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20 Cards in this Set
- Front
- Back
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What was the Food, Drug and Cosmetic Act of 1938?
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Said that drugs had to be safe
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What was the Kefauver-Harris Drug Amendment?
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Said that drugs also had to be effective
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What is DESI?
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Drug Efficacy Study Implementation - Took all drugs between 1938 and 1962 to see if they were effective
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What are the 3 major sections of the package insert?
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Highlights of Prescribing Information - When it was approved, what it is used for, indications/usage, dosage form, adverse reactions
Full Prescribing Information Table of contents - Indexes info Full Prescribing Information - Details on studies and citations |
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Who oversees OTC drugs?
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The Federal Trade Commission
Prescription drugs are under the FDA |
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What was the Food, Drug and Cosmetic Act of 1938?
|
Said that drugs had to be safe
|
|
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What was the Kefauver-Harris Drug Amendment?
|
Said that drugs also had to be effective
|
|
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What is DESI?
|
Drug Efficacy Study Implementation - Took all drugs between 1938 and 1962 to see if they were effective
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What are the 3 major sections of the package insert?
|
Highlights of Prescribing Information - When it was approved, what it is used for, indications/usage, dosage form, adverse reactions
Full Prescribing Information Table of contents - Indexes info Full Prescribing Information - Details on studies and citations |
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Who oversees OTC drugs?
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The Federal Trade Commission
Prescription drugs are under the FDA |
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What is the DDMAC and what is their mission?
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Division of drug marketing, advertising and communication
To protect the public health by assuring prescription drug information is truthful, balanced and accurately communicated |
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What are some of their activities?
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They review prescription drug advertising and promotional labeling to ensure that the information contained within is not false or misleading
Provide written comments to pharmaceutical sponsors on proposed promotional material Review complaints about promotional violations Initiate enforcement actions on promotional materials of various closely related products to ensure regulation is applied equitably. |
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What are 3 types of Prescription drug ads?
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Product Claim Ad
Reminder Ad Help-seeking ad |
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Describe a product claim ad.
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Names drug
Names the condition treated Discusses benefits and risks Brand and Generic name must be there Needs to say prescription only and state FDA use and risks |
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Describe a reminder ad.
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Names the drug
Does not name the condition Assumes the audience knows the drug Doesnt contain risk info Not permitted for drugs with a boxed warning in the FDA labeling |
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Describe a help seeking ad.
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Describes a disease or condition but does not recommend or suggest specific drugs
May include a pharmaceutical manufacturer name May include contact phone number |
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Describe the requirements for Drug Ads.
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Fair balance of risks vs benefits
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Is there a requirement for prior approval of an ad?
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No
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What is the FDA's response to Ads with violations?
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They communicate the violation with the drug company and tell them to stop using the ad
Ask them to fix it Enforcement letters issued by the DDMAC are posted on the FDA website (warning letters) They can take the company to court to enforce the ban of specific activities or seize supplies of the drug |
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What are some potential violations that can occur?
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Claim efficacy that is not FDA approved or no evidence
Misrepresent data from studies Overstate the drug's benefits Suggest efficacy or safety in certain populations without evidence or leave out or downplay risk info Lack fair balance Do not include the prescribing information |
