scholarly journals Considerations over a Case of Suspected Therapeutic Failure in Pediatric Patients after Switching Valproate Manufacturers

2020 ◽  
Vol 11 (3) ◽  
pp. 10
Author(s):  
Jaqueline Kalleian Eserian ◽  
Jair Ribeiro Chagas ◽  
José Carlos Fernandes Galduróz
Keyword(s):  
Pediatric Patients ◽  
Drug Prescription ◽  
Medication Management ◽  
Therapeutic Failure ◽  
Product Switching ◽  
Therapeutic Outcomes ◽  
Article Type ◽  
Post Marketing Surveillance ◽  
Post Marketing

Introduction: Product switching followed by suspected adverse events are common and unsettling for antiepileptic drugs. The objective of this case study was to describe the investigation performed after report of suspected therapeutic failure in pediatric patients following a switch to a different valproate manufacturer and identify strategies concerning medication management for improving therapeutic outcomes. Case description: It was reported that different pediatric patients’ condition changed (agitation/ seizures) after refilling the same drug prescription (sodium valproate syrup) from a different manufacturer. Medical staff reported a suspected therapeutic failure and some units of the product batch associated with the problem were seized by the local Post-marketing Surveillance Service for investigation of potential quality deviations. The seized units were evaluated by the State’s Surveillance Laboratory, nevertheless, drug potency was found to be 98.7%. Conclusion: We consider that the reported event could be associated with aspects of medication use, i.e. potential dose measurement deviations resulting from remaining of residual liquid in the cup or eventual delay at prescription refilling process and consequential - even though brief - pharmacotherapy discontinuity. Patient education and counseling by pharmacists are essential for preventing drug-related problems and enhancing positive outcomes of pharmacotherapy.   Article Type: Case Study

scholarly journals Pharmacogenomics (PGx) Patient with Mixed Levels of Actionable Variant Evidence

2020 ◽  
Vol 11 (2) ◽  
pp. 3
Author(s):  
Michael J. Schuh ◽  
Sheena Crosby
Keyword(s):  
Clinical Decision Making ◽  
Medical Literature ◽  
Medication Management ◽  
Clinical Decision ◽  
Trial And Error ◽  
Therapeutic Outcomes ◽  
Article Type ◽  
Literature Evidence ◽  
Medication Selection

Objective: To demonstrate the types of clinical recommendations a pharmacogenomics pharmacist may make to medical clinicians with regard to medication management to improve therapeutic outcomes based on varied levels of medical literature evidence. Summary: This case demonstrates how a common type of patient seen in a pharmacist practice may present with a varied pharmacogenomic (PGx) profile, how they may benefit from PGx analysis, and how varying levels of medical literature evidence can be used with clinical decision making. Conclusion: PGx testing can help avoid adverse drug reactions (ADRs) or medication inefficacy by assisting in the adjustment of current or future medication doses. It can also help predict the best medications to use or those to avoid in advance by eliminating much of the existing dosing or medication selection method of trial and error.   Article Type: Case Study

scholarly journals All-case Japanese post-marketing surveillance of the real-world safety and efficacy of rituximab treatment in patients with refractory nephrotic syndrome

2021 ◽  
Author(s):  
Mana Kobayashi ◽  
Yutaro Kageyama ◽  
Takashi Ando ◽  
Junko Sakamoto ◽  
Shohji Kimura
Keyword(s):  
Nephrotic Syndrome ◽  
Standard Deviation ◽  
Real World ◽  
Pediatric Patients ◽  
Safety And Efficacy ◽  
The Real ◽  
Post Marketing Surveillance ◽  
Post Marketing ◽  
Refractory Nephrotic Syndrome ◽  
Observation Period

Abstract Background Rituximab is conditionally approved in Japan for use in patients with refractory nephrotic syndrome. To meet the conditions of approval, an all-case post-marketing surveillance study was conducted to confirm the real-world safety and efficacy of rituximab in patients of all ages with refractory nephrotic syndrome. Methods All patients scheduled to receive rituximab treatment for refractory nephrotic syndrome were eligible to register (registration: August 29, 2014 through April 15, 2016); the planned observation period was 2 years from the initiation of rituximab treatment (intravenous infusion, 375 mg/m2 once weekly for four doses). The study was conducted at 227 hospitals throughout Japan. Adverse drug reactions (ADRs) were collected for safety outcomes. The efficacy outcomes were relapse-free period and the degree of growth in pediatric (< 15 years) patients. Results In total, 997 (447 pediatric) patients were registered; 981 (445) were included in the safety analysis set; 852 (402) completed the 2-year observation period; and 810 (429) were included in the efficacy analysis set. Refractory nephrotic syndrome had developed in childhood for 85.0% of patients, and 54.6% were aged ≥15 years. ADRs were observed in 527 (53.7%) patients, treatment-related infection/infestation in 235 (24.0%) patients, and infusion reactions in 313 (31.9%) patients. The relapse-free period was 580 days (95% confidence interval, 511–664). There was a significant change in height standard deviation score (pediatric patients; mean change, 0.093; standard deviation, 0.637; P = 0.009). Conclusion The safety and efficacy of rituximab treatment in patients with refractory nephrotic syndrome were confirmed in the real-world setting. Clinical trial registration UMIN000014997.

Post-marketing surveillance study on the safety of sublingual immunotherapy in pediatric patients

Allergy ◽  
1999 ◽  
Vol 54 (10) ◽  
pp. 1110-1113 ◽  
Author(s):  
V. Di Rienzo ◽  
A. Pagani ◽  
S. Parmiani ◽  
G. Passalacqua ◽  
G.W. Canonica
Keyword(s):  
Pediatric Patients ◽  
Sublingual Immunotherapy ◽  
Surveillance Study ◽  
Post Marketing Surveillance ◽  
Post Marketing

EDPS of Clinical Case Record and Scientific Document in the Industry Post-Marketing Surveillance of Drugs

1983 ◽  
Vol 22 (03) ◽  
pp. 135-148 ◽  
Author(s):  
T. Kitaguchi ◽  
T. Nojiri ◽  
S. Suzuki ◽  
T. Fukita ◽  
T. Kawana
Keyword(s):  
Data Base ◽  
Clinical Case ◽  
Drug Information ◽  
Case Record ◽  
Post Marketing Surveillance ◽  
Japanese Character ◽  
Record Data ◽  
Post Marketing ◽  
On Line ◽  
Line Drug

In order to meet the multifarious needs for drug information and to cope with the post-marketing surveillance of drugs adequately, an on-line drug information network, which is composed of two data bases, clinical case record data base and literature data base, has been developed. Primary considerations in designing these systems were input of clean data, accurate input, insuring that no ADRs are overlooked, accumulation of the latest data, saving manpower required for processing, and processing large quantities of data. This system is also designed to input and to output in Japanese character.

Office-based post-marketing surveillance study on the influence of long term therapy with aripiprazole in patients with schizophrenia

2007 ◽  
Vol 40 (05) ◽  
Author(s):  
M Kungel ◽  
A Engelhardt ◽  
T Spevakné-Göröcs ◽  
M Ebrecht ◽  
C Werner ◽  
...  
Keyword(s):  
Surveillance Study ◽  
Term Therapy ◽  
Post Marketing Surveillance ◽  
Post Marketing ◽  
Long Term Therapy
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