Knowledge, Perceptions, and Practices of Healthcare Professionals on Pharmacovigilance and Adverse Drug Reaction Reporting at Cheikh Zaid International University Hospital in Rabat

Knowledge, Perceptions, and Practices of Healthcare Professionals on Pharmacovigilance and Adverse Drug Reaction Reporting at Cheikh Zaid International University Hospital in Rabat | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Knowledge, Perceptions, and Practices of Healthcare Professionals on Pharmacovigilance and Adverse Drug Reaction Reporting at Cheikh Zaid International University Hospital in Rabat Hamza El Cadi, Mamat Jasseh, Samuel Inshutiyimana, Kabeerat Arike Balogun, and 5 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6593885/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background Adverse drug reactions (ADRs) are a major public health concern and a leading cause of morbidity and mortality worldwide. Pharmacovigilance, developed in response to drug safety incidents such as the thalidomide crisis, plays a key role in monitoring and preventing these reactions. The Centre Anti Poison et de Pharmacovigilance du Maroc (CAPM) coordinates national efforts in Morocco. However, underreporting of ADRs remains a persistent challenge. This study assessed the knowledge, perceptions, and practices of healthcare professionals regarding pharmacovigilance at Cheikh Zaid International University Hospital, identified reporting barriers, and proposed actionable solutions. Methods A cross-sectional survey was conducted from September 2023 to March 2024, involving 400 healthcare professionals, including physicians, pharmacists, nurses, and dentists. A structured questionnaire collected data on participants’ understanding of pharmacovigilance, their reporting behaviors, and perceived obstacles. Data were collected via electronic and paper formats and analyzed using Jamovi software with descriptive statistics and Chi-square tests. Ethical approval was obtained, and all participants provided informed consent. Results Of the respondents, 55% were female and 61.5% were aged 18–28. Physicians formed the largest group (52.8%), followed by pharmacists (26%) and nurses (18%). While 80% were familiar with the concept of pharmacovigilance and 83% acknowledged its importance in clinical practice, only 24% could correctly define an ADR. Key barriers to reporting included lack of knowledge about procedures (70%), unfamiliarity with the process (67%), and time constraints (60%). Structural issues such as the absence of an electronic reporting platform (98%) and the unavailability of forms (70%) also hindered reporting. Reporting was most commonly triggered by dosage errors (69%), therapeutic failure (65%), and drug quality concerns (64%). Conclusion Despite good awareness, reporting practices remain low due to systemic and educational gaps. The study recommends establishing a dedicated pharmacovigilance unit, implementing digital reporting tools, organizing continuous professional training, and educating patients to encourage participation. These steps are essential to promote a robust culture of medication safety. Pharmacovigilance knowledge adverse reactions healthcare professionals Introduction According to the World Health Organization (WHO), an adverse drug reaction (ADR) is defined as “a response to a drug which is harmful and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease or the modification of body functions”( 1 ). Pharmacovigilance is defined as “the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.” It is reported that ADRs are an important cause for morbidity and mortality and can impose a considerable financial burden ( 1 ) Historically, the concept of pharmacovigilance began in 1848 with the death of Hannah Greener following chloroform anesthesia, which sparked the first inquiries into drug safety ( 2 ). As concerns about ADRs grew, especially with incidents like the sulfanilamide tragedy in 1937 and the thalidomide disaster in the 1960s, various national and international bodies began developing drug safety regulations ( 3 , 4 ). These events led to the establishment of key institutions such as the U.S. FDA's drug safety standards, the European Medicines Agency (EMA), and the WHO Programme for International Drug Monitoring. Spontaneous ADR reporting systems, like the UK’s Yellow Card scheme, emerged to support systematic pharmacovigilance efforts ( 5 – 8 ). Over time, pharmacovigilance evolved into a global, structured discipline aimed at ensuring the safe and effective use of medicines, supported by legislation, collaborative surveillance programs, and advanced databases such as Vigibase, Vigifolw, and EudraVigilance ( 5 – 7 ). Regardless of the constant improvement, drug safety is still a complex issue due to the wide range of factors that can influence drug-related risks. These factors may be related to the patient, the drug itself, or how it is used. Traditionally, pharmacovigilance has focused on identifying side effects resulting from the correct use of medications, that is, the right drug given to the right patient, at the right dose, through the right route, and at the right time. However, since the late 1990s, studies have shown that over half of drug-related adverse events are linked to inappropriate use, including medication errors, misuse, or abuse, and thus could have been prevented ( 9 ). In Morocco, pharmacovigilance was introduced in the 1980s through academic initiatives and the creation of the Center of Antipoison ( Le Centre Anti Poison et de Pharmacovigilance du Maroc (CAPM) in French) in 1988, leading to the establishment of the National Center for Pharmacovigilance ( 9 ). The National Pharmacovigilance System is built on three key structures: the National Pharmacovigilance Center (Centre National de Pharmacovigilance: CNPV), the Technical Committee for Pharmacovigilance, and the National Commission for Pharmacovigilance. Its main goal is to ensure patient safety by detecting adverse drug reactions early, whether they arise from standard use, medication errors, misuse, or product defects. The system also aims to determine the frequency and severity of ADRs, train healthcare professionals and the public, advise health authorities, and strengthen patient trust in marketed medicines ( 9 ). The CNPV, integrated within Morocco's Center for AntiPoison and Pharmacovigilance Center (CAPM), plays a central role by coordinating national and regional pharmacovigilance efforts. It manages ADR databases, oversees the Technical Committee for Pharmacovigilance, and collaborates with the Uppsala Monitoring Centre (UMC), the international pharmacovigilance hub. In addition, the CNPV issues alerts, conducts drug safety investigations, informs both authorities and the public, and contributes to teaching and training healthcare professionals ( 9 ). This study was conducted at Cheikh Zaid International University Hospital in Rabat between September 2023 and March 2024. It aimed to assess the knowledge, perceptions, and practices of healthcare professionals concerning pharmacovigilance and ADR reporting. Additionally, the study sought to identify barriers to reporting and propose a structured hospital-based pharmacovigilance model to enhance medication safety and patient care. Materials and Methods Study Design This cross-sectional study was conducted at the Cheikh Zaid International University Hospital in Rabat, Morocco, a leading medical institution known for its commitment to high-quality healthcare, education, and research. The hospital offers a broad range of medical specialties and is equipped with advanced technologies that support both clinical excellence and innovation. It plays a crucial role in training future healthcare professionals and contributes to national and regional healthcare development through active participation in research projects and scholarly publications (10). It was carried out from September 2023 to March 2024. The primary aim of the study was to assess the knowledge, perceptions, and practices of healthcare professionals concerning pharmacovigilance and the reporting of ADR. The study also sought to identify barriers to ADR reporting and propose recommendations for improving pharmacovigilance practices within the hospital. Population The study focused on healthcare professionals working at the Cheikh Zaid International University Hospital. Inclusion Criteria All healthcare actors, including physicians, pharmacists, nurses, midwives, and dentists. Exclusion Criteria Individuals not affiliated with the healthcare sector and healthcare professionals not practicing at the Cheikh Zaid International University Hospital. Sample Size A total of 400 healthcare professionals were surveyed, representing a diverse range of roles within the hospital. This sample size was selected to provide a robust representation of healthcare professionals across different specialties and levels of experience. Survey Development A tailored survey was developed specifically for healthcare professionals. The questionnaire was in French and was based on existing research and review. The survey included questions on their: Sociodemographic information Knowledge of pharmacovigilance principles and the definition of adverse drug reactions. Perceptions of the importance of ADR reporting and the role of pharmacovigilance in patient safety. Current practices regarding ADR reporting, including frequency and barriers to reporting. Analysis of ADR Reporting Factors Influencing Reporting and Non-reporting Frequency of Reporting The survey was designed to be simple and concise, with both multiple-choice and open-ended questions. It was made available in both electronic and paper formats to maximize participation. Data Collection Data was collected for 7 months, from September 2023 to March 2024. Healthcare professionals were approached during their shifts or clinical activities. Both electronic and paper versions of the survey were distributed, and responses were compiled into an Excel 2024 database for analysis. Data Analysis The collected data was analyzed using Jamovi software. Descriptive statistics were used to summarize the data, with qualitative variables presented as percentages. Quantitative data were described using mean ± standard deviation for normally distributed variables. Chi-square tests were applied to assess relationships between categorical variables. Ethical Considerations This study was conducted in accordance with the ethical principles outlined in the Declaration of Helsinki. Ethical approval was granted by the Ethical Committee of Cheikh Zaid International University Hospital on 20 November 2023, under the reference number CEFCZ-TFE-6AP_23. Informed consent was obtained from all participating healthcare professionals, who were informed that their participation was voluntary and that their responses would be kept confidential. The study strictly adhered to ethical guidelines to ensure the protection of participant privacy and the integrity of the collected data. Results Sociodemographic and Professional Profile of Respondents As illustrated in Table 1 below, 400 healthcare professionals were surveyed, and a slight majority were female (55%). The respondents were predominantly young, with over 60% aged between 18 and 28 years. Physicians made up the largest professional group (52.8%), followed by pharmacists (26%) and nurses (18%). The professionals were drawn from diverse hospital departments, including Nephrology & Gastroenterology, intensive care (13.2%), surgery (11.1%), and oncology (9.8%). Table 1 Demographic and Professional Characteristics of Respondents (N = 400) Variable Category Percentage (%) Gender Female 55.0 Male 45.0 Age Group 18–28 years 61.5 29–39 years 27.1 40–50 years 10.6 51 + years 0.8 Profession Physicians 52.8 Pharmacists 26.0 Nurses 18.0 Dentists 2.3 Midwives 1.0 Hospital Services Nephrology, Gastroenterology, Day Hospital 47.8 Intensive Care Unit (ICU) 13.2 Surgery 11.1 Oncology 9.8 Cardiology 7.2 Gynecology 3.9 ophthalmology 7.0 Awareness and Perceptions of Pharmacovigilance As shown in Table 2 , the majority of respondents (80%) reported knowing the definition of pharmacovigilance, and 83% acknowledged its importance in clinical practice. Awareness of Morocco's national pharmacovigilance body was also high (80%). Also, 77% supported establishing a pharmacovigilance unit within the hospital, and 96% had been previously exposed to information regarding ADRs. However, only 24% could accurately differentiate between an ADR and an adverse event, highlighting a knowledge gap that may impact effective reporting. Table 2 Knowledge and Perceptions of Pharmacovigilance Indicator Yes (%) No (%) Aware of the definition of pharmacovigilance 80.0 20.0 Perceive pharmacovigilance as important 83.0 17.0 Aware of the Moroccan Center for Anti-Poison Control and Pharmacovigilance Center (CAPM) 80.0 20.0 Understand the need for a pharmacovigilance unit in the hospital 77.0 23.0 Previously exposed to information on adverse drug reactions (ADRs) 96.0 4.0 Able to distinguish between an ADR and an adverse event 24.0 76.0 Barriers to Reporting Adverse Drug Reactions A substantial proportion of respondents identified systemic and individual barriers to ADR reporting. The majority of them were a lack of information on how to report (70%), unawareness of the reporting process (67%), and lack of time (60%). Psychological and professional concerns also played a role, with 25.5% not viewing reporting as their responsibility and 22% expressing fear of being held accountable. The most striking structural obstacle was the near-total absence of electronic platforms (98%), alongside the unavailability of reporting forms (70%) as referred to in Table 3 . Table 3 Barriers to Reporting Adverse Drug Reactions Barrier n (%) Lack of information on reporting procedures 280 (70.0) Unfamiliar with the reporting process 268 (67.0) Lack of time 240 (60.0) Believe it is not their responsibility 102 (25.5) Fear of blame or legal consequences 88 (22.0) Concern for professional reputation 152 (38.0) Doubts about causality between the drug and the event 140 (35.0) Never report ADRs 124 (31.0) No access to the electronic reporting platform 392 (98.0) Reporting forms are not available 280 (70.0) Factors Influencing Reporting Behavior As referred to in Table 4 below, multiple factors influenced the likelihood of ADR reporting, which included medication-related issues such as dosage errors (69%), therapeutic failure (65%), and drug quality concerns (64%). Patient-related factors like death (45%), chronic conditions (40%), and pregnancy (32%) were also considered relevant triggers for reporting. These findings underscore the complexity of ADR evaluation and the multidimensional nature of pharmacovigilance in practice. Table 4 Factors Influencing ADR Reporting Influencing Factor n (%) Prescription, dosage, or administration errors 276 (69.0) Therapeutic failure 260 (65.0) Suspicion of drug quality 256 (64.0) Off-label drug use 252 (63.0) Misuse 248 (62.0) Overdose 192 (48.0) Complications during patient management 184 (46.0) Patient death 180 (45.0) Emergence of a new or unknown ADR 176 (44.0) Chronic comorbidities 160 (40.0) Need for dental intervention 140 (35.0) Advanced patient age 140 (35.0) Pediatric age group 136 (34.0) Pregnancy 128 (32.0) Recommendations for Improving Pharmacovigilance Practice In terms of proposed improvements, as shown in Table 5 , The 42% of respondents advocated for better risk management systems, while others emphasized the need for patient awareness campaigns (25.8%) and ongoing professional education (18.5%). A smaller proportion (13.8%) recommended making ADR reporting systematic within clinical routines, as shown in Table 5 . Table 5 Proposed Improvements to Pharmacovigilance Practice Suggested Improvement n (%) Strengthen drug safety and risk management 168 (42.0) Raise patient awareness 103 (25.8) Continuous professional training 74 (18.5) Promote systematic ADR reporting 55 (13.8) Discussion There are a limited number of studies that have evaluated the pharmacovigilance knowledge and reporting behavior of various Healthcare professionals in Morocco. In this study, conducted among a representative sample of 400 healthcare professionals, of which the majority were Physicians (52.8%), followed by pharmacists(26%), nurses (18%), and dentists (2.3%), slightly dominated by female participants (55%). It was found that 80% of participants were familiar with the definition of pharmacovigilance, while 20% were not. This indicates a widespread understanding of the concept among the majority of professionals surveyed. In contrast, another study conducted in Turkey by Ozlem Selik Aydin et al., involving 2,030 physicians, revealed less favorable results. Only 53.9% of the participants correctly defined pharmacovigilance, indicating a limited understanding of this field among the practitioners surveyed. Furthermore, although 80.9% of physicians who had encountered adverse drug reactions completed the reporting form, only 8.8% had received training on how to fill it out ( 11 ). These results suggest that while awareness of pharmacovigilance is generally high among most healthcare professionals, there are still significant gaps in the understanding of its specific objectives and procedures. Our study revealed that 80% of healthcare professionals were aware of the existence of the Poison Control and Pharmacovigilance Center, indicating a relatively high level of awareness. In contrast, a study by Khan et al. in Turkey showed that 69.1% of healthcare professionals were unaware of their national pharmacovigilance center, highlighting a significantly lower level of awareness that could impact drug safety monitoring ( 12 ). Similarly, a study in Namibia found that only 63.4% of professionals knew about the pharmacovigilance reporting center, suggesting lower awareness than in Morocco and emphasizing the need for continuous training and electronic reporting tools ( 13 ). In Saudi Arabia, however, a cross-sectional survey by Mona Y. Alseiskh et al. found that 86.7% of community pharmacists were aware of their National Pharmacovigilance and Drug Safety Center, reflecting strong awareness and possibly the result of national efforts to enhance drug safety surveillance ( 14 ). Regarding awareness of the potential for ADRs, 96% of healthcare professionals were aware of its potential in our study, indicating strong awareness of this key patient safety issue, though 4% were unaware, showing room for improvement in awareness. A similar study in Saudi Arabia reported 94% awareness of ADRs, showing shared concerns about patient safety ( 15 ). Regarding the reporting of adverse drug reactions, our study at Cheikh Zaid Hospital found that only 33% of healthcare professionals were willing to report adverse drug reactions (ADRs), with the majority (67%) opting for alternative approaches. A study in Vietnam by Thu Thuy Le et al. showed that while 59.3% of healthcare professionals had reported ADRs, a significant portion of the workforce, particularly pharmacists and doctors, remained less inclined to do so ( 2 ). These findings underscore the gap between understanding the importance of pharmacovigilance and the actual practice, highlighting the need for improved education, systems, and incentives to encourage consistent ADR reporting, as outlined in the Ministerial Circular (N°2 DR/10) ( 16 ). Several studies have highlighted factors influencing the underreporting of ADRs among healthcare professionals. In Nepal, a study by Krisha Danekhu et al. revealed that the primary reasons for not reporting ADRs were a lack of incentives from authorities (47%) and insufficient knowledge about reporting procedures (34.9%) ( 17 ). Similarly, at Cheikh Zaid Hospital, our study showed that most professionals felt it was not their responsibility to report ADRs, with concerns about accountability and inadequate infrastructure further hindering reporting. In Sudan, a lack of awareness about national and international reporting systems (26.5%) and knowledge about how to report (27%) were key barriers ( 18 ). Studies in Finland also pointed to uncertainties about the association of ADRs with medications, lack of clinical knowledge, and insufficient time as significant factors ( 19 , 20 ). Additionally, our findings and those of studies in Portugal and Serbia demonstrated a widespread reluctance to report, with a high percentage of professionals never having reported ADRs despite recognizing their importance ( 21 ). These findings emphasize the need for better education, infrastructure, and systems to encourage ADR reporting and improve pharmacovigilance practices. A survey conducted by Mrs. Anbouri in Rabat (2022) among 98 healthcare professionals found that 77.55% preferred using a paper form to report adverse drug reactions (ADR), while 16.33% favored a database. However, our study revealed that 50.50% preferred electronic reporting via a platform, and 18.50% still chose paper forms ( 22 ). These findings highlight the need for flexible reporting solutions to ensure accurate ADR notifications and enhance patient safety. Barriers to ADR reporting were identified in both a study conducted in Wuhan, China, and at Cheikh Zayed University Hospital ( 19 ). In Wuhan, significant challenges included ignorance of reporting requirements (71.4%), lack of access to reporting forms (67.9%), and unawareness of a national ADR reporting system (52.2%) ( 19 ). Our study shows that for Cheikh Zayed, the main barriers were the absence of an electronic platform for reporting (98%), the unavailability of reporting forms (70%), and a lack of knowledge on whom to report to (70%). These challenges underline the importance of improving ADR education and training for healthcare professionals. Training in pharmacovigilance is widely regarded as essential. A study in Saudi Arabia showed that 90.2% of pharmacists supported intensified training programs on ADR reporting ( 15 ). Similarly, 86% of healthcare professionals at Cheikh Zayed University Hospital emphasized the necessity of pharmacovigilance training. Moreover, 42% of professionals at the hospital felt that improving medication safety through risk management was crucial, while others highlighted the need for patient awareness and continuous education. These findings underscore the importance of investing in specialized training to improve medication safety practices and ADR reporting systems. Conclusion and Recommendations Pharmacovigilance plays a vital role in ensuring the safety of medications and improving the overall quality of healthcare delivery. Historical drug safety incidents such as those involving thalidomide and Mediator have demonstrated the critical importance of monitoring and promptly reporting ADRs. These cases underline the need for a proactive and well-organized pharmacovigilance system to prevent harm and safeguard public health. At the Cheikh Zaid International University Hospital, our study assessed the knowledge, perceptions, and practices of healthcare professionals and patients regarding pharmacovigilance and ADR reporting. The findings revealed that although there is general awareness of the importance of ADR reporting among healthcare providers, actual practices remain suboptimal. Several barriers hinder the reporting of ADRs, including a lack of time, inadequate knowledge of existing reporting procedures, and concerns over patient confidentiality. These limitations were also evident during data collection, where time constraints and hesitancy from some participants impacted the overall response rate. Despite these challenges, the study uncovered significant opportunities to improve pharmacovigilance practices. A more structured, systematic approach supported by institutional commitment and technology can help address these issues effectively. To overcome these obstacles, the study recommends the establishment of a dedicated pharmacovigilance unit within the hospital to centralize and streamline ADR reporting processes. Additionally, the implementation of a user-friendly online reporting platform can facilitate easier access and encourage the timely submission of ADR reports. Continuous professional training sessions should be organized to keep healthcare staff informed about the latest protocols and best practices in pharmacovigilance. At the same time, patient education should not be overlooked; targeted awareness campaigns can help patients understand their role in reporting adverse effects, thereby enhancing the comprehensiveness of drug safety monitoring. Incorporating advanced tools such as data analytics and artificial intelligence can further strengthen pharmacovigilance systems by enabling early detection and more accurate assessment of drug-related risks. Strengthening collaboration among healthcare professionals, regulatory bodies, and patients is essential to building a more resilient and responsive pharmacovigilance culture. Recommendations for Future Research Future research should adopt a longitudinal or mixed-methods design to better capture evolving practices and attitudes toward pharmacovigilance over time. Exploring the long-term effects of interventions such as digital reporting systems or educational initiatives would provide valuable insights into their effectiveness. Additionally, expanding the scope of studies to include comparisons between public and private healthcare institutions, as well as across different regions or countries, would enrich the understanding of systemic challenges and contextual variations. Declarations Ethics approval and consent to participate This study was conducted in accordance with the ethical principles outlined in the Declaration of Helsinki. Ethical approval was granted by the Ethical Committee of Cheikh Zaid International University Hospital on 20 November 2023, under the reference number CEFCZ-TFE-6AP_23. Informed consent was obtained from all participating healthcare professionals, who were informed that their participation was voluntary and that their responses would be kept confidential. The study strictly adhered to ethical guidelines to ensure the protection of participant privacy and the integrity of the collected data. Clinical trial number Clinical trial number: not applicable. Consent for publication Not applicable, as no identifiable personal data is included in the manuscript. Availability of data and materials The datasets generated and analyzed during the study are available upon reasonable request. Competing interests The authors declare that they have no competing interests. Funding This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. Authors’ Contributions Hamza El Cadi and Bouchra Meddah contributed to the study design and data collection. All other authors were involved in data analysis and manuscript preparation. All authors read and approved the final version of the manuscript. Acknowledgements We would like to thank the staff and healthcare professionals of Cheikh Zaid International University Hospital for their valuable participation and support during the study. References Danekhu K, Shrestha S, Aryal S, Shankar PR. Health-care Professionals’ Knowledge and Perception of Adverse Drug Reaction Reporting and Pharmacovigilance in a Tertiary Care Teaching Hospital of Nepal. Hosp Pharm. juin 2021;56(3):178‑86. Routledge P. 150 years of pharmacovigilance. Lancet Lond Engl. 18 avr 1998;351(9110):1200‑1. García-Abeijon P, Costa C, Taracido M, Herdeiro MT, Torre C, Figueiras A. Factors Associated with Underreporting of Adverse Drug Reactions by Health Care Professionals: A Systematic Review Update. 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Hospital pharmacists’ knowledge and opinions regarding adverse drug reaction reporting in Northern China. Pharmacoepidemiol Drug Saf. mars 2010;19(3):217‑22. Sandberg A, Salminen V, Heinonen S, Sivén M. Under-Reporting of Adverse Drug Reactions in Finland and Healthcare Professionals’ Perspectives on How to Improve Reporting. Healthcare. 31 mai 2022;10(6):1015. Perdigão M, Afonso A, de Oliveira-Martins S, Lopes MJ, Advinha AM. Pharmacovigilance teaching and learning: a mixed cross-sectional analysis of the Portuguese public higher education system. BMC Med Educ. 3 janv 2024;24(1):13. Additional Declarations No competing interests reported. Supplementary Files SupplementaryFileEnglishVersionoftheQuestionnaire.pdf Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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V","correspondingAuthor":false,"prefix":"","firstName":"Samira","middleName":"","lastName":"Serragui","suffix":""},{"id":465293465,"identity":"8b2b5961-966c-4cfe-b40c-9d2f29b8d75c","order_by":6,"name":"Amina Barakat","email":"","orcid":"","institution":"University Mohammed V","correspondingAuthor":false,"prefix":"","firstName":"Amina","middleName":"","lastName":"Barakat","suffix":""},{"id":465293466,"identity":"ad433f76-217e-4286-a2f8-7d2f12c03a30","order_by":7,"name":"Jouad El Harti","email":"","orcid":"","institution":"University Mohammed V","correspondingAuthor":false,"prefix":"","firstName":"Jouad","middleName":"El","lastName":"Harti","suffix":""},{"id":465293467,"identity":"3dced40f-c083-491e-9f01-27c65404411b","order_by":8,"name":"Bouchra Meddah","email":"","orcid":"","institution":"University Mohammed V","correspondingAuthor":false,"prefix":"","firstName":"Bouchra","middleName":"","lastName":"Meddah","suffix":""}],"badges":[],"createdAt":"2025-05-05 11:08:28","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-6593885/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-6593885/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":104790800,"identity":"69544612-c25a-4324-a49a-0a7f77dc7a42","added_by":"auto","created_at":"2026-03-17 08:35:10","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":873429,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6593885/v1/801a9a5b-c033-42e3-9ce8-17464351fc4e.pdf"},{"id":83846784,"identity":"f4c9e775-efee-433c-9d42-e4c3d3d5d0fc","added_by":"auto","created_at":"2025-06-03 15:20:50","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"supplement","size":124573,"visible":true,"origin":"","legend":"","description":"","filename":"SupplementaryFileEnglishVersionoftheQuestionnaire.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6593885/v1/d3df599093f586ff881d6232.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Knowledge, Perceptions, and Practices of Healthcare Professionals on Pharmacovigilance and Adverse Drug Reaction Reporting at Cheikh Zaid International University Hospital in Rabat","fulltext":[{"header":"Introduction","content":"\u003cp\u003eAccording to the World Health Organization (WHO), an adverse drug reaction (ADR) is defined as \u0026ldquo;a response to a drug which is harmful and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease or the modification of body functions\u0026rdquo;(\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e). Pharmacovigilance is defined as \u0026ldquo;the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.\u0026rdquo; It is reported that ADRs are an important cause for morbidity and mortality and can impose a considerable financial burden (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e)\u003c/p\u003e \u003cp\u003eHistorically, the concept of pharmacovigilance began in 1848 with the death of Hannah Greener following chloroform anesthesia, which sparked the first inquiries into drug safety (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e). As concerns about ADRs grew, especially with incidents like the sulfanilamide tragedy in 1937 and the thalidomide disaster in the 1960s, various national and international bodies began developing drug safety regulations (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e). These events led to the establishment of key institutions such as the U.S. FDA's drug safety standards, the European Medicines Agency (EMA), and the WHO Programme for International Drug Monitoring. Spontaneous ADR reporting systems, like the UK\u0026rsquo;s Yellow Card scheme, emerged to support systematic pharmacovigilance efforts (\u003cspan additionalcitationids=\"CR6 CR7\" citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e). Over time, pharmacovigilance evolved into a global, structured discipline aimed at ensuring the safe and effective use of medicines, supported by legislation, collaborative surveillance programs, and advanced databases such as Vigibase, Vigifolw, and EudraVigilance (\u003cspan additionalcitationids=\"CR6\" citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eRegardless of the constant improvement, drug safety is still a complex issue due to the wide range of factors that can influence drug-related risks. These factors may be related to the patient, the drug itself, or how it is used. Traditionally, pharmacovigilance has focused on identifying side effects resulting from the correct use of medications, that is, the right drug given to the right patient, at the right dose, through the right route, and at the right time. However, since the late 1990s, studies have shown that over half of drug-related adverse events are linked to inappropriate use, including medication errors, misuse, or abuse, and thus could have been prevented (\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eIn Morocco, pharmacovigilance was introduced in the 1980s through academic initiatives and the creation of the Center of Antipoison ( Le Centre Anti Poison et de Pharmacovigilance du Maroc (CAPM) in French) in 1988, leading to the establishment of the National Center for Pharmacovigilance (\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e). The National Pharmacovigilance System is built on three key structures: the National Pharmacovigilance Center (Centre National de Pharmacovigilance: CNPV), the Technical Committee for Pharmacovigilance, and the National Commission for Pharmacovigilance. Its main goal is to ensure patient safety by detecting adverse drug reactions early, whether they arise from standard use, medication errors, misuse, or product defects. The system also aims to determine the frequency and severity of ADRs, train healthcare professionals and the public, advise health authorities, and strengthen patient trust in marketed medicines (\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThe CNPV, integrated within Morocco's Center for AntiPoison and Pharmacovigilance Center (CAPM), plays a central role by coordinating national and regional pharmacovigilance efforts. It manages ADR databases, oversees the Technical Committee for Pharmacovigilance, and collaborates with the Uppsala Monitoring Centre (UMC), the international pharmacovigilance hub. In addition, the CNPV issues alerts, conducts drug safety investigations, informs both authorities and the public, and contributes to teaching and training healthcare professionals (\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThis study was conducted at Cheikh Zaid International University Hospital in Rabat between September 2023 and March 2024. It aimed to assess the knowledge, perceptions, and practices of healthcare professionals concerning pharmacovigilance and ADR reporting. Additionally, the study sought to identify barriers to reporting and propose a structured hospital-based pharmacovigilance model to enhance medication safety and patient care.\u003c/p\u003e"},{"header":"Materials and Methods","content":"\u003ch4\u003e\u003cstrong\u003eStudy Design\u003c/strong\u003e\u003c/h4\u003e\n\u003cp\u003eThis cross-sectional study was conducted at the Cheikh Zaid International University Hospital in Rabat, Morocco, a leading medical institution known for its commitment to high-quality healthcare, education, and research. The hospital offers a broad range of medical specialties and is equipped with advanced technologies that support both clinical excellence and innovation. It plays a crucial role in training future healthcare professionals and contributes to national and regional healthcare development through active participation in research projects and scholarly publications (10). It was carried out from September 2023 to March 2024. The primary aim of the study was to assess the knowledge, perceptions, and practices of healthcare professionals concerning pharmacovigilance and the reporting of ADR. The study also sought to identify barriers to ADR reporting and propose recommendations for improving pharmacovigilance practices within the hospital.\u003c/p\u003e\n\u003ch4\u003e\u003cstrong\u003ePopulation\u003c/strong\u003e\u003c/h4\u003e\n\u003cp\u003eThe study focused on healthcare professionals working at the Cheikh Zaid International University Hospital.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eInclusion Criteria\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll healthcare actors, including physicians, pharmacists, nurses, midwives, and dentists.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eExclusion Criteria\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eIndividuals not affiliated with the healthcare sector and healthcare professionals not practicing at the Cheikh Zaid International University Hospital.\u003c/p\u003e\n\u003ch4\u003e\u003cstrong\u003eSample Size\u003c/strong\u003e\u003c/h4\u003e\n\u003cp\u003eA total of 400 healthcare professionals were surveyed, representing a diverse range of roles within the hospital. This sample size was selected to provide a robust representation of healthcare professionals across different specialties and levels of experience.\u003c/p\u003e\n\u003ch4\u003e\u003cstrong\u003eSurvey Development\u003c/strong\u003e\u003c/h4\u003e\n\u003cp\u003eA tailored survey was developed specifically for healthcare professionals. \u0026nbsp; The questionnaire was in French and was based on existing research and review. The survey included questions on their:\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003eSociodemographic information\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eKnowledge of pharmacovigilance principles and the definition of adverse drug reactions.\u003c/li\u003e\n \u003cli\u003ePerceptions of the importance of ADR reporting and the role of pharmacovigilance in patient safety.\u003c/li\u003e\n \u003cli\u003eCurrent practices regarding ADR reporting, including frequency and barriers to reporting.\u003c/li\u003e\n \u003cli\u003eAnalysis of ADR Reporting\u003c/li\u003e\n \u003cli\u003eFactors Influencing Reporting and Non-reporting\u003c/li\u003e\n \u003cli\u003eFrequency of Reporting\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003eThe survey was designed to be simple and concise, with both multiple-choice and open-ended questions. It was made available in both electronic and paper formats to maximize participation.\u003c/p\u003e\n\u003ch4\u003e\u003cstrong\u003eData Collection\u003c/strong\u003e\u003c/h4\u003e\n\u003cp\u003eData was collected for 7 months, from September 2023 to March 2024. Healthcare professionals were approached during their shifts or clinical activities. Both electronic and paper versions of the survey were distributed, and responses were compiled into an Excel 2024 database for analysis.\u003c/p\u003e\n\u003ch4\u003e\u003cstrong\u003eData Analysis\u003c/strong\u003e\u003c/h4\u003e\n\u003cp\u003eThe collected data was analyzed using Jamovi software. Descriptive statistics were used to summarize the data, with qualitative variables presented as percentages. Quantitative data were described using mean ± standard deviation for normally distributed variables. Chi-square tests were applied to assess relationships between categorical variables.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthical Considerations\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study was conducted in accordance with the ethical principles outlined in the Declaration of Helsinki. Ethical approval was granted by the Ethical Committee of Cheikh Zaid International University Hospital on 20 November 2023, under the reference number CEFCZ-TFE-6AP_23.\u003c/p\u003e\n\u003cp\u003eInformed consent was obtained from all participating healthcare professionals, who were informed that their participation was voluntary and that their responses would be kept confidential. The study strictly adhered to ethical guidelines to ensure the protection of participant privacy and the integrity of the collected data.\u003c/p\u003e"},{"header":"Results","content":"\u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003eSociodemographic and Professional Profile of Respondents\u003c/h2\u003e \u003cp\u003eAs illustrated in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e below, 400 healthcare professionals were surveyed, and a slight majority were female (55%). The respondents were predominantly young, with over 60% aged between 18 and 28 years. Physicians made up the largest professional group (52.8%), followed by pharmacists (26%) and nurses (18%). The professionals were drawn from diverse hospital departments, including Nephrology \u0026amp; Gastroenterology, intensive care (13.2%), surgery (11.1%), and oncology (9.8%).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eDemographic and Professional Characteristics of Respondents (N\u0026thinsp;=\u0026thinsp;400)\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"3\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eVariable\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eCategory\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003ePercentage (%)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eGender\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eFemale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e55.0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e45.0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eAge Group\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e18\u0026ndash;28 years\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e61.5\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e29\u0026ndash;39 years\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e27.1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e40\u0026ndash;50 years\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e10.6\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e51\u0026thinsp;+\u0026thinsp;years\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.8\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eProfession\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePhysicians\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e52.8\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePharmacists\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e26.0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNurses\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e18.0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eDentists\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e2.3\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMidwives\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e1.0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eHospital Services\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNephrology, Gastroenterology, Day Hospital\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e47.8\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eIntensive Care Unit (ICU)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e13.2\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eSurgery\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e11.1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eOncology\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e9.8\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eCardiology\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e7.2\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eGynecology\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e3.9\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eophthalmology\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e7.0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003eAwareness and Perceptions of Pharmacovigilance\u003c/h2\u003e \u003cp\u003eAs shown in Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e, the majority of respondents (80%) reported knowing the definition of pharmacovigilance, and 83% acknowledged its importance in clinical practice. Awareness of Morocco's national pharmacovigilance body was also high (80%). Also, 77% supported establishing a pharmacovigilance unit within the hospital, and 96% had been previously exposed to information regarding ADRs. However, only 24% could accurately differentiate between an ADR and an adverse event, highlighting a knowledge gap that may impact effective reporting.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eKnowledge and Perceptions of Pharmacovigilance\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"3\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIndicator\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eYes (%)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eNo (%)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAware of the definition of pharmacovigilance\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e80.0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e20.0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePerceive pharmacovigilance as important\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e83.0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e17.0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAware of the Moroccan Center for Anti-Poison Control and Pharmacovigilance Center (CAPM)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e80.0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e20.0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eUnderstand the need for a pharmacovigilance unit in the hospital\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e77.0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e23.0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePreviously exposed to information on adverse drug reactions (ADRs)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e96.0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e4.0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAble to distinguish between an ADR and an adverse event\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e24.0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e76.0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec15\" class=\"Section2\"\u003e \u003ch2\u003eBarriers to Reporting Adverse Drug Reactions\u003c/h2\u003e \u003cp\u003eA substantial proportion of respondents identified systemic and individual barriers to ADR reporting. The majority of them were a lack of information on how to report (70%), unawareness of the reporting process (67%), and lack of time (60%). Psychological and professional concerns also played a role, with 25.5% not viewing reporting as their responsibility and 22% expressing fear of being held accountable. The most striking structural obstacle was the near-total absence of electronic platforms (98%), alongside the unavailability of reporting forms (70%) as referred to in Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eBarriers to Reporting Adverse Drug Reactions\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"2\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBarrier\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003en (%)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eLack of information on reporting procedures\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e280 (70.0)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eUnfamiliar with the reporting process\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e268 (67.0)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eLack of time\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e240 (60.0)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBelieve it is not their responsibility\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e102 (25.5)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFear of blame or legal consequences\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e88 (22.0)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eConcern for professional reputation\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e152 (38.0)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDoubts about causality between the drug and the event\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e140 (35.0)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNever report ADRs\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e124 (31.0)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNo access to the electronic reporting platform\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e392 (98.0)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eReporting forms are not available\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e280 (70.0)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec16\" class=\"Section2\"\u003e \u003ch2\u003eFactors Influencing Reporting Behavior\u003c/h2\u003e \u003cp\u003eAs referred to in Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e below, multiple factors influenced the likelihood of ADR reporting, which included medication-related issues such as dosage errors (69%), therapeutic failure (65%), and drug quality concerns (64%). Patient-related factors like death (45%), chronic conditions (40%), and pregnancy (32%) were also considered relevant triggers for reporting. These findings underscore the complexity of ADR evaluation and the multidimensional nature of pharmacovigilance in practice.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab4\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eFactors Influencing ADR Reporting\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"2\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eInfluencing Factor\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003en (%)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePrescription, dosage, or administration errors\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e276 (69.0)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTherapeutic failure\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e260 (65.0)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSuspicion of drug quality\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e256 (64.0)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eOff-label drug use\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e252 (63.0)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMisuse\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e248 (62.0)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eOverdose\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e192 (48.0)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eComplications during patient management\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e184 (46.0)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePatient death\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e180 (45.0)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEmergence of a new or unknown ADR\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e176 (44.0)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eChronic comorbidities\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e160 (40.0)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNeed for dental intervention\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e140 (35.0)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAdvanced patient age\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e140 (35.0)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePediatric age group\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e136 (34.0)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePregnancy\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e128 (32.0)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec17\" class=\"Section2\"\u003e \u003ch2\u003eRecommendations for Improving Pharmacovigilance Practice\u003c/h2\u003e \u003cp\u003eIn terms of proposed improvements, as shown in Table\u0026nbsp;\u003cspan refid=\"Tab5\" class=\"InternalRef\"\u003e5\u003c/span\u003e, The 42% of respondents advocated for better risk management systems, while others emphasized the need for patient awareness campaigns (25.8%) and ongoing professional education (18.5%). A smaller proportion (13.8%) recommended making ADR reporting systematic within clinical routines, as shown in Table\u0026nbsp;\u003cspan refid=\"Tab5\" class=\"InternalRef\"\u003e5\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab5\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 5\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eProposed Improvements to Pharmacovigilance Practice\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"2\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSuggested Improvement\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003en (%)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eStrengthen drug safety and risk management\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e168 (42.0)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eRaise patient awareness\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e103 (25.8)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eContinuous professional training\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e74 (18.5)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePromote systematic ADR reporting\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e55 (13.8)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eThere are a limited number of studies that have evaluated the pharmacovigilance knowledge and reporting behavior of various Healthcare professionals in Morocco. In this study, conducted among a representative sample of 400 healthcare professionals, of which the majority were Physicians (52.8%), followed by pharmacists(26%), nurses (18%), and dentists (2.3%), slightly dominated by female participants (55%). It was found that 80% of participants were familiar with the definition of pharmacovigilance, while 20% were not. This indicates a widespread understanding of the concept among the majority of professionals surveyed. In contrast, another study conducted in Turkey by Ozlem Selik Aydin et al., involving 2,030 physicians, revealed less favorable results. Only 53.9% of the participants correctly defined pharmacovigilance, indicating a limited understanding of this field among the practitioners surveyed. Furthermore, although 80.9% of physicians who had encountered adverse drug reactions completed the reporting form, only 8.8% had received training on how to fill it out (\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e). These results suggest that while awareness of pharmacovigilance is generally high among most healthcare professionals, there are still significant gaps in the understanding of its specific objectives and procedures.\u003c/p\u003e \u003cp\u003eOur study revealed that 80% of healthcare professionals were aware of the existence of the Poison Control and Pharmacovigilance Center, indicating a relatively high level of awareness. In contrast, a study by Khan et al. in Turkey showed that 69.1% of healthcare professionals were unaware of their national pharmacovigilance center, highlighting a significantly lower level of awareness that could impact drug safety monitoring (\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e). Similarly, a study in Namibia found that only 63.4% of professionals knew about the pharmacovigilance reporting center, suggesting lower awareness than in Morocco and emphasizing the need for continuous training and electronic reporting tools (\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e). In Saudi Arabia, however, a cross-sectional survey by Mona Y. Alseiskh et al. found that 86.7% of community pharmacists were aware of their National Pharmacovigilance and Drug Safety Center, reflecting strong awareness and possibly the result of national efforts to enhance drug safety surveillance (\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eRegarding awareness of the potential for ADRs, 96% of healthcare professionals were aware of its potential in our study, indicating strong awareness of this key patient safety issue, though 4% were unaware, showing room for improvement in awareness. A similar study in Saudi Arabia reported 94% awareness of ADRs, showing shared concerns about patient safety (\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e). Regarding the reporting of adverse drug reactions, our study at Cheikh Zaid Hospital found that only 33% of healthcare professionals were willing to report adverse drug reactions (ADRs), with the majority (67%) opting for alternative approaches. A study in Vietnam by Thu Thuy Le et al. showed that while 59.3% of healthcare professionals had reported ADRs, a significant portion of the workforce, particularly pharmacists and doctors, remained less inclined to do so (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e). These findings underscore the gap between understanding the importance of pharmacovigilance and the actual practice, highlighting the need for improved education, systems, and incentives to encourage consistent ADR reporting, as outlined in the Ministerial Circular (N°2 DR/10) (\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eSeveral studies have highlighted factors influencing the underreporting of ADRs among healthcare professionals. In Nepal, a study by Krisha Danekhu et al. revealed that the primary reasons for not reporting ADRs were a lack of incentives from authorities (47%) and insufficient knowledge about reporting procedures (34.9%) (\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e). Similarly, at Cheikh Zaid Hospital, our study showed that most professionals felt it was not their responsibility to report ADRs, with concerns about accountability and inadequate infrastructure further hindering reporting. In Sudan, a lack of awareness about national and international reporting systems (26.5%) and knowledge about how to report (27%) were key barriers (\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e). Studies in Finland also pointed to uncertainties about the association of ADRs with medications, lack of clinical knowledge, and insufficient time as significant factors (\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e, \u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e). Additionally, our findings and those of studies in Portugal and Serbia demonstrated a widespread reluctance to report, with a high percentage of professionals never having reported ADRs despite recognizing their importance (\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e). These findings emphasize the need for better education, infrastructure, and systems to encourage ADR reporting and improve pharmacovigilance practices.\u003c/p\u003e \u003cp\u003eA survey conducted by Mrs. Anbouri in Rabat (2022) among 98 healthcare professionals found that 77.55% preferred using a paper form to report adverse drug reactions (ADR), while 16.33% favored a database. However, our study revealed that 50.50% preferred electronic reporting via a platform, and 18.50% still chose paper forms (\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e). These findings highlight the need for flexible reporting solutions to ensure accurate ADR notifications and enhance patient safety.\u003c/p\u003e \u003cp\u003eBarriers to ADR reporting were identified in both a study conducted in Wuhan, China, and at Cheikh Zayed University Hospital (\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e). In Wuhan, significant challenges included ignorance of reporting requirements (71.4%), lack of access to reporting forms (67.9%), and unawareness of a national ADR reporting system (52.2%) (\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e). Our study shows that for Cheikh Zayed, the main barriers were the absence of an electronic platform for reporting (98%), the unavailability of reporting forms (70%), and a lack of knowledge on whom to report to (70%). These challenges underline the importance of improving ADR education and training for healthcare professionals.\u003c/p\u003e \u003cp\u003eTraining in pharmacovigilance is widely regarded as essential. A study in Saudi Arabia showed that 90.2% of pharmacists supported intensified training programs on ADR reporting (\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e). Similarly, 86% of healthcare professionals at Cheikh Zayed University Hospital emphasized the necessity of pharmacovigilance training. Moreover, 42% of professionals at the hospital felt that improving medication safety through risk management was crucial, while others highlighted the need for patient awareness and continuous education. These findings underscore the importance of investing in specialized training to improve medication safety practices and ADR reporting systems.\u003c/p\u003e "},{"header":"Conclusion and Recommendations","content":"\u003cp\u003ePharmacovigilance plays a vital role in ensuring the safety of medications and improving the overall quality of healthcare delivery. Historical drug safety incidents such as those involving thalidomide and Mediator have demonstrated the critical importance of monitoring and promptly reporting ADRs. These cases underline the need for a proactive and well-organized pharmacovigilance system to prevent harm and safeguard public health. At the Cheikh Zaid International University Hospital, our study assessed the knowledge, perceptions, and practices of healthcare professionals and patients regarding pharmacovigilance and ADR reporting. The findings revealed that although there is general awareness of the importance of ADR reporting among healthcare providers, actual practices remain suboptimal.\u003c/p\u003e\u003cp\u003eSeveral barriers hinder the reporting of ADRs, including a lack of time, inadequate knowledge of existing reporting procedures, and concerns over patient confidentiality. These limitations were also evident during data collection, where time constraints and hesitancy from some participants impacted the overall response rate. Despite these challenges, the study uncovered significant opportunities to improve pharmacovigilance practices. A more structured, systematic approach supported by institutional commitment and technology can help address these issues effectively.\u003c/p\u003e\u003cp\u003eTo overcome these obstacles, the study recommends the establishment of a dedicated pharmacovigilance unit within the hospital to centralize and streamline ADR reporting processes. Additionally, the implementation of a user-friendly online reporting platform can facilitate easier access and encourage the timely submission of ADR reports. Continuous professional training sessions should be organized to keep healthcare staff informed about the latest protocols and best practices in pharmacovigilance. At the same time, patient education should not be overlooked; targeted awareness campaigns can help patients understand their role in reporting adverse effects, thereby enhancing the comprehensiveness of drug safety monitoring. Incorporating advanced tools such as data analytics and artificial intelligence can further strengthen pharmacovigilance systems by enabling early detection and more accurate assessment of drug-related risks. Strengthening collaboration among healthcare professionals, regulatory bodies, and patients is essential to building a more resilient and responsive pharmacovigilance culture.\u003c/p\u003e\u003ch2\u003eRecommendations for Future Research\u003c/h2\u003e\u003cp\u003eFuture research should adopt a longitudinal or mixed-methods design to better capture evolving practices and attitudes toward pharmacovigilance over time. Exploring the long-term effects of interventions such as digital reporting systems or educational initiatives would provide valuable insights into their effectiveness. Additionally, expanding the scope of studies to include comparisons between public and private healthcare institutions, as well as across different regions or countries, would enrich the understanding of systemic challenges and contextual variations.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u003cbr\u003e\u003c/strong\u003eThis study was conducted in accordance with the ethical principles outlined in the Declaration of Helsinki. Ethical approval was granted by the Ethical Committee of Cheikh Zaid International University Hospital on 20 November 2023, under the reference number CEFCZ-TFE-6AP_23.\u003c/p\u003e\n\u003cp\u003eInformed consent was obtained from all participating healthcare professionals, who were informed that their participation was voluntary and that their responses would be kept confidential. The study strictly adhered to ethical guidelines to ensure the protection of participant privacy and the integrity of the collected data.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eClinical trial number\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eClinical trial number: not applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003cbr\u003e\u003c/strong\u003eNot applicable, as no identifiable personal data is included in the manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u003cbr\u003e\u003c/strong\u003eThe datasets generated and analyzed during the study are available upon reasonable request.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests\u003cbr\u003e\u003c/strong\u003eThe authors declare that they have no competing interests.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003cbr\u003e\u003c/strong\u003eThis research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors’ Contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eHamza El Cadi and Bouchra Meddah contributed to the study design and data collection. All other authors were involved in data analysis and manuscript preparation. All authors read and approved the final version of the manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003cbr\u003e\u003c/strong\u003eWe would like to thank the staff and healthcare professionals of Cheikh Zaid International University Hospital for their valuable participation and support during the study.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eDanekhu K, Shrestha S, Aryal S, Shankar PR. Health-care Professionals\u0026rsquo; Knowledge and Perception of Adverse Drug Reaction Reporting and Pharmacovigilance in a Tertiary Care Teaching Hospital of Nepal. Hosp Pharm. juin 2021;56(3):178‑86. \u003c/li\u003e\n\u003cli\u003eRoutledge P. 150 years of pharmacovigilance. Lancet Lond Engl. 18 avr 1998;351(9110):1200‑1. \u003c/li\u003e\n\u003cli\u003eGarc\u0026iacute;a-Abeijon P, Costa C, Taracido M, Herdeiro MT, Torre C, Figueiras A. Factors Associated with Underreporting of Adverse Drug Reactions by Health Care Professionals: A Systematic Review Update. Drug Saf. 2023;46(7):625‑36.\u003c/li\u003e\n\u003cli\u003eWard SP. Thalidomide and Congenital Abnormalities. Br Med J. 8 sept 1962;2(5305):646‑7.\u003c/li\u003e\n\u003cli\u003eThalidomide‐induced teratogenesis: History and mechanisms - PMC [Internet]. [cit\u0026eacute; 2 mai 2025]. Disponible sur: https://pmc.ncbi.nlm.nih.gov/articles/PMC4737249/\u003c/li\u003e\n\u003cli\u003eRegulation and Prequalification [Internet]. [cit\u0026eacute; 2 mai 2025]. Disponible sur: https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance\u003c/li\u003e\n\u003cli\u003eESoP/ISoP History - ISOP [Internet]. [cit\u0026eacute; 2 mai 2025]. Disponible sur: https://isoponline.org/about-isop/esop-isop-history/\u003c/li\u003e\n\u003cli\u003eEMA\u0026rsquo;s history | European Medicines Agency (EMA) [Internet]. [cit\u0026eacute; 2 mai 2025]. Disponible sur: https://www.ema.europa.eu/en/about-us/history-ema\u003c/li\u003e\n\u003cli\u003eEMA\u0026rsquo;s history | European Medicines Agency (EMA) [Internet]. 2015 [cit\u0026eacute; 2 mai 2025]. Disponible sur: https://www.ema.europa.eu/en/about-us/history-ema\u003c/li\u003e\n\u003cli\u003eCherkaoui RL. CENTRE NATIONAL DE PHARMACOVIGILANCE.\u003c/li\u003e\n\u003cli\u003eInstitution: H\u0026ocirc;pital Universitaire International Cheikh Zaid [Internet]. [cit\u0026eacute; 2 mai 2025]. Disponible sur: https://africaresearchconnects.com/institution/\u003c/li\u003e\n\u003cli\u003eAydin OC, Aydin S, Guney HZ. Defining the awareness and attitude of the clinicians through pharmacovigilance in Turkey. World J Clin Cases. 16 juill 2023;11(20):4865‑73.\u003c/li\u003e\n\u003cli\u003eKhan Z, Karatas Y, Martins MAP, Jamshed S, Rahman H. Knowledge, attitude, practice and barriers towards pharmacovigilance and adverse drug reactions reporting among healthcare professionals in Turkey: a systematic review. Curr Med Res Opin. janv 2022;38(1):145‑54.\u003c/li\u003e\n\u003cli\u003eAdenuga BA, Kibuule D, Rennie TW. Optimizing spontaneous adverse drug reaction reporting in public healthcare setting in Namibia. Basic Clin Pharmacol Toxicol. mars 2020;126(3):247‑53.\u003c/li\u003e\n\u003cli\u003eAlsheikh MY, Alasmari MM. A National Survey of Community Pharmacists\u0026rsquo; Viewpoints About Pharmacovigilance and Adverse Drug Reaction Reporting in Saudi Arabia. Front Pharmacol. 2022;13:819551.\u003c/li\u003e\n\u003cli\u003eA National Survey of Community Pharmacists\u0026rsquo; Viewpoints About Pharmacovigilance and Adverse Drug Reaction Reporting in Saudi Arabia - PubMed [Internet]. [cit\u0026eacute; 2 mai 2025]. Disponible sur: https://pubmed.ncbi.nlm.nih.gov/35721182/\u003c/li\u003e\n\u003cli\u003eGarc\u0026iacute;a-Abeijon P, Costa C, Taracido M, Herdeiro MT, Torre C, Figueiras A. Factors Associated with Underreporting of Adverse Drug Reactions by Health Care Professionals: A Systematic Review Update. Drug Saf. 2023;46(7):625‑36.\u003c/li\u003e\n\u003cli\u003eHealth-care Professionals\u0026rsquo; Knowledge and Perception of Adverse Drug Reaction Reporting and Pharmacovigilance in a Tertiary Care Teaching Hospital of Nepal - PubMed [Internet]. [cit\u0026eacute; 2 mai 2025]. Disponible sur: https://pubmed.ncbi.nlm.nih.gov/34024926/\u003c/li\u003e\n\u003cli\u003eElnour AA, Ahmed AD, Yousif MAE, Shehab A. Awareness and reporting of adverse drug reactions among health care professionals in Sudan. Jt Comm J Qual Patient Saf. juin 2009;35(6):324‑9.\u003c/li\u003e\n\u003cli\u003eSu C, Ji H, Su Y. Hospital pharmacists\u0026rsquo; knowledge and opinions regarding adverse drug reaction reporting in Northern China. Pharmacoepidemiol Drug Saf. mars 2010;19(3):217‑22.\u003c/li\u003e\n\u003cli\u003eSandberg A, Salminen V, Heinonen S, Siv\u0026eacute;n M. Under-Reporting of Adverse Drug Reactions in Finland and Healthcare Professionals\u0026rsquo; Perspectives on How to Improve Reporting. Healthcare. 31 mai 2022;10(6):1015.\u003c/li\u003e\n\u003cli\u003ePerdig\u0026atilde;o M, Afonso A, de Oliveira-Martins S, Lopes MJ, Advinha AM. Pharmacovigilance teaching and learning: a mixed cross-sectional analysis of the Portuguese public higher education system. BMC Med Educ. 3 janv 2024;24(1):13.\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Pharmacovigilance, knowledge, adverse reactions, healthcare professionals","lastPublishedDoi":"10.21203/rs.3.rs-6593885/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6593885/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eAdverse drug reactions (ADRs) are a major public health concern and a leading cause of morbidity and mortality worldwide. Pharmacovigilance, developed in response to drug safety incidents such as the thalidomide crisis, plays a key role in monitoring and preventing these reactions. The Centre Anti Poison et de Pharmacovigilance du Maroc (CAPM) coordinates national efforts in Morocco. However, underreporting of ADRs remains a persistent challenge. This study assessed the knowledge, perceptions, and practices of healthcare professionals regarding pharmacovigilance at Cheikh Zaid International University Hospital, identified reporting barriers, and proposed actionable solutions.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eA cross-sectional survey was conducted from September 2023 to March 2024, involving 400 healthcare professionals, including physicians, pharmacists, nurses, and dentists. A structured questionnaire collected data on participants\u0026rsquo; understanding of pharmacovigilance, their reporting behaviors, and perceived obstacles. Data were collected via electronic and paper formats and analyzed using Jamovi software with descriptive statistics and Chi-square tests. Ethical approval was obtained, and all participants provided informed consent.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eOf the respondents, 55% were female and 61.5% were aged 18\u0026ndash;28. Physicians formed the largest group (52.8%), followed by pharmacists (26%) and nurses (18%). While 80% were familiar with the concept of pharmacovigilance and 83% acknowledged its importance in clinical practice, only 24% could correctly define an ADR. Key barriers to reporting included lack of knowledge about procedures (70%), unfamiliarity with the process (67%), and time constraints (60%). Structural issues such as the absence of an electronic reporting platform (98%) and the unavailability of forms (70%) also hindered reporting. Reporting was most commonly triggered by dosage errors (69%), therapeutic failure (65%), and drug quality concerns (64%).\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e \u003cp\u003eDespite good awareness, reporting practices remain low due to systemic and educational gaps. The study recommends establishing a dedicated pharmacovigilance unit, implementing digital reporting tools, organizing continuous professional training, and educating patients to encourage participation. These steps are essential to promote a robust culture of medication safety.\u003c/p\u003e","manuscriptTitle":"Knowledge, Perceptions, and Practices of Healthcare Professionals on Pharmacovigilance and Adverse Drug Reaction Reporting at Cheikh Zaid International University Hospital in Rabat","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-06-03 15:20:46","doi":"10.21203/rs.3.rs-6593885/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"960a8bfd-f43a-4c23-8b6b-d575ff776833","owner":[],"postedDate":"June 3rd, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2026-03-17T08:24:31+00:00","versionOfRecord":[],"versionCreatedAt":"2025-06-03 15:20:46","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-6593885","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6593885","identity":"rs-6593885","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}