Marie Palamini, D. Hilliquin, Jean-François Delisle, Audrey Chouinard, J. Bussières
Abstract Background Hazardous drugs pose risks to health care workers. To reduce the risk of occupational exposure for all workers, several protective and monitoring measures have been recommended and implemented over the past two decades. This study was undertaken to describe traces contamination with ten antineoplastic drugs in the oncology care unit of two university hospitals. Methods In this descriptive interrupted time series study, data was collected in two hospitals (a pediatric hospital and an adult hospital) in two consecutive years (12 December 2017 and 27 March 2018, defined as Period 1; 17 April 2019 and 12 June 2019, defined as Period 2). In both Period 1 and Period 2, 36 sites were sampled in each inpatient care unit to explore the contamination of surfaces with hazardous drugs. Results A total of 144 samples from the oncology care unit of the two hospitals were obtained for measurement. Overall, 40 % (58/144) of the sampling sites were positive for at least one hazardous drug. In the pediatric centre, 50 % (18/36) and 36 % (13/36) of the sites sampled in Period 1 and Period 2, respectively, were positive for at least one hazardous drug, whereas in the adult hospital, the percentage of sites that were positive for at least one hazardous drug was 19 % (7/36) in Period 1 and 56 % (20/36) in Period 2. Conclusion The surfaces of inpatient care units sampled in this study were contaminated with antineoplastic drugs, and contamination was present throughout the care units (including structures, furniture, medical equipment, and office equipment). Hospitals’ environmental surveillance programs should encompass inpatient care units.
{"title":"Surface Contamination by Antineoplastic Drugs in Two Oncology Inpatient Units","authors":"Marie Palamini, D. Hilliquin, Jean-François Delisle, Audrey Chouinard, J. Bussières","doi":"10.1515/pthp-2019-0017","DOIUrl":"https://doi.org/10.1515/pthp-2019-0017","url":null,"abstract":"Abstract Background Hazardous drugs pose risks to health care workers. To reduce the risk of occupational exposure for all workers, several protective and monitoring measures have been recommended and implemented over the past two decades. This study was undertaken to describe traces contamination with ten antineoplastic drugs in the oncology care unit of two university hospitals. Methods In this descriptive interrupted time series study, data was collected in two hospitals (a pediatric hospital and an adult hospital) in two consecutive years (12 December 2017 and 27 March 2018, defined as Period 1; 17 April 2019 and 12 June 2019, defined as Period 2). In both Period 1 and Period 2, 36 sites were sampled in each inpatient care unit to explore the contamination of surfaces with hazardous drugs. Results A total of 144 samples from the oncology care unit of the two hospitals were obtained for measurement. Overall, 40 % (58/144) of the sampling sites were positive for at least one hazardous drug. In the pediatric centre, 50 % (18/36) and 36 % (13/36) of the sites sampled in Period 1 and Period 2, respectively, were positive for at least one hazardous drug, whereas in the adult hospital, the percentage of sites that were positive for at least one hazardous drug was 19 % (7/36) in Period 1 and 56 % (20/36) in Period 2. Conclusion The surfaces of inpatient care units sampled in this study were contaminated with antineoplastic drugs, and contamination was present throughout the care units (including structures, furniture, medical equipment, and office equipment). Hospitals’ environmental surveillance programs should encompass inpatient care units.","PeriodicalId":19802,"journal":{"name":"Pharmaceutical Technology in Hospital Pharmacy","volume":"6 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76037670","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}
Camille Schmitt, Julien Fouque, S. Blondeel-Gomes, Claire Provost, Emilie Da Costa Branquinho, Olivier Madar
Abstract Introduction To reduce costs of gallium-68 activity in nuclear medicine, a subcontracting activity has been settled for [68Ga]Ga-edotreotide preparations. Cold kits are radiolabeled in our radiopharmacy and shipped out to nearby hospitals. According to the Summary of Product Characteristics (SmPC), preparations must be stored below 25 °C until expiration (4 h). Objective The aim of this study was to define the impact of high temperature on preparation quality during shipping. Materials & methods After radiolabeling, vials were placed in “type A” package until their expiry date. Four kits were stored in “Type A” container exposed to an outside temperature of 50 °C to represent extreme temperature conditions and one kit was kept at room temperature and used as a control. For each preparation, pH, organoleptic properties and radiochemical purity (RCP) were evaluated. RCP was measured using two radio thin layer chromatography, to evaluate the rates of gallium-68 colloids and free gallium-68. Samples were withdrawn at the end of preparation (t0), at t0 + 1 h or at t0 + 2 h and at t0 + 4 h. Results RCPs and pH of the radiopharmaceutical were all conform from t0 to t0 + 4 h. Four hours storage in “type A” package at 50 °C does not show any impact on physical and chemical quality of the preparation. Thanks to it expanded polyethylene foam which absorbs impacts; “Type A” package might acts as thermal barrier and enables the temperature regulation of shipped vials. Conclusion A monitored expedition in temperature-controlled vehicle does not seem necessary in those conditions.
{"title":"Temperature impact on [68Ga]Ga-edotreotide for the shipping of radioactive material in shielded container","authors":"Camille Schmitt, Julien Fouque, S. Blondeel-Gomes, Claire Provost, Emilie Da Costa Branquinho, Olivier Madar","doi":"10.1515/pthp-2020-0007","DOIUrl":"https://doi.org/10.1515/pthp-2020-0007","url":null,"abstract":"Abstract Introduction To reduce costs of gallium-68 activity in nuclear medicine, a subcontracting activity has been settled for [68Ga]Ga-edotreotide preparations. Cold kits are radiolabeled in our radiopharmacy and shipped out to nearby hospitals. According to the Summary of Product Characteristics (SmPC), preparations must be stored below 25 °C until expiration (4 h). Objective The aim of this study was to define the impact of high temperature on preparation quality during shipping. Materials & methods After radiolabeling, vials were placed in “type A” package until their expiry date. Four kits were stored in “Type A” container exposed to an outside temperature of 50 °C to represent extreme temperature conditions and one kit was kept at room temperature and used as a control. For each preparation, pH, organoleptic properties and radiochemical purity (RCP) were evaluated. RCP was measured using two radio thin layer chromatography, to evaluate the rates of gallium-68 colloids and free gallium-68. Samples were withdrawn at the end of preparation (t0), at t0 + 1 h or at t0 + 2 h and at t0 + 4 h. Results RCPs and pH of the radiopharmaceutical were all conform from t0 to t0 + 4 h. Four hours storage in “type A” package at 50 °C does not show any impact on physical and chemical quality of the preparation. Thanks to it expanded polyethylene foam which absorbs impacts; “Type A” package might acts as thermal barrier and enables the temperature regulation of shipped vials. Conclusion A monitored expedition in temperature-controlled vehicle does not seem necessary in those conditions.","PeriodicalId":19802,"journal":{"name":"Pharmaceutical Technology in Hospital Pharmacy","volume":"24 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87343085","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}
Maïté Sangnier, Guillaume Bouguéon, A. Berroneau, V. Dubois, S. Crauste-Manciet
Abstract In the context of batch production of cytotoxic drugs in hospital pharmacies with the need of sterility testing, the objective was to validate the use of Rapid Microbiological Method (RMM), and to develop adequate neutralization method in case of inhibition of bacterial growth. The potential microbiological growth inhibitory effect of three anticancer drugs (5 fluorouracil, irinotecan and oxaliplatin) selected for batch production was assessed on BacT/ALERT® system. Among cytotoxic drugs, only 5FU exhibited inhibitory effect on microbiological growth using rapid microbiological method. To counteract this effect our purpose was to use neutralizing agents complexing the drug i. e. activated carbon or ion exchange resins. The microbiological bactericidal concentration of 5FU was very low (1.10–4 mg/mL) indicating the absolute need to neutralize the whole drug before sterility test. The complexation was validated by High Performance Liquid Chromatography control of the residual 5FU concentration in solution after the use of neutralizing agents. Only activated carbon was able to fully capture 5FU when previously diluted at 5 mg/mL. Conversely, the resins, in the condition of the study, were not able to fully capture 5FU whatever the dilution. The microbiological growth on BacT/ALERT® system after active carbon treatment was successfully confirmed with Staphylococcus aureus. Based on this validation results a method was then developed to routinely be able to perform sterility test of the batches produced and was confirmed on five microbiological species (i. e. S. aureus, Pseudomonas aeruginosa, Bacillus subtilis, Candida albicans, Aspergillus brasiliensis). Our work gives a new insight for considering sterility testing by rapid microbiological method even for drugs exhibiting inhibitory effect on microbiological growth.
{"title":"Removal of bacterial growth inhibition of anticancer drugs by using complexation materials","authors":"Maïté Sangnier, Guillaume Bouguéon, A. Berroneau, V. Dubois, S. Crauste-Manciet","doi":"10.1515/pthp-2019-0018","DOIUrl":"https://doi.org/10.1515/pthp-2019-0018","url":null,"abstract":"Abstract In the context of batch production of cytotoxic drugs in hospital pharmacies with the need of sterility testing, the objective was to validate the use of Rapid Microbiological Method (RMM), and to develop adequate neutralization method in case of inhibition of bacterial growth. The potential microbiological growth inhibitory effect of three anticancer drugs (5 fluorouracil, irinotecan and oxaliplatin) selected for batch production was assessed on BacT/ALERT® system. Among cytotoxic drugs, only 5FU exhibited inhibitory effect on microbiological growth using rapid microbiological method. To counteract this effect our purpose was to use neutralizing agents complexing the drug i. e. activated carbon or ion exchange resins. The microbiological bactericidal concentration of 5FU was very low (1.10–4 mg/mL) indicating the absolute need to neutralize the whole drug before sterility test. The complexation was validated by High Performance Liquid Chromatography control of the residual 5FU concentration in solution after the use of neutralizing agents. Only activated carbon was able to fully capture 5FU when previously diluted at 5 mg/mL. Conversely, the resins, in the condition of the study, were not able to fully capture 5FU whatever the dilution. The microbiological growth on BacT/ALERT® system after active carbon treatment was successfully confirmed with Staphylococcus aureus. Based on this validation results a method was then developed to routinely be able to perform sterility test of the batches produced and was confirmed on five microbiological species (i. e. S. aureus, Pseudomonas aeruginosa, Bacillus subtilis, Candida albicans, Aspergillus brasiliensis). Our work gives a new insight for considering sterility testing by rapid microbiological method even for drugs exhibiting inhibitory effect on microbiological growth.","PeriodicalId":19802,"journal":{"name":"Pharmaceutical Technology in Hospital Pharmacy","volume":"65 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76524255","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 In the context of securing medication management systems (MMS) in healthcare habilities, implementation of an electronic MMS is a priority area of work. The quality requirements for the production of radiopharmaceuticals have increased significantly in the field of radiopharmacy. The deployment of Information Technology (IT) tools is essential to secure the radiopharmaceutical medication use process. The aim of this work is to propose the first consensual tool to validate radiopharmacy software approved by a panel of experts. A literature review was conduced related to the validation of hospital pharmacy software. The Delphi method was chosen for achieving a consensus in this study. Surveys were sent by mail to selected experts involved in the MMS. Twenty-seven replies were recorded (77%) to the first round, and 17 responses were recorded to the second survey. The final tool is a grid with 44 items. We proposed the first consensual tool to validate radiopharmacy software. This tool could be implemented in all French radiopharmacy to improve quality.
{"title":"How to validate radiopharmaceuticals management software?","authors":"D. Léa, P. Damien, S. Blondeel-Gomes","doi":"10.1515/pthp-2020-0010","DOIUrl":"https://doi.org/10.1515/pthp-2020-0010","url":null,"abstract":"Abstract In the context of securing medication management systems (MMS) in healthcare habilities, implementation of an electronic MMS is a priority area of work. The quality requirements for the production of radiopharmaceuticals have increased significantly in the field of radiopharmacy. The deployment of Information Technology (IT) tools is essential to secure the radiopharmaceutical medication use process. The aim of this work is to propose the first consensual tool to validate radiopharmacy software approved by a panel of experts. A literature review was conduced related to the validation of hospital pharmacy software. The Delphi method was chosen for achieving a consensus in this study. Surveys were sent by mail to selected experts involved in the MMS. Twenty-seven replies were recorded (77%) to the first round, and 17 responses were recorded to the second survey. The final tool is a grid with 44 items. We proposed the first consensual tool to validate radiopharmacy software. This tool could be implemented in all French radiopharmacy to improve quality.","PeriodicalId":19802,"journal":{"name":"Pharmaceutical Technology in Hospital Pharmacy","volume":"4 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82794498","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 Infliximab diluted solutions have been shown to be physicochemically stable for long periods, however the adsorption of infliximab during infusions has not been readily investigated. This study aimed to evaluate potential adsorption phenomena of infliximab during administration through Polyvinylchloride (PVC) and Polyurethane (PU) infusion sets. Methods Infliximab (INFLECTRA®) solutions at 0.4 mg/mL and 2 mg/mL were submitted to static (at T0, 24 and 96 h) and dynamic contact (flow rate of 2 mL/min during 2 h with analysis times at T0, 5 min, 30 min, 60 min and 120 min) with three different infusion sets. Two contained PVC plasticized with tris(2-ethylhexyl) trimellitate (TOTM) tubings and one set was in PU tubing. Infliximab was quantified at each analytical time by protein total quantification using UV-spectroscopy according to European Pharmacopeia Monography (2.5.33) and size exclusion chromatography (SEC) which allowed a specific quantification of the monomeric form and was able to highlight potential modification such as aggregation or oligomer formation. Results For all analysis times and conditions, infliximab concentrations remained unchanged with a maximum variation of 2.81 and 4.63% from the initial concentrations assessed by SEC and UV spectroscopy and the percentage of monomeric form remained unaltered. Conclusions Our study showed that there was no significant loss of infliximab. According to these results each of the three infusion sets could be used for the administration of infliximab solutions without causing any loss of active substance.
{"title":"Do plasticized polyvinylchloride and polyurethane infusion sets promote infliximab adsorption?","authors":"P. Chennell, N. Tokhadzé, V. Sautou","doi":"10.1515/pthp-2020-0008","DOIUrl":"https://doi.org/10.1515/pthp-2020-0008","url":null,"abstract":"Abstract Objectives Infliximab diluted solutions have been shown to be physicochemically stable for long periods, however the adsorption of infliximab during infusions has not been readily investigated. This study aimed to evaluate potential adsorption phenomena of infliximab during administration through Polyvinylchloride (PVC) and Polyurethane (PU) infusion sets. Methods Infliximab (INFLECTRA®) solutions at 0.4 mg/mL and 2 mg/mL were submitted to static (at T0, 24 and 96 h) and dynamic contact (flow rate of 2 mL/min during 2 h with analysis times at T0, 5 min, 30 min, 60 min and 120 min) with three different infusion sets. Two contained PVC plasticized with tris(2-ethylhexyl) trimellitate (TOTM) tubings and one set was in PU tubing. Infliximab was quantified at each analytical time by protein total quantification using UV-spectroscopy according to European Pharmacopeia Monography (2.5.33) and size exclusion chromatography (SEC) which allowed a specific quantification of the monomeric form and was able to highlight potential modification such as aggregation or oligomer formation. Results For all analysis times and conditions, infliximab concentrations remained unchanged with a maximum variation of 2.81 and 4.63% from the initial concentrations assessed by SEC and UV spectroscopy and the percentage of monomeric form remained unaltered. Conclusions Our study showed that there was no significant loss of infliximab. According to these results each of the three infusion sets could be used for the administration of infliximab solutions without causing any loss of active substance.","PeriodicalId":19802,"journal":{"name":"Pharmaceutical Technology in Hospital Pharmacy","volume":"96 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91346033","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}
H. Hejaz, A. Kanan, Mahmood Al Mohtaseb, Ameer Ja’bari
Abstract Objectives The oral route is the most common route of administration of drugs because of the low cost of therapy, ease of administration, patient compliance, and flexibility in formulation. Taking oral medicine is extremely odious to some patients, such as pediatric and geriatric patients. Paracetamol is one of the most used antipyretic and analgesic drugs, used in the management of fever and headache. Difficulty in swallowing (dysphagia) is common among pediatric and geriatric patients. Accordingly, there is a need for a solid form of medicine that is in a form easy to take and swallow, such as lollipops. The main objective of the present research study is to provide a solid form of medicine that is in a form that makes it pleasant to take and swallow by pediatric, geriatric, and bedridden patients, and avoid the dangers of being swallowed as do the other solid forms in those patients. However, lollipop is designed to improve patient compliance, acceptability, transportation, etc. Methods In the present research study, an attempt has been made to prepare sugar-based paracetamol medicated lollipops for pediatrics, geriatrics, and bedridden patients to overcome the administration problem. The paracetamol medicated lollipops were prepared using sucrose and corn syrup. All the formulations prepared were subjected to various physicochemical parameters like hardness, friability, weight variation, drug content, etc. Results The hardness of these lollipops ranges between 8 and 11 kg/cm3 with good physical characteristics like taste and color, they have good stability and moisture content below 1% and no variation in the IR spectrum. Conclusions Conventional dosage forms have some limitations that make it hard to use in pediatric and geriatric patients such as dysphagia, while medicated lollipops are found to be favorable by them and also effective in delivering the drug with advantages like bypass of the first-pass metabolism and increasing drug contact time in the mouth which increases its bioavailability. Paracetamol medicated lollipops can provide an attractive alternative formulation in the treatment of fever and pain in pediatric and geriatric patients because they are easily swallowed.
{"title":"Development and characterization of paracetamol medicated lollipops","authors":"H. Hejaz, A. Kanan, Mahmood Al Mohtaseb, Ameer Ja’bari","doi":"10.1515/pthp-2020-0012","DOIUrl":"https://doi.org/10.1515/pthp-2020-0012","url":null,"abstract":"Abstract Objectives The oral route is the most common route of administration of drugs because of the low cost of therapy, ease of administration, patient compliance, and flexibility in formulation. Taking oral medicine is extremely odious to some patients, such as pediatric and geriatric patients. Paracetamol is one of the most used antipyretic and analgesic drugs, used in the management of fever and headache. Difficulty in swallowing (dysphagia) is common among pediatric and geriatric patients. Accordingly, there is a need for a solid form of medicine that is in a form easy to take and swallow, such as lollipops. The main objective of the present research study is to provide a solid form of medicine that is in a form that makes it pleasant to take and swallow by pediatric, geriatric, and bedridden patients, and avoid the dangers of being swallowed as do the other solid forms in those patients. However, lollipop is designed to improve patient compliance, acceptability, transportation, etc. Methods In the present research study, an attempt has been made to prepare sugar-based paracetamol medicated lollipops for pediatrics, geriatrics, and bedridden patients to overcome the administration problem. The paracetamol medicated lollipops were prepared using sucrose and corn syrup. All the formulations prepared were subjected to various physicochemical parameters like hardness, friability, weight variation, drug content, etc. Results The hardness of these lollipops ranges between 8 and 11 kg/cm3 with good physical characteristics like taste and color, they have good stability and moisture content below 1% and no variation in the IR spectrum. Conclusions Conventional dosage forms have some limitations that make it hard to use in pediatric and geriatric patients such as dysphagia, while medicated lollipops are found to be favorable by them and also effective in delivering the drug with advantages like bypass of the first-pass metabolism and increasing drug contact time in the mouth which increases its bioavailability. Paracetamol medicated lollipops can provide an attractive alternative formulation in the treatment of fever and pain in pediatric and geriatric patients because they are easily swallowed.","PeriodicalId":19802,"journal":{"name":"Pharmaceutical Technology in Hospital Pharmacy","volume":"653 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1515/pthp-2020-0012","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72437781","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}
Elodie Di-Falco, J. Bourbon, Isalyne Sbaffe, J. Kaiser
Abstract Alsace, in particular Haut-Rhin, is one of the main clusters of COVID-19 in France. There has been a shortage of essential supplies in the area, especially alcohol-based hand sanitizer. In this context, and in accordance with the decree dated March 6, 2020, our hospital management team asked us to start local production of alcohol-based handrub. This was a real challenge: In one week, we had to implement the production of handrub to meet the needs of a 1,400-bed hospital. The production had to comply with the French preparation guidelines and take place on specific premises, with qualified and calibrated equipment, by qualified staff, under the supervision of a pharmacist. The other big challenge we faced was the supply of pharmaceutical raw and packaging materials. During this particular critical period, all suppliers were out of stock. Here, we describe the organizational set-up and the decisions made, e. g., to use technical-grade ethanol before the publication of the decrees dated March 13 and March 23, 2020.
{"title":"Preparation of alcohol-based handrub in COVID-19 Alsatian cluster","authors":"Elodie Di-Falco, J. Bourbon, Isalyne Sbaffe, J. Kaiser","doi":"10.1515/pthp-2020-0004","DOIUrl":"https://doi.org/10.1515/pthp-2020-0004","url":null,"abstract":"Abstract Alsace, in particular Haut-Rhin, is one of the main clusters of COVID-19 in France. There has been a shortage of essential supplies in the area, especially alcohol-based hand sanitizer. In this context, and in accordance with the decree dated March 6, 2020, our hospital management team asked us to start local production of alcohol-based handrub. This was a real challenge: In one week, we had to implement the production of handrub to meet the needs of a 1,400-bed hospital. The production had to comply with the French preparation guidelines and take place on specific premises, with qualified and calibrated equipment, by qualified staff, under the supervision of a pharmacist. The other big challenge we faced was the supply of pharmaceutical raw and packaging materials. During this particular critical period, all suppliers were out of stock. Here, we describe the organizational set-up and the decisions made, e. g., to use technical-grade ethanol before the publication of the decrees dated March 13 and March 23, 2020.","PeriodicalId":19802,"journal":{"name":"Pharmaceutical Technology in Hospital Pharmacy","volume":"51 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76505666","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}
C. Polo, E. D’huart, Gwendoline Lesperlette, J. Vigneron, F. Meyer, B. Demoré
Abstract Objectives Concomitant administration of two incompatible drugs in the same infusion line can lead to a precipitation which could have clinical consequences for patients. The objective of this work was to study the physical compatibility of injectable posaconazole with other drugs commonly used in an adult hematology care unit. Methods The most widely used injectable drugs co-administered with posaconazole have been listed with a total of 19 drugs. For some drugs, different conditions have been tested. A total of 24 solutions were produced (not including the posaconazole). In the absence of compatibility data, the physical compatibility was tested for each pair including one of the 24 solutions and posaconazole. For each pair studied, three different ratios were prepared (9:1, 1:1, 1:9). Visual evaluations were performed after the mixture, after one and 4 h. Results Seventy two mixtures have been realised: 55.56% of pairs (n=40/72) resulted in a precipitation, against 44.44% (n=32/72) with no visual modification after a 4-h storage. On the 19 drugs tested, only filgrastim and tacrolimus showed no visual change with posaconazole during a 4-h storage. Conclusions In majority of cases, posaconazole was not compatible with drugs having alkaline pH, commonly used in a hematology unit.
{"title":"Compatibility of injectable posaconazole with drugs commonly used in a hematology care unit","authors":"C. Polo, E. D’huart, Gwendoline Lesperlette, J. Vigneron, F. Meyer, B. Demoré","doi":"10.1515/pthp-2020-0011","DOIUrl":"https://doi.org/10.1515/pthp-2020-0011","url":null,"abstract":"Abstract Objectives Concomitant administration of two incompatible drugs in the same infusion line can lead to a precipitation which could have clinical consequences for patients. The objective of this work was to study the physical compatibility of injectable posaconazole with other drugs commonly used in an adult hematology care unit. Methods The most widely used injectable drugs co-administered with posaconazole have been listed with a total of 19 drugs. For some drugs, different conditions have been tested. A total of 24 solutions were produced (not including the posaconazole). In the absence of compatibility data, the physical compatibility was tested for each pair including one of the 24 solutions and posaconazole. For each pair studied, three different ratios were prepared (9:1, 1:1, 1:9). Visual evaluations were performed after the mixture, after one and 4 h. Results Seventy two mixtures have been realised: 55.56% of pairs (n=40/72) resulted in a precipitation, against 44.44% (n=32/72) with no visual modification after a 4-h storage. On the 19 drugs tested, only filgrastim and tacrolimus showed no visual change with posaconazole during a 4-h storage. Conclusions In majority of cases, posaconazole was not compatible with drugs having alkaline pH, commonly used in a hematology unit.","PeriodicalId":19802,"journal":{"name":"Pharmaceutical Technology in Hospital Pharmacy","volume":"50 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82741897","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. Matheron, Marie-Noelle Guerault, R. Vazquez, Mireille Cheron, D. Brossard, S. Crauste-Manciet
Abstract Objectives The objectives were to assess the microbiological stability and the physical enclosure integrity of the overwrapping for batch production of standard cytotoxic injectable solutions. Methods Broth culture media were used in place of cytotoxic drugs to assess the worst case in term of microbiological contamination risk. Iterative sterility tests on batches were performed for 60 days using rapid microbiological method. Validation of microbiological growth of culture media was assessed by direct inoculation of <100 CFU/mL of six microbiological strains recommended by European Pharmacopeia. Validation of the ability of growth of microorganisms in 11 cytotoxic solutions and one monoclonal antibody was assessed using eight strains. In addition, the physical integrity of the seal of the overwrapping containing cytotoxic preparations was assessed by dynamometric method and dye penetration test. Results No microbiological contamination was observed on all units of batches for 60 days of investigation. The ability to detect microbiological growth in cytotoxic solutions was validated for the eight challenge microorganisms after 1/10 dilution for cytotoxic investigated, except for 5 Fluorouracil, gemcitabine and cisplatin. In addition, physical integrity testing of the seal of overwrapping pointed out the need of specific validation of heatsealer and operator education. Conclusions Besides physico-chemical testing, microbiological stability testing combined to physical integrity testing is the additional part of the development method for batch production of sterile drugs in hospital.
{"title":"Microbiological stability tests with simulated broth preparations and integrity testing for sterile standard cytotoxic preparations","authors":"A. Matheron, Marie-Noelle Guerault, R. Vazquez, Mireille Cheron, D. Brossard, S. Crauste-Manciet","doi":"10.1515/pthp-2020-0002","DOIUrl":"https://doi.org/10.1515/pthp-2020-0002","url":null,"abstract":"Abstract Objectives The objectives were to assess the microbiological stability and the physical enclosure integrity of the overwrapping for batch production of standard cytotoxic injectable solutions. Methods Broth culture media were used in place of cytotoxic drugs to assess the worst case in term of microbiological contamination risk. Iterative sterility tests on batches were performed for 60 days using rapid microbiological method. Validation of microbiological growth of culture media was assessed by direct inoculation of <100 CFU/mL of six microbiological strains recommended by European Pharmacopeia. Validation of the ability of growth of microorganisms in 11 cytotoxic solutions and one monoclonal antibody was assessed using eight strains. In addition, the physical integrity of the seal of the overwrapping containing cytotoxic preparations was assessed by dynamometric method and dye penetration test. Results No microbiological contamination was observed on all units of batches for 60 days of investigation. The ability to detect microbiological growth in cytotoxic solutions was validated for the eight challenge microorganisms after 1/10 dilution for cytotoxic investigated, except for 5 Fluorouracil, gemcitabine and cisplatin. In addition, physical integrity testing of the seal of overwrapping pointed out the need of specific validation of heatsealer and operator education. Conclusions Besides physico-chemical testing, microbiological stability testing combined to physical integrity testing is the additional part of the development method for batch production of sterile drugs in hospital.","PeriodicalId":19802,"journal":{"name":"Pharmaceutical Technology in Hospital Pharmacy","volume":"5 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81376222","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}
P. Boivin, P. Legendre, Anne-Claire Bonnaure, M. Lester
Abstract Objectives In patients suffering from chronic liver disease, the hepatic metabolism of drugs is perturbed and the metabolic capacity is difficult to assess. Midazolam could be used as a phenotypical probe to predict the metabolic capacity of CYP3A to adjust dosages of drug substrates of this cytochrome. In this context, a prospective clinical trial is going to be conducted in our institution and a hospital preparation of midazolam capsules suitable for the clinical trial was developed. The objective of the present work was to assess the physicochemical stability of the formulation over 12 months to set shelf life. Methods Three batches of 1 mg capsules were prepared using midazolam hydrochloride and microcrystalline cellulose as a diluent. The capsules were stored at ambient temperature and protected from light. To measure the evolution of the capsules content, a stability-indicating high-performance liquid chromatography (HPLC) method was developed with ultraviolet (UV) detection at 254 nm. Data were confirmed using a liquid chromatography-tandem mass spectrometry (LC-MS/MS) analytical method. Results After one year, midazolam hydrochloride content remained higher than 95% of the initial concentration in capsules. Conclusions The results show that 1 mg midazolam capsules are stable for 12 months at room temperature and under dark conditions.
{"title":"Physicochemical stability of compounded midazolam capsules over a one-year storage period","authors":"P. Boivin, P. Legendre, Anne-Claire Bonnaure, M. Lester","doi":"10.1515/pthp-2020-0015","DOIUrl":"https://doi.org/10.1515/pthp-2020-0015","url":null,"abstract":"Abstract Objectives In patients suffering from chronic liver disease, the hepatic metabolism of drugs is perturbed and the metabolic capacity is difficult to assess. Midazolam could be used as a phenotypical probe to predict the metabolic capacity of CYP3A to adjust dosages of drug substrates of this cytochrome. In this context, a prospective clinical trial is going to be conducted in our institution and a hospital preparation of midazolam capsules suitable for the clinical trial was developed. The objective of the present work was to assess the physicochemical stability of the formulation over 12 months to set shelf life. Methods Three batches of 1 mg capsules were prepared using midazolam hydrochloride and microcrystalline cellulose as a diluent. The capsules were stored at ambient temperature and protected from light. To measure the evolution of the capsules content, a stability-indicating high-performance liquid chromatography (HPLC) method was developed with ultraviolet (UV) detection at 254 nm. Data were confirmed using a liquid chromatography-tandem mass spectrometry (LC-MS/MS) analytical method. Results After one year, midazolam hydrochloride content remained higher than 95% of the initial concentration in capsules. Conclusions The results show that 1 mg midazolam capsules are stable for 12 months at room temperature and under dark conditions.","PeriodicalId":19802,"journal":{"name":"Pharmaceutical Technology in Hospital Pharmacy","volume":"120 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87947957","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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