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30 Cards in this Set
- Front
- Back
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What are the 3 types of DTCA?
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1. Reminder
2. Help Seeking 3. Product Claim Ads |
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Define direct to consumer advertising
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a form of promotion aimed at general audiences and used by pharmaceutical companies to market their products. These ads are shown on tv, radio, print, and the internet
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DTCA in NJ
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-legal
-manufacturers protected |
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What is the intermediary doctrine?
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companies do not need to warn consumers about risks or medications b/c the manufacturers had already warned the prescribing physician
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Only two countries that allow DTCA
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Us and New Zealand
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DTCA made legal in the US by FDA ruling in
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1985
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First US prescription DTCA ad
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Rufen (ibuprofen)
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All drug advertisements are required to meet two standards
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1. Brief Summary
DTCA must include info on side effects, precautions, and contraindications 2. Fair Balance Doctrine |
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Broadcast regulations DTCA
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1. Major Statement
description of the drug's major risks in either the audio or visual portion of ad 2. Adequate Provision Requirement |
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Ways around guidelines for DTCA
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run a help seeking ad, then a reminder ad 30 secs apart
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Regulation of DTCA
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FDA's DDMAC and CDER
Division of Drug Marketing and communication AND the Center for Drug Evaluation and Research |
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Distinguish between Untitled Letters and Warning Letters
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Untitled--minor violation
warning-Major violation--co. must disseminate ad |
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A pharmacist is responsible for providing pharmaceutical care with several desirable outcomes:
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-cure of disease
-elimination of reduction of a patient's symptomatology -arrest or slowing of disease process -prevention of a disease |
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who accredits residencies?
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ASHP
American Society of Health System Pharmacists |
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5 board specialties
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1. nuclear pharmacy
2. nutritional pharmacy 3. oncology 4. pharmacotherapy 5. psychiatry |
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Residencies are divided into how many years
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2; the second is more specialized and has 20 different types as opposed to 3
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define dietary supplement
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-supplements diet
-contains 1 or more dietary ingredient -intended to be taken by mouth -labeled on front panel as dietary supplement |
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define a residency
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an "organized, post graduate [experience] in defined areas of practice that enable entry-level practitioners to enhance existing competencies and/or acquire additional competencies that exceed entry level
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5 herbals discussed in class
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1. garlic
2. echinachea 3. st. john's wart 4. ginseng 5. gingko biloba |
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role of pharmacist in regards to herbals
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-must answer patient's questions, evaluate products' quality and claims, understand potential ddrs
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Two acts that regulate herbal medicine
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1. FDCA (the food and cosmetic act)
2. cGMP (current good manufacturing practice) |
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DDI for St. John's Wart
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-warfarin
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identify btc candidates
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-Statins
-Antihypertensives -Oral Flu Vaccine -Nasal Corticosteroids -Nicotine replacement therapies |
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what is BTC
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class of drugs/products designated to be accessed by patients only after discussion with the pharmacist and presenting proof of identification
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Who has authority to create a third class of drugs?
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Congress
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Countries with 3rd class
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UK, Canada, Germany
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This act distinguished between OTC and RX drugs
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Durhem Humphrey Amendment '51
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BTC in NJ
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Plan B, Cold/Allergy MEdicine
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NJ Stated Boards of Pharmacy Regulation of BTC sales
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-pharmacists judgment
-sales limit -schedule Class V OTC record book 2nd request (2-4 days); determine proper usage 3rd request (abuse potential, physician consultation 4th request--thorough pt. evaluation/physician documentation required |
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Organizations Opposing 3rd class
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AMA, Consumer Healthcare Products Association (CHPA), Food and Drug Adminstration (FDA)
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