11-22-2016 02:10 PM
Here are answered questions from our webinar with Eric S. Kastango, "Complying with USP 800 Hazardous Drug Compounding Requirements."
How do you suggest we stage vials that are being used in the hood? I know it was mentioned the vials are a major source of HD contamination. Alcohol wipes do not seem to eliminate HD residue in hoods
Our department is trying to buy an air sampling machine. Is there anyone that you think it is best? I have looked as SAS 180, minicapt and RCS from Millipore.
If splitting tablets of oral chemo meds prior to dispensing to nursing homes, what PEC is needed?
If the only HD potential exposure is splitting tabs and you don't have a BSC or fume hood, what else can you do?
For activity that require cutting, crushing or manipulating; handling uncoated tablets, only nonsterile preps require ventilated engineering control. So does this clause exclude situations where RNs are crushing tablets for direct administration?
For hazardous drugs listed in table 2 and 3 that are administered direct SubQ or IM that require withdrawing from vial, NIOSH requires it to be prepared in ventilated engineering control. How would you tackle medication like methylergonovine IM?
What is considered a "control device" as repeated mentioned in Table 5 under eye/face protection and resp protection?
Will outpatient pharmacies/retail pharmacies be required to store haz drugs in negative room, 12 ACPH?
One of the big challenges we are working on is the workflow for preparing oral haz med suspensions, split tablets and unit dose packaging in our sterile room. any comments ?
Is the storage area have to be negative pressure or can it be "neutral"?
What requirements are needed when receiving HDs
Table 4 (USP <800>. Summary of Requirements for Receiving and Handling Damaged HD Shipping Containers
If the shipping container appears damaged
o Seal container without opening and contact the supplier
o If the unopened package is to be returned to the supplier, enclose the package in an impervious container and label the outer container "Hazardous"
o If the supplier declines return, dispose of as hazardous waste
If a damaged shipping container must be opened
o Seal the container in plastic or an impervious container
o Transport it to a C-PEC and place on a plastic-backed preparation mat
o Open the package and remove undamaged items
o Wipe the outside of the undamaged items with a disposable wipe
o Enclose the damaged item(s) in an impervious container and label the outer container "Hazardous"
o If the supplier declines return, dispose of as hazardous waste
o Deactivate, decontaminate, and clean the C-PEC (see Deactivating, Decontaminating, Cleaning, and Disinfecting) and discard the mat and cleaning disposables as hazardous waste
When opening damaged shipping containers, they should preferably be transported to a C-PEC designated for nonsterile compounding. If a C-PEC designated for sterile compounding is the only one available, it must be disinfected after the decontamination, deactivation, and cleaning step before returning to any sterile compounding activity.
Damaged packages or shipping cartons must be considered spills that must be reported to the designated person and managed according to the entity's SOPs. Segregate HDs waiting to be returned to the supplier in a designated negative pressure area. Clean up must comply with established SOPs.
Quick question about a stat hood and the required PPE?
Gowning and gloving required even if the CACI company says they are not required?
Are there recommendations on decontaminating excretions (i.e. in the toilet, etc) from patients receiving chemo and for how long after administration?
Chemotherapy is on the outside of vials. What is being done to control this?
With respect to the receiving portion, at our site we order hazardous medications, often the company is sending hazardous products with nonhazardous, what are the chances those non-hazardous drugs are now contaminated?
Any insight to when a second draft or final version of USP 797 revision will be published?
How is veterinary-compounding affected? Especially with chemos.
Who will be enforcing 800?
The picture did not show an N95 mask- aren’t they required by <800>?
Do you offer any certification programs for hazardous handling?
Any suggestions as to how to get our WHOLESALERS to use the NIOSH list of hazardous meds and segregate those meds when they are boxing up our medication orders?
Does USP 800 mandate the use of an N95 mask rather than a surgical mask?
What do you clean the vials with?
The double shoe covers are difficult logistically. Booties go on first then handwashing and garbing. if you have to leave the neg pressure room into ante room, do you have to degarb because you have touched the shoe covers?
Do hazardous meds need to be stored in a separate negative pressure room from the hazardous compounding room?
With USP 800 can a facility have 2 doors between an employee and an eye wash that is compounding hazardous drugs?
Will 503B pharmacies (e.g. PharMEDium) be held accountable to USP 800?
If you got to choose between a BSC and a CACI which would you choose? Why? BSC's seem easier to manage workflow and cleaning. CACI's give the appearance of better protection but is it real or just an illusion? Decon seems harder with CACI
How can we get a copy of the USP 800 standard?
One of the things that I run into is hesitation from our wholesalers who does not want to separate HD and chemo drugs from regular drugs because USP 800 does not apply to them. Is there a way to pressure wholesalers to do this?
Is there a list available of cytotoxic medications that vaporize at room temp?
For the surface contamination - is there a level that is considered ok? How do you know if you have an issue? Nay residue at all? What are the recommendations if you have contamination? Decontaminate but with what?
Will there be any regulations for the shipping sites for sending these meds?
if 800 allows alternate containment strategies for antineoplastic drugs that do not require manipulation, does that mean it allows " Ready to use" antineoplastic injectables to be stored in neutral pressure air?
Can you confirm that USP 800 requires double chemo-tested gloves be worn when compounding in a CACI (i.e., in addition to the gloves attached to the CACI)? That is how I read the standard but, in the discussion, with others, they did not agree.
Can you comment on USP 800 and implications for drug vial optimization?
Is segregation of non-hazardous drugs explicitly required if the majority of the drugs compounded are hazardous?
Are medical surveillance protocols required or suggested based on risk assessment?
Is a negative pressure room required now or 7/2018?
For folks who have their cabinets in a basement I have heard of filtering through potassium permanganate as an option can you comment?
CA BOP has added language to the regulations that hazardous PEC should be independently vented to the outside. Do you think this language will become 'shall' in the future and/ or should we consider it as shall as we design remodels or new facilities?
Our current system shares a pipe between two hoods; clarification is each hood having its own pipe?
What are the best resource to guide in the selection of a BSC to better understand practical and engineering considerations?
Are there concerns of non-antineoplastic "hazardous" agents, such as oxytocin, valproate, or fosphenytoin, being prepared in a hazardous room where antineoplastics are prepared and potentially exposed to cross-contamination?
04-06-2017 09:08 PM
04-07-2017 10:38 PM
If you visit www.pppmag.com, Kate Douglass and others have published two great articles with pictures detailing how to do HD donning and doffing activities. I think you will find that their article will answer all your questions. Thanks.
04-18-2017 12:06 PM
Thank you; the articles by Kate Douglass and others with pictures regarding HD donning and doffing activities were helpful. Edmond