Robotic Automation is the Next Step for Hazardous Drug Compounding Practice

Hazardous Nature of Drugs

While all medications entail an element of risk to the consumer, those considered "hazardous" tend to be antineoplastic chemotherapy drugs used in the treatment of oncology patients. The mutagenic, cytotoxic and carcinogenic nature of these drugs makes them so effective at combating various forms of cancer. However, this simultaneously makes them extremely dangerous to the healthcare practitioners handling them.

Research conducted by the National Institute for Occupational Safety and Health (NIOSH), a division of the Center for Disease Control (CDC) has shown a link between exposure to these drugs and related health complications. These range from acute conditions such as rashes and skin infections, to long-term issues including miscarriages, birth defects and – in extreme cases – some forms of cancer. Those at greatest risk are hospital pharmacists, tasked to repeatedly compound large quantities of these drugs, in addition to nurses for administration to patients.

Current Practice in Pharmacy

Chemotherapy drugs are typically administered via an IV and remain highly patient-specific, compounded manually by in-house pharmacists.  Current compounding practices adhere to the NIOSH and USP chapter 800 recommendations for the use of protective measures throughout the storage, preparation, and administration of hazardous drugs.  These include the use of clean rooms and biological safety cabinets with external venting for compounding medications, while workers are required to utilize personal protective equipment (PPE) comprising of gowns, masks, safety goggles and double gloves.  A relatively new measure within the safe handling space is the introduction of Closed System Transfer Devices (CSTDs), designed specifically for hazardous drug containment during compounding and administration.

State of Automation Today

While automation in pharmacy compounding was first introduced in the 1990s, robotic systems have never experienced widespread adoption in hospital pharmacies for IV compounding. These systems tend to be cumbersome and bulky, are not easily integrated into existing infrastructure, and often require the complete remodeling of hospital pharmacies to accommodate them.  Capabilities are limited to compounding a narrow range of medications, while clumsy robotic arms and time-consuming measuring procedures significantly reduce productivity. Crucially, most systems do not prevent drug leakage or aerosols, making them wholly unsuitable for the compounding of hazardous materials.

How Advanced Robotics Can Change the Status Quo of this Industry

As robotic technology continues to advance, these improvements need to be incorporated into drug IV compounding systems. Cumbersome robotic arms, capable of handling only small amounts of medication doses at any time, must be replaced with simplified mechanisms to select and transfer drugs from station to station, increasing workflow and output. This is beginning to take place with advanced hazardous drug compounding robots, which utilize a multi-station compounding approach to minimize motion and preparation time, much like a factory assembly line.  

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Additionally, advanced robotics can enhance hazardous drug protection, reduce medication errors, improve compounding accuracy, and manage the increasingly individualized prescriptions needed to effectivity treat cancer patients. This is achieved by integrating advanced image processing algorithms to monitor and control all stages of the compounding process and dose verification.

For large scale adoption, compounding robots must become financially accessible. Current systems can cost up to two million dollars, with the addition of expensive installation costs. New systems will need to be small enough to easily integrate into existing pharmacy clean rooms and at price points compatible with most hospital budgets.  Finally, they must include integrated CSTDs, in keeping with the US Pharmacopeia (USP) best practices, found in the USP chapter 800, which strongly advises the use of closed systems in hazardous drug compounding practice and mandates them in the drug administration process. These robots must be designed from scratch, as simply integrating CSTDs into existing robots will make them even more cumbersome and not achieve the desired efficiency.

The next step in the pharmacy compounding industry is to automate the risk-laden task of manual compounding through integrating advanced robotics.  As robots begin to achieve the necessary throughput and accuracy, pharmacies will benefit from increased efficiency, creating a safer working environment for healthcare workers while reducing errors to protect patients.

Marino Kriheli, Co-Founder, Equashield

Marino Kriheli has some twenty years' experience in industry project management, in both the industrial engineering and medical device manufacturing spaces.

In 2010, Marino co-founded Equashield, a leading provider of a full range of manual and automated solutions for the compounding and administration of hazardous drugs. Equashield has recently entered the robotics space with Equashield® Pro, the industry's first closed system drug compounding robot.

Prior to founding Equashield, Marino co-founded medical device manufacturer Plastmed, an OEM for Johnson & Johnson.