Hazards in determining whether a drug is hazardous

Abstract

The US National Institute for Occupational Safety and Health list and evaluation criteria have provided an important foundation to help institutions identify and create a list of hazardous formulary drugs. However, further guiding principles were needed to make the adoption feasible at our organization. First, we developed separate directives for determining the inherent hazardous toxicity of a drug and for the requirements for safe handling based on dosage forms (exposure risks) of these drugs. Secondly, we created a systematic approach in determining the scope of the drugs reviewed by US National Institute for Occupational Safety and Health. Thirdly, we streamlined our review process by defining which drugs needed to be evaluated by our organization. Finally, we considered the pros and cons of creating a tiered system for classifying hazardous drugs beyond those recommended by US National Institute for Occupational Safety and Health.

Keywords

Hazardous substances occupational exposure pharmaceutical preparations consensus personnel hospital

Get full access to this article

View all access options for this article.

References

National Institute for Occupational Safety and Health (NIOSH). Preventing occupational exposures to antineoplastic and other hazardous drugs in healthcare settings, Cincinnati, OH: NIOSH – Publications Dissemination, September 2004, pp. 31–40.

National Institute for Occupational Safety and Health (NIOSH). NIOSH list of antineoplastic and other hazardous drugs in healthcare settings 2010, Cincinnati, OH: NIOSH – Publications Dissemination, September 2010, pp. 1–11.

National Institute for Occupational Safety and Health (NIOSH). NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings 2012, Cincinnati, OH: NIOSH – Publications Dissemination, June 2012, pp. 1–14.

American Society of Hospital Pharmacists. ASHP technical assistance bulletin on handling cytotoxic and hazardous drugs. Am J Hosp Pharm 1990; 47: 1033–1049.

National Institute for Occupational Safety and Health (NIOSH). New FDA drugs and warnings fitting NIOSH criteria for hazardous drugs 2006, Cincinnati, OH: NIOSH – Publications Dissemination, 2006, pp. 1–3.

National Institute for Occupational Safety and Health (NIOSH). New FDA drugs and warnings not fitting NIOSH criteria for hazardous drugs 2006, Cincinnati, OH: NIOSH – Publications Dissemination, 2006, pp. 1–5.

National Institute for Occupational Safety and Health (NIOSH). NIOSH response to peer review comments from draft proposed additions and deletions to appendix A of NIOSH alert on hazardous drugs (6 April 2009), Cincinnati, OH: NIOSH – Publications Dissemination, April 2009, pp. 1–8.

National Institute for Occupational Safety and Health (NIOSH). NIOSH list of antineoplastic and other hazardous drugs in healthcare settings 2012: proposed additions and deletions to the NIOSH hazardous drug list, Cincinnati, OH: NIOSH – Publications Dissemination, July 2011.

National Institute for Occupational Safety and Health (NIOSH). NIOSH draft proposed additions and deletions to appendix A of NIOSH alert on hazardous drugs (6 April 2009), Cincinnati, OH: NIOSH – Publications Dissemination, 6 April 2009, pp. 1–2.

10.

Chaffee

Armitstead

Benjamin

. Guidelines for the safe handling of hazardous drugs: consensus recommendations. Am J Health-Syst Pharm 2010; 67: 1545–1546.

11.

University HealthSystem Consortium. UHC consensus statement: model hazardous drug safety plan for institutions, Oak Brook, IL: University HealthSystem Consortium, 2009, pp. 1–22.

12.

Center for Disease Control and Prevention. NIOSH Docket 105: Submission to the docket from Reilly/Coffey (American Society of Health-System Pharmacists) 20 September 2007. http://www.cdc.gov/niosh/docket/archive/docket105.html (6 July 2010, accessed 6 March 2013).

13.

American Society of Health-System Pharmacists. ASHP guidelines on handling hazardous drugs. Am J Health-Syst Pharm 2006; 63: 1172–1193.

14.

Center for Disease Control and Prevention. NIOSH Docket 105A: Submission to NIOSH Docket from Sara Radcliffe (BIotechnology Industry Organization) 30 June 2009. October 12, http://www.cdc.gov/niosh/docket/archive/docket105A.html (2010, accessed 6 March 2013).

15.

Bos

Meinardi

MMHM

. The 500 Dalton rule for the skin penetration of chemical compounds and drugs. Exp Dermatol 2000; 9: 165–169.

16.

Hoang KT, ed. Dermal exposure assessment: principles and applications. Washington, DC: US Environmental Protection Agency, Office of Health and Environmental Assessment, EPA/600/8-91/011B, 1992.

17.

Lipinski

Lombardo

Dominy

. Experimental and computational approaches to estimate solubility and permeability in drug discovery and development settings. Adv Drug Deliv Rev 1997; 34: 3–25.

Supplementary Material

Please find the following supplemental material available below.

For Open Access articles published under a Creative Commons License, all supplemental material carries the same license as the article it is associated with.

For non-Open Access articles published, all supplemental material carries a non-exclusive license, and permission requests for re-use of supplemental material or any part of supplemental material shall be sent directly to the copyright owner as specified in the copyright notice associated with the article.

0.00 MB

4.82 MB