Topic of Interest Literature in which to Find Topic
Alcohol/sugar/gluten free Red Book (Drug Topics)
Adverse effects Meyler’s Side Effects of Drugs
Drug-Induced Diseases
Bioequivalence Orange Book (electronic version on FDA website)
Compounding Remington’s Pharmaceutical Sciences
Extemporaneous Formulations
Consumer health information USP DI Vol II: Advice for the Patient (obsolete) Clinical Pharmacology
Lexi-Comp Micromedex Websites:
www.drugdigest.org www.webmd.com
Diseases/General Medicine Cecil Textbook of Medicine
Harrison’s Principles of Internal Medicine Dosing
Dosing: Special populations
AHFS Drug Information Clinical Pharmacology Drug Facts and Comparisons Micromedex
Harriet Lane Handbook (pediatric) Drugs in Pregnancy and Lactation (Briggs) Drug Prescribing in Renal Failure
Drug Interactions Hansten and Horn Drug Interaction Analysis and Management Clinical Pharmacology
Drug Facts and Comparisons Micromedex
Foreign Drug Identifications Index Nominum
Martindale: The Complete Drug Reference
IV Compatibility Trissel’s Handbook on Injectable Drugs
King’s Guide to Parenteral Admixtures
Natural Products Natural Standard
Natural Medicines Comprehensive Database
Pharmacology/Pharmacokinetics Goodman and Gilman’s The Pharmacologic Basis of Therapeutics Pharmacotherapy: A Pathophysiologic Approach (DePiro) Applied Therapeutics: The Clinical Use of Drugs (Koda-Kimble)
Tablet Identification IDENTIDEX (Micromedex)
IDENT-A-DRUG WebMD
Clinical Pharmacology’s Drug Identifier
Unlabeled use Drug Facts and Comparisons
Micromedex
USP DI Volume 1 (obsolete) AHFS Drug Information Clinical Pharmacology
Vaccines www.cdc.gov
2. Double dummy: use of multiple controls to maintain blinding
a) Example: To compare two medicines, one presented as blue tablets and one as red capsules, researchers could also supply blue placebo tablets and red placebo capsules so that both groups of patients would take one blue tablet and one red capsule
3. Active control: use of an established therapy as the comparative group
4. Crossover: patients serve as their own control by receiving multiple interventions
F. Methods
G. Institutional review board (IRB), ethics committees H. Intervention, duration of treatment
I. Monitoring J. Follow-up K. Compliance
1. Measure of adherence L. Outcome Measures
1. Primary/secondary endpoints 2. Surrogate endpoints: easily measured
substitute markers in place of more clinically meaningful endpoints (e.g., CD4 count used as a surrogate endpoint for a trial regarding HIV infection)
M. Statistics
1. Goal: to be confident that the probability statement (p value) is valid and to maximize the possibility of detecting a difference when one actually exists1
N. Results
O. Reporting adverse effects (MedWatch) III. Assessing Trial Results
A. Findings related to primary outcomes 1. What type of data are presented?
a) Categorical (qualitative data)
(1) Nominal: named categories (e.g., blood type, gender, race)
(a) Mutually exclusive
(2) Ordinal: ordered categories of data; often sequenced (e.g., poor, good, excellent) (a) Mutually exclusive
b) Numerical (quantitative data)
(1) Continuous: ordered, sequenced, and has a set of distance or values between rank (e.g., blood pressure, glucose levels) B. Were the findings statistically significant?
1. Hypothesis testing
a) Tests against the null hypothesis (1) Null hypothesis (Ho): states that the
variable of interest is equal to a given value or that no relationship exists between various variables
2. Statistical and clinical significance
a) Statistical: probability that the results are due to chance or due to a true effect of treatment b) Clinical: importance of the practical relevance
or variation of a difference in outcomes (1) A statistically significant outcome may
not be clinically significant 3. P value
a) The probability of the observed result or a more extreme result occurring by chance alone
b) The probability of the observed difference occurring if the null hypothesis is true 4. Types of error
a) Type I error (false-positive error) (1) Rejecting the null hypothesis when it
should be accepted (2) Relates to validity (3) Alpha level
(a) It is the risk of finding a difference when there is not one (risk of experiencing a type I error) (b) Usually 5% by designation,
indicating there is a less than 5%
possibility that a finding is due to chance (does not really exist) b) Type II error (false-negative error)
(1) Accepting the null hypothesis when it should have been rejected (there was a difference that was not detected) (2) Relates to power
(3) Beta level
(a) The chance researchers are willing to risk that a difference will not be detected
(b) The probability of committing a Type II error
(c) Type II error (or beta) (d) Usually 20% by designation 5. Confidence interval (CI)
a) The range of values in which researchers can be certain that the true point estimate will fall
b) 95% CI most commonly reported
(1) 95% probability that the true result lies within the range of results found, and there is a 5% probability that the true range lies outside the interval
c) CI is calculated by subtracting from and adding to the sample mean the appropriate number of standard errors of the mean d) The narrower the CI, the greater the
reliability and more precise the data C. How large is the treatment effect (when the
primary outcome shows a statistically significant difference)?
1. Relative risk (RR)
a) The reduction in the risk from one therapy relative to another (RR¼ events in treatment group events in placebo group)
(1) A RR of 1 means that there is no difference.
(2) A RR that is<1 (e.g., 0.75) means that risk is decreased
(3) A RR that is>1 (e.g., 1.15) means that risk is increased
b) Commonly used to express the therapeutic benefit of a drug
2. Absolute reduction risk (ARR)
a) The absolute difference between the probabilities of the treatment event rate and control event rate (ARR¼ Probability of events in placebo group [PB] Probability of events in the active treatment group [PA]) b) Expressed as a percentage
3. Number needed to treat (NNT)
a) Number of subjects needed to treat over a defined period of time to experience one benefit of therapy
b) NNT¼ 1/ARR IV. Evaluating Clinical Trials
A. Questions to consider
1. Why was this study conducted?
2. Were previous trials conducted?
B. Consider the power/significance of the study 1. Statistically
2. Clinically C. Critique the trial
1. Population 2. Intervention
3. Endpoints: were they appropriate?
4. Statistics
a) Consider the appropriateness of each statistical test and result
D. Can the findings from this study be extrapolated to patient/consumer?
V. Study Types in Clinical Research A. Randomized controlled trial
1. An experiment in which investigators assign, by random allocation, eligible subjects into intervention groups to receive or not to receive one or more interventions that are being compared
2. Gold standard: Randomized controlled trials are considered to have the highest validity and reliability of various research designs, as they eliminate causes of bias and provide a high level of experimental control.
3. Necessary for Food and Drug Administration (FDA) approval
B. Cohort studies
1. Group of subjects who have not yet experienced the outcome of interest 2. Subjects exposed to a factor of interest are
compared to a group not exposed and followed prospectively over time
C. Case-control studies
1. Subjects with a particular characteristic are compared to a similar group without the characteristic to determine the cause 2. Retrospective
D. Case reports 1. No control
2. No designed intervention 3. Descriptive account of a subject E. Meta-analysis
1. A method of combining results of previous and similar research to determine a single estimate of treatment
F. Cross-sectional studies
1. Measurements taken at a single point in time G. Survey
1. Research used to study the incidence, distribution, and relationship
H. “N-of-1” trials
1. Randomized controlled study involving a single subject
2. Crossover design
3. Lack of generalizability to a population
VI. Research involved in the FDA Drug Approval Process A. Preclinical research
1. Goal: assess potential therapeutic effects 2. Does not predict human response B. Phase I
1. Initial study, usually in healthy human volunteers 2. Small number of subjects (fewer than 100
subjects); brief length of study (less than 1 year 3. Determines toxicology, metabolism, and
pharmacologic activities; early evidence of effectiveness
C. Phase II
1. Expanded drug study to obtain preliminary efficacy data and safety in humans
2. Small and highly homogeneous population of patients for whom the drug is intended (N¼ several hundred participants) D. Phase III
1. Pivotal trials
2. Larger study (N¼ hundreds to thousands of participants)
3. Long-term (up to several years)
4. Semidiverse population (representing target population)
5. Establishes final formulation, marketing claims, product stability, packaging, and storage concerns 6. Successful completion may mean ready to
submit compound to FDA for approval E. Phase IV (postmarketing surveillance) F. New Drug Application (NDA) form
G. Abbreviated NDA (aNDA) form: generic drug approval
H. Supplemental NDA (sNDA): approval for new indication
Reference
Haney MS, Meek PD: Essential clinical concepts of biostatistics, Kansas City, 1999, ACCP.
REVIEW QUESTIONS
(Answers and Rationales on page 320.)
1. A customer requests a recommendation for a
“reliable brand” for ginseng. To ensure that she gets a ginseng product that has been tested for quality, what website(s) should a pharmacist consult?
I. ConsumerLab.com II. ConsumerReports.org
III. American Society of Health-System Pharmacists (ASHP) Essentials
a. I only b. III only c. I and II only d. II and III only e. I, II, and III
2. A customer requests a recommendation for a
“reliable brand” for honeysuckle. To ensure that she gets a honeysuckle product that has been tested for quality, a pharmacist should NOT consult which of the following websites?
a. ConsumerLab.com b. ConsumerReports.org
c. www.USP.org d. www.nsf.org e. www.fda.gov
3. How is Drug Facts and Comparisons organized?
a. Alphabetically by generic name b. Alphabetically by manufacturer name c. By imprint code
d. By therapeutic use e. None of the above
4. How is Trissel’s Handbook of Injectable Drugs organized?
a. Alphabetically by generic name b. Alphabetically by manufacturer name c. By imprint code
d. By therapeutic use e. None of the above
5. In which of the following resources could you have found information on unlabeled uses for a drug?
I. Lexi-Comp
II. Drug Facts and Comparisons
III. United States Pharmacopeia (USP) Volume 1 (obsolete)
a. I only b. II only c. I and II only d. II and III only e. I, II, and III
6. Which of the following resources would you NOT use to identify a drug?
a. IDENTIDEX System b. Clinical Pharmacology
c. Facts and Comparisons eAnswers d. WebMD
e. Natural Standard
7. In which resource would you find separate age, height, and weight charts for boys and girls?
I. Drugs in Pregnancy and Lactation (Briggs) II. Harriet Lane Handbook
III. NeoFax a. I only b. II only c. III only d. I and II only e. I, II, and III
8. The FDA’s MedWatch is a service through which one can report:
I. product quality problems.
II. product use errors.
III. adverse reactions.
a. I only b. III only c. I and II only d. II and III only e. I, II, and III
9. Any original published research in regards to a medication is considered to be:
a. primary literature.
b. secondary literature.
c. tertiary literature.
10. Where would you best find a list of sound-alike look-alike drugs?
a. AHFS b. EMBASE c. IPA d. MEDLINE
e. Institute for Safe Medication Practices (ISMP) 11. True or False: PubMed requires the use of MeSH terms.
a. True b. False
12. If given a “PMID,” what is the quickest way to locate the article?
a. Micromedex b. EMBASE c. PubMed d. Ovid
13. Why is it difficult to detect new or rare adverse drug reactions (ADR)?
a. It is not mandated to report ADRs to a program such as MedWatch.
b. Patients are taking too many medications to determine which causes an ADR.
c. Patients are poorly monitored while on therapy.
d. Patients are hesitant to report an ADR.
14. True or False: Because MedWatch is an FDA program and not a manufacturer, MedWatch does not publish safety-related drug labeling changes.
a. True b. False
15. What do P and T in “P & T Committee” stand for?
a. Pharmacy and Therapeutics b. Pharmacology and Therapeutics c. Pharmacy and Times
d. Pharmacy and Toxicology
16. True or False: The P & T Committee, like the IRB, reviews, monitors, and has the authority to approve or disapprove research.
a. True b. False
17. A recent formulary protocol has taken effect at your hospital and the proton pump inhibitor (PPI) of choice is Prilosec (omeprazole). The clinical pharmacist receives a prescription for Protonix (pantoprazole) and automatically switches to Prilosec. This is an example of:
a. generic substitution.
b. pharmaceutical alternative.
c. pharmaceutical equivalence.
d. therapeutic interchange.
18. Which of the following are disadvantages in retrospective data collection?
a. There is no impact on clinical outcome.
b. There are limited resources.
c. It is time consuming.
d. All of the above.
19. Results of a study show that, compared with placebo, the investigational agent decreases blood pressure by 10 mm Hg with p value of 0.006. What is the best description of this result?
a. Statistically significant and clinically significant b. Statistically significant but not clinically significant c. Clinically significant but not statistically
significant
d. Not clinically significant and not statistically significant
20. Which of the following are limitations of clinical studies to detect adverse effects?
a. ADR studies use healthy, nonsymptomatic patients.
b. ADR studies use a relatively small sample size when compared to the numbers of patients estimated to be prescribed a drug.
c. ADR studies use a relatively short study duration when compared to the duration of treatment used for most chronic medications.
d. All of the above.
e. None of the above.
21. Type A adverse drug reactions:
I. are usually dose-dependent and predictable.
II. are unrelated to pharmacological actions.
III. are caused by immunological mechanisms.
a. I only b. III only c. I and II d. II and III e. I, II, and III
22. A type of data analysis in which the results of several studies are lumped together and analyzed refers to which type of study?
a. Randomized controlled study b. Cohort study
c. Case study d. Meta-analysis
23. The outcome measure of a study comparing the efficacy of a new sepsis drug with existing therapy is mortality at 28 days. What is this type of outcome?
a. Surrogate measure b. Primary outcome measure c. Secondary outcome measure d. None of the above
24. The primary outcome measure for a study comparing the efficacy of a new sepsis drug with existing therapy is mortality at 28 days. What type of data is this outcome?
a. Continuous b. Ordinal c. Nominal
d. None of the above
25. Which source contains information regarding foreign drugs?
a. Martindale: The Complete Drug Reference b. Red Book Drug Topics
c. Lexi-Comp
d. AHFS Drug Information
26. Which of the following people are blinded in a triple-blind study?
I. Statistician II. Investigators
III. Experimental subjects a. I only
b. III only c. I and II d. II and III e. I, II, and III
27. Which of the following is the form to report adverse drug reactions to the FDA?
a. Naranjo Causality Scale
b. Vaccine Adverse Event Reporting System (VAERS) c. MedWatch
28. The statistical analysis of a large collection of analysis results from individual studies for the purpose of integrating the findings. This definition refers to what type of study?
a. Meta-analysis
b. Randomized controlled trial c. Crossover study
d. Case-control study e. Cohort study
29. To achieve the least amount of bias, what study design should be used?
a. Open label b. Single blind c. Double blind
30. Which type of error is made if the researcher concludes that there is difference between the studied groups when there is NO difference?
a. Type II error b. Type I error c. Both a and b d. None of the above
31. True or False: MEDLINE is the database that is available to anyone free of charge.
a. True b. False
32. What type of literature is readily available in most pharmacies?
a. Primary literature b. Secondary literature c. Tertiary literature
33. The National Institutes of Health and the National Library of Medicine worked to develop what online drug information database?
a. DailyMed
b. Clinical Pharmacology c. Medscape Drug Reference d. Natural Standard
e. UptoDate
34. What is currently the name for the PDA counterpart of Micromedex?
a. DailyMed
b. Clinical Pharmacology c. mobileMicromedex d. Epocrates
e. Thomson mobile
35. Through which of the following is MEDLINE available free to the public?
a. Blackwell Synergy b. EBSCOHost c. EMBASE d. OVID e. PubMed
36. The truncation symbol for PubMed is:
a. # b. $ c. * d. &
e. ∧
37. The primary function of the Peer Review Process is to:
a. Reduce subscription costs
b. Ensure accuracy and quality of content c. Increase the journal revenues via reviewer fees d. Advance the publication process
e. Decrease the number of research papers submitted for publication
38. A nurse working on the pediatric unit of a hospital incorrectly administers 3 units of regular insulin to a child intramuscularly rather than subcutaneously.
The nurse is at fault for a(n):
a. Vaccine scheduling error b. Immunization injury c. Medication error d. Adverse drug event e. All of the above
39. A girl enters your pharmacy and asks you to identify a drug she found in her boyfriend’s gym bag. The ethical principle that would prohibit you from providing the answer is:
a. Autonomy b. Equality c. Sincerity d. Privacy
e. None of the above
40. Copyright Law is a subsection of which of the following laws?
a. Criminal Law b. Administrative Law c. Civil Law
d. Intellectual Property Law e. None of the above
41. Which of the following is an example of continuous data?
a. Gender b. NHYA class c. Blood pressure d. Mortality
42. Copying words or ideas without giving credit for the original idea or language is referred to as:
a. Plagiarizing b. Copyrighting c. Broadcasting d. Referencing e. Reproducing
43. A unique alphanumeric string assigned to an object such as an electronic journal article is a(n):
a. Digital Object Identifier (DOI) b. HyperTextMarkup Language (HTML) c. Extensible markup locator (XML) d. Uniform Resource Identifier (URI) e. HyperText Transfer Protocol (HTTP)
44. Which of the following resources may be used to check the compatibility of a drug with other drugs?
I. Trissel’s Handbook of Injectable Drugs II. King’s Guide to Parenteral Admixtures III. Drug-Induced Diseases
a. I only b. III only c. I and II d. II and III e. I, II, and III
45. Any undesirable effect associated with the use of a drug at a normal dose is referred to as a(n):
a. Adverse drug reaction b. Medication error
c. Medication misadventure d. All of the above
e. None of the above
46. Which of the following is most likely to be an example of primary literature?
a. A chapter in Harrison’s Principles of Internal Medicine entitled “Women’s Health”
b. A monograph in Natural Standard Database entitled “Saw Palmetto”
c. A journal entitled “The Annals of Pharmacotherapy”
d. An article in New England Journal of Medicine titled “The Relation between Blood Pressure and Mortality Due to Coronary Heart Disease among Men in Different Parts of the World”
e. All of the above
47. True of False: Double-blind, randomized controlled trials are associated with the least amount of bias.
a. True b. False
48. True or False: A well-conducted study has internal validity only.
a. True b. False
49. The results of a randomized controlled trial that compares insulin delivered via a pump with insulin injected 3 times daily shows 18% reduction in HbA1C for patients on the pump (95% confidence interval, 1%–
22%). True or False: The result is statistically significant.
a. True b. False
50. True or False: The confidence interval determines whether the result is clinically significant.
a. True b. False
51. Continuous data are used to describe which of the following?
a. Blood sugar level b. Blood pressure c. Mortality d. Gender e. a and b only
52. The combination of key words that will return the highest number of results is:
a. Propranolol AND hypertension b. Propranolol NOT hypertension c. Propranolol OR hypertension d. Propranolol WITH hypertension e. Propranolol WITHOUT hypertension
53. To find out if daptomycin and ceftazidime can be safely administered through aY-site, it would be best to consult:
a. Cecil Textbook of Medicine
b. Drugs in Pregnancy and Lactation (Briggs) c. King Guide to Parenteral Admixtures d. Merck Index
e. Stockley’s Drug Interactions 54. Yahoo.com is an example of a:
a. Search directory b. Search engine c. Web site d. Web dictionary e. None of the above 55. The Weber Effect states:
I. Adverse drug reactions always follow a normal distribution
II. Healthcare professionals must report adverse drug reactions in an online database
III. Reporting of adverse drug reactions increases until the middle to end of the second year of marketing a. I only
b. III only c. I and II only d. II and III only e. I, II, and III
56. A well-conducted study will have:
a. internal validity but no external validity.
b. both internal and external validity.
c. external validity but no internal validity.
d. no internal and external validity.
57. Phase IV clinical studies are commonly known as?
a. Pharmacokinetic study b. Preclinical study
c. Post-Marketing Surveillance study d. Prevention study
e. Quality of life study
58. In clinical research, beta refers to which of the following:
a. the null hypothesis being true
b. the probability of making a type II error c. degree to which conclusions about causes of
relations are likely to be true d. cause-effect relationships e. None of the above 59. Statistical power of a study is:
a. used to determine sample size.
b. determined after enrollment.
c. determined before enrollment.
d. a and c only.
e. All of the above.
60. A medication use evaluation is:
I. An evaluative method; reviewing practitioner prescribing, pharmacist dispensing, and patient use of medications is considered
II. An ongoing, systematic process designed to maintain the appropriate and effective use of the drug
III. Designed to improve quality of care for patients a. I only
b. III only c. I and II only d. II and III only e. I, II, and III 61. What is nominal data?
b. III only c. I and II only d. II and III only e. I, II, and III 61. What is nominal data?