Download 38 MCQs for Midterm Examination - Law and Ethics in Pharmacy | PHARM 543 and more Exams Health sciences in PDF only on Docsity!
Name: _________________________ Student Number: |||||||__|
PHARMACY 543 – PHARMACY LAWS & ETHICS
MIDTERM EXAMINATION
30 October 2006
Questions 1-30 are multiple choice. Please record your answers on Side 2 of a Standard Answer Sheet, Form 1158. Follow the instructions on Side 1. Carefully complete your name and student number (both characters and bubbles). Select the best answer from the available choices.
There are 5 short answer questions and one 2-part ethics question. Limit your answers to the space provided for each question.
Turn in:
(1) the Standard Answer Form, (2) your answers to the short answer and ethics questions (separate pages), and (3) other pages as necessary (see below).
Complete your NAME AND STUDENT NUMBER on any sheet you turn in if you want credit for that work.
Please do not turn in pages that do not need to be graded.
Grading: multiple choice questions are 1 point each (total 30 points); short answer question points are indicated (total 10 points) and the ethics question is 10 points. Exam total is 50 points.
Asking questions during the exam: you may NOT ask questions during the licensure examination, so none will be permitted during the midterm. However, if you believe that a question is technically flawed, please indicate your concern in a comment on the exam page and turn it in with your answer sheets.
So as to not confuse you, terms like NOT, TRUE, and FALSE are presented in BOLD, ALL-CAPS.
MULTIPLE CHOICE QUESTIONS (30 points)
- Drugs in which of the following controlled substances Schedules may NOT be prescribed unless the FDA authorizes the drug to be utilized for investigational purposes.
a. Schedule I* b. Schedule II c. Schedule III d. Schedule IV e. Schedule V
- Which controlled substances Schedule includes drugs from another schedule that are combined with other therapeutic ingredients. Examples include Acetaminophen 325mg with Hydrocodone 5 mg or Acetaminophen 325 mg with Codeine 30 mg.
a. Schedule I b. Schedule II c. Schedule III* d. Schedule IV e. Schedule V
- A multi-state corporation desires to operate a pharmacy in Washington. The corporation's Chief Financial Officer signs the application for a DEA Certificate of Registration. Who may sign the Schedule II controlled substance Order Form?
a. A non-pharmacist district manager b. Only pharmacists employed at the location c. Only the Chief Financial Officer d. Any person for whom a power of attorney is executed* e. Only those individuals registered with the DEA
- Receipt of controlled substances listed in Schedule II and completion of the Order Form may only be performed by:
a. pharmacists b. the pharmacist in charge c. any person to whom a power of attorney is granted d. any person designated by the pharmacist in charge* e. the person who signed the initial application for a DEA Certificate of Registration
- A pharmacist receives a request from a patient to transfer two prescriptions from another store within the same chain. The stores share an on-line, real-time computer system. The prescriptions are for alprazolam 0.25mg (a Schedule IV drug) and omeprazole 20mg capsules (a legend drug.) The omeprazole prescription has 3 refills remaining and the alprazolam has 1 refill remaining. The record also reflects that the prescriptions were originally dispensed at another pharmacy that did not share an on-line, real time computer system. The pharmacist may transfer and dispense:
a. the omeprazole and the alprazolam. b. the omeprazole and the alprazolam only if she contacts the original pharmacy. c. the omeprazole only* d. the omeprazole and the alprazolam for one dispensing only e. the omeprazole and alprazolam only if done by oral communication between pharmacists
- In the State of Washington, for which of the following medical conditions or diagnoses may authorized practitioners prescribe stimulant drugs that are controlled in Schedule II?
I. A.I.D.S II. Narcolepsy III. ADHD
a. I only b. II only c. II and III only * d. III only
- Under the new Federal law that restricts the amount of ephedrine, pseudoephedrine and phenylpropanolamine that may be purchased at retail, what is the maximum amount of pseudoephedrine that may be purchased by one person in any 24 hour period?
a. 60 mg b. 1.0 Gm c. 3.0 Gm d. 3.6 Gm *
- Under WA law, what quality standards are required for ingredients used in compounding?
a. Certificate of analysis b. Prescriber's recommendations c. FDA Quality Guidance d. International Conference on Harmonization (ICH) e. Pharmacists' professional judgment *
- Complete prescription labels are NOT required for C-IIs if no more than a 5 day supply is dispensed at one time if dispensed:
a. To a board and care home patient b. To an inpatient in an acute care hospital * c. To a hospice patient d. To a patient in a skilled nursing facility
- Under HIPAA, which is NOT a right of a patient?
a. Patients may request for communication through their cell phone rather than their office phone. b. Patients may complain about privacy practices used at their dentist office. c. Patients may request to see the credentials of their pharmacist * d. Patients may correct errors in their protected health information (PHI) e. Patients may choose to restrict disclosure of their protected health information (PHI)
- A statute differs from a regulation in that a statute:
a. is created by legislatures * b. is created by agencies c. is not reported in a federal or state register for public comment d. may be invalidated by the court
- The Washington Board of Pharmacy is established by the legislature by enacting or amending the:
a. Revised Code of Washington * b. Washington Administration Code c. United States Code d. Code of Federal Regulations
- Justice, in the context of ethics, refers to:
a. Doing things in accordance with the law b. Ensuring an equal distribution of society's "goods" c. Ensuring an fair distribution of society's "goods" * d. Making decisions that are fair only to the patient
- According to the US Food, Drug and Cosmetic Act, which of the following substances are NOT defined as drugs?
a. its active ingredient is contained in the United States Pharmacopeia b. it is used in manufacturing an active ingredient c. if the prescriber intends to use it for curative purposes * d. if it is intended to affect the structure of the body of man or other animals
Name: _________________________ Student Number: |||||||__|
- Stare decisis refers to:
a. a form of statutory law b. is established by previous court decisions * c. is binding on the rulings of courts in other jurisdictions d. is applicable only to lower courts in a jurisdiction
- Which of the following DEA numbers would be valid for Mark Jones, MD?
a. MJ 5831791 b. AJ 5831791 * c. MJ 5831794 d. AJ 5831792 e. BM 5831792
- Which of the following statements is true about drug recalls?
a. Recalls are usually conducted by the Food and Drugs Association b. A manufacturer may initiate recall without FDA authorization * c. Class III recalls apply to products likely to cause serious harmful effects d. Type 2 recalls are conducted at the consumer level
- A prescription for controlled substances must have all of the following EXCEPT :
a. The prescriber's address b. Date of issue c. The symbols C-I to C-V * d. Prescriber's DEA number e. Prescriber's signature
- For cases involving Washington law, which is the "court of last resort"?
a. U.S. Supreme Court b. 9th Circuit of U.S. Circuit Courts of Appeals c. U.S. District Courts d. Washington Supreme Court * e. Washington Court of Appeals
- What is the difference between common law and state law? Which of the following is true?
a. State law derives from previous court decisions b. Common law may derive from court decisions about agency rules * c. Common law derives from state laws d. Common law and state law are equivalent
- Who may NOT sign a request for additional schedule II order forms (DEA-222)?
a. Pharmacist in charge * b. Signatory on original DEA application c. Pharmacist with durable power of attorney d. Technician with durable power of attorney
Name: _________________________ Student Number: |||||||__|
Short Answer Questions. (10 points) Confine your answers to the space provided.
- The technical term used to describe the United States Code (USC) and the Revised Code of Washington (RCW) is: (1 point)
Laws or Statutes
- The technical term used to describe the Code of Federal Regulations (CFR) and the Washington Administrative Code (WAC) is: (1 point)
(Rules or Regulations)
- Name three characteristics of the Federal controlled substances distribution system. (3 points)
a. It is a closed system. b. All persons/firms must be registered with DEA to handle these drugs. c. Everyone must maintain proper records of receipt and disposition. d. The records must be made available to representatives of the DEA and Board of Pharmacy.
- Which controlled substances Schedule includes drugs that have a high potential for abuse, have an approved medical use, require a written prescription, and may not be refilled? (1 point)
(Schedule II)
- Excluding the initial inventory, controlled substance inventories must be taken every _________
years and documentation must be kept on-site for ____________ years. (1 point) (2,2)
- Under WA state law, a person who has already made two purchases must wait ________ before
the next purchases of over-the-counter codeine cough syrups. (1 point) (60 days)
- _________________ has jurisdiction over general pharmacy compounding. (1 point) (State
Boards of Pharmacy)
- HIPAA is the federal statute regulating confidentiality of health care information. What is the WA
state statute described in RCW 70.02 that regulates confidentiality of health care information?
_________________ (1 point) (Uniform Health Care Information Act)
Name: _________________________ Student Number: |||||||__|
Ethics Question. (10 points) Read the Wall Street Journal article by Tara Parker-Pope.
©2006 Dow Jones & Company, Inc. Parker-Pope Tara. 2006 21/22 October, Page R3.
WHEN IS A HORMONE not a drug?
As scores of menopausal women look for alternatives to traditional hormone treatments, a debate is raging about what to call hormones that are custom mixed by pharmacists -- and whether they are any safer than commercial hormone preparations or prescription-drug alternatives.
Women are flocking to the products, which promoters call "bio- identical hormones," because they have the same molecular makeup as the hormones produced in a woman's body. As a result, the compounds are often promoted as "natural" hormones that don't carry the same risks as hormone drugs sold by pharmaceutical companies. "I don't consider them drugs," says Steven F. Hotze, founder of the Hotze Health & Wellness Center in Houston and a staunch supporter of compounded hormones. "They are identical to the hormones in your body. They are hormones. Drug companies make drugs that mimic hormones."
But critics say the terms "bio-identical" and "natural" are misleading to women who think the products act differently in their bodies than commercial hormone drugs. There's no published evidence that compounded hormones are any safer or have any fewer risks or more benefits than traditionally prepared hormones.
Wulf Utian, executive director of the North American Menopause Society, notes that pharmacies get many of the ingredients for compounded hormones from the same suppliers that drug companies use for certain hormone products. In addition, the estrogen used in compounded hormones is derived from yams or plant sources. "The terms 'natural' and 'bio-identical' are scientifically nonwords," Dr. Utian says. "Natural hormones from yams or cactus or beans are totally foreign to women."
The Food and Drug Administration has said women should assume all hormone preparations carry the same risks and benefits. While commercial hormone products carry that warning, custom-mixed pharmacy hormones do not. Drug maker Wyeth has petitioned the FDA to look into the issue and require all hormone products to carry the same warnings. The FDA has yet to respond to the request.
But the debate about compounded hormones has been reignited in recent weeks by actress Suzanne Somers, whose new book, "Ageless," promotes compounded hormones. Her earlier book "The Sexy Years" is often credited with spurring widespread consumer interest in compounded hormones.
Dr. Hotze says criticism that bio-identical hormones are derived from plants is irrelevant. "If it came from concrete it wouldn't make any difference," says Dr. Hotze. "It's the molecule -- the body doesn't care where it comes from."
Last week, the menopause society's annual meeting in Nashville hosted a session on compounded hormones attended by a crowd of about 400 physicians -- about double the usual attendance of the society's sessions. Dr. Utian says the main message he wants to promote is that women be informed about the products they are using, and be aware that all hormones, whether made by pharmacies or drug companies, likely carry the same risks and benefits.
"The argument is not against the use of compounded hormones," says Dr. Utian. "The argument is that women aren't being informed."
39. How do WA regulations differ from FDA’s Pharmacy Compounding Compliance Policy Guide
with regard to selecting the active ingredients? (2 points)
Confine response to space provided.
CPG specifies that active ingredients come from FDA-approved sources. WAC permits
pharmacist judgement 246-878-
