PHARMACOVIGILANCE IN ONCOLOGY:
KNOWLEDGE AND PERCEPTION ON ADVERSE EVENTS REPORTING IN BRAZIL Holtz, L1.; Cecilio, L1.; .Julian, GS2; Minowa, E2
PCN1
1- Instituto Oncoguia, São Paulo, Brazil; 2 - Evidências Credibilidade Científica - Kantar Health, São Paulo, Brazil
INTRODUCTION • Pharmacovigilance represents an important tool to support the maintenance of drug safety through evaluation of spontaneous adverse events (AE) reporting. • Oncoguia is an independent non-profit institution, with the mission of helping cancer patients to live better. • The present study can contribute to identify barriers on AE reporting and improve Oncoguia´s strategy on patients’ awareness campaign.
METHODS • We developed an internet-based survey with 23 questions regarding adverse events and pharmacovigilance awareness, with a multi-professional team. • The survey was available online in Oncoguia Institute website and social media and data was collected from February to March 2015.
OBJECTIVE To evaluate the knowledge and perception related to pharmacovigilance in Brazil on patient´s perspective.
RESULTS •From February to March 2015, 260 respondents answered the survey. Most of the respondents were from 36 to 50 years old (39.5%), with high school degree (25.9%) and most from the Southeast region of Brazil (58.1%). Among the respondents most were covered by public health insurance (SUS) (45.8%), followed by private insurance (43.8%) (Figure. 1). • Among the respondents the most common type of cancer was Breast cancer (58.2%) followed by colorectal cancer (3.8%). The respondents were subjected to chemotherapy (68.8%), surgery (60.4%), radiotherapy (34.6%) and hormonotherapy (15%). • Seventy-two percent of the respondents answered to know what an AE and 85.5% of the respondents were educated by physicians and 67% by nurses (Figure 2). • 85.1% of the respondents presented the AE described by the healthcare professionals, being nausea (89.1), hair loss (86.1%), vomiting (49.7%), weight gain (54.5%), anemia (30.3%), weight loss (30.3%) and neuropathy (15.8%) were the most commonly reported. • The majority of the respondents reported the AE to their physicians (90.7%) and the most common managements to AE were introduction of a novel medication (87.6%), treatment alteration (7.6%) and chemotherapy dose alteration (4.8%). In addition, only 32.2% of the respondents presented an AE that the physician did not mention. • Regarding pharmacovigilance, the massive majority (87.6%) had never heard about pharmacovigilance, with only 10.3% of the respondents aware that AEs could be reported and only 5.9% knew that AE might be reported to ANVISA, in fact, only 28.8% knew the importance of reporting AEs. In case of AE, 23.6% of the respondents, due to lack of knowledge did not do anything when presenting AE. FIGURE 1. RESPONDENTS PROFILE REGARDING TYPE OF CANCER, AGE GROUP, EDUCATION, HEALTH INSURANCE COVERAGE AND TREATMENTS PERFORMED. AGE GROUPS
AE KNOWLEDGE
2%
From 36 to 50 old Over 51 years
22%
36%
85,5%
BREAST CANCER 58,2%
Up to 20 years From 21 to 35 old
FIGURE 2. RESPONDENTS´ KNOWLEDGE ON ADVERSE EVENTS, SOURCE OF EDUCATION, AE OCCURRENCE AS DESCRIBED AND MOST FREQUENT AES OTHER (PHARMACIST, PSYCHOLOGIST AND NUTRITIONIST)
67% NOT AWARE 28%
AWARE 72%
40%
2%
EDUCATION LEVEL
26% 10%
2%
High School degree incomplete
14%
Public + private insurances
46%
68,8%
44%
89,1%
AE DESCRIBED IN EDUCATION
No education
86,1%
Bachelor degree complete
49,7%
DID NOT OCCUR 15%
Private insurance Public insurance
Other
(pharmacist, psychologist and nutritionist)
High School degree Post-graduate degree
2%
Out of pocket
Nurse
Elementary school degree
23%
8%
Physician
9%
14%
HEALTH INSURANCE COVERAGE
11,5%
54,5% 30,3%
30,3% 15,8%
OCCUR 85%
60,4% 34,6%
Nausea Hair Vomiting Weight Anemia Weight NeuroLoss Gain Loss pathy
15%
Chemotherapy Surgery
90,7% of the patients reported the AE to their doctors.
Radiotherapy Hormonotherapy
FIGURE 3. PATIENTS AWARENESS REGARDING PHARMACOVIGILANCE AND AE REPORTING PROCESS HAVE HEARD ABOUT PHARMACOVIGILANCE?
DID YOU KNOW AE COULD BE REPORTED TO THE MANUFACTURER?
O O K O H I S IMPORTANT TO REPORT AEs?
DID YOU KNOW AE MUST BE REPORTED TO ANVISA?
IN CASE YOU PRESENT AN AE, HOW DO YOU PROCEED?
YES 6% YES 12%
74,7%
YES 10%
YES 29% NO 88%
NO 90%
23,6% NO 71%
NO 94%
1,7%
Reported to the pharmaceutical company
Talked to the physician and/or healthcare team
Did not do anything,because I did not know
CONCLUSIONS • This survey demonstrates that knowledge and perception regarding AEs, such as definition, importance and how to proceed in case of having one, including the importance of pharmacovigilance system, are very reduced among common public, including cancer patients. • These results demonstrate a scarce education regarding pharmacovigilance and adverse events reporting. • Therefore, there is an enormous need for educational intervention regarding AEs reporting importance in general public, patients and physicians, especially in oncology.
REFERENCES 1. Ahlberg K, Nordner A. The importance of participation in support groups for women with ovarian cancer. Oncol Nurs Forum. 2006 Jul;33(4):E53-61. 2. Coates A, Abraham S, Kaye SB, Sowerbutts T, Frewin C, Fox RM, et al. On the receiving end--patient perception of the side-effects of cancer chemotherapy. Eur J Cancer Clin Oncol. 1983 Feb;19(2):203-8. 3. Visacri MB, Souza CMd, Pimentel R, Barbosa CR, Sato CMS, Granja S, et al. Pharmacovigilance in oncology: pattern of spontaneous notifications, incidence of adverse drug reactions and under-reporting. Brazilian Journal of Pharmaceutical Sciences. 2014;50:411-22.
POSTER PRESENTED AT THE ISPOR 5TH LATIN AMERICA CONFERENCE 6-8 SEPTEMBER, 2015 SANTIAGO, CHILE ©COPYRIGHT 2015 INSTITUTO ONCOGUIA ALAMEDA LORENA, 131, CONJ. 116 JARDIM PAULISTA SÃO PAULO, SP - 01424-001 BRASIL + 55-11-3053-6917 E-MAIL: INSTITUTOONCOGUIA@ONCOGUIA.ORG.BR