Herbals, Placebos, OTCs Flashcards
What is the real reason that Naproxen became OTC?
It has a half-life of 12 hours, so it could be used for dysmenorrhea
What’s the issue with Cough/Cold Medicines?
Guaifenasin is an expectorant. Dextromethophan is a cough suppressant.
The two are usually formulated together…doesn’t make much sense
Why is their now tighter control on pseudoephedrine?
Because it can be extracted from cold medicines to make methamphetamines
Why does loperamide (antidiarrheal) cause less sedation
It does not cross the blood brain barrier
What are the characteristics of OTCs?
- Their benefits outweigh their risks
- The potential for misuse and abuse is low
- Consumer can use them for self-diagnosed conditions
- They can be adequately labeled
- Health professionals are not needed for safe and effective use of the product
Grading of OTCs
I: GRASE (generally recognized as safe and effective)
II: Not GRASE, misbranded
III: Available data insufficient to establish GRASE status (needs more studies but it can stay on the market)
Why do we need to care about OTCs?
- Misuse may cause complications
- Movement towards OTC status for many Rx drugs
- Ingredients may worsen condition or interact with prescription meds
Compare and contrast Prescription and OTCs…
Rx:
- Dispensed by prescription; disease oriented
- Potential for serious adverse complications
- Ads and safety/efficacy are both monitored by FDA
OTCs:
- Sold directly to consumer; symptom oriented
- Low risk of adverse reactions
- Ads regulated by FTC but safety/efficacy regulated by FDA
A dietary supplement is defined as what by Congress in 1994?
A product (other than tobacco) that:
- Is intended to supplement the diet
- Contains one or more dietary ingredients or their constituents
- Is intended to be taken by mouth as a pill, capsule, tablet, or liquid
- Is labeled on the front panel as being a dietary supplement
True or False: The FDA can get involved with the regulation of herbals and supplements.
FALSE!
What are the main concerns about herbals?
- Few clinical trials supporting health claims
- Complex mixtures
- Variability from lot to lot and manufacturer to manufacturer
- Contamination with pesticides
What did the 1994 Dietary Supplement Health and Education Act do?
Expanded dietary supplement definition to include vitamins, minerals, herbs, amino acids
What are some of the purported uses of garlic?
- Hypolipidemic
- Lowers BP, reduces platelet aggregation, antimicrobial
What is Ginkgo supposed to do and what is its alternative?
- Improve memory (used for dementia)
- Donepezil
What is St. John’s Wort’s purported use and what are they alternatives?
- Antidepressant
- SSRIs, MAOIs, tricyclics
Drug interactions that occur with St. John’s Wort…
Sedation (with SSRIs)
Increased BP and HR (with MAOIs)
St. John’s Wort can decrease the levels of which drugs?
- HIV protease inhibitors
- OCPs
- Anti-leukemia drug imatinib mesylate
What are some of the adverse effects of the “general cure-all” herbal?
- CNS excitation
- Abnormal menstruation
- Hypoglycemia
-Can also interfere with digoxin assays
Your patient comes to you seeking your advice about black cohosh. How do you advise her
She may want to try estrogen therapy
There have been some reported cases of liver toxicity. If she does decide to take it and notices abdominal pain or jaundice, she should stop
What is the major use of glucosamine?
Improve the pain and swelling in osteoarthritis
Evidence supports a significant decrease in triglycerides in which herbal?
Omega-3 Fatty Acid (Fish Oil)
Although Omega-3 can decrease the triglycerides, what can it increase?
LDL “bad cholesterol”
What are the adverse reactions associated with Kratom?
Addiction, N/V, Constipation, Confusion
Which of the discussed herbals have been looked into by the FDA?
Omega-3 and Kratom
Who responds best to placebos?
- Conditions with high levels of stress
- Milder diseases with milder overall symptoms
Characteristics of a Placebo
- May be inert or active
- Can be procedures
- Active placebos may be chosen for a response that mimics some aspect of the active drug being compared
What is an open placebo??
When the patient knows that they are receiving a placebo treatment
Neurobiology of Placebo Effect
Pain causes activation of endogenous anti-nociceptive system, utilizing mu opioid receptors
*Placebo analgesia uses this system but not always the same parts
Pharmacology of Placebo Effect
They have time-effect curves, peak, cumulative, and adverse effects similar to those of active metabolites
Which conditions respond best to placebos?
- Patient’s conditions must be capable of variable intensity over time
- Asthma, headache, cough/cold/influenza, sexual dysfunction, angina, HTN, UC, gastric ulcers, RA, incontinence
