The Development and Implementation of Airflow Visualization Studies ("Smoke" Studies) as a Training Tool in Aseptic Hospital Compounding Facilities

In the compounding facilities of hospital pharmacies, extemporaneous preparations for parenteral administration are produced using aseptic handling. The designated environment for this practice is a clean area, such as a laminar airflow (LAF) cabinet placed in a classified cleanroom complying with good manufacturing practices (GMP) and International Organization for Standardization (ISO) 14644-1 guidelines. The European GMP Annex 1 (Revision 2020) and United States Pharmacopeia (USP) &amp;lt;797&amp;gt; monograph state that airflow visualization studies ("smoke" studies) should be performed to substantiate the cleanroom and LAF cabinet performance and their qualification status. Even though smoke studies are required by these guidelines, current literature does not describe detailed practical protocols and acceptance criteria. The objective of this study was to develop and implement a practical smoke study protocol to ensure compliance with aseptic handling guidelines in hospital pharmacies. First, a literature search was performed to collect information about smoke study protocols and acceptance criteria. Subsequently, a smoke study protocol was developed for a downflow and crossflow LAF cabinet as well as for grade C/B cleanroom areas. As a proof of concept, the smoke study protocol for the downflow LAF cabinet was executed in the at-rest and in-operation states. Video recordings of the smoke studies were analyzed to assess the performance of the cabinet. Finally, the video recordings obtained from the smoke studies were used in a training program for hospital pharmacy operators, which showed that smoke studies might aid in operators' aseptic handling awareness. To the best of our knowledge, the present study provides for the first time a practical approach for the development of smoke study protocols in a hospital pharmacy setting and shows potential for training operators, process optimization, and continuous quality improvement.</p

The Development and Implementation of Airflow Visualization Studies ("Smoke" Studies) as a Training Tool in Aseptic Hospital Compounding Facilities

In the compounding facilities of hospital pharmacies, extemporaneous preparations for parenteral administration are produced using aseptic handling. The designated environment for this practice is a clean area, such as a laminar airflow (LAF) cabinet placed in a classified cleanroom complying with good manufacturing practices (GMP) and International Organization for Standardization (ISO) 14644-1 guidelines. The European GMP Annex 1 (Revision 2020) and United States Pharmacopeia (USP) monograph state that airflow visualization studies (“smoke” studies) should be performed to substantiate the cleanroom and LAF cabinet performance and their qualification status. Even though smoke studies are required by these guidelines, current literature does not describe detailed practical protocols and acceptance criteria. The objective of this study was to develop and implement a practical smoke study protocol to ensure compliance with aseptic handling guidelines in hospital pharmacies. First, a literature search was performed to collect information about smoke study protocols and acceptance criteria. Subsequently, a smoke study protocol was developed for a downflow and crossflow LAF cabinet as well as for grade C/B cleanroom areas. As a proof of concept, the smoke study protocol for the downflow LAF cabinet was executed in the at-rest and in-operation states. Video recordings of the smoke studies were analyzed to assess the performance of the cabinet. Finally, the video recordings obtained from the smoke studies were used in a training program for hospital pharmacy operators, which showed that smoke studies might aid in operators’ aseptic handling awareness. To the best of our knowledge, the present study provides for the first time a practical approach for the development of smoke study protocols in a hospital pharmacy setting and shows potential for training operators, process optimization, and continuous quality improvement

Active involvement of the end-user when developing web-based mental health interventions.

BACKGROUND: Although many web-based mental health interventions are being released, the actual uptake by end users is limited. The marginal level of engagement of end users when developing these interventions is recognized as an important cause for uptake problems. In this paper, we offer our perceptive on how to improve user engagement. By doing so, we aim to stimulate a discourse on user involvement within the field of online mental health interventions. METHODS: We shortly describe three different methods (the expert-driven method, intervention mapping, and scrum) that were currently used to develop web-based health interventions. We will focus to what extent the end user was involved in the developmental phase, and what the additional challenges were. In the final paragraph, lessons learned are summarized, and recommendations provided. RESULTS: Every method seems to have its trade-off: if end users are highly involved, availability of end users and means become problematic. If end users are less actively involved, the product may be less appropriate for the end user. Other challenges to consider are the funding of the more active role of technological companies, and the time it takes to process the results of shorter development cycles. CONCLUSION: Thinking about user-centered design and carefully planning, the involvement of end users should become standard in the field of web-based (mental) health. When deciding on the level of user involvement, one should balance the need for input from users with the availability of resources such as time and funding

Assessment of the use of partitioning and interfacial tracers to determine the content and mass removal rates of nonaqueous phase liquids

It was assessed whether partitioning and interfacial tracers can be used to determine the content and mass removal rate of nonaqueous phase liquid (NAPL) in porous media. Retardation factors for these tracers were determined for five different model matrices contaminated with hexadecane as NAPL. The retardation of the partitioning tracer 2,4-dimethyl-3-pentanol was correlated with the degree of NAPL saturation for four of the five matrices (r(2) = 0.93, n = 8), The observed retardation factors matched the retardation factors predicted with the independently determined hexadecane-water partitioning constant and the degree of NAPL saturation, indicating that this tracer may be used to estimate the degree of NAPL saturation of porous media. The mass removal rates of NAPL from columns packed with different matrices were determined by measuring the amount of hexadecane in the column effluent during elution with electrolyte solution. These removal rates differed over 3 orders of magnitude, dependent on the matrix used. The retardation of the interfacial tracer alkylbenzenesulfonate was higher for matrices with higher NAPL mass removal rates but was not correlated to the degree of NAPL saturation. This indicates that the retardation factors of alkylbenzenesulfonates in NAPL-contaminated media contain information related to the NAPL mass removal rates

Isotopic analysis of Solenopsis geminata diets in invaded Indonesian savanna.

OBJECTIVE: To examine the extent to which smokers express negative statements about quitting and the extent to which these statements influence general practitioners' (GPs') and practice nurses' (PNs') (dis)continuation of guideline-recommended smoking cessation care. METHODS: Fifty-two video-consultations were observed (GP-consultations: 2007-2008; PN-consultations: 2010-2011). Dialogues were transcribed verbatim and professionals' and patients' speech units were coded and analysed using sequential analyses (n=1424 speech units). RESULTS: GPs focused on asking about smoking (GPs: 42.4% versus PNs: 26.2%, p=0.011) and advising them to quit (GPs: 15.3% versus PNs: 3.5%, p<0.001), whereas PNs focused on assisting them with quitting (GPs: 25.4% versus PNs: 55.2%, p<0.001). Overall, patients expressed more negative statements about quitting than positive statements (negative: 25.3% versus positive: 11.9%, p<0.001), especially when PNs assessed their willingness to quit (OR 3.61, 95% CI 1.44-9.01) or assisted them with quitting (OR 2.23, 95% CI 1.43-3.48). PRACTICE IMPLICATIONS: An alternative approach to smoking cessation care is proposed in which GPs' tasks are limited to asking, advising, and arranging follow-up. This approach seems the least likely to evoke negative statements of patients about quitting during dialogues with GPs and is compatible with the tasks and skills of PNs who could, subsequently, assist smokers with quitting

Patient organisations and the reimbursement process for medicines: an exploratory study in eight European countries

<p>Abstract</p> <p>Background</p> <p>Little is known about the role European patient organisations play in the process of deciding on reimbursement for medicines. Therefore we <it>explore </it>the current role of patient organisations in the process of reimbursement for medicines in Western Europe. We focus in particular on collaboration between patient organisations and the pharmaceutical industry in this respect.</p> <p>Methods</p> <p>Sixty-eight patient organisations representing seven medical conditions, from ten Western European countries, were asked to participate in the study. The participating organisations reported their experiences in a web-based questionnaire.</p> <p>Results</p> <p>Twenty-one patient organisations completed the questionnaire (response rate: 31%), of which ten (47.6%) demanded reimbursement for medicines. Organisations demanding reimbursement were larger than those not demanding reimbursement. The main aim of these organisations was to create better accessibility of medicines for patients. Most organisations limited themselves to single actions. Only two engaged in multiple actions. Almost all organisations had general policies on cooperation with the pharmaceutical industry, with autonomy as the key feature. The patient organisations said they were reasonably successful and almost always satisfied with their own role in the reimbursement process.</p> <p>Conclusion</p> <p>Our study has found that the role of European patient organisations in the reimbursement process still seems limited, especially for small patient organisations.</p

Peroperative administration of tranexamic acid in sleeve gastrectomy to reduce hemorrhage:a double-blind randomized controlled trial

Introduction: In metabolic surgery, hemorrhage is the most common major complication. This study investigated whether peroperative administration of tranexamic acid (TXA) reduced the risk of hemorrhage in patients undergoing laparoscopic sleeve gastrectomy (SG). Methods: In this double-blind randomized controlled trial, patients undergoing primary SG in a high-volume bariatric hospital were randomized (1:1) to receive 1500-mg TXA or placebo peroperatively. Primary outcome measure was peroperative staple line reinforcement using hemostatic clips. Secondary outcome measures were peroperative fibrin sealant use and blood loss, postoperative hemoglobin, heart rate, pain, major and minor complications, length of hospital stay (LOS), side effects of TXA (i.e., venous thrombotic event (VTE)) and mortality. Results:In total, 101 patients were analyzed and received TXA (n = 49) or placebo (n = 52). There was no statistically significant difference in hemostatic clip devices used in both groups (69% versus 83%, p = 0.161). TXA administration showed significant positive changes in hemoglobin levels (millimoles per Liter; 0.55 versus 0.80, p = 0.013), in heart rate (beats per minute; -4.6 versus 2.5; p = 0.013), in minor complications (Clavien–Dindo ≤ 2, 2.0% versus 17.3%, p = 0.016), and in mean LOS (hours; 30.8 versus 36.7, p = 0.013). One patient in the placebo-group underwent radiological intervention for postoperative hemorrhage. No VTE or mortality was reported. Conclusion: This study did not demonstrate a statistically significant difference in use of hemostatic clip devices and major complications after peroperative administration of TXA. However, TXA seems to have positive effects on clinical parameters, minor complications, and LOS in patients undergoing SG, without increasing the risk of VTE. Larger studies are needed to investigate the effect of TXA on postoperative major complications. Graphical abstract: [Figure not available: see fulltext.]</p