Abstract Objectives The objective of this study was to investigate the physicochemical stability of human insulin 1 I.U./mL injection solutions (Insuman® Rapid) diluted with 0.9% NaCl solution in 50 mL disposable three-piece polypropylene syringes and stored refrigerated or at room temperature. Methods 1 I.U./mL test solutions were prepared with Insuman® Rapid and 0.9% sodium chloride infusion solution in 50 mL Original-Perfusor® syringes and BD® Perfusion syringes. Test solutions were stored for 90 days at 2–8 °C/dark or 48 h at 20–25 °C/diffuse room light in order to determine chemical stability. Additional test solutions were stored 28 days at 2–8 °C/dark followed by 24 h at 20–25 °C/diffuse room light to measure pH and particle counts. Human insulin concentrations were analysed by reversed-phase high-performance liquid chromatography at predefined time points. Test solutions were regularly inspected; subvisible particles and pH values were measured. Results Insuman® Rapid 1 I.U./mL injection solutions, stored at 2–8 °C/dark for 90 days showed a decrease of insulin content over time, regardless of the syringe type used. When kept at 20–25 °C/diffuse room light for 48 h, a slight decrease of the HI concentration was observed in both syringe types. No evidence of colour change, relevant particle formation or major pH-change was observed throughout the observation period in any test solution. Conclusions Insuman® Rapid 1 I.U./mL injection solutions can be prepared by dilution with 0.9% NaCl infusion solution in disposable 50 mL three-piece polypropylene syringes as suitable primary containers. Physicochemical stability has been demonstrated for at least 21 days stored at 2–8 °C/dark followed by 48 h at 20–25 °C/diffuse room light.
摘要目的研究1 iu /mL人胰岛素注射液(Insuman®Rapid)经0.9% NaCl溶液稀释后，在50 mL一次性三片式聚丙烯注射器中冷藏或室温保存的理化稳定性。方法用Insuman®Rapid和0.9%氯化钠注射液配制1 iu /mL的试验溶液，分别在50 mL Original-Perfusor®注射器和BD®灌注注射器中注射。测试溶液在2-8°C/黑暗条件下保存90天，或在20-25°C/漫射室内光条件下保存48小时，以确定化学稳定性。额外的测试溶液在2-8°C/黑暗条件下保存28天，然后在20-25°C/漫射室内光下保存24小时，以测量pH和颗粒计数。采用反相高效液相色谱法在预定时间点分析人胰岛素浓度。定期检查测试溶液;测量不可见颗粒和pH值。结果Insuman®快速1 iu /mL注射溶液，在2-8°C/黑暗条件下保存90天，无论使用哪种注射器，胰岛素含量都随着时间的推移而下降。在20-25°C/漫射室内光下保存48 h后，两种注射器的HI浓度均略有下降。在整个观察期间，在任何测试溶液中都没有观察到颜色变化，相关颗粒形成或主要ph变化的证据。结论Insuman®快速1 iu /mL注射溶液以0.9%氯化钠注射液稀释制备，一次性50ml三片式聚丙烯注射器为主要容器。在2-8°C/黑暗条件下储存至少21天，然后在20-25°C/漫射室内光下储存48小时，其物理化学稳定性已被证明。
{"title":"Physicochemical stability of human insulin 1 I.U./mL infusion solution in 50 mL polypropylene syringes","authors":"André Mohr, F. Erdnüss, I. Krämer","doi":"10.1515/pthp-2021-0005","DOIUrl":"https://doi.org/10.1515/pthp-2021-0005","url":null,"abstract":"Abstract Objectives The objective of this study was to investigate the physicochemical stability of human insulin 1 I.U./mL injection solutions (Insuman® Rapid) diluted with 0.9% NaCl solution in 50 mL disposable three-piece polypropylene syringes and stored refrigerated or at room temperature. Methods 1 I.U./mL test solutions were prepared with Insuman® Rapid and 0.9% sodium chloride infusion solution in 50 mL Original-Perfusor® syringes and BD® Perfusion syringes. Test solutions were stored for 90 days at 2–8 °C/dark or 48 h at 20–25 °C/diffuse room light in order to determine chemical stability. Additional test solutions were stored 28 days at 2–8 °C/dark followed by 24 h at 20–25 °C/diffuse room light to measure pH and particle counts. Human insulin concentrations were analysed by reversed-phase high-performance liquid chromatography at predefined time points. Test solutions were regularly inspected; subvisible particles and pH values were measured. Results Insuman® Rapid 1 I.U./mL injection solutions, stored at 2–8 °C/dark for 90 days showed a decrease of insulin content over time, regardless of the syringe type used. When kept at 20–25 °C/diffuse room light for 48 h, a slight decrease of the HI concentration was observed in both syringe types. No evidence of colour change, relevant particle formation or major pH-change was observed throughout the observation period in any test solution. Conclusions Insuman® Rapid 1 I.U./mL injection solutions can be prepared by dilution with 0.9% NaCl infusion solution in disposable 50 mL three-piece polypropylene syringes as suitable primary containers. Physicochemical stability has been demonstrated for at least 21 days stored at 2–8 °C/dark followed by 48 h at 20–25 °C/diffuse room light.","PeriodicalId":19802,"journal":{"name":"Pharmaceutical Technology in Hospital Pharmacy","volume":"26 2","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72475974","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Thomas Carpentier, Eve Maillard, Mathilde Royer, Lina Mustapha, F. Marçon
Abstract Objectives Amongst paediatric pharmaceutical forms, syrups offer advantages such as ease of administration and good palatability. They also exhibited microbial self-preservation properties that may be useful to enhance shelf life of liquid formulation. The objective of our works is to test the self-preservation efficacy of maltitol and glucose syrup without or with sorbic acid as described in the European pharmacopoeia. Methods The European Pharmacopoeia test of antimicrobial preservation efficacy was performed on liquid glucose syrup and liquid maltitol syrup with and without 0.1% sorbic acid. Results Unpreserved glucose and maltitol syrups did not meet the European Pharmacopoeia acceptance criteria for antimicrobial preservative efficacy due to the regrowth of Aspergillus brasiliensis on day 28 whereas glucose and maltitol syrups with 0.1% sorbic acid pass the test. Conclusions The addition of a preservative (sorbic acid) in glucose and maltitol syrups allows the validation of the antimicrobial preservative efficacy test of the European Pharmacopoeia. Further tests are needed to see if preservative efficacy is maintained despite dilutions or in the presence of active pharmaceutical ingredients.
{"title":"Antimicrobial preservation efficacy of liquid glucose and liquid maltitol syrups with and without 0.1% sorbic acid","authors":"Thomas Carpentier, Eve Maillard, Mathilde Royer, Lina Mustapha, F. Marçon","doi":"10.1515/pthp-2021-0007","DOIUrl":"https://doi.org/10.1515/pthp-2021-0007","url":null,"abstract":"Abstract Objectives Amongst paediatric pharmaceutical forms, syrups offer advantages such as ease of administration and good palatability. They also exhibited microbial self-preservation properties that may be useful to enhance shelf life of liquid formulation. The objective of our works is to test the self-preservation efficacy of maltitol and glucose syrup without or with sorbic acid as described in the European pharmacopoeia. Methods The European Pharmacopoeia test of antimicrobial preservation efficacy was performed on liquid glucose syrup and liquid maltitol syrup with and without 0.1% sorbic acid. Results Unpreserved glucose and maltitol syrups did not meet the European Pharmacopoeia acceptance criteria for antimicrobial preservative efficacy due to the regrowth of Aspergillus brasiliensis on day 28 whereas glucose and maltitol syrups with 0.1% sorbic acid pass the test. Conclusions The addition of a preservative (sorbic acid) in glucose and maltitol syrups allows the validation of the antimicrobial preservative efficacy test of the European Pharmacopoeia. Further tests are needed to see if preservative efficacy is maintained despite dilutions or in the presence of active pharmaceutical ingredients.","PeriodicalId":19802,"journal":{"name":"Pharmaceutical Technology in Hospital Pharmacy","volume":"87 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84216820","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Omar S. Abu Abed, Srilikha Mulkala, Israa Sharif, Asma M. Abdin, A. Elkordy
Abstract Objectives Cinnarizine is used for the treatment of vestibular disorders. However, its poor solubility limits its clinical uses due to many challenges. Liposomes were utilised to improve the release profile of many poorly soluble drugs. However, liposomes face many stability challenges during the storage period. This study aims to develop proliposomes designed for the oral delivery of cinnarizine with enhanced stability characteristics. Methods Three cinnarizine entrapping Proliposomal formulations were prepared with different ingredients and compared with their liposomal counterparts. Both vesicular approaches were characterised for their particle size, encapsulation efficiency, drug release and stability. Results The proliposomes were superior to liposomes in their stability and release profiles. Although no significant changes were noticed between the encapsulation efficiency percentage of the liposomal and proliposomal formulations on the day of preparation, storing the formulations for two weeks ended up with significant leakage of the drug from liposomes (p < 0.05) due to stability issues, but not in proliposomes. Moreover, the proliposomes released 100% of cinnarizine throughout the dissolution experiment in gastric fluid in comparison with the total released drug of 70% from the liposomes. Conclusions Proliposomes provided a successful approach to deliver lipophilic drugs orally to improve their pharmacokinetic properties by converting their crystalline nature into more amorphous agents.
{"title":"Lyophilization-free proliposomes for sustained release oral delivery of hydrophobic drug (cinnarazine): a comparative study","authors":"Omar S. Abu Abed, Srilikha Mulkala, Israa Sharif, Asma M. Abdin, A. Elkordy","doi":"10.1515/pthp-2021-0002","DOIUrl":"https://doi.org/10.1515/pthp-2021-0002","url":null,"abstract":"Abstract Objectives Cinnarizine is used for the treatment of vestibular disorders. However, its poor solubility limits its clinical uses due to many challenges. Liposomes were utilised to improve the release profile of many poorly soluble drugs. However, liposomes face many stability challenges during the storage period. This study aims to develop proliposomes designed for the oral delivery of cinnarizine with enhanced stability characteristics. Methods Three cinnarizine entrapping Proliposomal formulations were prepared with different ingredients and compared with their liposomal counterparts. Both vesicular approaches were characterised for their particle size, encapsulation efficiency, drug release and stability. Results The proliposomes were superior to liposomes in their stability and release profiles. Although no significant changes were noticed between the encapsulation efficiency percentage of the liposomal and proliposomal formulations on the day of preparation, storing the formulations for two weeks ended up with significant leakage of the drug from liposomes (p < 0.05) due to stability issues, but not in proliposomes. Moreover, the proliposomes released 100% of cinnarizine throughout the dissolution experiment in gastric fluid in comparison with the total released drug of 70% from the liposomes. Conclusions Proliposomes provided a successful approach to deliver lipophilic drugs orally to improve their pharmacokinetic properties by converting their crystalline nature into more amorphous agents.","PeriodicalId":19802,"journal":{"name":"Pharmaceutical Technology in Hospital Pharmacy","volume":"6 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89958152","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Abstract Objectives The aim of this study was to review studies describing the use and the impact of technology-assisted workflow (TAWF) systems for drug compounding in hospital pharmacy. Content This is a scoping literature review. A search was conducted on studies describing or evaluating the use of TAWF published from January 1st, 2015 to July 31st, 2021. Two databases were searched (PubMed and Embase), followed by a search on Google Scholar. Summary 218 articles were screened and 17 were identified as meeting the inclusion criteria. TAWFs all included preparation assistance software (17/17), barcode reader (17/17), photo or video taking (17/17), and some included gravimetric systems (8/17), and the use of robots (2/17). A majority of the studies included used technology for parenteral preparations (15/17, one for oral preparations only (1/17), and one used technology for both types of preparations (1/17). Most of the articles selected presented drugs prepared for adults (10/17), the others presented drugs intended for children (4/17) or for a mix of adults and children (3/17). Four parameters were evaluated: error detection rate (n=15), preparation and validation time (n=7), and costs generated or saved (n=7). Ten studies evaluated the pre-post impact of implantation of a TAWF (10/17). Outlook Given the heterogeneity of the data available, the use of TAWF was associated with an increased ability to detect preparation errors, a reduction in preparation time and costs, and increased satisfaction of pharmacy technicians and pharmacists. However, better quality studies are needed to confirm the positive impacts studied.
{"title":"Use and impact of technology-assisted workflow (TAWF) systems for drug compounding in pharmacy practice: a scoping literature review","authors":"E. Farcy, D. Bui, D. Lebel, J. Bussières","doi":"10.1515/pthp-2021-0009","DOIUrl":"https://doi.org/10.1515/pthp-2021-0009","url":null,"abstract":"Abstract Objectives The aim of this study was to review studies describing the use and the impact of technology-assisted workflow (TAWF) systems for drug compounding in hospital pharmacy. Content This is a scoping literature review. A search was conducted on studies describing or evaluating the use of TAWF published from January 1st, 2015 to July 31st, 2021. Two databases were searched (PubMed and Embase), followed by a search on Google Scholar. Summary 218 articles were screened and 17 were identified as meeting the inclusion criteria. TAWFs all included preparation assistance software (17/17), barcode reader (17/17), photo or video taking (17/17), and some included gravimetric systems (8/17), and the use of robots (2/17). A majority of the studies included used technology for parenteral preparations (15/17, one for oral preparations only (1/17), and one used technology for both types of preparations (1/17). Most of the articles selected presented drugs prepared for adults (10/17), the others presented drugs intended for children (4/17) or for a mix of adults and children (3/17). Four parameters were evaluated: error detection rate (n=15), preparation and validation time (n=7), and costs generated or saved (n=7). Ten studies evaluated the pre-post impact of implantation of a TAWF (10/17). Outlook Given the heterogeneity of the data available, the use of TAWF was associated with an increased ability to detect preparation errors, a reduction in preparation time and costs, and increased satisfaction of pharmacy technicians and pharmacists. However, better quality studies are needed to confirm the positive impacts studied.","PeriodicalId":19802,"journal":{"name":"Pharmaceutical Technology in Hospital Pharmacy","volume":"54 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91009243","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
V. Lebreton, B. Bourcier, Karine Cosson, F. Lagarce, L. Spiesser-Robelet, S. Vrignaud
Abstract Objectives Hydroxychloroquine (HCQ) presents many drug properties that increase its therapeutic use. There are, indeed, different research pathways in numerous autoimmune, inflammatory, and infectious diseases, as well as in cancerology. HCQ is only marketed as HCQ sulfate in film-coated or coated tablets for oral use. No pediatric liquid form is currently available on the market. The purpose of the present study is to develop oral liquid formulations for HCQ at 50 mg/mL with two different oral vehicle suspensions, namely ORA-Plus®/ORA-Sweet® (ORA) and Syrspend® SF PH 4 (SYR). Methods The suspension stability was assessed in different storage conditions (4 and 25 °C). A high-pressure liquid chromatography (HPLC) stability-indicating method with UV detection was developed to determine HCQ concentrations in the different formulations, and detect potential degradation products. Physical parameters, e.g. pH and osmolality were also monitored during the period of the stability study. Results HCQ concentration, osmolality, and pH remained stable for 90 days at 4 and 30 °C for HCQ in 50% ORA-Plus®/50% ORA-Sweet®. For HCQ suspension in SYR, the suspension remained stable 90 days at 4 °C and 60 days at 30 °C. Conclusions For all preparations, no significant physical or chemical modification was noticed during the period of the study.
{"title":"New liquid oral formulations of hydroxychloroquine: a physicochemical stability study","authors":"V. Lebreton, B. Bourcier, Karine Cosson, F. Lagarce, L. Spiesser-Robelet, S. Vrignaud","doi":"10.1515/pthp-2020-0013","DOIUrl":"https://doi.org/10.1515/pthp-2020-0013","url":null,"abstract":"Abstract Objectives Hydroxychloroquine (HCQ) presents many drug properties that increase its therapeutic use. There are, indeed, different research pathways in numerous autoimmune, inflammatory, and infectious diseases, as well as in cancerology. HCQ is only marketed as HCQ sulfate in film-coated or coated tablets for oral use. No pediatric liquid form is currently available on the market. The purpose of the present study is to develop oral liquid formulations for HCQ at 50 mg/mL with two different oral vehicle suspensions, namely ORA-Plus®/ORA-Sweet® (ORA) and Syrspend® SF PH 4 (SYR). Methods The suspension stability was assessed in different storage conditions (4 and 25 °C). A high-pressure liquid chromatography (HPLC) stability-indicating method with UV detection was developed to determine HCQ concentrations in the different formulations, and detect potential degradation products. Physical parameters, e.g. pH and osmolality were also monitored during the period of the stability study. Results HCQ concentration, osmolality, and pH remained stable for 90 days at 4 and 30 °C for HCQ in 50% ORA-Plus®/50% ORA-Sweet®. For HCQ suspension in SYR, the suspension remained stable 90 days at 4 °C and 60 days at 30 °C. Conclusions For all preparations, no significant physical or chemical modification was noticed during the period of the study.","PeriodicalId":19802,"journal":{"name":"Pharmaceutical Technology in Hospital Pharmacy","volume":"58 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88252407","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Clémence Delafoy, Claire Chabut, C. Tanguay, J. Bussières
Abstract Objectives To evaluate the efficacy of two decontamination protocols on cyclophosphamide surface contamination and to explore its lasting effect 30 days later. Methods All sampling sites that were systematically contaminated with cyclophosphamide in 2017–2020 were included, from a convenience sample of centers. The first decontamination protocol consisted of four steps, each with 20 mL and a Wypall® wipe: detergent, sodium hypochlorite 2%, isopropyl alcohol 70% and water. The second decontamination protocol consisted of eight steps, each with 15 mL and a Micronsolo® microfibre wipe: detergent, sodium hypochlorite 2%, isopropyl alcohol 70%, water and then a second round with each of the four products. A first sampling was done at the end of a regular working day (T0), a second immediately following decontamination (T1) and a third 30 days later (T2) after regular operations. Cyclophosphamide was quantified by ultra-performance liquid chromatography – tandem mass spectrometry (limit of detection 0.001 ng/cm2). Results Seventeen sampling sites were included: six biological safety cabinet (BSC) front grilles, eight floors in front of BSCs and three cyclophosphamide storage shelves. The second protocol was more effective; however they both failed to completely remove all cyclophosphamide traces. BSCs and floors were found to be contaminated again 30 days later, at similar concentrations than at T0. A lasting effect was observed on the cyclophosphamide storage shelves that were less prone to be contaminated again. Conclusions Periodic decontamination with many cleaning steps is necessary on all surfaces, including those less frequently contaminated. Regular surface monitoring identifies systematically contaminated areas.
{"title":"Efficacy of two intensive decontamination protocols and their effects after 30 days on environmental contamination by cyclophosphamide","authors":"Clémence Delafoy, Claire Chabut, C. Tanguay, J. Bussières","doi":"10.1515/pthp-2021-0006","DOIUrl":"https://doi.org/10.1515/pthp-2021-0006","url":null,"abstract":"Abstract Objectives To evaluate the efficacy of two decontamination protocols on cyclophosphamide surface contamination and to explore its lasting effect 30 days later. Methods All sampling sites that were systematically contaminated with cyclophosphamide in 2017–2020 were included, from a convenience sample of centers. The first decontamination protocol consisted of four steps, each with 20 mL and a Wypall® wipe: detergent, sodium hypochlorite 2%, isopropyl alcohol 70% and water. The second decontamination protocol consisted of eight steps, each with 15 mL and a Micronsolo® microfibre wipe: detergent, sodium hypochlorite 2%, isopropyl alcohol 70%, water and then a second round with each of the four products. A first sampling was done at the end of a regular working day (T0), a second immediately following decontamination (T1) and a third 30 days later (T2) after regular operations. Cyclophosphamide was quantified by ultra-performance liquid chromatography – tandem mass spectrometry (limit of detection 0.001 ng/cm2). Results Seventeen sampling sites were included: six biological safety cabinet (BSC) front grilles, eight floors in front of BSCs and three cyclophosphamide storage shelves. The second protocol was more effective; however they both failed to completely remove all cyclophosphamide traces. BSCs and floors were found to be contaminated again 30 days later, at similar concentrations than at T0. A lasting effect was observed on the cyclophosphamide storage shelves that were less prone to be contaminated again. Conclusions Periodic decontamination with many cleaning steps is necessary on all surfaces, including those less frequently contaminated. Regular surface monitoring identifies systematically contaminated areas.","PeriodicalId":19802,"journal":{"name":"Pharmaceutical Technology in Hospital Pharmacy","volume":"77 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87049864","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Marie-Pauline Gagaille, Rémi Pieragostini, Elise Girault, Yacine Touil, Marie Chalopin, Michael Besse, N. Pons-Kerjean
Abstract Objectives Preparation of injectable anticancer drugs in hospital pharmacies, in particular of cytotoxics, is a high-risk activity. We used Preliminary Risk Analysis (PRA) to analyse the risks in the different steps of our anticancer drug circuit, including the preparation step (PRA1). Then, to prepare an important change in management of the circuit with the software Chimio® (pooling of three databases for subcontracting), we repeated the analysis of preparation step (PRA2). PRA is known to be time and resource consuming. To overcome this, we developed a strict organisational framework to perform the analysis within a reasonable amount of time. We present the PRA method including its practical implementation, and its application to the anticancer drug preparation process, before and after pooling of Chimio® databases. Methods PRA has two main stages, PRA “system” and PRA “scenario”. A multidisciplinary working group is created for the entire PRA process. PRA “system” is an exploratory and qualitative stage. PRA “scenario” requires the creation of risk assessment tools and decision tools before actually developing, analysing and treating scenarios, with risk reduction actions structured in an action plan. For PRA2 we used the same working group, assessment and decision tools as for PRA1 and we only analysed dangerous situations (DS) that appeared or changed towards more risk, requiring a new action plan. The different PRA only required four 2 h meetings thanks to the investment of a coordinator who is expert in the method. Results In PRA1, the riskiest phase was production while it was the verification and delivery of the finished product in PRA2. The risks were mainly related to management, human and technical dangers in PRA1. Human danger was found to be the main danger in PRA2, followed by organisational danger. Among the 264 scenarios described in PRA1, six of criticality 3 and 69 of criticality 2 have been associated with risk reduction actions. These actions mainly involved managing the risk of human error, with the control system Drugcam® and the standardisation of the pharmaceutical assistants’ training program. In PRA2, 11 scenarios were analysed, including three of criticality 3 and 4 of criticality 2 for which risk reduction measures were taken. Conclusions PRA allowed us to perform an in depth analysis of the highly specific and technical process of anticancer drug preparation. Human danger was one of the most important dangers identified, and it should always be taken into consideration, whatever the measures taken to prevent it. PRA2 was extremely useful to plan the organisation that would result from the new Chimio® database, while involving the team and winning its commitment. It allowed an exhaustive and structured anticipation of this major change. Practical aspects of PRA method implementation we have adopted facilitate its application and can help to deploy it on many areas in our hospitals. Indeed, besides an exhaust
{"title":"Risk management in an anticancer drug preparation unit: use of Preliminary Risk Analysis method and application to the preparation process","authors":"Marie-Pauline Gagaille, Rémi Pieragostini, Elise Girault, Yacine Touil, Marie Chalopin, Michael Besse, N. Pons-Kerjean","doi":"10.1515/pthp-2021-0001","DOIUrl":"https://doi.org/10.1515/pthp-2021-0001","url":null,"abstract":"Abstract Objectives Preparation of injectable anticancer drugs in hospital pharmacies, in particular of cytotoxics, is a high-risk activity. We used Preliminary Risk Analysis (PRA) to analyse the risks in the different steps of our anticancer drug circuit, including the preparation step (PRA1). Then, to prepare an important change in management of the circuit with the software Chimio® (pooling of three databases for subcontracting), we repeated the analysis of preparation step (PRA2). PRA is known to be time and resource consuming. To overcome this, we developed a strict organisational framework to perform the analysis within a reasonable amount of time. We present the PRA method including its practical implementation, and its application to the anticancer drug preparation process, before and after pooling of Chimio® databases. Methods PRA has two main stages, PRA “system” and PRA “scenario”. A multidisciplinary working group is created for the entire PRA process. PRA “system” is an exploratory and qualitative stage. PRA “scenario” requires the creation of risk assessment tools and decision tools before actually developing, analysing and treating scenarios, with risk reduction actions structured in an action plan. For PRA2 we used the same working group, assessment and decision tools as for PRA1 and we only analysed dangerous situations (DS) that appeared or changed towards more risk, requiring a new action plan. The different PRA only required four 2 h meetings thanks to the investment of a coordinator who is expert in the method. Results In PRA1, the riskiest phase was production while it was the verification and delivery of the finished product in PRA2. The risks were mainly related to management, human and technical dangers in PRA1. Human danger was found to be the main danger in PRA2, followed by organisational danger. Among the 264 scenarios described in PRA1, six of criticality 3 and 69 of criticality 2 have been associated with risk reduction actions. These actions mainly involved managing the risk of human error, with the control system Drugcam® and the standardisation of the pharmaceutical assistants’ training program. In PRA2, 11 scenarios were analysed, including three of criticality 3 and 4 of criticality 2 for which risk reduction measures were taken. Conclusions PRA allowed us to perform an in depth analysis of the highly specific and technical process of anticancer drug preparation. Human danger was one of the most important dangers identified, and it should always be taken into consideration, whatever the measures taken to prevent it. PRA2 was extremely useful to plan the organisation that would result from the new Chimio® database, while involving the team and winning its commitment. It allowed an exhaustive and structured anticipation of this major change. Practical aspects of PRA method implementation we have adopted facilitate its application and can help to deploy it on many areas in our hospitals. Indeed, besides an exhaust","PeriodicalId":19802,"journal":{"name":"Pharmaceutical Technology in Hospital Pharmacy","volume":"68 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83437647","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
A. Villain, I. Sakji, E. Bogart, G. Strobbe, G. Marliot, F. Feutry
Abstract Objectives Preparation of 5-FU elastomeric pumps is a time-consuming activity inducing musculoskeletal disorders (MSDs). Our unit has developed an automated filling system consisting of two peristaltic pumps (one for the diluent, one for the cytotoxic drug). The objective was to validate the accuracy of the assembly and evaluate the impact of automation on the compounding time, occurrence of MSDs and cost of preparation. Methods Accuracy was determined by calculating the total error on the volumes injected by the pumps. Measurements were made for 2 brands (AMF, Baxter), 3 different volumes; repeated 3 times at 3 times of the day. The time-saving study compared 24 measurements in manual filling and 24 in automated mode. Impact of automation on the occurrence of MSDs was evaluated by a self-assessment questionnaire. Finally, a comparison between the price of a manually prepared elastomeric pump and an automated prepared elastomeric pump was performed. Results Volumes administered by the pumps were accurate (total error < 2.5%). Preparation time was divided by 2. Occurrence of MSD decreased (8.7 manual filling vs. 23.5/28 automated filling). Overcost was moderate (14.7% for AMF; 10.3% for Baxter). Conclusions Using peristaltic pumps, 5FU preparation was optimized for moderate additional cost.
{"title":"Optimisation of the preparation of chemotherapy based on 5-fluorouracil by the use of peristaltic pumps","authors":"A. Villain, I. Sakji, E. Bogart, G. Strobbe, G. Marliot, F. Feutry","doi":"10.1515/pthp-2020-0003","DOIUrl":"https://doi.org/10.1515/pthp-2020-0003","url":null,"abstract":"Abstract Objectives Preparation of 5-FU elastomeric pumps is a time-consuming activity inducing musculoskeletal disorders (MSDs). Our unit has developed an automated filling system consisting of two peristaltic pumps (one for the diluent, one for the cytotoxic drug). The objective was to validate the accuracy of the assembly and evaluate the impact of automation on the compounding time, occurrence of MSDs and cost of preparation. Methods Accuracy was determined by calculating the total error on the volumes injected by the pumps. Measurements were made for 2 brands (AMF, Baxter), 3 different volumes; repeated 3 times at 3 times of the day. The time-saving study compared 24 measurements in manual filling and 24 in automated mode. Impact of automation on the occurrence of MSDs was evaluated by a self-assessment questionnaire. Finally, a comparison between the price of a manually prepared elastomeric pump and an automated prepared elastomeric pump was performed. Results Volumes administered by the pumps were accurate (total error < 2.5%). Preparation time was divided by 2. Occurrence of MSD decreased (8.7 manual filling vs. 23.5/28 automated filling). Overcost was moderate (14.7% for AMF; 10.3% for Baxter). Conclusions Using peristaltic pumps, 5FU preparation was optimized for moderate additional cost.","PeriodicalId":19802,"journal":{"name":"Pharmaceutical Technology in Hospital Pharmacy","volume":"48 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84048798","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Abstract Objectives Several societies have published guidelines to limit the occupational exposure of workers. Several of these guidelines recommend periodic (once or twice a year) environmental monitoring of specific sites where antineoplastic drugs are prepared and administered. However, most of the guidelines provide no guidance concerning which antineoplastic drugs should be monitored, the preferred sampling sites, appropriate test methods or limits of detection. The aim of this study was to characterize providers that quantify antineoplastic drug measured on surfaces. Methods This was a cross-sectional descriptive study. To identify service providers offering environmental monitoring tests, we searched the PubMed database and used the Google search engine. We contacted each service provider by email between June 3rd and June 15th, 2020. We specified the objective of our study and described the information needed and the variables of interest with standardized questions. Additional questions were sent by emails or via teleconferences. No statistical analyses were performed. Results We identified six providers offering services to Canadian hospitals, either based in Canada or in the United States. Five of these providers were private companies and one was a public organization. Each service provider was able to measure trace contamination of 3–17 antineoplastic drugs. Five of the providers quantified drugs using ultra performance liquid chromatography coupled with tandem mass spectrometry (UPLC-MSMS), which allowed for lower LODs. The sixth provider offered quantification by immunoassay, which has higher LODs, but offers near real-time results; the surface area to be sampled with this method was also smaller than with UPLC-MSMS. The services offered varied among the service providers. The information about LODs supplied by each provider was often insufficient and the units were not standardized. A cost per drug quantified could not be obtained, because of variability in the scenarios involved (e.g. drug selection to be quantified, number of samples, nondisclosure of ancillary costs). Four of the six service providers were unable to report LOQ values. Conclusions Few data are available from Canadian service providers concerning the characteristics of wipe sampling methods for antineoplastics. This study identified six north-American providers. Their characteristics were very heterogeneous. Criteria to consider when choosing a provider include the validation of their analytical method, a low limit of detection, the choice of drugs to be quantified and the sites to be sampled, obtaining details about the method and understanding its limits, and price. This should be part of a structured multidisciplinary approach in each center.
{"title":"Characteristics of wipe sampling methods for antineoplastic drugs in North America: comparison of six providers","authors":"Claire Chabut, J. Bussières","doi":"10.1515/pthp-2020-0016","DOIUrl":"https://doi.org/10.1515/pthp-2020-0016","url":null,"abstract":"Abstract Objectives Several societies have published guidelines to limit the occupational exposure of workers. Several of these guidelines recommend periodic (once or twice a year) environmental monitoring of specific sites where antineoplastic drugs are prepared and administered. However, most of the guidelines provide no guidance concerning which antineoplastic drugs should be monitored, the preferred sampling sites, appropriate test methods or limits of detection. The aim of this study was to characterize providers that quantify antineoplastic drug measured on surfaces. Methods This was a cross-sectional descriptive study. To identify service providers offering environmental monitoring tests, we searched the PubMed database and used the Google search engine. We contacted each service provider by email between June 3rd and June 15th, 2020. We specified the objective of our study and described the information needed and the variables of interest with standardized questions. Additional questions were sent by emails or via teleconferences. No statistical analyses were performed. Results We identified six providers offering services to Canadian hospitals, either based in Canada or in the United States. Five of these providers were private companies and one was a public organization. Each service provider was able to measure trace contamination of 3–17 antineoplastic drugs. Five of the providers quantified drugs using ultra performance liquid chromatography coupled with tandem mass spectrometry (UPLC-MSMS), which allowed for lower LODs. The sixth provider offered quantification by immunoassay, which has higher LODs, but offers near real-time results; the surface area to be sampled with this method was also smaller than with UPLC-MSMS. The services offered varied among the service providers. The information about LODs supplied by each provider was often insufficient and the units were not standardized. A cost per drug quantified could not be obtained, because of variability in the scenarios involved (e.g. drug selection to be quantified, number of samples, nondisclosure of ancillary costs). Four of the six service providers were unable to report LOQ values. Conclusions Few data are available from Canadian service providers concerning the characteristics of wipe sampling methods for antineoplastics. This study identified six north-American providers. Their characteristics were very heterogeneous. Criteria to consider when choosing a provider include the validation of their analytical method, a low limit of detection, the choice of drugs to be quantified and the sites to be sampled, obtaining details about the method and understanding its limits, and price. This should be part of a structured multidisciplinary approach in each center.","PeriodicalId":19802,"journal":{"name":"Pharmaceutical Technology in Hospital Pharmacy","volume":"41 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78835328","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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