Pharmacovigilance in developing countries (part II): a path forward

Abstract

In recent years, attention to pharmacovigilance has gained momentum in developing countries, however awareness of, and policies or systems for pharmacovigilance in most developing countries still lags sharply behind developed countries. This article proposes different strategies to encourage the introduction and sustain the advancement of robust pharmacovigilance systems in developing countries. To this end, this article seeks to accomplish the ultimate goal of pharmacovigilance in a developing country context; ensuring patient safety and promoting safe and rational use of drugs.

Awareness, knowledge, attitude and practice of adverse drug reaction reporting among health workers and patients in selected primary healthcare centres in Ibadan, southwestern Nigeria

“…Overall, the health workers who are younger in the practice (≤1–5 years) significantly demonstrate positive attitude towards ADR reporting compared to those with greater than 5 years practice experience. Incorporation of ADRs and pharmacovigilance themes into the educational institutions and curricula where health disciplines are taught may therefore be an important use of formal educational channels, to actively incorporate ADR/pharmacovigilance concept into the future healthcare professional career, with the potential of strongly influencing perception and attitude towards ADR reporting [36] .…”

“…Studies have indicated the availability of ADR reporting form (i.e. Yellow form), as well as a user-friendly reporting form as impetus for improving ADR reporting practice [35, 36].…”

Pharmacovigilance of thalidomide in the Brazilian Health System and patient safety

“…Comparing this number of adverse events recorded in the medical records with the 23 spontaneous reports in a period of three years (2014 to 2016) to the Customer Service of the manufacturer laboratory and with the 15 notifications recorded in Notivisa in approximately six years (see Figure 1), it is noted that health professionals have not yet incorporated the notification activity in their work routine. Early pharmacovigilance training, integrated with undergraduate, postgraduate, and professional health curricula could contribute to create awareness and consider pharmacovigilance as a routine activity and necessary for patient safety at the beginning of careers (Isah et al, 2012;Elshafie, Roberti, Zaghloul, 2018).…”

“…Pharmacovigilance systems in developing countries, such as Brazil, rely mainly on spontaneous reporting and find barriers with its implementation, such as underreporting, resource constraints, and limited regulatory capacity (Isah et al, 2012;Elshafie, Zaghloul, Roberti, 2017). Some interventions have already been identified as effective tools to improve reporting, including educational activities, simpler and more easily available forms, facilitated notification procedures, feedback, and incentives for notifiers (Elshafie, Roberti, Zaghloul, 2018).…”

Overview of this issue: pharmacovigilance, what is new?

“…The balance of a global system versus country/regional systems needs to be explored [13]. Elshafie et al [32], in the second paper, presents the progress and continued needs for the developing nations. Many studies employing these databases and registries use proxies to identify ADRs; harmonization of the systems is important to avoid missing these reactions.…”