OTCs Flashcards
What is the definition of an Over-the-Counter (OTC) med?
Non-prescription medications
-Determined to be safe for public use by the FDA
-Usage governed by the consumer
-Not regularly monitored by health care providers
T/F: Ingredients designated as ineffective or unsafe for their claimed therapeutic use are being eliminated from OTC product formulations.
True; FDA regulates Safety & Efficacy of OTCs.
Give 2 examples of ingredients that have been removed from OTCs due to being ineffective or unsafe.
1) Antimuscarinic agents have been removed from sleep aids
2) Attapulgite & polycarbophil have been removed from antidiarrheal drugs
What are examples of drugs that were previously available only by prescription and are now OTC?
Cetirizine (Zyrtec)
Cimetidine (Tagament)
Esomeprazole (Nexium)
Famotidine (Pepcid)
Ibuprofen (Motrin)
Loratidine (Claritin)
Fexofenadine (Allegra)
Naproxyn Sodium (Naprosyn)
Nicotine Patch (Nicoderm)
Why have classification switches (prescription to OTC) declined significantly over the past decade?
Due to the fact that the reclassification process is both costly and rigorous
What drugs have been deemed inappropriate for consumer self-diagnosis and treatment?
1) Statins for cholesterol: b/c hyperlipidemia is a chronic condition with potentially life threatening consequences
2) Oral Acyclovir for genital herpes: Risk of misdiagnosis and self-treatment leading to increased viral resistance
Describe the 2008 Advisory Alert r/t OTC Cold Remedies in Children <12.
-Limited data on efficacy of OTC cold remedies in children < 12
-OTC cold & cough agents not to be used in infants & children less than 2 years of age (Antitussives, expectorants, decongestants, antihistamines)
-Concerned with the potentially serious and life threatening adverse events
-Pharmaceutical manufacturers modified labels: “do not use in children under 4 years of age”
-FDA continues to evaluate cold & cough remedies in children 2-11 years old
What is the provider’s role in OTC meds?
1) Can assist patients in selecting appropriate meds for common ailments
2) Inactive ingredients can worsen existing medical conditions or interact with prescription drugs
3) Misuse/abuse of OTCs can cause significant medical problems
4) Selecting one preparation over another is important in patients with certain conditions, due to interactions with the patient’s medication profile.
There is still regulation of safety and efficacy of OTC meds even when out on the market. List the 3 “Problematic” OTCs discussed.
1) Phenylpropanolamine
2) Dextromethorphan
3) Pseudoephedrine
What is Phenylpropanolamine?
-A sympathomimetic found in cold & allergy meds and weight control products
-Withdrawn from US store shelves due to reports of increased risk of hemorrhagic stroke
-Legal requirements for sale/purchase of drugs containing this
What is Dextromethorphan?
-Common OTC antitussive
-Abused in high doses by adolescents as a hallucinogen
-High doses defined as > 5-10 times the recommended cough suppressing dose
-Is often combined with acetaminophen or antihistamines or sympathomimetics which can be fatal at 5-10 times the normal dose
What is Pseudoephedrine?
-Decongestant initially in numerous cold remedies
-Moved from the OTC aisle of drug store to behind the pharmacy counter
-Must show ID to purchase
-Has been used in the illicit manufacturing of methamphetamines
-See FDA webpage regarding Pseudoephedrine posted on Brightspace
-Legal requirements for sale/purchase of drugs containing this
Severe liver damage may occur with OTC acetaminophen when consumers:
1) take dosages >4000 mg in 24 hours;
2) use acetaminophen in combination with other drugs containing acetaminophen
3) take acetaminophen and drink three or more alcoholic beverages daily.
Depletion of Glutathione.
___ ingredient preparations are preferred.
Single-ingredient preparations are preferred.
-Use the product in its simplest form
-Beware of combo drugs as their different ingredients may have different DOA’s
-Patients may be unaware of a combo cold medicine including acetaminophen and take additional doses of tylenol.
What are the OTC Recommendation Guidelines?
1) Single Ingredient preparation is preferred
2) Select a product that contains a therapeutically effective dose (ex: 325 mg aspirin vs baby aspirin)
3) Encourage patients to read the “Drug Facts” label that accompanies all OTCs
4) Recommend a generic product if one is available (usually cheaper; sometimes insurance will not pay for Rx if OTC is available)
5) Be wary of advertising claims of specific superiority over similar products
6) Dose, dosage form & palatability of the med are important things to consider in peds
