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Related Concept Videos

Drug Regulation01:25

Drug Regulation

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...
Pharmacovigilance01:19

Pharmacovigilance

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...
Drug Control Governance: Regulatory Bodies and Their Impact01:03

Drug Control Governance: Regulatory Bodies and Their Impact

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 a...
Dosage Regimen: Individualization01:24

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Individualization in dosing regimens is the customization of medication doses for individual patients. Its necessity arises from the goal of maximizing therapeutic benefits while minimizing risks. This approach is pivotal because human responses to drugs can vary widely; what is effective for one person may be inadequate or excessive for another. Interpatient (intersubject) variability refers to differences in drug responses between individuals, while intrapatient (intrasubject) variability...
Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions01:15

Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions

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 (CHF).
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...

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Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
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Responsive regulation of Internet pharmacy practice.

D B Brushwood1

  • 1University of Florida College of Pharmacy, USA.

Annals of Health Law
|August 11, 2001
PubMed
Summary

Professor Brushwood explores the internet's role in pharmaceutical care, advocating for responsive regulation to protect public health. The Verified Internet Pharmacy Practice Site program is proposed as a model for oversight.

Area of Science:

  • Pharmacy Practice
  • Health Regulation
  • Internet Technologies

Background:

  • The internet has emerged as a significant medium for healthcare delivery, including pharmaceutical care.
  • Regulatory frameworks are challenged by the rapid expansion of online pharmaceutical services.
  • Concerns exist regarding patient safety and the integrity of online pharmacies.

Purpose of the Study:

  • To evaluate the effectiveness of the internet as a platform for pharmaceutical care.
  • To propose a regulatory approach for internet-based pharmacy practices.
  • To advocate for a specific model that balances public health protection with innovation.

Main Methods:

  • Discussion and analysis of the internet's capabilities for pharmaceutical care delivery.
Keywords:
Food, Drug, and Cosmetic ActHealth Care and Public HealthLegal Approach

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  • Examination of existing regulatory challenges and potential pitfalls.
  • Advocacy for the Verified Internet Pharmacy Practice Site program as a regulatory solution.
  • Main Results:

    • The internet is an effective medium for delivering pharmaceutical care.
    • Responsive and adaptive regulation is crucial for safeguarding public health.
    • The Verified Internet Pharmacy Practice Site program offers a viable model for regulating online pharmacies.

    Conclusions:

    • Internet pharmacy offers significant potential for patient care.
    • Effective regulation, not prohibition, is key to harnessing internet pharmacy benefits.
    • The Verified Internet Pharmacy Practice Site program provides a practical framework for ensuring quality and safety in online pharmaceutical services.