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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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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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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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Adverse Drug Reactions (ADRs) are potential complications that arise during pharmacotherapy, influenced by multiple risk factors. Age plays a significant role; both neonates and the elderly are at heightened risk due to their respective immature and diminished metabolic and elimination processes. Gender also impacts ADRs, with females experiencing a 1.5 to 1.7-fold greater risk than males, which may be linked to pharmacokinetic, pharmacodynamic, and hormonal differences. Notably, neonates, the...
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Medication Safety During Pregnancy: Improving Evidence-Based Practice.

Susan M Sinclair, Richard K Miller, Christina Chambers

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    Nearly 90% of pregnant women use medications, but safety data is often limited. This review discusses challenges in accessing medication safety information for pregnant patients and highlights the need for better resources.

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    Area of Science:

    • Obstetrics and Gynecology
    • Pharmacology
    • Maternal-Fetal Medicine

    Background:

    • Medication use during pregnancy is common, affecting nearly 90% of US women.
    • Exposures can lead to adverse pregnancy and neonatal outcomes, including birth defects and developmental issues.
    • Current data limitations complicate informed counseling for pregnant patients regarding medication safety.

    Purpose of the Study:

    • To review the limitations of drug package inserts for pregnancy safety information.
    • To highlight accessible resources for healthcare providers counseling pregnant women on medication safety.
    • To emphasize the role of pregnancy registries in expanding knowledge on medication safety during pregnancy.

    Main Methods:

    • Literature review of existing resources and data on medication safety in pregnancy.
    • Analysis of the utility and limitations of drug package inserts.
    • Discussion of the role and challenges of pregnancy registries.

    Main Results:

    • Package insert information is often incomplete, based on animal studies, or lacks adequate safety data.
    • Accessing timely and comprehensive medication safety data for pregnant women is challenging for healthcare providers.
    • Pregnancy registries, while valuable, are slow to generate and disseminate findings.

    Conclusions:

    • Healthcare providers require readily available, up-to-date information to effectively counsel pregnant patients on medication risks.
    • Improved resources and faster dissemination of data from pregnancy registries are crucial for enhancing medication safety during pregnancy.
    • Leveraging clinical practice data can contribute to a more robust understanding of medication safety in pregnant populations.