Comparing Acute Kidney Injury Reports Among Antibiotics: A Pharmacovigilance Study of the FDA Adverse Event Reporting System (FAERS).

Drug Saf. 2020 01;43(1):17-22

Authors: Patek TM, Teng C, Kennedy KE, Alvarez CA, Frei CR

Abstract
BACKGROUND: A study using the US FDA Adverse Event Reporting System (FAERS) found significant acute kidney injury (AKI) reporting associations with vancomycin, fluoroquinolones, penicillin combinations, and trimethoprim-sulfamethoxazole. Other antibiotics may also lead to AKI, but no study has systemically compared AKI reporting associations for many available antibiotics.
OBJECTIVE: The objective of this study was to evaluate the reporting associations between AKI and many available antibiotics using FAERS.
METHODS: FAERS reports from 1 January 2015 to 31 December 2017 were included in the study. The Medical Dictionary for Regulatory Activities (MedDRA) was used to identify AKI cases. Reporting odds ratios (RORs) and corresponding 95% confidence intervals (CIs) for the reporting associations between antibiotics and AKI were calculated. A reporting association was considered statistically significant when the lower limit of the 95% CI was > 1.0.
RESULTS: A total of 2,042,801 reports (including 20,138 AKI reports) were considered. Colistin had the greatest proportion of AKI reports, representing 25% of all colistin reports. AKI RORs (95% CI) for antibiotics were, in descending order: colistin 33.10 (21.24-51.56), aminoglycosides 17.41 (14.49-20.90), vancomycin 15.28 (13.82-16.90), trimethoprim-sulfamethoxazole 13.72 (11.94-15.76), penicillin combinations 7.95 (7.09-8.91), clindamycin 6.46 (5.18-8.04), cephalosporins 6.07 (5.23-7.05), daptomycin 6.07 (4.61-7.99), macrolides 3.60 (3.04-4.26), linezolid 3.48 (2.54-4.77), carbapenems 3.31 (2.58-4.25), metronidazole 2.55 (1.94-3.36), tetracyclines 1.73 (1.26-2.36), and fluoroquinolones 1.71 (1.49-1.97).
CONCLUSION: This study found 14 classes of antibiotics having significant reporting associations with AKI. Among the antibiotics evaluated in this study, colistin had the highest AKI ROR and moxifloxacin had the lowest.

PMID: 31691256 [PubMed - indexed for MEDLINE]

Application of Augmented Intelligence for Pharmacovigilance Case Seriousness Determination.

Drug Saf. 2020 01;43(1):57-66

Authors: Routray R, Tetarenko N, Abu-Assal C, Mockute R, Assuncao B, Chen H, Bao S, Danysz K, Desai S, Cicirello S, Willis V, Alford SH, Krishnamurthy V, Mingle E

Abstract
INTRODUCTION: Identification of adverse events and determination of their seriousness ensures timely detection of potential patient safety concerns. Adverse event seriousness is a key factor in defining reporting timelines and is often performed manually by pharmacovigilance experts. The dramatic increase in the volume of safety reports necessitates exploration of scalable solutions that also meet reporting timeline requirements.
OBJECTIVE: The aim of this study was to develop an augmented intelligence methodology for automatically identifying adverse event seriousness in spontaneous, solicited, and medical literature safety reports. Deep learning models were evaluated for accuracy and/or the F1 score against a ground truth labeled by pharmacovigilance experts.
METHODS: Using a stratified random sample of safety reports received by Celgene, we developed three neural networks for addressing identification of adverse event seriousness: (1) a binary adverse-event level seriousness classifier; (2) a classifier for determining seriousness categorization at the adverse-event level; and (3) an annotator for identifying seriousness criteria terms to provide supporting evidence at the document level.
RESULTS: The seriousness classifier achieved an accuracy of 83.0% in post-marketing reports, 92.9% in solicited reports, and 86.3% in medical literature reports. F1 scores for seriousness categorization were 77.7 for death, 78.9 for hospitalization, and 75.5 for important medical events. The seriousness annotator achieved an F1 score of 89.9 in solicited reports, and 75.2 in medical literature reports.
CONCLUSIONS: The results of this study indicate that a neural network approach can provide an accurate and scalable solution for potentially augmenting pharmacovigilance practitioner determination of adverse event seriousness in spontaneous, solicited, and medical literature reports.

PMID: 31605285 [PubMed - indexed for MEDLINE]

Adverse Events Associated with Cumulative Corticosteroid Use in Patients with Castration-Resistant Prostate Cancer: An Administrative Claims Analysis.

Drug Saf. 2020 01;43(1):23-33

Authors: Schultz NM, Penson DF, Wilson S, Song Y, Yang H, Ramaswamy K, Lowentritt B

Abstract
INTRODUCTION: Corticosteroids are a mainstay treatment for castration-resistant prostate cancer (CRPC). Although corticosteroids have been associated with adverse events, long-term outcomes related to their sustained use have not been assessed in men with CRPC.
OBJECTIVE: This study evaluated the impact of cumulative corticosteroid exposure on the risk of developing specific adverse events in men with CRPC.
METHODS: Data were obtained from administrative claims databases. Adult chemotherapy-naïve men who initiated CRPC treatment following surgical or medical castration were selected. Patients were grouped into four cohorts based on cumulative corticosteroid dose: no exposure, low exposure (< 0.5 g), medium exposure (0.5-2.0 g), and high exposure (> 2.0 g). Time to each adverse event was assessed using Kaplan-Meier analyses and time-dependent Cox proportional hazard models, adjusting for baseline characteristics.
RESULTS: Overall, 9425 patients were included (no exposure, N = 6765; low exposure, N = 1660; medium exposure, N = 655; high exposure, N = 345). The mean age was 71-76 years across cohorts. During the study period, cumulative corticosteroid exposure was associated with a significantly higher risk of developing an infection [high vs. no exposure, adjusted hazard ratio (HR) 2.55; 95% confidence interval (CI) 2.27-2.85; p < 0.001 for trend], peptic ulcer (HR 1.91; 95% CI 1.39-2.64; p < 0.001), acute cardiovascular events (HR 1.62; 95% CI 1.43-1.83; p < 0.001), endocrine disorder (HR 1.61; 95% CI 1.34-1.94; p < 0.001), fracture (HR 1.59; 95% CI 1.37-1.86; p < 0.001), or mental health condition (HR 1.28; 95% CI 1.06-1.55; p = 0.014). Exposure to corticosteroids was associated with a more rapid onset of adverse events.
CONCLUSION: Patients with CRPC receiving corticosteroids had a higher risk of developing a wide range of adverse events than those not receiving them. The increased adverse event risk was observed after accounting, to the extent possible, for patients' overall disease severity.

PMID: 31587137 [PubMed - indexed for MEDLINE]

Reported Severe Hypersensitivity Reactions after Intravenous Iron Administration in the European Economic Area (EEA) Before and After Implementation of Risk Minimization Measures.

Drug Saf. 2020 01;43(1):35-43

Authors: Nathell L, Gohlke A, Wohlfeil S

Abstract
INTRODUCTION: Severe hypersensitivity reactions (HSRs) such as anaphylaxis are of great clinical concern because of their life-threatening potential. The adverse events attributable to intravenous iron products include HSRs. An investigation by the European Medicines Agency presented in late 2013 resulted in the implementation of risk minimization measures (RMMs).
OBJECTIVE: This study evaluated the number of severe HSRs reported for intravenous iron substances related to exposure for the 4-year periods before and after this implementation.
METHODS: This was a retrospective pharmacoepidemiologic study with a case-population design. We obtained information from the safety surveillance database EudraVigilance on spontaneously reported severe HSRs using the Medical Dictionary for Regulatory Activities preferred terms "anaphylactic reaction/shock" and "anaphylactoid reaction/shock". Exposure was estimated using IQVIA MIDAS sales data in European economic area countries.
RESULTS: Reporting rates for individual products were heterogenous, and the implementation of RMMs appeared to have no clear impact. Reporting rates remained low for the full study period for iron sucrose (0.03-0.20) and ferric gluconate (0.02-0.14) and were higher at the beginning and lower at the end of the study period for ferric carboxymaltose (1.47-0.18). No clear trend was detected for iron dextran (range 0.22-2.80) and iron (III) isomaltoside 1000 (range 0-7.94).
CONCLUSIONS: Future research is needed to investigate whether the wide variability in reporting rates for severe HSRs associated with these intravenous iron products are due to potential differences in the safety profiles of these substances.

PMID: 31583644 [PubMed - indexed for MEDLINE]

Potential Drug-Drug Interactions with Combination Volasertib + Itraconazole: A Phase I, Fixed-Sequence Study in Patients with Solid Tumors.

Clin Ther. 2020 Oct 30;:

Authors: Lang I, Liu D, Fritsch H, Taube T, Chizhikov E, Liptai B

Abstract
PURPOSE: This drug-drug interaction study determined whether the metabolism and distribution of the Polo-like kinase 1 inhibitor, volasertib, is affected by co-administration of the P-glycoprotein and cytochrome P-450 3A4 inhibitor, itraconazole.
METHODS: This was an uncontrolled, open-label, fixed-sequence trial of two 21-day treatment cycles in patients with various solid tumors. In cycle 1 (test), eligible patients were administered volasertib (day 1) plus itraconazole (days -3 to 15). In cycle 2 (reference), patients received volasertib monotherapy. The primary end point was the influence of co-administration of itraconazole on the pharmacokinetic profile (AUC0-tz; Cmax) of volasertib and its main metabolite, CD 10899, compared with that of volasertib monotherapy. Other end points included tolerability and preliminary therapeutic efficacy.
FINDINGS: Concurrent administration of itraconazole resulted in a slight reduction in the AUC0-tz (geometric mean ratio, 93.6%; 90% CI, 82.1%-106.8%) and a 20% reduction in Cmax (geometric mean ratio, 79.4%; 90% CI, 64.9%-97.1%) of volasertib compared with monotherapy. Of note, concurrent administration of itraconazole + volasertib had no effect on the AUC0-∞ of volasertib. More patients reported at least one drug-related adverse event in cycle 1 than in cycle 2 (75% vs 71%). The most commonly reported drug-related adverse events (cycles 1 and 2) were thrombocytopenia (68% and 33%, respectively), leukopenia (50% and 46%), and anemia (36% and 33%). No objective responses were observed. Stable disease was observed in 25 of 28 patients (89%).
IMPLICATIONS: While there was no clear evidence of a pharmacokinetic interaction between volasertib and itraconazole, co-administration reduced the tolerability of volasertib. Clinicaltrials.gov identifier: NCT01772563.

PMID: 33139055 [PubMed - as supplied by publisher]

Genome-Wide Association Study of Metamizole-Induced Agranulocytosis in European Populations.

Genes (Basel). 2020 Oct 29;11(11):

Authors: Cismaru AL, Rudin D, Ibañez L, Liakoni E, Bonadies N, Kreutz R, Carvajal A, Lucena MI, Martin J, Sancho Ponce E, Molokhia M, Eriksson N, EuDAC Collaborators, Krähenbühl S, Largiadèr CR, Haschke M, Hallberg P, Wadelius M, Amstutz U

Abstract
Agranulocytosis is a rare yet severe idiosyncratic adverse drug reaction to metamizole, an analgesic widely used in countries such as Switzerland and Germany. Notably, an underlying mechanism has not yet been fully elucidated and no predictive factors are known to identify at-risk patients. With the aim to identify genetic susceptibility variants to metamizole-induced agranulocytosis (MIA) and neutropenia (MIN), we conducted a retrospective multi-center collaboration including cases and controls from three European populations. Association analyses were performed using genome-wide genotyping data from a Swiss cohort (45 cases, 191 controls) followed by replication in two independent European cohorts (41 cases, 273 controls) and a joint discovery meta-analysis. No genome-wide significant associations (p < 1 × 10-7) were observed in the Swiss cohort or in the joint meta-analysis, and no candidate genes suggesting an immune-mediated mechanism were identified. In the joint meta-analysis of MIA cases across all cohorts, two candidate loci on chromosome 9 were identified, rs55898176 (OR = 4.01, 95%CI: 2.41-6.68, p = 1.01 × 10-7) and rs4427239 (OR = 5.47, 95%CI: 2.81-10.65, p = 5.75 × 10-7), of which the latter is located in the SVEP1 gene previously implicated in hematopoiesis. This first genome-wide association study for MIA identified suggestive associations with biological plausibility that may be used as a stepping-stone for post-GWAS analyses to gain further insight into the mechanism underlying MIA.

PMID: 33138277 [PubMed - in process]

Oral non-specific lesions in patient with Crohn's disease - a case report.

Pol Merkur Lekarski. 2020 Oct 23;48(287):349-353

Authors: Szczeklik K, Darczuk D, Krok-Ziółkowska J, Ligara J, Kuszaj M, Cibor D, Pytko-Polończyk J, Owczarek D

Abstract
Crohn's disease (CD) is a chronic and granulomatous inflammatory disease of the entire gastrointestinal tract. The etiopathogenesis is not fully elucidated. The most common symptoms in the active phase of the disease include abdominal pain, prolonged diarrhea, fever, fatigue, malaise and weight loss. Oral manifestations of CD are classified into specific for CD with granulomatous changes and non-specific ones. This rare extraintestinal manifestation of CD in adults may precede gastrointestinal tract involvement, occur together or appear after years of its duration. Oral lesions can be initiated by malnourishment, poor absorption of nutrients or side-effect of medications.
A CASE REPORT: We describe a 28-year-old female with a 9-years CD history, who presented in the active disease with oral lesions. They were classified as non-specific ones, and included oral candidiasis, irregular erythematous patches on the cheek mucosa, exfoliative lip inflammation, and angular cheilitis. The patient was treated with azathioprine, and since the last exacerbation of symptoms, induction therapy with adalimumab, (anti-TNF-alpha), has been prescribed. Nystatin was applied to treat the oral lesions, based on the microbiological assessment of the Candida albicans susceptibility, and symptomatic treatment. After a two-week treatment the oral mucosa was healed and angular cheilitis showed marked improvement compared to the initial presentation.
CONCLUSIONS: The young female with active CD presented the nonspecific lesions in the oral cavity. The lesions coexisted with the active inflammatory process in the intestinal tract with characteristic clinical symptoms, and were associated with sideropenic anemia. The implementation of the local therapy, systemic CD treatment and supplementation of micronutrient deficiencies have led to a healing of the oral lesions. We emphasize a personalized approach to treatment and close cooperation between the dentist and the gastroenterologist.

PMID: 33130798 [PubMed - indexed for MEDLINE]

Efficacy and Safety of Axitinib Therapy After Nivolumab for Patients With Metastatic Renal Cell Cancer.

Anticancer Res. 2020 Nov;40(11):6493-6497

Authors: Yasuoka S, Yuasa T, Fujiwara R, Komai Y, Numao N, Yamamoto S, Kondo Y, Yonese J

Abstract
BACKGROUND/AIM: Tyrosine kinase inhibitors (TKI) and immune-checkpoint inhibitors (ICI) are treatment options for metastatic renal cell cancer (mRCC). However, the treatment options after nivolumab are unclear.
PATIENTS AND METHODS: The medical records of 57 consecutive Japanese mRCC patients who underwent treatment with axitinib were reviewed. Among those, 17 patients received axitinib treatment after nivolumab and 40 patients received axitinib treatment after other chemotherapy regimens except nivolumab.
RESULTS: Of the 57 patients with mRCC, only 17 underwent axitinib therapy after nivolumab. Among these 17 patients, the objective response rate (ORR) and median tumor shrinkage rate were 56.3% and -30%, respectively. They were significantly better in patients who underwent axitinib therapy after nivolumab than after other therapies (p=0.026 and p=0.012, respectively). However, all 17 patients experienced some adverse events and nine patients (52.9%) required a dose reduction or axitinib treatment interruption.
CONCLUSION: Axitinib therapy after the immune checkpoint inhibitor nivolumab showed good efficacy with a moderate risk of adverse events. Careful management by skilled professionals may be required.

PMID: 33109588 [PubMed - indexed for MEDLINE]

Timing of Severe Toxicity from Chemotherapy in Patients With Lung Cancer.

Anticancer Res. 2020 Nov;40(11):6399-6406

Authors: SjØgren K, Jacobsen KA, GrØnberg BH, Halvorsen TO

Abstract
BACKGROUND/AIM: The aim of this study was to investigate the timing of severe toxicity in lung cancer patients receiving chemotherapy.
PATIENTS AND METHODS: Patients with advanced non-small cell lung cancer or limited disease small cell lung cancer included in two randomized controlled trials were analysed. Severe toxicity was defined as grade 3-5 toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) v3.0.
RESULTS: We analysed 569 patients and 433 (76.1%) experienced severe toxicity. Of these, 249 (57.5%) experienced the first episode of severe toxicity after the first, 109 (25.2%) after the second, 54 (12.5%) after the third and 18 (4.2%) after the fourth course of chemotherapy. Performance status (PS 2 vs. 0-1; p=0.046) and treatment arm were independent predictive factors for severe toxicity.
CONCLUSION: Severe toxicity was most frequent after the first chemotherapy course, but some patients did not experience severe toxicity until after the fourth course. Accounting for timing might be important when studying factors predicting severe toxicity.

PMID: 33109578 [PubMed - indexed for MEDLINE]

15 new pubmed citations were retrieved for your search. Click on the search hyperlink below to display the complete search results:

("drug-induced" OR "drug-related") AND ("adverse events" OR "side effects" OR "side-effects")

These pubmed results were generated on 2020/11/03

PubMed comprises more than millions of citations for biomedical literature from MEDLINE, life science journals, and online books. Citations may include links to full-text content from PubMed Central and publisher web sites.

Initiative to accelerate guideline distribution using the smartphone app ASRA Coags V.2.0.

Reg Anesth Pain Med. 2020 Oct 30;:

Authors: Gupta RK, Horlocker T, McEvoy MD

PMID: 33127809 [PubMed - as supplied by publisher]

Setting up pharmacovigilance based on available endTB Project data for bedaquiline.

Int J Tuberc Lung Dis. 2020 Oct 01;24(10):1087-1094

Authors: Lachenal N, Hewison C, Mitnick C, Lomtadze N, Coutisson S, Osso E, Ahmed S, Leblanc G, Islam S, Atshemyan H, Nair P, Kholikulov B, Aiylchiev S, Zarli K, Adnan S, Krisnanda A, Padayachee S, Stambekova A, Sahabutdinova Y, de Guadalupe S, Moreno P, Kumsa A, Reshid A, Makaka J, Abebe S, Melikyan N, Seung KJ, Khan U, Khan P, Huerga H, Rich M, Varaine F

Abstract
SETTING: Active pharmacovigilance (PV) is recommended for TB programmes, notably for multidrug-resistant TB (MDR-TB) patients treated with new drugs. Launched with the support of UNITAID in April 2015, endTB (Expand New Drug markets for TB) facilitated treatment with bedaquiline (BDQ) and/or delamanid of >2600 patients in 17 countries, and contributed to the creation of a central PV unit (PVU).OBJECTIVE: To explain the endTB PVU process by describing the serious adverse events (SAEs) experienced by patients who received BDQ-containing regimens.DESIGN: The overall PV strategy was in line with the 'advanced´ WHO active TB drug safety monitoring and management (aDSM) system. All adverse events (AEs) of clinical significance were followed up; the PVU focused on signal detection from SAEs.RESULTS and CONCLUSION: Between 1 April 2015 and 31 March 2019, the PVU received and assessed 626 SAEs experienced by 417 BDQ patients. A board of MDR-TB/PV experts reviewed unexpected and possibly drug-related SAEs to detect safety signals. The experts communicated on clusters of risks factors, notably polypharmacy and off-label drug use, encouraging a patient-centred approach of care. Organising advanced PV in routine care is possible but demanding. It is reasonable to expect local/national programmes to focus on clinical management, and to limit reporting to aDSM systems to key data, such as the SAEs.

PMID: 33126944 [PubMed - as supplied by publisher]

11 new pubmed citations were retrieved for your search. Click on the search hyperlink below to display the complete search results:

("drug-induced" OR "drug-related") AND ("adverse events" OR "side effects" OR "side-effects")

These pubmed results were generated on 2020/10/31

PubMed comprises more than millions of citations for biomedical literature from MEDLINE, life science journals, and online books. Citations may include links to full-text content from PubMed Central and publisher web sites.

15 new pubmed citations were retrieved for your search. Click on the search hyperlink below to display the complete search results:

("drug-induced" OR "drug-related") AND ("adverse events" OR "side effects" OR "side-effects")

These pubmed results were generated on 2020/10/31

PubMed comprises more than millions of citations for biomedical literature from MEDLINE, life science journals, and online books. Citations may include links to full-text content from PubMed Central and publisher web sites.

Sufentanil Reduces Emergence Delirium in Children Undergoing Transthoracic Device Closure of VSD After Sevoflurane-Based Cardiac Anesthesia.

Braz J Cardiovasc Surg. 2020 Oct 01;35(5):660-665

Authors: Xu N, Chen Q, Huang ST, Sun KP, Cao H

Abstract
OBJECTIVE: The aim of this study was to evaluate whether sufentanil can reduce emergence delirium in children undergoing transthoracic device closure of ventricular septal defect (VSD) after sevoflurane-based cardiac anesthesia.
METHODS: From February 2019 to May 2019, 68 children who underwent transthoracic device closure of VSD at our center were retrospectively analyzed. All patients were divided into two groups: 36 patients in group S, who were given sufentanil and sevoflurane-based cardiac anesthesia, and 32 patients in group F, who were given fentanyl and sevoflurane-based cardiac anesthesia. The following clinical data were recorded: age, sex, body weight, operation time, and bispectral index (BIS). After the children were sent to the intensive care unit (ICU), pediatric anesthesia emergence delirium (PAED) and face, legs, activity, cry, consolability (FLACC) scale scores were also assessed. The incidence of adverse reactions, such as nausea, vomiting, drowsiness and dizziness, was recorded.
RESULTS: There was no significant difference in age, sex, body weight, operation time or BIS value between the two groups. Extubation time (min), PEAD score and FLACC scale score in group S were significantly better than those in group F (P<0.05). No serious anesthesia or drug-related side effects occurred.
CONCLUSIONS: Sufentanil can be safely used in sevoflurane-based fast-track cardiac anesthesia for transthoracic device closure of VSD in children. Compared to fentanyl, sufentanil is more effective in reducing postoperative emergence delirium, with lower analgesia scores and greater comfort.

PMID: 33118730 [PubMed - as supplied by publisher]

Seletalisib for Activated PI3Kδ Syndromes: Open-Label Phase 1b and Extension Studies.

J Immunol. 2020 Oct 28;:

Authors: Diaz N, Juarez M, Cancrini C, Heeg M, Soler-Palacín P, Payne A, Johnston GI, Helmer E, Cain D, Mann J, Yuill D, Conti F, Di Cesare S, Ehl S, Garcia-Prat M, Maccari ME, Martín-Nalda A, Martínez-Gallo M, Moshous D, Santilli V, Semeraro M, Simonetti A, Suarez F, Cavazzana M, Kracker S

Abstract
Mutations in two genes can result in activated PI3Kδ syndrome (APDS), a rare immunodeficiency disease with limited therapeutic options. Seletalisib, a potent, selective PI3Kδ inhibitor, was evaluated in patients with APDS1 and APDS2. In the phase 1b study (European Clinical Trials Database 2015-002900-10) patients with genetic and clinical confirmation of APDS1 or APDS2 received 15-25 mg/d seletalisib for 12 wk. Patients could enter an extension study (European Clinical Trials Database 2015-005541). Primary endpoints were safety and tolerability, with exploratory efficacy and immunology endpoints. Seven patients (median age 15 years; APDS1 n = 3; APDS2 n = 4) received seletalisib; five completed the phase 1b study. For the extension study, four patients entered, one withdrew consent (week 24), three completed ≥84 wk of treatment. In the phase 1b study, patients had improved peripheral lymphadenopathy (n = 2), lung function (n = 1), thrombocyte counts (n = 1), and chronic enteropathy (n = 1). Overall, effects were maintained in the extension. In the phase 1b study, percentages of transitional B cells decreased, naive B cells increased, and senescent CD8 T cells decreased (human cells); effects were generally maintained in the extension. Seletalisib-related adverse events occurred in four of seven patients (phase 1b study: hepatic enzyme increased, dizziness, aphthous ulcer, arthralgia, arthritis, increased appetite, increased weight, restlessness, tendon disorder, and potential drug-induced liver injury) and one of four patients had adverse events in the extension (aphthous ulcer). Serious adverse events occurred in three of seven patients (phase 1b study: hospitalization, colitis, and potential drug-induced liver injury) and one of four patients had adverse events in the extension (stomatitis). Patients with APDS receiving seletalisib had improvements in variable clinical and immunological features, and a favorable risk-benefit profile was maintained for ≤96 wk.

PMID: 33115853 [PubMed - as supplied by publisher]

Observational study of drug-related problems and clinical pharmacists' interventions in a French paediatric hospital.

Eur J Hosp Pharm. 2020 Oct 28;:

Authors: Robert S, Ménétré S, Schweitzer C, Demoré B

Abstract
OBJECTIVES: Paediatric inpatients are a high-risk population for drug-related problems, yet there is a lack of data concerning drug-related problems and pharmaceutical interventions in paediatric hospitals in France. The objective of this study was to describe drug-related problems, pharmaceutical interventions and the acceptance rate of physicians based on the characteristics of both medication order and pharmaceutical interventions.
METHODS: A 12-month, monocentric, observational and prospective study was conducted from 1 June 2016 to 31 May 2017 in a French university paediatric hospital. Prescription analysis was performed at the central pharmacy. The data were collected by querying the drug prescription database of the e-prescription software. Data on drugs, prescribers, drug-related problems and interventions were recorded. The primary outcome was the measurement of the number of drug-related problems in paediatric hospitalised patients (medical and surgical wards). Secondary outcomes were classification of drug-related problems and pharmaceutical interventions. Physician acceptance of pharmaceutical interventions was additionally assessed.
RESULTS: The main types of drug-related problems were supratherapeutic dosage (33.8%), improper administration (22.9%) and subtherapeutic dosage (16.8%). A total of 1742 pharmaceutical interventions were recorded. The rate of pharmaceutical interventions was 2.48 per 100 drug prescriptions. Acceptance rate of physicians was 51.7%. Some 530 different drugs were involved. The drugs most frequently involved in pharmaceutical interventions were drugs for the nervous system (31.3%) and anti-infectives (20.2%). Pharmaceutical interventions related to dose adjustment accounted for half of the interventions ahead of drug choice interventions (35.4%).
CONCLUSIONS: This study illustrates the frequency of drug-related problems in paediatric inpatients and the ability of pharmacists to identify them in their daily work. However, it also highlights the difficulty in obtaining physician acceptance (or even clear refusal) of pharmaceutical interventions with a review of the prescription at the central pharmacy.

PMID: 33115799 [PubMed - as supplied by publisher]

Pharmacovigilance and radiologists: How well do they get along?

Br J Radiol. 2020 Nov 01;93(1115):20200596

Authors: Aydin OC, Aydin S, Guney HZ

Abstract
OBJECTIVES: Considering the growing use of imaging modalities and contrast agents, radiologists are prone to encounter adverse drug reactions (ADR). In the current study, we mainly aim to evaluate the knowledge of radiologists regarding pharmacovigilance (PV). Also, we intend to gather information about their previous ADR experiences. Secondarily, we hope to increase the awareness about contrast-medium-related ADRs and attract attention to the importance of properly reporting these ADRs.
METHODS: A survey was generated by using an online survey webpage, and the relevant link was e-mailed to radiologists and radiology residents. The survey begins with a short explanation about the study. The second section contains questions about PV knowledge level, and the final section aims to gather information about the experienced ADRs.
RESULTS: The survey was completed by 202 participants. 65.3% stated that they were aware of PV. 24.8% of the participants said that they know the national PV program. 97% told that they knew the term ADR. 66.3% of the participants encountered an ADR. 53.7% of them reported these ADRs. 70.8% of them reported these ADRs to a clinician.
CONCLUSIONS: Radiologists encounter ADRs almost as frequently as the other doctors. Their awareness about PV is similar with other healthcare professionals. They have fewer information about TUFAM and PvCPs. Radiologists generally prefer to communicate with a clinician about an ADR. Overall condition of radiologists about PV is quite similar with other healthcare professionals and education can improve it, as for the others.
ADVANCES IN KNOWLEDGE: Radiologists encounters ADRs almost as frequently as the other doctors. Overall condition of radiologists about PV is quite similar with other healthcare professionals and education can improve it, as for the others.

PMID: 32903029 [PubMed - indexed for MEDLINE]

Implementation of Genetic Screening to Prevent Severe Cutaneous Adverse Drug Reactions Is Crucial-Rebuttal From the Devil's Antagonist.

JAMA Dermatol. 2020 02 01;156(2):220-221

Authors: Chan FL, Dodiuk-Gad RP

PMID: 31851297 [PubMed - indexed for MEDLINE]

Implementation of Genetic Screening to Prevent Severe Cutaneous Adverse Drug Reactions Is Crucial-Rebuttal From the Devil's Antagonist-Reply.

JAMA Dermatol. 2020 02 01;156(2):221-222

Authors: Divito SJ

PMID: 31851296 [PubMed - indexed for MEDLINE]