Avoidance Of Adverse Drug Reactions Research Articles

Causality, Severity, and Avoidability of Adverse Drug Reactions in Hospitalized Children: A Prospective Cohort Study.

Adverse drug reactions are an important cause of morbidity and mortality in all patients. Information regarding adverse drug reactionsin the pediatric age group,especially with regard to the drugs involved and the clinical presentations is scanty. The aim of our study is to determine the incidence of adverse drug reactionsand to study theirfeatures in terms of causality, type, severity, avoidability, drugs implicated and their clinical presentations. The study was carried out on patients admitted to the pediatric ward and the pediatric intensive care unit over a one-year period (January 1, 2013 to December 31, 2013). Patientseither presenting with or developing an adverse drug reactionin the hospital were includedin the study. The incidence rate for adverse drug reactioncausing hospital admission was 1.79% (95% CI 1.48, 2.16) whereas it was 1.23% (95% CI 0.97, 1.53) for children exposed to a drug during their hospital stay. Type B (bizarre or idiosyncratic type) was seen in 114 (62.6%) of the ADRswhereas 53 (29.1%) were of type A (augmented pharmacologic effect). Severe ADRs were seen in 25 (13.7%) of the total ADRs. ADR was responsible for the death of two patients. 15.4% were rated as avoidable. Anti-microbials were the most common group responsible for ADRs (43.4%), followed by drugs acting on the immune system (15.9%) and drugs acting on the nervous system (14.3%). The most common ADRs were metabolic (29.3%) followed by neurological (17.6%). Adverse drug reactionscan occur in a substantial proportion of hospitalized patients with some of them being severe and potentially avoidable. Awareness among physicians should be encouraged regarding monitoring, documentation and notification of adverse drug reactions.

Translation, transcultural adaptation and validation to Brazilian Portuguese of tools for adverse drug reaction assessment in children

BackgroundChildren are more vulnerable to adverse drug reactions (ADRs) due to complex changes in the body during the growth process and lack specific pharmacoepidemiologic studies. Causality and Avoidability assessment of ADRs are relevant to clinical guidelines development and pharmacovigilance. This study aimed to translate and transcultural adapt two new tools—Liverpool Causality Assessment Tool (LCAT) and the Liverpool Avoidability Assessment Tool (LAAT)—to Brazilian-Portuguese and evaluate the psychometric properties of these tools to analyse ADRs in Brazilian children.MethodsThe validation of the cross-cultural adaptation of tools was obtained by the functional (conceptual, semantic, operational, and measurement) equivalence between the original and translated versions of each instrument. The translated version of LCAT and LAAT was applied to assessing the twenty-six case reports of suspected adverse drug reactions in a Brazilian teaching paediatric hospital. The inter-rater reliability (a pharmacist and a physician) was evaluated using Cronbach’s alpha. The exact agreement percentages (%EA) and extreme disagreement (%ED) were computed. Overall Kappa index was calculated with a 95% confidence interval.ResultsThere was a need to modify some terms translated into Portuguese for semantic and conceptual equivalence. The Cronbach’s alpha coefficient values obtained were 0.95 and 0.85, and the weighted Kappa (95% confidence interval) were 0.82 (0.67–0.97) and 0.68 (0.45–0.91) for LCAT and LAAT, respectively. The Brazilian-Portuguese versions of the LCAT and LAAT showed reliable and valid tools for the diagnosis and follow-up of ADRs in children.ConclusionThe methodological approach allowed the translation, transcultural adaptation, and validation to Brazilian-Portuguese of two easy and quick to perform tools for causality and avoidability of ADRs in children by a multidisciplinary expert specialist committee, including the authors of original tools. We believe these versions may be applied by professionals (patient safety teams) and researchers in Brazil in groups or by a single reviewer.Trial registrationThis study was evaluated and approved by the Research Ethics Committee (Instituto de Pediatria e Puericultura Martagão Gesteira – Federal University of Rio de Janeiro – Number: 3.264.238.

Causality and avoidability of adverse drug reactions of antibiotics in hospitalized children: a cohort study.

Adverse drug reactions are a problem in healthcare systems worldwide. Children are more susceptible than adults, especially when exposed to specific drug classes, such as antibiotics. To assess the incidence, causality, severity, andavoidabilityof antibiotic-associated adverse drug reactions in hospitalized pediatric patients. Pediatric ward of a high-complexity public hospital in northeast Brazil. A prospective cohort study was conducted over six months, including children aged between 28days and 12years, hospitalized for more than 48h, and receiving antibiotics. Liverpool's causality and avoidability assessment tools were used.Primary outcome measures: Incidence of adverse drug reactions, causality, severity, and avoidability,major antibiotics implicated, risk factors. A total of 183 patients were followed, and 35 suspected adverse drug reactions were recorded overall incidence equal to 14.7%. Most adverse drug reactions were classified as moderate severity (76.7%), probable (57.1%) and defined (28.6%) causality, and unavoidable (66.7%). The affected organs were the gastrointestinal system (74.1%) and skin (25.9%). Major antibiotics implicated were ceftriaxone (40.7%), azithromycin (25.9%), and crystalline penicillin (11.1%). The number of antibiotics prescribed per patient during hospitalization and the length of stay were the risk factors identified. Causality and severity assessment indicated that most adverse drug reactions were probable and moderate. Possibly avoidable reactions occurred due to inappropriate prescribing when preventive measures were not implemented. Monitoring the use of antibiotics in children is essential to ensure the safety of these patients.

1040. Real-World Implementation of Dolutegravir-Lamivudine to Achieve and Maintain HIV-1 Viral Suppression at an Academic Medical Center

BackgroundTwo-drug antiretroviral (ARV) regimens to achieve and maintain HIV viral suppression may lead to decreases in associated drug interactions, adverse events, and pill burden. Dolutegravir-lamivudine (DTG-3TC) has been established as safe and effective in treatment naïve and experienced adults. Further research is warranted to assess insertion into real-world practice.MethodsThis descriptive retrospective cohort consisted of all patients at an academic medical center HIV practice with a confirmed order of DTG-3TC between April 2019 and March 2020. Patients who were not linked to care by the site’s practices were excluded. The primary endpoint was number of patients initiated on DTG-3TC to determine uptake. Secondary endpoints included demographics and viral outcomes. Descriptive measures of central tendencies and variability were used for analysis.ResultsDTG-3TC was initiated in 49 patients. Sixty-nine percent were male (34/49), 90% carried publicly funded insurance (44/49), median age at DTG-3TC initiation was 55 years (IQR 46-60), and mean years since HIV diagnosis was 14 (SD ±8). The largest racial/ethnic category represented was Black (45%, 22/49). Forty-seven patients with a mean CD4 of 753 cells/mm3 (±413) and viral load of 88.2 copies/mL (±525) were switched from alternative regimens, mostly containing an integrase inhibitor (41/47, 87%), and with the primary rationale of medication modernization (27/47, 58%) followed by avoidance of adverse drug reactions (15/47, 32%). From 42 assessed patients, 62% had previous ARV exposure length of over 10 years. No patients were found to have significant resistance mutations to the involved agents. After initiation, 6% (3/49) of patients reported side effects. Among switch patients with follow up lab values, median CD4 (n=20) and viral load (n=21) deltas were -10 cells/mm3 (-59-67) and 0 copies/mL (0-0) respectively. Overall median length of therapy through April 1, 2020 was 110 days (71-156).ConclusionInitial implementation of DTG-3TC was successful in a northeast academic HIV practice primarily among virally suppressed treatment switch patients with long exposures to ARV and time since diagnosis. No clinically relevant change in CD4 or Viral Loads were immediately seen.Disclosures David E. Koren, PharmD, BCPS, AAHIVP, Gilead Sciences (Advisor or Review Panel member)Janssen Pharmaceuticals (Advisor or Review Panel member)Thera Technologies (Advisor or Review Panel member)

An investigation into the avoidability of adverse drug reactions using the LAAT and modified Hallas tools.

An adverse drug reactions avoidability tool called the Liverpool ADR avoidability assessment tool (LAAT) was recently developed (for research purposes), and subsequently validated with mixed interrater reliability (IRR). We investigated the comparative IRR of this tool in an inpatient cohort to ascertain its practical application in this setting.The patient population was comprised of 44 ADR drug pairs drawn from an observational prospective cohort of patents with ADR attending a Weill Cornell Medicine-affiliated tertiary medical Centre in Doha Qatar (Hamad General Hospital). Using the LAAT, and modified Hallas tools, 4 independent raters (2 Clinical Pharmacologists, and 2 General Physicians) assessed and scored the 44 ADR-drug pairs. Agreement proportions between the rating pairs were evaluated as well individual/overall kappa statistics and intraclass correlation coefficients. We evaluated the weight of each of the 7 questions on the LAAT tool to ascertain its determinative role.Across 44 ADR-drug pairs, the overall median Fleiss kappa using the LAAT, and modified Hallas tools were 0.67 (interquartile range (IQR) 0.55, 0.76), 0.36 (IQR, 0.23-0.71) respectively. The overall percentage pairwise agreement with the LAAT and modified Hallas tools were 78.5%, and 62.2% respectively. Exact pairwise agreement occurred in 37 out of 44 (range 0.71-1), and 27 of 44 (0.53-0.77) ADR-drug pairs using the LAAT and modified Hallas tools respectively. Using the LAAT tool, the overall intraclass correlation coefficient was 0.68 (CI 0.55, 0.79), and 0.37 (CI 0.22, 0.53) with the modified Hallas tool.We report a higher proportion of "possible" and "definite" avoidability outcomes of adverse drug reactions compared with the modified Hallas, or that reported by developers of the LAAT tool. Although initially developed for research purposes, our report has suggested for the first time a potential applicability of this tool in clinical environment as well.

Impact of awareness and knowledge about different types of drug-related interactions among nurses in a tertiary health center

Background: Drug interaction is a condition in which one drug influences the action of other drugs. The level of knowledge of nurses about drug-food interactions has a significant role in the avoidance of adverse drug reactions. Aim and Objective: This study aims to study the knowledge among nurses about drug-related interactions and to evaluate the impact of its awareness among nursing staff. Materials and Methods: A cross-sectional observational study about improvement in knowledge and awareness of drug-related interactions among nursing staffs of different departments in Government Doon Medical College, Dehradun, after an awareness training program was conducted using a modified validated, structure questionnaire. Results: Out of the four departments, nurses of surgery department had the best knowledge about drug-related interactions than other departments. Significant improvement was observed in the knowledge of nurses of operation theater and medicine department after educational training, whereas no significant improvement was observed in the nurses of surgery department about drug-related interactions. There was a positive correlation between knowledge and experience as nurses having a median experience of 10.87 years post-registration had better knowledge. Conclusion: To improve the patient safety, the knowledge of nurses about different types of drug-related interactions is highly essential.

Study to Find Out Predisposing Factors, Causality, Severity and Avoidability of Adverse Drug Reactions among Patients Treated under DOTS Centre of Northern India

Study to Find Out Predisposing Factors, Causality, Severity and Avoidability of Adverse Drug Reactions among Patients Treated under DOTS Centre of Northern India

Potential Cost Avoidance of Adverse Drug Reactions Prevention in Outpatient Pharmacy Department Ramathibodi Hospital Thailand

Pharmacists’ intervention in hospital setting is very beneficial both in patients’ clinical outcomeand economic aspect, in terms of cost avoidance due to adverse drug reactions. This study was conductedto calculate cost avoidance of adverse drug reactions (ADR) prevention in outpatient pharmacydepartment in Ramathibodi Hospital Thailand. A retrospective database review of hospital pharmacyinterventions preventing adverse drug reaction was conducted at second floor pharmacy unit, Somdech-PhraDebaratana Medical Center, Ramathibodi hospital between 1 July 2013 and 31 December 2013. Potentialcost avoidance of ADR was calculated using diagnosis-related groups (DRG’s) data. Results showedthat the detection of ADR was 0.239%. The most frequent ADR came from Penicillin group was accountedfor 32.4% of total case. The estimated cost avoidance generated during July-December 2013 was ThaiBaht (THB) 592,320 to THB 1,257,428 (USD 19,278 to USD 40,925, value 2013). It can be concludedthat hospital pharmacists positively impacted on economic benefit of patients by providing ADR detection.More complete data are needed to get a better results of a real cost avoidance of ADR prevention.

Development of the Liverpool Adverse Drug Reaction Avoidability Assessment Tool.

AimTo develop and test a new tool to assess the avoidability of adverse drug reactions that is suitable for use in paediatrics but which is also applicable to a variety of other settings.MethodsThe study involved multiple phases. Preliminary work involved using the Hallas scale and a modification of the existing Hallas scale, to assess two different sets of adverse drug reaction (ADR) case reports. Phase 1 defined, modified and refined a new tool using multidisciplinary teams. Phase 2 involved the assessment of 50 ADR case reports from a prospective study of paediatric inpatients by individual assessors. Phase 3 compared assessments with the new tool for individuals and groups in comparison to the ‘gold standard’ (the avoidability outcome set by a panel of senior investigators: an experienced clinical pharmacologist, paediatrician and pharmacist).Main Outcome MeasuresInter-rater reliability (IRR), measure of disagreement and utilization of avoidability categories.ResultsPreliminary work—Pilot phase: results for the original Hallas cases were fair and pairwise kappa scores ranged from 0.21 to 0.36. Results for the modified Hallas cases were poor, pairwise kappa scores ranged from 0.06 to 0.16.Phase 1: on initial use of the new tool, agreement between the two multidisciplinary groups was found on 13/20 cases with a kappa score of 0.29 (95% CI -0.04 to 0.62).Phase 2: the assessment of 50 ADR case reports by six individual reviewers yielded pairwise kappa scores ranging from poor to good 0.12 to 0.75 and percentage exact agreement (%EA) ranged from 52–90%.Phase 3: Percentage exact agreement ranged from 35–70%. Overall, individuals had better agreement with the ‘gold standard’.ConclusionAvoidability assessment is feasible but needs careful attention to methods. The Liverpool ADR avoidability assessment tool showed mixed IRR. We have developed and validated a method for assessing the avoidability of ADRs that is transparent, more objective than previous methods and that can be used by individuals or groups.

Economic and safety benefits of pharmaceutical interventions by community and hospital pharmacists in Japan.

Pharmaceutical interventions by community and hospital pharmacists can improve medication safety and result in financial savings. Their effect has not been fully explored in Japan. To evaluate the economic and safety contributions of various pharmaceutical interventions by community and hospital pharmacists in Japan. Two hospitals and eight community pharmacies in Ehime Prefecture, Japan, in 2014-2015. Pharmacists entered data about pharmaceutical interventions via the internet, and the data were divided into 11 types of interventions. The economic impact was estimated based on the rate of avoidance of serious adverse drug reactions and the monetary cost of these reactions in the Japanese compensation system. The cost saving from adjusting prescriptions to take account of unused prescription drugs was calculated using drug prices from the national health insurance scheme. Main The number of pharmaceutical interventions and their economic impact. RESULTS The total cost savings from 500 to 509 pharmaceutical interventions by community and hospital pharmacists were US$207,126.6 and US$592,840, respectively. Community pharmacists mainly intervened to correct prescription errors. They also adjusted 135 prescriptions to take account of unused prescription drugs. This potentially improved patients' adherence and contributed to effective use of medication. Pharmaceutical interventions by hospital pharmacists facilitated avoidance of 10 serious adverse drug reactions, and included 42 transvenous antimicrobial therapy interventions, 88 interventions in cancer chemotherapy, and 47 monitoring recommendations. Hospital pharmacists helped improve patients' quality of life using more aggressive interventions besides correcting prescription errors. Over half of pharmaceutical interventions by community and hospital pharmacists contributed to avoidance of adverse drug reactions. These results suggest the importance of pharmaceutical interventions by both community and hospital pharmacists in reducing increasing medical expenses and contributing to safety and effectiveness of medication. They also suggest that community and hospital pharmacists have different roles.

The SickKids Genome Clinic: developing and evaluating a pediatric model for individualized genomic medicine.

Our increasing knowledge of how genomic variants affect human health and the falling costs of whole-genome sequencing are driving the development of individualized genomic medicine. This new clinical paradigm uses knowledge of an individual's genomic variants to anticipate, diagnose and manage disease. While individualized genetic medicine offers the promise of transformative change in health care, it forces us to reconsider existing ethical, scientific and clinical paradigms. The potential benefits of pre-symptomatic identification of at-risk individuals, improved diagnostics, individualized therapy, accurate prognosis and avoidance of adverse drug reactions coexist with the potential risks of uninterpretable results, psychological harm, outmoded counseling models and increased health care costs. Here we review the challenges, opportunities and limits of integrating genomic analysis into pediatric clinical practice and describe a model for implementing individualized genomic medicine. Our multidisciplinary team of bioinformaticians, health economists, health services and policy researchers, ethicists, geneticists, genetic counselors and clinicians has designed a 'Genome Clinic' research project that addresses multiple challenges in pediatric genomic medicine--ranging from development of bioinformatics tools for the clinical assessment of genomic variants and the discovery of disease genes to health policy inquiries, assessment of clinical care models, patient preference and the ethics of consent.

PO-0926 Are Group Assessments Superior To Individual Avoidability Assessments? A Test Of The Liverpool Adverse Drug Reaction Avoidability Assessment Tool

Background There is currently no standardised method for determining avoidability of adverse drug reactions (ADRs) and many of the established tools are not suitable for use in paediatrics. We have developed a new tool; the Liverpool ADR avoidability assessment tool (LAAT). Initial testing showed mixed inter-rater reliability. Aim To test the hypothesis that group assessments are superior to individual avoidability assessments. Methods Participants were assigned either to a consensus group or to individually assess avoidability for a purposive sample of 20 ADR cases. Individual participants (nurses, pharmacists and doctors) independently assessed the cases. Groups took part in multidisciplinary meetings to assess the cases and reach consensus. The results were compared to the ‘gold standard’ (the avoidability outcome set by a panel of senior investigators). An ethnographic approach was taken; the consensus meetings were overseen by a facilitator and non-participant observations of the meetings were recorded. Post consensus meeting semi-structured interviews were conducted with the group members. Qualitative and quantitative analyses were carried out. We examined the extent to which individuals and groups agreed with the ‘gold standard’ using percentage exact agreement (%EA) (Figure 1). Results Agreement ranged from 35–70%. The mean agreement for individuals was 54% and 47% for the consensus groups. Conclusion In assessing avoidability of ADRs individual assessments had better agreement with the ‘gold standard’ evaluation than group assessments. Qualitative analysis of meeting observations and participant interviews may help identify reasons for this and inform the optimisation of the LAAT for assessment of ADR avoidability.

ADRIC: Adverse Drug Reactions In Children – a programme of research using mixed methods

AimsTo comprehensively investigate the incidence, nature and risk factors of adverse drug reactions (ADRs) in a hospital-based population of children, with rigorous assessment of causality, severity and avoidability, and to assess the consequent impact on children and families. We aimed to improve the assessment of ADRs by development of new tools to assess causality and avoidability, and to minimise the impact on families by developing better strategies for communication.Review methodsTwo prospective observational studies, each over 1 year, were conducted to assess ADRs in children associated with admission to hospital, and those occurring in children who were in hospital for longer than 48 hours. We conducted a comprehensive systematic review of ADRs in children. We used the findings from these studies to develop and validate tools to assess causality and avoidability of ADRs, and conducted interviews with parents and children who had experienced ADRs, using these findings to develop a leaflet for parents to inform a communication strategy about ADRs.ResultsThe estimated incidence of ADRs detected in children on admission to hospital was 2.9% [95% confidence interval (CI) 2.5% to 3.3%]. Of the reactions, 22.1% (95% CI 17% to 28%) were either definitely or possibly avoidable. Prescriptions originating in the community accounted for 44 out of 249 (17.7%) of ADRs, the remainder originating from hospital. A total of 120 out of 249 (48.2%) reactions resulted from treatment for malignancies. Off-label and/or unlicensed (OLUL) medicines were more likely to be implicated in an ADR than authorised medicines [relative risk (RR) 1.67, 95% CI 1.38 to 2.02;p < 0.001]. When medicines used for the treatment of oncology patients were excluded, OLUL medicines were not more likely to be implicated in an ADR than authorised medicines (RR 1.03, 95% CI 0.72 to 1.48;p = 0.830). For children who had been in hospital for > 48 hours, the overall incidence of definite and probable ADRs based on all admissions was 15.9% (95% CI 15.0 to 16.8). Opiate analgesic drugs and drugs used in general anaesthesia (GA) accounted for > 50% of all drugs implicated in ADRs. The odds ratio of an OLUL drug being implicated in an ADR compared with an authorised drug was 2.25 (95% CI 1.95 to 2.59;p < 0.001). Risk factors identified were exposure to a GA, age, oncology treatment and number of medicines. The systematic review estimated that the incidence rates for ADRs causing hospital admission ranged from 0.4% to 10.3% of all children [pooled estimate of 2.9% (95% CI 2.6% to 3.1%)] and from 0.6% to 16.8% of all children exposed to a drug during hospital stay. New tools to assess causality and avoidability of ADRs have been developed and validated. Many parents described being dissatisfied with clinician communication about ADRs, whereas parents of children with cancer emphasised confidence in clinician management of ADRs and the way clinicians communicated about medicines. The accounts of children and young people largely reflected parents’ accounts. Clinicians described using all of the features of communication that parents wanted to see, but made active decisions about when and what to communicate to families about suspected ADRs, which meant that communication may not always match families’ needs and expectations. We developed a leaflet to assist clinicians in communicating ADRs to parents.ConclusionThe Adverse Drug Reactions In Children (ADRIC) programme has provided the most comprehensive assessment, to date, of the size and nature of ADRs in children presenting to, and cared for in, hospital, and the outputs that have resulted will improve the management and understanding of ADRs in children and adults within the NHS. Recommendations for future research: assess the values that parents and children place on the use of different medicines and the risks that they will find acceptable within these contexts; focusing on high-risk drugs identified in ADRIC, determine the optimum drug dose for children through the development of a gold standard practice for the extrapolation of adult drug doses, alongside targeted pharmacokinetic/pharmacodynamic studies; assess the research and clinical applications of the Liverpool Causality Assessment Tool and the Liverpool Avoidability Assessment Tool; evaluate, in more detail, morbidities associated with anaesthesia and surgery in children, including follow-up in the community and in the home setting and an assessment of the most appropriate treatment regimens to prevent pain, vomiting and other postoperative complications; further evaluate strategies for communication with families, children and young people about ADRs; and quantify ADRs in other settings, for example critical care and neonatology.FundingThe National Institute for Health Research Programme Grants for Applied Research programme.

The Genome Clinic: A Multidisciplinary Approach to Assessing the Opportunities and Challenges of Integrating Genomic Analysis into Clinical Care

Our increasing knowledge of how genomic variants affect human health and the falling costs of whole-genome sequencing are driving the development of individualized genetic medicine. This new clinical paradigm uses knowledge of an individual's genomic variants to guide health care decisions throughout life, to anticipate, diagnose, and manage disease. While individualized genetic medicine offers the promise of transformative change in health care, it forces us to reconsider existing ethical, scientific, and clinical paradigms. The potential benefits of presymptomatic identification of at risk individuals, improved diagnostics, individualized therapy, accurate prognosis, and avoidance of adverse drug reactions coexist with the potential risks of uninterpretable results, psychological harm, outmoded counseling models, and increased health care costs. Here, we review the challenges of integrating genomic analysis into clinical practice and describe a prototype for implementing genetic medicine. Our multidisciplinary team of bioinformaticians, health economists, ethicists, geneticists, genetic counselors, and clinicians has designed a "Genome Clinic" research project that addresses multiple challenges in genomic medicine-ranging from the development of bioinformatics tools for the clinical assessment of genomic variants and the discovery of disease genes to health policy inquiries, assessment of clinical care models, patient preference, and the ethics of consent.

Compound I Reactivity Defines Alkene Oxidation Selectivity in Cytochrome P450cam

Prediction of the chemoselectivity of drug oxidation by the human cytochrome P450 enzymes will aid in the avoidance of adverse drug reactions. The chemoselectivity of alkene oxidation is an important problem to address, as it can result in the formation of epoxides, which can have toxic effects. In this paper the epoxidation and hydroxylation of cyclohexene and propene by the bacterial P450(cam) isoform are modeled with hybrid quantum mechanical/molecular mechanical (QM/MM) methods. Snapshots for QM/MM modeling are chosen from molecular dynamics trajectories, to sample the different conformations of the enzyme-substrate complex. The energy barriers obtained for these processes are in qualitative agreement with experimental work, supporting the use of QM/MM methods in the study of selectivity for this class of enzyme. This work highlights the complexity involved in modeling these systems with QM/MM and the importance in the selection of starting geometries.

Avoidability of Adverse Drug Reactions Spontaneously Reported to a French Regional Drug Monitoring Centre

Adverse drug reactions (ADRs) are now recognized as a major category of iatrogenic illness in terms of morbidity and mortality. To describe the type and frequency of avoidable ADRs spontaneously reported to a regional drug monitoring centre following inappropriate prescribing, as a basis for preventive actions. A prospective, observational study of ADRs reported to the Regional Drug Monitoring Centre of Tours, France, between 26 November 2002 and 28 November 2003. The outcome measure was ADRs secondary to inappropriate prescribing that were defined as entirely or partly avoidable, i.e. at least one of the recommendations in various sections of the summary of product characteristics (SPC; indication, route of administration, dose, duration of treatment, dose adaptation, precautions for use, monitoring of treatment, absolute contraindications and contraindicated interactions) had not been respected. The link between the lack of conformity of the drug prescription with the SPC and occurrence of the ADR was evaluated by a working group using two criteria: (i) is nonconformity of the prescription of this drug a known and validated risk factor for this ADR?; and (ii) are there other aetiologies or other risk factors for this ADR? Three hundred and sixty ADRs in 294 adults and 66 children were analysed. The prescription was considered inappropriate for 213 of the 659 (32%) drugs implicated in ADRs, corresponding to 161 patients (45%). The ADR was adjudged entirely avoidable for 32 (9%) patients, partly avoidable for 28 (8%) patients and unavoidable for 300 (83%) patients. Not taking into account a history of allergy or altered renal function and not respecting the recommended dose were the most frequent causes of entirely avoidable ADRs. Allopurinol and lamotrigine were the drugs most frequently involved in serious avoidable ADRs. Preventive actions should focus on more systematic allergy checks when prescribing drugs and on dose adaptation in cases of altered renal function.

Prevalence, Clinical Features and Avoidability of Adverse Drug Reactions as Cause of Admission to??a??Geriatric Unit

Drug use increases with advancing age, and in older patients it is associated with an increase in adverse drug reactions (ADRs). ADRs are a primary cause of morbidity and mortality worldwide. To evaluate the prevalence, clinical characteristics and avoidability of ADR-related hospital admissions in elderly patients. From November 2004 to December 2005, all patients aged >or=65 years consecutively admitted to the Geriatric Unit of the Casa Sollievo della Sofferenza Hospital, San Giovanni Rotondo in Italy, were evaluated for enrolment in the study. ADRs were defined according to the WHO Adverse Reaction Terminology system. Drugs were classified according to Anatomical Therapeutic Chemical classification system. The Naranjo algorithm was used to evaluate the relationship between drug use and the ADR (definite, probable, possible or doubtful) and Hallas criteria were used to evaluate the avoidability of the ADR (definitely avoidable, possibly avoidable or unavoidable). All cases of a suspected ADR were discussed by a team trained in drug safety, including three geriatricians, one clinical pharmacologist and one pharmacist. Only cases of an ADR with an agreement >or=80% were included. Of the 1756 patients observed, 102 (5.8%, 42 males, 60 females, mean age 76.5 +/- 7.4 years, range 65-93 years) showed certain (6.8%) or probable (91.2%) ADR-related hospitalization. Gastrointestinal disorders (48 patients, 47.1%); platelet, bleeding and clotting disorders (20 patients, 19.6%); and cardiovascular disorders (13 patients, 12.7%) were the most frequent ADRs. NSAIDs (23.5%), oral anticoagulants (20.6%), low-dose aspirin (acetylsalicylic acid) [13.7%] and digoxin (12.7%) were the drugs most frequently involved in ADRs. Of the ADRs, 45.1% were defined as definitely avoidable, 31.4% as possibly avoidable, 18.6% as unavoidable and 4.9% as unclassifiable. Of 78 patients with definitely or possibly avoidable ADRs, 17 patients (21.8%) had received an inappropriate prescription, 29 patients (37.2%) had not received a prescription for an effective gastroprotective drug concomitantly with NSAID or low-dose aspirin treatment and 32 patients (41%) were not monitored during drug treatment. In the elderly, almost 6% of hospitalizations are ADR related. Most of these ADRs are potentially avoidable. Strategies that reduce inappropriate prescriptions and monitoring errors, as well as improving active prevention of ADRs, are needed in elderly subjects.

薬剤管理指導業務の必要性と質的および量的拡大に関する研究

Pharmaceutical care for inpatients has been established as one of main duties of hospital pharmacists. It is therefore necessary to demonstrate the advantages of such care.Sasaguri Hospital has 3 different types of wards, one for the treatment of acute diseases, one for the longterm stay of elderly patients, and one for the provision of psychotherapeutic care. The percentage of inpatients receiving pharmaceutical care in the hospital has averaged about 99.6% of since October 2001. This report describes the results of such pharmaceutical care in Sasaguri Hospital.In 2000, the percentage of inpatients for whom drug information was offered from pharmacists to donors, was about 22% in the general ward for the treatment of acute diseases, but this rate was even higher in the other wards. In 2001, the percentages in the long-term stay and psychotherapeutic wards increased in comparison to the results of the previous year.The percentages of “pre-avoid” reports (pharmaceutical report of early detection of or avoidance of adverse drug reactions) among inpatients cared for by pharmacists in the general ward, the long-term stay ward, and the psychotherapeutic wards were 0.53%, 0.62%, and 0.42%, respectively. The number of “pre-avoid” reports increased with the increase in pharmaceutical care in all wards. These results demonstrate that appropriate pharmaceutical care is essential to ensure the adequate risk management of drug therapy.The number of insurance claims for pharmaceutical care per inpatient in the general ward, was smaller than that is the long-term stay or psychotherapeutic wards. In addition, the number of times that pharmaceutical advice was given to each inpatient per insurance claim in the general ward, was more than that in the other wards. Therefore, in the general ward, in order to increase claims for pharmaceutical care, it is necessary to step up the number of inpatients cared for by pharmacists, and to begin such care as soon as possible after admission.The percentage of inpatients for whom drug information was offered from pharmacists to doctors, the rate of prescription changes, and the number of “pre-avoid” reports during pharmaceutical care. showed no statistically significant differences between the short-term admission group and the long-term admission group in either the long-term stay or the psychotherapeutic ward. These results demonstrate that the necessity of appropriate pharmaceutical care in these wards is totally unrelated to the length of admission.

Drug therapy in cats: Mechanisms and avoidance of adverse drug reactions

Summary This is the first of a 4-part series concerning drug therapy in cats. In this article, factors that may increase the incidence of type-A adverse drug reactions in cats are discussed. Factors related to species and age differences, drug interactions, and the effects of disease are emphasized. Those that tend to be unique to cats, such as species-induced differences in drug disposition, are described in detail when sufficient information was available from the literature. General recommendations regarding drug administration are made, which will facilitate the implementation of rational drug therapy in cats, thus reducing the incidence of adverse reactions.