iPC Exam 1 Flashcards
patient’s use
Rx drugs
non-Rx self-care
- non-Rx med/OTC drugs
- complementary alternative medicine (CAM)
- dietary supplements & homeopathy
*Regulated and marketed differently
Legally two “classes” of drugs
Prescription
- Medical conditions that cannot be easily self-diagnosed
- Too great of a potential for harmful effects
- Habit forming or toxic
Non-prescription
- Consumers can safely (and effectively) use without medical supervision
Non-Prescription: What’s in a name?
Self Care
- OTC = Over The Counter Drug= Nonprescription Medicine (said when talking to the patient)
- Non-pharmacologic interventions
Complementary and Alternative Medicine
- Dietary Supplements
- Herbals
- Vitamins
- Homeopathic Products: using a small amount of treatment or toxin
Let’s Recap!
Prescription Drugs
- Submits NDA for approval with clinical trials
- Must prove safety and efficacy
- Prescription Drug Monograph (LexiComp)
Regulation of Nonprescription Drugs
- Available to consumers without a prescription
- Drug Monographs versus New Drug Application (NDA)
- Regulated by the FDA for saftey and efficacy
divisions of FDA
- CDER (Center for Drug Evaluation and Research = Division of FDA)
- Office of nonprescription drugs
- Nonprescription Drug Advisory Committee _OTC Drug Review Program
The OTC Drug Review Program
Established because many OTC products have been on the market since before laws that required proof of safety and efficacy before marketing
1938 - SAFETY pre-approval
1962- efficacy pre-approval
1972- monograph process
The OTC Drug Review Program
Goal
- to ensure all OTC products are safe and effective
1 - generally recognized as safe and effective (or GRAS/GRAE = GRASE),
2 - not generally recognized as safe or effective, or
3 - needing more studies before a GRAS/GRAE determination could be given
to establish an OTC drug monograph for each class
OTC Drug Monographs
“Recipe Book”
- Acceptable ingredients
- Doses
- Formulations
- Labeling
- Testing
If active ingredients comply with an established monograph, it is considered “generally recognized as safe and effective” (GRASE)
Products that conform to a monograph can be marketed without pre-approval, those that do not must undergo go through the NDA process
not the same as Lexicomp which tells you about the med
General Nonprescription Drug Lifecycle (1972-Current)
Rx NDA to OTC NDA to OTC drug monograph
NDA: New Drug Application
New ingredients entering the OTC marketplace for the first time/ drugs that do not conform to a monograph must go through the NDA process
Applicant (typically Pharma) submits an application to begin the process
- May require clinical trials and animal studies
- Includes how the drug is manufactured and will be packaged/labeled
- Must comply with post-approval NDA maintenance
This applies to drugs that are switched from Rx to OTC
Must prove safety and efficacy
Comparing NDAs & NonRx Monographs
NDA
- Pre-approval Required
- Clinical studies may be necessary
- Approved labeling is unique
- Possible marketing exclusivity
NonRx Monograph
- Pre-approval NOT required
- Clinical studies are not necessary
- Labeling is the same for all similar drugs
- No marketing exclusivity
Both NDA and Monograph
- Standards for safety and efficacy
- Manufacturing and GMP inspections
- Advertising regulations through the FTC
Self assess: Which applies to both the monograph and NDA process?
A
Pre-approval required
B
No marketing exclusivity
C
There are standards for safety and efficacy
C
There are standards for safety and efficacy
Brand name extensions
Brand name extensions are a marketing strategy employed by manufacturers, where they use a well-known brand name that consumers have come to trust and develop “new” products with different active ingredients, to leverage brand loyalty amongst consumers.
Ensuring Safety and Efficacy of Nonprescription Drugs
Patient safety in an unsupervised setting
- Self-diagnose?
- Self-manage?
- Self-help?
Label Comprehension Studies
- Drug Facts Label
Actual Use Studies
U.S. and worldwide adverse event data
Let’s Recap!
Prescription Drugs
- Submits NDA for approval with clinical trials
- Must prove safety and efficacy
- Prescription Drug Monograph (LexiComp)
Non-Prescription Drugs
- Pre 1972: GRASE status with OTC monograph. Post 1972: NDA process for OTC status
- Must prove safety and efficacy
- Non-prescription “Drug Facts” Label
Complementary Alternative Medicine (CAM)
Dietary Supplements
- Vitamins
- Minerals
- Herbs or other botanicals
- Amino acids
- Enzymes
- Dietary substances for use by people to supplement the diet by increasing total dietary intake
Homeopathic products
A product taken (by mouth) that contains a dietary ingredient intended to “supplement” the diet
CAM products are NOT Drugs
Drugs are used to either prevent, treat, or relieve, a disease or medical condition
- CAM products CANNOT make these claims
CAM Products do NOT have a monograph
CAM Products do NOT require submission of a New Drug Application (NDA)
Dietary Supplement Health and Education Act of 1994 (DSHEA)
- Regulates CAM products like food
- Balance between consumer access and the authority of the FDA to withdraw dangerous products and address false or misleading claims
- Places burden of proof on the FDA
- Manufacturers do not need to register a product or receive approval before producing or selling CAM products
Safety and Efficacy?
If ingredients were marketed before DSHEA passed, manufacturers do not need to submit safety and efficacy data before brought to market
- There is no documentation of what was available before 1994
Safety and Efficacy?
Safety:
- If ingredients have not been marketed before, must submit a pre-market review and have evidence of safety only
- The burden is on the FDA to determine if unsafe
Efficacy:
- No efficacy requirements
- Manufacturer responsible for any evidence of efficacy (it is NOT submitted to the FDA),
DSHEA – FDA responsibilities
Evaluate the safety AFTER the product is on the market
- Research
- Adverse event monitoring
The FDA may stop the sale of dietary supplements that are proven to be unsafe after they reach the market
FDA can go after companies that:
- Make false or misleading claims
- Produce unsafe, misbranded, or adulterated products
Bottom line:
- Consumers can not be assured that each product is subjected to rigorous review and approval to ensure product safety and efficacy
Dietary Supplements Gone BAD examples
Superpotent/ sub potent products
Adulterated/ misbranded
Not safe
- Ephedra from a plant which causes stroke…
False claims
- Enzyte
Self Assess: Which required efficacy data prior to marketing? (note there is more than 1 correct answer)
A
Calcium - mineral
B
Hydroxycut - dietary supplement
C
Lipitor - Rx
D
Vitamin D - dietary supplement
E
Zyrtec - OTC
C
Lipitor - Rx
E
Zyrtec - OTC
Let’s Recap!
Prescription Drugs
- Submits NDA for approval with clinical trials
- Must prove safety and efficacy
- Prescription Drug Monograph (LexiComp)
Non-Prescription Drugs
- Pre 1972: GRASE status with OTC monograph. Post 1972: NDA process for OTC status
- Must prove safety and efficacy
- Non-prescription “Drug Facts” Label
Complementary and Alternative Medicine
- Not generally regulatedPre 1994: No limitationsPost 1994: Must submit safety data for pre-review
- Pre 1994: “grandfathered in” Post 1994: Must prove safety only
- NOT a drug“Supplement Facts” label
