COVID-19 Vaccine Access for Homebound Older Adults Part 2;
Disclaimer: The purpose of this 2nd “article” is a quick share of my updated understanding of the situation and to continue a dialogue, I recognize that I may be missing something so I hope this post will create some learning opportunities for the author as well as the reader! Here is a link to the 1st post if you missed it!
I am so thankful for all of my friends and colleagues who reached out after my blog last week about this seemingly important but somewhat neglected issue of vaccines for the homebound. Surprisingly, nobody totally rejected the ideas, so I’m feeling pretty optimistic!
I’ve been reaching out to as many smart people as possible to get more ideas and advice on this topic. I have a bit more information and a few new thoughts that I think are worth sharing.
Vaccine Transport and Logistics for Home Vaccination
In the 1st blog, I brought up the idea of using the Moderna vaccine for home vaccination because it can be stored in “normal” freezers that medical offices and home care providers could theoretically maintain and also the Moderna vaccine can be kept at room temperature for 12 hours after thawing. However, the Moderna vials contain 10 doses, and the package insert says you must use all of the product within 6 hours after the vial is punctured. It’s very hard to imagine one clinician being able to go from home to home and fully use 10 doses in the 6 hour window while providing each patient with a 15+ minute in person post-vaccination observation period for severe allergic reactions.
I’ve been trying to get advice on how long the vaccine would be stable in a syringe that could be prefilled before a home visit so that we could empty one vial with pre-filled syringes for multiple home visiting clinicians and make sure we use it up within the 6 hour window. One piece of advice I have received is to follow the “Immediate Use Standards” of the Chapter 797 of the 2008 version of The United States Pharmacopeial Convention (USP). These standards indicate, among other things, that after drawing the product into a syringe it should be administered within 1 hour. That wasn’t what I was hoping to hear, so I’ve continued to try and learn whether there are any other options for pre-filling syringes.
Update 1/14/21: I called the Moderna Vaccine Help Line 1–866-MODERNA and chose the provider assistance option when prompted. I spoke with an associate who took my question and provided the following guidance that I’ve done my best to transcribe: “Question: Any information on preloading syringes and if so for how long can they be used? Answer: Once a needle is inserted into a vial any vaccine must be used within 6 hours or discarded, any vaccine drawn into preloaded syringe must be used within 6 hours or discarded.” This information would seem to support the idea of using prefilled syringes of the Moderna vaccine in the home care setting so long as they were used within 6 hours of puncture of the vial and handled with appropriate care.
I also received some really promising news relayed to me from the Philadelphia Veterans Affairs (VA)Home Based Primary Care program. One of their team pharmacists called the Pfizer Help Line (1.800.438.1985) and they took notes on their call:
“Question: Is there any stability data for a vaccine drawn into a syringe? Vials are stable between 36 deg F to 77 deg F for a period of 6 hours. Response: ‘Pfizer has conducted physical and chemical stability studies which have shown that the vaccine maintains all its measured quality attributes when diluted vaccine is stored in polycarbonate and polypropylene syringes with stainless steel needles for 6 hours at 2°C to 30°C ± 2°C. Degradation of RNA in the vaccine has been observed when stored for longer than 6 hours in syringes. Microbiological risk was assessed through a microbiological challenge study which showed that microbiological growth has a greater potential to occur after 6 hours. Pre-drawing diluted vaccine into syringes prior to use can increase the risk of medication errors. Pfizer has not studied or cannot support storage of diluted vaccine in syringes that have been stored between 2°C to 32°C for >6 hours, at temperatures <2°C or at temperatures >32°C. Diluted vaccine stored in syringes in this manner should not be used and should be discarded.”
What About the Pfizer-BioNTech and AstraZeneca Vaccines?
At 1st glance I tossed the idea of using the Pfizer-BioNTech product because it must be stored at -70 Celsius and this requires special freezers that most providers don’t have (I would venture to guess no home health providers have these types of freezers). The Pfizer-BioNTech product, unlike the Moderna product, must be diluted prior to using. Similar to the Moderna product, it can be kept at room temperature while in use and should be used within 6 hours of 1st puncturing the vials. However, there is some serious “good news” with respect to the Pfizer-BioNTech product for home care providers who collaborate with entities with special freezers. This product comes in smaller vials of 5–6 doses and it would be somewhat more conceivable that a clinician working in the field could use up the entire vial in the 6-hour window. And, the information above from the Philadelphia VA is promising for the concept of pre-filling, though I would advise all providers to discuss the whole protocol with a pharmacist to maximize safety. The other potentially helpful considerations for providers who could quickly get the vaccine into the field are that this Pfizer-BioNTech vaccine could be stored for a short period in temporary thermal containers with dry ice, and after thawing, the undiluted Pfizer-BioNTech vaccine may be stored in a refrigerator for up to 5 days.
From what I’ve been able to find about the AstraZeneca vaccine (which is not yet approved in the United States, but already being used in the United Kingdom and a few other countries) home care providers will run into some of the same issues. The “good news” with the AstraZeneca vaccine is that it can be stored at normal refrigerator temperatures and it looks like there’s an 8 dose vial as well as 10 dose, but still the guidance is to use within 6 hours of puncture.
Nothing I’ve shared above would make it clear how home care providers could easily provide home vaccination, but some options are emerging. The real “breakthroughs” here are that the Moderna and Pfizer-BioNTech vaccine MAY be reasonably left in pre-filled syringes for up to 6 hour , also the Pfizer-BioNTech vaccine is in 5–6 dose vials and in some densely populated geographies a solo vaccinator could schedule 5–6 home visits in the 6 hour window, and go out into the community with 1 vial and help 5–6 people get vaccinated. If you understand nursing labor costs and the billing rates for vaccine administration, this will clearly be unsustainable using Part B billing codes for vaccine administration alone (it would be more feasible if evaluation and management codes for observation were an option). Though, home health agencies may be able to pull this off if stand-alone vaccination visits would be considered billable visits under a home health agency plan of care, I am optimistic about this but still want to think through the details with others.
Single-dose prefilled syringes that could be stored at refrigerator or room temperature for many hours would be the best-case scenario, this type of packaging would open the door to wider home vaccination, but this remains a dream and not reality. I have been unable to get details on whether other vaccines in the pipeline will be stored differently or loaded into single dose packaging. Also, I have no more information of the status of the Apiject single dose syringe contract with the Department of Defense and whether this will be of benefit for home care providers.
A Few Other Ideas: “Vaccine Caddies,” “Float Nurses,” or “Family Cluster” Vaccination?
I’m really lucky to work with a lot of smart people and I even stumble onto an idea or two myself from time to time. In spite of all of the transport and logistics barriers, there are some potential solutions while we wait for a product that has better storage characteristics for home care use.
I’m going to start with my idea 1st because, well, when I take personality tests/indices I’m apparently attracted to my own ideas! My (totally untested and unproven) idea is around vaccinating a homebound patient and their “family cluster” of 1 or more additional people. The concept goes like this: we identify a homebound individual who needs home vaccination and set a date and time for a home visit, we then also try and encourage family caregivers, friends, or neighbors to register for vaccination at the homebound person’s home at the same date and time. We would need to create or modify a scheduling and registration app for this purpose. This model would allow for one vaccinator (likely a nurse) to vaccinate and observe more than one person at a time. If we could set up several households in a town or community on the same day, it seems plausible to me that all 10 doses of the Moderna vial or 5–6 doses of the Pfizer-BioNTech vials could be used within the 6 hour window. This model may also make it more financially feasible for Part B type providers using the existing vaccine administration billing codes and having 1 clinician to many observation instead of 1 to 1 like I described above. It would be even more achievable if CMS endorsed the use of evaluation and management codes for post-vaccination observation period.
One of the several challenges for this “family cluster” approach would be whether you can find other candidates for vaccination beyond the homebound person who are also being prioritized for vaccination by public health authorities. Given the advanced age of the typical home care patient and the likely advanced age of their family caregivers and friends it could work in many instances, and in order to not waste doses it would seem reasonable to cast a somewhat wider net. Also, if a clinician dedicated to home vaccination had a couple family clusters on their schedule, they may be able to include a vaccine or two to someone homebound in the same geographical area who doesn’t have any additional family or friends.
Andrew Wheeler, a doctor of physical therapy, who helps lead some of our home care innovation work has suggested another model, he had the idea of “float nurse” vaccinators. In this model there would be nurses dedicated to transporting and administering vaccine who would try and time their arrival at the home with a regularly scheduled home care visit by another clinician. In this model, the float nurse would go home to home trying to efficiently vaccinate people (get in and out of homes quickly) while leaving the observation and follow-up to the other clinician who was scheduled to be in the home for other reasons. In a relatively densely populated area with a lot of home care activity on a given day, this may work. The timing of the two home visitors’ arrival and workflow would be challenging and take some work to iron out.
Christopher Rinn, the Chief Executive Offices of the Visiting Nurse Association Community Health Centers, has suggested an idea that I’m referring to as “vaccine caddies.” I love the sport of golf, so I thought it would be fun to use an analogy to the role of caddies in golf. This model would have someone with a vehicle with refrigeration and the vaccine product and vaccination supplies out in the community. They would respond to requests (via an app or secure messaging platform) from other home care clinicians in the community who are making scheduled home visits and needed a vaccine dose to be brought to homes where they’re doing visits as an additional service during their visits. The “caddie” would meet the home care clinician at their home visit, prepare one vaccine dose, and hand this off to the home care clinician who would be the vaccinator as part of their scheduled visit. If this is happening in a geography where many home visits are being done then it’s conceivable the caddie could pop around town to enough homes to use up an entire vial of vaccine in the 6 hour window. There would need to be careful oversight of the handoff process to reduce risk of contamination. This “caddie” and “float nurse” model would also require a broader number of home care staff to have access to an epi-kit.
We will try and pilot one or more of the approaches discussed in this blog within our company in the coming weeks. I will provide an update to the home care community and anyone else interested if/when there’s anything to share. Big thanks to everyone concerned about helping homebound seniors gain access to the potentially life saving vaccines! I’m looking forward to more dialogue and problem solving.
1. USP. The United States Pharmacopeial Convention: 〈797〉 Pharmaceutical Compounding — Sterile Preparations 2008 [cited 2021 January]; Available from: https://www.pbm.va.gov/linksotherresources/docs/USP797PharmaceuticalCompoundingSterileCompounding.pdf.
2. UK. United Kingdom Medicines and Healthcare Products Regulatory Agency: Information for Healthcare Professionals on COVID-19 Vaccine AstraZeneca. 2020 [cited 2020 December]; Available from: https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca/information-for-healthcare-professionals-on-covid-19-vaccine-astrazeneca.