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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.
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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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Drug Nomenclature01:17

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During the development of a new pharmaceutical, the manufacturer initially assigns a code name to the drug. Once approved, the drug receives a United States Adopted Name (USAN)—a generic, nonproprietary designation. Upon being listed in the United States Pharmacopeia, this nonproprietary name becomes the drug's official name. Additionally, the manufacturer assigns a proprietary name or trademark, which serves as the brand name under which the drug is marketed. It is worth noting that...
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Drug Classes and Categories01:25

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Drugs can be classified according to their chemical composition or their intended therapeutic application. For instance, anti-infective agents that possess the ability to eliminate pathogens or suppress their growth and reproduction can be grouped based on the organisms they target or their chemical structure. Furthermore, drugs can be divided into prescription, nonprescription, or controlled substances. Prescription medications, such as antibiotics, require oversight from a licensed healthcare...
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Hazard Ratio01:12

Hazard Ratio

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The hazard ratio (HR) is a widely used measure in clinical trials to compare the risk of events, such as death or disease recurrence, between two groups over time. It reflects the ratio of hazard rates—the instantaneous risk of the event occurring—between a treatment group and a control group. This measure provides valuable insights into the relative effectiveness of a treatment by assessing how the risk of an event differs between the two groups.
For example, in a clinical trial...
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Cardiovascular Drugs: Classification based on Therapeutic Indications01:18

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Cardiovascular diseases, encompassing a range of conditions, can significantly affect the heart's operations and the overall circulatory system. These conditions impair the heart's ability to pump blood, leading to a deficit in oxygen supply to crucial organs. Anomalies in the heart's electrical system, known as arrhythmias, can cause heartbeats to accelerate or slow down. Usually, heart rates increase during physical activity and decrease while resting or sleeping. However,...
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Quantitation of Protein Expression and Co-localization Using Multiplexed Immuno-histochemical Staining and Multispectral Imaging
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MedDRA Labeling Groupings to Improve Safety Communication in Product Labels.

Ilona Große-Michaelis1, Scott Proestel2, Radhika M Rao3

  • 1Bayer AG, Research & Development, Pharmaceuticals, Leverkusen, Germany.

Therapeutic Innovation & Regulatory Science
|August 8, 2022
PubMed
Summary

The Medical Dictionary for Regulatory Activities (MedDRA) Preferred Terms (PTs) can be too detailed for product labels. A harmonized approach to MedDRA Labeling Groupings (MLGs) is needed for clearer communication of adverse reactions.

Keywords:
Adverse reactionsICHMedDRAMedDRA Labeling Groupings (MLG)Product labels

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Area of Science:

  • Pharmacovigilance
  • Regulatory Science
  • Medical Informatics

Background:

  • The Medical Dictionary for Regulatory Activities (MedDRA) provides granular coding for adverse events (AEs) crucial for data analysis.
  • However, the high granularity of MedDRA Preferred Terms (PTs) can hinder clear communication of adverse reactions (ARs) in product labeling for healthcare practitioners.
  • Existing institution-specific approaches to clustering AR terms lack standardized conventions, creating inconsistencies.

Purpose of the Study:

  • To address the need for improved safety communication in medical product labeling.
  • To propose a harmonized international approach for creating and utilizing groups of MedDRA PTs, termed MedDRA Labeling Groupings (MLGs).
  • To provide principles and considerations for the development of MLGs.

Main Methods:

  • Convening of a Council for International Organizations of Medical Sciences (CIOMS) Expert Working Group (EWG) with diverse stakeholder involvement.
  • Analysis of variations in MedDRA PT groupings within existing product labels.
  • Development of a consensus document outlining a strategy for improving drug safety labeling communication.

Main Results:

  • Identification of significant variations in how MedDRA PTs are currently grouped in product labels.
  • Proposal of a strategy for enhancing the communication of drug safety information through standardized groupings.
  • Establishment of principles and points to consider for the development of MedDRA Labeling Groupings (MLGs).

Conclusions:

  • There is an urgent need for a harmonized international approach to MedDRA Labeling Groupings (MLGs) to improve patient and healthcare provider understanding of adverse reactions.
  • The proposed strategy and consensus recommendations aim to standardize the communication of drug safety labeling.
  • The use of these recommendations is intended to be voluntary and compatible with existing regulatory frameworks.