Banca de QUALIFICAÇÃO: MAGDA CÉSAR RAPOSO

Uma banca de QUALIFICAÇÃO de MESTRADO foi cadastrada pelo programa.
STUDENT : MAGDA CÉSAR RAPOSO
DATE: 04/11/2021
TIME: 08:30
LOCAL: virtual
TITLE:

Drug-Food Interactions in Brazilian Drug Data Sheets: Is There Concordance With The Literature?

KEY WORDS:

Package leaflets, food-drug interactions, drug-drug interactions, food, pharmacokinetics.

PAGES: 29
BIG AREA: Ciências da Saúde
AREA: Farmácia
SUMMARY:

Objective: To analyze the existence of information about drug-food interactions in
Brazilian drug package inserts and whether there is agreement with the literature.
Methodology: Electronic package inserts for patients and health professionals, made
available by Anvisa, were analyzed. We identified 144 drugs with food interactions, of
these 15 were excluded, because they were registered as expired/canceled or non-
existent in Anvisa's files. After identifying all package inserts, a comparative analysis
was performed between the information contained in the Interactions Manual, the health
care professional's package insert, and the patient's package insert, and then we
categorized these results. For data analysis and interpretation, a database was
constructed in spreadsheet form using Microsoft Office Excel 2016. Results: Of the 129
package leaflets analyzed, in 66 (51.2%), the information contained in the professional
and patient leaflets agreed with each other, in 45 (34.9%) there was no information
about interactions between drugs with food in both the professional and patient leaflets,
in 13 (10.0%) the data contained in the professional and patient leaflets partially agreed,
and in 05 (3.9%) there was information that did not agree between the two information
sheets. In addition, there is no information on interactions between drugs and food in
the professional package leaflet. In the comparison between the patient package insert
and the Interactions Manual, in 45 (34.9%) there was no data on drug-food interactions
in the patient package insert. In 36 (27.9%) the information agreed with each other, in
30 (23.3%) the information in the patient package leaflet partially agreed with the
Interactions Manual, and in 18 (13.9%) there was no agreement between the two
sources of information. Partial Considerations: We found considerable divergence and
absence of information, both in professional and patient package leaflets, about drug-
food interactions. The absence or poor quality of information about drug-food
interactions in package leaflets reduces their value as informational/educational material
for the health care professional and patient. These factors may lead to risk exposure
related to changes in drug response and patient safety.

BANKING MEMBERS:
Interna - 1741307 - ADRIANA CRISTINA SOARES DE SOUZA
Presidente - 1581667 - DANYELLE ROMANA ALVES RIOS
Externa à Instituição - MARIANA MARTINS GONZAGA DO NASCIMENTO - UFMG
Externa à Instituição - THAYS SANTOS MENDONCA - UNA