Background: There are potential conflicts between authorities and companies to fund new premium priced drugs especially where there are safety and/or budget concerns. Dabigatran, a new oral anticoagulant for the prevention of stroke in patients with non-valvular atrial fibrillation (AF), exemplifies this issue. Whilst new effective treatments are needed, there are issues in the elderly with dabigatran due to variable drug concentrations, no known antidote and dependence on renal elimination. Published studies have shown dabigatran to be cost-effective but there are budget concerns given the prevalence of AF. There are also issues with potentially re-designing anticoagulant services. This has resulted in activities across countries to better manage its use.Objective: To (i) review authority activities in over 30 countries and regions, (ii) use the findings to develop new models to better manage the entry of new drugs, and (iii) review the implications for all major stakeholder groups.Methodology: Descriptive review and appraisal of activities regarding dabigatran and the development of guidance for groups through an iterative process.Results: There has been a plethora of activities among authorities to manage the prescribing of dabigatran including extensive pre-launch activities, risk sharing arrangements, prescribing restrictions, and monitoring of prescribing post-launch. Reimbursement has been denied in some countries due to concerns with its budget impact and/or excessive bleeding. Development of a new model and future guidance is proposed to better manage the entry of new drugs, centering on three pillars of pre-, peri-, and post-launch activities.Conclusion: Models for introducing new drugs are essential to optimize their prescribing especially where there are concerns. Without such models, new drugs may be withdrawn prematurely and/or struggle for funding.

In this study, we analyze the outcomes of transplant renal artery stenosis (TRAS), determine the different anatomical positions of TRAS, and establish cardiovascular and immunological risk factors associated with its development. One hundred thirty-seven of 999 (13.7%) patients had TRAS diagnosed by angiography; 119/137 (86.9%) were treated with angioplasty, of which 113/137 (82.5%) were stented. Allograft survival in the TRASþ intervention, TRASþ nonintervention and TRASÀ groups was 80.4%, 71.3% and 83.1%, respectively. There was no difference in allograft survival between the TRASþ intervention and TRASÀ groups, p ¼ 0.12; there was a difference in allograft survival between the TRASÀ and TRASþ nonintervention groups, p < 0.001, and between the TRASþ intervention and TRASþ nonintervention groups, p ¼ 0.037. TRAS developed at the anastomosis, within a bend/kink or distally. Anastomotic TRAS developed in living donor recipients; postanastomotic TRAS (TRAS-P) developed in diabetic and older patients who received grafts from deceased, older donors. Compared with the TRASÀ group, patients with TRAS-P were more likely to have had rejection with arteritis, odds ratio (OR): 4.83 p ¼ 0.0095, and capillaritis,), p ¼ 0.033. Patients with TRAS-P were more likely to have developed de novo class II DSA compared with TRASÀ patients hazard ratio: 4.41 (2.0-9.73), p < 0.001. TRAS is a heterogeneous condition with TRAS-P having both alloimmune and traditional cardiovascular risk factors.

Background Antipsychotic medications are used among 19%–58% of adults with intellectual disabilities to manage challenging behaviour against the NICE guideline recommendations. Studies show that it is possible to completely withdraw antipsychotics in about one third of adults with intellectual disabilities and a dose reduction of 50% or more in another third. Method In Cornwall, over three years the present authors developed a structured pathway to withdraw antipsychotics among adults with intellectual disabilities which involved people with intellectual disabilities and their carers, GPs, community learning disability team members and pharmacists. Results The present authors managed to withdraw antipsychotics totally among 46.5% (33/71) and reduced over 50% of dosage in another 11.3% (8/71) of adults with intellectual disabilities. At three months follow‐up no one required hospital admission or change in placement. Conclusion It is possible to withdraw/reduce antipsychotics in a high proportion of adults with intellectual disabilities if a concerted effort is made involving all stakeholders from the outset.

Background A high proportion of adults with intellectual disabilities are prescribed off-licence antipsychotics in the absence of a psychiatric illness. The National Health Service in England launched an initiative in 2016, ‘Stopping over-medication of people with a learning disability [intellectual disability], autism or both’ (STOMP), to address this major public health concern. Aims To gain understanding from UK psychiatrists working with adults with intellectual disabilities on the successes and challenges of withdrawing antipsychotics for challenging behaviours. Method An online questionnaire was sent to all UK psychiatrists working in the field of intellectual disability (estimated 225). Results Half of the 88 respondents stated that they started withdrawing antipsychotics over 5 years ago and 52.3% stated that they are less likely to initiate an antipsychotic since the launch of STOMP. However, since then, 46.6% are prescribing other classes of psychotropic medication instead of antipsychotics for challenging behaviours, most frequently the antidepressants. Complete antipsychotic discontinuation in over 50% of patients treated with antipsychotics was achieved by only 4.5% of respondents (n = 4); 11.4% reported deterioration in challenging behaviours in over 50% of patients on withdrawal and the same proportion (11.4%) reported no deterioration. Only 32% of respondents made the diagnosis of psychiatric illness in all their patients themselves. Family and paid carers’ concern, lack of multi-agency and multidisciplinary input and unavailability of non-medical psychosocial intervention are key reported factors hampering the withdrawal attempt. Conclusions There is an urgent need to develop national guidelines to provide a framework for systematic psychotropic drug reviews and withdrawal where possible.

An important part of health resources are spent on prescriptions for acid suppression therapy each year in Cornwall. In 1996 the cost of prescriptions for these drugs amounted to £6.15 million [Prescription Pricing Authority. Prescription analysis and cost (PACT) data. Financial year 1996, unpublished data], which represents 14% of the total prescription cost for the district and 2% of the health authority budget. In addition there has been a continuing rise in the cost associated with acid suppression drugs, due mainly to an increasing use of proton pump inhibitors ( Figure 1). This is a national trend, but it is particularly relevant in Cornwall where the cost of acid suppression therapy is above the average for England.Studies have shown that a majority of acid suppression drugs are prescribed on a repeat basis and about 80% of the cost associated with these drugs is generated by repeat prescriptions; 1, 2 a repeat prescription has been de®ned as a prescription issued without a consultation. 1 The ®nancial burden of acid suppression drugs on health resources is therefore linked to repeat prescriptions.In previous studies repeat prescription rates varied between 1% 3±5 and 4.4%, 6 but these studies were based on a small sample of practices that were not representative of all English practices. There is evidence suggesting that repeat prescriptions may lead to an inappropriate use of acid suppression drugs, in turn leading to a waste of resources and possible damage to patients' health. A recent study carried out in seven practices in Dundee 6 has shown that 44% of patients with repeat prescriptions for acid SUMMARY Background: Repeat prescriptions for acid suppression therapy represent an important burden on health care resources. Aim: To determine the prevalence of acid suppression therapy and its indications by general practitioners (GPs) in a larger sample of practices than previous studies. Method: Practices in Cornwall and the Isles of Scilly were invited to identify the number of patients on repeat prescription for acid suppression drugs in their practice, to review the indication for treatment in a sample of 50 patients, and to indicate the mode of review of these patients.