COMPLETE QUESTIONS WITH
VERIFIED CORRECT ANSWERS ||
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1. Nominal variable - ANSWER ✔ A variable that describes categories without
a natural order.
2. Health disparities - ANSWER ✔ Preventable differences in the burden of
disease, injury, violence, or opportunities to achieve optimal health that are
experienced by socially disadvantaged populations.
3. FDA Orange Book - ANSWER ✔ The FDA book that lists generic
equivalents for brand name drugs.
4. Cohort study - ANSWER ✔ An observational study design that has the
highest level of evidence.
5. Sample size representation - ANSWER ✔ A study with 10,000 participants
all meeting inclusion criteria has a large enough sample size to be
representative of the population.
,6. Phase 4 study objective - ANSWER ✔ Helps to detect rare ADRs and drug
interactions.
7. Phase 1 study objective - ANSWER ✔ To detect rare adverse drug reactions.
8. Phase 3 clinical study - ANSWER ✔ Focuses on efficacy and safety.
9. Political Advocacy - ANSWER ✔ Legislative and regulatory issues
10.Patient Advocacy - ANSWER ✔ Role of the professional (RPH) in
healthcare
11.Professional Advocacy - ANSWER ✔ Push for our patient's rights and
interests in healthcare
12.Federal Food, Drug and Cosmetic Act of 1938 - ANSWER ✔ US Federal
Drug Law that gave the FDA the authority to regulate the advertising of
prescription drugs
13.Kefauver-Harris Amendments of 1962 - ANSWER ✔ US Federal Drug Law
related to the regulation of drug advertising
14.Orphan Drug Act of 1983 - ANSWER ✔ US Federal Drug Law concerning
drugs for rare diseases
15.Adverse Drug Reactions (ADRs) - ANSWER ✔ Helps to detect rare ADRs
and drug interactions
,16.Phase 1 Study Objective - ANSWER ✔ To detect rare adverse drug
reactions
17.Phase 1 Study Objective - ANSWER ✔ To study efficacy and safety in a
large study population
18.Phase 1 Study Objective - ANSWER ✔ To assess a safe & tolerated dose
19.Sample Size Calculation - ANSWER ✔ Values needed include alpha, Type I
error, and clinical difference to detect, delta
20.Commercial IND - ANSWER ✔ Pharmaceutical companies whose ultimate
goal is to obtain marketing approval for new products
21.Institutional Review Board (IRB) - ANSWER ✔ Ensures informed consent
is obtained and the documents meet regulatory requirements
22.What is unprofessional conduct in the practice of pharmacy? - ANSWER ✔
- false advertising or displaying signs that promote dangerous drugs to the
public in a manner that is false or misleading
- selling a prescription drug without having received a prescription for
the drug
- knowingly dispensing medications from false or forged prescriptions
- knowingly failing to maintain complete an accurate records of all
dangerous drugs received or dispensed in compliance with federal
laws and regulation and state laws and rules
- obtaining any payment by fraud, misrepresentation, or deception
, 23.What if it's an issue that can't wait for a hearing? Summary suspesion -
ANSWER ✔ - the board may suspend a license by utilizing a telephone
conference call to review the allegations and take a vote
- use if situation puts public at immediate risk (addiction (automatic))
(any situation which the pharmacist's actions would be an immediate
threat to the public
- if the board has reasonable cause to believe that a pharmacist or
pharmacy intern is physically or mentally impaired, the board may
require the pharmacist or pharmacy intern to submit to a physical or
mental examination or both
24.Manner of issuance of a prescription - ANSWER ✔ - a prescription to be
valid must be issued for a legitimate medical purpose by a prescriber acting
in the usual course of his/her professional practice
- prescription must be in the usual course of bona fide treatment of a
patient
- bonafide must be made or carried out in good faith, sincere, authentic,
genuine
- the pharmacist has a corresponding responsibility to see the that this
requirement is met
25.Prescription requirements - ANSWER ✔ - Dated on the day when issued
- Bear the full name, professional title (MD, DO etc..) and address of
the prescriber
- Indicate a telephone number where prescriber can be contacted during
normal business hours
- Full name & residential address of patient
- Indicate the drug name & strength
- Quantity to be dispensed
- Indicate the appropriate & explicit directions
- Specify the # of refills or the time period for refills**see next slide