Australian consensus guidelines for the safe handling of monoclonal antibodies for cancer treatment by healthcare personnel

Abstract

These consensus guidelines provide recommendations for the safe handling of monoclonal antibodies. Definitive recommendations are given for the minimum safe handling requirements to protect healthcare personnel. The seven recommendations cover: (i) appropriate determinants for evaluating occupational exposure risk; (ii) occupational risk level compared with other hazardous and non-hazardous drugs; (iii) stratification of risk based on healthcare personnel factors; (iv) waste products; (v) interventions and safeguards; (vi) operational and clinical factors and (vii) handling recommendations. The seventh recommendation includes a risk assessment model and flow chart for institutions to consider and evaluate clinical and operational factors unique to individual healthcare services. These guidelines specifically evaluated monoclonal antibodies used in the Australian cancer clinical practice setting; however, the principles may be applicable to monoclonal antibodies used in non-cancer settings. The guidelines are only applicable to parenterally administered agents.

Surface wipe sampling for antineoplastic (chemotherapy) and other hazardous drug residue in healthcare settings: Methodology and recommendations

“…Some newer antineoplastic drugs, such as monoclonal antibodies, can have a molecular weight >40,000 Daltons, which presumably limit their potential for dermal uptake from contaminated surfaces. (23–25) Although 500 Daltons is considered the maximum molecular weight for effective uptake of transdermal drugs by pharmaceutical companies, it is not an absolute cut-off point and some drugs with molecular weights of >1000 Daltons can penetrate the skin, but they do so at a lower efficiency. (22) In addition, solvents in some pharmaceuticals, such as N,N-Dimethylacetamide may pose an additional health risk (26) or may enhance drug penetration of the skin.…”

Utility of PhaSeal, a closed‐system drug transfer device, in facilitating vial sharing to reduce waste and assist in medication cost savings

“…The advantages of using a CSTD to reduce the potential exposure of healthcare workers to hazardous medicines is well documented . mAbs do not require preparation within a cleanroom environment because they do not have the same health risks as cytotoxic drugs . However, the present study shows the cost benefit in using a CSTD to reduce vial wastage for mAbs.…”

Hazardous non‐cytotoxic medicines: uncertainty around safe handling? A new workplace guideline for hospital staff

“…Monoclonal antibodies are a group of drugs increasingly used for non‐cancer indications. The Western and Central Melbourne Integrated Cancer Service developed consensus guidelines in 2014; this group of medicines was excluded from our review. Other specific exclusions were oral cytotoxic medicines (except for low‐dose methotrexate for autoimmune conditions), parenteral cytotoxic chemotherapy, hazardous medicines used during medical procedures (e.g.…”