What are Over-the-Counter Drugs?

Over-the-counter Drugs (OTCs) are those that are used to treat common ailments and are deemed safe enough to be used without a prescription. There are over 80 different therapeutic categories for OTCs and they must meet the following qualifications:

- minimal risk for abuse or misuse

- consumer can diagnose self and alleviate their own symptoms (for example, runny nose, headache)

- benefits must outweigh risks

Common Over-the-Counter Drugs?

Some of the most common OTC drugs include: Tylenol, Zyrtec, Aspirin, and Benadryl.

What are Prescription Drugs?

Prescription drugs require a qualified health care professional such as a physician to prescribe them. These medications generally fall into one of the following categories and generally have increased abuse risks:

-Central Nervous System (CNS) Depressants

-Pain Management

-Stimulants

Additionally, these medications may be branded or generic medications.

What are Common Prescription Medications?

Some of the most common prescription medications include OxyContin, Dilaudid, and Valium.

Regulations Considerations

While prescription and OTCs drug approvals require oversight by the Food and Drug Administration (FDA) the process is different. Over-the-counter drugs are managed through “Drug Monographs” which specify drug ingredients and label information. As long as there isn’t deviation from this, these drugs may be marketed freely. Drug monographs are similar to formulas or recipes.

Prescription drugs must under go a “New Drug Application” process (a.k.a NDA). This process requires the documentation and approval of the drugs’ performance, as well as its safety profile. This approval process is broken into 4 phases and can take as long as 8 years or more for final entry into the market.

No Comments »

No comments yet.

RSS feed for comments on this post. TrackBack URL

Leave a comment

You must be logged in to post a comment.