Medication Access and Drug Shortage Concerns During the COVID-19 Pandemic: Frequently Asked Questions

Updated 5/27/2020

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Medication Access and Drug Shortage Concerns During the COVID-19 Pandemic: Frequently Asked Questions

American Society of Transplantation Transplant Pharmacy Community of Practice/American College of Clinical Pharmacy Immunology/Transplant Practice and Research Network Medication Access Workgroup*

Introduction:

Information regarding COVID-19 is changing rapidly. This document will be updated with the evolving issues related to medication access and drug shortages/supply chain issues within the United States of America during the pandemic.

Medication Access:

  1. What should be done to enhance medication home supply?
    a. During the COVID-19 pandemic, we recommend patients have extra medication on hand as their insurance plan allows.
    • Patients may contact the dispensing pharmacy or insurance plan and ask about the ability to fill a 90-day supply of medications.
      • Ability to obtain 90-day supply is dependent on insurance plan, dispensing pharmacy, state law, and specific medications.
        • Medicare Part B: historically limited to 30-day supplies.
        • Medicare Advantage plans and certain Medicaid programs: some reports of success with extended fill supplies.
        • Insurance may require a specific mail order pharmacy for 90-day supply. 
  • ​Limited stability of compounded medications and commercially available liquids may prevent dispensing of 90-day supplies
  • Patients should contact the prescriber for a 90-day supply prescription, if eligible.
  • If patients are unable to get a 90-day supply, they may still be eligible for early refills of the 30-day supply.

    b. Advise patients to contact the transplant clinic if they have difficulty obtaining medications or have questions after calling the pharmacy or insurance plan.
    c. Requests for extended supplies of medications should be limited to patients on stable or established doses.
    d. Requests for extended supplies of medications must be balanced with risk of potential drug shortages.

2. Have state governments taken any actions pertaining to prescription medication access and supply?

  1. Yes, use this link for state-specific actions: State-Specific Actions on Medication Access

3. Have any of the state Medicaid programs made adjustments because of COVID-19?

  1. Yes, use this link for state-specific adjustments: State-Specific Medicaid Adjustments

4. What state-specific medication assistance programs are available?

a. Please use this link for state-specific examples of patient assistance programs: State-Specific Medication Assistance Guidance

5. Have there been issues with early refill requests?

a. Payers may or may not allow members to obtain early refills due to COVID-19

b. Some pharmacy corporations may have internal rules or regulations limiting early refills.

c. Retail pharmacists: if a patient requests an early refill due to this reason, and if in your professional judgment filling the prescription(s) early is in the best interest of the patient, and if claim is rejected and there is not a pharmacy corporate rule preventing you from doing so, attempt to submit a Submission of Clarification Code of 13. Follow the specific payer override processes listed as follows or refer the member to call their plan for further assistance. Documentation of the reasons for the override should be noted on the prescription or in a log.  If the override is approved and the patient uses a copay card, most companies are allowing the early refill on the copay card (see information below regarding use of copay cards to assist with patient out of pocket costs). Also, consider emergency refill requests and quantity limit exception requests.

d. Contact information and override codes for several insurance companies can be found here: Pharmacy Overrides: Insurance Override Codes

From a pharmacy perspective, which strategies can be utilized to enhance social distancing?

a. Telehealth
b. Mail order pharmacy
c. Medication home delivery through outpatient pharmacy
d. Drive through/curbside pick up
e. Use of a support person for pick-up
f. Of note, pharmacies must follow federal and state pharmacy laws, insurance company stipulations, and corporate rules and regulations. Due to variation, this may impact available options. 

  • Signature requirements upon prescription receipt may still apply depending on federal and state laws. This should be anticipated and patients can be advised to use their own pen and/or gloves if desired.  In addition they should be advised to wash their hands with soap and water for 20 seconds after signing/accepting deliveries. If soap and water are not available, use of a hand sanitizer with at least 60% alcohol is recommended.
  • Patients can check with their respective pharmacist or pharmacy manager regarding options to enhance social distancing. If patients are not comfortable with the services a pharmacy is providing, they have the option of  transferring prescriptions elsewhere as allowed by insurance. 
  • Using a local transplant specialty pharmacy can be considered as they may be more attuned to the unique needs of a transplant recipient and transplant family.

g. In regards to patients who currently receive intravenous infusions at infusion centers, options may exist for home infusion depending on insurance coverage. A couple of examples of manufacturers of medications utilized in transplant recipients that have programs available to assist with coordination of home infusion include:

What strategies can be used to expedite medication access when faced with insurance mandates, including prior authorizations, step therapy requirements, and specialty mail-order pharmacy mandates?

a. Overrides are often available for specialty medications to be filled at local retail pharmacies, if urgently needed
b. Some mail-order pharmacies are offering same day courier services

How should transplant teams handle loss of transplant patient employment?

a. Involve social work to help navigate government assistance/insurance
b. Be aware of emergency enrollment periods for state health exchanges
c. If available, consider patient enrollment in state-specific discounted health care service programs for low-income individuals and families (some examples are provided in the state-specific assistance program section)
d. See below for information on patient assistance programs to assist with emergency supplies between coverage gaps as well as other resources to decrease cost of prescription medications including discount programs and foundation funds

What are the available resources for discount coupons, patient assistance programs, and copay cards?

a. PhPRMA’s Medicine Assistance Tool (MAT) (https://mat.org/) is a search engine designed to help patients, caregivers and health care providers learn more about the resources available through the various biopharmaceutical industry programs. MAT is not its own patient assistance program, but rather a search engine for many of the patient assistance resources that the biopharmaceutical industry offers.
b. Needymeds.org is a great resource to find collated patient assistance programs that are currently available as well as some forms.
c. Discounted pricing coupons for generic, and some brand-name, medications include:

  • www.goodrx.com: Offers reduced pricing on medications, not using insurance, on select medications at specific pharmacies. An online application is available. Of note, GoodRx collects data from users, but recently users can have their data deleted from GoodRx by completing the following form found at: https://www.goodrx.com/blog/goodrx-data-privacy/
  • Certain patients with Medicare Part D may qualify for a Medicare prescription drug coverage low income subsidy/extra help based on annual income (i.e. <150% federal poverty level). Extra help is estimated to cover up to $5000 per year. More information can be found at: https://www.ssa.gov/benefits/medicare/prescriptionhelp/
  • Many resources are available for brand-name products through the pharmaceutical manufacturers
    • Copay Cards: Help cover a portion of patients’ out-of-pocket expenses up to an annual limit. Copay cards can only be used with commercial insurance if the prescription costs are partially covered by the insurance plan (i.e., patients with Medicare or no insurance are not eligible to use copay cards).
    • Patient Assistance Programs: Provide medications at no cost, typically through a mail order pharmacy designated by the manufacturer, for patients meeting certain criteria, which may include, but not limited to:
      • Annual household income
      • Percent of out of pocket medication expense in relation to annual household income
      • If applicable, insurance denials, including unsuccessful appeals
         
        1. Several companies are trying to develop all electronic prescription assistance program options, but these are not in place yet. Several companies have acknowledged that they are aware of issues related to this now and will work with the provider and patient to develop a solution. Doximity application may assist with HIPAA protected fax needs.

d. Many resources are available for brand-name products through the pharmaceutical manufacturers

  • Copay Cards: Help cover a portion of patients’ out-of-pocket expenses up to an annual limit. Copay cards can only be used with commercial insurance if the prescription costs are partially covered by the insurance plan (i.e., patients with Medicare or no insurance are not eligible to use copay cards).
  • Patient Assistance Programs: Provide medications at no cost, typically through a mail order pharmacy designated by the manufacturer, for patients meeting certain criteria, which may include, but not limited to:
    • Annual household income
    • Percent of out of pocket medication expense in relation to annual household income
    • If applicable, insurance denials, including unsuccessful appeals
  • Patients may require new prescriptions for many patient assistance programs and copay card programs that designate Brand Medically Necessary/NS/DAW 1/DNS for medications with available generics. Check local state requirements.
  • Several companies are trying to develop all electronic prescription assistance program options, but these are not in place yet. Several companies have acknowledged that they are aware of issues related to this now and will work with the provider and patient to develop a solution. Doximity application may assist with HIPAA protected fax needs.
  • Some common transplant-related resources are collated here.

What foundation support is available to help transplant patients who are in need of assistance?

  • Healthwell has opened a new fund to assist individuals who are at risk or have been quarantined due to COVID-19. Through this unique fund, HealthWell will provide up to $250 in financial assistance for a 12-month grant period to eligible patients who have annual household incomes up to 500 percent of the federal poverty level. Grants awarded through the fund will provide reimbursement assistance for delivered food and medication and transportation costs to manage COVID-19, while maintaining social distancing protocols, including drive-through testing, delivery of test kits and future treatments. In addition, eligible copayment and incidental costs associated with tele-health treatments and diagnostics related to COVID-19 will also be covered under the fund.
  • American Kidney Fund Coronavirus Emergency Fund - Due to incredible demand for Coronavirus Emergency Fund Assistance, as of May 26, 2020, there is currently a waitlist for $250 grants for low income kidney transplant recipients or dialysis patients. However, the organization is actively seeking for additional sources of funding so that it can be reopened quickly. American Kidney Fund is also looking for independent donors. Donations can be made on the Emergency Fund website.
  • American Transplant Foundation (ATF) is the only 501 (c)(3) nonprofit that provides three tiers of support for living donors, transplant recipients, and their families. Patient assistance programs for living donors to cover essential living expenses due to lost wages during recovery after surgery and for transplant recipients to cover delinquent insurance premiums to prevent loss of insurance coverage, medication co-payments during insurance gap periods, and/or changes to insurance provider. Emergency assistance grants are also offered as of April 24, 2020 to provide transplant recipients with up to $1,000 to cover expenses that pose a direct financial barrier to post-transplant care.
  • Good days® is an independent 501(c)(3) non-profit organization that provides support and assistance for Hepatitis C treatments. Currently, the program is open to enrollment and provides assistance in the amount of $15,000 for eligible patients. If approved for an open fund, Good Days will provide financial assistance for the full calendar year, or until funds are exhausted.
  • PAN Foundation is an independent, national 501 (c)(3) organization dedicated to helping federally and commercially insured people living with life-threatening, chronic and rare diseases with the out-of-pocket costs for their prescribed medications. PAN offers a fund for eligible patients to receive up to $6,800 per year in financial assistance for Hepatitis C related medications.

What options are available for patients who are in need of an emergency supply of medications without insurance coverage?

a. Veloxis and Novartis offer 30-day free or bridge programs. Use contact information above for the respective assistance program.

b. Bristol Myers Squibb expanded its current program to include patients who lose their insurance due to the COVID-19 pandemic and will provide access to free branded medication.  

Drug Shortages:

1. What are the current drug shortages that may impact transplant patients?

Generic Name

Companies Affected

Shortage Status

Revision Date

Companies that still have supply

Tacrolimus capsules

(0.5, 1, and 5 mg)

Accord, Biopharma, Major, Sandoz

Current

March 4, 2020

Mylan, Strides Pharma, Dr. Reddy’s, brand-name Prograf from Astellas

Tacrolimus extended-release capsules and tablets

Astellas

(only Astagraf XL)

Current

April 27, 2020

Veloxis (Envarsus XR) supply unaffected

Tacrolimus injection

Astellas

Current

April 27, 2020

No other company makes IV Tacrolimus

Mycophenolate mofetil capsules and tablets

Ascend, Hikma, Sandoz, Mylan

Current

April 6, 2020

Brand-name Cellcept from Genentech, Accord, Mylan and Sandoz have some products available

Cyclosporine oral solution

Teva

Current

May 8, 2020

Sandimmune and Neoral from Novartis; Gengraf from Abbvie

***As of 05/11/2020 – No current shortages reported for mycophenolic acid (Myfortic), sirolimus,  everolimus, belatacept

***Sandimmune/Neoral blister pack recall is related to failure of child-proof packaging. Patients do NOT need to send the medication back and can continue to use the medication as directed. Patients should immediately secure the product out of the sight and reach of children and contact the firm to request a free child-resistant pouch to store the blister package medications. Novartis toll-free at 866-629-6182 from 8 a.m. to 8 p.m. ET daily, email at Novartis5060@stericycle.com or online at www.pharma.us.novartis.com and in the top navigation of the page go to the News tab and click on Statements, or visit https://www.pharma.us.novartis.com.

What are current recommendations and availability for COVID-19 associated medications?

Generic Name

Companies Affected

Shortage Status

Revision Date

Companies that still have supply

Albuterol sulfate MDI

Teva, Par, Prasco, GSK

Current

March 24, 2020

Merck

Azithromycin IV

Pfizer, Apotex, Auromedics, Sun Pharma, Fresenius Kabi

Current

March 23, 2020

Slate Run Pharmaceuticals

Hydroxychloroquine sulfate tablet

Amneal, Major, Mylan, Teva,

Current

March 24, 2020

Concordia, Sandoz, Zydus, Prasco

Chloroquine

Phosphate Tablet

Rising Pharmaceuticals, Sun Pharma

Current

March 24, 2020

None

***States are enacting 14-day supply restrictions on hydroxychloroquine, as well as limiting to FDA approved indications or confirmed positive COVID-19 cases. Please visit your respective state board of pharmacy’s website for specific stipulations with regards to COVID-19.

***No pharmacist should dispense hydroxychloroquine or chloroquine except when prescribed for an FDA-approved indication or as approved by their state for COVID.

https://www.ama-assn.org/press-center

There are several investigational agents including, but not limited to:

 

Inhaled Medications:

  • Given the potential for spread via aerosolization of COVID-19 with the use of nebulizers, metered dose inhalers (MDIs) should be used for all COVID-19 rule-out and confirmed cases
  • Ipratropium should be restricted to suspected or confirmed COVID-19 patients with concomitant COPD
  • Recommend use of albuterol nebulizers for non-COVID patients to conserve supply of MDIs

Controlled Substances:

  • Controlled substances have been in short supply due to increase in mechanically ventilated patients.
  • The Drug Enforcement Agency (DEA) has made changes to Annual Production Quotas (APQs) to address these shortages
    • APQs determine the annual quantities of schedule I and II controlled substances that may be manufactured in the United States. This quota system was established by the Controlled Substances Act of 1970 and was enhanced in 2018 in response to the nationwide opioid epidemic.
    • APQs are based on predicted annual needs to provide adequate quantities for the estimated medical, scientific, research, and industrial needs of the United States market, for lawful exports, and to establish reserve stocks. All APQs and assessments of annual needs are subject to adjustment based on DEA Codes of Federal Regulations.
    • On April 7, 2020, the DEA adjusted the 2020 APQs to provide for the increased estimated needs. (https://www.dea.gov). Under this order, the DEA committed to monitoring manufacturing and procurement quotas to ensure that the increases in APQs will be utilized primarily to manufacture medications involved in sedation, intubation, and pain relief for patients being treated for COVID-19 to ensure an uninterrupted supply during the public health emergency.
    • APQs may be updated as needs are identified. All APQ adjustments will be published by the DEA in the Federal Register general notices (https://www.federalregister.gov).

503A Compounding of COVID-related medication

  • 503A compounding facilities are typically not registered with the FDA as outsourcing facilities and are not subject to CGMP regulations.
    • 503A pharmacies follow guidelines requiring a product to be compounded for an identified individual patient based on a valid prescription.
    • 503A pharmacies cannot compound regularly or inordinate amounts of drug products that are essentially copies of commercially available drug products.
  • The FDA has published new guidelines regarding the scope and function of 503A pharmacies nationwide as a temporary solution for potential pandemic-related drug shortages.
  • The FDA stated that it does not intend to take action against a pharmacy for compounding a drug that is essentially a copy of a commercially available product or if the product attained is not produced in response to a patient-specific prescription if all of the following conditions are present and the other conditions of section 503A of the FD&C Act are met.
    • The drug must be included on the FDA’s list of drugs that hospitals use to treat COVID-19 patients and must contain only one of the active ingredients included in appendix A (https://www.fda.gov/media/137125/download).
    • The hospital purchasing the medication must inform the 503A pharmacy that they will use the product to treat COVID-19 patients and that ‘reasonable attempts to obtain’ an FDA-approved product have been unsuccessful.
    • The drug must be labeled with a default beyond-use date (BUD) that meets the FDA requirements in Appendix B (https://www.fda.gov/media/137125/download).
    • The 503A pharmacy must use a shorter BUD if literature suggests the product will not remain stable for the duration of the default BUD.
    • If the 503A pharmacy has not been able to obtain a sufficient supply of PPE that ensures typical sanitary conditions, a 24-hour BUD must be applied to products stored at room temperature and a 3-day BUD for products stored refrigerated.
    • If the 503A pharmacy is not owned by the hospital, the label of the product must denote that the drug is intended to treat COVID-19 patients and provide adequate administration documentation to the extent allowed by applicable laws.
    • The pharmacy must notify the pharmacy compounding authority in the state where the pharmacy is located, and the authority that regulates pharmacy compounding in the state the hospital is located (if located in a different state), to receive permission to provide the compounded product without first obtaining a patient-specific prescription.

Additional Information

Are there concerns with transmission of the virus via food or packages?

Are angiotensin-converting enzyme inhibitors (ACE-I) and angiotensin receptor blockers (ARBs) safe during the COVID-19  pandemic?

Are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) safe to take during the COVID-19 pandemic?

  • Acetaminophen is recommended for treatment of fevers.  FDA is aware of news reports stating the use of non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, could worsen coronavirus disease (COVID-19). These news reports followed a March 11, 2020, letter in The Lancet medical journal, which hypothesized that an enzyme (a molecule that aids a biochemical reaction in the body) is increased by NSAIDs and could aggravate COVID-19 symptoms. At this time, FDA is not aware of scientific evidence connecting the use of NSAIDs, like ibuprofen, with worsening COVID-19 symptoms. The agency is investigating this issue further and will communicate publicly when more information is available.

Are there at home laboratory testing options for transplant recipients?

  • Some regions and centers (e.g. - University of Washington in Seattle) may have the availability to do at home tacrolimus testing. Where possible, this may be a good strategy to manage currently outpatient and stable transplant recipients. Where home testing is not possible, optimizing the use of local laboratories versus coming into busy and potentially contaminated academic medical centers is advised.
  • CareDx is offering RemoTraC, a service to provide at-home blood draws for transplant patients. RemoTraC includes AlloSure and AlloMap, CareDx’s surveillance tests, along with a panel of routine tests. More information can be obtained from: https://xynmanagement.secure.force.com/RemoTraC/
  • Eurofins Viracor’s Labs@HOME is an in-home blood draw service offering the option to order routine infectious disease and transplant-related testing and Viracor’s TRAC™ (Transplant Rejection Allograft Check). Eurofins Transplant Genomics offers a similar service to collect samples for TruGraf blood tests and standard labs. More information can be obtained via email at info@viracor-eurofins.com or https://trugraf.com/
  • Natera’s ProReach Program utilizes their nationwide mobile phlebotomy network to draw both Prospera transplant assessment test and routine labs remotely. Providers can customize how to follow transplant patients with a dedicated Natera clinical concierge team. More information can be obtained from: https://www.natera.com/organ-transplant/proreach-program

     

*AUTHORSHIP TEAM ON BEHALF OF: American Society of Transplantation Transplant Pharmacy Community of Practice/American College of Clinical Pharmacy Immunology/Transplant Practice and Research Network Medication Access Workgroup

Editors

Jennifer McDermott

Elizabeth Goswami

Karen Khalil

Laura Lourenco

Renu Nathan

Patricia West-Thielke

Barrett Crowther

 

Contributors

Melissa Durst

Lisa Fuller

Reed Hall

Matthew Harris

Alexandra James

Nicole Kenyon

Patrick Klem

Vineeta Kumar

Danielle Lazear

Erin Lushin

Gregory Malat

Amanda (Condon) Martinez

Daniel Migliozzi

Joelle Nelson

Anisa Oparaku

Talia Papiro

Lisa Potter

Anesia Reticker

Christin Rogers Marks

Christina Ruggia-Check

Shelley Skibinski

Tracy Sparkes

Teresa Tan

Benito Valdepenas

 

Reviewers

Nicole Alvey

Lyndsey Bowman Anger

Christina Doligalski

Alicia Lichvar

Helen Sweiss

Amanda Szczepanik

David Taber