Contribution of UK Prescription-Based Event Monitoring Methods in the Pharmacovigilance of Psychotropic Medications

Abstract

Psychotropic drugs are widely used in clinical practice. The balance between drug safety and efficacy is affected by many factors including the prescriber, the patient, the disease as well as other environmental effects. Physician factors include failure to diagnosis conditions because of the complex nature and pattern of presenting symptoms. Thus patients may not receive the treatment they need, whether that is a particular medication or the appropriate medication at sub-therapeutic doses. Patient factors include failure to recognize existence of a condition accompanied by denial and reluctance to seek medical attention. In addition, many patients prescribed antipsychotic medications do not take their medicines in accordance with instructions. Such factors, accompanied by large inter- and intra- individual manifestation of mental health disease severity contribute to difficulties in appropriately managing such patients, especially long -term. In this chapter, examples of real-life studies about some of these challenging issues will be described, as reported from the post-marketing event-monitoring systems, now known as Modified Prescription-Event Monitoring (M-PEM) and Specialist Cohort Event Monitoring (SCEM).