Introduction Chemotherapies are handled using Good Manufacturing Practices, which ensure asepsis and high-quality production. Continuous education is compulsory and usually includes theoretical and practical exercises. Objectives This work aimed to validate an innovative method of teaching good manufacturing practices based on an escape room mixing simulation and gaming. Method Pairs of learners were locked in a simulated clean room (Esclean Room) and had 1 hour to produce a chemotherapy and escape by finding solutions to 23 “Good Manufacturing Practices mysteries” linked to combination locks. To measure the experiment’s impact on teaching, questionnaires including the 23 mysteries (in different orders) were filled in before, just after and one month after escape from the Esclean Room. Pharmacy staff’ degrees of certainty were noted for each question. A satisfaction survey was completed. Results Seventy-two learners (29% senior pharmacists, 14% junior pharmacists, and 57% pharmacy technicians) escaped the Esclean Room and 56 answered every questionnaire. The educational intervention resulted in increases in correct answers and certainty. Correct answers rose from 57% in the first questionnaire to 80% in the third ( p < 0.001). Certainty scores rose from 50% before the experiment to 70% one month afterwards ( p < 0.001). Despite 68% of learners having never taken part in an escape room game before, 79% liked this educational method. Conclusion This study built and tested a pedagogical escape room involving a high risk, professional, pharmacy process. The use of this pharmacy technology simulation had a positive impact on pharmacy staff theoretical knowledge.
Purpose Assess whether full-scale simulation exercises improved hospital pharmacies’ disaster preparedness. Methods Swiss hospital pharmacies performed successive full-scale simulation exercises at least four months apart. An interprofessional team created two scenarios, each representing credible regional-scale disasters involving approximately fifty casualties (a major road accident and a terrorist attack). Four exercise assessors used appraisal forms to evaluate participants’ actions and responses during the simulation (rating them using five-point Likert scales). Results Four hospital pharmacies performed two full-scale simulation exercises each. Differences between exercises one and two were observed. On average, the four hospitals accomplished 69% ± 6% of the actions expected of them during exercise one. The mean rate of expected actions accomplished increased to 84% ± 7% (p < 0.005) during exercise two. Moreover, the average quality of actions improved from 3.0/5 to 3.6/5 (p = 0.01), and the time required to gather a crisis management team drastically decreased between simulations (from 23 to 5 min). The main challenges were communication (reformulation) and crisis management. Simulation exercise number one resulted in three hospital pharmacies creating disaster action plans and the fourth improving its already existing plan. Conclusion This study highlighted the value of carrying out full-scale disaster simulations for hospital pharmacies as they improved overall institutional preparedness and increased staff awareness. The number of expected actions accomplished increased significantly. In the future, large-scale studies and concept dissemination are warranted.
Background Delivering infusions in paediatric and neonatal intensive care units (PICU/NICU) is a high-risk process. In our institution, IV drugs are prepared on a weight-based equation (rule of 6), which standardises infusion rates by varying the concentration of the active ingredient. Transition to standardised concentrations (StdC) and smart pumps is advised in the USA to reduce risks of preparation errors. Purpose To conduct a European survey to assess current preparation and administration practices in PICU/NICU, as well as the level of implementation of StdC and smart pumps. Materials and methods An electronic standardised questionnaire (SurveyMonkey) was sent by email (May 2013, reminder at 6 weeks) to all members of the European Society of Paediatric and Neonatal Intensive Care (ESPNIC) and the Swiss associations of hospital pharmacists (GSASA), as well as to the country delegates of the European Association of Hospital Pharmacists (EAHP), with a request to forward the survey to everyone involved. Criteria:% of infusions prepared as StdC (StdC >80%, StdC 20–80%, StdC <20%), type of drugs prepared as StdC, use of smart pumps. Results 97 answers (physicians: 45.3%, hospital pharmacists: 37.9%, nurses: 16.8%) were recorded from 21 countries (mainly Germany (15%), England (11%), Netherlands (11%), Spain (10%)). 41.5% concerned PICU, 19.1% NICU and 39.4% PICU/NICU. 23/97 (23.7%) reported using StdC for > 80% of infusions prepared, 31/97 (32.0%) for 20–80% and 45/97 (46.4%) for <20%. The use of smart pumps was reported in 37/74 (50%) of the institutions. StdC >80% was mainly used in PICU (16/23), for drugs such as adrenergic agonists, analgesics, sedatives and insulin. StdC were based on concentrations routinely used in the institution in 16/21 (76.2%) of the cases and used since more than 5 years in 14/21 (66.7%). In StdC 20–80% responders, 20/26 (76.9%) thought that total implementation of StdC would reduce medication errors. In StdC <20% group, 23/34 (77.3%) with no experience in StdC thought that moving to StdC would reduce medication errors. Ten centres reported the failure of StdC implementation because of fluid balance problems, the need for too many concentrations to cover all patients’ needs and nurse resistance. Conclusions Standardised concentrations and smart pumps are in use in 25% and 50% of the answering European centres, respectively. StdC are used for high-risk medicines and are perceived as a safety strategy. Factors associated with implementation failure have been fluid balance, logistics and human factors and should be considered before moving to StdC. No conflict of interest.
research where there is exposure to background radiation and no therapeutic benefit to participants. Methods The ethical and regulatory issues encountered in the ERA-NET PRIOMEDCHILD project 'Paediatric Accelerator Mass Spectrometry Evaluation Research Study (PAMPER)' were analysed. These included the project design, scientific and ethical reviews, informed consent and recruitment processes. Infants 0-2 years were recruited in Estonia and the UK to study the pharmacokinetics (PK) of acetaminophen using accelerator mass spectrometry (AMS) bioanalysis. The study was considered in the context of the scientific, regulatory, and ethical frameworks guiding Phase 0 studies in adults and children. Results The science and ethics were developed in the protocol design and informed consent process, which resulted in approval of the study by research ethics committees in the UK and Estonia. Fifty-two babies were recruited into the study, with an acceptance rate of 50% among the parents approached. The study results demonstrated PK comparability between microdosing and therapeutic dosing in young children. Conclusions The PAMPER study showed the feasibility and validity of microdosing AMS PK studies in children, This methodology may provide a safer and more ethically robust approach for paediatric PK studies in certain drug models than more traditional PK study designs. The parameters and validation methods for microdosing AMS PK studies need to be reflected in regulatory guidance from the EMA, FDA and other authorities.Intensive Care I Background and aims The last decade gave clear evidence that hyper/hypoglycemia and glucose variability are associated with increased mortality in critically ill patients. Continuous glucose monitor (CGM) is a new device in paediatric critical care units (PICU) with clear advantages in glucose monitoring. The aim of our study was to survey the incidence of glucose regulation disorders in our PICU and specify the association between the PRISM III score and the glycemic variability [mean amplitude of glycemic action (MAGE)]. Methods We evaluated 22 children: mean age: 1.3 years, mean length of PICU stay: 18 days; 20/22 patients were on invasive mechanical ventilation; 6/22 needed vasoactive agent therapy. CGM duration: 1-12 days. Interstitial glucose level was monitored by Guardian ® REAL Time CGM (Medtronic ® ). Reference glucose values were obtained from blood gas analyzer or pointof-care glucose analyzer. We used Spearman correlation to evaluate the association between PRISM III and the MAGE. Results Hypo-and hyperglycemia (CGM glucose < 55 mg/dl / CGM glucose > 180 mg/dl) were detected in 4.6% and 2.5% of measurements, respectively. The mean MAGE (meaningful excursion >45 mg/dl) and PRISM III were 78 mg/dl and 19. We found a significant correlation between PRISM III and MAGE (r = 0,55; p < 0.05). Pearson's correlation coefficient (0.82) and Clarke Error Grid analysis (96% clinical accuracy) proved a good reliability of the CGM. PS-129Conclusions Glucose homeostasis disorders are frequent...
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