3% of those on placebo, with the most common RG7422 adverse events being decreased appetite and somnolence. To address the issue of possible early cessation of treatment with atomoxetine, the Strattera Support Service (SSS) was set up in 2006 in the UK to support carers of child and adolescent patients with ADHD for 12 weeks after initiation of treatment with atomoxetine, with the aim of reducing discontinuations from therapy [Lenox-Smith et al. 2011b]. This nurse-led service Inhibitors,research,lifescience,medical assists in the management of adverse effects of treatment and helps manage expectations appropriately in the initial phase of treatment. Table 1. Incidence of treatment-related adverse events [data
from Montoya et al. 2009]. Patient support programmes (PSPs) are usually initiated by pharmaceutical companies with the aim of optimizing Inhibitors,research,lifescience,medical treatment and improving outcomes and are becoming increasingly used. Patient safety is a critical component of such programmes. Adverse events are not surprisingly reported more often in programmes with telephone support and there are strict protocols for adverse event reporting which enables pharmacovigilance requirements to be adhered to. That potential adverse events may be reported Inhibitors,research,lifescience,medical has been demonstrated in a trial of duloxetine alone compared with duloxetine plus telephone intervention. While there was no statistically significant
difference between groups on the primary outcome measure of remission, more adverse events were reported in patients receiving the telephone support service [Perahia et al. 2008]. Guidance notes on PSPs have been developed by the Association of British Pharmaceutical Industry (ABPI) Pharmacovigilance Expert Network (PEN) and shared with the Medicines and Healthcare Inhibitors,research,lifescience,medical Products Regulatory Agency (MHRA). Within the guidance provided, a patient support programme is defined as a service for direct patient or patient–carer interaction/engagement Inhibitors,research,lifescience,medical designed to help manage
medication and/or disease outcomes such as adherence, awareness and education, or to provide healthcare professionals with support for their patients [ABPI, 2011]. There are three main types of patient support programmes: compliance programmes, when the consenting patient is contacted also on an agreed basis to provide them with support; call centre programmes, when the patient makes contact requiring advice or information; and nurse educator programmes, when nurses are employed by the company, often via a third party, to directly interact with patients to aid adherence and other aspects of treatment. The SSS is an example of both the first and third type of programme combined, when trained nurses offer support around the medication prescribed, in this case, atomoxetine. The provision of patient support services to aid adherence to medications or provide aspects of care such as physical health programmes in severe mental illness have been increasing over the past decade.