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

BackgroundIron deficiency (ID) is an important comorbidity associated with chronic heart failure. This often leads to worsening functional class, quality of life and poor prognosis. Diagnosis and prompt treatment of ID are essential.PurposeThe aim of this study was to analyse compliance with a new protocol for intravenous ferric carboxymaltose (FCM) in the heart failure unit and the short term safety and analytical profile of intravenous FCM.Material and methodsA review was conducted by a multidisciplinary team (MT). After review, the MT decided to implement a new protocol using FCM in a definite group of patients. Absolute ID was defined as ferritin <100 μg/L, functional ID was defined as ferritin 100–299 μg/L and transferrin saturation (TSAT) <20%. All patients were administered intravenous FCM in one or two doses (maximum iron dose per infusion 1000 mg) in an outpatient setting. ID was calculated using the simplfied Ganzoni formula. Patient identification was performed using the electronic prescription programme; pharmaceutical validation mainly allowed us to identify prescription, dose, dilutions and the analytical parameters. The Student’s t-test for related samples was used to compare continuous variables before and after iron infusion. Statistical significance was defined as a two tailed p value <0.05.Results62 patients were analysed in this retrospective observational study. Mean age was 65.2±12.9 years, and patients were predominantly men (70%). Relevant laboratory parameters before and after treatment with intravenous FCM were requested and analysed according to the protocol. Haematological and iron status parameters: haemoglobin (13.04 vs 13.78 mg/dL), haematocrit (38.5 vs 41.6), blood iron level (67.85 vs 109.11 mg/dL), ferritin (79.65 vs 424.62 mg/dL) and TSAT (17.23% vs 33.64%) improved significantly (p<0.001) in the first 3 months after FCM infusion. No adverse reactions were observed during the study.ConclusionIn our study, this therapy safely and effectively corrected deficient iron stores in the short term. Studies that analysed the effects of intravenous iron treatment in patients with heart failure have demonstrated improved quality of life and functional capacity. The intravenous FCM protocol had an acceptable degree of compliance but the importance of diagnosis and monitoring patients must be stressed as the long term effects of intravenous iron therapy are not yet well defined.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

BackgroundDisease modifying therapies (DMT) for multiple sclerosis (MS) have a considerable economic impact on hospitals’ annual budgets. Since February 2017, there has been a shift of power from our Health Service Area to local MS committees to evaluate the appropriateness of DMT prescriptions.PurposeTo evaluate the benefits of including a pharmacist in the MS Committee in a third-level hospital.Material and methodsDescriptive, observational and retrospective study based on the information arising from the prescription of DMT for MS from February to August2016 vs February to August 2017. Patient and treatment data (prescriptions, previous DMT, costs) were retrieved from the Farmatools® management tool (outpatients clinical module).The MS Committee organised weekly meetings with the neurologists in charge of monographic consultations for MS in our centre. The objective was to choose the most cost-effective alternative for those patients who were candidates to initiate or change their DMT. An evidence-based algorithm was designed to assist the Committee in decision-making.ResultsPatients were classified regarding if they used home treatment: oral (dimethyl fumarate, teriflunomide, fingolimod) or injectable (interferon ß1A and 1B, glatiramer acetate), or infusion therapies (natalizumab and alemtuzumab). In 2016 215 patients received home treatment vs 243 in 2017, and the estimated annual cost per patient decreased by 10.5% (€10.428 vs €9.326). Despite the increase in patients being treated, the positive economic results were possible due to the prescription of more cost-effective alternatives for initial treatments such as interferon ß1B (2016, 0% vs 2017, 23%) and glatiramer (2016, 0% vs 2017, 13%) both considered as safe first-line treatments in MS. The same trends were observed in infusion therapies: 2016, 59 patients vs 2017, 61 patients, decrease of 12.5% in estimated annual cost per patient (€17.106 vs €14.962). In this case, this was explained by the administration of natalizumab using extended interval dosing (every 5 weeks).ConclusionIncluding a pharmacist on the MS Committee has permitted the optimisation of the management of DMT in a Rational Use of Medicines context. Evidence-based clinical protocols are essential in order to contribute to the financial sustainability of public healthcare and to improve patient access to existing medicines.No conflict of interest