iPC Exam 1

Question 1

patient’s use

Answer 1

Rx drugs

non-Rx self-care
- non-Rx med/OTC drugs
- complementary alternative medicine (CAM)
- dietary supplements & homeopathy

*Regulated and marketed differently

Question 2

Legally two “classes” of drugs

Answer 2

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

Question 3

Non-Prescription: What’s in a name?

Answer 3

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

Question 4

Let’s Recap!

Answer 4

Prescription Drugs
- Submits NDA for approval with clinical trials
- Must prove safety and efficacy
- Prescription Drug Monograph (LexiComp)

Question 5

Regulation of Nonprescription Drugs

Answer 5

• 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

Question 6

The OTC Drug Review Program

Answer 6

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

Question 7

The OTC Drug Review Program

Answer 7

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

Question 8

OTC Drug Monographs

Answer 8

“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

Question 9

General Nonprescription Drug Lifecycle (1972-Current)

Answer 9

Rx NDA to OTC NDA to OTC drug monograph

Question 10

NDA: New Drug Application

Answer 10

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

Question 11

Comparing NDAs & NonRx Monographs

Answer 11

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

Question 12

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

Answer 12

C
There are standards for safety and efficacy

Question 13

Brand name extensions

Answer 13

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.

Question 14

Ensuring Safety and Efficacy of Nonprescription Drugs

Answer 14

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

Question 15

Let’s Recap!

Answer 15

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

Question 16

Complementary Alternative Medicine (CAM)

Answer 16

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

Question 17

CAM products are NOT Drugs

Answer 17

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)

Question 18

Dietary Supplement Health and Education Act of 1994 (DSHEA)

Answer 18

• 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

Question 19

Safety and Efficacy?

Answer 19

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

Question 20

Safety and Efficacy?

Answer 20

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),

Question 21

DSHEA – FDA responsibilities

Answer 21

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

Question 22

Dietary Supplements Gone BAD examples

Answer 22

Superpotent/ sub potent products

Adulterated/ misbranded

Not safe
- Ephedra from a plant which causes stroke…

False claims
- Enzyte

Question 23

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

Answer 23

C
Lipitor - Rx

E
Zyrtec - OTC

Question 24

Let’s Recap!

Answer 24

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

Question 25

Nonprescription “Drug Facts” Label

Answer 25

Primary communication tool with the patient

Must communicate all the information necessary for safe and appropriate use of the product (without medical assistance)

Drug Facts Format:
- Standardizes all the label elements
- All information must be clear, and concise in consumer language

If the drug has this, then it is an OTC

Question 26

The Drug Facts Label

Answer 26

Active ingredients , strengths, and their purpose

Indications (uses, symptoms treated)

Warnings: See next slide for subheadings

Directions: Adults and children (by age/ weight)

Other Information (storage conditions)

Inactive Ingredients (USUALLY listed alphabetically)

Questions? (toll-free number)

Question 27

Warning heading

Answer 27

Allergy alert

Do not use if…

Ask your doctor before use if you have…

Ask your doctor or pharmacist before use if you are taking…

When using this product… (side effects)

Stop using and ask a doctor if…

Pregnancy/breastfeeding

Question 28

Drug Facts Label

Answer 28

Signifies that it is an FDA-approved OTC / nonprescription drug
- Safety and efficacy in the disease state it is treating

Communicates important information to consumers in a standardized format

Pharmacists can rely on labels to identify active ingredients in brand name extensions

Question 29

Self Assess: Which heading would include the allergy alert?

A
Uses

B
Directions

C
Warnings

D
Other information

Answer 29

C
Warnings

Question 30

supplement fact label

Answer 30

serving size

volume

% daily value

Serving Size: How many tablets or capsules you should take
Suggested Use: How to use the product safely and correctly

Question 31

How to read a Supplement Facts Label:

Answer 31

Amount Per Serving: Listing of nutrients contained within supplement & quantity

% Daily Value: what % of recommended daily intake serving size would provide

Question 32

Supplement Facts: “Seals”

Answer 32

USP seal: testing has been done to ensure what is in the bottle is in the label

Question 33

Supplements: Label Claims

Answer 33

Nutrient content
- Mostly for substances with an established daily value
- Examples: Free, high, low

Health claims
- Describe a relationship between a disease or health condition and a food, diet, or dietary product
- Example: Diets high in calcium may reduce the risk of developing osteoporosis

Structure/ Function
- How the supplement affects structure or function in humans

Question 34

Supplements: Label Claims

Answer 34

Dietary supplements can claim to affect some structure or function of the body or make claims regarding nutrient content
Must be:
- Truthful and not misleading
- Able to document scientific data (by manufacturer)
- Accompanied by a disclaimer…

After a structure/function claim, the manufacturer must write:
- “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.”

Question 35

Structure / Function Claims

Answer 35

Describe the role of a nutrient or dietary ingredients intended to affect normal structure or function in humans:
Calcium builds strong bones.
NOT: Calcium can help treat osteoporosis

Fiber maintains bowel regularity.
NOT: Fiber relieves constipation

Antioxidants maintain cell integrity.
NOT: Antioxidants prevent cancer

Support the immune system
NOT: Treats the common cold

Support a healthy heart
NOT: Prevents heart attacks

Helps maintain urinary tract health
NOT: Relieves urinary tract infections

Question 36

CAM & “Supplement Facts”

Answer 36

NOT optimal for communication with the patient
- Difficult for consumers to understand and use

NO Safety information (warnings section) included
- Difficult for consumers to ensure the safe use of products

Often are being used as “drugs,” but not regulated like drugs
- No evidence of efficacy is required

Some products that are supplements submit NDAs/OTC monograph review through the FDA and therefore can have either prescription (Lovaza) or non-prescription status (Senna)
- Always choose a regulated product when possible for assurance of safety AND efficacy
- If not available choose one that has been through a QA program (logo on label/trustworthy brand).

Question 37

Self Assess: Which is an appropriate Structure/Function claim?

A
Prevents cancer

B
Relieves cold symptoms

C
Supports heart health

D
Treats osteoporosis

Answer 37

C
Supports heart health