LibGuides: PHAR 523 / 524: Drug Delivery Project: Drug Information Starting Points

Drug Monograph Information

Look up your drug in at least 1 of the following databases to view the drug monograph to find extensive product information. Suggested databases to find drug monographs include (Note: see the next box down for what details to pay attention to in the monographs for this product):

Drug Facts & Comparisons This link opens in a new window
Comparative charts and drug information for on-label and off-label use, affect on pregnancy and lactation, and risk mitigation. Also includes herbal information, boxed warnings, manufacturer index, medication guides, and immunization schedules. Drug reports searchable by adverse reaction, indication, and contraindication.
UpToDate Lexidrug This link opens in a new window
Drug and disease information including drug identification, drug dosing calculation, AHFS content, and patient education materials. Also includes Trissel’s IV compatibility, drug reports searchable by adverse reaction, indication, and contraindication, as well as MSDS and toxicology information.
Formerly named Lexicomp.
Micromedex This link opens in a new window
Comprehensive evidence-based resources on drugs, medication management, toxicology, diseases, acute care, alternative medicine, and condition management.

After Locating the Prescribing Information: Unique Drug Product Characteristics

Determine Unique Characteristics of your Assigned Drug Product

Now that you've located your drug product's prescribing information, do several things:

1) Go to Drug Facts and Comparisons and click on the Product List tab. Look at the Routes and Dosage Form and see what makes your assigned drug product unique from the other ones on the list.

Drug Facts & Comparisons This link opens in a new window

2) Look at your drug's Prescribing Information again, and notice how the drug is described, particularly as it relates to the dosage form. Pick up key description terms, like proprietary technology, spray, sublingual, tablet, capsule, dispersible, extended release, disintegrating, film..........

3) Write down the key things that distinguish your Drug Product from other ones (if there are others) that have the same active ingredient!

Determine How Long Ago Product was Approved

How long ago was your drug product approved? This will give you a good idea of where you can find information.

To determine when your drug product was approved, go to the FDA's Orange Book and search on the proprietary (brand) name:

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations This link opens in a new window
Drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act and related patent and exclusivity information. Searchable by active ingredient, proprietary name, applicant, application number, dosage form, route of administration or patent number.

In the Orange Book, when your product comes up, there will be a list for different strengths. Click on the Application Number for one of the strengths, and note the Approval Date.
- Newly approved drug products won't yet have information in books; however, the technology they use may be found within books.
- Drugs that have been around for 2+ years may have information in books.
Was your drug approved over 2 years ago?
- Yes, drug product approved more than 2 years ago > See if you can find information on your specific drug in the Ebooks databases and listed ebooks in the next page of this course guide
- No, drug product is newer than 2 years > Have you found a specific technology that is being used for your assigned drug?
  - Yes > Technology Located > Search on the technology in the Ebooks databases and listed ebooks in the next page of this course guide
  - No > Technology Not Located >
    - Look again on your Prescribing information for patent numbers, and also look at the drug's website again to see if a technology is touted
  - Still no technology information: Your best bet is going to be Journal articles and FDA Information. See the Primary Sources page of this course guide for locating articles and search for drug product information in the Suggested Databases for finding Articles. For FDA Information, see the Patents tab of this course guide and read through that entire page to determine next places to look.