Confidence and accuracy in identification of adverse drug reactions reported by outpatients

Background Patient reporting of adverse drug reactions (ADRs) could supplement the existing reporting system and contribute to early detection of ADRs. The confidence in ADR identification and their attribution of ADRs were limited to outpatients. Objective To determine the type and frequency of ADRs reported by outpatients, to evaluate confidence and accuracy in ADR identification as well as contributing factors. Setting University hospital in northeastern Thailand Method Cross-sectional study using questionnaires distributed to 500 outpatients who claimed to have experienced an ADR. Confidence in identifying ADRs was measured by visual analogue score (VAS), while accuracy of reported ADRs was determined using Naranjo algorithm and WHO criteria. Main outcome measure Number and type of ADRs, confidence rating and accuracy category. Results In total, 390 outpatients completed the questionnaire (response rate?=?78.0%). Rash (19.0%), nausea/vomiting (7.4%), and dizziness (5.8%) were the top three reported ADRs. Sixty-one percent of respondents rated their level of confidence in identifying ADRs as high (VAS 9.2?±?0.95), which was associated with having underlying diseases (OR 1.93), low number of reported symptoms (OR 0.38) and severe ADRs (OR 1.33). Causality assessment was classified as true ADRs in 90.0% and 88.9% of cases, using Naranjo algorithm and WHO criteria, respectively. Respondents with low number of reported symptoms (OR 0.27) and high level of confidence had greater accuracy in ADR identification (OR 1.11). Conclusion The outpatients reported a high proportion of potential ADRs with high confidence and accuracy. Patient reporting of ADRs has potential to support the pharmacovigilance system.     

A comprehensive intervention for adverse drug reactions identification and reporting in a Pediatric Emergency Department

Background Physicians identify from 45.7 to 96.2 % of Adverse Drug Reactions (ADRs) in their patients, with under-reporting ranging from 6 to 100 %. In order to improve ADR reporting, several interventions have been evaluated in different studies, but not with regard to ADR identification. In addition, it is not known whether some patient characteristics might influence on ADR identification and reporting by physicians. Objectives (a) To assess the effectiveness of a comprehensive intervention directed to Emergency Department physicians and coordinated by a pharmacist in a tertiary care pediatric hospital on ADR identification and reporting. (b) To assess if some of the children’s characteristics might influence on ADR identification and reporting. Setting The Emergency Department of the Hospital Infantil de México “Federico Gómez”, which is a national pediatric institute of health in México. Methods A Quasi-experimental, pre-post test trial was designed. During the intervention, the pharmacist gave talks on Pharmacovigilance and on the program for electronic capture of data, took part in patient visits, left reminders, improved accessibility to ADR report format and performed feedback activities. To classify and quantify correctly identified ADRs and ADRs reported to the Institutional Pharmacovigilance Center (IPC), 1136 clinical records were reviewed. The models were adjusted for patient variables. Main outcome measures Total ADRs, ADRs correctly identified by physicians, ADRs reported to the IPC by physicians. Results Before the intervention, 97 % of ADRs were correctly identified and 6.1 % reported by physicians. During the intervention, 99.6 % were correctly identified and 41.2 % were reported, and after the intervention, 99.6 and 41.7 %, respectively. Identification during the intervention showed a sevenfold increase with regard to preintervention and was maintained post-intervention. ADR reporting during the intervention showed a 14-fold increase with regard to pre-intervention and was maintained during post-intervention. Conclusion Physicians do identify ADRs, but fail to report them. The intervention increased ADR correct identification and reporting. The effect was maintained after the intervention.     

Reporting adverse drug reactions: contribution,knowledge and perception of German pharmacy professionals

Background The detection, assessment and prevention of adverse drug reactions along the product’s life cycle is known as pharmacovigilance. German pharmacists are obliged by law to conduct pharmacovigilance measures, a specific training is not required. Objectives To assess the knowledge, contribution and perception of German pharmacy professionals regarding pharmacovigilance activities, in order to identify their needs to report better on the issue. Setting A semi-quantitative survey among German pharmacy professionals was conducted in November 2017. Method A questionnaire with 20 questions was developed and distributed to pharmacy professionals in four different German regions. Main outcome measures To assess the knowledge the number of right answered questions were examined; for perception a six-point-Likert was used and for contribution, yes or no questions. Results The participation ratio was 64.5% (n?=?127). Nearly half of the participants (47.2%, n?=?60) stated that they had already reported adverse drug reactions. Regarding the knowledge questions, there was neither a statistically significant difference between the correct answers of pharmacists and pharmacy technical assistents (p?=?0.7209), nor between the different regions (p?>?0.5054). For better reporting, the participants recommended better training, shorter forms to fill in and/or a contact person to call. Conclusion For the successful integration of pharmacovigilance reporting in daily practice, we suggest the following: (1) A structured, mandatory training of the pharmacy team. (2) The preparation of a standard operating procedure for the pharmacy or its integration into the pharmacy software.     

Factors that affect adverse drug reaction reporting among hospital pharmacists in Western China

Background Hospital pharmacists can make a considerable contribution to the spontaneous reporting system of adverse drug reactions. The factors that influence adverse drug reaction reporting among hospital pharmacists remain largely unknown in China. Objective This study aims to identify factors that affect hospital pharmacist-led adverse drug reaction reporting in Xi’an, and to obtain suggestions from pharmacists about how to improve the current adverse drug reaction reporting system. Setting Hospital settings throughout Xi’an, a region of Western China. Method A matched case–control study was conducted on a population of 2,814 hospital pharmacists in Xi’an during 2011. Cases included all pharmacists who had reported at least one adverse drug reaction between 2008 and 2010 and agreed to participate in the study (186/204; 91.2 %); controls (n = 372) were pharmacists who had not reported any adverse drug reaction during the same period. A self-administered questionnaire was distributed to the participants. Logistic regression was performed to evaluate the association between indicator variables and the outcome of having reported at least one adverse drug reaction. Main outcome measure Pharmacists’ knowledge, attitude and practice towards adverse drug reaction reporting and factors affecting reporting. Results Higher professional title (adjusted OR 1.44; 95 % CI 1.07–1.94; p = 0.018), having received training about adverse drug reaction reporting (1.64; 1.04–2.57; p = 0.032), better knowledge about reporting (1.53; 1.12–2.08; p = 0.007), “lack of access to adverse drug reaction reporting form” (0.29; 0.12–0.72; p = 0.008) was independently associated with adverse drug reaction reporting. Clinical pharmacists were more likely to report an adverse drug reaction than dispensary pharmacists (1/adjusted OR 5.26; p < 0.001), pharmacy administrators (5.00; p = 0.003), and other technicians (5.56; p = 0.001). Conclusions Higher professional title, having received training, mastering knowledge about reporting, and being a clinical pharmacist were positive predictors of pharmacist-led adverse drug reaction reporting. Lack of access to reporting forms was a negative predictor. Continuous training and establishing incentive mechanisms are needed to promote adverse drug reaction reporting among hospital pharmacists.     

Effects of e-mails containing ADR information and a current case report on ADR reporting rate and quality of reports

Background

Spontaneous reporting of adverse drug reactions (ADRs) is one approach to increasing our knowledge on the risks of drugs in clinical practice. Under-reporting is a shortcoming of this system.

Objectives

To evaluate if repeated e-mails with attachments on ADR information can affect (1) the reporting of ADRs and (2) the quality of the ADR reports.

Methods

All 117 heads of primary health care units in the region of Västra Götaland in Sweden were randomly allocated (1:1) to an intervention group or a control group. The intervention consisted of e-mails with attachments sent out to each of the 117 heads in January, May and September 2007. These e-mails included (1) the heading “Every ADR report is important”, (2) a current case report of an ADR and (3) instructions on how to report. The number of reports from each primary health care unit run by the same head was registered, as was the quality of the report. The quality was defined as high if the ADR was (1) serious, (2) unexpected or (3) related to the use of new drugs and not labeled as common in the summary of product characteristics. All other reports were regarded as low-quality reports.

Results

The total number of reports increased from 89 in 2006 to 111 in 2007 (P?=?0.037). No difference in the number of reports between intervention (n?=?56) and control (n?=?55) units could be detected. The proportion of high-quality reports before and after the intervention was 36 and 48%, respectively (intervention, P?=?0.11) and 40 and 36%, respectively (control, P?=?0.55).

Conclusions

No apparent effect of repeated ADR e-mails on the reporting of ADRs could be detected, although an increase in the reporting rate in general was noted.

     

Factors associated with adverse drug reactions in older inpatients in teaching hospital

Background Adverse drug reactions (ADRs) occur frequently during hospital stays and are an important public health problem, particularly in the care of the older. Objectives This study aimed to determine the prevalence of ADRs among older inpatients and the factors associated with their occurrence. Setting Brazilian teaching hospital. Methods This was a cross-sectional study with older inpatients in the internal medicine ward of a teaching hospital. The dependent variable was the occurrence of an ADR during hospitalization. The independent variables were gender, age, length of hospitalization, number of health problems, medications, and potentially inappropriate medications for the older. Logistic regression was performed to analyze the association between an ADR and the independent variables. Main outcome measure Factors associated with ADR in older inpatients. Results Among the 237 inpatients investigated, 50 (21.1%) developed at least one ADR. The total number of ADRs observed was 62 and the most frequent were acute kidney injury, hypotension, and cutaneous adverse reactions A multivariate analysis demonstrated a positive and independent association between the occurrence of an ADR and the presence of heart failure [odds ratio (OR) 2.4; 95% confidence interval (CI) 1.2–4.6], and with hospitalization time exceeding 12 days (OR 2.3; 95% CI 1.2–4.4). Conclusions The study showed a high prevalence of ADRs among the older and a positive association with hospitalization time and heart failure. Understanding the factors associated with the occurrence of ADRs among older inpatients provides elements for improving the safety of care and optimization of pharmacotherapy.     

Targeted therapies and adverse drug reactions in oncology: the role of clinical pharmacist in pharmacovigilance

Background The majority of adverse drug reactions (ADRs) reported in the summary of product characteristics (SPCs) are based on pivotal clinical trials, performed under controlled conditions and with selected patients. Objectives (1) to observe ADRs in the real-world setting and to evaluate if the supervision of the pharmacist impacts on the management of ADRs and on the satisfaction of patients; (2) to sensitise health professionals and patients on the need to increase the reporting of ADRs, in compliance with Pharmacovigilance. Setting CRO Aviano, Italian National Cancer Institute. Method From February 2013 to April 2015, we conducted an observational study enrolling 154 patients (≥?18 years) undergoing treatment with at least one of ten targeted-therapies included in the study. Main outcome ADR reporting in the real-world setting. Patient satisfaction with clinical pharmacist support. Results Reported ADRs in the real setting do not always correspond with data described in the respective SPCs. Unknown ADRs were also identified such as hyperglycaemia with lenalidomide and sorafenib; and hypomagnesaemia with bevacizumab. We also observed a 124.3% increase in spontaneous reports. Conclusion This study shows the high value of active pharmacovigilance programs, and our results might be a starting point for developing a randomised trial which should aim to demonstrate the impact of the pharmacist on improving patient’s adherence and in measuring the difference in ADRs reports in the different arms followed or not by the pharmacist.     

Antihypertensive-related adverse drug reactions among older hospitalized adults

Background Antihypertensive medications are commonly used for a wide range of indications, yet it is unknown to what extent older adults are at risk of adverse drug reactions (ADRs) associated with their antihypertensive medication use. Objective The aim of this study was to determine the prevalence and characteristics of antihypertensive-related ADRs on hospital admission. Setting Metropolitan teaching hospital in Sydney, Australia. Method A retrospective cross-sectional audit of 503 older patients (≥ 65 years) admitted to hospital was conducted. Potential ADRS were identified from the medical record. Two independent clinical pharmacists reviewed each potential ADR using validated tools for causality, severity, preventability and contribution to hospitalization. Characteristics associated with an increased ADR risk among antihypertensive users were identified via logistic regression. Main outcome measure Antihypertensive related ADRs. Results Antihypertensives were used on admission by 68% of the cohort and the prevalence of ‘definite/probable’ antihypertensive-related ADRs among antihypertensive users was 16.4%. Antihypertensive medications were associated with a threefold ADR risk (OR = 3.09, 95% CI 1.85–5.16). Angiotensin II Receptor Blockers (ARB), impaired renal function, recent medication changes and previous history of allergy or ADR were all associated with an increased risk of experiencing an ADR. Conclusions ADRS associated with antihypertensive medicines were relatively common among older adults admitted to hospital. Increased awareness of those older persons who are most at risk of experiencing an antihypertensive-related ADR in the clinical setting may lead to early detection and minimization of ADR associated harms.     

Pharmacovigilance in oncology

Background Side effects of cancer therapy are one of the most important issues faced by cancer patients during their illness. Pharmacovigilance, namely the science and activities aimed at monitoring the safety of drugs, is particularly important in oncology, due to the intrinsic biologic toxicity of antineoplastic agents, their narrow therapeutic windows, and the high doses and rigid timing of treatment regimens. Aim of the review To identify the main issues in carrying out an effective pharmacovigilance activity in oncology. Method We searched PubMed for articles about pharmacovigilance in relation to chemotherapy, radiotherapy and targeted therapy for cancer, using MeSH terms and text words. We also searched Embase, CINAHL, Scopus, Micromedex, the Cochrane Library, two pharmacovigilance databases and the gray literature for articles published in 2012–2018. Overall, 137 articles were considered potentially relevant and were critically appraised independently by two authors, leading to the inclusion of 44 relevant studies, guidelines and reviews. Another 10 important research reports were included in the review. Results Eight critical issues of pharmacovigilance in oncology were identified. These issues pertain to: terminology; range of side effects; targeted therapy and immunotherapy; chemoradiotherapy; generic drugs and biosimilars; drug interactions, pharmacogenetics and polypharmacy; special patient categories; and under-reporting of ADRs. Conclusion The importance of pharmacovigilance in oncology must be highlighted with every effort, to improve safety and offer cancer patients every possible help to improve their quality of life during such a critical period of their lives.     

优化现行版“全国药品不良反应监测网络”软件功能的探讨

目的:探讨如何优化"全国药品不良反应监测网络"的软件功能。方法:从项目内容及操作功能方面分析现行版"全国药品不良反应监测网络"软件功能存在的不足,并提出修改意见。结果与结论:现行不良反应报告收集系统需进行升级和修改,以更大程度地保证我国药品不良反应报告的真实性、规范性、完整性。     

2003--2007年上海市药品不良反应报告表质量分析

目的：评价上海市2003—2007年药品不良反应（adverse drug reaction，ADR）报告表的质量。方法：根据《药品不良反应／事件报告表规范分级标准》对ADR报告表质量进行评价，影响ADR报告表质量的危险因素进行多个自变量的logistic逐步回归分析。结果：2003年12月-2007年4月上海市ADR报告总数为32752份。2006年已经达到每百万人口650份ADR报告，来源于医师的占61．94％，严重ADR比例为3．1％。影响ADR报告表质量的危险因素及优势比（OR）、95％可信区间（CI）为：新的严重ADR（OR=2．19，95％CI：1．38～3．47）、新的一般ADR（OR=2．13，95％CI：1．51～3．00）、已知严重ADR（OR--5．32，95％CI：4．15～6．81）、生产企业（OR--35．74，95％CI：28．27～45．19）、军队医院（OR=21．05，95％CI：14．62～30．32）、监测机构（OR=6．16，95％CI：2．38～15．92）、个人（OR=11．17，95％CI：2．33～53．43）、其他（OR=2．22，95％CI：1．04～4．76）。结论：上海市ADR报告百万人13每年上报率已达世界卫生组织（WHO）要求的标准，但整体质量仍需提高，建议加强ADR的宣传培训，充分发挥医师、药师和护十的作用，改善ADR榍告存纬录入功能．     

Safety of an injection with a mixture of extracts from <Emphasis Type="Italic">Herba Artemisiae annuae</Emphasis>, <Emphasis Type="Italic">Fructus Gardeniae</Emphasis> and <Emphasis Type="Italic">Flos Lonicerae</Emphasis>

Objective This study aimed to evaluate the safety for an injection with a mixture of extracts from Herba Artemisiae annuae, Fructus Gardeniae and Flos Lonicerae and to determine the risk factors that may affect its adverse drug reactions. Methods A drug-oriented prospective observational study was performed. Physicians filled in clinical observation forms with detailed information of the patients including general information, drug information, therapeutic effects and adverse drug events. The adverse drug reaction factors were analyzed by both mono-factor and multiple-factor logistic regression methods. Results From April to July 2007, we collected 12,427 observation forms from 46 hospitals in Jiangsu Province of China. Among the 11,707 observation forms we analyzed, 8,074 patients were children younger than 14 years old (69%). Among 51 reported adverse drug events, 45 cases were adverse drug reactions. The total adverse drug reaction incidence of the injection was 0.38%. While most adverse drug reactions were previously known (e.g., rash, pruritus, vomiting and diarrhea), we observed three new ADR symptoms: shiver, phlebitis and anhelation. All the adverse drug reactions were controlled very well through the follow-up therapy, and none of them was life threatening. The mono-factor analysis showed that adverse drug reactions of the injection were significantly correlated with total medication dose (P = 0.0049) and combination medication (P = 0.0143), especially with antimicrobial drugs (P = 0.0079) and macrolides (P = 0.0017). The multiple factor analysis confirmed these results: medication dosage and combination medication had a crucial impact on adverse drug reactions of the injection; the risk was increased by 24.8% (the estimated value of relative risk was 1.248, 95% confidence interval: 1.054–1.479) and 89% (1.890, 1.001–3.566), respectively. Conclusion The total adverse drug reaction incidence of the injection was 0.38% and lower than we expected. Moreover, we observed three new adverse drug reactions, none of which was severe.     

Factors associated with prescribing restriction on oncology formulary drugs in Malaysia

Background Drugs listed on formularies are often subjected to a variety of utilization restriction measures. However, the degree of restriction is influenced by multiple factors, including the characteristics and attributes of the listed drugs. Objective To identify the factors that are associated with the levels of prescribing restriction on oncology formulary drugs in Malaysia. Setting Oncology formulary in Malaysia. Method The Malaysia Drug Code assigned to each of the drug products on the Malaysia Ministry of Health (MOH) drug formulary was used to identify oncology drugs belonging to WHO ATC class L (antineoplastic and immunomodulating agents). Main outcome measures Categories of prescribing restrictions, therapeutic class, drug type, administration mode, number of sources and the post-approval use period. Results Oncology drugs having a shorter post-approval use period (p < 0.001), biologic oncology drugs (p = 0.01) and oncology drugs belonging to immunosuppressant therapeutic class (p = 0.03) were all significantly associated with a greater likelihood of being subjected to a higher level of prescribing restriction. Conclusion This study suggests that safety concerns, costs and potentials for inappropriate use were the important considerations influencing a higher level of prescribing restriction placement on oncology drugs in the Malaysia MOH drug formulary.     

Polypharmacy and potential drug–drug interactions in emergency department patients in the Caribbean

Background Potential Drug–Drug Interactions (DDI) account for many emergency department visits. Polypharmacy, as well as herbal, over-the-counter (OTC) and combination medication may compound this, but these problems are not well researched in low-and-middle-income countries. Objective To compare the incidence of drug–drug interactions and polypharmacy in older and younger patients attending the Emergency Department (ED). Setting The adult ED of a tertiary teaching hospital in Trinidad. Methods A 4 month cross sectional study was conducted, comparing potential DDI in older and younger patients discharged from the ED, as defined using Micromedex 2.0. Main outcome measure The incidence and severity of DDI and polypharmacy (defined as the use of ≥5 drugs simultaneously) in older and younger patients attending the ED. Results 649 patients were included; 275 (42.3%) were ≥65 years and 381 (58.7%) were female. There were 814 DDIs, of which 6 (.7%) were contraindications and 148 (18.2%) were severe. Polypharmacy was identified in 244 (37.6%) patients. Older patients were more likely to have potential DDI (67.5 vs 48.9%) and polypharmacy (56 vs 24.1%). Herbal products, OTC and combination drugs were present in 8, 36.7 and 22.2% of patients, respectively. On multivariate analysis, polypharmacy and the presence of hypertension and ischaemic heart disease were associated with an increased risk of potential DDI. Conclusion Polypharmacy and potential drug–drug interactions are common in ED patients in the Caribbean. Older patients are particularly at risk, especially as they are more likely to be on multiple medications. The association between herbal medication and polypharmacy needs further investigation. This study indicates the need for a more robust system of drug reconciliation in the Caribbean.     

应用ASP动态网页技术在医院局域网上建立药品不良反应电子报表

目的：在医院局域网上建立药品不良反应电子报表系统。方法：在药学信息室设立动态网页服务器，利用VBScript语言编辑ASP动态网页，实现药学信息服务器与临床科室工作站上数据的互动。结果：在医院局域网上建成了一套系统药品不良反应的电子报表，临床科室的有关人员只需在本科室的计算机工作站上输入监测到的药品不良反应的数据，该信息便可直接提交到药学信息室，并存入药学信息服务器的相关数据库中。结论：应用ASP动态网页建立的药品不良反应报表系统使用方便，快捷，数据便于保存和共享。     

Knowledge, attitudes, and perceptions of pharmacists to adverse drug reaction reporting in Iran

Objective Adverse Drug Reactions (ADRs) are a major cause of patient morbidity and mortality. Spontaneous reporting of ADRs remains the cornerstone of pharmacovigilance and is important in maintaining patient safety. In order to determine whether our pharmacovigilance system could be improved, and identify reasons for under-reporting, a study to investigate the role of pharmacists in ADR reporting was performed in Shiraz. Setting: The pharmacies in Shiraz, capital of Fars province in Iran. Methods A questionnaire was prepared to investigate knowledge and attitude of pharmacists regarding ADR reporting. The questionnaire was given to 200 pharmacists who participated in a pharmacist association meeting. Main outcomes measured: The knowledge of pharmacovigilance practice, reasons for not reporting ADR, and perceptions of the Iranian pharmacists on pharmacovigilance practice were evaluated Results The response rate was 55% (n = 110). 29% of the respondents were not aware of the Iranian Pharmacovigilance Center. More than half of those responding felt that ADR reporting should be voluntary, while 26% felt it was a professional obligation. As for the purposes of ADR reporting scheme, 60% of the pharmacists falsely believed that monitoring ADR spontaneous reports aims at measuring the incidence of ADR. 42% of the pharmacists indicated that they have suspected an ADR without reporting it. Doubt about causality was the major reason for not reporting an ADR. Although our ADR center states that all suspected reactions to any drug on the market must be reported, only 17% of the respondents seemed to be aware of this responsibility. Conclusion Our pharmacists have little knowledge regarding the operation, purposes, and usefulness of ADR spontaneous reporting system. However, education and training will be important in maintaining and increasing ADR reports from pharmacists.     

Potential negative impact of informing patients about medication side effects: a systematic review

Background Pharmacovigilance, as it is carried out primarily by healthcare professionals is more focused on being very objective in nature. Acknowledging the importance of the subjective experience of patients in pharmacovigilance was underpinned by its unique ability to bring about a more holistic understanding through the deep information unraveled by the patients. Medication safety-related information has to be shared with patients to allow them to be actively involved in their therapy and pharmacovigilance. Despite the advantages of sharing information, it stands to reasons whether sharing information related to possible side effects would negatively affect patients and impinge upon their treatment plan and process. Aim of the Review The purpose of this systematic review was to critically assess the potential negative impact of informing patients about medication side effects by written and/or oral information on medication compliance, occurrence/development of suspected side effects and clinical outcomes. Method A comprehensive search was conducted in PubMed, and Cochrane library to identify potential records between the year 1975 and 2017; then titles, abstracts, and full texts were screened using the inclusion criteria to filter out irrelevant studies. The data extraction, and the results were narratively synthesized and presented in tables. Results A total of 2012 articles were screened for inclusion, 32 full-text articles were assessed for eligibility and finally resulting in the inclusion of 17 randomized control studies which met the set criteria. Findings unraveled that the educational intervention did not result in increased occurrence/reporting of side effects in most of the evaluated studies; except 4 studies, and no significant impact on compliance to medications and negative clinical outcome was observed. Apprehension of negative events to medications were observed in two of the four studies which evaluated these parameters. Conclusion The present review did not find enough evidence to support the over concerns on the potential negative impact of sharing of information on the adverse effects to patients, though the influence could manifest as nocebo-effect. The various components and methods employed for this information sharing process can influence the potential impact of this activity. These concerns about the undesirable effects should not deter the active involvement of patients in pharmacovigilance activities. There is a definite need to have more studies in this area, where much of concern still does exist among the various stakeholders of drug safety information.