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PubMedDate not supplied

Gastrointestinal reactions and rotavirus vaccination based upon analysis of the Vaccine Adverse Events Reporting System (VAERS) database for 1999. A model for the calculation of the incidence rates and statistical significance of adverse events following immunization.

BACKGROUND/AIMS: The purpose of this study was to extend previous publications and examine the Vaccine Adverse Events Reporting System (VAERS) database for the incidence of gastrointestinal reactions reported following tetra-valent rhesus-human reassortant rotavirus vaccine (RRV-TV). METHODOLOGY: The VAERS database was analyzed for adverse reactions reported for the entire year of 1999 following RRV-TV using Microsoft Access. In this study, the incidence rates of adverse reactions reported to VAERS following acellular diphtheria, pertussis and tetanus (DTaP) vaccine, whole-cell DTP vaccine, live polio (OPV) vaccine and pediatric hepatitis B vaccine were used as control vaccine groups. RESULTS: The results of a chi-square analysis showed that rotavirus vaccine was statistically significantly over represented by serious gastrointestinal reactions in comparison to vaccine control groups. CONCLUSIONS: This analysis demonstrated that the VAERS database provides a way to detect whether RRV-TV elevates the risk of adverse reactions compared to control vaccines given to similar age groups when appropriate denominators (number of annual doses given) are employed. Because of its massive size and the availability of numerous vaccine control groups, the VAERS database provides data on adverse reactions following vaccination that is available nowhere else.

Adverse Drug Reaction Reporting Systems↗

PubMedDate not supplied

A case-series of adverse events, positive re-challenge of symptoms, and events in identical twins following hepatitis B vaccination: analysis of the Vaccine Adverse Event Reporting System (VAERS) database and literature review.

OBJECTIVES: Adverse events and positive re-challenge of symptoms reported in the scientific literature and to the Vaccine Adverse Event Reporting System (VAERS) following hepatitis B vaccination (HBV) were examined. METHODS: The VAERS and PubMed (1966-2003) were searched for autoimmune conditions including arthritis, rheumatoid arthritis, myelitis, optic neuritis, multiple sclerosis (MS), Guillain Barré Syndrome (GBS), glomerulonephritis, pancytopenia/thrombocytopenia, fatigue, and chronic fatigue, and Systemic Lupus Erythematous (SLE) following HBV. RESULTS: HBV was associated with a number of serious conditions and positive re-challenge or significant exacerbation of symptoms following immunization. There were 415 arthritis, 166 rheumatoid arthritis, 130 myelitis, 4 SLE, 100 optic neuritis, 101 GBS, 29 glomerulonephritis, 283 pancytopenia/thrombocytopenia, and 183 MS events reportedfollowing HBV A total of 465 positive re-challenge adverse events were observed following adult HBV that occurred sooner and with more severity than initial adverse event reports. A case-report of arthritis occurring in identical twins was also identified. CONCLUSIONS: Evidence from biological plausibility, case-reports, case-series, epidemiological, and now for positive re-challenge and exacerbation of symptoms, and events in identical twins was presented. One would have to consider that there is causal relationship between HBV and serious autoimmune disorders among certain susceptible vaccine recipients in a defined temporal period following immunization. In immunizing adults, the patient, with the help of their physician, should make an informed consent decision as to whether to be immunized or not, weighing the small risks of the adverse effects of HBV with the risk of exposure to deadly hepatitis B virus.

Adolescent↗

PubMed2000

Understanding the nature of errors in nursing: using a model to analyse critical incident reports of errors which had resulted in an adverse or potentially adverse event.

Human errors are common in clinical practice, but they are under-reported. As a result, very little is known of the types, antecedents and consequences of errors in nursing practice. This limits the potential to learn from errors and to make improvement in the quality and safety of nursing care. The aim of this study was to use an Organizational Accident Model to analyse critical incidents of errors in nursing. Twenty registered nurses were invited to produce a critical incident report of an error (which had led to an adverse event or potentially could have led to an adverse event) they had made in their professional practice and to write down their responses to the error using a structured format. Using Reason's Organizational Accident Model, supplemental information was then collected from five of the participants by means of an individual in-depth interview to explore further issues relating to the incidents they had reported. The detailed analysis of one of the incidents is discussed in this paper, demonstrating the effectiveness of this approach in providing insight into the chain of events which may lead to an adverse event. The case study approach using critical incidents of clinical errors was shown to provide relevant information regarding the interaction of organizational factors, local circumstances and active failures (errors) in producing an adverse or potentially adverse event. It is suggested that more use should be made of this approach to understand how errors are made in practice and to take appropriate preventative measures.

Adult↗

PubMed2002

Differential effect of environmental adversity by gender: Rutter's index of adversity in a group of boys and girls with and without ADHD.

OBJECTIVE: This study examined the effect of gender in mediating the association between environmental adversity and the risk of attention deficit hyperactivity disorder (ADHD) and associated impairments. METHOD: The authors studied 280 ADHD and 242 healthy comparison probands of both genders who were between the ages of 6 and 17 years. They tested the association between Rutter's indicators of adversity (including family conflict, social class, family size, maternal psychopathology, and paternal criminality) and ADHD, comorbidity, and functioning. RESULTS: Greater levels of environmental adversity were associated with a greater risk for ADHD and other comorbidity in both genders in a dose-dependent fashion. However, learning disability and global functioning were modified by gender, with more detrimental effects observed in boys than in girls. Low social class, maternal psychopathology, and family conflict were significantly associated with psychopathology and functional impairment in the probands, with control for gender, parental ADHD, proband ADHD status, and maternal smoking during pregnancy. CONCLUSIONS: Psychosocial adversity in general and low social class, maternal psychopathology, and family conflict in particular increased the risk for ADHD and associated morbidity independently of gender and other risk factors, but gender modified the risk for adverse cognitive and interpersonal outcomes; boys were more vulnerable to the disorder than girls. Because of the difficulties in separating the effects of genetics from environment, these results must be interpreted as provisional until confirmation from twin and adoption studies.

Adolescent↗

PubMedDate not supplied

Prospective cohort study of adverse events monitored by hospital pharmacists. Hospital Adverse Event Monitoring Study (HAEMS) Group.

PURPOSE: To examine the feasibility of pharmacist-led intensive hospital monitoring of adverse events (AEs) associated with newly marketed drugs. SUBJECTS/SETTING: 303 patients admitted to Southampton Hospitals who were prescribed selected newly marketed drugs during their inpatient stay in 1998. METHODS: Prospective observational study. Patients were identified from computerized pharmacy records, clinical pharmacist ward rounds, dispensary records or via nursing staff. The pharmacist reviewed medical notes and recorded AEs, suspected adverse drug reactions (ADRs) and reasons for stopping drugs. OUTCOMES: Incidence of AEs, ADRs; proportionate agreement between the physician's and pharmacist's event recording. RESULTS: 303 patients were monitored. Of the patients taking newly marketed drugs 92% were identifiable using pharmacy computer systems and pharmacist ward visits. There were 21 (7%) suspected ADRs detected during this pilot study. The types of adverse events detected were broadly similar to those identified by general practice-based prescription event monitoring. However, biochemical changes featured more frequently than in general practice. Differences between adverse events recorded by pharmacist and physician were systematic and attributed to differences in event coding. CONCLUSION: Pharmacist-led monitoring in a typical NHS hospital setting was effective at detecting ADRs in newly marketed drugs. However, this effort might have been substantially less time-consuming and more effective were electronic patient records (EPRs) available. Pharmacy computer systems are not designed to be patient focused and are therefore unable to identify patients taking newly marketed drugs. It is argued that future EPR and computerised patient-specific prescribing systems should be designed to capture this data in the same way as some US systems are currently able to do.

Computers↗

PubMed2006

Did intense adverse media publicity impact on prescribing of paroxetine and the notification of suspected adverse drug reactions? Analysis of routine databases, 2001-2004.

AIM: To document the impact on clinical practice in England of media attention around possible adverse effects of paroxetine. DESIGN: Analysis of national selective serotonin reuptake inhibitor (SSRI) prescribing trends and yellow-card adverse drug reaction reports, 2001-2004. RESULTS: From a steady state in 2001, paroxetine prescribing declined sharply from April 2002, coinciding with a USA regulatory action; the subsequent decline in paroxetine prescribing was 1.87% per month (95% confidence interval - 2.06, -1.68). Other SSRI prescribing increased by 1% per month until a major UK review of SSRIs in children in December 2003, after which prescribing plateaued. Media publicity was associated with short-term peaks in yellow-card reports related to paroxetine. CONCLUSION: Falls in paroxetine and other SSRI prescribing in the UK coincided, respectively, with regulatory communications from the USA and the UK, but associations may have noncausal or other explanations. Reports of adverse reactions to paroxetine appeared to increase after adverse media publicity about the drug.

Adverse Drug Reaction Reporting Systems↗

PubMed1983

Identification of adverse reactions to new drugs. I: What have been the important adverse reactions since thalidomide?

A consensus process was used to establish an agreed list of important adverse reactions to drugs identified since thalidomide. Ten physicians working in medicine in Britain and 10 physicians responsible for drug regulatory agencies in different countries were asked to list 10 important adverse reactions to drugs since thalidomide. From these 20 lists a measure of agreement was apparent. Eighteen important adverse reactions were identified for further study of the discovery processes now operating and of the delays occurring from marketing to alerting, from alerting to verification, and from verification to regulatory action. The results suggest that an empirical review of this type is necessary as a starting point for discussion of better systems to reduce delays in the discovery of adverse reactions to new drugs.

Drug Evaluation↗

PubMed2002

Adverse effects of observational studies when examining adverse outcomes of drugs: case-control studies with low prevalence of exposure.

OBJECTIVES: The case-control study is commonly used to examine adverse drug events, in which prevalence of exposure in the source population is frequently very low. The objective of the current study was to examine the bias inherent in the odds ratio assessing the association between exposure and an adverse outcome when prevalence of exposure in the source population is extremely low. DESIGN: Monte Carlo simulations examined the effect of sample size, exposure prevalence, and magnitude of the underlying odds ratio on the bias of the estimated risk ratio, and the power to detect a non-zero risk ratio. RESULTS: Once the underlying odds ratio was at least four, the adverse effects of low prevalence of exposure was minimal. Studies with small sample sizes and low prevalence of exposure, coupled with small to moderate effect sizes, can result in biased estimates of association between exposure and disease status. With a sample size of 200 and an exposure prevalence of 0.5% in the control population, the bias in the estimated odds ratio can be as large as 115%. However, bias becomes negligible as sample size becomes large (n > or = 2000), even when prevalence of exposure is very low. Once the expected number of exposed controls is at least eight, the bias in the estimated odds ratio was no more than 5%. CONCLUSIONS: Studies with small sample sizes and low prevalence of exposure, coupled with small to moderate effect sizes can result in biased estimates of association between exposure status and adverse drug effects. However, bias becomes negligible as sample size becomes large.

Bias↗

PubMed1998

Some unusual and severe forms of adverse drug reactions: a call for setting adverse drug reaction monitoring centres.

Thirty four patients aged 14 to 65 years (18 males and 16 females) admitted to the University Hospital with various unusual and severe forms of adverse drug reactions were studied. It comprised of toxic epidermal necrolysis in 8 patients, systemic vasculitis in 7 of which 3 patients had gangrene of fingers and/or toes, severe erosive gastritis in 9 patients, Stevens-Johnson syndrome in 7 patients, thrombocytopenic purpura in 2 patients and generalised convulsions in 1 patient. Various drugs responsible for causing these adverse drug reactions included antibacterials, antimalarials, anticonvulsants, antituberculars and nonsteroidal anti-inflammatory drugs. Most of the patients recovered. However, 5 of the 8 patients having toxic epidermal necrolysis died of which 2 patients had developed tetanus as a preterminal event. In view of ongoing addition of newer drugs to the therapeutic armamentarium and an increasing incidence of various unusual and severe forms of adverse drug reactions, it is our contention that a separate adverse drug reaction monitoring cell should be established in every hospital setting.

Adolescent↗

PubMed1997

Adverse drug reaction monitoring--cost and benefit considerations. Part I: frequency of adverse drug reactions causing hospital admissions.

In an era of health care cost containment it is of particular interest to identify measures that reduce costs and at the same time improve health care quality. One of these cost cutting measures might be the reduction of the frequency of Adverse Drug Reactions (ADR). The objective of this paper is to summarize all original work on ADR frequencies at hospital admission and to come up with a valid estimate for the actual frequency of ADR-related hospital admissions. Additionally, we compared established concepts of ADR monitoring with respect to their utility for drug safety monitoring and pharmacoepidemiologic research. We reviewed 25 studies from the past 25 years. Analysing the effect of methodological characteristics showed that variation of reported ADR frequency mainly depends on differing study bases and the concepts of ADR monitoring. Investigations that thoroughly screened all members of the study population for the presence of adverse drug reactions (comprehensive ADR monitoring) generally yielded highest ADR proportions. Studies that concentrated screening on selected high-risk patients (preselective ADR monitoring) and those applying spontaneous or intensified spontaneous reporting detected lower ADR proportions (2.9% and 2.5%). The ADR proportion among admissions to departments of internal medicine was higher than among mixed hospital populations including surgical patients. In conclusion 4.2-6.0% (lower and upper quartile) and in median 5.8% of all admissions to medical departments are caused by adverse drug reactions. A two-step preselective ADR monitoring appears to be appropriate and efficient for both signal generation and signal validation as compared to spontaneous reporting and comprehensive monitoring. In conclusion, adverse drug reactions are a common cause of hospital admissions. As hospital care is expensive, attempts to prevent ADR and thus hospital admission need active encouragement.

Journal Article↗

PubMed2003

Placebo adverse events in headache trials: headache as an adverse event of placebo.

We analysed the adverse events of placebo in acute and preventive randomized, double-blind, placebo-controlled studies for migraine treatment. Fifty-seven trials (oral triptans, non-steroidal anti-inflammatory drugs, nasal ergot alkaloids and preventive agents) were included. From 10 to 30% of subjects reported adverse events after placebo. Most common were features associated with a migraine attack, such as nausea, phono- and photophobia. Other frequent complaints resembled those of the active drug (e.g. chest pressure in triptan trials). A third group of adverse events appeared to be coincidental (e.g. sleep disturbance). Adverse events following placebo are probably related to the drug under study and the symptomatology of migraine; some have no obvious explanation.

Administration, Intranasal↗

PubMed2002

Sulphasalazine and mesalazine: serious adverse reactions re-evaluated on the basis of suspected adverse reaction reports to the Committee on Safety of Medicines.

BACKGROUND: 5-aminosalicylates are extensively prescribed for the treatment of ulcerative colitis but have a wide range of described adverse effects. AIMS: To determine whether serious adverse effect profiles differ for sulphasalazine and mesalazine. METHODS: Analysis of suspected serious adverse reactions reported to the Committee on Safety of Medicines of the UK in 1991-1998. Adverse effect profiles were categorised for interstitial nephritis, pancreatitis, serious skin reactions, hepatitis and hepatic failure, and blood dyscrasias. Report rates were calculated using prescribing data from the Department of Health and compared for mesalazine and sulphasalazine. Further analysis was undertaken for sulphasalazine according to disease indication of inflammatory bowel disease or rheumatoid arthritis. RESULTS: A total of 4.7 million prescriptions were dispensed for sulphasalazine compared with 2.8 million for mesalazine. Interstitial nephritis was only described for mesalazine, with 11.1 reports per million prescriptions. Pancreatitis was reported seven times as frequently for mesalazine (7.5 per million prescriptions) compared with sulphasalazine (1.1 per million prescriptions) (odds ratio (OR) 7.0; 95% confidence interval (CI) 2.6-18.6; p<0.001). There were no reports of serious skin disorders in patients prescribed sulphasalazine for inflammatory bowel disease. Blood dyscrasias were reported significantly more often in patients receiving sulphasalazine for rheumatoid arthritis than for inflammatory bowel disease (OR 5.31; 95% CI 2.6-11.0; p<0.001), and there was a similar trend for hepatic disorders. CONCLUSIONS: Spontaneous reports suggest that within the five sets of disorders considered, there is no evidence to indicate a safety advantage of mesalazine over sulphasalazine in the treatment of inflammatory bowel disease. Pancreatitis and interstitial nephritis appear significantly more common with mesalazine, and advice on renal monitoring in patients who receive mesalazine may need reinforcing.

Anti-Inflammatory Agents, Non-Steroidal↗

PubMed1996

[Can we know the frequency of true late adverse reactions to nonionic contrast media?: Late adverse reactions due to factors other than contrast media].

We investigated the frequency and causative factors of symptoms unrelated to contrast media (false late adverse reactions) among patients who were evaluated as having late adverse reactions to contrast media. The nature and frequency of complaints stated by each 200 of patients who underwent plain CT scans and enhanced CT scans were evaluated. In the plain CT group, three patients showed false late adverse reactions. The frequency was 2.6% among respondents and 1.5% in the population. These symptoms encompassed psychological effects and diseases that developed after CT scanning. It is difficult to detect only true late adverse reactions, because of survey bias.

Adult↗

PubMed2002

Identifying clinically significant preventable adverse drug events through a hospital's database of adverse drug reaction reports.

The ability of a hospital's adverse drug reaction (ADR) database to identify common and repeated patterns of preventable adverse drug events (ADEs) was analyzed. ADR reports collected from 1994 through 2000 were extracted from a teaching hospital's ADR database. Reports were assessed concurrently in accordance with seven previously published explicit criteria for preventability. Only cases considered clinically significant were included in this analysis. Events that occurred in the ambulatory care setting were excluded. Preventable ADEs were categorized by drug or drug class, type of medication error, and the subsequent adverse outcome. Novel in this analysis was the linking of these three descriptors. Of the 2571 ADR reports assessed, 415 ADEs were deemed preventable. Of the preventable ADEs, 98 were not analyzed because they occurred in the ambulatory care setting, leaving 317 preventable ADEs in 275 inpatients (mean age +/- S.D., 48.5 +/- 23.9 years) for analysis. Although 93 drugs were associated with these ADEs, only 10 drugs accounted for more than 60% of the events. Analysis and categorization by type of error and outcome suggested that three high-priority preventable ADEs accounted for 50% of all reports: (1) overdoses of anticoagulants or insufficient monitoring and adjustments (according to laboratory test values) were associated with hemorrhagic events, (2) overdosing or failure to adjust for drug-drug interactions of opiate agonists was associated with somnolence and respiratory depression, and (3) inappropriate dosing or insufficient monitoring of insulins was associated with hypoglycemia. Analysis of a hospital ADR database identified prevalent and preventable clinically significant ADEs.

Adverse Drug Reaction Reporting Systems↗

PubMedDate not supplied

Using the Adverse Reactions Register to study the effects of age and sex on adverse drug reactions.

Many countries maintain a register of reports of adverse reactions to drugs. Although reports are made voluntarily by doctors and dentists these registers contain much information that may be useful in pharmaco-epidemiological studies. We show how the epidemiology of adverse drug reactions (ADRs) can be studied using data from such a register, together with estimates of the numbers of prescriptions of the drug, categorized by age and sex of the patient. Reporting rates of ADRs are compared for different ages and sexes by logistic analysis, using extrapyramidal reactions to metoclopramide as an example. Highly significant effects of sex and age on reporting rates are found, with young women being most at risk. We consider possible alternative explanations of this finding, and show that relative overdosage does not account for the differences between the age and sex groups. Other possible errors in the data are also considered unlikely to alter these conclusions; these include differential bias in reporting ADRs for various age-sex groups, and errors in the prescription data. Studies based on the adverse reactions registers are useful for formulating hypotheses which can be tested in a prospective study.

Adolescent↗

PubMed1995

Incidence of adverse drug events and potential adverse drug events. Implications for prevention. ADE Prevention Study Group.

OBJECTIVES: To assess incidence and preventability of adverse drug events (ADEs) and potential ADEs. To analyze preventable events to develop prevention strategies. DESIGN: Prospective cohort study. PARTICIPANTS: All 4031 adult admissions to a stratified random sample of 11 medical and surgical units in two tertiary care hospitals over a 6-month period. Units included two medical and three surgical intensive care units and four medical and two surgical general care units. MAIN OUTCOME MEASURES: Adverse drug events and potential ADEs. METHODS: Incidents were detected by stimulated self-report by nurses and pharmacists and by daily review of all charts by nurse investigators. Incidents were subsequently classified by two independent reviewers as to whether they represented ADEs or potential ADEs and as to severity and preventability. RESULTS: Over 6 months, 247 ADEs and 194 potential ADEs were identified. Extrapolated event rates were 6.5 ADEs and 5.5 potential ADEs per 100 nonobstetrical admissions, for mean numbers per hospital per year of approximately 1900 ADEs and 1600 potential ADEs. Of all ADEs, 1% were fatal (none preventable), 12% life-threatening, 30% serious, and 57% significant. Twenty-eight percent were judged preventable. Of the life-threatening and serious ADEs, 42% were preventable, compared with 18% of significant ADEs. Errors resulting in preventable ADEs occurred most often at the stages of ordering (56%) and administration (34%); transcription (6%) and dispensing errors (4%) were less common. Errors were much more likely to be intercepted if the error occurred earlier in the process: 48% at the ordering stage vs 0% at the administration stage. CONCLUSION: Adverse drug events were common and often preventable; serious ADEs were more likely to be preventable. Most resulted from errors at the ordering stage, but many also occurred at the administration stage. Prevention strategies should target both stages of the drug delivery process.

Boston↗

PubMed1994

[Registration of suspected adverse effects by the Bureau Adverse Effects Drugs; research activities in 1993].

In 1993, the Netherlands Centre for Monitoring of Adverse Reactions to Drugs received 1585 reports of suspected adverse reactions. The most important reports concerned myocardial infarction due to sumatriptan, cholestatic hepatitis due to itraconazole, agranulocytosis due to trazodone and bleeding due to fluoxetine and fluvoxamine. Other published reports concerned cholestatic hepatitis due to amoxicillin/clavulanic acid, hair loss due to beta-blockers, muscle necrosis due to diclofenac, bronchospasm, apnoea and cardiac arrest due to dipyridamole perfusion scintigraphy, interaction of fluvoxamine/fluoxetine and coumarins, liver enzyme elevations due to heparin, skin reactions due to Imedeen, deafness due to neomycin, addiction to nicotine chewing gum, atrial fibrillation and skin reactions due to nicotine patches, interaction between oral contraceptives and terbinafine, neonatal problems caused by psychopharmacological agents, parapemphigus caused by sulfasalazine, taste loss due to terbinafine en intracranial bleeding after use of tranylcypromine and beer. Pharmacoepidemiological studies were performed concerning methods for record linkage, the communication process with respect to the acitretin alert and the adverse events due to sumatriptan.

Drug-Related Side Effects and Adverse Reactions↗

PubMedDate not supplied

Immune responses: adverse versus non-adverse effects.

The adaptive immune system in vertebrates has evolved to provide host resistance to infectious microorganisms and malignant disease. Normal immune function and the induction of specific immune responses require the orchestrated interaction between cells and molecules both within and outside the lymphoid system. Immunotoxicology can be defined as the study of adverse health effects that may result from the interaction of xenobiotics with the immune system. In general terms such effects can take one of two forms. The first of these is immunotoxicity (or immunosuppression) where there is a perturbation of, or damage to, one or more components of the immune system resulting in impaired immune function and reduced host resistance. The design and interpretation of experimental immunotoxicity studies and the investigation of clinical immunosuppression require consideration of the relationship between changes in the structure and/or function of discrete components of the immune system and holistic changes in the susceptibility to infectious and malignant disease. The other main way in which chemicals may cause adverse health effects secondary to interaction with the immune system is through stimulation of specific immune responses that result in allergic disease. Allergy to chemicals and proteins can take many forms, including allergic contact dermatitis, allergic sensitization of the respiratory tract (associated with rhinitis and/or asthma), systemic allergic reactions (associated frequently with drug treatment), and gastrointestinal disease. Here there is a need to distinguish between immunogenic responses per se and those immune responses that are of sufficient vigor and of the quality necessary to provoke allergic sensitization. The purpose of this article is to explore the extent to which distinctions can be drawn between adverse and nonadverse effects in the context of immunotoxicity and allergy.

Animals↗