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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.
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In some cases, there...
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Pharmaceutical Poisoning: Potential Scenarios01:26

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Analysis of population pharmacokinetic data involves studying the behavior of drugs within diverse populations to understand their pharmacokinetic parameters. Traditional pharmacokinetic methods typically involve collecting samples from a few individuals and estimating these parameters. While these methods are commonly used, they have limitations in capturing the variability in drug response among individuals or heterogeneous populations. Population pharmacokinetics is employed to address these...
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It is not uncommon for complete drug pharmacokinetic profiles to remain elusive in pharmacokinetics. This necessitates certain educated assumptions by pharmacokineticists to determine appropriate dosage regimens without comprehensive pharmacokinetic data from animal or human studies. One prevalent assumption is setting the bioavailability factor, denoted as F, to 1 or 100%. This assumption caters to the scenario where a drug doesn't achieve full systemic absorption, resulting in the patient...
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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 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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Pharmacovigilance in resource-limited countries.

Sten Olsson1, Shanthi N Pal, Alex Dodoo

  • 1WHO Collaborating Centre for International Drug Monitoring, Box 1051, S-751 40 Uppsala, Sweden.

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PubMed
Summary

Many low- and middle-income countries have established pharmacovigilance (PV) systems, but few are fully functional. Strengthening these systems requires legislation, funding, and broader engagement to ensure medication safety.

Keywords:
Pharmacovigilanceadverse drug reactionsconsumer involvementdrug regulationharmlow and middle income countriesmedicinespatient safetypublic health programs

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Area of Science:

  • Public Health
  • Pharmacovigilance
  • Global Health Security

Background:

  • Low- and middle-income countries have increasingly developed national pharmacovigilance (PV) systems over the past two decades.
  • Despite participation in the WHO's global PV network, a significant gap exists in the functionality of these national systems.
  • There is a lack of local scientific evidence detailing the burden and preventability of medicine-related harm.

Purpose of the Study:

  • To highlight the deficiencies in existing pharmacovigilance systems in low- and middle-income countries.
  • To identify key requirements for establishing sustainable and functional national PV systems.
  • To emphasize the need for integrating PV into public health programs and fostering multi-stakeholder collaboration.

Main Methods:

  • This study is a review and analysis of the current state of pharmacovigilance systems in low- and middle-income countries.
  • It synthesizes information on existing frameworks, challenges, and recommendations for improvement.
  • Focus is placed on identifying gaps in evidence and necessary policy interventions.

Main Results:

  • Few national pharmacovigilance systems in these regions are fully functional.
  • Essential elements such as robust legislation, regulatory frameworks, and adequate financial support are often lacking.
  • There is insufficient data on the local burden of adverse drug events and their preventability.

Conclusions:

  • Sustainable pharmacovigilance requires comprehensive legislation, financial investment, and integration into public health initiatives.
  • Effective signal analysis targeting high-burden, preventable adverse drug events is crucial.
  • Enhanced collaboration among healthcare professionals, pharmaceutical companies, academic institutions, and the public is vital for ensuring drug therapy safety, with the WHO playing a key coordinating role.