Pushing to protect pharmacies and patients from the spread of COVID-19

OPA has been working around the clock maintaining your membership services, fielding calls and questions from members, rescheduling our Annual Conference, and engaging media and state officials in an effort to help deploy strategies to protect Ohioans from the spread of COVID-19.

As we field feedback from our member pharmacists on the ground, we are assessing all suggestions, opportunities, and concerns, and we are pushing them to officials at the governor's office, board of pharmacy, department of health, health plans, and other state leaders.

We are pleased to report that much of our feedback and recommendations are being embraced, and much of it is in the process of being implemented, if not already. And we are continuing to refine and build our strategies for success — much like all of you are doing back at your practices and in your homes.

First, we have launched a special section of our website dedicated to COVID-19 news and resources. We continue to update with any and all relevant information. In the interest of serving the profession and the public, we have made this open to all members and non-members alike. Please bookmark it and check it often.

The Ohio Department of Health has created a special checklist of the top 10 things pharmacies can do prepare for and protect from COVID-19. They also created a general guide for businesses and employers.

Second, we have been pushing state officials for emergency guidance and policy changes to help better equip pharmacists and pharmacy staff with they tools they need to protect themselves and the public. Here is a rundown of the latest:

• March 13: Pharmacies empowered to perform remote prescription processing
  This ensures that workflow can be better managed by off-site personnel for pharmacies, keeping administrative functions outside of the pharmacy area.
• March 14: Pharmacists empowered to compound hand sanitizer
  As hand sanitizer supplies are diminished, many pharmacies struggled to keep their pharmacies clean and to offer needed supplies to their patients. Recognizing that pharmacists can compound sanitizer from scratch, OPA worked with the board to create a temporary allowance for pharmacists to compound their own alcohol-based sanitizer for their own use and distribution to the public.
  • The FDA issued additional guidance on March 27 permitting the use of alcohol (i.e., ethanol or ethyl alcohol) produced by alcohol production firms to be used as the Active Pharmaceutical Ingredient (API) in alcohol-based hand sanitizers for consumer use and for use as health care personnel hand rubs for the duration of the public health emergency declared by the Secretary of HHS on January 31, 2020. Therefore, compounding pharmacies may utilize ethanol or ethyl alcohol to compound hand sanitize products that is consistent with this guidance. Additionally, the pharmacy compounding guidance has been updated to include the use of denatured alcohol.
• March 14: Allowing reuse of Personal Protective Equipment (PPE) for compounding activities
  Recognizing the diminished supply of PPE, and the need to conserve needed supplies, the board has created new allowances for sterile compounders to reuse certain types of PPE.
• March 16: Extending and expanding pharmacists' authority to dispense emergency refills
  With many patients and pharmacists having difficulties obtaining reauthorizations of current drug therapy from prescribers, OPA worked with the board to expand emergency dispensing authority. Specifically, the guidance allows the following:
• Extends the emergency refill of schedule III-V controlled substances to not exceed a thirty-day supply or the days’ supply as indicated in the pharmacy’s records, whichever is less (as opposed to a 72-hour supply limitation).
• Permits a pharmacist to authorize emergency refills for a particular drug up-to three times
  in any twelve-month period (as opposed to once in any twelve-month period). This applies to both schedule III-V controlled substances and non-controlled substances.
• In lieu of three 30-day emergency refills, a pharmacist may dispense a one-time emergency refill of a 90-day supply for a particular non-controlled substance medication.
• The board also authorized the use of oral prescriptions for schedule II controlled substances as
  permitted in 21 CFR 1306.11(d).
• March 16: Empowering compounding pharmacists to step in to address drug shortages
  As the drug shortages mount, the need for pharmacists to get pragmatic with drug supply grows. Recognizing this, OPA worked with the board to unleash the expertise and skills of Ohio's compounding pharmacists to help fill the void of drugs that are in shortage.
• March 17: Easing hiring and onboarding of pharmacy personnel to maintain adequate staffing
  As pharmacies see increased levels of demand, constrained staffing levels due to sickness and family responsibilities, and the need to add services, OPA has worked with the board of pharmacy to ease some of the hiring and onboarding requirements for new pharmacy personnel. The board's recent barrier erosions include:
  • Authorization for pharmacists and pharmacy technicians licensed in other states to work in Ohio
    Pharmacists and pharmacy technicians not licensed or registered in Ohio, but currently licensed and in good standing in another state, may practice pharmacy in this state under a limited set of conditions.
  • Expedited onboarding of pharmacy technician trainees
    Upon the submission and processing of a trainee license, including payment of the registration fee and any other requirements specified by the Executive Director or the Director’s designee, the applicant will be granted a status of “In-Review - Conditional Approval.” This status will permit the technician trainee to practice as a trainee in accordance with rule 4729:3-3-01 of the Administrative Code for the duration of this resolution, unless otherwise notified in a Notice for Opportunity for Hearing or until the licensing status has been made “Active.”
  • Extension of registered pharmacy technician renewal and technician trainee extensions
    The registered pharmacy technician renewal date is being extended by 120 days. Pharmacy technician registrations are now valid until July 29, 2020. This means that registered pharmacy technicians have until July 29, 2020 to renew as well as complete the required continuing education requirements. Technician trainees who are set to have their registrations expire any time between 3/16/2020 through 5/31/2020 will be provided an automatic six-month extension to the trainee’s registration. 
• March 18: Expansion of the maximum days’ supply for multiple drugs in single-dose containers in long-term care facilities
  To address patient access to medication, the Board of Pharmacy has adopted guidance allowing for the temporary expansion of the authorized maximum days’ supply permitted under rule 4729-9-23 of the Administrative Code from 31 days to 60 days. This extension only applies to prescriptions dispensed to patients residing in long-term care facilities.
• March 18: Temporary extension of basic life support requirements
  To ensure that pharmacists aren't being held back by having to renew basic life-support training requirements, the Board has delayed expiration dates to July 16, 2020.
• March 19: New guidance aimed at protecting the safety of pharmacy staff and the patients they serve (rescinded)
  After days of OPA fielding phone calls and messages from pharmacists and pharmacy technicians concerning some instances of poor protective measures at pharmacies and absurd prohibitions placed on pharmacy staff to protect themselves and their patients, OPA worked with the Board of Pharmacy to ensure the risks of transmission and spread are minimized. Their guidance ensured that at-risk pharmacy staff members are permitted to wear personal protective equipment (PPE). The guidance also ensured safe distances are kept and that proper equipment must be worn in giving immunizations. The guidance also suggested developing special procedures for caring for high-risk patients and required adequate breaks for staff to maintain cleanliness.
  
  • In conjunction with Governor DeWine's "Responsible RestartOhio" initiative, the above pharmacy safety and infection control guidance has been replaced by new guidance issued on May 8.
• March 20: Expanded administrative roles for pharmacy technicians to alleviate workload issues
  In order to mitigate possible staffing shortages, the Board of Pharmacy has adopted guidance to permit registered pharmacy technicians to stock automated drug storage systems and send and receive copies of non-controlled prescriptions, under certain conditions. Additionally, this guidance provides clarification
  on the positive identification requirements for technicians transferring prescriptions. This guidance is being issued in accordance with a Board resolution adopted on March 2, 2020 and shall remain in effect until rescinded by the Board.
• March 20: Central compounding for compounded sterile products
  In order to mitigate reported shortages of personal protective equipment (PPE) and address staffing concerns, the State of Ohio Board of Pharmacy has adopted the following guidance to permit licensees to perform sterile compounding for another licensee, referred to as central compounding. This guidance is being issued in accordance with a Board resolution adopted on March 2, 2020.
• March 20: Moratorium placed on PBM audits in Ohio
  OPA has spoken with several pharmacies who were continuing to be pursued by PBMs and insurers for audits during the height of the COVID-19 pandemic. These were unnecessarily wasting the time and resources of already-constrained pharmacies that were scrambling to provide care. In response to our requests, the Ohio Department of Insurance graciously ordered for all pharmacy audits to be suspended during the declared emergency period.
• March 22: Curbing the stockpiling and inappropriate prescribing of chloroquine and hydroxychloroquine
  In OPA's work to assess what is happening on the ground in pharmacies, we were alarmed in mid-March as pharmacies started to report shortages of hydroxychloroquine. The shortages coincided with some early hype over the drug's possible use as a treatment for COVID-19. Regardless of its possible utility, the attention on the drug created a massive push for prescriptions - many of which pharmacists reported as being likely inappropriate prescribing. As such, OPA worked with the board of pharmacy and Governor DeWine's office to create appropriate guardrails as supply dwindled. Effective March 22, all new hydroxychloroquine prescriptions (for non-clinical trials) must be accompanied with a diagnosis code, with COVID-19 diagnoses being limited to a 14-day supply. For more on the problem and the board's solution, see this Columbus Dispatch feature on the move that is now catching on in states across the country.
• March 24: Sale and shipment of non-reportable drugs from unlicensed out-of-state facilities
  In order to address any drug shortages during the COVID-19 outbreak, the Board of Pharmacy issued  guidance on the sale and shipment of non-reportable dangerous drugs that are in shortage by unlicensed, out-of-state facilities. The guidance allows Ohio pharmacies to receive non-reportable dangerous drugs from an unlicensed pharmacy, wholesale distributor of dangerous drugs, third-party logistics provider, or manufacturer of dangerous drugs located in another state in order to alleviate a drug shortage if certain criteria are met.
• March 24: Delay of drug distributor customer due diligence requirements
  In order to ensure the continuity of the drug supply chain during the COVID-19 outbreak, the Board of Pharmacy issued guidance that the annual drug distributor customer due diligence requirements are hereby extended until August 31, 2020, so as not to place undue burden on licensees.
• March 31: Annual controlled substance inventory requirements extended
  In order to provide licensees added flexibility during the COVID-19 outbreak, the Board of Pharmacy has adopted guidance for compliance with annual controlled substance inventory requirements. For any annual controlled substance inventory that is required between March 2, 2020 and June 30, 2020, the Board has extended the date to obtain the annual inventory to August 1, 2020. The inventory must incorporate the additional months included as part of the extension period.
• April 3: Use of temporary satellite locations for the storage and use of dangerous drugs
  In order to expand treatment capacity during the COVID-19 outbreak, the Board of Pharmacy has adopted guidance for the temporary off-site storage of dangerous drugs. An in-state facility licensed as a terminal distributor of dangerous drugs may maintain possession, custody, or control of dangerous drugs for the treatment of patients due to COVID-19 at a satellite location other than or in addition to its actual licensed location if the facility complies with several pre-conditions and requirements.
• April 3: Reinstatement of lapsed or expired Ohio pharmacist licenses during COVID-19
  In order to address possible workforce shortages during the COVID-19 outbreak, the Board of Pharmacy has adopted guidance on the reinstatement of lapsed or expired Ohio pharmacist licenses. A pharmacist who has had an Ohio license lapse or expire, may apply for a temporary, no-cost
  license reinstatement under a number of conditions.
• April 7: Authorization for nurses to stock automated drug storage systems
  In order to mitigate possible staffing shortages, the Board of Pharmacy has adopted guidance to permit nurses (LPNs, RNs, APRNs) to stock automated drug storage systems within a terminal distributor of dangerous drugs.
• April 8: Expansion of pharmacist, pharmacy intern, and certified pharmacy technician testing authority during COVID-19
  In order to address testing capacity during the COVID-19 outbreak, the Board of Pharmacy has adopted guidance expanding the authority of pharmacists, pharmacy interns, and certified pharmacy technicians to conduct FDA-authorized COVID-19 testing under certain conditions.
  
  • Related, additionally on April 8, the U.S. Department of Health & Human Services issued new guidance under the Public Readiness and Emergency Preparedness Act authorizing licensed pharmacists to order and administer COVID-19 tests that the U.S. Food and Drug Administration has authorized. The Board of Pharmacy updated their guidance on May 5.
• April 9: Expansion of inpatient pharmacist consult agreements to mid-level practitioners
  We are pleased to report that building on the success of HB 188 in the 131st General Assembly that empowered pharmacists to work with physicians to manage drug therapy for patients, the Board of Pharmacy issued emergency guidance that expands pharmacist collaboration to certified nurse practitioners (CNPs), clinical nurse specialists (CNSs), certified nurse midwives (CNMs), and physician assistants (PAs) in hospitals and institutional facilities.
  • The move, which was requested by OPA, and in consultation with the Medical Board and Nursing Board, will enable pharmacists to be better activated to manage chronic diseases in collaboration with providers who may need the additional expertise and resources to provide care for patients during the COVID-19 pandemic.
• April 9: Ohio Department of Medicaid lowers barriers for prescription drug access
  The Ohio Department of Medicaid (ODM) has announced new measures aimed at reducing provider burdens and opening up access to medications to Medicaid beneficiaries. These progressive measures will help ensure patients have the medications and care they need as unprecedented strain hits Ohio's health care system. ODM, in conjunction with the managed care organizations (MCOs) and MyCare Ohio Plans (MCOPs), has eased several restrictions in their pharmacy benefits to ensure members can promptly receive current and new prescriptions. These changes will cover both managed care and fee-for-service providers. The emergency provider agreement:
  • Allows members to receive new prescriptions, bypassing prior authorization requirements on covered outpatient drugs, with limited exceptions.
  • Enables members to receive pharmacy benefits regardless of the pharmacy’s status as an in-network or out-of-network provider.
  • Relaxes the current medication refill threshold on selected pharmaceuticals; billing documents should include the code to SCC 13 when submitting claims.
  • Authorizes reimbursements to pharmacies to dispense an emergency medication refill without a prescription, in accordance with ORC section 4729.281.
  • Will reimburse pharmacies dispensing over the counter (OTC) medications without a prescription, not to exceed a 30-day supply. Providers should use clinical judgment on appropriate count and types of OTCs to dispense and should include an NPI number in the prescriber field when submitting a claim for payment.
  • Temporarily waives member co-pays, regardless of whether the use is related to COVID-19.
  • Authorizes 90-day supplies of certain maintenance medications continues through this time.
  • Removes all barriers that may exist for home or mail delivery services, as well as diabetic testing supplies and respiratory aerosol machines, in the pharmacy benefit.
  • Waives the requirement for signatures for prescriptions pick-up.
  • Permit and provide coverage for pharmacy compounding in accordance with the Automatic Exemptions to ORC 4729-16-10 and Expanded Definitions of Drug Shortages released by the Ohio Board of Pharmacy.
• April 14: Use of temporary satellite locations for the storage and use of dangerous drugs during COVID-19
  In order to expand treatment capacity during the COVID-19 outbreak, the Board of Pharmacy has adopted guidance for the temporary off-site storage of dangerous drugs.  An in-state facility licensed as a terminal distributor of dangerous drugs may maintain possession, custody, or control of dangerous drugs for the treatment of patients due to COVID-19 at a satellite location other than or in addition to its actual licensed location if the facility complies with a number of provisions.
• April 14: Sale and shipment of non-reportable patient-specific medications by non-Ohio licensed border state facilities
  In order to promote social distancing during the COVID-19 outbreak, the Board of Pharmacy issued a resolution on the sale and shipment of patient-specific, non-reportable dangerous drugs by non-Ohio licensed border state facilities to patients residing in the state. A border state facility that is not licensed in Ohio may sell patient-specific, non-reportable dangerous drugs to Ohio patients if certain provisions are met.
• April 17: Waiver of the 5 percent limit on occasional wholesale sales
  In order to mitigate reported drug shortages, the Board of Pharmacy has adopted a resolution waiving the 5 percent limitation on occasional wholesale sales established in rule 4729:5-3-09 of the Administrative Code.
• April 23: Repackaging or combining propofol drug products during the COVID-19 public health emergency
  The Board of Pharmacy adopted this FDA policy for Ohio-licensed pharmacies, repackagers, and
  outsourcing facilities on the repackaging or combining propofol drug products during the COVID-19
  public health emergency.
• April 23: COVID-19 drug shortage guidance
  Due to the COVID-19 pandemic, hospitals and other healthcare facilities may experience shortages of drugs necessary to care for patients. The Board of Pharmacy has developed guidance to assist hospitals and other healthcare facilities in obtaining drugs that may not be commercially available from manufacturers or wholesalers.

OPA would like to thank Governor DeWine, Board of Pharmacy Executive Director Steve Schierholt, board president Shawn Wilt, and board policy director Cameron McNamee for consistent and thorough communication with OPA, swift reviews and considerations, and an overall proactive approach that is clearing ambiguity and keeping pharmacy staff and patients safe. We'd also like to thank the Ohio Department of Medicaid and Director Maureen Corcoran for delivering on several of our requests to eliminate barriers for patients.

Recognizing the need for further reforms, OPA has sent a letter to the governor's office to also make requests for the following:

• In light of pharmacy safety concerns, securing reasonable amounts of personal protective equipment (PPE) for pharmacies without the ability to maintain safe distances
• Temporarily eliminate insurer/PBM requirements for patient signatures, and to protect pharmacies from audit takebacks due to a lack of signatures
  • The Columbus Dispatch highlighted this issue, CMS has pushed to suspend signature requirements, Ohio Medicaid has waived signatures, and even the Pharmaceutical Care Management Association showcased how some PBMs were waiving signatures. We have been asking for the state to temporarily suspend these insurer/PBM requirements for weeks, but have yet to receive guidance on the matter.
• Empowering pharmacists to test and treat for flu, strep, and other tests, including COVID-19 as appropriate and as it becomes available, and if adequate PPE is made available for testing
  • In March, the Buckeye Institute issued a number of policy recommendations for the state of Ohio to address, including authorizing pharmacists to test and treat minor common illnesses and prescribe necessary medication to ease the increasing strain on the state’s health care system. News Channel 2 Cleveland recently highlighted this issue.
  • While not completely addressing our "test & treat" recommendation, as mentioned above, on April 8, both the Board of Pharmacy and HHS instituted new guidances opening up pharmacist testing for COVID-19.
• Allowing pharmacists to dispense emergency medications without a prescription.
• Creating a formal assessment and referral process for pharmacies encountering high-risk patients
• Allowing therapeutic substitution for drugs of concern and medications that are out of supply or in shortage
• Implementing Medicaid provider ID numbers for pharmacists
  • In March, Haley Nelson at WSYX 6 Columbus aired a special segment highlighting the need and opportunity to deploy pharmacists to alleviate the strain on the health care system. Ohio's provider status law has now been on the books for over a year, but despite our best attempts to work with Department of Medicaid officials, and despite the fact that Ohio's managed care plans have been seeking to better utilize pharmacists for over a year as well, the state has yet to implement the law and deploy pharmacists - even as the need to have "all hands on deck" grows.
• Allowing insurance coverage for pharmacist-initiated medications and OTC products, as the Ohio Department of Medicaid has already done.
• Authorizing and incentivizing pharmacist-rendered services (consult agreement drug therapy management, INRs, etc.) to relieve pressure on health systems and emergency departments
• Opening up pharmacist consult agreements to mid-level practitioners outside of inpatient settings

These are just a few of our suggestions, but we are open to hear many more. We are gathering feedback hourly at this point. If you see any opportunities or concerns that you feel need to be addressed, please contact aciaccia@ohiopharmacists.org. 

Another note on pharmacy safety: While we appreciate the Board of Pharmacy's quick action to protect pharmacy staff and patients, you all are instrumental in making sure that pharmacies comply with these requirements. If you feel that your pharmacy is not taking adequate measures to maintain safe distancing between staff and and patients, provide for a clean practice setting, or provide reasonable amounts of protective equipment (recognizing the shortage of PPE), please keep us informed, and let the board of pharmacy know as well. 

We have heard from a number of pharmacists that they are documenting safety concerns and sending formal questions, issues, and complaints to managers and leaders at their pharmacies, but instead of receiving a written response, pharmacists are instead receiving phone call responses. Pharmacists have stated that they believe that a lack of written responses are being done as a means to possibly avoid the accountability that documentation provides. We have been advised by the board of pharmacy that if you feel that something nefarious is occurring in this regard, you should file a complaint.

A reminder to all pharmacists: it is your license, and if you feel that someone is unreasonably getting in the way of the safe practice of pharmacy, it is important to speak out. We will be working to make sure your voices are heard.

In closing, we are so incredibly proud of how pharmacists and pharmacy teams are stepping up in this moment of disruption and risk. We have already heard a number of amazing stories of pharmacists being nimble, clever, and resourceful in their efforts to meet the growing and complex needs of their patients and their communities. Please let us know what you are doing, so that we can keep track of how you are innovating, adapting, and succeeding. Fill out this brief survey. If a member of OPA's team reaches out to you to get more information, please take a few minutes to respond. If you are willing and able, we want to share your stories with other pharmacists, media, and state officials. It's time to show the public the value of pharmacists.

Stay tuned, and stay safe. Keep watching the coronavirus section of our website. OPA will continue working for you while you continue working for your patients.