### NIOSH res onse to NIOSH Docket No.233, Hazardous Dru List U date 2014

Commenter Drug Comment NIOSH Response Stephen R, Gomez, PhD; bevacizumab Requested the exclusion of NIOSH re-evaluated bevacizumab in light of Patricia Weideman, bevacizumab from the new information on its bioavailability in the PhD, Genentech NIOSH hazardous drug list occupational setting provided by the based on lack of exposure in manufacturer and it was determined that the new occupational setting. wamings were not sufficient to warrant its

listing. Following a final review, the expert panel concurred with not listing this drug as
hazardous. William H. Houser, dexmedetomidine Requested that Initially, the expert panel recommended listing PhD, DABT, Hospira dexmedetomidine not be dexmedetomidine as a hazardous drug based on
listed as hazardous based on fetal toxicity in laboratory studies. The NIOSH limited exposure potential Hazardous Drug Committee re-evaluated
for healthcare workers. dexmedetomidine in light of new information

provided by the manufacturer on the limited potential for occupational exposure and
determined that it will not be listed for 2014. Following a final review, the expert panel concurred with not listing this drug as hazardous. Christopher J. Topoleski, Fluconazole Only those workers who are Fluconazole will be listed on the 2014 hazardous American Society of at reproductive risk, and not drug list with specific recommendations about its Health-System all workers, should be reproductive risk. NIOSH will be adding a table
Pharmacists protected from exposure. of recommendations for personal protective Occupational exposure is equipment and engineering controls. limited due to dosage formulation. May support listing if additional information on managing these drugs were provided on personal protective equipment.nevirapine Occupational exposure is limited due to dosage formulation. May support listing if additional information on managing these drugs were provided on personal protective equipment. Nevirapine will be listed on the 2014 hazardous

drug list with specific recommendations about its
formulation. It will be listed on the 2014 hazardous drug list in a non-antineoplastic drug category based on hepatocellular adenomas and carcinomas in laboratory studies at doses lower
than human dose

### inlaboratory studies. NIOSH will be adding a table of recommendations for personal protective equipment and engineering
controls. propylthiouracil Only those workers who are Propylthiouracil will be listed on the 2014

at reproductive risk, and not hazardous drug list in a non-antineoplastic drug all workers, should be category based on its IARC classification of 2B, protected from exposure. with additional recommendations about its Occupational exposure is reproductive risk. NIOSH will be adding a table limited due to dosage of recommendations for personal protective formulation. May support equipment and engineering controls. listing if additional information on managing these drugs were provided on personal protective
e ui ment. spironolactone Only those workers who are Spironolactone will be listed on the 2014

at reproductive risk, and not hazardous drug list. It will be listed on the 2014 all workers, should be hazardous drug list in a non-antineoplastic drug protected from exposure. category based on a new black box warning for Occupational exposure is tumorogenicity in laboratory studies. No limited due to dosage adverse reproductive effects were identified for formulation. May support this drug. N10SH will be adding a table of listing if additional recommendations for personal protective information on managing equipment and engineering controls. these drugs were provided on personal protective equipment.voriconazole Only those workers who are Voriconazole will be listed on the 2014 at reproductive risk, and not hazardous drug list with specific all workers, should be recominendations about its reproductive risk. protected from exposure. NIOSH will be adding a table of Occupational exposure is recommendations for personal protective limited due to dosage equipment and engineering controls. formulation. May support listing if additional information on managing these drugs were provided on personal protective equi ment.

bevacizumab Requested the exclusion of NIOSH re-evaluated bevacizumab in light of

bevacizumab from the new information on its bioavailability in the NIOSH hazardous drug list occupational setting provided by the based on lack of exposure in manufacturer and it was determined that the new occupational setting. warnings were not sufficient to warrant its

listing. Following a final review, the expert panel concurred witli not listing this drug as
hazardous. Annie Lambert, abacavir Recommend a low risk NIOSH does not separate drugs into a high/low PharmD; Jeff Rochon, category risk category. Listing a drug as hazardous is PharmD; Alex Truchot, typically based on effects at therapeutic or lower MM, HEM, Washington doses. Abacavir will be listed on the 2014 State Hazardous Drug hazardous drug list in a non-antineoplastic drug Advisory Committee category based on malignant tumors observed in
male and female mice and rats and its genotoxicity in vivo. NIOSH will be adding a table of recommendations for personal protective equipment and engineering controls.Bevacizumab Stated that there is no occuparional risk NIOSH re-evaluated bevacizumab in light of

new information on its bioavailability in the occupational setting provided by the
manufacturer and it was determined that the new wamings were not sufficient to warrant its listing. Following a final review, the expert panel concurred with not listing this drug as
hazardous. apomorphine Recommend a low risk NIOSH does not separate dmgs into a high/low

category risk category. Listing a drug as hazardous is

typically based on effects at therapeutic or lower doses. Apomorphine will be listed on the 2014 hazardous drug list in a non-antineoplastic drug category based on its genotoxicity in several in vitro assays. NIOSH will be adding a table of recommendations for personal protective e ui ment and en ineering controls. deferiprone Risk at therapeutic doses NIOSH does not separate drugs into a high/low

only risk category. Listing a drug as hazardous is

typically based on effects at therapeutic or lower doses. Deferiprone will be listed on the 2014 hazardous dmg list in a non-antineoplastic dmg category based on genotoxicity in vitro and in vivo, and with specific recommendations about its reproductive risk. NIOSH will be adding a table of recommendations for personal protective equipment and engineering controls.dexmedetomidine No evidence to support listing as hazardous Initially, the expert panel recommended ]isting

dexmedetomidine as a hazardous drug based onfetal toxicity in laboratory studies. NIOSH reevaluated dexmedetomidine in light of new information provided by the manufacturer on the limited potential for occupational exposure and
determined that it would not be listed for 2014. Following a final review, the expert panel concurred with not listing this drug as hazardous. ezogabine Recommend a low risk Ezogabine was initially recommended as

category meeting the criteria for a hazardous drug based

on adverse fetal effects. However, most effects
on the fetus were associated with maternal toxicity. It was re-evaluated by the NIOSH Hazardous Drug Committee and it was
detennined that it does not meet the criteria for a hazardous drug and will not be listed on the 2014 hazardous drug list. Following a final review, the expert panel concurred with not listing this drug as hazardous. fingolimod Recommend a low risk NIOSH does not separate drugs into a high/low

category; Risk at therapeutic risk category. Listing as a hazardous drug is doses only typically based on effects at therapeutic or lower

doses. Fingolimod will be listed on the 2014 hazardous drug list in a non-antineoplastic drugcategory based on malformations and embryofetal deaths at low doses and the observation of malignant lymphomas in laboratory studies, and with specific recommendations about its reproductive risk. NIOSH will be adding a table of recommendations for personal protective equipment and engineering controls.fluconazole Little evidence to support listing as hazardous Fluconazole will be listed on the 2014 hazardous

drug list with specific recommendations about its reproductive risk. NIOSH will be adding a table of recommendations for personal protective e uipment and engineering controls. liraglutide Risk at therapeutic doses NIOSH does not separate drugs into a high/low

only risk category. Listing as a hazardous drug is

typically based on effects at therapeuric or lower doses. Liraglutide will be listed on the 2014 hazardous drug list in a non-antineoplastic drug category based on the black box warning for thyroid C-cell tumors with supporting evidence in laboratory studies, and with specific recommendations about its reproductive risk. NIOSH will be adding a table of recommendations for personal protective e ui ment and engineering controls. nevirapine Recommend a low risk NIOSH does not separate drugs into a high/low

category; Risk at therapeutic risk category. Listing as a hazardous drug is doses only typically based on effects at therapeutic or lower

doses. Nevirapine will be listed on the 2014 hazardous drug list in a non-antineoplastic drug category based on hepatocellular adenomas and carcinomas in laboratory studies at doses lower than human dose. NIOSH will be adding a table of recommendations for personal protective equipment and engineering controls.propylthiouracil Risk at therapeutic doses NIOSH does not separate drugs into a high/low only risk category. Listing as a hazardous drug is

typically based on effects at therapeutic or lower doses. Propylthiouracil will be listed on the 2014 hazardous drug list in a non-antineoplastic drug category based on its IARC classiflcation of 2B, and with additional recommendations about its reproductive risk. NIOSH will be adding a table of recommendations for personal protective equi ment and engineering controls.

tesamorelin Recommend a reproductive Tesamorelin will not be listed on the 2014

risk category only; Risk at hazardous drug list. It is listed as a Preb ancy tberapeutic doses only Category X because there is no benefit to a

pregnant woman. The NIOSH Hazardous Drug
Committee re-evaluated tesamorelin and
determined that it did not meet the criteria for a hazardous drug and would not be listed for 2014. Following a final review, the expert panel concurred with not listing this drug as hazardous. topiramate Recommend a low risk NIOSH does not separate drugs into a high/low

category; Risk at therapeutic risk category. Listing as a hazardous drug is doses only typically based on effects at therapeutic or lower

doses. Topiramate will be listed on the 2014 hazardous drug list with specific recommendations about its reproductive risk. NIOSH will be adding a table of recommendations for personal protective e uipment and engineering controls. ulipristal Recommend a reproductive Ulipristal will be listed on the 2014 hazardous

risk category only drug list witli specific recommendations about its

reproductive risk. NIOSH will be adding a table of recoinmendations for personal protective equipment and engineering controls.voriconazole Recommend a reproductive Voriconazole will be listed on the 2014 risk category only hazardous dnag list with specific

recormnendations about its reproductive risk. NIOSH will be adding a table of recommendations for personal protective equipment and engineering controls.

warfariu Recornmend a low risk NIOSH does not separate drugs into a high/low

category risk category. Listing as a hazardous drug is

typically based on effects at therapeutic or lower
doses. Warfarin will be listed on the 2014 hazardous drug list with specific recommendations about its reproductive risk. NIOSH will be adding a table of recommendations for personal protective e ui ment and en ineering controls. general comments Support a tiered approach NIOSH does not separate drugs into a high/lowrisk category. NIOSH has developed a multicate ory approach similar to a tiered ap roacb. Elizabeth A. Treanor, Monoclonal Worker exposure is minimal At the cun

-ent time, NIOSH only lists conjugated Phylmar Group antibodies due to large molecular monoclonal antibodies that have manufacturers' weight safe handling warnings. The NIOSH Hazardous

Drug Committee re-evaluated bevacizumab in light of new infonnation provided by the manufacturer on its bioavailability and
detennined that it would not be listed for 2014. Following a final review, the expert panel concurred with not listing this drug as hazardous.general comments 

### NIOSH should describe its The multi-category approach that 

### NIOSH has approach in adding or proposed will include this type of infonnation. deleting a drug from the list The process will be described in detail the 2014 by incorporating this update.

infonnation into the alert general comments Describe how the This is not practical as the review process

assessment process was involves several steps in the process. In general, applied to each drug there is a review by an expert panel and a public

comment period. 

### NIOSHreviews all available
information and makes the final decision on each individual drug.

### NIOSH willbe listing the reasons why each drug is listed in the 20141ist. Ryan A. Forrey, abacavir Should not be added to list The fonnat will change to a multi-category PhannD, MS, Ohio State in its current format approach. Abacavir will be listed on the 2014 University hazardous drug list in a non-antineoplastic drug category based on malignant tumors observed in
male and female mice and rats and its genotoxicity in vivo. 

### NIOSH willbe adding a table of recommendations for personal protective equipment and engineering controls. apomorphine Should not be added to list The fonnat will change to a multi-category

in its current fonnat approach. Listing as a hazardous drug is

typically based on effects at therapeutic or lower doses. Apomorphine will be listed on the 2014 hazardous drug list in a non-antineoplastic drug category based on its genotoxicity in several in vitro assays. 

### NIOSH willbe adding a table of recommendations for personal protective equipment and engineering controls.deferipone Should not be added to list
in its current fonnat The fonnat will change to a multi-category

approach. Deferiprone will be listed on the 2014

. hazardous drug list in a non-antineoplastic drug category based on genotoxicity in vitro and in vivo, and with specific recommendations about its reproductive risk. NIOSH will be adding a table of recommendations for personal protective equi ment and engineerin controls.

dexmedetomine Should not be added to list Initially, the expert panel recommended listing

in its current fonnat dexmedetomidine as a hazardous drug based on

fetal toxicity in laboratory studies. The NIOSH Hazardous Drug Committee re-evaluated dexmedetomidine in light of new infonnation provided by the manufacturer on the limited potential for occupational exposure and
detennined that it will not be listed for 2014. Following a final review, the expert panel
concurred with not listin this dru as hazardous. ezogabine Should not be added to list Ezogabine was initially recommended as

in its cunent fonnat meeting the criteria for a hazardous drug based

on adverse feta] effects. However, most effects
on the fetus were associated with matemal toxicity. It was re-evaluated by the NIOSH Hazardous Drug Committee and it was
detennined that it does not meet the criteria for a hazardous drug and will not be listed on the 2014 hazardous drug list. Following a final review, the expert panel concurred with not listing this drug as hazardous.

10fingolimod Should not be added to list The format will change to a multi-category

in its current fonnat approach. Listing as a hazardous drug is

typically based on effects at therapeutic or lower
doses. Fingolimod will be listed on the 2014 hazardous drug list in a non-antineoplastic drugcategory based on malformations and embryofetal deaths at low doses and the observation of malignant lymphomas in laboratory studies, and with specific recommendations about its reproductive risk. NIOSH will be adding a table of recommendations for personal protective e ui ment and engineering controls.

icatibant Should not be added to list The fonnat will change to a multi-category

in its current fonnat approach. Icatibant will be listed on the 2014

hazardous drug list with specific recommendations about its reproductive risk. NIOSH will be adding a table of recommendations for personal protective e ui ment and engineering controls. liraglutide Should not be added to list The format will change to a multi-category

in its cun

-ent format approach. Listing as a hazardous drug is

typically based on effects at therapeutic or lower doses. Liraglutide will be listed on the 2014 hazardous drug list in a non-antineoplastic drug category based on the black box waming for thyroid C-cell tumors with supporting evidence in laboratory studies; and with specific recommendations about its reproductive risk. NIOSH will be adding a table of recommendations for personal protective equipment and engineering controls.

11misoprostol Should not be added to list The fonnat will change to a multi-category

in its current fonnat approach. Misoprostol will be listed on the 2014

hazardous drug list with specific recommendations about its reproductive risk. NIOSH will be adding a table of recommendations for personal protective equi ment and engineerin controls. nevirapine Should not be added to list

in its cun•ent format The fonnat will change to a multi-category

approach. Nevirapine will be listed on the 2014 hazardous drug list in a non-antineoplastic drug category based on hepatocellular adenomas and carcinomas in laboratory studies at doses lower than human dose. NIOSH will be adding a table of recommendations for personal protective equi ment and engineering controls. propylthiouracil Should not be added to list The fonnat will change to a multi-category

in its current format approach. Listing as a hazardous drug is

typically based on effects at therapeutic or lower doses. Propylthiouracil will be listed on the 2014 hazardous drug list in a non-antineoplastic drug category based on its IARC classification of 2B, and with additional recominendations about its reproductive risk. NIOSH will be adding a table of recommendations for personal rotective e ui ment and engineering controls. spironolactone Should not be added to list The fonnat will change to a rnulti-category

in its current fonnat approach. Spironolactone will be listed on the

2014 hazardous drug list in a non-antineoplastic drug category based on a new black box warning for tumorogenicity in ]aboratory studies. NIOSH will be adding a table of recommendations for personal protective equipinent and engineering controls.

12tesamorelin Should not be added to list Tesamorelin will not be listed on the 2014

in its current format hazardous drug ]ist. It is listed as a Pregnancy

Category X because there is no benefit to a pregnant woman. The NIOSH Hazardous Dnxg
Committee re-evaluated tesamorelin and
determined that it did not meet the criteria for a hazardous drug and would not be listed for 2014. Following a final review, the expert panel concurred with not listing this drug as hazardous. topiramate Should not be added to list

in its currerit fonnat The format will change to a multi-category

approach. Topiramate will be listed on the 2014 hazardous drug list with specific recommendations about its reproductive risk. NIOSH will be adding a table of recommendations for personal protective e uipment and engineering controls. ulipristal Should not be added to list The format will change to a multi-category

in its current fonnat approach. Ulipristal will be listed on the 2014

hazardous drug list with specific recommendations about its reproductive risk.

, NIOSH will be adding a table of ', recommendations for personal protective

, e ui ment and en ineering controls.

voriconazole Should not be added to list The fonnat will change to a mLilti-category i

- in its current fonnat approach. Voriconazole will be listed on the I

2014 hazardous drug list with specific recommendations about its reproductive risk. NIOSH will be adding a table of recommendations for personal protective equipment and engineering controls.

13warfarin Should not be added to list The format will change to a multi-category '

in its current fonnat approach. Warfarin will be listed on the 2014

hazardous drug list with specific recommendations about its reproductive risk.

~ NIOSH will be adding a table of recommendations for personal protective e uipment and en ineering controls. general comments Encourages NIOSH to NIOSH performs a hazazd identification only.

develop a risk-stratification Each institution using a drug should determine methodology for its the risk to employees in that institution. The hazardous dnxg list fonnat will change to a multi-category approach

which will be similar to what is being recommended. NIOSH will be adding a table of recommendations for personal protective e uipment and engineering controls.

14