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Drug compounding in hospital pharmacy

Compounding of medication

Hospital Pharmacies are responsible for the safe and accurate compounding of medication. This compounding can be performed either manually, or with the help of automation and robotics. Which method is used depends entirely on the type and quality of drugs that need to be prepared. Each of these production methods are associated with their own risks and benefits. B. Braun's extensive portfolio focuses on helping hospital pharmacies compound drugs accurately and safely irrespective of how they are produced.

A healthcare professional draws red liquid from a bottle using a syringe

Products for hazardous drug preparation

Cyto-Set® Mix, Cyto-Set® Line

Single-use, sterile infusion system for the preparation and administration of different cytotoxic drugs via one single closed line-system by gravity or pressure with bottles and bags according to the SPC (Summary of product characteristics) of the drugs/solutions. Cyto-Set® is used for the application of cytotoxic agents in a closed system.The Cyto-Set® system reduces the probability of contamination of person and environment when preparing and applying cytotoxic drugs ensured by its technical components forming a closed system and the resulting workflow.Cyto-Set® MixConnection system for Cyto-Set® gravity infusion- and Infusomat® Space sets.The Cyto-Set® Mix allows to connect a normal infusion container with a solution dedicated for cytotoxic drugs (NaCl 0,9% or Glucose 5%) to vent the line. The drug is put in the container via a needle-free injection valve. So the line of the Cyto-Set® Mix leading to Cyto-Set® Infusion, Cyto-Set® Infusomat® Space or Cyto-Set® Infusomat® plus is free of cytotoxic drugs.Cyto-Set® LineConnection system for Cyto-Set® gravity infusion- and Infusomat® Space sets.Cyto-Set® Line connects primed solutions. This component consists of only one spike and a polyurethane transition tube, clamp and a fill-stop-cap (Prime Stop).Cyto-Set® can be used for all patients to whom cytotoxic drugs are prescribed in hospitals. Depending on the particular therapeutical concept and sensibility of the tumor to one or more cytotoxic agents the administration of these drugs represents an important role besides surgery and radiation therapy.

Mini-Spike® 2 Chemo

Vented dispensing pin with swabable needle-free access valve designed for injections and withdrawals of toxic fluids from containers (i.e. glass vials, semi-rigid and glass containers).Main benefits:Protection against the risk of chemical contamination:0.2 μm air filter prevents toxic aerosols from escapingSwabable valve reduces the risk of drug spillageProtection against sharps injury through needle-free technologyProtection against the risk of microbiological contaminationSwabable valve automatically closes upon disconnection of syringeNeedle-free access valve easy to swab with alcohol pad (i.e. Softa®-Cloth CHX 2%) thanks to its flat surfaceIntegrated air vent making over-pressure release techniques avoidableCompatible with Luer-Lock and Luer-SlipAllows multiple access for direct aspiration or fluid injectionConsistent flow rateTwo-lumen spike fitting with common vials and containersDesigned to ensure clean, leak-proof and convenient injections and withdrawalsProtection against DEHP exposureProduct is PVC-, DEHP, and Latex-freeFurther benefits:Mini-Spike® 2 Chemo:Protection against the risk of particulate contamination through an inbuilt 5 µm particle filter which retains i.e. undissolved lyophilisates, rubber and plastic particlesMini-Spike® 2 Chemo Micro-Tip:Micro-Tip suitable for efficient withdrawal from smaller drug vials in terms of neck diameter

PureSite Closed Male Connector

The permanent connection with the female Luer Lock syringe or IV tubing set and the auto-closure feature of the male Luer Lock connector, allows the user to have a safe protection against chemical and microbiological contamination. Needle-free technologyNon-removable connection to syringe and/or IV set from the female Luer Lock connectorMale Luer Lock designed with microbial ingress barrierAuto-closure technology upon disconnectionCompatible with any standard Luer Lock connectionBroad use of application with proven chemical compatibility of most commonly used hazardous drugsBi-directional fluid flowPVC-, DEHP-, Latex-free

Dust Cover Cap

One-hand cap attachmentFilled syringe (> 20 ml) can stand vertically alone with PureSite Dust Cover CapPVC-, DEHP-, Latex-free 

Omnifix® Luer Solo

Omnifix® Luer Solo is a hypodermic 3-piece syringe with Luer connector and without detached needle. The single-use device is intended to be used for the following purposes:Aspiration and injection of fluids in combination with adequate medical devices via clinically intended access routes (intravascular, intramuscular, subcutaneous, intracutaneous injections, intrathecal, intranasal, enteral, intraurethral, intravaginal, joint and soft tissue injections).Admixture of drugs to an infusion solution according to SPC of medication in combination with adequate medical devices.Extraction of body fluids and tissue via aspiration together with adequate medical devices.The devices are intended to be used for which the respective intended therapy for 3-piece syringes is prescribed (e.g. infusion therapy, injection therapy, nutrition therapy, extraction of body fluids and tissue). No gender or age related limitations. 3-piece syringes can be used for adults, pediatric and neonates.The syringe barrel and plunger are made of polypropylene. The plunger stopper with double sealing ring is made of polyisoprene.

Products for non-hazardous drug preparation

Ecoflac® Mix

Provides a stable connection between both containersSpecially designed to fit with Ecoflac® plus and standard vialsConvenient handling helps improving aseptic technique

Ecoflac® Connect

Provides a stable connection between vial and container. Especially designed to fit with Ecoflac® plus and standard vialsProtection for staff and patients through the closed systemLow chance of medication error since vial remains attached during infusionEasy handling and ergonomic design save time, reduce complexity and improve aseptic technique

Mini-Spike® 2 Filter

Vented dispensing pin with swabable needle-free access valve for injections and withdrawals of lyophilized fluids from containers (i.e. glass vials, semi-rigid and glass container). Featured with an integrated air filter (0,45 µm) and particle filter (5 µm).Protection against the risk of chemical contamination:Bacteria retentive 0,45 µm air filter reduces contamination of drug with environmental airProtection against the risk of particulate contamination:Inbuilt 5 µm particle filter retains i.e. undissolved lyophilisates, rubber and plastic particlesProtection against sharps injury through needle-free technologyProtection against the risk of chemical contamination:Swabable valve reduces the risk of drug spillageProtection against the risk of microbiological contamination:Swabable valve automatically closes upon disconnection of syringeNeedle-free access valve easy to swab with alcohol pad (i.e. Softa®-Cloth CHX 2%) thanks to its flat surfaceMore time for patients or operative tasksIntegrated air vent making over-pressure release techniques unnecessary:Compatible with Luer-Lock and Luer-SlipAllows multiple access for direct aspiration or fluid injectionConsistent flow rateTwo-lumen spike fitting with common vials and containersDesigned to ensure clean, leak-proof and convenient injections and withdrawalsProtection against DEHP exposure:Product is PVC-, DEHP, and Latex-freeMini-Spike® 2 Filter Micro-Tip:Micro-Tip suitable for efficient withdrawal from smaller drug vials in terms of neck diameter

Easypump® II ST/LT

Easypump® elastomeric infusion pumps are designed to give clinicians and nurses the option of delivering pre-determined amounts of medication to the patient in a continuous and accurate manner, either at the hospital or at home.Easypump® is independent of main power supplies or batteries, enabling the patient to be treated in an ambulatory manner. Medication is delivered to the patient by positive pressure applied by the elastomeric membrane. The flow rate is determined by the combination of the flow regulation device (flow restrictor) and the positive pressure of the elastomeric membrane. This pressure delivers the solution against the back pressure of catheters and blood pressure in the patient. Back pressure affects the flow rate.

A healthcare professional stands in a hospital room, wearing a mask, and presses on the screen of an automated compounding device

A draft showing two hands with a patient wearing a mask in between

A patient in a hospital bed

Products for hazardous drug preparation

KIRO Oncology

KIRO Oncology helps to protect health care workers from the potential risks associated with manual drug admixture, especially from exposure to hazardous drugs. Additionally, the fully automated process optimizes the drug preparation output of the Hospital Pharmacy and enables digital control and tracing of complex workflows to help reducing medication errors. The benefits of B. Braun Safe Infusion Systems, combined with Kiro Grifols Automated Compounding Portfolio offer a complete solution for safe automated drug admixture and delivery.

OncoSafety Remote Control®

OncoSafety Remote Control® is a technology supporting nursing during the administration of Onco-hematological treatments. OncoSafety Remote Control® daily receives from HIS (Hospital Information System) the information regarding treatments to be administered by the nurse for each patient. The HIS information includes administration conditions such as patient name, rate, volume, time, order of administration ... etc. The nursing staff will proceed to administer these treatments received electronically from the HIS, following the established order/sequence introduced in HIS to avoid medication errors and ensuring total traceability. The wireless devices of OncoSafety Remote Control® with barcode readers will support the nurse by matching patient and chemo drug and order, according to information set in HIS. Additionally, OncoSafety Remote Control® will receive information (such as volume infused and time lapse) from the infusion pump software to create records. Nurses can also record side effects occurred during treatment.

B. Comp

The B. Comp Application grants you an easy access to compatibility data of selected drugs with the B.Braun products

PureSite Closed Male Connector

The permanent connection with the female Luer Lock syringe or IV tubing set and the auto-closure feature of the male Luer Lock connector, allows the user to have a safe protection against chemical and microbiological contamination. Needle-free technologyNon-removable connection to syringe and/or IV set from the female Luer Lock connectorMale Luer Lock designed with microbial ingress barrierAuto-closure technology upon disconnectionCompatible with any standard Luer Lock connectionBroad use of application with proven chemical compatibility of most commonly used hazardous drugsBi-directional fluid flowPVC-, DEHP-, Latex-free

Omnifix® Luer Solo

Omnifix® Luer Solo is a hypodermic 3-piece syringe with Luer connector and without detached needle. The single-use device is intended to be used for the following purposes:Aspiration and injection of fluids in combination with adequate medical devices via clinically intended access routes (intravascular, intramuscular, subcutaneous, intracutaneous injections, intrathecal, intranasal, enteral, intraurethral, intravaginal, joint and soft tissue injections).Admixture of drugs to an infusion solution according to SPC of medication in combination with adequate medical devices.Extraction of body fluids and tissue via aspiration together with adequate medical devices.The devices are intended to be used for which the respective intended therapy for 3-piece syringes is prescribed (e.g. infusion therapy, injection therapy, nutrition therapy, extraction of body fluids and tissue). No gender or age related limitations. 3-piece syringes can be used for adults, pediatric and neonates.The syringe barrel and plunger are made of polypropylene. The plunger stopper with double sealing ring is made of polyisoprene.

Cyto-Set® Mix, Cyto-Set® Line

Single-use, sterile infusion system for the preparation and administration of different cytotoxic drugs via one single closed line-system by gravity or pressure with bottles and bags according to the SPC (Summary of product characteristics) of the drugs/solutions. Cyto-Set® is used for the application of cytotoxic agents in a closed system.The Cyto-Set® system reduces the probability of contamination of person and environment when preparing and applying cytotoxic drugs ensured by its technical components forming a closed system and the resulting workflow.Cyto-Set® MixConnection system for Cyto-Set® gravity infusion- and Infusomat® Space sets.The Cyto-Set® Mix allows to connect a normal infusion container with a solution dedicated for cytotoxic drugs (NaCl 0,9% or Glucose 5%) to vent the line. The drug is put in the container via a needle-free injection valve. So the line of the Cyto-Set® Mix leading to Cyto-Set® Infusion, Cyto-Set® Infusomat® Space or Cyto-Set® Infusomat® plus is free of cytotoxic drugs.Cyto-Set® LineConnection system for Cyto-Set® gravity infusion- and Infusomat® Space sets.Cyto-Set® Line connects primed solutions. This component consists of only one spike and a polyurethane transition tube, clamp and a fill-stop-cap (Prime Stop).Cyto-Set® can be used for all patients to whom cytotoxic drugs are prescribed in hospitals. Depending on the particular therapeutical concept and sensibility of the tumor to one or more cytotoxic agents the administration of these drugs represents an important role besides surgery and radiation therapy.

Dust Cover Cap

One-hand cap attachmentFilled syringe (> 20 ml) can stand vertically alone with PureSite Dust Cover CapPVC-, DEHP-, Latex-free 

Mini-Spike® Chemo

The range of red Mini-Spike® Chemo are used to withdraw or inject cytostatic and cytotoxic drugs from medication vial or semi-rigid containers.Featured with a 5µm particle filter and a 0,2µm bacteria retentive air filter, the red Mini-Spike® Chemo are a rational solution to reduce chemical, microbial and particle contamination.The integrated air channel of Mini-Spike® Chemo enables to automate pressure balancing steps which significantly increase efficiency. The 0,2µm air filter retains all aerosols which the toxic powdered drugs produces during reconstitution.Designed with a snap cap, Mini-Spike® Chemo enables to reduce touch contamination, by allowing the user to work conveniently away from the critical luer connection.The molded tight-sealing cap improves working hygiene by preventing loss of cap and potential leakages when closed.The ergonomic design of Mini-Spike® Chemo ensures an optimal flow rate during injections and withdrawals.Mini-Spike® Chemo is PVC-, DEHP, and Latex-free

Ecoflac® plus

A wide range of B. Braun solutions for infusion are available in Ecoflac® plus, which are used for administration of fluid and essential electrolytes for maintenance, correction and replacement and for compatible drugs as carrier. Also a range of pre-mixed injectable drugs is available in Ecoflac® plus. Advantages: Ecoflac® plus container design characteristics help reduce the potential risks during the processes of drug admixture and delivery. The ergonomic design of the bottle and its large neck ring help protect from sharps injuries and allow a comfortable and stable handlingThe Twincap port system has two identical ports which can be used for admixture and/or delivery interchangeablyThe germ-free port under the aluminum foil can be used without prior disinfection and thanks to its design protects from potential microbial ingress into the IV solutionThe full collapsibility of Ecoflac® plus in a closed system helps to reduce microbial and chemical contaminationThe regular flow rate and accurate graduation scale facilitate patient monitoring and help reduce medication errorsThe large-sized text, color coding and geometrical elements of the label help reduce potential selection errorsThe material resistance of Ecoflac® plus helps to prevent damages during transportThanks to its shape, Ecoflac® plus is easy to store and countThe Polyethylene material is free of PVC, DEHP and Latex offers good compatibility with most drugsThe wide range of Protective Admixture Tools especially designed for Ecoflac® plus allow a needle-free drug admixture

References

1.Carrez L, Falaschi L, Cingria L, Sadeghipour F, Bouchoud L, Bonnabry P. Organisation et sécurisation du circuit des chimiothérapies: exemple de la pharmacie des Hôpitaux Universitaires de Genève. Pharmactuel 2014;47: 119–24.

2. Soumoy L, Hecq JD. Automated Compounding of Intravenous Therapy in European Countries: A Review in Pharmaceutical Technology in Hospital Pharmacy 2019;4(2): 51-57. https://doi.org/10.1515/pthp-2019-0008.

3. Seger AC, Churchill WW, Keohane CA, Belisle CD, Wong ST, Sylvester KW, et al. Impact of robotic antineoplastic preparation on safety, workflow, and costs. J Oncol Pract 2012;8: 344–9.

4. Banasser G, Karpow C, Gaunt MJ, Grissinger M. Medication Errors in Outpatient Hematology and Oncology Clinics. Pa Patient Saf Advis 2017;14(4).

5. Kromhout H, Hoek F, Uitterhoeve R, Huijibers R, Overmars RF, Anzion R, Vermeulen R. Postulating a dermal pathway for exposure to anti-neoplastic drugs among hospital workers. Applying a conceptual model to the results of three workplace surveys. Ann Occup Hyg 2000;44(7): 551-60.

6. Schierl R, Böhlandt A, Nowak D. Guidance Values Surface Monitoring of Antineoplastic Drugs in German Pharmacies. Occup Hyg 2009;53(7): 703-711.

7. Gielen K, Goossens A. Occupational allergic contact dermatitis from drugs in healthcare workers. Contact Dermatitis 2001;45(5): 273-9.

8. Swedish Work Environment Authority. Microbiological Work Environment Risks – Infection, Toxigenic Effect, Hypersensitivity. AFS 2005:1.