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Safe Handling of Monoclonal Antibodies in Healthcare Settings

Monoclonal antibodies, or mAbs, were first introduced in the 1980s, and their clinical use has only been increasing. Since the 1990s, many different types of mAbs have been approved and sold. In fact, by 2013, the global sales of mAbs made up about half of all biopharmaceutical sales.6

Monoclonal antibodies have many beneficial applications in oncology. They also treat other medical conditions such as rheumatoid arthritis, psoriasis, asthma, and transplanted organ rejection.3 Monoclonal antibodies can provide targeted therapy that lessens the impact of these conditions, improving patients' lives. For those who have cancer, treatment with mAbs could mean fewer side effects than chemotherapy drugs.

But despite being an important treatment modality, monoclonal antibodies carry the risk of side effects for patients or occupational exposure for medical staff. Healthcare professionals need to practice safe handling of mAbs not only to ensure safe and proactive treatment for patients but also a safe work environment for everyone on their team. Let's take a closer look at mAbs and how medical professionals can work with them safely.

Simplivia Monoclonal Antibodies mAb CSTD

What Are Monoclonal Antibodies?

Monoclonal antibodies are special proteins created in a laboratory setting, designed to mimic natural antibodies within the immune system. These man-made proteins can target particular antigens, such as ones found in a cancer cell. MAbs can be made from human or mouse protein or a combination of the two.

There are a few common types of mAbs, including:

  • Naked monoclonal antibodies — mAbs that are not attached to any drug or substance
  • Conjugated monoclonal antibodies — mAbs that are attached to a chemotherapy drug or radioactive particle
  • Bispecific monoclonal antibodies — drugs composed of two different mAbs, which can attach to two cell proteins simultaneously1

MAbs are innovative drugs because they bind to specific harmful substances such as cancer cells and aid the body in fighting against them.9

How are Monoclonal Antibodies Used in Oncology Treatment?

MAbs have precise mechanisms of action within the body, depending on how they are designed. Different mAbs can:

  • Block cancer cells from growing or spreading
  • Bind to specific antigens to act as a marker, thus boosting the immune system's ability to find and kill cancer cells
  • Deliver radioactive particles or chemotherapy drugs directly to cancer cells when the mAbs are combined with these drugs (conjugated monoclonal antibodies)

MAbs are an essential tool in the fight against cancer and other conditions. However, like any medical therapy, they could present certain risks to healthcare professionals if not handled correctly.8

Simplivia Monoclonal Antibodies mAb CSTD

What Are the Risks of Handling Monoclonal Antibodies?

The risks of exposure to antineoplastic drugs have been a concern since the 1970s and are now well-established.5 Conjugated monoclonal antibodies are considered hazardous drugs because they are bound to cytotoxic substances or radioisotopes. However, naked mAbs don't meet the criteria to be tested as hazardous drugs.8

Although monoclonal antibodies are widely used, there is not enough definitive research on the effects of occupational exposure to them. And, to date, there is no known safe maximum level of exposure to mAbs. However, the concern around the potential problems from repeated exposure to monoclonal antibodies remains high.

Healthcare professionals could be at risk of dermal, oral, or inhalation exposure during preparation or administration. It is possible that mAbs could lead to allergic and immunogenic reactions8, or reproductive toxicity3 if exposure occurs over time.

According to the Cancer Nurses College2, internal exposure to monoclonal antibodies could potentially pose a risk for:

  • toxicity
  • genotoxicity
  • cytotoxicity
  • organ toxicity at low doses
  • immunogenicity
  • teratogenicity

Some believe the more considerable molecular weight of monoclonal antibodies may prevent dermal absorption. But there is no direct evidence supporting this concept4, and their bigger cell size could make them more challenging to control. Since there are many unknowns about the long-term effects of exposure, safe handling of mAbs is of the utmost importance.

How Healthcare Professionals Can Practice Safe Handling of Monoclonal Antibodies

To safely handle mAbs, staff should be well-trained and competent in aseptic techniques and reconstitution of drugs.8 Basic precautions like wearing a gown, gloves, eye protection, and hand washing are always important to follow.3

The use of closed system drug-transfer devices (CSTDs) in drug preparation and administration is one way to reduce the risk of drug exposure significantly. CSTDs can prevent aerosolization of substances during use. CSTDs present a lower risk of leakage or disconnection than needles, syringes, and unprotected IV ports.8 This means less chance of drugs ending up on the skin, or injury from needle sticks. In addition, CSTDs can ensure drugs remain sterile and uncontaminated. According to a Hospital Pharmacy Europe article,7 using CSTDs when treating patients with monoclonal antibodies can improve care, reduce costs, and minimize occupational exposure.

As the field of medicine continues to evolve, healthcare professionals will face an ever-changing landscape. Certain drugs may carry exposure risks that aren't fully understood yet. Advances in medical technology and treatments may mean shifting policies or the need for additional staff training.

Healthcare professionals regularly work in environments that put them at increased risk of exposure to drugs or pathogens. Ensuring that medical workers have the supplies they need to do their job safely is essential in healthcare. Patients also need and deserve safe, effective care. Patients need drugs that are properly prepared and uncontaminated. They need to know the drug is ending up just where it is meant to.

Simplivia is dedicated to keeping both healthcare professionals and patients safe, no matter the treatment being given. Our Chemfort™ and Tevadaptor® CSTDs can provide confidence to medical staff during every step of drug preparation and administration. When using Simplivia CSTDs, you can rest assured that the drug is only going exactly where it is needed, without risk of exposure to medical personnel or patients. Simplivia CSTDs provide a safer infusion environment for both patients and medical staff.

To learn more about our scientifically proven products and their benefits, visit simplivia.com.

Sources
1. American Cancer Society. Monoclonal Antibodies and Their Side Effects. https://www.cancer.org/treatment/treatments-and-side-effects/treatment-types/immunotherapy/monoclonal-antibodies.html
3. Clinical Oncology Society of Australia. Position Statement: Safe Handling of Monoclonal Antibodies in Healthcare Settings. https://www.cosa.org.au/media/173517/cosa-cpg-handling-mabs-position-statement_-november-2013_final.pdf
4. De Lemos, M., Badry, N., et al. Safe Handling of Monoclonal Antibodies: Too Large to Be Hazardous? Journal of Oncology Pharmacy Practice. March 2017. https://www.researchgate.net/publication/
315309486_Safe_handling_of_monoclonal_antibodies_Too_large_to_be_hazardous
5. Department of Health and Human Services. NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016. https://www.cdc.gov/niosh/docs/2016-161/pdfs/2016-161.pdf
6. Ecker, D.M., Jones, S.D., et al. The Therapeutic Monoclonal Antibody Market. mAbs. January-February 2015. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4622599/
https://academic.oup.com/annweh/article/61/8/1003/4062280
7. Hospital Pharmacy Europe. Preparing mAbs: Improving Care and Protecting Staff. https://hospitalpharmacyeurope.com/news/editors-pick/preparing-mabs-improving-care-and-protecting-staff/
8. Meade, E. Use of closed-system drug transfer devices in the handling and administration of MABs. https://clearvoice-media.s3.amazonaws.com/act_bIfy6fAJQzK1gLfS/reference-materials/1619015740227-meade2015.pdf
9. National Cancer Institute. Dictionary of Cancer Terms: Monoclonal Antibodies. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/monoclonal-antibody

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