Looking for guidance on best practices for a hazardous medication surveillance program? Many employee health professionals may be making changes to their hazardous medication surveillance program (HMSP) in response to United States Pharmacopeia (USP) <800> standards.

“Absence of best practices for HMSPs and limitations on the ability of such programs to correlate health effects identified on surveillance with workplace exposures historically, have left healthcare institutions to determine if and how to design an HMSP for their workforce,” the authors of a new study reported.1

They discussed designing an HMSP using resources such as a health questionnaire and declination forms. “This information is intended to generate further discussion and collaboration among leaders of employee occupational health services on a national level to address the benefits and challenges of HMSPs,” they concluded.

Seeking further comment on the paper, Hospital Employee Health interviewed lead author Laura Breeher, MD, MPH, occupational medicine medical director at the Mayo Clinic.

HEH: Can you comment on whether the USP has revised any guidelines since your study was published that would have any implications for your findings?

Breeher: USP’s Chapter <800> was published in 2016 with an implementation date of December 2019. USP <800> outlines standards and recommendations for “cradle-to-grave” management of hazardous medications in the healthcare setting. The survey my colleagues and I conducted of practices in hazardous medication surveillance was sent in 2017. Healthcare institutions may have reviewed their policies related to hazardous medications, and may have made adjustments to the approach to surveillance, considering USP <800>. Hazardous medication surveillance programs have been a hot topic in healthcare for the past couple of years as institutions strive to ensure the health and safety of employees; that is, whether to have one. If the institution has one, what it should include and who should be included?

HEH: About half the survey respondents reported not implementing a medical surveillance program. Did you see any responses or trends that could explain why these programs are not implemented in these healthcare settings?

Breeher: Multiple survey respondents reiterated this challenge: inability to clearly connect workplace exposure to hazardous medications with adverse health effects. The primary reason for this is that many of the potential effects are common (i.e., miscarriage, cancer). The limited number of healthcare workers enrolled in smaller institutions further limits the ability to identify trends in health effects among healthcare workers handling and administering hazardous medications who are enrolled in surveillance programs. Many institutions also reported a focus on exposure controls, such as closed-system transfer devices, and environmental testing with wipe sampling to ensure controls are adequate rather than implementing an HMSP.

HEH: There were some consensus tests in those that have these programs, but can you discuss the lack of standardized recommendations?

Breeher: The survey results showed which tests are more commonly performed at institutions with HMSPs, but there was no consensus standard. Even with the most common test, 72% of HMSPs included this lab test rather than 100%. USP <800> includes recommendations for core elements of an HMSP, but these are nonspecific (“updated health and exposure history, physical assessment, and laboratory measures, if appropriate”). I believe the flexibility within these recommendations is due to lack of clear evidence that hazardous medication surveillance programs result in improved workplace health and safety at present. I would not recommend regulations for HMSPs until evidence exists on the effectiveness of surveillance programs to guide program design.

HEH: There have been studies showing that pregnant healthcare employees work with, for example, hazardous oncology drugs, but they do not always wear personal protective equipment (PPE).2 Does the challenge of compliance underscore the need for surveillance programs? Should clinicians working with hazardous drugs be followed long term, perhaps for life?

Breeher: Use of PPE is a primary prevention measure for health effects that may result from work with hazardous medications. I agree with the authors of the study you cited that further education and training are needed to ensure frontline staff understand the hazards and reasons for PPE, but there may be other reasons for this lack of use of the PPE. It’s important to understand why the nurses aren’t wearing the recommended PPE. Is it lack of availability? Poor fit? Time pressures? Concern for patient perception? Lack of knowledge of the hazards? Lack of managerial support?

A culture of safety is extremely important, and we can learn a lot about potential barriers to compliance from colleagues doing this work every day. For example, in identifying gowns for use with antineoplastics, a gown that gapes at the neck or is constricting at the wrists is less likely to be worn than one that fits well. A surveillance program is a secondary preventive measure with a goal of early identification of health effects if primary preventive measures fail, but it shouldn’t be a substitute for primary prevention of exposure. I don’t feel there are enough data to comment on the recommended duration of surveillance at present.

HEH: Given the lack of medication surveillance programs at many facilities, and the lack of standardization in those that employ them, do you think there could be many resulting illnesses and long-term effects in healthcare workers that are not being reported?

Breeher: I believe the absence of hazardous medication surveillance programs at some facilities and lack of standardization in those that have an HMSP reflect that there isn’t the evidence-based data to show that these programs are able to identify health effects resulting from work with hazardous medications. Surveillance programs for other hazards have been shown to be effective at early identification of health effects to improve the health of the worker(s). An example includes surveillance for lead toxicity with blood lead levels in those exposed above the OSHA permissible exposure limit. (More information can be found at: https://bit.ly/38QqXhh.)

Another example is surveillance for silicosis where chest X-rays show characteristic findings of lung fibrosis resulting from silica inhalation. In both of these situations, surveillance can screen for a specific health effect that is more likely than not to be associated with the workplace hazard. Regulations were put in place to support these best practices based on evidence that surveillance improves the health of workers. With hazardous medications, the potential health effects from unprotected exposure also are common in the general population, which results in the challenges outlined earlier.

I don’t feel sufficient research has been done to determine the significance of unreported health outcomes. That being said, I do think standardization of HMSPs is an important step toward determining if these programs add to the health and safety of healthcare workers. We need more data with purposeful statistical analysis to determine the best approach to HMSPs. Some healthcare institutions may include all workers who administer hazardous medications. Other institutions may include only healthcare workers who have an unprotected exposure (i.e., chemo spill without PPE). Still others may include anyone with a potential risk of exposure. There are benefits and challenges to each approach. In response to the survey data, USP <800> recommendations, our own experience with our historic HMSP, and input from a multisite, multidisciplinary team, we have recently standardized our HMSP at Mayo. A summary of the approach, including forms (a standardized questionnaire and a declination form) we will use at our institution across all enterprise sites was published ahead of print in Journal of Occupational and Environmental Medicine (https://bit.ly/310wzD6) so that other institutions could use some of these tools in their programs if they desire.

REFERENCES

  1. Breeher, LE, Stonelake-French, HL. An approach to hazardous medication surveillance. J Occup Environ Med 2019; Dec 11. doi: 10.1097/JOM.0000000000001788. [Epub ahead of print].
  2. Lawson CC, Johnson CY, Nassan FL, et al. Antineoplastic drug administration by pregnant and nonpregnant nurses: An exploration of the use of protective gloves and gowns. Am J Nurs 2019;119:28-35.