To develop your facility specific hazardous drug (HD) list, you will need:
A copy of NIOSH 2016 (current revision)
Also, a copy of NIOSH 2020 (Draft) used for supplementation
The NIOSH 2016 includes drugs that NIOSH has reviewed and found have one or more hazardous properties (don’t worry about the 2020 DRAFT just yet).
NIOSH 2016 places HDs into 3 tables:
Table 1: Antineoplastic drugs
Table 2: Non-antineoplastic drugs that meet one or more HD criteria
Table 3: Non-antineoplastic drugs that are primarily reproductive hazards
Your HD program must also include a way for employees to know to what type of hazard they could be exposed so it is important to keep these 3 categories (i.e., tables) in mind so that potential exposure can also be included on your list (example to follow).
Although, NIOSH has done a lot of the work for you, there are a couple important items to keep in mind as you develop your HD list.
NIOSH 2016 stopped evaluating drugs that came to market AFTER January 2014
NIOSH no longer evaluates “biologics” – this will be up to each facility to research (more later)
Investigational drugs are not evaluated (addressed later)
Step1: Walk the shelves and identify all drugs listed in NIOSH 2016 from any of the three tables (again making sure to note what table they are on, which in turn will tell you what type of potential hazard the employee could encounter)
Ensure that you find ALL dosage forms for the drug (tabs, caps, IV, oral liquid, powder, patches, etc.) – this is very important for evaluation and risk assessments (more later)
Ensure that you make note of each dosage form you have in your facility – this will become important later as we discuss the Assessment of Risk (AOR) – more on AOR later
Once this is done, you can use the NIOSH 2020 DRAFT as a supplement. This draft includes drugs that have been evaluated through December 2015. If using this draft as a supplement to identify HDs, you will only need to review drugs that came to the market January 2016 and after.
Step 2: Now that you have used the NIOSH list(s) to identify hazardous drugs, each facility must review drugs individually that were not reviewed by NIOSH. This would be:
Drugs coming to market after January 2014 (if using NIOSH 2016 alone)
Drugs coming to market after January 2016 (if using the NIOSH 2020 DRAFT as a supplement)
Biologics: No longer evaluated by NIOSH and will need to be evaluated individually
Investigational drugs
How to determine if a drug, not on the NIOSH list(s), should be considered hazardous:
A drug is hazardous if it exhibits one or more of the following:
Carcinogenicity
Teratogenicity (or other developmental toxicities)
Reproductive toxicity
Organ toxicity at low doses
Genotoxicity
Structure and toxicity profile of new drug that mimics existing drugs that are hazardous
MFR states special handling instructions
The following is used to evaluate:
FDA Package Insert
Section 8 - reproductive or developmental toxicity
Section 13 – carcinogenicity, teratogenicity, genoteoxicity
Section 16 – safe handling warnings by the MFR
SDS
IARC (www.iarc.fr)
DrugBank (www.drugbank.ca)
Professional journals
For investigational drugs – In almost all circumstances, these drugs will need to be included on your HD list and handled as hazardous with full containment requirements of USP <800>. If the manufacturer has sufficient data that supports that the drug is not meet hazardous criteria as defined above, then the facility “could” decide to not handle as hazardous. However, special caution should be taken since investigational drugs have not gone through full post marketing testing to 100% identify any/all criteria for a hazardous drugs, therefore the data produced by the manufacture may still be insufficient. It would be advisable to handle all investigational drugs as hazardous unless there is proof otherwise.
Step 3: Now that hazardous drugs in the facility have been identified, it is time to place them in an alphabetical list with the following:
Drug: Generic name (may list Name Brand if desired but generic should be default)
Classification: Antineoplastic, anticonvulsant, etc.
Primary Risk: Description of the risk (taken directly from NIOSH)
Dosage Form: This would be just the dosage forms you have in the facility (tab, cap, IV, oral liquid, etc.)
Additionally, you will want to assign each table a color and color-code your Facility Specific HD List. These colors will play an important role in helping employees know to what type of hazard they may be exposed even if they do not have the list readily available (this will be explained in more depth once we get to separating your hazardous drugs in the pharmacy). In the example below, the colors red, blue, and green were used:
Red = Used for Drugs on table 1 of the 2016 NIOSH list – Red denotes antineoplastic drugs
Blue = Used for drugs on table 2 of the 2016 NIOSH list – Blue denotes non-antineoplastic HDs with one or more multiple hazards
Green = Used for drugs on table 3 of the 2016 NIOSH list – Green denotes non-antineoplastic HDs with primarily reproductive or developmental hazards
As an example:
Now that you have identified all the hazardous drugs in your facility, you should also label all your bins containing these drugs with the color indicated on your list. This will allow employees to immediately identify drugs without the list in hand as:
Hazardous
To what type of hazard they may be exposed (based on the color)
This concludes the making of your hazardous drug list. Next we will discuss what drugs must follow all containment requirements of USP <800> and which ones may be released from the containment requirements if there is an Assessment of Risk (AOR) on file and alternate containment requirements are evaluated and in place.
Thank you for visiting my site. For more information please visit www.SoignerSolutions.com or email me directly at smilstead@SoignerUniversal.com
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