ATTENTION
This web page is updated multiple times a day. Check back frequently for the most up to date information. As always, please reach out to us if you have any questions at admin@azpharmacy.org!
The Arizona Poison and Drug Information Center is available to answer questions about COVID-19 from Arizona providers (for testing, patient guidance) and the general public (for testing, isolation, quarantine): 1-844-542-8201
211 Arizona: If you need assistance finding food, paying house bills, accessing free childcare, or other essential services, dial 211, search on the homepage of 211Arizona.com or download the 211 Arizona app.
Antigen Testing:
New antigen test approved for POC
At Home Test:
- Saliva based test approved on May 8th
- Nasal test approved on April 21st
HHS Guidance for Pharmacists:
- On April 8th, HHS authorized pharmacists to order and administer COVID-19 tests. CLICK HERE
April 10th, 2020: APhA Pharmacists' Guide to Coronavirus: Weekly Summary on COVID-19 | Updates on testing.
FDA Warning:
Pharmacies are being inundated with companies promoting potentially fraudulent materials related to COVID-19 testing, including marketing FDA certification. The FDA is still in the process of reviewing many of these authorizations and have shared with us a few key points to help discern whether a company is legitimate.
CLICK HERE: FDA list of all current authorized tests, updated daily
As of March 29, 2020:
- There is no “Home Test” authorized for SARS-CoV-2 (COVID-19).
- There are emergency use authorized (EUA) point of care (POC) tests, but these tests are not CLIA waived.
Concerns regarding fraudulent products, including tests, should be sent to: FDA-COVID-19-Fraudulent-Products@fda.hhs.gov
AzPA Town Hall updates on COVID-19
Keeping you updated on all the latest information on COVID-19 for health care providers.
NOTE: Effective August 18th we are going to reduce the frequency of our Town Hall meetings. Webinars will be scheduled as often as needed to update you on critical issues as our situation changes. Notices will be sent out via email.
Previous Town Hall Slide Decks:
- December 23, 2020: CLICK HERE
- December 16, 2020: CLICK HERE
- December 9, 2020: CLICK HERE
- November 18, 2020: CLICK HERE
- November 4, 2020: CLICK HERE
- October 28, 2020: CLICK HERE
- October 21, 2020: CLICK HERE
- Sept. 16, 2020: CLICK HERE
- Sept. 9, 2020: CLICK HERE
- Sept. 2, 2020: CLICK HERE
- August 12, 2020: CLICK HERE
- August 5, 2020: CLICK HERE
- July 29, 2020: CLICK HERE
- July 22, 2020: CLICK HERE
- July 15, 2020: CLICK HERE
- July 8, 2020: CLICK HERE
- July 1, 2020: CLICK HERE
- June 24, 2020: CLICK HERE
- June 17, 2020: CLICK HERE
- June 10, 2020: CLICK HERE
- June 3, 2020: CLICK HERE
- May 27, 2020: CLICK HERE
- May 20, 2020: CLICK HERE
- May 13, 2020: CLICK HERE
- May 6, 2020: CLICK HERE
- April 29, 2020: CLICK HERE
- April 22, 2020: CLICK HERE
- April 15, 2020: CLICK HERE
- April 8, 2020: CLICK HERE
- April 1, 2020: CLICK HERE
- March 25, 2020: CLICK HERE
- March 18, 2020: CLICK HERE
Question and Feedback Form:
- For any questions concerning COVID-19: https://pharmacy.az.gov/covid-19-questions
Frequently Asked Questions:
Emergency Statutes and Rules: In Effect Now Due to the State of Emergency:
A.R.S. 32-1910 Emergencies; continued provision of services
- Refer to D) 2
R4-23-412 Emergency Refill Prescription Dispensing
R4-23-413 Temporary Recognition of Nonresident Licensure
R4-23-617 Temporary Pharmacy Facilities or Mobile Pharmacies
Other Helpful Guidance:
- Refer to F)-Remote Work
Gov. Doug Ducey's Guidance:
Governor Ducey Executive Orders: CLICK HERE
- The Drug Enforcement Administration (DEA) announced flexibilities for satellite hospitals or clinics as a result of COVID-19, including:
- Allowing a DEA-registered hospital or clinic to handle controlled substances at a satellite hospital or clinic location under their current registrations. (See qualifying requirements).
- Providing flexibility to allow distributors to ship controlled substances directly to these satellite hospitals or clinics. (See qualifying requirements).
DEA Updates:
Drug Enforcement Administration (DEA) takes additional steps to allow increased production of controlled substances used in COVID-19 care. CLICK HERE
Drug Enforcement Administration (DEA) guidance for health care practitioners, pharmacists, and patients with regard to early refills on prescriptions for controlled substances. CLICK HERE
DEA issued a guidance letter clarifying when oral Schedule II prescriptions are permitted and provides temporary exceptions to this regulation during this Public Health Emergency declared by the Secretary of Health and Human Services. ( 21 CFR 1306.11(d)(1)-(4).
1) DEA recognizes that it may not be feasible for a practitioner to deliver, in response to an emergency oral prescription, the follow-up paper prescription to the pharmacy within 7 days therefore the DEA hereby grants practitioners 15 days within which to provide that prescription to the pharmacy. This exception is granted from March 16, 2020, through the duration of the Public Health Emergency.
2) DEA recognizes there may be times when providing the pharmacy with a paper prescription as a follow up to an emergency oral prescription may prove very challenging or impossible. Thus, for the duration of the Public Health Emergency, DEA hereby allows the practitioner to send the follow-up prescription to the pharmacy via facsimile, or to take a photograph or scan of this follow-up prescription and send the photograph or scan to the pharmacy in place of the paper prescription. It is the responsibility of the practitioner to ensure that, whichever method the practitioner uses, the prescription contains all of the required information outlined in 21 CFR 1306.05 and 1306.11(d), including the statement that the prescription is “Authorization for Emergency Dispensing.” As a condition of this exception, the practitioners who choose to send this specific type of prescription to the pharmacy via facsimile, photograph, or scan must maintain the original paper prescription in the patient file.
Regardless of any exceptions that DEA has made in response to COVID-19, pharmacists continue to have a corresponding responsibility to ensure that any controlled substance prescription for they fill was issued for a legitimate medical purpose by a practitioner acting in the usual course of his/her professional practice. 21 CFR 1306.04(a).
Drug Shortages:
FDA Updates:
FDA issues EUA for potential COVID-19 treatment:
- FDA issued an emergency use authorization (EUA) for remdesivir (Gilead Sciences) for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease. The investigational antiviral drug was shown in a clinical trial to reduce the time to recovery in some patients. Under the EUA, remdesivir can be distributed in the United States and administered intravenously by health care providers, as appropriate, to treat severe disease.
- According to FDA, severe disease indicates patients with low blood oxygen levels or needing oxygen therapy or more intensive breathing support such as a mechanical ventilator. The agency noted, "Based on evaluation of the emergency use authorization criteria and the scientific evidence available, it was determined that it is reasonable to believe that remdesivir may be effective in treating COVID-19, and that, given there are no adequate, approved, or available alternative treatments, the known and potential benefits to treat this serious or life-threatening virus currently outweigh the known and potential risks of the drug's use."
- The EUA requires that fact sheets with important information about using remdesivir in treating COVID-19 be made available to healthcare providers and patients, including dosing information, potential adverse effects, and drug interactions. "Today's action is an important step in our efforts to collaborate with innovators and researchers to provide sick patients timely access to new therapies where appropriate, while at the same time supporting research to further evaluate whether they are safe and effective," said FDA Commissioner Stephen M. Hahn, MD.
FDA steps up scrutiny of coronavirus antibody tests to ensure accuracy:
- FDA on Monday announced commercial coronavirus antibody tests will have to pass agency muster, including meeting standards for quality and accuracy. Officials said "unscrupulous actors" have been "marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans’ anxiety." The new requirements will make it more difficult to buy questionable tests, but agency officials say there should still be enough reliable options for hospitals, doctors, and consumers.
- FDA already has authorized 12 antibody tests for emergency use, and is working with companies on authorizations for an additional 200 serology tests. Under the new rules, companies already marketing tests will be required to file applications for FDA emergency-use authorizations, including data on their tests, within 10 business days.
- Makers of new tests will have to file such applications within 10 days of notifying the agency of their plans to go to market. Under such authorizations, FDA allows unapproved medical products to be used in a public health emergency without being subjected to a full-fledged review.
- If commercial test makers do not submit applications for authorizations within the 10-day time limit, the agency plans to make that information public and consider enforcement action to take the products off the market.
FDA issued a guidance explaining the temporary policy regarding repackaging or combining propofol drug products during the COVID-19 public health emergency
April 21st, 2020: FDA announced new flexibilities for 503A pharmacies, including this in hospitals and health systems, that are compounding these medications for hospital use that is:
- CLICK HERE - RECOMMENDED GUIDELINES
- Essentially a copy of a commercially available drug;
- Provided to a hospital without a patient-specific prescription (i.e., anticipatory or compounding)
- CLICK HERE
April 20th, 2020: FDA Updates Coronavirus Treatment Acceleration Program (CTAP) Webpage
April 16th, 2020: Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency
April 8th, 2020: FDA Approves First Generic of a Commonly Used Albuterol Inhaler to Treat and Prevent Bronchospasm.
April 6th, 2020 Compounding Policy Clarifications
Guidance for hospital and health systems is still in draft and the FDA is planning to issue a revision.
Federal law specifies a 5% limit on interstate distribution of compounded drug products for pharmacy compounders. This is not intended to be enforced until after the finalization of Memorandum of Understanding (MOU). Currently in draft form.
Drugs on the FDA’s shortage list or discontinued and no longer marked as “commercially available” are not considered under the “essentially a copy” provision for pharmacy compounders.
Compounded drug produced by an outsourcing facility is no considered “essentially a copy” if it is identical or nearly identical to an FDA-approved drug that is on FDA’s drug shortage list. The agency also does not intend to take action under this provision if the facility fills orders for a compounded drug that is essentially a copy of an approved drug that has been discontinued and is no longer marketed.
See human drug compounding and drug shortages for more information. Please email compounding@fda.hhs.gov with questions.
USP Operational Considerations for Sterile Compounding during COVID-19 pandemic:
USP | Compounding Alcohol-Based Hand Sanitizer During COVID-19 Pandemic
On March 20, 2020, the FDA updated its guidance on the compounding of hand sanitizer by licensed pharmacies. There are two notable updates from the initial announcement: (1) the updated guidance makes it clear that hand sanitizer may be compounded without a prescription order; and (2) the ingredients may be either USP or Food Chemical Codex grade
Sources for wholesale acquisition of pharmaceutical and food grade ethyl alcohol are available by Arizona distributors and orders are being collected by the Arizona Pharmacy Association.
NEW! COVID-19 Testing: Healthcare Provider Guidance : CLICK HERE
-
- Includes updates to tier 2:
- Fever AND signs/symptoms of a lower respiratory illness has been changed to “fever OR signs/symptoms of a lower respiratory illness”
- Children in foster care have been added to this testing group
- Includes updates to tier 2:
- COVID-19 Healthcare Facility Guidance : CLICK HERE
- Includes guidance on:
- Monitoring healthcare personnel for fever and respiratory symptoms
- Recommendations on allowing exposed healthcare personnel to continue working
- What to do if healthcare personnel become ill while working
- Isolation and discharge recommendations for patients with COVID-19
- Includes updates on:
- Nebulizer treatments – per CDC, “it is uncertain whether aerosols generated from nebulizer administration and high flow O2 delivery are infectious.”
- Includes guidance on:
- The State Disaster Medical Advisory Committee approved the implementation of the Treat and Keep Home and Treat and Refer guidelines. These strategies will reduce the number of patients seeking medical care at hospitals when hospitalization is not clinically necessary.
- COVID-19 Guidance for Long-Term Care Facility: CLICK HERE
- Includes guidance on:
- Accepting patients/residents from higher acuity healthcare facilities
- Clarifies guidance on cohorting:
- Room sharing (“cohorting”) might be necessary if there are multiple residents with known or suspected COVID-19 in the facility. As roommates of symptomatic residents might already be exposed, it is generally not recommended to separate them in this scenario.
- Residents who are symptomatic and being tested for COVID-19 should not be roomed with those who are confirmed to have COVID-19 unless they are already a roommate of a positive resident.
- Room sharing (“cohorting”) might be necessary if there are multiple residents with known or suspected COVID-19 in the facility. As roommates of symptomatic residents might already be exposed, it is generally not recommended to separate them in this scenario.
- Includes guidance on:
Arizona Department of health Services (ADHS)
Maricopa County Department of Public Health
March 20, 2020: Pharmacist Advocacy Groups Call for New Action to Enhance COVID-19 Patient Care
CDC-Information for Healthcare Professionals
Johns Hopkins University COVID-19 Global Cases Map
National Pharmacy Associations/Organizations:
PPE Vendors:
PPE Procurement Face Filter USA - sourcing supply direct from FDA Authorized manufacturers to logistics, importing, and delivery
- FDA EUA Authorized N95 and KN95 Masks for Order: CLICK HERE
CDC Update:
CDC provides guidance to pharmacies and pharmacy personnel. Changes include:
- Everyone entering the pharmacy should wear a face covering, regardless of symptoms. Cloth face coverings should not be placed on young children under age 2, anyone who has trouble breathing, or is unconscious, incapacitated or otherwise unable to remove the mask without assistance.
- Pharmacists and pharmacy technicians should always wear a facemask while they are in the pharmacy for source control.
- Postpone and reschedule delivery of some routine clinical preventive services, such as adult immunizations, which require face to face encounters.
- Special considerations for clinics that are co-located in pharmacies.
- Added more information about cleaning and disinfecting surfaces and included a link to more information about how to clean/disinfect.
Additional Resources
- Decontamination and Reuse of Filtering Facepiece Respirators
- USP Response to Shortages of Garb and Personal Protective Equipment (PPE) for Sterile Compounding During COVID-19 Pandemic
- ADHS | COVID-19 Infection Control and Personal Protective Equipment (PPE) Guidance for Arizona
Contact your local health department of PPE is needed for your facility.
General Information:
- Updated List of Health Insurance Companies COVID-19 Coverage Known in Arizona
- PBM COVID-19 Concessions
- PCMA - Promoting Patient Access to Rx Drugs During COVID-19
Audit Information:
Delivery and Signature Logs:
CMS Update:
- ASHP Issue Brief: New CMS Flexibilities for Hospitals and Other Providers
- The Centers for Medicare & Medicaid Services has announced a number of new flexibilities for hospitals and other providers during the COVID-19 response. The loosening of restrictions on verbal orders, physician supervision, and the reuse of masks for sterile compounding may be of particular interest to pharmacists who practice in hospitals and health systems.
NCPA Resources:
- NCPA connects hospitals with compounding resources. Alliance for Pharmacy Compounding has launched a free resource for connecting hospitals with 503B outsourcing facilities, or alternatively, 503A sterile compounding pharmacies, that can supply their needs.
- Click here
- The Shortage Drug Source is intended to assist hospitals in procuring the drugs they need to treat COVID-19 patients quickly and efficiently. Click here to learn more.
- If you have patients who have recovered from COVID-19, consider encouraging them to donate plasma. The plasma of those who have recovered from the virus is now rich with COVID-19 antibodies. This plasma, known as convalescent plasma, could potentially be used to treat patients who are fighting the infection. Visit this COVID-19 plasma website to find the location of an accredited AABB blood donation site or for more information.
ASHP Resources:
- ASHP has expanded access to their geriatric resources to everyone (including non-ASHP members): CLICK HERE
- Open Access to ASHP's Interactive Handbook on Injectable Drugs
- ASHP is providing free access to our Interactive Handbook on Injectable Drugs in response to the rapidly increasing use of parenteral medications needed for the care of critically ill patients with COVID-19.
APhA Resources:
- COVID-19: Demystifying Testing for the SARS-CoV-2 Virus: CLICK HERE
FDA Resources:
- March 19, 2020: FDA advises patients on use of non-steroidal anti-inflammatory drugs (NSAIDs) for COVID-19
Additional Resources:
- Evidence that Vitamin D Supplementation Could Reduce Risk of Influenza and COVID-19 Infections and Deaths: CLICK HERE
Continuing Education:
- ASHP Opens Access To Critical Care Pharmacy Specialty Resources: Use Code COVID-19
- ASCP: In an effort to support our senior care pharmacists during the fight against COVID-19, we are opening access to our elite workshop recording worth 4.0 continuing pharmacy education (CPE) credits.Five-Star Antibiotic Stewardship for Older Adults
- APhA: APhA's 15 on COVID-19 Series is designed to provide you with the answers you need to educate yourself, your colleagues, and your patients about COVID-19. CPE credits are available.
- Topics Include:
- Role of remdesivir in treatment of COVID-19
- Connections between ACE-i/ARB therapy
- Facts and Myths of NSAIDs in COVID-19
- Broad overview of COVID-19
- Real of two older antimalarial drugs in COVID-19
- Link: https://www.pharmacist.com/coronavirus/resources-training
Staffing Shortages:
New Free Service Helps Alleviate Potential Staffing Shortages During Pandemic
ASHP CareerPharm Rapid Connect is a new online service that unites healthcare facilities with pharmacy personnel who can provide surge support, remote medication order review and verification, remote clinical pharmacy specialist services, pharmacy technician support, and temporary onsite staffing. Candidates (pharmacists or pharmacy technicians) who are willing and able to work are encouraged to create a profile and post their CV. There is no fee for this service.
Express Scripts Update:
- Express Scripts would like to clarify that pharmacies are not required to obtain signatures from patients during this unprecedented pandemic, unless required by law.
- This policy was implemented on March 19, and was originally scheduled to remain in place until April 30. This policy has been extended and will be in effect until further notice.
- If you need a member’s specific prescription processing information or other help with a claim, please visit our Pharmacist Resource Center at https://prc.express-scripts.com.
Additional News:
- Randomized Open Label Study of Standard of Care plus Intravenous Immunoglobulin Compared to Standard of Care Alone in the Treatment of COVID-19 Infection:CLICK HERE
- How to see if your Provider Relief Fund check in on the way: CLICK HERE
- Study on Chloroquine for Coronavirus Stopped Due to Heart Problems: CLICK HERE
April 7th, 2020: COVID-19 - Fraudulent Medical Product and Scams