Download PDF
Pharmacopsychiatry 2007; 40(1): 30-36
DOI: 10.1055/s-2007-970059
Original Paper

© Georg Thieme Verlag KG Stuttgart · New York

Off-label Prescribing in a German Psychiatric Hospital

H. J. Assion 1 , C. Jungck 1
  • 1Westphalian Center Bochum, Dep. of Psychiatry and Psychotherapy, Ruhr-University Bochum
Further Information

Publication History

received 18. 5. 2006

accepted 8. 1. 2007

Publication Date:
27 February 2007 (online)

Also available at
    Permissions and Reprints

Abstract

Introduction: This study examines the prevalence of off-label prescriptions in a large German psychiatric hospital. The influence of a 2002 decision by the Federal Social Court regarding reimbursement issues is investigated.

Methods: Two random samples (n 1=125; n 2=126) of all patients treated in the years 2001-2002 and 2003-2004, respectively, were examined. All prescriptions of psychotropic drugs were evaluated and categorized as clearly off-label, probably off-label, or on-label. Label status for each product was judged according to the information stated in the officially authorized Summary of Product Characteristics.

Results: In 2001-2002 20% of all prescriptions of psychotropic drugs were clearly off-label, and 19% were probably off-label. In 2003-2004 the numbers were 21% and 26%, respectively. There was a significant increase in probable and combined probable and clear off-label use. There was no significant influence of sex and patients’ age on off-label prescribing, but treatment duration showed a significant positive correlation with off-label use. Drugs prescribed on discharge were significantly more often prescribed off-label than drugs prescribed during the whole duration of treatment.

Discussion: Prevalence of psychiatric off-label use in Germany is high. These results are in accordance with international surveys. The restrictive interpretation of the legal reimbursement provisions applied by the German Federal Social Court has not caused a decrease in off-label use. Although measures have been taken to solve the legal problems arising from off-label-use, further solutions are needed to ensure both patient and prescriber safety.

Keywords

psychiatry - psychotropic drugs - off-label use - sex differences - drug regulation - Federal Social Court

References

  • 1 Barbui C, Ciuna A, Nosé M, Patten SB, Stegagno M, Burti L, Amaddeo F, Tansella M. Off-Label and non-classical prescriptions of antipsychotic agents in ordinary in-patient practice.  Acta Psychiatrica Scandinavia. 2004;  109 275-278
    CrossrefPubMedGoogle Scholar
  • 2 Barbui C, Danese A, Guaiana G, Mapelli L, Miele L, Monzani E, Percudani M. Prescribing second-generation antipsychotics and the evolving standard of care in Italy.  Pharmacopsychiatry. 2002;  35 239-243
    Article in Thieme ConnectPubMedGoogle Scholar
  • 3 BMGS (Bundesministerium für Gesundheit und Soziale Sicherung) . Erlass über die Einrichtung der Expertengruppe zur „Anwendung von Arzneimittel außerhalb des zugelassenen Indikationsbereichs” (Expertengruppe Off-Label).  , Bonn, den 17. September 2002.
    Google Scholar
  • 4 BMGS (Bundesministerium für Gesundheit und Soziale Sicherung) . Erlass über die Einrichtung von Expertengruppen zur Anwendung von Arzneimitteln außerhalb des zugelassenen Indikationsbereichs (Expertengruppen Off-Label) nach § 35b Absatz 3 SGB V.  , Bonn, den 31. August 2005.
    Google Scholar
  • 5 Boos J. Off label use-label off use?.  Annals of Oncology. 2003;  14 1-5
    CrossrefPubMedGoogle Scholar
  • 6 Bortz J. Statistik für Human- und Sozialwissenschaftler. 6. Auflage. Springer Medizin Verlag, Heidelberg 2005
  • 7 Brosgart C L, Mitchell T, Charlebois E, Coleman R, Mehalko S, Young J. et al . Off-label drug use in human immunodeficiency virus disease.  J Acquir Immune Defic Syndr Hum Retrovirol. 1996;  12 ((1)) 56-62
    PubMedGoogle Scholar
  • 8 BVerfG (Bundesverfassungsgericht) . 2005;  , Urteil vom 6.12.2005, 1 BvR 347/98
  • 9 Chen H, Deshpande AD, Jiang R, Martin BC. An epidemiological investigation of off-label anticonvulsant drug use in the Georgia Medicaid population.  Pharmacoepidemiology and Drug Safety. 2004;  , published online 14.12.2004
    PubMedGoogle Scholar
  • 10 Citrome L, Levine J, Allingham B. Utilization of valproate: extent of inpatient use in the New York State Office of Mental Health.  Psychiatric Quarterly. 1998;  69 283-300
    CrossrefPubMedGoogle Scholar
  • 11 DGPPN (Deutsche Gesellschaft für Psychiatrie, Psychotherapie und Nervenheilkunde) . Leitlinie Affektive Erkrankungen. , Kurzfassung. AWMF Online, downloaded 2.3.2005
  • 12 Dierks C, Nitz G. Aktuelle Fragen des Off-Label-Use.  Deutsche Medizinische Wochenzeitschrift. 2003;  128 2138-2142
    Article in Thieme ConnectPubMedGoogle Scholar
  • 13 Federal Social Court . , Decision of March 19, 2002, B1 KR 37/00 R
  • 14 Fritze J, Schmauß M. Off-Label-Use in der Psychopharmakotherapie.  Der Nervenarzt. 2002;  73 796-799
    CrossrefPubMedGoogle Scholar
  • 15 Gartenmaier A, Pelzer E, Soyka M. Treatment of alcohol withdrawal syndrome with combined carbamazepine and tiapride in a patient with probable sleep apnoe syndrome. A case report.  Pharmacopsychiatry. 2005;  38 96-98
    Article in Thieme ConnectPubMedGoogle Scholar
  • 16 G-BA (Gemeinsamer Bundesausschuss) . , Beschluss zur Erteilung von Aufträgen zur Erstellung von Bewertungen an die Expertengruppen Off-Label nach § 1 Abs. 3 des Erlasses über die Einrichtung von Expertengruppen Off-Label nach § 35b Abs. 3 SGB V vom 20. Dezember 2005.
  • 17 Grohmann R, Engel RR, Geissler KH, Rüther E. Psychotropic drug use in psychiatric inpatients. Recent trends and changes over time-data from the AMSP Study.  Pharmacopsychiatry. 2004;  37 ((Suppl 1)) 27-38
    Article in Thieme ConnectPubMedGoogle Scholar
  • 18 Hamer AM, Haxby DG, McFarland BH, Ketchum K. Gabapentin use in a managed medicaid population.  Journal of Managed Care Pharmacy. 2002;  4 266-271
    PubMedGoogle Scholar
  • 19 Häser I. Fallstricke für die Klinik - Wandel der Arzneimittelpreispolitik.  Klinikarzt. 2005;  34 XiX-XX
    PubMedGoogle Scholar
  • 20 Haw C, Stubbs J. A survey of off-label prescribing for inpatients with mild intellectual disability and mental illness.  Journal of Intellectual Disability Research. 2005;  49 ((II)) 858-864
    CrossrefPubMedGoogle Scholar
  • 21 Haw C, Stubbs J. A Survey of the off-label-use of mood stabilizers in a large psychiatric hospital.  Journal of Psychopharmacology. 2005;  19 402-407
    CrossrefPubMedGoogle Scholar
  • 22 Heinze M, Andreae D, Grohmann R. Pharmacotherapy of personality disorders in German speaking countries: state and changes in the last decade.  Pharmacopsychiatry. 2005;  38 201-205
    Article in Thieme ConnectPubMedGoogle Scholar
  • 23 Karow A, Schnedler D. What would the patient choose? Subjective comparison of atypical and typical neuroleptics.  Pharmacopsychiatry. 2006;  39 ((2)) 47-51
    Article in Thieme ConnectPubMedGoogle Scholar
  • 24 Lambert M, Conus P, Schimmelmann BG. et al . Comparison of olanzapine and risperidone in 367 first-episode patients with non-affective or affective psychosis: results of an open retrospective medical record study.  Pharmacopsychiatry. 2005;  38 ((5)) 206-213
    Article in Thieme ConnectPubMedGoogle Scholar
  • 25 Lowe-Ponsford FL, Baldwin DS. Off-label prescribing by psychiatrists.  Psychiatric Bulletin. 2000;  24 415-417
    PubMedGoogle Scholar
  • 26 Ludwig WD, Müller-Oerlinghausen B, Willich SN. Off-Label-Verordnung - Soll und kann sie begrenzt werden?.  Bundesgesundheitsblatt - Gesundheitsforschung -Gesundheitsschutz. 2003;  46 455-457
    PubMedGoogle Scholar
  • 27 Meyer F, Grunert G. Off-Label-Use: Haftungs- und Regressrisiken für Ärzte, Apotheker und Pharmaunternehmen.  Pharma-Recht. 2005;  5 205-207
    PubMedGoogle Scholar
  • 28 Naber D. Cited in: Regressrisiko Off-Label-Verordnung. Kassen drohen mit Rasterfahndung.  Medical Tribune Deutschland. 2002;  20 33
    PubMedGoogle Scholar
  • 29 Pomerantz J, Finkelstein SN, Berndt ER, Poret AW, Walker LE, Alber RC. et al . Prescriber intent, off-label usage, and early discontinuation of antidepressants: a retrospective physician survey and data analysis.  J Clin Psychiatry. 2004;  65 ((3)) 395-404
    PubMedGoogle Scholar
  • 30 Rawal PH, Lyons JS, MacIntyre JC, Hunter JC. Regional variation and clinical indicators of antipsychotic use in residential treatment: a four state comparison.  The Journal of Behavioral Health Services & Research. 2004;  31 178-188
    PubMedGoogle Scholar
  • 31 Rijcken CAW, Boelema GJ, Slooff CJ, Beuger PJ, Tanja TA, de Jong-van den Berg LTW. Off-label use of antipsychotics in the community-pharmacy: the sex differences.  Pharmacopsychiatry. 2003;  36 187-191
    Article in Thieme ConnectPubMedGoogle Scholar
  • 32 Trifirò G, Spina E, Brignoli O, Sessa E, Caputi AP, Mazzaglia G. Antipsychotic prescribing pattern among Italian general practitioners: a population-based study during the years 1999-2002.  European Journal of Clinical Pharmacology. 2005;  61 47-53
    CrossrefPubMedGoogle Scholar
  • 33 Wagner B, Albrecht H. Einnahme nur nach Genehmigung. Patienten werden Arzneimittel vorenthalten, weil die Medikamente nicht die richtige Zulassung haben.  Die Zeit. 2005;  10 31-32
    PubMedGoogle Scholar
  • 34 Wallesch C-W. „Off-label use” in Psychiatrie und Neurologie.  Fortschr Neurol Psychiat. 2004;  72 243-244
    PubMedGoogle Scholar
  • 35 Weiss E, Hummer M, Koller D, Ulmer H, Fleischhacker W. Off-label use of antipsychotic drugs.  Journal of Clinical Psychopharmacology. 2000;  20 695-698
    CrossrefPubMedGoogle Scholar
  • 36 Wetterling T. Verabreichung von Medikamenten außerhalb der zugelassenen Indikationsgebiete („off-label-use”). Für welche Medikamente und psychiatrischen Indikationen liegen hinreichend wissenschaftlich fundierte Studien vor?.  Fortschr Neurol Psychiat. 2004;  72 245-254
    PubMedGoogle Scholar
  • 37 WHO . The ICD-10 Classification of Mental and Behavioural Disorders. Diagnostic Criteria for research.  http://www.who.int/entity/classifications/icd/en/grnbook.pdf , downloaded 1.3.2005
    Google Scholar
  • 38 WHO . The ICD-10 Classification of Mental and Behavioural Disorders. Clinical Descriptions and Diagnostic Guidelines.  http://www.who.int/entity/classifications/icd/en/bluebook.pdf , downloaded 1.3.2005
    Google Scholar

Correspondence

H.J. Assion

Westphalian Center Bochum

Psychiatry and Psychotherapy

Ruhr-University Bochum

Alexandrinenstr. 1

44791 Bochum

Tel: +234/5077/0

Fax: +234/5077/234

Email: hans-joerg.assion@wkp-lwl.org

      >