Journal of Pharmaceutical Care & Health Systems
Open Access

Abstract

Importance of Information on Excipients with a Known Action or Effect in the Package Leaflet and an Oversight of the Situation in Albania

Irisi Sukaj

Pharmaceutical dosage forms incorporate both Active Pharmaceutical Ingredients (APIs) and excipients, which aid in formulation and manufacturing processes. Excipients, often perceived as inert, can possess pharmacological effects or trigger adverse reactions, necessitating their declaration on medicine labels and package leaflets to ensure safe use. This review focuses on commonly used excipients in orally administered pharmaceuticals, highlighting their characteristics and potential adverse effects, particularly significant for over-the-counter medications where patient self-administration is common.

In the European Union (EU), regulations under Directive 2001/83/EC mandate the disclosure of excipients with known actions or effects on medicine labels and package leaflets. Conversely, Albania's regulatory framework, while aligning partially with EU directives, lacks specific guidelines for listing excipients with known effects in package leaflets, potentially compromising comprehensive patient safety information.

An observational study was conducted in the Albanian market to assess compliance with excipient information standards across various medicinal products. The study found that most products, except those from Canada and some Swiss companies, included information on excipients with known actions or effects in their package leaflets, despite varying regulatory requirements among exporting countries.

The discussion underscores the importance of regulatory harmonization to ensure consistent and adequate information on excipients, thereby enhancing medication safety and patient outcomes. It also identifies gaps in current regulatory frameworks, suggesting improvements for Albania to align more closely with EU standards and enhance patient protection.

In conclusion, addressing the information gap on excipients in pharmaceuticals is crucial for ensuring rational medication use and minimizing adverse effects. The findings stress the need for Albania to develop comprehensive guidelines and lists of excipients with known actions or effects, akin to EU standards, to enhance medication safety and regulatory compliance.

Published Date: 2025-01-02; Received Date: 2024-10-22