Generic Product Substitution Flashcards
1
Q
Brand Name
A
-AKA Trade Name or Proprietary Name
-All terms used for a pharmaceutical manufacturer selected name for a product that made
EX: Prozac
2
Q
Generic Name
A
“Chemical” assigned name for a specific drug
EX: Fluoxetine
3
Q
Substitution
A
- Legal in New Mexico
- Pharmacists can substitute generic product for a trade name or another equivalent generic product when a SUITABLE PRODUCT EXISTS
- Choose from Approved Substitution List (“Orange Book”)
- *DO NOT NEED TO CONSULT DOCTOR**
4
Q
Substitution Prevention
A
- Can be done by prescriber
- Must write in their own handwriting on prescription “No Substitution
- Can also use DAW 1
- Stamps or preprinted statements of no substitution do not count
5
Q
1830
A
- Establish of US Pharmacopeia
- 1st national attempts at setting drug standards for country
- First few gathering did not include pharmacists, only physicians
6
Q
1906
A
- Passage of Pure Food & Drug Act
- Enacted by Congress that states that drugs marked in interstate commerce had to meet labeled claims of purity/potency
7
Q
1912
A
- Sherley Amendment
- First attempt to regulate labeling claims with intent to eliminate false therapeutic claims (Snake Oils)
8
Q
1938
A
- Federal Food, Drug, & Cosmetic Act
- Referred to as “The Act” in USP and drug literature
- Established FDA as well to reinforce and administer The Act
9
Q
The Act
A
- Developed after ~100 deaths of children from sulfanilamide liquid preparations that used diethylene glycol as its solvent (practically antifreeze)
- Any drug involved in interstate commerce had to be proven SAFE
- All drugs on market prior to 1938 were “grandfathered” and allowed to stay on market without need to prove safety
- All drugs after 1938 had to be approved by FDA prior to marketing
- NDA were required to submit to FDA that proved product met purity, potency, and safety standards
10
Q
1950s-1960s
A
- Most states passed anti-substitution laws
- Restricted pharmacist’s role, had to dispense EXACT drug prescribed, few generics were available at this time
- Even Pharmacist Association was AGAINST substitution
11
Q
1962
A
- Kefauver-Harris Amendment
- Followed 1960 thalidomide tragedy
- Caused phocomelia in mainly children (Flipper Syndrome), mainly in Europe, when given to pregnant women
- Drug must be pure, potent, safe, AND EFFECTIVE
12
Q
Important Issues Covered by 1962 (4)
A
- Drug companies would now by called upon to provide more extensive NDA
- FDA had authority to inspect manufacturing facilities
- Pre-1938 drugs were still grandfathered in
- Drugs that came onto the market between 1938 and 1962 were somewhat grandfathered, could stay on while efficacy was documented
13
Q
1965
A
- Medicaid & Medicare Amendments added to Social Security Act
- Greatly expanded role of government as purchaser of drugs
- Focused on costs of prescription drugs, anti-substitution laws and prescribing by brand names had created a monopoly
- Without competition, no safeguard and increased drug prices
- Fueled debate about how substitution affected the doctor-pharmacist-patient relationship and whether pharmacists were capable of making educated drug product selections
14
Q
Groups Against Pharmacy in Drug Selection (2)
A
- Physicians - perceived loss of control
2. Pharmaceutical Industry - potential loss in profit by choosing generic over brand
15
Q
1971
A
- APhA came out firmly in favor of repealing anti-substitution laws
- Condemned pharmacist involvement with substitution about 20 years prior
16
Q
1974
A
- Michigan became the first state to repeal anti-substitution laws
- 45 states followed its lead by 1980
17
Q
Two Formulary Approaches
A
- Positive Formulary - ONLY drugs on list can be substituted
- Negative Formulary - ALL drugs can be substituted EXCEPT those on list
18
Q
1980
A
- FDA posted list of drugs and dosage forms that had been properly evaluated by common criteria
- Called “Approved Drug Products with Therapeutic Equivalence Evaluations,” also known as The Orange Book or The List
19
Q
Orange Book/List
A
- Multi-source drug products that have been evaluated by FDA according to their criteria
- Short list until 1984
- FDA gives results of their evaluations of drug’s therapeutic equivalence based on data and judgement
- List = ADVICE, not law
- FDA doesn’t take a stance on whether a particular product is better or worse than another
- No comparisons between different active drugs
- Products are listed with name of holder of approved FDA application, may not be current manufacturer or repackager
20
Q
1984
A
- Drug Price Competition & Patent Term Restoration Acts
- Sped up the FDA approval process for generic drugs with the introduction of ANDA
- Provided extensions of patient life: 5 years for new drugs, 3 years for new uses of previously approved drugs
21
Q
Post-1984
A
- Gigantic increase in generic products and companies
- Problems arisen by submitting fake data and lying to FDA
- “Generic Drug Scandal”
- Bad business and science
- Congress set up committees to examine the industry, statements from government officials gave generics a bad name and reputation
22
Q
1992
A
- Generic Drug Enforcement Act
- Allow FDA to deny approvals and suspend applications for companies violating laws
- Prevention of individuals being involved in the industry
- Made requirements for scientific information and more extensive ANDA
- ALL TO RE-ESTABLISH GENERICS AS CREDIBLE
- Led to a decrease of generic companies, the ones that lasted were larger and better financed
- Now individual generic companies and bussinesses that are subsidiaries or larger pharmaceutical companies
23
Q
Designation of Interchangability
A
- Via a two letter system
- Intention was to make it easy to determine whether a product can be substituted for another
24
Q
First Letter of System
A
A- Therapeutically Equivalent
B- Not therapeutically equivalent
25
Second Letter of System
-More specifics based on lack of criteria or dosage form
26
AA
Drug products in conventional dosage forms that don't have bioequivalence problems
27
AB
- Found sufficient bioequivalent form studies
| - May be AB1, AB2, AB3
28
AN
- Solution and powders for aerosolization delivery
| - Drug deliver systems often keeps drugs out of the category
29
AO
- Injectable oil solutions
| - Same active ingredient, concentration, and oil vehicle as innovator's product
30
AP
- Injectable aqueous solutions
| - Subtle exceptions: injectable solutions with different routes of administration
31
AT
- Topical products
- Includes dermatologics, ophthalmic, otics, local delivery rectal and vaginal
* *Can also include solutions, suspensions, creams, ointments, gels, lotions, sprays, pastes, suppositories**
32
Reasons for B Codes (3)
1. Active drug or dosage form has KNOWN bioavailability problem with significant potential for problems. Company didn't provide sufficient studies to prove FDA differently
2. Quality standards for drug or dosage form are insufficient for FDA to determine therapeutic equivalence
3. Drug product is still under regulatory review
33
BC
- ER tablets, capsules, or injectables
- Extensive studies are required to examine rate and extent of delivery as part of bioequivalence study
- Becomes AB rated if bioequivalency is established
34
BD
- New product contains active ingredient that has documented bioavailability problems
- Dosage form with documented bioavailability problems that haven't been proven bioequivalent with studies
- If proven bioequivalent, can become AB
35
BE
- Delayed release or enteric coating
- Available or dose-dependent on dissolution or break-down of coating which varies widely by formulation
- Proved with in-vivo studies
36
BN
- Aerosol-nebulizer drug delivery systems
- One product that usually starts and possibly stops here is metered dose inhalers
- Sufficient studies conducted to prove bioequivalency with innovators product can then change status to AN
37
BP
- Active drugs/dosage forms with potential of bioavailability problems
- Injectable suspension always start here
38
BR
- Suppositories and enemas intended for systemic absorption
| - Always considered to have possible bioavailability problems
39
BS
- Standards for active drug are deficient
| - Impossible to properly compare bioavailability
40
BT
- Topicals that give good performance but are not bioequivalent with innovators
- Lack of studies to prove bioequivalence
41
BX
-Code where bioequivalence studies are submitted but FDA says they are insufficient or inadequate
42
B*
- New info has raised questions and FDA is reevaluating product
- Currently taking NO position on if it is therapeutically equivalent
