No effective medicine is without risk and the use of medicines has become more complex than ever before! While medicines bring significant benefits, there are also inherent risks to public health and patient safety mainly due to adverse reactions. Adverse drug reactions (ADRs) are an important public health issue because of high morbidity, mortality and cost that they generate [1]. Specifically, every medicine can have both wanted and unwanted effects which may occur in some or all patients. It is precisely for this reason that the benefits of medicinal product should always be weighed up against its risks and failing to manage the risks may lead to crisis situations with harmful consequences for patient safety and public health. Because of the strong impact in public health, regulatory authorities (RAs) worldwide have raised the bar and have implemented new pharmacovigilance legislation to protect public health by reducing the burden of ADRs through the detection of safety signals. Although, signal detection activities have mainly been performed based on spontaneous reporting databases, new pharmacovigilance legislation underlines the relevance of other sources of information e.g. scientific literature, epidemiology, large automated databases for the evaluation of the benefit–risk balance of medicinal product.

Factors that determine the effectiveness of the digital pharmacovigilance database are considered in the example of the development and analysis of the OtiPharm® Data Pro platform. Factors were divided into two groups: highly specialized, in which compliance with legal requirements for pharmacovigilance has the highest-priority; and non-specialized, that influence on the user experience of experts when working with the system. Such stages of pharmacovigilance processes as medicine safety data collection, processing and structuring and reporting to regulatory authorities are subject to automation. The task of the pharmacovigilance platform should be high-quality and convenient performance of its structuring and organizing functions, regardless of the type of internal process of working with information in the company. The base should become a convenient auxiliary tool and comply with the principles of ALCOA +. An effective pharmacovigilance platform allows devoting more expert`s time to implement product safety solutions, instead optimizing processes and functions that can be automated. The main parameter for assessing the effectiveness of digital platforms for pharmacovigilance is the change in the balance of the distribution of working time of specialists in routine operating processes to expert work.

NThe pharmacovigilance (PV) of drugs for orphan diseases present problems related to the small patient population. Obtaining high-quality information on individual reports of suspected adverse reactions is of particular importance for the PV of orphan drugs (Price J, 2016).

Every occasion when a patient is exposed to a medical product, is a unique situation and we can never be certain about what might happen. A good example for this is thalidomide tragedy in late 1950s and 1960s. Thalidomide prescribed as a safe hypnotic to many thousands of pregnant women caused severe form of limb abnormality known as phocomelia in many of the babies born to those women.

It is well known that prescription drugs can result in a myriad of ADRs, including psychiatric ADRs. Psychiatric effects of drugs can impact sensorium, attention, concentration, memory and higher cognitive functions resulting in distressing physical illness and psychiatric consultation. Generally in regards to psychiatric effects associated with drug therapy, complications such as depression and suicidality (suicidal thinking and behaviour) are those most frequently reported. Prescription drugs with known psychiatric ADRs include: steroids, antibiotics, hormonal drugs, acne drugs, attention-deficit hyperactivity disorder (ADHD) drugs, anti-depressants, anti-parkinsonians, anti-convulsants, anti-malarials, antihypertensives, antihistamines, sedatives tranquillizers, statins, and anti-smoking agents.