PTCB Study Guide: Generic Drug Substitution

Brand Name Drugs and Generic Drugs

<div class="separator" style="clear: both; text-align: center;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgkINMz-0clBYrVmdHdQtHVH_SGtca2qmQ1ZwJ5ysSE9jtrJD0baDsYVU6ia-sm09td19YjYXsyTQPf2bThDBjK7c93quGWTLD43OYObyJcOIBcS0VzA6-GkuvQanMVxnFyF8DPkQH3F1a9/s1600/600x428.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgkINMz-0clBYrVmdHdQtHVH_SGtca2qmQ1ZwJ5ysSE9jtrJD0baDsYVU6ia-sm09td19YjYXsyTQPf2bThDBjK7c93quGWTLD43OYObyJcOIBcS0VzA6-GkuvQanMVxnFyF8DPkQH3F1a9/s1600/600x428.jpg" /></a></div>
The FDA approves all drugs that are available for distribution in the U.S. to assure that they are safe and effective. 
 
Before a new drug is approved, the manufacturer must submit a New Drug Application (NDA) to the FDA. The NDA includes: 
<ol>
<li>Info about the drug</li>
<li>Results from human clinical trials </li>
<li>Results from animal clinical trials</li>
<li>How drugs acts in the body</li>
<li>How it is manufactured, processed and packaged</li>
</ol>
Most companies market new drugs with a trade or brand name. Lipitor is an example of a brand name for a drug that is produced and distributed by the manufacturer Pfizer. 
<ol>
<li>The generic name for Lipitor is atrovastatin</li>
<li>Pfizer developed atrovastatin</li>
<li>Pfizer submitted a NDA to the FDA</li>
<li>FDA approved atrovastatin</li>
<li>Pfizer is granted patents for an average of 11 years.</li>
<li>Once the patent expires other drugs companies may apply for approval of generic or copies of the drug.</li>
</ol>
Generic equivalents contain the same active ingredients and have the same dosage form, strength and formulations as their brand name counterparts. 
 
Generic drug companies must submit an Abbreviated New Drug application (ANDA). Generic manufactures must meet the same standards for: 
<ol>
<li>Manufacturing</li>
<li>Quality</li>
<li>Labeling</li>
<li>They do not need to repeat the original research.</li>
<li>Must show bioequivalence to the brand name drug.</li>
</ol>
Generic Drug Substitution 
Pharmacists are permitted to substitute the generic equivalent drug for the brand name unless the prescriber prohibits generic substitution. 
 
Generic substitution is regulated by state laws. These laws and regulations set requirements for when pharmacists may or may not substitute therapeutically equivalent generic drugs for brand name drugs. 
Indications of no substitution include: 
<ol>
<li>“Dispense as written”</li>
<li>“DAW”</li>
<li>“no substitution”</li>
<li>“do not substitute” </li>
<li>“DNS”</li>
</ol>
Pharmacists use the “Orange Book” to find the FDA’s decision on whether or not a generic drug is therapeutically equivalent to the brand name.

Brand Name Drugs and Generic Drugs

The FDA approves all drugs that are available for distribution in the U.S. to assure that they are safe and effective. Before a new drug...

1:09 PM