enterocolitis and acute renal failure. The next day, hemicolectomy had to be performed for signs of intestinal ischaemia. Finally, the patient was discharged after multiple infectious complications and 56 days of hospital stay. The Naranjo algorithm established as 'probable' (score 6) the relationship between docetaxel and neutropenic enterocolitis. The Spanish Pharmacovigilance System was notified. Conclusion and relevance In this case, docetaxel was probably responsible for neutropenic enterocolitis. In order to know the real incidence of adverse events listed as rare, it is essential that healthcare professionals officially report suspected adverse reactions.

and evolocumab were approved for primary hypercholesterolaemia (heterozygous family (HFHe) and non-familial (HNF)) and mixed dyslipidaemia (DM). Due to their recent approval and high cost, it is crucial to evaluate their real world results. Aim and objectives To analyse the long term effectiveness of PCSK9I over 3 years, approved by the pharmacy service (PS). Material and methods This was an observational retrospective study conducted at a third level hospital from January 2016 to March 2019. All PSCK9I were evaluated by the PS according to the criteria of the Regional Pharmacotherapeutic Commission. Patients approved who initiated the treatment were included. Biodemographic, clinical and pharmacotherapy data was collected from the medical records. Parameters were evaluated at treatment initiation and after 6 months. Clinical response, defined as a reduction in low density lipoprotein (LDL) >30%, was analysed by indication. Results PS accepted 93 of 123 patient requests. Only 72 patients (median age 58 years (37-84), 56% men) were included due to lack of data. Cardiovascular risk factors were: hypertension (47.2%), family history of ischaemic heart disease (40.3%), smoking (38.3%), obesity (15.3%), diabetes (12.5%) and ischaemic heart disease (58.3%). Initial LDL values (mg/dL) were 100-129 (23.6%), 130-159 (34.8%), 160-190 (20.8%), and >190 (20.8%). Frequency of additional lipid lowering drugs were: atorvastatin (40.3%), rosuvastatin (27.8%), fluvastatin (2.8%), pitavastatin (2.8%), statin free (26.4%) and ezetimibe (72.2%). During the study, 41.7% of patients showed statin intolerance and 88.9% reached their maximum tolerated dose. After initiating PCSK9I, 83.3% of patients maintained the same dose of statin, 8.3% reduced the dose, 6.9% stopped taking the medication, 4.3% switched to another statin and 1.4% increased the dose. LDL plasma concentration decreased by more than 50% in 52.1% of patients, by 30-50% in 31.2% of patient and by <30% in 16.7%. of patients. The clinical response in primary HFHe prevention was alirocumab 16.7% versus evolocumab 50%, and in secondary HFHe, alirocumab 68.8% versus evolocumab 83.3%. The clinical response in primary HNF prevention was alirocumab 60% (no evolocumab patient) and in HNF/DM secondary prevention, alirocumab 50% versus evolocumab 100%. Conclusion and relevance We found that 16.7% of our population did not achieve a clinical response; PS may play a relevant role, suggesting treatment cessation in these patients. Evolocumab could be especially effective in HFHe; more studies are needed to confirm this finding. REFERENCES AND/OR ACKNOWLEDGEMENTS No conflict of interest.

Background Tenofovir alafenamide (TAF) in clinical trials demonstrated less impact than tenofovir disoproxil (TDF) in affecting renal and bone parameters, whereas TDF protects from hypercholesterolaemia and hypertriglyceridaemia. Purpose To analyse in clinical practice of human immunodeficiency virus-infected (HIV-infected), how renal function and fasting lipid parameters are modified when switching TDF to TAF. As a second aim, to evaluate effectiveness and the immunological system. Material and methods Retrospective observational study (July 2016 to August 2018) conducted in HIV-infected patients treated for !6 months with a TDF regimen who switched to a TAF regimen kept >48 weeks. We considered virological success if HIV-1 RNA <35 copies/mL. Demographic variables were registered. Follow-up variables: serum-creatinine, phosphataemia, glomerular filtration rate (GFR calculated by CKD-EPI), total cholesterol (TC), hightdensity-lipoprotein (HDL), low-density-lipoprotein (LDL), triglycerides, CD4 +cell counts and HIV RNA-concentration.Two-sided t-student test was used for comparing pre-post variables except for GFR with two-sided Wilcoxon signed-rank test. We used Pearson correlation coefficient (r) evaluating the relation with TC and HDL-LDL.Variables were extracted from: electronic clinical records (SAP) and the pharmacy-dispensation program (Silicon). The statistical data were analysed with SPSS. Results Forty-eight patients were included, mean age 44 years (range 21-70), 79.2% males. Most received antiretroviral treatment (ART) with emtricitabine/elvitegravir/cobicistat (44/48).There were significant differences from baseline to 48 weeks with serum-creatinine, TC, HDL and CD4+. Serumcreatinine decreased 0.08 mg/dL with TAF (0.98±0.18 mg/dL with TDF, p=0.0001); TC, HDL and CD4 were greater with TAF; difference 19.8 mg/dL (173.4 mg/dL with TDF, p=0.0001), 8.7 mg/dL (47.6 mg/dL with TDF, p=0.0001) and 76 cells/mL (694.2 cells/mL with TDF, p=0.02) respectively. There were no significant differences with phosphataemia, LDL and TG, but all increased with TAF (difference 0.06, 8.03 and 10.77 mg/dL, concentration with TDF 3.31, 106 and 115.4 mg/dL respectively; p>0.05). There were no statistical differences with GFR (p>0.05).Cholesterol correlated with LDL (p=0.0001; r=0.94), but not with HDL (p>0.05; r=0.03).All patients achieved virological success, even three patients with RNA-concentration >35 copies/mL before switching. Conclusion After 48 weeks of patients, in clinical practice, who changed to TAF on their ART, 100% of patients archived virological suppression, with reduction in serum-creatinine and improvement in the immunological system. Nevertheless, hypercholesterolaemia was observed based mainly on LDL elevation.

regarding an ideal registration system. This information was used to develop a preliminary version of the classification system, which was further evaluated by major stakeholders (hospitals, universities, government) during a focus group discussion (September 2018). A final version was validated and assessed for interrater reliability in a second nationwide electronic non-Delphi survey (March-April 2019), comprising the classification of DRPs and PIs in 45 theoretical cases. Participants were also asked to score interpretability, user friendliness and user satisfaction. Results Following the literature review, 22 classification systems were identified, all with different categories and numbers of categories. Both the survey and focus group discussion revealed that the use of validated systems is very scant, but desirable in Belgium, with practicality and time investment as the most important characteristics. The final classification system included seven clinical activities, grouped into four activity classes. The most extensive activity class (ie, medication review) included 29 DRPs and 22 PIs. Forty-four hospital pharmacists participated in the validation study. Interrater reliability was substantial for the DRPs (Fleiss' k=0.731) and PIs (Fleiss' k=0.784). The classification system was found to be user friendly, with good interpretability and user satisfaction, resulting in a very high interest to use our system in daily practice. Conclusion and relevance A classification system, adapted to Belgian clinical pharmacy activities, was developed and validated, and was well received by hospital pharmacists. The final version will be promoted at different levels for use in daily practice.

the effectiveness and safety of the eye drops in a premature infant. Material and methods Case description: a premature infant (26 weeks' gestation) was diagnosed with conjunctivitis due to Stenotrophomonas maltofilia multi-resistant, sensitive to levofloxacin. The neonatal intensive care unit requested the manufacture of levofloxacin based eye drops. The pharmacy service initiated a bibliographic search to find out the indication, dosage, manufacture and stability of levofloxacin 0.05% based eye drops. Results We decided to prepare it with injectable levofloxacin 500 mg/100 mL, taking into account the physical and chemical characteristics an ophthalmic drug should have:. non-contraindicated excipients (injectable excipients: water, HCl and NaOH);. acceptable pH (4.4-5.5) and osmotic concentration (300-310 mOsm/l).