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Describes the University of Maryland Medical System pharmacy department's development of its Adverse Drug Reaction Surveillance Program (ADRSP). Concerns about ADR monitoring and reporting; Goals of the program; Steps in the development of the program; Observations after the implementation of the program.

The article reports that adverse reactions to drug therapy are the bane of the practitioner and all the more so when they occur in an idiosyncratic or apparently unpredictable, fashion. At baseline, risk factors for development of torsades de pointes in the present study were female gender, premature ventricular contractions and treatment with diuretics. The concept of repolarization reserve is also consistent with the notion of a genetic predisposition to torsades de pointes. The development of Torsades de pointes at low plasma quinidine concentrations may reflect the drug's multiple electrophysiological effects interacting with other risk factors as described below.

Spontaneous adverse drug reaction (ADR) reporting is the mainstay of national and international drug safety evaluation in the post-approval phase. A major criticism of the method has been a high, but essentially unquantifiable, level of under-reporting by doctors. A direct comparison has been made between spontaneous ADR reporting and an observational event monitoring system for a group of more than 44 000 patients receiving one or other of a group of seven new drugs. The data suggests that under-reporting by the spontaneous system may be as high as 98% for several clinical events believed to be associated with drug treatment. [ABSTRACT FROM AUTHOR]

The article focuses on safety aspects of medicines in Australia in relation to quetiapine and QT prolongation. Topics discussed include health experts advises on the prescription of quetiapine in Qt prolongation cases, prescription of Fluvax drug from bioCSL for children above five years, and self-regulation of medicines. Also mentioned are factors that should be reported for suspected adverse reactions to medicines such as herbal medicines, vaccines, and over-the-counter medicines. INSET: What to report? You don't need to be certain, just suspicious!.

Standard systems for recording and reporting data on smoking withdrawal clinics are needed. The proposals in this paper may be considered a first step to development of an acceptable procedure. Experience with this approach and reactions to it can lead to further changes and improvements. [ABSTRACT FROM AUTHOR]

The article presents a study to determine levels of public awareness of consumer adverse drug reaction (ADR) reporting systems in Australia. The survey ascertains proportion of respondents experiencing ADRs, the type of medicine involved, and whether participants reported the adverse events. Results of the study suggest that consumers can contribute in understanding the medicines safety.

The U.S. Food and Drug Administration's (FDA) Adverse Event Reporting System (AERS), familiarly known as "MedWatch," is the nation's primary tool for postmarket pharmaceutical safety surveillance. This system relies on adverse events voluntarily reported by health care providers and consumers either directly to the FDA or to drug manufacturers, which are required to prepare and forward the information to the agency. Little is known about how frequently adverse events are reported. Previous estimates range from 1 to 31% depending on the event, drug, and time period. We used published incidence studies to calculate reporting rates for hemorrhage, emergency hospitalization, and venous thromboembolism (VTE) associated with four drugs. We estimated annual reporting rates of 1.07% for 33,171 emergency hospitalizations of patients older than 65 years associated with warfarin, 0.9% for 13,363 hospitalizations of clopidogrel and ticlopidine, and 1.02% for an estimated 67,200 hemorrhage cases associated with warfarin. We also estimated a 9-year reporting rate of 2.3% for VTE associated with thalidomide. The incidence of these hematologic adverse drug events is high and reporting rates are low, and near the lower boundary of the 1 to 15% range seen for other events. [ABSTRACT FROM AUTHOR]

The article focuses on a new European pharmacovigilance legislation and the perspective of Great Britain Medicines and Healthcare Products Regulatory Agency (MHRA) over this measure. It says that MHRA is co-chair of Project 3 involved with Good Vigilance Practice (GVP) development for adverse drug reaction (ADR) reporting. It mentions the key areas in the pharmacovigilance process covered by Implementing Regulation including Quality Management System, use of terminologies, and ADR reporting.

Introduction: The Arab emirate of Qatar is an emerging economy seeking to augment its healthcare infrastructure. Currently, there is no national pharmacovigilance centre in place, and no health professional associations exist to formally advocate or provide training for the diverse healthcare provider population on suspected adverse drug reaction (ADR) identification and reporting. However, local pharmacovigilance may take place within hospitals, especially those accredited by international agencies. A descriptive survey of all inpatient healthcare settings in Qatar was conducted to inventory pharmacovigilance activity. Methods: A ten-item questionnaire was administered to hospital pharmacy directors to characterize current pharmacovigilance practices, including processes for reporting suspected ADRs, documentation and adjudication policies, health professional staff participation, communication and the fate of ADR reports. If ADR forms were utilized, copies were obtained for comparison and assessed for content, including demographic information, drug exposure and reaction data, patient management and outcome description. Results: Presently, ten hospitals exist in Qatar. All public hospitals (n = 5) have a common written policy and procedure for spontaneous reporting of suspected ADRs and share a common, paper-based reporting form. This document details patient information but does not include data required for causality estimates or outcome assessments. Only one of the private hospitals (n = 5) supports suspected ADR-reporting activity. The reports of the participating hospitals are submitted to their respective Pharmacy and Therapeutics committees, and are aggregated and forwarded to the Supreme Council of Health; however, it is unclear what response is then taken at this administrative level and limited feedback is available to those who have submitted reports. Conclusion: Pharmacovigilance activity exists in some Qatar hospitals, but a transparent national programme, which incorporates reporter feedback and electronic submission, could increase spontaneous ADR reporting in the country. [ABSTRACT FROM AUTHOR]

The article presents a case study of a 65-year-old woman with open-angle glaucoma. The patient developed regimentation of her previously white hair after latanoprost therapy. The article also discusses the side effects of latanoprost therapy and offers a list of drugs that have been reported to induce hair-colour changes.

The article reports on the impact of detecting adverse drug reactions (ADRs) in children. It provides an overview on the story of an athletic adolescent boy who experienced mood changes that covers from altered self-perception to depression and suicidal thoughts after introducing a medical therapy for seasonal allergies and asthma. It notes on the importance of reporting early suspicions of ADR despite the certainty of the casual relationship between the drug and the effect.

The authors comment on a study which determined the trends in the Adverse Event Reporting System (AERS) of the U.S. Food and Drug Administration (FDA). They discuss the identification of the adverse event reports received by the FDA from January 1, 2000 to December 31, 2009. They reveal that adverse events reporting was clearly stimulated by the release of new drug safety information.

The article presents the author's insights on the alleged demonizing of the pharmaceutical industry by the press. The author cites media reports regarding the pharmaceutical industry such as it harbors great profits, illegal drug marketing to physicians, and cover up of drug side effects. However, the author says that most of them develop innovative and better technologies in medicine that benefit society in the hopes of gaining profits from their investments.

The article focuses on legislation in the European Union mandating that herbal medicines must have a product license or registration to be able to be sold as of April 2011. In order to obtain traditional herbal registration (THR), the herbal medicine must meet safety and quality standards including regarding pharmacovigilance (adverse event reporting).

The article presents news items related to prescription drugs and over the counter drugs in the U. S. The U.S. Food and Drug Administration has warned U.S. consumers to be wary of web sites that advertise swine influenza products that could be fraudulent or ineffective. The U.S. Food and Drug Administration has advised consumers not to use the weight loss supplement Hydroxycut because of 23 cases of liver damage that have been reported in Hydroxycut users that are thought to be linked to its use.

The article describes the difficulty of distinguishing widely known and oft-repeated facts about the pharmaceutical industry from research that has been independently verified. It asserts that the claimed costs of drug development and dire predictions of the effects of reduced prices are unverified claims that are used by pharmaceutical companies to keep prices high. The authors claim that unbiased and independent research is needed to verify drug efficacy and safety claims.

The article discusses the application of intravenous immunoglobulin (i.v. IG) in dermatology. It explains that an i.v. IG is a sterile highly purified immunoglobulin G preparation that was developed from pooled human plasma and consists of over 95% of unmodified IgG. One study reported the benefit of high dose (hd) i.v. IG to patients with toxic epidermal necrolysis (TEN). Among the cutaneous adverse events cited with the administration of i.v. IG are petechiae, pruritus and alopecia.

The article focuses on the reported side effects of antiviral agent oseltamivir. It notes that the World Health Organization (WHO) has recommended the use of the drug in the treatment of avian influenza A. However, reports received by WHO indicated hepatic and skin disorder reactions to the drug. An overview of the WHO review on oseltamivir is presented.

A table is presented that offers an overview on case reports of serious adverse drug reactions named by the drug safety alerting service "Reactions Weekly."

The author reflects on pharmacogenomics and drug toxicity. He suggests that one of the major causes of adverse drug reactions is genetic variants that cause susceptibility to a drug reaction. They argue that the identification of these variants is expected to improve the management of patient care by determining which patients should avoid a specific drug and which patients should take a modified dose.

Moxifloxacin is an advanced-generation fluoroquinolone with a broad spectrum of antimicrobial activity that is not metabolized by cytochrome P450 system. Therefore, the drug interaction of moxifloxacin is rarely seen. It has been reported that moxifloxacin is safe and well tolerable. We aimed to report a drug interaction between moxifloxacin and warfarin in a 74-year-old patient with a prosthetic mitral valve. [ABSTRACT FROM AUTHOR]

The authors comment on the usability of the current version of the Common Terminology Criteria for Adverse Events (CTCAE) in reporting the adverse events that commonly occur with the recent targeted therapies. They assert that the said coding system cannot adequately code the subacute adverse events resulted in the use of targeted therapies. They contend that the current criteria and reporting mechanism should be partially revised to assess properly the toxicity of new drugs.

A published report of one or more adverse events can provide a useful signal of possible risks associated with the use of a drug or medical product. However, shortcomings in vital information in published cases can often limit the value of such reports by failing to provide sufficient details. Recent guidelines endorsed by the International Society for Pharmacoepidemiology and the International Society of Pharmacovigilance have identified information that should always be considered for inclusion in a report submitted for publication [ABSTRACT FROM AUTHOR]

The article discusses the need for pharmacovigilance of ayurvedic medicines in India given growing concerns about the safety of ayurvedic medicines. It is noted that is a misconception that ayurvedic medicines are devoid to adverse reactions. In fact, a number of adverse reactions to ayurvedic drugs were reported. Thus, the National Pharmacovigilance Program has been introduced to detect, assess, and prevent the adverse reactions of ayurvedic drugs.

Abstract: Aim: In this single-center cohort, we retrospectively analyzed the efficacy and safety of tacrolimus in pediatric renal transplantation. Methods: We examined the medical records of 22 consecutive renal transplantation recipients (12 boys, 10 girls) receiving tacrolimus, to evaluate occurrence of acute rejection (AR) episodes, glomerular filtration rates (GFR), and side effects. Results: The mean recipient age was 15.07 ± 3.96 years. Seven grafts came from cadaveric, and 15 from living related donors. The patients were placed on immunosuppression with prednisolone and tacrolimus plus azathioprine (n = 8) or mycophenolate mofetil (MMF) (n = 12) or enteric-coated mycophenolate sodium (n = 2). Eighteen patients received basiliximab on days 0 and 4. There were three AR episodes at 5, 9, and 12 months. Mean GFR at the end of 1 and 2 years were 97.1 ± 24.0 mL/min/1.73 m2 and 116.9 ± 42.2 mL/min/1.73 m2, respectively. There was no graft loss. Hypertension, hyperlipidemia, and hyperglycemia were present in 14 (63.6%), 3 (13.6%), and 3 (13.6%) patients, respectively, without gingival hyperplasia, tremor, or hypertrichosis. Supraventricular tachycardia was noticed in five patients (22.7%), three of whom needed antiarrhythmic drugs (13.6%). Conclusion: Our single-center experience with tacrolimus, steroid plus azathioprine or MMF or enteric-coated mycophenolate sodium regimen in pediatric kidney recipients showed a low rate of AR with excellent graft survival and function at 1 and 2 year posttransplantation. The increased rate of supraventricular tachycardia in this regimen had not been previously reported; this association merits further studies. [Copyright &y& Elsevier]

This article comments on a study of sunitinib which is used to treat some cancers and is associated with adverse effects. The study in this issue suggests that cardiac toxicity might be a side effect of the drug therapy. The author believes that the study's authors are correct in their findings on the side effects of the drug and warn that patients who are being treated with sunitinib need careful cardiac monitoring.

The author discusses the history of the U.S. Food and Drug Administration (FDA) and new legislation that changes its mission to include the oversight of a drug's safety after its approval. The author considers the challenges facing the FDA, particularly with regard to epidemiologic data and drug safety.

This article comments on the report of the U.S. Institute of Medicine (IOM) addressing the need for reform in postmarket drug testing by the U.S. Food and Drug Administration (FDA). The IOM report issued a set of recommendations which the U.S. Congress took up quickly, creating legislation for the FDA Amendments Act of 2007. Details of the proposed legislation are presented. It basically gives the FDA the authority to monitor and test all drugs postmarket.

This article presents an analysis of guidelines for reporting observational studies in epidemiology written by an international group of methodologists, researchers and medical journal editors in the STROBE study. Medical research relies on observational studies. They are especially useful in detecting late adverse reactions to treatments but poor reporting of this research puts the results in question. The STROBE checklist is presented to help researchers put their information into a uniform system that will be easily understood by all. Separate versions of the checklist for cohort, case-control and cross-sectional studies are available at www.strobe-statement.org.

This editorial comments on the Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes (RECORD) study where the use of rosiglitazone in the treatment of diabetes was specifically examined in terms of increasing heart failure. Patients and physicians need to weigh the benefits and risks of the drug. Glycemic control is gained by taking the medication but the side effects include weight gain and an increased risk of heart failure.

This editorial comments on the evidence presented from the Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes (RECORD) study. This study was specifically designed to measure the effects on cardiovascular outcome of treatment with rosiglitazone. The study does suggest that congestive heart failure increased with the use of the drug and the author suggests that physicians should look for alternative treatments for their diabetic patients.

Prescription-event monitoring (PEM) is a non-interventional intensive method for post-marketing drug safety monitoring of newly licensed medicines. PEM studies are cohort studies where exposure is obtained from a centralised service and outcomes from simple questionnaires completed by general practitioners. Follow-up forms are sent for selected events.Because PEM captures all events and not only the suspected adverse drug reactions, PEM cohorts potentially differ in respect to the distribution of number of events per person depending on the nature of the drug under study. This variance can be related either with the condition for which the drug is prescribed (e.g. a condition causing high morbidity will have, in average, a higher number of events per person compared with a condition with lower morbidity) or with the drug effect itself.This paper describes an exploratory investigation of the distortion caused by product-related variations of the number of events to the interpretation of the proportional reporting ratio (PRR) values (“the higher the PRR, the greater the strength of the signal”) computed using drug-cohort data.We studied this effect by assessing the agreement between the PRR based on events (event of interest vs all other events) and PRR based on cases (cases with the event of interest vs cases with any other events). PRR were calculated for all combinations reported to ten selected drugs against a comparator of 81 other drugs. Three of the ten drugs had a cohort with an apparent higher proportion of patients with lower number of events. The PRRs based on events were systematically higher than the PRR based on cases for the combinations reported to these three drugs. Additionally, when applying the threshold criteria for signal screening (n ≥3, PRR ≥1.5 and Chi-squared ≥4), the binary agreement was generally high but apparently lower for these three drugs.In conclusion, the distribution of events per patient in drug cohorts shall be examined when comparing the ‘strength of the signals’ across drugs using PRR values. Further research will be required to address the sensitivity and specificity of the two ways of calculating PRR using data derived from drug cohorts. [ABSTRACT FROM AUTHOR]

An important role for the WHO Programme for International Drug Monitoring is to identify signals of international drug safety problems as early as possible. Since 1998, Bayesian Confidence Propagation Neural Network (BCPNN) data mining has been in routine use for screening of the WHO adverse reaction database, Vigibase. The identification of drug/adverse drug reaction combinations that have disproportionately high reporting relative to the background of all reports constitutes the first, quantitative step in the Uppsala Monitoring Centre (UMC) signal-detection process. In order to improve the signal-to-noise ratio and to focus on possible signals that are less likely to be detected by individual national pharmacovigilance centres, an expert group considered a number of possible subsidiary selection algorithms to be added as a second filtering step before potential signals were sent to the UMC expert panel for clinical review. As a result of these deliberations, three selection algorithms were implemented for routine use in 2001: 'serious reaction and new drug', 'rapid reporting increase' and 'special interest terms'. The effect of applying these algorithms has been critically evaluated on the basis of the ratio of associations selected to signals found and some modifications decided. Bearing in mind that any filtering strategy is likely to exclude some potential true signals from consideration, we think that triage strategies based on a combination of pragmatic thinking and experience are effective, provided that the results are reviewed at regular intervals and the algorithms adjusted on the basis of performance. [ABSTRACT FROM AUTHOR]

Numerous reports have documented drug interactions with grapefruit juice (GFJ) that occur via inhibition of CYP3A enzymes. As reported by Glaeser et al.1 in the March 2007 issue of this journal, there is increasing recognition that GFJ may also affect the activity of influx (e.g., OATPs) and efflux (e.g., P-glycoprotein) transporters. This commentary focuses on these interactions between GFJ and drug transporters.Clinical Pharmacology & Therapeutics (2007) 81, 631–633. doi:10.1038/sj.clpt.6100185 [ABSTRACT FROM AUTHOR]

A letter to the editor is presented about promoting the adverse drug reaction (ADR) reporting program in hospitals.

The article addresses whether some reportings of drug reactions need to be proved by further testing. The authors argue that some adverse drug reactions are so convincing that they do not require clinical trials. They identify four types of adverse events for which further testing is unnecessary, including tissue deposition of the drug or a metabolite, specific anatomical location, and physicochemical testing. INSET: Summary points.

The article provides legal checkpoints for nurses to disclose an adverse event. Guidelines to help the healthcare provider disclose an adverse event to the patient include giving a description of the event using simple language and expressing empathy and regret. Documentation of the event needs to be accurate and complete, as it may be used in the event of a lawsuit or licensure investigation.

Asthma is a worldwide chronic disorder that is characterised by airway inflammation and hyper-responsiveness, which results in intermittent airflow obstruction and subsequent perception of symptoms and exacerbations. Inhaled corticosteroids are a fundamental component in the prevention of the short- and long-term complications associated with inadequately controlled asthma. However, many individuals experience persistent symptoms and exacerbations despite receiving low-to-medium doses of an inhaled corticosteroid (400–800 µg/day of beclometasone or equivalent). In these symptomatic asthmatic patients, guidelines advocate the initiation of a long-acting β2-adrenoceptor agonist (LABA) as additional second-line controller therapy.The recent SMART (Salmeterol Multi-centre Asthma Research Trial) study was designed to compare the effects of add-on salmeterol 42µg (ex-actuator) twice daily with placebo over 28 weeks in a randomised, double-blind, parallel-group fashion, with the intention to enrol 60 000 asthmatic patients. However, the study was halted prematurely because preliminary data revealed an increased mortality associated with regular use of salmeterol. Moreover, concerning rates of respiratory-related deaths, asthma-related deaths and life-threatening events were observed among African Americans, who constituted up to 18% of the study population. This in turn prompted the US FDA to announce important safety information regarding inhalers containing LABAs and advise that new labelling be produced outlining the “small but significant risk in asthma-related deaths” associated with their regular use. This evidence-based review discusses the data from SMART and highlights potentially important drawbacks with regular use of LABAs in persistent asthma. [ABSTRACT FROM AUTHOR]

Focuses on the concerns of the health care community on the increase in suicide risk among children and adolescents who are into antidepressant therapy in the U.S. Problems associated with the approach employed by researchers in determining the psychological effects of antidepressants; Rate and frequency of suicide attempts among the groups; Need for a postmarketing surveillance program to supplement the Food and Drug Administration MedWatch program of volunteer adverse drug reaction reporting.

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, this newsletter 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]

This article presents information on several web sites which provide information on adverse drug reactions and drug interactions. Canada's Adverse Drug Reaction Database uses data collected from 1965 to Sept. 30, 2003. It contains information from all adverse drug reaction reports currently held in Canada's Canadian Adverse Drug Reaction Information System database which is used to monitor adverse drug reactions in drugs approved for the Canadian market. Medscape provides clinicians with a reliable source of information that is relevant to their patients and practice. One can do a drug information search using the generic name or the American trade name. This provides comprehensive information about the drug including the adverse effects.

Comments on drug safety and governmental drug regulation. Contrasting views regarding statins; Question of whether the drug is safe; Reference to rhabdomyolysis or myopathy, or both, associated with a fatal outcome during the use of various statins; Suggestion that the use of a statin has some risk; View that under-reporting of suspected adverse drug reactions is common and widespread; Why a new drug such as rosuvastatin should enter the population of patients in a slow, monitored and noninterventional way; Benefits of pharmacovigilance, if sufficiently developed and used intelligently; Ways that spontaneous reporting can be improved; Criticism of the current system of drug regulation; High-speed marketing of new medicines; Call for limitations and control of drug promotion.

Reports on the investigation on the adverse effects of antidepressants on children in the U.S. Meeting of the U.S. Food and Drug Administration to consider the scientific evidence on giving drugs called selective serotonin reuptake inhibitors; Accounts on the testimony of parents who committed suicide after taking antidepressant pills; Arrival of evidence on the drugs' side effects from the Treatment for Adolescents with Depression Study.

The following table contains an overview of first published case reports of adverse drug reactions identified in the international literature in recent weeks by the drug safety alerting service Reactions Weekly. Summarising information selected from over 1700 biomedical publications, this newsletter 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]

Recommends improvements to MedWatch, the safety information and adverse-event reporting program of the United States Food and Drug Administration. Regional surveillance of adverse drug reactions (ADR); Need for pharmacists to be vigilant in detecting and reporting suspected ADR; Continuing education of pharmacists on ADR identification and reporting.

Reports that an electronic adverse drug reaction (ADR) reporting system was effective in increasing the number of ADR reports and interdisciplinary involvement in ADR-reporting program. Experience at the VA Ann Arbor Healthcare System; Incorporation of requests for consultation with a pharmacist.