Adverse drug reactions have a great impact on the quality of life of patients, and in addition, they increase the burden on the healthcare system. ADRs are one of the causes that lead to increased morbidity and mortality at the international level. With the increasing complexity of drugs to treat various diseases in different societies, this issue has become an important public health issue [1]. Drug safety is essential in any country, especially in developing countries, because the occurrence of ADRs and other drug problems in any country can be diverse. Information related to ADRs that is created in the region or country, meanwhile having a high educational value, could play an effective role in regulatory decision- making at the national level [2]An adverse drug reaction (ADR) is defined as “any response to a drug which is noxious and unintended that occurs at doses normally used in human beings for prophylaxis, diagnosis, therapy of disease, or for the modification of physiological functions”[3]With the emergence of new technologies, policymakers in the field of medicine are trying to develop new technologies in the health care system that can promise effective pharmaceutical care and also prevent unwanted side effects of drugs in the future [4, 5].
On the other hand, some studies have stated that patient participation in the ADR reporting process could directly or indirectly have reduced hospitalization and treatment costs and improved health services [6].The first ideas for computerizing the registration and investigation of adverse drug reactions were formed in the mid-1970s[7].The International Spontaneous Reporting System on Yellow Cards is one of the most valuable methods of monitoring drug side effects and is of unique importance in identifying severe and rare drug reactions [8, 9].
National pharmacovigilance centers have developed paper based methods to facilitate reporting.
A necessity minimum dataset for a validity report has been offered, which includes patient identifiable data, an ADE, have a suspect medicinal product and an identifiable reporter [10].
In Iran, the status and efficiency of the pharmacovigilance system is not known and there is not enough information about its performance and effectiveness. Most of the researches done regarding evaluation- knowledge, attitude and performance of pharmacovigilance system. Meanwhile, the existence of a drug monitoring system has led to the improvement of the quality and quantity of drug side effect reports and provides more accurate decision-making in this field [11].Around the world voluntary reporting systems have been working in the field of pharmacovigilance for over forty years. Along with the activities carried out in many countries, also in Iran, the National Center for Registration and Investigation of Adverse Drug reactions is responsible for organizing the activities of adverse drug reactions and also to collect and review the reports at the national level. Since 1991, efforts and activities for the formation of ADR began in Iran. In 1997, the first cases of drug side effects were sent to the newly established ADR center of the country, and in 1998, Iran joined the WHO international program [12]. The Center for Registration and Investigation of Adverse Drugs, as the only national center in the country, collects and registers reports of drug side effects observed by the medical community in order to collect adverse drug reactions reports, according to international standards, yellow forms (Yellow card) has been prepared by this center [11].
The ratio of adverse drug reactions reporting was 15.3 per 100 000 residents and 10.0 per 100 000 entrance in 2017, and it was growing with 16.3% average change per annum during 19 years. The median of estimated percepts of underreporting was 76.0%. After the correction, the mean ratio of adverse drug reactions reporting reached from 5.87 to 10.33 per 100 000 residents for 19 years [13]. For successful implementation a system such adverse drug reactions reporting system as when users work with information systems be comfortable and satisfy. Therefore, designing a user interface of these systems should be based on a series of standard principles and rules. Usability tests usually refer to viewing the user's system display (or user interface) when the user interacts with the system while performing tasks [14]. Exploratory evaluation is used in human-computer interaction studies to evaluate the usability of information systems. One of the most common methods of usability assessment is the exploratory assessment method. Viewing system status, match the system with the real world, freedom of user operation and system control, compliance with uniformity and standards, error prevention, detection instead of reminders, flexibility and efficiency of use, aesthetic aspects and simple design, help users to detect, identify and correct errors, and also guidance and documentation. In this method, a small set of evaluators based on a predefined checklist evaluate the system on the principles of system usability. The standard method often involves a troubleshooting step as the first step in resolving system problems and determining the severity of the problem. Ranking the problem by severity can help to identify problems that urgently need to be addressed and allocate resources to solve them [15, 16].
Therefore, this study intends to assess the usability of National Adverse Drug Reactions Reporting System with the prospect of identifying the challenges and the most required pharmacovigilance priorities. The results of this study can help to create areas for improvement of challenges and thus provide a basis for improve health and safety regarding the use of medicines.