Are you ready for USP 800?
The clock is ticking on implementation of new guidelines designed for the proper handling of hazardous drugs in oncology and other settings.
Cancers occur in domestic animals, particularly household pets, at almost the same level as they do in humans. The methods of treating our mammalian companions do not differ drastically when compared to how we treat human oncology patients — namely via the use of chemotherapy drugs. These drugs are cytotoxic and anti-neoplastic, posing considerable risk to health care professionals tasked with treating the disease.
Occupational exposure to such agents can lead to significant long-term complications, such as infertility, birth defects and even some forms of cancer. According to the National Institute for Occupational Safety and Health (NIOSH), about 500,000 veterinary health care workers are estimated to be at risk of exposure.
Introducing USP <800>
Awareness of the risks and the importance of protecting health care professionals has grown over the years. In 1996, NIOSH unveiled the National Occupational Research Agenda (NORA) with the intention of identifying the information and actions most urgently needed to improve occupational safety and health. This past February, NORA listed veterinary/animal care as a target audience requiring reform and acknowledged that veterinarians are exposed to diverse hazards that often exceed those in human health care.
In 2010, NIOSH published recommendations designed to help veterinarians mitigate the risk of exposure when they handle hazardous drugs. The guidelines required veterinarians to use various levels of engineering controls — primary, secondary and supplemental — to serve as barriers between people and hazards. The guidelines endorsed using closed-system transfer devices (CSTDs), specialized syringes and adaptors to keep all hazardous materials within the system and prevent environmental contaminants from spreading.
Combatting the threat of hazardous drug exposure is the United States Pharmacopeia’s General Chapter <800>, which goes into effect Dec. 1, 2019. USP < 800>, based on the original Chapter <797>, which was introduced in the 1990s, focuses on protecting all workers in human and veterinary medicine who handle hazardous drugs.
What’s Done Today
The majority of U.S. veterinary clinics consist of small teams of veterinarians who, if they don’t refer cases to a specialist, are likely to provide chemotherapy regimens for their patients. Larger clinics often have a cancer specialist on staff who is well-educated about the proper handling of hazardous drugs and follows compliance protocols like those used at some small infusion centers for human patients.
According to a recent study of 148 board-certified veterinary oncologists and 20 specialty hospitals, 92% of hospitals use engineering controls and CSTDs, but only 19% met USP <800> standards. This demonstrates an overall awareness of occupational safety issues but recognizes the need for more measures.
Ensuring that veterinarians fully comply with USP drug-handling standards is essential for everyone’s protection. Yet, some doctors undoubtedly administer chemotherapy drugs without necessary equipment. They often lack the budgets to build USP <797> or <800> clean rooms and implement CSTDs.
Steps Towards Compliance
Veterinary oncology specialists are familiar with CSTDs, biological safety cabinets and personal protective equipment such as specialized gloves and gowns. However, smaller general clinics tend to be less aware of all the options for preventing contamination by hazardous drugs. The risk of exposure increases mainly due to animal patients being unwilling to consume drugs or physically resisting drug administration. Research shows that animal resistance significantly raises the risk of contamination beyond work stations.
For veterinary clinics aiming to become compliant ahead of the December 2019 deadline, the first step is for veterinarians to start using engineering controls and personal protective equipment, and then progress to full USP General Chapter <800> implementation, which requires the use of CSTDs and other drug-handling equipment.
The USP safety guidelines were created to limit the risk of contamination and keep oncology health practitioners and drug handlers safe. The veterinary world has a duty to increase awareness and make all clinics USP <800> compliant. Only through awareness, education and the implementation of standards can veterinarians, team members and patients be kept safe.
Ronak Kadakia is director of marketing and business development for Equashield, a provider of closed-system transfer devices for the compounding and administration of hazardous drugs in oncology settings.
The United States Pharmacopeia’s General Chapter <800> sets standards for the safe handling of hazardous drugs. Failure to follow safety guidelines endangers staff members, patients and the environment. More information is available at http://bit.ly/2Vhd8Gy.