A clinical dilemma – the logistics of applying ‘guidelines’ in practice – facilitated by Associate Professor Treasure McGuire.

Reference

NIOSH. NIOSH list of antineoplastic and other hazardous drugs in healthcare settings 2012. U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2012−150.  Available at: http://www.cdc.gov/niosh/docs/2012-150/pdfs/2012-150.pdf

The paper presents the current (2012) update of the National Institute for Occupational Safety and Health (NIOSH) ‘List of Antineoplastics and Other Hazardous Drugs’ designed to assist health professionals and institutions in managing occupational safe handling of these medication, together with a commentary on the updated publication. The ‘NIOSH List’ was first published in September 2004 (http://www.cdc.gov/niosh/docs/2004-165/) and updated in 2010. The 2012 update adds 26 medicines to the 2010 list. The review process for the addition of the new listings is described in the Federal Register: http://www.cdc.gov/niosh/docket/archive/pdfs/NIOSH-190/0190-080211-frn.pdf

 

Background

Occupational risk from handling of therapeutic medicines in a healthcare setting carries the potential risk of adverse effects. Risks associated with occupational exposure to cytotoxics are well-established. However, other medicines, e.g. monoclonal antibodies, antivirals, hormones and some immunosuppressants, including those used for the treatment of cancer and other conditions, may also have damaging effects on the body.  When these medicines are prepared and administered, workplace practices which minimise the risk of potentially harmful occupational exposure, must be utilised. These include the use of biological safety cabinets, closed system transfer devices and personal protective equipment.  Several national and international health professional organisations have published guidelines on handling hazardous medicines, but in order to use these guidelines appropriately and effectively, healthcare workers need to be aware of which medicines pose a hazard, and the degree of hazard involved.

The recently published 2012 NIOSH List has led to concern being raised by staff within Mater Health Services (a tertiary hospital treating adult, paediatric and maternity patients) about the potential risk of occupational exposure to ‘hazardous’ medicines. There is not only debate about which medicines should be considered hazardous, but also absence of clear guidance regarding their handling and administration. In addition, there is difficulty distinguishing between toxicity caused by systemic administration for therapeutic purposes, and exposure from occupational handling and manipulation. This has led to a wide range of non-standardised, non-evidence based and costly strategies being employed by staff when handling new medication, based on their individual interpretation of ‘potentially hazardous’ medication. This is particularly evident in Mater’s public and private paediatric hospitals where staff maybe required to manipulate dose forms for administration to children. Recommendations for the preparation and handling of hazardous medicines should be based on evidence available of occupational toxicity and the inherent pharmacology of the medicines.

 

Discussions of the group

We initially discussed the process by which medicines are included on the NIOSH List; they are included if the medicine exhibits one or more of the following characteristics in humans or animals:

  • Carcinogenicity
  • Teratogenicity or other developmental toxicity
  • Reproductive toxicity
  • Organ toxicity at low doses
  • Genotoxicity

Structure and toxicity of new medicines that mimic existing medicines determined hazardous by the above criteria.

However, NIOSH recommends that each organisation should create its own medicines list considered to be potentially hazardous. Also, there are no recommendations regarding how individual medicines rated as hazardous should be handled. The group agreed that this approach placed both institutions and staff in an almost impossible position to navigate.

The facilitator provided the group with the approach Mater Health Services has taken to develop an occupational risk assessment tool to assess the risk potential of medication handled by staff.

Method: Medicines included for risk assessment were identified using the NIOSH list and expanded to include newly marketed therapeutic classes e.g. monoclonal antibodies and medicines identified by hospital staff as potentially hazardous. A search of primary literature was conducted using bibliographic databases, with additional studies identified through snowballing search techniques. Search terms included medicines of interest and the hazardous concepts – teratogenicity, carcinogenicity, genotoxicity, mutagenicity and tissue irritation. Citations retrieved were assessed by a three member panel and assigned potential relevance, in terms of quantum and quality of evidence; and study type: in-vitro, in-vivo, human (treatment exposure) and human (occupational exposure). These studies contributed to the overall occupational hazard risk category, using a rating scale developed by the team.

Results:  The occupational hazard risk tool incorporated risk categories that quantified the level of available evidence, using a 7-point scale, ranging from “strong evidence of occupational risk” to “strong evidence of no occupational risk”. The tool was successfully applied to identify and stratify individual medicines and/or therapeutic classes of interest. Based on this stratification, recommendations for risk appropriate handling were created: Low occupational risk (no additional handling precautions); insufficient evidence to determine risk (defined handling precautions); High occupational risk (follow personal protective equipment (PPE) guidelines). This resulted in all medicines of interest receiving a “handling” recommendation, based on current evidence.

 Conclusion:

The group felt that such a tool could potentially reduce clinician anxiety over the occupational handling of medicines, by more closely linking evidence with handling recommendations. However, they recommended that each institution needs to make explicit their mission and perspective in conducting such an evidence-based strategy, to ensure that the staff occupational safety rather than, for example, institutional convenience is the driver of activity.

References of interest:

Traynor K. 2012 NIOSH hazardous-drugs update contains surprises. Am J Health-Sys Pharm 2012;69:1446-51.