Week 1 - Intro to Self Care Flashcards
What is self-care?
The diagnosis, treatment, and prevention of one’s own illness without having professional expertise
What are the classifications of self-care?
- Healthy lifestyle behaviors
- Medical behaviors for treating symptoms
- Behaviors that relate to improving quality of life and daily living in individuals with disabling limitations
What regulates OTC drug advertising?
Federal Trade Commission
What regulates prescription drug advertising?
FDA
What is charged toy congress to oversee the approval of OTC medicines and devices?
FDA
What is the arm of the FDA that carries out the evaluations?
Center of Drug Evaluation Research
What is the role of CDER?
- Evaluate all new drugs
- Ensures that the drugs already on the market
- Oversees ads
- Provide info to consumers
- Ensures that OTCs are properly labeled
- Review benefits vs risk of OTC
What law required a NDA for proof of safety on all new drugs
Food Drug and Cosmetic Act
What law split Rx drugs from OTC drugs from controlled substances?
Durham-Humphrey Amendment
What law requires proof of effectiveness for Rx and OTC drugs marketed after 1938?
Kefauver-Harris Amendments
What law required FDA approval of all medical devices?
Medical Device Amendments
What is the purpose for NDAs?
- Sponsors submit applications that must be approved before the product can be markets
- FDA reviews the safety and effectiveness of the product
- Clinical studies required
- Approved label is unique to the drug
What are the types of NDAs
- RX-to OTC switches
- Fullswitch (NDA supplement)
- Partial switch (new NDA)
- Direct
- Direct to OTC
- Rx
What is an OTC monograph?
- Set of marketing requirements that make the product Generally Recognized as Safe and Effective
- A recipe book for marketing requirements for an OTC drug
Who reviews the safety and effectiveness of the ingredients in an OTC monograph?
FDA
What are the requirements of an OTC product label?
- Approved use of product
- Detailed instructions on safe and effective use
- Cautions or warnings to those at risk
- Contact info for reporting side effects
What are the characteristics of OTC medication?
- Benefits outweigh risk
- Safe and effective
- Low misuse and sbuse potential
- Condition to be treated is self-diagnosable
- Don’t require health care practitioner for safe and appropriate use
- Can be adequately labeled
What must the customers be able to do regarding OTC medication?
- Self-diagnose
- Self-treat
- Self-manage
- Self-help
What are the risks of self-treatment?
- Drug-drug or drug-disease interactiosn
- Overuse or misuse
- Incorrect diagnosis
- Misinterpretation of drug facts
- Patient confusion
What is a nutraceutical?
Product intended to supplement the diet that bears or contains:
1. Vitamins, minerals, amino acid
2. Herbs or botanicals
3. Dietary substance
4. Concentrate or combination
5. Constituent or combination
What law permitted the use of therapeutic claims made about vits/mins
Nutrition labeling and education act
What law had FDA take action to remove products from the market that were misbranded or adulterated?
Dietary supplement health and education act
Who regulates the finished dietary supplement products and ingredients?
FDA
Who enforces laws outlawing unfair or deceptive acts or practices?
Federal Trade Commission (FTC)
What are the common-sense proportions of FTC?
- Advertising must be truthful and not misleading
- Before disseminating an ad, advertisers must have adequate substantiation for all objective product claims
What is the USP?
Sets official standards for dietary supplements
What is the approval process of a drug?
- No premarket approval
- No evaluation for safety and efficacy
- Manufacture is responsible for safety eval
- FDA determines drug is unsafe once product is markets
- If drug contains new ingredient manufacturers submit a statement ingredient is safe
What does it mean to be safe?
No significant risk of illness
What does the DSHEA require?
- Detailed direction for use
- Specific warnings
- SIde effects
- Contraindications
- Does not reach the level of labeling for OTC products
- Warning, side effects, and contraindications are absent
What should an OTC label include?
- Name of ingredients
- Quantity of ingredient
- Total weight
- Identify of part of plant derived from
- Dietary supplement if necessary
What is the required statement for supplements?
This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, curve, or prevent any disease
What are some FDA approved health claims?
- FOlic acid and neural tube pregnancies
- Calcium and osteoporosis
- Sodium and hypertension
- Fruit and vegetables and cancer
- Dietary lipids and cancer
6/ Saturated fat and cholesterol and coronary artery disease
What are the requirement of prescription medicine?
- New drugs an unsafe till proven safe
- Intended to diagnose, treat, and cure
What are the requirement of OTC medicine?
- New drugs an unsafe till proven safe
- Intended to diagnose, treat, and cure
- Self-diagnose, treat, and mange
What are the requirement of dietary supplements?
1.New products are unsafe till proven safe
2. New ingredients don’t need clinical trials
3. Supplement the diet not to treat or diagnose
What is the duty of a pharmacist?
- Fore-see-ability
- Duty to warn
- Duty to inquire
What is the role of pharmacists?
- Helping patients with selection of appropriate drug
- Choose quality OTC to be sold in pharmacy
- Provide balance to info
- Review risks
- Provide direction
What is the guide to making a recommendation?
- Confirm dose
- Check interactions
- Suggest monitoring
- Document specifics
What is the guide to making a D/S recommendation?
- Source of supplements
- Type of supplement
- Dose and frequency
- Reason patient is taking supplement
- Confirm dose
- Check interactions
- Suggest monitoring
- Document specifics
