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Case Examples for Discussion of Laws Pertinent to Operating a Pharmacy
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Case 29.1: Why Won't the Pharmacist Just Refill My Prescription?
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A Federal Drug Law: The Controlled Substances Act of 1970
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Maureen Smith, R.Ph., the pharmacist manager of ABC Drugs Community Pharmacy, encounters the following situation within 10 minutes of arriving at the pharmacy on a Tuesday morning. She finds herself dealing with a complaint from a patient, Mr. Jones, about one of the staff pharmacists. Yesterday evening, Monday, at about 8:30 p.m., Mr. Jones came to the pharmacy and presented an empty prescription vial to the pharmacist on duty and asked for a refill of his acetaminophen with codeine no. 3 tablets. Acetaminophen no. 3 is a schedule III controlled substance, and the federal Controlled Substances Act limits prescriptions for such medications to a maximum of five refills within 6 months of the time they are issued. Mr. Jones had not seen the prescribing physician in about 7 months and was now experiencing pain unrelated to the reason for his visit 7 months ago. However, the label on his vial stated that he had three refills remaining, and he wanted one right away.
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Sally Howard, Pharm.D., the pharmacist who was on duty Monday evening, explained to Mr. Jones that she would need further authorization from Mr. Jones' prescriber because the prescription had been written over 6 months ago and was now no longer valid for refilling. Sally tried to reach Mr. Jones's doctor to obtain authorization but was unsuccessful in reaching the prescriber before the pharmacy closed at 9:00 p.m. Therefore, she informed Mr. Jones that the pharmacy would not be able to refill the prescription until it could reach the prescriber. Mr. Jones became angry when he heard this and remains very angry as he tells Maureen about the situation.
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1. What are the essential legal issues involved?
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2. How should the pharmacy manager handle this situation?
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3. How might another manager deal with the problem presented by this difficult patient?
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Case 29.2: The Grandmother WHO Did Not Need an Easy-Open Prescription Vial
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A Federal Consumer Protection Law: The Poison Prevention Packaging Act
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The (federal) Poison Prevention Packaging Act requires that prescription medications (with very few exceptions, such as sublingual nitroglycerin tablets) be dispensed in child-resistant containers. Mrs. Mabel Brown, a 79-year-old great grandmother to 2-year-old Barbara Brown, is a longstanding patient at the community pharmacy where you are the manager. You have just been informed by Mrs. Brown's great grand daughter's pediatrician that little Barbara was treated at the local hospital emergency room yesterday evening. It seems that while Barbara and her parents were visiting Mabel at her house, Barbara climbed up on the kitchen counter and grabbed Mabel's prescription vial containing propranolol 80 mg long-acting capsules. Little Barbara had only been out of her mother's sight for about 2 minutes when her mother walked into the kitchen and found Barbara sitting on the kitchen counter munching away on Mabel's medicine. Although she became a bit lethargic, luckily she did not have enough time to consume a dangerous quantity and was treated and released.
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After speaking with the pediatrician, you do some checking in Mabel's patient record, and you discover that all her medications have been dispensed in nonchild-resistant containers (i.e., “easy open” flip-top containers). On further investigation, you discover that there is no request on file where Mabel or her physician actually asked for easy-open containers. While discussing this with your pharmacy staff, you learn that everyone just assumed that a 79-year-old patient would want the nonchild-resistant containers but that no one had ever asked her if she wanted them.
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1. How would the pharmacy manager need to articulate and address the issues presented by this situation?
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2. What are the key issues, and how should a pharmacy manager handle them with pharmacy staff?
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3. What recommendations for change, if any, would be appropriate to assist the pharmacy in refining the pharmacy's policies and procedures?
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4. What additional civil liability issues arise from situations like this one?
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Case 29.3: The Super-Technician
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A State Practice Act/Board of Pharmacy Provision
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Trudy Hamilton, Pharm.D., is a licensed pharmacist and is currently the manager of a hospital pharmacy department. In the state where Dr. Hamilton is licensed, nonpharmacist personnel are prohibited by both statute (the state pharmacy practice act) and state board of pharmacy regulation from engaging in activities defined as the practice of pharmacy. The specific activities that fall within the definition of the practice of pharmacy are limited to being personally performed by licensed pharmacists only. Such activities include counseling patients about their medications and responding to drug information requests from other health care professionals (e.g., physicians and nurses).
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Robert Allen recently earned his certification as a certified pharmacy technician (C.Ph.T.) and has been working as a technician in the pharmacy department for the past 3 years. Robert is rightly proud of his accomplishment and recently has expressed interest in applying for admission to pharmacy school. Today, Dr. Hamilton received a phone call from Ann Brown, D.O., an attending physician at her institution. Dr. Brown was noticeably angry. Yesterday, Dr. Brown called the pharmacy with a drug-interaction question about a drug that is new to the hospital's formulary (i.e., the list of drugs that the hospital pharmacy regularly keeps in stock). She was told by the “pharmacist” who answered the phone that the pharmacy department's computer system showed no interactions. Today, Dr. Brown's patient experienced a severe interaction between the new drug and a medication that the patient was already taking.
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At a recent continuing-education seminar, Dr. Hamilton and her staff pharmacists learned of the potential for a significant interaction between the two medications in question. She was puzzled as to why one of the pharmacists would have told a physician that there are no drug interaction problems with the new drug. Dr. Hamilton and the staff pharmacists are aware that the hospital information technology department has not yet updated the pharmacy department computer system to include this interaction. As she concludes her conversation with Dr. Brown, she promises to find out what happened and take corrective action.
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In Dr. Hamilton's investigation, she discovers that technician Robert Allen in fact took the phone call and answered Dr. Brown's question. Dr. Hamilton calls a meeting of the pharmacists to discuss how to prevent such problems from occurring in the future. During the meeting, she discovers that a few of the staff pharmacists have, on occasion, observed Robert stepping outside his technician role because he was trying to be helpful. They tell her that they have attempted to correct his behavior but have had little success. This is the first time Dr. Hamilton has heard of the problem.
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1. How should Dr. Hamilton address this situation?
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2. Are there problems with the way the department is functioning as a unit?
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3. Is this situation simply a “personnel” issue confined to Robert's behavior?
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4. Are there other issues or combinations of issues that should be addressed?
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Case 29.4: A Recently Hired Pharmacist and the Nonpharmacist Store Manager
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Federal Statutes (Social Security Act and HIPAA)
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Pauline Rodgers, Pharm.D., recently started working as a staff pharmacist at Big Box Stores, Inc. right after she passed her board examinations and became licensed as a pharmacist. The pharmacy manager, Len Roberts, R.Ph., has been working for Big Box for about 20 years and has a fairly cordial relationship with Don Smith, the store manager. Mr. Smith, a business school graduate, is very pro-pharmacy and wants to do all he can to help the pharmacy department increase its business through various marketing promotions. After working at the store for a few weeks, Pauline notices that Len makes a practice of giving in-store coupons to patients who are Medicare and Medicaid beneficiaries. These coupons, each worth $10, can be used toward the purchase groceries, DVDs, clothing, and so on. Realizing that she will soon likely encounter a situation where a Medicare or Medicaid beneficiary will expect to receive a coupon from her, Pauline asks Len what recordkeeping system is in use for tracking the total annual value of coupons given to each beneficiary. Len responds with a puzzled look on his face and asks: “Why would we do that? Mr. Smith wants us to keep handing out these coupons to increase our business. When it comes to running the business, I do what Mr. Smith wants and I don't ask questions.”
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1. How should Pauline respond to Len?
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2. What do you think are the important legal and managerial issues here?
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3. How should Pauline respond to a request for a coupon from a Medicaid beneficiary?
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4. Describe how you would handle this situation if you were Pauline.
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Case 29.5: The Poorly Written Prescription and the Hurried Pharmacist
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Civil Liability (Tort Law)
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Stuart Johnson, R.Ph., is manager of Johnson's Apothecary, a community pharmacy. When he arrived at the pharmacy today, there was a frantic voice-mail message left for him in the middle of the night while the pharmacy was closed. It seems that a staff pharmacist, Dave, made a dispensing error yesterday, and Suzie Jones, a 3-year-old child, was taken unconscious by ambulance to the local community hospital emergency room at 2:00 a.m. Suzie and her family had just moved to town about 2 weeks ago, and yesterday was their first visit to Johnson's Apothecary.
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In the process of both calling the hospital and interviewing Dave, the staff pharmacist, Stuart learns the following: Somehow Dave misinterpreted a poorly written prescription that was supposed to be for glycerin suppositories (Directions: “Use as directed”) as a prescription for Glynase 5-mg tablets (a drug used to treat diabetes in adults). As a result of this error, Suzie's blood sugar dropped to dangerously low levels, and she is now in a coma. Dave was very busy when the error occurred and did not determine that the patient, Susan Jones, was in fact a 3-year-old child. He also did not speak to Suzie's mother, who brought in the prescription. Because he was very busy, he quickly checked a pharmacy technician's work and let her dispense the prescription to Mrs. Jones, an uninsured cash-paying customer. The sad truth is that the doctor had not even intended this written note to be a prescription (glycerin suppositories are available without a prescription); it just looked like one because it was on one of the doctor's prescription blanks.
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1. From this case, describe violations of both state and federal law and the tort law implications (i.e., potential for being sued).
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2. What is the manager's role in determining what happened internally that was out of conformance with standards, with external regulatory bodies, and with professional performance standards beyond the letter of the law?
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3. How can all these be brought to bear on the pharmacy?
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4. How should Stuart as the manager respond when the local TV station and newspaper want interviews?