Inferential Problems in Postmarketing Surveillance

2016 ◽  
pp. 545-570
Keyword(s):  
Postmarketing Surveillance

Methylphenidatbehandlung von Kindern und Jugendlichen mit hyperkinetischen Störungen

2003 ◽  
Vol 22 (06) ◽  
pp. 311-317
Author(s):  
H. Uebel ◽  
R. Fischer ◽  
A. Rothenberger ◽  
T. Banaschewski
Keyword(s):  
Postmarketing Surveillance

Zusammenfassung Fragestellung: Die Anwendung von Methylphenidat (MPH) in der Alltagspraxis niedergelassener Ärzte wird immer wieder hinterfragt. Ziel der Studie war es daher, die Handhabung, Wirksamkeit, Verträglichkeit und Akzeptanz der Behandlung unter breiter Anwendung im niedergelassenen ärztlichen Bereich zu untersuchen. Methode: Im Rahmen einer nicht-interventionellen PostMarketing-Surveillance-Studie wurde die Behandlung von 659 Kindern und Jugendlichen (Alter: 3 bis 20 Jahre) mit hyperkinetischen Störungen, die Methylphenidat (Medikinet®) erhielten, anhand von Fragebogen deskriptiv dokumentiert. Der Beobachtungszeitraum lag bei durchschnittlich 11,4 Wochen. Ergebnisse: Die Behandlung der ADHS bei Kindern und Jugendlichen mit MPH erwies sich als sehr effektiv, gut verträglich und für die Patienten annehmbar. Die Wirksamkeit wurde nicht durch Alter, Geschlecht, Art der Subdiagnose, Schweregrad oder den Zeitpunkt des Beginns erster Auffälligkeiten modifiziert. Relativer Risikofaktor für das Auftreten von unerwünschten Arzneimittelwirkungen war ein junges Alter sowie die körpergewichtsbezogene hohe Dosis (insbesondere bei jüngeren Kindern). Sowohl die absolute als auch die körpergewichtsbezogene durchschnitt liche Tagesdosis lag aber in der Regel im empfohlenen Bereich. Schlussfolgerung: Die Daten belegen erneut die gute Wirksamkeit und Verträglichkeit von MPH und zeigen eine generell adäquate Dosierung der Substanz durch Kinderund Jugendpsychiater sowie Pädiater. Dies widerspricht den Auffassungen, wonach MPH häufig zu hoch dosiert oder unkritisch verschrieben werde.

Postmarketing Surveillance Based on Electronic Patient Records: The IPCI Project

1999 ◽  
Vol 38 (04/05) ◽  
pp. 339-344 ◽  
Author(s):  
J. van der Lei ◽  
B. M. Th. Mosseveld ◽  
M. A. M. van Wijk ◽  
P. D. van der Linden ◽  
M. C. J. M. Sturkenboom ◽  
...  
Keyword(s):  
General Practitioner ◽  
General Practitioners ◽  
Validation Studies ◽  
Resource Planning ◽  
Routine Practice ◽  
Patient Records ◽  
Postmarketing Surveillance ◽  
Electronic Patient Records ◽  
Use Of Data ◽  
Data Requirements

AbstractResearchers claim that data in electronic patient records can be used for a variety of purposes including individual patient care, management, and resource planning for scientific research. Our objective in the project Integrated Primary Care Information (IPCI) was to assess whether the electronic patient records of Dutch general practitioners contain sufficient data to perform studies in the area of postmarketing surveillance studies. We determined the data requirements for postmarketing surveil-lance studies, implemented additional software in the electronic patient records of the general practitioner, developed an organization to monitor the use of data, and performed validation studies to test the quality of the data. Analysis of the data requirements showed that additional software had to be installed to collect data that is not recorded in routine practice. To avoid having to obtain informed consent from each enrolled patient, we developed IPCI as a semianonymous system: both patients and participating general practitioners are anonymous for the researchers. Under specific circumstances, the researcher can contact indirectly (through a trusted third party) the physician that made the data available. Only the treating general practitioner is able to decode the identity of his patients. A Board of Supervisors predominantly consisting of participating general practitioners monitors the use of data. Validation studies show the data can be used for postmarketing surveillance. With additional software to collect data not normally recorded in routine practice, data from electronic patient record of general practitioners can be used for postmarketing surveillance.

Safety and effectiveness of adalimumab in Japanese rheumatoid arthritis patients: Postmarketing surveillance report of 7740 patients

2013 ◽  
Vol 24 (3) ◽  
pp. 390-398 ◽  
Author(s):  
Takao Koike ◽  
Masayoshi Harigai ◽  
Naoki Ishiguro ◽  
Shigeko Inokuma ◽  
Syuji Takei ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Postmarketing Surveillance ◽  
Surveillance Report

Phase IV Study (Postmarketing Surveillance) of Tarivid® (Ofloxacin) in China†

Drugs ◽  
1995 ◽  
Vol 49 (Supplement 2) ◽  
pp. 474-476
Author(s):  
J.T. Li ◽  
M. Yoshida ◽  
K. Nakatsuka
Keyword(s):  
Postmarketing Surveillance ◽  
Phase Iv

scholarly journals Pharmacovigilance of Sodium-Glucose Cotransporter-2 Inhibitors for Genital Fungal Infections and Urinary Tract Infections: A Review of the Food and Drug Administration Adverse Event Reporting System Database

2018 ◽  
Vol 34 (4) ◽  
pp. 144-148
Author(s):  
Hannah Mohammad ◽  
Nancy Borja-Hart
Keyword(s):  
Urinary Tract ◽  
Tract Infection ◽  
Adverse Events ◽  
Fungal Infections ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Sglt2 Inhibitors ◽  
Postmarketing Surveillance ◽  
Sodium Glucose Cotransporter ◽  
Tract Infections

Background: Postmarketing surveillance had previously identified the need for revisions in the labeling of the sodium-glucose cotransporter-2 (SGLT2) inhibitors drug class related to the risk of diabetic ketoacidosis. Other adverse events have been reported. Objective: To examine postmarketing surveillance data of the SGLT2 inhibitors, using the Food and Drug Administration Adverse Event Reporting System (FAERS) database, specifically to assess prevalence of urinary tract infections (UTIs) and genital fungal infections. Methods: FAERS case reports submitted between March 2013 and November 2015 were reviewed for 6 SGLT2 inhibitors (mono and combo therapies). The Medical Dictionary for Regulatory Activities (MedDRA) was used to define preferred terms (genital fungal infections: vulvovaginal mycotic infection, vulvovaginal candidiasis, urinary tract infection fungal, and genital candidiasis; UTI: urinary tract infection, genitourinary tract infection, kidney infection, cystitis, and pyelonephritis). Word frequencies were queried using the qualitative data analysis software NVivo 11 (QSR International), and results were then individually reviewed. Results: A total of 12 581 cases were received, but 466 were excluded (total n = 12 115). A total of 348 cases related to genital fungal infections were reported (2.9% of reports submitted): dapagliflozin = 53, empagliflozin/linagliptin = 6, canagliflozin = 267, canagliflozin/metformin = 3, empagliflozin = 17, and dapagliflozin/metformin HCl ER = 2. A total of 727 cases related to UTIs were reported (6% of reports submitted): dapagliflozin = 168, empagliflozin/linagliptin = 5, canagliflozin/metformin = 8, canagliflozin = 503, empagliflozin = 38, and dapagliflozin/metformin HCl ER = 5. Conclusions: A causal relationship between SGLT2 inhibitors and the adverse events reported cannot be established due to the nature of postmarketing surveillance. However, health care providers should counsel patients about these potential adverse events.

scholarly journals Monitoring Temporal Changes in the Specificity of an Oral HIV Test: A Novel Application for Use in Postmarketing Surveillance

PLoS ONE ◽  
2010 ◽  
Vol 5 (8) ◽  
pp. e12231 ◽  
Author(s):  
Joseph R. Egger ◽  
Kevin J. Konty ◽  
Jessica M. Borrelli ◽  
Julia Cummiskey ◽  
Susan Blank
Keyword(s):  
Temporal Changes ◽  
Postmarketing Surveillance ◽  
Hiv Test
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