TY - JOUR
T1 - Prevalence and predictors of patients reporting adverse drug reactions to health care providers during oral targeted cancer treatment
AU - Monestime, Shanada
AU - Page, Ray
AU - Jordan, William M.
AU - Aryal, Subhash
N1 - Funding Information:
The authors would like to thank SaferCare Texas, USA for financially supporting our research through an intramural grant; Joanna Garcia for data management and project development; Roberto Montealegre and Nicole Shaw for completing data collection; Samantha Watson for creating the tables; Julia Aiken for data cleaning; Brook Amen for conducting an extensive literature search; and Barry Russo and John Clagg for assisting with project development. Disclosure: The authors declare no relevant conflicts of interest or financial relationships. Funding: SaferCare Texas Patient Safety Institute.
Publisher Copyright:
© 2021 American Pharmacists Association®
PY - 2021/1/1
Y1 - 2021/1/1
N2 - Background: Pharmacovigilance is a critical component to facilitate clinicians’ decision-making to alter or discontinue therapy. However, self-administration of oral targeted therapy (OTT) requires fewer clinical visits than parenteral infusions, potentially leading to an increase in the under-reporting of adverse drug reactions (ADRs). Objective(s): To identify factors associated with patients reporting ADRs to their health care provider (HCP) and to identify the prevalence of unreported ADRs while on OTT. Methods: Patients aged ≥18 years who received care from a community oncology clinic and newly prescribed an OTT between August 1, 2018, and October 31, 2018, were included. Six-monthly follow-up calls were conducted by the pharmacy staff to assess for gradable ADRs—validated by the NCI Common Terminology Criteria for Adverse Events—and ungradable ADRs. Descriptive analysis was used to analyze the prevalence of unreporting ADRs, and a multivariate logistic regression model was utilized to evaluate predictors of reporting ADRs to an HCP. Predictors included sociodemographic factors, severity of ADRs, insurance type, pharmacy setting, type of OTT, and the number of prescribed medications Results: Of the 76 patients analyzed, the mean age was 63.32 ±11.55 years, 84.2% were women, 68.8% were non-Hispanic white, and 76.3% had breast cancer. During the follow-up calls, 306 ADRs were identified and 22.2% were not previously reported to an HCP. Of the unreported gradable ADRs, 63.2% were grade 1, 19.3% were grade 2, and 17.5% were grade 3. We found that for every 1-year increase in age, there was a 5% decrease in the likelihood of reporting ADRs (95% CI, 0.91–0.99), and men were 11.4 times more likely to report ADRs (95% CI, 1.29–100.8). Conclusion: Follow-up calls served as an outlet to collect pharmacovigilance data by identifying over 20% of unreported ADRs to HCPs, in which over one-third were moderate to severe. However, future studies are needed to further understand the statistically significant differences found in under-reporting for women and the older population.
AB - Background: Pharmacovigilance is a critical component to facilitate clinicians’ decision-making to alter or discontinue therapy. However, self-administration of oral targeted therapy (OTT) requires fewer clinical visits than parenteral infusions, potentially leading to an increase in the under-reporting of adverse drug reactions (ADRs). Objective(s): To identify factors associated with patients reporting ADRs to their health care provider (HCP) and to identify the prevalence of unreported ADRs while on OTT. Methods: Patients aged ≥18 years who received care from a community oncology clinic and newly prescribed an OTT between August 1, 2018, and October 31, 2018, were included. Six-monthly follow-up calls were conducted by the pharmacy staff to assess for gradable ADRs—validated by the NCI Common Terminology Criteria for Adverse Events—and ungradable ADRs. Descriptive analysis was used to analyze the prevalence of unreporting ADRs, and a multivariate logistic regression model was utilized to evaluate predictors of reporting ADRs to an HCP. Predictors included sociodemographic factors, severity of ADRs, insurance type, pharmacy setting, type of OTT, and the number of prescribed medications Results: Of the 76 patients analyzed, the mean age was 63.32 ±11.55 years, 84.2% were women, 68.8% were non-Hispanic white, and 76.3% had breast cancer. During the follow-up calls, 306 ADRs were identified and 22.2% were not previously reported to an HCP. Of the unreported gradable ADRs, 63.2% were grade 1, 19.3% were grade 2, and 17.5% were grade 3. We found that for every 1-year increase in age, there was a 5% decrease in the likelihood of reporting ADRs (95% CI, 0.91–0.99), and men were 11.4 times more likely to report ADRs (95% CI, 1.29–100.8). Conclusion: Follow-up calls served as an outlet to collect pharmacovigilance data by identifying over 20% of unreported ADRs to HCPs, in which over one-third were moderate to severe. However, future studies are needed to further understand the statistically significant differences found in under-reporting for women and the older population.
UR - http://www.scopus.com/inward/record.url?scp=85092112062&partnerID=8YFLogxK
U2 - 10.1016/j.japh.2020.09.001
DO - 10.1016/j.japh.2020.09.001
M3 - Article
C2 - 33032945
AN - SCOPUS:85092112062
VL - 61
SP - 53
EP - 59
JO - Journal of the American Pharmacists Association
JF - Journal of the American Pharmacists Association
SN - 1544-3191
IS - 1
ER -