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Reference Guide for Pharmacy Management and Pharmacoeconomics Questions and Answers Krisman www.pharmacyexam.com 1 REFERENCE GUIDE FOR PHARMACY MANAGEMENT & PHARMACOECONOMICS Questions and Answers SECOND EDITION 2013-2014 MANAN H. SHROFF

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Page 1: REFERENCE GUIDE FOR PHARMACY - Pharmacy Exam

Reference Guide for Pharmacy Managementand Pharmacoeconomics Questions and Answers

Krisman

www.pharmacyexam.com 1

REFERENCE GUIDE FORPHARMACY MANAGEMENT

&PHARMACOECONOMICS

Questions and Answers

SECOND EDITION 2013-2014

MANAN H. SHROFF

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This book is not intended as a substitute for the advise of physicians. Students or readers mustconsult their physician about any existing problem. Do not use information in this book for anykind of self treatment. Do not administer any dose of mentioned drugs in this book withoutconsulting your physician. This is only a review guide for the preparation of the Foreign PharmacyLicensing Exam (FPGEE ), and North American Pharmacy Licensing Exam (NAPLEX )

The author is not responsible for any kind of misinterpreted, incorrect, or misleadinginformation or any typographical errors in this book. Any doubtful or questionable answers shouldbe checked in other available reference sources.

All rights reserved.

No part of this book may be reproduced or transmitted in any form or by any means, electronicallyphotocopying, recording, or otherwise, without prior written permission of the publisher.

RXEXAM is a registered trademark of Pharmacy Exam of Krishna Publications Inc. Anyunauthorized use of this trademark will be considered a violation of law.

NAPLEX and FPGEE are registered trademarks of the National Association of Boards ofPharmacy (NABP). This reference guide is in no way authorized by or sponsored by NABP.

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Reference Guide for Pharmacy Managementand Pharmacoeconomics Questions and Answers

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REFERENCE GUIDE FORPHARMACY MANAGEMENT

&PHARMACOECONOMICS

Questions and Answers

SECOND EDITION 2013-2014

Dedicated ToMy beloved

grandmother

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PREFACE:

I am very happy to introduce this new review guide that covers the major portion ofpharmacy management and pharmacoeconomics. As in recent years, FPGEE exam isputting more weight on management and the economic portion of the pharmaceuticalfield, which has inspired me to introduce a guide that may help students to answersquestions in the exam related to these topics.

I tried to cover all the pharmacy management and pharmacoeconomics aspects in thisguide. The reason to introduce this review guide is to provide foreign students withenough information regarding the management aspect of health care in the U.S.

The students must try to understand the information provided in this guide since that’sthe only way to apply your logic to answer management and economics related ques-tions in the exam. You may not receive straightforward questions from this guide, how-ever the information presented in this guide will definitely help you to guess the bestlogical answer for a given question.

I hope my efforts will bring you much success.

Best of luck,

Manan H. Shroff

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TABLE OF CONTENTS

1. Questions 62. Answers 79

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QUESTIONS

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1. For two drug products to be consid-ered bioequivalent:

I. The rate of absorption between theproducts may differ by -20%/+25% orless.

II. The 90% confidence interval for theratio of the mean response is withinthe limits of 0.8 to 1.25.

III. The extent of absorption between theproducts may differ by -20%/+25% orless.

a. I onlyb. I and II onlyc. II and III onlyd. All

2. A prescription for Lorazepam issuedon 01/01/2001 should not be filled after:

a. 04/01/2001.b. 07/01/2001.c. 10/01/2001.d. 01/01/2002.

3. Which of the following statements isTRUE about physician assistants (PAs)?

I. PAs are healthcare professionalslicensed to practice medicine withphysician supervision.

II. PAs are allowed to write prescriptions.

III. PAs are educated in the medical modeldesigned to complement physiciantraining.

a. I onlyb. I and II only

c. II and III onlyd. All

4. Current DUR procedure in most healthplans usually focuses on:

I. Product-centered DUR study.II. Patient-centered DUR study.III. Healthcare system-centered

DUR study.

a. I onlyb. I and II onlyc. II and III onlyd. All

5. Which of the following best describesthe Medicare Advantage Plan?

I. The Medicare Advantage plan includesHMOs offering prescription drugcoverage.

II. The Medicare Advantage plan includesPPOs offering prescription drugcoverage.

III. The Medicare Advantage plan wasformerly known as Medicare + Choice.

a. I onlyb. I and II onlyc. II and III onlyd. All

6. The Medicare Part D prescription drugbenefit program was enacted as part of theMedicare Prescription Drug under the:

a. DBA.b. OBRA.c. MCA.d. MMA.

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7. Which of the following factors is themost responsible for lower medication adher-ence rates in blood-glucose lowering therapy?

a. Medication side effectsb. Frequent dosingc. Lack of perceived regimen benefitsd. Medication costs

8. Mrs. Gomes seems to be reluctant toanswer Mr. Shah’s direct questions about hercompliance with high blood pressure medica-tion. What type of questions should Mr. Shahask to get a more detailed explanation?

a. Open-endedb. Closed-endedc. Authorized. Affirmative

9. According to WHO, health is definedas:

a. The absence of illness.

b. A healthy state of well-being, free fromdisease.

c. A state of complete physical, mentaland social well-being and not merelythe absence of disease or infirmity.

d. The overall condition of an organismat a given time in regard to soundnessof body.

10. Which of the following codes is clas-sified as a “Diagnosis-code” in the currenthealthcare setting?

I. ICD 9II. CPTIII. NDC

a. I onlyb. I and II onlyc. II and III onlyd. All

11. Mrs. Gomes states, “ I am tired of tak-ing this medication. Sometimes I don’t takethem like I should.” Mr. Shah responds by say-ing, “How long have you been taking thismedication, Mrs. Gomes? Is it causing you anyparticular side effects?” Mr. Shah’s responseis an example of what type of response?

a. Analyzingb. Evaluatingc. Quizzingd. Advising

12. The Poison Prevention Packaging Actis generally enforced by the:

a. FDA.b. CPSC.c. DEA.d. FTC.

13. The approval of new packaging and la-beling of already marketed drugs should bedone by filling out a(n):

a. NDA.b. ANDA.c. SNDA.d. IND.

14. All of the following are disease spe-cific quality of life instruments EXCEPT:

a. AIMS.b. FLIC.c. QOLIE.d. KDQOL.

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15. What should be measured in a CUAstudy?

I. CostII. ConsequencesIII. Survival rate

a. I onlyb. I and II onlyc. II and III onlyd. All

16. Schedule V prescription controlleddrugs:

a. Can be refilled 999 times.b. Can be refilled 5 times.c. Can be refilled indefinitely.d. Can never be refilled.

17. Pharmacies may transfer the refillprescription for Schedule III, IV and V con-trolled substances only:

a. One time.b. Two times.c. Three times.d. Four times.

18. All of the following are principal com-ponents of a Pharmacy Benefit Management(PBM) program EXCEPT:

a. Drug formulary.b. Mandatory generic substitution.c. Prescription co-payment.d. Prospective DUR.

19. Which of the following shall be in-cluded in protocol prepared pursuant to the col-laborative drug therapy management agree-ment?

I. The list of specific drug or drugs to bemanaged by the pharmacist.

II. The terms and conditions under whichdrug therapy may be implemented,modified or discontinued.

III. The conditions and events upon whichthe pharmacist is required to notify thephysician.

a. I onlyb. I and II onlyc. II and III onlyd. All

20. The warning “Caution: Federal lawprohibits the transfer of this drug to any per-son other than the patient for whom it was pre-scribed” is required when dispensing:

I Schedule II controlled drugs.II Schedule III controlled drugs.III Schedule V controlled drugs.

a. I onlyb. I and II onlyc. II and III onlyd. All

21. Which of the following are classifiedas NTI drugs?

I. CarbamazepineII. TheophyllineIII. Naltrexone

a. I onlyb. I and II onlyc. II and III onlyd. All

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22. Which of the following barriers has themost significant effect on communication be-tween pharmacists and prescribers?

a. Timeb. Knowledgec. Attituded. Money

23. Which of the following is NOT TRUEabout emergency prescribing of controlled IIdrugs?

I. Pharmacists can only dispense 30 unitsof prescribed drug.

II. Prescribers should send coverprescriptions within 7 days fromauthorizing emergency controlleddrugs.

III. Pharmacists have to make reasonableefforts to ensure that the informationprovided by the prescriber is correct.

a. I onlyb. I and II onlyc. II and III onlyd. All

24. Common abuses of the fee-for-servicesystem include which of the following?

I. ChurningII. UpcodingIII. Unbundling

a. I onlyb. I and II onlyc. III onlyd. All

25. The program of palliative and support-ive care services that provides physical, psy-chological, social, and spiritual care for ter-minally ill persons, their families, and otherloved ones is defined as:

a. Home infusion care.b. Skilled nursing facility care.c. Hospice care.d. Long-term care.

26. The partial filling of Oxycodone +APAP to a patient who resides in Charlestownnursing home should be done within:

a. 24 hours.b. 72 hours.c. 48 hours.d. 60 days.

27. What is the most stated reason for non-compliance?

a. Costb. Forgetfulnessc. Side effectsd. Confusion

28. A diabetic patient has been asked:“Have you ever had a low blood sugar reac-tion?” by a caregiver provider. This type ofquestion usually:

a. Encourages patients to discuss thedisease.

b. Is classified as too personal and shouldnot be asked.

c. Discourages patients to discuss thedisease.

d. Is classified as the most appropriatequestion according to BloomsTaxonomy of Education.

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29. Which of the following communitypharmacy provider networks have the highestreimbursement rates and program costs?

a. Pre-contracted networksb. Customized networksc. Closed networksd. Specialized networks

30. Medicare is a health insurance programfor:

I. People 65 years of age and older.II. People with disabilities under 65 years

of age.III. People with End-Stage Renal Disease.

a. I onlyb. I and II onlyc. II and III onlyd. All

31. If the expiration date on a bulk bottleof Cephalexin is MAY 2007, the drug shouldnot be used after :

a. April 30, 2007.b. May 31, 2007.c. May 1, 2007.d. April 15, 2007.

32. Which of the following is the correctDEA number for Dr. Bridge, Robert?

a. AB 3254767b. BB 1244691c. AR 1354789d. MR 2489432

33. The Medicare Advantage program isalso known as:

a. Medicare Part A.b. Medicare Part B.c. Medicare Part C.d. Medicare Part D.

34. A personal care health service givento a patient who is not a bed patient in ahealthcare institution is defined as:

a. Primary care.b. Ambulatory care.c. Manage care.d. Secondary care.

35. What are instruments that help to mea-sure utility values?

I. Rating scaleII. Standard gambleIII. Time-trade off

a. I onlyb. I and II onlyc. II and III onlyd. All

36. The principal goal of a CMA studywould be to determine:

a. The long-term outcome of theparticular illness.

b. The cost associated with two differenttreatments that have clinicallyidentical effectiveness.

c. The benefits in terms of monetaryunits.

d. Cost and outcomes in monetary units.

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37. Which of the following is an advantageof using Cost of Illness Analysis (CIA)?

I. This method allows researchers tocollect and assess disease specific data.

II. It provides a true definition of theparticular illness.

III. It provides researchers informationabout epidermology and potential outcome of illness, and the consequencesassociated with the illness.

a. I onlyb. I and II onlyc. II and III onlyd. All

38. Which of the following factors affectthe prescriber’s drug decision?

I. Medical management protocolsII. Financial incentivesIII. Formularies

a. I onlyb. I and II onlyc. II and III onlyd. All

39. Which of the following statements areTRUE regarding Medicare Part B premiumsstarting 2007?

I. The member monthly premium will behigher if they file an individual taxreturn and their annual income is morethan $80,000, or if they are married(file a joint tax return) and theirannual income is more than $160,000.

II. Social Security will use the incomereported two years ago on themember’s IRS income tax return todetermine the premium if the planmember income is more than $80,000or $160,000 jointly.

III. Most people will pay the standardmonthly Part B premium if theirannual income is less than $80,000, orif they are married (file a joint taxreturn) and their annual income is lessthan $160,000.

a. I onlyb. I and II onlyc. II and III onlyd. All

40. What is often used by employers andhealth benefit consultants in evaluating the ef-ficiency of a health plan?

a. PCPb. RADc. UPCd. MLR

41. Which of the following help to calcu-late pharmacy program performance metrics?

a. Acid ratiob. MLR ratioc. PMPM cost ratiod. DUR/DUE ratio

42. The abuse of prescription drugs in theUnited States is:

a. An ongoing problem that is unlikelyto change.

b. On the rise and has a dramatic impacton society in a multi-factorial way.

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c. Mostly due to endemic prescribingproblems.

d. Mostly due to endemic dispensingproblems.

43. Which of the following is/are trueabout dispensing CII prescriptions in emer-gency situations?

I The quantity prescribed and dispensedshould be limited to emergencysituations.

II The prescription must be immediatelyreduced to writing and shall contain allthe information except the prescriber’ssignature.

III The prescriber must submit a writtenprescription for the emergencyquantity prescribed within 72 hoursafter authorizing a verbal prescription.

a. I onlyb. I and II onlyc. II and III onlyd. All

44. What type of formulary is preferred byphysicians?

a. Open formularyb. Closed formularyc. Intermediate formularyd. Negative formulary

45. Managed care plans are trying to en-courage pharmacies to accept the prescriptionreimbursements through capitated plans by:

I. Applying stop-loss provisions that cappotential losses.

II. Carving out certain high-cost diseasestates.

III. Creating risk pools that include largenumbers of pharmacies that share risk.

a. I onlyb. I and II onlyc. II and III onlyd. All

46. Which of the following controls Medi-care?

a FTCb PTCc HCFAd CSA

47. Which of the following should be partof a Drug Utilization Review?

I. Drug-food interactionII. Duplication of therapyIII. Direction for use

a. I onlyb. I and II onlyc. II and III onlyd. All

48. To prevent accidental poisoning inyoung children, which of the following lawswere developed?

a. PPPAb. CSAc. PPId. FTC

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c. Patients should carry their walkingcane on the side opposite their weaklimb.

d. The cane provides a means to transferweight off the strong limb.

314. All of the following can be consideredthe current liability of a pharmacy EXCEPT:

a. Accounts payable.b. Notes payable within 1 year.c. Accrued expenses.d. Notes payable beyond 1 year.

315. DEA form 224a should be used for

I Renewal of a registrationII New registrationIII Stolen controlled substances

a. I onlyb. I and II onlyc. II and III onlyd. All

316. What is the mean binomial distributionif the probability of success is 0.20 in 100 tri-als?

a. 56b. 20c. 18d. 43

317. Which of the following ratios gener-ally indicates the efficiency of a pharmacy?

a. Net profit to total assetsb. Inventory turnover ratec. Capitalization of net profitd. Net profit to net sales

318. Rite Care Pharmacy’s part of the finan-cial balance sheet is as follows:

YEAR 2007 SALES

RX $800,000Merchandise $170,000Total $970,000Cost of goods sold $400,000Beginning inventory $175,000Ending inventory $140,000

What would be the inventory turnover rate forRite Care Pharmacy?

a. 4.39b. 2.54c. 3.05d. 6.11

319. Patient: “I will take the medicine. I justdon’t like that I have to take it to be okay.” Apharmacist should respond:

a. You do need to take it. You have todecide to take the medicine.

b. It is for your own good.

c. You really do need to take themedicine each day.

d. I believe that taking the medicine is thebest decision for controlling yourblood pressure.

320. Patient: “I never used to have to takemedicine. I don’t like getting old.” A pharma-cist should respond:

a. Even young people have to take drugs.

b. Growing older has been difficult foryou to accept.

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c. You are healthy otherwise.

d. What concerns you the most about thismedicine?

321. Which disease state has demonstratedthe benefit of having pharmacists working ina collaborative setting?

a. Hypertensionb. Depressionc. Diabetesd. Hemodialysis

322. What would be the Pearsonian coeffi-cient of skewness if a sample has a mean of145 and a median of 125. The standard devia-tion of the sample is 110.

a. 0.86b. 0.65c. 0.54d. 0.35

323. The reproducibility of results of a num-ber of experiments is generally known as:

a. Precision.b. Bias.c. Accuracy.d. Classlessness.

324. Which of the following statements areTRUE about a paired t-test?

I. It has the advantage of reducedvariability over a two sample t-test.

II. It needs less experimental materialcompared to a two sample t-test.

III. It has the potential disadvantage ofcarry-over effect from previousexperiment.

a. I onlyb. I and II onlyc. II and III onlyd. All

325. Which of the following accounts formost healthcare expenditure coverage?

a. Medicaidb. Medicarec. Private insuranced. Out-of-pocket

326. The net sales of the Rite Care pharmacyare $150,000. Find out the ratio of net salesto inventory of the pharmacy. (Assume inven-tory of Rite Care pharmacy at time of calcula-tion is $50,000.)

a. 3b. 5c. 9d. 0.33

327. Which of the following prevents themisleading advertising of OTC products?

a. FDAb. NABPc. USANd. FTC

328. The acid test generally measures apharmacy’s:

a. Financial position.b. Liquidity.c. Profitability.d. Inventory.

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329. Which of the following is known asthe Drug Efficacy Amendment?

a. Food, Drug and Cosmetic Actb. Durham-Humphrey Amendmentc. Kefauver-Harris Amendmentd. Orphan Drug Act

330. Which of the following is the mostcommon site of accidental poisoning outsidethe home?

a. Garageb. Gardenc. Patiod. Deck

331. Mr. Brace, a long-term care resident,has been a member of the same Medicare pre-scription drug plan for the first 6 months of2007 and is in the catastrophic portion of hiscoverage. One weekend night he comes downwith a urinary tract infection and the doctoron call prescribes a non-formulary antibioticthat Mr. Brace has never taken before. Whichof the following statements is true?

a. Mr. Brace will have to pay the full pricefor the medication and make aformulary exception request onMonday.

b. Due to the fact that Mr. Brace is an LTCresident, he will be allowed anemergency supply of medication totreat his condition.

c. Antibiotics are in one of the excludedclasses so it is not covered anyway.

d. The plan must cover the antibiotic because it is in one of the 6 protectedclasses.

332. Which of the following is the greatestbarrier for pharmacists in terms of giving morecognitive services?

a. Lack of physician approvalb. Inadequate reimbursementc. Inadequate resourcesd. Patients not accepting pharmacist’s

knowledge of drug therapy

333. If the value of p = 0.7 in binomial distri-bution, what is the probability of failure?

a. 0.2b. 0.4c. 0.3d. 1.0

334. A percentage of the costs of each ser-vice that must be paid by the insured alongwith the insurance policy payment should bedefined as the:

a. Deductible.b. Co-pay.c. Coinsurance.d. Medigap.

335. When the hypothetical value of a pa-rameter is the same as the observed value of aparameter, the error should be considered:

a. Alfa error.b. Beta error.c. Gamma-error.d. Infinitive.

336. Which of the following would meet thequalifications of incident-to billing?

a. Performed by a physicianb. Physician must directly supervise the

visit by being in the same room as theother healthcare professional

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c. Services are separate from thephysician’s normal course of treatment

d. A service ordinarily done in aphysician’s office

337. Find out the retail price of a box of insu-lin syringes if the cost complement of the prod-uct is 30% and the cost of one box of insulinis $11.25.

a. $14.95b. $37.50c. $25.26d. $12.99

338. In a clinical experiment, drug A is com-pared to a placebo using 30 patients for thedrug treatment and 30 different patients for theplacebo treatment. Which of the following sta-tistical tests would be appropriate?

a. Chi squareb. Paired t-testc. Two independent t-testsd. F-test

339. Cognitive services primarily focus on:

I. Optimizing a patient’s drug therapy.II. Ensuring appropriateness of a patient’s

drug therapy.III. Ensuring safety and efficacy of a

patient’s drug therapy.

a. I onlyb. I and II onlyc. II and III onlyd. All

340. All of the following indicate the ratiothat measures the efficiency of a pharmacyEXCEPT:

a. Inventory turnover rate.b. Net sales to inventory.

c. Acid test.d. Net sales to net working capital.

341. Which of the following is the greatestbarrier for pharmacists in terms of giving col-laborative services?

a. Lack of physician approvalb. Inadequate reimbursementc. Inadequate resourcesd. Patients not accepting pharmacist’s

knowledge of drug therapy

342. Which of the following duties can beperformed by a certified pharmacy technician?

I. Taking a stock bottle from the shelf fora prescription.

II. Reconstituting medication.III. Initiating and receiving refill

authorization requests.

a. I onlyb. I and II onlyc. II and III onlyd. All

343. Which of the following laws inspiredthe FDA to publish the Orange Book ?

a. Durham-Humphreyb. Waxman-Hatchc. Kefauver-Harrisd. OBRA-90

344. Which of the following is correct withrespect to training requirements for pseu-doephedrine sales under the new federal law?

a. Only pharmacists and techniciansrequire training.

b. The training must be performed byDEA personnel.

c. Pharmacies may self-certify thatemployees have been trained.

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d. There is no training requirement.

345. A pharmacist is adding 500 mg of purecodeine powder to 100 cc of acetaminophenwith codeine Elixir (120mg/12mg/5cc). Theresultant mixture should be classified as:

a. Schedule V.b. Schedule II.c. Schedule III.d. Schedule IV.

346. Who is responsible for assuring that aprescription has been issued for a legitimatemedical purpose?

a. The prescriber onlyb. The dispensing pharmacist onlyc. The prescriber and the dispensing

pharmacist share this responsibilityd. The DEA only

347. The average rate of compliance forpatients with a chronic illness is approxi-mately:

a. 75%.b. 25%.c. 50%.d. 90%.

348. Which of the following controlledsubstance(s) requires an exact count when tak-ing inventory?

I. DextroamphetamineII. HydromorphoneIII. Fentanyl

a. I onlyb. I and II onlyc. II and III onlyd. All

349. Which of the following about a Bino-mial experiment is NOT true?

a. Each trial results in an outcome that isclassified as success or failure.

b. The repeated trials are dependent uponprevious experiment.

c. The experiment generally consists ofn-repeated trials.

d. The probability of success remainsconstant from trial to trial.

350. Which of the following drugs requiresa DEA 222 order form in order to purchase?

I. MethylphenidateII. PentobarbitalIII. Secobarbital

a. I onlyb. I and II onlyc. II and III onlyd. All

351. Which of the following is most con-sistent with the American Association of Col-leges of Pharmacy’s definition of clinical phar-macy?

a. Focus on outcomesb. Development of patient oriented

attitudesc. Obtaining collaborative practice

agreements with physicians in lieu ofacquisition of knowledge

d. Maximizing patient outcomes withemphasis on patient education

352. A collaborative drug therapy manage-ment agreement may authorize a pharmacistto:

I. Implement, modify or discontinue adrug therapy that has been prescribedfor a patient.

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II. Order associated laboratory tests.III. Administer drugs.

a. I onlyb. I and II onlyc. II and III onlyd. All

353. Which of the following are principalgoals of collaborative practice?

I. To promote the most efficient andclinically appropriate use of resources.

II. To reduce unnecessary variationbetween caregivers and effectstandardized practice guidelines.

III. To collect valuable outcomes and/orutilization data.

a. I onlyb. I and II onlyc. II and III onlyd. All

354. Mrs. Shenaz, a Medicare part D eli-gible beneficiary, turns 65 in 2007 and signsup for a Medicare Part D prescription drug planwith no enhanced benefits. She has been amember in the plan for 20 days and goes toher neighborhood pharmacy with a prescrip-tion for diazepam. Which of the followingstatements is true?

a. Mrs. Shenaz is within the first 90 daysof coverage so her plan should pay forthis prescription.

b. We would need to know what phaseof coverage she is in before we couldtell if this prescription would becovered, regardless of how long shehas been a member.

c. Diazepam is considered a Part Dexclusion, therefore it would not becovered even if she was in hertransition period.

d. The pharmacist will not fill herprescription, but tell her to go homeand wait for a letter from the plan.

355. Which of the following organizationscompiles the NDC directory?

a. FDAb. CSAc. DEAd. USAN

356. The partial supply of which of the fol-lowing should be filled within 72 hours fromits initial dispensing?

a. Alprazolamb. Dextroamphetaminec. Pemolined. Zaleplon

357. Mr. Mehta is in charge of controlleddrugs at Rite Care Pharmacy. One of his tech-nicians reports a whole stack of DEA 222 or-der forms has gone missing. Mr. Mehta must:

I. Prepare another form in triplicate withthe statement indicating serial numberand date of lost forms.

II. Notify the DEA in the nearest localarea.

III. Submit copies 1 and 2 of the secondform with a statement to the supplier.

a. I Onlyb. I and II onlyc. II and III onlyd. All.

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(c) If it is a drug and the methods used in,or the facilities or controls used for, itsmanufacture, processing, packing, orholding do not conform to or are notoperated or administered in conformitywith current good manufacturingpractice to assure that such drug meetsthe requirements of this Act as to safetyand has the identity and strength, andmeets the quality and puritycharacteristics, which it purports or isrepresented to possess.

(d) If its container is composed, in wholeor in part, of any poisonous ordeleterious substance which mayrender the contents injurious to health.

(e) It bears or contains, for purposes ofcoloring only, a color additive that isunsafe.

(f) If it purports to be or is represented asa drug the name of which is recognizedin an official compendium, and itsstrength differs from, or its quality orpurity falls below, the standards setforth in such compendium.

(g) If it is a drug and any substance hasbeen mixed or packed therewith so asto reduce its quality or strength orsubstituted wholly or in part thereof.

236.(b) Below expectation.

= Total liabilities Net worth

= 85,000 x 100 115000

= 73.91%

The target value for total liabilities to net worthratio would be 50% or less.

237.(d) A Cochrane database reviewshowed that pharmacist intervention can im-prove patient adherence, physician prescrib-ing, decrease drug-related morbidity, and de-crease healthcare costs.

238.(d) All. This ratio is calculated bydividing profit by inventory. It is a good indi-cator of profitability as well as efficiency. Itcan be used for new and old pharmacies. Itincreases with an increase in sales of a phar-macy.

239.(d) Ativan (Lorazepam) should beclassified as a Schedule IV controlled drug. Itis indicated for the treatment of anxiety andinsomnia.

240.(d) This is an example of resis-tance. When patients are faced with change,like taking a newly prescribed medicine tocontrol a new illness, they are often resistantto doing what is needed. Resistance behaviorcan take many forms. Patients can negatethings you say by blaming, disagreeing, ex-cusing, minimizing, etc. They may argue withyou by challenging you, discounting what yousay or becoming hostile or agitated. They mayresist by interrupting frequently or by ignor-ing things you say. The point is that sensitivehealthcare providers listen for resistance onthe part of the patient. Resistance may occurbecause patients are ambivalent or there maybe other factors involved. A patient may notbe able to afford the medicine or simply doesnot believe the problem is that bad and is not asignificant health threat. In any case, resistanceneeds to be explored. The key word here indealing with ambivalence or resistance isEXPLORE. Arguing for the benefits forcesthe patients to argue for the reasons they don’twant to take the medicine (blood pressure,

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etc.). This is a time to ask the patient ques-tions about the resistance or ambivalence.Therefore, explore resistance by asking ques-tions. For example, the patient says, “I justcan’t believe that I have high blood pressure.I have always been so healthy.” In the abovestatement we feel that the patient is still notbelieving that he is ill and require medicine.The choices “a” and “c” make the patient atease and may end up in noncompliance. Thechoice “d” would help the pharmacist to ini-tiate communication with the patient withoutchallenging the beliefs of the patient (i.e. be-lief of being healthy). By initiating communi-cation, the pharmacist can address the signifi-cance of taking blood pressure medicationregularly.

241.(a) Pharmacists are permitted tomake changes to prescriptions, even to Sched-ule II prescriptions. But the permitted changesare limited. A pharmacist may add the patient’saddress or change the patient’s address with-out consulting the prescriber. The pharmacistmay change or add the dosage form, drugstrength, drug quantity, directions for use, orissue date only after consultation with andagreement of the prescriber. The pharmacistis never permitted to make changes to thepatient’s name, controlled substance pre-scribed (except for generic substitution per-mitted by state law) or the prescriber’s signa-ture.

242.(b) Under Part D, Medicare is setto pay 75% of initial drug costs up to $2400after a $250 deductible for most seniors. Butthen the program pays nothing until drug ex-penses reach $3840, after which the govern-ment pays 95% of all costs. The complete lackof coverage for drug spending between $2400and $3840 is often called Medicare’s “DonutHole.” This amount is reached by taking intoconsideration the full cost of the drugs, notjust the beneficiary’s out-of-pocket cost-shar-

ing. For example, if a drug costs $150 and thebeneficiary’s co-payment is $40, the full $150counts towards the initial coverage limit. Morethan one-quarter of all Medicare beneficiariesare projected to have drug spending that fallsin the Donut Hole’s range. The following ex-ample will help to clarify.

Mrs. Gomes has monthly drug costsof $800 for three drugs that cost $200, $300and $300, with a co-pay for each prescriptionat $40. Assuming that all of the plans in whichshe is interested have a $2400 initial coveragelimit, and that all of her drugs are on the plans’formularies, she will reach the Doughnut Holeor coverage gap in three months (800 x 3 =$2400). As stated previously, the full $800counts towards the initial coverage limit, eventhough the true out-of-pocket expenses aremerely $120 ($40 x 3 = $120). After threemonths, she has to pay all expenses out-of-pockets until she passes the limit of $3840 (i.e.from $2400 to $3840 = $ 1440 out-of-pocket).After passing $3840, the insurance will againkick in with 95% coverage provided by Medi-care and 5% patient’s out-of-pocket expenses.

243.(c) Oxycontin is a Schedule II con-trolled substance. When dealing with Sched-ule II controlled substances, it is better to re-verse the claim and return the prescription tothe patient. The other option would be to dis-pense the partial quantity within 72 hours ofinitial dispensing of the drug.

244.(c) A pharmacist may partially dis-pense a prescription for a Schedule II (Co-deine) drug if the pharmacist is unable to sup-ply the full quantity prescribed. The pharma-cist must note the quantity prescribed on thefront of the written prescription. The remain-ing portion may be dispensed within 72 hoursof the first partial dispensing. If the remainingportion cannot be dispensed within the 72-hourperiod, the pharmacist must notify the pre-

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scriber. No further quantity may be suppliedbeyond the 72 hours, except on a new prescrip-tion.

245.(a) Floor stock distribution sys-tem: In this type of dispensing, a bulk supplyof each drug product is maintained on the nurs-ing unit in advance of need and nurse preparesthe doses for administration. The lines of com-munication for drug orders are short (the phar-macist is excluded), decisions about orders anddose preparations are decentralized and can bemade at patient’s bedside. Nurses order drugsin bulk supplies from the pharmacy; the drugsare stored in a medication room on the ward.Nurses are responsible for any necessary la-beling. Any medications taken from stockbottles and not administered to patients aregenerally disposed of. Historically, this did notwork well because the unit dose preparationprocess demanded drug knowledge beyondthat of the typical nurse. A 1999 national sur-vey of drug dispensing and administrationpractices indicated that about half of the sur-veyed hospitals reported drug distribution“systems” that bypassed the pharmacy, includ-ing hospitals that reported using floor stocks,borrowing other patients’ medications, andhidden drug supplies. However, when accessto floor stock drugs that are stored in auto-mated dispensing machines is required by thenurse, he/she can access them only after thepharmacist has reviewed the order and acti-vated the dispenser.

Unit dose dispensing system: In thistype of system, when physicians write ordersfor inpatients, these orders are sent to the cen-tral pharmacy (by pharmacists, nurses, otherpersonnel, or computer). Pharmacists verifythese orders and technicians place drugs inunit-dose carts. The carts have drawers inwhich each patient’s medications are placedby pharmacy technicians’ one drawer for eachpatient. The drawers are labeled with the

patient’s name, ward, room, and bed number.Before the carts are transported to the wards,pharmacists check each drawer’s medicationsfor accuracy. Sections of each cart containingall medication drawers for an entire nursingunit often slide out and can be inserted intowheeled medication carts used by nurses dur-ing their medication administration cycles. Amedication administration recording form sitson top of the cart and is used by the nurse tocheck off and initial at the time of each ad-ministration of each medication. The next day,the carts are retrieved from the wards and re-placed by a fresh and updated medication sup-ply. Medications that have been returned to thecentral pharmacy are credited to the patient’saccount.

Patient prescription system: This sys-tem is distinguished by the fact that all drugsare retained in the pharmacy until the order isreceived, and then a multiple-dose supply isdispensed to the nursing unit labeled for useby a specific patient.

246.(b) Under the revised law, retailsales may not exceed 3.6g PSE (pseudoephe-drine) base per day per purchaser, regardlessof the number of transactions. The previouslaw placed limits only on individual transac-tions. Moreover, individual consumers are pro-hibited from purchasing more than 9g PSE per30-day period. All non-liquid forms (includ-ing gel caps) of PSE products must be sold inblister packs with no more than two dosagesor in unit dose packets or pouches.

247.(d) All. Each PDP must have aMedicare P&T committee that meets CMSdefined specifications. These requirements arebased on the current best practices also referredto as industry standard practices. P&T com-mittee members must come from various clini-cal specialties that adequately represent theneeds of plan beneficiaries.

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The membership requirements for this com-mittee are as follows:

1. A majority of the P&T committeemembers must be practicingphysicians, practicing pharmacistsor both.

2. At least one P&T committeepracticing pharmacist and onepracticing physician must be an expertin the care of elderly or disabledpersons.

3. At least one P&T committeepracticing pharmacist and onepracticing physician must beindependent and free of conflictwith respect to the PDP andpharmaceutical manufacturers.

All P&T committee members mustreveal any economic relationship they havewhich may influence their decisions and pro-vide this disclosure in writing. In addition, thecommittee must meet at a minimum of every3 months and document all formulary deci-sions in writing.

248.(d) All. A pharmacist should offerpatient counseling on new prescription drugorders, refill orders and once yearly on main-tenance drugs (maintenance medications aredefined as any medication the patient has takenfor one year or longer).

249.(b) The new law, the CombatMethamphetamine Epidemic Act of 2005,places new restrictions on the sale of pseu-doephedrine (PSE) because of its illicit use asa precursor for the illegal manufacture of meth-amphetamine, whose skyrocketing abuse hasforced Congress to respond.

250.(c) Median is classified as a non-parametric statistical test. Nonparametric sta-tistical procedures, commonly referred to as“distribution-free” statistics, do not require theassumption of normality and homogeneity ofvariance. The major underlying assumption ofnonparametric statistics is that the observationsare independent. Examples of nonparametricstatistics include the mode, median, Sperman’srho, and the Chi-square test.

251.(b) Neither walking canes norwalkers can provide support to the patient’swrists and elbows. The forearm crutch is de-signed specifically to provide such support inthat it has a vertical membrane that extendsabove the wrist and is secured reasonably wellto the fleshy part of the forearm by a collar orcuff. If only one crutch is used, it should beused on the side opposite the weak leg. Whentwo crutches are used, the patient should beinstructed to step forward with the right legand left crutch, followed by the left leg andright crutch.

252.(b) Noncompliance is defined aswhen the patient is at fault for inappropriateuse of medication. The noncompliance can bedetected by use of a Medication Event Moni-toring System (MEMS). The device is used inthe caps of prescription vials. Each time a pa-tient removes the cap of the vial (presumablythe same time the medication is ingested), thetime and data are recorded. At the time the dataare to be analyzed, the monitor can be con-nected to an IBM personal computer or equiva-lent. At the current time these systems are be-ing used primarily to monitor compliance inclinical trials.

253.(c) Congress first addressed thisproblem in 1988 with the passage of theChemical Diversion and Trafficking Act(CDTA), an amendment to the Controlled Sub-stances Act, which imposed mandatory con-

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trols over listed chemicals (pseudoephedrine,ephedrine, phenylpropanolamine) that couldbe used in the illicit production of controlledsubstances. The Act imposed reporting, record-keeping, and import/export notification re-quirements for regulated transactions of con-trolled chemicals. Under this law, the DrugEnforcement Administration (DEA) has au-thority to stop shipments of controlled chemi-cals from US suppliers to companies outsidethe United States suspected of reselling or di-verting them to drug traffickers. Under theCDTA, bulk ephedrine and pseudoephedrinetransactions were regulated; however, the lawexempted OTC ephedrine and PSE drug prod-ucts from the record-keeping and reportingrequirements if they were products lawfullymarketed under the Food, Drug, and CosmeticAct.

254.(b) The degree of freedom for aChi-square test can be calculated by:

= ( R-1) x (C-1)= (2-1) x (3-1) = 2

255.(c) In an emergency situation, apharmacist may dispense a Schedule II con-trolled substance pursuant to a verbal authori-zation. An emergency means that the immedi-ate administration of the drug is necessary forproper treatment of the patient, that no alter-native is available, and it is not possible forthe prescriber to provide a written prescrip-tion for the drug at that time. In such an emer-gency, the prescriber may telephone a Sched-ule II prescription to a pharmacy, or fax theprescription to a pharmacy, provided that:

1. The drug prescribed and dispensedmust be limited to the amount neededto treat the patient during theemergency period.

2. The prescription order must beimmediately reduced to writing by thepharmacist and must contain allinformation, except for the prescriber’ssignature.

3. If the prescriber is not known to thepharmacist, the pharmacist must makea reasonable effort to determine thatthe phone authorization came from avalid prescriber, by verifying theprescriber’s telephone number withthat listed in the directory and bymaking other good faith efforts toassure proper identity.

4. Within seven days after authorizing anemergency telephone prescription, theprescriber must furnish the pharmacistwith a written, signed prescription forthe Schedule II controlled substanceprescribed. The prescription must havewritten on its face “Authorization forEmergency Dispensing.” The writtenprescription may be delivered inperson or by mail, which must be postmarked within the seven-day period.

256.(d) All. Dalmane (Flurazepam),Prosom (Estazolam) and Doral (Quazepam)are benzodiazepines. They are classified asSchedule IV controlled drugs. They are indi-cated for treatment of insomnia.

257.(c) The partial supply of scheduleII controlled drugs should be done within 72hours from its initial dispensing. Dilaulid(Hydromorphone) is classified as a scheduleII controlled substance; and required to befilled within 72 hours from its initial filling.

258. (b) In the AAPCC (American Associa-tion of Poison Control Centers), the substancesmost frequently involved in human poisoningexposures were cleaning supplies (9.4%) fol-

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lowed by analgesics (9.1%), cosmetics (7.7%),plants (7.2%), cough and cold preparations(5.1%), and hydrocarbons (3.8%).

259.(a) More common than the fore-arm crutch is the ordinary wooden or alumi-num underarm crutch called the axillarycrutch. There are several axillary crutch gaits.The safest, most stable, and most common isthe four-point gait. The patient begins by mov-ing the left crutch forward. Next, they movethe right leg forward. The right crutch is thenbrought up to the right foot and, finally, theleft leg is brought up to the left crutch. Whentwo crutches are used, the patient should beinstructed to step forward with the right legand left crutch, followed by the left leg andright crutch. This is commonly known as thetwo-point gait. The three-point gait has twovariations: the swing-to gait and the swing-through gait. In either form, the patient beginsby moving both crutches forward simulta-neously. Another common crutch gait is thehemiplegic gait. It is nothing more than theuse of a single axillary crutch in place of asingle cane. The crutch is carried on the strongside and is moved forward together with theweak limb alternating with the good leg.

260.(d) The highest incidence of acci-dental childhood poisoning is in the late after-noon and around the dinner hour or in the earlymorning hours. Poisoning in the late morninghours often occurs in the kitchen and the sub-stances most frequently involved are commonhousehold cleaning products. Poisoning thatoccur in the bedroom may involve cosmeticsand medications. Bathroom incidents usuallyinvolve either medications or cosmetics.

261.(a) Primary literature: Articles ap-pearing in pharmaceutical and medical jour-nals have the most current and accurate health-related information. They are classified as pri-mary literature.

Secondary literature: Informationabout primary sources, usually a compilationor synthesis of various ideas and data. Sec-ondary sources may rearrange or modify dataand include such sources as indexes to the pri-mary literature, reference works derived fromprimary research, and reviews. Examples in-clude encyclopedias, review articles, hand-books, bibliographies, and abstracts/indexes.

Tertiary literature: Reference booksand textbooks are considered tertiary literature.

262.(a) The investment of Rite CarePharmacy in fixed assets meet the requirement.The target value for this ratio would be 20%or below.

= Fixed assets x 100Net worth

= 60,000 x 100115,000

= 52.17%

263.(a)

264.(d) All. Parametric statistic is agroup of statistical procedures that research-ers use to test data that are normally distrib-uted. The population must have similar vari-ances (known as homogeneity of variance). Itcan be carried out on data that is interval orratio scale, and thus is suitable for arithmeticoperations such as addition and subtraction.This enables parameters such as mean andstandard deviation to be defined. Examples ofparametric statistical tests include the mean,standard deviations, t-test, and Pearson’s cor-relation coefficient. For example, if we draw100 random samples of 100 adults each fromthe general population, and compute the meanheight in each sample, then the distribution ofthe standardized means across samples willlikely approximate the normal distribution.Now imagine that we take an additional sample

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in a particular city (“Tallburg”) where we sus-pect that people are taller than the averagepopulation. If the mean height in that samplefalls outside the upper 95% tail area of the tdistribution, then we conclude that, indeed, thepeople of Tallburg are taller than the averagepopulation. Are most variables normally dis-tributed? In the above example we relied onour knowledge that, in repeated samples ofequal size, the standardized means (for height)will be distributed following the t distribution(with a particular mean and variance). How-ever, this will only be true if in the populationthe variable of interest (height in our example)is normally distributed, that is, if the distribu-tion of people of particular heights follows thenormal distribution (the bell-shape distribu-tion). For many variables of interest, we sim-ply do not know for sure that this is the case.For example, is income distributed normallyin the population? Probably not. The incidencerates of rare diseases are not normally distrib-uted in the population, the number of car acci-dents is also not normally distributed. For thesetypes of variables we are required to use non-parametric statistical procedures.

265.(d) All. Medicare Part D wasimplemented on January 1, 2006. The enroll-ment is voluntary and coverage is guaranteed.It is offered to individuals who have Medi-care Part A or B. The plan is usually adminis-tered by private health insurance companies.

266.(c) Concertra , Ritalin (Meth-ylphenidate ) requires a DEA 222 order formin order to purchase. It is a Schedule II con-trolled substance. It is indicated for the treat-ment of ADHD.

267.(c) $37.50

MU/C = Known retail mark-upcost of complement

= 70/30 = 2.33 = 233%R = cost of drug x (100 + MU/C)

= 11.25 x (100 + 233%)= 11.25 x (333%)= 11.25 x 3.33 = $37.46= $37.50

268.(d) None of the above. ScheduleII controlled substances are safe and effectivepharmaceuticals that have a high potential forabuse. These are the drugs that are most sub-ject to diversion and that are most highly re-stricted in their prescribing and dispensing.Perhaps the most significant restriction appli-cable to Schedule II prescriptions is a generalrule that they must be in writing. This generalrule is in effect unless one of several appli-cable exceptions to the rule applies. There isno time limit during which a Schedule II pre-scription must be filled under federal law, al-though some states do impose such a limit.Any pharmacist who fills a Schedule II pre-scription several days or weeks after its issu-ance must determine that the prescribed medi-cation is still needed by the patient, and thismay require contact with the prescriber. Fed-eral law places no quantity limits on any pre-scriptions, including Schedule II prescriptions.Refilling of a Schedule II prescription is neverpermitted. There are no exceptions to the “norefills” rule for Schedule II prescriptions.

269.(b) The degree of freedom in a t-test can be calculated by using the followingformula:

DF = (n - 1) where n = sample sizeDF = (20 - 1)DF = 19

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270.(d) All. Zero-Base Budgeting is atechnique of planning and decision-making.It reverses the working process of traditionalbudgeting. In traditional budgeting, depart-mental managers need to justify only increasesover the previous year’s budget. This meanswhat has been already spent is automaticallysanctioned. In the case of ZBB, no referenceis made to the previous level of expenditure.Every department function is reviewed com-prehensively and all expenditures rather thanonly increases are approved. ZBB is a tech-nique, by which the budget request has to bejustified in complete detail by each divisionmanager starting from the Zero-base. TheZero-base is indifferent to whether the totalbudget is increasing or decreasing.

Advantages of Zero-Base Budgeting:

1. Results in efficient allocation ofresources as it is based on needs andbenefits.

2. Drives managers to find out costeffective ways to improve operations.

3. Detects inflated budgets.4. Useful for service department where

the output is difficult to identify.5. Increases staff motivation by

providing greater initiative andresponsibility in decision-making.

6. Increases communication andcoordination within the organization.

7. Identifies and eliminates wastage andobsolete operations.

Disadvantages of Zero-Base Budgeting:

1. Dif ficult to define decision units anddecision packages, as it is very time-consuming and exhaustive.

2. Forced to justify every detail relatedto expenditure. The R&D departmentis threatened whereas the productiondepartment benefits.

3. Necessary to train managers. ZBBshould be clearly understood bymanagers at various levels otherwisethey cannot be successfullyimplemented. Difficult to administerand communicate the budgetingbecause more managers are involvedin the process.

271.(c) Federal and State PharmacyLaw prohibit pharmacists from re-dispensingany medication that has already been dis-pensed.

272.(b) The inventory turn over ratecan be calculated by dividing the cost of goodsthe goods sold by the average of beginningand ending inventory.

= 400000175000 + 140000

2

= 2.53

The inventory turnover rate should be a mini-mum of 4 with a target of 6 or higher. RiteCare Pharmacy’s turnover rate is below ex-pectations.

273.(b) The Prescription Drug PlanFinder is located at www.Medicare.org. Theweb site allows patients to enter the medica-tions they are currently taking. Patients cancompare up to three plans side by side. Theweb site shows a list of plans in area that in-clude the patient current medications in theirformulary sorted by the lowest cost of thedrugs the patient is currently taking. Patientscan also sort plans based on premiums,deductibles, and other benefits. The site alsoidentifies plans accepted by the patient’s pre-ferred pharmacy or other nearby pharmacies.

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274.(c) The t-test is most commonlyused to test the significance of a differencebetween two group means. A t-test concerns anumber of procedures concerned with com-paring two averages. It can be used to com-pare the difference in weight between twogroups on a different diet, or to compare theproportion of patients suffering from compli-cations after two different types of operations,or the number of traffic accidents on two busyjunctions. The t-test gives the probability thatthe difference between the two means is causedby chance. To test the significance, one needsto set a risk level (called the alpha level). Inmost social research, the “rule of thumb” is toset the alpha level at .05. This means that fivetimes out of a hundred you would find a sta-tistically significant difference between themeans even if there were none (i.e. by“chance”). It is customary to say that if thisprobability is less than 0.05, that the differ-ence is “significant,” and the difference is notcaused by chance.

275.(b) The Orange Book is updatedmonthly and published yearly.

276.(c) The retailer is obligated to en-ter the name of the product and quantity soldand to check information entered by the pur-chaser against a photo ID. The photo ID mustbe one issued by a state or the federal govern-ment, a passport, or an Alien Registration Re-ceipt Card or Permanent Resident Card(“Green Card”). Each record must be retainedfor a period of 2 years after entry.

277.(d) The frequency of distributioncan be bell shaped, skewed, U shaped and orJ shaped.

278.(c) Do not refill the drug. No pre-scription may be knowingly filled or refilledfor a patient if the prescription was written forprior use by a prescriber who is deceased orno longer in practice.

279. (a) E = Q where:P

E = Coefficient of elasticityQ = % of sales quantities changeP = % of price change

In our example, the sales quantities of Bengayhave been changed from 50 to 110 (120%change), and the price of balm has changedfrom 4.5 to 2.75 (61%). Therefore the coeffi-cient of elasticity would be:

= 120 = 1.96 61

280.(b) Positively skewed. The fre-quency distribution of a sample is calculatedby = Mean - Median (Mode).

= 90-80 = +10

If the value of (mean-mode) is nega-tive, the frequency distribution of the samplewould be negatively skewed. If the value ispositive, then the frequency distribution of thesample would be positively skewed.

281.(b) Acid Test ratio can be calcu-lated by dividing the sum of cash and accountsreceivable by the current liabilities.

= 150,000 + 35,000 = 2.0590,000

282.(a) 252.The mean blood pressure for Mr.Jacob can be calculated as follows:

325 + 240 + 270 + 180 + 245 = 252 5

283.(b) The range of a set can be cal-culated by the difference between the highestvalue and the lowest value of the experiment.

= 140 - 110= 30

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284.(a) One tailed t-test. A one- or two-tailed t-test is determined by whether the totalarea of alfa is placed in one tail or dividedequally between the two tails. The one-tailedt-test is performed if the results are interestingonly if they turn out in a particular direction.The two-tailed t-test is performed if the resultswould be interesting in either direction. Thechoice of a one- or two-tailed t-test affects thehypothesis testing procedure in a number ofdifferent ways. In the above example the pro-fessor wants a class to be able to score at least70 on the test. That means 70 or more. There-fore, a one-tailed test would be implied. Itwould have been a two-tailed t-test if the pro-fessor wants the class to be able to score 70 ormore but not less than 50.

285.(d) The acceptable ratio of Netprofit to net sales generally lies between 5 to7%.

286.(a) The resultant mixture shouldbe classified as a Schedule II controlled drug.Under the CSA, the maximum permissiblequantity of morphine is 0.5 mg/ml to be clas-sified as a Schedule III controlled substance.The compounded mixture contains 4 mg ofmorphine per ml of solution, therefore it shouldbe classified as a Schedule II controlled sub-stance.

287.(d) Just as the Medicare prescrip-tion drug benefit has 6 classes that require in-clusion of all or substantially all of the medi-cations contained within them, there is also alist of medication classes that are excludedfrom Medicare Part D coverage. These classesare:

1. Benzodiazepines.2. Barbiturates.3. Non-prescription drugs (with the

exception of insulin, insulin syringes,gauze and alcohol swabs).

4. Rx vitamin and mineral products (withthe exception of prenatal vitamins andfluoride preparations).

5. Agents used for symptomatic relief ofcoughs and colds.

6. Agents used for cosmetic purposes orhair growth.

7. Agents used to promote fertility.8. Agents used for anorexia, weight loss,

or weight gain.

288.(c) The Orange Book is publishedyearly.

289.(d) Adderall (Amphetamine) is aSchedule II controlled prescription that can-not be refilled under any circumstances. Theprescription is written for a 90-day supply ofmedication and third party insurance hasagreed to pay for 30 days worth of medica-tion. In this case, the patient has to pay out-of-pocket for the 60-day supply of the medica-tion.

290.(b) Fixtures and equipment wouldbe considered fixed assets of a pharmacy.

291.(d) Hospital care accounts for$382.8 billion (or 37.6 percent) of all personalhealthcare expenditures. Physician servicescome next, accounting for $229.5 billion (or22.5 percent). Nursing-home care accounts for$87.8 billion (or 8.6 percent), whereas homehealthcare accounts for $35 billion.

292.(a) The category of toxic sub-stances most frequently involved in reportedfatalities was antidepressants, followed byanalgesics, stimulants, street drugs, gases andfumes.

293. (b) Codein sulfate is classified as aSchedule II controlled substance.

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294.(c) The acceptable net profit to networth ratio for a 10-year-old pharmacy wouldbe 15%. The target value for this ratio wouldbe 20%. A 40% figure can be achieved in anew pharmacy.

295.(d) Retailers must maintain a log-book of information on transactions involv-ing PSE. The logbook (NOT notebook) maybe in either printed or electronic form, and theretailer must provide notice to the purchaserthat misrepresentations or false statements maysubject the purchaser to criminal penalties andspecify the maximum fine and term of impris-onment. This logbook information is requiredby federal law and may be provided to federalauthorities in accordance therewith. Under 18USC § 1001, anyone who makes a materiallyfalse, fictitious, or fraudulent statement to theUS Government is subject to criminal penal-ties. Penalties may include a fine of up to$250,000 and/or imprisonment for up to 5years. This part of the Act becomes effectiveon September 30, 2006. The logbook mustcontain the following information for eachsale:

1. Purchaser’s name and address;2. Date and time of sale;3. Name of product sold;4. Quantity sold; and,5. Purchaser’s signature.

296.(a) The drug benefit, which beganon January 1, 2006, is provided by private “atrisk” entities called Prescription Drug Plans(PDPs). The U.S. was divided into 34 geo-graphic PDP regions. Each region contains oneor more states. In addition, there are five U.S.territories including the U.S. Virgin Islands,Guam, American Samoa, Commonwealth ofPuerto Rico, and the Commonwealth of North-ern Marianas, which are included in the Medi-care Part D program. A PDP may apply to pro-vide prescription coverage for as many or as

few regions as they desire.297. (b) The mean blood pressure of thepatient can be calculated as follows:

75 + 92 + 60 + 110 + 95 + 79 6

= 85.16

298.(d) All. The following factors gen-erally cause patients’ noncompliance:

1. Advancing age2. Duration of therapy3. Number of drugs in the regimen4. Frequency of administration5. Drug-induced side effects6. Relief of symptoms7. Fear of drug dependency8. Unpalatable dosage form9. Absence of viable patient-physician

relationship10. Excessive waiting to see the physician

or pharmacist11. Nature of the illness (e.g. psychiatric

disorders)12. Cost of the medication.

299.(c) The Act allows for the sale ofpseudoephedrine (PSE) only from locked cabi-nets or behind the counter. The law:

1. Limits the monthly amount of PSE thatan individual may purchase;

2. Requires individuals to present photoidentification to purchase suchmedications; and,

3. Requires retailers to keep personal information about these customers for atleast two years after purchase of theproducts.

300. (c) 70%

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The retail price of a drug is $110, thereforethe mark-up on prescriptions would be $45 ($110 - $ 65).

For a $ 65 drug, $ 45 would be the mark-up.For a $100 drug ?

45 x 100 / 65 = 69.23% mark-up

301.(b) I and II only. A prescriptionmay not be issued so that a prescriber can ob-tain a supply of controlled substances for thepurpose of general dispensing to their patients.Therefore a prescription written for “officestock” or “medical bag” is not valid. The ap-propriate way for a prescriber to acquire suchcontrolled substances is to use the ordering andinvoicing methods commonly used to trans-fer controlled substances between registrants.For Schedule II controlled substances, this willrequire the use of a DEA form 222.

302.(a) 40. The bulk bottle of Cephal-exin has an expiration date of Jan/05, whichindicates that the drug will be expiring on Janu-ary 31, 2005. The prescription is presented onJanuary 20 and is written for 10 days, there-fore the pharmacist can fill the whole supplyof the drug.

303.(a) Hypodermic needles are char-acterized by their different points. A long-bevelor long-taper needle is used for local anesthe-sia, aspirating, hypodermoclysis and subcuta-neous administration. A short-bevel needle isused for intravenous administration, infusionand transfusions. A special short-bevel needleis employed for intradermal and spinal admin-istration.

304.(c) The following requirementsapply to the dispensing of non-prescriptioncontrolled substance products:

1. The dispensing must be done by apharmacist and not by a non-pharmacist employee, although thepayment for the product may bereceived by a non-pharmacist.

2. The pharmacist must assure themedical necessity for the product.

3. Not more than 240ml. or not more than48 solid dosage units of any substancecontaining opium, and not more than120ml, or not more than 24 solid dosage units of any substance containingcodeine, may be dispensed to the samepurchaser in any 48-hour period.

4. The purchaser (not the patient) mustbe at least 18 years old.

5. The pharmacist must require thepurchaser to provide identification.

A bound record book must be main-tained by the pharmacist, recording the nameand address of the purchaser, name and quan-tity of the controlled substance purchased, dateof each sale, and initials of the dispensing phar-macist.

305.(b) Liquidity generally expressesa pharmacy’s ability to meet its current liabili-ties.

306.(c) Medication Therapy Manage-ment is a distinct service or group of servicesthat optimize the therapeutic outcomes for in-dividual patients. Medication Therapy Man-agement services are independent of, but canoccur in conjunction with, the provision of amedication product.

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307.(d) The t distribution is suitable fora statistical test comparing two means. The Fdistribution is used to compare two variances.

308. (b) The degree of freedom for a t distri-bution can be calculated by n-1:

= 100-1= 99.

309.(c) The degree of freedom in Chi-square can be calculated by using the follow-ing formula:

DF = (number of rows - 1) x(number of columns - 1)

DF = (3 - 1) x (4 - 1)DF = (2) x (3)DF = 6

310.(a) Pharmacists always prefer tobuy drugs with an AAC (Actual AcquisitionCost) lower than their AWP (Average Whole-sale Price). AAC is defined as the actual pricepharmacists pay when purchasing drugs. AWPis defined as a published wholesale price fordrugs. AWP is generally used to determineprices of prescription drugs. Pharmacists pre-fer to buy drugs at a lower price than the AWP.

311.(b) Mean = 588

= 350+420+530+600+620+635+700+8508

= 588

312.(a) Community pharmacists arepositioned to be integral members of the pri-mary healthcare team because they can iden-tify under-treated patients and patients at riskfor improper management. They can also of-fer education and advice to patients in areassuch as cardiovascular disease and smokingcessation. Pharmacists are currently educatingpatients on the risks and benefits of treatment,

adverse drug events/effects, drug interactions,monitoring, and encouraging compliance. Insome instances, this role can be expanded toinclude authorizing pharmacists to decide ifrefills should be given, a practice that is cur-rently used by several pharmacists working inphysician’s offices.

313.(c) The cane provides a means totransfer weight off the weak limb. If patientscarry their cane on the same side as their weaklimb, the base of support will be narrow (i.e.the distance between cane tip and the weaklimb is small); they will have to transfer weightfrom side to side, increasing the possibility offalling. If they carry the walking cane on theside opposite the weak limb, the base of sup-port will be wide and the center of gravity canmove primarily forward rather than side toside. They use the cane together with the weaklimb, alternatively swinging the strong limbthrough for the next step.

314.(d) Notes payable beyond 1 yearare considered current long-term liabilities ofthe pharmacy. Accounts payable, accrued ex-penses and notes payable within 1 year areconsidered current liabilities of the pharmacy.

315.(a) DEA 224a form should be usedfor renewal of registration. Below is the list offorms and their uses:

Forms Uses

DEA 222 For purchase ofSchedule II controlledsubstances

DEA 224 New registrationDEA 225 New registrationDEA 363 New registrationDEA 224a Renewal of registrationDEA 225a Renewal of registrationDEA 363a Renewal of registrationDEA 106 Theft or stolen of

controlled substances

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DEA 41 Disposal or destruction ofcontrolled substances

FDA-2635 Consent to Treatment with anApproved Narcotic Drug

316.(b) The mean of binomial distribu-tion can be calculated by:

Mean = n x p= 100 x 0.2= 20

317.(b) Inventory turnover rate gener-ally describes the efficiency of a pharmacy. Itis generally calculated by dividing the cost ofthe goods sold by the average of beginningand ending inventory.

318.(b) The inventory turnover rate canbe calculated by dividing cost of goods soldby the average of beginning and ending in-ventory.

Cost of goods sold = $400,000Beginning inventory = $175,000Ending inventory = $140,000

IN TOR = cost of goods soldbeg inv + end inv

2 = 400,000 175,000 + 140,000

2 = 2.54

319.(d) Patient: “I will take the medi-cine. I just don’t like that I have to take it to beokay.” Choice “a” would be too harsh andmay result in a resistance (by not taking medi-cation). Choice “b” and “c” will keep the pa-tient at ease and may result into noncompli-ance. A pharmacist should respond: “I believethat taking the medicine is the best decisionfor controlling your blood pressure."

320.(d) Everyone has the need to feelappreciated, respected, and protected. Theseare called face needs. When people are chal-lenged, face may be threatened. As a result,defensiveness may occur. There are two typesof face that need to be protected. They are au-tonomy face and competence face. When theyare threatened, effective communication be-comes very difficult. Motivational interview-ing was developed to not threaten either typeof face. A few examples will help clarify. Apatient says, “I don’t want to quit smoking.”The pharmacist responds, “Don’t you knowthat smoking is bad for you and can make yourheart problems worse?” This response, evenif said politely, violates competence face. Amotivational interviewing response would be,“What would make you consider quitting?”or “What would have to happen for you toconsider quitting?”Another patient says, “I just don’t know if Iwant to take this medicine. I don’t know if itreally works.” The pharmacist responds,“Well, you really need to take this if you wantto get your blood pressure down.” This re-sponse violates autonomy face. A motivationalinterviewing response would be, “What wouldmake you feel more confident that the medi-cine really is working?” or “What would haveto happen for you to believe that the medicinewas working?” Note that in all of the motiva-tional interviewing responses, defensivenesson the part of the patient would not be engaged.

321.(b) Pharmacists have demon-strated effective collaborative practice mod-els in the areas of primary care and familymedicine. Depression and chronic pain man-agement are successful models whereby phar-macists are utilized in the team, improvingpatient outcomes and decreasing costs. Onestudy for depression in a large nonprofit staff-model HMO allowed pharmacists to have lim-ited prescribing privileges to modify dosagesof antidepressants, to start adjunctive therapy,

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and to make recommendations to the primarycare provider (PCP). The PCP referred all pa-tients in the intervention group to the pharma-cist-managed clinics, where they completed aninterview and followed up with the pharma-cist at 6 weeks and 24 weeks (telephone con-tact occurred in the meantime). Success of pri-mary care pharmacists was supported by ahigher level of adherence, higher overall sat-isfaction, and a decreased number of PCP vis-its, justifying the potential role of pharmacistsin primary care.

322.(c) The Pearsonian coefficient canbe calculated by the following formula:

3 (Mean - Median) Standard deviation

= 0.54

323.(a) The reproducibility of resultsof a number of experiments is generally knownas precision.

324.(d) All. The paired t-test is gener-ally used when measurements are taken fromthe same subject before and after some ma-nipulation such as injection of a drug. For ex-ample, you can use a paired t-test to determinethe significance of a difference in blood pres-sure before and after administration of an ex-perimental pressor substance. You can also usea paired t-test to compare samples that are sub-jected to different conditions, provided thesamples in each pair are identical otherwise.For example, you might test the effectivenessof a water additive in reducing bacterial num-bers by sampling water from different sourcesand comparing bacterial counts in the treatedversus untreated water sample. Each differentwater source would give a different pair of datapoints. This differs from the independent twosample t-test in that each of two different treat-ments is applied to single group of a patients.

For example, in bioavailability study, a genericdrug is compared to a standard drug in thesame group of 20 patients, whereas in a twosample t-test this would be two different groupof 20 patients.

In a two independent sample t-test, thevariability is a result of the difference amongdifferent experimental environments (for ex-ample, two different groups of patients mayreact to the drug in different ways); whereasin a paired t-test, the variability results fromdifferences within experimental units (for ex-ample, we will use effects of the drug on thesame 20 patients). Therefore, the paired samplet-test has advantages of reduced variability.

It also requires less experimental ma-terial (for example, to conduct two indepen-dent sample t-tests we require 40 patients,whereas to conduct paired t-tests we only re-quire 20 patients).

A disadvantage of paired t-tests is thatif treatments cannot be applied concurrentlyit may prolong the experimental time and in-crease the chances of patients’ dropout rate (forexample, we want to compare bioavailabilityof a generic drug to a standard drug via anoral route; patients have to wait for a consid-erable time in order to avoid carry-over effectsof the previous experiment).

325.(c) The private insurance compa-nies account for the most healthcare expendi-tures (32.6%) followed by Medicare (18.8%),out-of-pocket (17.4%), and Medicaid (14.8%).

326.(a) The ratio of net sales to inven-tory can be calculated as :

= 150,00050,000

= 3

3 (145 - 125) 110

=

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327.(d) The FTC (Federal Trade Com-mission) prevents misleading advertising ofOTC products. It is also responsible for han-dling unfair business practices.

328.(b) The acid test generally mea-sures a pharmacy’s liquidity.

329.(c) The Kefauver-Harris Amend-ment is also know as the Drug EfficacyAmendment. This law requires that all mar-keted drugs in the US have to be safe as wellas effective. This act also gives the power tothe FDA to regulate advertising of prescrip-tion drugs. It also provides the GMP (GoodManufacturing Practice) guideline to manu-facturers to manufacture drugs in US.

330.(a) Among cases that occur out-side the home, the garage and automobile arecommon sites of accidental poisoning in youngchildren.

331.(b) Patients who reside in the LTCsetting are also eligible for a transition periodduring their first 90 days of coverage in a newPDP. However, due to the complicated natureof these patients, Part D plans are required toallow multiple transition fills within this 90-day period. Furthermore, due to the fact thatLTC facilities often dispense medications ona 31-day cycle, PDPs are required to allow upto a 31-day supply of medication per fill.Again, medications that require prior authori-zation, step therapy, or are non-formulary areeligible for these transition fills, whereas Medi-care Part D excluded medications are not.Another differentiating factor of the LTC tran-sition requirement is that an emergency sup-ply beyond the first 90 days of coverage is re-quired. This emergency fill is available to LTCbeneficiaries any time during their eligibilityin quantities up to a 31-day supply. This willprevent any delay in LTC beneficiaries receiv-ing their medications, and allow time for aformulary exception request.

332.(b) There are currently many bar-riers for pharmacists who try to provide cog-nitive services and the primary reason is thelack of adequate reimbursement and compen-sation. In the community, pharmaceutical careand associated cognitive services are typicallyincluded in the dispensing fee. Pharmacists arenot typically reimbursed for the time spent witha patient beyond the dispensing of the medi-cation. In one survey, pharmacists were lesslikely to spend more time with patients becausethere was not enough time to do so. However,the survey results also indicated that if phar-macists were reimbursed for their time spent,it would be more likely that they would takemore time with patients. Another factor is thatpharmacists had no incentive/reward fromtheir employers, making these services lesslikely to exist.

333.(c) The sum of all the probabili-ties (failure and success) in binomial distribu-tion is equal to 1, therefore if the probabilityof success is p = 0.7, the probability of failure(q) should be 0.3.

p + q = 1q = 1-p = 1-0.7 = 0.3

334.(c) A percentage of the costs ofeach service that must be paid by the insuredalong with the insurance policy payment (e.g.a payment of 80 percent of the cost by the in-surance and 20 percent of the cost by the con-sumer) is defined as coinsurance, whereasmoney the patients must pay before the insur-ance policy provides benefit is defined as de-ductible. A flat fee paid for each type of ser-vice (e.g. the patient pays $20 for eachphysician’s visit or $10 for each prescriptionfilled) is known as co-pay. An additional in-surance policy taken by many of the elderlyto cover the Medicare deductibles and co-pay-ments is defined as Medigap.

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335.(b) When the hypothetical value ofa parameter is the same as the observed valueof a parameter, the error should be consideredbeta error.

336.(b) In the current Medicare model,a pharmacist receives reimbursement for ser-vices only if meeting the Healthcare Financ-ing Administration (HCFA) criteria for reim-bursement even if the pharmacist provided thesame services of a physician, nurse practitio-ner (NP), or physician assistant (PA). Evenafter the criteria are met, reimbursement is onlygiven at the lowest rate known as “incident-to.” These services are billed under Part B, butreimbursement is given to the physician un-der whom the pharmacist is billed. These ser-vices can be performed in a physician’s of-fice, whether the office is located in a sepa-rate building or is an office within an institu-tion or a patient’s home. A physician must per-sonally perform the initial service and continueto remain actively involved throughout thecourse of treatment. The physician does nothave to be physically present while thepatient’s service is being rendered but mustbe available for assistance and to provide di-rect supervision. This means that a physicianmust be present with a pharmacist for a homevisit if he/she were to bill under “incident-to.”Four general “incident-to” rules set by theCenters for Medicare and Medicaid Services(CMS) must be satisfied in order for a phar-macist to receive reimbursement. The servicemust be:

1. An integral part of a physician’sdiagnosis or treatment;

2. Provided under the direct supervisionof a physician;

3. Performed by an employee of thephysician; and

4. Something ordinarily done in aphysician’s office or physician-directed clinic.

337. (b) $37.50

R = C P

R = Retail price of drugC = Cost of drugP = Cost complement in %

Therefore the retail price of insulin would be:

= 11.25 0.30

= $37.50

Cost complements % + % mark-up = 100%

338. (c) Two independent sample t-tests should be performed to find the clinicalsignificance of drug A over the placebo. An-other example would be the dissolution of tab-lets prepared by a marketed formulation thatis compared to the dissolution of tablets pre-pared from an experimental formulation. Thesetypes of designs differ from the one-sampletest in that averages are obtained from twogroups for the purposes of comparison,whereas in a one-sample test the average of asingle group is compared to some hypotheti-cal value. To make it more clear take the fol-lowing example. Let’s say we have a marketeddrug with a label potency of 500 mg. We ran-domly pick 30 tablets to find out the actualpotency of the marketed product. In this typeof test we compare the mean values of 30 tab-lets with some hypothetical value (in our ex-ample it should be 500 mg). This is calledsimple t-test. Now let’s say we want to com-pare a drug A effect on 20 patients over itsplacebo effect on 20 different patients. Thistype of study requires two independent samplet-tests.

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339.(d) All. Cognitive services are acomponent of pharmaceutical care that phar-macists have been providing for many years.Cognitive services are defined as “servicesprovided by the pharmacist for the patient orhealthcare professionals for the purposes ofpromoting optimal health and/or drug therapy;not necessarily drug-product-related.” Theseservices primarily focus on optimizing apatient’s drug therapy and ensuring appropri-ateness, safety, and efficacy.

340.(c) An acid test generally mea-sures the liquidity of the pharmacy. It can becalculated by dividing the sum of cash andaccounts receivable by the current liabilities.

341.(a) Barriers to establishing phar-macists as collaborative service providers aresimilar to those faced by NPs and PAs in thepast. Mainly, these include physician and nurs-ing opposition as well as certain pharmaceuti-cal driven challenges. In a survey to pharmacystate organizations, 41% of responders statedmedical associations or physicians as the larg-est barrier. Difficulty in educating healthcareprofessionals about pharmacists’ capabilities(16%), pharmaceutical manufacturers (16%),nursing associations (9%), and lack of phar-macist lobbying (9%) were among the otherbarriers mentioned.

342.(d) All. A certified pharmacy tech-nician can perform the following duties:

1. Taking a stock bottle from the shelf fora prescription.

2. Reconstituting medication.3. Initiating and receiving refill

authorization requests.4. Preparing and packaging prescriptions.5. Loading bulk unlabeled drugs into an

automated dispensing system provideda pharmacist verifies that the systemis properly loaded prior to use.

6. Affixing prescription labels andauxiliary labels to a prescriptioncontainer.

7. Entering prescription data into a dataprocessing system.

343.(b) Waxman-Hatch (Drug PriceCompetition and Patent Restoration Act) in-spired the FDA to publish an up-to-date list ofall marketed drug products through the OrangeBook.

344.(c) The Act specifies training re-quirements for store personnel. Retailers musttrain all individuals who deliver PSE-contain-ing products to purchasers, and cashiers whoreceive payments for them, to ensure that thesepersons understand the requirements that ap-ply. Retailers must also certify that all storeemployees who conduct PSE sales have beentrained and submit a “self-certification” to theDepartment of Justice. Certifications muststate that the retailer understands the legal re-quirements and agrees to comply with them.The retailer will be required to retain a copyof both the self-certification and records evi-dencing the employee training. The Depart-ment of Justice will issue regulations estab-lishing criteria for filing certifications for em-ployee training. State and local officials willhave access to certifications. Retailers will bepermitted to file self-certification via anInternet site to be established by the DEA.Separate certifications are required for eachplace of business, although training may beconducted centrally. Training applies to thelocation and not the individual. Periodic re-certification is required to cover new employ-ees.

345.(c) The compounded mixtureshould be classified as a Schedule III con-trolled drug. The amount of codeine presentin the final mixture is 0.74 gms (500 mg plus240 mg). It has been stated under the CSA that

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if a mixture contains less than 1.8 gms of co-deine per 100 cc, it should be classified as aSchedule III controlled substance.

346.(c) To be valid, a prescription fora controlled substance must be issued for a le-gitimate medical purpose by a prescriber act-ing in the usual course of professional prac-tice. The prescriber is responsible for theproper prescribing of controlled substances.However, a corresponding responsibility restswith the pharmacist who dispenses the pre-scription. An order for a controlled substancethat purports to be a valid prescription, but isnot issued in the usual course of professionalpractice, is not a prescription. Any pharmacistwho knowingly dispenses controlled sub-stances pursuant to a purported prescription,as well as the prescriber issuing the prescrip-tion, is subject to criminal and/or civil penal-ties and administrative sanctions.

347.(c) Pharmacists are in a uniqueposition to assist patients in taking medicinesproperly and moving them toward healthybehaviors and outcomes. Compliance is theextent to which patients follow advice givento them by healthcare providers, whether theadvice concerns taking medications, makinglifestyle changes, or other interventions. Whilestudies estimate that 50-60% of patients arenoncompliant with their medication regimens,compliance with lifestyle changes is evenlower, at 30%. Of all patients, 30-40% fail tofollow preventative regimens, and 20-30% failto follow curative (relief of symptoms) medi-cation regimens. Moreover, when long-termor chronic care medication is prescribed 50%fail to adhere. Each year millions of peoplesuffer from drug-related morbidity and mor-tality as a result of noncompliance.

348. (d) All. Fentanyl, dextroamphetamineand hydromorphone are schedule II controlledsubstances. These substances require an exactcount when taking inventory.

349.(b) Each trial in a Binomial experi-ment comes out a success or failure. The re-peated trials are independent of previous ex-periments. The experiments generally consistof “n” repeated trials. The probability of suc-cess remains constant from trial to trial. Anexample of this is tossing a quarter for “n”times to get heads (tails would be considereda failure) each time.

350.(d) All. Methylphenidate, Pento-barbital, Secobarbital and Amobarbital areclassified as Schedule II controlled substances.They require a DEA 222 order form. How-ever, Schedule II barbiturates such as Pento-barbital, Amobarbital and Secobarbital areclassified as Schedule III controlled substanceswhen combined with Aspirin or Acetami-nophen or when they are formulated as sup-pository dosage form.

351.(b) According to the American As-sociation of Colleges of Pharmacy, clinicalpharmacy is defined to be “an area within thepharmacy curriculum which deals with patientcare with emphasis on drug therapy; develop-ment of a patient-oriented attitude; acquisitionof new knowledge and learn a skill to opti-mize patient communications.”

352.(d) All. A collaborative drugtherapy management agreement may autho-rize a pharmacist to implement, modify or dis-continue a drug therapy that has been pre-scribed for a patient, order associated labora-tory tests, and administer drugs, all in accor-dance with a patient-specific written protocol.In instances where drug therapy is discontin-ued, the pharmacist shall notify the treatingphysician of such discontinuance no later thantwenty-four hours from the time of such dis-continuance. Each protocol developed, pursu-ant to the collaborative drug therapy manage-ment agreement, shall contain detailed direc-tion concerning the actions that the pharma-cist may perform for that patient.

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470.(b) To be classified as schedule V,the maximum permissible quantity of Codeineis 2 mg/ml (Not more than 200 mg/ 100 cc).

471.(b) Every two years the FDA vis-its drug manufacturers’ premises to ensure thatthey meet GMP guidelines.

472.(c) The cascade of emotions thatmight affect a patient or responsible caregiverafter discovering a dispensing error typicallyoccurs in the order of confusion, anxiety, fearand anger. From the pharmacist’s point ofview, a range of emotions are also experiencedincluding confusion, anxiety about what willhappen, a fear of law suit, board or college ofpharmacy punishment, and often irritation andanger over the frustration of having one’s lifedisrupted.

473.(b) Cognitive barriers in counsel-ing patients are due to a lack of pharmacisttraining and confidence. Pharmacists are of-ten reluctant to engage patients in counselingbecause of doubt in their consultation abili-ties and pharmaceutical knowledge. Deficientcommunication skills decrease the quality andlikelihood of such interactions. Cultural andlanguage differences are also classified as cog-nitive barriers.

474.(d) All. Healthcare plans must es-tablish Medication Therapy Managements(MTMs) for individuals who:

1. Have multiple chronic diseases;2. Take multiple covered Part D drugs;3. Are likely to incur costs above a

certain level.

The services may be furnished by phar-macists, and MTM programs must be devel-oped by consulting practicing pharmacists.

475.(a) The above DUR study is de-fined as Prospective DUR since it has beendone at the time of dispensing.

476.(a) The sublingual form of Nitro-glycerine is exempt from the requirements ofthe CFR. This drug is too small and it is prac-tically impossible to imprint an identificationcode on tablets.

477.(a) Only patients and prescriberscan request the dispensing of drugs without aCRC.

478.(a) New drugs are generally clas-sified in two categories: Type-P or Type-S.Drugs classified under Type-P are given pri-ority. To be classified under Type-P, the drugmust meet one of the following criteria:

1 The drug must be more superior in itsclass than the currently marketed drugs.

2 The new drug must have the uniqueability to treat symptoms or diseases for whichthere are no drugs in the market.

Type-S category is described as Stan-dard Review. The products classified underthis category have been cleared more slowlycompared to Type-P.

479.(b) The Sherman Antitrust Act hasbeen introduced to prevent restrain of trade orthe establishment of monopolies. Accordingto this law, companies or groups of compa-nies may not have agreements among them-selves that may affect the general public orrestrain trade. The above illustration is con-sidered as price fixing.

480.(d) Under FDA guideline for com-pounding prescription, the quantity of com-pounded products should be limited to fillingthe current and refill requirement of the pre-scription.

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481.(c) According to a recent survey,households with the highest mean income usedor preferred mail order or online pharmaciesmost often. Below is the list of pharmacy typewith household mean income:

Household MeanIncome(Thousands)

67 Mail order/online62 Food based pharmacies

(e.g. Giant, Safeway, etc.)61 Chain pharmacies

(e.g. Rite Aid, CVS, etc.)60 Clinic based pharmacies59 Mass merchant pharmacies

(e.g. Walmart,Costco, etc.)59 Independent pharmacies

482.(d) “I guess you’re pretty frus-trated that the medication didn’t work.” An-swer “a” offers a solution, answer “b” is pla-cating and answer “c” disregards the unique-ness of the patient’s medication experience.

483.(b) The Dingle Bill Act (Prescrip-tion Marketing Act) prevents the reselling ofwholesale purchased drugs at higher prices toindividual institutions or pharmacies.

484.(a) Having products for sale in apatient counseling area may increase the num-ber of customers nearby and reduce the senseof privacy for patients who are being coun-seled.

485.(d) Pharmacists have and will con-tinue to make errors; however, incorporatingcounseling into a pharmacist’s daily routinecan reduce these errors. In fact, a study thatlooked at outpatient medication errors showedthat 89% of errors were detected during phar-macist consultations with a patient. Patient

counseling is a valuable tool, which can dras-tically reduce medication errors and decreasethe chance that the pharmacists will make theerror themselves.

486.(d) A PPI (Patient Package Insert)contains the following:

1. Therapeutic indication;2. Adverse reactions;3. Dosage administration;4. Dosage of drug;5. Drug interactions.

It does not contain any information regardingpricing of the drug.

487.(b) An orphan drug is defined as adrug that is used for the treatment of rare dis-ease.

488.(d) All the above mentioned cau-tionary statements are required on an OTCIpecac syrup bottle.

489.(b) Effective patient communica-tion is central to being able to provide phar-maceutical care; identifying patient issues andneeds, developing and communicating solu-tions and ensuring patient agreement and un-derstanding are essential skills for pharmaciststoday. Some of the more tangible benefits pa-tients experience when pharmacists use effec-tive communication are:

1. Improved adherence with medicationuse;

2. Increased satisfaction with theirrelationship with the pharmacist;

3. Greater likelihood that patients will askfor help when it is needed, resulting infewer unaddressed side effects andadverse effects;

4. Improved patient trust in pharmacistadvice and education.

Pharmacy Type

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490.(d) All. Environmental barriersmay include accessibility to the pharmacist,lack of a quiet, private space in which to speakwith patients, or lack of time to engage inmeaningful discussion with patients. One wayfor the pharmacist to identify environmentalbarriers is to place him- or herself in thepatient’s shoes. Suggestions to overcome en-vironmental barriers affecting communicationinclude:

1. Reduce the number of products for salenear the counseling area to reduce the numberof customers nearby and increase the sense ofprivacy for patients who are being counseled.

2. Place a computer terminal near thepatient counseling area to reduce walking andincrease access to needed information.

3. Reduce the number of items on thecounter where the pharmacist will be engagedin a patient interview to reduce the distractionsand create a professional atmosphere.

4. Use support staff such as techniciansand assistants effectively, to free up time tospeak with patients.

491(d) All. Hastily written prescrip-tions can also cause problems when a zero ordecimal point is not utilized or put in the properplace. Not only can hard to read prescriptionsbe a problem but the use of abbreviations canlead to errors since many are not standardizedor can have multiple meanings. According tothe USP MEDMARX error reporting program,nearly 19,000 errors due to abbreviations as acause were reported over a four-year period;however, only 0.55% of these errors wereharmful.

492.(b) Physicians and pharmacists inmany states are already using electronic datainterchange (EDI) technology to transmit pre-

scriptions for non-controlled substances. How-ever, this technology cannot be used for con-trolled substances. Current DEA regulationsspecifically require that a pharmacist musthave the original physical prescription slipprior to dispensing Schedule II controlled sub-stances (with exceptions for long-term carefacilities and emergency dispensing). Prescrip-tions for substances on Schedules III throughV can be transmitted orally but must be re-duced to writing by the pharmacist prior to fill-ing. Until the DEA finalizes its EPCS (Elec-tronic Prescribing Controlled Substances)rules, there are three methods available totransmit controlled substance prescriptions:written, oral, and faxed. Apomorphine is not acontrolled substance.

493.(d) All. Electronic prescribing(EP) is the totally electronic transmission ofprescription information from a prescriber’ssoftware application to a pharmacist’s prac-tice management system. There are a numberof important stakeholder groups that stand tobenefit from the adoption and utilization of e-prescribing, but the stakeholders of primaryimportance are patients, pharmacists, and pre-scribers. In addition to these three primary in-terest groups, prescribers, patients and phar-macists, there are other stakeholders who havean interest in seeing e-prescribing move for-ward. These include large employers,healthcare plans, pharmaceutical manufactur-ers and payers.

494.(b) Management by objectives(MBO) is defined as a process whereby thesuperior and subordinate managers of an or-ganization jointly identify its common goals,define each individual’s major area of respon-sibility in terms of results expected of him/her, and use these measures as guides for op-erating the unit and assessing the contributionof each of its members. The primary effectsof management by objectives are tangible re-

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sults in the form of profit, increased sales,growth, and lower costs. The secondary effectsare less tangible, but very valuable in thatmanagement itself becomes more efficient andmore responsive to the needs of the firm, itsemployees, and society. Public and profes-sional relations are also enhanced due to thesesecondary effects. Tertiary effects are seen inimproved employee morale, improved service,improved delegation, and a happier businessfamily. Employee relations are improved asmeasured in terms of turnover rate, tardinessand other measures of employee satisfaction.

495.(d) The most commonly cited rea-son for not getting prescribed medicationsfilled is “did not need.”

Reason for Non-compliancePercentage

Pharmacist advice 0.9Out of stock 2.9Used OTC product instead 10.7Changed by Doctor 12.6Other 13.6Side effects 18Insurance did not cover 19.7Too costly 29.9Did not need 38.3

496.(d) The NDC consists of 10 or 11numbers. The first five numbers represent themanufacturer, the middle four numbers repre-sent the product ID (includes the name andstrength of drug), and the last two numbersrepresent the package ID of the drug.

497.(d) All. It is important to note thatthe MMA (Medicare Modernization Act) doesnot require that e-prescribing be used by pre-scribers or pharmacists who serve Medicarebeneficiaries at any point in the future. Rather,it specifies a process through which standardsfor an e-prescribing program will be devel-oped, adopted, recognized, or modified by the

Secretary of HHS, and will be followed by allprescribers, pharmacies, and pharmacists whoserve Medicare beneficiaries with Part D ben-efits. The MMA states that information shouldbe made available on:

1. The drug being prescribed or dispensedand other drugs on the patient’s medicationhistory, including drug-drug interactions,warnings or cautions, and when indicated,dosage adjustments.

2. Eligibility and benefits, including for-mulary, tiered formulary, and prior authoriza-tion requirements.

3. The availability of lower cost, thera-peutically appropriate alternatives (if any) forthe drug prescribed.

4. The patient’s medical history relatedto a covered Part D drug being prescribed ordispensed, upon request of the prescriber orpharmacist involved.

498.(c) Medicare is Title XVIII of theSocial Security Act. It was first proposed in1965. It provides medical coverage to peopleover 65 years of age. It is funded by the HealthCare Financing Administration (HCFA). In1972, disabled persons under age 65 and thosewith end-stage renal disease become eligiblefor coverage. Services also expanded to in-clude some chiropractic services, speechtherapy and physical therapy.

In the same year, a Supplemental Se-curity Income (SSI) program was establishedfor the elderly and disabled poor. SSI recipi-ents are automatically eligible for Medicaid.

499.(d) According to a recent healthsurvey, approximately 50% patients preferrednot to be contacted by any means for remind-ing them of their refill.

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Refill Reminder Preferred (%)Methods

Don’t want to be contacted 50Personal call 16Letter 13E mail 10Automated phone call 8Other 3

500.(b) I and II only. Characteristics ofForged Prescriptions:

1. The prescription looks “too good”; theprescriber’s handwriting is too legible.

2. Quantities, directions, or dosages dif-fer from usual medical usage.

3. The prescription does not comply withthe acceptable standard abbreviations or ap-pears to be a textbook presentation.

4. The prescription appears to be photo-copied.

5. Directions are written in full with noabbreviations.

6. The prescription is written in differentcolored inks or written in different handwrit-ing.

7. The prescription has apparent erasuremarks.

501.(b) One of the major barriers tocontinuous quality improvement identified inthe field of pharmacy is that pharmacists andpharmacy managers have traditionally actedon the attitude “if it’s not broke, don’t fix it.”

502.(d) The post marketing survey ofnew drug is carried out in Phase IV clinicaltrial. This phase deals with the post marketingexperience of a newly introduced drug.

503.(d) TRICARE is the health careprogram for active duty and retired membersof the uniformed services, their families, andsurvivors. TRICARE’s primary objectives areto optimize the delivery of health care servicesin the military’s direct care system for all Mili-tary Health System (MHS) beneficiaries andattain the highest level of patient satisfactionthrough the delivery of a world-class healthcare benefit. TRICARE brings together thehealth care resources of the Army, Navy, andAir Force and supplements them with net-works of civilian health care professionals toprovide better access and high quality healthcare services while maintaining the capabilityto support military operations.

TRICARE Prime is a managed careoption similar to a civilian health maintenanceorganization (HMO). This option requires en-rollment. Active duty service members are re-quired to enroll in Prime. Active duty familymembers, retirees and their family membersare encouraged, but not required, to enroll inPrime. However, to receive the TRICAREPrime benefit, they must reside whereTRICARE Prime is offered. If enrollment forTRICARE Prime and TPR/TPRADFM is re-ceived by the 20th of the month, it is effectivethe first day of the next month. For instance,if an enrollment is received by March 20, cov-erage will begin April

1. If a family enrolls March 25, they will becovered under the TRICARE Prime benefitstarting May 1. If an individual un-enrolls fromTRICARE Prime, he or she is locked out for12 months.

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TRICARE Prime offers less out-of-pocket costs than any other TRICARE option.Active duty members and their families do notpay enrollment fees, annual deductibles or co-payments for care in the TRICARE network.Retired service members pay an annual enroll-ment fee of $230 for an individual or $460 fora family, and minimal co-pays apply for carein the TRICARE network. TRICARE Primeoffers a “point-of-service” option for care re-ceived outside of the TRICARE Prime net-work, but point-of-service care requires pay-ment of significant out-of-pocket costs.

TRICARE Prime enrollees receivemost of their care from military providers orfrom civilian providers who belong to theTRICARE Prime network. Enrollees are as-signed a primary care manager (PCM) whomanages their care and provides referrals forspecialty care. All referrals for specialty caremust be arranged by the PCM to avoid point-of-service charges.

TRICARE Extra and TRICARE Stan-dard are available for all TRICARE-eligiblebeneficiaries who elect or are not able to en-roll in TRICARE Prime. Active duty servicemembers are not eligible for Extra or Stan-dard. There is no enrollment required forTRICARE Extra or Standard, no annual en-rollment fees, no enrollment forms. Benefi-ciaries are responsible for annual deductiblesand cost-shares. Beneficiaries may see anyTRICARE authorized provider they choose,and the government will share the cost withthe beneficiaries after deductibles.

TRICARE Extra is a preferred pro-vider option (PPO) in which beneficiarieschoose a doctor, hospital, or other medical pro-vider within the TRICARE provider network.Network providers can be located by callingthe local TRICARE service center or visitingtheir Web page.

TRICARE Standard is a fee-for-ser-vice option. You can see an authorizedTRICARE provider of your choice. Havingthis flexibility means that care generally costsmore. TRICARE Standards include:

1. Network pharmacy access within 2miles of 90% of the beneficiaries in urbanareas.

2. Network pharmacy access within 5miles of 90% of beneficiaries in suburbanareas.

3. Network pharmacy access within 15miles of 70% of beneficiaries in rural areas.

504. (a) The following are pharmacist ser-vice improvement techniques. These include:

1. Be available to answer questions in atimely and dependable manner.

2. Take the time to explain problems withdate and references to support advice,rather than informing the physicianthat an error has been made.

3. Suggest several alternatives rather thanone recommendation, allowing thephysician to make an informed finaldecision.

4. Continue to provide services such aswarning of potential drug abuse/misuse, prescription errors, and druginteractions.

505. (c) The CPSC (Consumer Product SafetyCommission) is responsible for implementa-tion of the PPPA (Poison Prevention Packag-ing Act).

506. (c) Patients also have the right to obtaina copy of their pharmacy records. If a phar-macist receives a request, they have 30 daysto provide the patient with a copy. Patients canalso request a change to their records. It’s best

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to ask the patient to put the request in writingand include the reason for the change. A phar-macist must act within 60 days to determinewhether the change is appropriate and thencorrect the records if necessary.

507.(b) When faced with a stressfulsituation, research and clinical practice showsthat it is not unusual to over-generalize, to thinkthe worst, or to look at events in extreme andabsolute ways. Such thinking patterns are de-fined as “irrational thinking.” This is not crazyor delusional thinking, but thinking patternsthat prevent us from obtaining a balanced per-spective on events. There are different typesof irrational beliefs. “The old ways of doingthings are always best” (living in past) wouldbe defined as stoppers irrational belief. Stop-pers keep us from taking actions, hold us backand otherwise make us behave as we alwayshave. It gives us a good excuse for doing noth-ing. “Only totally incompetent people makemistakes” (perfectionism) is an example ofdrivers irrational belief. Drivers keep us froma natural pace. While often rewarded in dailylife, they may lead us to become fatigue, ex-hausted, and frustrated. “This is the most hor-rible thing that could ever happen to me” (over-estimate) is an example of distorters irrationalbelief. Distorters lead to false impression aboutpeople, other events and ourselves. They addconfusion to our lives and keep us from ob-taining a good idea of what is happening tous.

508.(c) The quantity of Oxycodoneshould be limited to treatment for emergencysituations. This could be a 2-day, 3-day, 24-hour or other supply. The oral prescriptionshould be immediately reduced to writing. Thepharmacist must make a reasonable effort toidentify the legitimacy of the prescriber.

509.(c) Pharmacists need to take re-sponsibility for their behavior, particularly inchoosing the content provided to patients andthe manner in which it is provided. To helppharmacists ensure effective communication,consider the five “S’s”. Be sincere, keep com-munication simple, short and specific, andlastly, summarize. These five “S” words willensure pharmacists’ information in a mannerthat is clear and specific and supported withsummary statements to reinforce importantpoints.

510.(a) I only. The HIPPA mentionswho a pharmacist can give information to, andwho it cannot be given to. One concept is thatinformation can be disclosed to another healthcare provider as long as the other health careprovider has a treatment relationship with thepatient and has informed the patient of his orher own privacy policy. In the above choices,the patient’s insurance payer requires a mini-mum amount of information about process-ing claims. For example, if you are submit-ting a claim for a prescription for a patient,and the payer does not need to know the diag-nosis, do not provide the diagnosis.

511.(d) Ambien (Zolpidem) is classi-fied as a benzodiazepine. It is indicated for thetreatment of insomnia. It is a Schedule IV con-trolled substance. It cannot be refilled morethan 5 times within six months from the datethe prescription was issued.

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