Pharmaceutical Technology in Hospital Pharmacy, 2021
The physico-chemical stability of an injectable preparation (IV) is conditioned by different para... more The physico-chemical stability of an injectable preparation (IV) is conditioned by different parameters. A collaboration between the pharmacy, the chemistry laboratory and the statisticians of the scientific support unit was established in 1996, in order to carry out long-term chemical stability studies of commonly used IVs and to be able to take charge of their preparation in pharmacy. In 24 years of activity, the Drug Stability Research Group (DSRG) tested 39 IV at different concentration and temperature of storage. The DSRG has organized an annual symposium since 2015. The theme of the 2019 edition was devoted to the robotization of injectable reconstitution operations, focused on their impact on the workplace and the existing equipment.
The recommandations for the practical stability of anticancer drugs published in 2010 by the Fren... more The recommandations for the practical stability of anticancer drugs published in 2010 by the French Society of Hospital Pharmacists (SFPO) and the European Society of Oncology Pharmacists (ESOP) have been updated. Ten new molecules have been included (asparaginase, azacitidine, bevacizumab, clofarabine, eribuline mesylate, folinate sodium, levofolinate calcium, nelarabine, rituximab, temsirolimus).
Stability studies performed by the pharmaceutical industry are only designed to fulfi l licensing... more Stability studies performed by the pharmaceutical industry are only designed to fulfi l licensing requirements. Thus post-dilution or reconstitution stability data are frequently limited to 24 h only for bacteriological reasons, regardless of the true chemical stability, which could, in many cases, be ▶ preparation in advance for a whole treatment cycle of a particular patient, for several days;
Objectives Patients hospitalized in intensive care units often require multiple drug infusions. D... more Objectives Patients hospitalized in intensive care units often require multiple drug infusions. Due to limited intravenous accesses, concomitant administration of drugs in the same infusion line is often necessary. Compatibility studies of Y-site administration are available in the literature, but data of several combinations are lacking. Previous work from d’Huart et al. have performed an observation of the administration of injectable drugs in three adults ICUs and identified a list of Y-site administration without compatibility data. The objective of this study was to test the physical compatibility of the main drugs of this list used in pairs in Y-site infusions in critical care units, in order to provide new compatibility data to the literature, and to secure the administration of intravenous drugs. Methods The physical compatibility in Y-site of nine drugs with other drugs commonly used in intensive care units has been tested. Examinations were performed on 75 mixtures after t...
Objectives To the best of our knowledge, few studies have been published on the stability of caba... more Objectives To the best of our knowledge, few studies have been published on the stability of cabazitaxel in infusion bags. Stabilis® database has selected a study demonstrating the stability of this molecule at 0.15 mg/mL for 28 days at 4 °C and 25 °C in polyolefin bags. The aim of this work was to study the physicochemical stability of Cabazitaxel Zentiva® solutions in vials after “opening” with a vented ChemoClave® Spike, at 25 °C, protected from light and in solutions diluted at 0.1 and 0.26 mg/mL in 0.9 % sodium chloride (0.9 % NaCl) or dextrose 5 % (D5W) in 3 types of infusion bags (Easyflex® and Viaflo® at 25 °C, Freeflex® between 2 and 8 °C, protected from light). Methods The chemical stability was analyzed after preparation and then after 14 and 28 days of storage by high performance liquid chromatography (HPLC), coupled to a diode array detector, at the analysis wavelength of 232 nm. The method has been validated according to ICH Q2 (R1) standards. For the study in infusion...
The use of continuous infusion to improve the therapeutic efficacy of time-dependent antibiotics ... more The use of continuous infusion to improve the therapeutic efficacy of time-dependent antibiotics has been demonstrated. There is still a lack of data to safely perform these continuous infusions. The objectives in this study were to evaluate the stability by using stability-indicating methods (High-Performance Liquid Chromatography) of 16 antibiotics in concentrated solutions, especially for administration in intensive care units and solutions in elastomeric diffusers at 37 °C for outpatient parenteral antimicrobial therapy. The solutions were considered stable if the percentage of the drug was ≥90%, and the colour and clearness remained unchanged. In syringes, the stability data vary from 4 to 8 h (h) for meropenem in Dextrose 5% (D5W) and Normal Saline (NS), respectively, 6 h for cefotaxime, 12 h for cefoxitin, and 24 h for aztreonam, cefazolin, cefepime, cefiderocol, ceftazidime/avibactam, ceftolozane/tazobactam in NS and D5W, and in water for injection for cloxacillin. A stabili...
Pharmaceutical Technology in Hospital Pharmacy, 2018
Background Many publications described sodium thiosulfate used to prevent the renal toxicity indu... more Background Many publications described sodium thiosulfate used to prevent the renal toxicity induced by cisplatin hyperthermic intraperitoneal chemotherapy. After around 60 or 90 minutes of hyperthermic chemotherapy, cisplatin was drained and then, sodium thiosulfate was infused by intravenous route. Sodium thiosulfate is used in two steps: a first step, at 9 g/m2 in 250 mL of 0.9 % sodium chloride over 10 minutes followed by a second step, at 12 g/m2 in 1000 mL of 0.9 % sodium chloride over 6 hours. The purpose of this work was to study the stability of sodium thiosulfate at 16 mg/mL in 0.9 % sodium chloride polyolefin bags 1000 mL and at 72 mg/mL in 0.9 % sodium chloride polyolefin bags 250 mL, at 25 °C, protected or unprotected from light. Methods Chemical stability was analysed by high performance liquid chromatography (HPLC) coupled to a photodiode array detector after preparation and after 6-hour or 24-hour storage. The method was validated according to the International Confe...
Pharmaceutical Technology in Hospital Pharmacy, 2019
In hospitals, the majority of medication therapy is administered intravenously. Especially, in in... more In hospitals, the majority of medication therapy is administered intravenously. Especially, in intensive care units, simultaneous of various injectable drugs is a common practice Drug incompatibilities have been reported to be associated with up to 60 % of all serious and life-threatening adverse drug events. Several databases are used by hospital pharmacists to answer the questions of (in)compatibility of co-administered injectable drugs. The objective of this article is to present the European databases on compatibility and stability of injectable drugs. According to a questionnaire which was sent to the National Hospital Pharmacy Associations of the 28 countries of European Community there are three national databases available in EU countries which are in alphabetical order, Belgium, France and Germany. The Belgian database is dedicated to injectable medications, is updated and distributed annually in French language on a USB key. STABILIS® is an international database giving in...
Objectives The measurement of osmolality is used by many authors as an additional stability crite... more Objectives The measurement of osmolality is used by many authors as an additional stability criterion of a drug in solution. In the current state of knowledge, no scientific publication correlates the osmolality values and the stability of a solution. To study the relevance of this analytical technique by measuring the osmolality of injectable solutions whose instability has been chemically demonstrated by high performance liquid chromatography (HPLC). Methods Selection of 13 drug preparations whose chemical instability has been demonstrated in the literature. Realization of three identical samples per selected preparation and measurements of the osmolality of the freshly prepared solutions, then, at various storage times until a chemical degradation of the molecule validated by HPLC of at least 10% and possibly up to 40%. Results Measurements of the osmolality were performed on five antibiotics (amoxicillin/clavulanic acid, cefepime, cefoxitine, meropenem and temocillin and cefoxit...
pH of 5.4. There are no published data to support how pH affects mitomycin C stability in 0.9% so... more pH of 5.4. There are no published data to support how pH affects mitomycin C stability in 0.9% sodium chloride solutions (NSS). Aim and objectives To study the stability of mitomycin C in NSS under different pH conditions and storage temperatures. Material and methods A stability study was carried out in eight NSS with a commonly used mitomycin C concentration of 0.12 mg/mL. Solutions were prepared in duplicate for each pH: 4.5, 5.5, 6 and 7. The pH was adjusted with sodium hydroxide or phosphoric acid. Four solutions were stored at room temperature and four at 5°C. Mitomycin C concentration was assessed at 0, 30, 60, 120 and 300 min and 24 hours by high performance liquid chromatography. The areas obtained were compared with the initial area (time 0 min) to calculate the remaining mitomycin C percentage. A 10% level of degradation is assumed as the limit in terms of stability. Results Remaining mitomycin C percentages were calculated. Analysing the results at room temperature, the remaining mitomycin C percentages were 98.5% at 30 min; 97.2% at 60 min; 92.7% at 120 min; 89.3% at 300 min; and 88.4% at 1 hour at pH=7. Remaining percentages were 99.2%, 98.6%, 97.6%, 95.8% and 87.4%, respectively, at pH=6. Percentages were 98.9%, 98,2%, 96.6%, 93.5% and 87.3%, respectively, at pH=5.5. Percentages for pH=4.5 were 98.0%, 96.7%, 88.1%, 85.4% and 83.2%, respectively. The concentration of all solutions remained above 90% of the initial concentration after 1 hour, regardless of the pH value, in contrast with the values at 24 hours. Analysing the concentrations at 5°C, the remaining mitomycin C percentages were 99.2%, 98.4%, 97.3%, 94.9% and 90.0% at pH=7. Remaining percentages were 99.5%, 99.2%, 98.6%, 97.4% and 94.0%, respectively, at pH=6. Percentages were 99.8%, 99.6%, 99.2%, 98.4% and 95.3%, respectively, at pH=5.5. Percentages for pH=4.5 were 99.8%, 99.7%, 99.3%, 98.5% and 93.1%, respectively, for each time studied. All solutions stored in the fridge were stable over the 24 hours of the study. Conclusion and relevance We demonstrated that the stability of mitomycin C solutions decreased over time and with lower pH values in NSS. Furthermore, room temperature significantly affected mitomycin C stability. However, degradation was greatly reduced at 5°C, regardless of pH. This proves that mitomycin C solutions in NSS can be stored in the fridge for 24 hours.
knowledge when performing continuous infusion of cefepime in syringe. In elastomeric devices, cef... more knowledge when performing continuous infusion of cefepime in syringe. In elastomeric devices, cefepime solution at 50 mg/ mL in 0.9% NaCl stored at 37°C was unstable. These preparations are not recommended. In view of these results, the stability of cefepime in D5W in elastomeric devices was not studied.
Preliminary data was presented as a poster during the Hopipharm Congress in Bordeaux France, in M... more Preliminary data was presented as a poster during the Hopipharm Congress in Bordeaux France, in May 2018-Etude de stabilité physico-chimique de solutions d'étoposide diluées en poches polyoléfine à des concentrations comprises entre 0.38 et 1.75 mg/mL. ED'H, JV, PL, BD. University hospital of Nancy, France.
Pharmaceutical Technology in Hospital Pharmacy, 2018
Background Bendamustine is used for the treatment of non-Hodgkin lymphoma, chronic lymphocytic le... more Background Bendamustine is used for the treatment of non-Hodgkin lymphoma, chronic lymphocytic leukaemia and myeloma. The stability of bendamustine is highly dependent on temperature and chloride-ion concentration. Limited stability data are available. The objective of this work was to study the stability of the bendamustine reconstituted solution at 2.5 mg/mL and the diluted solution in normal saline and 1.5 % sodium chloride to evaluate a potential increase in stability. Methods A stability indicating High Performance Liquid Chromatography method with Diode Array Detection was used. A first study was carried out in glass vials and then in polyolefin containers at 0.25 and 0.60 mg/mL. Solutions were stored at room temperature and at 2–8 °C for 7 days. Results Stability was defined as a concentration above 95 % of the initial concentration [10]. The reconstituted solution at 2.5 mg/mL was stable for only 2 hours at room temperature and 8 hours at 2–8 °C. The stability of diluted sol...
Pharmaceutical Technology in Hospital Pharmacy, 2019
Background Cefotaxime sodium is an antibiotic used to treat severe infections such as in intensiv... more Background Cefotaxime sodium is an antibiotic used to treat severe infections such as in intensive care units (ICUs). The recommended dose of cefotaxime sodium can vary from 3 grams (g) to 24 g per day and publications have demonstrated that continuous administration of cefotaxime sodium is the preferred mode of administration. In ICUs, a minimum volume is used for patients requiring fluid restriction, leading to high concentrations of cefotaxime sodium. The objective was to study the stability of cefotaxime sodium solutions at 83.3 mg/mL and 125 mg/mL, diluted in 0.9 % sodium chloride (0.9 % NaCl) or in 5 % glucose (G5 %), stored in polypropylene syringes, after the preparation and after a 6-hour and a 12-hour storage at 20–25 °C. Methods Three syringes for each condition were prepared. At each time of the analysis, three samples for each syringe were prepared and analysed by high performance liquid chromatography (HPLC) coupled to a photodiode array detector. The method was valida...
Pharmaceutical Technology in Hospital Pharmacy, 2019
Background The objectives were to perform an observation of the administration of injectable drug... more Background The objectives were to perform an observation of the administration of injectable drugs in three ICUs, to identify injectable drugs administered by Y-site infusion or mixed in the same container, to compare with physical compatibility data available in the literature and to test the physical compatibility for missing data. Methods An observational study was realised over two weeks and patients receiving more than one injectable drug in the same line simultaneously were included. Physical compatibilities were assessed in pairs by comparing with three databases. For some missing data, three tests were realised for pairs including an anti-infective drug. Visual and subvisual evaluations were performed after the preparation, 1 and a 4-hour storage. Results A total of 389 combinations between two injectable drugs was observed for Y-site infusions and 31 mixtures in the same container. According to the literature, 21.1 % associations were physically compatible, 1.8 % as physica...
European Journal of Hospital Pharmacy: Science and Practice, 2013
Background The high off-label use of albumin persuaded the pharmacy to introduce a request form t... more Background The high off-label use of albumin persuaded the pharmacy to introduce a request form that uses the internationals guidelines to assess whether the use of albumin is appropriate. This has resulted in a clear reduction in the costs. Purpose To monitor the wards using six sigma methodology (a statistical concept that measures a process in terms of defects); to ensure that all procedures have been followed correctly. Materials and Methods 696 forms for albumin prescriptions coming from 26 wards (August to December 2011) were analysed using Minitab software, which cheques the frequency of the best correct requests (type 1), partially correct requests (type 2) and incorrect requests (type 3). For each ward the β coefficient was used to connect the relationship between the ward and their requests. The wards were grouped into 4 ranges on confidence intervals for the odds ratio (OR) of a width equal to 0.3 called A,B,C,D and then a final logistic regression analysis was made. Results The analysis showed that group A was the most efficient in terms of probability of obtaining better results, followed by groups D (OR 0.36), C (OR 0.19) and B (OR 0.09). The total number of requests received was: 43% type 1 (299/696); 26% type 2 (181/696); 31% type 3 (216/696). Group B showed the worst result with 51% type 3 requests (58% of the total requests for type 3). Using six sigma we have achieved a cost saving of about €15,000. Conclusions The results encourage us to apply this methodology to other fields. No conflict of interest. Stability of frozen Ceftazidime Solution in PolyProPylene SyringeS for intravitreal injeCtion
Pharmaceutical Technology in Hospital Pharmacy, 2021
The physico-chemical stability of an injectable preparation (IV) is conditioned by different para... more The physico-chemical stability of an injectable preparation (IV) is conditioned by different parameters. A collaboration between the pharmacy, the chemistry laboratory and the statisticians of the scientific support unit was established in 1996, in order to carry out long-term chemical stability studies of commonly used IVs and to be able to take charge of their preparation in pharmacy. In 24 years of activity, the Drug Stability Research Group (DSRG) tested 39 IV at different concentration and temperature of storage. The DSRG has organized an annual symposium since 2015. The theme of the 2019 edition was devoted to the robotization of injectable reconstitution operations, focused on their impact on the workplace and the existing equipment.
The recommandations for the practical stability of anticancer drugs published in 2010 by the Fren... more The recommandations for the practical stability of anticancer drugs published in 2010 by the French Society of Hospital Pharmacists (SFPO) and the European Society of Oncology Pharmacists (ESOP) have been updated. Ten new molecules have been included (asparaginase, azacitidine, bevacizumab, clofarabine, eribuline mesylate, folinate sodium, levofolinate calcium, nelarabine, rituximab, temsirolimus).
Stability studies performed by the pharmaceutical industry are only designed to fulfi l licensing... more Stability studies performed by the pharmaceutical industry are only designed to fulfi l licensing requirements. Thus post-dilution or reconstitution stability data are frequently limited to 24 h only for bacteriological reasons, regardless of the true chemical stability, which could, in many cases, be ▶ preparation in advance for a whole treatment cycle of a particular patient, for several days;
Objectives Patients hospitalized in intensive care units often require multiple drug infusions. D... more Objectives Patients hospitalized in intensive care units often require multiple drug infusions. Due to limited intravenous accesses, concomitant administration of drugs in the same infusion line is often necessary. Compatibility studies of Y-site administration are available in the literature, but data of several combinations are lacking. Previous work from d’Huart et al. have performed an observation of the administration of injectable drugs in three adults ICUs and identified a list of Y-site administration without compatibility data. The objective of this study was to test the physical compatibility of the main drugs of this list used in pairs in Y-site infusions in critical care units, in order to provide new compatibility data to the literature, and to secure the administration of intravenous drugs. Methods The physical compatibility in Y-site of nine drugs with other drugs commonly used in intensive care units has been tested. Examinations were performed on 75 mixtures after t...
Objectives To the best of our knowledge, few studies have been published on the stability of caba... more Objectives To the best of our knowledge, few studies have been published on the stability of cabazitaxel in infusion bags. Stabilis® database has selected a study demonstrating the stability of this molecule at 0.15 mg/mL for 28 days at 4 °C and 25 °C in polyolefin bags. The aim of this work was to study the physicochemical stability of Cabazitaxel Zentiva® solutions in vials after “opening” with a vented ChemoClave® Spike, at 25 °C, protected from light and in solutions diluted at 0.1 and 0.26 mg/mL in 0.9 % sodium chloride (0.9 % NaCl) or dextrose 5 % (D5W) in 3 types of infusion bags (Easyflex® and Viaflo® at 25 °C, Freeflex® between 2 and 8 °C, protected from light). Methods The chemical stability was analyzed after preparation and then after 14 and 28 days of storage by high performance liquid chromatography (HPLC), coupled to a diode array detector, at the analysis wavelength of 232 nm. The method has been validated according to ICH Q2 (R1) standards. For the study in infusion...
The use of continuous infusion to improve the therapeutic efficacy of time-dependent antibiotics ... more The use of continuous infusion to improve the therapeutic efficacy of time-dependent antibiotics has been demonstrated. There is still a lack of data to safely perform these continuous infusions. The objectives in this study were to evaluate the stability by using stability-indicating methods (High-Performance Liquid Chromatography) of 16 antibiotics in concentrated solutions, especially for administration in intensive care units and solutions in elastomeric diffusers at 37 °C for outpatient parenteral antimicrobial therapy. The solutions were considered stable if the percentage of the drug was ≥90%, and the colour and clearness remained unchanged. In syringes, the stability data vary from 4 to 8 h (h) for meropenem in Dextrose 5% (D5W) and Normal Saline (NS), respectively, 6 h for cefotaxime, 12 h for cefoxitin, and 24 h for aztreonam, cefazolin, cefepime, cefiderocol, ceftazidime/avibactam, ceftolozane/tazobactam in NS and D5W, and in water for injection for cloxacillin. A stabili...
Pharmaceutical Technology in Hospital Pharmacy, 2018
Background Many publications described sodium thiosulfate used to prevent the renal toxicity indu... more Background Many publications described sodium thiosulfate used to prevent the renal toxicity induced by cisplatin hyperthermic intraperitoneal chemotherapy. After around 60 or 90 minutes of hyperthermic chemotherapy, cisplatin was drained and then, sodium thiosulfate was infused by intravenous route. Sodium thiosulfate is used in two steps: a first step, at 9 g/m2 in 250 mL of 0.9 % sodium chloride over 10 minutes followed by a second step, at 12 g/m2 in 1000 mL of 0.9 % sodium chloride over 6 hours. The purpose of this work was to study the stability of sodium thiosulfate at 16 mg/mL in 0.9 % sodium chloride polyolefin bags 1000 mL and at 72 mg/mL in 0.9 % sodium chloride polyolefin bags 250 mL, at 25 °C, protected or unprotected from light. Methods Chemical stability was analysed by high performance liquid chromatography (HPLC) coupled to a photodiode array detector after preparation and after 6-hour or 24-hour storage. The method was validated according to the International Confe...
Pharmaceutical Technology in Hospital Pharmacy, 2019
In hospitals, the majority of medication therapy is administered intravenously. Especially, in in... more In hospitals, the majority of medication therapy is administered intravenously. Especially, in intensive care units, simultaneous of various injectable drugs is a common practice Drug incompatibilities have been reported to be associated with up to 60 % of all serious and life-threatening adverse drug events. Several databases are used by hospital pharmacists to answer the questions of (in)compatibility of co-administered injectable drugs. The objective of this article is to present the European databases on compatibility and stability of injectable drugs. According to a questionnaire which was sent to the National Hospital Pharmacy Associations of the 28 countries of European Community there are three national databases available in EU countries which are in alphabetical order, Belgium, France and Germany. The Belgian database is dedicated to injectable medications, is updated and distributed annually in French language on a USB key. STABILIS® is an international database giving in...
Objectives The measurement of osmolality is used by many authors as an additional stability crite... more Objectives The measurement of osmolality is used by many authors as an additional stability criterion of a drug in solution. In the current state of knowledge, no scientific publication correlates the osmolality values and the stability of a solution. To study the relevance of this analytical technique by measuring the osmolality of injectable solutions whose instability has been chemically demonstrated by high performance liquid chromatography (HPLC). Methods Selection of 13 drug preparations whose chemical instability has been demonstrated in the literature. Realization of three identical samples per selected preparation and measurements of the osmolality of the freshly prepared solutions, then, at various storage times until a chemical degradation of the molecule validated by HPLC of at least 10% and possibly up to 40%. Results Measurements of the osmolality were performed on five antibiotics (amoxicillin/clavulanic acid, cefepime, cefoxitine, meropenem and temocillin and cefoxit...
pH of 5.4. There are no published data to support how pH affects mitomycin C stability in 0.9% so... more pH of 5.4. There are no published data to support how pH affects mitomycin C stability in 0.9% sodium chloride solutions (NSS). Aim and objectives To study the stability of mitomycin C in NSS under different pH conditions and storage temperatures. Material and methods A stability study was carried out in eight NSS with a commonly used mitomycin C concentration of 0.12 mg/mL. Solutions were prepared in duplicate for each pH: 4.5, 5.5, 6 and 7. The pH was adjusted with sodium hydroxide or phosphoric acid. Four solutions were stored at room temperature and four at 5°C. Mitomycin C concentration was assessed at 0, 30, 60, 120 and 300 min and 24 hours by high performance liquid chromatography. The areas obtained were compared with the initial area (time 0 min) to calculate the remaining mitomycin C percentage. A 10% level of degradation is assumed as the limit in terms of stability. Results Remaining mitomycin C percentages were calculated. Analysing the results at room temperature, the remaining mitomycin C percentages were 98.5% at 30 min; 97.2% at 60 min; 92.7% at 120 min; 89.3% at 300 min; and 88.4% at 1 hour at pH=7. Remaining percentages were 99.2%, 98.6%, 97.6%, 95.8% and 87.4%, respectively, at pH=6. Percentages were 98.9%, 98,2%, 96.6%, 93.5% and 87.3%, respectively, at pH=5.5. Percentages for pH=4.5 were 98.0%, 96.7%, 88.1%, 85.4% and 83.2%, respectively. The concentration of all solutions remained above 90% of the initial concentration after 1 hour, regardless of the pH value, in contrast with the values at 24 hours. Analysing the concentrations at 5°C, the remaining mitomycin C percentages were 99.2%, 98.4%, 97.3%, 94.9% and 90.0% at pH=7. Remaining percentages were 99.5%, 99.2%, 98.6%, 97.4% and 94.0%, respectively, at pH=6. Percentages were 99.8%, 99.6%, 99.2%, 98.4% and 95.3%, respectively, at pH=5.5. Percentages for pH=4.5 were 99.8%, 99.7%, 99.3%, 98.5% and 93.1%, respectively, for each time studied. All solutions stored in the fridge were stable over the 24 hours of the study. Conclusion and relevance We demonstrated that the stability of mitomycin C solutions decreased over time and with lower pH values in NSS. Furthermore, room temperature significantly affected mitomycin C stability. However, degradation was greatly reduced at 5°C, regardless of pH. This proves that mitomycin C solutions in NSS can be stored in the fridge for 24 hours.
knowledge when performing continuous infusion of cefepime in syringe. In elastomeric devices, cef... more knowledge when performing continuous infusion of cefepime in syringe. In elastomeric devices, cefepime solution at 50 mg/ mL in 0.9% NaCl stored at 37°C was unstable. These preparations are not recommended. In view of these results, the stability of cefepime in D5W in elastomeric devices was not studied.
Preliminary data was presented as a poster during the Hopipharm Congress in Bordeaux France, in M... more Preliminary data was presented as a poster during the Hopipharm Congress in Bordeaux France, in May 2018-Etude de stabilité physico-chimique de solutions d'étoposide diluées en poches polyoléfine à des concentrations comprises entre 0.38 et 1.75 mg/mL. ED'H, JV, PL, BD. University hospital of Nancy, France.
Pharmaceutical Technology in Hospital Pharmacy, 2018
Background Bendamustine is used for the treatment of non-Hodgkin lymphoma, chronic lymphocytic le... more Background Bendamustine is used for the treatment of non-Hodgkin lymphoma, chronic lymphocytic leukaemia and myeloma. The stability of bendamustine is highly dependent on temperature and chloride-ion concentration. Limited stability data are available. The objective of this work was to study the stability of the bendamustine reconstituted solution at 2.5 mg/mL and the diluted solution in normal saline and 1.5 % sodium chloride to evaluate a potential increase in stability. Methods A stability indicating High Performance Liquid Chromatography method with Diode Array Detection was used. A first study was carried out in glass vials and then in polyolefin containers at 0.25 and 0.60 mg/mL. Solutions were stored at room temperature and at 2–8 °C for 7 days. Results Stability was defined as a concentration above 95 % of the initial concentration [10]. The reconstituted solution at 2.5 mg/mL was stable for only 2 hours at room temperature and 8 hours at 2–8 °C. The stability of diluted sol...
Pharmaceutical Technology in Hospital Pharmacy, 2019
Background Cefotaxime sodium is an antibiotic used to treat severe infections such as in intensiv... more Background Cefotaxime sodium is an antibiotic used to treat severe infections such as in intensive care units (ICUs). The recommended dose of cefotaxime sodium can vary from 3 grams (g) to 24 g per day and publications have demonstrated that continuous administration of cefotaxime sodium is the preferred mode of administration. In ICUs, a minimum volume is used for patients requiring fluid restriction, leading to high concentrations of cefotaxime sodium. The objective was to study the stability of cefotaxime sodium solutions at 83.3 mg/mL and 125 mg/mL, diluted in 0.9 % sodium chloride (0.9 % NaCl) or in 5 % glucose (G5 %), stored in polypropylene syringes, after the preparation and after a 6-hour and a 12-hour storage at 20–25 °C. Methods Three syringes for each condition were prepared. At each time of the analysis, three samples for each syringe were prepared and analysed by high performance liquid chromatography (HPLC) coupled to a photodiode array detector. The method was valida...
Pharmaceutical Technology in Hospital Pharmacy, 2019
Background The objectives were to perform an observation of the administration of injectable drug... more Background The objectives were to perform an observation of the administration of injectable drugs in three ICUs, to identify injectable drugs administered by Y-site infusion or mixed in the same container, to compare with physical compatibility data available in the literature and to test the physical compatibility for missing data. Methods An observational study was realised over two weeks and patients receiving more than one injectable drug in the same line simultaneously were included. Physical compatibilities were assessed in pairs by comparing with three databases. For some missing data, three tests were realised for pairs including an anti-infective drug. Visual and subvisual evaluations were performed after the preparation, 1 and a 4-hour storage. Results A total of 389 combinations between two injectable drugs was observed for Y-site infusions and 31 mixtures in the same container. According to the literature, 21.1 % associations were physically compatible, 1.8 % as physica...
European Journal of Hospital Pharmacy: Science and Practice, 2013
Background The high off-label use of albumin persuaded the pharmacy to introduce a request form t... more Background The high off-label use of albumin persuaded the pharmacy to introduce a request form that uses the internationals guidelines to assess whether the use of albumin is appropriate. This has resulted in a clear reduction in the costs. Purpose To monitor the wards using six sigma methodology (a statistical concept that measures a process in terms of defects); to ensure that all procedures have been followed correctly. Materials and Methods 696 forms for albumin prescriptions coming from 26 wards (August to December 2011) were analysed using Minitab software, which cheques the frequency of the best correct requests (type 1), partially correct requests (type 2) and incorrect requests (type 3). For each ward the β coefficient was used to connect the relationship between the ward and their requests. The wards were grouped into 4 ranges on confidence intervals for the odds ratio (OR) of a width equal to 0.3 called A,B,C,D and then a final logistic regression analysis was made. Results The analysis showed that group A was the most efficient in terms of probability of obtaining better results, followed by groups D (OR 0.36), C (OR 0.19) and B (OR 0.09). The total number of requests received was: 43% type 1 (299/696); 26% type 2 (181/696); 31% type 3 (216/696). Group B showed the worst result with 51% type 3 requests (58% of the total requests for type 3). Using six sigma we have achieved a cost saving of about €15,000. Conclusions The results encourage us to apply this methodology to other fields. No conflict of interest. Stability of frozen Ceftazidime Solution in PolyProPylene SyringeS for intravitreal injeCtion
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