Pharmacy Law Final 2016

The learned intermediary doctrine states that manufacturers have a duty to warn _______ about warnings for adverse drug effects. A. patients and prescribers B. prescribers C. pharmacists D. patients

B. Prescribers

A court determined that a generic drug company failed to change its labeling to warn of an adverse effect discovered post-market. The manufacturer argued that it complied with FDA labeling requirements and could not change the label without FDA approval. An injured patient sued the manufacturer in state court under strict product liability. The company's compliance with FDA labeling would preempt the patient's product liability claim. True or False

True

Medication Guides (MedGuides): a. Must be distributed when required, to avoid an FDCA misbranding charge b. Replaced PPIs c. May ne replaced by a pharmacy's CMI d. Are mandatory the first time a patient receives a new drug

a. Must be distributed when required, to avoid an FDCA misbranding charge

A pharmacist received a prescription for 500 oxycodone tablets with the directions that the patient was to significantly taper down the dosage over the next four weeks. The pharmacist called the prescriber, who informed the pharmacist that the patient is an addict and that the prescriber is trying to detoxify the patient. Which statement is correct? a. this prescription is not for a legitimate medical purpose and should not be dispensed b. this prescription is for a legitimate medical purpose and should be dispensed c. this prescription is valid under DATA d. this prescription of valid of the prescriber works at a registered narcotic treatment program

a. this prescription is not for a legitimate medical purpose and should not be dispensed

What is the source of legal authority for pharmacists to engage in drug product substitution? a. The FDCA b. State law c. The orange book d. Professional judgment

b. State law

Which statement accurately describes the history of the FDA's position that pharmacy-compounded drugs are "new drugs?" a. Prior to the FDAMA enacted in 1997, the FDA considered pharmacy-compounded drugs "new drugs" by policy b. A federal court of appeals ruled that pharmacy-compounded drugs are not "new drugs," provided the pharmacy follows FDAMA requirements. c. The DQSA of 2013 established that pharmacy-compounded drugs are not "new drugs" d. All of these are correct

d. All of these are correct

Who is allowed to prescribe controlled substances? a. mid-level practitioners may prescribe controlled substances if authorized by state law b. an agent or employee may communicate the prescription to a pharmacist c. am agent or employee may prepare the prescription for the individual practitioner's signature d. all of the above

d. all of the above

John is a pharmacist and an alcoholic who often drinks while in the pharmacy. In most states, the board of pharmacy has no alternative but to suspend or revoke John's license. True or ​False

false

Which statement about the "beyond use date" on the label of a dispensed multiple-unit drug container by a pharmacy is correct? A. USP guidelines allow the earlier of the manufacturer's expiration date, or one year from the date of dispensing B. FDA guidelines allow the earlier of the manufacturer's expiration date, or one year from the date of dispensing C. All state laws mandate that the pharmacist must type the same date that is on the manufacturer's label D. Most state laws do ot mandate that an expiration or "beyond use" date be typed on the label

A. USP guidelines allow the earlier of the manufacturer's expiration date, or one year from the date of dispensing

Which description of consumer medication information (CMI) is most accurate? A. The FDA initially proposed that CMI be required for drugs posing serious and significant concers; however, Congress established a voluntary private-sector program B. The FDA initially proposed that CMI be required for all new prescriptions; however, Congress established a voluntary private-sector program C. The FDA has historically opposed distributing CMI to patients D. Pharmacy organizations have historically supported distributing CMI to patients

B. The FDA initially proposed that CMI be required for all new prescriptions; however, Congress established a voluntary private-sector program

Which statement regarding Medication Guides (MedGuides) is correct? A. The FDA can require manufacturers to publish MedGuides only for drugs that pose a serious and significant concern B. Since the enactment of the FDAAA, the FDA has considered every new MedGuide to be part of a REMS C. A MedGuide is required the first time a drug is dispensed to a healthcare professional for administration to a patient in an outpatient setting. D. All of these are correct

D. All of these are correct

A court determined that an innovator drug manufacturer failed to change its labeling to warn of an adverse effect discovered post-market. The manufacturer argued that it complied with FDA labeling requirements and could not change the label without FDA approval. An injured patient sued the manufacturer in state court under strict product liability. The company's compliance with FDA labeling preempts the patient's product liability claim. True or False

False

Pursuant to the Prescription Drug Marketing Act, a prescriber can receive samples from a manufacturer by means of: a. A written request on a proper form each time the prescriber wants samples b. A standing written request for samples c. A verbal request from the manufacturer's representative d. The manufacturer can supply the samples without request

a. A written request on a proper form each time the prescriber wants samples

Which statement about state pharmacy licensure exams is correct? a. All states require licensure candidates to pass the NAPLEX. b. All states require licensure candidates to pass the MPJE. c. All states require licensure candidates to pass other exams, such as a practical demonstration of ability. d. All of these are correct.

a. All states require licensure candidates to pass the NAPLEX

A patient brings a written prescription for Tylenol #3 (schedule III) to the pharmacy on July 1, 2017. The prescription was written and dated June 15, 2017 and has two refills authorized under it. What is the last date the patient can obtain the refills for this prescription? a. December 15, 2017 b. December 31, 2017 c. January 15, 2018 d. never. Refills are not allowed with this prescription

a. December 15, 2017

What is the best advice for patients who ask you about getting their prescription medications dispensed from an Internet pharmacy? a. Do business only with Internet pharmacies with the VIPPS seal. b. All Internet pharmacies are in violation of federal law. c. All Internet pharmacies are in violation of state law. d. There is no problem doing business with an Internet pharmacy.

a. Do business only with Internet pharmacies with the VIPPS seal.

Tax-free alcohol may be used by: a. Hospital pharmacies for compounding medications for inpatients b. Hospital pharmacies for compounding medications for outpatients c. Community pharmacies for compounding medications for patients d. Outpatient charity clinics for compounding medications for patients, provided they charge the patients for the compound

a. Hospital pharmacies for compounding medications for inpatients

A court refused to apply a general duty to warn requirement on the defendant pharmacy, but instead adopted a duty based upon special circumstances. Applying this approach means that the pharmacy has a duty to warn the patient in which circumstance? a. If the patient gave the pharmacy particular information about a medical condition that, if used by the pharmacy, would have prevented the harm b. If the patient was a regular patient of the pharmacy c. If the pharmacy had a computer system that warned of drug-drug interactions d. If the pharmacist regularly counseled patients

a. If the patient gave the pharmacy particular information about a medical condition that, if used by the pharmacy, would have prevented the harm

What did the Drug Quality and Security Act of 2013 accomplish regarding the traditional compounding practice of community pharmacies pursuant to prescriptions? a. It reinstated the constitutional provisions of Section 503A enacted in 1997by the FDAMA b. It shifted enforcement authority from state pharmacy boards to the FDA c. It established that pharmacy-compounded drugs are new drugs d. It prohibits pharmacies from compounding in anticipation of prescriptions

a. It reinstated the constitutional provisions of Section 503A enacted in 1997by the FDAMA

A pharmacist dispensing a drug pursuant to prescription is exempt from the labeling requirements applicable to a manufacturer, except: a. That the drug not be sold under the name of another drug b. The quantity of the drug dispensed c. The manufacturer's name d. All of these are correct

a. That the drug not be sold under the name of another drug

What did the U.S. Supreme Court decide regarding the Virginia Advertising Case decision? a. The First Amendment applies to recipients of speech b. The First Amendment does not apply to commercial speech c. The Virginia law served a valid interest in protecting its citizens d. The First Amendment applies to recipients of speech, but does not apply to commercial speech

a. The First Amendment applies to recipients of speech

Which statement best describes continuous quality improvement laws? a. They are outcomes oriented. b. They typically do not protect records from discovery in negligence actions. c. They require that all dispensing errors be reported to the state board. d. All of these are correct.

a. They are outcomes oriented.

Under strict product liability, what is an accurate assumption about drugs? a. They are unavoidably unsafe products. b. If they cause harm they are defective. c. They can always be made safer. d. They are defective products even if properly manufactured and accompanied by proper warnings.

a. They are unavoidably unsafe products.

What does the FDCA specify about prescribing prescription drugs? a. They may be prescribed by practitioners licensed by law b. Which practitioners may be licensed by law to prescribe (physicians, dentists, etc.) c. The scope of prescriptive authority of a practitioner d. All of these are correct

a. They may be prescribed by practitioners licensed by law

Which statement regarding patient package inserts (PPIs) is correct, assuming the drug is one for which a PPI is required? a. They must be included for new prescriptions and refills b. They must be given to an inpatient prior to administration of the first dose and for each subsequent dose administered c. A hospital physician can decide whether an inpatient should receive a PPI d. A pharmacy may exercise professional judgment as to whether a PPI should be dispensed to a patient

a. They must be included for new prescriptions and refills

What is the objective of licensure for pharmacists? a. To increase the quality of health care. b. To increase the cost of health care. c. To promote self-governance of the profession. d. To not distinguish between qualified and unqualified providers.

a. To increase the quality of health care.

A pharmacy repackages nonsterile solid dosage forms into PVC unit dose packaging. Which statement about USP beyond-use date guidelines is correct? a. USP guidelines do not apply b. The earlier of one year form the date of repackaging or the expiration date on the bulk container c. The earlier of six months from the date of repackaging or the expiration date on the bulk container d. Not to exceed six months provided it does not exceed 25% of the remaining time between the date of repackaging and the manufacturer's unopened bulk container

a. USP guidelines do not apply

A pharmacist dispensed the wrong drug to a patient. However, the patient never took the drug but gave it to a family member who suffered harm. Had the right drug been dispensed, the family member would not have suffered this harm. The family member sued the pharmacist. What is the critical issue in this situation? a. Whether it was foreseeable to the pharmacist that the patient would have given the drug to the family member b. Whether the pharmacist breached a duty to the family member c. Whether the pharmacist has a duty to the patient d. Whether the patient would have suffered harm had the patient taken the drug

a. Whether it was foreseeable to the pharmacist that the patient would have given the drug to the family member

Plan B can be sold: a. Without age or point-of-sale restriction b. Only from a licensed pharmacy, without age restriction c. Only from a licensed pharmacy to females only d. Only from a licensed pharmacy to purchasers over the age of 16

a. Without age or point-of-sale restriction

A pharmacist dispensed the wrong drug to a patient, which caused the patient serious harm. The drug dispensed and the drug prescribed have similar names. The patient sued. Is the pharmacist liable? a. Yes, as a matter of law. b. No, because reasonable pharmacists make these types of errors. c. No, if the pharmacist can prove that dispensing the wrong drug was not foreseeable. d. Yes, if the patient can prove the duty of a pharmacist is to dispense the right drug.

a. Yes, as a matter of law.

A pharmacist was very busy and typed the directions for the patient to take the drug four times a day instead of once per day. The patient followed the directions, was seriously injured as a result, and sued. Is the pharmacist negligent? a. Yes, as a matter of law. b. The pharmacist may or may not be negligent, depending upon whether the pharmacist acted reasonably and prudently. c. No, on the basis of lack of foreseeability. d. No, on the basis of lack of proximate cause.

a. Yes, as a matter of law.

During a controlled substances inventory, which medications require an exact count? a. a 100 count bottle of hydrocodone with acetaminophen b. a 1000 count bottle of lorazepam c. a 500 ml bottle of a schedule V cough syrup d. a box of 20 diazepam suppositories

a. a 100 count bottle of hydrocodone with acetaminophen

A physician phones a pharmacy to call in a two-week supply of a C-II Rx (hydrocodone) for a patient. The pharmacist is familiar with the patient and the physician, and knows the patient is terminally ill and has received hydrocodone prescriptions before. The physician says the patient's wife will be in to pick up the medication in about an hour. What is the best response from the pharmacist to the physician, combining federal and state law? a. we cannot dispense a 2 week supply, but only enough hydrocodone for the emergency period. We must receive an original written prescription with the notation 'Authorization for Emergency Dispensing' within seven days. b. "We cannot dispense a two-week supply, but only enough hydrocodone for the emergency period. The oral order will substitute for the original written file." c. "We can dispense a two-week supply. We must recieve the original written prescription with the notification 'Authorization for Emergency Dispensing' within seven days." d. This is most likely not an emergency situation, and we cannot dispense the prescription.

a. we cannot dispense a 2 week supply, but only enough hydrocodone for the emergency period. We must receive an original written prescription with the notation 'Authorization for Emergency Dispensing' within seven days.

Harry Smith lives in a long-term care facility. The prescriber faxed to Pharmacist Phil a prescription for Oxycontin (schedule II) for 90 pills. Harry's insurance will only pay for 30 pills at a time. Can Pharmacist Phil fill the prescription for 30 pills at a time until all 90 are dispensed? a. yes, however, all the tablets must be filled within 60 days from the date the prescription was issued b. yes, however, Mr. Smith must also be diagnosed as a terminally ill patient c. yes, however, pharmacist Phil must obtain a new written prescription for his records each time he fills another 30 pills d. no, if Harry decides to get less than 90 tablet, he cannot obtain the remainder because schedule II drugs cannot have refills

a. yes, however, all the tablets must be filled within 60 days from the date the prescription was issued

For automated controlled substance records kept at a central location, within what business time frame must requested printouts be available at the pharmacy? a. 24 hours b. 48 hours c. 72 hours d. within a reasonable times

b. 48 hours

A plaintiff was injured by using a prescription drug that was prescribed for a use that the drug's labeling warns against. The plaintiff wishes to introduce the labeling into evidence. What is the court likely to do? a. Not allow the labeling into evidence b. Allow the labeling as evidence of the standard of care c. Allow the labeling as prima facie evidence of negligence

b. Allow the labeling as evidence of the standard of care

Which statement about consumer medication information (CMI) is correct? a. Federal law mandates that CMI be dispensed to patients b. Approximately 71% of CMI was deemed useful c. About 50% of patients actually receive CMI d. The FDA dose not favor the use of CMI

b. Approximately 71% of CMI was deemed useful

A dietary supplement manufacturer contracted with a pharmacy to include the pharmacy's name on television ads for the product as a place where the product may be purchased. Unknown to the pharmacy, the ads contained false and misleading statements. The FTC sued the manufacturer and the pharmacy. Is the pharmacy liable? a. The manufacturer is liable for false advertising, but not the pharmacy b. Both, the manufacturer and the pharmacy are liable for false advertising c. Neither the manufacturer nor the pharmacy is liable for false advertising

b. Both, the manufacturer and the pharmacy are liable for false advertising

A hospital has excess inventory of drug products. Local community pharmacies would like to purchase the excess inventory since they can buy the products for less from the hospital than from the wholesaler. The hospital: a. Can sell inventory to the pharmacies, provided it charged the same amount as the wholesaler b. Can sell inventory to the pharmacies for emergency reasons to alleviate a temporary shortage c. Can sell inventory to the pharmacies without restriction d. Cannot sell inventory to the pharmacies

b. Can sell inventory to the pharmacies for emergency reasons to alleviate a temporary shortage

Pharmacists are required to dispense Medication Guides (MedGuides): a. For all prescription drugs b. For prescription drugs the FDA has determined require MedGuides c. For prescription drugs that, in the pharmacist's professional judgment, require MedGuides d. For oral contraceptives

b. For prescription drugs the FDA has determined require MedGuides

For what reason would a court hold that pharmacists have a duty to warn patients of a drug's dangers? a. Patients rely primarily on the prescriber rather than the pharmacist for drug information. b. Harm suffered by the patient should have been foreseeable by the pharmacist. c. Imposing the duty is in the best interests of pharmacists. d. Prescribers do not have as much knowledge of drugs as pharmacists.

b. Harm suffered by the patient should have been foreseeable by the pharmacist.

Which statement accurately describes pharmacy regulation? a. In the 19th century, pharmacists chose to self-regulate as retail merchants rather than healthcare professionals. b. In the 20th century, pharmacists organized themselves and developed clear systems of self-governance. c. States did not begin to regulate pharmacists by licensure until the 1960s. d. All of these are correct

b. In the 20th century, pharmacists organized themselves and developed clear systems of self-governance.

Physicians' authority to dispense medication: a. Is prohibited under federal law b. Is not covered by FDCA dispensing standards under Durham-Humphrey c. Can set more restrictive for physicians than for pharmacists when set by the state d. All of these are correct

b. Is not covered by FDCA dispensing standards under Durham-Humphrey

How do state laws and regulations apply to hospital pharmacy practice? a. Hospital pharmacy practice is so similar to community pharmacy practice that the laws and regulations are the same for each. b. Many state pharmacy practice acts have not kept up to date with changes in hospital pharmacy practice. c. Hospital pharmacies generally do not require licensure. d. Hospital pharmacies are much more closely regulated than community pharmacies.

b. Many state pharmacy practice acts have not kept up to date with changes in hospital pharmacy practice.

Which statement about state-enacted continuous quality improvement (CQI) laws is correct? a. All states that have enacted CQI laws require error reporting to the state board of pharmacy. b. Pharmacies in states that have enacted CQI laws are required to record, investigate, and act upon errors. c. Pharmacies are provided no protection under state laws from discovery in negligence actions for CQI reports. d. States have ample resources to monitor CQI programs.

b. Pharmacies in states that have enacted CQI laws are required to record, investigate, and act upon errors.

Drug product A is identical to drug product B, each made by a different manufacturer. A is a prescription drug, and B is an OTC drug. This is likely because the FDA: a. Switched the active ingredients of the drugs to OTC by monograph b. Switched B from prescription to OTC, by means of an SND c. Switched A from OTC to prescription, by monograph d. All of these are correct

b. Switched B from prescription to OTC, by means of an SND

A pharmacy wishing to advertise prescription drug prices must meet which requirements, under federal law? a. There are no requirements, because this is reminder advertising b. The advertising must contain the proprietary and established name of the drug if it has both c. The advertising must contain the indications of the drug d. The advertising must meet the fair balance requirements

b. The advertising must contain the proprietary and established name of the drug if it has both

A state pharmacy board revoked the license of a pharmacist in Arizona. The pharmacist also held a license in another state and moved there to practice. Which statement is correct? a. The other state pharmacy board would likely revoke the pharmacist's license and the pharmacist would not be entitled to a hearing. b. The other state pharmacy board would likely revoke the pharmacist's license; however, the pharmacist would be entitled to a hearing. c. The other state pharmacy board would not likely find out about the revocation in Arizona. d. The other state pharmacy board would not likely take any action against the pharmacist's license even with knowledge of the revocation in Arizona.

b. The other state pharmacy board would likely revoke the pharmacist's license; however, the pharmacist would be entitled to a hearing.

A pharmacist dispensed the wrong drug to a patient. The tablets looked different than the ones the patient had received before but the patient assumed a different generic was dispensed. After taking a tablet the patient called the pharmacy to verify and was told the drug he received was the incorrect drug and to not take another. The patient suffered no injury but was so irate he sued the pharmacist for negligence. What is the likely outcome of the lawsuit? a. The patient would not succeed because he should have verified the drug before taking it. b. The patient would not succeed because the act did not cause injury. c. The patient would succeed because the pharmacist breached the duty she owed the patient. d. The patient would succeed because this is negligence per se.

b. The patient would not succeed because the act did not cause injury.

Which statement about a jurisdiction that applies comparative negligence is correct? a. Any negligence by the plaintiff would bar recovery of damages for the pharmacist's negligence. b. The percentage of fault by the plaintiff would reduce the amount of damages to be awarded by that percentage. c. Any negligence by the plaintiff would not reduce the amount of damages to be awarded.

b. The percentage of fault by the plaintiff would reduce the amount of damages to be awarded by that percentage

A pharmacist left the pharmacy on a break and left the technician in charge with instructions not to fill any prescriptions until he returned. Nonetheless, the technician filled and dispensed a new prescription to a patient. The drug was contraindicated for use in the condition that the patient suffered and the patient was injured. State law requires that the pharmacist be present in the pharmacy when a new prescription is dispensed and requires direct supervision of a technician. What would happen if the court applied the doctrine of negligence per se in the lawsuit filed by the patient? a. The technician would be liable, but not the pharmacist because he was not present. b. The pharmacist might be found liable even if he had dispensed the drug. c. The technician would be liable, but not the pharmacist because he told the technician not to dispense any prescriptions. d. The pharmacist would not likely be liable if he did not know the patient's condition

b. The pharmacist might be found liable even if he had dispensed the drug.

A pharmacist is licensed and has been practicing in state A for three years. The pharmacist now wants to practice in state B. Which statement is correct? a. The pharmacist must take the NABLEX exam in state B. b. The pharmacy may receive a license from state A, through license transfer. c. The pharmacist may practice in state B using the license from state A. d. The pharmacist must be licensed in state A for five years before practicing in another state.

b. The pharmacy may receive a license from state A, through license transfer.

Which statement regarding state freedom of choice laws is correct? a. They are unconstitutional. b. They allow any willing pharmacy the right to participate in a third party plan. c. They allow any willing patient the right to be a beneficiary in a health plan. d. All of these are correct.

b. They allow any willing pharmacy the right to participate in a third party plan.

Pharmacist Polly dispensed the wrong drug to a patient. The drug prescribed was an analgesic, but the drug that Polly dispensed was a cardiac drug contraindicated in diabetes. The patient was a diabetic and suffered injury. Had the patient not been diabetic, injury would not have occurred. Is Polly liable in this situation? a. No, because she did not owe the patient a duty. b. Yes, under the eggshell rule. c. No, because she did not breach her standard of care. d. No, because a reasonable patient would not have been injured.

b. Yes, under the eggshell rule.

A faxed prescription for any CII from the prescriber to the pharmacy is acceptable in place of the original for which situation? a. any situation b. a resident of a skilled nursing facility c. an emergency situation d. for terminally ill patients

b. a resident of a skilled nursing facility

Which copy of the DEA 222 form does the supplier forward to the DEA? a. copy 1 b. copy 2 c. copy 3 d. copy 4

b. copy 2

Which statement regarding PMPs is not correct? a. PMPs require pharmacist to report dispensed controlled substance prescriptions to a database b. states are mandated by the DEA to report all schedules of controlled substances c. states may share reported information across state lines d. states can determine which individuals have access to the database

b. states are mandated by the DEA to report all schedules of controlled substances

Which statement correctly describes the written 222 form? a. controlled substances may be ordered from schedules III - V b. the form contains 10 lines and the purchaser must record on the form the number of the lines completed c. only a pharmacist may complete and sign the form d. all of the above

b. the form contains 10 lines and the purchaser must record on the form the number of the lines completed

Pharmacist Phil fills a new written prescription and two refills for Tylenol #3-a schedule III controlled substance. A couple months later, Phil learns from drug enforcement agents that the prescription was altered by the patient to receive refills that were never authorized by the prescriber. Could Phil be held responsible under the CSA by allowing the patient to receive the unauthorized refills? a. yes, Phil violated the CSA when he filled the refills b. yes, but only if Phil knew that the refills were not authorized c. no, Phil does not have a duty to be alert for altered prescriptions d. no, pharmacies are exempt from violating the CSA in circumstances such as this

b. yes, but only if Phil knew that the refills were not authorized

A patient phoned the pharmacy saying she was just at her physician's office and the physician discovered she had been taking the wrong medication. She said her health had become so bad that her physician was going to hospitalize her. How should the pharmacist respond? a. "I'm sorry, but I'm sure this is not our fault." b. "I will investigate." c. "I am sorry this happened and I feel very badly for you. I will file an incident report. Please keep us informed of your condition." d. "I cannot comment, but I wish you well."

c. "I am sorry this happened and I feel very badly for you. I will file an incident report. Please keep us informed of your condition."

Which statement is correct, pursuant to the Orange Book? a. Drugs rated BX have been proved as not bioequivalent b. Substitution of a B-rated product violates the FDCA c. Bioequivalent drugs are presumed to be therapeutically equivalent d. Pharmaceutically-equivalent drugs are presumed therapeutically equivalent

c. Bioequivalent drugs are presumed to be therapeutically equivalent

Bling Pharmacy called Zing Pharmacy requesting a transfer of a C-III Rx to Bling for a patient. The prescription has two refills remaining. Which statement is correct (assume that Bling and Zing do not share common electronic files)? a. the Zing pharmacist can instruct the technician to verbally convey the required prescription information to Bling. b. if the patient wants the last refill at Zing, Bling can transfer the prescription back. c. Bling must record on the prescription it transfers from Zing the word "transfer" along with several other points of information, including Zing's prescription number d. Zing should Bling that the prescription legally can't be transferred.

c. Bling must record on the prescription it transfers from Zing the word "transfer" along with several other points of information, including Zing's prescription number

How has the Employee Income Security Act (ERISA) affected state efforts to regulate third party prescription insurance plans? a. ERISA has had little affect on state efforts to regulate the plans. b. ERISA has enhanced state efforts to regulate the plans. c. ERISA has hindered state efforts to regulate the plans. d. ERISA does not impact state efforts to regulate the plans.

c. ERISA has hindered state efforts to regulate the plans.

The FDA is considering switching a product from OTC to prescription. The manufacturer has challenged the FDA in court to prevent the switch. In order to prevail, what must the FDA prove? a. The toxicity of the drug requires the supervision of a prescriber b. The mthod of use of the drug requires the supervision of a prescriber c. Either the toxicity of the drug or the method of use requires the supervision of a prescriber d. Both the toxicity of the drug and the method of use together requires the supervision of a prescriber

c. Either the toxicity of the drug or the method of use requires the supervision of a prescriber

A dentist issued a prescription to a patient for a statin drug for the purpose of reducing the patient's cholesterol level. This prescription is: a. Valid, because a dentist has prescriptive authority under state law b. Valid, because a dentist has prescriptive authority under federal law c. Invalid, because the dentist has exceeded the scope of practice under state law d. Invalid, because the dentist has exceeded the scope of practice under federal law

c. Invalid, because the dentist has exceeded the scope of practice under state law

John Johnson is a physician's assistant authorized by the state he is licensed in to prescribe certain controlled substances. What is an acceptable DEA number for John? a. JJ b. AJ c. MJ d. BJ

c. MJ

What best describes meals and other breaks for pharmacists? a. It has been established that providing work breaks does not reduce dispensing errors. b. No state will allow a pharmacist to take a break away from the pharmacy and leave the pharmacy open with only ancillary personnel in the pharmacy. c. Many states require that employers allow pharmacists a meal break, depending upon the number of hours of the pharmacist's shift. d. All of these are correct.

c. Many states require that employers allow pharmacists a meal break, depending upon the number of hours of the pharmacist's shift.

Under the Drug Quality and Security Act's regulations, an entity compounding and dispensing sterile products: a. Must register as an "outsourcing facility" with the FDA b. Must register as a manufacturer wit the FDA c. May register as an "outsourcing facility with the FDA d. May register either with the FDA or the state board as a "compounder"

c. May register as an "outsourcing facility with the FDA

A patient, Mrs. Harvey, tells the pharmacist about a drug manufactured and sold in France, but not approved in the U.S. Mrs. Harvey wants to obtain that drug since no drug approved in the U.S. is effective for her serious medical condition and this drug sounds promising. What is the pharmacist's best advice for Mrs. Harvey, pursuant to the FDA compassionate use policy? a. The pharmacy could order the drug for Mrs. Harvey. b. Mrs. Harvey could personally import small amounts of the drug into the U.S. c. Mrs. Harvey could personally import small amounts of the drug into the U.S. only if the drug does not present an unreasonable risk to her and she provides the name of her treating physician. d. Mrs. Harvey's physician must order the drug for her.

c. Mrs. Harvey could personally import small amounts of the drug into the U.S. only if the drug does not present an unreasonable risk to her and she provides the name of her treating physician.

A drug manufacturer marketed a drug for five years before studies discovered that the drug causes heart problems. As soon as the company discovered the adverse effect, it sent out warnings to all healthcare professionals and included the warning in its labeling. What would happen if patients who used the drug and suffered heart problems sued the manufacturer under strict liability? a. Those who were injured before the adverse effect was discovered would likely succeed. b. Those who were injured after the adverse effect was discovered would likely succeed. c. Neither those injured before or after the adverse effect was discovered would likely succeed. d. Both those injured before and after the adverse effect was discovered would likely succeed.

c. Neither those injured before or after the adverse effect was discovered would likely succeed.

Which statement about the beyond-use date for non-sterile or liquid drugs repackaged into unit containers, as established in the final 1995 FDA CPG, is correct? a. One year from the date of repackaging, unless stability data or manufacturer's labeling indicates otherwise b. Not to exceed six months from the date of repackaging c. Not to exceed six months, provided it does not exceed 25% of the remaining time between the date of repackaging and the manufacturer's unopened bulk container d. Not to exceed six months, provided it does not exceed 50% of the remaining time between the date of repackaging and the manufacturer's unopened bulk container

c. Not to exceed six months, provided it does not exceed 25% of the remaining time between the date of repackaging and the manufacturer's unopened bulk container

Drug product P is the original patented drug product. Drug products X, Y, and Z are generic drug products to P. The Orange Book classifies X as A rated to P. It classifies drugs Y and Z as B rated to P. Which statement is correct? a. X, Y, and Z are therapeutically equivalent to P b. Y and Z are therapeutically equivalent to one another c. P and X are therapeutically equivalent to one another d. Y and Z are therapeutically equivalent, and P and X are therapeutically equivalent

c. P and X are therapeutically equivalent to one another

Under the Durham-Humphrey Amendment, the law provides, in part that a prescription drug is one that is unsafe for use except under the supervision of a practitioner because of " the collateral measures necessary to use the drug." In this instance, "collateral measures" means that the: a. Toxicity of the drug requires physician supervision b. Pharmacological effects of the drug requires physician supervision c. Patients may take the drug for a condition that it will not cure, and postpone seeing a physician d. Route of administration requires physician supervision

c. Patients may take the drug for a condition that it will not cure, and postpone seeing a physician

Which term is often used for state laws regulating the practice of pharmacy? a. Licensing Act b. Pharmacy Board Act c. Pharmacy Practice Act d. Pharmacy Licensing Act

c. Pharmacy Practice Act

Why does society choose to license pharmacies and pharmacists? a. Ensure the honesty and integrity of pharmacists. b. Protect the profession. c. Protect the public. d. Increase healthcare costs.

c. Protect the public.

Ringem Pharmacy is out of Oxycodone 5 mg and needs 100 tablets to fill an order. The Ringem pharmacist calls Marwall Pharmacy, which is next door; Marwall Pharmacy can supply the tablets. What must occur for the transaction? a. Marwall must execute a 222 form, keeping copy 3, sending copy 2 to the DEA and copy 1 to Ringem b. Marwall must execute a 222 form, keeping copy 2, sending copy 1 to the DEA and copy 3 to Ringem c. Ringem must execute a 222 form, keeping copy 3, sending copy 2 to the DEA and copy 1 to Marwall d. this transaction does not require the execution of a 222 form. Ringem and Marwall both need to keep a record of the transaction.

c. Ringem must execute a 222 form, keeping copy 3, sending copy 2 to the DEA and copy 1 to Marwall

What best describes the Drug Quality and Security Act of 2013, and its regulation of sterile compounding of products? a. The compounding entity must register as an outsourcing facility b. The compounding entity must register as a manufacturer c. The compounding entity may register as an outsourcing facility d. Enforcement authority is vested with the state pharmacy board

c. The compounding entity may register as an outsourcing facility

A pharmacy promoted its professional services, especially counseling and detecting potential drug interactions. A patient received two prescription drugs at the pharmacy that together pose a very high risk of a serious drug interaction. No one at the pharmacy detected the problem and the interaction occurred, seriously injuring the patient and the patient sued. The state supreme court had ruled in an earlier case that pharmacists did not owe a general duty to warn patients. Based on the ​Baker case, what is the likely outcome of the lawsuit? a. The court would follow the state supreme court decision and find for the pharmacist. b. The court would reverse the state supreme court decision and find for the patient. c. The court would find for the patient on the basis that the pharmacy's promotional activities created a duty where one had not previously existed. d. The court would find for the patient on the basis that the interaction was foreseeable.

c. The court would find for the patient on the basis that the pharmacy's promotional activities created a duty where one had not previously existed.

Which of the following is not required to be included on the label of a dispensed drug under the FDCA? a. The dispenser name and address b. The prescription serial number c. The drug name d. The prescriber name

c. The drug name

Mailem is a mail order pharmacy in Nevada that dispenses prescriptions to patients in nearly every state. What regulatory authority do the states, other than Nevada, have? a. The states have no authority to regulate Mailem. b. The states can legally require that Mailem be licensed and conform to the same requirements as pharmacies in that state. c. The states can legally require Mailem to register with the state board and meet certain requirements that are not unduly burdensome. d. The states can impose stricter requirements on Mailem than it does on in-state pharmacies.

c. The states can legally require Mailem to register with the state board and meet certain requirements that are not unduly burdensome.

A state board of pharmacy inspector found a pharmacy in violation of the law. The pharmacy was sent a notice of violation within two weeks, with a fine. The notice provides that the pharmacy has the option to pay the fine, or contest the violation, in which case the pharmacy could face license revocation or suspension. Which statement is correct? a. This is legal, provided the board is following state law. b. This is legal, even without a state law to the effect. c. This violates the pharmacy's due process rights. d. This is illegal, since boards cannot issue fines.

c. This violates the pharmacy's due process rights.

Pharmacist Phil received an illegible prescription. Rather than calling the prescriber, Phil was pretty confident about which drug the prescriber intended, and dispensed the prescription. Later, it turned out that Phil guessed incorrectly and the patient was injured. Did Phil breach his duty to the patient? a. No, it was the prescriber's fault. b. No, not if it could be determined that a reasonable pharmacist would have guessed the same way. c. Yes, because he did not call the prescriber. d. No, this is not the type of duty a pharmacist owes a patient.

c. Yes, because he did not call the prescriber.

A pharmacist received a prescription for Zostat (fct) with the direction to take t.i.d. for migraine headaches. Zostat is indicated only for anxiety and labeled for once a day use. Is it legal to use Zostat as prescribed? a. Yes, it is legal under the FDCA and the pharmacist should dispense it b. Yes, it is legal under the FDCA. However, the pharmacist should confirm the prescription accuracy with the prescriber and, if confirmed, dispense the drug without further consideration. c. Yes, it is legal under the FDCA. However, the pharmacist should confirm the prescription accuracy with the prescriber and, if confirmed, exercise professional judgment regarding the reasonableness of the risk in deciding whether to dispense the prescription. d. No, it's not legal to use Zostat in this manner and the pharmacist should not dispense it.

c. Yes, it is legal under the FDCA. However, the pharmacist should confirm the prescription accuracy with the prescriber and, if confirmed, exercise professional judgment regarding the reasonableness of the risk in deciding whether to dispense the prescription.

If a patient sued a pharmacist under strict liability and the court applied the rationale of the California Supreme Court, would the pharmacist win the case? a. Yes, on the basis that a pharmacy is not a retailer. b. Yes, on the basis that the prescription product is incidental to the provision of professional services. c. Yes, on the basis that the pharmacist is an extension of the physician and state law provides that pharmacists are professionals. d. Yes, on the basis that strict liability does not apply to professional services.

c. Yes, on the basis that the pharmacist is an extension of the physician and state law provides that pharmacists are professionals.

The objectives of negligence law include: a. retribution b. rehabilitation c. compensation d. All of these are correct

c. compensation

The requirement under negligence law that a pharmacist must use the degree of care that a reasonable and prudent person would use under similar circumstances applies: a. causation b. damages c. duty d. statute of limitation

c. duty

Pharmacist John did not advise the patient of a potential drug-drug interaction and the patient suffered injury. If the patient sues, this is an example of: a. negligence b. intentional tort c. negligence and unintentional tort d. negligence and intentional tort

c. negligence and unintentional tort

Pharmacist Phil calls Dr. Smith's office to inform the office that Mrs. Jones is out of refills on her schedule IV drug prescription, and that she is requesting additional refills for it. Nurse Nancy tells Pharmacist Phil that Dr. Smith is on vacation but that he authorized her to use her judgment on any refill authorizations, and tells Pharmacist Phil to refill the prescription. Can Pharmacist Phil legally fill the prescription for Mrs. Jones one more time? a. yes, pharmacist Phil contacted the office and verified that Mrs. Jones is allowed to receive 1 additional refill b. yes, Dr. Smith properly delegated authority to nurse Nancy to add refills c. no, nurse Nancy must verify with Dr. Smith prior to allowing the refill d. no, refill requests and authorizations for controlled drugs cannot be made over the phone

c. no, nurse Nancy must verify with Dr. Smith prior to allowing the refill

Most state pharmacy boards are composed of: a. community pharmacists b. hospital pharmacists c. pharmacists from different practice settings d. pharmacists elected by voters

c. pharmacists from different practice settings

A patient was injured as the result of a prescription drug side effect. This side effect is listed in the package insert, but is not common. Assume the patient sued the pharmacist based on strict product liability and the court allowed the case to go to trial. The patient must prove that: a. the pharmacist breached the duty to the patient b. the pharmacist-patient relationship is independent of the physician-patient relationship c. the product is defective and unreasonably dangerous d. the pharmacist failed to convey the manufacturer's warnings to the patient

c. the product is defective and unreasonably dangerous

The FDA's attitude about the practice of the prescribing of approved drugs for off-label indications is that it: a. Regards the practice as illegal b. Frowns on the practice but tolerates it c. Encourages the practice d. Accepts that the practice is appropriate and rational

d. Accepts that the practice is appropriate and rational

The Drug Supply Chain Security Act: a. Preempts state pedigree laws b. Requires pharmacies to quarantine, investigate, and notify the FDA of suspect products c. Requires pharmacies to receive a transaction history with the drug product d. All of these are correct

d. All of these are correct

Which statement about whether there should be a third class of drugs, also known as "behind the counter" or "under conditions for safe use" is correct? a. Pharmacists have been in favor of the concept b. The FDA has opposed the concept until recently c. Medical organizations have opposed the concept d. All of these are correct

d. All of these are correct

A jury determined that a pharmacist's negligent act caused the patient to be hospitalized and require home care for two years. The patient could not return to work for four years. Damages likely owed by the pharmacist are: a. medical expenses, including hospital and home care b. lost wages for four years c. for pain and suffering d. All of these are correct.

d. All of these are correct.

A jury determined that a pharmacist's negligent act caused the patient to be hospitalized and require home care for two years. The patient could not return to work for four years. Damages likely owed by the pharmacist include: a. medical expenses, including hospitalization and home care b. lost wages c. pain and suffering d. All of these are correct.

d. All of these are correct.

A pharmacist at DispensMor Pharmacy dispensed the wrong drug to a patient resulting in the patient's death. An investigation showed that the pharmacy had a history of errors, but did not keep incident reports and made no effort to change its dispensing system to prevent errors from occurring in the future. Which statement is correct? a. DispensMor would likely be liable for the pharmacist's negligence under the doctrine of respondeat superior. b. DispensMor would likely be corporately negligent because of its dispensing system. c. DispensMor would likely be liable for punitive damages. d. All of these are correct.

d. All of these are correct.

A pharmacist dispensed the wrong drug to a patient. The patient shared the drug with a friend, who was injured. Had the right drug been dispensed the friend would not have been injured. What is the issue, if the friend sues? a. Proximate causation b. Foreseeability c. Whether the pharmacist's negligent act has been severed by the act of the patient d. All of these are correct.

d. All of these are correct.

It is constitutional for a state to impose which restriction for pharmacy licensure? a. The majority ownership of a pharmacy is by pharmacists. b. Physicians may not own a pharmacy. c. A pharmacy must designate a pharmacist-in-charge as responsible for the pharmacy. d. All of these are correct.

d. All of these are correct.

State pharmacy practice acts should focus on: a. structure requirements b. process requirements c. outcome requirements d. All of these are correct.

d. All of these are correct.

What is a common justification for disciplinary action against a pharmacist at the state level? a. Providing false information when applying for a license. b. Being convicted of an act involving moral turpitude. c. Engaging in unprofessional conduct. d. All of these are correct.

d. All of these are correct.

What is a typical state requirement for pharmacist licensure? a. Graduate from pharmacy school b. Attain a specific age c. Demonstrate good moral character d. All of these are correct.

d. All of these are correct.

What is the correct description of negligence per se? a. The statute establishes the standard of care. b. The plaintiff must be in the class of persons the statute intended to protect. c. The harm to the plaintiff must be the type that the statute intended to protect the plaintiff from. d. All of these are correct.

d. All of these are correct.

A patient visits the pharmacy and requests a particular OTC product, drug product A. Pharmacist Phil does not have Drug A in stock, but he does have drug product B from another manufacturer, which is identical to Drug A but is a prescription drug product. Since the two products are identical, what can Pharmacist Phil legally do? a. Sell the patient Drug B and charge the price of Drug A b. Sell the patient Drug B after explaining that, although the products have different names, they are the same c. Sell the patient Drug B after verifying that the patient's condition requires the product d. Explain to the patient that he is unable to provide Drug A at this time

d. Explain to the patient that he is unable to provide Drug A at this time

Which might a particular activity by a pharmacist be described as a standard of practice? a. It is prescribed by a law or regulation. b. It is not prescribed by a law or regulation. c. It is prescribed by the code of ethics. d. It is an activity that most pharmacists are expected to perform.

d. It is an activity that most pharmacists are expected to perform.

The package insert for a drug states that the risk of liver damage is extremely rare. A patient of Bill's Pharmacy nevertheless incurred liver damage from using the drug, and sued. Two years earlier, the state supreme court held that pharmacists have a duty to warn. Did Bill have a duty to warn the patient? a. Yes, based upon his relationship with the patient. b. Yes, based upon public policy. c. No, based upon his relationship with the patient. d. No, based upon foreseeability.

d. No, based upon foreseeability.

What is not an appropriate first letter for a physician's DEA registration number? a. A b. B c. G d. P

d. P

Pharmacist Phil receives a call from Dr. Young, a new pediatrician in town. Dr. Young informs Pharmacist Phil that his mother is in town and is experiencing back pain from a recent surgery. Dr. Young has tried to contact his mother's physician, but was unsuccessful. Dr. Young would like to phone in a prescription for his mother for Tylenol #3 (schedule III pain medicine) until they can get a hold of her physician. How should Pharmacist Phil respond? a. Pharmacist Phil should tell Dr. Young that he will fill the prescription as a professional courtesy, but only for a 3 day supply b. Pharmacist Phil should tell Dr. Young that he is allowed to perscribe that medication for his mother, and will fill the prescription c. Pharmacist Phil should tell Dr. Young that he can't fill the prescription because it is illegal for physicians to prescribe for their family members d. Pharmacist Phil should tell Dr. Young that he can't fill the prescription because it is not in the usual field of Dr. Young's practice.

d. Pharmacist Phil should tell Dr. Young that he can't fill the prescription because it is not in the usual field of Dr. Young's practice.

Harry sued pharmacist Mary for failing to advise him that the prescription drug he was prescribed and dispensed could cause tendon damage. Harry suffered extensive tendon damage and argued that had he been aware of the potential for harm, he would have stopped taking the drug sooner and would not have suffered the harm. Why did the court award Mary summary judgment? a. Harry could not prove that the drug actually caused the harm. b. Harry could not prove that Mary did not advise him of the risks. c. Mary proved that she did advise Harry of the risks. d. The court decided that a pharmacist has no legal duty to advise patients of these types of adverse risks

d. The court decided that a pharmacist has no legal duty to advise patients of these types of adverse risks

Which statement about the historical evolution of Plan B is most accurate? a. It was originally approved as an OTC drug but opposition caused it to be switched to prescription b. In the mid-2000s, the FDA denied an SNDA that Plan B could be sold only from behind the counter of a pharmacy with proof of age 18 or older c. A court decision agreed with the FDA's decision to reject the Citizen Petition requesting the elimination of an age requirement d. The decision that Plan B be made available OTC without point of sale or age restrictions was initially made by a court, not the FDA

d. The decision that Plan B be made available OTC without point of sale or age restrictions was initially made by a court, not the FDA

A prescriber would like a patient to be able to obtain a three-month supply of a CII without having to return to the office for new written prescriptions during that time frame. Which are the legal options for the patient and the prescriber, assuming legitimacy is not an issue? a. the prescriber can issue one CII prescription for a 3 month supply b. the prescriber can issue 3 prescriptions, each for a 30-day supply. each prescription except the first would specify the earliest date upon which the prescription can be filled c. the prescriber can issue an electronic prescription for the CII medication at any required time interval without the patient having to come to the office d. all of the above

d. all of the above

How may a prescription for a CIII drug be communicated to the pharmacy? a. phone order b. electronically c. fax d. all of the above

d. all of the above

In order to issue a controlled substance prescription, a prescriber must be: a. an individual practitioner b. authorized by state law to prescribe controlled substances c. registered or exempt from registration under the CSA d. all of the above

d. all of the above

Which of the following does the CSA require to be on the pharmacy label of a dispensed controlled substance in schedule II, III, and IV? a. patient name b. pharmacy address c. the statement "Caution: federal law prohibits the transfer of this drug to any person other than the person for whom it was prescribed" d. all of the above

d. all of the above

Is the partial filling of a C-II drug permitted? a. it is not permitted b. it is permitted, provided the pharmacist is unable to provide the full quantity c. it is permitted however, the balance may not be dispensed d. it is permitted, provided the pharmacist is unable to supply the full quantity, and if the balance is dispensed it must be within 72 hours.

d. it is permitted, provided the pharmacist is unable to supply the full quantity, and if the balance is dispensed it must be within 72 hours.

A pharmacy received a hand-written CII prescription for a one month supply of a pain medication without the prescriber's signature. Is this a valid prescription that the pharmacist can dispense? a. yes, but only after the pharmacist contacts the prescriber and documents that the prescriber verified the prescription b. yes, but only after the pharmacist verifies that the prescriber wrote the prescription, and the prints the prescriber's name on the prescription c. yes, but only after the pharmacist contacts the prescriber and converts the prescription to an emergency verbal order. d. no, the prescription is not valid and cannot be dispensed

d. no, the prescription is not valid and cannot be dispensed

Which statement regarding a pharmacy reporting lost or stolen controlled substances is accurate? a. the pharmacy must report the theft to the DEA, but not the loss. b. the pharmacy must report all stolen and lost medications to the DEA. c. the pharmacy must report any loss to the DEA, but may report to either the police or the DEA d. the pharmacy must report thefts to the DEA and any losses that were significant

d. the pharmacy must report thefts to the DEA and any losses that were significant

A pharmacist dispensed a drug refill to a patient without contacting the prescriber for authorization. The patient used the drug to commit suicide. The patient's estate sued the pharmacist. The central issue to be decided in this case is: a. whether the prescriber would have authorized the drug had she been contacted b. whether the pharmacist owed the patient a duty of care c. whether the patient would have committed suicide without the drug d. whether the pharmacist was the proximate cause of the suicide

d. whether the pharmacist was the proximate cause of the suicide

Pharmacist Phil receives a call from a chain pharmacy located in a different state. Mrs. Neely is on vacation and would like to transfer her prescription for Ativan (schedule IV), for which she has three refills remaining. The state Pharmacist Phil is in and the state Mrs. Neely is visiting follow the same CSA restrictions regarding transferring controlled substances. Can Pharmacist Phil legally transfer the prescription? a. no, the CSA prohibits controlled drug prescriptions from being transferred to a different state b. no, the CSA prohibits transferring any controlled substances c. yes, the CSA allows Mrs. Neely to transfer her controlled prescriptions prescriptions to another state this time and then back to Phil's pharmacy for the next fill d. yes, the CSA allows Mrs. Neely to transfer her controlled prescription this one time only

d. yes, the CSA allows Mrs. Neely to transfer her controlled prescription this one time only

In addition to individual pharmacists being disciplined, license revocations, suspensions, and civil penalties may be assessed against the license of a pharmacy. ​ True or False

true

The FDA is considering combining the PPI, CMI, and Medication Guide into an easy-to-read document. True or False

true