FIPP 4 Final Exam Review Latest Update 100% Verified
Pure Food and Drug Act of 1906-ANSWER- Banned the interstate commerce of food and
drugs which are adulterated or misbranded.
- Labeling issue was addressed
- FDA was established as a result
Adulteration- ANSWER Medicament that contains poisonous or deleterious substance
which renders it injurious to users
-EXPIRED MEDICATIONS
1997 Food and Drug Administration Modernization Act (FDAMA) What is it? - ANSWER
Established a mechanism for the dissemination of \\"Off label" information (information
not approved by the manufacturers
OBRA 90 What is it? - ANSWER - Federal legislation for MEDICAID patients
- Most states BOPs adopted these federal regulations for all patients--Not just Medicaid
and applied it to ALL patients
- Designed to encompass primarily 3 major areas:
1) PROSPECTIVE DUR: looking ahead or forward, preventative
2) Patient Counseling standards
3) Maintaining Patient Records
How can patients dispose drugs? *Secure and Responsible Drug Disposal Act of 2010 -
ANSWER 1) Take back events (law enforcement only)
2) Mail back programs
3) Use of collection receptacle --> can't place liquid meds or needles/syringes
, What is the FDA Orange Book? - ANSWER For generic/therapeutic equivalents
- Small molecules
- Purple Book: large molecule; biosimilars
When is a generics dispensing allowed by a pharmacist? - ANSWER 1) Prescriber did
not write a DAW code
2) Purchaser is informed about the substitution
3) The purchaser is aware that they may refuse
What if prescriber wants just the brand, NOT generic? - ANSWER - Must HAND WRITE
"DAW" or manually click box on e-Rx
- E-Rx CANNOT have a default DAW box auto checked
Why does DEA schedule drugs? - ANSWER 1) Proven medicinal purpose
2) Addiction potential
3) Abuse potential
- The lower the schedule #, the greater the addiction or abuse potential
Foundational requirements for a valid prescription: - ANSWER A prescription must be
issued for a LEGITIMATE MEDICAL PURPOSE by a prescriber acting in the USUAL
COURSE OF HIS/HER PROFESSIONAL PRACTICE and the prescription must be of BONA
FIDE TREATMENT of a patient
- Pharmacist has a CORRESPONDING RESPONSIBILITY to see that this requirement is
met
Federal Dispensing Requirements for C2's: - ANSWER Technically C2's do not have any
expiration or quantity restrictions FEDERALLY
- Most states have fill within timeframes or expirations for C2's as well as quantity limits
Pure Food and Drug Act of 1906-ANSWER- Banned the interstate commerce of food and
drugs which are adulterated or misbranded.
- Labeling issue was addressed
- FDA was established as a result
Adulteration- ANSWER Medicament that contains poisonous or deleterious substance
which renders it injurious to users
-EXPIRED MEDICATIONS
1997 Food and Drug Administration Modernization Act (FDAMA) What is it? - ANSWER
Established a mechanism for the dissemination of \\"Off label" information (information
not approved by the manufacturers
OBRA 90 What is it? - ANSWER - Federal legislation for MEDICAID patients
- Most states BOPs adopted these federal regulations for all patients--Not just Medicaid
and applied it to ALL patients
- Designed to encompass primarily 3 major areas:
1) PROSPECTIVE DUR: looking ahead or forward, preventative
2) Patient Counseling standards
3) Maintaining Patient Records
How can patients dispose drugs? *Secure and Responsible Drug Disposal Act of 2010 -
ANSWER 1) Take back events (law enforcement only)
2) Mail back programs
3) Use of collection receptacle --> can't place liquid meds or needles/syringes
, What is the FDA Orange Book? - ANSWER For generic/therapeutic equivalents
- Small molecules
- Purple Book: large molecule; biosimilars
When is a generics dispensing allowed by a pharmacist? - ANSWER 1) Prescriber did
not write a DAW code
2) Purchaser is informed about the substitution
3) The purchaser is aware that they may refuse
What if prescriber wants just the brand, NOT generic? - ANSWER - Must HAND WRITE
"DAW" or manually click box on e-Rx
- E-Rx CANNOT have a default DAW box auto checked
Why does DEA schedule drugs? - ANSWER 1) Proven medicinal purpose
2) Addiction potential
3) Abuse potential
- The lower the schedule #, the greater the addiction or abuse potential
Foundational requirements for a valid prescription: - ANSWER A prescription must be
issued for a LEGITIMATE MEDICAL PURPOSE by a prescriber acting in the USUAL
COURSE OF HIS/HER PROFESSIONAL PRACTICE and the prescription must be of BONA
FIDE TREATMENT of a patient
- Pharmacist has a CORRESPONDING RESPONSIBILITY to see that this requirement is
met
Federal Dispensing Requirements for C2's: - ANSWER Technically C2's do not have any
expiration or quantity restrictions FEDERALLY
- Most states have fill within timeframes or expirations for C2's as well as quantity limits
