Banca de DEFESA: LUIZA BORGES FRANCO

Uma banca de DEFESA de MESTRADO foi cadastrada pelo programa.
STUDENT : LUIZA BORGES FRANCO
DATE: 15/08/2025
TIME: 14:00
LOCAL: Plataforma Teams
TITLE:

EVALUATION OF THE PRESENCE OF POTENTIAL FOOD ALLERGENS IN THE LIST OF MEDICINES OF THE BRAZILIAN POPULAR PHARMACY PROGRAM

KEY WORDS:

Allergens, Restrictive Food, Medicine Package Inserts, Drug, Programa Farmácia Popular, Anvisa

PAGES: 100
BIG AREA: Ciências da Saúde
AREA: Saúde Coletiva
SUMMARY:

“_Introduction: Commercially available medications may contain various excipients derived from food substances, such as lactose, sugars, gluten, and dyes. These components have been reported to cause adverse reactions and hypersensitivity, particularly in individuals with food allergies, intolerances, or sensitivities. In Brazil, current legislation mandates that medications containing potentially allergenic substances include warnings on their labels and package inserts. However, there is no requirement to specify warnings based on the quantity present. Thus, it is essential to identify potential gaps in the adequacy and clarity of the information provided in package inserts to assess the risks posed to vulnerable patients. This study aims to analyze the presence of food allergens in medications distributed through the Popular Pharmacy Program (PPP) in Brazil. Methods: This is a cross-sectional, documentary, and quantitative study. All medications with valid registrations with ANVISA that corresponded to the 39 PPP-listed items from the January 2024 catalog were evaluated for the presence of gluten, lactose, sugar, milk, soy, and dyes. For medications found to contain allergens, compliance with current legislation—specifically, whether package inserts included the required warnings in accordance with RDC No. 770/2022—was assessed. Results: Of the 504 medications analyzed, 36 were excluded due to the unavailability of their package inserts on the ANVISA website. Among the remaining 468 medications, 287 (61.3%) contained at least one allergen. Of these, 227 (79.1%) failed to include the required warnings in their package inserts, as mandated by law. The most common allergens identified were gluten, sugar, and lactose. Medications indicated for dyslipidemia, hypertension, and contraception exhibited the highest frequency of allergens. Notably, all contraceptive medications contained gluten, yet they were all compliant with regulatory requirements. Several labeling issues were identified, including ambiguity regarding the origin of starch, which poses a significant risk to individuals with celiac disease. Certain marketing authorization holders consistently failed to comply with the legislation, suggesting a need for prioritized regulatory oversight by ANVISA. Conclusion: The study concludes that many medications distributed by the PFP contain food allergens, and most do not meet the regulatory requirements for allergen disclosure, potentially putting patients with dietary restrictions at risk. Measures to improve regulatory compliance and mitigate or eliminate these risks are essential to ensuring the safe use of medications in Brazil for these populations.”

COMMITTEE MEMBERS:
Presidente - 1055549 - HELAINE CARNEIRO CAPUCHO
Externa à Instituição - MARIANA MARTINS GONZAGA DO NASCIMENTO - UFMG
Externa à Instituição - PRISCILA FARAGE DE GOUVEIA - UFG
Externo ao Programa - 1012620 - RAFAEL SANTOS SANTANA - null