Background and Importance Paediatric population are predisposed to have more adverse drug reactions (ADR) and other drug related problems (DRP). Social media (SM) could be an innocuous source of pharmacovigilance. Aim and Objectives Assess ADR and DRP evidence reported in SM. Material and Methods A systematic review according PRISMA recommendations was conducted in MEDLINE, Embase and LILACS. Articles in English, Spanish and Catalan languages from inception up to September 2021 were reviewed using search terms related to paediatric age, SM and DRP. In the screening phase, articles not mentioning paediatrics and SM were excluded including grey literature. In the eligibility phase, articles related to non-pharmacological treatments/substances, surveys, recruitment protocols, sociological studies, professional use of SM and technological implementation were excluded. Articles including information about commonly used drugs in paediatrics were evaluated.Demographic variables, SM platforms, medicines and type of information (ADR, DRP or experiences and opinions (EO)) were analysed. Results 6079 articles were assessed and 28 (0,4%) met the inclusion criteria. 16 (57%) studies werequalitative, 6 (21%) quantitative and qualitative and quantitative 6 (21%). When mentioned, most articles analysed data from parents/caregivers (10;36%) and adolescents (2;7%). Gender of SM userwas not systematically reported but females were reported in 7 (25%) articles in a range in of 22-77%, in an article 245 females compared to 74 males and one referred that posts were mostly from mothers of young children. Most articles included data from forums (13;46%), Twitter (5;18%) and Facebook (6;21%). 17 (61%) reported information about vaccines, 3 (11%) asthma medications and 8 (28%) other medicines.8 articles (28%) reported an ADR including tremor, auto-injector wounds and vaccine ADR. Only in one article the severity was reported. EO were reported in 25 (89%) studies and 10 (36%) articles mentioned a DRP. Studies reported lack of adherence (4;14%), difficulties (3;11%) or doubts (2;7%) about drug administration of asthma inhalers (2;7%), epinephrine auto-injector (1;4%), antibiotics (1;4%), oral drugs (1;4%), ophthalmic drugs (1;4%) and topical drugs (1;4%). Conclusion and Relevance Articles evaluating pharmacological drugs in paediatrics focused mostly on EO and scarce data about ADR and DRP were mentioned in SM. Consequently, more studies are required to take advantage from SM as a potential tool in paediatric pharmacovigilance. References and/or Acknowledgements Conflict of Interest No conflict of interest
Background and Importance Social Media (SM) could be a source of unmet needs of parents about drug use in paediatrics. Knowing subjective information (SI) can lead to improve pharmaceutical care. Aim and Objectives Analyse content of posts from parent forums (PF). Material and Methods Observational, ambispective study on PF related to primary care medicines in paediatrics. PF were selected if included child-health sections in Catalan, Spanish or English and permission was obtained. Data mining software was developed using ontologies from Spanish Agency of Medicines and Medical Devices and Medical Dictionary for Regulatory Activities. Posts were excluded if written by professionals, referred to non-pharmacological treatments, adults, pregnancy, hospital drugs, non-original entries or duplicates. SI was classified into positive, negative or doubts according tone and adjectives expressed. Results 3572 posts from two PF were downloaded, 821 (26%) analysed. Excluded entries (94;11%): non-pharmacological treatments (42;5%), hospital drugs (12;1%), adults (12;1%), non-originalentries (9;1%), pregnancy (2;0,02%) or duplicates (2;0,02%).444 (72%) users mentioned SI in 591 posts (1,3 SI/post). Notifier were mainly parents(177;40%) and caregivers (233;52%). SI posts contained neutral (223;38%), doubts (259;44%), negative (63;10%), positive (47;8%) SI. Posts referred to 453 children, infants (28 days-23 months) (156;26%) and children (3-11 years) (107;18%) and not classified (190;56%).Reported drugs: antibiotics (214;36%), respiratory (99;17%) and nervous system (78;13%) medications, other (200, 34%). Routes: oral (330;56%), parenteral (123;21%), other (138, 23%).Topics reported were: Conclusion and Relevance Doubts, negative attitudes towards a future medicine and positive opinions about drugeffectiveness were the most SI expressed by PF users. Pharmacists can have a main roleproviding more information and knowledge to parents about drugs. References and/or Acknowledgements Conflict of Interest No conflict of interest
Background and Importance Improved survival of people living with HIV(PLWH) increases comorbidities burden leading to polypharmacy and drug-drug interactions(DDIs). DDIs suppose a higher concern in PLWH due to antiretroviral therapy(ART). Presence so risk factors(RF) for developing DDIs are of interest to detect cases needing for pharmaceutical assessment. Aim and Objectives Assess literature on the pharmacological RF for developing DDIs in PLWH. Material and Methods Following the PRISMA recommendations, a search combining terms associated with 'ART', 'DDIs' and 'RF' was conducted in MEDLINE database for relevant English- and Spanish-language articles from 2006 through January 2022. Longitudinal and cross-sectional studies were included. Articles not mentioning data on DDIs between ART and non-ART were excluded in a first screening phase. In a subsequent selection phase, articles were excluded if they did not contain information on RF for DDIs. The outcome of interest was the pharmacological RF for DDIs (or grouped by severity) between ART and non-ART in PLWH ≥18 years. Data was synthesised narratively. Results 349 articles were identified and 10 included (4 longitudinal and 6 cross-sectional). Kunimoto-et-al, found an association between the occurrence of potential DDIs and number of comedications(OR=1.52[1.16–1.99]), similar correlation was reported by Okoli-et-al(OR=1.3[1.2–1.3]), Pontelo-et-al(OR=1.13[1.11–1.15]) and Bastida-et-al(OR=1.18[1.14-1.22]). El Moussaoui-et-al found that the number of comedications independently associated with orange-(OR=1.8[1.6–2.0]) and red-flag(OR=1.4[1.3–1.6]) DDIs. Related to comedication, Kunimoto-et-al found polypharmacy as a severe RF for DDIs(OR=11.69[3.01–45.40]), this also reported by López-Centeno-et-al for red-(OR=2.65[1.98–3.54]) and orange-flag(OR=2.17[1.90–2.47]) DDIs. Halloran-et-al reported that ART-regimens containing protease inhibitors (PIs) were more likely to have DDIs compared with those containing non-nucleoside reverse transcriptase inhibitors(NNRTI)- and integrase inhibitors(II). This increased risk of IP-regimens was also notified by Chen-et-al(OR=2.54[1.25-5.16]) and Bastida-et-al(OR=1.18[1.14-1.22]), instead Fernández Cañabate-et-al found it in PI-regimens(OR=8.82[4.07–19.14]) as also NNRTI-regimens(OR=2.65[1.25–5.16]). Moreover, El Moussaoui-et-al found PIs as an independent RF for red-(OR=7.9[3.2-19.5]) and orange-flag(OR=7.5[4.5-12.5]) DDIs while NNRTI(OR=2.4[1.5-4.0]) and the II(OR=1.6[1.0-2.6]) only it were for orange-flag. This risk of PIs of were more involved in red-flag/contraindicated was also reported by López-Centeno-et-al and Holtzman-et-al. Conclusion and Relevance This is the first systematic review summarising literature in this field and is helpful to stratify patients at need for specialised management to reduce DDIs and polypharmacy burden. References and/or Acknowledgements Conflict of Interest No conflict of interest
Background and Importance Hospitalised patients with COVID-19 are often exposed to immunosuppressive and anti-inflammatory drugs in addition to systemic antibiotic treatments. Nosocomial bloodstream infections (nBSI) have been associated with the need for mechanical ventilation or venous catheter insertion. However, there is current controversy regarding the influence of immunosuppressive, anti-inflammatory and antimicrobial drugs on nBSI occurrence. Aim and Objectives Assess the association between glucocorticoids, tocilizumab, systemic antibiotics and nonpharmacologic health interventions and the occurrence of nBSI in hospitalised patients with COVID-19. Material and Methods Case–control study including cases of nBSI episodes in adult inpatients with SARS-CoV-2 pneumonia over a one-year period and controls without nBSI. Sociodemographic and clinical data were collected during hospitalisation. Bivariable analysis was performed. Numerical variables were compared using the Student's t-test or the Mann-Whitney test and categorical variables using the χ2 or Fisher's exact test. Variables with a p-value<0.1 in bivariable analysis were included in a multivariable logistic regression model to assess the factors independently associated with nBSI occurrence (p-value<0.05). Results 50 cases with COVID-19 and 50 controls were included. Mean age was 63.0 ± 12.4(66% men, 2.3 ± 2.1 mean Charlson index and comparable between groups). nBSI episodes showed significantly higher length of hospital stay(LOS) (OR 1.173, 95% CI: 1.144-1.257, p<0.001), surgeries (OR 10.80, 95% CI: 1.310-88.5, p=0.008), need for mechanical ventilation(OR 8.10, 95% CI: 3.31-19.8, p<0.001) antibiotic and glucocorticoids therapy days (OR 1.166, 95% CI: 1.112-1.122, p=0.017 and OR 3.20, 95% CI: 1.325-7.287, p=0.010, respectively), and tocilizumab use (OR 9.33, 95% CI: 1.115-77.125, p=0.017). Non-significant higher number of chronic renal failure cases were present among nBSI episodes (p=0.1). Multivariate regression analyses showed mechanical ventilation (aOR 4.892, 95% CI: 1.206-19.845, p=0.026) and LOS (aOR 1.231, 95% CI: 1.104-1.371, p<0.001) as independent risk factors for nBSI when corrected for the presence of surgeries, central venous catheter, tocilizumab, chronic renal failure and the days of antibiotic and glucocorticoid treatment. Conclusion and Relevance This study found nBSI independently associated with mechanical ventilation and LOS and did not find an association between nBSI and the pharmacological interventions assessed. However, given the bivariate association between these pharmacological interventions and nBSI, and previous inconclusive literature on the effects of these treatments on bacterial and fungal infections occurrence, further investigation with a larger sample is required.1 Reference Codina-Jiménez C., et al. Risk factors for nosocomial bloodstream infections in COVID-19 affected patients: protocol for a case-control study. Eur J Hosp Pharm.2022 Conflict of Interest No conflict of interest
Background and Importance Post-stroke oropharyngeal dysphagia (PS-OD) causes significant high costs during hospitalisation that increase with the development of malnutrition and respiratory infections at long-term. This data suggests that the appropriate management of PS-OD including the use of early detection programmes, texture-modified diets, commercially thickened fluids, domiciliary enteral nutrition, and rehabilitation programmes including restorative treatments could lead to cost-effective reduction of clinical complications.1 Aim and Objectives To assess literature on the efficiency and cost-effectiveness of available healthcare interventions on the management of PS-OD. Material and Methods Systematic review following PRISMA recommendations. MEDLINE, Embase, NHS-EED and CEA-Registry were searched up to 30 June 2021 to include studies on PS-OD. Outcomes of interest were the efficiency and the cost-effectiveness of healthcare interventions on the management of PS-OD. Economic evaluation studies were included. Oesophageal dysphagia and non-stroke studies were excluded. Results 235 studies were identified and 10 included. Svendsen-et-al found lower hospitalisation costs (HC) (USD12,556 CI95% 9,751-15,361) when PS-OD was assessed during the first 24 hours after admission. Liu-et-al did not find differences in HC when PS-OD was assessed with the water swallowing vs volume-viscosity swallowing test if the water test failed. Schwartz-et-al found a non-significant reduction on HC (Australian dollars18,053 vs 16,548, p=0.722) using a protocol to manage OD after thrombolysis. Wilson et-al showed video fluoroscopy as the most cost-effective screening method compared to bedside evaluation and a combination of both. Khiaocharoen et-al and Suksathien et-al showed cost-effective rehabilitation programmes that included OD management. Pelczarska et-al showed that the use of texture-modified diets using a gum-based thickener (Nutilis Clear®) was cost-effective (PLN21,387-20,977 per QALY), and Kotecki et-al that commercially thickened fluids use was more efficient than in situ preparation. Elia et-al showed domiciliary enteral nutrition cost-effective (£12,817 per QALY) and Beavan-et-al showed higher nutrient intake and low HC increase using looped-nasogastric tube (5,20 sterling for every 1% increase). Conclusion and Relevance Healthcare interventions to manage PS-OD with a positive clinical effect tend to be cost-effective. Future studies assessing the cost-effectiveness of applying compensatory and/or restorative strategies among with reporting cost-savings by appropriate PS-OD early evaluation and management are ne References Marin S, et al. Economic evaluations of health care interventions in oropharyngeal dysphagia after stroke: protocol for a systematic review. Syst Rev. 2022;11(1): 92. Conflict of Interest No conflict of interest
Background and Importance Increased life expectancy has supposed a higher presence of comorbidities leading to polypharmacy rising the prevalence of potentially inappropriate prescriptions (PIPs) and high-risk medication (HRM) burden. PIPs can be a cause of harm or no longer provide health benefits which is why pharmacists-led interventions aimed at detecting and reducing it have emerged during recent years. Aim and Objectives Assess the prevalence of PIPs, HRM and contraindicated medications in chronic complex patients (CCP) to whom pharmacist-led in-hospital reconciliation have been performed and to determine de HRM burden consequence of PIPs. Material and Methods Cross-sectional study on hospitalised CCP between March and April 2022. Pharmacist-led medication reconciliation, PIPs identification (using the List of Evidence-based deprescribing for chronic patients (LESS-CHRON) criteria) and contraindicated (using the Spanish datasheet) and HRM (using the High-Alert Medications in chronic patients Institute for Safe Medication Practices (ISMP) list) identification was performed. Demographic data together with Pfeiffer and Barthel index were collected from patients' medical records. Chi-square test was utilised to determine differences in the proportion of PIPs between HRM and non-HRM. Results 60 patients were included, (43.3% women, mean age was 76.8 ± 9.8 years). Pfeiffer index was 0-2 (normal cognitive level) in 35(58.3%) and Barthel index was 60-99 (low dependence level in 26(43.4%) of patients. Mean number of prescribed medications was 12.8 ± 4.7. At least one PIP was detected in 100% of patients (mean number of 4.7 ± 4.1 PIPs). In 11 patients (18.3%) the detected HMR also was PIPs. Mostly involved drugs were benzodiazepines (72.7% of cases), spironolactone (9.1%), vildagliptine (9.1%) and quetiapine (9.1%). In 13 cases (21.7%) HRM was also contraindicated (23% oral anticoagulants, 23% digoxine and 15% eplerenone). There were non-significant differences in the proportion of PIPs between HRM and non-HRM (3.9% vs 3%, p≥0.05). Conclusion and Relevance Considering these findings, a high prevalence of PIPs was found through pharmacist-led assessment in hospitalised CCP according to LESS-CHRON criteria. Moreover from HRM assessed by IRMP, a high number of PIPS and contraindicated medication were identified, of which benzodiazepines and anticoagulants were the most detected according to the literature and the results obtained. This fact highlights the need for pharmacists-led treatment-assessment and optimisation programs in this population. References and/or Acknowledgements Conflict of Interest No conflict of interest
Background and Importance Standard parenteral nutrition (PN) solutions should generally be used over individualised PN solutions in the majority of paediatric and newborn patients, including very-low-birth-weight premature infants,1 starting as soon as possible and within 8h at the latest.2 In 2021 our Paediatric and Pharmacy Departments designed a standard central PN (CPN) to have ready to use, in order to meet the nutritional needs of most newborn patients in their first day of life. Aim and Objectives Evaluate the use of the standard first day of life CPN and describe clinical data of patients and the time frame for its start. Material and Methods Observational, retrospective and longitudinal study conducted between March 2022 and September 2022 in a tertiary hospital. A database was designed to record all prepared CPN, their use and data of patients who received them. Results 55 CPN were prepared and 32 (58.2%) were administered. 31 newborn required PN and 100% received the standard first day of life CPN, 18 (58.1%) patients were female, the mean gestational age was 28.5 weeks, the mean weight was 1138.2g and 12 (38.7%) were multiple pregnancies. The indication of PN was: 23 (74.2%) preterm infants born <32.0 weeks with birth weight <1500g, 4 (12.9%) preterm babies born >32.0 weeks with <1500g and 4 (12.9%) patients born <32.0 weeks with birth weight >1500g. The mean time to start CPN was 6:01h (range 1:13-22:54h), 26 (83.9%) babies initiated within 8h at the latest and 5 (16.1%) patients after 8h of life (3 due to a lack of central line, 1 lack of 2 ready to use CPN for twins and 1 delayed prescription). 30 patients (96.8%) started trophic feeding with breast milk (maternal or bank) within the first 24h of life. Conclusion and Relevance Standard first day of life CPN ready to use has considerably reduced the time to start PN in newborn patients. However, CPN was initiated after 8h of life in 5 patients (mostly due to a lack of central line). Standard first day of life CPN met the nutritional requirements of all newborn requiring PN, not needing to produce individually tailored CPN in any case. References and/or Acknowledgements 1. 2018 ESPGHAN/ESPEN/ESPR/CSPEN guidelines 2. Neonatal parenteral nutrition. NICE guideline 2020 Conflict of Interest No conflict of interest
Background and Importance The clinical manifestations of inflammatory bowel disease (IBD) compromise patient9s daily life. In this regard, the use of Patient Reported Outcome Measures (PROMs) to determine health status, quality of life and treatment effectiveness from the patient's perspective can add significant value in clinical practice. Aim and Objectives Assess disease impact in patients affected with IBDs using PROMs. Material and Methods Cross-sectional study including outpatients treated with biological agents for ulcerative colitis (UC) and Crohn9s disease (CD) ≥18 years. Socio-demographic and clinical characteristics were collected from clinical records: age, gender, type of IBD, diagnosis year, biological treatment, starting date of biological treatment, previous biological treatment, concomitant immunosuppressive treatment, previous surgeries due to IBD and smoking habits. We used 2 questionnaires to evaluate PROMs: IBD-Control (IBD-Control-8 sub-score plus visual analog scale (VAS), that range from 0-16 and 0-100, respectively, higher scores representing better disease control) and IBD-Disk (that ranges from 0-100, higher score representing higher IBD daily-life burden). Results 42 patients with CD and 21 with UC were included (mean age 44.25 ± 14.67, 54% men). 44 patients were treated with infliximab (69.84%), 9 with ustekinumab (14.29%), 7 with vedolizumab (11.11%), 2 with golimumab (3.17%) and 1 with adalimumab (1.59%). 22 (34.92%) were previously treated with biological agents. 4 were diagnosed during the last 18 months while others were diagnosed before. 44 patients (69.84%) took oral immunosuppressant. 60 were treated >6 months with their current biological agent, the other 3 cases for 3-5 months. Mean IBD-Control-8 score was 12.41 ± 3.87. Mean VAS score was 87.19 ± 18.17. Mean IBD-Disk score was 33.22 ± 25.95 (69.84% of patients being below 50 points). 4 out of 63 cases had worse overall measurements (IBD-Control-8 score ≤7, VAS score ≤60 and IBD-Disk score ≥63). 3 were women with CD and smoking habits (2 current smokers and 1 ex-smoker). 3 of them were treated with infliximab and 1 with vedolizumab (3 requiring concomitant immunosuppressants). 2 required previous surgery. Conclusion and Relevance This study adds novel literature on health status of these patients using PROMs. Measurements were generally favorable but 4 patients out of 63 had worse overall measurements. Literature on this topic is scarce. PROMs are useful tools that could be incorporated in pharmaceutical practice. References and/or Acknowledgements Conflict of Interest No conflict of interest
Background and importance A large number of patients with systemic autoimmune diseases (SAD) do not respond or relapse to firstline therapies. Current guidelines recommend the off-label use of rituximab for many severe refractory SAD even though most of the available data rely on observational studies and case reports Aim and objectives The aim of this study was to analyse the efficacy and safety of the off-label use of rituximab for patients with severe refractory SAD in a tertiary hospital Material and methods Off-label use of rituximab between January 2016 and December 2018 was reviewed. Clinical data were collected retrospectively. Therapeutic response was evaluated after 12 months of rituximab initiation based on clinical judgement: complete response was defined as no disease activity, partial response as a significant improvement (>50% of initial disease activity) and no response if there was no improvement or worsening of symptoms Results A total of 52 applications were analysed. There were 28 men (54%) and 24 women (46%) with a mean age of 54.41 years (SD 15.31). The indications for rituximab included systemic lupus erythematosus (SLE) (17.3%), glomerulonephritis (15.4%), inflammatory myopathy (9.6%), cryoglobulinaemia (7.7%), polyneuropathy (7.7%) and other SAD. As for previous therapies, 42 patients (82.4%) received corticosteroids and 37 (71.2%) received at least one immunosuppressive drug. From all patients with an assessable treatment (n=47), 70.2% achieved an improvement in disease after 12 months: 34% (n=16) a complete response and 36% (n=17) a partial response. The most favourable results were found in the treatment of SLE, glomerulonephritis, cryoglobulinaemia, multiple sclerosis and optic neuromyelitis in which >80% of patients obtained a complete or partial response. Adverse events were reported in 22 patients (42.3%): the most frequent were infections (n=7) followed by infusion related reactions (n=3). No serious or death related adverse events were reported Conclusion and relevance Rituximab had acceptable tolerance and reduced disease activity in some severe refractory SAD. Future controlled trials are needed to confirm the potential use of rituximab in patients with SAD. In the meantime, it is necessary to closely follow-up these patients. References and/or acknowledgements 1. Ramos-Casals M, et al. Off-label use of rituximab in 196 patients with severe, refractory systemic autoimmune diseases. Clin Exp Rheumatol 2010;28:468–476. No conflict of interest.