Pharmacy Practice And The Law 9th Edition Richard R. Abood, Kimberly A. Burns - Solutions

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Explain why your answer in question 3 might change if Sue labeled Acuxen for use in insomnia? Assuming this is a health or disease claim, would it matter whether the claim was made on the label or in pamphlets attached to the product?Question 3Based on the facts in this case, is Acuxen most likely
You are a pharmacist talking to a patient. The patient remarks, “I really don’t understand why the FDA has to approve every drug before it can be marketed. I have cancer, and there is a very promising drug in Europe that I can’t get in the United States because of the FDA. Do you think
The patient continues, “I also don’t understand why someone has to have a pharmacy degree and a license to practice pharmacy. Doesn’t it make sense that anyone should be allowed to dispense medications? All that the law should require is that the dispenser be required to post his or her
An elderly patient visits a pharmacy at night and needs a refill on her maintenance prescription medication that she has been taking regularly for 10 years. The physician customarily renews the prescription for one year at a time. However, it is the end of one year, and the patient and the pharmacy
Assume the Board of Pharmacy passed a regulation prohibiting any pharmacy from accepting any third-party insurance plan whose dispensing fee is less than $2. You are the owner of a pharmacy that wants to accept a plan offering a fee of $1. On what basis might you challenge this regulation in court?
Assume the Board of Pharmacy passed a regulation that pharmacists may not wear facial jewelry (from piercing). You are a pharmacist who has a number of rings in your eyebrows, nose, and lips. On what basis might you challenge this regulation in court?
The state has a law mandating that pharmacists must counsel patients in certain circumstances. Your pharmacy is simply too busy to provide counseling personally and keep up with the volume; so, being the tech wizard you are, you program computers to provide counseling to the patients. The computers
Makeit Laboratories in New Jersey shipped one of its prescription drugs to a wholesaler in Sacramento, California, which sold it to a pharmacy in Stockton, California. The pharmacy in Stockton sold it to a Stockton patient without a prescription. The FDA charged the pharmacy with violating federal
A state passed a law that a pharmacist could refill a schedule II prescription two times when the patient requires continual use of the medication. Federal law states that a schedule II prescription may not be refilled. If you were a pharmacist in that state, which law would you follow and why?
In criminal law, the state takes action against an individual who has committed an act so unacceptable that all of society is offended by it. Theft and assault are examples of crimes that harm all of society, not just their immediate victims. Reprehensible crimes such as these threaten to degrade
This case explored the limits of the authority of a state board of pharmacy to discipline a pharmacist for obviously inappropriate conduct. There was no question that the pharmacist described in this case violated the law, but the board of pharmacy did not follow the rules it was given by the
This case is a lawsuit within a lawsuit. The primary case was a malpractice lawsuit brought by a patient against a pharmacist who had allegedly dispensed to her an incorrect medication. The judge in that lawsuit ruled that evidence from a previous board of pharmacy disciplinary action could be used
A patient asked the pharmacist, “When did the United States first start regulating drugs under the FDCA?” The patient continued, “Why do there have to be so many other laws besides the FDCA, such as the PTRA, the PDMA, the FDAMA, the FDAAA, the DQSA, the 21st Century Cures Act, just to name a
A company manufactures and markets capsules filled with pulverized sheep bone. It promotes the product as a treatment for anemia and various blood disorders. Explain whether this product is a drug or a dietary supplement or both.
Assume for question 1 that the company promoted the product with the claim that it “restores healthy blood” instead. Explain whether this would change your answer.
Based on the facts in this case, is Acuxen most likely a food, drug, or dietary supplement, or all three and why? To answer this question, you must consider both the composition of Acuxen and the indication. How does the Nutrilab case play into your analysis?
If Sue made the root product as a topical patch, why might your answer be different?
Assume that, before purchasing Acuxen, a patient in a pharmacy asked the pharmacist about the product and that the pharmacist remarked that in his opinion the product seemed to be effective for insomnia and also in preventing some types of dementia. Has the pharmacist violated the FDCA? Why or why
The Exachol decision was issued prior to DSHEA. How might the decision be different today?
Differentiate between the disclaimer required for a structure/function claim on a dietary supplement product label and a health claim pursuant to the Pearson decision.
A pharmacist received a bottle of cephalosporin capsules. Unknown to the pharmacist, the capsules also contained small amounts of penicillin. The pharmacist dispensed the capsules to a patient who is allergic to penicillin and who then suffered an anaphylactic shock. Assuming that the product is
A hospital pharmacy received ampules of a commonly stocked drug contained in a pink solution. Previously the drug had always been in a clear solution. The pharmacist dispensed the drug for IV administration. The drug was contaminated and injured the patient. Assuming that the product is
A pharmaceutical company issued a Class I recall of one of its drug products. Two months later, two bottles of the drug product were discovered in the inventory of a community pharmacy. The pharmacy argued to the FDA that (1) it had no knowledge of the recall; (2) even if it had knowledge, it had
A pharmacist counted cephalosporin capsules on a counting tray that contained powder from penicillin tablets that had been counted previously and dispensed the capsules to a patient who is allergic to penicillin. The patient suffered anaphylaxis. Explain how this might constitute adulteration
A pharmacy received a prescription for a drug product compound containing 2% active ingredient. The pharmacy compounded and dispensed the compound and labeled it as containing 2% active ingredient. In reality, the product only contained 1% of active ingredient. Explain how this might constitute
A pharmacist received a prescription for a brand name drug and substituted a generic drug pursuant to state law. The pharmacist labeled the dispensed generic drug using the brand name drug name. Explain whether the pharmacist has violated the FDCA.
A patient hands a pharmacist a prescription for Spondicin 20 mg (fictitious), a prescription-only drug. As the patient is waiting for the prescription to be filled, the patient notices that Spondicin 10 mg is available OTC and asks the pharmacist how it can be that one strength is prescription only
A manufacturer of a dietary supplement made a disease claim for its product in such a manner that the FDA deemed that the claim made the product a new drug. The manufacturer responded that it did not deny that the claim would make the product a drug; however, it contended the product is not a
A drug manufacturer wishes to market its approved drug for use in a disease for which it has not been approved (off-label use). Explain whether marketing the drug for this use would make it a new drug.
A patient who has been prescribed a newly marketed drug complains to you, the pharmacist, about the high price of the drug. The patient remarks that it cannot cost more than a few cents to make such a little tablet. “Who is making all the profit?” the patient queries. How would you completely
A pharmacist who is a member of a managed care formulary evaluation committee is evaluating whether to include on the formulary a newly marketed drug. The drug is much more expensive than other drugs in its class and is rated by the FDA as type 5 and S. If you were the pharmacist, explain why you
A manufacturer learns postmarket that its drug is increasingly being linked to an adverse effect not apparent during the IND process. Explain the process required if the manufacturer decides it wants to include a warning in its labeling.
As a pharmacist, you inform a patient that the patient’s copay will be $15 less if the pharmacist substitutes the generic drug for the brand prescribed. The patient is concerned about quality and asks you whether the generic drug is as safe and effective as the brand name drug and whether the FDA
A patient tells the pharmacist that he has heard that the FDA does not approve OTC drug products and he is concerned whether they are safe and effective. Provide a complete explanation to this patient.
A patient is prescribed a brand name drug. The patient asks the pharmacist if generics are available. The pharmacist’s research shows generics are available but unapproved by the FDA. The pharmacist tells the patient this and the patient asks how it is legally possible that unapproved drugs can
Mentadine (fictional) has just passed phase 1 of the IND process. A terminally ill patient asks you, the pharmacist, if it is legally possible for her to get this drug. Respond to the patient’s inquiry.
As a pharmacist is administering a flu vaccination to a patient, the patient asks if the vaccine is considered a drug and approved by the FDA prior to marketing. What would be the correct information for the pharmacist to provide to the patient?
A patient phones his pharmacist to inform her that he has started having serious problems swallowing, which he believes can be attributed to the drug he was recently prescribed. The pharmacist told the patient to discontinue the drug and call his prescriber immediately. The patient asked the
A patient purchasing syringes and needles for insulin injection asked the pharmacist whether the FDA regulates these products and if so, in what manner. Provide a complete response to this patient.
A patient asks the pharmacist whether the FDA regulates cosmetics and if so, in what manner. How should the pharmacist answer the patient?
You are the only pharmacist at a meeting with other healthcare professionals. A physician brings up the topic of DTC drug ads on television and in magazines, lamenting that the ads are so seductive and misleading that some of his patients practically demand he prescribe the drugs for them. The
Xecor makes several drugs, including Anxless, approved by the FDA for the treatment of anxiety. Recent studies sponsored by Xecor indicate that Anxless may be a promising treatment for hypertension. Dr. Mabel is a pharmacy professor whom Xecor approached to see if she would be willing to present
The FDA issued a final compliance guidance related to pharmacy compounding. In the guidance, the FDA clarified which activities compounding pharmacies could lawfully engage and which activities the FDA considered unlawful. The owner of the compounding pharmacy directed the staff pharmacists to
The court confronted the issue of whether a product is really a food or a drug under the FDCA. Often, courts are faced with ambiguous statutes and have to draw on their perception of legislative intent.Distinguishing a food from a drug has very significant regulatory implications. Food products are
Like the Nutrilab case, this is a case in which a product becomes a drug on the basis of the intended use of the product by the sellers. Unlike Nutrilab, the defendants in this case committed a felony by allowing greed to blind their regard for public safety. Fortunately, a case like Hiland does
The FDA has historically been criticized for taking too long to approve new drugs for market, especially drugs intended for use in the terminally ill, where any delay is critical. In the 1970s and early 1980s, Laetrile gained considerable notoriety as a possible cure for cancer, despite little good
The FDA has decided to switch an OTC drug to prescription only. The manufacturer has sued the FDA to prevent the switch. What must the FDA prove in court in order to prevail in this lawsuit?
The expiration date on the labeling of the manufacturer’s prescription drug container is 12/20. The pharmacist dispenses the prescription on 3/21/19 in the same container; however, the pharmacy labels the expiration date as 3/21/20. The patient asks the pharmacist why the dates differ. What
A manufacturer would like to have its drug product switched from prescription to OTC. What procedures can a manufacturer follow in order to attempt this? What might the manufacturer likely have to prove to affect the switch?
A pharmacist received a prescription from a psychiatrist for a cardiac antiarrhythmic drug. Explain if it would violate the law to dispense this prescription and the procedure that the pharmacist should follow in this situation.
A pharmacist received a prescription from a dentist for an antibiotic written to take tid for a urinary infection. Explain if it would violate the law to dispense this prescription and the procedure that the pharmacist should follow in this situation. How does this situation differ from the
A patient presents a pharmacist with a prescription for a drug product that can be used to induce abortion. The pharmacist is opposed to abortion and refuses to fill the prescription. What is the pharmacist’s legal responsibility in your state? How might this situation have been avoided?
A community pharmacy dispenses prescriptions to a patient for conjugated estrogen, warfarin, and amoxicillin. Discuss what type of written patient information is required for each of these drugs, if any.
A hospital pharmacy dispensed DrugX to an inpatient pursuant to a medication order. A MedGuide is available for DrugX. When the nurse administered the drug to the patient, the patient asked if there is any literature that she could read about the drug. The nurse replied that the hospital did not
A patient who has recently been dispensed a prescription medication angrily confronts the pharmacist. The patient has read the CMI included with the product and notes that the drug is not indicated for the purpose for which the drug was prescribed. The patient wants to know if the drug is correct
Through the power of its purchasing cooperative and its nonprofit status, Mercy Hospital’s pharmacy is able to purchase prescription drugs at much lower prices than community pharmacies. The director of the pharmacy decided to purchase more inventory than the pharmacy needed and to sell the
Blueway Pharmacy and Redway Pharmacy commonly sell one another prescription drug products when one or the other is out of stock. They also sell prescription drug products to a local physician for his office use and to the local ambulance service. Explain whether Blueway and Redway must transmit
Tom and Mary are a middle-aged couple who pay out of pocket nearly $2,000 per month for prescription drugs in your pharmacy. One of their friends told them that they could buy the drugs in Canada for about half that price. Tom and Mary ask you if they could legally buy the drugs in Canada. If so,
Compoundit is a retail pharmacy that specializes in compounding prescription drugs. The local hospital purchases a certain sterile injectable from Compoundit. Two patients suffered injury allegedly because of contamination of the product supplied by Compoundit and the FDA sent an inspector to
Blevco Pharmacy and Dietco, the manufacturer of an OTC diet product, entered into a contract whereby in local promotional television ads, Dietco would tout Blevco as the place to purchase the product. In those ads, unknown to Blevco, Dietco engaged in false and misleading advertising. The FTC
A new state law allows pharmacists to prescribe and dispense oral contraceptive drugs from a licensed pharmacy. Clinic Pharmacy placed an ad that it would furnish a one month supply of a particular brand for $25. However, when patients requested the product, the pharmacy added a $5 consultation
Package inserts are labeling directed at healthcare professionals. Historically, the FDCA had left it up to prescribers and dispensers to determine what written drug information should be provided to patients for prescription drugs. This policy changed somewhat in the mid-1970s, however, because
It is not uncommon for healthcare practitioners to prescribe and dispense medications for off-label uses or dosages. As discussed earlier, it is not a violation of federal or state law to do so. However, deviating from a drug’s labeling can present civil liability concerns in the event of a bad
The PTRA facilitated the marketing of generic drugs by allowing generic drug sponsors to file ANDAs rather than NDAs. This case provides additional insight into the procedures followed by the FDA to determine if a product is similar enough to the parent drug such that the sponsor may file an ANDA.
Even though this case is not an FDCA case and is really about damages, it highlights important issues under the FDCA, including substitution without authorization and the issue of generic and therapeutic substitution. In this case, the pharmacist substituted what he thought was a generic equivalent
A hospital pharmacist regularly resold his excess inventory to a drug wholesaler. Although the PDMA was not an issue in this case, perhaps it should have been. The PDMA was passed in 1987 in part to prevent hospitals from reselling prescription drugs that they purchased at preferred prices. Some
Butrazid (fct) is a controlled substance placed in schedule II by the federal government. One state has been having abuse and diversion problems with Butrazid, especially among teenagers. The drug has proven to be addictive and has even caused deaths, including the death of the daughter of a state
Your state has recently passed a medical marijuana law, which will allow specific patients to register and obtain marijuana legally. The state will require the marijuana to be grown in a state-approved facility and dispensed from a state-licensed dispensary, which must employ a registered state
Currently, GARDA (fct) is an FDA approved medication that is not a controlled substance. GARDA has been known to be abused for years, and the attorney general would like to have the medication scheduled under the CSA. What process must occur for the medication to become controlled?
A pharmacist received a prescription from a physician employed at the county hospital. The prescription was written on a prescription form that contained the DEA registration number of the hospital, but not the physician. The pharmacist called the physician, who told the pharmacist that he had no
Sue is a pharmacist at Small Town Pharmacy that is registered with the DEA as a dispenser. Occasionally, other local pharmacies that run out of controlled substances request to purchase them from Sue to obtain them that day to provide to their patients. What registration concerns should Sue
Mary decided to open a new pharmacy in a growing town. She applied for a pharmacy license from the state board, but is not sure how to get a DEA registration. She would like to open the pharmacy as soon as possible and wonders if she could purchase and dispense controlled substances while her
John is a new pharmacist at XYZ Pharmacy. John noticed that the pharmacy kept the C-II drugs on the shelf interspersed with other drugs. All the other pharmacies where John had worked kept the C-IIs in a safe. John told the pharmacy manager that it was his understanding that the CII drugs must be
Lim is a new pharmacist heavily in debt. A couple of Lim’s patients at the pharmacy who regularly received prescriptions for controlled substances told Lim they could make it worth his while if he would simply dispense to them more tablets than what was prescribed. Lim did so and was caught.
Two DEA agents walked into DrugCo Pharmacy and presented the pharmacist on duty with an AIW. The pharmacist informed the agents that she did not have the authority to allow them to search because the manager was not present. The agents informed her that they would proceed anyway. The audit
A consumer angrily approached the pharmacist on duty and asked where the pharmacy was hiding the PSE products. The pharmacist politely informed the patient that the pharmacy kept the drug behind the prescription counter in order to comply with the law. The patient then asked for four boxes of 30
Congress passed the federal CSA in 1970 with the purpose of establishing a uniform system of regulation of controlled substances in partnership with the states. In this case, an Iowa law has been interpreted by the board of pharmacy as prohibiting the filling of controlled substance prescriptions
Medical boards have the authority to regulate the practice of medicine, in part through rulemaking. Technically speaking, administrative agencies cannot make new law through rulemaking. Rather, regulations must be based on a statute that grants the agency the authority to regulate that particular
This case actually incorporates several issues. The defendants in this case are Little’s Pharmacy and its owner, James Little. The DEA conducted an audit of the pharmacy and determined that there were significant shortages and overages of controlled substances. An audit involves examining a
Alex Swanson is a pharmacist in a modern chain pharmacy located in a new strip mall in a trendy suburb of a major metropolitan area. Alex got a telephone call one day from a nearby community pharmacist who is part of a “hot line” to alert area pharmacists about suspicious prescriptions. The
Mary Lee is a terminally ill patient in chronic, severe pain. Her physician has elected to aggressively treat her pain with oxycodone and other schedule II drugs for breakthrough pain. Mary gets her prescriptions filled at LessPay Pharmacy. Tom Tam, a pharmacist at LessPay, knows Mary’s condition
Tammy is a nurse at a skilled nursing facility. One of the residents, Ben, has been experiencing increasing pain as the result of a condition with which he was diagnosed a couple of months ago by his physician. Until now, an NSAID had controlled Ben’s pain. Tammy called the physician, who told
A patient presented a prescription to the pharmacy for Oxycontin 10 mg, #60, 1 tablet bid. The patient had no insurance and told the pharmacist that she could only afford to pay for 20 tablets presently but would come back in 5 or 6 days with enough money to pay for the balance. What should the
Mary, a patient at Primrose Pharmacy, requested a refill of her diazepam prescription on June 12. The prescription was issued on April 15 and written for one refill, which she received on May 10. Sally, the pharmacist at Primrose, called the prescriber’s office for refill authorization. The
A patient asked the pharmacist at Redwing Pharmacy if she could get her diazepam prescription transferred to Redwing from Bluewing Pharmacy, which was in another part of the town. The pharmacist said that she would find out. After contacting Bluewing, the pharmacist discovered that the prescription
Mary is a newly licensed pharmacist hired to work at a small independent pharmacy in town. On her first weekend at work as a pharmacist, she is instructed by the owner to complete a controlled substance inventory. Describe the steps Mary should take to properly complete the inventory.
You are a pharmacist at SlowGo Pharmacy. The manager noted some outdated bottles of controlled substances for which the pharmacy would not get credit if returned. He instructs you to pour them into the toilet and flush them away. Under the CSA, what should you do?
A few months into working at her new job, while Mary was completing a monthly audit of CII medications, she notices a shortage for two of the CII medications stocked by the pharmacy—Ritalin 10 mg and Percocet 10 mg. Mary goes back to all the prescriptions dispensed for these medications over the
Mary, the newly licensed and hired pharmacist, determined that the pharmacy needed additional CII medications for its inventory. Describe what Mary should do and the process for ordering the CII medications.
Sally’s Pharmacy did not have enough oxycodone in stock to complete a prescription, and partially filling it was not an option. The pharmacist at Sally’s called Tim’s Pharmacy to ask if the pharmacy could sell the necessary quantity to Sally’s. The pharmacist at Tim’s said they had enough
In this case, the pharmacist, Hayes, has been charged with dispensing invalid prescriptions in violation of the corresponding responsibility doctrine. The government contends that Hayes should be charged under § 841 because he knew the prescriptions were not for a legitimate medical purpose. Hayes
The pharmacist in this case was an employee at will, which means that he was not subject to an employment contract and as such could be terminated for any reason or no reason at all. Despite this broad authority of an employer over an at-will employee, however, an employer cannot generally
This case demonstrates the adverse consequences that result when a pharmacist overzealously applies the corresponding responsibility doctrine without bothering to determine the facts. It also shows how important communication and the need to exercise common sense are in a pharmacy. As you read this
This is an administrative hearing before the DEA, not a court case. The pharmacist in this case initially meant well by refilling a narcotic prescription for an employee that he was certain would be authorized. The prescriber, however, refused authorization, and what transpired after the refill
About six or seven states require that schedule II drugs be prescribed pursuant to triplicate prescription forms. The states passed these laws in an attempt to better control the illegal diversion of schedule II drugs by physicians and pharmacists. These prescription forms are issued by the state
Jack is the V.P. for Pharmacy Services for a drugstore chain whose pharmacies are extremely busy. Some of the chain pharmacies and pharmacists have been fined for not counseling and not following other OBRA ‘90 requirements as adopted by the state. As a result, Jack sent out instructions to all
Sue is the privacy officer for a chain pharmacy and responsible for HIPAA compliance. Top management has told Sue that they do not want to be caught with any HIPAA violations or to be subject to any HIPAA complaints. In keeping with this philosophy, Sue has developed an extensive list of rules with
A 64-year-old patient of a pharmacy will retire at age 65 and will be switching from her employer-sponsored plan to Medicare. She wonders if she will have drug coverage like she does with her current plan and has several questions for the pharmacist. How should the pharmacist answer each of the
Pharmacist Bob owns an independent community pharmacy that dispenses Medicaid prescriptions. Bob received a prescription for a brand name drug for which there are generic drug products available. The drug is listed on the FUL list. Because of a question about the directions written on the
Bob’s Pharmacy has several Medicaid patients. One of the physicians tends to write his Medicaid prescriptions for brand name drugs, even though generic drugs are available. When Bob calls the prescriber to seek authority to substitute, the prescriber tells him to write “medically necessary”

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Pharmacy Practice And The Law 9th Edition Richard R. Abood, Kimberly A. Burns - Solutions

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