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Registered: ‎02-22-2010
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Q&A from Complying with USP 800 Hazardous Drug Compounding Requirements Webinar

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

  • In sterile compounding, wipe all components with sterile 70% IPA since contamination control is also needed. Wok from left to right. When compounding is complete, place the finished CSP on the deck to the right of the disposable prep pad where there is less HD contamination. Then remove contaminated outer gloves and use a low-lint wipe that is pre-saturated with your chosen HD decontamination agent to decontaminate the final CSP.

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.

  • My personal recommendation/preference is the Biosciences International SAS-180. You can use any standard media plate size, it is easy to use and collects 1,000 liters of air in about 6 minutes.  We own and use them at our training facility and I have several clients who have them and are quite happy with them but there are many others available as well. Overall, it’s best to select an air sampler that can accommodate generic media.

If splitting tablets of oral chemo meds prior to dispensing to nursing homes, what PEC is needed?

  • You can use a different PECs as long as they are negative pressure, including a powder hood (also known as a containment ventilated enclosure, BSC or CACI. Regardless of the C-PEC you use, you still need to protect yourself by wearing full HD PPE. See refer to the 2016 NIOSH List of Hazardous Drugs http://www.cdc.gov/niosh/topics/antineoplastic/pdf/hazardous-drugs-list_2016-161.pdf . IF you use a C-PEC that is also used for sterile compounding (BSC or CACI) then the C-PEC must be decontaminated, cleaned and disinfected prior to resuming sterile compounding

If the only HD potential exposure is splitting tabs and you don't have a BSC or fume hood, what else can you do?

  • Nurses need to be protected when an exposure risk exists. USP Chapter 800 states: “Healthcare personnel should avoid manipulating HDs such as crushing tablets or opening capsules if possible. Liquid formulations are preferred if solid oral dosage forms are not appropriate for the patient. If HD dosage forms do require manipulation such as crushing tablet(s) or opening capsule(s) for a single dose, personnel must don appropriate PPE and use a plastic pouch to contain any dust or particles generated.” Systems like Silent Knight or other containment devices are permitted by the chapter.

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?

  • No it does not. The Pharmacy must dispense the dose in its final format ready for administration. See my response above.

 

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?

  • The drugs like this one are found in Table 3 primarily because they meet the NIOSH criteria for reproductive hazards. They represent a potential occupational hazard to males or females who are actively trying to conceive, women who are pregnant or may become pregnant, and women who are breast feeding, as they may be present in breast milk. Unopened, intact tablets and capsules may not pose the same degree of occupational risk as injectable drugs that usually require extensive preparation. Cutting, crushing, or otherwise manipulating tablets and capsules will increase the risk of exposure to workers. The manufacturer’s safe-handling guidance (MSHG) is typically in Section 16 of the Drug Package Insert. See Table 5 for safe handling recommendations. An Assessment of Risk can be conducted if a different handling strategy is desired. See refer to the 2016 NIOSH List of Hazardous Drugs http://www.cdc.gov/niosh/topics/antineoplastic/pdf/hazardous-drugs-list_2016-161.pdf

What is considered a "control device" as repeated mentioned in Table 5 under eye/face protection and resp protection?

  • In the header box to Table 5, a control device is described as a ventilated engineering control such as a fume hood or Class I BSC or a HEPA-filtered enclosure (such as a powder hood) is sufficient if the control device exhaust is HEPA filtered or appropriately exhausted to the outside of the building. It is recommended that these activities be carried out in a control device, but it is recognized that under some circumstances, it is not possible. If the activity is performed in a ventilated engineering control that is used for sterile intravenous preparations, a thorough cleaning is required following the activity.

Will outpatient pharmacies/retail pharmacies be required to store haz drugs in negative room, 12 ACPH?

  • Yes, if they handle HDs that are required to be stored under negative-pressure such as antineoplastics requiring manipulation or any bulk container of active pharmaceutical ingredients (API). If the drug is in its final dosage form, that does not require any further manipulation, they can be stored with other inventory.

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 ?

  • This activity is permitted according to USP 800 assuming that no sterile compounding is being done at the same time as handling these medications. Consideration should be given to establishing a separate C-SCA for these non-sterile dosage forms. 

Is the storage area have to be negative pressure or can it be "neutral"?

  • The chapter says neutral or negative-pressure for receiving drugs. HDs need to be stored under negative-pressure if they are antineoplastics or bulk container of active pharmaceutical ingredients (API).  If the drug is in its final dosage form, that does not require any further manipulation, they can be stored with other inventory.

What requirements are needed when receiving HDs

  • The entity must establish SOPs for receiving HDs. HDs should be received from the supplier in impervious plastic to segregate them from other drugs and to allow for safety in the receiving and internal transfer process. HDs must be delivered to the HD storage area immediately after unpacking.
  • PPE, including chemotherapy gloves, must be worn when unpacking HDs (see Personal Protective Equipment). A spill kit must be accessible in the receiving area.
  • The entity must enforce policies that include a tiered approach, starting with visual examination of the shipping container for signs of damage or breakage (e.g., visible stains from leakage, sounds of broken glass). Table 4 summarizes the steps for receiving and handling of damaged shipping containers.

 

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?

  • Required PPE must be worn anytime hazardous drugs are compounded whether they are sterile or nonsterile.

Gowning and gloving required even if the CACI company says they are not required?

  • When handling HDs, appropriate and complete HD PPE is ABSOLUTELY required! Not just gowning and gloving but use of double shoe covers. Remember that the intent of the PPE is to protect YOU.

Are there recommendations on decontaminating excretions (i.e. in the toilet, etc) from patients receiving chemo and for how long after administration?

  • The safe handling period post-administration is going to be dependent on the drug given. Many HDs are excreted unchanged so any waste or potentially-contaminated body fluid needs to be handled as hazardous waste. Currently, there is no clear guidance on how to best handle this waste stream. 

Chemotherapy is on the outside of vials. What is being done to control this?

  • It is a multi-faceted issue starts at the manufacturer who is trying to reduce the contamination from the manufacturing How your wholesaler handles the drugs can also affect this issue. It should be assumed that all HD vials are contaminated.

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?

  • I don’t know. Work with your wholesaler to separate your medications to eliminate the potential contamination of non-hazardous drug vials.

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.

  • It is affected and all of the requirements of USP 800 should be followed since animals are being treated with many of same human HDs. NIOSH published a document for the veterinary community http://www.cdc.gov/niosh/docs/wp-solutions/2010-150/pdfs/2010-150.pdf that should be reviewed. Remember, the intent of USP Chapter <800> is to safeguard healthcare workers so that applies regardless of who the patient is.

Who will be enforcing 800?

  • Typically, it will be State Boards of Pharmacy, accreditation organizations or CMS.

The picture did not show an N95 mask- aren’t they required by <800>?

  • Only if respiratory protection is required by the activity being performed. USP Chapter <800> provides more information on the use of N95/N100 respirators. If you are referring to compounding, as long as you are using a negative pressure C-PEC, a N-95 respirator is not required. Remember N-95 respirators protect against particles and not vapors. If you choose to wear a N-95 respirator while performing sterile compounding, it must be changed when you regarb.

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?

  • You can work through your GPO to put pressure on them. Some hospitals have established a separate account when ordering HDs so they will be the only drugs shipped in the totes.  It will require some creativity. 

Does USP 800 mandate the use of an N95 mask rather than a surgical mask?

  • No it does not. See my earlier response to a similar question.  It is best to consult the chapter for more detail on the use of these types of respiratory protection.

What do you clean the vials with?

  • When we are handling HDs used in sterile compounding, there are TWO concerns. One is containment of HD residues and the other is simultaneous reduction in microbial risk. These are hard to do at the same time. There are several different approaches but this is one approach that could be used: In sterile compounding, wipe all components with sterile 70% IPA since contamination control (reduction of microbial risk) is also needed. Work from left to right. When compounding is complete, place the finished CSP on the deck to the right of the disposable prep pad where there is less HD contamination. Then remove contaminated outer gloves and use a low-lint wipe that is presaturated with your chosen HD decontamination agent (strong EPA registered oxidizing agent, 2% sodium hypochlorite or PeridoxRTU) to decontaminate the final CSP.

 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?

  • I don’t agree that wearing two shoe covers is difficult. Don two pairs prior to washing your hands and when leaving the HD room, the outer pair needs to be removed, along with the HD gown and gloves.  After exiting the C-SCA or C-SEC, wash hands with soap and water.  Consult USP Chapter <800> for more detail. 

Do hazardous meds need to be stored in a separate negative pressure room from the hazardous compounding room?

  • No, HDs can be stored in the HD buffer room. Some states like Washington require a separate HD storage room because they don’t like a refrigerator in the HD buffer room (which is allowed by USP <800>).

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?

  • No, not by the FDA but they need to prevent cross-contamination according to GMPs.

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

  • I agree with your assessment of BSCs. If I had to open a new pharmacy, I would choose BSCs as my C-PEC of choice.

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?

  • Many hospitals have successfully “tricked” their wholesaler by setting up a separate ordering account for just HDs so only HDs are picked and delivered in a tote to that location.

Is there a list available of cytotoxic medications that vaporize at room temp?

  • Some of the drugs reported in the literature as sublimating include carmustine, cyclophosphamide, cisplatin, ifosfamide, thiotepa, 5-fluorouracil and mustargen demonstrated vaporization at 37˚ You can do a literature search and find several articles that discuss this phenomenon.

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?

  • There is no safe level of HDs. There are several articles in the literature that discuss how to best decontaminate HD work areas and the types of agents to use.  Some suggestions on wiping the vials were provided in an earlier question. 

Will there be any regulations for the shipping sites for sending these meds?

  • You will have to consult the carriers (USPS, FedEx and UPS) for specific guidance on shipping hazardous drugs.

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?

    • No, because it is an antineoplastic injectable.

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.

  • I agree with your reading of the standard.

Can you comment on USP 800 and implications for drug vial optimization?

  • NO CSTD on the market has been approved by the FDA as being able to extend the BUD of single-dose vials.

Is segregation of non-hazardous drugs explicitly required if the majority of the drugs compounded are hazardous?

  • If non-hazardous drugs are compounded in the same room (C-SEC) and C-PEC as hazardous drugs, those medications needed to be labeled as hazardous and handled as such according to USP Chapter <800>.

Are medical surveillance protocols required or suggested based on risk assessment?

  • Medical surveillance is a “should” in USP Chapter <800>.

Is a negative pressure room required now or 7/2018?

  • A negative-pressure room has been required by USP <797> since June 2008 unless you qualify for the low-volume exemption.

For folks who have their cabinets in a basement I have heard of filtering through potassium permanganate as an option can you comment?

  • There is no evidence showing that chemical filter packs with charcoal or KMnO4 are universally effective for all HDs. I don’t believe this technology is appropriate for this application.  I believe that the manufacturer and/or user of such equipment would need to have efficacy performance testing for each and every drug (and potentially every drug/diluent combination) the system will be exposed to plus there should be some form of system to detect filter bypass/failure and data‐driven guidance for filter change out. 

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?

  • It is a “shall” by the California Board of Pharmacy today and USP <800> on July 1, 2018.

Our current system shares a pipe between two hoods; clarification is each hood having its own pipe?

  • Ideally, each C-PEC should be exhausted with its own exhaust. Consult with a mechanical engineer to determine how to meet the relevant standard.

What are the best resource to guide in the selection of a BSC to better understand practical and engineering considerations?

  • The 2004 NIOSH Alert has some good guidance on BSC selection. Baker Company and Nuaire both have excellent technical resource guidance on BSC selections.

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?

  • I believe there is a great risk for cross-contamination.  The drugs you mention are not antineoplastics so alternative containment strategies may be employed. 

 

EY
Senior Member
Posts: 2
Registered: ‎04-06-2017
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Re: Q&A from Complying with USP 800 Hazardous Drug Compounding Requirements Webinar

Please clarify the sequence of degarbing when exiting the negative pressure room. I understand it to be removing second outer bootie pair and second glove pair and discard in buffer room, exit to anteroom and remove gown. Thank you.

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?
I don’t agree that wearing two shoe covers is difficult. Don two pairs prior to washing your hands and when leaving the HD room, the outer pair needs to be removed, along with the HD gown and gloves. After exiting the C-SCA or C-SEC, wash hands with soap and water. Consult USP Chapter <800> for more detail.
Expert
Posts: 1,167
Registered: ‎02-23-2010
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Re: Q&A from Complying with USP 800 Hazardous Drug Compounding Requirements Webinar

EY,

 

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. 

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
EY
Senior Member
Posts: 2
Registered: ‎04-06-2017
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Re: Q&A from Complying with USP 800 Hazardous Drug Compounding Requirements Webinar

Thank you; the articles by Kate Douglass and others with pictures regarding HD donning and doffing activities were helpful.  Edmond