WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT• Attitude is an important factor impacting pharmacists' reporting of adverse drug events (ADE) to pharmacovigilance centres. • However, little is known about United States (US) pharmacists' attitudes with respect to ADE reporting. No known study has assessed US pharmacists' attitude to report serious ADEs to the FDA.
WHAT THIS STUDY ADDS• This study results suggest that pharmacists hold favourable attitudes toward reporting serious ADEs to the FDA and there is an association between pharmacists' attitude and intention to report serious ADEs.• Pharmacists' beliefs that reporting serious ADEs was time consuming and disrupted the normal workflow impact on reporting intentions.• Pharmacists' attitudes towards reporting need to be improved in order to enhance patient and drug safety.
AIMTo investigate the influence of pharmacists' attitudes on intention to report serious adverse drug events (ADEs) to the Food and Drug Administration (FDA).
METHODSThis cross-sectional study used a mail survey to collect data from hospital and community pharmacists practicing in Texas, United States. Three and 16 items were used to measure intention and attitudes, respectively, using a seven-point bipolar scale. Pharmacists' demographic and practice characteristics, and past reporting were also measured.
RESULTSThe response rate was 26.4% (n = 377/1500 pharmacists). Most pharmacists intended (n = 297, 78.8%) to report serious ADEs that they will encounter to the FDA through MedWatch. Overall, pharmacists held favourable attitudes towards reporting serious ADEs (mean = 24.5, SD = 6.7, possible range 1-49, neutral = 16). Pharmacists intending to report serious ADEs had more favourable attitudes than those who did not (P < 0.001). About 90% of the pharmacists believed that reporting serious ADEs would improve patient safety. However, 72.6% indicated that reporting serious ADEs was time consuming and over half (55.5%) of the respondents believed that reporting serious ADEs disrupted the normal workflow. Non-intenders held stronger beliefs that ADE reporting would disrupt the normal workflow and was time consuming compared with intenders. Years of experience, number of hours worked and practice setting were associated with pharmacists' attitudes towards reporting (P < 0.05).
CONCLUSIONSMost pharmacists held moderately favourable attitudes and high intentions toward reporting serious ADEs to the FDA. This study's findings contribute to an increased understanding of individual factors that influence pharmacists' attitude and intention towards reporting serious ADEs to the FDA.
Objectives. To determine pharmacy students' attitude toward and knowledge of reporting serious adverse drug events (ADEs) to the Food and Drug Administration (FDA). Method. A 58-item survey questionnaire constructed to measure respondents' intention to report ADEs (3 items), attitude toward reporting ADEs (20 items), knowledge of ADE reporting (9 items), and demographic data was administered to all third-year (final-year) pharmacy students at the Appalachian College of Pharmacy.Results. The majority of the 58 students who responded (91% response rate) intended (84%) and planned (85.3%) to report serious ADEs when they encounter them. Most respondents had favorable attitudes toward reporting serious ADEs to the FDA; respondents believed that reporting serious ADEs was valuable (5.6 6 1.5, mean 6 SD), good (3.0 6 1.7), and beneficial (5.7 6 1.5). Many students also believed that ADE reporting resulted in increased risk of malpractice, compromised relationships with physicians, broken trust with patients, disruption of the normal workflow, and was time consuming. Many students had inadequate knowledge on reporting ADEs. Conclusion. Although pharmacy students had strong intentions and favorable attitudes toward ADE reporting, they had inadequate knowledge of how to report serious ADEs.
This study assessed the state of health economic evaluation (including pharmacoeconomic) research in Nigeria. A literature search was conducted to identify health economic articles pertaining to Nigeria. Two reviewers independently scored each article in the final sample using a data collection form designed for the study. A total of 44 studies investigating a wide variety of diseases were included in the review. These articles were published in 34 different journals, mostly based outside of Nigeria, between 1988 and 2009. On average, each article was written by four authors. Most first authors had medical/clinical affiliations and resided in Nigeria at the time of publication of the study. Based on a 1 to 10 scale, with 10 indicating the highest quality, the mean quality score for all studies was 7.29 (SD 1.21) and 59% of the articles were of fair quality (score 5-7); 5% were of even lower quality. The quality of articles was statistically significantly (p < or = 0.05) related to the country of residence of the primary author (non-Nigeria = higher), country of the journal (non-Nigeria = higher), primary objective of the study (economic analysis = higher) and type of economic analysis conducted (economic evaluations higher than cost studies). The conduct of health economic (including pharmacoeconomic) research in Nigeria was limited and about two-thirds of published articles were of sub-optimal quality. More and better quality health economic research in Nigeria is warranted.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.