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Objective evaluation of generic drug information.
Hisashi Iijima1, Miwako Kamei, Toshimasa Koshimizu
1Social and Administrative Pharmacy Science, College of Pharmacy, Nihon University. h-iijima@c-yaku.or.jp
Summary
Pharmacists must evaluate generic drugs for effectiveness, safety, and cost. This study quantified information for generics, finding significant variation between manufacturers and highlighting the need for maker-specific evaluations.
Area of Science:
- Pharmaceutical Sciences
- Health Economics
- Drug Information Science
Background:
- Healthcare professionals require robust data to assess generic drugs.
- Evaluating the quality and quantity of information accompanying generics is crucial for appropriate use.
- Previous assessments have not sufficiently addressed manufacturer-specific information disparities.
Purpose of the Study:
- To objectively evaluate the information provided for generic drugs.
- To quantify the amount of information available for generics compared to original drugs.
- To analyze the relationship between generic drug prices and the quantity of information provided by manufacturers.
Main Methods:
- Evaluated drug package inserts and interview form data for a minimum of 20 products per pharmaceutical ingredient.
- Developed criteria to quantify information amounts objectively.
- Calculated information quantities relative to drug prices for original and generic drugs.
- Analyzed 14 different pharmaceutical ingredients (327 product items).
Main Results:
- Information quantity for generics was 27.9-46.3% of that for original drugs.
- Manufacturer-specific information ratios varied widely, from 15.1% to 62.4%.
- For generics, the relationship between price and information quantity showed significant variability.
Conclusions:
- The quantity of information provided for generic drugs varies considerably.
- Evaluating generic drug information on a manufacturer-by-manufacturer basis is essential.
- This highlights the need for improved and standardized drug information for generics.