Glossary

The American Society of Health-System Pharmacists (ASHP) is a professional organization representing pharmacists serving as patient care providers in hospitals, health systems, ambulatory clinics, and other healthcare settings. ASHP has over 60,000 members, including pharmacists, student pharmacists, and pharmacy technicians. For more than 80 years, ASHP has led efforts to improve medication use and boost patient safety.

Antineoplastic drugs, also known as chemotherapy medications or cytotoxic agents, are a class of pharmaceuticals specifically designed to inhibit the growth and proliferation of cancer cells. These potent drugs target malignant cells and disrupt their ability to divide and reproduce, effectively controlling the spread of cancer within the body. Due to their cytotoxic nature, antineoplastic drugs can also pose a significant risk to healthcare professionals handling them, as exposure may lead to serious health consequences.

As a result, closed system drug-transfer devices (CSTDs) are vital tools for ensuring the safe handling, preparation, and administration of antineoplastic drugs. CSTDs function as a barrier between the healthcare worker and the hazardous medication, preventing the escape of drug vapors, aerosols, and spills during the transfer process. By mitigating the risk of exposure to these hazardous substances, CSTDs play a crucial role in safeguarding the health and well-being of healthcare professionals involved in the treatment of cancer patients.

NIOSH, the National Institute for Occupational Safety and Health, is a top US health protection agency. As part of the Centers for Disease Control and Prevention, NIOSH defines a Closed System Drug-Transfer Device (CSTD) as “a drug transfer device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of the hazardous drug or vapor concentrations outside the system.”

There are two CSTD design types covered by the NIOSH definition: CSTDs that operate using air-cleaning technology, and CSTDs that use a physical barrier. Both CSTD types can be used to prevent hazardous drug release into the environment.

A drug leak in the context of chemotherapy drugs refers to the unintended release or spillage of these drugs. This can occur during the handling, storage, or transportation of the drugs, and it can pose a serious health hazard to anyone who comes into contact with the leaked drugs.

To prevent drug leaks and minimize the risk of exposure to hazardous drugs, healthcare facilities often use closed system drug-transfer devices (CSTDs) like Simplivia’s Chemfort^®. These devices are specifically designed to prevent the release of drugs into the environment, and they are used to transfer chemotherapy drugs from one container to another.

The use of CSTDs is an important part of safely handling and administering chemotherapy drugs, and it can help to prevent drug leaks and protect the health and safety of healthcare workers and patients.

The effects of hazardous drugs mishandling can be severe. In Europe, healthcare professionals, including 7.3 million nurses, are exposed to carcinogenic, mutagenic and reprotoxic hazardous drugs every year.

2,200 New cases of leukemia are diagnosed year each as a result
of occupational exposure to hazardous drugs. In addition, 17,185 miscarriages occur every year as a result of occupational exposure.

Safe handling during hazardous drug administration is essential for healthcare professionals, particularly for pharmacists, nurses and veterinarians. In combination with using personal protective equipment (PPE), best practices and other controls, Simplivia’s Chemfort^® CSTD product portfolio provides safety when handling and administering cytotoxic medications.

Hazardous drugs are medications that have the potential to cause harm to the people who handle them, either through inhalation, ingestion, absorption, or injection. These drugs are often used in healthcare settings, and they can be dangerous if not handled properly.

One type of hazardous drug is chemotherapy drugs, which are used to treat cancer. These drugs are highly toxic and can cause serious side effects in the people who take them. As such, they must be handled with extreme care to minimize the risk of exposure to healthcare workers and others who may come into contact with them.

Proper handling of chemotherapy drugs involves wearing personal protective equipment (PPE), such as gloves, masks, and gowns, to prevent contact with the skin or inhalation of the drugs. Preparation and administration of these drugs should be done using closed system drug-transfer devices (CSTDs) like Simplivia’s Chemfort^®. In addition, these drugs must be stored and transported in special containers to prevent spills or leaks.

Overall, it is important to take appropriate precautions when handling hazardous drugs, including chemotherapy drugs, to protect the health and safety of those who come into contact with them.

Certain drugs, such as chemotherapy drugs used in oncology, antibiotics, and monoclonal antibodies, can put medical staff at risk of skin irritation, reproductive issues, cytotoxicity, and cancer if not handled properly. According to the Centers for Disease Control and Prevention (CDC), around 8 million healthcare workers in the United States alone are at risk of such exposure to these hazardous drugs.

USP is an independent, scientific nonprofit organization dedicated to ensuring the supply of safe, high-quality medicines. USP is committed to strengthening the world’s supply chain so that the medicines people require to ensure health are available when needed and work as expected.

In particular, USP <800>, also known as USP General Chapter <800>, outlines standards, requirements, and responsibilities for safe handling of hazardous drugs to reduce the risk of exposure for healthcare professionals, patients, and the environment. This includes facility and engineering controls, deactivation, decontaminating and cleaning, spill control, and documentation.

Antibodies are made by the body to help fight disease. When bacteria and viruses enter the body, the body makes antibodies designed to fight each specific pathogen. Monoclonal antibodies (mAbs) are usually produced produced in rodents even if they are "humanized" or "fully human." Some mAbs are made using human genes that form antibodies in E coli. Produced in large quantities in bioreactors, they are concentrated and can then be administered to patients either by injection or infusion.

The National Institute for Occupational Safety and Health (NIOSH) is a key US health protection agency. As part of the Centers for Disease Control and Prevention, NIOSH defines what medical devices qualify as Closed System Drug-Transfer Devices.

In Europe, healthcare professionals, including 7.3 million nurses, are exposed to carcinogenic, mutagenic and reprotoxic hazardous drugs every year. 2200 new cases of leukemia are diagnosed year each as a result of occupational exposure to hazardous drugs. And 17,185 Miscarriages occur every year as a result of occupational exposure to hazardous drugs.

Exposure to toxic drugs as droplets or vapor can occur through inhalation, skin contact, unintentional hand-to-mouth ingestion or accidental needle stick and sharps injuries. In wards, and especially oncology wards, unintentional exposure to hazardous drugs poses a risk not only to nurses, but also to other hospital personnel, patients and their families, and the environment.

Studies show that nurses who handle antineoplastic drugs are exposed to the active ingredients. A recent study showed that 61% of wipe tests in hospital settings were positive for antineoplastics, with the highest concentrations on toilet floors, an IV pump, and a waste bin cover.

Occupational safety from hazardous drug exposure starts with Simplivia's Closed System Drug-transfer Device (CSTD).

When handling hazardous drugs, healthcare professionals should use personal protective equipment (PPE) in combination with closed system drug-transfer devices (CSTDs). PPE can include face and eye protection, gloves, gowns, and shoe covers. These items should not be reused even when using CSTDs. NIOSH guidelines recommend the use of PPE when engineering controls are not sufficient to reduce the risk of hazardous drug exposure. Guidelines and training should be kept current as the most up-to-date regulations may require changes in PPE.

Robotic chemotherapy compounding refers to the use of automated robotic systems to prepare chemotherapy medications for cancer patients. Chemotherapy is a common treatment for cancer, and the preparation of these medications must be done with extreme precision to ensure patient safety and treatment efficacy. Robotic systems are increasingly being employed in healthcare settings, including pharmacies and hospitals, to improve the accuracy and efficiency of chemotherapy compounding.

Here are some key points about robotic chemotherapy compounding:

Accuracy: Robotic systems are highly precise and can ensure that the right amounts of chemotherapy drugs are mixed together to create the patient's specific treatment. This minimizes the risk of dosing errors, which can be life-threatening.

Safety: Chemotherapy drugs are toxic, and their preparation can expose healthcare workers to health risks. Robotic systems help reduce the risk of exposure to hazardous drugs by handling them in a controlled and sealed environment. This is why the use of CSTDs (closed system drug-transfer devices) is recommended when compounding chemotherapy drugs manually. Automated compounding systems minimize direct contact with the drugs, ensuring the safety of pharmacy staff during the compounding process.

Workflow Efficiency: Automation of the compounding process can significantly improve workflow efficiency. Robotic systems can work 24/7 without fatigue, which can be especially important in high-demand healthcare settings.

Standardization: Robotic systems can follow pre-programmed protocols, ensuring that chemotherapy compounds are prepared consistently and according to established standards.

Reduced Contamination: Robotic systems can help reduce the risk of contamination during the compounding process. They are designed to minimize human contact with the drugs and the environment where compounding takes place.

Traceability: Many robotic systems used in chemotherapy compounding are equipped with software that provides detailed records of each step in the process, offering traceability and accountability.

Compounding Customization: Robotic systems can be programmed to prepare chemotherapy compounds tailored to each patient's unique prescription, allowing for personalized treatments.

Regulatory Compliance: The use of robotic systems can help healthcare facilities meet regulatory requirements and quality assurance standards in the preparation of chemotherapy medications.

Robotic chemotherapy compounding offers many benefits, but it doesn't eliminate the need for human oversight. Trained pharmacy staff and healthcare professionals still play essential roles in supervising and verifying the robotic compounding process to ensure patient safety and the accuracy of the medications.

Robotic chemotherapy compounding is an example of how innovative technology is being integrated into healthcare to improve patient care and safety for healthcare professionals. It can improve the accuracy and efficiency of the chemotherapy compounding, reduce the risk of errors, and enhance the overall quality of cancer treatment.

Drug sterility is the absence of any viable microorganisms, such as bacteria, viruses, or fungi, within a pharmaceutical product. This ensures that the drug remains uncontaminated and safe for administration to patients. The effective use of CSTDs play a key role in maintaining drug sterility. CSTDs are designed to prevent the escape of hazardous drug vapors, spills, or leaks during the preparation and administration of hazardous drugs, while simultaneously protecting the drug from external contamination.

For example, Simplivia’s Chemfort^® CSTD product family uses patented technology and leakproof connections to create a barrier between the drug and the environment. This minimizes the risk of contamination and ensures the highest level of sterility. CSTDs are crucial in the handling of hazardous drugs, such as chemotherapy agents, which can pose significant health risks to healthcare professionals and patients. Adhering to proper aseptic techniques and comprehensive staff training is essential for preserving drug sterility when using CSTDs.

In order to achieve optimal drug sterility with CSTDs, it is vital to comply with relevant guidelines and standards, such as the United States Pharmacopeia (USP) General Chapter <797> and <800>, which outline the procedures and requirements for sterile compounding and handling of hazardous drugs. By following these guidelines and adopting best practices, including the use of CSTDs, healthcare professionals can safeguard drug sterility and while protecting themselves and ensuring patient safety.

A sterile medication transfer device (SMTD) is a specialized piece of equipment that is used to transfer chemotherapy drugs from one container to another in a safe and sterile manner. SMTDs are typically used when administering chemotherapy drugs to patients, and they are designed to prevent the drugs from coming into contact with the external environment.

SMTDs are typically made of plastic or other non-permeable materials, and they have special seals and valves that prevent the drugs from leaking out. They also have barriers that prevent vapor from escaping, which helps to prevent inhaling of the drugs.

In addition to their safety features, SMTDs are also sterile, which means that they have been treated to eliminate any microorganisms that could potentially contaminate the drugs. This is an important consideration when administering chemotherapy drugs, as these drugs can be highly toxic and any contamination could pose a serious health hazard.

Overall, sterile medication transfer devices like Simplivia’s Chemfort^® CSTD are an essential part of safely administering chemotherapy drugs, and they help to prevent drug leaks and protect the health and safety of healthcare workers and patients.

In relation to oncology, veterinary medicine encompasses the prevention, diagnosis, and treatment of cancer in animals. Veterinarians play a crucial role in safeguarding animal health and well-being by applying leading medical techniques and therapies such as chemotherapy to treat malignant diseases in animals. Veterinarians are responsible for developing and implementing effective treatment plans tailored to the specific needs of each patient.

When handling cytotoxic chemotherapy medications, exposure is an ever-present possibility. Veterinary clinic staff are at risk of exposure while compounding and administering these hazardous drugs. Pet owners are also at risk when coming into contact with pet excreta, as are veterinary personnel. Potential exposure pathways include absorption through the skin, breathing in drug aerosols and vapors, accidental ingestion as well as needle-stick injuries. The consistent use of CSTDs like Chemfort^® in veterinary medicine can reduce the risk of exposure to toxic substances for the veterinary professionals involved in the treatment process, as well as for pets and their owners.

The 2018 consensus statement from The American College of Veterinary Internal Medicine (ACVIM) provides guidelines and recommendations for the use of CSTDs in veterinary medicine. The statement is based on recommendations from the US Occupational Safety and Health Administration, NIOSH, The United States Pharmacopeia, and others. The document highlights the importance of proper handling and administration of hazardous drugs in veterinary clinics. The guidelines are intended to protect the health of both the animals being treated and the healthcare professionals involved in their care.

Simplivia offers a range of innovative, user-friendly Vial Adaptors which connect to standard vials. The Vial Adaptors are sized to match all standard vial neck sizes (20 mm, 28 mm or 32 mm and a 13 mm convertor, which connects to the 20 mm Vial Adaptor). Our Vial Adaptors are mounted on the drug vial to allow drug transfer in a closed system. The process is designed to be brilliantly simple to make drug preparation and compounding easy.

Our Chemfort^® Syringe Adaptor / Syringe Adaptor Lock connects with minimal effort to a Simplivia Vial Adaptor, allowing safe drug transfer from the drug vial to the syringe and then to another container. For repeated use, up to 10 Syringe Adaptor to Vial Adaptor connections and disconnections, the Vial Adaptor’s protective cap can be used for safe, cost-effective vial storage.