AMSP Project Background

It has been estimated, that around 5–10% of all worldwide hospital admissions are due to adverse drug reactions (ADRs). In Germany, 6.5% of emergency presentations are due to ADRs [1]. Of course, ADRs not only lead to hospitalization – they also occur during inpatient care when new drugs are introduced or a drug regimen is changed. Studies have demonstrated, that up to 10% of inpatients suffer from at least one ADR during the course of inpatient care [2, 3].

Psychotropic drugs are an effective treatment option for many psychiatric conditions and have proven their efficacy and tolerability in numerous clinical studies. If, from a clinical and medical point of view, a patient suffering from a mental illness requires drug treatment, treatment with psychotropic drugs should be initiated. Deciding which psychotropic drug to use is based on an individual risk-benefit assessment, considering various clinical factors, such as the age and gender of the patient. Despite their recognized efficacy and tolerability, psychotropic drugs can cause a wide range of ADRs. Subjectively stressful but medically harmless ADRs such as transient drowsiness after start of a new treatment occur relatively often. More significant - albeit much less often – for example are hormonal or weight changes, cardiac arrhythmia or movement disorders. In very rare cases, the use of psychotropic drugs can also lead to potentially life-threatening ADRs such as serotonin syndrome or neuroleptic malignant syndrome [4].

Because psychotropic drugs are often used over an extended period of time, safety and tolerance are particularly important. Both factors have a decisive influence on how reliably a patient takes his medication (so-called adherence).

It is important that ADRs are not to be mistaken with errors in application (such as incorrect dosing). Every form of drug therapy is inherently associated with a certain risk of ADRs. This risk must be weighed against the benefits of a drug together with the patient. In the event that an ADR does occur, different measures can be taken. In some cases a dose reduction is sufficient, in other cases the drug in question has to be discontinued completely. Under certain circumstances, treatment of the ADR may require the initiation or another drug. In any case, the ADR identified as such should be documented in the patient file and in the discharge report and also recorded in a database for research purposes.

The systematic documentation and thorough evaluation of psychotropic drug-induced ADRs caused are the primary aims of the program “drug safety in psychiatry” (German: Arzneimittelsicherheit in der Psychiatrie, AMSP) project. Besides 33 German hospitals, 21 hospitals in Austria and Switzerland take part in AMSP. The ADR cases documented at the respective participating German hospitals are forwarded to the Federal Institute for Drugs and Medical Devices (German: Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) in accordance with the professional regulations of the German Medical Association. BfArM then forwards all case reports to the European Medicines Agency (EMA) and the World Health Organization (WHO) [5]. Alongside the previously mentioned institutions, AMSP is part of a spontaneous reporting system, aiming to make information about ADRs available to treating physicians and the interested public in a transparent manner.

References

  1. Schurig AM, Böhme M, Just KS et al. Unerwünschte Arzneimittelwirkungen (UAW) in der Krankenhausnotaufnahme — Prävalenz von UAW-Verdachtsfällen in vier Notaufnahmezentren in Deutschland. Deutsches Ärzteblatt 2018, 115: 251–258

  2. Ludwig WD, Schuler J (Hrsg.). Unerwünschte Arzneimittelwirkungen als Grund für eine Krankenhausaufnahme. Arzneimittelbrief 2002, 36:94

  3. Thürmann P. Arzneimittelrisiken im Krankenhaus — klinische und ökonomische Konsequenzen. In: Patientenorientierte Arzneimittelversorgung. Hrsg.: von Eiff W. Georg Thieme Verlag, Stuttgart, 2011

  4. Benkert O, Hippius H (Hrsg.). Kompendium der Psychiatrischen Pharmakotherapie. 12. Auflage, Springer-Verlag, Berlin, 2019

  5. Arzneimittelkommission der deutschen Ärzteschaft (AkdÄ). Nebenwirkungen melden — Ein Leitfaden für Ärzte. 1. Auflage, 2019