Journal of Pharmacovigilance

Pharmacovigilance of Over-the-Counter Medications and Herbal Supplements

Juan Fueyo^* Department of Psychological Medicine, University of Paris Saclay, Gif-sur-Yvette, France
^*Correspondence: Juan Fueyo, Department of Psychological Medicine, University of Paris Saclay, Gif-sur-Yvette, France, Email:

Received: 31-Oct-2023, Manuscript No. JP-22-23987; Editor assigned: 02-Nov-2023, Pre QC No. JP-22-23987(PQ); Reviewed: 16-Nov-2023, QC No. JP-22-23987; Revised: 23-Nov-2023, Manuscript No. JP-22-23987(R); Published: 30-Nov-2023, DOI: 10.35248/2329-6887.23.11.460

About the Study

Pharmacovigilance, the science and practice of monitoring the safety of pharmaceutical products, plays a crucial role in ensuring the well-being of the public. While prescription medications undergo rigorous scrutiny, Over-The-Counter (OTC) medications and herbal supplements also require close attention due to their widespread use and accessibility. This article explores the importance of pharmacovigilance in the context of OTC medications and herbal supplements, highlighting the key considerations, challenges, and regulatory mechanisms in place.

OTC medications are readily available without a prescription, making them a popular choice for self-medication. These drugs include pain relievers, antacids, cough and cold remedies, and more. Despite their accessibility, they are not exempt from potential risks. Common adverse effects can range from mild, such as drowsiness or upset stomach, to severe, such as allergic reactions or interactions with other medications. The lack of physician oversight heightens the importance of monitoring these products.

Pharmacovigilance activities for OTC medications involve ongoing surveillance to identify and assess adverse effects and other safety concerns. The primary objectives are:

• Identifying potential safety concerns or trends through data analysis, including reports from healthcare professionals and consumers.

• Evaluating the severity and frequency of adverse events associated with OTC medications to determine if regulatory actions are necessary.

• Continuously monitoring the safety of OTC products even after they are on the market, as new safety information may emerge.

Pharmacovigilance for OTC medications faces several challenges are

• Many consumers and healthcare professionals may not report mild adverse events, leading to incomplete data.

• Herbal supplements are not subject to the same rigorous quality controls as pharmaceutical drugs, which can lead to inconsistent product safety.

• OTC medications are subject to different regulations across the world, making harmonization a challenge.

Herbal supplements, derived from plant-based sources, are often perceived as natural and safe. They are widely used for various health-related purposes, including improving well-being, managing chronic conditions, and preventing illnesses. However, this perception of safety can be misleading, as herbal supplements can interact with other medications and cause adverse effects.

Pharmacovigilance for herbal supplements is significant for several reasons are

• Herbal products are not always standardized, leading to variability in composition and potency.

• Some herbal supplements can interact with prescription medications, leading to unforeseen complications.

• The presence of contaminants or undeclared ingredients in herbal products can pose significant health risks.

Regulatory framework

The regulation of OTC medications and herbal supplements varies from country to country. In the United States, the Food and Drug Administration (FDA) oversees OTC medications, while the Dietary Supplement Health and Education Act (DSHEA) governs herbal supplements. These regulations aim to ensure product safety, labeling accuracy, and good manufacturing practices.

Pharmacovigilance plays a critical role in supporting these regulatory efforts, as it helps identify safety concerns that may necessitate product recalls or labeling changes. Collaborative efforts between regulatory agencies, healthcare professionals, and consumers are essential to maintaining the safety and quality of OTC medications and herbal supplements.

Conclusion

Pharmacovigilance is a fundamental aspect of ensuring the safety of over-the-counter medications and herbal supplements. The accessibility and popularity of these products make it imperative to monitor them for adverse effects and potential risks. By fostering a culture of reporting, conducting robust risk assessments, and promoting transparency, pharmacovigilance can contribute to safer self-medication choices and better protect public health.