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Related Concept Videos

Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence

Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...
Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence01:19

Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence

Pharmaceutical products contain more than just the active drug; they also contain various excipients such as binders, solubilizers, stabilizers, preservatives, and other elements. In some cases, impurities or contaminants might be present. Traditionally, quality control in pharmaceuticals has primarily focused on the analysis of the active drug, often overlooking the impact of these additional components. The recent issue with heparin contamination by over-sulfated chondroitin sulfate, a...
Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence01:22

Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence

Generic intravenous (IV) drugs are considered bioequivalent to their branded counterparts due to their 100% bioavailability upon administration. However, variations in stability among different drug products can significantly influence their therapeutic performance, even if they are pharmaceutically equivalent.Cefuroxime, a prophylactic antimicrobial, is often used as a single-dose IV injection for patients undergoing coronary artery bypass grafting surgery. A 3 g dose typically provides...
Pharmaceutical Poisoning: Potential Scenarios01:26

Pharmaceutical Poisoning: Potential Scenarios

Pharmaceutical poisoning can occur through various channels, impacting an estimated 2 million hospitalized patients in the U.S. annually with serious adverse drug responses. These scenarios encompass both therapeutic uses, such as drug toxicity, where even standard dosages can lead to severe central nervous system depression, and non-therapeutic exposures, including accidental ingestion by children, and environmental and occupational exposures.Unintentional poisonings often involve exploratory...
Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules01:18

Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules

Bioequivalence in generic drugs, such as tablets and capsules, refers to their pharmaceutical equivalence to the brand-name counterparts. However, for therapeutic equivalence, manufacturers must also consider physical attributes like size, shape, and weight (FDA Guidance for Industry, December 2003). Discrepancies in these aspects could impact patient compliance and cause medication errors. For instance, swallowing difficulties, often experienced with larger tablets or capsules, can lead to...
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Pharmaceutical Equivalents

As defined by regulatory standards, pharmaceutical equivalents require generic drug products to have identical dosage forms and chemically identical active pharmaceutical ingredients (APIs). They must adhere to compendial or applicable standards for potency, content uniformity, disintegration times, and dissolution rates. In the case of modified-release dosage forms, variations in drug content are permissible as long as the delivered amount remains consistent with the innovator drug product.

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Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
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Published on: December 11, 2016

Pharmacists' responsibility and potential liability regarding generic substitition.

Hendrika Laetitia Hattingh1

  • 1School of Pharmacy, Griffith University, Gold Coast, Australia.

Medicine and Law
|February 18, 2010
PubMed
Summary

The growing generic medicines market in Australia increases pharmacist workload and error risk. Implementing good practice standards is crucial for managing pharmacist liability in generic dispensing.

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Last Updated: Jun 16, 2026

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
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Published on: March 11, 2017

Area of Science:

  • Pharmacy Practice
  • Health Economics

Background:

  • The Australian generic medicines market is expanding, driven by government policies promoting generic substitution.
  • Generic dispensing introduces time pressures and necessitates increased professional judgment for pharmacists.

Purpose of the Study:

  • To analyze the implications of increased generic dispensing on pharmacists' professional responsibilities and liability.
  • To emphasize the importance of adopting robust practice standards for managing risks associated with generic substitution.

Main Methods:

  • Literature review on generic substitution policies and their impact on pharmacy practice.
  • Analysis of potential risks and liabilities faced by pharmacists in community and hospital settings.

Main Results:

  • Generic dispensing elevates the risk of errors due to time constraints and the need for enhanced professional judgment.
  • Pharmacists face increased practice and liability risks as a direct consequence of generic substitution.

Conclusions:

  • Pharmacists must implement stringent good practice standards and guidelines to effectively manage liability risks.
  • Proactive risk management strategies are essential for both community and hospital pharmacists navigating the evolving landscape of generic dispensing.