Survey of guidelines and current practices for safe handling of antineoplastic and other hazardous drugs used in 24 countries

J Oncol Pharm Pract. 2019 Jan;25(1):148-162. doi: 10.1177/1078155217726160. Epub 2017 Aug 25.

Abstract

Purpose: A survey of guidelines and current practices was conducted to examine the safe handling procedures for antineoplastic and other hazardous drugs that are used in 24 countries including the Americas, Europe, the Mideast, Far East, and Australia.

Methods: Subject experts were asked to complete a brief survey regarding safe handling guidelines and practices for hazardous drugs in their countries. Questions addressed practices for handling monoclonal antibodies, the use of closed-system transfer devices, medical surveillance practices, and measurements of compliance with existing guidelines.

Results: Responses from 37 subject experts representing 24 countries revealed considerable variation in the content and scope of safe handling guidelines and pharmacy practices among the participating countries. Guidelines in the majority of countries used the term "cytotoxics," while others referred to "hazardous" or "antineoplastic" drugs. The International Society of Oncology Pharmacy Practice standard was cited by six countries, and five cited the National Institute for Occupational Safety and Health Alert. Others cited international guidelines other than International Society of Oncology Pharmacy Practice, or they have created their own guidelines. Approximately half reported that their guidelines were mandatory under federal, state, or provincial legislation. Only 11 countries reported that monoclonal antibodies were covered in their guidelines. Closed-system drug-transfer devices are widely used, but were not specifically recommended in four countries, while one country required their use. Medical surveillance programs are in place in 20 countries, but only in The Netherlands is surveillance mandatory. Nine countries reported that they have completed recent updates or revisions of guidelines, and the measures for their adoption have been initiated.

Conclusions: Although the overall goals in the participating countries were similar, the approaches taken to assure safe handling of hazardous drugs varied considerably in some cases.

Keywords: Safe handling guidelines; antineoplastic or cytotoxic drugs; closed system drug-transfer devices; measures of compliance; medical surveillance; monoclonal antibodies.

MeSH terms

  • Antineoplastic Agents / adverse effects*
  • Asia, Eastern
  • Australia
  • Europe
  • Guidelines as Topic / standards*
  • Hazardous Substances / adverse effects
  • Health Personnel
  • Humans
  • Internationality*
  • Middle East
  • Occupational Exposure / prevention & control
  • Occupational Exposure / standards*
  • Occupational Health / standards
  • Pharmaceutical Services / standards
  • Pharmacies / standards*
  • Pharmacy / methods
  • Pharmacy / standards
  • Protective Devices / standards
  • Surveys and Questionnaires*
  • United States

Substances

  • Antineoplastic Agents
  • Hazardous Substances