nap manage calc qualityjprod

A company recently learned that several lots of their popular coffee creamer were contaminated with a human carcinogen. It is unknown what effect consuming this carcinogen in small quantities may have on humans. An immediate recall is announced. A massive media campaign is underway to identify people who used these lots of coffee creamer so they can receive medical attention immediately. The company plans to conduct a study that will follow these patients over time to determine the effect of this exposure compared to other patients who used their coffee creamer who were not exposed. What study design does this trial represent? Answer ACross-sectional study BCase series CCase-control study DCohort study ECase report

D This is a prospective cohort study design. Cohort studies start with an exposure / intervention and look for an outcome of interest (disease). In this case the study starts with the exposure (contaminated coffee creamer) and patients will be followed prospectively to look for an outcome (disease such as cancer). This design is useful when randomization to the exposure would be unethical.

Which of the following statements is true regarding statistical power of a study? Answer AA trial without adequate statistical power is at risk of a type I error. BHigher statistical power results in more confidence that the null hypothesis was accepted correctly. CRisk of type II error can be eliminated if statistical power is high enough. DStatistical power and type II error are not related. EIt is the probability of failing to accept the null hypothesis when it is false.

E Risk of type I or type II error can never be completely eliminated. As power increases, the chance of type II error decreases.

Approximately, how many milliequivalents of ferrous sulfate are present in each dose of the Feosol tablets? [mol wt ferrous sulfate = 152; iron = 56] (A) 1 (B) 2 (C) 4 (D) 6 (E) 9 Answer

Feosol tablets contain exsiccated (dried) ferrous sulfate. The exsiccated form of ferrous sulfate contains approximately 30% elemental iron, considerably higher than that contained in hydrous ferrous sulfate or ferrous gluconate. Feosol tablets contain 200 mg of dried ferrous sulfate in which iron is present in the reduced form with a valence of +2. Using the equation: mg = (mEq) (Formula wt) 200 mg = (x mEq) (152) Valence 2 2 x = 2.6 mEq

BIOSTATISTICS & PHARMAECONOMICS The absolute risk reduction is the

absolute difference in outcome rates between two groups. 146/1,990 = 0.073, or 7.3%. 219/2,001 = 0.109, or 10.9%. 10.9% - 7.3% = 3.6%.

Hazard ratio (HR) =

hazard rate in the treatment group / hazard rate in the control group. Hazard rate in the treatment group = 282 / 1718. Hazard rate in the control group = 275 / 1696.

The relative risk is the

probability of the event occurring in the exposed group versus the non-exposed group. 146/219

The absolute risk reduction is calculated by

subtracting the event rates of the 2 groups. Therefore, 28.7% - 16.4% = 12.3%

NNH is calculated

the same way as NNT. ARR = 16.2 - 16.4 = -0.2% (implying risk from the treatment vs the placebo). NNH = 1/ARR (expressed as a decimal) = 1/0.002 = 500.

What is the definition of a Type II error? Answer AThe clinical trial was not large enough to detect a meaningful difference between treatment groups. BThe null hypothesis is true, but is rejected in error. CThe null hypothesis is false, but it is rejected in error. DThe null hypothesis is false, but is accepted in error. EThe null hypothesis is true, but it is accepted in error.

D A Type II error means that the null hypothesis is false, yet it is accepted in error. The study authors conclude that there is no difference, when there actually is a difference.

Over 35,000 nurses were studied in a longitudinal study based in Framingham, Massachusetts. Each year, the nurses were followed up and asked to report on any incidence of heart disease. The researchers wanted to study incidence of heart disease in the subjects using hormone therapy versus those who did not use hormone therapy. Describe this type of study: Answer AControlled clinical trial BMeta analysis CCase control trial DCohort study ECrossover analysis

D A study group (the cohort) is followed over time and outcomes are compared to a subset of the group who were not exposed to an intervention, such as a drug. This example is prospective in design.

BACKGROUND: Although trends in the prevalence of obesity and obesity-attributable deaths have been examined, little is known about the resultant burden of disease associated with obesity. PURPOSE: This study examined trends in the burden of obesity by estimating the obesity-related quality-adjusted life years (QALYs) lost—defined as the sum of QALYs lost due to morbidity and future QALYs lost in expected life years due to premature deaths—among U.S. adults along with differences by gender, race/ethnicity, and state. Question: What type of pharmacoeconomic analysis is this? Answer ACost-Minimization Analysis BCost-Benefit Analysis CCost-Effectiveness Analysis DCost-Utility Analysis EECHO Model Analysis

D Cost-utility analysis includes a quality of life component, generally expressed in quality-adjusted life years (QALYs). CUA considers both quality (morbidity) and quantity (mortality) of life gained.

A new drug for stroke prevention, CLOTBUST, was studied. The trial enrolled 2,546 patients. In the CLOTBUST arm, 39 out of 1,281 patients had a stroke compared with 64 patients out of 1,265 patients in the aspirin arm, p-value = 0.025. What was the relative risk of stroke in this trial? Answer A1 B0.9 C0.7 D0.6 E0.33

D The relative risk of stroke in this trial is calculated by taking the risk of stroke in each arm: 39/1,281 = 0.03 and 64/1,265 = 0.05. Therefore, 0.03/0.05 = 0.6.

A new drug for stroke prevention, CLOTBUST, was studied. The trial enrolled 2,546 patients. In the CLOTBUST arm, 39 out of 1,281 patients had a stroke compared with 64 patients out of 1,265 patients in the aspirin arm, p-value = 0.025. What is the number needed to treat to prevent one stroke in this trial? Answer

50 - Number needed to treat (NNT) is 1/ARR. Therefore, 1/0.02 = 50 patients. Fifty patients will need to be treated to prevent one stroke.

What is the median in the following data set? 78, 34, 2, 11, 103, 88, 6, 212 Answer

56 For an even number of values: arrange the numbers in order from lowest to highest, select the middle two numbers, add them together and divide by 2.

A pharmacist is presenting the Helsinki trial which investigated gemfibrozil 1,200 mg daily versus control. The results showed that CHD events were 2.7% in the gemfibrozil arm versus 4.1% in the control group, with a p-value of < 0.02. What is the number needed to treat to prevent one CHD event in this trial? Round up to the nearest number of patients. Answer

72 Number needed to treat (NNT) is 1/ARR. Therefore, 1/0.014 = 72 patients. 72 patients will need to be treated with gemfibrozil to prevent one CHD event.

Choose the best description of the purpose of a pharmacoeconomic analysis: Answer ATo identify and measure the costs and the consequences of drugs. BTo quantify the value of surgical services and drugs in extending human life. CTo keep the country from going bankrupt by importing more generics from overseas, due to the high costs of branded drugs. DTo assess the acquisition costs of drugs and their impact on the pharmacy budget to determine what medications to add to the formulary. ETo assess which drugs will prevent the most patient harm and encourage their use.

A Pharmacoeconomics takes into account broader costs beyond just drug acquisition costs and is an important tool to ensure resources are used wisely.

The JUPITER trial studied the benefits of rosuvastatin 20 mg PO daily versus placebo. The primary outcome of the trial was the occurrence of a first major cardiovascular event, defined as nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina, an arterial revascularization procedure, or confirmed death from cardiovascular causes. At the time of study termination, 142 first major cardiovascular events had occurred in the rosuvastatin group, as compared with 251 in the placebo group, p-value = 0.00001. Each arm had 8,901 patients. What was the relative risk reduction if randomized to rosuvastatin in this trial? Answer A43% B39% C33% D12% E9%

A Relative risk reduction = 1-RR. Event rates per arm: 142/8,901 = 1.6% in rosuvastatin arm and 251/8,901 = 2.8% in placebo arm. 1.6/2.8 = 0.57. Therefore, 1-0.57 = 0.43, or 43%.

A trial compared Drug A to placebo and found that Drug A lowered LDL by an additional 5%, on average. The p-value was reported to be 0.03. Which of the following is/are true regarding this trial? (Select ALL that apply.) Answer ADrug A is stastically significantly better than placebo BThe difference between Drug A and placebo is clinically significant CThe chance of a Type I error is less than 3% DThe chance of a Type II error is less than 3% EThe investigator should fail to accept the null hypothesis

ACE A measure of statistical significance is not the same as "clinical significance". For example, if a drug lowers LDL by 5%, it may be statistically significant versus the placebo, but clinically it probably would not be used much since other drugs lower LDL to a much greater degree.

In the trial above, what is/are the dependent variable/s? (Select ALL that apply.) Answer AVertebral fractures BZoledronic acid CPlacebo DHip fractures ECost of the medication

AD In a clinical trial, the dependent variable/s are the outcome/s of interest.

Which of the following statements regarding specificity are true? (Select ALL that apply.) Answer AThe percentage of time a test is negative when disease is not present. BThe percentage of time a test is positive when disease is not present. CThe percentage of time a test is negative when disease is present. DThe percentage of time a test is positive when disease is present. EIt is equal to 1 - type I error.

AE

A pharmacy intern has been asked by his preceptor to gather 200 discharged patient charts from the chart room. He has been told that half the charts should be patients who received proton pump inhibitor (PPI) therapy while hospitalized. The other half should be patients with similar conditions and length of stay but who did not receive PPI therapy. The pharmacist wishes to conduct a study to see if there is any difference in the incidence of nosocomial infection in the PPI group versus the non-PPI group. Which of the following describes this type of study? (Select ALL that apply.) Answer ACohort study BMeta analysis CCase control study DControlled clinical study EObservational study

AE A cohort study is a type of observational study. This study describes a retrospective cohort (the cohort is discharged patients). These patients are then evaluated to determine if they were receiving PPIs, and then the outcome of nosocomial pneumonia is assessed. To be a case control study, you would need to start out by identifying the outcome (the patients who developed pneumonia) which was not done at the onset of the study.

A director of pharmacy for a large hospital employs two clinical coordinators. The director asked each clinical coordinator to submit a proposal for a new clinical program that could be implemented in the future that would improve patient care and reduce cost. The Ambulatory Care clinical coordinator proposed rotating clinical pharmacists through the pulmonology clinic to focus on COPD patients with high readmission rates. The pharmacist would see patients with the team, review medication regimens, and provide patient counseling. An extra pharmacist would be needed 3 mornings per week, but he believes the service could decrease COPD readmission rates, improve prescribing, and improve patient satisfaction. The Critical Care clinical coordinator proposed expanding the ICU prolonged infusion beta-lactam protocol to the entire hospital. The protocol is working well in the 25-bed ICU and costs have been reduced. Expanding to the entire hospital will require significant multidisciplinary education, since this would be a major practice change. It could further reduce drug expenditure, reduce antimicrobial resistance rates, and possibly reduce length of stay. What type of pharmacoeconomic analysis would be best to determine which proposal would provide the most benefit to department of pharmacy? Answer ACost-Minimization Analysis BCost-Benefit Analysis CCost-Effectiveness Analysis DCost-Utility Analysis EECHO Model Analysis

B A cost-benefit analysis is useful for comparing programs with similar or unrelated (as in this example) outcomes as long as the outcome measures can be converted to dollars. Even antimicrobial resistance can be converted to dollars (resistant pathogens lead to more expensive antimicrobials being used and for longer durations). Certainly improving patient satisfaction is an important goal for a program, but the director of pharmacy will likely need to justify the program to his superiors in terms of dollars, with this as an additional benefit.

A pharmacist is considering which intravenous vasodilator should be preferred at her institution. She has narrowed her search down to two agents. Each drug provides similar health benefits and similar tolerability. The pharmacist will base her decision on drug acquisition, administration, and monitoring costs. The pharmacist should use the following analysis to decide which intravenous vasodilator should be added to her institution: Answer AA cost-utility analysis BA cost-minimization analysis CA cost-effectiveness analysis DA cost-benefit analysis EA cost-optimization analysis

B A cost-minimization analysis (CMA) is used when two or more interventions have already demonstrated equivalency outcomes and the costs of each intervention are being compared. CMA measures and compares the input costs and assumes outcomes are equivalent.

Marital status (married, single, divorced) can be described as this type of data: Answer AOrdinal BNominal CContinuous DRandom EInterval

B Discrete data can be divided into groups or categories (e.g., marital status, gender, ethnicity). These are called nominal discrete values.

A pharmacist is presenting the Helsinki trial which investigated gemfibrozil 1,200 mg daily versus control. The results showed that CHD events were 2.7% in the gemfibrozil arm versus 4.1% in the control group, with a p-value of < 0.02. What is the relative risk reduction of CHD events in this trial? Answer A44% B34% C24% D22% E18%

B Relative risk reduction = 1-RR. Since RR = 0.66, then relative risk reduction is 1 - 0.66 = 0.34.

A new diagnostic test detects a certain genetic marker linked to the development of colon cancer. The test has 89% sensitivity and 82% specificity. Which of the following statements are correct? (Select ALL that apply.) Answer AThis test will be negative 89% of the time in patients who do not have the colon cancer marker. BThis test will be positive 89% of the time in patients who have the colon cancer marker. CThis test will be negative 82% of the time in patients who do not have the colon cancer marker. DThis test will be positive 82% of the time in patients who have the colon cancer marker. EThis test will be positive 89% of the time in patients who do not have the colon cancer marker.

BC

Blood pressure, hemoglobin A1C and LDL cholesterol can each be described as this type of data: Answer AOrdinal BNominal CContinuous DRandom EDiscrete

C Continuous variables can take an infinite number of possible values (within a range), such as height, weight, A1C, blood pressure. For example, a patient's A1C can be 7.2 or 7.3 or 7.4 and so on.

A new drug for stroke prevention, CLOTBUST, was studied. The trial enrolled 2,546 patients. In the CLOTBUST arm, 39 out of 1,281 patients had a stroke compared with 64 patients out of 1,265 patients in the aspirin arm, p-value = 0.025. What was the relative risk reduction of stroke in this trial? Answer A1 B0.9 C0.4 D0.3 E0.2

C Relative risk reduction = 1-RR. Since the RR is 39/64= 0.6, the relative risk reduction is 1 - 0.6 = 0.4.

A report of a clinical trial of a new antipyretic, Feverstop, versus a placebo, noted that the new drug gave a higher proportion of success than did the placebo. The report ended with the statement that the trial was statistically significant (p-value < 0.05). In light of this information, we may conclude: Answer AFewer than 1 in 20 patients will fail to benefit from the drug. BThe chance that an individual patient will fail to benefit is less than 0.05. CThe probability of the reported finding or one more extreme is less than 1 in 20. DThere is still a chance (although less than 5%) that the drug is ineffective. EThe power of the test exceeds 0.95.

C The p-value refers to the null hypothesis which is Group 1 = Group 2 (meaning there is no difference between the drug and the placebo). The P-value is the probability of obtaining a test statistic as extreme as the one actually observed as a result of chance alone.

A cardiologist believes that atrial fibrillation may be caused by chronic exposure to zolpidem. He intends to conduct a study of patients at his current practice. He will select a group of patients with atrial fibrillation and a group of matched patients without atrial fibrillation. He will review the medical records of both groups looking for exposure to zolpidem. What type of study design does this trial represent? Answer ACross-sectional study BCase series CCase-control study DCohort study ECase report

C This is a case-control study design. Case-control studies start with patients who have the disease (and controls) and looks back retrospectively for an exposure. In this case the study starts with atrial fibrillation patients (and controls) and looks for exposure to zolpidem. If the cardiologist finds an association, a trial would need to be conducted to prove cause and effect.

100. Charles Fox has an IV hanging that has 40 mEq of potassium chloride in 1000 mL of Dextrose 5% in Half Normal Saline. The IV has been running at a rate of 80 mL per hour for the past 6.5 hours. A recent lab report indicates that Mr. Fox's serum potassium level is only 3.5 mEq/L and his physician wants to increase the potassium dose. The physician ask you to slow the IV flow rate to 40 mL per hour and also add enough potassium chloride injection, 14.9%, so that Mr. Fox will receive a total of 80 mEq of potassium over the next 12 hours. K = 39, Cl = 35.5

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118. Don Smith is a 35 year old male who has been diagnosed with AIDS. Mr. Smith is 5 feet, 8 inches tall and weighs 180 pounds. Mr. Smith's physician wants to use Epivir and knows the drug must have its dose adjusted based on a patient's renal function. Mr. Smith's serum creatinine is 2.6 mg/dL and has held at that same level for 5 days. Calculate Mr. Smith's creatinine clearance.

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119. The dosing literature for Epivir has the following information concerning use in renal failure. What is the appropriate dose for Mr. McClure? Check page 11 to see chart

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120. Mr Smith is unable to take his Epivir and will have a NG tube inserted to make oral drug administration more practical. If the physician prescribes Epivir Oral Solution, 10 mg per ml, what will be the actual volume administered to Mr Smith?

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19. Digoxin Injection is supplied in ampules of 500 mcg per 2 ml. What quantity, in mL, must a nurse administer to provide a dose of 0.2 mg? 20. Gentamicin Injection is supplied in a concentration of 80 mg per 2 ml vial. How many milliliters are needed to give a single dose of 4 mg per kg to a patient weighing 165 pounds? 21. You have Sodium Phenobarbital Injection, 13%. How many ml will be needed to obtain 2 grains? 22. Concentrated Acetic Acid is supplied at a concentration of 90% weight/weight and has a specific gravity of 1.11. What volume is needed to obtain enough acetic acid to prepare 60 mls of Acetic Acid Solution, 5% (e.g., vinegar)?

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25. A patient is to prepare one liter of a 1:5000 potassium permanganate (KMnO4) solution as a foot soak. You have a stock solution of KMnO4, 5%. How many milliliters of the stock solution must be used to prepare one liter of the foot soak?

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28. You have a vial that contains 5 gms of drug and the chart to the right for mixing the drug for use. Nurses want to mix the vial so that it comes out with 200 mg per ml and ask you how much diluent they should add to make that concentration. Diluent Added Concentration Resulting 9.6 ml 500 mg per ml 19.6 ml 250 mg per ml 49.6 ml 100 mg per ml

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29. You receive an order for 30 grams of 0.1 percent hydrocortisone cream for use on an infant. You have available 1 percent hydrocortisone cream and cold cream that can be mixed with the hydrocortisone. How many grams of the cold cream will be needed to fill the order? 30. A physician orders one liter of 3% sodium chloride injection for a sodium depleted patient. You have 0.9% sodium chloride injection in one liter bags and sodium chloride injection, 23.4%, in 50 ml vials. How many milliliters of the 23.4% NaCl solution will you ADD TO the one liter bag of 0.9% NaCl to prepare the 3% sodium chloride injection? Molecular weights sodium = 23, chlorine = 35.5 31. In question number 30, you calculated the number of ml of 23.4% NaCl to make the 3% NaCl solution. How many milliequivalents of sodium chloride did you add to the bag? Molecular weights sodium = 23, chlorine = 35.5 32. After you finished mixing the 3% sodium chloride, how many milliosmoles of sodium chloride, per liter, are in the final product? Molecular weights sodium = 23, chlorine = 35.5 33. YouareoutofRobitussin-AC,acoughsyrupthatcontains10mgofcodeineper5ml.Youcanmake Robitussin-AC by adding codeine injection to Robitussin. If the codeine injection has 60 mg per ml, how many milliliters of the injection will you ADD TO a four fluid ounce bottle of Robitussin to produce the same amount of codeine as in Robitussin-AC?

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39. A balance has a sensitivity of 5 milligrams. What is the least amount you can weigh on this balance if you need to work with an accurary of 2%?

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42. A drug product costs $62.20 an avoirdupois ounce. What will be the cost of the 60 mg of drug you need for a prescription? 43. A patient is to receive IV theophylline 24 mg every hour. If aminophylline is 80% theophylline, how much aminophylline must the pharmacist use to prepare a 24 hr supply? 44. Aminophylline Injection is supplied as 25 mg per ml. What volume of Aminophylline Injection will the pharmacist need to obtain the dose in Number 43 above? 45. A drug product has 0.05% active drug. If the dose is one-half (1⁄2) teaspoonful four times a day for ten days. How many milligrams will be consumed in total? 46. You have a stock drug solution that contains 10% active drug. What volume of this stock solution will you use to prepare 120 ml of a 1:1000 solution?

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47. A formula calls for using 0.01% of hydrochloric acid in a formula for 1000 ml of a topical liquid. HCl has a specific gravity of 1.2 and is supplied as a 40% weight/weight solution. How many ml of hydrochloric acid are needed to prepare the 1000 ml? 48. Amikacin Injection is supplied as 500 mg in 2 ml. Mr. Johns weighs 198 lbs and is to receive a dose of 15 mg per kg. How many milliliters will be needed for the dose? 49. CalciumChlorideDihydrateInjectionissuppliedasa10%solutioninwater.Howmanymilliosmoles arepresentinasingle10mlvial? Ca=40,Cl=35.5,H=1,O=16 50. Sodium Bicarbonate Injection is an 8.4% solution. How many milliequialents of sodium are in a singlevialof50ml? Na=23,C=12,O=16,H=1 51. Lidocaine Injection for cardiac use is a 4% solution. If the dose is 2 mg per minute, how long will a 500 ml bag run? 52. I have 10 ml of a solution that contains one gram per 5 ml. How many ml of water must I add to the 10 ml to make a solution that is 1:5000 in strength?

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55. The proper concentration of benzalkonium to prevent bacterial contamination in an eye drop is 1:750. You have a stock solution of 17% benzalkonium chloride and a dropper that delivers 50 drops per ml. How many drops will you need for a 30 ml bottle of eye drops? 56. A patient has been receiving oral Aminophylline Tablets. Aminophylline is 80% theophylline. The doctor wants to change giving oral theophylline. If the patient has been receiving 500 mg of aminophylline, and theophylline is available in tablets of 100 mg. How many tablets will the patient need per dose? (NOTE: Bioavailability will be the same for both.) 57. Dimethyl Sulfoxide Liquid is supplied as a 50% weight / weight solution with a specific gravity of 1.40. What is the percent weight / volume of liquid dimethyl sulfoxide?

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Information for questions 105, 106 and 107. Ms. Roberta Snagg has a recurring mycotic infection of the bladder. Her physician wants to use a bladder irrigation of amphotericin B to be continuously run through the bladder for at least 24 hours. You are to prepare a 2 liter bag of amphotericin B irrigation solution, 1:5000 concentration, that will be administered at a rate of 80 mL per hour. You have vials of amphotericin B, 50 mg, that, when properly reconstituted, contain 50 mg of amphotericin B in a total volume of 10 mL. 105. How much amphotericin B must be mixed in the 2 liter bag to provide the desired concentration of irrigation solution? 106. Your irrigation set delivers 12 drops per mL. What will be the flow rate, in drops per minute, to administer the amphotericin B at the desired dose? 107. What type of catheter will be inserted into the patient's bladder and used for administration of the amphotericin B bladder irrigation? A. Swan-Ganz catheter B. PICC catheter C. Foley catheter D. Central catheter E. Robinson catheter

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Information for questions 108, 109 and 110. A patient (weight, 176 pounds) in cardiology is receiving a heparin drip, currently running at 15 units per kilogram per hour. The concentration of heparin in the IV drip is 10,000 units per 100 mL and the IV set delivers 15 drops per mL. The most recent partial thromboplastin time (PTT) indicates that the patient is being under dosed and that the heparin rate should be increased by 20% according to the hospital's weight based heparin protocol. Answer the following questions: 108. What will be the new dosage in units per kilogram per hour? 109. What will be the new flow rate in drops per minute? 110. Once the heparin drip was stopped, the physician wanted to change to a subcutaneous agent for further anticoagulation. A possible drug for this purpose would be A. Warfarin B. Alteplase D. Daltaparin C. Argatroban E. Lepirudin

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A clinical trial is published about a new drug, NOPAINZ, for pain reduction. There are 200 patients randomized; 100 patients to NOPAINZ and 100 patients to placebo. The study found that pain was alleviated in 90 patients taking NOPAINZ and in 50 patients taking placebo. Calculate the absolute risk reduction (ARR) in this trial. (Enter the absolute risk reduction as a decimal and not a percentage.) Answer

(50/100)-(90/100) = 0.4 Absolute risk reduction (ARR) = 0.5 - 0.1 = 0.4

A clinical trial is published about a new drug, NOPAINZ, for pain reduction. There are 200 patients randomized; 100 patients to NOPAINZ and 100 patients to placebo. The study found that pain was alleviated in 90 patients taking NOPAINZ and in 50 patients taking placebo. Calculate the relative risk in this trial. (Enter the relative risk as a decimal and not a percentage.) Answer

0.2 - Relative risk is the likelihood of an unfavorable event (in this case, pain) occurring in the exposed group versus in the non-exposed group. Therefore, 10 of the 100 patients had pain in the Nopainz group, and 50 of the 100 patients had pain in the placebo group. Therefore, 0.1/0.5 is 0.2.

A clinical trial is published about a new drug, NOPAINZ, for pain reduction. There are 200 patients randomized; 100 patients to NOPAINZ and 100 patients to placebo. The study found that pain was alleviated in 90 patients taking NOPAINZ and in 50 patients taking placebo. Calculate the relative risk reduction (RRR) in this trial. (Enter the relative risk reduction as a decimal and not a percentage.) Answer

0.8 Relative risk reduction (RRR) = 1-RR (relative risk). The relative risk is 0.2 = (10/100)/(50/100). Therefore, 1-0.2 = 0.8.

A pharmacist is presenting the Helsinki trial which investigated gemfibrozil 1,200 mg daily versus control. The results showed that CHD events were 2.7% in the gemfibrozil arm versus 4.1% in the control group, with a p-value of < 0.02. What is the absolute risk reduction of CHD events in this trial? (Round to the nearest tenth. Type in just the number; do not include the percentage sign in the answer.) Answer

1.4 The absolute risk reduction is the difference in risk of the outcome in question (in this case, CHD events). The rate of CHD events in the control arm was 4.1%. The rate of CHD events in the gemifibrozil arm was 2.7%. 4.1% - 2.7% = 1.4%.

NNT =

1/ARR (expressed as a decimal). ARR = 32.4% - 29.8% = 2.6%. Therefore, NNT = 1/0.026 = 38.5. Round up to 39 for the correct response.

The number needed to treat is defined as

1/ARR, or 27.7 rounded up to 28. Therefore, 28 patients need to be treated for 1 year to prevent 1 death. Be careful not to confuse the secondary outcomes (sudden death and deaths from worsening heart failure) with the primary outcome of the study, which was all cause mortality.

Information for questions 111 through 117 is included in the box to the right. A physician has found a new formula for an IV fluid to be administered after surgery that can be described as "TPN Lite". The formulation is shown in the box to the right. Use the formula provided to answer the following questions: 111. How many mLs of Dextrose Injection, 700 mg/mL, will be needed to prepare one liter of the formula? 112. How many mLs of Amino Acids Injection, 10% will be needed to prepare one liter of the formula? 113. How many mLs of Sodium Chloride Injection, 4 mEq per mL, will be needed to prepare one liter of the formula? Na = 23; Cl = 35.5 114. How many mLs of Potassium Chloride Injection, 2 mEq/ml, will be needed to prepare one liter of the formula? K = 39; Cl = 35.5 115. How many mL of water will be required to prepare one liter of the formula? 116. The first patient to receive this IV fluid had GI tract surgery and needs to be NPO for 5 days. The patient weighs 85 kilograms. How many calories from the dextrose and the amino acids will the patient receive in 24 hours? 117. The IV set used to administer this solution delivers 12 drops per mL. What will be the flow rate to administer the solution at the dose ordered for this patient?

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Information for questions 53 and 54 is contained in the box to the left. This formulation is for 24 hours of a total parenteral nutrition (TPN) formulation. Dextrose provides 3.4 calories (or kilocalories or kcals) per gram and Amino Acids provide 4 calories per gram. The electrolytes and vitamins do not provide any calories. (Fat provides 9 calories per gram.) Total Parenteral Nutrition Formula Dextrose Injection, 50% 1000 ml Amino Acids, 10% 400 ml Electrolytes / Vitamins 200 ml Sterile Water 800 ml 53. How many calories, from all sources, will the patient receive in 24 hours? 54.TheIVsetwilldeliver10dropsperml.Whatwillbetheflowrate,indropsperminute,toadminister the formula above over 24 hours?

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Information for questions 88 through 91. A patient is receiving Dextrose 5% in 0.45% Sodium Chloride Injection and 40 mEq of potassium chloride in a total volume of 1000 mL through an IV set that delivers 15 drops per mL. The IV fluid has been running at a rate of 12 drops per minute for 15 hours. Molec Weights: Dextrose = 180, Na = 23, K = 39, Cl = 35.5 88. How many mEq of potassium chloride have been administered so far? K = 39; Cl = 35.5; Na = 23; Dextrose = 180 89. How many grams of KCl have been administered over the 15 hour period? 90. How many millimoles of KCl have been administered over the 15 hour period? 91. WhatisthetotalosmolarityoftheIVfluidbeingadministered?Expressyouranswerasmilliosmoles, rounded to the nearest whole number, per 1000 mL.

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Information for questions 95 and 96. A physician wants to put 10 mEq of calcium into a 500 ml bag of Normal Saline Solution and administer the calcium at a rate of 0.5 mEq per hour. You have Calcium Chloride Dihydrate, 10% Injection in 10 mLvials. Ca=40,Cl=35.5,H=1,O=16 95. How many mLs of this injection must you add to the bag of IV fluid to make the desired product? 96. You have an IV set that delivers 12 drops per mL. At what flow rate (drops per minute) will the IV fluid be administered to give the desired dose?

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Information for questions 97 through 99. Mr Shirrah is very ill and needs antibiotic therapy for an infection. The microbiology lab reports that the infecting agent will require a higher than normal blood level to be effective. The attending physician asks you to determine exactly how often each dose of the antibiotic should be administered to keep the blood level at, or above, the determined minimum inhibitory concentration (MIC). You receive the following pharmacokinetic data on Mr. Shirrah for a drug eliminated 100% by the kidney. Mr Shirrah has normal renal function. IV bolus dose:0.5 gram; Peak level: 12 mcg/mL; Trough level at 12 hrs: 0.75 mcg/ml Therapeutic MIC level: 3 mcg/ml 97. What is the volume of distribution of this drug? 98. Based on first order pharmacokinetics, what is the half life of this drug? 99. Howoftenshouldadoseofthedrugbeadministeredinordertomaintainthedruglevelat,orabove, the therapeutic level? Use the half-life calculated in No. 97

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Look TPN chart on page 6 of 2006 Calc Problem to do 64-69 64. How many calories (or kilocalories; kcals) will the dextrose provide per 24 hours? 65. You have dextrose available as a 70% solution. What quantity will be needed to provide the required amount? 66. Magnesium sulfate is available as a 50% solution of magnesium sulfate heptahydrate (7 waters of hydration). What volume of this injection is needed for this formula? Mg = 24, S = 32, H = 1, 0 = 16 67. The pharmacist will be using Pepcid Injection, 40 mg per 4 ml vial, to prepare the product. What quantity of Pepcid Injection will be used? 68. How many ml of 23.4% Sodium Chloride Injection will be needed to prepare the TPN? Na = 23, Cl = 35.5 69. Sodium Phosphate is being added as Na3PO4. How many mEq's of sodium will be added as a result of using sodium phosphate? Na = 23, P = 31, O = 16

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Provide the correct conversion factor for each instance below: 14. 1 grain = mg 15. 1 avoirdupois pound = g 16. 1 fluid ounce = ml 17. 1 US gallon = fluid ounces 18. 1 US pint = ml

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Question 11 thru 13. You are to mix this IV using the materials shown. You must ADD the volumes of the dextrose and NaCl to the 1000 ml of Sterile Water. Sterile Water for Injection 1000 ml Dextrose 10 % Sodium chloride 60 mEq Administer over 24 hours Sterile Water for Injection, 1000 ml Sod Chloride Inj, 23.4% (MW = 58.5) Dextrose 70% in Water Injection 11. HowmanymloftheSodiumChlorideInjection,23.4%, will you add to the sterile water? 12. How many ml of the Dextrose 70% in Water Injection will you add to the sterile water? 13. After all of the ingredients are mixed, what will be the flow rate in milliliters per hour?

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Questions 82, 83 and 84 use the same information to demonstrate the differences, and similarities, between millimoles, milliosmoles and milliequivalents. 82. Lactated Ringer's Injection contains 20 mg of calcium chloride dihydrate per 100 ml of IV fluid. How many milliMoles of calcium are present in one liter of Lactated Ringer's Injection? Molecular weights: Ca = 40, Cl = 35.5, H = 1, O = 16 83. Lactated Ringer's Injection contains 20 mg of calcium chloride dihydrate per 100 ml of IV fluid. How many milliOsmoles of calcium chloride are present in one liter of Lactated Ringer's Injection? Molecular weights: Ca = 40, Cl = 35.5, H = 1, O = 16 84. Lactated Ringer's Injection contains 20 mg of calcium chloride dihydrate per 100 ml of IV fluid. How many mEq of calcium are present in one liter of Lactated Ringer's Injection? Molecular weights: Ca = 40, Cl = 35.5, H = 1, O = 16

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Questions 9 and 10. You need to prepare 30 grams of 0.25% triamcinolone in Cold Cream. Triamcinolone is available in a suspension of 40 mg per ml that has a specific gravity of 1.0. 9. How many ml of the triamcinolone solution will be needed? 10. How many grams of the Cold Cream will be needed?

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The information provided in the prescription shown to the left is for questions 37 and 38. Hyoscine HBr 0.3 mg Oxycodone 7.5 mg Acetaminophen 300.0 mg DTD: caps no. XX Sig: i or ii caps q 4-6 hrs prn pain Dr Lotta Scripts 37. What will be the total amount of Hyoscine HBr used to fill the prescription? 38. You have Hyoscine HBr tablet triturates (similar to nitroglycerine tablets) that contain 1/150th grain per tablet. How many will you need for the RX?

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The prescription to the right has information for questions 58, 59 and 60. Indomethacin 0.05% Boric Acid qs Water qs ad 15 ml 58. Boric Acid can be used as a preservative in ophthalmic solutions. It can also be used to replace NaCl when making a product isotonic. What quantity of boric acid will be needed to make the eye drop shown isotonic? E values are boric acid = 0.52, indomethacin = 0.16 59. Youhaveboricacidinasaturatedsolutionthatis5.5%boricacid.Whatvolumeofthissolutionwill you need to use to obtain the needed amount of boric acid? 60. Indomethacin is available in an injection of 1 mg powder for solution per vial. How many vials will you need to obtain the needed amount of indomethacin?

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Total WBC Count 14,000/mm3 Bands 5 Segs 65 Basophils 1 Eosinophils 2 Lymphocytes 24 Monocytes 3 61. This patient is most likely to have what type of infection - bacterial, viral, fungal? I. Bacterial II. Viral III. Fungal A. I only B. III only C. I and II only D. II and III only E. I, II and III only 62. What will be the absolute neutrophil count for a patient with the WBC result shown above? 63. What will be the absolute granulocyte count for a patient with the WBC result shown above?

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Use the information in the box provided to answer questions 79 through 81. Check Page 7 79. Approximately how much atropine sulfate, IN GRAINS, will you need to use to compound the prescription? 80. How many grams of acetaminophen will you need for the 20 capsules? 81. What will be the total weight of ingredients, in milligrams, to prepare the entire quantity?

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Use the information provided for questions 1 through 3. You receive an order for 500 mg of aminophylline in normal saline in a total volume of 250 ml. The patient weighs 132 pounds. The aminophylline is to be administered at a dose of 0.3 mg per kg per hour. Aminophylline Injection is supplied in vials with 25 mg per ml. The IV set you will use delivers 60 drops per ml. 1. How many milligrams of theophylline will the patient receive each hour? 2. How many hours will the 250 ml last if administered at the correct dose? 3. What will be the flow rate, in drops per minute, to administer the dose ordered? 4. A dose of 120 mg of gentamicin is administered IV. After 10 minutes, a blood sample is assayed for gentamicin content. The result is 8 mcg per ml. What is the volume of distribution for gentamicin?

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Use the prescription shown for questions 40 and 41. Morphine Sulfate 7.5 mg Acetaminophen 325 mg DTD: XX caps Sig: one cap q 4 hrs prn pain 40. Morphine Sulfate is available in 15 mg tablets. How many tablets would provide the amount of morphine needed for this prescription? 41. If each morphine tablet weighed a total of 100 mg, what would be the weight of material in one capsule?

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Use the prescription shown for questions 5 through 8. You have tablets that contain 0.25 mg of reserpine per tablet. You can mix ground up reserpine tablets in cherry syrup to make a liquid that will be stable for at least 3 months. The patient is a child that weighs 22 pounds. Reserpine Liquid 0.1 mg per ml Disp 60 ml Sig: 0.01 mg per kg per dose one dose twice a day 5) How many reserpine tablets will be needed to compound the prescription? 6) What volume (ml) will be in each dose? 7) How long will this prescription last at the dose ordered? 8) If reserpine tablets cost $20.00 per 100 tablets, what will be the cost of the tablets used?

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Use the prescription to the left for questions 23 and 24. Aspirin 300 mg Caffeine 30 mg Codeine 15 mg DTD 15 caps SIG: i cap q 4 hrs PRN pain 23. How many milligrams of codeine will be needed to compound the prescription? 24. What will be the total final weight, in grains, of ingredients for one capsule?

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Choose the categories that represent direct medical costs: (Select ALL that apply.) Answer ACost of a prescription BQuality of life CCost of a surgery DLength of a hospital stay EPain and suffering

ACD The cost of drugs, the cost of surgery, hospital length of stay are all examples of direct costs. The absolute risk reduction is the absolute difference in outcome rates between two groups. 1.6% - 1.28% = 0.32%.

A very large study has measured the body weight of everyone living west of the Mississippi River. If the values of all the weights were plotted, the graph would resemble this shape: Answer AA bell-shaped curve BA parabola CA quadrilateral DA bell-shaped curve skewed to the left EA bell-shaped curve skewed to the right

A If many data points are plotted from a large population group, the distribution would look like a normal or Gaussian bell-shaped curve.

A clinical trial reports that patients taking a new drug, NO-GO, experience less incontinence episodes. The number of incontinent episodes (the primary endpoint) was 16.4% in the NO-GO group and 28.7% in the placebo group. The trial randomized 600 patients (300 patients in each arm). What is the number needed to treat to prevent 1 incontinence episode? Answer

9 The number needed to treat is 1/ARR. ARR = 28.7% - 16.4% = 12.3%. Therefore, NNT = 1/0.123 = 8.13, rounded up to 9 since we cannot treat a fraction of a person.

A clinical trial is conducted on a new drug, LoSod. LoSod is found to reduce serum sodium to 131 mEq/L, with a 95% confidence interval of 128.7 mEq/L to 133.3 mEq/L. What is the correct interpretation of this 95% confidence interval? Answer AThere is a 95% chance that the interval contains the true population value. BWhen using this drug in a larger population, one can expect that 95% of the patients will have a serum sodium between 128.7 to 133.3 mEq/L. CWhen using this drug in a larger population, one can say with 95% confidence that the serum sodium will be 131 mEq/L. DThere is a 5% chance that the true population mean is within the stated range. EThere is a 5% chance that the results of this study are rejected in error.

A A confidence interval gives an estimated range of values which is likely to include an unknown population parameter; the estimated range being calculated from a given set of sample data.

Which of the following situations best represents a Type I error? Answer AA clinical trial investigating Drug X is found to be statistically significant and is approved for use by the FDA. A subsequent trial of the same inclusion and exclusion criteria with adequate statistical power is performed and is not found to be statistically significant. BA clinical trial investigating Drug X is found to be statistically significant and is approved for use by the FDA. A subsequent trial of the same inclusion and exclusion criteria and same number of patients is performed and is found to be statistically significant. CA clinical trial investigating Drug X is not found to be statistically significant. A subsequent trial of the same inclusion and exclusion criteria and same number of patients with adequate power is performed and is not found to be statistically significant. DA clinical trial investigating Drug X is not found to be statistically significant. A subsequent trial of the same inclusion and exclusion criteria with adequate power is performed and is found to be statistically significant. EA clinical trial investigating Drug X is found to be statistically significant and is approved for use by the FDA. A subsequent trial of the same inclusion and exclusion criteria with adequate power is performed and is found to be statistically significant.

A A type I error occurs when when the null hypothesis is rejected in error. In the example, the first study had a statistically significant result. The investigator failed to accept (rejected) the null hypothesis. The subsequent study (with adequate power) had conflicting results. This is a type I error.

The pharmacist is presenting a clinical trial to the medical team. The trial includes a 95% confidence interval for the primary endpoint. If the confidence interval was greater (98% or 99%), what effect will be seen with the interval? Answer AThe interval will be wider. BThe interval will be more narrow. CThere will be no effect on the interval. DThe interval will no longer have valid meaning at a greater confidence level. EIt will cause the p-value to be invalid.

A Having a higher confidence interval will widen the interval. For example, 99% CIs are wider than 95% CIs. 95% CIs are wider than 90% CIs.

In the trial above, what is/are the independent variable/s? (Select ALL that apply.) Answer AZoledronic acid BVertebral fractures CPlacebo DHip fractures EOsteonecrosis of the jaw

A In a clinical trial, the independent variable is the intervention.

A clinical trial evaluated the effects of a chemotherapeutic given to patients with osteosarcoma. The trial duration was three months. During this time, there were two deaths among patients receiving placebo and one death among patients receiving active drug. It could be stated that the drug decreased the risk of death by 50%. The "relative risk" of death in the placebo group was 2, or twice the amount in the drug group. The benefit sounds great, but in reality the benefit was very small. Choose the correct statements: (Select ALL that apply.) Answer AThe relative risk can be used to make a small benefit appear larger than is warranted. BRelative risk is also called the risk ratio. CAn important feature of relative risk is that it tells you little about the actual risk outside the trial. DA relative risk > 1 means that the event is less likely to occur in the group with the intervention compared to the control group. EA relative risk < 1 means that the event is less likely to occur in the group with the intervention compared to the control group.

ABCE Relative risk (RR) gives you a measure of the risk of an event in one group compared to the risk of that event in a comparison group. It does not give you an idea of how important (or large) the treatment effect really is in the population-at-large.

Which of the following statements are true regarding the p-value? (Select ALL that apply) Answer AIt represents the level of statistical significance. BIt represents the level of clinical significance. CIt can also be called the alpha level. DIt provides information for accepting or not accepting the null hypothesis. EIt can be set to any number by the investigator and be clinically relevant.

ACD Generally a p-value of < 0.05 indicates statistical significance in a clinical trial. The p-value does not measure the clinical significance of the result.

70. For adults, the maximum daily dose from a Beclovent Inhaler is 840 micrograms. A Beclovent Inhaler contains 8.4 milligrams of deliverable drug in 200 puffs. What is the maximum number of Beclovent puffs a patient may use in one day? 71. A physician has requested a 20 mL vial of Lidocaine 1% with Epinephrine 1:200,000 from your pharmacy. The shelf spot for that product is empty but you do have Lidocaine 1% Injection and Epinephrine Amps, 1%. How much of the Epinephrine Injection must you add to the vial of Lidocaine Injection to prepare the needed product? 72. Human Growth Hormone (somatropin, Nutropin-AQ) is dosed at a rate of 0.3 mg per Kg per week given in equally divided daily doses. Nutropin-AQ Injection is supplied at a strength of 10 mg per 2 mL. What will be the daily dose for a patient who weighs 55 pounds? 73. On a mercy mission to a Third World country you have been asked to calculate the correct amounts of ferric gluconate injection (Ferrlecit) to administer to severely anemic patients. You are given the following formula for such calculations. (NOTE: this is an old formula that is no longer used.) The first patient weighs 110 pounds and has a hemoglobin of 8 gms/dl. Ferrlecit contains 12.5 mg elemental iron per mL; what volume of drug will be given each dose? Normal Hgb (15 gm/dl) minus Patient's Hgb (gm/dl) = Hgb deficiency Hgb deficiency (x) Patient's weight (in kg) = milligrams of elemental iron required Give 5% of the total dose calculated every other day 74. Ms Thomas wants to take one gram of elemental calcium every day and thinks calcium citrate is the best way to do so. She is confused, however, by instructions on the container she is purchasing that say each tablet contains 560 mg of Calcium Citrate Tetrahydrate (20% calcium) and she should take three tablets 3 times a day to obtain 1 gram of elemental calcium daily. Ms Thomas thinks this is a very great overdose and wants you to explain the dose to her and tell her how much calcium the recommended dose would provide.

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75. You need a 1:5000 solution of benzalkonium chloride as a preservative. You have 20 ml of a 1:200 solution in stock. How much of the 1:5000 solution can you prepare by using all 20 ml of the 1:200 solution? 76. You need a 1:750 solution of Zephiran Chloride to disinfect the pharmacy counters. Zephiran is available as a 17% concentrated solution. How much Zephiran concentrate will you mix with enough water to make one gallon of the 1:750 solution you need? 77. An IV solution containing potassium chloride is being administered at a rate of 30 drops per minute using IV tubing that delivers 15 drops per mL. At the end of 8 hours, the patient has received 30 mEq of potassium chloride. What was the initial concentration of potassium chloride in the IV fluid? K = 39, Cl = 36 78. You told your assistant to make a 3 percent morphine solution but something got misunderstood and the result is 80 mL of a 20 percent solution. How much water must you add to the 80 mL to reduce the concentration to 3 percent?

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85. You dilute 1 ml of Fungizone Injection (50 mg per 10 ml) to one liter. The concentration in the diluted solution will be (express as N:XXXX, such as 1:1000) 86. Neupogen Injection is supplied at a concentration of 0.48 mg/1.6 ml. Your patient (weighs 132 pounds) and is to receive a dose of 5 mcg/kg/day. What volume of Neupogen Injection is required for this dose? 87. The parents of a child cannot read or speak English and a pediatrician knows the mother is going to give the child one teaspoonful of medication per dose no matter what dose is ordered. The pediatrician wants you to add enough water to make Biaxin Oral Suspension to a concentration of 150 mg per 5 mL. You have a container of Biaxin powder for oral suspension that says that addition of 55 mL of water will result in a final volume of 100 mL at a concentration of 250 mg per 5 mL. How much water must you use to change the final concentration of this container to 150 mg per 5 mL?

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92. A formulation for an oral liquid of sumatriptan succinate (Imitrex - for migraine headaches) indicates that the final product should have a pH between 4.2 and 5.3. What pH would represent the middle of this range? 93. A table of pKa values gives 4.75 as the pKa for acetic acid. Use the Henderson-Hasselbach Equation to calculate the relative molar ratios of sodium acetate and acetic acid required to prepare a pH 4.75 buffer. 94. Determine the actual quantities, in grams, for a buffer that uses one mole of sodium acetate (NaC2H3O2) and the corresponding amount of acetic acid (C2H4O2). Molecular Weights: Na = 23, C = 12, H = 1, O = 16

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For questions 34 and 35, use the RX in the box to the left. Tetracycline HCl 2 percent NaCL to isotonicity qs 30 ml SIG: 2 drops into OS QID 34. You have tetracycline HCl powder and sodium chloride crystals. How much sodium chloride will you need to add to make the final 30 ml volume isotonic? E value for tetracycline HCl = 0.12 35. In order to obtain the sodium chloride amount you calculated in No. 32, you will need to use Sodium Chloride Injection, 2.5 mEq per ml as your source for NaCl. How many ml will you use? MW Na = 23, Cl = 35.5 36. Pediatric Lanoxin Injection is supplied in ampules of 100 mcg per ml. What quantity must a nurse administer to provide a dose of 0.04 mg?

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Information For Problems 26 and 27. Your patient is receiving lithium carbonate (Li2CO3) capsules but needs to change to a liquid form (lithium citrate; Li3C6H5O7). Molecular weights: lithium = 7, carbon = 12, hydrogen = 1, oxygen = 16 26. If the patient's dose of lithium carbonate was 300 mg three times a day, how many millimoles of lithium did the patient receive in a day? 27. Lithium citrate syrup is available as 300 mg of lithium citrate per 5 ml of syrup. How many milliliters of syrup will be required per day to provide the dose calculated in No. 26?

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Information for questions 101 through 104. You are told to prepare a double strength Dopamine IV drip because a patient is requiring large doses to obtain the drug's effects. The usual Dopamine drip concentration is 400 mg in 250 ml. The patient weighs 176 pounds and needs the pressor dose level of dopamine (10 mcg/kg/min). Dopamine Injection is available as 40 mg per mL in 10 mL vials. Answer the following questions: 101. How many mL of the 40 mg per mL Dopamine Injection should be added to a 500 mg bag of IV fluid to prepare the double concentration? (Ignore volume of the dopamine injection.) 102. To what IV fluid should the dopamine be added? A. Dextrose 5% in Water B. Sodium Bicarbonate Injection, 5% in Water C. Sodium Chloride Injection, 3% D. Sterile Water E. Amino Acids Injection, 10% 103. What will be the dose, in ml per hour of dopamine, will the patient be receiving? 104. If the IV set delivers 15 drops per mL, what will be the flow rate for the dose ordered?

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