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Related Concept Videos

Pharmacovigilance01:19

Pharmacovigilance

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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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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 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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Drug Regulation01:25

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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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Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions01:15

Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions

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PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure...
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Pharmacokinetic–Pharmacodynamic Relationship: Problems01:24

Pharmacokinetic–Pharmacodynamic Relationship: Problems

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The empirical approach to drug therapy optimization relies on correlating pharmacological response with administered dosage. Such an approach can be costly, time-consuming, and often yields poor correlation due to variables like formulation factors and drug elimination characteristics. A more precise approach correlates response with plasma drug concentration or the amount of drug in the body, rather than dosage. This is achieved through pharmacokinetic-pharmacodynamic (PK/PD) modeling, which...
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Multiplex Therapeutic Drug Monitoring by Isotope-dilution HPLC-MS/MS of Antibiotics in Critical Illnesses
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Ongoing challenges in pharmacovigilance.

Gerald J Dal Pan1

  • 1US Food and Drug Administration, 10903 New Hampshire Ave., Building 22, Room 4304, Silver Spring, MD, USA, gerald.dalpan@fda.hhs.gov.

Drug Safety
|November 23, 2013
PubMed
Summary
This summary is machine-generated.

Pharmacovigilance systems face ongoing challenges in public engagement, collaboration, informatics, global strategy, and impact assessment. Addressing these requires adapting to scientific advances and societal expectations for improved drug safety.

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Area of Science:

  • Pharmacovigilance and Drug Safety Surveillance

Background:

  • Pharmacovigilance systems have advanced significantly over decades.
  • Current systems face persistent challenges in key operational areas.

Purpose of the Study:

  • To identify and discuss the principal interrelated challenges in drug safety surveillance.
  • To explore how scientific and technological advancements influence these challenges and offer new opportunities.

Main Methods:

  • The study reviews common challenges across pharmacovigilance systems.
  • It analyzes the impact of scientific progress and societal expectations.

Main Results:

  • Five principal areas of challenge are identified: public engagement, collaboration, informatics integration, global approach, and impact assessment.
  • These challenges are evolving due to technological and societal changes.

Conclusions:

  • A one-size-fits-all approach is unsuitable due to regional and developmental differences in pharmacovigilance.
  • Sharing best practices is crucial for advancing drug safety surveillance globally.