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Vista previa 4 fuera de 43 páginas
Examen

Fipp 4 Exam Study Guide 2026/2027 Complete Questions With Verified Correct Answers || 100% Guaranteed Pass Newest Version

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Vista previa 4 fuera de 43 páginas

FIPP 4 EXAM STUDY GUIDE 2026/2027 COMPLETE QUESTIONS WITH VERIFIED CORRECT ANSWERS || 100% GUARANTEED PASS NEWEST VERSION 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

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FIPP 4 EXAM STUDY GUIDE 2026/2027
COMPLETE QUESTIONS WITH
VERIFIED CORRECT ANSWERS ||
100% GUARANTEED PASS
<NEWEST VERSION>



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

Información del documento

Subido en
14 de marzo de 2026
Número de páginas
43
Escrito en
2025/2026
Tipo
Examen
Contiene
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