Assessment of Risk

In order to understand how the assessment of risk can help support employee and patient’s safety while decreasing the impact to operational workflow, it is necessary to understand what is required to be included in a hazardous drug list.  The National Institute for Occupational Safety and Health (NIOSH) has developed and provides updates to the “NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings.”  This list contains three groups of drugs designated as Table 1, Table 2, and Table 3.

• Table 1: Antineoplastic drugs, including those with the manufacturer’s safe-handling guidance (MSHG)
• Table 2: Non-antineoplastic drugs that meet one or more of the NIOSH criteria for a hazardous drug, including those with the manufacturer’s safe-handling guidance (MSHG)
• Table 3: Non-antineoplastic drugs that primarily have adverse reproductive effects

All drugs on the current NIOSH list MUST be on an entity’s hazardous drug list if they handle that drug.  A process must be in place to evaluate new drugs that have a toxicity or structural similarity to known hazardous drugs.

Drugs that are required to follow all requirements in chapter USP Chapter <800> include any hazardous drug active pharmaceutical ingredient (API) (Table 1, 2, or 3) and any antineoplastic requiring manipulation (Table 1).  This would include examples such as compounding IV chemotherapy from a vial. 

An assessment of risk can be performed to identify alternate containment strategies for final dosage forms of hazardous drugs (Table 1, 2, and 3) where no additional manipulation other than counting or packaging are required (unless required by the manufacturer).  Entities may perform an assessment of risk for Table 2 and 3 drugs unless noted above.

The assessment of risk is defined by USP Chapter <800> as an evaluation of risk to determine alternative containment strategies and/or work practices.  Alternate containment strategies can include use of personal protective equipment (PPE), purchasing in a unit of use packaging from the manufacturer instead of bulk packaging, or purchasing in a ready to administer form.  Without an assessment of risk, all dosage forms of all drugs that are considered hazardous drugs must be treated as needing the highest level of protection and containment strategies as outlined by USP Chapter <800>.

In addition to taking into consideration the type of hazardous drug (i.e. Table) as noted above, there are other factors that need to be taken into consideration for the assessment of risk.  As outline from USP Chapter <800> at a minimum the assessment of risk must include:

• Type of Hazardous Drug- (Table 1, 2, or 3)
• Dosage form- (tablet, capsule, oral solution, IV, etc.- A separate assessment of risk must be completed for each dosage form as each dosage form has a different level of risk of exposure.  For example, a capsule would have less of a risk at the point of administration compared to the administration of the IV dosage form of a drug)
• Risk of exposure- (Consideration of potential opportunities for exposure including, but not limited to, receipt, dispensing, compounding, administration, spills, waste, transport, and other patient care activities)
• Packaging- (Example: Bulk packaging compared to Unit of Use from the manufacturer)
• Manipulation- (Example: Premix IV product compared to a compounded preparation have differing risk during the compounding process)

Table 5 on the NIOSH list provides recommendations for personal protective equipment (PPE).   Use of all the items listed is not required by USP <800> but can be used to develop organizational policy.

It is important to note that the assessment of risk must be reviewed at a minimum of every 12 months and the review is required to be documented.