BackgroundImplantable medical devices (IDs) management in the hospital is a complex process, with a large scope for improvement that satisfies technical, logistical, economic and clinical needs.PurposeIntegrate into a single process all the activities and interests related to the use of IDs.Material and methodsProject in a highly specialised hospital with scheduled surgical activity. Designed by a multidisciplinary group and integrated into the hospital information system (HIS). It uses an external company that ‘certifies’ (technical and economic criteria) IDs and providers for insurers and surgeons. Pharmacy service (PS) manages all IDs in the hospital.Stages have been: creation of multidisciplinary working group, SWOT-analysis and pilot economic study. Project approval by the hospital. Software development and IDs data mapping (hospital and company). Providers and insurers were informed. Pilot project was started for 6 months with two surgical departments (SD). The OR-pharmacist was responsible for providing the information, training and incorporation of SDs.ResultsA simple and effective procedure has been designed. Surgical procedure (SP) is scheduled by the doctor in the HIS (patient, SP code and date) recording IDs expected in an electronic form. Doctor’s signature generates automatically two orders: a ‘devices submission proposal’ which is sent by PS to the provider. and an application for ‘economic authorisation’ that the company will manage with the insurer before SP. Pharmacy receives IDs temporary deposits that are registered and sent to the surgical area. All ID are recorded (optical reading of product code, batch, expiration date). When SP is completed OR-pharmacist checks unused IDs with those received and returns the surplus material, issuing an order for IDs implanted to the billing department. Company controls economic agreements between providers, insurers and the hospital. An implant file associated with SPs has been created for safety, results analysis and cost studies. Logistic traceability helps to schedule activity in the surgical area (average delivery time ID/supplier 2–3 days). This procedure ensures the conformity of ID’s cost before surgery, avoiding claims. Nineteen per cent of the spending has been reduced.ConclusionProcess integrated into the SD’s activity and the HIS. It incorporates in a sequential way habitual tasks. A multidisciplinary work with a vision and global resolution has been the leadership by the OR-pharmacist.No conflict of interest

BackgroundALK-inhibitors are indicated in adult patients with ALK-positive advanced NSCLC, with crizotinib being the first choice. Hepatotoxicity has been described for crizotinib and ceritinib.PurposeTo describe a case of alectinib hepatic-tolerance in patients with an hepatotoxicity background with other ALK-inhibitors.Material and methodsData were obtained by review of the electronic medical records. Karch-Lasagna, Naranjo and WHO-UMC algorithms have been used.ResultsA 76-year-old male diagnosed with ALK-positive advanced NSCLC (2016) began crizotinib 250 mg twice daily on 27 October 2016 with basal laboratory hepatic parameters in the normal range. An initial brain and thoracic response was observed but 36 days from the start of crizotinib (3 December 2016) a marked elevation appeared in transaminases ALT 1542UI/L (37.6xULN) and AST 684UI/L (18.5xULN) and a minimal rise in total bilirrubin 2.0 mg/dL (1.67xULN). Crizotinib was discontinued and AST recovered its normal range within 24 days and ALT within 32 days. Then ceritinib 750 mg daily was started (3 January 2017) with frequent evaluations of liver function, showing a progressive increase in transaminases from day +8 until 8 March 2017 with maximum values of ALT 214UI/L (5.2xULN) and AST 128UI/L (3.5xULN). Ceritinib was stopped despite the patient presenting brain and thoracic response. Treatment was changed to pembrolizumab 200 mg every 3 weeks and 4 months’ later was discontinued for brain progression. On 12 July 2017 the patient began alectinib 600 mg twice daily with exhaustive hepatic monitoring. Three months’ later he presented an adequate treatment tolerance, without signs of clinical progression and transaminasesin in the normal range.Karch-Lasagna and Naranjo algorithms established a ‘probable’ relationship between hepatotoxicity and crizotinib/ceritinib. The WHO-UMCalgorithm established this relationship as ‘probable’ to crizotinib and ‘certain’ to ceritinib. In all cases there was a temporal correlation of the facts and an apparent absence of another factor responsible for liver damage.ConclusionAlectinib may be a therapeutic option in patients with ALK-positive NSCLC who have developed hepatic toxicity to other ALK-inhibitors. Further follow-up is needed to ratify this statement. Hepatic toxicity to ALK-inhibitors has frequently a reversible pattern and transaminases appear to be the most sensitive marker.References and/or Acknowledgements(ULN)=upper limit normalNo conflict of interest