Pharmacy Practice: New Drug Development/ndc/schedules

Front 1

New drug development

Back 1

Lab Research→Animal Studies→IND→Humans (Phase I-III)→NDA→FDA Approval→Market (Phase IV)

Front 2

Lab research

Back 2

-is the drug safe for humans?
-does the drug have pharmacological activity?
-identify biological target
-identify chemical compounds by assays, microorganisms, computer simulations

Front 3

Animal studies

Back 3

-2 or more species needed
-ADME

Front 4

ADME

Back 4

-absorption
-distribution: where it goes in the body. Does it reach the target?
-metabolism: liver, kidney metabolism. Is the metabolite toxic?
-excretion: how do we get rid of drug? kidney?

Front 5

Investigation new drug (IND)

Back 5

FDA determines a drug is reasonably safe to test in humans based on:
-Animal Pharmacology/Toxicology
-Manufacturing Information: how are you going to make it?
-Clinical Protocols and Investigator Information: how are you going to test it in humans?

Front 6

Human clinical trial phase 1

Back 6

-length: 6-9 months
-emphasis: safety
-patients: small group of health individuals (20-80). Side effects with increasing doses; metabolism/excretion studied

Front 7

Human clinical trial phase 2

Back 7

-length: 6 months-3 years
-emphasis: effectiveness
-patients: with the condition being studied (100-300); placebo controlled, safety/side effects, dosage.
-establish min/max dosing

Front 8

Human clinical trial phase 3

Back 8

-length: 1-4 years
-emphasis: safety, efficacy, dosage
-patients: with the condition being studied (100s-1000s)

-expanded trials: interactions, effects, toxicities

-special trials: renal insufficiency, hepatic insufficiency, elderly vs young, lactating women.

Front 9

New drug application (NDA)

Back 9

1. Several 100,000 pages data
2. Documentation of Safety/Efficacy
3. Information from development
4. Benefits vs. Risks
5. Manufacturing Process

Front 10

FDA Review/Approval

Back 10

(one year)

1. Review of submitted data
2. Review of package insert
3. Inspection of Manufacturing Plant
4. Grants Approval or Non-approval

Front 11

Market/Post-Marketing ("Phase IV")

Back 11

-addition studies
-medwatch
-FDA may require: black box warning, patient medication guides, drug withdrawal (taking drugs off market)

Front 12

Drug nomenclature

Back 12

empirical formula, chemical name, investigational name (letters and numbers)

Front 13

US Adopted Names Council (USAN)

Back 13

-generic name/brand name
-short and distinctive
-indicate general pharmacologic/therapeutic class

Front 14

National drug codes (NDC)

Back 14

10 digit code for drug identification

-first segment: labeler, manufacturer, distributor
-second segment: product, strength, dosage, formulation
-third segment: package size

Insurance requires 11 digit NDC code in a 5-4-2 format.

Front 15

Insurance requires this type of NDC

Back 15

5-4-2

Add a zero to the left of the segment that needs another digit.

Front 16

Drug categories

Back 16

OTC, legend, controlled dangerous drugs (schedules 1-5)

Front 17

Legend drugs

Back 17

prescription only

Front 18

Schedule I

Back 18

Abuse Potential: Highest
Accepted Medical Use: None
Examples: Heroin, LSD, or any non-medical substance being abused

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Schedule II

Back 19

Abuse Potential: High
Accepted Medical Use: Yes
Dependency: May lead to psychological/physical dependence

Front 20

Schedule III

Back 20

Abuse Potential: Less than Schedule I or Schedule II
Accepted Medical Use: Yes
Dependency: May lead to MODERATE psychological/physical dependence
-hydrocodones for now

Front 21

Schedule IV

Back 21

Abuse Potential: Less than Schedule III
Accepted Medical Use: Yes
Dependency: May lead to LIMITED psychological/physical dependence relative to Schedule III
-benzos

Front 22

Schedule V

Back 22

Abuse Potential: Less than Schedule IV
Accepted Medical Use: Yes
Dependency: May lead to LIMITED psychological/physical dependence relative to Schedule IV
-sudafed

Front 23

Generic vs name brand

Back 23

-identical in strength and dosage form
-average rate and extent of drug absorption in the body is within 20%-125% of the brand
-most generics vary by only 3-4%
-generics can have different inactive ingredients

Front 24

Generic substitution

Back 24

-"Orange Book"
-A means it has therapeutic equivalence
-B means it doesn't
-AB means its bioequivalent

Front 25

Authorized generic

Back 25

actual brand name drug that has been relabeled and marketed as a generic
-look exactly like the brand

Front 26

Dispense as written (DAW)

Back 26

0 - no product selection indicated
1 - substitution not allowed by prescriber
2 - substitution allowed - patient requested product dispensed