The AMSP Drug Safety Program: Methods and Global Results

The AMSP (Arzneimittelsicherheit in der Psychiatry) study is a drug safety program that ensures the continuous assessment of severe adverse drug reactions (ADR) in psychiatric inpatients under the natural conditions of routine clinical treatment. It developed out of the preceding drug surveillance study AMÜP (Arzneimittelüberwachung in der Psychiatrie). Currently 35 hospitals participate in the study. This paper describes the methods of the AMSP, gives detailed definitions of ADRs assessed to be ”severe,” and discusses the implications of these definitions and the methodological approach for evaluating the AMSP data. In addition, some overall data compiled on ADR rates from 1993 to 2000 are given.

References

• 1 Allhoff T, Bender S, Banger M, Gaspar M. Atrial Arrhythmia in a Women treated with Fluoxetine: Is there a causal Relationship?.  Annals of Emergency Medicine. 2001;  37 116-117
• 2 Bandelow B, Degner D, Kreusch U, Rüther E. Myocarditis under therapy with clozapine.  Schizophrenia Research. 1995;  17 293-294
• 3 Bender S, Grohmann R, Engel R R, Degner D, Dittmann-Balcar A, Rüther E. Severe adverse drug reactions in psychiatric in-patients treated with neuroleptics.  Pharmacopsychiatry. 2004;  37 Suppl 1 S46-53
• 4 CPMP Working Party on Efficacy of Medicinal Products: Note for Guidance Good Clinical Practice for Trials on Medicinal Products in the European Community. Pharm Ind 1990 52: 1476-1504
• 5 Degner D, Bleich S, Grohmann R, Bandelow B, Rüther E. Myocarditis associated with clozapine treatment.  Australian and New Zealand journal of psychiatry. 2000;  34 880
• 6 Degner D, Grohmann R, Kropp S, Rüther E, Bender S, Engel R R, Schmitt L G. Severe Adverse Reaction of Antidepressants: Results of the German Multicenter Drug Program AMSP.  Pharmacopsychiatry. 2004;  37 Suppl 1 S39-45
• 7 Engel R R, Grohmann R, Rüther E, Hippius H. Research Methods in Drug Surveillance.  Pharmacopsychiatry. 2004;  37 Suppl 1 S12-15
• 8 Göder R, Friege L, Treskov V, Grohmann R, Aldenhoff J B. Association of paroxetine with suicide attempt in obsessive-compulsive disorder.  Pharmacopsychiatry. 2000;  33 116-117
• 9 Greil W, Horvath A, Sassim N, Erazo N, Grohmann R. Disinhibition of libido: an adverse effect of SSRI?.  J Affect Disord. 2001;  62 225-228
• 10 Grohmann R, Engel R R, Geissler K H, Rüther E. Psychotropic Drug Use in Psychiatric Inpatients: Recent Trends and Changes over Time - Data from the AMSP Study.  Pharmacopsychiatry. 2004;  37 Suppl 1 S27-38
• 11 Grohmann R, Hippius H, Müller-Oerlingheusen B. et al . Assessment of adverse drug reactions in psychiatric hospitals.  Eur J Clin Pharmacol. 1984;  26 727-734
• 12 Grohmann R, Rüther E, Schmidt L G. (Hrsg.) .Unerwünschte Wirkungen von Psychopharmaka - Ergebnisse der AMÜP-Studie. Springer Verlag Berlin; 1994
• 13 Grohmann R, Rüther E, Engel R R, Hippius H. Assessment of adverse drug reactions in psychiatric inpatients with the AMSP drug safety program: methods and first results for tricyclic antidepressants and SSRI.  Pharmacopsychiatry. 1999;  32 21-28
• 14 Grohmann R, Hippius H, Helmchen H, Rüther E, Schmidt L G. The AMÜP study for drug surveillance in psychiatry - a summary of inpatient data.  Pharmacopsychiatry. 2004;  37 Suppl 1 S16-26
• 15 Heinze M, Andreae D, Grohmann R. Rivastigmin and Impaired Motor Function.  Pharmacopsychiatry. 2002;  35 79-80
• 16 Hippius H. From case reports to drug surveillance. Pharmacopsychiatry. 2004
• 17 Hurwitz N, Wade O. Intensive hospital monitoring of adverse reactions to drugs.  Brit Med J. 1969;  1 531-536
• 18 Kropp S, Grohmann R, Hauser U, Rüther E, Degner D. Hyperglycemia associated with antipsychotic treatment in a Multicenter Drug Safety Project.  Pharmacopsychiatry. 2004;  37 Suppl 1 S79-83
• 19 Kropp S, Hauser U, Emrich H, Grohmann R. Metoclopramide-Related Pisa Syndrome in Clozapine Treatment.  J Neuropsychiatry Clin Neurosci. 2001;  13 427-428
• 20 Kropp S, Ziegenbein M, Grohmann R, Engel R, Degner D. Galactorrhea due to psychotropic drugs.  Pharmacopsychiatry. 2004;  37 Suppl 1 S84-88
• 21 Pedrosa Gil F, Grohmann R, Rüther E. Asymtomatic Bradycardia Associatzed with Amisulpride.  Pharmacopsychiatry. 2001;  34 259-261
• 22 Schmid C, Grohmann R, Engel R, Rüther E, Kropp S. Cardiac adverse effects associated with psychotropic drugs.  Pharmacopsychiatry. 2004;  37 Suppl 1 S65-69
• 23 Seidl L G, Thornton G F. Cluff LE. Epidemiological studies of adverse drug reaction.  Am J Publ Health. 1965;  55 1190
• 24 Sommer M, Dieterich A, Krause C, Rüther E, Wiltfang J. Subclinical Pancreatitis Related to Mirtazapine - A Case Report.  Pharmacopsychiatry. 2001;  34 158-159
• 25 Steinwachs A, Grohmann R, Pedrosa F, Rüther E, Schwerdtner I. Two cases of olanzapine-induced reversible neutropenia.  Pharmacopsychiatry. 1999;  32 154-156
• 26 Stübner S, Padberg F, Grohmann R. et al. Pisa syndrome (Pleurothotonus): Report of a multicenter drug safety surveillance project.  J.Clin.Psychiatry. 2000;  61 569-574
• 27 Stübner S, Rustenbeck E, Grohmann R, Wagner G, Engel R, Neundörfer G, Möller H -J, Hippius H, Rüther E. Involuntary Movement Disorders due to Psychotropic Drugs.  Pharmacopsychiatry. 2004;  37 Suppl 1 S54-64
• 28 Stübner S, Grohmann R, Engel R, Bandelow B, Ludwig W -D, Wagner G, Müller-Oerlinghausen B, Möller H -J, Hippius H, Rüther E. Blood Dyscrasias Induced by Psychotropic Drugs.  Pharmacopsychiatry. 2004;  37 Suppl 1 S70-78
• 29 Wolstein J, Grohmann R, Rüther E, Hippius H. Antipsychotic drugs and venous thromboembolism.  Lancet. 2000;  356 252
• 30 Zullino D, Borgeat F. Hypertension Induced by St. John’s Wort.  Pharmacopsychiatry. 2003;  36 32
• 31 Zullino D, Brauchli S, Horvath A, Baumann P. Inappropriateantidiuretic hormone secretion and rhabdomyolysis associated with citalopram.  Therapie. 2000;  55 649-656
• 32 Zullino D, Delessert D, Eap C B, Preisig M, Baumann P. Tobacco and cannabis smoking cessation can lead to intoxication with clozapine or olanzapine.  International Clinical Psychopharmacology. 2002;  17 141-143
• 33 Zullino D, Lyon I, Morena P, Baumann P. Pathologic Laughter Associated with Paroxetine Treatment.  J Clin Psychopharmacol. 2002;  22 231