Form 4 Antineoplastic Agents (Compound)

MODULE B: Antineoplastic Agents (Compound) Form Approved

7/23/10 OMB No. 10AP-xxxx

Expiration Date: xx/xx/2011

PROGRAMMING INSTRUCTIONS APPEAR IN BLUE.

	During your career, how long have you compounded antineoplastic agents?		Less than one year 1-5 years 6-10 years 11-20 years More than 20 years
	What training have you received on the safe handling of antineoplastic agents? Please  all that apply.		American Society of Health-System Pharmacists (ASHP) Oncology Pharmacy Development course National Pharmacy Technician Association (NPTA) Best Practices for Safe Handling Hazardous Medications in the Pharmacy Oncology Nurses Society (ONS) Safe Handling of Hazardous Drugs course ONS Chemotherapy and Biotherapy course ChemoTEQTM Safe Handling of Hazardous Drugs Training Other (Please specify): _________________________________ I have not received training è GO to Question 4
	When was the last time you received training on the safe handling of antineoplastic agents?		Within past 12 months More than 12 months ago
	How familiar are you with the following guidance documents on the safe handling of antineoplastic agents?		Very	Somewhat	Not at All
	a. ASHP guidelines for handling hazardous drugs				
	b. NIOSH Alert on Preventing Exposures to Antineoplastic Agents and Other Hazardous Drugs				
	c. ONS Safe Handling of Hazardous Drugs				
	d. Occupational Safety and Health Administration (OSHA) guidelines for the management of antineoplastic drugs				
If you work for more than one employer, the following questions apply to your primary employer, i.e., the one for which you typically work the most hours. If you are self-employed, consider yourself the employer.
	Does your employer have procedures that address safe compounding of antineoplastic agents?		Yes No I don’t know

	During the past 7 calendar days, which of the following antineoplastic agents did you compound? Please  all that apply. display calendar highlighting the past 7 calendar days. applies to all questions with ‘in the past 7 calendar days.
	Aldesleukin Alemtuzumab Alitretinoin Altretamine Aminoglutethimide Amifostine Amsacrine Anastrozole Arsenic trioxide Asparginase Azacitidine BCG live Bevacizumab Bexarotene Bicalutamide Bleomycin Bortezomib Busulfan Capecitabine Carboplatin Carmustine Cetuximab Chlorambucil Cisplatin Cladribine Cyclophosphamide Cytarabine Dacarbazine Dactinomycin Daunorubicin Denileukin Docetaxel Doxorubicin Epirubicin Estramustine Etoposide Exemestane	Floxuridine Fludarabine Fluoxymesterone Flutamide Fluorouracil Fluvestrant Gemcitabine Gemtuzumab ozogamicin Goserelin Hydroxyurea Ibritumomab Tiuxetan Idarubicin Ifosfamide Imatinib mesylate Interferon Alfa Irinotecan Lapatinib Lenalidomide Letrozole Leuprolide Levamisole Lomustine Megestrol Melphalan Mercaptopurine Merchlorethamine Methotrexate Mitomycin-C Mitotane Mitoxantrone Motexafin gadolinium Nilutamide Oprelvekin Oxaliplatin	Paclitaxel Palifermin Pegaspargase Pemetrexed Pentostatin Plicamycin Procarbazine Raloxifene Rituximab Sargramostim Sorafenib Streptozocin Sunitinib Tamoxifen Temozolomide Teniposide Thalidomide Thioguanine Thiotepa Topotecan Toremifene Trastuzumab Trimetrexate Tretinoin Valrubicin Vinblastine Vincristine Vinorelbine Investigational compounds (not yet named) Other (Please specify up to 2 more antineoplastic agents): ____________________________ ________________________

	During the past 7 calendar days, on how many days did you compound antineoplastic agents?			1 day 2 days 3 days 4 days 5 days 6 days 7 days
	During the past 7 calendar days, what was the total number of doses of antineoplastic agents that you compounded?			1-5 doses 6-10 doses 11-20 doses 21-40 doses More than 40 doses
	During the past 7 calendar days, the total number of doses of antineoplastic agents you compounded was...			…more doses than usual …fewer doses than usual …about the same number of doses as usual
	Of the total number of antineoplastic drug doses you compounded during the past 7 calendar days…
	a. …what percent was liquid?			_______ % IF 100%, SKIP QUESTION 18
	b. …what percent were tablets or capsules?			_______% FILL IN DIFFERENCE BETWEEN 100% AND NUMBER ENTERED IN 10a IF 100%, SKIP QUESTIONS 14-17, 19b,19c, and 44-46
	During the past 7 calendar days, in which of the following areas did you compound antineoplastic agents? Please  all that apply.			Main inpatient pharmacy Satellite inpatient pharmacy Outpatient pharmacy Oncologist’s office/clinic/center Some other location (Please specify): _________________________________
If only one response marked in Question 11 è Go to Question 13.
	Of the locations you checked above, please indicate the area where you most often compounded antineoplastic agents.			list areas marked in Question 11 (use radio buttons)
	During the past 7 calendar days, how often did you compound antineoplastic agents in a…			Always		Sometimes	Never
	a. …room or area dedicated to the preparation of these agents?						
	b. …biological safety cabinet?						
	c. …isolator?						
	d. …other (Please specify):____________					
if ‘100%’ tablets/capsules in question 10b, skip questions 14-17
	During the past 7 calendar days, did you prime IV tubing?			Yes No è go to Question 17
	During the past 7 calendar days, how often did you prime IV tubing inside a ventilated cabinet or isolator?			Always Sometimes Never
	During the past 7 calendar days, how often did you prime IV tubing with a liquid other than the antineoplastic agent?			Always Sometimes Never
		During the past 7 calendar days, which of the following devices did you use when transferring liquid antineoplastic agents from primary packaging (such as vials) to dosing equipment (e.g., infusion bags)? Please  all that apply.			Closed-system transfer device (e.g., PhaSealR) Needle-less system Glove box None of the above
IF ‘100%’ LIQUID in Question 10a, skip Question 18
		During the past 7 calendar days, how often did you crush tablets or open capsules of antineoplastic agents?			Always Sometimes Never

Questions addressing work practices and use of personal protective clothing and equipment will help us understand what is currently used and under what circumstances. Depending on your job and exposures, these may not be required.

if ‘100%’ tablets/capsules in question 10b, skip questions 19b and 19c.
	During the past 7 calendar days when compounding antineoplastic agents, how often did you …		Always	Sometimes	Never
	…wipe drug vials before placement in the biological safety cabinet or isolator?				
	…use Luer-Lock fittings for all needleless systems, syringes, needles, infusion tubing, and pumps?				
	c. …use a plastic-backed absorbent pad under the open drug vials and other preparation materials?				
	d. …change gloves at least every 30 minutes?				
	e. …change gloves immediately when damaged or contaminated?				
	f. …change disposable gowns after wearing for more than 3 hours?				
	g. …change disposable gowns immediately when damaged or contaminated?				
	h. …wash hands after removing gloves?				
	i. …wear shoe covers?				
	j. …wear a head cover?				

During the past 7 calendar days when packaging antineoplastic agents for delivery to the area(s) where they are administered, how often did you…

Always

Sometimes

Never

a. …package antineoplastic agent dosages in sealable plastic bags?







b. …attach a warning label (e.g., “hazardous”, “chemotherapy”, etc) to packages of antineoplastic agents?







c. …store prepared antineoplastic agents in an area restricted to authorized personnel?







d. …obtain signature acknowledging receipt of antioneoplastic agent(s) from person administering the drug(s) or his/her designee?







e. …carry a spill kit during transportation of antineoplastic agent(s)?







IF ‘100%’ tablets/capsules in Question 10b, skip Questions 21-28.

During the past 7 calendar days, how many spills (even a few drops) occurred inside of a ventilated cabinet or isolator while you were compounding liquid antineoplastic drugs?

No spills

1-2 spills

3-5 spills

More than 5 spills

a. Spills of less than 5 ml









b. Spills of 5 ml or more









If ‘No spills’ marked in BOTH 21a and 21b è Go to Question 25. Otherwise è Go to Question 22.

How often was/were the spill(s) cleaned up?

Always Sometimes Never è go to Question 25 I don’t know è go to Question 25

How often did you yourself clean up the spill(s)?

Always è go to Question 25 Sometimes Never

Who cleaned up the spill(s)? Please  all that apply.

You Designated spill cleanup team Other (please specify): ____________________________ I don’t know

In the past 7 calendar days, how many spills (even a few drops) occurred anywhere outside of a ventilated cabinet or isolator while you were compounding or otherwise handling liquid antineoplastic drugs?

No spills

1-2 spills

3-5 spills

More than 5 spills

a. Spills of less than 5 ml









b. Spills of 5 ml or more









If ‘No spills’ marked in BOTH 25a and 25b è Go to Question 29. Otherwise è Go to Question 26.

How often was/were the spill(s) cleaned up?

Always Sometimes Never è GO to Question 29 I don’t know è GO to Question 29

How often did you yourself clean up the spill(s)?

Always è GO to Question 29 Sometimes Never

Who cleaned up the spill(s)? Please  all that apply.

You Designated spill cleanup team Other (please specify): ____________________________ I don’t know

Are hazardous drug spill kits readily available?

Yes No I don’t know

During the past 7 calendar days, did your skin come into direct contact with antineoplastic agents during compounding activities?

Yes No

Has exposure monitoring (e.g., air sampling, wipe sampling) been conducted in the past 12 months to assess your or your co-workers’ exposure to antineoplastic agents?

Yes No I don’t know

A medical surveillance program may include work history, physical exam, blood and/or urine tests, etc. Do you participate in a medical surveillance program that addresses potential health effects of exposure to antineoplastic agents?

Yes No, my (primary) employer offers such a program but I did not participate in it. My (primary) employer does not provide/I am not aware that my employer provides such a program.

In the past year, have you accidentally punctured your skin with a sharp while compounding antineoplastic agents?

Yes No

Questions addressing work practices and use of personal protective clothing and equipment will help us understand what is currently used and under what circumstances. Depending on your job and exposures, these may not be required.

During the past 7 calendar days, how often did you wear a nonabsorbent disposable gown with closed front and tight cuffs while compounding antineoplastic agents?

Always è GO to Question 37 Sometimes Never

	What were the reason(s) you did not always wear a nonabsorbent disposable gown with closed front and tight cuffs while compounding antineoplastic agents? Please  all that apply.		An engineering control (e.g., ventilated safety cabinet, chemo hood or enclosure) was being used Skin exposure was minimal Not part of our protocol Not provided by employer No one else who does this work uses them Too uncomfortable or difficult to use Not readily available in work area Cross contamination to other areas is not a concern Concerned about raising the patient’s anxiety Other (Please specify):
If only one response marked in Question 35 è Go to Question 37.
	Of the reasons you checked above, please indicate the most important reason you did not always wear a nonabsorbent disposable gown with closed front and tight cuffs while compounding antineoplastic agents.		list reasons marked in Question 35 (use radio buttons)
	In your current job, have you taken home any clothing that came into contact with antineoplastic agents?		Yes No I don’t know
	During the past 7 calendar days, how often did you wear chemotherapy gloves while compounding antineoplastic agents? Note: Chemotherapy glove: a medical glove that has been approved by FDA for use when handling antineoplastic agents.		Always Sometimes Neverè GO to Question 40 I don’t know if the gloves I wore were chemotherapy gloves è GO to Question 42
3	When wearing chemotherapy gloves, how often did you wear two pairs (i.e., double glove)?		Always Sometimes Never I don’t know

If ‘always’ is marked in Question 38 è Go to Question 42.

If ‘sometimes’ is marked in Question 38 è Go to Question 40.

	What were the reason(s) you did not always wear chemotherapy gloves while compounding antineoplastic agents? Please  all that apply.		Skin exposure was minimal Not part of our protocol Not provided by employer No one else who does this work uses them Too uncomfortable or difficult to use Not readily available in work area Cross contamination to other areas is not a concern Concerned about raising the patient’s anxiety Other (Please specify): ______________________________
If only one response marked in Question 40 è Go to Question 42.
	Of the reasons you checked above, please indicate the most important reason you did not always wear chemotherapy gloves while compounding antineoplastic agents.		list reasons marked in Question 40 (use radio buttons)

	During the past 7 calendar days, did you perform any of the following activities while wearing gloves that had been used to handle antineoplastic agents?							Yes	No
	a. Use phone/ cell phone/pager								
	b. Touch a computer keyboard, mouse, monitor or calculator								
	c. Handle files or charts								
	d. Touch door knobs, cabinets, drawers or product bins								
	e. Eat, drink, chew gum or smoke								
	f. Use pen or pencil (outside of lab hood)								
	g. Touch waste basket/garbage bags (outside of lab hood)								
	h. Use restroom								
	i. Apply cosmetics (e.g., lip balm)								
	During the past 7 calendar days, did you remove and later put back on the gloves you had worn while compounding antineoplastic agents?							Yes No
if ‘100%’ tablets/capsules in question 10b, skip questions 44-46
	During the past 7 calendar days, how often did you wear eye or face protection (e.g., goggles, face shield) while compounding liquid antineoplastic agents? Do not include personal eye glasses.					Always è GO to Question 47 Sometimes Never
	What were the reason(s) you did not always wear eye or face protection while compounding liquid antineoplastic agents? Please  all that apply.		An engineering control (e.g., ventilated safety cabinet, chemo hood or enclosure) was being used Exposure was minimal Not part of our protocol Not provided by employer No one who does this work uses them Too uncomfortable or difficult to use Not readily available in work area Concerned about raising the patient’s anxiety Other (Please specify): ___________________________
If only one response marked in Question 45 è Go to Question 47.
.	Of the reasons you checked above, please indicate the most important reason you did not always wear eye or face protection while compounding liquid antineoplastic agents.			list reasons marked in Question 45 (use radio buttons)

	During the past 7 calendar days, did you wear any of the following while compounding antineoplastic agents? Please  all that apply.
	N95 respirator (includes surgical N95 respirator)		Half-facepiece air purifying respirator with particulate cartridge(s)
	Powered air-purifying respirator (PAPR)		Standard surgical mask
	None of above		q I don’t know
DISPLAY FOLLOWING NOTE ON A SEPARATE SCREEN for all respondents (except those who marked ‘I don’t know’): THE FOLLOWING QUESTIONS ASK ABOUT RESPIRATORS. STANDARD SURGICAL MASKS ARE NOT RESPIRATORS. IF RESPONDENT MARKED ‘N95 RESPIRATOR’, ‘HALF-FACEPIECE AIR PURIFYING RESPIRATOR’ OR ‘POWERED AIR PURIFYING RESPIRATOR’ IN QUESTION 47 è GO to Question 48. IF RESPONDENT MARKED ONLY ‘STANDARD SURGICAL MASK’ OR ‘NONE OF THE ABOVE’ IN QUESTION 47 è GO to Question 49. IF RESPONDENT MARKED ‘I DON’T KNOW’ IN QUESTION 47 è GO to INSTRUCTIONS IN QUESTION 51.

		How often did you wear a N95 respirator, half-facepiece air purifying respirator or a powered air purifying respirator while compounding antineoplastic agents?				Always ègo to Question 51 Sometimes
.	What were the reason(s) you did not always wear a N95 respirator, a half-facepiece air purifying respirator with particulate cartridge, or a powered air purifying respirator while compounding antineoplastic agents? Please  all that apply.			An engineering control (e.g., ventilated safety cabinet, chemo hood or enclosure) was being used Exposure was minimal Not part of our protocol Not provided by employer No one else who does this work uses them Too uncomfortable or difficult to use Not readily available in work area Concerned about raising the patient’s anxiety Other (Please specify): ______________________________
If RESPONDENT marked more than one reASON in Question 49 è Go to Question 50. Otherwise è Go to INSTRUCTIONS BEFORE QUESTION 51
.	Of the reasons you checked above, please indicate the most important reason you did not always wear a respirator while compounding antineoplastic agents.			list reasons marked in Question 49 (use radio buttons)
If RESPONDENT marked ‘N95 respirator’ or ’Half-facepiece air purifying respirator’ in Question 47 è Go to Question 51. Otherwise è EXIT MODULE AND Go to Core Module IF THIS IS THE FIRST HAZARD MODULE COMPLETED IF THIS IS THE SECOND HAZARD MODULE COMPLETED, END SURVEY. end with ‘Thank you’ statement.
	Have you been fit-tested for the respirator(s) you use for compounding antineoplastic agents?			Yes No è EXIT MODULE AND Go to Core Module IF THIS IS THE FIRST HAZARD MODULE COMPLETED IF THIS IS THE SECOND HAZARD MODULE COMPLETED, END SURVEY. end with ‘Thank you’ statement.

Thank you for participating in the NIOSH Health and Safety Practices Survey of Healthcare Workers. Your answers have been submitted.

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