scholarly journals Use of Identical INN “Imiglucerase” for Different Drug Products: Impact Analysis of Adverse Events in a Proprietary Global Safety Database

Drug Safety ◽  
2022 ◽  
Author(s):  
So-Fai Tsang ◽  
Shirali Pandya ◽  
Kristina Barakov ◽  
Joan Keutzer ◽  
Grace Lewis ◽  
...  
Keyword(s):  
Adverse Events ◽  
Impact Analysis ◽  
Safety Database ◽  
Drug Products

scholarly journals Container Closure and Delivery Considerations for Intravitreal Drug Administration

2021 ◽  
Vol 22 (3) ◽  
Author(s):  
Ashwin C. Parenky ◽  
Saurabh Wadhwa ◽  
Hunter H. Chen ◽  
Amardeep S. Bhalla ◽  
Kenneth S. Graham ◽  
...  
Keyword(s):  
Adverse Events ◽  
Product Development ◽  
Drug Product ◽  
Healthcare Providers ◽  
Standard Of Care ◽  
Volume Determination ◽  
Common Procedure ◽  
Drug Products ◽  
Fill Volume ◽  
Container Closure

AbstractIntravitreal (IVT) administration of therapeutics is the standard of care for treatment of back-of-eye disorders. Although a common procedure performed by retinal specialists, IVT administration is associated with unique challenges related to drug product, device and the procedure, which may result in adverse events. Container closure configuration plays a crucial role in maintaining product stability, safety, and efficacy for the intended shelf-life. Careful design of primary container configuration is also important to accurately deliver small volumes (10-100 μL). Over- or under-dosing may lead to undesired adverse events or lack of efficacy resulting in unpredictable and variable clinical responses. IVT drug products have been traditionally presented in glass vials. However, pre-filled syringes offer a more convenient administration option by reducing the number of steps required for dose preparation there by potentially reducing the time demand on the healthcare providers. In addition to primary container selection, product development studies should focus on, among other things, primary container component characterization, material compatibility with the formulation, formulation stability, fill volume determination, extractables/leachables, and terminal sterilization. Ancillary components such as disposable syringes and needles must be carefully selected, and a detailed administration procedure that includes dosing instructions is required to ensure successful administration of the product. Despite significant efforts in improving the drug product and administration procedures, ocular safety concerns such as endophthalmitis, increased intraocular pressure, and presence of silicone floaters have been reported. A systematic review of available literature on container closure and devices for IVT administration can help guide successful product development.

Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines

Vaccine ◽  
2008 ◽  
Vol 26 (51) ◽  
pp. 6630-6638 ◽  
Author(s):  
Thomas Verstraeten ◽  
Dominique Descamps ◽  
Marie-Pierre David ◽  
Toufik Zahaf ◽  
Karin Hardt ◽  
...  
Keyword(s):  
Adverse Events ◽  
Safety Database ◽  
Autoimmune Aetiology

scholarly journals Drug change: ‘a hassle like no other’. An in-depth investigation using the Danish patient safety database and focus group interviews with Danish hospital personnel

2019 ◽  
Vol 10 ◽  
pp. 204209861985999 ◽  
Author(s):  
Joo Hanne Poulsen ◽  
Rikke Mie Rishøj ◽  
Hanne Fischer ◽  
Trine Kart ◽  
Lotte Stig Nørgaard ◽  
...  
Keyword(s):  
Patient Safety ◽  
Focus Group ◽  
Adverse Events ◽  
Hospital Personnel ◽  
Drug Shortage ◽  
Focus Group Interviews ◽  
Safety Database ◽  
Danish Patient ◽  
Group Interviews ◽  
Danish Hospital

Background: Drug change (DC) is a common challenge in Danish hospitals. It affects the work of hospital personnel and has potentially serious patient safety consequences. Focus on medication safety is becoming increasingly important in the prevention of adverse events. The aim of this study is to identify and describe patient safety challenges related to DCs, and to explore potential facilitators to improve patient safety in the medication process in Danish hospital setting. Method: Two qualitative methods were combined. Data were obtained from the Danish Patient Safety Database (DPSD) containing incidents reports of adverse events related to DCs. Additionally, five semi-structured focus group interviews with hospital personnel (doctors, nurses, pharmacists and pharmacy technicians) from the five regions of Denmark were held. Results: The DPSD search identified 88 incidents related to DCs due to tender or drug shortage. The incidents were linked to prescribing errors, incorrect dose being dispensed/administered, and delayed/omitted treatment. Four themes from the interviews emerged: (1) challenges related to the drug itself; (2) situational challenges; (3) challenges related to the organization/IT systems/personnel; (4) facilitators/measures to ensure patient safety. Conclusion: DC is as a complex challenge, especially related to drug shortage. The results allow for a deeper understanding of the challenges and possible facilitators of DCs on the individual and organizational level. Pharmacy personnel were identified to play a key role in ensuring patient safety of DCs in hospitals. Indeed, this emphasizes that pharmacy personnel should be engaged in developing patient safety strategies and support hospital personnel around drug changes.

scholarly journals Pregnancy Outcomes of Patients Exposed to Adalimumab in Japan

2018 ◽  
Vol 37 (2) ◽  
pp. 123-130 ◽  
Author(s):  
Yumi Kawai ◽  
Tsuyoshi Tsuchiya ◽  
Shigeru Aoki
Keyword(s):  
Adverse Events ◽  
Pregnancy Outcomes ◽  
Outcome Data ◽  
Full Term ◽  
Third Trimester ◽  
Serious Adverse Events ◽  
Additional Risk ◽  
Safety Database ◽  
Induced Abortions ◽  
Adalimumab Treatment

Background: This is the first retrospective report of pregnancy outcomes after exposure to adalimumab treatment in Japan. Methods: Using the AbbVie safety database, we analyzed pregnancy outcome data from patients who received adalimumab treatment from April 16, 2008, to May 15, 2017. Results: Data were extracted retrospectively for 74 pregnancies in 73 patients. More than half of the patients included in the study received adalimumab for the treatment of Crohn’s disease (37.8%) or ulcerative colitis (20.3%), while 9.5% received adalimumab for rheumatoid arthritis. Of the 53 pregnancies with available outcome data, 45 newborns (45/53 [84.9%]) were delivered. Of these births, 30 were full-term, 2 were preterm, and 13 were unknown. Apgar scores were available for 11 of the 16 newborns whose mothers were exposed to adalimumab in the third trimester; all scores were within the normal range. Low birth weight was observed in 5 infants out of the 30 full-term deliveries. There were also 5 miscarriages (5/53 [9.4%]), 2 induced abortions (2/53 [3.8%]), and 1 stillbirth (1/53 [1.9%]). Eight maternal adverse events were observed in 5 pregnancies; no serious adverse events occurred. Conclusion: Although safety concerns were inconclusive, these data do not report additional risk to pregnancy outcomes with adalimumab exposure.

scholarly journals Response to “Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines” by Verstraeten et al.

Vaccine ◽  
2009 ◽  
Vol 27 (19) ◽  
pp. 2529 ◽  
Author(s):  
Allan Hildesheim ◽  
Mark Schiffman ◽  
Diane Solomon ◽  
Sholom Wacholder ◽  
Ana Cecilia Rodriguez ◽  
...  
Keyword(s):  
Adverse Events ◽  
Safety Database ◽  
Autoimmune Aetiology

scholarly journals A Budget Impact Analysis of the VENTANA PD-L1 SP142 Immunohistochemistry Assay Versus the Dako PD-L1 IHC 22C3 Assay in Patients With Advanced or Metastatic Triple-Negative Breast Cancer Treated With Atezolizumab in Combination With Nab-Paclitaxel

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Cristian Scatena ◽  
Roberto Ravasio ◽  
Paola Raimondo ◽  
Mario Giuliano
Keyword(s):  
Adverse Events ◽  
Pharmacological Treatment ◽  
Impact Analysis ◽  
Budget Impact ◽  
Budget Impact Analysis ◽  
Cancer Drug ◽  
Base Case ◽  
Specialist Visit ◽  
Tissue Biopsy ◽  
Number Of Patients

OBJECTIVE: To estimate the budget impact determined by the adoption of two different diagnostic strategies, SP142 assay or 22C3 assay, in the identification (in terms of PD-L1 status) of patients with mTNBC eligible for treatment with atezolizumab in combination with nab-paclitaxel.METHODS: The budget impact analysis (BIA) was conducted using a budget impact model (BIM) considering the Italian National Health Service’s (iNHS) perspective. The analysis assessed only the direct medical cost (tissue biopsy, PD-L1 assay, specialist visit, pharmacological treatment with atezolizumab in combination with nab-paclitaxel) of patients with PD-L1 positive mTNBC, and management of the adverse events associated with the pharmacological treatment administered. The BIM also considered the clinical benefits (progression free survival, PFS) resulting from the drug therapy administered on the basis of the results of the post-hoc analysis of the IMpassion130 clinical trial. The BIA was conducted over a 1-year time horizon. The median cost per patient in the progression-free state was also calculated. The costs were calculated using the net ex-factory prices (cancer drugs) and regional or national tariffs (tissue biopsy, PD-L1 assay, specialist visit and adverse events management). A sensitivity analysis was conducted to evaluate the base case result.RESULTS: The SP142 assay diagnostic pathway would result in a reduction of the iNHS expenditure of approximately 5.6 million euros (-12%). Almost all of the reduction in iNHS expenditure would be determined by the lower number of patients treated (SP142: 689 patients vs 22C3: 786 patients) with immunotherapy (-€ 5,530,871). Compared with 22C3 assay, the SP142 assay shows a cost per PFS month reduction of € 736 (€ 7,010 vs € 7,746).CONCLUSIONS: The use of the SP142 assay proved to be cost-effective compared to the 22C3 assay; the SP142 assay can support the choice of the most appropriate cancer drug, maximizing the effectiveness and minimizing the waste of healthcare resources.

scholarly journals 702. Hepatic Safety Among Patients Treated with Anti-Fungal Triazole Agent Posaconazole: Characterization of Adverse events in a Manufacturer’s Safety Database

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S317-S317
Author(s):  
Yun-Ping Zhou ◽  
Rose O’Flynn ◽  
Hetty Waskin ◽  
Ronald W Leong ◽  
Walter Straus
Keyword(s):  
Adverse Events ◽  
Drug Exposure ◽  
Entire Group ◽  
Cell Transplant ◽  
Medical Conditions ◽  
Hepatocellular Injury ◽  
Hematopoietic Stem ◽  
Safety Database ◽  
Concomitant Medications ◽  
Anti Fungal

Abstract Background Second-generation triazoles including posaconazole are highly efficacious for the prophylaxis and salvage treatment of life-threatening invasive fungal diseases. All triazoles have been associated with hepatic adverse events (AEs), which may affect their clinical use; however, risk factors for those AEs are poorly defined. Methods Reports of hepatobiliary AEs for posaconazole from clinical trials and post-market use in our company’s global safety database were reviewed to characterize concomitant medical conditions and drug exposure. Results As of 2018, 444 cases of hepatic AEs were reported; 139 (31%) led to discontinuation of posaconazole. Most hepatic AEs had a time to onset >20 days (55.5%). The most frequent AEs reported (per Medical Dictionary for Regulatory Activities) were: Hyperbilirubinaemia (17%); Hepatotoxicity (13.5%); Hepatic function abnormal (11.5%); and Hepatocellular injury (11.3%). Most patients were adults (18–64 years old) (65%). Hematological malignancy (128 cases, 29%) and hematopoietic stem cell transplant (91 cases, 20%) were leading concurrent medical conditions. Notably, 75% of the cases reported exposure to other drugs (often multiple ones) with known risks for drug-induced liver injury (DILI, e.g., acetaminophen, cytarabine, cyclosporine). Among 139 cases in which posaconazole treatment was discontinued due to hepatic AEs, 6 of the 20 most frequently used co-medications (used by >4.5% of the cases) were classified by the FDA in its DILIRank as “Most-DILI-Concern” (resulting in drug withdrawal, or prominent labeling for severe DILI risk in boxed warning or warnings and precautions), and 7 were “Less-DILI-concern” drugs (DILI risk language in warnings and precautions or adverse reactions). Similarly, of the top 35 concomitant medications for the entire group, 9 are classified as “Most-DILI-Concern” and 12 are “Less-DILI Concern” drugs. Conclusion The use of concomitant medications with known risks for hepatic injury appears to be an important contributor to the development of hepatotoxicity in patients treated with posaconazole. Co-administration of these drugs with anti-fungal triazole agents such as posaconazole, when needed, will continue to be carefully monitored. Disclosures All authors: No reported disclosures.

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