Research Student, University of Sheffield


To assess the effectiveness of interventions to improve adverse drug reaction reporting.

Adverse drug reactions (ADRs) are a significant public health problem responsible for patient hospitalizations, morbidity, mortality, and increased healthcare costs. Healthcare professionals (HCP) play a vital role in identification and reporting of ADR but there is gross under- reporting. Various approaches have been used globally to improve ADR reporting but few studies have explored the effectiveness of such interventions specifically on doctors, nurses and pharmacist. This review therefore seeks to assess the effectiveness of interventions to improve ADR reporting.


Workshop- and telephone-based interventions to improve adverse drug reaction reporting: a cluster-randomized trial in Portugal.

Abstract: Spontaneous reporting of adverse drug reactions (ADRs) is the method most widely used by pharmacovigilance systems, with the principal limitation being the physician's underreporting.This study sought to evaluate the results of workshop and telephone-interview interventions designed to improve the quantity and relevance of ADR reporting by physicians.A cluster-randomized controlled trial was conducted on 6579 physicians in northern Portugal in 2008. Following randomization, we allocated 1034 physicians to a telephone-interview intervention, 438 to a workshop intervention and the remaining 5107 to the control group. At the workshop, a real clinical case was presented and participants were then asked to report on it by completing the relevant form. In the telephone intervention, participants were asked (i) whether they had ever had any suspicion of ADRs; (ii) whether they had experienced any difficulties in reporting; (iii) whether they remembered the different methods that could be used for reporting purposes; and (iv) whether they attached importance to the individual physician's role in reporting. We followed up physicians to assess ADR reporting rates to the Northern Pharmacovigilance Centre. In terms of relevance, adverse reactions were classified as serious or unexpected. Statistical analysis was performed on an intention-to-treat basis, and generalized linear mixed models were applied using the penalized quasi-likelihood method. The physicians studied were followed up over a period of 20 months.Two hundred physicians underwent the educational intervention. Comparison with the control group showed that the workshop intervention increased the spontaneous ADR reporting rate by an average of 4-fold (relative risk [RR] 3.97; 95% CI 3.86, 4.08; p < 0.001) across the 20 months post-intervention. Telephone interviews, in contrast, proved less efficient since they led to no significant difference (p = 0.052) vis-à-vis the control group in ADR reporting (RR 1.02; 95% CI 1.00, 1.04). The effects of the interventions on the reporting rate of serious and high-causality ADRs indicated that the RRs associated with workshops were 6.84 (95% CI 6.69, 6.98; p < 0.001) for serious ADRs and 3.58 (95% CI 3.51, 3.66; p < 0.001) for high-causality ADRs.Whereas telephone interventions only increased spontaneous reporting in the first 4 months of follow-up, workshops significantly increased both the quantity and relevance of spontaneous ADR reporting for more than 1 year.

Pub.: 14 Jul '12, Pinned: 25 Sep '17

Attitudes of Portuguese health professionals toward adverse drug reaction reporting.

Abstract: Adverse drug reactions are a major public health problem. Underreporting is an important limitation of all reporting systems, partially due to attitudes of health professionals.This study sought: (1) to evaluate the reproducibility of a questionnaire on attitudes to and knowledge of adverse drug reaction (ADR) reporting among physicians, nurses and pharmacists: and (2) to compare the attitudes and knowledge of these three groups of health professionals.This study targeted a sample of physicians (n = 30), nurses (n = 30) and pharmacists (n = 20) in the central region of Portugal. A structured questionnaire was administered to each health professional twice, at an interval of 2-4 weeks. Most attitudes were based on Inman's 'seven deadly sins' and measured using a continuous visual analog scale (VAS), with answers scored from 0 (total disagreement) to 10 (total agreement). Questionnaire reproducibility was determined using the intraclass correlation coefficient (ICC).The response rate was 100 %. Attitudes that registered the highest ICCs were Complacency (the belief that really serious ADRs are well documented by the time a drug is marketed) (physicians, ICC 0.84; nurses, ICC 0.70; pharmacists, ICC 0.99), and Diffidence (the belief that one would only report an ADR if one were sure that it was related to the use of a particular drug) (physicians, ICC 0.73; nurses, ICC 0.65; pharmacists, ICC 0.98). In most cases, there were no differences among the three groups of professionals in terms of attitudes and knowledge.The Horizontal continuous VAS is reliable to detect the knowledge and attitudes about ADRs.

Pub.: 01 Sep '12, Pinned: 25 Sep '17

Determinants of Under-Reporting of Adverse Drug Reactions

Abstract: A voluntary reporting system of adverse drug reactions (ADRs) is fundamental to drug safety surveillance but under-reporting is its major limitation. This bibliographic review sought to assess the influence of personal and professional characteristics on ADR reporting and to identify knowledge and attitudes associated with ADR reporting.A systematic review was conducted using the MEDLINE and EMBASE databases. We included papers that were published in English, French and Spanish, and covered a study population made up of health professionals. In each case, the following data were extracted: study population; workplace; study type; sample size; type of questionnaire; type of scale for measuring knowledge; response rate; personal and professional factors; and knowledge and attitudes (based on Inman’s ‘seven deadly sins’) associated with reporting.Based on a search of computerized databases, we identified a total of 657 papers in MEDLINE and 973 in EMBASE. In all, the review covered 45 papers that fulfilled the inclusion criteria. Medical specialty was the professional characteristic most closely associated with under-reporting in 76% of studies involving physicians. Other factors associated with under-reporting were ignorance (only severe ADRs need to be reported) in 95%; diffidence (fear of appearing ridiculous for reporting merely suspected ADRs) in 72%; lethargy (an amalgam of procrastination, lack of interest or time to find a report card, and other excuses) in 77%; indifference (the one case that an individual doctor might see could not contribute to medical knowledge) and insecurity (it is nearly impossible to determine whether or not a drug is responsible for a particular adverse reaction) in 67%; and complacency (only safe drugs are allowed on the market) in 47% of studies.While personal and professional factors display a weak influence, the knowledge and attitudes of health professionals appear to be strongly related with reporting in a high proportion of studies. This result may have important implications in terms of public health, if knowledge and attitudes are viewed as potentially modifiable factors.

Pub.: 20 Nov '12, Pinned: 25 Sep '17

Factors that Influence Under-Reporting of Suspected Adverse Drug Reactions among Community Pharmacists in a Spanish Region

Abstract: Background: The spontaneous reporting system is the most efficient warning system of adverse drug reactions (ADRs). Pharmacists can play an important role in the detection and reporting of ADRs. The factors that affect under-reporting among these professionals are unknown in Spain.Objective: To identify the factors that influence community pharmacists’ ADR under-reporting in Navarra, a Northern Spanish region.Methods: A case-control study was conducted on a population of 802 community pharmacists working in Navarra. Cases were pharmacists who had reported at least two ADRs to the region’s drug surveillance unit between 2003 and 2005 and who agreed to participate in the study (18/20; 90%). A random sample of 60 controls was selected from the 762 pharmacists who had not reported any ADR during the same period of time.Results: Factors positively associated with ADR reporting were age, years of work experience as a pharmacist, participation in educational activities related to the detection and resolution of drug-related problems, the habit of detecting ADRs as part of pharmacists’ duties, having the basic knowledge needed to report ADRs, and disagreement with the common belief among healthcare professionals that ’to report an ADR it is necessary to be sure that the reaction is related to the use of a particular drug’. The most frequently mentioned reasons for not reporting ADRs were the ADR is not serious, the ADR is already known, uncertainty concerning the causal relationship between the ADR and the drug, forgetting to report the ADR and a lack of time.Conclusions: Pharmacists’ knowledge, beliefs, behaviour and motivation play an important role in ADR reporting. Under-reporting might be improved through activities focused on modifying such factors.

Pub.: 03 Jan '13, Pinned: 25 Sep '17

Effect of an educational intervention to improve adverse drug reaction reporting in physicians: a cluster randomized controlled trial.

Abstract: The yellow-card scheme continues to be one of the principal methods for signal generation in pharmacovigilance. Nevertheless, under-reporting, one of its disadvantages, delays alert signals and has a negative influence on public health. Educational interventions in pharmacovigilance may have a positive impact on the spontaneous reporting of adverse drug reactions (ADRs).To assess the duration of the effect and effectiveness of an educational intervention in pharmacovigilance designed to improve ADR reporting in a robust pharmacovigilance system.A spatial, cluster randomized controlled trial was conducted covering all National Health System physicians in the northwest of Spain and targeting those who were actively engaged in clinical practice (n = 7,498). Of these, 2,120 were assigned in three spatial clusters to the intervention group (six hospitals and 138 primary care centers) and 3,614 in four clusters to the control group (seven hospitals and 267 primary care centers). The educational intervention consisted of two complementary approaches--one active (group sessions), the other passive (educational material, reporting form)-implemented from November 2007 to December 2008, with a follow-up period of 8 months.Intervention participation was 53.7 % in a hospital setting and 60.5 % in primary care settings. ADR reporting in the intervention group increased by 65.4 % (95 % confidence interval [CI]: 8.2-153.4) across the follow-up. The ADR reporting rate per 1,000 physicians/year in the intervention group rose from 28.1 to 39.6 following the intervention (51.7 and 27.4 in the first and second 4-month period, respectively). For the intervention group, relative risk (RR) was 2.31 (95 % CI: 1.46-3.68) and 1.04 (95 % CI: 0.61-1.77) in the first and second 4-month period, respectively adjusted to baseline values. There was an increase in unexpected ADR reporting (RR 2.06, 95 % CI 1.19-3.55).Pharmacovigilance educational interventions that have proved effective can be successfully applied in different geographical areas. A high baseline notification rate could account for the educational program having a moderate effect.

Pub.: 30 Dec '14, Pinned: 25 Sep '17

Safety Alerts: An Observational Study in Portugal.

Abstract: The information that is available when marketing authorizations are approved is limited. Pharmacovigilance has an important role during the postauthorization period, and alerts published by national authorities allow health care professionals to be informed about new data on safety profiles. This study therefore sought to analyze all safety alerts published by the Portuguese National Authority of Medicines and Health Products I.P. (INFARMED).We conducted an observational study of all alerts published on the INFARMED website from January 2002 through December 2014. From the data included in the alerts, the following information was abstracted: active substance name (and trade name), event that led to the alert, and the resulting safety measures. Active substances were classified according to the Anatomical Therapeutic Chemical (ATC) code.A total of 562 alerts were published, and 304 were eligible for inclusion. The musculoskeletal system was the ATC code with more alerts (n = 53), followed by the nervous system (n = 42). Communication of the information and recommendations to the health care professionals and the public in general was the most frequent safety measure (n = 128), followed by changes in the Summary of the Product Characteristics and package information leaflet (n = 66). During the study period, 26 marketing authorizations were temporarily suspended and 10 were revoked.The knowledge of the alerts published during the postmarketing period is very useful to the health care professionals for improving prescription and use of medicines and to the scientific community for the development of new researches.

Pub.: 11 Aug '15, Pinned: 25 Sep '17

Strategies to improve adverse drug reaction reporting: a critical and systematic review.

Abstract: Underreporting is the major limitation of a voluntary adverse drug reaction (ADR) reporting system. Many studies have assessed the effectiveness of different interventions designed to reduce underreporting.We aimed to conduct a critical review of papers that assessed the effectiveness of different strategies to increase ADR reporting, regardless of the health professionals or patients included.Scientific papers were selected after a search of the MEDLINE-PubMed and EMBASE scientific databases up to 7 December 2010.We included papers in English, French or Spanish that analysed an intervention aimed at increasing the number of reported ADRs, and quantify the results of the intervention in terms of number of reports.The abstracts retrieved in both computerized searches were reviewed independently by two of the authors. Initially selected papers were thoroughly read to evaluate if they met inclusion and exclusion criteria. Data in finally selected papers were independently extracted by both authors and set in pre-designed tables. A third author took the final decision in case of disagreement. For each study, we analysed study design, type of intervention, assessment period, and results of the intervention.Of the 4,221 papers located that fulfilled the search criteria, 43 met the selection criteria. With the exception of one study, the interventions assessed were deemed to be effective. The vast majority of papers displayed methodological and formal limitations that lowered the grade of evidence. Multiple interventions seem to have had more impact than did single interventions. There were very few cases in which interventions were designed on the basis of inappropriate attitudes and mistaken beliefs about ADRs.In general, there is a need for studies of better methodological quality in this topic, so that more evidence of the effectiveness of the respective strategies can be collected for the purpose of improving ADR reporting by health professionals. It is probable that multiple interventions cause greater increases in the ADR reporting rates than single.

Pub.: 04 May '13, Pinned: 25 Sep '17

Spontaneous adverse drug reaction reporting by patients in Canada: a multi-method study-study protocol.

Abstract: Monitoring adverse drug reactions (ADRs) through pharmacovigilance are vital to patient safety. Spontaneous ADR reporting is one method of pharmacovigilance, and in Canada all reporter types admitted to report an ADR to the Canadian Vigilance Program at Health Canada. Reports are submitted to Health Canada by post, telephone, or via the internet. The Canada Vigilance Program electronically records submitted information to detect medication safety alerts. Although previous studies have shown differences between patients and healthcare professionals (HCPs) on the types of drugs and reactions reported, relatively little is known about the importance of patient reports to pharmacovigilance activities. This article proposed a multi-method approach to evaluate the importance of patient ADR reporting on pharmacovigilance activities, by systematically review the available literature, comparing patient-versus HCPs-generated ADR reports that were submitted to the Canada Vigilance Program, and exploring patient views and experiences regarding the Canadian ADR reporting system.Guided by a risk-perception theoretical lens, the proposed multi-methods research study will involve three phases. Phase I is a systematic review of all studies that analyse the factors influence ADR reporting by patients to the pharmacovigilance schemes. Phase II is a descriptive statistical analysis of all ADR reports received by the Canada Vigilance Program database between 1 January 2000 and 31 December 2014 from patients and HCPs to compare ADRs reported by patients with those reported by HCP reports in terms of ADR seriousness, ADR classification by system organ class, and the medication involved based on the anatomical therapeutic class system. In phase III, an interpretative descriptive approach will be used to explore patient's views and experiences on ADR reporting and usability of the Canadian Vigilance ADR report. Participants will be purposefully selected to ensure diverse backgrounds and experiences. Interviews will be digitally-recorded, transcribed verbatim, and inductively analysed to identify themes. Patients will be interviewed until theoretical saturation is achieved.Findings from this research will highlight the role of the patients in directly reporting ADRs, and provide information that may guide streamline and optimizing patient ADR reporting. Policy makers, public health officials, and regulatory agencies will require this critical information in order to improve medication safety in Canada and worldwide.

Pub.: 31 Mar '16, Pinned: 25 Sep '17

Perspectives on the Emergence of Pharmacovigilance in Public Health Programmes in South Africa

Abstract: Pharmacovigilance in South Africa was formalised in 1987 with the creation of the first pharmacovigilance centre in Africa. This pharmacovigilance centre subsequently became a full member of the World Health Organization (WHO) Collaborating Centre for International Drug Monitoring in 1992. In 2004, pharmacovigilance received a major boost with the roll-out of the South Africa antiretroviral treatment (ART) programme and the establishment of a National Pharmacovigilance Centre for Public Health Programmes (NPC) within the National Department of Health (NDOH). The NPC’s activities maintain a special focus on public health pharmacovigilance, monitoring patient safety in important treatment programmes such as TB, HIV and others. In comparison, pharmacovigilance, assessing the risk–benefit profile of registered medical products in both the pre- and post-approval periods, continues to be conducted by the Medicines Control Council (MCC). This article provides past, current and future perspectives of pharmacovigilance in the South African public health programmes. These were informed by the review of published articles, international and regional reports, health law and policy documents, as well as strategic plans and reports from within the South African NDOH. South Africa now understands that the benefit–harm ratio of medicines is a dynamic variable that has to be monitored continuously. Reconceptualising the pharmacovigilance system in South Africa to focus on treatment programmes and individual patients has gradually set the stage for a holistic system and established a decentralised but structured and highly participative national pharmacovigilance programme that significantly benefits public health and patient care.

Pub.: 11 Jun '16, Pinned: 25 Sep '17

Improving Drug Safety: from Adverse Drug Reaction Knowledge Discovery to Clinical Implementation

Abstract: Adverse drug reactions (ADRs) are a major public health concern, causing over 100,000 fatalities in the United States every year with an annual cost of $136 billion. Early detection and accurate prediction of ADRs is thus vital for drug development and patient safety. Multiple scientific disciplines, namely pharmacology, pharmacovigilance, and pharmacoinformatics, have been addressing the ADR problem from different perspectives. With the same goal of improving drug safety, this article summarizes and links the research efforts in the multiple disciplines into a single framework from comprehensive understanding of the interactions between drugs and biological system and the identification of genetic and phenotypic predispositions of patients susceptible to higher ADR risks and finally to the current state of implementation of medication-related decision support systems. We start by describing available computational resources for building drug-target interaction networks with biological annotations, which provides a fundamental knowledge for ADR prediction. Databases are classified by functions to help users in selection. Post-marketing surveillance is then introduced where data-driven approach can not only enhance the prediction accuracy of ADRs but also enables the discovery of genetic and phenotypic risk factors of ADRs. Understanding genetic risk factors for ADR requires well organized patient genetics information and analysis by pharamacogenomic approaches. Finally, current state of clinical decision support systems is presented and described how clinicians can be assisted with the integrated knowledgebase to minimize the risk of ADR. This review ends with a discussion of existing challenges in each of disciplines with potential solutions and future directions.

Pub.: 30 Jul '16, Pinned: 25 Sep '17