Uncovering the Hidden Hurdles: Exploring Challenges in Pediatric Pharmacovigilance in the Netherlands

Abstract

Introduction

The use of drugs carries risks, as adverse drug reactions (ADRs) can occur. In the Netherlands, a voluntary pharmacovigilance system is in place, allowing healthcare professionals and patients to report (suspected) ADRs. Previous research has highlighted underreporting as a significant problem; however, barriers for ADR reporting are not clear.

Objectives

The aim was to assess perceptions of ADR reporting among pediatricians (in training), to identify barriers hindering reporting, and to study differences between our hospital and other Dutch hospitals.

Methods

A cross-sectional survey was conducted among pediatricians (in training) in the Netherlands. The study questionnaire was based on a validated questionnaire and adjusted for the Dutch context, addressing aspects related to ADR reporting, attitudes toward ADRs in work environment, personal vision, reasons for nonreporting, and future perspectives.

Results

A dataset of 127 respondents was included. Of these, 93% reported knowing how to report an ADR. Overall, 95% believed that reporting ADRs has the potential to enhance knowledge and improve drug safety, and 93% acknowledged the overall importance of ADR reporting. However, 19% of respondents indicated that they had never reported an ADR. The most commonly cited reason (61%) for not reporting was prior knowledge of the ADR. Other barriers included uncertainty about whether a symptom constituted an ADR, the perception that the ADR was not severe, and time constraints.

Conclusions

This study highlights the importance of addressing barriers to ADR reporting in pediatric healthcare. While healthcare professionals recognize the significance of ADR reporting, several impediments hinder their reporting efforts.

Supplementary Information

The online version contains supplementary material available at 10.1007/s40264-025-01593-y.

Key Points

Respondents recognize the significance of adverse drug reaction (ADR) reporting for improving drug safety.

Uncertainty about symptom classification, perceptions of nonseverity, and time constraints are barriers to ADR reporting.

Introduction

The use of drugs is never without risks, since adverse drug reactions (ADR) can occur at any time. Especially vulnerable patients, such as children, in whom medication is often used off-label or unlicensed [1, 2], are at risk for developing ADRs.

To ensure the safe use of drugs, it is imperative to conduct (clinical) trials that establish both drug safety and efficacy before gaining approval from regulatory authorities (for example, the US Food and Drug Administration (FDA) in the USA and the Medicines Evaluation Agency (EMA) in Europe). However, the participants and/or patients in premarketing trials will not always be representative of the population of all potential users of the drug. After marketing, in general, the patient population using the drug expands significantly, and treatment conditions become much more diverse [3, 4]. In addition, the circumstances under which the drugs are used may differ from the setting in which the trials were conducted. Furthermore, ADRs that are rare or occur after prolonged use or with a long latency may not be detected in premarketing trials [5, 6]. Therefore, postmarketing surveillance is important to continue monitoring and evaluating the efficacy and safety of a drug once it is on the market.

Postmarketing surveillance is important during the whole lifetime of a drug. Changes in the conditions of clinical use of a drug may occur at any time, even for drugs that have been on the market for decades. Such changes, such as the population for whom the drug is prescribed, eventually off-label, and concomitant use with other (new) drugs, may give rise to previously unobserved adverse effects [7, 8]. As an example, a study of Pacurariu et al., evaluating signals discussed at the Pharmacovigilance Risk Assessment Committee (PRAC) meetings of the EMA, showed that the median time since approval for marketing in Europe for the drugs discussed was 12 years, with 58% being longer than 10 years on the market [9].

Postmarketing surveillance has traditionally been carried out by systematic manual review of spontaneous reports of ADRs. This is an affordable, versatile, and highly efficient approach for gathering information from healthcare professionals and patients who willingly submit case reports of ADRs. Information that arises from these spontaneous reporting systems may lead to initial potential safety signals. Unfortunately, underreporting by healthcare professionals limits the possibility to detect safety signals [10–13]. Previous studies suggested that a low reporting rate may be due to lack of time, lack of knowledge on how to report [14], as well as other factors such as unawareness, indifference, uncertainty, or contentment [15, 16].

In the Netherlands, similar to many other countries, a nationwide, voluntary pharmacovigilance system is in place. Healthcare professionals and patients can report (suspected) ADRs to the national pharmacovigilance centre Lareb. In previous studies we demonstrated that underreporting of ADRs is also a common problem in the Netherlands [10, 17]. This is especially a problem in pediatrics, where off-label prescribing is so commonly used [1, 2], making postmarketing pharmacovigilance particularly important. To improve the knowledge on drug safety in pediatric patients, it is important to stimulate reporting of ADRs by all healthcare professionals. In Italy, De Angelis et al. carried out a survey among nurses to investigate their intention to report ADRs and the factors influencing this intention [18]. As far as we know, this has never been investigated in pediatricians or medical doctors working in pediatrics. In addition, in the Netherlands, an investigation into the hurdles faced by pediatricians when reporting adverse drug reactions (ADRs) has not been previously undertaken. For that reason, we conducted a cross-sectional survey involving both pediatricians and pediatricians in training across the Netherlands. Our objective was to evaluate perceptions about ADR reporting and unveil the barriers impeding the reporting of ADRs in clinical practice.

As a result of our prior studies [10, 17] on the recognition and reporting of ADRs in pediatric patients conducted at our institution (Radboud University Medical Center in Nijmegen, the Netherlands), our colleagues were more informed about ADRs and reporting requirements compared with pediatricians at other hospitals. Our secondary objective was to compare the perceptions and barriers in ADR reporting between pediatricians (in training) within our hospital and those from other hospitals.

Methods

Questionnaire Design

An anonymous questionnaire was developed using a validated questionnaire previously described by De Angelis et al. [18]. This Italian language questionnaire was translated into Dutch by the official Language and Translation Institute of our University (Radboud University, Nijmegen, the Netherlands). In addition, a few adjustments were made (A.D. and M.t.L) to make the questionnaire suitable for the Dutch situation. For example, the question of whether a reporting form is available was removed because in the Netherlands, reporting can only be performed digitally. Two questions were added, namely: “What was the main reason for not reporting ADRs seen in the past?” and “Besides the main reason for not reporting ADRs, what were other reasons for not reporting ADRs in the past?” Both the original questionnaire and the newly created questionnaire can be found in the Supplementary Material.

The questionnaire underwent testing by a panel of ten pediatricians from our University Medical Center to determine the clarity of the questions. This panel included three residents (pediatricians in training), two fellows (pediatricians pursuing subspecialties), and five pediatricians. They all completed the questionnaire and gave feedback about the questions. On the basis of their feedback, two small modifications to the questionnaire were made.

The questionnaire was constructed in LimeSurvey and comprised a cover letter with an explanation of the aim of the study, including an informed consent statement. The questionnaire consisted of 47 questions that were divided into five subsections: (1) attention to ADR reporting in work environment, (2) attitude toward reporting ADRs in work environment, (3) personal attitude toward reporting ADRs, (4) reasons for not reporting ADRs in the past, and (5) future perspectives. All questions were multiple choice. Moreover, participants had the opportunity to provide comments in an open-text field following each question. The estimated time for completing the questionnaire was 20 min.

Responder Characteristics

As explained before, our colleagues from the Radboud University Medical Center in Nijmegen, the Netherlands, were more informed about ADRs and reporting them compared with pediatricians at other hospitals. Given the focus on this topic in our hospital, we expected a higher response rate from participants affiliated with our institution. Consequently, in our questionnaire, we inquired about participants’ workplace affiliation, distinguishing between “Radboud” and “non-Radboud institutions” to be able to evaluate answers separately. Furthermore, we asked for the level of education, years of experience, and the type of hospital where the respondents work. In the Netherlands, we distinguish three types of hospitals: academic hospitals, general hospitals, and top clinical hospitals. A general hospital provides a broad range of basic medical and surgical services to the local population. It offers essential healthcare, including emergency care and standard specialist treatments. In addition to providing “general hospital care,” a top clinical hospital also administers complex healthcare services that necessitate specialized facilities. Most top clinical hospitals collaborate with other healthcare institutions, provide a training ground for medical professionals, and frequently engage in scientific research. An academic hospital in the Netherlands is affiliated with a university that has a medical faculty. These hospitals combine patient care with scientific research and education. In the Netherlands, pediatricians also work outside of hospitals, for example, in clinics or rehabilitation centers.

Inclusion and Exclusion Criteria

The inclusion criteria were as follows:

• Currently practicing in the pediatric field as a medical doctor, pediatrician in training, or pediatrician.

• Practicing in the Netherlands.

• Language proficiency: Participants had to have sufficient proficiency in Dutch to understand and complete the survey.

The exclusion criteria were as follows:

• Greater than 50% of survey not complete.

Questionnaire Distribution

To reach out to participants for the questionnaire, we implemented a multifaceted approach. The initial step involved distributing invitations to participate using a variety of digital platforms. These platforms included the Dutch Society for Pediatrics’ online newsletter, where we shared the invitation twice, as well as through social media channels such as LinkedIn, Facebook, and Instagram. We chose these platforms because they provide direct access to our target population. The Dutch Society for Pediatrics’ is a central professional association with a broad and representative membership of pediatricians, making it an effective and efficient way to reach a large and relevant group of potential respondents. Distribution via the newsletter ensured that the invitation was seen by active members who regularly stay informed about professional matters, while social media offered the opportunity to also engage a broader, younger audience. Furthermore, the coronavirus disease 2019 (COVID-19) pandemic and the associated restrictions made it difficult to reach participants through other means (such as face-to-face), making digital distribution not only practical but also necessary. In 2021, the Dutch Society for Pediatrics’ had a total of 2319 members, comprising 1490 practicing (regular) members, 351 junior members, 190 other (extraordinary/special) members, and 288 senior members (these numbers were requested from the secretariat of the the Dutch Society for Pediatrics’. In the invitation, the link to the questionnaire was provided, and participating and completing the questionnaire was anonymous and voluntary. No compensation or honorarium for participants was provided. Originally, the plan was to gather responses from January 2021 through June 2021. However, in response to the challenges posed by the COVID-19 pandemic, this timeframe was extended through December 2021.

Analysis

The answers of all respondents were collected via LimeSurvey. IBM SPSS Statistics version 29.0.0.0 was used to analyze the data using Fisher’s exact test. Two independent researchers (A.D. and Y.K.) familiar with reporting ADRs carried out content analysis of all answers in open-fields. They examined whether the responses given in the open-text fields could still be classified as one of the suggested categories. If this was possible, the answer was classified accordingly. Any differences in the classifications were discussed between the two researchers until a consensus was reached. All results are available on request from the corresponding author.

Informed Consent

Completion of the questionnaire was considered informed consent. This study was submitted to the local ethics committee (CMO Radboudumc; file no. 2018-5070), and it was approved.

Results

A total of 145 responses were collected, which is 8% of the possible responses (approximately all pediatricians (in training) are members of the Dutch Society for Pediatrics). Overall, 13 of these responses were excluded from the analysis as they did not meet the inclusion criteria for individuals working in pediatrics. Furthermore, an additional five questionnaires were deemed ineligible for analysis, as they were no filled out, lacking responses to any of the questions posed. Consequently, a final dataset of 127 responses (%) was subjected to analysis.

Responder Characteristics

Of the 127 respondents, 37 were general pediatricians, 63 were pediatric subspecialists, 17 were pediatricians in training, and 10 were residents not in training working in pediatrics. Of all the respondents, 60 (47%) were working at the Radboud University Medical Center. Figure 1a shows the type of hospital the respondents were working at, and Fig. 1b shows their years of experience.

Fig. 1.

a Distribution of respondents according to their workplace (total n = 127). b Distribution of number of respondents by years of work experience in pediatrics (total n = 127)

Results per Section/Barriers and Facilitators to ADR Reporting

All results are presented in Table 1. The key findings are discussed in more detail in the following sections.

Table 1.

Barriers and facilitators to adverse drug reaction (ADRs) reporting; responses to the questionnaire

Attention to ADR reporting in work environment
I know how and where to report an ADR (n = 123)	No: 5 (4%)	Yes: 118 (96%)

	Totally disagree	Disagree	Neutral	Agree	Totally agree
I have enough time to report an ADR (n = 124)	8 (6%)	48 (39%)	42 (34%)	25 (20%)	1 (1%)
I can consult a colleague/expert regarding ADRs (n = 124)	0 (0%)	6 (5%)	13 (10%)	89 (72%)	16 (13%)
I am encouraged to report ADRs in my organization (n = 124)*	8 (6%)	31 (25%)	28 (23%)	37 (30%)	20 (16%)

Attitude toward reporting ADRs in work environment
	Very unlikely	Unlikely	Somewhat likely	Likely	Very Likely
Reporting an ADR will be positively valued by colleagues (n = 120)	2 (2%)	6 (5%)	31 (26%)	55 (46%)	26 (21%)
Reporting an ADR will be positively valued by patients/family (n = 120)	1 (1%)	3 (3%)	12 (10%)	71 (59%)	33 (27%)
Reporting an ADR will be positively valued by the hospital quality committee (n = 119)	3 (3%)	16 (13%)	20 (17%)	44 (37%)	36 (30%)
Reporting an ADR will be positively improved by greater attention in their hospital (n = 119)	1 (1%)	6 (5%)	20 (17%)	72 (60%)	20 (17%)

Personal attitude toward reporting ADRs
	Very unlikely	Unlikely	Somewhat likely	Likely	Very likely
Reporting an ADR contributes to the enhancement of drug-related knowledge (n = 119)	1 (1%)	3 (3%)	24 (20%)	58 (48%)	33 (28%)
Reporting an ADR contributes to safer drug utilization (n = 119)	0 (0%)	3 (3%)	22 (18%)	70 (59%)	24 (20%)
Reporting an ADR contributes to changes in drug utilization practices (n = 119)	0 (0%)	11 (9%)	40 (34%)	49 (41%)	19 (16%)

Personal attitude toward reporting ADRs
	Totally disagree	Disagree	Neutral	Agree	Totally agree
Reporting an ADR is a straightforward task (n = 119)**	1 (1%)	21 (18%)	36 (30%)	30 (25%)	8 (7%)
Reporting an ADR is time-consuming (n = 119)***	3 (3%)	31 (26%)	35 (29%)	21 (18%)	5 (4%)
Reporting an ADR is meaningful (n = 118)	0 (0%)	0 (0%)	7 (6%)	76 (64%)	35 (30%)

Future perspectives
	Very unimportant	Unimportant	Somewhat important	Important	Very important
It is important to report an ADR in the future (n = 118)	0 (0%)	0 (0%)	25 (21%)	76 (65%)	17 (14%)
Addressing ADRs, for instance, through continuing education, is important (n = 115)	0 (0%)	1 (1%)	30 (26%)	70 (61%)	14 (12%)
Addressing reporting ADRs, for instance, through continuing education, is important (n = 114)	0 (0%)	3 (3%)	20 (18%)	78 (68%)	13 (11%)

Future perspectives
	Very unlikely	Unlikely	Somewhat likely	Likely	Very likely
I intend to report ADRs in the future (n = 118)	0 (0%)	3 (2%)	49 (42%)	55 (47%)	11 (9%)
An easy-to-use system, for example, integrated into the electronic patient record, is likely to contribute to reporting ADRs (n = 116)	0 (0%)	1 (1%)	8 (7%)	52 (45%)	55 (47%)
Easily accessible colleagues, such as a clinical pharmacologist, are likely to contribute to reporting ADRs (n = 116)	1 (1%)	6 (5%)	19 (16%)	64 (55%)	26 (23%)

The number of responses is in parentheses (n =)

^aThis is the only response with a significant different answer between responders from the Radboud University Medical Center and other hospitals (see also Sect. 3.2.1)

^bIncluding 23 respondents (19%) who acknowledged that they had never reported an ADR

^cIncluding 24 respondents (20%) who acknowledged that they had never reported an ADR

Attention to ADR Reporting in Work Environment

Overall, 118 (93%) respondents indicated that they know how to report an ADR. A total of 56 (45%) respondents disagreed or totally disagreed with the statement “I have enough time to report an ADR during a workday.” When asked if they had the option to consult experts for discussions regarding ADRs, 105 (85%) of the respondents affirmed that they could. The statement “You are encouraged to report ADRs in your hospital” revealed a disparity in responses between individuals working at the Radboud University Medical Center and those in other healthcare institutions. Specifically, 44 (74%) of the respondents from Radboud University Medical Center reported feeling encouraged to report ADRs, while 13 (19%) of respondents from other hospitals shared the same sentiment. This is the only question were there was a clinically significant difference between respondents from Radboud University Medical Center and respondents from other institutions.

Attitude Toward Reporting ADRs in Work Environment

A total of 112 (93%) respondents believed that reporting an ADR will be positively valued by their colleagues, as well as by patients and their families, with 116 (97%) acknowledging this appreciation. In addition, 100 (84%) participants also anticipated that their hospital’s quality committees would appreciate ADR reporting. Moreover, 112 (93%) of respondents claimed that their ADR reporting practices could be improved by greater attention to ADRs in their healthcare community or institution.

Personal Attitude Toward Reporting ADRs

The majority of respondents believed that reporting ADRs has the potential to contribute to the enhancement of drug-related knowledge, as well as contribute to safer drug utilization (more than 95%). In addition, 108 (91%) respondents also contended that reporting ADRs could bring about changes in drug utilization practices, including alterations in product information or the provision of more precise warning information. Of the responders, 111 (93%) answered “agree” or “totally agree” to the statement “Reporting ADRs is meaningful,”

and 38 (32%) concurred with the statement that “Reporting ADRs is a straightforward task,” while 22 (19%) expressed disagreement. Another 36 (30%) respondents neither concurred nor dissented. In this regard, the number of years of experience or the specific subspecialty within pediatric medicine did not influence the outcome; in all subgroups, the distribution of respondents who agreed, disagreed, or remained neutral with the statement was consistent. A total of 23 (19%) respondents acknowledged that they had never reported an ADR. These respondents primarily belonged to the subgroup with 6–10 years of experience, and in terms of the type of pediatrician, they consisted of pediatricians in training and general doctors working in pediatrics. Furthermore, 26 (22%) respondents considered reporting adverse effects not to be a time-consuming task.

Reasons for Not Reporting ADRs in the Past

Respondents were questioned regarding their main reason for not reporting ADRs in the past. The data revealed that 77 (61%) of the respondents identified the preexistence of knowledge about the ADR as the most pivotal factor in their nonreporting decisions. Respondents were then asked to select all other reasons for their past nonreporting of ADRs; these included the perception that the ADR was already a known issue, uncertainty about the presence of an ADR, the perception of nonseverity of the ADR, time constraints, and a perception of the lack of meaningfulness in reporting. In addition, some participants mentioned that they had not previously considered ADR reporting. Results are shown in Fig. 2. The reasons for not reporting given in the open-text fields are as follows: respondents did not consider making a report, the interaction of underlying conditions with multiple medications makes it challenging to determine the specific cause of each effect, perceives the procedure as too complex, insufficient awareness regarding the significance of reporting, and uncertainty regarding when to report and when not to report.

Fig. 2.

Reasons reported by respondents for not having reported ADR(s) in the past

The figure distinguishes between the main reason indicated by each respondent (in blue) and any additional reasons they selected (in orange)

Future Perspectives

A total of 115 (98%) of the responders answered that they were “somewhat likely” to “very likely” to report an ADR in the future.

Discussion

A voluntary reporting system of ADRs is fundamental to drug safety surveillance, but underreporting is an important characteristic of such systems [14]. In this study, we identified perspectives about ADRs and the experienced barriers to reporting ADRs in pediatricians and pediatricians in training in the Netherlands. This was studied using a questionnaire based on the questionnaire created by De Angelis et al. [18]. De Angelis et al. developed and validated a questionnaire targeted at nurses, a different profession. Their aim was slightly different from ours. Their study sought to assess an explanatory model regarding nurses’ intentions to report ADRs in hospital settings, on the basis of Ajzen’s Theory of Planned Behavior (TPB) [19]. Ajzen’s TPB explains how people come to perform certain behaviors. It suggests that behavior is driven by behavioral intentions, which are influenced by three factors: attitude toward the behavior, subjective norms, and perceived behavioral control. These factors shape a person’s intention to engage in a behavior, which in turn predicts the actual behavior [19]. So, De Angelis et al. measured the “intention” to report ADRs and the factors influencing this intention, rather than the execution of actually reporting ADRs and the reasons for not doing so. Nevertheless, we found the questionnaire highly applicable to our research question; the reasons and factors influencing the intention to report are comparable to those influencing actual reporting behavior.

The first and most important outcome of our study is that the vast majority of respondents believed that reporting adverse drug reactions is meaningful. They also recognized that reporting ADRs increases knowledge and can contribute to the enhancement of drug safety. Furthermore, more than 90% of the respondents hold the belief that reporting ADRs is positively valued by patients and colleagues. However, as documented in existing literature, underreporting of ADRs is a significant issue [11–13]. In line with this, we have previously demonstrated the extent of underreporting of ADRs in our hospital and country [10]. Of interest is that 19% of the respondents of the current study indicated that they have never reported an adverse drug reaction. These respondents are predominantly derived from the group of respondents with 6–10 years of experience, and those who were working in different hospitals. One might expect that during these years, they would have encountered adverse effects, but they may have had reasons not to report or just did not think to do so.

It is worth noting that the only question where respondents from Radboud University Medical Center differed from those at other hospitals was whether they felt encouraged to report ADRs. This significant difference (74% Radboud versus 20% in other hospitals) in the feeling of encouragement to report ADRs suggests that Radboud has a stronger culture and/or infrastructure that motivates medical doctors to report such events. This is probably due to our previous work regarding reporting ADRs [10, 17]. The outcomes suggest that, apart from the reporting culture, both groups are likely to share similar experiences, attitudes, or knowledge regarding the topics covered in this questionnaire.

The primary inquiry addressed in this survey is why respondents did not report ADRs they had encountered. The predominant reason cited by the majority of the responders is that the ADR in question concerned a well-known ADR, and the responders believed there was no necessity to report it. This is clearly a misunderstanding, because the reporting of known ADRs enhances the accuracy and comprehensiveness of drug safety data and is therefore of important value [8]. These data are subsequently used by the health authorities to accurately assess and continually evaluate the risks and benefits of medications. Occasionally, ADRs may be more common in specific population groups or under certain conditions. Ongoing reporting allows health agencies to utilize this information for more focused recommendations regarding medication usage in those specific situations [8]. This is especially relevant for pediatric patients, given the amount of off-label use [1, 2]. Information is, by definition, not available for this population.

The three other most frequently mentioned reasons by the respondents for not reporting ADRs were uncertainty regarding whether the symptoms experienced constituted an ADR, perceiving the ADR as not sufficiently severe to warrant reporting, and a lack of time to submit a report. These reasons have also been documented in literature [14–16]. Our results confirmed that in the Netherlands, the same reasons apply with respect to ADR reporting. We anticipate that in other countries with a similar reporting system, the results will likely be more or less consistent.

The rationale behind “uncertainty regarding whether certain symptoms are caused by an ADR” is noteworthy. This could imply insufficient knowledge among clinicians in assessing ADRs. However, it is sometimes challenging in clinical practice to determine whether certain symptoms constitute an ADR, especially when the patient is using multiple medications and/or has a complex medical condition. Nevertheless, we would like to encourage prescribers to report suspicions of ADRs to their national pharmacovigilance center, even when unsure. Expert evaluators are available at these centers to assess the reports, compare them with others, or evaluate the specific medication in question. Nonetheless, such reports may contain valuable information.

Furthermore, the respondents expressed that the act of reporting, in and of itself, is perceived as time-consuming and not straightforward. In summary, while the respondents do seem to recognize the significance of reporting ADRs, they still have reasons to abstain from doing so. This is a pity, as it results in the loss of valuable information that could further enhance our understanding of medications and contribute to the safer prescription of drugs in the field of pediatric medicine. Therefore, it is imperative to lower the barriers to reporting ADRs. One potential approach, as previously outlined [17], involves establishing dedicated ADR expert teams within each hospital, comprising specialists in (clinical) pharmacology, to whom other healthcare professionals can submit their ADR reports for expert assessment. This may ensure that reporting ADRs becomes significantly more convenient and time efficient. In addition, prioritizing increased awareness and emphasis on ADR reporting within healthcare organizations is essential. This could encourage healthcare professionals to report ADRs seen in clinical practice. The majority of respondents (93%) indicated that organizational support would significantly enhance ADR reporting. This is what we also observed in previous research; consistently emphasizing the importance of reporting side effects significantly increases the number of reports [17].

Moreover, there is substantial potential for enhanced education on the recognition of ADRs. Respondents commonly cite uncertainty about whether an observed occurrence constitutes an ADR as a significant reason for not reporting. This is independent of the number of years of work experience. Instruction on ADRs has the potential to improve this issue. Furthermore, what we can learn from the study by De Angelis et al. [18] is that nurses consider monitoring ADRs to be important and have a high intention to report ADRs. This could be a potential solution for clinical practice; nurses, particularly in clinical settings, have significantly more patient contact and are more likely to observe potential adverse reactions. However, this information needs to be conveyed to potential reporters, as De Angelis et al. also observed that nurses rarely report ADRs themselves [18]. Therefore, it is crucial for physicians to inquire about ADRs during patient rounds. Finally, but perhaps one of the most crucial approaches, is to leverage information and communication technology (ICT) and artificial intelligence. Most hospitals in our country use electronic patient records. It should be feasible to receive notifications when the system detects a potential adverse effect, extracting all necessary information (such as medication name and dosage, concurrent medications, and symptoms) from the patient’s record and forwarding it with a single click to an expert team within the hospital or directly to the relevant authority. This would truly streamline the process of reporting adverse effects.

The findings of this study have several implications across different levels of the healthcare system. For patients, improved reporting of ADRs contributes to safer pharmacotherapy and reduces the risk of preventable harm, particularly in the vulnerable pediatric population. For healthcare providers, insight into barriers to ADR reporting may inform the development of targeted interventions, such as training, feedback systems, or simplified reporting procedures. At the policy level, our results underline the importance of structural and systemic measures that facilitate routine ADR reporting, including integration into electronic health records, institutional support, and national pharmacovigilance strategies. Addressing these aspects collectively can help strengthen the culture of medication safety in pediatrics.

Strengths and Limitations

A notable strength of this study lies in the comprehensiveness of the questionnaire administered and the effort to validate the survey. It addresses various facets, providing a comprehensive understanding of respondents’ perceptions regarding ADRs. Furthermore, the questionnaire probes reasons for nonreporting in various ways, affording a nuanced insight into this aspect as well. To enhance the reliability of the questionnaire, we employed several measures, namely basing the questionnaire on an existing validated instrument [18] and implementing feedback of the target audience. We made efforts to reach as many respondents as possible, but regrettably, our endeavors were impeded by the COVID-19 pandemic. This situation resulted in healthcare professionals, including pediatricians and those in training, being heavily engaged in patient care, potentially reducing their availability to participate in the survey. Consequently, our response rate fell short of our initial expectations. Another contributing factor to the low response rate may have been the use of a general recruitment strategy, without individual or direct outreach to potential participants. The latter was not possible, according to current legislation. Owing to the General Data Protection Regulation (GDPR) regulations in effect since May 2018, direct emailing of the survey to pediatricians was not permissible without their prior consent, as it involves processing personal data without a lawful basis. To comply with data protection laws, alternative distribution methods respecting the privacy of the participants were employed. Nonetheless, the responses provided are coherent, allowing valid conclusions to be drawn. Furthermore, the respondents comprise a representation of all levels of experience and all types of pediatricians, which we believe provides relevant and meaningful preliminary insights. There was a representation of respondents from Radboud University Medical Center, but during the analysis of the responses, no difference was observed between these respondents and those from other hospitals. The only exception was with one question, which pertained to encouragement to report ADRs from their organization.

Conclusions

This study highlights the importance of addressing barriers to adverse drug reaction (ADR) reporting in pediatric healthcare. Despite several impediments, such as a belief that ADRs are already known, uncertainty, and time constraints, hindering their reporting efforts, healthcare professionals recognize the significance of ADR reporting.

Supplementary Information

Below is the link to the electronic supplementary material.

Declarations

Funding

Open access funding provided by Radboud University Medical Center.

Conflicts of Interest

Eugène van Puijenbroek is an Editorial Board member of Drug Safety. Eugène van Puijenbroek was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions. All other authors have no conflicts to declare.

Data Availability

All results are available upon reasonable request. All requests should be submitted in writing to the corresponding author.

Ethics Approval

This study was submitted to the local ethics committee (CMO Radboudumc; file no. 2018-5070), and it was approved.

Consent to Participate

Completion of the questionnaire was considered informed consent.

Consent for Publication

Not applicable.

Code Availability

Not applicable; survey responders are anonymous and not known by the authors

Author Contributions

A.D., J.D., E.v.P., and M.t.L. contributed to the study conception and design. A.D., Y.K., M.W., J.D., E.v.P., and M.t.L. approved the final version of the survey. A.D. and Y.K. contributed to the data analysis. A.D., Y.K., M.W., J.D., E.v.P., and M.t.L. contributed to interpretation of the data. A.D. and M.t.L. contributed to drafting and revising of the manuscript. All authors read and approved the final version.