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Limitations of OTC package labeling?
- Co-morbidity (other medical conditions)
- Polypharmacy (other drugs)
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Monograph requirements?
- Description
- Ingredients
- Labeling
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OTC Category I
Generally recognized as safe and effective for the claimed indication
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OTC Category II
Not generally recognized as safe and effective for the claimed indication
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OTC Category III
Insufficient data available to permit final classification
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Under the new rules, oral OTC meds must state the exact amount of particular ingredients such as:
- Calcium
- Potassium
- Magnesium
- Sodium
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Mechanisms for reclassification (Rx to OTC)
- Full NDA
- "Switch regulation"
- A supplement to NDA
- The OTC advisory panels recommend changing many Rx ingredients to OTC (Petition from manufactures)
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Define pharmaceutical care (Patient Care)
Designing, implementing and monitoring a therapeutic plan, in cooperation with the patient and other health care professionals that will produce specific therapeutic outcomes.
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Skills necessary to care for patients with self-care needs:
- Communication
- Effective questioning
- Effective listening
- Nonverbal communication
- Techniques for special populations
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Alternatives for self-medication
- OTC
- Nutritional Supplements
- Natural Products and homeopathic remedies
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Reasons why patients prefer OTC
- Avoid contact with doctors
- Fear of what they may be told
- Convenience
- Cost
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Define Self-care
The independent act of preventing, diagnosing and treating one's own illness without seeking professional advice
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What are the two types of self-care?
- Preventing self-care
- Sickness self-care
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What is the first level of self-care?
Self medication
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Define dietary supplements
Products intended to supplement the diet and bear contain one of more dietary ingredients such as vitamin, mineral, herb and amino acid.
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Top selling supplements
- Garlic
- Echinacea
- Saw Palmetto
- Ginkgo Biloba
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Natural products with the highest interactions recorded:
- St John's wart
- Ginkgo biloba
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Factors that drive trust on self-medication includes:
- Increasing cost of health care
- Increasing aging population
- Gender difference
- Restricted access to prescribers through health management organizations
- High number of uninsured and under-insured people
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What kind of questions should be avoid in patient care?
Leading and multipart questions
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Two factors determining teratogenic effects?
- Stage of pregnancy
- Ability of medication to pass from placenta
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Important counseling points:
- 1. Selection of fright product
- 2. Rx-OTC drug interaction
- 3. Side effects / ADRs
- 4. Directions / instructions for use
- 5. Cost
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Steps in self-care encounter:
- QuEST
- Quick assess the patient
- Establish if pt is self-care candidate
- Suggest appropriate strategies
- Talk about the strategies
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Therapeutic significant drug interactions with Tylenol
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Recommended adult dosage of Tylenol
- 325-650 Q4h
- 325-500 Q6h
- 650-1000 Q8h
- Not to exceed 4g in 24hs
Same as aspirin dose for mild-moderate pain
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Ibuprofen OTC analgesic dose
- 200-400mg Q4-6h
- Not to exceed 1200mg in 24hs
- Do NOT take for pain >10days or fever>3days, unless directed by physician
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Ibuprofen Therapeutic Considerations
- GI tract (dyspepsia, heartburn, nausea, anorexia and epigastric pain)
- Platelet aggregation
- Renal blood flow
- Weight gain
- Cross-reactivity with aspirin
- Pregnancy (Contraindicated during 3rd trimester of pregnancy)
- Chicken Pox
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Aleve
- Naproxen 220mg
- Dose 12-65yo: 1tab PO Q8-12h
- Person >65yo should not take more than 2tabs/day, or 1tab Q12h
- Take with food, water or milk
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Main drug interactions with ASA
- Valproic Acid
- Sulfonylureas
- Probenecid
- Ethanol
- Warfarin
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