Jordanians' knowledge,attitude and practice regarding adverse drug reactions reporting

ObjectivesThe purpose of the current study was to evaluate the general public knowledge, attitudes, and practice regarding Adverse Drug Reactions (ADRs) reporting and pharmacovigilance in Jordan.MethodsA cross‐sectional study was conducted between July 16, 2022, and July 30, 2022, in Jordan. During the study period, an electronic survey consisting of 4 sections was administered to a convenience sample of Jordanians (aged 18 or above) using 2 social media platforms (Facebook and WhatsApp). Logistic regression analysis was used to screen the predictors of ADRs reporting by the participants.ResultsA total of 441 participants completed the survey. The majority of the participants (67.6%) were females, 53.1% between 26 and 45 years old. Almost all participants (96.3%) were always aware of the indication of the medications they take, the time and frequency (87.8%), and the duration of medications (84.4%). Nearly one-third of the participants (37.4%) asked about their medications' ADRs. However, the drug information leaflet was the most frequently used source of ADR information (33.3%). The majority of responders believed that both healthcare providers and consumers should report ADRs (93.4% and 80.3%, respectively). Only one-quarter of respondents (27.2%) believed that consumers could directly report ADRs through the Jordan pharmacovigilance program. The majority of patients who had experienced ADRs (70.3%) were aware that ADRs should be reported, and among them, 91.9% had reported the ADRs to healthcare providers. Furthermore, few participants (8.1%) reported it to the Jordan National Pharmacovigilance Centre (JNCP). Linear regression revealed that none of the demographic characteristics (age, gender, education, job, and social status) were affecting public reporting practice of the ADRs (P > 0.05 for all).ConclusionRespondents showed fair knowledge about adverse drug reactions and their reporting. However, there is a need to initiate educational activities and intervention programs to raise awareness about the JNPC, which will have a positive impact on public health and ensure safe medication use in Jordan.     

Knowledge,attitudes & practices of healthcare professionals in hospitals towards the reporting of adverse drug reactions in Saudi Arabia: A multi-centre cross sectional study

Introduction

Adverse drug reactions (ADRs) are a major global clinical problem, causing substantial mortality and morbidity especially in hospitals. Healthcare professionals (HCPs) knowledges’, attitude and practices are crucial points to evaluate the hospital safety environment. Objective of the study was to investigate the knowledge, attitudes, and practices of HCPs regarding the ADRs reporting system.

Attitudes and knowledge of hospital pharmacists to adverse drug reaction reporting

AIMS: To investigate the attitudes of UK hospital pharmacists towards, and their understanding, of adverse drug reaction (ADR) reporting. METHODS: A postal questionnaire survey of 600 randomly selected hospital pharmacists was conducted. RESULTS: The response rate was 53.7% (n = 322). A total of 217 Yellow Cards had been submitted to the CSM/MCA by 78 (25.6%) of those responding. Half of those responding felt that ADR reporting should be compulsory and over three-quarters felt it was a professional obligation. However, almost half were unclear as to what should be reported, while the time available in clinical practice and time taken to complete forms were deemed to be major deterrents to reporting. Pharmacists were not dissuaded from reporting by the need to consult a medical colleague or by the absence of a fee. Education and training had a significant influence on pharmacists' participation in the Yellow Card Scheme. CONCLUSIONS: Pharmacists have a reasonable knowledge and are supportive of the Yellow Card spontaneous ADR reporting scheme. However, education and training will be important in maintaining and increasing ADR reports from pharmacists.     

The Weber-curve pitfall: effects of a forced introduction on reporting rates and reported adverse reaction profiles

BACKGROUND: In May 1999 Losec MUPS (MUPS) were granted a marketing authorization in the Netherlands, followed by the withdrawal of the Losec capsules (capsules) in September 1999. Both formulations contain omeprazole as active substance. This forced switch resulted in a large number of spontaneous reports of adverse drug reactions (ADRs) to the Netherlands Pharmacovigilance Centre Lareb. METHODS: We calculated and compared the reporting rate of both formulations and grouped the reported adverse reactions into system and organ classes (SOCs) in order to analyse possible differences in the type of reported ADRs. RESULTS: Lareb received 480 reports on omeprazole formulations between May 1997 and December 2000. A quarter of the reports concerned a decrease in therapeutic effect. The reporting rate on MUPS showed a sharp rise after withdrawal of the capsules, but did not differ significantly from the reporting rate on the capsules. A comparison of the type of reported ADRs showed differences in six SOCs. Elimination of the reports concerning a decreased therapeutic effect reduced the number of different SOC reporting rates. Certain gastrointestinal complaints were reported more frequently as an ADR of MUPS. CONCLUSION: The forced switch caused an increase in reports resembling an early Weber effect rather than a decrease in safety of the newer formulation. However, our analysis cannot exclude differences in pharmacokinetic, pharmacodynamic or safety characteristics.     

Under-reporting of adverse drug reactions Estimate based on a spontaneous reporting scheme and a sentinel system

Objective: Spontaneous reporting is the most common method used in pharmacovigilance and the best one to generate signals on new or rare adverse drug reactions (ADRs). Under-reporting is a major drawback of this system. The objective of this study was to quantify the extent of under-reporting in general practice and to assess the factors which influence it. Methods: Details of ADRs collected through a short intensive survey were compared with primary care spontaneous reports received by the Castilla y Leon Regional Pharmacovigilance Centre during a 12-month reference period. The survey was undertaken by a random sample of 146 general practitioners (GPs), providing care to 149 487 people. The pharmacovigilance centre received reports concerning the whole regional population (2.5 million) covered by primary health care. The under-reporting coefficient (U) was estimated as the ratio between the number of effects observed by physicians in the survey and those spontaneously reported to the pharmacovigilance centre. Results: The overall under-reporting rate was 1144 [95% confidence interval (CI): 928–1409]. Under-reporting was greater for psychiatric (2119; 945–4752) and gastrointestinal (1946; 1424–2659) disorders. Severe effects were more reported (U=605; 151–2431) than moderate (863; 473–1575) and mild (1209; 973–1503) ones. The under-reporting rate was lower for drugs recently marketed (706; 406–1230) and slightly lower for unlabelled effects (1031; 641–1657). Conclusion: The under-reporting rate of ADRs is considerable, though not homogeneous for the different cases. This should be taken into account when comparing adverse effects (AEs) for different drugs. Under-reporting seems to be positively selective, as it involves mainly the less severe and better-known effects, preserving the value of spontaneous reporting for signal detection. Received: 21 November 1997 / Accepted in revised form: 28 April 1998     

Adverse-drug reaction reporting by Pharm D students during hospital training

BackgroundHospital pharmacists can play an important role in the detection, prevention, and reporting of adverse drug reaction (ADR) since they interact with patients in hospital settings. The ADR reporting practice by Pharm D students, who represent the future hospital pharmacists, has not been adequately investigated in the literature.ObjectiveTo evaluate Pharm D students' knowledge, attitude, and practice regarding ADR reporting, and the associated barriers and motivators to ADR reporting during clinical training at different hospital sites in Jordan.MethodsThe present cross-sectional study was conducted on sixth year pharm D students during clinical training at different hospital departments in different hospital sites Jordan. In addition to socio-demographic variables, a structured self-reported questionnaire was used to assess students’ knowledge, attitude, practice, barriers, and motivators towards ADR reporting. Binary logistic regression was used to explore the variables associated with the study outcomes.ResultsA total of 497 students participated in the study. The participants showed inadequate knowledge regarding ADR reporting, with a mean knowledge score of 3.20 (±1.78). On the other hand, the study participants showed positive attitude towards ADR reporting with a total mean score of 13.6 (±1.96). However, the ADR reporting practice was low with a mean score of 5.78 (±1.88). Not knowing how to report (60.2%) and not knowing where to report (55.9%) were the most common barriers to ADR reporting, while the most reported motivators for ADR reporting were seriousness of reaction (84.1%) and involvement of new drug (51.1%). Logistic regression analysis showed that time from the start of training (OR = 0.510; 95%CI = 0.305–0.852; P = 0.010), female gender (OR = 1.759; 95%CI = 1.083–2.857; P = 0.022), and attending a course/workshop about pharmacovigilance (OR = 0.213; 95%CI = 0.137–0.332; P = 0.00) were significant predictors of knowledge about ADR reporting. Increased age (OR = 0.93; 95%CI = 0.880–0.997; P = 0.041) and low knowledge (OR = 0.564; 95%CI = 0.380–0.837; P = 0.004) were significantly associated with negative attitude toward ADR reporting. Female gender (OR = 0.481; 95%CI = 0.302–0.766; P = 0.002) and attitude level (OR = 1.837; 95%CI = 1.205–2.802; P = 0.005) were significant predictors of ADR reporting practice.ConclusionsPharm D students showed positive attitude towards ADR reporting, however, the knowledge and practice of ADR reporting were inadequate and the participants reported several barriers. Therefore, the topic of ADR reporting and pharmacovigilance, as well as, educational training programs need to be included in future pharmacy curriculum in order to improve students’ awareness and practice of ADR reporting.     

临床药师在不良反应监测中的实践与体会

目的浅析临床药师在临床实践中开展不良反应监测的工作模式及体会。方法通过对4例典型患者进行药学监护,从正确认识药品不良反应、特殊剂型药物的规范服用、重症患者的用药调整及输液管理等诸方面,阐述临床药师在不良反应监测工作中的切入点。结果临床药师判断出与突发不良反应相关的药物,并采取积极抢救措施,减少了药源性损害。结论临床药师应重点着眼于不良反应报告与监测工作,收集安全性信息,提出相应的药物警戒建议,保障公众用药安全。     

Assessment of knowledge,attitude and practice of adverse drug reaction reporting among healthcare professionals in secondary and tertiary hospitals in the capital of Pakistan

Adverse Drug Reactions (ADRs) underreporting is a great challenge to pharmacovigilance. Healthcare professionals should consider ADR reporting as their professional obligation because the effective system of ADR reporting is important to improve patient care and safety. This study was designed to assess the knowledge, attitude, practice and factors associated with ADR reporting by healthcare professionals (physicians and pharmacists) in secondary and tertiary hospitals of Islamabad. A pretested questionnaire comprising of 27 questions (knowledge 12, attitude 4, practice 9 and factors influencing ADR reporting 2) was administered to 384 physicians and pharmacists in public and private hospitals. Respondents were evaluated for their knowledge, attitude and practice related to ADR reporting. Additionally, the factors which encourage and discourage respondents to report ADRs were also determined. The data was analysed by using SPSS statistical software. Among 384 respondents, 367 provided responses to questionnaire, giving a response rate of 95.5%. The mean age was 28.3 (SD?=?6.7). Most of the respondents indicated poor ADR reporting knowledge (83.1%). The majority of respondents (78.2%) presented a positive attitude towards ADR reporting and only a few (12.3%) hospitals have good ADR reporting practice. The seriousness of ADR, unusualness of reaction, new drug involvement and confidence in the diagnosis of ADR are the factors which encourage respondents to report ADR whereas lack of knowledge regarding where and how to report ADR, lack of access to ADR reporting form, managing patient is more important than reporting ADR legal liability issues were the major factors which discourage respondents to report ADR. The study reveals poor knowledge and practice regarding ADR reporting. However, most of the respondents have shown a positive attitude towards ADR reporting. There is a serious need for educational training as well as sincere and sustained efforts should be made by Government and Hospital Authorities to ensure proper implementation of ADR reporting system in all of the hospitals.     

Association between concomitant use of several systemic NSAIDs and an excess risk of adverse drug reaction. A case/non-case study from the French Pharmacovigilance system database

Aims To examine whether the risk of some selected adverse effects increases with the number of systemic non-steroidal anti-inflammatory (NSAID) drugs.Methods The French Pharmacovigilance database was examined for an association between drug reaction reports and the exposure to one and two or more NSAIDs using a case/non-case study design. In the analysis, 54,583 spontaneous reports of adverse drug reactions were included, consisting of 2270 reports of hepatic injury, 994 reports of acute renal failure, 194 reports of gastrointestinal bleeding and 525 reports of angioedema, among others.Results Use of NSAIDs significantly increased the risk of hepatic injury, gastrointestinal bleeding, acute renal failure and angioedema. The odds ratios tended to increase with the number of NSAIDs for hepatic injury, gastrointestinal bleeding and acute renal failure but not for angioedema. In comparison with reports that did not mention any use of NSAIDs, the odds ratios associated with the use of a single NSAID and two or more NSAIDs were respectively 1.2 (95%CI: 0.9–1.5) and 2.2 (95%CI: 1.3–3.8) for hepatic injury, 7.3 (95%CI: 4.9–10.9) and 10.7 (95%CI: 2.9–40.2) for gastrointestinal bleeding, 3.2 (95%CI: 2.5–4.1) and 4.8 (95%CI: 2.6–8.8) for acute renal failure. For angioedema, the odds ratios were roughly similar when a single NSAID (OR=2.7; 95% CI: 2.2–3.4) or two or more NSAIDs (OR=2.0; 95%CI: 0.7–6.0) were used. The risk of severe ADRs (hepatic injury and acute renal failure) was six- to sevenfold higher in reports mentioning concomitant use of two NSAIDs or more than in those that did not.Conclusion This study shows that concomitant use of two or more NSAIDs was associated with an excess risk of adverse effects such as hepatic injury, acute renal failure and gastrointestinal bleeding. Although simultaneous use of several systemic NSAIDs has no pharmacological justification, this may raise a serious public health problem with the increasing use of over-the-counter non-steroidal anti-inflammatory agents.     

Factors that facilitate reporting of adverse drug reactions by pharmacists in Saudi Arabia

Objectives: Adverse drug reactions (ADRs) are a pervasive global problem, and its management is integral to patient safety and healthcare quality. Pharmacists play a pivotal role in monitoring and reporting ADRs, which has a direct impact on patient care. The aim of this study was to identify potential factors that facilitate pharmacists in community and hospital settings to report ADRs.

Methods: A cross-sectional, online survey using a validated questionnaire was administered to pharmacists working in community and hospital pharmacies in Saudi Arabia.

Results: 1,717 community and 153 hospital pharmacists participated in this study. Only 10.2% and 26.8% of community and hospital pharmacists, respectively, admitted ever reporting an ADR. The most reported factors that may facilitate ADRs reporting have included ongoing improvements in therapeutic knowledge about ADRs, attending educational programs with continuous medical education credits, the seriousness of the experienced ADRs and accessibility to patients’ medical profile. The impact of peers by seeing colleagues reporting ADRs and ADRs due to herbal or traditional medicine were the least important factors reported by pharmacists.

Conclusion: The study identified factors that can effectively address the under-reporting of ADRs by pharmacists. A multi-stakeholder, multi-pronged approach of ADR reporting is needed to develop greater awareness of this issue among pharmacists.     

药物不良反应原因及解决方法

药物的不良反应(ADR)不可避免。结合本院实际情况,分析ADR产生的原因,并提出防范或避免ADR的措施,最终促进临床用药安全。     

小儿药物不良反应综合分析

目的：了解儿科由于各种药物引起的药物不良反应（ADR）情况。方法：通过对1150例药物不良反应进行分类统计分析,按卫生部药品不良反应监察中心推荐的评分方法对因果关系进行综合评估．作出正确判断。结果：由抗生素类药物引起的ADR比例最高（60．09％）,以药物性皮疹最多（31．65％）。结论：惠儿在应用药物中,应重视各种药物引起的ADR。     

我院96例药品不良反应报告

目的分析本院不良反应报告情况,提高对药品不良反应的警惕和早期发现,最大限度保证患者用药安全。方法对本院2013年1~6月收集的96例药品不良反应报表进行分析评价。结果本院96例药品不良反应中,〉60岁的患者药品不良反应发生率最高,占37.5%;给药途径中静脉注射引起的药品不良反应64例,占66.7%;抗菌药物引起的药品不良反应最为多见,为46例,占47.9%;涉及受损系统以及临床表现中皮肤损伤最常见,为31例,占32.3%。结论掌握本院药品不良反应发生的规律和特点,针对特殊用药患者,尽量减少药品不良反应发生率,尽量减轻药品不良反应发生所造成的后果,为临床合理用药提供参考。     

我院药品不良反应报告的特点分析

目的了解该院上报全国药品不良反应（ADR）监测网络中心的报告特点,促进ADR监测工作的全面开展,提高ADR报表质量。方法对该院的149例ADR报告分别从给药途径、涉及药品种类、临床表现及报告人职业等方面进行统计分析。结果以静脉滴注给药方式引发的ADR较多（93.9%）;抗菌药物引发的ADR比例最高（42.3%）;ADR的临床表现以皮肤损害为主（50.3%）。结论抗菌药物是不良反应监测的重点,应进一步加强药品不良反应监测,确保用药安全。     

氟喹诺酮类药物不良反应分析

目的探讨氟喹诺酮类药物的合理使用。方法对我院2010年1月～2011年12月间126例氟喹诺酮类药物不良反应报告进行回顾性分析,对不良反应的发生情况进行分类汇总,并对所采取救治措施进行总结。结果氟喹诺酮类药物不良反应中左氧氟沙星和氟罗沙星所占比例最高,给药方式中静脉滴注给药所占比例最高,各种不良反应中以过敏反应最为多见。结论应密切关注氟喹诺酮类药物使用过程中可能出现的不良反应,采取必要的防治措施,确保用药的安全性和有效性。     

药物不良反应报告分析

目的 分析药物不良反应(ADR)的规律和特点,为临床合理使用药品、减少不良反应发生提供依据.方法 对淮安市第四人民医院2009年1月至2010年6月收集的36例ADR报告进行统计分析.结果 36例ADR报告中男性不良反应发生率明显偏高[69.4%(25/36)],且主要分布于41～60岁人群[58.3%(21/36)];静脉给药途径引起ADR的比例较高[61.1%(22/36)];ADR涉及的器官及系统主要为皮肤及其附件[38.9%(14/36)]和全身性反应[38.9%(21/36)].结论 医院应加强ADR监测及相关知识的宣传,以避免或减少ADR的发生.     

盘锦市2007年药品不良反应报告分析

目的汇总分析盘锦市2007年药品不良反应报告,发挥药品不良反应监测工作的指导作用,保障公众用药安全。方法采用病例回顾性研究方法,对盘锦市2007年1-12月收集到的977例药品不良反应病例报告进行综合分析。结果药品不良反应报告有62.33来源于医疗机构。新的严重的药品不良反应报告占27.94。不良反应累积的主要系统及器官为皮肤及其附件。抗微生物药物占47.08。静脉给药占给药途经的51.79。结论应加强药品不良反应监测工作,提高报告质量和分析评价能力,为保障公众用药健康服务。     

Healthcare professionals' awareness,attitudes and practices towards pharmacovigilance and spontaneous adverse drug reaction reporting in Jazan Province,Saudi Arabia: A survey study

BackgroundGlobally, adverse drug reactions (ADRs) are the foremost cause of morbidity as well as mortality. This necessitates a system of surveillance that can effectively and efficiently monitor the effect of drugs on the general population. The role of pharmacovigilance (PV) is paramount in ensuring drug safety through spontaneous ADR reporting.MethodsData collection in the current research was carried out by an anonymous, online 36-item self-report questionnaire amongst a sample of 351 working healthcare professionals (HCPs) across different regions of Jazan Province, Kingdom of Saudi Arabia (KSA). The current sample comprised 54.4% males and 45.6% females, having an age range of 26–57 years, and was conducted between August 21 and October 21, 2022. Participants were recruited using the convenience snowball sampling technique.ResultsThe participants' awareness of PV as well as spontaneous ADR reporting, had a significant association with having <40 years of age (χ² = 27.40; p < 0.001), being pharmacists (χ² = 212.20; p < 0.001), with more than five years of experience (χ² = 40.80; p < 0.001), having Masters (or) Doctorate/Fellowship (χ² = 171.94; p < 0.001), and having their practice located in an urban area (χ² = 50.30; p < 0.001). It was also observed that most participants with excellent awareness of PV and spontaneous ADR reporting also demonstrated excellent attitudes (χ² = 147.70; p < 0.001). Similarly, it was also seen that almost all (97%) of the study sample with excellent attitudes towards PV and spontaneous ADR reporting also demonstrated excellent practices (χ² = 250.73; p < 0.001).ConclusionOur results demonstrate a need for designing and conducting educational programs, providing training and conducting workshops for all the HCPs to improve their awareness towards PV and spontaneous ADR reporting while also highlighting the need and importance of having positive attitudes towards spontaneous ADR reporting. Cooperation between different HCPs should be encouraged to improve their practices towards spontaneous ADR reporting.