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Pediatric ART Dosage Formulation Shortages

  • 1.  Pediatric ART Dosage Formulation Shortages

    Posted 07-22-2020 13:51

    Over the last several years, it seems to be increasingly difficult to obtain various dosage forms most commonly used for our pediatric patients with HIV. Unfortunately, there does not appear to be a common denominator or theme between drugs, dosage forms, or manufacturers. As a clinical pharmacist at an academic medical center, I'm acutely aware of the impact of drug shortages and manufacturer backorders have on the care of patients during admission. What concerns me is this problem with backorder specifically with ART medications persists and appears to be getting worse. Even though I learn of new and novel ART formulations in the pipeline, I continue to be frustrated, disheartened, and embarrassed almost daily with the ability to acquire ART right here in the US for some of our most vulnerable children patients because of supply chain issues.

    I have spoken with colleagues in other states and in different practices and this appears to be a much more common problem than even I was aware. Because these issues involve different drugs, different manufacturers, different considerations/restrictions, etc., I am not sure there is a single, universal solution. But I believe if the US plans to End the HIV Epidemic, there will need to be an initiative to specifically address this ART supply chain issue or the pediatric population (and some adults) will continue to struggle with having ART options available to them.

    I'm wondering whether others are experiencing similar issues and what the Academy can do to raise awareness and advocate for improvements on a national level.

     

     



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    Eric Farmer
    Indiana University Health
    IndianapolisIN
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  • 2.  RE: Pediatric ART Dosage Formulation Shortages

    Posted 07-23-2020 12:00
    I would also be interested in the impact that these shortages have on our patients and if the shortages have increased over the past few months. Given the lack of alternatives and growing concerns over the supply chain, it would be great to start an advocacy path for this important issue!

    Thank you for bringing up this discussion, Dr Farmer!

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    Milena Murray
    Midwestern University
    Downers Grove IL
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  • 3.  RE: Pediatric ART Dosage Formulation Shortages

    Posted 07-23-2020 23:51
    Edited by Brooke Stevens 07-23-2020 23:52
    Thanks, Eric, for bringing this up! I feel like this is something I'm dealing with daily, and it seems to be getting worse. You're right – there doesn't seem to be a theme with regards to which medications may go on backorder. When I first started working with children living with HIV, it seemed to only be formulations that were infrequently used in my practice. However, just this week, I found out zidovidine liquid, which is very common, is on backorder.

    In just the last several years, I have dealt with shortages of pediatric strengths of Truvada, chewable raltegravir tablets, nevirapine liquid (both brand name and generic), atazanavir powder packets, darunavir liquid, and ritonavir liquid. There are likely more I am forgetting. When I approach a patient's appointment, I am always asking myself if I can do better for the patient in regards to pill/liquid burden, palatability, tolerability, etc., and unfortunately, I am often forced to stay the course since I know many of these alternative medications will go on and off backorder without notice. While most of the children in my clinic are tolerating their current regimens well and do not need an immediate change, I do have several with significant resistance, and I am left with no choice but to roll the dice on a new medication and hope it is available consistently.

    While this is certainly an issue for children living with HIV, I worry more about newborns born to mothers living with HIV. As mentioned, zidovudine liquid is currently on backorder. This is the only guideline recommended medication for low-risk newborns. Many of these newborns are transferred to our academic medical center from more rural hospitals in the state only to receive these prophylactic medications, which we may not be able to provide depending on supply. Nevirapine solution has been an even bigger issue. The generic seems to always be on backorder, and the brand name is only occasionally available. The brand name usually requires a prior authorization explaining the generic isn't currently commercially available, and while these have been approved quickly, there has been more than one instance where a high-risk newborn on presumptive treatment did not receive this medication (and was rather on 2 NRTIs only) because they were born at another facility and our ID department didn't know it was an issue until many weeks after birth. Our hospital system has changed our treatment regimen to include raltegravir granules in hopes of eliminating this problem, but many local hospitals are still using the nevirapine.

    While it is difficult (and sometimes near impossible depending on resistance history) for providers to formulate new regimens to work around these drug shortages, it is even more difficult to call a parent or guardian and explain their child may not be able to get all of the needed medications. As we consistently educate on the importance of strict adherence to ART, these shortages place unnecessary stress on parents who are doing their best to keep their children healthy.

    I don't think anyone can or should have to continue to function on a week-to-week basis hoping medications will become available. It puts a significant burden on the clinical team, the retail pharmacy, and the families. Above all else, it puts us in a position where we're all providing suboptimal care. We need to find a solution.


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    Brooke Stevens
    Indiana University Health
    Indianapolis IN
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  • 4.  RE: Pediatric ART Dosage Formulation Shortages

    Posted 07-24-2020 15:51
    Edited by Deidra Schmidt 07-24-2020 15:52

    ​Thank you for bringing up this important issue.  In my ~19 years as a pharmacist caring for children with HIV, I have never had medication access issues like I have faced in recent times.  The discontinuation of many older medications and/or dosage forms and the backorder of other commonly used medications has forced our hands to move (typically stable) patients to new medications or less ideal dosage forms.  This is highly concerning because we want to preserve as many medications options as possible for these children to use as they age, and unnecessarily exposing them to new drugs or drug classes opens them up to potential drug resistance development.  In addition, insecurity about medication availability from month to month is extremely stressful for our patients' parents and using less than ideal dosage forms causes daily stress and inconvenience to patients and parents alike.

    My largest concern currently is for HIV exposed infants, particularly those at high risk.  Access difficulties with zidovudine are increasing, nevirapine is extremely difficult to obtain, and raltegravir powder packets are stocked in a very low supply by our wholesalers and have a shipping delay.  I spend an increasing amount of time obtaining medications for these babies, and it's very hard to explain these supply issues to mothers in this already challenging situation.

    At the last national HIV meeting I attended, one of the speakers said "we don't use these medications anymore" in reference to medications used frequently in pediatric patients.  I think pediatric patients are an overlooked population in our HIV care community.  We need to advocate for them and their unique medication related needs!



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    Deidra Schmidt
    Children's of Alabama
    Birmingham, AL
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  • 5.  RE: Pediatric ART Dosage Formulation Shortages

    Posted 07-24-2020 19:16

    Thank you for posting this and for everyone sharing their experiences!! We have the same issues here in Oregon. At first I thought it was maybe a regional or volume related issue but, from other responses, it sounds like a more common, widespread issue. 

    These Pediatric ARV supply issues have seemed to be at a much higher level than what I can figure out after spending hours on the phone with manufacturers, distributors, and dispensing pharmacies.

    We are also often left with having to use less optimal, more cumbersome ARV regimens for our kids simply due to not having access at all or stable access to the ARVs that we would rather be using. I hope that the AAHIVM can advocate on a national level with the supply chain stakeholders and any policies related to the national pharmacy distribution system that may be contributing to these issues. It seems like it's been worsening over the last 3 years or so. 

    I echo other responders' concerns for:
    --The less optimal ARV regimens we are forced to use
    --The added frustration and stress for the families each time they are due for a refill and our inability to help navigate through the supply issues
    --The intermittent availability of infant prophylaxis for all perinatal transmission risk categories

    I'll add also that it once took us a month to get raltegravir 25 mg chewable tablets for kid with extensive resistance. This is also the preferred third agent for pediatric PEP so the inability to get this in a timely manner is disturbing for prevention as well. Especially now that the alternative pediatric strength of lopinavir/ritonavir is also difficult to get in stock.

    I'm happy to share more specific case scenarios or other information to help in any to work toward finding a solution to this.
    Thank you again for starting the conversation!



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    Devon Flynn, PharmD, MPH, BCPS, AAHIVP
    HIV Clinics Pharmacist
    Portland, OR
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