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Adverse Reactions to Drugs of Special Interest in a Pediatric Oncohematology Service.

ABSTRACT: Introduction: Drugs used in oncological diseases are frequently related to adverse drug reactions (ADR). Few studies have analyzed the toxicity of cancer treatments in children in real practice. Methods: An observational, longitudinal and prospective study has been carried out in an Oncohematology Service of a tertiary hospital. During 2017, patients exposed to one or more drugs of a previously agreed list were identified and followed-up for at least 6 months each. Characteristics of ADR, incidence, causality and possible preventability, have been evaluated. Results: 72 patients have been treated with at least one study drug, and 159 ADR episodes involving at least one of these drugs have been identified, with a total of 293 ADR. Most episodes required hospital admission (35.2%) or happened during the hospital stay (33%), and 91.2% were severe. Blood disorders were the most frequent ADR (96; 32.8%), related to thioguanine (42) and pegaspargase (39) mainly, followed by infections (86; 29.4%) related to thioguanine (32), pegaspargase (27), Erwinia asparaginase (14) and rituximab (13). Two ADR were unknown. Most ADR were dose-dependent or expectable (>90%). The global incidence of ADR was 3.1/100 days at risk (95% CI 2.7-3.5), with 3.5 ADR/100 days at risk with pegaspargase (95% CI 2.9-4.2), 1.2/100 days at risk with rituximab (95% CI 0.8-1.8) and 11.6/100 days at risk with thioguanine (95% CI 9.4-14.2). Controversial additional measures of prevention, other than those already used, were identified. Conclusion: ADR are frequent in pediatric oncohematological patients, mainly blood disorders and infectious diseases. Findings regarding incidence and preventability may be useful to compare data between different centers and to evaluate new possibilities for action or prevention.

SUBMITTER: Amaro-Hosey K

PROVIDER: S-EPMC8131830 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ObjectiveTo assess the effectiveness, accessibility, and acceptability of a general practitioner with special interest service for skin problems compared with a hospital dermatology clinic.DesignRandomised controlled trial.SettingGeneral practitioner with special interest dermatology service and hospital dermatology clinic.ParticipantsAdults referred to a hospital dermatology clinic and assessed by a consultant or the general practitioner with special interest service,. Suitable patients had non-urgent skin problems and had been identified from the referral letter as suitable for management by a general practitioner with special interest.InterventionsParticipants were randomised in 2:1 ratio to receive management by a general practitioner with special interest or usual hospital outpatient care.Main outcome measuresPrimary outcomes were disease related quality of life (dermatology life quality index) and improvement in patients' perception of access to services, assessed nine months after randomisation. Secondary outcomes were patient satisfaction, preference for site of care, proportion of failed appointments, and waiting times to first appointment.Results49% of the participants were judged suitable for care by the general practitioner with special interest service. Of 768 patients eligible, 556 (72.4%) were randomised (354 to general practitioner with special interest, 202 to hospital outpatient care). After nine months, 422 (76%) were followed up. No noticeable differences were found between the groups in clinical outcome (median dermatology life quality index score = 1 both arms, ratio of geometric means 0.99, 95% confidence interval 0.85 to 1.15). The general practitioner with special interest service was more accessible (difference between means on access scale 14, 11 to 19) and waited a mean of 40 (35 to 46) days less. Patients expressed slightly greater satisfaction with consultations with a general practitioner with special interest (difference in mean satisfaction score 4, 1 to 7), and at baseline and after nine months 61% said they preferred care at the service.ConclusionsThe general practitioner with special interest service for dermatology was more accessible and preferred by patients than hospital outpatient care, achieving similar clinical outcomes. Trial registration ISRCTN31962758.

Project description:IntroductionThe GAIA (Global Alignment on Immunisation Safety Assessment in Pregnancy) consortium was established in 2014 with the aim of creating a standardised, globally coordinated approach to monitoring the safety of vaccines administered in pregnancy. The consortium developed twenty-six standardised definitions for classifying obstetric and infant adverse events. This systematic review sought to evaluate the current state of adverse event reporting in maternal vaccine trials following the publication of the case definitions by GAIA, and the extent to which these case definitions have been adopted in maternal vaccine safety research.MethodsA comprehensive search of published literature was undertaken to identify maternal vaccine research studies. PubMed, EMBASE, Web of Science, and Cochrane were searched using a combination of MeSH terms and keyword searches to identify observational or interventional studies that examined vaccine safety in pregnant women with a comparator group. A two-reviewer screening process was undertaken, and a narrative synthesis of the results presented.Results14,737 titles were identified from database searches, 435 titles were selected as potentially relevant, 256 were excluded, the remaining 116 papers were included. Influenza vaccine was the most studied (25.0%), followed by TDaP (20.7%) and SARS-CoV-2 (12.9%).Ninety-one studies (78.4%) were conducted in high-income settings. Forty-eight (41.4%) utilised electronic health-records. The majority focused on reporting adverse events of special interest (AESI) in pregnancy (65.0%) alone or in addition to reactogenicity (27.6%). The most frequently reported AESI were preterm birth, small for gestational age and hypertensive disorders. Fewer than 10 studies reported use of GAIA definitions. Gestational age assessment was poorly described; of 39 studies reporting stillbirths 30.8% provided no description of the gestational age threshold.ConclusionsLow-income settings remain under-represented in comparative maternal vaccine safety research. There has been poor uptake of GAIA case definitions. A lack of harmonisation and standardisation persists limiting comparability of the generated safety data.

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Adverse Reactions to Drugs of Special Interest in a Pediatric Oncohematology Service.

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