What is included in the Orange Book?

• A. Information on the lowest-priced medications
• B. Approved Drug Products with Therapeutic Equivalence
• C. Patient treatment protocols for approved medications
• D. Reaction assessments for adverse medication effects

Answer: (B)

The correct answer is based on the function and contents of the Orange Book, formally known as the "Approved Drug Products with Therapeutic Equivalence Evaluations." This publication is issued by the FDA and serves as a comprehensive resource that lists all FDA-approved drug products alongside their therapeutic equivalence evaluations.

The Orange Book categorizes approved medications based on their active ingredients and indicates whether those drugs can be considered therapeutically equivalent. This means that the drugs can be substituted for one another without risk of therapeutic failure or adverse effects, which is crucial for pharmacists and prescribers when considering generic alternatives.

The other options do not accurately reflect the purpose of the Orange Book. It does not provide information on the lowest-priced medications; rather, it focuses on therapeutic equivalency and FDA approval status. Additionally, it does not contain patient treatment protocols or specific adverse reaction assessments; those topics are covered elsewhere within the broader scope of pharmaceutical guidelines and literature.

Thus, the Orange Book is a vital tool for health professionals in ensuring that they are providing the safest and most effective drug therapies through the appropriate substitution of medications when generics are available and deemed equivalent.