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- Chimeric antigen receptor T-cell (CART) therapy in non-Hodgkins lymphoma:
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Messori, A; Bartoli, L, Mengato, D, Chiumente, M. PubDate: 2022-04-22T01:03:26-07:00 DOI: 10.1136/ejhpharm-2020-002609 Issue No: Vol. 29, No. 3 (2022)
- Web searches for anxiolytic drugs during the COVID-19 outbreak in the USA
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Lippi, G; Henry, B. M, Sanchis-Gomar, F. Keywords: COVID-19 PubDate: 2022-04-22T01:03:26-07:00 DOI: 10.1136/ejhpharm-2020-002671 Issue No: Vol. 29, No. 3 (2022)
- SARS-COV-2 pandemic: establishing three risk levels for 19 Italian regions
and two autonomous provinces-
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Messori, A; Angileri, M, Chiumente, M, Agnoletto, L, Baldo, P, Bartoli, L, Cirino, M, Damuzzo, V, Ferracane, E, Giron, M. C, Laudisio, C, Mengato, D, Palozzo, A. C, Trippoli, S. Keywords: COVID-19 PubDate: 2022-04-22T01:03:26-07:00 DOI: 10.1136/ejhpharm-2021-002692 Issue No: Vol. 29, No. 3 (2022)
- Antibiotic lock therapy in paediatric patients: primum non nocere.
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Baez-Gutierrez, N; Rodriguez-Ramallo, H, Alvarez Del Vayo, C. PubDate: 2022-04-22T01:03:26-07:00 DOI: 10.1136/ejhpharm-2021-002696 Issue No: Vol. 29, No. 3 (2022)
- Medicine packaging pictograms in the context of the electronic product
information (ePI) proposal-
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Getova, V; Getov, I. Pages: 121 - 122 PubDate: 2022-04-22T01:03:26-07:00 DOI: 10.1136/ejhpharm-2021-002960 Issue No: Vol. 29, No. 3 (2022)
- Use of dornase alfa in the paediatric intensive care unit: current
literature and a national cross-sectional survey-
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den Hollander, B; Linssen, R. S. N, Cortjens, B, van Etten-Jamaludin, F. S, van Woensel, J. B. M, Bem, R. A, On behalf of the Dutch Collaborative PICU Research Network Pages: 123 - 128 Abstract: ObjectivesAirway mucus obstruction is a major challenge in children admitted to the paediatric intensive care unit (PICU). We aimed to evaluate the evidence and contemporary use of the mucolytic medication dornase alfa for non-cystic fibrosis conditions in the PICU.Methods(1) We performed a systematic review with searches in PubMed, EMBASE, and the Cochrane Library. Study selection: for quality assessment and data synthesis, we included only randomised controlled trials (RCTs) that compared dornase alfa to standard care or placebo in critically-ill paediatric patients ( Keywords: EAHP Statement 1: Introductory Statements and Governance PubDate: 2022-04-22T01:03:26-07:00 DOI: 10.1136/ejhpharm-2020-002507 Issue No: Vol. 29, No. 3 (2022)
- Therapeutic efficacy of tacrolimus in vernal keratoconjunctivitis: a
meta-analysis of randomised controlled trials-
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Zhao, M; He, F, Yang, Y, Lin, W, Qiu, W, Meng, Q, Zhang, J, Zhou, Z. Pages: 129 - 133 Abstract: Background and objectiveTacrolimus has been widely used in recent years for treating allergic conjunctivitis, but there is currently no available meta-analysis regarding its therapeutic efficacy. This study systematically evaluated the effectiveness of tacrolimus in the treatment of allergic conjunctivitis.MethodsData obtained from literature searches of the PubMed, Cochrane Library, Embase, CNKI, and Wanfang databases were retrieved by combining medical subject words and free words. Literature was selected on the basis of established inclusion and exclusion criteria, and the extracted data were evaluated for risk of bias using RevMan 5.3 for meta-analysis.ResultsA total of 177 articles were retrieved, of which 5 articles were eventually selected, all of which involved tacrolimus treatment for vernal keratoconjunctivitis. A total of 203 samples were analysed. Results of the meta-analysis showed that the tacrolimus treatment group had significantly lower ocular objective sign scores (SMD –1.39, 95% CI –2.50 to –0.27; p Keywords: EAHP Statement 4: Clinical Pharmacy Services PubDate: 2022-04-22T01:03:26-07:00 DOI: 10.1136/ejhpharm-2020-002447 Issue No: Vol. 29, No. 3 (2022)
- Omega-3 for the prevention of cardiovascular diseases: meta-analysis and
trial-sequential analysis-
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Cabiddu, M. F; Russi, A, Appolloni, L, Mengato, D, Chiumente, M. Pages: 134 - 138 Abstract: ObjectivesThe effectiveness of omega-3 fatty acids (PUFAs) in cardiovascular diseases (CVD) remains a matter of debate. The aim of this work was to evaluate PUFAs in the reduction of cardiovascular mortality in primary and secondary prevention of CVD to determine if further original studies are needed or the available data can be considered conclusive.MethodsA meta-analysis was performed according to a dichotomous endpoint followed by a trial-sequential analysis (TSA). Clinical data were identified through a PubMed search based on the following keywords: omega-3 fatty acids; cardiovascular disease; death; and cardiovascular risk. The clinical trials identified by this procedure were subjected to standard meta-analysis and TSA.Results and conclusionsA total of 11 randomised studies for 100 609 patients were analysed. Our meta-analysis showed a statistically significant reduction in mortality due to cardiovascular issues (RR=0.937; 95% CI: 0.88 to 0.98; P=0.018). The TSA indicated that no further trials are needed to better evaluate the efficacy of PUFAs in preventing death related to CVD. Keywords: EAHP Statement 4: Clinical Pharmacy Services, EAHP Statement 6: Education and Research PubDate: 2022-04-22T01:03:26-07:00 DOI: 10.1136/ejhpharm-2020-002207 Issue No: Vol. 29, No. 3 (2022)
- Cost-effectiveness analysis of pembrolizumab plus standard chemotherapy
versus chemotherapy alone for first-line treatment of metastatic non-squamous non-small-cell lung cancer in China-
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Jiang, Y; Wang, X. Pages: 139 - 144 Abstract: ObjectiveTo determine whether the first-line treatment using pembrolizumab plus standard chemotherapy of platinum and pemetrexed for patients with metastatic, non-squamous, non–small-cell lung cancer (NSCLC) is cost-effective in China.MethodsWe applied partitional survival analysis to assess the cost-effectiveness of pembrolizumab plus the cytotoxic chemotherapy (cisplatin/carboplatin and pemetrexed) in metastatic NSCLC in China. We took into account direct medical costs according to the data derived from the KEYNOTE-189 trial and literature. Incremental cost-effectiveness ratio (ICER) was assessed as per life-year (LY) and per quality-adjusted life-year (QALY), with 3% per year discounted rate of costs and outcomes. In the performance of sensitivity analysis, cost of disease-management, utility-PFS (progression-free survival), utility-PD (progressive disease) and the discount were considered as variables. In scenario analysis, a philanthropic support programme in China was considered. The threshold was set to be $28 106/QALY (corresponding to three times the GDP in China).ResultsTreatment with pembrolizumab plus platinum and pemetrexed chemotherapy was estimated to increase cost by $139 168 compared with $73 081 (the cost of treatment with chemotherapy alone), leading to ICER of $80 444/LY and $96 644/QALY. Incremental costs/QALY are $90 419, $91 399 and $109 229 for programmed death ligand-1 TPS (tumour proportion scores) ≥50%, 1%–49% and Keywords: EAHP Statement 4: Clinical Pharmacy Services PubDate: 2022-04-22T01:03:26-07:00 DOI: 10.1136/ejhpharm-2020-002208 Issue No: Vol. 29, No. 3 (2022)
- Discontinuation of cholinesterase inhibitor treatment in institutionalised
patients with advanced dementia-
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Garcia-Garcia, R; Calleja-Hernandez, M. A. Pages: 145 - 150 Abstract: ObjectiveTo evaluate the impact of discontinuation of treatment with cholinesterase inhibitors (ChEIs) on cognitive, behavioural and functional outcomes in patients with severe dementia.MethodsA prospective observational study in which the prescribing physician decides, depending on multidisciplinary assessment and following the recommendations of the clinical practice guidelines, whether to withdraw or continue ChEI treatment in institutionalised patients, with a follow-up of 3 months. Cognitive abilities were measured using the Mini-Mental State Examination (MMSE) and Reisberg’s Global Deterioration Scale (GDS). Other measures were the behavioural and psychological symptoms of dementia (BPSD) according to the Neuropsychiatric Inventory (NPI), the activities of daily living using the Barthel index, the pharmacological and the non-pharmacological measures to treat the BPSD.ResultsChEI treatment was discontinued in 23 of 43 patients. After 3 months there were no differences in MMSE (p=0.441), GDS (p=0.976), NPI (p=0.882) or Barthel index (p=0.080) scores, or the establishing of new pharmacological measures (p=0.919) or non-pharmacological measures (p=0.832).ConclusionsChEI discontinuation in advanced stage dementia was not related to clinical deterioration in terms of cognitive function, BPSD, or functional status. Discontinuing ChEI treatment according to a multidisciplinary assessment and the recommendation of the guidelines appears to be a possible way of optimising pharmacotherapy without altering the main clinical evaluation scales. Keywords: EAHP Statement 4: Clinical Pharmacy Services PubDate: 2022-04-22T01:03:26-07:00 DOI: 10.1136/ejhpharm-2019-002106 Issue No: Vol. 29, No. 3 (2022)
- Reducing the risk of non-sterility of aseptic handling in hospital
pharmacies, part A: risk assessment-
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Boom, F. A; Ris, J. M, Veenbaas, T, Le Brun, P. P. H, Touw, D. Pages: 151 - 156 Abstract: ObjectivesTo determine prospectively the sources of risk of non-sterility during aseptic handling and to quantify the risks of each of these sources.MethodsA risk assessment (RA) of non-sterility according to Failure Mode and Effect Analysis was executed by a multidisciplinary team of (hospital) pharmacists and technicians, a consultant experienced in aseptic processing and an independent facilitator. The team determined the sources of risk of non-sterility, a 5 point scale for severity, occurrence and detection, and risk acceptance levels. Input about general applied risk reduction was collected by audits in 10 hospital pharmacies. The results of these audits were used for determining the remaining risks. The results, as well as scientific information and the experience of the team members, was used to determine scores for severity, occurrence and detection.ResultsMultiplying the scores for severity, occurrence and detection results in the risk prioritisation number (RPN) which is a relative value of the remaining risks of non-sterility for each source. Incorrect disinfection techniques of non-sterile materials and the chances of touching critical spots were estimated as the greatest risks. The risk of non-sterility via the airborne route was low. RPN values were helpful in prioritising measures for additional risk reduction (this will be described in an accompanying article).ConclusionThe RA, described here, was a systematic survey related to all sources of risk of non-sterility during aseptic handling. The determined RPN values were helpful in prioritising measures for additional risk reduction. Keywords: EAHP Statement 3: Production and Compounding PubDate: 2022-04-22T01:03:26-07:00 DOI: 10.1136/ejhpharm-2019-002178 Issue No: Vol. 29, No. 3 (2022)
- Determination of the cross-contamination and validation of the cleaning
process for an automated personalised dosing system-
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Ferro Uriguen, A; Beobide Telleria, I, Martinez Arrechea, S, Miro Isasi, B, Sampedro Yangüela, C, Urretavizcaya Anton, M. Pages: 157 - 163 Abstract: ObjectiveTo determine the degree of cross-contamination and to validate a cleaning process for an Automated Personalised Dosing System (APDS), respecting the permitted residue transfer limits.MethodAn analytical determination by high pressure liquid chromatography with mass spectrometry was performed for 11 drugs considered critical for their potential for contamination, toxicity (National Institute for Occupational Safety and Health (NIOSH) List 2016) and/or narrow therapeutic index. The test was carried out for three consecutive weeks, seven repetitions per week, in a state of maximum contamination and maximum cleanliness. The main validation criterion of the cleaning protocol was to quantify that the active ingredients measured were below the Permitted Daily Exposure index or fraction 1/1000 of the minimum daily dose, both in a state of maximum contamination and when the APDS is in a clean condition, for an average number of tablets consumed per person per day.ResultsIn all the samples analysed, some compound could always be quantified below 2% of the permitted transfer limits, highlighting the presence of paracetamol and carbamazepine. In the state of maximum contamination, the mean±SD values of paracetamol and carbamazepine were 5.83±1.56 µg and 0.22±0.07 µg, respectively, without significant differences in mean values over the 3 weeks of the study. After the cleaning protocol was executed, only paracetamol and carbamazepine were detected, with the average values being 4.67 µg (95% CI 3.92 to 5.43, p Keywords: EAHP Statement 5: Patient Safety and Quality Assurance PubDate: 2022-04-22T01:03:26-07:00 DOI: 10.1136/ejhpharm-2020-002301 Issue No: Vol. 29, No. 3 (2022)
- In-use stability of diluted thiamazole (methimazole) infusion solutions in
prefilled 0.9% sodium chloride infusion bags for continuous infusion-
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Mohr, A; Krämer, I. Pages: 164 - 168 Abstract: ObjectiveIn patients with severe hyperthyroidism unable to tolerate oral antithyroid therapy, diluted thiamazole infusion solutions (dose 120–240 mg) are administered by continuous infusion over 24 hours. Information about the type of diluent and compatibility/stability of the ready-to-administer thiamazole preparation is missing in the summary of product characteristics of the injection concentrate marketed in Germany. We studied the in-use stability of diluted infusion solutions over 24 hours.MethodsThiamazol 40 mg inject. Henning was diluted in prefilled polyolefin infusion bags containing 250 mL 0.9% sodium chloride (NaCl) infusion solution and kept for 24 hours at room temperature and diffuse room light. Content of the diluted infusion solutions (0.48 and 0.96 mg/mL) was analysed every 4 hours over the course of 24 hours by reversed-phase high-performance liquid chromatography. pH was measured after 0, 12 and 24 hours. The infusion bags were regularly inspected for visible particles. Subvisible particles were measured by particle counting.ResultsThiamazole infusion solutions of the nominal concentrations 0.48 and 0.96 mg/mL in 0.9% NaCl diluent, kept at room temperature under diffuse room light, are physicochemically stable over a period of at least 24 hours. No evidence of colour change, particle formation or pH change was observed throughout the observation period.ConclusionDilution of 120 or 240 mg doses of licensed thiamazole injection concentrate with 0.9% NaCl infusion solution in prefilled polyolefin containers is recommendable for continuous infusion over 24 hours in the treatment of thyrotoxicosis. Keywords: EAHP Statement 3: Production and Compounding, EAHP Statement 4: Clinical Pharmacy Services PubDate: 2022-04-22T01:03:26-07:00 DOI: 10.1136/ejhpharm-2020-002408 Issue No: Vol. 29, No. 3 (2022)
- Multiprofessional intervention to improve adherence to medication in
stroke patients: a study protocol for a randomised controlled trial (ADMED AVC study)-
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Khettar, S; Jacquin Courtois, S, Luaute, J, Decullier, E, Bin, S, Dupuis, M, Derex, L, Mechtouff, L, Nighoghossian, N, Dussart, C, Rode, G, Janoly-Dumenil, A. Pages: 169 - 175 Abstract: IntroductionAdherence to secondary preventive medications is often suboptimal in patients with stroke, exposing them to an increased risk of recurrent cerebral and/or cardiovascular events. Effective actions in the long term to improve adherence to medication are needed. The study will evaluate the efficacy of a collaborative multiprofessional patient-centred intervention conducted by a pharmacist on adherence to secondary preventive medication in stroke survivors.Methods and analysisThis is a multicentre cluster-randomised controlled trial. Two groups of 91 patients (intervention vs standard care) will be recruited. The clinical pharmacist intervention targeting secondary preventive medication will consist of three parts over 1 year: (1) an individual semi-structured interview at hospital discharge; (2) follow-up telephone interviews at 3, 6 and 9 months after discharge; and (3) a final individual semi-structured interview 1 year after discharge. Information on patient follow-up will be shared with the general practitioner and the community pharmacist by sending a report of each interview. The primary outcome is adherence to medication during the 12 months after hospital discharge, assessed using a composite endpoint: the medication possession ratio associated with a self-administered questionnaire.Ethics and disseminationThe local ethics committee, the national committee for use of personal data in medical research and the national data protection agency approved the study. The sponsor has no role in study design; collection, analysis and interpretation of data; or report writing.DiscussionThis pharmacist-led educational programme has the potential to significantly improve adherence to medication in stroke survivors which could lead to a decrease in recurrent cerebral and/or cardiovascular events.Trial registration number NCT02611440 Keywords: Open access, Editor''s choice PubDate: 2022-04-22T01:03:26-07:00 DOI: 10.1136/ejhpharm-2020-002425 Issue No: Vol. 29, No. 3 (2022)
- Role of EMA for crises strengthened
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Kohl; S. Pages: 176 - 177 PubDate: 2022-04-22T01:03:26-07:00 DOI: 10.1136/ejhpharm-2022-003341 Issue No: Vol. 29, No. 3 (2022)
- Results of EAHPs ePI survey released
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Kohl; S. Pages: 177 - 178 PubDate: 2022-04-22T01:03:26-07:00 DOI: 10.1136/ejhpharm-2022-003340 Issue No: Vol. 29, No. 3 (2022)
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