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Webinar: The Missing Link: Practical Tips for Preparing for USP 800

Thanks for joining our webinar, "The Missing Link: Practical Tips for Preparing for USP 800" with Patricia C. Kienle, RPh, MPA, FASHP and Eric S. Kastango, MBA, BSPharm, FASHP. 

 

If you have a question regarding the content provided in the webinar only, please post it here. We will post answers to the questions asked in the webinar over the next few days.

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Re: Webinar: The Missing Link: Practical Tips for Preparing for USP 800

We were unable to listen to this much anticipated webinar!  Will it be available soon to view so we may ask questions if needed?

Betsy Sammarco RPh, MS
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Re: Webinar: The Missing Link: Practical Tips for Preparing for USP 800

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Re: Webinar: The Missing Link: Practical Tips for Preparing for USP 800

I have a question regarding CSTDs. It was mentioned during the webinar that the proposed USP 800 standards state CSTDs should be used during compounding and MUST be used during administration. Since we have everything in place - negative pressure room, BSC hood, PPE, etc - we were thinking about not using CSTDs during compounding but only for administration. We are doing this simply because of cost reasons since these items are very expensive and time-consuming to use. But we do not want to compromise the safety of our compounders

Are there good CSTD products for administration? Is this good practice? Need some direction please!

 

Thanks!

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Re: Webinar: The Missing Link: Practical Tips for Preparing for USP 800

The use of a CSTD during is not best practice but a core safety provision for the nurses and patients.  We have all of the "bells and whistles" of a negative-pressure room, a BSC or CACI and other work and administrative controls. There have been a number of articles published in Pharmacy, Purchasing and Products Magazine on the use of CSTDs.  Visit www.pppmag.com and search the article archives.  I have attached a couple of the most recent articles.  Hope this helps.   

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
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Re: Webinar: The Missing Link: Practical Tips for Preparing for USP 800

My hospital is implementing a CSTD in the near future and we as a pharmacy department are working on writing P&P stating that all hazardous drugs will be compounded using the CSTD.  Our official hazardous drug list contains all of the NIOSH (2014) hazardous drugs that we keep on formulary. Our inital thoughts were that we would only need to train IV pharmacy staff and nurses on our oncology floor how to use the CSTD. However, as you know, there are non anti-neoplastic medications on the NIOSH list.  So when developing and adopting our HD list, can we pick and choose which meds will be included off of the NIOSH list, or do we HAVE to use this list in entirety?

 

The reason for asking is that nuses all over the hospital administer things such as fosphenytoin and valproic acid (especially in the ER). Should I go ahead and make plans to have all nurses house-wide trained on the use of the closed system?

 

Sorry for the long question, and I really enjoyed the webinar last week.

 

Will  Edmiston

Pharm.D.

Compounding is the easy part...
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Re: Webinar: The Missing Link: Practical Tips for Preparing for USP 800

Will,

 

First, thanks for the kind words.  I think that if you can identify where HDs are routinely administered, start your training in those areas with the nurses and systematically work on getting everyone trained.  Get the nurse educators and the vendor's experts to assist in your endeavors so you can create super users/go to people in your hospital. Hope this helps.   

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
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Re: Webinar: The Missing Link: Practical Tips for Preparing for USP 800

Here are answered questions asked during the live presentation:

 

Disclaimer: The information provided in the webinar and these answers are not endorsed by or affiliated with USP.

It is critical for all practitioners to read USP Chapter <800> when is released on February 1, 2016. The responses to the questions from the webinar are meant to provide general guidance and insight but if you handling hazardous drugs, you need to read the chapter and work with the leadership of your organization to develop a robust compliance strategy. Additionally, NIOSH has a couple of resource rich websites with additional resources to aid in developing a robust compliance strategy. They can be accessed at: http://www.cdc.gov/niosh/topics/hazdrug/default.html and http://www.cdc.gov/niosh/topics/antineoplastic/default.html

 

ASSESSMENT OF RISK – NIOSH LIST – NON-ANTINEOPLASTICS

 

 

Q: ­When developing our hospital's list of HD, do we have to include all meds on the NIOSH list?­

You have to review the list and identify the drugs and the dosage forms you use. You probably do not handle all the drug on the list; those you don’t handle don’t need to be on your list.

 

Q: ­Do non-sterile, non-antineoplastic, hazardous medications need to be compounded/prepared in a negative pressure environment? ­

It depends on your Assessment of Risk. <800> allows you to perform an assessment of risk for specific dosage forms of those drugs that are non-antineoplastic or reproductive hazards. You can exempt the dosage forms from some or all of the containment strategies and/or work practices listed in <800> if you identify and implement alternative containment strategies and/or work practices.

 

Q: ­is PPE (other than gloves) required for the admin of oral hazardous drugs?­

<800> states that two pairs of chemotherapy gloves are required for administering antineoplastic hazardous drugs. You could perform an assessment of risk for non-antineoplastic and/or reproductive hazard oral agents and identify and use alternative containment strategies.

 

Q: ­Can hazardous and chemotherapy drugs be stored in the same area?­

If you mean can antineoplastic agents be stored in the same area as other hazardous drugs on the NIOSH list, it depends if you perform an assessment of risk. You must store the antineoplastic agents separately from non-hazardous drugs. If you don’t perform an assessment of risk, or if your assessment of risk determines that you will store some or all of the non-antineoplastic and/or reproductive hazards as you would antineoplastic agents, then yes, you could store them together. However, you then need to treat all of those drugs as you would chemo agents, since they could be contaminated with hazardous drug residue. More likely, you will want to perform an assessment of risk for the non-antineoplastics and reproductive hazards, and store them with alternative containment strategies.

 

Q: ­Do all HDs have to be compounded in a neg pressure room or just antineoplastic drugs?­

It depends on your assessment of risk. You must compound the antineoplastic agents in a BSC or CACI in a negative pressure room. If you don’t perform an assessment of risk, or if your assessment of risk determines that you will compound some or all of the non-antineoplastic and/or reproductive hazards as you would antineoplastic agents, then you would have to compound them in a negative pressure room. However, you then need to treat all of those drugs as you would chemo agents, since they could be contaminated with hazardous drug residue. More likely, you will want to perform an assessment of risk for the non-antineoplastics and reproductive hazards, and compound them with the alternative containment strategies you identify.

 

Q: ­Can you elaborate a little about antineoplastic HD contamination mentioned in USP 800? Is there a statement about not compounding non-antineoplastic HD in negative pressure room?­

It’s not worded like that. Antineoplastics must be compounded in a negative pressure room. You can perform an assessment of risk for those agents that are non-antineoplastic and/or reproductive hazards and determine alternative containment strategies and/or work practices for those agents. You may determine that some or all of the non-antineoplastic agents or reproductive hazards can be compounded in a positive pressure room, but you would have to identify what your alternative containment strategies are for dosage forms of those agents.

 

Q: ­for Non-neoplastic hazardous oral solutions, does drawing up patient-specific doses from a bulk bottle need to be in a negative pressure room? We are a pediatric hospital.­

This is manipulation of a hazardous drug, so some containment strategies are necessary. You need to define them in your Assessment of Risk.

 

Q: ­What about Rituxan and treating it as a hazardous drug? Should all "mabs" be treated as hazardous?­

Not all MABS are on the NIOSH list of hazardous drugs. You must treat the ones that are on the list as hazardous. You also may add other agents to your list.

 

Q: ­How are hospitals managing Warfarin administration if it requires cutting/splitting of tablet? Who crushes tablet for NGT administration (RN, RPH)?­

This is manipulation of a hazardous drug, so needs to be done under proper conditions. <800> allows nursing to split one dose of a hazardous drug using appropriate PPE (as defined in your policy) and containing the drug in a plastic pouch. However, there are other issues beyond <800> here. CMS and hospital accreditation organizations expect pharmacy to provide ready-to-use dosage forms. For all these reasons, splitting tablets of hazardous drugs should be done by pharmacy under proper conditions.

 

Q: ­Is unit-dosing of antineoplastics considered compounding and does it have to be done in a controlled environment?­

Yes, since this is handling of a hazardous drug. <800> permits use of the BSC or CACI in your sterile negative pressure compounding room for occasional nonsterile use, as long as the stipulations listed in <800> are followed. If you do this routinely, you need to have the proper equipment for nonsterile hazardous drug compounding/repackaging.

 

Q: ­what is the recommendation for hazardous drugs that are needed emergently such as valproic acid or fosphenytoin? should they be compounded in the BSC and no longer in the ED?­

There are several issues here: need for stat meds for urgent patient situations, ability to provide ready-to-use dosage forms (which is more of a regulatory and accreditation issue), and types of hazardous drugs. Fosphenytoin is listed in the non-antineoplastic table of the 2014 NIOSH list of hazardous drugs; valproic acid is listed in the reproductive hazards. After performing an assessment of risk, you might determine that there are alternative containment strategies that you could employ. Consider: the ability for pharmacy to mix these, provision of ready-to-use dosage forms (which, I realize would be pharmacy-prepared rather than purchased in these cases), and the containment strategies and/or work practices that you could employ if pharmacy is not able to provide these in time for stat doses.

 

Q: ­Not all drugs are antineoplastics. How much volume is needed to invest in a negative pressure room? We compound a very low volume HD drugs. 1-2 items a week. So this requires a whole negative room.

There is no “low use” exemption in <800>, and it will be removed from <797> so the two chapters are in synch. If you do any antineoplastic compounding, you need the proper facilities. The two options in <800> are either a negative pressure cleanroom (positive pressure anteroom opening into a negative pressure cleanroom), or a Containment Segregated Compounding Area, which needs to be negative, but does not need to be an ISO 7 cleanroom.

 

Q: ­Could you repeat the area/facility requirements for nonsterile compounding of haz drugs? It sounds like USP800 will require CPEC for nonsterile compounding activities but what if I'm just cutting tablets in half or packaging bulk tablets into unit doses?

If you are manipulating antineoplastic agents – even oral tablets – you need to do this in the proper facility. <800> permits use of the BSC or CACI in your sterile negative pressure compounding room for occasional nonsterile use, as long as the stipulations listed in <800> are followed. If you do this routinely, you need to have the proper equipment for nonsterile hazardous drug compounding/repackaging.

 

PPE

 

Q: ­Did I hear correctly that there is now no need for gown permeation data i.e. that if you have no data the gown should be changed every 2-3 hours? Is this something that will change anytime in the future? ­

This information has been in the ASHP Guidelines for Handling Hazardous Drugs for years, and has also been in other guidance documents. There is no ASTM standard for permeation of hazardous drugs through gowns, so you need to rely on the manufacture’s information. If no permeation information is available, change them every 2-3 hours. Of course, if there is a spill, you need to change the gown right away.

 

MEDICAL SURVEILLANCE

­

 

Q: ­Could you give us an example of the type of medical surveillance that will be required yearly??­

There is no requirement for medical surveillance; it is a recommendation. Of course, if your organization has specific policies, you are required to follow them. NIOSH has a document on medical surveillance available at http://www.cdc.gov/niosh/docs/wp-solutions/2013-103/pdfs/2013-103.pdf and the Oncology Nursing Society has excellent information in their publication, Safe Handling of Hazardous Drugs.

 

Q: ­is it your recommendation that nurses that are pregnant or wish to become pregnant avoid taking care of patients who are on hazardous drugs due to administration and drug elimination in bodily fluids?­

That is an issue that your Employee Health and Risk Management leaders must determine. The NIOSH document on medical surveillance available at http://www.cdc.gov/niosh/docs/wp-solutions/2013-103/pdfs/2013-103.pdf and the Oncology Nursing Society publication, Safe Handling of Hazardous Drugs are excellent resources.

 

SPILL MANAGEMENT

 

Q: ­If a facility contracts Hazmat for all hazardous spills, do infusion staff still need to be trained in HD spill clean up, and are spill kits required in clean rooms?­

Spill kits need to be in all areas where hazardous drugs are handled. Spill management should be a competency that is documented for all personnel who handle hazardous drugs. Not all personnel need to be expected to handle all situations, but they need to know how to contain a spill, who to call, where the spill kit and other supplies are located, and other components of the organization’s procedure. Personnel who could respond to a spill need to be available at all times when hazardous drugs are compounded and administered. Your policy and procedure should include response to small vs. large spills. Infusion staff are the front line of this issue, so they need to know how to handle a spill based on your organization’s policy.

 

DISPOSAL

 

 

Q: It seems like section about disposal got the short end of the stick. It just says “all applicable federal, state, and local regulations.” Disposition of hazardous components within the healthcare setting seems to me to be just as important as the other areas listed in the chapter

This is a different issue from the intent of <800>. <800> deals with hazardous drugs that are hazardous to healthcare personnel. The issue of disposal of hazardous materials is an EPA issue. Those regulations differ by state and region. They are beyond the scope of <800>.

 

GENERAL 800 QUESTIONS

 

Q: ­Can you share where the reference is that states the Federal requirement of July 2018?­

The official date can be found: http://www.usp.org/usp-nf/notices/general-chapter-hazardous-drugs-handling-healthcare-settings-publi...

 

Q: ­Where can I obtain a list of hazardous medications that release volatile vapor during storage?­

Unfortunately there isn’t a master list of these drugs. The information has come from articles that have been published. One of the seminal article is titled: Vapour pressures, evaporation behaviour and airborne concentrations of hazardous drugs: implications for occupational safety. Thekla Kiffmeyer, lead author of this research uploaded the article on the following website https://www.academia.edu/5477028/Vapour_pressures_evaporation_behaviour_and_airborne_concentrations_...

 

Q: ­Should all manufacturers be mandated to unit dose package any oral NIOSH HD?­

Knowing what we know, pharmacists should stop buying bulk bottles when unit-dose or unit-of-use are available and manufacturers will stop packaging them that way.

 

TRAINING

 

Q: ­Where can we get the informed consent for staff regarding exposure to HD­?

A copy of sample written confirmation of risk form is provided for your consideration.

 

FACILITIES

 

Q: ­Is there any recommendation for how to store refrigerated hazardous drugs? Should there be a refrigerator in the negative pressure room?­

Yes. Chapter <800> provides guidance on placing a refrigerator in a negative-pressure room if it is used to store hazardous drugs.

 

Q: ­Must CACIs be located in a negative pressure room per USP800­

Since the 2008 revision of the USP, CACIs have been required to be located in a negative-pressure room with 12 ACPHs, unless the low volume exemption was applicable. They will be required to be exhausted outside of the building and be in a negative-pressure room.

 

Q: ­Does the USP 800 mention anything about the Pass-Through refrigerators for both IV and Chemo

Yes. Pass-through refrigerators are prohibited

 

Q: ­Are we allowed to have refrigerator in the negative room to store refrigerated antineoplastics?­

Yes, refer to USP Chapter <800> for specific guidance

 

Q: ­Is negative pressures required for storage of chemos? have Neg room for compounding but no facility for negative pressure receiving/storage. Can't store in our compounding rooms.­

Yes, hazardous drugs are required to be stored in a separate room with negative-pressure and 12 ACPHs. Receiving does not have to be under negative-pressure. Please refer to USP Chapter <800> for the specifics on receiving and storage of HDs.

 

Q: ­Can a neg. pressure chemo cleanroom be vented outside only through the BSC exhaust/ventilation?­

No, all exhaust be vented outside of the building.

 

Q: ­Per USP 800, can non-antineoplastic hazardous med such as anti-epileptic and immunosuppressant’s be compounded in a BSC located in a positive pressure room?­

Yes. However, you need to include in your policies a method to safely transport the medications to the compounding area, such as in a dedicated cleanable tackle box or sealed container.

 

Q: ­What are the requirements of segregating glassware and cleaning, rising these glassware?­

Preventing cross-contamination is going to be key when cleaning glassware that was used in the preparing HDs. There isn’t specific guidance in USP 800 but please refer to Section 15. Deactivating, Decontaminating, Cleaning and Disinfecting of USP Chapter <800>.

 

Q: ­Do I understand correctly, that not only do chemo-therapy agents are compounded in a negative pressure room but they also need to be stored prior to use, even if it is in the manufacturer's sealed box, in a negative pressure room?­

Yes, please refer to USP Chapter <800> for the specifics on storage.

 

Q: ­Is it okay to compound non-hazardous drugs in the negative pressure hazardous drug compounding BSC/room?­

Any non-hazardous drug you place in the negative pressure compounding area needs to be treated as a hazardous drug, since it could be contaminated with HD residue. If you are talking about mixing chemo pre-meds in your BSC, there are details in 800 concerning the labeling you need to use on that agent.

 

CSTDs

 

Q: ­Does PhaSeal use meet USP 800 requirements for occasional haz med compounding and administration?

USP 800 does not require the use of CSTDs when compounding but does require one to be used for administration. The current low-volume exemption of compounding a hazardous drug in a negative-pressure PEC in positive-pressure buffer area when used with a CSTD has been eliminated in USP 800. USP 800 does not evaluate the performance of CSTDs.

­

 

Q: ­Do you know if anyone is working on a closed system chemo system for oral drug prep?­

The major performance element of a CSTD is that it captures vapors or gases. None of the oral HD drug dosage forms to our knowledge has not been shown to volatize during preparation. Oral HD prep needs to be done in containment ventilated enclosure (aka powder hood) obviating the need for a CSTD.

 

Q: ­Please comment on the evidence of the effectiveness of CSTDs in preventing contamination.­

Several studies have been shown to reduce HD contamination but not eliminating it completely. CSTDs are effective at the compounding and administration phases of drug handling but not receiving and disposal.

 

Q: ­If I have a negative pressure room and a BSC to compound HDs. Since the proposed 800 standards state "CSTDs should be used during compound and MUST be used during administration" - what type of CSTD is acceptable for administration only­

You have to survey the CSTD marketplace to determine an appropriate CSTD to meet this requirement.

 

EM – WIPE SAMPLES

 

Q: ­Where can you find the list of companies that perform or test wipe sampling? ­

Fred Massoomi published an article that identifies five companies who offer testing. The article can be accessed at: http://www.pppmag.com/article/1358/?search=Massoomi

 

Q: ­Are there any patient centered guidelines when HD are administered a mixed use outpatient infusion setting (i.e. chemo and non-chemo patients) to do surface testing etc. ­

The core objective of USP 800 is to prevent occupational exposure. Everything in the chapter is designed to protect the healthcare provider, patient and the environment. It should be assumed that settings where chemo and non-chemo patients are treated will have trace contamination. Surface sampling for HD residue is a strategy to evaluate the effectiveness of a HD handling and cleaning program.

 

 

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Re: Webinar: The Missing Link: Practical Tips for Preparing for USP 800

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Re: Webinar: The Missing Link: Practical Tips for Preparing for USP 800

Deb,

 

Thanks.  It is good to see that architects are sharing the design requirements of the chapter with their readers.  There are a couple points from the Array blog that needs to be addressed.  The blog states: "To assist with proper air flows, low air returns are to be installed in the direction of air flow."  Any air from the HD room must be exhausted out of the building because it needs to be considered contaminated.  You don't want to return the air to building system.  It also says: "Pass-through cabinets and refrigerators must be carefully placed and installed, keeping air from leaking from one room to another in clean room spaces."   A pass-through refrigerator between the HD buffer room and anteroom is not permitted. 

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.