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Background: There are limited published comparative data regarding the sensitivity and timing of early signal detection with commonly used signal detection methods (SDMs), including the reporting odds ratio (ROR), proportional reporting ratio (PRR), information component (IC) and gamma Poisson shrinker (GPS). Objective: To examine the sensitivity and timing of early signal detection across four SDMs using the Adverse Events Reporting System (AERS) database of the US Food and Drug Administration. Methods: The four SDMs were applied to retrospectively detect ten confirmed drug-event combinations (DECs). The sensitivity to detect adverse events was defined as the percentage of DECs detected by the respective SDMs as positive signals. The timing of early signal detection was measured by comparing the index date of withdrawal (IDW), defined as the date on which the drug was removed from the market, with the index date of detection (IDD), defined as a date on which the signal was significantly detected by the SDM. Results: The estimated sensitivity was 100% for ROR, 90% for PRR and IC and 70% for GPS. The sensitivity increased with increasing numbers of reports per DEC. Compared with the IDW, the signals were detected on average 10 quarters earlier by ROR, 9 quarters earlier by PRR, 9.9 quarters earlier by the IC and 4.7 quarters earlier by GPS. Conclusions: The sensitivity and timing of early signal detection varies across the four SDMs. Numerically, the ROR showed better performance in sensitivity and early signal detection based on ten selected DECs. Given the limited number and range of DECs selected in this study and the unavailability of specificity assessment, further large-scale prospective studies are warranted in order to provide better guidance on the selection of SDMs. [ABSTRACT FROM AUTHOR]

Abstract: Background: Idiopathic thrombocytopenic purpura (ITP) is often diagnosed in the elderly, but no specific guidelines exist for such patients. We describe our experience with ITP management in elderly patients and analyze the therapeutic response. Methods: We retrospectively reviewed a cohort of 47 consecutive elderly ITP patients (≥60 years old) followed in a single reference center. We specifically analyzed the clinical characteristics, therapies used, patient response rates, and side effects. Results: The mean age of the 47 patients was 66 (range 60–82) years; 31 patients were female. Their initial presentation included bleeding limited to the skin (n =10, 21%) and bleeding at one or more other sites (n =26, 56%); 11 patients (23%) were asymptomatic. The mean platelet count was 52×109/L (range 1–120×109/L). After 1 and 6 months, the overall response rate was: 61% and 33% with corticosteroids (n =43), 80% and 50% with splenectomy (n =10), and 14% and 60% with danazol (n =15), respectively. Side effects of these therapies were reported in 100% of these elderly ITP patients, 60% and 50% with these drugs, respectively. No response was reported using IVIg. One case of fatal sepsis was noted after splenectomy. Conclusions: The results confirm (1) that age influences the hemorrhagic pattern of ITP expression, response, and adverse effects of conventional ITP therapies, and (2) that danazol has the potential to be an effective therapeutic alternative to splenectomy in elderly ITP patients. [Copyright &y& Elsevier]

The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), discuss methods of prevention, and promote reporting of ADRs to the US Food and Drug Administration's (FDA's) MEDWATCH program (800-FDA-1088). If you have reported an interesting, preventable ADR to MEDWATCH, please consider sharing the account with our readers. Write to Dr. Shuster at ISMP, 1800 Byberry Road, Suite 810, Huntingdon Valley, PA 19006 (phone: 215-947-7797; fax: 215-914-1492; e-mail: joel.shuster@temple.edu). Your report will be published anonymously unless otherwise requested. This feature is provided by the Institute for Safe Medication Practices (ISMP) in cooperation with the FDA's MEDWATCH program and Temple University School of Pharmacy. ISMP is an FDA MEDWATCH partner. [ABSTRACT FROM AUTHOR]

The efficacy of disulfiram has been well known for over 50 years in alcohol dependence management. If disulfiram is in the body, whenever the patient consumes alcohol, it causes accumulation of a toxic intermediate metabolite called acetaldehyde and produces unpleasant side effects. However, for adequate efficacy, it must be taken per os daily. Therefore, the major difficulty of its usage is compliance of treatment. When patients are recommended to self administer drugs, most of them stop their treatment after a short time. An implantable, slowrelease, depot-form of the drug may solve this compliance problem. There are placebo-controlled studies in the literature which prove the efficacy of this procedure. An additional "psychological deterrent" effect can be mentioned with this method. Its most important difficulty is requirement of a surgical approach. Furthermore, high rates of surgical wound infection and rejection of implants have been reported. There was poor treatment compliance of this patient by reason of second axis pathology of cluster B. Implantation is prefered as the route of administration as the drug cannot be used under supervision because of the deficiency of the patient's social support system. The aim of this article is to discuss the practice and possible complications of disulfiram implantation in the patient with a diagnosis of alcohol dependency and borderline personality disorder. [ABSTRACT FROM AUTHOR]

Objectives The deployment of new antimalarials in Africa provides an important opportunity to develop systems for pharmacovigilance. To inform strategies for reporting adverse events in Uganda, we investigated local perceptions and experiences with antimalarial treatment, and evaluated existing and potential systems for pharmacovigilance. Methods Focus group discussions (FGD) were conducted with community members and health workers from urban and rural Uganda exploring knowledge of fever/malaria, perceptions and expectations of treatment, understanding of adverse effects, and experiences with adverse events. Sessions were recorded, transcribed into English, and analysed using a coding scheme developed from pre-defined topics together with themes emerging from the data. Results Between April and July 2006, we conducted 25 FGDs; 16 with community members and nine with health workers. All respondents had extensive experience with malaria and its treatment. Community members commonly recognized adverse effects of antimalarial therapy. However, events were uncommonly reported, and certain events were often interpreted as signs of successful treatment. Community members often felt that the costs of reporting or seeking additional care outweighed the potential benefits. Health workers were unfamiliar with formal pathways for reporting, and were deterred by the additional work of reporting and fear of incrimination. Respondents provided suggestions for incentives and methods of reporting, emphasizing that pharmacovigilance should ideally encompass the public and private sector, and the community. Conclusions To be successful, pharmacovigilance relying on voluntary reporting will require active participation of patients and health workers. Addressing the costs and benefits of reporting, and providing sensitization, training and feedback will be important. [ABSTRACT FROM AUTHOR]

As the number of patient registries for marketed products increases, it is important for investigators and manufacturers to understand the public health responsibilities and potential regulatory requirements for reporting adverse drug events (AEs). Requirements for reporting AEs will vary depending upon sponsorship of the registry (regulated versus non-regulated industry). If registries are sponsored or supported by a regulated entity and AEs are noted in the course of a registry's direct patient contact concerning a marketed drug product, the seriousness, expectedness, and possible relationship of the AE to the drug product should be assessed. Recommendations are presented for good registry practices for detecting, processing, and reporting adverse events. [ABSTRACT FROM AUTHOR]

The main aim of the WHO International Drug Monitoring Programme, started in 1968, is to identify the earliest possible pharmacovigilance signals. The program now has more than 80 member countries from all parts of the world contributing individual case safety reports (ICSRs) to the WHO Global ICSR Database System, VigiBase. VigiBase is maintained and developed on behalf of WHO by the Uppsala Monitoring Centre (UMC), situated in Uppsala, Sweden. The database system includes the ICH E2B compatible ICSR database, the WHO Drug Dictionaries (WHO-DD and -DDE), and the medical terminologies WHO Adverse Reaction Terminology (WHO-ART), International Classification of Diseases (ICD), and the Medical Dictionary for Regulatory Activities (MedDRA). Apart from data management and quality assurance tools, the VigiBase system includes a web-based reporting tool, an automated signal detection process using advanced data mining, and search facilities, available to the member countries and, on request, to other stakeholders. [ABSTRACT FROM AUTHOR]

The US Food and Drug Administration (FDA) recently published a warning regarding pancreatitis in association with the use of exenatide, an incretin mimetic used for the treatment of patients with diabetes mellitus. We note that this safety issue is not associated with a signal of disproportionate reporting (SDR) in the FDA Adverse Event Reporting System (AERS) database or the World Health Organization (Uppsala Monitoring Centre) Vigibase for any of four data-mining algorithms we tested (proportional reporting ratio, the multi-item gamma-Poisson shrinker, an urn model and the Bayesian Confidence Propagation Neural Network). Exenatide and acute pancreatitis may thus represent a 'false-negative' result for disproportionality-based data-mining methodology generally. We evaluate the possibility that this lack of an SDR is caused by the phenomenon known as 'masking' (or 'cloaking') and reject this hypothesis. While positive findings are understandably more exciting, we discuss why publishing negative findings, such as in this example, is important for placing the capabilities and limitations of drug safety data mining into proper perspective. [ABSTRACT FROM AUTHOR]

About one-third of the published literature on adverse drug reactions (ADRs) and adverse events (AEs) consists of case reports. Unfortunately, the majority of case reports fall short of providing sufficient details for critical evaluation. Potentially valuable information is therefore frequently lost. The study was aimed at developing a quality assessment tool for case reports of AEs. A preliminary scale of 35 items for conventional drugs (and an additional 6 items for herbal preparations) was initially developed. Forty-eight (48) experts were invited to assess this list and modify it for face and content validity in three rounds of a Delphi process. The resulting scale of 21 items, 18 of which relates to general AEs and three items specific to herbal preparations. These items evaluate the quality of case reports in three domains: (i) drug information and therapeutic regimen (5 items); (ii) patient history, diagnosis and medications (8 items); and (iii) details of adverse events (5 items). It was tested for reliability by 16 experts using 5 randomly selected case reports. Our quality score is comprehensive and reliable. It could be an advance over existing instruments and form a basis for further developments in this area of pharmacovigilance. [ABSTRACT FROM AUTHOR]

Preparing cancer patients and their families for chemotherapy treatment is difficult. The challenge lies in finding ways to promote self-care and improve their ability to recall instructions. The aim of this study was to evaluate the usefulness of an educational video with regard to patients' ability to recall and report side effects of treatment. Patients referred for adjuvant chemotherapy for breast and colorectal cancer were randomized to receive standard pre-chemotherapy education or standard education plus addition of a video. Patients completed a base line questionnaire assessing existing knowledge and another questionnaire prior to the second chemotherapy cycle evaluating recall of information. Patients who watched the video were asked to assess the video after six cycles of chemotherapy. Telephone calls to the department reporting symptoms were monitored for both groups. The video group demonstrated trends towards higher recall in information concerning fever, mouth problems, low red cell count and prevention of constipation. They more commonly telephoned reporting medical problems of nausea, vomiting and signs of infection compared with the standard group. In summary, our study demonstrated inclusion of video to standard chemotherapy education improves retention of information regarding management of predictable chemotherapy side effects and reporting of treatment-related symptoms. [ABSTRACT FROM AUTHOR]

The author reflects on tainted heparin which was manufactured in China and which resulted in hypotensive episodes and even death in many patients in the U.S. He suggests that the relationship between the U.S. Food and Drug Administration, physicians and representatives from the drug industry was crucial in detecting the tainted heparin. He argues that without the relationship the recognition of the episodes would have been delayed and the magnitude of human suffering related to them would have increased.

Adverse drug reactions (ADRs) are a frequent cause for hospitalization and occur often in hospitalized patients. The objective of this study was to establish an ADR reporting and monitoring system at a teaching hospital. The pharmacovigilance unit of Masih Daneshvari hospital was established by a clinical pharmacist and a clinical pharmacologist. Healthcare professionals were encouraged to report any suspected ADRs encountered in in-patients. The incidence, pattern, seriousness, severity and preventability of the reported ADRs were analysed. During the period of 12 months, for 6840 patients, 112 spontaneous reports were received. The most frequently reported reactions were due to anti-infective agents (58.2%). Ceftriaxone accounted for the highest number of the reported ADRs among anti-infective agents. The skin and appendages system was the most frequently affected system (32.5% of all reactions). Seventeen per cent of the ADRs were reported as serious reactions. Although the incidence of ADRs reported by physicians and nurses was found to be low, this programme was useful as a preliminary programme in initiating a culture of ADR reporting among healthcare professionals. Improved communication between the physicians and nurses with the pharmacovigilance centre in the hospital is suggested. [ABSTRACT FROM AUTHOR]

Background: There has been discussion about the acceptance of adverse drug reactions (ADRs) reported by patients to spontaneous reporting systems. Lack of experience with patient reporting in real life was one of the main drawbacks in this debate. This study covers 3 years of experience with patient reporting in daily practice. We compared patient reports with reports from healthcare professionals. Although patients have the opportunity to report ADRs in several countries, little is published in the literature about the contribution that patient reports have in practice. To our knowledge, this paper is the first to describe long-term experiences with patient reporting as part of a spontaneous reporting system.Methods: The number of reports received, age and sex of the reporters, characteristics of the most frequently reported drugs and characteristics of the ADRs (most frequently reported ADRs, seriousness, outcome) in a 3-year period (April 2004-April 2007) were compared between patient reports and reports from healthcare professionals.Findings: During this 3-year period, the Netherlands Pharmacovigilance Centre Lareb received 2522 reports directly from patients, concerning 5401 ADRs. In the same period, healthcare professionals submitted 10 635 reports, concerning 16 722 ADRs. Differences were found in the categories of seriousness and outcome of the reported ADRs between patients and healthcare professionals. Conversely, similarities between patient reports and reports from healthcare professionals were found in age, sex, most frequently reported ADRs and most frequently reported drugs.Interpretation: Our study highlights clearly that valuable differences between ADR reports from patients and reports from healthcare professionals exist. Differences in interpretation by patients and healthcare professionals may cause the observed disparities in seriousness and outcome of reported ADRs. However, the similarities between patient reports and reports from healthcare professionals in most frequently reported ADRs and most frequently reported drugs are striking. After 3 years of experience with patient reporting, we conclude that patient reporting in spontaneous reporting systems is feasible and that it contributes significantly to a reliable pharmacovigilance. [ABSTRACT FROM AUTHOR]

What is already known about this subject • The benefits of adverse drug reaction (ADR) monitoring are well-known. • Poor awareness and nonavailability of a central co-ordinating body resulted in lack of ADR monitoring in India. • The National Pharmacovigilance Programme was recently initiated, encouraging ADR monitoring in selected centres, including our centre. What this study adds • This is the first study of its kind at GHQH, Ootacamund that has provided insight into the burden of ADRs here. • The incidence and severity of ADRs documented in our study is lower than those reported in comparable populations in Western studies but more than those reported in India. Aims To ascertain the current burden of ADRs at a Government hospital in Ooty and to assess the severity of reported ADRs and the additional financial burden associated with ADRs. Methods A prospective, spontaneous reporting study was conducted over a period of 9 months of inpatient admissions to the medical wards, co-ordinated by clinical pharmacists. The WHO definition of an ADR was adopted. The Naranjo algorithm scale was used for causality assessment. Confirmed ADRs were classified according to the Wills & Brown [ 7 ] method and assessed for severity and patient outcomes. The average cost incurred in treating the ADRs was calculated. Results Of the total of 187 adverse drug events (ADEs) reported, 164 reports from 121 patients were confirmed as ADRs, giving an overall incidence of 9.8%. This included 58 (3.4%) ADR related admissions and 63 (3.7%) ADRs occurring during the hospital stay. About two thirds of the reactions (102, 62.2%) were classified as probable. The majority of the reactions (88, 53.7%) were mild. Most patients (119, 72.6%) recovered from the incidence. The majority of the reactions were of type H (100, 61%) which indicates that they were not predictable and not potentially preventable. An average cost of 481 rupees (£6) was spent on each patient to manage ADRs. Conclusions The incidence and severity of ADRs documented in our study are lower than those reported in comparable populations in Western studies but more than those reported in India. [ABSTRACT FROM AUTHOR]

Background: To describe how frequently harm is reported in the abstract of high impact factor medical journals. Methods: Design and population: We carried out a blinded structured review of a random sample of 363 Randomised Controlled Trials (RCTs) carried out on human beings, and published in high impact factor medical journals in 2003. Main endpoint: 1) Proportion of articles reporting harm in the abstract; and 2) Proportion of articles that reported harm in the abstract when harm was reported in the main body of the article. Analysis: Corrected Prevalence Ratio (cPR) and its exact confidence interval were calculated. Non-conditional logistic regression was used. Results: 363 articles and 407 possible comparisons were studied. Overall, harm was reported in 135 abstracts [37.2% (CI95%:32.2 to 42.4)]. Harm was reported in the main text of 243 articles [66.9% (CI95%: 61.8 to 71.8)] and was statistically significant in 54 articles [14.9% (CI95%: 11.4 to 19.0)]. Among the 243 articles that mentioned harm in the text, 130 articles [53.5% (CI95% 47.0 to 59.9)] reported harm in the abstract; a figure that rose to 75.9% (CI95%: 62.4 to 86.5) when the harm reported in the text was statistically significant. Harm in the abstract was more likely to be reported when statistically significant harm was reported in the main body of the article [cPR = 1.70 (CI95% 1.47 to 1.92)] and when drug companies (not public institutions) funded the RCTs [cPR = 1.29 (CI95% 1.03 to 1.67)]. Conclusion: Abstracts published in high impact factor medical journals underreport harm, even when harm is reported in the main body of the article. [ABSTRACT FROM AUTHOR]

The article presents a continuing education series on advanced practice on acute and critical care nursing in the U.S. It describes the vulnerability of older adults to medication errors and adverse drug reactions (ADR). According to McLean and Le Couteur, there is a difficulty in examining medication errors because older adults are underrepresented in pharmacotherapy research. Based on available data, ADR experienced by this population include anticholinergic symptoms, mental status changes, orthastatic hypotension and mood and behavior changes.

This article presents the results of a review of patients who were treated with Sunitinib, a multitargeted tyrosine-kinase inhibitor for treatment of renal cell carcinomas and gastrointestinal cancer to see if the drug had an associated risk for cardiovascular disease. The study found that there were various problems in patients on the medication including congestive heart failure, left ventricular ejection fraction (LVEF) reductions and increases in blood pressure. The authors conclude that the LVEF might be due to direct cardiomyocyte toxicity made worse by hypertension. They caution physicians to carefully check patients for hypertension and LVEF reduction especially in those with a history of heart disease or risk factors.

Abstract: Background: Recent evidence suggests that duloxetine may increase the effect of warfarin, thereby increasing the possibility of bleeding. However, a MEDLINE search for articles published between 1980 and May 2007 (terms: duloxetine, anticoagulants, acenocoumarol, and interaction; no language restriction) did not yield any reports of an interaction between concomitant use of duloxetine and acenocoumarol. Objective: The aim of this study was to describe a potential drug-drug interaction between duloxetine and acenocoumarol in a patient with Alzheimer''s disease. The possible mechanism of this potential interaction is examined. Case summary: This report presents the case of a 63-year-old white female patient weighing 64 kg receiving oral treatment with the synthetic coumarin anticoagulant acenocoumarol (mean dosage, 9 mg/wk) for 8 years who experienced a persistent (3-week) decrease in international normalized ratio (INR) to 1.49 after taking a single 60-mg dose of duloxetine. Three weeks after discontinuation of duloxetine, the INR returned to the previous baseline level (2.58). Conclusions: This case report suggests a possible drug-drug interaction between duloxetine and acenocoumarol. Duloxetine should be administered with caution in patients receiving acenocoumarol therapy. [Copyright &y& Elsevier]

To assess experiences related to antidepressant use reported to an internet-based medicine reporting system and to compare the nature of the side effects reported by patients with those reported by health care professionals (HCPs). All reports submitted from May 2004 to May 2005 to an internet-based medicine reporting system in The Netherlands related to the use of antidepressants were analysed. Spontaneous reports of adverse drug reactions on antidepressants from HCPs received by The Netherlands Pharmacovigilance Centre Lareb from May 2004 to May 2005 were included for comparison. Of the 2232 individuals who submitted a report to the internet-based medicine reporting system, 258 submitted a report on antidepressants. Of these, 92 individuals (36%) reported on effectiveness, 40 (16%) of whom reported on ineffectiveness, and 217 (84%) submitted a report on side effects, with 202 (78%) reporting a total of 630 side effects that were experienced as negative. Fourteen individuals (5%) reported a practical issue and four (2%) reported a reimbursement issue. Of all 630 side effects reported, 48% resulted in the patient discontinuing the antidepressant therapy; of these 29% did not inform their HCP. Of all the side effects reported, 52% were perceived as “very negative”. In comparison to the side effects reported by HCPs, patients more often reported apathy, excessive sweating, ineffectiveness, somnolence, insomnia, sexual problems and weight increase. Patients report the ineffectiveness and side effects of antidepressant therapy as negative and leading to discontinuation of the therapy. Patients and HCPs differ in the nature of the reported side effects. Patient experiences should be included in the evaluation of antidepressant treatment in clinical practice. [ABSTRACT FROM AUTHOR]

Little information is available concerning adverse drug events (ADEs) in cardiac patients. Therefore, the investigators report the results of cardiac patients in an ADE surveillance program, with the intent of reducing the frequency of future events. All reported adverse drug reactions and medication errors in cardiac patients over a 5-year period at Brigham and Women’s Hospital were reviewed. There were 547 ADEs in cardiac patients, a rate of 1.9 events for every 100 patient admissions. Preventable ADEs most often occurred during medication administration (34.2%), with wrong rate or frequency of medication administration the most widespread event. Cardiovascular agents (29.8%), anticoagulants (28.5%), and antimicrobial agents (10.8%) were the most common drug classes associated with ADEs. Injury or prolonged hospitalization occurred in 5.3% of patients. ADEs occurred most frequently on the admission day, on weekdays, and in the early morning hours. Peak frequencies of ADEs coincided with nursing shift changes. In conclusion, ADEs occur often in hospitalized cardiac patients and affect 2 of every 100 patient admissions. Given the high percentage of ADEs associated with drug administration, more resources should be directed at this step of medication use. Focusing interventions around nursing shift changes may further enhance preventive strategies. [Copyright &y& Elsevier]

This article presents the results of a clinical trial on the use of topiramate for treating alcoholism. Previous studies have shown that topiramate can decrease alcohol reinforcement by reducing corticomesolimbic dopamine release through at least two processes. This study sought to find out if the drug is a safe and effective drug for the treatment of alcohol dependence. The main outcome measures were reports of heavy drinking days and alcohol content of the blood. The study found that topiramate was more effective than placebo at reducing the number of heavy drinking days. Reported side effects of the medication included paresthesia, taste perversion, anorexia and difficulty with concentration. The authors find that topiramate is a promising treatment for alcoholism.

Background: The extended use of vitamin K antagonists for prophylaxis against venous thromboembolism is often constrained by risk–benefit limitations and inconvenience. We evaluated the efficacy and safety of a 6-month extension of prophylaxis against recurrent venous thromboembolism with idraparinux in patients who had initially received 6 months of prophylaxis with an anticoagulant. Methods: We randomly assigned patients who had completed 6 months of prophylaxis with idraparinux or a vitamin K antagonist and in whom extended anticoagulation was warranted to receive once-weekly injections of 2.5 mg of idraparinux or placebo for 6 months without monitoring. The primary efficacy and safety outcomes were recurrent venous thromboembolism and major bleeding. Results: Of 1215 patients, 6 of 594 (1.0%) in the idraparinux group and 23 of 621 (3.7%) in the placebo group had recurrent venous thromboembolism (P=0.002). Major bleeding occurred in 11 patients (1.9%) in the idraparinux group and in none in the placebo group (P<0.001). Of these 11 episodes, 3 were fatal intracranial hemorrhages. As compared with patients whose initial treatment was a vitamin K antagonist, patients whose initial treatment was idraparinux who were assigned to 6 months in the placebo group had a lower incidence of recurrent thromboembolism (0.7% vs. 5.9%); patients who received 6 additional months of idraparinux therapy had a higher incidence of major bleeding (3.1% vs. 0.9%). Conclusions: During a 6-month extension of thromboprophylaxis, idraparinux was effective in preventing recurrent thromboembolism but was associated with an increased risk of a major hemorrhage. (ClinicalTrials.gov number, NCT00071279.) N Engl J Med 2007;357:1105-12. [ABSTRACT FROM AUTHOR]

The article discusses the conceptual framework of the Health Professional Reporting of Adverse Drug Reactions (ADR), an online education tool which is developed by Health Canada. It is inferred that its module and reporting mechanism is presented in the form of a case presentation. Description of adverse reaction, its reportable undesirable effects, ADR guidelines, and informational resources are also presented.

The article focuses on the activities of the pharmacovigilance system in Ukraine. It is inferred that the system's activities include safety and monitoring of adverse reactions, which was based on the guidelines of the European Union. The system also worked with health care programmes and medical doctors, and annually handles over 4,000 cases of adverse reaction reports. In addition, it also responsible for the organization, methodology and educational activities related to pharmacovigilance.

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

BACKGROUND: Cholinesterase inhibitors (ChEIs) could be involved in several drug-drug interactions (DDIs) because of their complex pharmacodynamic and/or pharmacokinetic properties. AIM:  To identify spontaneous reports in the French Pharmacovigilance Database containing DDIs with the three ChEIs marketed in France (donepezil, galantamine or rivastigmine) and to compare the informativity of two national drug references, the French national formulary (Vidal) and the British National Formulary (BNF), for their ability to identify ChEI-related DDIs. METHODS: Spontaneous reports submitted to the French Pharmacovigilance Database concerning donepezil, galantamine or rivastigmine were reviewed by two clinical pharmacologists from Toulouse Regional Pharmacovigilance Centre. Spontaneous reports containing DDIs were identified according to Vidal, BNF or their own judgement (and with use of the interaction supplement of the French independent drug information bulletin La Revue Prescrire). Then, the potential of DDIs to result in adverse drug reactions (ADRs) was evaluated. Finally, the presentations of the different ChEIs in the two references (Vidal, BNF) were compared for their DDI informativity. RESULTS: A total of 1058 spontaneous reports were identified that involved ChEIs in the French Pharmacovigilance Database up to 31 March 2006; of these 376 (35.5%) contained at least one DDI according to experts’ judgement. In total, 118 DDIs (31.4%) were the cause of ADRs. Most of the DDIs were due to pharmacodynamic interactions (247 cases, 65.7%). The most frequently encountered drugs involved in DDIs were bradycardic (205 cases, 54.5%) and anticholinergic (118 cases, 31.4%) drugs. DDIs were found in 309 spontaneous reports (29.2%) according to Vidal and in 127 (12.0%) according to BNF. In total, 88 ‘serious’ ADRs were related to DDIs (including seven deaths, mainly due to cardiovascular ADRs). The most frequently observed ADRs due to DDIs were cardiovascular (67 cases, mainly bradycardia, atrioventricular block and arterial hypotension) and neurological (33 cases, mainly mental confusion). Comparison of the different presentations of summary of product characteristics (SPC) showed that Vidal was more informative than BNF for all the ChEIs, and that galantamine had the most complete data in the two references. CONCLUSION: DDIs were present in more than one-third of spontaneous reports including ChEIs registered in the French Pharmacovigilance Database. Approximately, one-third of these DDIs were the cause of ADRs. The informativity of European drug dictionaries differs substantially and Vidal was found to be more informative than BNF for all the ChEIs. [ABSTRACT FROM AUTHOR]

This article presents an editorial on weighing the hazards of erythropoiesis stimulation in cancer patients. Possible risks from taking erythropoiesis-stimulating agents (ESAs) are thromboembolic disease, promotion of tumor growth and decreased survival. The drug, used to treat anemia caused by chemotherapy in cancer patients, has been the subject of several studies which are outlined here. The author says the U.S. Food and Drug Administration needs to adopt new guidelines for use.

The article discusses a study that investigates physicians' level of understanding of dietary supplement regulation and the adverse event reporting process and determines whether an interactive online curriculum could help in knowledge improvement. Results suggest that physician knowledge of dietary supplement regulation and adverse event reporting is poor. Results also indicate that an online didactic module may improve knowledge and enhance patient-physician communication.

Objective The aim of the study was to assess the frequency of the concurrent use of gastric acid-reducing agents among HIV-1-infected patients treated with highly active antiretroviral therapy (HAART) combinations. Methods An anonymous, semistructured, self-administered questionnaire was consecutively distributed among HIV-1-infected patients at routine visits to specialized HIV clinics. The questionnaire contained 17 items asking specifically for information on current antiretroviral treatments and the use of gastric acid-reducing agents as well as demographic data. Results A total of 424 patients in 12 centres participated in the study: 85% were male, 88% were of German nationality, 82% were >35 years of age and 201 (47.4%) were receiving a protease inhibitor (PI)-containing HAART regimen. Of these, 74 (37%) had received an acid-reducing drug within the previous 6 months and 43 (58%) were currently still on it. Two-thirds of patients (64.9%) were treated with proton-pump inhibitors (pantoprazole, omeprazole or esomeprazole) and 56% of patients on PI-containing regimens had been taking these drugs for longer than 2 months and up to a maximum of 3 years. The majority of patients (77%) had received the prescription for the acid-reducing drugs from their HIV specialist and the remaining patients had received over the counter (OTC) medication or prescriptions from other medical personnel. Conclusions A substantial subset of patients treated with HAART combinations, including those on PI-containing regimens, were using concomitant acid-reducing drugs, most often proton-pump inhibitors. As negative drug–drug interactions between some of the (boosted) PIs and gastric acid-reducing agents have recently been reported, HIV physicians should take this into account when prescribing PI-containing HAART combinations in order to avoid an additional risk of treatment failure. [ABSTRACT FROM AUTHOR]

Introduction: Adverse drug reaction (ADR) reporting makes a vital contribution to pharmacovigilance, although the factors that influence the reporting rate remain unclear. The aim of this study was to investigate whether the variation in the rate of reporting of suspected ADRs in different regions of Scotland was explained by differences in local prescribing practice and to quantify the extent of this influence.Methods: Population and primary care prescribing data were obtained for ten geographical areas based on the 15 administrative regions of the National Health Service in Scotland. All reports of suspected ADRs received from within Scotland for 2000 and 2001 were available from the regional monitoring centre (Committee on Safety of Medicines, Scotland). The primary analysis was based on 14 medications that appeared in the 'top ten' list for the frequency of reported ADRs for either year. Reporting rates for each area were expressed both in terms of population (reports per million people) and in terms of estimated exposure to those medications in primary care (reports per 1000 prescriptions). For each analysis, the Pearson correlation coefficient between reporting and prescribing data was calculated using SPSS software.Results: The 'top ten' medications accounted for 1715 of 2817 (60.9%, 95% CI 59.1, 62.7) ADR reports but only 2.2 million out of a total of 128 million primary care prescriptions (1.7%). Although there was a 3-fold geographical variation in the per-population ADR reporting rate, there was a close correlation between local reporting of ADRs and prescribing of the index medications (p = 0.66, p = 0.04, respectively). This implies that 44% of the observed variation in reporting rate can be attributed to variation in prescribing within the same population.Discussion: Spontaneous ADR reporting in Scotland over the 2 years studied was highly concentrated on a small number of medications that were under intensive surveillance. Although there was a 3-fold variation in reporting rates from individual geographic areas when corrected for the size of the population, primary care prescribing data showed nearly half of this local variation in reporting rates could be explained by differences in prescribing. This study highlights the importance of considering prescribing practice when interpreting spontaneous ADR reporting data. [ABSTRACT FROM AUTHOR]

Worldwide, drug regulation safety requirements in the past can be seen as responses to major drug disasters, such as thalidomide or diethylstilbestrol. In the light of the more recent drug disasters, the public is less willing to accept risk associated with drug therapy. Increased emphasis has to be placed on the proactive identification of potential safety issues with new drugs at the earliest possible occasion, and before large populations have already been exposed to the drug. The concept of balance between potential benefit and risk also has to be communicated more strongly. This article presents an overview of spontaneous reporting systems and signal detection and evaluation. It also discusses regulatory issues and risk management with an emphasis on the new European Community system. A number of new initiatives and obligations are introduced that are handled by the European regulatory agencies. [ABSTRACT FROM AUTHOR]

Aims To synthesize data from published studies and international experience to identify evidence of potential benefits and drawbacks of direct patient reporting of suspected adverse drug reactions (ADRs) by patients. Methods Structured search of MEDLINE, CINAHL and PsycINFO supplemented by internet searches and requests for information to key contacts. Results Seven studies (eight papers) were included in the review. None of the studies concerned spontaneous reporting by patients. Information on patient reporting systems was obtained for six countries, with summary data reported by four. Patient reports identified possible new ADRs that had not previously been reported by health professionals. The quality of patient reports appears to be similar to that of health professional reports. There is some evidence that patients report an ADR when they consider their health professional has not paid attention to their concerns. Patient reports may, at least initially, be more time consuming to process. Conclusions Overall, the evidence indicates that patient reporting of suspected ADRs has more potential benefits than drawbacks. Evaluation of patient reporting systems is needed to provide further evidence. [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]

The article offers information on the reports of suspected adverse reactions (SARs) to veterinary medicinal products (VMP) received by the Irish Medicines Board (IMB) for the period January 1, 2005 to December 31, 2005 in Ireland. Five of the equine reports were associated with the use of a vaccine against Steptococcus equi infection. Twenty-six of the 84 SAR reports submitted to the IMB in the above-mentioned period related to lack of expected efficacy of veterinary medicinal products.

The aim of the present study was to evaluate a computerised monitoring system (CMS) based on laboratory test results for the detection of adverse drug reactions (ADRs) on a paediatric ward. A prospective, 6-month pharmacoepidemiological survey was performed on a 22-bed paediatric isolation ward. ADRs were identified by intensive chart review. In addition to spontaneous reporting by the treating physician, automatic laboratory signals generated by a CMS were evaluated for their association with ADRs. ADRs were classified by the affected target organs according to the WHO–ART system organ classes. A total of 73 ADRs were identified in 439 admissions (396 patients) by chart review. The CMS alerted 31 (42.4%) ADRs while 23 (31.5%) ADRs were found solely by treating physicians. Eight ADRs were detected by both approaches resulting in a total detection rate of 74% (compared with intensive pharmacovigilance). Out of a total of 27,434 laboratory tests performed routinely, 1,563 were classified as abnormal by the predefined CMS and used as the basis of alerts. The sensitivity of the system with respect to patients alerted was 90.3% and the specificity only 19.6%. This study demonstrates that, using CMS, a different kind of mild adverse events were detected compared to the observation by the treating physician. The system presented appears to be sufficiently sensitive, but the specificity is too low to make it acceptable for physicians in daily practice. In children, clinically important ADRs can be detected best by intensified surveillance. [ABSTRACT FROM AUTHOR]

The article looks into the limitations and the changes needed in drug safety regulation by the U.S. Food and Drug Administration (FDA). Problems with the current system of drug safety assessment include underreporting of adverse drug reactions to the FDA after the approval process and the limited resources of FDA in drug safety evaluations. The authors suggest that the Congress should give FDA more legal authority to pursue violations and give additional funds to assist the safety evaluations.

The article presents a case report of a 40 year old female malignant melanoma patient suffering from severe fatigue. Modafinil with a daily dose of 100 mg relieved tiredness in the patient but had to be discontinued following signs of side effects such as nervousness and restlessness. A dose of 20 mg/d of methylphenidate was effective and well tolerated over a period of 4 weeks. The case report suggests that the process of treatment goal identification, prioritization and adaptation is needed.

OBJECTIVES: To determine the association between use of selective serotonin reuptake inhibitors (SSRIs) and objective measures of sleep disturbances in older community-dwelling women, including women without evidence of depression. DESIGN: Cross-sectional study. SETTING: Four U.S. clinical centers. PARTICIPANTS: Two thousand eight hundred fifty-three women aged 71 and older (2,630 nonusers of antidepressants and 223 taking SSRIs alone, not in combination with other antidepressants). MEASUREMENTS: Medication use, assessed using an interviewer-administered questionnaire with verification of use from medication containers and computerized dictionary used to categorize type of medication; evidence of depression assessed using self-report or a score of 6 or higher on the Geriatric Depression Scale; and sleep parameters measured using a wrist actigraph, with data collected for an average of four consecutive 24-hour periods. RESULTS: Of the overall cohort of 2,853 women and of 2,337 women without evidence of depression, sleep disturbances were more common in women taking SSRIs than in those not taking antidepressants. After excluding women with evidence of depression and adjusting for multiple potential confounders, women taking SSRIs were more likely to have a sleep duration of 5 hours or less (multivariate odds ratio (MOR)=2.15, 95% confidence interval (CI)=1.04–4.47), sleep efficiency less than 70% (MOR=2.37, 95% CI=1.32–4.25), sleep latency of 1 hour or more (MOR=3.99, 95% CI=2.29–6.96) and eight or more long wake episodes (MOR=1.75, 95% CI=0.99–3.10). CONCLUSION: SSRI use by older women, including those without evidence of depression, is associated with a greater likelihood of sleep disturbances, including poorer sleep efficiency, longer sleep latency, and sleep fragmentation, manifested by multiple long wake episodes. These results add to the uncertainty regarding risks and benefits of SSRI use in aged populations. [ABSTRACT FROM AUTHOR]

The article provides the findings of a research study on the effectiveness of educational outreach visits meant to improve the reporting of adverse drug reactions (ADR) by physicians. The article reports that because drug safety information tends to be limited when a new drug is licensed and marketed, previously unidentified ADRs may occur. Voluntary reporting of these cases by physicians can aid postmarketing surveillance of the drugs. The study shows that a targeted outreach program to physicians may improve the reporting of ADRs.

The article presents abstracts of medical research. They include "A Comparison of Publically Available Spontaneous Adverse Drug Reaction Data from National Spontaneous Reporting Schemes," "A Multicentre Study on Adverse Drug and Vaccine Reactions in Children," and "A National Register for the Monitoring of Adverse Drug Reactions in Children and Adolescents Treated with Psychostimulants Reporting Schemes."

The high mortality, morbidity and cost associated with adverse drug reactions (ADRs) represent an important public health concern. Cutaneous ADRs, the most common ADRs constitute of 15 to 30% of the total ADRs. The economic impact of cutaneous ADRs is not known. The present study analyzed the cutaneous ADRs reported to the Regional Pharmacovigilance Center, Manipal Teaching Hospital, Western Nepal and established their causality, severity, preventability and calculated the cost of drug therapy in managing them. The filled ADR reporting forms received by the center from September 2004 till August 2005 were analyzed. Additional patient details were obtained from the medical records department. Altogether, fifty seven ADRs were reported (men 22 and women 35). Mean ± SD age distribution was 30.21±17.89 years. Department of Dermatology reported 22 (38.59%) ADRs followed by Medicine department 14 (24.56%). Antibiotics were responsible for 18 (31.57%) cases of ADRs. Maculopapular rashes were reported in 18 (31.57%) of the cases followed by contact dermatitis in 9 cases (15.78%). The causality assessment (Naranjo algorithm) revealed that 47 (82.45%) ADRs could be probably attributed to the suspected drugs, 50 (87.71%) ADRs were Moderate (Level 3) [Modified Hartwig and Siegel scale] 2 (3.5%) of the ADRs could be definitely preventable (Schumock and Thornton scale). Fifty four (94.73%) patients were prescribed 181 drugs (average 3.17) for managing the ADRs. Antihistamines were most commonly used [56 (30.93%)] followed by corticosteroids [53 (29.28%)]. The average treatment duration was 13±7 days with an average cost burden of US$ 1.58±1.41 for drug therapy. Early detection and prevention may be beneficial in minimizing the economic implications of the cutaneous ADRs. [ABSTRACT FROM AUTHOR]

Methotrexate (MTX) is one of the most widely used anticancer agents, and administration of high-dose methotrexate (HDMTX) followed by leucovorin (LV) rescue is an important component in the treatment of a variety of childhood and adult cancers. HDMTX can be safely administered to patients with normal renal function by the use of alkalinization, hydration, and pharmacokinetically guided LV rescue. Despite these measures, HDMTX-induced renal dysfunction continues to occur in approximately 1.8% of patients with osteosarcoma treated on clinical trials. Prompt recognition and treatment of MTX-induced renal dysfunction are essential to prevent potentially life-threatening MTX-associated toxicities, especially myelosuppression, mucositis, and dermatitis. In addition to conventional treatment approaches, dialysis-based methods have been used to remove MTX with limited effectiveness. More recently carboxypeptidase-G2 (CPDG2), a recombinant bacterial enzyme that rapidly hydrolyzes MTX to inactive metabolites, has become available for the treatment of HDMTX-induced renal dysfunction. CPDG2 administration has been well tolerated and resulted in consistent and rapid reductions in plasma MTX concentrations by a median of 98.7% (range, 84%-99.5%). The early administration of CPDG2 in addition to LV may be beneficial for patients with MTX-induced renal dysfunction and significantly elevated plasma MTX concentrations. [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]

Objectives: Inhaled corticosteroids (ICS) are widely used in the treatment of asthma. We studied the suspected adverse drug reactions (sADRs) reported during the use of ICS in the Netherlands. Methods: In the Netherlands, health professionals and patients can report suspected ADRs to the Pharmacovigilance Centre Lareb. All reported sADRs on ICS were categorised and assessed as to whether these were likely to be associated with use of the steroid. Age and gender adjusted Reported Odds Ratios (RORs) and Naranjo Scores (NS) were computed for sADRs reported more than 3 times. Results: Since 1984, sADRs of ICS were reported in 89 children (mean age 6 years), 48 (54%) were boys. Suspected drugs were fluticasone in 46 children (52%), budesonide in 21 (24%), and beclomethasone in 22 cases (24%). Psychiatric symptoms were reported in 19 children (21%; ROR 3.8, NS 3.6), growth retardation in 6 children (7%; ROR 47.8, NS 3.0) and rashes in 6 cases (7%; ROR 0.7, NS 2.4). There were 7 reports (8%; ROR 2.1, NS 3.4) concerning abnormalities of the teeth, 4 reports of alopecia (4%; ROR 3.3, NS 3.5), and 3 reports of hirsutism and hypertrichosis (NS 4.0). Non-fatal adrenal insufficiency was reported once. Conclusions: Alteration of behaviour was the most frequently reported sADR. There are more indications that alterations of behaviour could be a real sADR of ICS. Non-fatal adrenal insufficiency was the only reported possible life threatening sADR. The association of hypertrichosis and teeth abnormalities after ICS in children has not been reported in the literature before. [ABSTRACT FROM AUTHOR]

Focuses on designing a spontaneous adverse drug reaction reporting form as an exercise for medical students. Learning pharmacology at the Manipal College of Medical Sciences, Pokhara, Nepal; Activity-based learning of pharmacovigilance; Description of student-designed forms; Informal feedback obtained from the students regarding the sessions.

Provides information on various adverse drug reactions reported by the Institute for Safe Medication Practices in the U.S. as of March 2006. Details of a case involving an elderly woman who suffered from hyperphosphatemia associated with a phosphosoda bowel preparation; Role of intravenous immune globulin in the development of myocardial infarction; Information on hepatotoxicity caused by acarbose therapy.

The purpose of this review was to estimate the extent of under-reporting of adverse drug reactions (ADRs) to spontaneous reporting systems and to investigate whether there are differences between different types of ADRs. A systematic literature search was carried out to identify studies providing a numerical estimate of under-reporting. Studies were included regardless of the methodology used or the setting, e.g. hospital versus general practice. Estimates of under-reporting were either extracted directly from the published study or calculated from the study data. These were expressed as the percentage of ADRs detected from intensive data collection that were not reported to the relevant local, regional or national spontaneous reporting systems. The median under-reporting rate was calculated across all studies and within subcategories of studies using different methods or settings.In total, 37 studies using a wide variety of surveillance methods were identified from 12 countries. These generated 43 numerical estimates of under-reporting. The median under-reporting rate across the 37 studies was 94% (interquartile range 82--98%). There was no significant difference in the median under-reporting rates calculated for general practice and hospital-based studies. Five of the ten general practice studies provided evidence of a higher median under-reporting rate for all ADRs compared with more serious or severe ADRs (95% and 80%, respectively). In comparison, for five of the eight hospital-based studies the median under-reporting rate for more serious or severe ADRs remained high (95%). The median under-reporting rate was lower for 19 studies investigating specific serious/severe ADR-drug combinations but was still high at 85%.This systematic review provides evidence of significant and widespread under-reporting of ADRs to spontaneous reporting systems including serious or severe ADRs. Further work is required to assess the impact of under-reporting on public health decisions and the effects of initiatives to improve reporting such as internet reporting, pharmacist/nurse reporting and direct patient reporting as well as improved education and training of healthcare professionals. [ABSTRACT FROM AUTHOR]

Objective To determine whether anecdotal reports of suspected adverse drug reactions are valuable early warning signals. Design Systematic literature survey Data sources We evaluated all case reports of adverse drug reactions published in 1997 in five medical journals. Reports were excluded if the adverse reaction had previously been described in earlier publications and was already listed in the product information of the drug reference source (the British National Formulary (BNF) or the Medicines Compendium). We used the Web of Knowledge Citation Index and Medline for 2003 to identify follow-up studies. Main outcome measures Primary: the number of suspected adverse reactions subjected to formal validation studies and the findings of these studies. Secondary: the number of instances in which the warning from the case report was incorporated into the product information. Results We evaluated 63 suspected adverse reactions and found that most (52/63, 83%) had not yet been subjected to further detailed evaluation. Data from controlled studies that supported the postulated link between the drug and the adverse event were available in only three cases. Of the 48 agents listed in the drug reference sources, details of the suspected reaction were subsequently added to the Medicines Compendium in 15 instances, and to the BNF in seven instances. In each case, only one reaction had been confirmed. Conclusions Published case reports of suspected adverse reactions are of limited value as suspicions are seldom subjected to confirmatory investigation. Furthermore, these alerts are not incorporated into drug reference sources in a systematic manner. [ABSTRACT FROM AUTHOR]

The following table contains an overview of first published case reports of adverse drug reactions (ADRs) identified in the international literature in recent weeks by the drug safety alerting service Reactions Weekly. Summarising information selected from over 1700 biomedical publications, Reactions Weekly is produced by Adis International Limited and is available in a variety of formats. Please contact your nearest Adis office for subscription details. [ABSTRACT FROM AUTHOR]

Objective: Since the approach of the general population to phytomedicine is that the therapy is natural and therefore safe, the aim of this study was to investigate the relationship between the use of herbal compounds, alone or in combination with traditional drugs, and the appearance of side-effects among a sample of Italian women. Methods: Our research was conducted over a 5-month period in the outpatient ambulatories of an urban university general hospital. The sample population consisted of women who were interviewed about phytotherapy use on the basis of a pre-structured questionnaire. Results: Among 1,063 women contacted, 1,044 completed the interview and 491 (47%) reported taking at least one herbal compound in the last year; 272 women (55.4%) consumed only phytomedicines, while 219 (44.6%) also took traditional drugs. Seventy-three different herbal products were used, 32 were consumed in association with traditional drugs. Forty-seven of 491 (9.6%) women reported side-effects, 22 after taking only phytomedicines (8.1%), 25 in combination with traditional drugs (11.4%). The observed adverse manifestations included the following: gastrointestinal after dandelion, propolis and fennel; cardiovascular after liquorice, ginseng, and green tea; dermatological after propolis, thyme, arnica, and passionflower; and neurological after guarana and liquorice. Drugs taken in association and potentially involved in adverse reactions were NSAIDs, antibiotics, benzodiazepines, antihypertensives and oral contraceptives. In some cases (n=5), side-effects were so serious to justify an admission to the hospital. In 29/47 of cases (61.7%), the adverse reaction was not communicated to the doctor. Conclusions: Our data confirm that herbal products are largely taken on a self-treatment basis, and users have the convinction that these therapies are natural and therefore safe. [ABSTRACT FROM AUTHOR]