Identification of adverse drug reactions that may be related to pharmacogenetics in a public hospital in the South of Brazil

ABSTRACT

Background

Adverse drug reactions (ADRs) are of great concern in clinical practice. Pharmacogenetics can identify individuals and groups at increased risk of developing ADRs, enabling treatment adjustments to improve outcomes. The study aimed to determine the prevalence of ADRs related to drugs with pharmacogenetic evidence level 1A in a public hospital in Southern Brazil.

Research design and methods

ADR information was collected from the pharmaceutical registries from 2017 to 2019. Drugs that have pharmacogenetic evidence level 1A were selected. Public genomic databases were used to estimate the genotypes/phenotypes frequency.

Results

During the period, 585 ADRs were spontaneously notified. Most were moderate (76.3%), whereas severe reactions accounted for 33.8%. Additionally, 109 ADRs caused by 41 drugs presented pharmacogenetic evidence level 1A, representing 18.6% of all notified reactions. Depending on the drug-gene pair, up to 35% of individuals from Southern Brazil could be at risk of developing ADRs.

Conclusions

Relevant amount of ADRs were related to drugs with pharmacogenetic recommendations on drug labels and/or guidelines. Genetic information could guide and improve clinical outcomes, decreasing ADR incidence and reducing treatment costs.

KEYWORDS:

• Adverse drug reaction
• guideline
• pharmacogenetics
• pharmacogenomics
• pharmacovigilance

Acknowledgments

The authors thank to Hospital de Clínicas de Porto Alegre for providing the necessary data for this study; the pharmacists Tatiana Von Diemen and Janaína Rodrigues Chagas from the Clinical Pharmacy of HCPA for helping with the data provided.

Declaration of interests

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

AC Camargo: analyzing and interpreting the data, drafting the paper, or revising it critically for intellectual content. U Matte: conception and design, drafting the manuscript, or revising it critically for intellectual content. MR Botton: conception and design, drafting the paper or revising it critically for intellectual content, final approval of the version to be published. All authors agree to be accountable for all aspects of the work.

Additional information

Funding

MR Botton received a fellowship from Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul – FAPERGS. No other funding was received for this study.