Q: Should hospitals manage viral vector drug storage, preparation, and administration as hazardous drugs (HDs) subject to USP <800>?

A: When deciding how to manage the storage, preparation, and administration of viral vector based drugs, it is important to highlight that not all viral vector based drugs are hazardous. For example, the current Janssen COVID-19 vaccines incorporate attenuated Adenoviruses for the delivery of the mRNA technology; however, they are not deemed as a hazard to health care providers who handle them.1

Conversely, it would be a grave error to assume that all Adenovirus based biologicals are not hazardous without a formal assessment of risk, as it would be detrimental to assume that all viral based vehicles pose no risks to health care providers. Hertig et al provides an excellent source that addresses this topic as well as measures the risks associated with drugs that incorporate nanotechnology.2

Q: Should the HD risk acknowledgment form be signed annually or solely upon hire?

A: Both; an employee of any business has the right to know that their employer has identified hazards in the workplace as defined by the Occupational Safety and Health Agency (OSHA), which includes the OSHA section on Hazardous Drugs. Sites must educate employees on identified hazards, train employees on handling those hazards, provide the equipment/tools needed for safety when working with the hazard(s), establish a monitoring program, create a channel for employees to provide feedback on the process, and acknowledge that employees have the right to report any violations directly to OSHA without repercussions.

The acknowledgment process is a two-way understanding between the employee and the employer that the required information and training has been provided and that both parties agree to the understanding of the hazards and the rights of the employee. This acknowledgment must be signed and dated prior to the employee being allowed to work without training supervision.

As businesses progress, hazards can change, and thus a hazards risk assessment should be an ongoing part of the business and employees must be educated on the changes in risks as they occur, or annually at a minimum. The annual hazards acknowledgment process should be a time in which the employer provides a formal feedback loop for the employee.

Q: Does OSHA review hospitals’ HD procedures?

A: Yes, OSHA does review HD procedures in both hospitals and ambulatory oncology clinics. There are case reports of these reviews available on the NIOSH site in addition to examples of NIOSH teams inspecting infusion centers as a response to employee complaints filed with OSHA about an inappropriate provision of protective measures. In these cases, a NIOSH team has conducted robust wipe sampling and identified a list of deficiencies at each site. I encourage reading the case reports to better understand the steps NIOSH will take following a formal complaint.

Q: What percentage of drug administration is initiated by nursing versus pharmacy?

A: That is a difficult question to answer as there are still sites where nurses, rather than pharmacists, are preparing medications. Particularly in ambulatory or standalone clinics, nurses may be mixing HDs without proper training or oversight. Recognizing that this practice is ongoing, pharmacy should track all HDs in their facility to identify any sites where compounding may be occurring without pharmacy oversight.

As a best practice, facilities can utilize wholesaler purchasing software to establish a purchasing formulary, which limits the purchase of institutionally defined HDs to the pharmacy. This requires pharmacy purchasing staff to identify all hospital departments, including ambulatory, office based clinics where hazardous drugs may be in use. Additionally, pharmacy purchasing staff can work with the health system financial department to screen drug invoices to identify any drugs purchased outside of the preferred wholesaler.

Q: What is the best way to store the safety data sheets (SDS) for HDs?

A: In order to have the most current references available, maintain the SDS electronically. Most drug wholesalers have copies of the SDS integrated into the ordering software. However, I also encourage using the belt and suspender method, which entails having a printed copy to back up the electronic system. The redundant paper copy is key for emergency situations such as losing power or Internet access. This backup system is only effective if there is a process in place to ensure that the printed copies are current. The last thing you want is to have a staff member who needs the most current copy of an SDS due to an emergent incident (eg, a spill), or have an inspector request an SDS and find it is dated to 2011. Before finalizing your system, review both state regulations and your accreditor’s requirements as they may have different standards.

From a process perspective, educate your staff as to the critical components of an SDS, outline key scenarios when timely SDS access is warranted, and share the location(s) of the SDS. As noted, most wholesalers include the SDS in their ordering software which allows staff to pick the drug and then access a subtab on the ordering form that provides direct access to the SDS. However, for those staff members that have never been oriented to the use of the wholesaler software or do not have access to it, this SDS access point is unreliable.

Q: What is the benefit of wearing an N95 over a surgical mask when working in the negative pressure cleanroom?

A: USP <800> states, “Surgical masks do not provide respiratory protection from drug exposure and must not be used when respiratory protection from HD exposure is required. A surgical N95 respirator provides the respiratory protection of an N95 respirator, and like a surgical mask, provides a barrier to splashes, droplets, and sprays around the nose and mouth.”3 As facilities work toward full USP <800> compliance, it is critically important to conduct a risk assessment for their staff and plan accordingly.

USP goes on to state: “For most activities requiring respiratory protection, a fit-tested NIOSH-certified N95 or more protective respirator is sufficient to protect against airborne particles. However, N95 respirators offer no protection against gases and vapors and little protection against direct liquid splashes (see the Centers for Disease Control and Prevention’s Respirator Trusted-Source Information).”3

Facilities should work with their local employee health professionals to define whether a surgical paper mask is appropriate or if an N95 is warranted. In light of the recent COVID-19 driven shortages of N95s, most sites should have previously assessed the necessity of N95s.

References

1. FDA Briefing Document Janssen Ad26.COV2.S Vaccine for the Prevention of COVID-19; US Food and Drug Administration, Vaccines and Related Biological Products Advisory Committee; 2021. https://www.fda.gov/media/146217/download.
2. Hertig JB, Shah VP, Flühmann B, et al. Tackling the challenges of nanomedicines: are we ready? Am J Health Syst Pharm. 2021;78(12):1047-1056.
3. United States Pharmacopeia (USP). USP General Chapter <800> Hazardous Drugs – Handling in Healthcare Settings. https://www.usp.org/compounding/general-chapter-hazardous-drugs-handling-healthcare.

Fred Massoomi, PharmD, BCSCP, FASHP, is a senior pharmacist consultant for Visante, Inc. He received his doctorate from the University of Kansas School of Pharmacy. Fred is a member of Pharmacy Purchasing & Products’ Editorial Board.