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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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Drug Control Governance: Regulatory Bodies and Their Impact01:03

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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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Pharmaceutical Poisoning: Potential Scenarios01:26

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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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Therapeutic Drug Monitoring: Drug Analysis Methods01:26

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Therapeutic Drug Monitoring (TDM) is a clinical practice that measures specific drug levels in a patient's blood or body tissues to tailor drug therapy effectively. This monitoring is critical for managing drugs with narrow therapeutic indices like digoxin and phenytoin, ensuring they are both safe and effective. For instance, monitoring theophylline levels in asthma patients involves precision and sensitivity to adjust doses according to individual responses to therapy, ensuring efficacy and...
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Therapeutic Drug Monitoring: Affecting Factors01:29

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Therapeutic Drug Monitoring (TDM) is the clinical practice of measuring specific drug levels in a patient's blood or body tissues to manage and optimize therapy. TDM is crucial for drugs with narrow therapeutic windows, like warfarin and phenytoin, where incorrect doses can lead to treatment failure or severe side effects. This monitoring ensures the dosage administered is within a safe and effective range. The factors affecting therapeutic drug monitoring include:Patient-Specific Factors:a.
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Pharmacovigilance activities in ASEAN countries.

Wimon Suwankesawong1, Teerapon Dhippayom2, Wei-Chuen Tan-Koi3,4

  • 1Health Product Vigilance Center, Thai Food and Drug Administration, Nonthaburi, Thailand.

Pharmacoepidemiology and Drug Safety
|May 14, 2016
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Summary

Four Association of Southeast Asian Nations (ASEAN) countries have functional pharmacovigilance (PV) systems. Strengthening PV capacity requires improved communication strategies and advisory committee support across the region.

Keywords:
ASEANUppsala Monitoring Centeradverse drug reactionpharmacoepidemiologypharmacovigilance

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Area of Science:

  • Pharmacovigilance
  • Drug Safety
  • Regulatory Science

Background:

  • Pharmacovigilance (PV) systems are crucial for monitoring drug safety post-market.
  • The Association of Southeast Asian Nations (ASEAN) region presents a diverse landscape for PV implementation.
  • Understanding the current state of PV in ASEAN is essential for regional drug safety initiatives.

Purpose of the Study:

  • To explore the current pharmacovigilance (PV) landscape in ASEAN countries.
  • To identify challenges hindering the development and functionality of PV systems in the region.
  • To assess the performance and adherence to international standards of national PV centers.

Main Methods:

  • A cross-sectional survey was conducted from May 2014 to December 2015.
  • Data collected via questionnaires on resources, processes, roles, responsibilities, and functions of PV systems.
  • PV system functionality assessed against World Health Organization (WHO) minimum requirements; performance measured by ICSRs, signal detection, and global database contribution.

Main Results:

  • Eight ASEAN countries participated in the survey.
  • Four countries (Indonesia, Malaysia, Singapore, Thailand) met WHO minimum requirements for functional PV systems.
  • Significant variation in PV capacity, reporting rates (7-3817 ICSRs/million population/year), signal detection, and legislative frameworks was observed.

Conclusions:

  • Only four ASEAN countries possess fully functional pharmacovigilance systems.
  • PV system maturity is influenced by local healthcare ecosystems and regulatory environments.
  • Enhanced communication strategies and technical assistance from advisory committees are vital for strengthening regional PV capacity.