ABSTRACT
Purpose
Our study aimed to investigate the knowledge, attitudes, and information sources about adverse drug reactions (ADRs) among healthcare professionals (HCPs) and non‐healthcare professionals (non‐HCPs) in Poland.
Methods
A self‐administered questionnaire was designed in two versions (non‐HCPs and HCPs). The questionnaire, available in electronic and paper format, was distributed between August 2023 and April 2024 using various means, including HCP and patient organisations, senior citizens centres, and community pharmacies. The anonymous survey included a series of statements regarding ADRs and single‐ and multiple‐choice questions.
Results
Answers collected from 981 non‐HCPs and 481 HCPs were analysed. Most respondents correctly identified the essential aspect of the ADR definition regardless of their medical education (non‐HCP, n = 700 (71.36%) vs. HCP, n = 346 (71.93%) p = 0.818). Still, few respondents in both groups identified additional elements of the definition, with less than one‐third of HCP respondents believing an ADR can result from improper medication use (non‐HCP, n = 338 (34.45%) vs. HCP, n = 128 (26.61%) p = 0.002). Most respondents did not identify a “common ADR” as defined in the current rules of communicating about the frequency of ADRs. Most respondents indicate a lack of specific information in summary of product characteristics or package leaflet, with only 15.46% (n = 226) stating that they believe nothing is missing from those resources.
Conclusions
Our survey results show the need to effectively educate HCPs and non‐HCPs on ADRs. Exploring ways to communicate about ADRs may help patients and HCPs better understand the risks of pharmacotherapy and their role in the pharma covigilance system.
Keywords: adverse drug reactions, communication, drug safety, healthcare professionals' knowledge, patients' knowledge, pharmacovigilance
Summary
Most respondents identified an adverse drug reaction (ADR) as an adverse symptom that disrupts daily activities.
Few respondents—regardless of medical education—are aware that ADRs can also result from improper medication use.
Both patients and healthcare professionals misinterpret ADR frequency term “common”.
Non‐healthcare professionals rely on package leaflets for ADR information, while healthcare professionals prefer online databases and summaries of product characteristics. Many respondents noted gaps in current information materials.
Targeted educational interventions and identifying effective ways to communicate information are essential to improving ADR knowledge.
Plain Language Summary
An adverse drug reaction (ADR) is a harmful and unintended response to a medicine. In 2012, the definition expanded to include reactions from misuse or medication errors.
Regulatory authorities and pharmaceutical companies share information about ADRs through official documents like the summary of product characteristics and package leaflets for each medicine.
However, it is unclear if healthcare professionals and patients fully understand what ADRs are.
We developed a questionnaire to assess what people in Poland know about ADRs and their information sources.
We found that most people correctly recognise an ADR as a symptom that interferes with daily life.
However, few respondents, including healthcare professionals, are familiar with other important aspects, like ADRs caused by incorrect medication use or how often exactly “common ADR” occurs.
Patients rely mainly on information from package leaflets, while healthcare professionals use online databases and official summaries.
Most respondents indicate a lack of specific information in summary of product characteristics or package leaflet, with the most common concern being how to avoid ADRs.
We conclude that improving education—particularly for healthcare professionals—and enhancing how ADR information is communicated could strengthen understanding of medication risks and support safer medication use.
1. Introduction
An adverse drug reaction (ADR) is defined in European Union (EU) legislation as “a response to a medicinal product which is noxious and unintended” [1]. The definition was updated in 2012 and now includes all noxious and unintended reactions, including those arising from the use of a medicine outside the marketing authorisation, such as misuse or medication errors [2]. Reporting suspected ADRs by healthcare professionals (HCPs) and patients is essential in establishing medicine's safety profile [1]. According to Polish law, physicians, dentists, pharmacists, nurses, midwives, laboratory diagnosticians, and paramedics have a legal obligation to report ADRs to the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products or the marketing authorisation holder (MAH) [3, 4, 5, 6, 7]. The Pharmaceutical Law Act states that patients can report ADRs to the HCPs listed above and to feldshers (historical medical profession) and pharmacy technicians [8]. Since the implementation of EU pharmacovigilance legislation in 2012, direct patient reporting to the Polish regulatory authority and MAH has also been implemented [2, 8]. The term ADR does not refer to dietary supplements, and no uniform system is available for their safety data collection analogous to medicinal products [9].
Regulatory authorities and MAHs communicate ADRs to patients and HCPs mainly through the summary of product characteristics (SmPC) and the package leaflet (PL). The SmPC is a regulatory document for HCPs that details a medicine's properties, approved uses, and safety information, while the PL is a patient‐friendly document included in medicine packaging that explains how to use the medicine safely and outlines precautions [10, 11]. The frequency of ADRs for a medicinal product is reported in SmPC and PL in a standardised way, with common ADRs being defined as those that affect between 1% and 10% of people [12].
It remains unclear if HCPs and patients fully understand ADR as defined in current legislation. Understanding what an ADR is and, therefore, what to report is crucial for the effective contribution of patients and HCPs to the pharmacovigilance system through ADRs reporting [13, 14]. Our study aimed to investigate the knowledge, attitudes, and information sources about ADRs among patients and HCPs in Poland.
2. Methods
2.1. Study Design
A nationwide cross‐sectional study was conducted between August 2023 and April 2024. The study was preceded by a focus group of seven independent experts representing HCPs (including specialist physicians, a pharmacist, and a dentist). Then, seven non‐medical reviewers, including a psychologist and a sociologist, evaluated the questionnaire's clarity, transparency, and visual design in paper and electronic formats. Following this stage, a pilot study was conducted with 186 respondents, resulting in the final version of the questionnaire being developed.
2.2. Sample and Setting
The study sample comprised two groups: HCPs identified by the Pharmaceutical Law Act [8] and non‐healthcare professionals (non‐HCPs). The inclusion criterion for HCPs was possessing the qualification to practise a medical profession, while for non‐HCPs, it was being at least 18 years of age. We aimed to collect at least 1000 non‐HCP questionnaires based on the Polish Public Opinion Research Center's method, which surveys about 1000 people (0.003% of Poland's adult population) [15]. The HCP group sample size was calculated using 2021 data from the Central Statistical Office of Poland on the total number of authorised medical professionals: physicians, dentists, nurses, midwives, pharmacists, and laboratory diagnosticians [16].
2.3. Ethical Considerations
The survey questionnaire outlined the study's purpose and data handling methods. Completing it indicated consent to participate and acceptance of the terms. Participants were informed that the survey was anonymous and voluntary, and that data would be used only for research. The authors received approval from the Bioethics Committee of the Medical University of Warsaw (approval No. AKBE/20/2023).
2.4. Variables
An original survey questionnaire was created in two versions: one for HCP and one for non‐HCP. All HCPs answered the same questions, regardless of profession. Both questionnaires had seven identical statements rated on a five‐point scale (where 1 indicated “definitely false”; 5 indicated “definitely true”) and three common multiple‐choice questions, formulated similarly for both groups, with the following differences:
Non‐HCPs referred to PL, while HCPs referred to the SmPC for missing information in drug information materials.
Regarding sources of information on ADRs, HCPs and non‐HCPs had different response options, but both could write their own in the “other” field.
The questionnaire included a shared question about the term “common ADR.” The non‐HCP version was a single‐choice question with six options, while HCP respondents were asked to explain the term in their own words. Additionally, the HCP questionnaire included a single‐choice question about discussing ADRs with patients, whereas the non‐HCP version contained an extra question about the frequency of reading PLs.
In addition to the above questions, the questionnaire included items regarding medicines under additional monitoring and respondents' experiences with ADR reporting. The results of this part of the study will be presented in a separate publication.
2.5. Data Collection
The study was conducted in both paper and electronic formats. The survey was distributed through several professional organisations (including the District Pharmaceutical Chamber in Warsaw and in Wroclaw, the Warsaw District Chamber of Nurses and Midwives, the Polish Society of Family Medicine, and the Polish Society of Pharmacovigilance) and various patient organisations. Additionally, it was shared via social media. Paper surveys were distributed to attendees of universities for seniors, cultural centres, community pharmacies and healthcare centres. A total of 700 paper questionnaires were distributed, of which 447 were returned (response rate of 64%). Among these, 396 were fully completed (301 non‐HCP and 95 HCP). All questionnaires were archived using Microsoft Forms. A total of 1555 questionnaires were collected. Ninety‐three questionnaires (41 non‐HCP and 52 HCP) were excluded due to incomplete data, failure to meet inclusion criteria, or outlier data (e.g., residence abroad or contradictory responses suggesting a lack of understanding of the questions). A total of 1462 questionnaires were included in the final analysis.
2.6. Data Analysis
The focus group was asked to assess the relevance of each question to the study's subject using a four‐point scale. Based on their responses, content validity index (CVI) values were calculated. According to the literature on survey validation methods [17, 18, 19], the CVI for a group of six to eight experts should be at least 0.83. For the group of seven experts, a value of 0.95 was recorded, indicating excellent agreement among experts that the questionnaire items are relevant and thus suitable for assessing the intended concept.
The statements referring to the definition of ADR were classified as correctly assessed by the respondents if they selected option 4 (somewhat true) or 5 (definitely true). Knowledge was also evaluated by the number of respondents who accurately assessed all four statements. For this analysis HCPs were categorised into three groups: 1: physicians and dentists, 2: nurses, midwives, and paramedics, 3: pharmacists and technicians. Laboratory diagnosticians were excluded due to a small sample size. When analysing HCPs' answers written in their own words (“common ADR” question), a correct answer was a frequency of ≥ 1/100 to < 1/10, while a frequency ≥ 1/100 was considered an incomplete answer.
The distribution of variables was assessed using the Shapiro–Wilk test. Owing to the absence of a normal distribution, non‐parametric tests were employed. Differences between variables measured on a quantitative scale were analysed using the U Mann–Whitney and Kruskal–Wallis ANOVA tests, with the Bonferroni correction applied and post hoc tests. Correlations between variables were calculated using Spearman's rank correlation test. Qualitative variables were compared employing the χ 2 test. A significance level of 0.05 was established. Calculations were carried out using Statistica 13.3 software.
3. Results
3.1. Study Group Characteristics
The study included participants from across Poland (all provinces). The average age of respondents was 47.52 ± 16.68 years (median 46, min. 18—max. 94). The non‐HCP group was statistically significantly older than the HCP group (n = 981, 48.38 ± 18.35 vs. n = 481, 43.75 ± 11.73, p < 0.001). A statistically significant difference was found between HCP and non‐HCP respondents in terms of sex (p = 0.002), education level (p = 0.001), and place of residence (p = 0.023). The complete characteristics of the group are presented in Table 1.
TABLE 1.
Demographic characteristics of the survey respondents (n = 1462).
| Entire group (n = 1462) | Non‐healthcare professionals (n = 981) | Healthcare professionals (n = 481) | χ 2/p values | |
|---|---|---|---|---|
| Sex | ||||
| Female | 1118 (76.47%) | 724 (73.8%) | 394 (81.91%) |
χ 2 = 12.38 p = 0.002* |
| Male | 342 (23.39%) | 255 (25.99%) | 87 (18.09%) | |
| Non‐binary | 2 (0.14%) | 2 (0.2%) | 0 | |
| Education | ||||
| Higher | 1128 (77.15%) | 684 (69.72%) | 444 (92.31%) |
χ 2 = 94.69 p < 0.001* |
| Secondary | 312 (21.34%) | 275 (28.03%) | 37 (7.69%) | |
| Vocational | 19 (1.3%) | 19 (1.94%) | — | |
| Primary | 3 (0.21%) | 3 (0.31%) | — | |
| Place of living | ||||
| Rural area | 169 (11.56%) | 111 (11.31%) | 58 (12.06%) |
χ 2 = 11.38 p = 0.023* |
| Town population ≤ 50 000 | 174 (11.9%) | 110 (11.21%) | 64 (13.30%) | |
| 50 000 < town population ≤ 150 000 | 180 (12.31%) | 110 (11.21%) | 70 (14.55%) | |
| 150 000 < city population ≤ 500 000 | 182 (12.45%) | 113 (11.52%) | 69 (14.35%) | |
| City population > 500 000 | 757 (51.78%) | 537 (54.74%) | 220 (45.74%) | |
p < 0.05.
66% (n = 959) of all respondents indicated that they had taken at least one medication (prescribed or over the counter) the day before completing the survey. 6% (n = 87) of participants reported taking more than five medications, while 56% (n = 824) declared using at least one dietary supplement.
3.2. Understanding the Definition of an Adverse Drug Reaction
Correct responses are shown in Table 2. The only statistically significant difference between the two groups was observed in answers to the statement regarding ADRs caused by improper medication use. In the non‐HCP group, the basic aspect of the definition (statement 1) was more frequently assessed correctly by younger individuals (47.53 ± 17.81 vs. 53.94 ± 18.90, p < 0.001). No significant age differences were seen in other responses from both groups.
TABLE 2.
Number of respondents who correctly assessed the statements regarding adverse drug reactions (n = 1462).
| Statement | Number of respondents (%) | χ 2/p values | ||
|---|---|---|---|---|
| Entire group (n = 1462) | Non‐healthcare professionals (n = 981) | Healthcare professionals (n = 481) | ||
| 1. An adverse drug reaction is an adverse symptom that disrupts the daily activities of the person taking the medication | 1046 (71.55%) | 700 (71.36%) | 346 (71.93%) |
χ 2 = 0.053 p = 0.818 |
| 2. An adverse drug reaction is a minor adverse symptom that does not significantly affect the daily activities of the person taking the medication | 346 (23.67%) | 236 (24.06%) | 110 (22.87%) |
χ 2 = 0.25 p = 0.616 |
| 3. An adverse drug reaction is an adverse effect of a medication that was not described in the package leaflet | 377 (25.79%) | 266 (27.12%) | 111 (23.08%) |
χ 2 = 2.75 p = 0.097 |
| 4. An adverse drug reaction is an adverse effect that occurred when the medication was used against the manufacturer's instructions (e.g., incorrect dosage, method of administration) | 466 (31.87%) | 338 (34.45%) | 128 (26.61%) |
χ 2 = 9.14 p = 0.002* |
p < 0.05.
The percentage of respondents who assessed all statements (1–4) as somewhat or definitely true was 4.89% (n = 48) in the non‐HCP group and 5.82% (n = 28) among HCPs. No statistically significant differences were found between the different professions (p = 0.365). The percentage of HCP respondents who assessed all statements as true was: nurses/midwives/paramedics 7.33% (n = 11), pharmacists/technicians 6.29% (n = 11), doctors/dentists 4.32% (n = 6).
3.3. Understanding the Definition of a Common Adverse Drug Reaction
29.66% (n = 291) of non‐HCPs correctly identified the definition of a “common ADR.” Among HCPs, 8.73% (n = 42) answered correctly, and 16.22% (n = 78) gave an incomplete definition. All the answers are presented in Tables 3 and 4.
TABLE 3.
Understanding of the term common adverse drug reaction among non‐healthcare professionals (n = 981).
| A common adverse drug reaction is an adverse symptom which… | Number of responses (%) |
|---|---|
| Happens to more than 1 out of 100 patients taking the medication but to less than 1 out of 10 a | 291 (29.66%) |
| Usually recurs when I use the medication | 156 (15.90%) |
| Happens to more than 1 out of 10 patients taking the medication, but to fewer than half | 138 (14.07%) |
| Happens to more than half of the patients taking the medication | 85 (8.66%) |
| Has happened to me/a person I know at least twice | 50 (5.10%) |
| Other | 8 (0.82%) |
| I don't know | 253 (25.79%) |
Correct answer.
TABLE 4.
Understanding of the term common adverse drug reaction among healthcare professionals (n = 481).
| Number of responses (%) | |
|---|---|
| Correct answer | 42 (8.73%) |
| Incomplete answer | 78 (16.22%) |
| Incorrect answer | 248 (51.56%) a |
| I don't know | 113 (23.49%) |
Note: Respondents were asked to explain the term in their own words.
The types of errors were as follows: underestimation of frequency 11 (4.44%), overestimation of frequency 77 (31.05%), answer not referring to frequency 66 (26.61%), other explanations 94 (37.90%).
3.4. Attitudes Regarding Adverse Drug Reactions
In both groups, the majority of respondents believed that the statement “Adverse drug reactions can always be avoided” is false. HCPs were more firmly convinced of the falseness of this statement (1.56 ± 0.91 vs. 2.00 ± 1.1, p < 0.001). In both groups, the majority of respondents agreed that the statement “Dietary supplements can cause adverse reactions” is true, with HCPs being more firmly convinced of the truth of this statement (4.41 ± 0.94 vs. 3.93 ± 1.04, p < 0.001). The statement “In most cases, it is possible to predict whether a given adverse drug reaction will occur” was assessed as false by 54% (n = 790) of all the respondents, with no statistically significant differences between the groups. The results are presented in Figures 1, 2, 3.
FIGURE 1.
Assessment of the statement Adverse drug reactions can always be avoided (n = 1462). Labels represent the number of respondents and the corresponding percentage.
FIGURE 2.
Assessment of the statement Dietary supplements can cause adverse reactions (n = 1462). Labels represent the number of respondents and the corresponding percentage.
FIGURE 3.
Assessment of the statement In most cases, it is possible to predict whether a given adverse drug reaction will occur (n = 1462). Labels represent the number of respondents and the corresponding percentage.
3.5. Sources of Information on Adverse Drug Reactions
47.5% (n = 466) of non‐HCPs always read the PL, while 34.05% (n = 334) often do. Only 1.73% (n = 17) never read it. Most non‐HCPs (82.36%, n = 808) view the PL as their primary source for ADR information. HCPs mostly turn to online databases (46.99%, n = 226) and the SmPC (33.26%, n = 160) for ADR details. Other sources are listed in Figures 4 and 5.
FIGURE 4.
Sources of information about adverse drug reactions indicated by non‐healthcare professionals (n = 981). Multiple answers were allowed. Labels represent the number of respondents and the corresponding percentage.
FIGURE 5.
Sources of information about adverse drug reactions indicated by healthcare professionals (n = 481). Multiple answers were allowed. Labels represent the number of respondents and the corresponding percentage.
Figure 6 summarises responses to the question about the information respondents find missing in drug informational materials (PL or SmPC). The most common response was “What to do to avoid adverse drug reactions” (41.04%, n = 600). Respondents also reported that they often lack information on what to do if an ADR occurs, particularly in the HCPs group (48.86%, n = 235 vs. 33.03%, n = 324, p < 0.001). Non‐HCPs more often felt nothing was missing (18.45%, n = 181 vs. 9.36%, n = 45, p < 0.001).
FIGURE 6.
Summary of responses to the question: What information related to adverse drug reactions is missing in the package leaflet or the summary of product characteristics? (n = 1462). Multiple answers were allowed. Labels represent the number of respondents and the corresponding percentage.
Table 5 summarises HCP responses to the question about discussing ADRs with patients.
TABLE 5.
Healthcare professionals' answers to the question: Do you discuss the adverse drug reactions of your patients' medications during conversations with them? (n = 481).
| Number of responses (%) | |
|---|---|
| I often talk with patients about the adverse reactions of the medications they are taking | 192 (39.92%) a |
| I rarely talk with patients about the adverse reactions of the medications they are taking | 149 (30.98%) |
| I never talk with patients about the adverse reactions of the medications they are taking | 23 (4.78%) |
| I rarely have contact with patients in my daily work | 66 (13.72%) |
| It's hard to say | 51 (10.60%) |
The professionals who discuss adverse drug reactions most often are physicians (61.74%, n = 71), pharmacists (38.41%, n = 58) and nurses (35.04%, n = 41).
4. Discussion
Most respondents, regardless of their medical education (n = 1046, 71.55%), correctly identified an essential aspect of the ADR definition, which our survey described as an adverse symptom disrupting daily activities. However, only a small percentage identified complementary elements of the definition (including instances arising from medication errors or novel ADRs not documented in the SmPC). Although such level of knowledge might be anticipated among patients, it is particularly concerning that among HCPs only 5.82% (n = 28) assessed all definition‐related statements as true. The limited knowledge of HCPs is further reflected in their interpretation of the term “common ADR.” Less than 10% provided definitions consistent with ADR frequency communication recommendations [12], while others offered incomplete or incorrect responses. These findings highlight a significant gap in comprehensive understanding of ADRs within the HCP group.
Several factors may contribute to this phenomenon. First, undergraduate pharmacovigilance (PV) training may be inadequate, with insufficient emphasis on the diverse aspects of ADR recognition. Studies exploring undergraduate education show that medical students believe that PV topics are not sufficiently addressed in curricula and therefore they possess limited knowledge in this area [20, 21]. Second, HCPs may depend primarily on clinical experience and peer‐observed practises rather than on structured postgraduate training, which may limit their awareness of regulatory definitions. In daily practise, competing priorities and time constraints may also limit opportunities for familiarisation with ADR terminology. In 2020, the Supreme Audit Office of Poland published a report on the system of ADR monitoring [22]. The audit included the results of a survey of 840 HCPs in 20 hospitals. The results indicate that HCPs have insufficient knowledge and important misconceptions of the ADR definition, which affects appropriate identification and reporting. It was noted that insufficient institutional support for PV activities remains a concern, including limited training opportunities for HCPs.
To address these gaps, targeted educational reform is required. Strengthening ADR‐related content in undergraduate curricula and continuing professional development is essential. For practising HCPs, regular training—such as mandatory e‐learning or refresher courses—may improve understanding of ADRs. These trainings should focus not only on ADR recognition and reporting but also on ADR frequency classification. It is important to place this knowledge in a broad context, providing examples aligned with diverse specialist audiences and extending to general topics such as vaccination safety.
Numerous studies have identified a lack of knowledge as a significant factor contributing to the underreporting of ADRs [13, 14]. Effective education interventions can therefore help promote reporting. Training is also essential for HCPs to communicate ADR information effectively to patients, interpret ADR frequencies accurately, and avoid inappropriate influence on treatment decisions.
The continued need for HCP guidance to patients is highlighted by the finding that important knowledge gaps exist among non‐HCP respondents. Most of them declare reading PLs always or often. The leaflets convey ADR frequency in verbal and numerical formats [11], but this does not appear to enhance respondents' knowledge of what constitutes a common ADR. Nearly one‐fourth of non‐HCPs attribute to the term “common ADR” a higher frequency than assigned by the current regulations, and just over 20% associated “common” with their own or someone else's ADR occurrences. This is consistent with other studies that show patients as well as HCPs interpret frequency expressed verbally in diverse ways, with overestimation being the most typical [23, 24]. Misconceptions around ADR frequency definitions can lead to the overestimation of risk by patients, potentially increasing anxiety and reluctance to use beneficial medications. Similarly, although the PLs urge patients to report unlisted ADRs to doctors or pharmacists [11] most survey participants do not recognise that ADRs can also be reactions not included in the PL. Patients may fail to report symptoms that they find too trivial or unrelated to the drug.
Most surveyed physicians indicated that they regularly discuss ADRs with patients, and a notable proportion of non‐HCPs identified doctors as a source of ADR information. While this is encouraging, the knowledge gaps identified among HCPs are therefore of particular concern. Patients evidently need guidance in ADR‐related matters, and insufficient HCP preparation to communicate about ADRs may lead to misunderstandings that compromise informed decision‐making.
Most respondents in both groups point to gaps in SmPCs and PLs, with only a small fraction stating that they believe no information is missing from those resources. Since HCPs mainly consult online databases for ADR information, assessing how these platforms can be optimised to address knowledge gaps is warranted. Qualitative research may help clarify the informational needs of patients and HCPs and identify effective strategies for improving ADR communication.
Comparing our findings with existing research is challenging. While many studies examine respondents' knowledge of ADR reporting systems and reporting behaviours [25, 26, 27, 28], relatively few explore how patients or HCPs define ADRs or obtain related information. Among those assessing ADR knowledge and beliefs, differences in methodologies complicate cross‐study comparisons. The single‐choice format of questions applied in some studies may limit conclusions regarding respondents' broader understanding of the definition. For example, a 2022 study of 404 non‐HCPs in Lithuania found that 36.1% define an ADR as a negative reaction to medications used at normal doses as well as a reaction resulting from misuse or non‐compliance. At the same time, 35.9% chose a similar definition that did not include the element of incorrect medication use [29]. Similarly, a recent survey of 412 HCPs in Turkey found that 69.7% chose an answer defining ADR as “any undesirable effect of a drug at normal doses and conditions,” whereas 8.5% opted for “adverse health outcomes from irrational drug use” [30].
Several studies were conducted in countries with regulatory frameworks distinct from those in Europe. For example, a 2019 study of 869 Chinese non‐HCPs found that 51.9% agreed that ADRs result from the use of substandard, fake, or overdosed drugs [31]. This conflicts with the EU's definition, as it does not refer to counterfeit medication. A study in Saudi Arabia found that 16% (n = 130) of respondents understood ADR as “an unexpected reaction after taking a normal dose.” Additionally, 37.6% believed ADR refers to “any effect of a medication”, while 13.6% thought it pertains to “any effect after taking a high dose” [32].
Overall, substantial differences in study design and regulatory contexts limit the comparability of our findings with those from other surveys.
5. Conclusion
Our survey results reveal the need for systematic education of HCPs on ADRs. Education should include aspects of ADRs caused by the misuse of a medical product and unexpected reactions not described in the SmPC. It is essential to focus not only on undergraduate education but also on postgraduate education, regularly revisiting those topics as part of continuous professional development. Non‐HCPs may also benefit significantly from educational campaigns increasing their awareness of ADRs and drug safety monitoring.
Since the level of knowledge is insufficient and respondents point to gaps in informational materials, it is worth considering how to better inform patients and HCPs about ADRs to meet their needs. It may be helpful to use qualitative research to explore further patients' and HCPs' views on ADRs and effective ways to convey ADR‐related information.
Funding
The authors have nothing to report.
Conflicts of Interest
Marcin Kruk and Anastazja Markowska are permanent employees of Pfizer.
Acknowledgements
We thank everyone involved in creating the survey questionnaire, especially the reviewers. We sincerely appreciate the support provided by all those involved in distributing the survey, particularly the members of the Polish Society of Pharmacovigilance and the Polish Society of Clinical Pharmacy. Most importantly, we extend our heartfelt thanks to all participants who agreed to take our survey.
Niedzielko M., Kiersnowska I., Kwiećkowska L., et al., “Knowledge, Attitudes and Sources of Information About Adverse Drug Reactions—A Survey Study Among Patients and Healthcare Professionals in Poland,” Pharmacoepidemiology and Drug Safety 35, no. 2 (2026): e70312, 10.1002/pds.70312.
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