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
