Ohio Board of Pharmacy Takes Additional COVID-19 Response Efforts

On March 24, 2020, the State of Ohio Board of Pharmacy (“OBP”) took additional COVID-19 response efforts to protect the health and safety of Ohioans during the COVID-19 outbreak. These efforts include, but are not limited to:

  • Authorized expedited licensure of drug distributors; and
  • Authorized sale and shipment of non-reportable dangerous drugs that are in shortage by unlicensed, out-of-state facilities.

The OBP also reminded its licensees that pharmacies and terminal distributors of dangerous drugs are not required to submit a notification to the OBP for any temporary closures or reduction in operating hours. If modifying operating hours, a pharmacy must update signage to reflect the change in store hours.

Read more HERE and HERE.

As a reminder, the OBP also implemented required infection control procedures effective March 19, 2020.

Read more HERE.

If you are seeking guidance concerning obtaining expedited licensure as a drug distributor or have questions concerning OBP requirements during COVID-19, contact Todd Collis.

 

State of Ohio Board of Pharmacy Implements Infection Control Procedures in Face of Corona Virus

Updated 3/19/2020

The State of Ohio Board of Pharmacy issued new requirements to implement safeguards to allow pharmacy professionals employed by a terminal distributor to practice pharmacy in a safe and effective manner.

The Ohio Pharmacy Board issued the following (emphasis added):

Section 4729.55 of the Revised Code requires a pharmacy to implement adequate safeguards that allow pharmacy professionals employed by a terminal distributor to practice pharmacy in a safe and effective manner. This includes implementing safeguards to protect pharmacy professionals (pharmacists, interns, technician, and support personnel) and patients during a public health emergency.

To comply with the requirements of section 4729.55 of Revised Code, the Board has determined the following steps shall be implemented by all pharmacies located in Ohio starting no later than 5 p.m. on Thursday, March 19, 2020 to ensure the practice of pharmacy can be conducted in a safe and effective manner:

  • For pharmacies open to the public, consider developing a process for older adults (60+), pregnant women, and individuals with chronic health conditions to pick up medications without waiting in line (i.e. post signs directing to drive-thru, offer curb-side delivery, mail delivery, senior hours, etc.).
  • Implement infection control procedures, especially for waiting areas, to include the following:
  • Pharmacies with workspaces that currently allow patients to get closer than the minimum recommended distance of 3 feet should post signage or utilize other methods to ensure patients who are waiting are maintained at a safe distance. NOTE: This does not apply to patients who must interact with pharmacy staff (i.e. for purposes of payment, immunizations, etc.) or pharmacies that are not open to the public.
  • Pharmacists and pharmacy interns shall no longer be permitted to administer immunizations or other injections without standard protective measures, which includes gloves and proper hand hygiene (i.e. routinely washing hands with soap and water for at least 20 seconds). Standard protective measures do not include the use of masks or gowns.
  • Pharmacists and pharmacy interns shall not administer any immunizations or other injections to patients displaying or reporting symptoms of respiratory illness, including any of the following:
    • Fever (NOTE: This does not require mandatory temperature checks);
    • Cough; or
    • Shortness of breath.
  • Pharmacy professionals who are older adults, pregnant women, or individuals with chronic health conditions shall not be prohibited from wearing appropriate PPE to operate within a pharmacy.
  • Regularly clean and disinfect counters, credit/debit card devices, waiting areas, and other spaces where public interaction occurs with an EPA-approved disinfectant. Clean at least every hour or after every 10 patients, whichever is more frequent. If cleaning and disinfecting products are in short supply, the Ohio Department of Health has developed the following guidance. Read here.
  • If available, place alcohol-based hand sanitizer next to the checkout window so people can sanitize their hands after using common items, like the pen used to sign for prescriptions or devices used to process credit/debit card transactions. REMINDER: Manual signatures from patients are not required by Board of Pharmacy rule (see Important COVID-19 Reminders section of this guidance document for more information).
  • Provide regular breaks for staff to engage in proper hand hygiene (i.e. routinely washing hands with soap and water for at least 20 seconds).
  • Monitor pharmacy staff for symptoms of respiratory illness, including any of the following:
    • Fever (NOTE: This does not require mandatory temperature checks. However, the Ohio Department of Health recommends pharmacies take staff temperatures once per shift);
    • Cough; or
    • Shortness of breath.

Staff exhibiting or reporting any of these symptoms must be sent home.

Failure to comply with the requirements set forth in this document may result in administrative discipline for the pharmacy and the pharmacy’s responsible person.

As always, if you have any questions concerning this post, contact Todd Collis or Beth Collis.

Ohio Board of Pharmacy Issues Important Notice to all Licensees Regarding Extortion Scam

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The Ohio Board of Pharmacy (“Board of Pharmacy”) recently issued a notice to all Board of Pharmacy licensees to be on alert for a scam being perpetrated against Ohio health care providers.

The Board of Pharmacy instructed that these scammers have been communicating with prescribers and pharmacists stating they are under investigation by the Drug Enforcement Administration (“DEA”), and that their DEA registration will be revoked or suspended, or they will be arrested if they do not agree to pay a fine immediately via phone or fax. The DEA is aware of this scam.

Additionally, individuals posing as Board of Pharmacy or State Medical Board agents are contacting health care providers by phone and/or fax in an attempt to fraudulently obtain payment to resolve a disciplinary matter.

If a licensee of the Board of Pharmacy or State Medical Board faces potential disciplinary action against their license, the licensee will receive an official Notice of Opportunity for a Hearing in writing either via USPS Certified Mail or by personal service.

Verify Questionable Contact

If you are unsure whether any individual claiming to be a Board of Pharmacy or State Medical Board agent or inspector is legitimate, ask for their name and contact information and contact the Board of Pharmacy at 614-466-4143, or the State Medical Board at 614-466-3934.

Compliance Requirements Heightened Under New Pharmacy Board Rules

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Beginning Dec. 1, 2019, pharmacists licensed by the State of Ohio Board of Pharmacy (“Board”) will have new reporting requirements. The Board enacted similar reporting requirements for pharmacy interns, pharmacy technician trainees, and registered and certified pharmacy technicians. These new reporting requirements add to existing compliance considerations and burdens for licensees, registrants, their employers, and owners and operators of retail and institutional pharmacies.

Under the new rules, a pharmacist licensed by the Board must report the following to the Board:

  1. Conduct indicating another Board licensee or registrant is addicted to or is suspected of abusing alcohol, drugs or other chemical substances, or is impaired physically or mentally such that he or she is unfit to carry out his or her professional duties.
  2. Violations, attempts to violate, or assisting in a violation of the Ohio Pharmacy Practice Act, the Ohio Controlled Substances Act, certain other Ohio laws, or any Board rule adopted under such laws, by an individual or entity licensed or registered by the Board.
  3. Conduct by another Board licensee or registrant of unprofessional conduct or dishonesty.

Reports are to be based on the pharmacist’s direct observation or objective evidence. There are certain limited exceptions to the above required reports.

Additionally, a pharmacist licensed by the Board must self-report to the Board:

  1. A criminal conviction within 10 days following the conviction date, except for minor traffic violations, such as speeding or running a red light.
  2. A conviction, guilty plea, or finding of eligibility for intervention in lieu of conviction in Ohio or the equivalent in another jurisdiction within 10 days after being deemed eligible.
  3. Being granted entry into a diversion or deferral program or the equivalent within 10 days after being granted entry.
  4. Being arrested for a felony within 10 days after the arrest.
  5. Any disciplinary action taken by the DEA or another state within ten days of the notice action.

A pharmacist who reports under the new rules will remain confidential; however, he or she may be required to testify in a disciplinary proceeding as to the report. In the absence of fraud or bad faith, a person who reports or testifies is not liable for damages in a civil action as a result of the report or testimony.

Seek legal counsel if you are unsure

Note that certain terms in the new rules are specifically defined. A fact-based review with legal counsel is recommended, because a failure to report in accordance with the new rules may result in a disciplinary action against a licensee or registrant.

If you have any questions concerning your duty to report to the Board under the new rules, please contact Eric Plinke, Todd Collis, or Courtney White. You may also visit our visit our website.