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At least 19 recordsLinked to original sources
PubMed1988

Adverse reactions to isotretinoin. A report from the Adverse Drug Reaction Reporting System.

Between October 1982 and June 1985 the Adverse Drug Reaction Reporting System received reports of 104 suspected adverse reactions occurring in 93 patients who took isotretinoin. Adverse reactions involving the skin and mucous membranes (29 reports), central nervous system (23), musculoskeletal system (12), pregnancy (11), and eyes (8) were most commonly reported. Severe headache was the most frequently reported adverse reaction (15 reports). In four cases headaches were attributed to pseudotumor cerebri. Some of the reported reactions, for example, a disulfiram (Antabuse)-like reaction and oculogyric crisis, have not been described previously in the literature. Other reports, such as congenital malformations, serve to emphasize some of the serious reactions that are known to occur. These spontaneous reports of adverse reactions associated with isotretinoin use, together with the literature we review, may help alert physicians to the diverse spectrum of adverse reactions that may develop in patients taking isotretinoin.

Abnormalities, Drug-Induced↗
PubMed2002

Developing and integrating an adverse drug reaction reporting system with the hospital information system.

We have developed an adverse drug reaction (ADR) reporting system integrating it with Hospital Information System (HIS) of the University of Tokyo Hospital. Since this system is designed with JAVA, it is portable without re-compiling to any operating systems on which JAVA virtual machines work. In this system, we implemented an automatic data filling function using XML-based (extended Markup Language) files generated by HIS. This new specification would decrease the time needed for physicians and pharmacists to fill the spontaneous ADR reports. By clicking a button, the report is sent to the text database through Simple Mail Transfer Protocol (SMTP) electronic mails. The destination of the report mail can be changed arbitrarily by administrators, which adds this system more flexibility for practical operation. Although we tried our best to use the SGML-based (Standard Generalized Markup Language) ICH M2 guideline to follow the global standard of the case report, we eventually adopted XML as the output report format. This is because we found some problems in handling two bytes characters with ICH guideline and XML has a lot of useful features. According to our pilot survey conducted at the University of Tokyo Hospital, many physicians answered that our idea, integrating ADR reporting system to HIS, would increase the ADR reporting numbers.

Adverse Drug Reaction Reporting Systems↗
PubMed1986

Adverse drug reaction reporting system: developing a well-monitored program.

The spontaneous reporting of adverse drug reactions (ADRs) at the St. John's Hospital and Memorial Medical Center was well below that reported in the literature. After review of procedures for reporting of ADRs at these institutions, the authors developed a system that was approved by their joint P & T Committee. The ADR reporting program developed uses concurrent monitoring of most hospital inpatients and a retrospective review of all emergency room patients. In the year after program implementation, 162 ADR reports were documented. From this program, a group of serious ADRs to one agent was identified and reported, both to the Food and Drug Administration and to the manufacturer. A well-developed ADR monitoring program may lead to heightened physician and nurse awareness and early problem identification, possibly decreasing morbidity for hospitalized patients.

Documentation↗
PubMed2002

Physicians' knowledge and attitudes regarding the spontaneous reporting system for adverse drug reactions.

The spontaneous reporting system (srs) is the most important early warning system of adverse drug reactions. As there is serious under-reporting we studied the respective knowledge and attitudes of two samples of physicians in Germany. Five hundred randomly sampled physicians and 815 physicians who had actually reported an ADR were included; the response rate to the mail questionnaire was 51.4 and 43.9%, respectively; 61.3% said to have reported at least one case in their life. As many as 75-85% of physicians said never to have sent an ADR report to the governmental or professional reporting systems. Reporting to pharmaceutical companies, on the other hand, has been substantially better. Sixty-eight and two-tenths percent indicated to have suspected an ADR without reporting it. Major reasons for not reporting were: ADR well known (75.6%), too trivial (71.1%), causality uncertain (66.3%). The ADR with the highest probability of being reported were serious unknown adverse reactions of a new drug (81.1%) or an established drug (72.9%) and serious known reactions to a new drug (65.2%). Almost 20% of the physicians admitted to not know the spontaneous reporting system and 30% to not know how to report; 54% would rather report an ADR if therapeutic advice was offered. The results indicate that the traditional ways of advertising the srs and communicating with physicians could be improved. Proactive services and professional marketing of srs are needed to reduce underreporting.

Adult↗
PubMed1991

An adverse drug reaction reporting system as an integral part of a drug-usage evaluation program.

The Adverse Drug Reaction program at CSMC identifies patients whose charts have been encoded with an ICD-9 code of E930 through E949, inclusively. Incidences per drug or drug category have permitted the Department of Pharmacy, acting through the Pharmacy and Therapeutics Committee, to review patient charts, identify trends and risk factors, and subsequently develop usage criteria for DUE studies. It is hoped that these activities will result in an improvement in usage of these drugs and a reduction in adverse drug reactions to them.

Digoxin↗
PubMed1997

[Clostridium difficile associated diarrhea in cephalosporin administration: experiences of the Swiss Adverse Drug Reaction Reporting System 1981-1995].

20-25% of antibiotics-associated diarrhea cases are caused by infection with toxin-producing Clostridium difficile. Since the advent of broad-spectrum antibiotics Clostridium difficile-associated diarrhea has been observed both in ambulatory practice and as a nosocomial infection in medical and nursing institutions. Clindamycin, aminopenicillins, and cephalosporines are by far the most common triggers for this infection. We reviewed all cases of Clostridium difficile-associated diarrhea due to cephalosporines which were reported to the Swiss Drug Monitoring Center (SANZ) between 1981 and 1995. 87 cases were reported (0.9% of 9720 spontaneous reports in this period), 69 (79%) of which were considered to be due to cephalosporines. In 74% of the cases the indication for the antibiotic treatment was an upper respiratory tract infection. 61 patients received cephalosporines by oral route and 9 patients by intravenous route. Two patients had to be hospitalized. There were no deaths. The pathogenesis, clinical picture, and therapy of Clostridium difficile-associated diarrhea is discussed. We conclude from these cases in the spontaneous reporting system of SANZ that Clostridium difficile infection due to cephalosporines is a frequent occurrence. Because the course can be severe, cephalosporines should be used restrictively.

Adolescent↗
PubMed1987

Adverse drug reaction reporting: a working system.

Adverse drug reactions (ADRs) are a severe problem. Up to 30% of hospitalized medical patients may have an ADR, and up to 5% of hospitalizations may be caused by an ADR. Reporting systems that track these reactions vary widely as to their capture rates. In a 12-month period, with the aid of the Medical Record Department at St. Elizabeth Hospital Medical Center, 150 adverse drug reactions were catalogued. Fifty-eight of these resulted in admission, while 92 occurred during hospitalization. Cardiovascular agents and antibiotics produced the most reports. Reactions are evaluated and tabulated by the Department of Pharmacy, and subsequently presented to the Pharmacy (P&T) Committee as part of the quality assurance program, which meets the standards mandated by the Joint Commission on Accreditation of Hospitals. The reporting system is described in this article.

Drug-Related Side Effects and Adverse Reactions↗
PubMed1986

An evaluation of spontaneous adverse drug reaction monitoring systems.

The Food and Drug Administration maintains an adverse drug reaction reporting system. Physicians report suspected adverse reactions that occur while a patient is taking a drug; reporting is voluntary and spontaneous. Data from spontaneous adverse drug reaction reporting systems are designed to signal that rare, unsuspected adverse reactions exist as a result of using a specific drug. Problems arise when attempts are made to use such data for other purposes. Specifically, spontaneous adverse drug reaction data, such as those published by the Food and Drug Administration, are inappropriate for calculating actual adverse drug reaction rates for specific drugs or for making safety comparisons among drugs. This is because these data are subject to numerous biases that can be easily identified and described but not easily corrected. As a result, data from spontaneous adverse drug reaction reporting systems bear little relationship to the actual incidence of adverse drug reactions.

Adult↗
PubMed2003

Application of quantitative signal detection in the Dutch spontaneous reporting system for adverse drug reactions.

The primary aim of spontaneous reporting systems (SRSs) is the timely detection of unknown adverse drug reactions (ADRs), or signal detection. Generally this is carried out by a systematic manual review of every report sent to an SRS. Statistical analysis of the data sets of an SRS, or quantitative signal detection, can provide additional information concerning a possible relationship between a drug and an ADR. We describe the role of quantitative signal detection and the way it is applied at the Netherlands Pharmacovigilance Centre Lareb. Results of the statistical analysis are implemented in the traditional case-by-case analysis. In addition, for data-mining purposes, a list of associations of ADRs and suspected drugs that are disproportionally present in the database is periodically generated. Finally, quantitative signal generation can be used to study more complex relationships, such as drug-drug interactions and syndromes. The results of quantitative signal detection should be considered as an additional source of information, complementary to the traditional analysis. Techniques for the detection of drug interactions and syndromes offer a new challenge for pharmacovigilance in the near future.

Adverse Drug Reaction Reporting Systems↗
PubMedDate not supplied

[Setup of a national system of adverse drug reaction reporting in Lebanon: results of the first year of activity].

OBJECTIVE: The aim of this publication is to present the results of the first year of activity of the national adverse drug reactions (ADR) reporting system in Lebanon. METHODS: We started our survey with 3 teaching hospitals (more than 160 beds/hospital). Pharmacy students were responsible for collecting and investigating ADRs reported by physicians. RESULTS: After 7 months, 40 cases of suspected ADRs were reported, of which the majority (32 cases) had a causality score of "probable" according to the French method of causality assessment. Skin and allergic reactions occurred in the largest proportion of the ADRs reported (46%). The most common drugs involved in the ADRs were antimicrobial agents (43%) followed by anticonvulsant and anticoagulant drugs (12% each). CONCLUSION: Our objectives are to extend the reporting system in other hospitals throughout Lebanon.

Adverse Drug Reaction Reporting Systems↗
PubMedDate not supplied

A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions.

PURPOSE: A continuous systematic review of all combinations of drugs and suspected adverse reactions (ADRs) reported to a spontaneous reporting system, is necessary to optimize signal detection. To focus attention of human reviewers, quantitative procedures can be used to sift data in different ways. In various centres, different measures are used to quantify the extent to which an ADR is reported disproportionally to a certain drug compared to the generality of the database. The objective of this study is to examine the level of concordance of the various estimates to the measure used by the WHO Collaborating Centre for International ADR monitoring, the information component (IC), when applied to the dataset of the Netherlands Pharmacovigilance Foundation Lareb. METHODS: The Reporting Odds Ratio--1.96 standard errors (SE), proportional reporting ratio--1.96 SE, Yule's Q--1.96 SE, the Poisson probability and Chi-square test of all 17,330 combinations were compared with the IC minus 2 standard deviations. Additionally, the concordance of the various tests, in respect to the number of reports per combination, was examined. RESULTS: In general, sensitivity was high in respect to the reference measure when a combination of point- and precision estimate was used. The concordance increased dramatically when the number of reports per combination increased. CONCLUSION: This study shows that the different measures used are broadly comparable when four or more cases per combination have been collected.

Adverse Drug Reaction Reporting Systems↗
PubMed2001

Determinants of signal selection in a spontaneous reporting system for adverse drug reactions.

AIMS: Detection of new adverse drug reactions (ADR) after marketing is often based on a manual review of reports sent to a Spontaneous Reporting System (SRS). Among the many potential signals that are identified, only a limited number are important enough to require further attention. The goal of this study is to gain insight into factors contributing to the selection and dissemination of possible signals originating from the SRS maintained by the Netherlands Pharmacovigilance Foundation. METHODS: In a case control design, all signals (n = 42) disseminated to the Medicines Evaluation Board from the second quarter of 1997 until the third quarter of 2000, which could be expressed as a combination of a single ATC code and a single WHO preferred term, were included. For each case, four controls were matched in time. Logistic regression analysis was used to investigate the influence of various factors, such as the fact whether the ADR or drug is new, the strength of the association, the seriousness of the reaction and the documentation of the reports. RESULTS: Multivariate analysis showed that the presence of a 'serious report' (Odds Ratio 3.8, 95% CI 1.3, 11.0), a WHO 'critical term' (OR 4.7, 95% CI 1.8, 13), the ADR being unlabelled (OR 6.1, 95% CI 2.3, 16) and the presence of a disproportionate association (OR 3.5, 95% CI 1.4, 8) were all independently associated with signal selection. The number of reports and the time after marketing of the drug had no influence. CONCLUSIONS: This study showed that selection of signals is based on both qualitative and quantitative aspects. Knowledge of these factors may improve the efficiency of the underlying signal selection process.

Adverse Drug Reaction Reporting Systems↗
PubMed1984

An expanded profile of cutaneous reactions to nonsteroidal anti-inflammatory drugs. Reports to a specialty-based system for spontaneous reporting of adverse reactions to drugs.

The nonsteroidal anti-inflammatory drugs are widely used in the United States and are a frequent cause of cutaneous reactions. Since December 1980, dermatologists have reported 135 of these drug reactions to a specialty-based Adverse Drug Reaction Reporting System. Reactions to piroxicam were most frequently reported; the majority of reactions to this drug were vesiculobullous and occurred most often in sun-exposed areas. Other reactions to nonsteroidal anti-inflammatory drugs not previously recognized include serum sickness, exfoliative erythroderma, and photosensitivity associated with sulindac; toxic epidermal necrolysis was reported with tolmetin, zomepirac sodium, and piroxicam. Fixed drug eruptions were noted with ibuprofen and naproxen, and photosensitivity was reported with sulindac and indomethacin. These findings illustrate the usefulness of a specialty-based system for spontaneous reporting of new and serious adverse reactions to drugs.

Aged↗
PubMedDate not supplied

Contribution of pharmacists to the reporting of adverse drug reactions.

PURPOSE: The aim of the study is to get a better view about the possible contribution of pharmacists' reports to the quantity and the quality of reports and in this way to the quality of a voluntary reporting system of adverse drug reactions. METHODS: A total of 15,293 reports, sent to the Netherlands Pharmacovigilance Foundation Lareb between 1995 and 2000 were analysed for the characteristics of pharmacists' reports and the differences with reports from physicians i.e. dispersion of adverse drug reactions in relation to the different System and Organ Classes, the seriousness of the reports according to the CIOMS criteria and the documentation grade of the reports. A total of 200 reports were selected at random and their quality assessed. RESULTS: Pharmacists are responsible for 40% of the reports sent in to Lareb during this period. Their reports more frequently concern adverse effects in relation to skin and the eyes. Adverse drug reactions reported by pharmacists tend to be less severe than those reported by physicians and pharmacists' reports tend to be of a lower documentation grade than those of physicians. Also, the quality of the clinical information is higher in physicians' reports. CONCLUSIONS: The contribution of pharmacists to the voluntary reporting system in the Netherlands is of great importance, both for the number and quality of the reports.

Adverse Drug Reaction Reporting Systems↗