Navigating Drug Shortages

It’s opening time at our little pharmacy, and the phone is already ringing off the hook. The first two callers are patients looking for Adderall XR. They live far from us, and they will probably not become regular customers if we fill their Rx today. Unfortunately, I must turn them away because my supply is very low, and I expect regular customers to need it this week. An hour later a new Rx comes in for cefdinir suspension. Cefdinir has been backordered from my primary supplier for months. It’s not available from any of my secondary suppliers either. I spend 25 minutes calling around to see if any colleagues have it, and BINGO — Rite Aid can help this little girl! I transfer her prescription and her business to a competitor. A few hours later, a patient calls looking for Concerta. After checking my inventory and the PDMP for her control record, I am happy to tell her we can help today.

After we get caught up with daily tasks, I log into each of my supplier’s websites and search for items that have been backordered. Our team keeps a list of items to order daily, either because our primary supplier has limited amounts that we can purchase, or because the medications are simply not available to us at all. Today I am lucky enough to order some cherry acetaminophen suspension — Score! Weeks ago, this same search unexpectedly yielded 80 bottles of children’s ibuprofen. Now, if I could just get my hands on some ipratropium/albuterol, it would be a great day!

Most pharmacies have one primary supplier. Companies like McKesson, Cardinal, or Value Drug ship to pharmacies daily and generally carry everything we need. At our small independent pharmacy, we are fortunate to also have several secondary suppliers. These smaller companies provide limited inventory but are sometimes able to get items the primary suppliers cannot. When we need a backordered item, the first thing we do is look at all our secondary suppliers. If it’s not available to us, the legwork begins. Depending on a patient’s preference, we will either call the physician to request a substitution for a stocked medicine or call a few pharmacies in the area to see if they are willing and able to share.

Many pharmacists simply do not have time to call around and instead ask the patient to search. The average hold time at a busy chain pharmacy is at least ten minutes. Patients are getting frustrated with the process. If the medicine needed is controlled, it’s even harder to find by calling around because many pharmacists don’t feel comfortable disclosing controlled inventory over the phone. My customer today said I was the 16th store she called looking for her daughter’s Adderall XR. demand that comes from higher rates of diagnosis. Injectable diabetic medicines are currently backordered because the media has publicized their weight loss potential. Adding a new factory production line for drugs like Ozempic and Trulicity is expensive and time consuming, but our diabetic patients will struggle to find their medicines until this happens.

This year, more medications have been on backorder than we’ve seen since 2014. The shortages are not limited to specific drug classes, disease states, or patient populations, and they are causing disruptions across all practice settings and patient groups. The most impacted drug classes are antibiotics, stimulants, anesthetics, basic hospital medicines, ophthalmic and otic medicines, and hormones. The shortages cause delays in care and inconvenience for patients while contributing to increased workload for pharmacies and physicians.

A portion of shortages are simply business decisions by the manufacturers. If the product is not profitable, companies have little incentive to produce. Patented medicines come from a single source and don’t respond nimbly to supply disruptions or unexpected demand changes. Generic medicines have a larger supplier pool, but low profit margins provide little motivation for over-production, and high up-front costs limit a manufacturer’s ability to increase production during a shortage.

Manufacturing issues like factory shutdowns or staffing challenges contribute to shortages as well. Many active pharmaceutical ingredients used to produce medications come from China or India, and both countries experienced workforce disruptions due to COVID. Lastly, a small number of shortages are due to regulatory issues or raw material shortages.

Last year’s baby formula shortage stemmed from a combination of these factors: baby formula was not very profitable, most US factories had closed or left the country, Congress regulated against importing baby formula from overseas, the last remaining U.S. factory had quality control issues in its manufacturing process, and building a new factory takes too long. The end result was empty shelves and hungry babies.

Why are so many medicines backordered? Several factors are in play. American Society of Health-System Pharmacists (ASHP) estimates supply and demand imbalances cause the most shortages. Manufacturing capacity for Adderall production is lagging behind the increased

Drug shortages certainly cause frustration to patients, pharmacists, and physicians. Until these drug shortages resolve, pharmacy and physician teams will have to work harder to serve patients by multisourcing inventory, communicating with each other to find products, and substituting medications with those available.

How the End of the Public Health Emergency for COVID-19 Will Impact Providers and Patients

Pennsylvania Medical Society

President Biden announced that the administration plans to end the public health emergency (PHE) for COVID-19 on May 11, 2023, which corresponds with the end of the PHE Extension by the Secretary of Health and Human Services (HHS), Xavier Becerra. The PHE has been in effect since January 2020. Throughout the PHE, there have been flexibilities for those in health care. Some of the flexibilities have been extended thanks to legislation, though some will end once the PHE is over. PAMED is here to prepare you for what is staying and what will not be around once the PHE is over after May 11.

Medicare: Physician Supervision Requirement: During the PHE, CMS temporarily modified the definition of direct supervision. This modification allowed for physicians to perform direct supervision virtually by way of telecommunication services (video and audio communications). This flexibility is currently set to return to pre-PHE rules at the end of the calendar year when the PHE ends.

Expedited Enrollment with CMS: During the PHE, physicians were given expedited enrollment into Medicare. When the PHE ends, this will no longer be in effect.

Signature Requirements: CMS has been waiving signature and proof of delivery requirements for Part B drugs and durable medical equipment (DME) when a signature cannot be obtained because of the inability to collect signatures. Suppliers should document in the medical record the appropriate date of delivery and that a signature was not able to be obtained because of COVID-19. After the PHE, signature and proof of delivery requirements will be reinstated.

The Quality Payment Program (QPP) Merit-based Incentive Payment System (MIPS): The Automatic Extreme and Uncontrollable Circumstances’ (EUC) policy that was created allowed for providers or groups to apply for their practice to be excluded or have performance categories reweighted given the extenuating circumstances that were preventing them from achieving performance goals in this program. After the PHE, CMS will evaluate whether to continue to allow practices to apply for this exception or not. They recommend checking the qpp.cms.gov site for updates.

Telehealth: As a result of President Biden signing the 2023 Consolidated Appropriations Act, the flexibilities that were expected to be extended for 151 days after the PHE will now be extended through December 31, 2024. Keep in mind that these flexibility extensions only affect those who are rendering services to Medicare patients.

The first flexibility is a temporary suspension of the geographic site requirement. This suspension allows patients to receive telehealth services regardless of where in the United States they are located at the time of service. This allows patients to be in their homes when receiving telehealth care as well.

There was a requirement for mental health providers to have an in-person visit with a patient within six months before seeing the patient by way of telehealth. During the PHE, this requirement was waived and is also a part of these flexibilities. The ability for Federally Qualified Health Center (FQHC) and Rural Health Clinic (RHC) providers to be reimbursed for non-mental health telehealth services as a distant-site provider will be extended under the telehealth flexibilities as part of the Consolidated Appropriations Act of 2023.

Under these flexibilities, specific services will continue to be covered when rendering audio-only telehealth services beyond the PHE. A list of these services can be found on the cms.gov website [1]. Once the extension of these flexibilities is over, one will see reimbursement pulled for audio-only telehealth services for physical health, FQHC and RHC telehealth services that were rendered, and distant-site telehealth services. Another change will be the in-person requirement

Continued on page 30 for mental health services being rendered. Most private payors have separate policies and make their decisions on whether to follow Medicare’s golden standard or not.

PA Medicaid Continuous Coverage: When the 2023 Consolidated Appropriations Act was signed into law, effective April 1, 2023, PA Medicaid will no longer provide continuous coverage to patients. This means that patients will need to reapply for Medicaid and will receive renewal applications in the mail.

FDA Emergency Use Authorization: The FDA released a list of FAQs regarding what will happen to Emergency Use Authorizations (EUAs) that were authorized during the pandemic and what the ending of the PHE means for them. The FDA will issue a federal register notice regarding which EUAs they will temporarily extend or allow to expire once the PHE ends. EUAs, unlike the continued extensions of the PHE, will continue to be active until the Secretary of HHS terminates the EUA. For medical products, there will be a transition time period and time for the disposition of medical products that fall under the EUA for the COVID-19 Pandemic. For more information regarding these Emergency Use Authorizations please see the FAQs page on the fda.gov website [2].

Also, Kaiser Family Foundation (KFF) has created a chart regarding what will happen to COVID-19 vaccinations and treatments among payers once the PHE ends. For more information and to view the chart, visit the KFF website at kff.org [3].

The Office of Civil Rights (OCR): Under the Department of Health and Human Services, OCR released flexibilities in March 2020 that were to remain in effect till the end of the PHE. These flexibilities were:

OCR’s Notice of Enforcement Discretion is allowing providers to serve patients where they are through commonly used apps like FaceTime, Skype, and Zoom to provide telehealth remote communications. OCR also provided empowerment to first responders and others who receive protected health information about individuals who have tested positive or been exposed to COVID-19 to help keep both first responders and the public safe. And finally, the flexibility allowed health care providers to share protected health information with the CDC, family members of patients, and others, to help address the COVID-19 emergency. With the PHE ending in May, these flexibilities will not be in effect once the PHE is declared over.

Resources

1. https://www.cms.gov/medicare/medicare-general-information/telehealth/ telehealth-codes?url=https%3A%2F%2Fwww. cms.gov%2Fmedicare%2Fmedicare-general-information%2Ftelehealth%2Ftelehealth-codes&data=05%7C01%7Cmmerkel%40pamedsoc. org%7Cb4818cbd83724c3ca45108db2a0a806b%7C4320565b470146a4b27b855c4ba de69b%7C0%7C0%7C638149996824827125%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=qf8FT1e1Eu4DnnxlcZKT6ulvLF5AU0aDggathbnTMng%3D&reserved=0

JVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=qf8FT1e1Eu4DnnxlcZKT6ulvLF5AU0aDggathbnTMng%3D&reserved=0

2. https://www.fda.gov/emergency-preparedness-and-response/ mcm-legal-regulatory-and-policy-framework/ faqs-what-happens-euas-when-public-health-emergency-ends

3. https://www.kff.org/coronavirus-covid-19/ issue-brief/what-happens-when-covid-19-emergencydeclarations-end-implications-for-coverage-costs-andaccess/#coverage-costs-and-payment

ADDITIONAL SOURCES https://www.cms.gov/About-CMS/Agency-Information/Emergency/EPRO/Current-Emergencies/ Current-Emergencies-page https://www.deadiversion.usdoj.gov/GDP/(DEADC-022)(DEA068)%20DEA%20SAMHSA%20 buprenorphine%20telemedicine%20%20(Final)%20 +Esign.pdf https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/ emergency-use-authorization https://www.hhs.gov/hipaa/for-professionals/special-topics/hipaa-covid19/index.html https://www.hhs.gov/sites/default/files/ february-2020-hipaa-and-novel-coronavirus - PDF https://public3.pagefreezer.com/content/HHS. gov/31-12-2020T08:51/https://www.hhs.gov/about/ news/2020/03/24/ocr-issues-guidance-to-help-ensurefirst-responders-and-others-receive-protected-health-information-about-individuals-exposed-to-covid-19.html https://public3.pagefreezer.com/content/HHS. gov/31-12-2020T08:51/https://www.hhs.gov/hipaa/ for-professionals/special-topics/emergency-preparedness/ notification-enforcement-discretion-telehealth/index.html