Improving reporting of adverse drug reactions: Systematic review (original) (raw)
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Improving the Reporting of Adverse Drug Reactions
Drug Safety, 2008
Background: Adverse drug reaction (ADR) reporting systems are the basic Abstract component for comprehensive postmarketing surveillance of the risk of druginduced adverse effects. The aim of this study was to evaluate the effectiveness of educational outreach visits aimed at improving ADR reporting by pharmacists. Methods: The study population comprised all pharmacists working in a catchment area covered by Portugal's Northern Regional Health Authority. Using unequal randomization, four spatial-clusters were assigned to the intervention group (n = 342) and eleven to the control group (n = 1091). The intervention took the form of 1-hour long educational outreach visits tailored to training needs detected in a previous study, with a 13-to 16-month follow-up period (March-June 2004 through June 2005). This study is registered as an international standard randomized controlled trial, number ISRCTN45894687. Results: At baseline, ADR reporting rates (per 1000 pharmacist-years) did not differ significantly between the intervention and control groups (32.28 vs 29.16). The adjusted increase in ADR reporting attributable to the intervention was 275.63 per 1000 pharmacist-years (95% CI 162.15, 389.12; relative risk [RR] = 5.87, 95% CI 1.98, 17.39). The intervention succeeded in multiplying the reporting rate of: serious ADRs, 10-fold (RR = 9.79; 95% CI 2.24, 42.66); unexpected ADRs, 4-fold (RR = 4.41; 95% CI 1.11, 17.53); high-causality ADRs, 9-fold (RR = 8.67; 95% CI 2.12, 35.42); and new drug-related ADRs, 9-fold (RR = 9.33; 95% CI 2.53, 34.40). While the greatest effect was registered during the first 4 months post-intervention, differences remained statistically significant for 8 months. Conclusions: Educational outreach visits improve ADR reporting by pharmacists in terms of quantity and relevance.
Promoting adverse drug reaction reporting: comparison of different approaches
Revista de saúde pública, 2016
OBJECTIVE To describe different approaches to promote adverse drug reaction reporting among health care professionals, determining their cost-effectiveness. METHODS We analyzed and compared several approaches taken by the Northern Pharmacovigilance Centre (Portugal) to promote adverse drug reaction reporting. Approaches were compared regarding the number and relevance of adverse drug reaction reports obtained and costs involved. Costs by report were estimated by adding the initial costs and the running costs of each intervention. These costs were divided by the number of reports obtained with each intervention, to assess its cost-effectiveness. RESULTS All the approaches seem to have increased the number of adverse drug reaction reports. We noted the biggest increase with protocols (321 reports, costing 1.96 € each), followed by first educational approach (265 reports, 20.31 €/report) and by the hyperlink approach (136 reports, 15.59 €/report). Regarding the severity of adverse drug...
Background: Adverse drug reactions (ADRs) are a well-recognized public health problem and a major cause of death and hospitalization in developed countries. The safety of a new drug cannot be established until it has been on the market for several years. Keeping drug reactions under surveillance through pharmacovigilance systems is indispensable. However, underreporting is a major issue that undermines the effectiveness of spontaneous reports. Our work presents a systematic review on the use of information systems for the promotion of ADR reporting. The aim of this work is to describe the state of the art information systems used to promote adverse drug reaction reporting.
2016
Background: In India, the system of reporting Adverse Drug Reactions (ADRs), Pharmacovigilance (PV), has not progressed well and it’s still in infancy stage. This can be determined by the reporting of only 1% of ADRs as compared to 5% of the other countries of world. The major drawback of the slow progress of PV system is the lack of sufficient knowledge towards it by healthcare professionals. Objective: To evaluate the knowledge and practice of ADR reporting by physicians and pharmacists in community settings.Method: A self-administered questionnaire was prepared. After explaining the intention of survey, it was distributed to pharmacists and doctors (General practitioners, MDs, and Surgeons), in the community setting. Participants were requested to fill out the questionnaire. Healthcare professionals, who did not wish to participate in the study, were excluded.Result: A total of 110 questionnaire were circulated in the two major cities of Gujarat, namely Ahmedabad and Gandhinagar,...
2005
Background: Since the 1960's, a world-wide system of spontaneous adverse drug reaction (ADR) reporting has provided a centralised means for monitoring post-marketing drug safety. However, under-reporting to this system remains a major problem. In addition, whether consumers should participate is controversial and largely unexplored. Aim: This study investigated whether the intervention of a pharmacist-operated telephone helpline and/or an educational workshop could increase the number, quality and breadth of ADRs reported to the Australian Adverse Drug Reaction Advisory Committee (ADRAC) by consumers and health professionals (HPs) and how the results of each group would compare. Method: Two independent studies were conducted. In the HP study, 381 doctors, nurses, pharmacists, dentists and complementary medicine (CM) practitioners were recruited and randomly assigned to one of four intervention groups: 1) access to the ADR Reporting Hotline; 2) small-group workshop on ADR reporti...
Analysis of reporting of adverse drug reactions in a tertiary care hospital: One year survey
IP Innovative Publication Pvt. Ltd, 2020
Introduction: Adverse drug reactions (ADRs) are inevitable component of drug therapy which negatively affects quality of life, increases physician visits, hospitalizations and even death. It also poses economic burden on health care system. Aim: To ascertain various ADRs occurring in our hospital; this can generate a notion to inculcate the culture of ADR reporting in view of improving the health safety of patients. Materials and Methods: A retrospective, record based study, conducted by analyzing ADR forms, reported over a period of 12 months and were further analyzed for demographic details, organ system involved, types of ADRs, suspected drugs, causality, severity, outcome and reporters qualification. Results: A total of 532 ADR reporting forms were studied in which 563 types of ADRs were seen. Male preponderance (57.1%) was seen with majority of ADRs between 40-59 yrs. of age (33.2%). Gastrointestinal tract (47.24%) was most commonly affected with abdominal pain, diarrhea and nausea. Antibiotics were the most common suspected group of drugs. Majority of ADRs were probable/likely (46.35%) and were of moderate category (56.12%). Most of the patients recovered/resolved (91.35%) from the reaction and majority of reports was from non-health professionals/consumers (53.19%). Conclusions: Results drawn from this study suggests reinforcing Pharmacovigilance Programme of India as it can help in minimization/prevention of ADRs through early detection. Also, it would be helpful if the system of ADR monitoring is designed in such a way that it encourages health care professionals to report ADRs spontaneously and intensively through a proper communication channel for ensuring patient safety.
Objectives: To measure awareness about adverse drug reaction (ADRs) reporting among doctors, pharmacists and nurses and to determine reasons of ADRs under‑reporting in Pakistan. Methods: In present study, a self‑administered questionnaire was used to measure the awareness level about ADRs reporting among health care professionals (HCPs) of Pakistan. This was a cross sectional study. Results: Out of the respondents 51 % were physicians, 29.7 % pharmacists and 19.3 % were nurses. 65.5 % of HCP population observed ADRs, out of which only 57.4 % reported these in their respective hospitals. About 77.3 % of population understood the importance of reporting ADRs while 67.3 % of population agrees that pharmacists are chief personnel for the development of system. 71.8 % of HCPs agrees that ADRs are not reported because Commu‑ nity pharmacy lacks legally qualified pharmacists. Only 14.3 % of HCPs population knows that there is any ADR report‑ ing organization in Pakistan. Conclusion: The study recommends the need of such reporting system and more than half of the studied popula‑ tion agreed that pharmacists are required in developing such system.
Experiences with Adverse Drug Reaction Reporting by Patients
Drug Safety, 2012
Background: Patients are important stakeholders in pharmacovigilance; however, little formal evaluation has been undertaken of existing patient reporting schemes within and outside Europe. If patient reporting is to be recognized as beneficial for pharmacovigilance and further optimized, methodology and best practice must be internationally shared and promoted. Objective: This study aims to review the methods of patient reporting of adverse drug reactions (ADRs) in 11 countries worldwide and to compare different aspects of their experiences. Methods: A survey based on telephone interviews, e-mail discussions and field visits of existing practices in consumer and patient reporting of ADRs was performed in the second half of 2010.