BackgroundEtanercept is a biological drug that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF) with a considerable economic impact on the hospital’s annual budget. Biosimilar therapies are expected to be less costly for healthcare systems.PurposeThe primary endpoint was to analyse treatment costs with etanercept biosimilar (EB) vs etanercept reference product (ERP) as initial treatment and the potential economic impact of switching to EB for maintenance therapy.Material and methodsRetrospective observacional study including all patients treated with etanercept from March to September 2017. Data on prescription details, number of prescriptions and costs, were retrieved from the Farmatools® management tool (outpatients clinical module). The Pharmacy and Therapeutics Committee included EB as a cost-effective alternative and in the light of available scientific data, prescribers agreed with the pharmacy staff to use it as initial therapy. Regarding switching maintenance therapy from ERP to EB, prescribers were responsible for individualising the decision according to patients’ medical records.ResultsDuring the study period 190 patients were treated with etanercept. Seventy-eight per cent were rheumatology patients and 22% were dermatology patients. EB was prescribed as initial treatment in 100% of cases (25 new treatments in rheumatology, nine in dermatology). No switching to EB was prescribed in maintenance therapy. A total of 256 doses of EB 50 mg were dispensed, which generated savings of €43.491, when compared to ERP’s best offer. Regarding the potential economic impact of switching maintenance therapy, we estimated that this strategy would mean savings of €339.012 to our centre. No adverse effects or low efficacy data were reported with EB treatments.ConclusionIntroducing EB as initial therapy for rheumatology and dermatology patients has resulted in a modest reduction in drug spending in our centre. Potential savings justify the urgent need to implement agreed protocols for switching to EB in maintenance therapy as well. This would mean significant cost savings and improved access for patients to these highly effective therapies. A cross-sectoral collaboration among prescribers, pharmacists and nurses facilitate pharmacovigilance activities, in order to assure the quality, safety and efficacy of EB.No conflict of interest

BackgroundDrug shortages are becoming more common and may involve a reduction in pharmacotherapeutic efficacy and increased medication errors. Problems caused by medicines’ shortages are serious, threaten patient care in hospitals and require urgent action.PurposeTo analyse the impact of shortages and to describe the different actions carried out by the Pharmacy Department.Material and methodsA retrospective descriptive study was carried out from January 2017 to October 2017. The data collected were: affected drug, duration of the shortage and measures implemented. The data were obtained from the drug shortages’ list of the Spanish Agency for Medicines and Health Products (AEMPS). We analysed every drug included in the hospital pharmacotherapy guide.ResultsDuring the study period, there were 226 drugs affected by supply problems, 172 of them active principles included in our pharmacotherapy guide, specifically 98 pharmaceutical specialties.The strategies for the management were:To change the provider or the form of presentation (packaging) in 38 cases (38.77%).To use a therapeutic alternative in 13 cases (13.26%).The AEMPS authorised temporarily the importation of six medicines with the outer packaging and package leaflet in a language other than Spanish, but this option was not used.In eight cases (8.16%) there was controlled distribution of certain drugs just in case of clinical need.Despite the AEMPS offer to import 17 foreign medicinal products, only nine applications (9.18%) were processed. The foreign medicinal products were relabelled in Spanish before being dispensed in the hospital.No action was taken in 30 cases due to the low prescription rate in our centre or the availability of sufficient stock.ConclusionThe unpredictability of shortages and lack of information provided to healthcare professionals make it increasingly difficult to plan effective coping strategies to provide medication to patients. In fact, it implies a greater workload for hospital pharmacists due to administrative procedures, the determination of therapeutic alternatives and the need to inform all health professionals so as not to compromise the continuity of treatment, increased stress and confusion within safety-critical working environments, the frequent high costs of procuring alternative medicines and the cancellation of service improvements due to resources needing to be reallocated to deal with medicines’ shortages.No conflict of interest

BackgroundA study was presented during the 31st Meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in October 2015 showing that extending the time frame between natalizumab doses from 4 to 8.5 weeks seems to neither increase the risk of relapse nor increase the risk of progressive multifocal leukoencephalopathy in patients diagnosed with relapsing remitting multiple sclerosis (RRMS). On May 2016, a joint protocol was created between the department of pharmacy and neurology to increase the standard interval for natalizumab to 5 weeks.PurposeTo assess compliance and the economic impact associated with progressive implementation of the aforementioned protocol in RRMS patients receiving treatment in our centre.Material and methodsA retrospective observational study including all RRMS patients under active natalizumab treatment was conducted from May to September, 2016. For the economic analysis, both direct and administration costs of the drug at the hospital’s outpatient care unit were taken into consideration. The estimated cost of administering the antibody every 4 weeks was calculated as per the data sheet. This estimate was then compared with the cost incurred by extending the administration interval to 5 weeks, bearing in mind the real compliance of the patients. In addition, we calculated the potential amount saved if all patients had started with the extended interval after protocol approval. Unit costs associated with outpatient care were gathered from the Oblikue Consulting’s e-Health healthcare costs (retrieved 2014).ResultsOver the studied period, 53 patients were given natalizumab as treatment for RRMS. Progressively, 96% of patients started natalizumab every 5 weeks, as per the protocol. For our sample and during the studied period, the cost of administering natalizumab every 4 weeks was €515 540, and €423 708 for every 5 weeks. Therefore, the potential amount saved by switching from the first to the second administration schedule was €91.832€. As patients were progressively included into the new protocol, the real administration cost was calculated as €474 020, which is equal to only 45.21% of the amount that could actually have been saved.ConclusionAdministering natalizumab under an extended interval schedule has translated into a major saving for our health centre, both in direct costs and costs related to outpatient care.No conflict of interest

BackgroundNeuroendocrine tumours (NET) overexpress somatostatin receptors on cell membranes. Imaging tests with somatostatin analogue tracers (SAT) are used for diagnosis and follow-up of NET and their metastases. Current guidelines recommend 111 In(DTPA)-octreotide for this use but new alternatives are available, such as 99mTc-labelled SAT.PurposeTo study the consolidation of 99mTc-EDDA/HYNIC-TOC (99mTc-Tektrotyd) as SAT for the diagnose of NET in our centre.Material and methodsWe analysed the requests for 99mTc-Tektrotyd received from the nuclear medicine service from November 2015 to September 2016. This tracer was not commercialised in our country until September 2016, so it was necessary to justify its use to obtain National Medicines Agency approval. We created a database which included: age, diagnose and reasons to justify 99mTc-Tektrotyd use, instead of 111 In-labelled SAT in imaging tests. Data were retrieved from electronic health records, including clinical history and nuclear medicine service requests.Results32 requests were analysed: 28.125% of patients were <50 years old, 28.125% 50–70 years and 43.75% were older than 70 years. All patients had a NET diagnosis. The reasons for using the 99mTc-Tektroyd contrast were:100% of patients had demonstrated mobility issues, specifically: home away from our centre (37.5%), advanced age (25%), poor health state (18.75%), patient’s comfort (6.25%), social issues (3.125%), mental health issues (3.125%) and family issues (3.125%). This was due to the fact that the imaging protocol of 111In is 2 days, 1 day longer than 99mTc-Tektroyd (1 day protocol).In 62.5% of cases, clinicians highlighted the importance of the ALARA principle (As Low As Reasonably Achievable) to reduce to a minimum exposure of patients to radioactive substances. The lower radiation dose associated with 99mTc-Tektrotyd imaging was particularly desirable for patients undergoing repeated scanning, such as cancer patients.In 31.25% of cases it was remarked that there was a higher resolution with the 99mTc-Tektroyd contrast, especially depending on the location of the tumour.ConclusionA 1 day imaging protocol, lower radiation and high resolution are the main reasons that justify the use of 99mTc-Tektrotyd in imaging tests for NET patients. The pharmacy and therapeutics committee will propose including 99mTc-Tektrotyd in our therapeutic arsenal for diagnose of NET in our centre.No conflict of interest

BackgroundThe introduction of PCSK9 inhibitors in the treatment of hypercholesterolaemia marks a breakthrough for patients unresponsive to traditional treatment. However, in our country, 44.9% of adults have high LDL-C levels (≥ 130 mg/dL or under treatment), so inadequate use of these innovative drugs might have a strong impact on efficiency and safety. The national atherosclerosis association published a document regarding the restricted indications for use of the PCSK9 inhibitors, and we adapted it to our centre.PurposeWe evaluated compliance with the protocol for prescription of PCSK9 inhibitors in our centre.Material and methodsIn March 2016, the pharmacy and therapeutics committee created their own protocol together with internal medicine, cardiology and endocrinology services. It turned out to be more restrictive than the national guidelines, with higher LDL-C levels required. Based on the available evidence and taking into account criteria of efficacy and safety, four indications were included: (1) HoFH: homozygous familial hypercholesterolaemia with LDL-C >120 mg/dL with the maximum tolerated dose of statin and ezetimibe; (2) HeFH: heterozygous familial hypercholesterolaemia with LDL-C >120 mg/dL with the maximum tolerated dose of statin and ezetimibe; (3) previous cardiovascular event (pCVE) with LDL-C >100 mg/dL with the maximum tolerated dose of statin and ezetimibe; and (4) any of the above with LDL-C >120 mg/dL in patients who are statin intolerant, or for whom a statin is contraindicated. We evaluated the compliance with our protocol for prescribing PCSK9 inhibitors from March to September 2016, based on computerised medical records.ResultsWe received 26 prescriptions, 20 from the internal medicine service, 3 from the endocrinology service and 3 from the cardiology service. All complied with the protocol, except for 1 that was approved by the committee for the treatment of hyperlipoproteinaemia. The following patients were treated: 18 HeFH, 6 pCVE and 1 pCVE who was statin intolerant.ConclusionIn our centre, there was high compliance with the protocol for the prescription of PCSK9 inhibitors. Due to the major economic impact of these new drugs, continuous follow-up would be required to ensure that every prescription meets the requirements of the protocol in the treatment of hypercholesterolaemia with PCSK9 inhibitors.No conflict of interest