Exam 2 Flashcards
Our R&D team recently completed several studies using compound RZ43 that revealed beneficial effects on blood pressure in rats. What is the next legal step in order to perform testing in humans?
IND- allows them to ship in interstate commerce. .
What must be approved by the FDA before we may legally distribute a new drug in interstate commerce for patient use?
NDA
RZ43 was approved by the FDA for hypertension. Further rat studies show that the drug also shows promise in lowering cholesterol. Can we add this as an indication?
No, need supplemental new drug application
Fast forward 20+ years from the date the patent for RZ43 was originally filed. A
competitor company would like to manufacturer a generic version of RZ43. What type of application must they file with the FDA? What must they prove in this application?
aNDA (abbreviated NDA)
Need to prove bioequivalence only, allowed to be 80% the same.
Your company wants to maximize the time on the market for one of its drugs whose patent is expiring so it produces an “authorized generic” under a private label. What is the benefit of doing this?
They do not have to make an NDA, its basically just the brand drug.
FDAs purple book
Lists approved biological products with biosimilarity/interchangeability evaluations
First biosimilar FDA approved
Zarxio biosimilar to filgrastim by Amgen
FDA found no clinically meaningful difference in regards to structure/function, animal study data, human PK data, clinical immunogenicity data, clinical safety and efficacy data.
Does biosimilar mean interchangeable?
No
First interchangeable biosimilar product
Semglee interchangeable with Lantus
Can a biosimilar be substituted at the pharmacy without prescriber intervention?
No, within 5 business days after dispensing a biologic for which an interchangeable product is available, regardless of whether a substitution was made, the pharmacist shall communicate to the prescriber which was dispensed.
REMS
Risk Evaluation and Mitigation Strategies
Required risk management plans that use risk minimization strategies to ensure drug benefits outweigh the risks.
FDA can require before or after drug approval.
REMS may contain the following elements:
Medication guide
Communication plan
Elements to assure safe use (ETASU)
Implementation system
How is bioequivalence of generics determined?
Must be same in the following regards to the innovator drug:
(Pharmaceutically equivalent)
Active ingredient
Strength
Dosage form
Route of administration
Must have virtually the same rate and extent of absorption (must be within 80-125% of innovator drug)
Bioequivalence also refers to
Therapeutic equivalent
In the state of Ohio, bioequivalent drugs are referred to as:
generically equivalent drugs
A pharmacist may NOT select a generically equivalent drug if the prescriber:
Handwrites DAW
Indicates that the prescribed drug is medically necessary.
Cannot be preprinted, stamped, default
The pharmacist may not select a generically equivalent drug unless
Its price to the patient is less than or equal to the price of the brand drug
The pharmacist (or the pharmacist’s agent, assistant, or employee) MUST inform the patient (or the patient’s agent):
If a generically equivalent drug is available at a lower or equal cost.
Of the persons right to refuse the generically equivalent drug
(does not apply to any agency that will reimburse the pharmacy or for patients of a hospital or nursing home.
As a pharmacist, how can I determine if a product is generically equivalent?
Use the Orange Book
Orange book
Lists pharmaceutically equivalent drugs in a table and indicates if they are bioequivalent (aka therapeutically equivalent, or “generically equivalent”).
Drug products that the FDA considers to be therapeutically equivalent (generically
equivalent):
Those with no known or suspected bioequivalence problems.Designated AA, AN, AO, AP, or AT, depending on the dosage form.
Those with actual or potential bioequivalence problems that have been resolved
with adequate in vivo and/or in vitro evidence supporting bioequivalence. Designated AB.
Drug products that FDA at this time, considers NOT to be therapeutically equivalent (NOT generically equivalent)
Those for which actual or potential bioequivalence problems have not been
resolved by adequate evidence of bioequivalence. Often the problem is with
specific dosage forms rather than with the active ingredients. These are designated BC, BD, BE, BN, BP, BR, BS, BT, BX, or B*
In the state of Ohio, may a prescriber indicate that they do not want a drug
substituted by having 2 signature lines printed on their Rx pads – one line for
substitution permissible and one line that indicates “dispense as written”?
No, must be written out
If a prescriber writes DAW on a prescription but the patient requests the generic, may we legally perform the substitution?
No
In the state of Ohio, if a prescriber writes “lisinopril” on a prescription may the pharmacist dispense the brand name Zestril instead?
Yes
Any special exceptions in Ohio for substituting epinephrine autoinjectors like
EpiPen®?
Yes, in addition to generic substitution (AB rating in orange book), epi substitution may occur if it is pharmaceutical equivalent, FDA approved, and has not been excluded from BOP
This essentially allows the substitution of an epinephrine autoinjector that
contains the same active ingredient but not the same inactive ingredient even
if it has not been identified in the FDA Orange Book as being a therapeutic
equivalent (i.e. an A rating). Therefore, it would be permissible to substitute
an epinephrine autoinjector that has a BX rating in the Orange Book.
OTC labeling requirements
"Drug facts" label A statement of the identity of the product. This includes (for each drug it contains) established name, general pharmacologic category. The name/address of manufacturer Net quantity of contents of the package Cautions and warnings needed to protect the consumer Adequate directions for use Lot/control # Exp date
Dietary Supplement and nonprescription drug consumer protection act
An amendment to the FDCA
Requires all OTC drugs and dietary supplements to have the manufacturers or retailers domestic address or phone #.
What is the purpose of the Dietary Supplement and Nonprescription Drug Consumer Protection Act?
So consumers may report SAE that occur when taking the product
Under the Dietary Supplement and Nonprescription Drug Consumer Protection Act, when must companies report pertinent information?
Within 15 days
Federal Anti-tampering Act
Tampering with consumer products is a federal crime.
Tamper proof packaging required for all OTC drugs, cosmetics, devices
What are exceptions from the tamper proof rule?
Dermatologicals
Dentrifices
Insulin
Lozenge-type products
Commericial unit dose labeling requirements
Name of drug
Quantity of active ingredient in each dosage unit
Expiration date
Lot or control number
Name or place of business of manufacturer
What if a pharmacy unit dose packs medications?
Include normal label requirements
For place of business- include pharmacies name or last 7 digits of terminal distributor
For expiration date- 1 year or actual exp date if less
According to 21 CFR §206 all solid dosage forms must be uniquely identifiable
Must be imprinted, unless the pill is too small or has unique physical characteristics
Includes Rx and OTc
Does NOT include dietary supplements.
NDC
Universal product identifier for human drugs
Contains 10 or 11 digits
3 segments of NDC
Labeler code assigned by FDA
Product code
Package code
Does the existence of an NDC on the label mean that it is FDA approved?
No
Does an NDC have to be on the label?
no
Package insert
Part of the labeling, must accompany drug product
Info must be approved by FDA
Required to have highlights, TOC, and list of major labeling changes
BBW
When is a BBW required?
When use may lead to death or serious injury
Is it illegal to prescribe or dispense against a BBW?
No
What if a patient requests a package insert?
Can give or say no
Patient package insert
FDA mandates these be supplied for certain medications.
Must be given with each New and Refill Rx
Do you supply a package insert if the medication is provided by an institution?
Give either with every dose or with first dose and every 30 days thereafter
Failure to dispense the product with a PPI deems the product
misbranded
FDA mandates that MedGuides accompany drugs (that it has determined) pose a serious and significant public health concern.
Part of the product______
labeling
Manufacturers must provide medguides to
distributors/dispensers
Is a MedGuide required for new and refills?
Yes
Are medguides required for patients in an institution?
No
May a pharmacies patient education printout replace a medguide?
No
A competitor calls you ans asks you to transfer all of your favorite patients prescriptions to them. You refuse to do so. Are you allowed to do this?
No, not allowed to refuse transfers unless the transfer is illegal.
You receive a written prescription for a patient and they would like you to submit it to Ohio Medicaid for payment. It is not on a tamper-resistant prescription blank. What must you do?
- ) Verbal, write out new prescription
2. ) Cant get hold of prescriber, may still fill but must call within 72 hours.
Are prescriptions with checked boxes for drugs allowed?
Yes only if 1 box is checked
When can CIIs be transmitted by fax?
Resident of a long term care facility
Narcotic for a patient in hospice
Compounded sterile product prescription may for narcotic. In these cases, the faxed Rx may serve as the original.
May a registered pharmacy technician take oral prescriptions?
No only certified tech
What conditions need to be met for an oral CII?
Emergency
- ) Immediately reduced to writing
- ) The quantity prescribed is sufficient for emergency period only.
- ) A prescription must be received from the prescriber within 7 days and attached to the emergecy order.
Pharmacists are required to document their positive identification when dispensing a prescription. How may this be accomplished?
- ) Password + randomly generated questions
- ) Badge + password
- ) Fingerprint
- ) Sign
What 3 things can you not change on a C2?
Pt name
Drug
Prescribers signature
You receive a prescription for “Percocet 5/325 mg #60”. Your pharmacy is out of
Percocet but you have plenty of Vicodin 5/300 mg in stock. You call the prescriber
and she states this interchange is okay with her. May you fill the prescription with
Vicodin instead?
No
Any information given to the pharmacist by the patient or caregiver shall be presumed to be accurate, unless there is reasonable cause to believe the information is inaccurate. What are examples of this?
Mental disability
Under the influence
Under 18 years old
What should a pharmacist do if he/she identifies potential issue while performing a DUR?
“Upon recognizing any of the above, a pharmacist, using professional judgement,
shall take appropriate steps to avoid or resolve the potential problem. These steps may include … consulting with the prescriber and/or counseling the patient.”
