CPJE CORRECT STUDYS ANSWERS AND QUESTIONS
SET A+
✔✔Orange Book (p. 42) - ✔✔Approved Drug Products with Therapeutic Equivalence
Evaluations
1. Published by the FDA
2. Guide for therapeutically equivalent drugs
Orange book available via:
1. Print
2. FDA website
Purpose:
1. to provide pts w/ cheaper medications
2. *Cost-Savings* MUST be communicated to the pt if a generic substitution is made
3. If generic is picked: must include generic name and manufacturer's name
4. If brand is used: ONLY need to have the brand name (since it is registered directly w/
the manufacturer)
✔✔Substituting Drug Formulations (p. 43) - ✔✔Pharmacist CAN select a different
*formulation* if:
1. Same strength
2. same duration of therapy
3. change will improve ability of pt to comply w/ tx
Ex.
child prescribed a med in tablet form, but unable to swallow tablets, pharmacist may
choose to switch to suspension
✔✔Cannot Substitute (p. 43) - ✔✔1. Long acting to short acting
2. Combination drug products to multiple single agents
✔✔Substituting Biologicals (p. 44) - ✔✔Lists of Licensed Biological Products w/
Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations
,aka *The Purple Book*
Only 2 biologic Biosimilars approved:
1. Neupogen biosimilar: Filgrastim-sndz (Zarxio)
2. Remicade biosimilar: infliximab-dyyb (Inflectra)
May make this substitution unless the "biosimilar costs more" or the physician says no
Must communicate to pt and physician that the pt got the biosimilar
✔✔Therapeutic Interchange Protocol (p. 47) - ✔✔Protocol established as a *Cost-
saving strategy* to *substitute* one drug for another drug in the same class that is
therapeutically similar
i.e. substituting Crestor for Atorvastatin
Can also include *IV:PO conversions/substitutions*
✔✔Automated Drug Delivery Systems (ADDS) - ✔✔cabinets used to store and
dispense drugs in
1. Hospitals
2. Skilled nursing facilities (SNF)
3. Intermediate Care facilities (ICF)
Risk of diversion in SNF and ICF are higher than at hospitals
If the cabinet is used to house and dispense *scheduled drugs* a DEA registered
pharmacy must manage the cabinet (p. 47 bottom)
*Requirements for SNF and ICF*
1. Policies and procedures to ensure proper dispensing and storage of meds
2. pharmacist reviews each med order + pt's profile before the drug is removed from the
ADDS
3. Override functions are ONLY used in emergencies
4. When cabinet is stocked directly in the facility, MUST be done by a pharmacist
5. If containers are to be filled offsite, they can only be restocked (put back into the
machine by a pharmacist, intern pharmacist or pharmacy technician) (p. 48)
✔✔Drugs in cabinets MUST be labeled with: (p. 48) - ✔✔1. Name of drug
2. strength & dosage form
3. Manufacturer
4. Lot #
5. Expiration date
✔✔Repackaging (p. 48) - ✔✔Put from larger container into smaller vials
can be used for fast movers
, MUST be labeled with (at least):
1. Name of drug
2. strength
3. dosage form
4. manufacturere's name
5. lot #
6. expiration date
7. Quantity
any original packaging/handling instructions must be followed when repackaging or else
may conflict w/ approved labeling
✔✔Repackaging previously Dispensed drugs into blister packs (p. 49) - ✔✔Medication
blister pack aka bubble blister pack aka medication pill card
any pharmacy providing repackaging services needs Policy and Procedures in place for
the repachaging proce
MUST label the repackaged meds w/
1. All info required for an Rx label
2. Name and address of the pharmacy that initially dispensed the drugs to the pt
3. Name and address of pharmacy repackaging the drugs (if different from above)
✔✔Refill pharmacies - ✔✔*Label must contain:*
1. name and address of refilling *and/or* originating pharmacy must be included on the
label
2. Written info describing which pharmacy to contact for questions
*BOTH* pharmacies are responsible for:
1. accuracy of fills
*Originating pharmacy is responsible for:*
1. counseling pts
2. maintain med profiles
3. performing drug utilization review BEFORE delivery of each Rx
✔✔Traditional Compoudning; 503A
(p. 49) - ✔✔Drug Quality and Security Act (*DQSA*) - section *503A*
compound a drug when the health needs of a pt cannot be met by an FDA-approved
medication
503A permits a pharmacy to prepare *small batches* of a compounded preparation in
*advance* if the dispensing hx and the store supports the need
SET A+
✔✔Orange Book (p. 42) - ✔✔Approved Drug Products with Therapeutic Equivalence
Evaluations
1. Published by the FDA
2. Guide for therapeutically equivalent drugs
Orange book available via:
1. Print
2. FDA website
Purpose:
1. to provide pts w/ cheaper medications
2. *Cost-Savings* MUST be communicated to the pt if a generic substitution is made
3. If generic is picked: must include generic name and manufacturer's name
4. If brand is used: ONLY need to have the brand name (since it is registered directly w/
the manufacturer)
✔✔Substituting Drug Formulations (p. 43) - ✔✔Pharmacist CAN select a different
*formulation* if:
1. Same strength
2. same duration of therapy
3. change will improve ability of pt to comply w/ tx
Ex.
child prescribed a med in tablet form, but unable to swallow tablets, pharmacist may
choose to switch to suspension
✔✔Cannot Substitute (p. 43) - ✔✔1. Long acting to short acting
2. Combination drug products to multiple single agents
✔✔Substituting Biologicals (p. 44) - ✔✔Lists of Licensed Biological Products w/
Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations
,aka *The Purple Book*
Only 2 biologic Biosimilars approved:
1. Neupogen biosimilar: Filgrastim-sndz (Zarxio)
2. Remicade biosimilar: infliximab-dyyb (Inflectra)
May make this substitution unless the "biosimilar costs more" or the physician says no
Must communicate to pt and physician that the pt got the biosimilar
✔✔Therapeutic Interchange Protocol (p. 47) - ✔✔Protocol established as a *Cost-
saving strategy* to *substitute* one drug for another drug in the same class that is
therapeutically similar
i.e. substituting Crestor for Atorvastatin
Can also include *IV:PO conversions/substitutions*
✔✔Automated Drug Delivery Systems (ADDS) - ✔✔cabinets used to store and
dispense drugs in
1. Hospitals
2. Skilled nursing facilities (SNF)
3. Intermediate Care facilities (ICF)
Risk of diversion in SNF and ICF are higher than at hospitals
If the cabinet is used to house and dispense *scheduled drugs* a DEA registered
pharmacy must manage the cabinet (p. 47 bottom)
*Requirements for SNF and ICF*
1. Policies and procedures to ensure proper dispensing and storage of meds
2. pharmacist reviews each med order + pt's profile before the drug is removed from the
ADDS
3. Override functions are ONLY used in emergencies
4. When cabinet is stocked directly in the facility, MUST be done by a pharmacist
5. If containers are to be filled offsite, they can only be restocked (put back into the
machine by a pharmacist, intern pharmacist or pharmacy technician) (p. 48)
✔✔Drugs in cabinets MUST be labeled with: (p. 48) - ✔✔1. Name of drug
2. strength & dosage form
3. Manufacturer
4. Lot #
5. Expiration date
✔✔Repackaging (p. 48) - ✔✔Put from larger container into smaller vials
can be used for fast movers
, MUST be labeled with (at least):
1. Name of drug
2. strength
3. dosage form
4. manufacturere's name
5. lot #
6. expiration date
7. Quantity
any original packaging/handling instructions must be followed when repackaging or else
may conflict w/ approved labeling
✔✔Repackaging previously Dispensed drugs into blister packs (p. 49) - ✔✔Medication
blister pack aka bubble blister pack aka medication pill card
any pharmacy providing repackaging services needs Policy and Procedures in place for
the repachaging proce
MUST label the repackaged meds w/
1. All info required for an Rx label
2. Name and address of the pharmacy that initially dispensed the drugs to the pt
3. Name and address of pharmacy repackaging the drugs (if different from above)
✔✔Refill pharmacies - ✔✔*Label must contain:*
1. name and address of refilling *and/or* originating pharmacy must be included on the
label
2. Written info describing which pharmacy to contact for questions
*BOTH* pharmacies are responsible for:
1. accuracy of fills
*Originating pharmacy is responsible for:*
1. counseling pts
2. maintain med profiles
3. performing drug utilization review BEFORE delivery of each Rx
✔✔Traditional Compoudning; 503A
(p. 49) - ✔✔Drug Quality and Security Act (*DQSA*) - section *503A*
compound a drug when the health needs of a pt cannot be met by an FDA-approved
medication
503A permits a pharmacy to prepare *small batches* of a compounded preparation in
*advance* if the dispensing hx and the store supports the need
