Term
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Definition
| independent act of preventing, diagnosing, and treating one's own illnesses without seeking professional advice |
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Term
| 3 processes: how OTC comes to market |
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Definition
1.) Drug Approval Process (NDA is submitted; Drug is either switched from RX to OTC or directly becomes OTC)
2.) Monograph Process
3.)Pending determination under the OTC Drug Review monograph process |
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Term
| Give an example of an Rx that was switched to OTC through Drug Approval Process |
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Definition
| PPI's (Prevacid, Prilosex) |
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Term
| Example of drug that directly became an OTC through Drug approval Process |
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Definition
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Term
| Example of drug that was reclassified from prescription to OTC under Monograph Process |
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Definition
Hydrocortisone cream
Benadryl |
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Term
| How many days do manufacturers, packers, and distributors have to notify FDA of harm associated with their product? |
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Definition
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Term
| what program is used to report adverse events? |
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Definition
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Term
| Are drugs approved by FDA? |
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Definition
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Term
| Are supplements approved by FDA? |
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Definition
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Term
| Do drugs need proof of safety? |
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Definition
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Term
| do supplements need proof of safety? |
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Definition
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Term
| do drugs need proof of effectiveness? |
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Definition
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Term
| do supplements need proof of effectiveness? |
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Definition
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Term
| do drugs require adverse event reporting? |
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Definition
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Term
| do supplements require adverse event reporting? |
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Definition
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Term
| do drugs require good manufacturing processes? |
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Definition
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Term
| do supplements require good manufacturing processes? |
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Definition
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Term
| do drugs have disease treatment claims? |
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Definition
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Term
| do supplements have disease treatment claims? |
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Definition
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Term
| what is the pharmacist's role in self care? |
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Definition
ensures safe, appropriate, effective, and economical use of OTC
maintains accurate patient profile |
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Term
| when are OTCs exempt from expiration dates? |
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Definition
| if there is no dosage limit and the product is stable for at least 3 years |
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Term
| How often should open ended questions be used? |
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Definition
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Term
| how often should closed ended questions be used? |
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Definition
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Term
| how often should leading questions be used? |
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Definition
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Term
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Definition
Qu: Quickly assess patient
E: Establish that patient is appropriate self care candidate
S: suggest self care strategies
T: Talk with patient |
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Term
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Definition
S: symptoms
C: Characteristics
H: History
O: Onset
L: Location
A: Aggravating factors
R: Remitting factors |
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Term
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Definition
| Quickly and accurately assess patient |
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Term
| when should patient consult doc? |
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Definition
severe symptoms
persisting symptoms |
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