The Challenge

Traditional needle and syringe-based manual pharmacy compounding practices may present significant risks to clinician and patient safety.1

Pharmaceutical drug compounding is required in order to create unique patient medication mixes. However, when these drugs are compounded manually, human factors such as interruptions, fatigue, and memory lapse are recognized in clinical literature to contribute to preparation errors.1,2

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Contamination of patient drug preparations can result in serious injury and patient mortality. 

Recent incidents involving drug contamination and patient deaths associated with a compounding pharmacy underscore the safety challenges associated with current drug compounding processes throughout the country. Organizations such as the National Institute for Occupational Safety and Health (NIOSH) and the United States Pharmacopeia (USP <797>) have recommended the use of closed systems to help protect clinicians from exposure to hazardous drugs while protecting the patient preparation from exposure to environmental contaminants.3,4

In the oncology pharmacy, exposure to hazardous drugs during preparation and reconstitution presents a significant risk to healthcare worker safety. 

The toxicity of hazardous drugs and the dangers of prolonged exposure have been proven to cause hair loss, skin rashes, infertility, miscarriage, birth defects, and even leukemia or other forms of cancer in healthcare workers.5,6,7,8 Studies have shown that workers can be at risk of exposure to these drugs throughout their lifecycle - from manufacturing, to distribution, to use in the clinical or home care environment, to waste disposal. Healthcare workers who handle these drugs may be exposed by inhaling aerosols or dust generated during pharmacy preparation and nursing administration, or by direct contact with the skin during accidental needlesticks, spills, or spill cleanup.

Clinicians engaged in pharmacy compounding may also be at risk for musculoskeletal injuries.9

Sterile drug compounding requires technicians to prepare medications under the hood of a biological safety cabinet. Many of these cabinets have a sash window that restricts range of motion. This restriction can force technicians to hold awkward, static postures while compounding medications. In addition, repetitive motions, such as filling syringes, as well as contact stresses, such as leaning on work surfaces, can also contribute to musculoskeletal injuries.

Our Solution

The Diana hazardous drug compounding system is the world’s first needlefree user-controlled automated sterile compounding system for the accurate, safe, and efficient preparation and reconstitution of hazardous drugs.

The Diana system takes the variation out of manual drug preparation practice and lets clinicians create a repeatable sterile preparation and safe-handling process. The Diana system is designed to facilitate both low-volume and high-volume preparation of drugs, fits inside the pharmacy’s biological safety cabinet and complements existing pharmacy workflows. The system also provides automated checks and reminders to improve workflow efficiency and safety.

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Accurate, safe, and efficient hazardous drug compounding technology right at your fingertips. 

  • User-controlled automated compounding for maximum accuracy & safety.
    Unlike automated technologies that require huge investments and do not fit within existing workflows, the Diana system cost-effectively keeps pharmacists and technicians in control of the compounding process from beginning to end.

  • ASEClosed system assures safety of clinicians and the sterility of the mix.
    The Diana system fits under the hood of your biological safety cabinet and protects clinicians from exposure to hazardous drugs and accidental needlesticks while protecting the patient preparation from exposure to environmental contaminants.

  • Reduces risk of repetitive stress injuries.
    Free up pharmacists and technicians from many of the repetitive motions required during preparation and reconstitution and reduce the stresses and injuries that can occur as a result.

  • Increases efficiencies and reduces drug waste.
    By helping you improve the efficiency of high-volume compounding, the Diana system can deliver workflow efficiencies while helping you reduce drug waste by extracting every drop of drug from every container.

References

  1. http://www.ashpmedia.org/advantage/2cpe/compounding/handout_compounding_ondemand.pdf

  2. http://www.usp797.org/QA-E25.htm

  3. NIOSH (US). Prevention of Occupational Exposure to Antineoplastics and Other Hazardous Drugs in Healthcare Settings. September 2004.

  4. United States Pharmacopeia (USP) 797. Pharmaceutical Compounding, Sterile Preparations. 2007.

  5. Connor TH, McDiarmid MA. Preventing occupational exposures to antineoplastic drugs in health care settings. CA Cancer J Clin 2006; 56: 354-365.

  6. National Institute for Occupational Safety and Health. NIOSH Alert: preventing occupational exposures to antineoplastic and other hazardous drugs in the health care setting. Centers for Disease Control and Prevention, National Institute for Occupation Safety and Health, DHHS (NIOSH) Publication No. 2004-165. Washington, DC: U.S. Department of Health and Human Services.

  7. Valanis B, Vollmer WM, Steele P. Occupational exposure to antineoplastic agents: self-reported miscarriages and stillbirths among nurses and pharmacists. Journal of Occupational and Environmental Medicine: 41(8) August 1999;632-638.

  8. Skov T, Maarrup B, Olsen J et al. Leukaemia and reproductive outcome among nurses handling antineoplastic drugs. British J of Industrial Medicine 1992; 49:855-861.

  9. http://www.viha.ca/NR/rdonlyres/BBBA8A3A-8C54-484D-9CF3-5A2B8E0A4971/0/guide_ohsah_ergo_guide_for_hospital_pharmacies.pdf