the supervision of a practitioner c) any narcotic drug d) a and b e) b and c - correct answer d 88) The definition to practice pharmacy in Ohio includes reviewing drug regimens with patients and reviewing drug utilization with health care professionals authorized to prescribe. a) True b) False - correct answer a 89) Physicians who dispense must keep records of purchasing and dispensing of all dangerous drugs. a) True b) False - correct answer a 90) Tim Ward, a pharmacist employee for Beachside Drugs, has been discounting copays, who would the Board of Pharmacy bring up on charges? a) Beachside Drugs b) Pharmacist Ward c) the manager for that particular Beachside Drugs location d) a and b e) all of the above - correct answer a 91) A prescription is brought to you for Tenormin 50mg. You dispense the generic atenolol. Under Ohio law, which of the following are true regarding this generic substitution? Select all that apply. a) A generic substitution sticker must be attached to Rx bottle dispensed or printed on the label. b) The name of the generic manufacturer must be included on the prescription label. c) The name of the generic manufacturer must be included on the prescription by the pharmacist d) You must verbally te - correct answer a, b, and c 92) You receive a prescription for Allerton Syrup 1mg/mL for allergies. The directions are 2 teaspoonfuls (10mg) QD. Allerton Syrup does not come in a generic, but the Allerton 10mg tablets do. Can you dispense the generic 10mg tablets with the directions take one tablet daily? a) Yes b) No - correct answer a 93) Can a physician legally write on a prescription for an elderly patient "no childproof caps"? a) Yes b) No - correct answer a 94) In Ohio, the trigger point or "push pause point" for the morphine equivalent dose (MED) is.... a) 60 b) 70 c) 80 d) 100 - correct answer c 95) Which of the following conditions can medical marijuana be used to treat? Select all that apply. a) Sickle Cell Anemia b) Cancer c) Traumatic Brain Injury d) Congestive Heart Failure e) COPD - correct answer a, b, and c 96) Which DEA form must be used to report lost or stolen controlled substances? a) Form 222 b) Form 41 c) Form 106 d) Form 224 - correct answer c 97) Steve Scribe, DO is an employee at Lakeside Hospital in the emergency department. Can he use the hospital's DEA number with a suffix number attached identifying him to write prescriptions for controlled substances in he ER? a) Yes b) No - correct answer a (Physicians employed by the hospital can use the hospital's DEA number with a suffix) 98) You mail a prescription profile to Jane Smith. Her husband, Tim Smith, opens her mail and reads her profile. You have just committed a HIPAA violation because you should have given it to Jane Smith in person. a) True b) False - correct answer b (The United States mail is considered a secure way to communicate with a patient) 99) A Board of Pharmacy inspector comes into your pharmacy and asks for all the prescriptions that you have filled written by a Dr. Thompson for the last two years. How long do you have to produce these records? a) 24 hours b) 48 hours c) 72 hours d) 7 days - correct answer c 100) Which of the following must be on an outpatient prescription label? a) full name of the prescriber b) prescription number c) pharmacist's initials d) pharmacy's DEA number if a controlled substance e) federal caution if a controlled substance - correct answer a, b, and e 101) What are library requirements for pharmacies under Ohio law? a) Must have access to and utilize the references necessary to conduct a pharmacy in a manner that is in the best interest of the patients served and comply with all state and federal laws. b) Phone number of nearest poison control center c) All pharmacists working in a pharmacy must be able to access all current federal and state laws, regulations, and rules governing the legal distribution of drugs in Ohio if only electronic res - correct answer e 102) Can a physician (MD) write a prescription for Cefaclor 250 mg for his dog? a) Yes b) No - correct answer b (Only veterinarians can write prescriptions for animals) 103) If a hospital pharmacy is closed, two nurses may enter the pharmacy for medication if a physician has ordered them to do so. a) True b) False - correct answer a 104) A prescription was written for Omnicef (an antibiotic) on January 3, 2018. The patient has until _____________ to have it filled for the first time. a) January 30, 2018 b) January 3, 2019 c) May 3, 2018 d) July 3, 2018 e) July 30, 2018 - correct answer d 105) A drug product has an NDC number of 00025-2356-04. The "00025" indicates... a) Manufacturer b) Package size c) Drug product d) None of the above - correct answer a 106) Can a nurse who works for an assisted living facility call in prescriptions for residents of that facility? a) Yes b) No - correct answer b (No, this is not a nursing home. The nurse is not an agent of the physicians of those patients.) 107) How many milligrams of codeine can a consumer purchase in a schedule V cough syrup over-the-counter per 48 hours? a) 125 mg [Show Less]
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OHIO MPJE QUESTION BANK 2023 430 QUESTIONS WITH 100- CORRECT ANSWERS
A prescription is written for atenolol 50 mg and dated August 15, 2020. The patient brings the prescription in to be filled on March 1, 2021. Can you legal... [Show More] ly fill the prescription? a) Yes b) No - correct answer b (> 6 months) Prescription record must be kept for ______ under federal law, and ______ under Ohio law. a) 3 years, 3 years b) 2 years, 2 years c) 2 years, 3 years d) 2 years, 5 years e) none of the above - correct answer c Records for poisons must be kept 5 years. a) True b) False - correct answer a It is legal for a physician to write prescriptions for rosuvastatin 10 mg and alprazolam 0.5 mg on the prescription form. a) True b) False - correct answer b A pharmacy with a category III terminal distributor's license may dispense controlled substances, dangerous drugs, and IV solutions. a) True b) False - correct answer a The labels of both inpatient and outpatient IV (intravenous medications) must have an expiration date on it. a) True b) False - correct answer a A prescription container (like a bottle Timoptic XE) too small to bear a complete label must have at least the following information on it. Select all that apply. a) Rx number b) patient name c) directions for use d) prescriber name e) refills - correct answer a and b A pharmacist comes to work one day early in the morning and notices that all of the Adderall XR has been stolen. The pharmacist must notify... a) Board of Pharmacy b) Local Law Enforcement c) DEA d) a and c only e) a, b, and c - correct answer e Which of the following are false regarding multiple drugs in the same container? Select all that apply. a) Only a maximum of 31 days supply of medication can be dispensed b) The expiration date of the container cannot be for more than 31 days. c) When one drug is discontinued, everything in the package is adulterated d) There must be regular outpatient labels for each drug in the container e) The number of drugs cannot exceed the capacity of the container - correct answer b A doctor licensed in Florida writes a prescription in Florida for a patient on vacation. The patient brings that prescription back to Ohio. Can you fill it? a) Yes b) No - correct answer a Which of the following are true regarding elder abuse. Select all that apply. a) Ohio Law requires pharmacists to report elder abuse to the County Department of Job and Family Service or Ohio Adult Protective Services. b) An "elder adult" is defined as someone 65 years or older and handicapped by age-related conditions or mental impairments which prevents the individual from providing her own care and lives independently. c) The law says a pharmacist must have a reasonable cause to believe an el - correct answer a and c (Elder is defined as 60 and older) When a patient requests their medical records from a pharmacy, HIPAA states that they will have access to all patient notes and comments the pharmacist has entered into the computer as well. a) True b) False - correct answer a Under Ohio law, atorvastatin 20mg is considered a drug of abuse. a) True b) False - correct answer a (Any prescription drug is considered a drug of abuse) Pharmacists have _____ hours to verify all prescriptions filled for a specific day. a) WIthin a reasonable amount of time b) 48 hours c) 96 hours d) 1 week e) 24 hours - correct answer a Insurance companies have access to only those patient prescription records for medications they paid for. a) True b) False - correct answer a The number of controlled substance prescriptions per written prescription form is 2. a) True b) False - correct answer b ______ drugs are those drugs required to meet the therapeutic needs of patients when a pharmacist is unavailable. ______ drugs are those drugs required to meet immediate needs to save or sustain life. a) emergency; contingency b) crash cart; contingency c) contingency; emergency d) crash cart; floor stock e) emergency; floor stock - correct answer c All hard-copy prescriptions for non-controlled substances may be electronically filed and destroyed after _____ from the date of creation or receipt. a) 30 days b) 90 days c) 180 days d) 1 year - correct answer c A lab technician and a doctor may legally enter the pharmacy to obtain medications when the pharmacy is closed. a) True b) False - correct answer a (2 people must enter, one must be a licensed health care professional authorized to administer drugs) All of the following are considered hospital orders. Select all that apply. a) a faxed order from the physician b) an original written order c) an oral order from a physician, but the order must be verified by the physician - correct answer a, b, and c Refills for schedule III and IV controlled substances are good for _____ from the date the prescription was written or a maximum of _____ total refills. a) 1 year; 5 b) 6 months; 4 c) 1 year; 4 d) 6 months; 5 e) none of the above - correct answer d Which of the following is/are a schedule IV drug(s)? Select all that apply. a) chlordiazepoxide b) midazolam c) dihydrocodeine d) ketamine e) clorazepate - correct answer a, b, and e Cancer drugs (anti-neoplastics) can be copmounded in horizontal flow hood with annual certification. a) True b) False - correct answer b (Must be compounded in a vertical flow hood and certified every 6 months) Invoices of C-II's, C-III's, C-IV's, and C-V's (all controlled substances purchased) must be kept together in one file. a) True b) False - correct answer b (Invoices for C-IIs must be in one file and C-IIIs, C-IVs and C-V in another file) A dog breeder comes into your pharmacy and wants to buy some syringes to give his puppies immunizations. Can you sell him the syringes? a) Yes b) No - correct answer a You must be _____ years old to buy a C-V as an OTC and at least ____ years old to buy a poison. a) 18; 18 b) 16; 16 c) 18; 16 d) 16; 18 e) 18; 21 - correct answer c If pharmacies sell more than 5% of what they purchase at wholesale (example: selling injectable medications to a doctor's office), they need a wholesaler's license. a) True b) False - correct answer a Which if the following are true regarding naltrexone dispensing when the patient is out of refills of their long-acting, injectable naltrexone? Select all that apply. a) The pharmacist must be able to verify the record of a prescription for injectable, long acting naltrexone for the patient that does not have any remaining refills. b) It can only be done if it was filled at your pharmacy c) If naltrexone is dispensed without a prescription, you must notify the prescriber within 7 days d) There i - correct answer a and d Under Ohio law, outdated drugs are: a) misbranded b) adulterated c) both adulterated and misbranded - correct answer b Which of the following can be used to mail/deliver controlled substance prescriptions? Select all that apply. a) United States Postal Service b) UPS c) FedEx d) Delivery driver employed by the pharmacy - correct answer a, b, c, and d If you dispense fluoxetine without a prescription, the bottle it is dispensed in is: a) adulterated b) misbranded and adulterated c) misbranded - correct answer c A prescription is brought to your pharmacy for 100 Zohydro ER (schedule II controlled substance). You only have 30 in stock. How long do you have to fill the remaining 70 capsules? a) 24 hours b) 48 hours c) 72 hours d) 7 days e) 60 days - correct answer c If you make a mistake on DEA Form 222 when ordering schedule II's, you can erase the mistake and correct it. a) True b) False - correct answer b In which of the following cases can a doctor fax a schedule II (C-II) prescription for a patient? Select all that apply. a) a patient in an assisted living facility b) a prescription for Dilaudid 2mg for a hospice patient c) a home IV prescription for morphine for a cancer patient d) a patient who resides in a nursing home e) a prescription for Adderall XR 20mg for a child homebound in a wheelchair - correct answer b, c, and d (Nursing home patients, but not patients in an assisted living facility) Which of the following are considered to be professional duties of an intern under Ohio Law? Assume the intern is being supervised by a pharmacist. Select all that apply. a) Patient counseling b) Transferring controlled substance prescriptions c) Selling schedule V cough syrups as an OTC d) Receive an oral prescription for a controlled substance e) Give a flu vaccine to a 6 year old child - correct answer a, c, and d (Interns cannot transfer controlled substances & cannot give flu shots to a child under 7) Which of the following are schedule III drugs. Select all that apply. a) promethazine with codeine cough syrup b) zaleplon c) perampanel d) glutethimide e) sodium oxybate (Xyrem) - correct answer c and e If a prescription drug has an NDC number, then it must be FDA approved and can be sold. a) True b) False - correct answer b 38) A medical device that requires pre-marketing approval, and must demonstrate safety and effectiveness is a _____ device. a) Class I b) Class II c) Class III - correct answer c A patient is discharged from Surfside Plastic Surgery Hospital. She gets her prescriptions filled at the inpatient pharmacy before she's discharged. A month later she needs a refill. Can she have the prescription filled at the outpatient pharmacy across the street in Surfside Hospital Medical Building Pharmacy? a) Yes b) No - correct answer a (Yes, they can have it refilled at the outpatient pharmacy but not the inpatient pharmacy) Pharmaceutical sales representatives must do an inventory of their samples every two years in pharmacies. a) True b) False - correct answer b (It must be done annually.) A pharmacist can give travel vaccines. a) True b) False - correct answer a Pharmacists and interns can give immunizations recommended by the Advisory Committee on Immunization Practice of the Centers for Disease Control and any immunization specified in the rules adopted by the Board to individuals 12 years and older without a prescription. a) True b) False - correct answer b (Individuals must be 13 years and older) Pharmacists and interns can give immunizations recommended by the Advisory Committee on Immunization Practice of the Centers for Disease Control and any immunization specified in the rules adopted by the Board to individuals between the ages of 7 and 13 years of age with a prescription. a) True b) False - correct answer a Which of the following are true regarding immunizations? a) Pharmacists and interns can give flu shots to patients 7 years of age and older. b) You must receive & document consent from the parent or guardian of any patient under the age of 18. c) Pharmacists and interns can give an MMR immunization to a 10 year old child with a prescription from a physician. d) a and b are true e) a, b, and c are true - correct answer e Pharmacists can enter into a consult agreement with which of the following? Select all that apply. a) physician assistants b) dentists c) nurse practitioners d) certified nurse midwives - correct answer a, c, and d (This law changed in fall 2020) An intern wants to give immunizations at a flu shot clinic. The intern is immunization certified. The pharmacists supervising the intern is not immunization certified. Can the intern give flu shots at the clinic? a) Yes b) No - correct answer b A pharmacist has been seeing a lot of prescriptions from Dr. Acne, a dermatologist from down the street, for a specific compound containing several ingredients. It takes the pharmacist about 30 minutes to make each one. Under federal law, how much can the pharmacist make up in advance and have ready for her patients? a) 7 days supply b) 10 days supply c) 30 days supply d) 60 days supply e) There is no limit - correct answer c (Federal law says you can have a 30-day supply on hand for anticipatory compounded products) Under Ohio law, to practice pharmacy means. Select all that apply a) give drug therapy advice b) counsel patients c) dispense and compound drugs d) enter prescription data into the computer e) review drug regiments - correct answer a, b, c and e An "oral" DAW from a physician is legally considered the same as a written "DAW" in Ohio. a) True b) False - correct answer a Can a dentist write a prescription for a hypertension medication? a) Yes b) No - correct answer b How many C.E.U.s of continuing education does a pharmacist have to complete every two years? a) 45 b) 4.0 c) 0.4 d) 40 e) 60 - correct answer b Pharmacist Lauren Smith is getting married on September 10, 2021. Once she becomes married, she has 30 days to notify the Board of Pharmacy of her change of name. a) True b) False - correct answer a The date for renewing a terminal distributors license is: a) January 1st b) July 1st c) September 15th d) April 1st e) None of the above - correct answer d Which of the following conditions can medical marijuana be used to treat? Select all that apply. a) AIDS b) Alzheimer's disease c) Crohn's disease d) Epilepsy e) Parkinson's disease - correct answer a, b, c, d and e Which of the following cannot write prescriptions under Ohio law? Select all that apply. a) dentists b) MDs c) chiropractors d) psychologists e) podiatrists - correct answer c and d Theft or loss of prescription blanks or documents must be reported to the Board of Pharmacy. a) True b) False - correct answer a Fred Thomas, a physician, has decided that he is tired of practicing medicine. He decides he wants to be a pharmacist again and has taken a job with CVS Pharmacy. His license has lapsed for two years. Does he have to retake the pharmacy board exams? a) Yes, he has to retake the board exams b) No, he does not have to retake the board exams - correct answer b (If your license has lapsed for more than 3 years, you must retake the Boards.) The maximum number of times a pharmacy graduate can take the NAPLEX in Ohio is.... a) 2 b) 3 c) 5 d) 7 e) An unlimted number of times - correct answer c Warren Buffett's investments have been performing poorly. Therefore, Mr. Buffett decides he's going to start buying pharmacies. Can Mr. Buffett have the keys to the prescription department? a) Yes b) No - correct answer b Dr. Jack Johnson writes a prescription for a controlled substance. He gives you the following DEA number: BJ 7980457. Is this a valid DEA number? a) Yes b) No - correct answer a John Perry is in the hospital for gall bladder surgery. John is mad at the nurses because they are slow to give him his medications. He wants the nurse to start leaving his unit-dose labeled medications for the entire day at his bedside so he can self medicate. Is this legal? a) Yes b) No - correct answer b (Patients who self-medicate in a hospital must have outpatient labels on their medications) Phil Mickelson comes into your pharmacy with a prescription for Protonix 40mg. The doctor has typed on the prescription "DAW". Phil wants the generic no matter what his doctor says. Can you dispense the generic? a) Yes b) No - correct answer a (If the MD has hand-written DAW, brand necessary, no substitution or any other similar words, the pharmacist must dispense the brand) A generic drug must contain identical active and inactive ingredients of the brand name product. a) True b) False - correct answer b (Generic drugs must only have identical "active" ingredients.) Regarding multiple drugs in the same container (nursing homes), the maximum amount of drug that can be dispensed is _____ supply and cannot have an expiration date of not more than _____. a) 60 days; 31 days b) 7 days; 45 days c) 31 days; 31 days d) 31 days; 60 days e) 45 days; 45 days - correct answer d Which of the following is/are a schedule II drug? Select all that apply. a) ecstasy b) levorphanol c) secobarbital d) Remoxy e) methaprylon - correct answer b, c, and d Dr. Stephens writes a prescription for atorvastatin 10 mg for Mr. Mike Jones. The prescription is written on September 1st, 2020, but is not filled for the first time till October 30th, 2020. The prescription has one year's worth of refills. When do the refills expire? a) The refills never expire. b) The refills expire on October 30th, 2021. c) The refills expire on September 1st, 2021. d) The refills expire on March 1st, 2021. e) The refills expire on April 30th, 2021. - correct answer c Dr. Stone likes to use prescription blanks with 25 pre-printed drugs on them. He chooses two drugs on one pre-printed blank he wishes to prescribe for Ken Karson. Neither of these drugs are controlled substances. Is this a legal prescription? a) Yes b) No - correct answer b ( A physician can only select one drug per form on a pre-printed Rx form with several drugs on it) Pharmacists can enter into a consult agreement with which of the following? Select all that apply. a) podiatrist b) certified registered nurse anesthetist c) DO d) psychologist - correct answer c Pharmacist Jack Frost is closing the prescription department (pharmacy) early so he can make it to the ball park on time. Even though the prescription department is closed, the rest of the store is open. Can he leave a patient's prescription with the cashier up front for her to pick-up after the prescription department is closed? a) Yes b) No - correct answer b Which of the following are misbranded? Select all that apply. a) An OTC without proper labeling b) A stock bottle of lisinopril 20mg whose label gets destroyed c) A stock bottle of lisinopril 20mg whose contents have smoke damage from a fire d) A stock bottle of lisinopril 20mg whose contents gets wet during a fire (sprinklers get it wet) e) A prescription bottle missing the directions for use - correct answer a, b, and e If a MedGuide is required to be given with a prescription, it must be given with both new and refilled prescriptions. a) Yes b) No - correct answer a Under Ohio law, a prescriber's professional credentials (MD, DO, etc) must be on every prescription. a) True b) False - correct answer a If a physician calls in an emergency oral prescription for hydromorphone (schedule II), he has ______ to get the written original prescription to the pharmacy. a) 24 hours b) 72 hours c) 7 days d) 30 days e) 60 days - correct answer c Jim Carey has taken up a new hobby, sculpture. He is building a 10-foot sculpture out of pop cans. He wants to buy some syringes from the pharmacist to inject rubber cement between the cans as an adhesive. Can a pharmacist legally sell him syringes for this purpose? a) Yes b) No - correct answer a If a wholesaler does not have enough of a schedule II drug (Adderall XR 10mg) in stock, they have _____ to fill the remainder of the prescription. a) 7 days b) 60 days c) 30 days d) 48 hours - correct answer b Pharmacists order schedule II medications on which form? a) DEA 221 form b) DEA 223 form c) DEA 41 form d) DEA 222 form e) Pharmacists don't need a special form to order schedule II controlled substances - correct answer d Pharmacies have _____ to dispose of outdated drugs and wholesalers have _____. a) 1 year; 1 year b) 2 years; 2 years c) 1 year; 2 years d) 2 years; 1 year e) 1 year; 3 yearsd - correct answer c Can Dr. Tommy Timmons (a psychiatrist) legally write a prescription for birth control for a patient? a) Yes b) No - correct answer a (In some cases, this is appropriate because all MDs went to medical school, just different specialties) Under Ohio law, a podiatrist can write a prescription for lisinopril 10 mg for blood pressure. a) True b) False - correct answer b (A podiatrist is considered a limited prescriber and can only prescribe within scope of practice) Which of the following controlled substances does the pharmacist have to do an exact count: I. an opened 100 tablet bottle of meperidine (schedule II) II. an opened 1000 tablet bottle of zolpidem (schedule IV) III. an opened 2000 tablet bottle of diazepam (schedule IV) IV. an opened 500 tablet bottle of Tylenol 4 (schedule III) a) I, II, III b) I, II, III, and IV c) II and III d) II, III, and IV e) I and III - correct answer e A pharmacist goes on medical leave for 2 weeks. She can still be the responsible pharmacist. a) True b) False - correct answer a Can a physician write a prescription for the controlled substance Dexedrine (schedule II) for weight loss? a) Yes b) No - correct answer b (Schedule II controlled substances cannot be prescribed for weight loss) A patient brings you a prescription for the controlled substance phentermine 37.5 mg #30, one daily for weight loss. The prescription has 1 refill. Can you dispense that refill? a) Yes b) No - correct answer a (Yes, but you must call the MD and verify they were seen by the MD before dispensing the refill.) Ohio law authorizes the Board to waive the 2:1 intern to pharmacist ratio upon documentation and special approval. a) True b) False - correct answer a For terminally ill patients, prescriptions for schedule II's can be split (partially dispensed) for up to _____ as long as the tablets dispensed don't exceed the total written on the prescription. a) 15 days b) 30 days c) 60 days d) 90 days e) none of the above, schedule II's cannot be partially dispensed under any circumstances - correct answer c A controlled substances inventory must be taken every two years within the calendar year the inventory is due. a) True b) False - correct answer b (Under Ohio law, a controlled substance inventory must be taken every 13 months as of 2019.) The definition of a prescription drug under federal law is a) any drug that is habit forming b) any drug unsafe for use except under the supervision of a practitioner c) any narcotic drug d) a and b e) b and c - correct answer d The definition to practice pharmacy in Ohio includes reviewing drug regiments with patients and reviewing drug utilization with health care professionals authorized to prescribe. a) True b) False - correct answer a Physicians who dispense must keep records of purchasing and dispensing of all dangerous drugs. a) True b) False - correct answer a Tim Ward, a pharmacist employee for Beachside Drugs, has been discounting copays, who would the board of pharmacy bring up on charges? a) Beachside Drugs b) Pharmacist Ward c) the manager for that particular Beachside Drugs location d) a and b e) all of the above - correct answer a A prescription is brought to you for Tenormin 50 mg. You dispense the generic atenolol. Under Ohio law, which of the following are true regarding this generic substitution? Select all that apply. a) A generic substitution sticker must be attached to Rx bottle dispensed or printed on the label. b) The name of the generic manufacturer must be included on the prescription label. c) The name of the generic manufacturer must be included on the prescription by the pharmacist. d) You must verbally tell - correct answer a, b, and c You receive a prescription for Allerton Syrup 1 mg/mL for allergies. The directions are 2 teaspoonfuls (10 mg) QD. Allerton Syrup does not come in a generic, but the Allerton 10 mg tablets do. Can you dispense the generic Allerton 10 mg tablets with the directions take one tablet daily? a) Yes b) No - correct answer a Can a physician legally write on a prescription for an elderly patient "no childproof caps"? a) Yes b) No - correct answer a In Ohio, the trigger point or "push pause point" for the morphine equivalent dose (MED) is.... a) 60 b) 70 c) 80 d) 100 - correct answer c Which of the following conditions can medical marijuana be used to treat? Select all that apply. a) Sickle Cell Anemia b) Cancer c) Traumatic Brain Injury d) Congestive Heart Failure e) COPD - correct answer a, b, and c Which DEA form must be used to report lost or stolen controlled substances? a) Form 222 b) Form 41 c) Form 106 d) Form 224 - correct answer c Steve Scribe, DO is an employee at Lakeside Hospital in the emergency department. Can he use [Show Less]
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NEBRASKA MPJE 176 QUESTIONS WITH 100- CORRECT ANSWERS
What legistation was created for the provisions for the fast track review of some NDA submissions to expedite approval of new drugs used to treat life-thre... [Show More] atening conditions? - correct answer Food and Drug Administration (FDA) Modernization Act 1997 What legistation encouraged manufacturers to conduct research for new uses of drugs and to submit SNDAs for these uses? - correct answer FDA modernization act 1997 What act reduced the cose of orphan drugs? - correct answer Orphan drug act 1983 What act prohibited the adulteration or misbranding of food and drugs? - correct answer Pure Food and Drug Act 1906 What act required tha active ingredients be placed on the label of a drug's packaging and that drugs couldn't fall below purity levels established by the USP or National Formulary? - correct answer Pure food and drug act 1906 What amendment defined two categories - legend and OTC - correct answer Durham-humphrey 1951 What amendment mandated there must be "adequate directions for use" on the manufacturer's label for OTC's - correct answer Durham-Humphrey 1951 What amendment declared that all new drugs marketed in the U.S. had to be shown to be safe and effective - correct answer Kefauver-Harris 1962 What act was passed to correct the problem of diversion from the normal distribution channels. Prohibits drug from being re-imported into the U.S. Except by the manufacturer of said drugs. - correct answer Prescription Drug Marketing Act 1987 What act requires proper storage of drugs and maintenance of appropriate distribution records? - correct answer Prescription Drug Marketing Act 1987 What act prohibits sale, purchase, or trade of any drug which was purchased by a public or private hospital or other health care entity? - correct answer Prescription Drug Marketing Act 1987 What act prohibits the sale, purchase, or trade of any drug sample or drug coupon redeemable for a drug product? - correct answer Prescription Drug Marketing Act 1987 To be PIC what are the hourly requirements they must physically work in a pharmacy? - correct answer majority of the hours per week that the pharmacy is open averaged over a 12 - month period or 30 hours per week Who must submit the Pharmacy Quality Assurance Report and when? - correct answer PIC and Annually Who submits the Parkinson's Disease Registry Act to the Department semiannually? - correct answer PIC Who needs to be notified if there's a change in pharmacy ownersip, address, PIC, or pharmacy closes? - correct answer Department of Health and Human Services Within how many days should the department be notified that a pharmacy is closing? - correct answer 30 days prior Within how many days should the department be notified of the disposition/sale of inventory, prescription records, etc due to pharmacy closing? - correct answer 15 days When shold the department be notified of a change in PIC? - correct answer Immediately What information is reported under the Parkinson's disease registry - correct answer Report shall include the name, address, and socical security number of the person for whom the drugs were prescribed and the name and address of the prescribing physician How long must a pharmacy maintain inventory records - correct answer 5 years Within how many days should a copy of the initial CS inventory, annual inventory, and/or CS inventory take pursuant to change in PIC be forwarded to the Department? - correct answer Within 30 days after completion In the event of a pharmacy closing what documents must be returned to the Department - correct answer Pharmacy license, pharmacy's DEA registration, all unused DEA 222 Forms If CS inventory is transferred to another pharmacy, how long must those transfer records be maintained? - correct answer 2 years How often does a consult pharmacist have to physically be in the public health clinic? - correct answer 30 days May a pharmacy intern transfer CS? - correct answer Yes May a pharmacy intern conduct DUR? - correct answer Yes May a pharmacy intern oversee technicians? - correct answer No May a technician receive an oral medication order? - correct answer No May a technician Drug Product Select? - correct answer No May a technician counsel or provide any professional consultations? - correct answer No May a technician clarify a medical order? - correct answer No Can supervision and/or verification be fulfilled via real-time audiovisual cmmunication? - correct answer Yes, for verification only if patient is resident of a facility Requirements to be a pharmacy technician - correct answer Must be at least 18 years old, have met the educational requirements of a high school diploma, never been convicted of any nonalcohol, drug-related misdemeanor/felony, fulfill training requirements within the first 30 days of employment, apply for registration w/in 30 days of being hired Supervision Ratio - correct answer 2 technicians : 1 RPh 3 interns : 1 RPh 2 technicians and 1 intern : 1 RPh Are interns receiving their experiential training applied to the supervision ratios - correct answer No May retail pharmacies receive starter packs? - correct answer Yes, they are not considered samples and are intended for initiation of drug therpy for a patient. Also not labeled as a sample Possession of prescription drug samples by retail pharmacies would be considered ________ ___________ by the FDA. - correct answer Drug diversion When may institutional pharmacies receive prescription drug samples? - correct answer Licensed prescriber requested (disposition precisely recorded and stored separately from normal drug stock) If a licensed practitioner provides written requiests for prescription drug samples, for how long must the manufacturer keep the request and who is responsible for the annual inventory of the samples? - correct answer 3 years; sales representatives are responsible for prescription drug samples, including the annual inventory What is proper refrigeration temperatures - correct answer 36 to 46'F or 2 to 8'C What is the proper freezer temperatures - correct answer -4 to 14'F or -20 to -10'C What is the proper room temperature? - correct answer 46 to 59'F or 8 to 15'C A pharmacy must register as a wholesale drug distributor if it distributes more than: - correct answer 5% gross dollar value of the total prescription drug sales revenue in a 12month period Define long-term detox treatment - correct answer 30 to 180 days Define maintenance treatment - correct answer > 21 days Define short term detox treatment - correct answer < 30 days What act enables qualifying physicians to receive a waiver from the special registration requirements in the Controlled Substance Act for the provision of medication-assisted opioid therapy - correct answer Drug Addiction Treatment Act 2000 (DATA 2000) May an optometrist prescribe C2's? - correct answer Yes but only topical ophthalmics May a prescriber prescribe controlled substances to themselves? - correct answer No Can an APRN dispense samples? - correct answer Yes, but not a APRN-CNS (clinical nurse specialist) they have no prescribing authority May a midwife (APRN-CNM) prescribe C2's? - correct answer Only for up to 72 hours for pain only When is the name of the prescriber (supervisor of PA) required to be on the label of a prescription written by a Physician's Assistant? - correct answer When required for reimbursement purposes How can a pharmacist verify a prescriber is allowed to prescribe suboxone? - correct answer Confirm prescriber has been granted a waiver via SAMHSA website/phone, Check DEA# for leading letter "X" What part of an RX may a pharmacist never change? - correct answer Patient name, drug name, Dr. Name/signature Who should be contacted in the event that the pharmacist does not receive a cover script for an emerency verbal within 7 days of the oral C2 order? - correct answer The dea What schedule is glutathione? - correct answer C2 What schedule is oxandrolone (Oxandrin)? - correct answer C3 What schedule is phendimetrazine? - correct answer C3 What schedule is be petaling (didrex)? - correct answer C3 What schedule is Ephedrine? - correct answer C4 According to federal law how much C5 containing opium can a Pharmacist sell within 48 hrs? - correct answer Not more than 240mL/8oz. Or 48 dosage units According to federal law how much C5, other than opium containing, can be sold by a Pharmacist in 48 hrs? - correct answer Not more than 120mL/4oz or 24 dosage units What are legal letters for the first letter in a prescriber's DEA number? - correct answer A, B, F, G, M Prescription quantity for residents of LTCF must be ____ days, unless otherwise limited by the prescriber - correct answer 60 days If a RPh enters a practice agreement with a licensed medical practitioner to provide pharmaceutical care according to written protocols, how often must the agreement be reviewed, signed, and dated? - correct answer Every 12 months A chart order in a hospital must contain? - correct answer Patient Name, Date of order, Drug name, strength, and sig, and prescriber's name How long must a poison registry be maintained? - correct answer 2 years from the last entry When refilling a prescription that was initially dispensed in a threaded child-resistant container, the RPh must always replace: - correct answer The plastic closure The labeling requirements do not apply when no more than how many days supply of a C2 is dispensed at one time for an institutionalized patient? - correct answer 7 day supply The labeling requirements do not apply when no more than how many days supply of a C3 through 5 may be dispensed at one time for an institutionalized patient? - correct answer 34 day supply or 100 dosage units Filing systems for prescription hard-copies? - correct answer 2 file system - C2 in one drawer and C3 through non-controlled in another (C3-5 must be marked with a red C) 3 file system How long should prescription hard-copies be maintained? - correct answer 5 years What is the purposes of drug product select? - correct answer To provide for the drug product selection of equivalent drug products and promote the greatest possible use of such products What does Bioequivalent mean? - correct answer Same dosage form of identical active ingredients in identical amounts What does Chemically equivalent mean? - correct answer Contain amounts of the identical therapeutically active ingredients in the identical strength, quantity, and dosage form and meet present compendial standards When can a RPh not product select? - correct answer Patient or caregiver instructs not to, Prescriber specifies on phone or writes NDPS, DAW, or BMN How many times may a prescription be transferred? - correct answer Once, unless they share a real-time online database Who can conduct controlled and non-controlled transfers? - correct answer RPh or Intern When a prescriber writes "do not label" on the original written prescription, what isn't placed on the dispensing label? - correct answer Drug name When a prescription is written for an animal which of the following should be on the label: (A) name of animal, (B) species of animal, (C) name of owner - correct answer Species of animal and name of owner List the requirements of Unit-Dose packaging system - correct answer (1) contains individually sealed doses, (2) May or may not attach the sealed doses to each other by placement in a card, (3) May not contain doses for greater than 14 days, (4) non-reusable How long must a cancer drug repository logbook be maintained? - correct answer 5 years In accordance with Nebraska Pharmacy Law a RPh may accept return of the dispensed drug or device when? - correct answer Device is defective/malfunctioning, collected for the purpose of disposal, in response to a recall How long should record of Form 41 be maintained? - correct answer 5 years Theft occurs at your pharmacy, what should you do? - correct answer Complete a DEA Form 106 (send org. To DEA, keep copy for pharmacy, and send copy to NE Department) and contact local law enforcement What should be on the exterior of an e-kit box? - correct answer "Emergencies only"; listings of drugs: name, strength, quantity, route, and expiration; name, address, and telephone of pharmacy What are the restrictions on the contents of an e-kit? - correct answer Can not contain multi dose vials, no more than 10 CS drugs, and no more than 50 total drugs What information shall be on repackaged containers - correct answer Manufacturer, lot #, drug name, strength, dosage form, NDC, route, and expiration on a typewritten label How often shall a e-kit be inspected by a RPh? - correct answer Once every 30 days and after reported use (must be inspected by a pharmacist) How long shall record of inspection and delivery of e-kit be maintained? - correct answer 5 years Who determines the contents of an E-kit? - correct answer Supplying pharmacy and LTCF How soon after the e-kit is opened, should the pharmacy be notified? - correct answer Within 24 hours The licensee must notify the Department in writing by e-mail, fax, or postal within how much time of any change in environment which will adversely affect the potency, efficacy, safety, or security of the drugs, devices, or biological a in the pharmacy (accident, natural disaster, interruption in utility services)? - correct answer 24 hours The pharmacy must establish and implement disaster preparedness plans and procedures that address: - correct answer (1) How the pharmacy will provide storage of drugs at proper temp (2) how the pharmacy will provide disposal of drugs in quality affected (3) how the pharmacy will secure the drugs from the public (4) how the pharmacy will maintain patient and inventory records What drugs are allowed on a public health clinic's formulary? - correct answer Contraception, STD, and vaginal infections Delegated dispensing permit, worker qualifications? - correct answer At least 18 y/o, earned high school diploma or equivalent, completed training, demonstrated proficiency Requirements of a RPh, due to OBRA 90? - correct answer DUR (prospective and retrospective [medicaid]), Offer to Counsel, Maintain patient profile Minimum required to maintain patient profile? - correct answer Name, address, telephone#, don, gender, significant medical history (allergies), RPh comments relevant to drug therapy When is counseling not required? - correct answer Patient is in facility, refused by patient/caregiver, counseling may hurt patient-practitioner relationship, prescriber specifies to be "contacted prior to counseling" Drugs required to have PPI - correct answer Statins, accurate, oral contraceptives, estrogenic substances When should PPI be included? - correct answer Ambulatory: initial fill and every refill Institutions: prior to first fill and every 30 days Who dispenses PPI? - correct answer Hospital pharmacy, LTCF, doctors Failure to distribute a PPI is considered? - correct answer Misbranding Common drugs that require a medguide? - correct answer Antidepressants (SSRI), ADHD, NSAIDs, Fluoroquinolones, Thiazolidinedions Who is required to dispense medguides? - correct answer Dispensers to outpatients What Form or Program is used by healthcare providers and consumers for voluntary reporting of ADR - correct answer FDA Form 3500 or MedWatch Does a RPh have to be the one to make the "offer for counseling"? - correct answer No, but it has to be verbally offered by a pharmacy staff member What act protects against intential contamination of OTCs? - correct answer Federal Anti-Tampering Act 1982 [Show Less]
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