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
Q
Second Letter of System
A
-More specifics based on lack of criteria or dosage form
26
Q
AA
A
Drug products in conventional dosage forms that don’t have bioequivalence problems
27
Q
AB
A
- Found sufficient bioequivalent form studies
- May be AB1, AB2, AB3
28
Q
AN
A
- Solution and powders for aerosolization delivery
- Drug deliver systems often keeps drugs out of the category
29
Q
AO
A
- Injectable oil solutions
- Same active ingredient, concentration, and oil vehicle as innovator’s product
30
Q
AP
A
- Injectable aqueous solutions
- Subtle exceptions: injectable solutions with different routes of administration
31
Q
AT
A
- Topical products
- Includes dermatologics, ophthalmic, otics, local delivery rectal and vaginal
- *Can also include solutions, suspensions, creams, ointments, gels, lotions, sprays, pastes, suppositories**
32
Q
Reasons for B Codes (3)
A
- Active drug or dosage form has KNOWN bioavailability problem with significant potential for problems. Company didn’t provide sufficient studies to prove FDA differently
- Quality standards for drug or dosage form are insufficient for FDA to determine therapeutic equivalence
- Drug product is still under regulatory review
33
Q
BC
A
- 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
Q
BD
A
- 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
Q
BE
A
- 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
Q
BN
A
- 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
Q
BP
A
- Active drugs/dosage forms with potential of bioavailability problems
- Injectable suspension always start here
38
Q
BR
A
- Suppositories and enemas intended for systemic absorption
- Always considered to have possible bioavailability problems
39
Q
BS
A
- Standards for active drug are deficient
- Impossible to properly compare bioavailability
40
Q
BT
A
- Topicals that give good performance but are not bioequivalent with innovators
- Lack of studies to prove bioequivalence
41
Q
BX
A
-Code where bioequivalence studies are submitted but FDA says they are insufficient or inadequate
42
Q
B*
A
- New info has raised questions and FDA is reevaluating product
- Currently taking NO position on if it is therapeutically equivalent
