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News Coronavirus Disease 2019 (COVID-19) Frequently Asked Questions

5/10/2021
  • Board of Registration in Pharmacy

                                                  Coronavirus Disease (COVID-19)

                                                      Frequently Asked Questions

 

Contents:

  1.  Live CE Requirement
  2.  12 Hour Maximum
  3.  Supervisory Ratios
  4.  Oral Prescriptions
  5.  Emergency Refills
  6.  Clozapine / REMS Drugs
  7.  Curbside Delivery
  8.  Identification for PMP Drugs
  9.  Signatures for Pickup / Delivery
  10.  Perpetual Inventory
  11.  Insurance Issues
  12.  Changing Hours of Operation
  13.  Store Closing for greater than 1 Day
  14.  Store Closing for less than 1 Day
  15.  MOR Illness
  16.  Non-Resident Pharmacist / Technician Practice
  17.  Remote Technician Practice
  18.  Central Fill
  19.  Garb Shortages
  20.  Hand Sanitizer Compounding
  21.  Compounding Copies of Commercially Available Drugs
  22.  General Prescription Filling Guidance
  23.  DPH Orders Affecting Pharmacy Practice:
    • COVID Pharmacy Assistance Team
    • Recommendations for pharmacies to open early for seniors / infection control
    • Pharmacist administration of methadone / buprenorphine
  24.  LTCF Emergency Kit Restock
  25.  Physician Prescribing for Self and Family
  26.  Beyond Use Dates (BUDs)
  27.  COVID-19 Positive Employees
  28.  Qualified Technicians Administering Vaccines
  29.  COVID-19 Vaccinations
  30.  COVID-19 Testing
  31.  COVID-19 Vaccination Plan
  32.  Retired Pharmacists Performing Vaccinations
  33.  License Expiration and CE
  34.  CE Requirements to Immunize

1. Will the Board waive the live CE requirement since so many live programs have been canceled?

There are several online CE offerings that meet the requirement of 5 live CE credit hours per year.

ACPE approved courses are considered “live” as long as the activity provides direct interaction between presenter and learner, including lectures, live teleconferences, workshops, etc. An online course (i.e. webinar) that is approved for live CE credits would be designated with an “L” in its ACPE number.

Please see following link for details: http://elearning.ashp.org/acpe-designations

2. Can a pharmacist work more than 12 hours?

During the emergency period, a pharmacist, pharmacy intern, or pharmacy technician may remain on duty for more than 12 hours per day in order to act in the best interest of patients, provided that the time in excess of 12 hours is minimized (to the extent possible) and licensees are able to accurately and safely dispense prescriptions.

3. What about supervisory ratios for interns and technicians?

During the emergency period, the Board of Pharmacy does not intend to take any enforcement action against pharmacies that may be temporarily out of compliance with required supervisory ratios (247 CMR 8.06) provided that there is at least one licensed pharmacist in the pharmacy and the pharmacy is able to accurately and safely dispense prescriptions.

4. Can I still accept oral prescriptions?                                                          

As always, pharmacies should continue to accept oral prescriptions for any Schedule III - V medication as long as a follow-up prescription is requested to be sent within 15 business days. The prescription should indicate: "Issued to document an Oral Prescription". 

The Massachusetts DPH has indicated that the current state of public health emergency qualifies for Schedule II emergency exceptions. The prescriber must dictate the needed quantity, up to a 30-day supply. The prescriber should notate "Authorization for Emergency Dispensing” on the follow-up prescription to be provided within 15 business days.

Follow-up prescriptions for Schedule II – V oral prescriptions may be issued by          any method approved by the DEA for the transmission of a written prescription, including sending the follow-up prescription to the pharmacy through the U.S. mail (postmarked within 15 days of the oral prescription), e-prescribed, facsimile, or by taking a photograph or scan of the follow-up prescription and sending the photograph or scan to the pharmacy via secure email.

Please see the following link for details:

https://www.mass.gov/doc/order-of-the-commissioner-of-public-health-follow-up-procedures-for-oral-prescriptions/download

Oral Schedule VI prescriptions are acceptable and do not require follow-up prescriptions.

**It is the prescriber’s responsibility to ensure that the follow-up prescription is sent.

Patient prescriptions should not be denied if a prescriber continually fails to send follow-up prescriptions.

Pharmacists need only document on the prescription each time follow-up prescriptions are requested.

5. Can I dispense an “emergency supply” on a prescription with no remaining refills?

Yes. See the following link for details: 

https://www.mass.gov/news/covid-19-order-of-the-commissioner-of-public-health-related-to-pharmacy-practice

6. Can I refill clozapine without lab results?

In accordance with current practice, pharmacies may refill clozapine prescriptions if current lab results cannot be obtained in a timely manner provided that the pharmacist uses professional judgment after consulting the prescriber. Required lab results must be obtained as soon as possible and the pharmacist must document all pertinent details.

See the FDA guidance regarding REMS drug requirements during the COVID-19 emergency:

https://www.fda.gov/media/136317/download        

7. Can I provide curbside delivery so patients do not have to come into the pharmacy?

Pharmacies may certainly provide this service if designated personnel provide the medication to the patient or his/her agent and offer counseling to be provided by a pharmacist. Counseling may be provided by phone. Provisions should be established for the security and accountability of medications.

8. Do I still have to get identification when a customer receives a prescription for a federally controlled substance or gabapentin?

No. See link to the PMP guidance document:

https://www.mass.gov/news/covid-19-waiver-of-requirement-for-pharmacies-to-collect-and-submit-customer-id-information-to

9. Can you waive the signature for pickup and delivery to limit the amount of surface touching?

Board regulations do not require any signature at pick up to document either acceptance or refusal of counseling. Additionally, the Drug Control Program is waiving the requirement in 105 CMR 700.012(A) for pharmacies to collect and report a patient ID and signature in association with dispensing a controlled substance or gabapentin.

Although the Board does not require a signature for delivery, it recommends that some method of acceptance confirmation should be established upon delivery.

If there are 3rd party insurer requirements for a signature at pickup or delivery, please contact the insurer for guidance.

10. Do I still have to do perpetual inventory every 10 days during the emergency?

During the emergency period, the Board of Pharmacy does not intend to take any enforcement action against pharmacies that perform and reconcile perpetual inventory counts as least every 30 days. Back counts are strongly recommended.

11. Can you address insurance issues such as early refills and signature requirements?

The Division of Insurance has issued this bulletin that addresses these concerns:

https://www.mass.gov/doc/bulletin-2020-06-administration-of-precription-drug-benefits-during-covid-19-coronavirus-public/download

12. Can I change my hours of operation during the emergency period?

Yes. Use the following form at any time to change store hours:

https://www.mass.gov/doc/pharmacy-store-hours/download

13. Can we request permission to close a pharmacy for more than 1 day, directing patients to other locations and transferring to other pharmacies as needed?

If your organization makes a decision to temporarily close, the Board would require notification via email prior to this occurring with all pertinent details such as the effective date, estimated duration, continuity of care plan, communication plan, etc. Current patients must also be notified of the continuity of care plan.

14. What if I need to open late, close early, or temporarily close during the day?

To the extent possible, provide methods to notify patients such as signage and emergency contact information. Pharmacies must ensure patient needs are met in a timely manner. Notify the Board as soon as possible via email.

15. Due to illness and quarantine, I’m not sure how long my MOR will be out. Do I have to let the Board know?

The Board must always know which pharmacist is currently responsible for a pharmacy and should be notified of these incidents by email.

16. Can pharmacists and technicians from other states practice in Massachusetts during the emergency period?

Yes. For authorization to practice in Massachusetts please submit "Application for Emergency Authorization for Out-of-State Pharmacists and Pharmacy Technicians to Practice During the COVID-19 State of Emergency" form as well as sign up for NABP Passport in your e-Profile account. If you do not have an e-Profile account please sign up through the NABP website.

See the following link for the application and details:

https://www.mass.gov/news/covid-19-order-of-the-commissioner-of-public-health-related-to-pharmacy-practice

Technicians licensed in other states may work inside a Massachusetts pharmacy only after an application has been received and approved by the Board.          

17. Can support personnel (e.g. pharmacy technicians) work remotely?

Yes. See the following link for details: 

https://www.mass.gov/doc/2021-02-shared-pharmacy-service-models-including-central-fill-central-and-remote-processing-and/download

18. Is it possible to conduct a central fill process for compounded medications during this state of emergency? 

Yes. See the following link for details: 

https://www.mass.gov/news/covid-19-order-of-the-commissioner-of-public-health-related-to-pharmacy-practice

19. Is there guidance for how to handle compounding garb shortages?

Yes. See the following links for details: 

https://www.mass.gov/news/covid-19-order-of-the-commissioner-of-public-health-related-to-pharmacy-practice

https://www.fda.gov/media/136841/download

20. Can pharmacies compound hand sanitizer?

Yes. See requirements here:

https://www.mass.gov/news/covid-19-hand-sanitizer-guidance

21. Can I compound products that are essentially copies of commercially available products in the event of shortages of the commercially available products?

In accordance with Board Policy 2020-02 (https://www.mass.gov/doc/2020-02-compounding-copies-of-commercially-available-drugs/download), the compounding of products that are essentially copies of commercially available products may not occur unless:

  • a compound would meet the unique medical need of an individual patient by producing a significant difference between the compounded drug preparation and a comparable commercially available drug; or
  • there is a shortage of the commercially available product, as determined by the FDA.

If these conditions do not exist, during the emergency period a pharmacy may compound a product that is essentially a copy of a commercially available product only if it can document that it has attempted and failed to obtain the commercially available product.

22. Is there any general guidance for pharmacies and the filling of prescriptions?

Yes. Please see the following links from the CDC and the Commissioner of Public Health:

https://www.cdc.gov/coronavirus/2019-ncov/healthcare-resources/pharmacies.html

23. See additional Updates, Emergency Orders, and Guidance from DPH affecting pharmacies and pharmacists:

https://www.mass.gov/doc/dph-ehs-order-authority-for-covid-pharmacy-assistance-team/download

https://www.mass.gov/doc/retail-businesses-protocol-summary-051021/download

https://www.mass.gov/doc/march-18-2020-pharmacist-opioid-misuse-disorder-medication/download

  1.  My pharmacy provides emergency kits to long term care facilities. Do I still have to restock them within 48 hours of use?

No. See the following link for details:

https://www.mass.gov/news/extension-of-time-for-inspecting-re-stocking-and-resealing-of-emergency-medication-kit

  1.  Can physicians prescribe for themselves and family members during the emergency period?

Yes, but prescribing must be for a legitimate medical purpose, in the usual course of professional practice. Please see the Board of Medicine’s Policy 20-02 Interim Policy on Prescribing: 

https://www.mass.gov/lists/physician-regulations-policies-and-guidelines

  1.  Can I extend beyond use dates (BUDs) for compounded sterile preparations (CSPs) so I can conserve drug supply?

During the emergency period, pharmacists may use the BUDs outlined in the USP Compounding Expert Committee’s guidance document.

See the following link for details:

https://go.usp.org/l/323321/2020-04-11/345w2b

  1.  What should I do if I am notified that an employee is presumed or confirmed to be positive for COVID-19?

See the following link for details:

https://www.mass.gov/news/recommended-actions-for-a-pharmacy-if-an-employee-is-presumed-or-confirmed-to-be-positive-for

  1.  Qualified Technicians Administering Vaccines

Qualified technicians may prepare and administer certain vaccines during the emergency period. Requirements are outlined in the Board’s policy:

https://www.mass.gov/doc/joint-policy-2020-12-vaccine-administration-by-qualified-pharmacy-technicians/download

Pharmacies must update their standing orders to include qualified pharmacy technicians.

  1. COVID-19 Vaccinations

Pharmacists, interns, and qualified pharmacy technicians are all authorized to administer any FDA-licensed or FDA-authorized COVID-19 vaccines, whether or not they appear on the ACIP list, for patients aged 3 years and older. See policy for details:

https://www.mass.gov/doc/joint-policy-2020-13-administration-of-fda-authorized-fda-licensed-and-investigational-covid-19/download

Pharmacists and qualified pharmacy technicians licensed in other states with emergency authorization to practice in Massachusetts may provide immunizations provided they adhere to the requirements of Board policies:

https://www.mass.gov/doc/2020-11-vaccine-administration-0/download

https://www.mass.gov/doc/joint-policy-2020-12-vaccine-administration-by-qualified-pharmacy-technicians/download

Other state authorized vaccinators for influenza and COVID-19 can be found here:

https://www.mass.gov/news/order-of-the-commissioner-of-public-health-allowing-certain-individuals-to-administer-2

Other COVID-19 vaccinators authorized by the PREP Act:

https://www.phe.gov/emergency/events/COVID19/Documents/covid19-vaccination-wrkfrc-factsheet-508.pdf

Pharmacists may “order” the vaccines in accordance with the policy or it may be added to the pharmacy’s standing order for vaccinations.

  1.   COVID-19 Testing

Details outlining requirements for pharmacists and pharmacy interns to order, administer, process, read, and report the results of FDA-authorized COVID-19 tests and for qualified pharmacy technicians to administer and process the tests can be found in the Board’s policy.

The document also includes requirements for those pharmacies who wish to become participating sites.

https://www.mass.gov/doc/2020-14-covid-19-testing/download

  1.   COVID-19 Vaccination Plan

The COVID-19 vaccination plan can be found at the link below. It will be continually updated:

https://www.mass.gov/covid-19-vaccine-in-massachusetts

  1. Retired Pharmacists Performing Vaccinations

Pharmacists who have an expired or retired status license may immunize if:

  • They have been out of practice for less than 10 years.
  • The license is reactivated.
  • They have a valid certification to immunize, have current CPR certification, and meet all other requirements of the Board’s immunization policy:

https://www.mass.gov/doc/2020-11-vaccine-administration-0/download

  • Have 2 CEs in immunization since 1/1/19 before starting to vaccinate.
  1.  License Expiration and CE

Pharmacist and pharmacy technician licenses that were due to expire between March 10, 2020 and June 30, 2021 will remain in “current” status until June 30, 2021. However, the license can still be renewed as usual.  

If not renewed prior to June 30, 2021, the license will expire effective June 30, 2021.

Continuing education credits for 2020 have not been waived and must be completed by June 30, 2021. Bear in mind that the additional CE credits required for calendar 2021 must also be completed by December 31, 2021. (See guidance in #1 above regarding the live CE requirement.)

  1. What CEs do I need in order to immunize?

Pharmacists and qualified pharmacy technicians must obtain 2 contact hours in immunization every 2 years.

CE credits in the areas of sterile or complex non-sterile compounding are not required as long as the vaccine is reconstituted according to manufacturer instructions and drawn up for immediate administration.

See the following link for CE details:

https://www.mass.gov/doc/2020-10-pharmacist-continuing-education-ce-requirements/download

Additional resources:

CDC:

https://www.cdc.gov/coronavirus/2019-ncov/hcp/pharmacies.html

https://www.cdc.gov/coronavirus/2019-ncov/cases-in-us.html

Massachusetts DPH:

https://www.mass.gov/info-details/covid-19-state-of-emergency

https://www.mass.gov/resource/information-on-the-outbreak-of-coronavirus-disease-2019-covid-19

MassHealth:

https://www.mass.gov/doc/pharmacy-facts-141-march-12-2020-0/download

https://www.mass.gov/files/documents/2020/03/25/pharmacy-facts-143.pdf

DEA:

https://www.deadiversion.usdoj.gov/coronavirus.html

FDA:

https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/coronavirus-disease-2019-covid-19

WHO:

https://www.who.int/health-topics/coronavirus#tab=tab_1

NABP:

https://nabp.pharmacy/coronavirus-updates/

APhA:

https://www.pharmacist.com/coronavirus

ASHP:

https://www.ashp.org/Pharmacy-Practice/Resource-Centers/Coronavirus        

Please direct any questions and communications to:

Pharmacy.Admin@MassMail.State.MA.US

 

 

Coronavirus Disease 2019 (COVID-19) Frequently Asked Questions

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