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Background: Spontaneous reporting is the most used method to monitor post-marketing safety information. Although patient involvement in spontaneous reporting has increased overtime, little is known about factors associated with patients' adverse drug reaction (ADR) reporting. Aim: To identify and assess the sociodemographic characteristics, attitudes and knowledge that influence spontaneous reporting and the reasons associated with ADR underreporting by patients. Method: A systematic review was conducted according to PRISMA guidelines. A search on the MEDLINE and EMBASE scientific databases was performed to retrieve studies published between 1 January 2006 and 1 November 2022. Studies were included if they addressed knowledge and attitudes associated with ADR underreporting. Results: A total of 2512 citations were identified, of which 13 studies were included. Sociodemographic characteristics were frequently identified with ADR reporting in 6 studies, being age (3/13) and level of education (3/13) the most often reported. Older age groups (2/13) and individuals with higher level of education (3/13) were more likely to report ADRs. Underreporting was shown to be motivated by reasons related to knowledge, attitudes, and excuses. Ignorance (10/13), complacency (6/13), and lethargy (6/13) were the most frequent reasons for not reporting. Conclusion: This study highlighted the scarcity of research conducted with the aim of assessing ADR underreporting by patients. Knowledge, attitudes, and excuses were commonly observed in the decision to report ADRs. These motives are characteristics that can be changed; hence strategies must be designed to raise awareness, continually educate, and empower this population to change the paradigm of underreporting. [ABSTRACT FROM AUTHOR]

Background: Children and adolescents are at particular risk for adverse drug reactions (ADRs). We investigated physicians' perceptions on ADRs in pediatric routine care. Methods: In this exploratory study from April to November 2020, we invited physicians treating pediatric patients across Germany to complete an online questionnaire consisting mainly of closed questions. Results: Completion rate was 98% (127/129). Of all participants, 23% (29/127) stated they were not able to estimate how many of their pediatric patients experienced ADRs during drug therapy. The remaining physicians estimated that 7.5% (median; Q25/Q75 3%/20%) of their pediatric patients were affected by ADRs. Regarding counseling on ADRs, 61% (77/127) stated they do not ask regularly the extent to which parents want to be informed. In total, 26% (33/127) stated they avoid counseling on ADRs concerning commonly used approved therapies, whereas only 4% (5/127) did so concerning off-label use (P < 0.001). Altogether, 16% (20/127) stated they rather prescribe new medicines as they hope for better effectiveness; 72% (91/127) said they are cautious about doing so owing to yet unknown ADRs. Of all respondents, 46% (58/127) stated they do not report ADRs to the authorities. Concerning the black triangle symbol, a European pharmacovigilance measure, 11% (14/127) stated they knew it and 6% (7/127) stated they reported any suspected ADR for drugs with that symbol. Conclusions: Physicians' perspectives on ADRs were ambivalent: ADRs influenced their parent counseling and drug prescribing; yet, they struggled to estimate the impact of ADRs on their patients and were not aware of specific pharmacovigilance measures. [ABSTRACT FROM AUTHOR]

Background: Antimicrobial resistance (AMR) is no longer an expected upcoming threat; it has become a real public health concern, challenging all existing control tools, requiring multidisciplinary innovative solutions. Antimicrobial stewardship (AMS) programs require a set of tools and skills which can be put to service by health systems. However, there is an immense capacity gap between health systems in developed countries compared to developing ones. Systems in developed countries can rely on well-established laboratory services that can carry out microbial cultures and drug susceptibility tests. For many low- and middle-income countries (LMICs) with limited laboratory resources, it will take time and long-term investments to have systems that can timely and reliably perform laboratory-based AMR monitoring. In the meantime, we must explore the possibility of using other indirect measures that can provide estimates of the growing burden of AMR in settings with weak laboratory capacity. Objectives: In this point of view, we describe the potential contribution of the global pharmacovigilance (PV) networkers in the process of mapping and estimating the AMR burden in settings with less laboratory coverage and capacity, within the framework of AMS. Conclusion: The heavy toll caused by AMR will not be brought down by a singular interventional approach, it will require a multidisciplinary and multifaceted set of strategies. Closing the laboratory capacity gap will require tremendous long-term investments, but the AMR data scarcity is a question that cannot wait any longer. The global pharmacovigilance network is a robust scientific community with experience in tracking suspected adverse events caused by new and old medicinal products. As AMR becomes a global health issue, AMS programs need all available tools to address resistance data scarcity and inform appropriate of antimicrobials. The solid global pharmacovigilance infrastructure could play an important role in countries with limited laboratory coverage and capacity. [ABSTRACT FROM AUTHOR]

Purpose: Little is known about the informativeness of initial patient reports before they are reviewed by a pharmacovigilance centre (PVC). We aim to describe the patterns of patient adverse drug reaction (ADR) reporting in France and estimate the contribution of a review by a PVC assessor on the informativeness of these reports. Methods: A retrospective study was conducted on patient reports between July 2011 and July 2015. Informativeness of 16 key elements of information (including drug start and end date, duration of treatment, time to onset and duration of the ADR, outcome, medical history and concomitant medication) was assessed in initial reports before and after review by a pharmacovigilance assessor. Results: Overall, 240 reports concerning 522 ADR and involving 278 drugs were reported over this 4-year period. Mean number of available key elements of information in initial reports was increased from 11/16 to 15/16 after review of reports by the PVC. Time to onset and duration of the ADR were respectively available in only 51 and 58% of the reports before review compared to 83 and 90% after review. Medical history and concomitant medication were missing in 75% of the initial reports compared to less than 30% of the reports after review. Contacting the reporter enabled an increase of informativeness of most elements of information for more than 90% of the reports. Conclusion: Patient reports often need to be completed on key elements of information that are required to assess reports. Both upstream education of patients and downstream intervention of a pharmacovigilance assessor to complete missing information could help to enhance the informativeness of such reports. [ABSTRACT FROM AUTHOR]

Purpose: In March 2007, a legislative amendment was issued in Sweden compelling nurses to report all suspected adverse drug reactions (ADRs) to the national pharmacovigilance system. The aims of this study were to describe the status of ADR reporting, before and after the implementation of the legislative changes, and to describe the general characteristics of suspected ADRs reported by nurses. Methods: The Swedish pharmacovigilance system during the study period constituted six regional centres responsible for the handling of all spontaneous ADR reports within their region. In this study, we identified all individual ADR reports from 2005 and 2010, analysed in depth the ADR reports from two regional centres and collated information about the reporter and the nature of the reported ADR. Results: From the two regional centres, a total of 898 and 1074 reports were submitted in 2005 and 2010 respectively. Nurses submitted 31 % (275 reports) of the reports in 2005 and 24 % (260 reports) in 2010. Nurses' reporting of serious ADRs was 3 % (seven reports) in 2005 and 7 % (17 reports) in 2010 with reporting of unlabelled ADRs at 4 % (11 reports) in 2005 and 17 % (45 reports) in 2010. Most of the serious and/or unlabelled reactions were related to vaccine administration (14 reports in 2005 and 36 reports in 2010). Conclusions: The overall ADR reporting by nurses did not appear to increase after the change in reporting legislation. The proportion of serious and/or unlabelled ADRs reported by nurses did however appear to increase during the same period. Taken together, our data suggests that further pro-active measures should be considered in order to involve nurses in the reporting of suspected ADRs. [ABSTRACT FROM AUTHOR]

The European Union has thoroughly reformed its pharmacovigilance legislation in July 2012. Despite the changes, underreporting of adverse drug reactions remains a concern. This underreporting seems to be partially associated with incorrect customs and beliefs by healthcare professionals. Therefore, strengthening teaching and training in drug safety monitoring and reporting are essential. Sustained campaigns and education on pharmacovigilance are key elements to enhance its performance and effectiveness. In general, all healthcare professionals as well as patients should be more sensitized and empowered to contribute to pharmacovigilance programmes in order to improve drug safety. [ABSTRACT FROM AUTHOR]

The most common indication for treatment with warfarin is the prevention of ischemic stroke in patients with atrial fibrillation. Time in therapeutic range (TTR) is an important tool to evaluate the quality of anticoagulation treatment. The aim of this study was to investigate the quality of treatment and the incidence of bleeding complications in patients on warfarin treatment treated by the anticoagulation clinic in Helsingborg. This is the first study that has specifically focused on the spontaneous reporting of bleeding complications in a real-world population. A total of 4,400 patients with a total of 8,394 patient years were registered, in the database Journalia AVK, during the time period November 1, 2007 to November 1, 2010. The mean age was 72 years. TTR was 73.3 % for the whole population. 421 patients suffered from haemorrhagic events. The frequency of major and fatal bleedings and intracranial haemorrhage (ICH) were 1.6, 0.2 and 0.5 % per patient-year, respectively. A correlation between age and severe bleeding (major, fatal and ICH) ( p = 0.003) was seen, but no correlation between gender and severe bleeding ( p = 0.27). In 60 out of 455 bleeding events the complication had been reported to the anticoagulation clinic. At the anticoagulation clinic in Helsingborg the quality of warfarin treatment is good compared to previous results described in the literature, with regards to bleeding complications and efficacy. However, in our study, we confirm that the spontaneous reporting of bleeding complications related to warfarin is inadequate, and that review of patient records is needed to assure proper follow-up. [ABSTRACT FROM AUTHOR]

Purpose: Data mining in spontaneous reporting databases generates large numbers of signals of disproportionate reporting (SDRs) that need to be prioritised for assessment. The pharmacological relevance of drug-event associations is not considered in SDR prioritisation algorithms. This aimed to propose and test a pharmacological score for SDR prioritisation. Methods: The Pharmacological Score for SDRs Prioritisation (PS-SP) was developed using a Delphi approach. An expert group agreed that PS-SP should include general criteria concerning SDRs and criteria concerning pharmacological relevance, and that criteria should be weighted for their risk representation. Once defined, the PS-SP was tested for prioritisation of SDRs for extrapyramidal syndrome in the French Pharmacovigilance database; the SDR classification was compared to that obtained using a traditional disproportionality approach. Results: For a given drug, the general criteria retained were the reporting rate of the adverse drug reaction (ADR) and value of the 95% confidence interval (CI) lower boundary of the Reporting Odds Ratio (ROR). Pharmacological criteria consisted of the ADR reporting rate without concomitant at-risk drugs or those indicated for ADR treatment, and the value of the ROR 95% CI lower boundary as estimated in the subset of reports concerning drugs from the same therapeutic and then pharmacological class. Compared with traditional disproportionality, PS-SP prioritised specific drugs within congeners: metoclopramide, indoramin, and trimetazidine appeared as outliers within their classes; conventional antipsychotics had higher prioritisation than atypical antipsychotics. Conclusion: The pilot evaluation of PS-SP performed in extrapyramidal syndrome advocates for the use of pharmacological criteria in SDR prioritisation algorithms. [ABSTRACT FROM AUTHOR]

Despite the effectiveness of biologics approved for the treatment of rheumatoid arthritis, they have been associated with serious adverse events (AEs). Biologics are used under close supervision of health care professionals. In Portugal, they are legally required to report AEs occurring during the treatment. This study aims at investigating post-marketing safety monitoring data of biologics in Portugal by comparing the frequency of spontaneously reported adverse events between 2009 and 2011 with the frequency of such events in the summary of the product characteristics of each biologic. Sales data for biologics were obtained from IMS Health and converted into defined daily doses/1,000 inhabitants/day in order to estimate a proportion of the population treated. The frequency of AEs was estimated as the percentage of patients in which an AE may have occurred. The use of each biologic was estimated for adalimumab at 1,439 patients/year, etanercept 1,944 patients/year, and infliximab 3,211 patients/year. A total of 992 AEs were reported: 207 for adalimumab, 199 for etanercept, and 586 for infliximab. Of the 515 different spontaneously reported AEs, 194 were included for comparisons with the SPCs. Of those, 31 (16 %) were similarly frequent, and 163 (84.0 %) occurred less frequently compared with SPCs' data. These results suggest an insufficient post-marketing safety monitoring of biologics in Portugal. [ABSTRACT FROM AUTHOR]

Purpose: This study was conducted to evaluate relevant new information about ADRs reported in the Spanish paediatric population over a 6-year period. Methods: Adverse drug reactions (ADRs) for individuals aged 0-17 years reported to the Spanish Pharmacovigilance System from 2004 to 2009 were analysed with respect to time, age and sex, category of ADR [System Organ Class (SOC)], seriousness, suspected medicines [level 2 of the Anatomical Therapeutic Chemical (ATC) Classification System] and type of reporter. Results: In total, 4,279 ADR reports corresponding to 8,196 ADRs were analysed, approximately two ADRs per report. The rate of paediatric ADR reports in 2009 was 165 per million, of which nearly half (46 %) were for children (age group 2-11 years). Similar total numbers of ADRs were reported for boys and girls. The most frequent ADRs reported were from the following SOCs: general disorders and administration site conditions (34 %); skin and subcutaneous tissue disorders (15 %); nervous system disorders (14 %). Reports encompassed medicines from various ATC groups: vaccines and anti-infectives for systemic use (67 %); nervous system (9 %); respiratory system (9 %). On average, 37 % of ADRs were classified as serious. There were 33 fatal ADRs, and 35 % of the paediatric population associated with the ADR notifications required hospitalization or extended hospital stay. Conclusions: In Spain, ADR reporting rate in the paediatric population has increased since 2004. The proportion of suspected ADR reports related to vaccines was predominant, which highlights the important role played by nurses. ADR notification of congenital malformations in newborn infants highlights the need for joint action between the Spanish System of Pharmacovigilance of Medicines for Human Use (SEFV-H) and paediatricians, obstetricians and gynaecologists. The publication of safety reports by regulatory agencies is determinant for the increased number of ADR notifications. [ABSTRACT FROM AUTHOR]

Objective The aim of this study was to assess the situation regarding spontaneous adverse drug reaction reporting in the Czech Republic during a 5-year period (2005-2009). Setting descriptive study was conducted using the data from the Czech State Institute for Drug Control pharmacovigilance database. Methods The data referring to all spontaneous adverse drug reaction reports received, by the pharmacovigilance department of the Czech State Institute for Drug Control during 2005-2009 were collected, analysed and compared with data from the Slovak Republic, Denmark, and the United Kingdom. Main outcome measures The number of received spontaneous adverse drug reactions reports by year per 10,000 inhabitants, the seriousness and outcome of reactions, the reporting groups, and the top ten molecules which contributed to the highest number of reports. Results During the study period 2005-2009, the pharmacovigilance department of the State Institute for Drug Control received 7,708 spontaneous adverse drug reactions reports of which 73.6% were serious and 2.1% resulted in death. The number of spontaneous adverse drug reactions reports per 10,000 inhabitants ranged from 1.3 to 1.7, which was lower when compared with the number of reports from three other EU countries. The healthcare professionals contributed to 64.2% of the adverse drug reactions reports, whilst marketing authorization holders provided 35.5%, and finally patients with 0.3%. Vaccines, ketoprofen, amoxicillin, statins, and estradiol were amongst the top ten molecules that gave the highest number of spontaneous adverse drug reactions reports. Conclusions Our assessment of adverse drug reactions spontaneous reports received by the Czech Institute for Drug Control during 2005-2009 showed that the reporting rate is relatively low and remains constant over the 5 year period. More emphasis on academic/professional training is needed to educate all potential reporters on the mechanism of reporting of adverse drug reactions and to also emphasize the importance of the whole pharmacovigilance process. [ABSTRACT FROM AUTHOR]

This study was designed to investigate attitudes to and incentive for reporting adverse drug reactions (ADRs) in general and towards nurses as reporters of ADRs in particular in a sample of hospital physicians. A questionnaire was sent to 1,201 randomly selected hospital physicians. The main factors for the decision to report an ADR were the severity of the reaction, a reaction to a new drug, and an unusual reaction. The most important factor for refraining from reporting was that the reaction was well known. There were no significant differences between males and females or between age groups in these aspects. A majority were positive or neutral to nurses as reporters. Only 6% stated that their willingness to report ADRs would be affected in a negative way if nurses were involved in the program for reporting. The results of this survey showed that inclusion of hospital nurses as reporters will not decrease the reporting rate from the physicians. [ABSTRACT FROM AUTHOR]

Pharmacovigilance, defined by the World Health Organisation as ‘the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem’ plays a key role in ensuring that patients receive safe drugs. Our knowledge of a drug’s adverse reactions can be increased by various means, including spontaneous reporting, intensive monitoring and database studies. New processes, both at a regulatory and a scientific level, are being developed with the aim of strengthening pharmacovigilance. On a regulatory level, these include conditional approval and risk management plans; on a scientific level, transparency and increased patient involvement are two important elements. To review and discuss various aspects of pharmacovigilance, including new methodolgical developments. [ABSTRACT FROM AUTHOR]

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To investigate whether nurses could be a useful tool for improving the reporting rate of adverse drug reactions (ADRs). Furthermore, we wanted to study how physicians working at the study departments would respond to nurses as reporters of ADRs and if the reporting from the nurses affected the reporting rate from the physicians. Three departments of internal medicine and one unit for orthopaedics were selected for the study. Nurses with special drug responsibilities were invited to participate. At the start of the study period, the nurses received an introduction with background, objective, method and other practical issues concerning the study. After this, an education programme about ADR reporting, definitions, and ADR classification according to mechanism and organ system was given. To study their knowledge about and attitude towards ADRs, a questionnaire was handed out to the nurses. A questionnaire was also handed out to all physicians at the participating departments in order to investigate their attitude towards nurses as reporters of ADRs. Fifty-four nurses participated in the study. During the study period, a total number of 23 reports with 39 ADRs were sent to the regional centres by the nurses. Seventeen (74%) of the reports were assessed as serious. Eight of the 39 ADRs were unlabelled and all reports were considered appropriate. The reporting rate from the physicians during the study period was similar to the previous year, indicating that the nurses contributed with additional reports. At the end of the study, the nurses thought that they had enough knowledge to report ADRs. Sixty-eight percent of the physicians did not object to nurses being included as reporters of suspected ADRs. Adverse drug reaction reporting by nurses could improve the overall safety of drugs. [ABSTRACT FROM AUTHOR]

The purpose of this study was to investigate two different feedback alternatives to doctors reporting adverse drug reactions (ADRs) concerning (1) effects on reporting rates and (2) doctors’ opinions. When reporting an ADR during January through March 2006, doctors in the western part of Sweden were randomised according to working address to receive feedback I or feedback II. Feedback I consisted of the conventional mode of feedback. Feedback II consisted of the contents of feedback I supplemented with information on the reported drug from the regional drug information centre. A questionnaire was administered 2 weeks after the feedback. The doctors were asked to give their opinion on the feedback concerning amount of information, quality and overall impression on a 6-point scale, where 1 corresponded to too little/very bad and 6 to too much/very good. During the inclusion period and the 6-month follow-up period, additional ADR reports originating from receivers of either feedback I or II were identified and compared. Sixty-six doctors received feedback I, and 49 received feedback II. The number of doctors reporting more than once was greater in the group receiving feedback II (39% vs. 22%; P = 0.039). Feedback II was judged to contain more information than feedback I (4.1 ± 0.8 vs. 3.6 ± 0.9; P = 0.014). No difference between the feedback alternatives concerning doctors’ opinions on quality and overall impression could be detected. Sixty-five doctors (70%) stated that the content of the feedback letter could affect their willingness to report ADRs. The content of the feedback to doctors reporting ADRs may influence reporting rates. [ABSTRACT FROM AUTHOR]

To analyse and discuss the use and the safety profile of individual antiepileptic drugs (AEDs) in Italy. The AED safety data referred to the period January 1988–June 2005 and were obtained from the database of the Italian Interregional Group of Pharmacovigilance (GIF). This database collects all spontaneous reports of suspected adverse drug reactions (ADRs) from six Italian regions which are the main contributors to the Italian spontaneous reporting system. Individual AED consumption data (defined daily dose/1,000 inhabitants per day) in the GIF area and in the whole of Italy referred to the period January 2003-June 2005 and were derived from drug sales data (Institute for Medical Statistics Health). Phenobarbital was the most frequently used AED in the GIF area (4.26 DDD/1,000 inhabitants per day) followed by carbamazepine (1.97), valproic acid (1.33) and gabapentin (1.10). AED consumption in the whole of Italy showed a similar pattern. Gabapentin was the most frequently used AED among newer AEDs. In the GIF database 37,906 reports (up to June 2005) were present; 666 of them (1.76%) were associated with at least one AED (Anatomical Therapeutic Chemical code N03A). The AED with the highest number of reports was carbamazepine (208 reports) followed by phenobarbital (98), gabapentin (80), phenytoin (56), valproic acid (55), lamotrigine (51), oxcarbazepine (43) and vigabatrin (35). Use and toxicity profile were evaluated only for AEDs associated with at least 30 reports. Skin reactions were the most frequently reported ADRs, followed by haematological, general condition, hepatic, neurological and gastrointestinal adverse reactions. Phenobarbital, lamotrigine, carbamazepine and phenytoin had the highest percentage of skin reactions (69, 67, 60 and 54%, respectively). Many haematological reactions were reported for each AED; the highest percentage was related to valproic acid (25%). Vigabatrin was associated with the highest percentage of reactions related to hearing, vision and other senses (97%). Phenytoin and valproic acid had the highest percentage of hepatic reactions (30 and 20%), whereas gabapentin of nervous system, psychiatric, gastrointestinal and urinary reactions (26, 21, 21 and 14%, respectively) and phenobarbital of musculoskeletal reactions (13%). In Italy antiepileptic drug therapy appears to be still dominated by traditional drugs. Our analysis showed a different safety profile related to each AED. Some of the drug-adverse reaction associations discussed are not included in the Italian drug leaflets or have not been reported before in the literature. [ABSTRACT FROM AUTHOR]

Adverse drug reactions (ADRs) can involve all tissues and organs. Liver injuries are considered among the most serious and are a cause for concern among physicians and patients. To assess the extent of drug-induced liver injuries in Italy we compared the number of cases of hepatic ADRs with reports of all other drug-related reactions present in the same database. Spontaneous reports from six Italian Regions collected from January 1990 to May 2005 were analysed. Adverse reactions were classified according to WHO Adverse Reaction Terminology for causality assessment, and only those with “certain”, “probable” or “possible” causality assessment were included. Association between drugs and hepatic ADRs was assessed using the case/non case method, calculating the ADR reporting odds ratio (ROR) as a measure of disproportionality. On May 2005, the database contained 35,767 ADR reports, of which 11,829 were excluded because they were unclassifiable or unlikely in terms of causality assessment. Therefore, the analysis was carried out on 23,938 reports, of which 1,069 concerned hepatic ADRs (cases) and 22,869 concerned non-cases. The proportion of serious ADRs was about 40% in the overall database, and about 74% among cases. The drug classes with the highest number of cases were statins (ROR = 2.9, 95% CI 2.4–3.5), antiplatelet agents (ROR = 3.5; 95% CI 2.6–4.6), NSAIDs (ROR = 2.9; 95% CI 2.1–3.9) and macrolides (ROR = 1.7; 95% CI 1.2–2.3). Hepatic adverse drug reactions remain a serious concern for several drugs widely used in clinical practice. Monitoring hepatic enzymes on a monthly basis for the first 6 months of treatment has been suggested for patients taking medications known to be hepatotoxic. A better knowledge of the epidemiology and mechanisms of hepatic ADRs may contribute to minimising their occurrence. [ABSTRACT FROM AUTHOR]

Purpose: To assess the effect of a small economic inducement on the rate of spontaneous reporting of adverse drug reactions (ADRs) and the attitudes of general practitioners and physicians towards reporting of ADRs. Method: One intervention and one control county were selected for the study. Written information about the main purpose of spontaneous reporting of ADRs was personally addressed to all physicians in the two counties. The information was identical, except for the addition that during a period of 6 months two lottery tickets would be given to the receivers in the intervention area with the standard personal feedback to the reporter of the ADR. After the 6-month study period, the actual number of reported ADRs and the seriousness of the reported ADRs were assessed. To investigate the attitude towards this stimulation of reporting, a questionnaire was addressed to all physicians within the intervention area (IA). Results: From the IA a total number of 57 ADR reports were received containing 62 suspected ADRs, 40% of which were assessed as serious reactions. From the control area (CA), 49 reports containing 50 suspected ADRs were received, 32% of which were assessed as serious reactions. The increase of ADR reports from the IA compared to the same time period the previous year was 59% as compared to an unchanged reporting from the CA. Of those responding to the questionnaire, 80% did not believe that a small economic bonus would be a useful tool to improve the reporting rate. Conclusion: A small economic inducement is associated with an increase in the reporting of suspected ADRs. [ABSTRACT FROM AUTHOR]

Objective. To test a method for registration of adverse drug reactions (ADRs) resulting in hospital admission and of ADRs occurring during hospital stay. Spontaneous reporting was compared with data from patient interview. Methods. Spontaneous reporting of ADRs by nurses and physicians, as well as patient interviews by pharmacists. This pilot project was carried out in the geriatric ward of the Ghent University Hospital over a period of 8 months in order to develop suitable registration forms and to test feasibility. Causality, severity, type and level of intervention of the reported ADRs were analysed. Reports from physicians and nurses were compared with the data obtained by patient interviews. Results. During the 8 months, for 168 patients, 12 spontaneous reports were received from physicians and nurses. Fifty-six of these patients were interviewed and 32 ADRs were reported. Only 2 ADRs detected by patient interview were also reported spontaneously. The interviews of the 56 geriatric patients indicated that 20% of them were admitted to the hospital because of an ADR. ADRs occurred during hospital stay in another 20% of those patients. Conclusion. Spontaneous reporting by physicians and nurses revealed considerably fewer ADRs than patient interview by pharmacists. Physicians and nurses reported the more serious ADRs that occurred during hospital stay, whereas the interviews revealed more ADRs that caused hospital admission. Our data confirm that ADRs are an important cause of hospital admission of geriatric patients and occur frequently during their hospital stay. [ABSTRACT FROM AUTHOR]

Objectives: This study was designed to investigate attitudes of general practitioners (GPs) and hospital physicians in Sweden towards spontaneous reporting of adverse drug reactions (ADRs). Method: Two areas in the northern region of Sweden were selected for the study. A knowledge and attitude questionnaire followed by a reminder letter 2 weeks later was addressed to all GPs and hospital physicians in the study areas. Result: The total response rate from the study areas was 748 of the 1274 questionnaires sent out (58.7%). Of those who responded, 236 were GPs, 433 were hospital physicians and 79 had other positions. Of the responders, 252 stated that they had never reported any ADR and 488 that they had reported at least once in their career. Issues that came out as important in the decision to report or not to report were whether the reaction was considered well-known or not, the severity of the reaction, hesitance to report only on suspicion, lack of knowledge of existing rules, giving priority to other matters and lack of time to report ADRs. Only minor differences in these regards were observed between male and female physicians. Conclusion: Our investigation shows that the physicians in northern Sweden have a fairly good knowledge about the existing rules for reporting ADRs in Sweden. However, the attitudes leave room for considerable under-reporting due to matters related mainly to the medical impact of the reaction and of reporting it, but also to the scientific "paradox" of reporting only on suspicion and of course due to lack of time in the health care setting. [ABSTRACT FROM AUTHOR]

Objectives: To analyse from spontaneous reporting data the renal adverse reactions associated with the use of nimesulide. Methods: Case reports were obtained from a Northern Italian Regional database (Veneto Pharmacovigilance System), containing all the spontaneous reports filed between 1988 and 1997. The Veneto Region is the principal contributor to the Italian spontaneous reporting system, with an annual report rate of approximately 17 per 100 000 inhabitants. The clinical records of hospitalized patients were also analysed. Results: Of the 120 reports associated with oral nimesulide, 11 referred to suspected renal adverse reactions. The drug was taken by ten patients for a short period. All the patients discontinued the therapy and hospitalization was required in six cases. Other risk factors were identified in six cases. Discussion: Together with the new insights into the possible consequences of renal cyclooxygenase-2 (COX-2) inhibition, the reported cases should draw the attention of doctors and patients to the importance of recognizing any possible signs of renal impairment during nimesulide therapy, although only extensive epidemiological data can define the real impact of its renal toxicity. [ABSTRACT FROM AUTHOR]

This survey was carried out to test physicians' knowledge of the principles of adverse drug reaction (ADR) reporting. Structured interviews were carried out with 500 physicians in all regions of the Czech Republic. The questions were aimed at observing ADR, the obligation and the means of reporting, and the source of drug information used in practice. Ninety percent (n=448) reported that they faced ADR in their practice, and 92% (n=458) were aware of the obligation to report, but most (180 general practitioners, 138 specialists) were unclear as to what should be reported. Knowledge of the subject of ADR reporting was significantly lower (18.4%) among physicians who used primarily the drug information provided by pharmaceutical companies than among those who used other information sources (38.4%). The low level of knowledge of ADR spontaneous reporting system found in our study is one of the reasons for the substantial underreporting of ADR in the Czech Republic compared to other European countries. [ABSTRACT FROM AUTHOR]

Since the withdrawal of phenformin in 1978, the use of metformin has increased from 13,500 to 22,00 patient years/year. During the period 1977-91 a total of 18 cases of metformin - associated acidosis was reported, of which 16 had lactic acidosis. The incidence of reported acidosis and lactic acidosis decreased from 1.50 cases per 10,000 patient years in 1977-81 to 0.24 cases per 10,000 patient years 1987-91, probably due to lower doses doses and reduced usage in the very old. All the reports described patients with several other concomitant diseases, mainly cardiovascular and renal, when the acidosis was diagnosed. It is important continuously to re-evaluate metformin therapy and to stop treatment at the onset of impaired renal or cardiovascular function. [ABSTRACT FROM AUTHOR]