KEY PAPER EVALUATIONCarcinogens, Mutagens and Reprotoxic substances Directive (CMRD)
EDITORIAL ARTICLEReducing the risk of hazardous drug exposure to health care workers
Hazardous Drug Exposure – summary of the guidelines
Organisations focused on occupational safety have evaluated and presented strategies in an attempt to improve the safety of health care workers who are exposed to hazardous drugs (HD).1
The complex and interdisciplinary nature of HD handling means that processes involved are particularly error-prone.1 Additionally, the toxic nature of these drugs means that HDs pose serious risks for both the patient and the professionals involved.1 For these reasons, it is essential that these processes are standardised. Correct implementation of clinical guidelines in protocols lead to improved quality of procedures and minimised risks associated with HD.1
Guidelines on HD handling vary in scope; a 2018 review revealed that 62.3% of guidelines focus their recommendations on the handling of hazardous substances in health centres, 19.5% also took into account the home setting, 8.2% had a more general scope, and 9.8% included recommendations for other sectors, such as the pharmaceutical industry and regulatory agencies.1
These guidelines also varied with respect to the type of hazardous drugs they covered; 39.3% focused on hazardous drugs as a whole, 44.3% focused on antineoplastic drugs, and 16.4% of guidelines addressed other types of substances, such as monoclonal antibodies, gene medicine and other chemical and biological agents.1
Widely cited guidelines include the Occupational and Safety and Health Administration (OSHA), the European Agency for Safety and Health at Work (EU-OSHA), United States Pharmacopeia (USP) and National Institute for Occupational Safety and Health (NIOSH).2–5 OSHA, NIOSH and USP all provide guidelines for health care workers with recommendations at various points of the hazardous drug pathway including preparation and administration (Table 1).1,6
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and spill control
*Directive 2004/37/EC of the European Parliament and the Council (CMRD)
Pharmacists and Nurses
Pharmacists and nurses take part in the HD pathway at different points, with pharmacists playing a vital role in drug preparation while nurses are essential in drug administration.
OSHA, NIOSH AND USP guidelines cover any worker exposed to hazardous drugs but the American Society of Health System Pharmacists (ASHP) and the Oncology Nursing Society (ONS) guidelines focus on pharmacists and nurses.
ASHP guidelines on hazardous drug handling are aimed at pharmacists and other healthcare professionals and include literature from NIOSH and USP. The 2018 ASHP guidelines provides information on:7
- New and continuing concerns for healthcare workers handling HDs
- Recommendations and requirements, including those regarding controls and equipment that have been developed since the publication of the 2006 ASHP guidelines.
ONS has guidelines specifically for nurses on the ordering, preparing, dispensing and administration of HD.8 In the third and latest edition of their book, “Safe Handling of Hazardous Drugs”, ONS refers to their own recommendations and those of NIOSH, OSHA, ASHP, and USP.9
The term “hazardous drug” was first introduced in 1990 by ASHP.10 The term was then adopted by NIOSH in 200411 and led to the globally accepted definition of a hazardous drug. In 2014, NIOSH further divided hazardous drugs into groups; antineoplastic drugs, non-antineoplastic drugs and drugs that primarily have adverse reproductive effects.11 As new information emerged on the effects of and best practices for hazardous drug handling, guidelines continued to be revised and updated.
The Directive 2004/37/EC of the European Parliament and the Council (CMRD) has recently expanded its scope to include guidance on reprotoxic substance exposure due to new evidence on the dangers of reprotoxic substances.6 The updated CMRD guidelines were approved on 8 March 2022 and are set to be published before the end of 2022.
You can view a summary of the key updates of the CMRD guidelines here.
The study of HD exposure is ongoing, therefore new findings are anticipated. For this reason, it is important that healthcare professionals stay up to date with the latest guidelines on hazardous drug handling.
- Bernabeu-Martínez MA, Ramos Merino M, Santos Gago JM, et al. Guidelines for safe handling of hazardous drugs: A systematic review. Ahmad A, ed. PLOS ONE 2018;13:e0197172. Available at: https://dx.plos.org/10.1371/journal.pone.0197172.
- Occupational Safety and Health Administration (OSHA). Hazardous Drugs. OSHA 2022. Available at: https://www.osha.gov/hazardous-drugs. Accessed March 15, 2022.
- European Agency for Safety at Work (EU-OSHA). Current and emerging issues in the healthcare sector, including home and community care European Risk Observatory Report European Agency for Safety and Health at Work. In: EU-OSHA. Available at: https://op.europa.eu/en/publication-detail/-/publication/3e538d87-18e7-4880-9660-9e4d092692ed/language-en. Accessed March 15, 2022.
- USP. USP General Chapter <800> Hazardous Drugs – Handling in Healthcare Settings.; 2017. Available at: https://www.usp.org/sites/default/files/usp/document/our-work/healthcare-quality-safety/general-chapter-800.pdf. Accessed November 16, 2021.
- NIOSH. NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016.; 2016. Available at: https://www.cdc.gov/niosh/docs/2016-161/pdfs/2016-161.pdf. Accessed October 29, 2021.
- THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION. DIRECTIVE 2004/37/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens, mutagens or reprotoxic substances at work (Sixth individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC).; 2022.
- Power LA, Coyne JW, Hawkins B. ASHP guidelines on handling hazardous drugs. American Journal of Health-System Pharmacy 2018;75:1996-2031.
- Neuss MN, Gilmore TR, Belderson KM, et al. 2016 Updated American Society of Clinical Oncology/Oncology Nursing Society Chemotherapy Administration Safety Standards, including standards for pediatric oncology. Oncology Nursing Forum 2017;44:31-43.
- Polovich M, Olsen MM. Safe Handling of Hazardous Drugs (Third Edition). 3rd ed. Oncology Nursing Society; 2018.
- American Society of Health System Pharmacists. ASHP technical assistance bulletin on handling cytotoxic and hazardous drugs. American journal of hospital pharmacy 1990;47:1033-49. Available at: http://www.ncbi.nlm.nih.gov/pubmed/2186621.
- NIOSH. Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings.; 2004. Available at: https://www.cdc.gov/niosh/docs/2004-165/pdfs/2004-165.pdf. Accessed October 29, 2021.
- National Institute for Occupational Safety and Health (NIOSH). NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2014.; 2014.