Different indications, warnings and precautions, and contraindications for the same drugan international comparison of prescribing information for commonly used psychiatric drugs

被引：20

作者：

Pfistermeister, Barbara ^{[1
]}

Schenk, Christian ^{[1
]}

Kornhuber, Johannes ^{[2
]}

Buerkle, Thomas ^{[3
]}

Fromm, Martin F. ^{[1
]}

Maas, Renke ^{[1
]}

机构：

[1] Univ Erlangen Nurnberg, Inst Expt & Clin Pharmacol & Toxicol, D-91054 Erlangen, Germany

[2] Univ Erlangen Nurnberg, Univ Hosp, Dept Psychiat & Psychotherapy, D-91054 Erlangen, Germany

[3] Univ Erlangen Nurnberg, Chair Med Informat, D-91054 Erlangen, Germany

来源：

PHARMACOEPIDEMIOLOGY AND DRUG SAFETY | 2013年 / 22卷 / 03期

关键词：

prescribing information; Summary of Product Characteristics; antidepressive agents; international comparison; serotonin agents; pharmacoepidemiology; COUNTRIES; SPC;

D O I：

10.1002/pds.3389

中图分类号：

R1 [预防医学、卫生学];

学科分类号：

1004 ; 120402 ;

摘要：

Purpose We aim to derive an internationally applicable data set to improve prescription safety of psychiatric drugs. Methods We performed an in-depth analysis of the concordance of prescribing information of 10 key psychiatric drugs across four major drug markets with regard to indications, warnings and precautions, and contraindications. Results The individual prescribing information covered on average 71.4 +/- 30.3% of all named indications, 59.5 +/- 17.1% of all potential warnings and precautions and 70.1 +/- 24.4% of all applicable contraindications. Conclusion This substantial variation in key prescribing information across countries highlights the need for a better international cooperation and standardization of prescribing information. Copyright (c) 2012 John Wiley & Sons, Ltd.

引用

页码：329 / 333

页数：5

共 12 条

[1]

[Anonymous], DEF GEN CONS

[2] Information deficits in the summary of product characteristics preclude an optimal management of drug interactions: a comparison with evidence from the literature [J].

Bergk, V ;

Haefeli, WE ;

Gasse, C ;

Brenner, H ;

Martin-Facklam, M .

EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY, 2005, 61 (5-6) :327-335

[3] Treatment adequacy for anxiety and depressive disorders in six European countries [J].

Fernandez, A. ;

Haro, J. M. ;

Martinez-Alonso, M. ;

Demyttenaere, K. ;

Brugha, T. S. ;

Autonell, J. ;

De Girolamo, G. ;

Bernert, S. ;

Lepine, J. P. ;

Alonso, J. .

BRITISH JOURNAL OF PSYCHIATRY, 2007, 190 :172-173

[4] Contraindication labelling changes in the United States and Germany [J].

Garbe, Edeltraut ;

Andersohn, Frank .

EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY, 2007, 63 (01) :87-93

[5]

Lohse M, 2011, ARZNEIVERORDNUNGS RE

[6] e-SPC - delivering drug information in the 21st century: developing new approaches to deliver drug information to prescribers [J].

Maxwell, Simon ;

Eichler, Hans-Georg ;

Bucsics, Anna ;

Haefeli, Walter E. ;

Gustafsson, Lars L. .

BRITISH JOURNAL OF CLINICAL PHARMACOLOGY, 2012, 73 (01) :12-15

[7]

Nutt David J, 2010, J Clin Psychiatry, V71 Suppl E1, pe08, DOI 10.4088/JCP.9058se1c.08gry

[8] Different Black Box Warning Labeling for Same-Class Drugs [J].

Panagiotou, Orestis A. ;

Contopoulos-Ioannidis, Despina G. ;

Papanikolaou, Panagiotis N. ;

Ntzani, Evangelia E. ;

Ioannidis, John P. A. .

JOURNAL OF GENERAL INTERNAL MEDICINE, 2011, 26 (06) :603-610

[9] Prescribing information in 26 countries:: a comparative study [J].

Reggi, V ;

Balocco-Mattavelli, R ;

Bonati, M ;

Breton, I ;

Figueras, A ;

Jambert, E ;

Kopp, C ;

Montane, E ;

Rägo, L ;

Rocchi, F .

EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY, 2003, 59 (04) :263-270

[10] French summaries of product characteristics: content in relation to therapeutic monitoring of psychotropic drugs [J].

Rougemont, Michael ;

Ulrich, Sven ;

Hiemke, Christoph ;

Corruble, Emmanuelle ;

Baumann, Pierre .

FUNDAMENTAL & CLINICAL PHARMACOLOGY, 2010, 24 (03) :377-384

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