Examination of pharmacists’ intention to report serious adverse drug events (ADEs) to the FDA using the theory of planned behavior

Background

Adverse drug event (ADE) reporting by pharmacists is an indispensable part of the drug safety system. U.S. pharmacists may submit reports of serious ADEs that they encounter to the Food and Drug Administration (FDA) through MedWatch. However, underreporting of serious ADEs is a common problem. Little is known about pharmacists’ decision making with respect to ADE reporting.

Objectives

This study explored the utility of the theory of planned behavior (TPB) model in predicting Texas pharmacists’ intention to report serious ADEs to the FDA.

Methods

Data were collected from practicing Texas pharmacists using a mail questionnaire. A total of 1500 surveys were mailed, and 377 usable responses were obtained for a response rate of 26.4%.

Results

A majority (70.2%) of the 377 respondents were white/Caucasian, and 52.9% were male. Overall, pharmacists intended to report serious ADEs (mean = 15.87 ± 4.22; possible range: 3-21), had a positive attitude toward reporting (mean = 4.62 ± 4.92; possible range: −15 to +15), perceived that important others wanted them to report (subjective norm [SN] score = 5.65 ± 2.99; possible range: −9 to +9), and believed that they had control over their reporting behavior (perceived behavioral control [PBC] score = 3.54 ± 2.69; possible/actual range: −6 to +6). Attitude (β = 0.221, P < .001) and SN (β = 0.438, P < .001) significantly predicted intent; however, PBC (β = 0.028, P > .05) did not. Attitude, SN, and PBC together accounted for 34.0% of the variance in intention to report serious ADEs (P < .001). The addition of past reporting behavior (P = .021) and perceived moral obligation (P < .001) significantly increased the variance in intention explained by the TPB model.

Conclusions

Pharmacists showed a strong positive intent to report serious ADEs to the FDA. Strategies to increase pharmacists’ intentions to report serious ADEs should focus on helping them see the value of reporting and altering their perception of social pressure toward reporting. The TPB may have utility in predicting ADE-reporting behavior.     

Quality check of spontaneous adverse drug reaction reporting forms of different countries

Adverse drug reactions (ADRs) are considered as one of the leading causes of death among hospitalized patients. Thus reporting of adverse drug reactions become an important phenomenon. Spontaneous adverse drug reaction reporting form is an essential component and a major tool of the pharmacovigilance system of any country. This form is a tool to collect information of ADRs which helps in establishing the causal relationship between the suspected drug and the reaction. As different countries have different forms, our aim was to study, analyze the suspected adverse drug reaction reporting form of different countries, and assess if these forms can capture all the data regarding the adverse drug reaction. For this analysis we identified 18 points which are essential to make a good adverse drug reaction report, enabling proper causality assessment of adverse reaction to generate a safety signal. Adverse drug reaction reporting forms of 10 different countries were collected from the internet and compared for 18 points like patient information, information about dechallenge–rechallenge, adequacy of space and columns to capture necessary information required for its causality assessment, etc. Of the ADR forms that we analyzed, Malaysia was the highest scorer with 16 out of 18 points. This study reveals that there is a need to harmonize the ADR reporting forms of all the countries because there is a lot of discrepancy in data captured by the existing ADR reporting forms as the design of these forms is different for different countries. These incomplete data obtained result in inappropriate causality assessment. Copyright © 2010 John Wiley & Sons, Ltd.     

Feedback for patients reporting adverse drug reactions; satisfaction and expectations

Objective: Due to the rising number of patient reports in pharmacovigilance, the manner in which feedback is provided to patients is an element to be considered. The objective is to explore the satisfaction of patients towards personalized and general feedback in response to their reported adverse drug reactions (ADRs).

Methods: Patients who reported an ADR to the Dutch Pharmacovigilance Centre for the first time in the period between October 2012 and April 2013 were included. Reporters received personalized feedback or a general acknowledgement letter. Satisfaction towards the received feedback, expressed on a 5-point Likert scale (1 very good to 5 very poor), was studied using a web-based questionnaire. Data were analyzed using Pearson Chi-square test and linear regression analysis. Statistical significance was based on p < 0.05.

Results: A total of 471 patient-reporters were contacted with a total response of 52.5%. Respondents of both groups were satisfied with the received feedback, average score 2 (good). Respondents of the personalized feedback-group were however more satisfied score 2.0 versus 2.5 (p < 0.001) and considered the feedback more clear and useful compared with respondents of the acknowledgement letter-group, respectively score 1.6 versus 1.7 (p = 0.01) and score 2.1 versus 2.5 (p < 0.001).

Conclusion: Patients reporting ADRs are satisfied with feedback received from the pharmacovigilance centre, whether this is a personalized feedback or a general acknowledgment letter. They find it clear, useful and it meets their expectation. Although differences were found between the two types of feedback, these differences did not indicate dissatisfaction towards the received feedback.     

The importance of direct patient reporting of suspected adverse drug reactions: a patient perspective

AIM

To explore the opinions of patient reporters to the UK Yellow Card Scheme (YCS) on the importance of the scheme.

METHODS

Postal questionnaires were distributed on our behalf to all patient reporters submitting a Yellow Card to the Medicines and Healthcare Regulatory Agency (MHRA) between March and December 2008, with one follow-up reminder to non-responders. Qualitative analysis was undertaken of responses to an open question asking why respondents felt patient reporting was important. This was followed up by telephone interviews with a purposive sample of selected respondents.

RESULTS

There were 1362 evaluable questionnaires returned from 2008 distributed (68%) and 1238 (91%) respondents provided a total of 1802 comments. Twenty-seven interviews were conducted, which supported and expanded the views expressed in the questionnaire. Four main themes emerged, indicating views that the YCS was of importance to pharmacovigilance in general, manufacturers and licensing authorities, patients and the public and health professionals. Reporters viewed the YCS as an important opportunity to describe their experiences for the benefit of others and to contribute to pharmacovigilance. The scheme''s independence from health professionals was regarded as important, in part to provide the patient perspective to manufacturers and regulators, but also because of dismissive attitudes and under-reporting by health professionals.

CONCLUSION

Direct patient reporting through the YCS is viewed as important by those who have used the scheme, in order to provide the patient experience for the benefit of pharmacovigilance, as an independent perspective from those of health professionals.     

Pharmacists' attitudes towards the reporting of suspected adverse drug reactions in Norway

BACKGROUND: In Scandinavian countries, pharmacists have not reported adverse drug reactions (ADRs), either due to legislative restrictions or because of lack of tradition. From 1 January 2005, Norwegian pharmacists have been encouraged by the Norwegian Medicines Agency to take a larger role in the reporting of ADRs. OBJECTIVE: To explore pharmacists' attitudes towards pharmacovigilance and their experiences with ADR reporting, to evaluate the effect of an educational programme and to compare these findings to the attitudes in a control group. METHODS: From September 2004, pharmacies in two of Norway's five health regions were invited to attend a 3-month ADR reporting study, and 39 pharmacies were recruited. One pharmacist from each pharmacy participated in a 1 day pre-study educational programme and a 1 day post-study evaluation meeting. Pharmacists involved in the study answered a questionnaire (A) regarding their attitudes to ADR reporting (active group). A control group answered the same questionnaire. One reminder was sent. The active group evaluated the study by answering questionnaire A once more and an evaluation questionnaire (B). Qualitative aspects of ADR reporting were discussed with the active group post-study. RESULTS: The response rate for questionnaire A was 97% (n = 158) in the active group, 74% (n = 184) in the control group and the response rate for questionnaire A and B post-study was 68% (n = 105) in the active group. Pharmacists in the active group had more positive attitudes to ADR reporting after taking part in the study than the control group (p < 0.001). Lack of time, confidence and knowledge of reporting rules could potentially prevent them from reporting ADRs. CONCLUSIONS: The pharmacists had positive attitudes towards pharmacovigilance, but very little experience with reporting. The educational programme clarified their role and increased their knowledge about the reporting requirements.     

Under-reporting of serious adverse drug reactions in Sweden

INTRODUCTION: Adverse drug reactions (ADR) constitute a major problem, both from a medical point of view and as an economical burden. Spontaneous reporting of ADRs is one of the methods for post marketing surveillance of drug safety. Under-reporting can also provide an important obstacle to rapid and relevant signal detection. AIM: To investigate the rate of under-reporting serious ADRs of selected ICD 10 diagnoses. METHOD: In order to investigate the under-reporting rate we investigated at five hospitals within the county of Norrbotten in Sweden the total number of diagnosed cases during a period of 5 years (1996-2000) with the following diagnoses: cerebral haemorrhage (I 61.0-I 61.9), pulmonary embolism (I 26.0 and I 26.9), embolism or thrombosis (I 74.0-I 74.9), phlebititis, thrombophlebitits or venous thrombosis (I 80.0-I 80.3, I 80.8 and I 80.9) and portal vein thrombosis and other thrombosis or emboli (I 82.0-I 82.3, I 82.8 and I 82.9). The identity of these patients was obtained through a database search. The patients' case records were then scrutinized by a specially trained nurse and the drugs used at the time of the event were noted. An assessment of the possibility of an ADR was performed using standard WHO causality criteria. Later, database search in the Swedish ADR registry was performed in order to investigate whether these suspected ADRs had been reported to the national authority in Sweden or not. RESULTS: In total 1349 case records were found and scrutinized. Of these, 107 patients had received drugs that could have been a probable or possible cause to the diagnoses. Of these 92 cases had not been reported and only 15 patients were found in the database, giving an overall under-reporting rate of all ADRs of 86%.The most commonly occurring diagnoses were cerebral haemorrhage followed by venous thrombosis, 545 and 468 respectively. Among those cases that should have been reported according to the existing rules for spontaneous reporting of suspected ADRs the most frequently occurring diagnosis was cerebral haemorrhage (I 61.0) in connection to treatment with anticoagulants. CONCLUSION: The rate of spontaneous ADR reporting is very low, also for serious and fatal reactions.     

The quality of spontaneous adverse drug reaction reports from the pharmacovigilance centre in western China

Background: High-quality adverse drug reaction (ADR) reports are essential for conducting drug safety monitoring in pharmacovigilance. The study aim was to assess the current quality of ADR reports in western China, and to identify problems with ADR report quality.

Research design and methods: A sample of 1139 reports received by the Shaanxi ADR Monitoring Center from January 2015 to December 2017 was selected. ADR report quality was evaluated using an ADR report quality evaluation system.

Results: None of the reports were rated as excellent and 1.40% (n = 16) as good. Report quality was better for new and serious reports than for general reports. Medical institutions generated higher quality reports than pharmaceutical manufacturers. Nurses generated higher quality reports than doctors, pharmacists, and other professionals. Reporters of different occupations showed significant differences in the quality of the indicators Reporting time limit, Intervention ADR time, ADR termination time, ADR intervention measures, Original disease, and Cause of medication (P = 0.000).

Conclusions: The ADR data quality was poor in western China, and of lower quality than reported data from previous research in other regions. Improvements in the quality and availability of ADR reports are urgently needed.     

南京地区358例严重药品不良反应/事件分析

目的 分析南京地区严重药品不良反应/事件的发生规律和特点,为推进药品不良反应监测工作和临床合理用药提供参考。方法 从国家药品不良反应监测系统库南京市药品不良反应监测中心调取并筛选2017年接收的严重药品不良反应/事件数据,将患者性别、年龄、怀疑药品名称、严重不良反应/事件名称、过程描述等信息进行统计分析。结果 358份严重药品不良反应/事件报告中,新的严重的不良反应占23.18%。60岁以上患者占48.60%。抗感染药物和抗肿瘤药物发生率较高,分别为115例（32.12%）和80例（22.35%）。静脉滴注为主要的给药方式（294例,82.12%）。在累及器官、系统中,全身性损害发生频次最高（195频次,28.97%）,其次为呼吸系统损害。结论 本次分析中严重药品不良反应/事件与患者年龄、给药途径、药品种类有关。医疗机构、经营企业和生产企业应加强严重药品不良反应/事件的监测,促进合理用药。     

Clinical perspectives in drug safety and adverse drug reactions

Adverse drug reactions (ADRs) remain a common clinical problem since they can mimic many diseases and cause significant morbidity and mortality. Judicious prescribing is important to minimize their occurrence. Apart from the recent identification of a few pharmacogenomic biomarkers for serious reactions, many remain unpredictable. Spontaneous reporting continues to play an important role in pharmacovigilance and the value of astute clinical observation and well-documented reports of suspicions of a causal link cannot be underestimated. Many national reporting schemes have developed considerable experience and expertise over many years and have large ADR databases, which are national assets. Despite advances in pharmacovigilance, numerous deficiencies have been identified; postmarketing surveillance remains the weakest link in the regulatory process. Regulatory authorities have tended to act later rather than sooner in response to safety signals, and this, when combined with under-reporting, may have led to exposure of a large number of patients to drug-related harm before restriction or withdrawal. In an attempt to improve vigilance, international surveillance may benefit by moving from its current passive/reactive mode toward active surveillance systems with a prospective, comprehensive and systematic approach to monitoring, collecting, analyzing and reporting data on ADRs. This will include increased pressure on pharmaceutical companies to conduct postmarketing studies. Such an active/proactive approach, while maintaining focus on ADR detection, could also aim to extend knowledge of safety, such that emerging changes in risk–benefit during a drug’s marketed life are effectively communicated to clinicians and patients. Drug safety monitoring and its regulation are now undergoing an overhaul and it is hoped that vigilance, public safety and trust will improve as a result.     

从药物不良事件报告看头孢曲松的不合理使用

目的通过分析头孢曲松的相关不良事件,以期为临床合理使用提供理论参考,减少头孢曲松药物不良反应和药源性疾病的发生。方法采用回顾性研究的方法,对江苏省2006年上报的头孢曲松相关不良事件进行分析。结果头孢曲松的不良事件发生比例较高,尤其是10岁以下年龄段病人。38例超出适应证用药。84例使用剂量不合理,其中成人用药剂量过低9例、超剂量29例;12岁以下儿童用药剂量不合理46例。因配伍禁忌使用不当的有6例。孕妇和哺乳期妇女中有25例用药剂量不当,老年病人中共有7例用药剂量不当,肝、肾功能不全病人中有2例用药剂量不当。结论临床使用头孢曲松时应严格掌握其用药适应证和用药剂量,注意配伍禁忌和特殊人群用药,以提高临床疾病治愈率,减少不良事件的发生。