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Related Concept Videos

Pharmaceutical Poisoning: Potential Scenarios01:26

Pharmaceutical Poisoning: Potential Scenarios

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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...
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Drug Regulation01:25

Drug Regulation

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Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
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Prescription, Nonprescription and Orphan Drugs01:02

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Prescription drugs require a prescription from a medical practitioner and can only be obtained from a pharmacy. They have many applications, including treating pain, anxiety, and hypertension.
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Pharmacovigilance01:19

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Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
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Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

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Body:Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...
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Drug Control Governance: Regulatory Bodies and Their Impact01:03

Drug Control Governance: Regulatory Bodies and Their Impact

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Drug control governance involves the oversight and regulation of pharmaceuticals to ensure their safety and efficacy while preventing illegal drug use and trafficking. Regulatory bodies, including the US Food and Drug Administration (FDA) and the European Union's European Medicines Agency (EMA), play a central role in this process. These agencies evaluate the safety and efficacy of drugs before they can be marketed. They fund clinical trials and assess the benefits and risks associated with...
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Addressing Pharmaceutical Injuries: The US Landscape.

Cecilia Bakker1, Nicholaas Honig2

  • 1Pfizer Inc., Collegeville, Pennsylvania, USA.

Clinical Pharmacology and Therapeutics
|August 30, 2017
PubMed
Summary

Pharmaceutical injury compensation laws differ globally. This commentary examines Japan

Area of Science:

  • Pharmaceutical Law
  • Comparative Legal Studies
  • Public Health Policy

Background:

  • Legal frameworks for pharmaceutical product injury compensation vary significantly across nations.
  • Approximately 10 countries utilize no-fault compensation systems for medicine-related injuries.
  • No-fault systems require proof of injury causation by the medicine, not manufacturer negligence.

Purpose of the Study:

  • To compare and contrast the legal approaches to pharmaceutical injury compensation in Japan and the United States.
  • To analyze the implementation and implications of different compensation models for patients and manufacturers.

Main Methods:

  • Comparative legal analysis of pharmaceutical injury compensation statutes and case law.
  • Review of no-fault compensation schemes in Japan and the United States.

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  • Examination of legal precedents and policy considerations in both jurisdictions.

    • Main Results:

    • Significant differences exist in the legal requirements and procedural aspects of pharmaceutical injury claims between Japan and the US.
    • Japan's system may offer a different balance of claimant protection and manufacturer liability compared to the US approach.
    • The commentary highlights key distinctions in establishing causation and recovery under each country's legal framework.

    Conclusions:

    • The varying legal landscapes necessitate careful consideration for global pharmaceutical regulation and patient advocacy.
    • Understanding these differences is crucial for harmonizing international standards in pharmaceutical injury compensation.
    • Further research can explore the effectiveness and patient outcomes of each compensation model.