Federal Pharmacy Law and Regulation: Reading 6

Question 1

Instead of specific pregnancy categories A, B, C, D, and X, labeling has been updated to include which three categories?

NOTE: only applies to drugs approved AFTER June 30, 2015

Answer 1

Pregnancy
Lactation
female and males of reproductive potential

*These new categories were developed with the intent to make the information about using a drug during pregnancy easier to understand

Question 2

Which pregnancy category?

An adequate number of studies in pregnant women have been conducted, which demonstrate no risk to the fetus during any trimester. Drugs within this category should still have a statement to the effect that these studies do not rule out the possibility of harm and should still only be used in pregnancy if necessary.

Answer 2

A

Question 3

Which pregnancy category?

No adequate studies in pregnant women have been conducted, but animal reproductive studies have not demonstrated a risk to the fetus. Again a statement should be included noting that these studies do not rule out the possibility of harm and should still only be used in pregnancy if necessary.

Answer 3

B

Question 4

Which pregnancy category?

No adequate studies have been conducted in pregnant women, and either animal reproductive studies have been conducted and show potential for fetal risk or animal reproductive studies have not been conducted. Drugs within this category should contain a statement stating that the drug should only be used if the potential benefits outweigh the potential risks.

Answer 4

C

Question 5

Which pregnancy category?

There is evidence that there is risk to the human fetus based on investigational experience, marketing experience, or human studies. The potential benefits in using the drug may be acceptable despite the risks to the fetus, and these should be weighed when deciding if the drug should be used over an alternative treatment or no treatment. There should be a statement warning of fetal harm, and the patient should be made aware of the risks.

Answer 5

D

Question 6

Which pregnancy category?

Studies in human or animals have demonstrated risk to the fetus, and the risk outweighs any possible benefits of the drug. Statements should be added in the “Contraindications” section of the package insert stating that the drug may cause harm to the fetus if administered while a woman is pregnant. A statement should also be included warning that the patient should be made aware of the potential issues with taking the drug while pregnant.

Answer 6

X

Question 7

Who can pharmacies be inspected by?

Answer 7

FDA
DEA
BoP

Question 8

Pharmacies are exempted from ______ inspection per the Food, Drug, and Cosmetic Act UNLESS the pharmacy manufacturers, prepares, or compounds drugs or devices.

Answer 8

FDA

HOWEVER; despite the exemption, the FDA CAN come in and inspect a pharmacy to determine if they manufacture, prepare, or compound in situations outside their normal business practices or in large amounts.

AND THEY DONT NEED A WARRANT NOR A REASON TO STATE FOR INSPECTION (dang!)

Question 9

T or F?

The FDA only needs to show a notice of inspection and their credentials to perform an inspection of a pharmacy.

Answer 9

True

refusing an inspection could result in fines and/or imprisonment!

Question 10

Where can the DEA inspect?

Answer 10

In any place where controlled substances are kept.

The inspector may examine and copy any records and reports relating to controlled substances, inspect the premises within reasonable limits, and take an inventory of controlled substances without a warrant.

Question 11

What can’t a DEA inspector inspect?

Answer 11

The inspector cannot review financial data, sales data, or pricing data unless given written consent by the owner or pharmacist in charge or pursuant to a warrant.

Question 12

T or F?

DEA Inspectors are required to state the purpose of their inspection and provide their credentials and a written notice of inspection to the pharmacy owner or PIC.

Answer 12

True

(The written notice of inspection has a statement of rights on it. These rights say that you can refuse to give consent to an inspection and require the agent to get an administrative inspection warrant (AIW), that anything incriminating found may be used against you in a criminal prosecution, and that you can withdraw consent at any time during the inspection.)

Question 13

___________ are similar to search warrants, and DEA agents may choose to obtain either to gain entry into a pharmacy.

Answer 13

Administrative inspection warrants (AIW)
*they tend to have an easier to satisfy requirement for probable cause, so if a search warrant is issued for your pharmacy, you might be facing some issues. BUT have more restrictions that search warrants.

Question 14

What restrictions do AIWs have?

Answer 14

They can only be served during regular business hours, while search warrants can be served at any time day or night. You can’t refuse to consent to a search if you’ve been presented with an AIW and if you do you can face fines and/or imprisonment.3 There are a few times when agents don’t need an AIW. The most obvious is when the owner or pharmacist in charge consents to the inspection. Others include, but are not limited to, situations where there is an imminent danger to the health and safety of the public, emergency situations where obtaining a warrant isn’t practical, or situations where a warrant isn’t constitutionally required

Question 15

In Indiana, the BoP can inspect without a warrant. T or F?

Answer 15

TRUE

Question 16

What should a pharmacist do when an inspection by the FDA, DEA, or BoP is coming up?

Answer 16

for inspections; pharmacists should ask for the inspector’s credentials, be cooperative and cordial, document important details about the inspections, and never sign anything unless it is completely understood what is being signed.

Question 17

What resource should we use to determine substituting products? (ie. substituting a generic for a brand, substituting one generic for another, or substituting one brand for another, among other combinations – how we know when one product is equivalent to another product)

Answer 17

Orange Book, which provides equivalency ratings for different products.

Question 18

______________ is “the listed drug identified by the FDA as the drug product upon which an applicant relies in seeking approval of its ANDA”

Answer 18

Reference listed drug (RLD)

** in most cases, this is the original brand name product, but there can be more than one RLD.

Question 19

T or F?

The Orange Book provides ratings on whether or note pharmaceutical equivalents are also therapeutic equivalents?

Answer 19

True

Drugs CAN be pharmaceutical equivalents but not therapeutic equivalents***

Question 20

The FDA uses a two-letter rating system to indicate:

Answer 20

therapeutic equivalence

the first letter is either A or B and indicate therapeutic equivalence.

The second letter with the rating provides additional bioequivalence information or dosage form information.

Question 21

___- rated products are bioequivalent to the RLD and are therefore therapeutically equivalent to that product.

Answer 21

A-rated.

A-rated products CAN be substituted with one another while B-rated products cannot be substituted with one another

Question 22

__-rated drugs are not bioequivalent and therefore are not therapeutically equivalent to the RLD.

Answer 22

B-rated

Question 23

____ is “products in conventional dosage forms not presenting in bioequivalence problems”

Answer 23

AA

Question 24

____ is “products for which the data are insufficient to determine therapeutic equivalence,”

Answer 24

BX

Question 25

_____ is

Answer 25

bioequivalent “solutions and powders for aerosolization.”

Question 26

T or F?

The orange book does rate pharmaceutical alternatives or therapeutic substitutions.

Answer 26

FALSE

Question 27

_______________ are products that “contain the same therapeutic moiety, but are different salts, esters, or complexes of that moiety, or are different dosage forms or strengths (e.g., tetracycline hydrochloride 250mg vs. tetracycline phosphate complex 250mg; quinidine sulfate 200mg tablets vs. quinidine sulfate 200mg capsules).”

Answer 27

Pharmaceutical alternatives

Question 28

_______________ is substituting one drug in a class for another drug in the same class, such as changing pravastatin to atorvastatin, which is often done in hospitals based on their formularies.

Answer 28

Therapeutic substitution

Question 29

An _____ application is the application that you send to the FDA asking them for an exemption to the NDA requirements in order to investigate and conduct clinical trials on a new drug.

Answer 29

IND

Question 30

An _____ is an application that you send to the FDA once all clinical trials and data have been collected on a new drug in order to have the drug approved for marketing

Answer 30

NDA

Question 31

In order for a company to begin clinical trials on a new drug, the company must submit an ____ to the FDA for approval

Answer 31

IND

Question 32

FDA’s review of Phase 1 submissions (clinical trial phase) include

Answer 32

focus on assessing the safety of Phase 1 investigations

Question 33

T OR F?

FDA’s review of Phase 2 and 3 submissions will also include an assessment of the scientific quality of the clinical investigations and the likelihood that the investigations will yield data capable of meeting statutory standards for marketing approval.

Answer 33

True

Annual reports are required as supplements to the IND and “should serve as the focus for reporting the status of studies being conducted under the IND and should update the general investigational plan for the coming year.”

Question 34

A company can begin human trials if they have not received a rejection from the FDA within ____ days of submitting their IND.

Answer 34

30

Question 35

Phase ___ is the first introduction of the drug into human subjects

Answer 35

1

These studies take place in healthy volunteers and are designed to better understand the pharmacokinetics, pharmacologic effects, and adverse effects of a drug. Phase 1 studies may also include studies designed to study the mechanism of action in humans, drug metabolism, or where the drug is used as a research tool to understand disease processes better. Phase 1 studies generally involve less than 100 patients.

Question 36

Phase __ studies are the first introduction of the drug in patients with the disease.

Answer 36

2

These studies “evaluate the effectiveness of a drug for a particular indication” and “determine the common short- term side effects and risks associated with the drug.”10 Phase 2 studies involve less than 1000 patients; in fact, these studies usually involve only a few hundred.

Question 37

Phase ___ studies are “intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug to provide an adequate basis for physician labeling.”
These studies often involve several thousand patients.

Answer 37

3

Question 38

When can a company submit an NDA to the FDA for approval of their drug?

Answer 38

once phase 3 trials have been completed.

Question 39

By law, once the NDA is submitted, the FDA has ____ days to respond to it.

Answer 39

180

however, lengthy delays often occur.

manufacturers could legally take the FDA to court over the lengthy delays and to have the courts order the FDA to expedite the process; however, many manufacturers realize that a legal battle would not help with the situation and may delay the decision as the FDA focuses on preparing for the legal issues.

Question 40

T or F?

If the FDA decides not to approve a drug, the manufacturer can contest the decision in court

Answer 40

true

however, the FDA’s decision not to approve a drug has never been overturned by a court

Question 41

A ___________ is used to manage serious risks associated with the use of a medication

Answer 41

A risk evaluation and mitigation strategy (REMS)

Question 42

Which Act introduced REMS?

Answer 42

Food and Drug Administration Amendments Act (FDAAA) of 2007.

Question 43

When does the FDA require a REMS from a manufacturer?

Answer 43

to ensure that the benefits of using a product outweigh the risks associated with it.3,4 A REMS may be required for a single drug or entire class. In addition, the FDA may make this a requirement at any time. The FDA may decide before approving the drug due to potential risks or after a drug has been approved due to newly discovered safety information.

Manufacturers are responsible for developing the REMS program; however, the program must be reviewed and approved by the FDA

Question 44

What is an example of REMS that may be used as part of a larger strategy?

Answer 44

1) MEdication guides

2) Communication plans for disseminating information to healthcare practitioners about the risks of the drugs and the REMS program in place may also be used.

3) Elements to assure safe use (ETASU) is another potential aspect of a REMS.

Question 45

_______ are “required medical interventions or other actions healthcare professionals need to execute prior to prescribing or dispensing the drug to the