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1 APOTECA

2 Preparation of chemotherapy drugs with automation

3 APOTECAchemo

4 Workflow

5 Design

5 Performance evolution

6 Best practices

7 Quality

7 Maximum security and safety

9 Manual compounding challenges

10 Patient centered workflow

11 Customer experience

12 System features

In oncology, the integration of materials, information and activities requires the utmost care: the oncologist and pharmacy professionals become a team around the patient to ensure the highest quality, safety and efficiency in a continuously growing area of medicine. The rising incidence of cancer and the continuous introduction of new drugs escalates the complexity. In hospitals around the world, the development of new therapies with cancer-fighting drugs, customized to the individual patient occurs on a frequent basis. Once the treatment regimen is defined, orders are transmitted and lab parameters are satisfied, the preparation begins.

The manual preparation of chemotherapy carries its own set of risks. Consider:

| patient specific dosing and variability increases the possibility of error

| wrong patient label placed on the final container

| chemotherapy drugs are hazardous and exposure threatens operator health

| manual tasks can lead to operator repetitive stress and workplace injuries

| staff recruiting and retention can be challenging for chemotherapy

Many of our partners have highlighted the importance of managing the flow of information, capturing a reliable audit trail to monitor the history of each preperation. Data omissions and transcription errors can have serious consequences for the patient and possibly the provider healthcare organization. In this scenario, automation and measurement are valuable tools for increasing efficiency and safety. Loccioni humancare developed the first automatic system for hazardous drug compounding and currently has devices installed and operating in top class centers all over the world (USA, Europe, Japan).

Preparation of chemotherapy

drugs with automation

APOTECAchemo fully automates the complex and critical tasks associated with preparations of intravenous chemotherapeutic compounds.

APOTECAchemo is a robotic system capable of weighing the active ingredients and solutions, reconstituting powdered drugs (thanks to the use of a dedicated, six way anthropomorphic mechanical arm and actuators) preparing syringes, bags and other final containers while safely loading and unloading the materials and preperations.

APOTECAchemo provides for patient safety. Patients are protected by a unified, redundant safety system of technological advances such as automatic recognition of products, an automated weighing system and a barcode labelling process for total accuracy.

APOTECAchemo ensures sterility by utilizing five HEPA filters with total air exchanges every 2.3 seconds. This results in a self contained chamber for ISO 5 compliance (in accordance with ISO 14644).

APOTECAchemo also ensures safety for the pharmacy staff. The staff is protected from vapors and accidental exposure by restricting interaction with high risk medications. The compounding process takes place in a negative pressure, closed chamber, designed to prevent and contain any form of contamination.

APOTECAchemo further enhances the accountability of the provider institution with a fully automated audit trail with the ability to define process surveillance alerts, intelligent workflow queing and robust reporting for operational analytics. This is potentially helpful with risk management and clinical trials data reporting.

Since the beginning of the project, the rapid process of continuous development deployed by Loccioni humancare has enabled further significant progress with APOTECAchemo: automation becomes faster, more interconnected and simplistic. Reliability is the center piece of APOTECAchemo.

APOTECAchemo

Once accuracy and sterility concerns were mastered, our attention turned to optimizing throughput without sacrificing core measures in accuracy and sterility. After years of prototyping and experimentation, we applied a series of hardware and software changes to advance the performance in every measurement area. APOTECAchemo is the only chemotherapy robot in the world

with these proprietary design advances. The results have been profound. New management of the loading worklists, new carousel placements, new software platform, structural changes and carefully defined robotic arm routes, greatly improve the speed and performance of APOTECAchemo. This is the safest, fastest chemotherapy automation system we have ever produced.

Preparation

Single sample preparation syringe

Single sample preparation bag

Time (seconds)

100

145

APOTECAchemo is the result of numerous interactions with healthcare professionals, many years of evolving product development, and ergonomic

study such as that of Isao Hosoe, a noted aerospace engineer and designer, winner of four Compassi d’Oro (Italian industrial design award) awards.

Design

Performance evolution

10 complete preparations - 7 bags, 3 syringes in approximately 25 minutes

Each hospital has its own needs and work patterns and the integration of technology in hospitals requires attention and care.

The choice of APOTECAchemo is the first step in an ongoing partnership with Loccioni humancare to continuously improve efficiency, accuracy and safety. Our application specialists interact with medical oncologists, pharmacists, technicians and nursing to process a system startup plan. Skilled technicians perform a pre-installation visit to ensure a perfect match with the technical requirements of the site installation, method of installation and test activities necessary for the integration of information.

During the installation, all the parameters necessary for the proper functioning of the System are analyzed and configured in the machine. They are specific to the client (database of drugs, printing management, IT integration, etc).

Best practices

APOTECAchemo is the key node of a safer and more efficient care network.

Thanks to its full integrability with prescription order entry software (via interchange tables or HL7 messages), each stage of the oncology workflow can be fully controllable.

That means a completely paperless management, from prescription to administration, in a continuous flow of data, components and people.

| Safety is enhanced because manual transcription is no more needed, additional checks are added to the validation process and each step of the workflow (activities, materials, people) is fully traced. Add to those benefits the ones directly deriving from automatic compounding.

| Efficiency is enhanced because operators are no more required to perform no value-added tasks, drugs are automatically managed, idle times disappear.

That is what we call the safe and integrated onco-hematology workflow.

Integrability

Percentage frequency of medication errors for the various operational steps [L. L. Leape et al Jama 1995, 274, 35.]

Therapy errors

Administration 38%

Prescription 39%

Supply 12%

Transcription 11%

0% 100%

Percentage of samples contaminated surface samples divided by the active ingredients [T. Kiffmeyer et al. J Oncol Pharm Practice 2008, 14, 92.]

Surface contamination Fluorouracil

Gemcitabine

Methotrexate

Cyclophosphamide

Paclitaxel

Docetaxel

Etoposide

Ifosfamide

0 10 20 30 40

Percentage

Percentage of contaminated biological samples (urine) divided by the active ingredients [A. Barbieri et al. Epidemiol Prev 2005, 29, 87 (blue bar), C. Schreiber et al. Int Arch Environ Health 2003, 76, 11 (red bar)]

Biological contamination

0 10 20 30 40

Percentage

Cyclophosphamide

Ifosfamide

Epirubicin

Doxorubicin Cisplatin and Carboplatin

Methotrexate

Manual compounding challenges

In partnering with top class hospitals worldwide, Loccioni humancare relies the quality of its service and a team of skilled technicians. Loccioni humancare customercare guarantees safety, efficiency and performances of the APOTECAchemo by continuous preventive maintenance, remote assistance and on site intervention.

The help desk is always available to reply to each question and continously checks the status of APOTECAchemo through the VPN connection. Technicians are ready to assist 24 hours per day throughout the world. The support personnel are in direct contact with Research and Development to listen to the needs of each user (doctor, pharmacist, technicians, patient): the proposals are analyzed, developed and utilized to generate new functionalities within APOTECAchemo.

Courses are provided on site or at Loccioni facilities for the new staff in order to give continuity to the use of the System. Software updates are installed and training courses are held on the proposed new function.

With APOTECAchemo entering the pharmacy it is possible to join the APOTECACommunity, a team composed by users of the System worldwide and Loccioni humancare network. The team meets regularly to discuss and design new functionality developments and set future targets. The ultimate goal is total quality, the combination of maximum efficiency, process improvement, productivity gains, while reducing risks and improving the patient experience.

Customercare

APOTECAchemo manages

| Vials up to 100 ml, elastomeric pumps, IV bags up to 1000 ml, syringes 5, 20, 50 ml

Warehouse Area

| Carousel, vision system for drugs recognition, barcode reader

Preparation Area

| 6-axis robot, high precision scale, powder drugs mixer

Air treatment system

| 5 input HEPA filters and 1 output HEPA filter

Special waste collection unit

| Interchangeable rigid trash automatically sealed

User interface

| Touch screen

Size and weight

| Height 240 cm, width 260 cm, depth 190 cm (Including ventilation)

| Weight 3580 lbs

Electrical requirments

| Supply type: 3P+PE

| Connection Type grounding TT, TN, EN

| Input voltage (configurable at installation): 400 VAC ±10% 440 VAC ±10% 480 VAC -10%, +0%

| Frequency: 50/60 Hz

| Electrical power consumption: 5kW

Compliance

| EMC Class A (according to IEC 61326-1)

| ISO 5 (according to ISO 14644)

System features

Via Fiume 16, 60030 Angeli di Rosora, Ancona, Italy

Phone +39 0731 8161 Fax +39 0731 814700

[email protected] humancare.loccioni.com

www.apoteca.it