EH 6_2015

EUROPEAN HOSPITAL  Vol 24 Issue 6/15 4 NEWS & MANAGEMENT In two decades USA analgesics prescriptions killed over 100,000 people EU aims to avoid opioid epidemic Effectiveness, safety and cost of fluorescence cystoscopy UK hosp few post Anaesthesiologist, intensive care physician and pain expert Bart Morlion MD is president-elect of the European Pain Federation EFIC. He studied at the University of Leuven, Belgium, and completed a specialist residency at the Ruhr University, Bochum, Germany. He returned to Leuven in 1998 to become professor in the Department of Cardiovascular Sciences and head of the multidisciplinary pain centre. From 2006 until 2012 Morlion presided over the Belgian Pain Society and is the principal investigator in 28 national and international multicentre clinical trials (Phases II, III and IV). In the USA, there is already talk of an ‘opioid epidemic’. Whereas in the past 20 years some 100,000 people died directly or indirectly through prescribed opioids, reports indicate that more than 16,000 died in 2010 alone. Since the sales of opi- oid analgesics quadrupled between 1999 and 2010 recent debates have intensified surrounding the use of opioids for non-tumour-related pain in the USA, as well as Canada and Australia, with dependency and risks moving into the spotlight. The US Food and Drug Administration (FDA) restricted the indication for prescribing opioids and demanded that manufacturers conduct more studies on risks, such as abuse, addiction, excessive pain sensitivity, overdoses and fatalities. This trend has reached Europe: The European Council has initiated a discussion of abuse and depend- Bladder cancer is associated with high recurrence rates, necessitating prolonged surveillance and repeat- ed treatments. As a result, it is one of the most challenging and costly of all solid tumours to manage. Although most patients present at an early stage with non-muscle- invasive bladder cancer (NMIBC), between 13% and 61% will experi- ence recurrence within 1 year of initial transurethral resection of the bladder (TURB). It is believed that many cases of recurrence may be due to incomplete initial resection caused by limited ability to visual- ise the whole extent of the tumour using the current standard, white- light cystoscopy (WLC). Improved detection and management are therefore urgently needed. Fluorescence cystoscopy (FC) with photosensitive agents, such as hexaminolevulinate (HAL), has demonstrated enhanced ability to visualise malignant areas, includ- ing flat or multifocal lesions that are difficult to detect using WLC, thereby resulting in more complete resections and reduced recurrence rates. Many clinical trials, including registration trials, meta-analyses and systematic reviews confirm these benefits of HAL-FC as an adjunct to WLC in clinical practice. One meta- analysis of prospective trials involv- ing a total of 1,345 patients showed that, in comparison with WLC, HAL- FC significantly improved tumour detection and significantly reduced recurrence rates at 12 months, inde- pendently of patient’s risk category and whether HAL was used at ini- ency on medications, with a focus on opioid analgesics.  European pain experts are worried about this development. Professor. Bart Morlion, president-elect of the European Pain Federation EFIC, warned those attending the 9th Congress of the European Pain Federation, in Vienna, against exag- gerated caution; not to toss the baby out with the bathwater: ‘Opioids provide important therapeutic options in bringing relief from acute and chronic pain. We should not re-stigmatise these analgesics, but instead clarify how they can be used safely and effectively.’ The professor is emphatically against generalising USA data and applying them to Europe. The abuse problem is virulent mainly in North America and Australia, since pre- scriptions are less regulated than in Europe, where access is strictly reg- tial presentation or on recurrence. Furthermore, a retrospective analy- sis showed that HAL-FC can signifi- cantly improve recurrence-free sur- vival and overall survival in patients undergoing TURB and subsequent radical cystectomy. The said ben- efits seem pronounced in high risk NMIBC. HAL-FC can also improve disease staging, resulting in more appropriate treatment selection, such as adjuvant chemo- or immu- notherapy or early cystectomy. In a ulated by special prescription forms, or the addictive substances regis- try: ‘Reports on increasing prob- lems with opioids, particularly from North America, are mostly related to long-term prescription with a lack of careful patient selection and patient reassessment.’ In some US states, so-called ‘pill mills’ – medical facilities that prescribe controlled substances without regard for guide- lines and indicators – are allegedly responsible for numerous opioid- related fatalities. ‘There are certainly many good reasons for the increase in prescription rates. However, in future more care needs to be taken to ensure that opioids are the right choice for the individual patient,’ Prof. Morlion emphasises. ‘Opioids are not without side effects. For this reason they should only be prescribed in cases where there is a good balance between pain relief phase III study, 22% of patients with confirmed NMIBC had a change of treatment after HAL-FC compared with WLC (p<0.001). Use of FC in the diagnosis of bladder cancer is recommended by the European Association of Urology (EAU), the International Consultation on Urological Diseases (ICUD) and the National Institute for Health and Care Excellence (NICE). The 2015 EAU guidelines and the second ICUD-EAU report recom- mend FC to guide initial TURB and biopsy and to aid diagnosis of carcinoma in situ (CIS). ICUD-EAU guidelines also recommend FC for patients with positive urine cytol- ogy but negative WLC. Numerous expert groups have addressed best- practice implementation of HAL-FC into clinical management of patients with NMIBC (Table 1). In addition to improving patient outcomes, HAL-FC has been shown to realise both short- and long- term cost effectiveness, despite the initial cost of equipment. Results from a UK analysis suggest that, compared with WLC alone, adjunc- tive HAL-FC would be expected to result in 0.060 incremental quality- adjusted life years (QALYs) and a cost saving per patient of £391 (€516) due to fewer recurrences and recurrence-associated procedures. A German analysis reported cost sav- ings with FC compared with WLC to be €168 per patient per year over a median follow up of 7.1 years. In an Italian analysis, use of HAL- FC improved the completeness of lesion resection and tumour stag- ing, leading to a lower recurrence rate and fewer associated TURBs and hospitalisations, compared with WLC. The incremental cost saving was €435. For the incremental cost- effectiveness ratio, HAL-FC was dominant, compared with WLC, as a result of increased QALYs and lower costs over the short term. HAL-FC remained the dominant strategy in univariate sensitivity analyses, in which the key drivers of the model included the cost of HAL-FC, the cost of WLC-assisted TURB and rela- tive risk of recurrence. In probabilis- tic sensitivity analyses, HAL-FC was expected to be dominant in 92% of iterations (Table 2). In conclusion, incorporation of HAL-FC as an adjunct to WLC into the routine management of patients with NMIBC should be considered, given the significant benefits in detecting lesions, thus reducing recurrence rates and providing both short- and long-term cost savings. Funding/Support and role of the sponsor: Ipsen SA provided financial support for editorial assis- tance in manuscript preparation. The author retained editorial control over the content. References can be obtained from the author or read the full story in internet. Contact: mburger@caritasstjosef.de, maximilian.burger@ukr.de Internet: www.healthcare-in-europe.com and side effects, where there are long-term benefits, and where other methods of treatment have failed.’ It cannot be that abuse in some parts of the world leads to a global call for restrictions that could mean insurmountable hurdles for those urgently needing opioids for pain control. Therefore, the European pro- fessional society seeks a reason- able approach between dramatic undersupply, over-prescription and the abuse problem. EFIC commis- sioned a working group to prepare Europe-wide recommendations for an appropriate and responsible han- dling of opioids, especially in long- term therapy of chronic pain. With recommendations expected this autumn, Prof. Morlion expects the ‘… guidelines should provide doc- tors throughout Europe with sup- port and advice for optimal use of opioid analgesics that’s easy to put into practice.’ Report: Mark Nicholls Post mortems are now rarely carried out within UK hospitals – accord- ing to a study that examined all acute NHS Trusts within England, NHS Boards in Scotland and Wales and Social Care Trusts in Northern Ireland, and found that the pro- cess has disappeared completely in around a quarter (23%) of NHS trusts. In 2013, the average autopsy rate (percentage of adult in-patient deaths that undergo consented autopsy) in the UK was 0.7%. ‘With the rapid rate of the decline, it will not be many years before this practice is extinct throughout the vast majority, if not all, of the UK,’ suggests Angus Turnbull from Imperial College London, who led the research. ‘This is the grave situ- ation currently surrounding hospital autopsy. Thirty years ago, up to 28% of all in-patient adult deaths under- went consent autopsy.’ In the UK autopsy is divided into medico-legal autopsy – one required by law under the jurisdiction of a coroner – and consented autopsy, performed with the consent of the family of the deceased. Professor Bart Morlion is head of the multidisciplinary pain centre at Leuven University, Belgium Maximilian Burger is Chairman Professor of Urology and Chairman of the Department of Urology, University of Regensburg, since October 2013. He is also Fellow of the European Board of Urology, member of the bladder cancer guideline panel of the European Association of Urology (EAU), a member of the bladder cancer guideline panel of the German Association of Urology (DGU) and DGU-board member. ©B&K/NicholasBettschar

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