The reality is that physicians are

often unaware of the indicated disorders for many medicines. In one large US study of primary care physicians and psychiatrists, less than 50% could identify the FDA approved diagnoses for Tivantinib solubility dmso selected medicines [Chen et al. 2009]. Similar rates are seen in the UK. General practitioners (GPs) are unaware of the extent of off- label prescribing [Ekins Daukes et al. 2005], although many are aware of the explicit problems with dosing in children [Ekins Daukes et al. 2005]. Perhaps Inhibitors,research,lifescience,medical most importantly clinicians often have only a limited understanding of the issues around off-label prescribing, the frequency of side effects and lack of efficacy data. There can also be problems concerning informed consent [Ekins Daukes et al. Inhibitors,research,lifescience,medical 2005], as while prescribers of psychotropics may be aware that the prescription is off-label, it is clear that it is only rarely known by the patient [Haw and Stubbs,

2005]. Overall there are few established systems to support and manage off-licence medicine prescribing [Ansani et al. 2006]. Psychiatrists continue to express unease about the extent of prescribing off-licence in the mental health field and the legal, as well as clinical risk that they expose themselves to [Lowe-Ponsford and Baldwin, 2000]. Furthermore, while it is not considered a Inhibitors,research,lifescience,medical breach of care to prescribe off-licence, if and when that decision is supported by clinical evidence and a broad body of clinical opinion, it is possible to face sanction if a off-label treatment is withheld [Henry, 1999]. In reality, only a small minority are ever involved Inhibitors,research,lifescience,medical in such a grievance [Lowe-Ponsford and Baldwin, 2000]. Safeguards can be implemented to ensure drug accessibility is controlled, and that prescribing remains the prerogative of appropriately

trained clinical practitioners. Medicines prescriber information sheets list patient safety data, while black-box warnings continue to update clinicians when extra vigilance is needed [Stafford, 2008]. In the UK at least there appears to be a confusing range of opinion on what can Inhibitors,research,lifescience,medical be prescribed and for whom, from national medicines information services, expert opinion such as the Maudsley Prescribing Guidelines [Taylor et al. 2012], the MHRA and NICE, to guidance from individual hospitals, NHS trusts and insurance companies [Bücheler et al. 2002]. A framework to protect unlicensed groups Blinded randomised controlled trials remain the highest quality individual study design. They 4-Aminobutyrate aminotransferase provide the most reliable and objective data to support effectiveness, efficacy and safety of innovative treatments, and need to be conducted before regulators award full licensed approval for a medicine. However, change in the current regulatory process is required, to generate greater incentive to conduct new drug research for mental disorders and, to guarantee long-term added efficacy and safety [Segman and Weizman, 2008].