Pharmacovigilance practice among pediatric neurologists from Poland and Germany

Based on the lack of literature concerning a similar theme of the study, it seems believed that it is an innovative study. Besides, to strengthen the value of the study, the results were gathered from two countries- Poland and Germany, and comparison analysis was performed. The presented study is a continuation of a larger study [11] whose aim was to assess whether the effect of a “well-established PV position” in the existing healthcare system influences compliance with the obligation to participate in national PV and ADR reporting by pediatric neurologists.

Due to the lack of literature based on pediatric neurologics as a study group, the discussion refers to studies involved general professional group, i.e. medical doctors.

The results of the study have shown that the pediatric neurologists had a good knowledge of the general issues connected with PV process and such knowledge was dependent on the age of the respondents. It was similar to previous observations [12, 13]. Despite having such a good knowledge of PV and ADR, the neurologists participating in our study were unaware of the existence of pharmacotherapy safety monitoring centers responsible for PV in their countries [14]. Similar conclusions were reached by researchers from Malaysia, who confirmed that this was the main reason (40%) for not reporting ADRs [15,16,17,18]. One way to address this problem is to incorporate PV as an essential part of healthcare personnel training, especially among doctors. The vast majority of pediatric neurologists did not recognize the contribution of other healthcare professionals as potential ADR reporters [19, 20], but they were aware of their responsibility to include PV in their daily duties, including PV reporting as part of their daily responsibilities. For instance, in one of the recent german study [14] 54% of responders said that ADRs play a minor role in their routine care, and 4 (3%) stated that they play no role at all.

In addition, most neurologists knew the timeframe for reporting major ADRs, but this was not correlated with the number of reported ADRs seen in children with epilepsy, as the vast majority reported that they only reported < 5 ADRs in the last 6 months. This may be due to a number of systemic factors indicated by both Polish and German neurologists as barriers to PV processing. Among the barriers in carrying out PV, the pediatric neurologists participating in our study most often mentioned the fear that the report will generate additional work and poor lack of knowledge about general PV process. It was similar to other studies [19, 21, 22], in which the main reason for underreporting ADRs was lack of time, little knowledge of the types of reactions to be preferentially reported and also the absence of a fee for reporting ADRs.

The results of the study suggested a positive attitude of pediatric neurologists to the PV process, which is very positive, as was observed in other studies in which participants were eager to learn and apply the knowledge about ADR reporting in their daily routine [17]. It was similar among the pediatric neurologists from Poland and Germany, as well. Unfortunately, besides such a positive attitude toward general PV practice, a small number of pediatric neurologists believed that ADR reporting was their professional obligation, especially among polish pediatric neurologists’ (33.12%). It is naturally correlated with the next statements among polish neurologists concerning the regular basis of ADRs reporting- only 23.34% of polish pediatric neurologists’ declared ADRs reporting on their a regular basis. The same small percentage in mentioned fields was presented by German pediatric neurologists, so we can assume that both compared countries have the same problem with a legal obligation to participate in the national and European PV process. A significant percentage of neurologists also believed that only serious adverse events should be considered important or were unsure about the types of adverse events that should be reported. This finding was consistent with previous studies [18, 19]. It is important to acknowledge that less severe and atypical adverse events are also significant, as they can serve as indicators of the potential occurrence of fatal adverse events in the future. Factors identified by physicians as barriers to reporting adverse events should be promptly addressed, including the barriers mentioned earlier [20].

We also inquired about the frequency of reporting ADRs and the number of reported ADRs within a 6-month period. The most common response from pediatric neurologists was “yes” regarding regular reporting, while the most common response to the second question was “<5.“ According to various research findings, physicians’ practice in reporting ADRs fell significantly below expectations. Meanwhile, the pace of reporting ADRs to the appropriate regulatory bodies was quite overwhelming, with a majority of physicians who encountered ADRs submitting few reports or not reporting at all [21]. Surveys done in Malaysia have shown that only 5.3% of doctors had ever reported ADRs [21], a similar result was found in UAE 11% [22].

Similarly, a study conducted in Romania found that 79.9% of surveyed doctors did not report any ADRs [23], and a comparable result was obtained in India 77% [24]. In contrast, an article from Sweden yielded a positive outcome, with 62% of doctors having ever reported an ADR [18].

The research findings indicate the most commonly used sources of obtaining information about adverse drug reactions (ADRs). The most popular source of information among neurologists in Poland was the Internet and medication package inserts, while in Germany, it was journals and the Internet. Studies conducted in Pakistan revealed that 24% of doctors refer to the Internet, 33.6% to seminars, 18.4% to journals, and 10.4% to drug advert [25], similarly, in Nigeria 41.4% refer to books/ journals, 18.3 to seminars/ training, 4.4% to the internet [26], and in India 63% of doctors identified the internet as the source of information, 65% seminars, 69% journals, 40% medical books [24], other doctors (89%) emphasised the role of information technology [19], 93.6% [27], and 75% [28].

The pediatric neurologists in our study suggested different activities which should be implemented for the improvement of the PV process, among many of these activities the most frequently mentioned were strengthening the training program on ADR reporting, activating institutional role in ADRs reporting, and also including reporting exercise in the undergraduate examination as an important tool for increasing physicians’ awareness of ADRs in practice. In 2009, Oshikoya and Awobusuyi also recommended including pharmacovigilance as a topic in continuing education programmes [29]. Various studies have shown that the optimization of the knowledge, attitude, and practices about pharmacovigilance is essential to promote reporting [30, 31].

The participants also encouraged the governments to take the necessary steps to ensure the safe and effective use of drugs among the population. In addition, pediatric neurologists to improve the PV system, including lifelong learning, seminars as well as training. The literature also confirms that ensuring optimal knowledge, awareness of attitudes and PV practices is essential to promoting ADR reporting [30, 31]. Globally, in the developed world, ADR reporting is shifting from the prescribing physician to the consumer or patient.