Drug reconstitution and compounding made easier and safer

Drug reconstitution and compounding for administration to patients in hospitals or at home can pose risks to workers and patients. Benedetta Cadorin, Haemopharm Healthcare, describes a system that is simpler, safer and more cost-effective

Fillchoice room from Haemopharm was a runner-up in the CPhI Pharma Awards in Paris in October 2014

Haemopharm Healthcare is an Italian manufacturer of flexible bags and medical devices that has been in operation since the 1970s. In addition to its manufacturing operations, Haemopharm also invests heavily in research and development, mainly focused on reducing the concerns arising from pharmaceutical handling, such as drug reconstitution and compounding.

There are many drugs that need to be reconstituted or mixed with a liquid before they can be administered. This practice is currently carried out in hospital pharmacies, where pharmacists manipulate often dangerous materials such as antitumorals, antibiotics and other drugs, either under laminar flow hoods or in isolators.

The multi-step procedure is long and complicated, and this increases the possibility of mistakes. There are high costs involved for the disposable equipment and consumables, and for the time of pharmacists and nurses.

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Figures 1 to 5 show a typical drug reconstitution process using the Fillchoice room vial-in-a-bag

There are important drawbacks relating to this standard practice, which are confirmed by data in the literature: mistakes have been found in 14% of medication preparations, relating to either the sterility of the products, unreadable writing or data on the reconstituted drug packaging, or in the preparation or administration phase.

Furthermore, any leakage, creation of aerosols or accidental breakage of the vial exposes the operators to serious health risks, such as toxicity, reproductive toxicity and carcinogenicity. There are some studies that report that residual drug compounds have been found in the urine of nurses and pharmacists, and on door handles, sockets and furniture, not only in the hospital pharmacy but also in patient rooms: this can be explained by the transport of the reconstituted drug from the hospital pharmacy to the ward, and presents a patient risk.

There are a few ready-to-use products for the reconstitution of certain drugs currently available on the market but those that exist have limitations in terms of volume, and require the use of bespoke aseptic filling machines.

Thanks to its links with the medical/pharmacy community, Haemopharm understood there were specific needs in the drug reconstitution and compounding pharmacy fields, and has tried to find a solution that will connect a standard sterile vial with a sterile solvent, while maintaining sterile conditions without the need for isolators or a hospital pharmacy.

This is how Haemopharm came to invent and patent its latest innovation, ‘Fillchoice room’. This innovative system for drug reconstitution and pharmacy compounding provides both the vial and the solvent in a single closed package and maintains sterile conditions when connecting the vial and the solvent.

As the system is completely closed and already contains everything that is required for the drug reconstitution and compounding inside the bag, the hospital pharmacy, dedicated equipment and personnel can all be dispensed with. Fillchoice room can be used directly in the ward, next to the patient’s bed.

When the vial-in-a-bag arrives in the hospital it is ready-to-use; the nurse simply has to follow an easy procedure to reconstitute the drug and begin the infusion to the patient (see Figures 1 to 5). The procedure is as follows:

  1. Press the vial to the Fillchoice connector, to open the vial.
  2. Snap off the breakable cone and fill the vial partially by gently squeezing the bag and allowing the solvent to fill the vial.
  3. Squeeze the bag a few times to complete solubilisation of the active principal, mix and return it to the bag by continuing to squeeze and release.
  4. Hang the bag and connect the infusion line to the bag port and to the patient and start a standard infusion, directly from the bag where the drug has been reconstituted.

Major benefits

Fillchoice room offers many advantages.

A closed system: Because it is closed, it is safe for the operator and patient and it guarantees 100% isolation of the drug from external environment and contamination. Pharmacists and nurses are isolated from the drugs, obviating any potential harm from leakage, aerosol or accidental breakage of the vial. Safety is increased by the direct sterile vial-bag connection; Fillchoice room is the first system to connect the vial and bag in sterile conditions.

Clear visibility of the drug in situ: Because the packaging is completely transparent, the operators can see what is inside the bag, such as the vial, the label (which carries important data, such as the name of the drug, the quantity, the concentration, the expiry date, etc). This means there are no problems of unreadable data, which minimises medical errors and favours the correct match of therapy to patient.

Furthermore, the system packages the precise amount of diluent and drug and guarantees the complete emptying of the vial contents, improving dosing accuracy.

Ready to use: There is no need for a hospital pharmacy and the reconstitution can be easily performed directly in the ward, next to patient’s bed. Fillchoice room is ready to hang for infusion into the patient from the same bag in which the drug has been reconstituted, saving pharmacist and nurses’ time and effort.

An important added value of the Fillchoice room system is compliance with the practice of homecare therapies: in most instances, reconstituted drugs are administered in non-clinical settings (typically at home) by patients or caregivers who are not trained healthcare professionals. Fillchoice room is safe, easy to use, without risk of harm for the user, and thus suitable for non-professionals.

No need to modify standards: the main components are the same used in standard practice – a drug and a solvent. There is no need for special regulatory authorisation and the system can be easily adjusted for several drugs.

Customisation: Fillchoice room is available for many types of drug and solvent, and any vial size or solvent volume. It is also possibile to customise the bag with multiple connectors for multiple vials if a particular mode of compounding is required (useful for some antibiotics) and the system remains the same – a sterile connection vial-bag; one single package, with 100% isolation and ready-to-use.

Fillchoice room can also be provided with different bag materials on request for compatibility with particular drugs or solvent.

Sustainability: The system enables the complete emptying of the vial, even if the drug forms a layer of foam. This means that the patient receives the correct amount of drug and there is less waste of the active principal as it is all returned to the bag and infused to the patient. Fillchoice room also helps to limit the overfill of vials.

Furthermore, cost-savings can be made on solvent, consumables and disposables, management and logistics of pharmacy equipment.

Fillchoice room is a registered trademark of Haemopharm Healthcare