Road to USP <800> Compliance
Section 18 Medical Surveillance
Sections 1 through 17 of USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings outlines all the mechanical aspects associated with establishing a hazardous drug safety program.[i] Within USP <800>’s sections, sites must review and update standard operation procedures, facilities, equipment, and handling practices to establish a comprehensive program. Section 18 represents one of the most critical and controversial components of a hazardous safety program – medical surveillance of individuals who handle hazardous drugs as part of their job function. Of note, within section 18 of USP <800>, every aspect of establishing an employee medical surveillance program is a recommendation, not a mandate. This recommendation status is in sync with the OSHA Technical Manual, Section VI: Chapter 2. Categorization of Drugs as Hazardous[ii], and the 2004 NIOSH Alert: Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings.
The recommendation status versus the mandate may be due to the lack of definitively, conclusive studies demonstrating a direct effect of handling hazardous drugs and the development of health issues. It is important to note, there are numerous case reports and casual epidemiological surveys that surmise workers exposed to HDs have developed acute problems such as skin disorders and hair loss, adverse reproductive effects, and possibly leukemia and other cancers.,[iii],[iv]A recent epidemiological evaluation of nurses found a statistically significant, nearly two-fold increase in the risk for spontaneous abortion among those exposed to antineoplastic agents for more than one hour per day during the first trimester of pregnancy.[v]In such, organizations that handle hazardous drugs should consider a comprehensive medical surveillance program for at risk personnel; those workers who handle, prepare, and administer hazardous drugs.
The discussion of establishing any type of employee surveillance program should not be in a vacuum and should include representatives from Human Resources, Employee Health and Risk Management in the discussions surrounding such programs. Since these types of programs are not mandated, there could be legal implications associated with establishing an employee monitoring program. A risk assessment should be prepared and provided to organizational leadership for guidance.
A simple program site should consider, at a minimum, includes baseline hazardous drug handling acknowledgment questionnaire, education of the risks associated with handling hazardous drugs, education of symptomology associated with a hazardous drug exposure, and education on how to report if an exposure is suspected. Education and establishing a baseline understanding of the risks and effects of acute to chronic exposures builds the basis for a collaborative program.
In addition to the noted simple program, USP <800> outlines more facets to consider when developing a comprehensive program in addition to the acknowledgment and education:
- Identifying job codes where hazardous drug exposure is a potential
- stratifying risk of exposure: High; Medium; None to Absolutely No Contact
- Using an employee health service to administer, monitor and provide protection of personnel confidentiality;
- Baseline health status and medical history; including reproductive history, work history with regards to working with hazardous drugs, physical examination, and laboratory testing (which may be standard employee health on-boarding).
- If an employee has a history of working with hazardous drugs sites may want to gather additional work history information, such as:
- Summary of hazardous drug handled and estimated quantities;
- Estimated number of doses handled per day/week/month;
- Estimated number of hours handling hazardous drugs per day;
- Laboratory studies to include a complete blood count with differential, liver function test (LFTs), and a urine analysis
- Repeat laboratory work should be considered annually and when an exposure is suspected;
- Education of findings of laboratory results should be part of the plan and include documentation of results in the medical record and notification of the employee’s primary care provider of the exposure.
- Surveillance should be documented in medical records as outlined in OSHA;
- Concurrently monitoring and trending at risk employees visits to employee health and self-reported sick calls;
- Establishment of a formal plan with employee health to address suspected or actual exposure risks which should include a complete gap-assessment of all 18 sections of USP <800>;
- Development of an exit employment program for at-risk employees leaving their assigned positions and/or job codes to document information on the employee’s medical record to include reproductive and estimated exposure risks.
- Sites collecting laboratory specimens on hire and/or due to an exposure may elect to conduct laboratory tests on exit to match with pre-employment results.Health care workers are typically exposed to numerous HDs, and no single biological monitor is suitable for all drugs.
- If an employee has a history of working with hazardous drugs sites may want to gather additional work history information, such as:
For sites with simple to comprehensive medical surveillance programs, a formal response to a suspected or actual exposure should be clearly outlined in a standard operation procedure. Steps should clearly articulate the actions the employer intends to take and the role of the employee. USP <800> provides guidance on pre-establishing the following steps for a formal follow-up program:
- If an individual has been deemed exposed to a hazardous drug, an event-specific hazardous drug post-exposure program should include documentation in the employee’s medical record, tracking of symptom episodes, the date of exposure, the drug(s) involved, the route of exposure,
- Documentation of any additional monitoring of illness events
- Documentation of additional education for individuals reporting symptoms of hazardous drug exposure.
- A comprehensive gap assessment of current practices surrounding the event should be conducted and included;
- Review of staffing model, hazardous drug trending volumes, product assessment, drug shortages of hazardous drugs, changes to standard operation procedures and education, new training, new devices for compounding or administration, engineering controls, documentation of cleaning program, drug delivery, drug administration, drug disposal, etc.
- Review and document all events surrounding the exposure with attention to the following:
- Verification and documentation of all equipment in good working order;
- Verification, acknowledgment and documentation of compliance with established standard operation procedures,
- Documentation of any out of defined specifications or out of Standard Operation Procedure gaps noted and all corrective and preventative actions
- Documentation in the employee medical health record
- Ensure confidentiality between employee and employee health
- Education to employee on notification process for changes in health and progression of adverse effects
- A plan to provide appropriate follow-up to include clinical evaluation, medical history, physical examination, laboratory tests
- Offer exposed employee alternative or temporary duty assignment
- Documentation of survey results from gap assessment and implementation of plans
Health care organizations stating compliance with hazardous drugs handling standards should have a program in place to monitor the safety of personnel. Medical surveillance can help sites validate and demonstrate a trust with employees and a return on investment for holistically implementing USP <800> standards while mitigating occupational exposure to hazardous drugs.
As the official implementation date of December 1, 2019 for proposed USP <800> and subsequent revisions to USP <795> and USP <797> compliance allows time for sites to prepare for overall compounding compliance. The time for review of USP’s newest chapter in combination with keeping up with USP’s website for revisions to USP is now.
Don’t know where to start with a hazardous drug safety program? Visante offers a full line of sterile compounding consulting services, including USP <795>, USP <797>, USP <800>, and USP <825> to clients just starting down the road to compliance to practice sites on the journey and wanting to go beyond minimal practice standards. Contact us today to get started.
References
[i]USP <800> Hazardous Drugs—Handling in Healthcare Settings. First Supplement to USP 39–NF 34 Physical Tests.https://www.usp.org/compounding/general-chapter-hazardous-drugs-handling-healthcare. Accessed April 5, 2019
[ii]Occupational Safety & Health Administration (OSHA). OSHA Technical Manual. Section VI: Chapter 2. Categorization of Drugs as Hazardous. Accessed April 5, 2019. https://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html
[iii]American Society of Health-System Pharmacists (ASHP). ASHP guidelines on handling hazardous drugs. Am J Health-Syst Pharm. 2006;63:1172-1193.
[iv]Connor TH, McDiarmid MA. Preventing occupational exposures to antineoplastic drugs in health care settings. CA Cancer J Clin. 2006 Nov-Dec;56(6):354-365.
[v]Lawson CC, et al. Occupational exposures among nurses and risk of spontaneous abortion. Am J Obstet Gynecol. 2012 Apr;206(4):327.e1-8. 2011.