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Generic drugs. Therapeutic equivalence

P A Meredith1

  • 1University Department of Medicine and Therapeutics, Western Infirmary, Gardiner Institute, Glasgow, Scotland.

Drug Safety
|October 1, 1996
PubMed
Summary

Generic substitution is promoted for economic reasons but may pose risks for narrow therapeutic index drugs if quality control is inadequate. Branded products remain the safest choice in regions with minimal quality assurance.

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Area of Science:

  • Pharmacoeconomics
  • Drug Quality Control
  • Pharmaceutical Policy

Background:

  • Generic substitution is increasingly favored by health authorities for economic reasons.
  • Concerns exist regarding the quality and bioequivalence of generic drugs, particularly those with a narrow therapeutic window.
  • Substandard and counterfeit drugs are prevalent, especially in developing countries lacking robust quality control infrastructure.

Purpose of the Study:

  • To evaluate the potential risks associated with generic substitution, focusing on drug quality and bioequivalence.
  • To assess the adequacy of current bioequivalence testing in ensuring therapeutic interchangeability.
  • To provide recommendations for ensuring drug safety in the context of generic substitution.

Main Methods:

  • Review of existing literature and reports on generic drug quality and bioequivalence.
  • Analysis of bioequivalence study designs, typically involving randomized crossover trials comparing serum concentration-time curves.
  • Examination of anecdotal reports of treatment failures and adverse events following brand switching.

Main Results:

  • Bioequivalence testing may not be sufficient to guarantee therapeutic interchangeability for all drugs, especially sustained-release formulations.
  • Reports of treatment failures and adverse events after switching generic brands have been documented across various drug classes.
  • Inadequate quality control and regulatory oversight in many regions increase the risk of substandard or counterfeit drugs entering the market.

Conclusions:

  • The safety and efficacy of generic substitution are contingent upon stringent quality control and validated bioequivalence.
  • Anecdotal evidence suggests limitations in current bioequivalence testing, necessitating a cautious approach.
  • In regions with minimal regulatory oversight, branded medications are recommended to ensure patient safety and therapeutic consistency.

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