Development of a standardised method to recommend protective measures to handle hazardous drugs in hospitals

Abstract

Purpose Healthcare professionals frequently have to handle hazardous drugs in the hospital setting. Data on the inherent toxicity of drugs cannot be directly applied to occupational exposure. We developed a standardised method to evaluate occupational risks and to recommend protective measures. Methods Step 1: evaluation of chronic and acute toxicities and toxicity for reproduction. Step 2: toxicity weighting according to risk of exposure related to drug formulations. Step 3: definition of protective measures. Step 4: toxicity assessment of drugs used in our institution and comparison with hazardous drug lists published in the literature. Results The whole process resulted in a standardised evaluation algorithm. Risks of exposure were determined by a panel of experts to balance intrinsic toxicity of each drug formulation or administration route. Protective measures were recommended. 80 substances (109 drug formulations) were screened for toxicity. Centralisation of compounding in the pharmacy was recommended for 12/24 (50%) of intravenous liquids, 19/32 (60%) of intravenous powders and 7/26 (27%) tablets (crushing). We found a slightly different estimation of risk for only two products (prednisone and mycophenolate mofetil) compared with the literature lists (National Institute for Occupational and Safety in Health Alert and University Health System Consortium Consensus). Conclusions We developed a simple standardised method to generate a list of hazardous drugs in our hospital according to the risk of exposure. We determined reasonable protective measures that could be easily introduced into practice to protect healthcare workers.

Systematic Review of Control Measures to Reduce Hazardous Drug Exposure for Health Care Workers

“…Across the set of publications, 5 major strategies were identified: engineering controls, 1,7,12-32 personal protective equipment (PPE), * medical and environmental monitoring, † hazard identification, 1,7,12,15,[20][21][22][23][24][25][26][27][28][29][30][31][32]36,37 and the need for a comprehensive hazardous drug control program that includes education and training for health care workers. 26,27,31,32,36 …”

“…26,27,31,32,36 The prospective intervention study by Keat et al 15 was found to demonstrate the difference in environmental or worker contamination with one type of BSC compared with another, specifically for class 2 type A2 versus class 2 type B2. This differentiation is important, as primary engineering controls such as BSCs are expensive to obtain and upgrade.…”

A survey of manufacturing and handling practices for monoclonal antibodies by pharmacy, nursing and medical personnel

“…14 Material safety data sheets from pharmaceutical companies provide varying levels of recommendations: no special control measures (ofatumumab), 15 restriction of handling to specific areas and by restricted personnel (cetuximab), 16 use of personal protective equipment (PPE) with respiratory protection (ipilimumab) 14 or without respiratory protection (bevacizumab) 17 and handling in enclosed processes or within a chemical hood (panitumumab). 18 In recent years, several guidelines (published and unpublished) for the safe handling of MABs have been developed, [19][20][21][22][23][24][25] unfortunately confounding rather than clarifying the issue of safe handling and occupational exposure risks. Guidelines have employed differing methodological approaches considering a range of drug and occupational factors.…”

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

“…Five guidelines were located that included their own list of medicines: (1) the US 2016 NIOSH list of antineoplastic and other hazardous drugs in healthcare settings; (2) the 2015 Australian Don't Rush to Crush Handbook , which details therapeutic options for people unable to swallow solid oral medicines; (3) the 2015 Australian Pharmaceutical Formulary (APF); (4) the development of a standardised method to recommend protective measures to handle hazardous drugs in hospitals in the European Union (2013); and (5) the 2009 US University Health‐System Consortium (UHC) consensus statement Model Hazardous Drug Safety Plan for Institutions . The five lists were analysed to identify similarities and differences.…”