COVID 19 Memo 3/20/2020

West Virginia Board of Pharmacy Current COVID-19 Update 3-20-2020

In response to the national public health emergency associated with the COVID-19 virus, the WV BOP is issuing the following information and reminders. As this is a rapidly developing situation, additional information will be available on our website, www.wvbop.com, as it becomes available.

These waivers will CEASE to be in effect when the WV State of Emergency related to the COVID-19 pandemic ends.

Remote Processing of Prescriptions for Social Distancing

Due to the WV State of Emergency, the WV BOP has adopted the following guidance to permit licensed pharmacy professionals (pharmacists, pharmacy interns, and pharmacy technicians/pharmacy technician trainees) to process prescriptions and medication orders from remote locations. This guidance is being adopted based on §15-14-4, §15-15-7.7, and §15-1-24.

For the purpose of this guidance, "remote processing" is defined as the processing of a medication order or prescription for a WV pharmacy from a location other than the physical licensed pharmacy.

An additional frequently asked questions document for this topic will be placed on the WV BOP Website ASAP.

For pharmacists, remote processing does not include the dispensing of a drug, but may include receiving, interpreting, evaluating, clarifying, and approval of medication orders and prescriptions. Additionally, remote processing may include order entry, other data entry, performing prospective drug utilization review, interpreting clinical data, insurance processing, performing therapeutic interventions, providing drug information services, and authorizing release of medication for administration. A pharmacist at all settings must hold the physical product in hand to do the physical product final check. This does not change current procedure at rural access facilities.

For pharmacy technicians, registered pharmacy technicians, technician trainees, and pharmacy interns, remote processing does not include the dispensing of a drug, but may include prescription or order entry, other data entry, insurance processing, and clarifying prescriptions and medication orders.

Provided that the pharmacies/pharmacists: have computer software and hardware that is adequate for the task being performed, steps are taken to safeguard protected health information and the Board is notified (approval not necessary).

Signature for Received Prescriptions

Signatures for the receipt of prescriptions is only required to pick up controlled medications in §60A-10-5.e.2 and with the purchase of pseudoephedrine (PSE) products in §15-11-3 and over-the-counter controls §15-13-4.4.3. Signatures are no longer required for the purchase of PSE or OTC controls. However, the PSE reporting requirements are still in effect.

The WV BOP has made a recommendation to the Governor’s office to ensure PBMs are not requiring patient signatures on non-controls at pick-up. The WV BOP will provide further information as it is available. Until such time, please utilize gloves, sanitizer, etc. to help minimize contact and ensure patient and pharmacy staff safety. At this time we have heard from Optum, ExpressScripts, and CMS indicating that they are willing to waive patient signatures as long as notation of the reason is made. However, check your other PBM contracts.

Early Refills for Controls

WV law prohibits early refills on controlled substances no more than 3 days early per §15-2-8.15. Refilling of Schedule III or IV prescriptions. The WV BOP guidance is that the pharmacist may dispense the refill early using his or her professional judgement and shall document the reason for the early refill.

Pharmacy Technician to Pharmacist Ratios

Per §15-7-5.3. A ratio of no more than four pharmacy technicians and/or pharmacy technician trainees per on-duty pharmacist operating in any pharmacy shall be maintained. This ratio shall not include pharmacy interns. During the COVID-19 WV State of Emergency, only if exceeding the ratio is due to actual impact of COVID-19 virus directly on the pharmacy, facility or staff involved, the pharmacy may exceed the ratio of 4 to 1. If the pharmacy will exceed the ratio for more than 2 days, the Board must be notified at boardofpharmacy@wv.gov.

Out of state pharmacy staffing

West Virginia Code 30-5-6(5) gives the Board the authority to "determine the qualifications of any applicant for a license, permit, and registration. The WV BOP will allow a pharmacist, pharmacy intern, or pharmacy technician to work in WV with a temporary permit.

The "temporary permit" is defined as a limited, legal authorization issued by the board to a pharmacist, pharmacy technician, or pharmacy intern in this state while serving under special circumstances of public need after having demonstrated he/she has identification to verify current unrestricted licensure in another state.

The process for utilizing the Temporary Permit will be available on the WV BOP website for pharmacists, pharmacy interns, and pharmacy technicians.

Conserving Personal Protective Equipment/Sterile Compounding

In anticipation of possible shortages of masks, USP supports appropriate risk-based enforcement discretion during the COVID-19 pandemic, in the interest of conserving garbing and personal protective equipment. FDA has also issued a statement regarding conservation strategies. Therefore, pharmacists may implement a process for reusing masks in a manner that does not compromise the microbial state of control in cleanrooms. The user should visibly inspect the product prior to use and, if there are concerns (such as degraded materials or visible tears), discard the product.

• A policy and procedure should clearly indicate how an employee’s reused mask will be identified, stored, and under what conditions it may no longer be used.

• Garb (gowns and masks) for non-hazardous drug compounding may be reused in accordance with facility standard operating procedures. Gowns must be stored in a manner that minimizes contamination (e.g., away from sinks to avoid splashing).

• Soiled, contaminated, torn, or punctured garb must be changed immediately and not re-used.

• Be aware that counterfeit masks and gowns may be on the market, especially during this time of reduced supply.

• Weekly surface sampling inside ISO 5 space must be performed when garbing in a manner that is not consistent with USP requirements.

• Refer to:

o CDC’s Interim Guidance on preventing COVID-19 from spreading, which includes Strategies for Optimizing the Supply of N95 Respirators https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirators-strategy/

o Healthcare Supply of Personal Protective Equipment and https://www.cdc.gov/coronavirus/2019-ncov/hcp/healthcare-supply-ppe-index.html

o FDA’s Surgical Mask and Gown Conservation Strategies - Letter to Healthcare Providers at https://www.fda.gov/medical-devices/letters-health-care-providers/surgical-mask-and-gown-conservation-strategies-letter-healthcare-providers

An additional resource for information for up-to-date information on sterile compounding is the CriticalPoint Peer Network. We would suggest to subscribe to the Silver level which is free and you can see the latest webinars, recommendations and other material. This should be done ASAP because CriticalPoint will continually monitor the situation and make updates. https://peernetwork.criticalpoint.info/

Pharmacy Preparedness and Reducing Risks of Person-to-Person Transmission

ï‚· Have a handout of information available for patients on refill requests, emergency supplies, and other prescription medication information.

ï‚· Develop a process to care for high risk populations (elderly, pregnant, and those with chronic health conditions) so they can pick up medications without waiting in long, crowded lines.

　

ï‚· The Board recommends reworking workflows to minimize person-to-person transmission. These efforts could include having special times for high risk populations, signage to direct flow, moving of chairs in waiting areas, and utilization of curbside or drive-thru services.

ï‚· Implement appropriate infection control measure in the pharmacy:

o Maintain social distance: 3 feet from asymptomatic patients, 6 feet from those actively coughing

o Clean and disinfect counters and other spaces every hour or every 10 patients with appropriate disinfectant.

o Place alcohol-based hand sanitizer or gloves next to the checkout area like the pen where patients sign for prescriptions

ï‚· Develop an Emergency Response Plan for your pharmacy including monitoring staff for sickness, evaluating sick-leave policies, determining how staff absences will be handled and post-illness return to work policies.

Controlled Substance Monitoring Program Reporting

Per §15-8-4.1 a pharmacy or dispenser of controlled substances is required to report a daily "zero" report if there are no dispensings. The WV BOP waive the requirement to submit reports of "zero" when the pharmacy is closed due to COVID-19 during the state of emergency. The notice that the pharmacy is closed will serve as the notice for this, also.

Continuing Education

If you are unable to obtain the 6 required hours of live continuing education since all of the programs have been canceled due to COVID-19. How will I renew?

Rule:

1. §15-3-4.3 Six (6) hours of the thirty (30) CPE hours required every two (2) years shall be obtained through a live presentation requiring the physical presence of the pharmacist at the CPE program.

2. §15-3-4.4 3 hrs Drug diversion requirement

3. §15-12-4.1.c basic life-support training for immunization renewal

The WV BOP anticipates completing online renewals as usual this renewal season. Because of the COVID-19 emergency pharmacists who have not met the 6 hours live CE requirement or 3 hour drug diversion requirement are expected to renew on time as usual, however, note that they are missing the live CE or drug diversion requirement. The WV BOP determined today to grant everyone missing those two requirements, OR the CPR immunization requirement, 90 days after the END of the WV State of Emergency to complete the necessary licensure requirements. It is vital that the renewal be completed on time for the waiver of live hours, drug diversion or CPR to be utilized. Failure to renew on time will result in the pharmacist license being inactive.

Technician and technician trainees

Pharmacy technician trainees who have licenses that are expiring during the State of Emergency will be granted a blanket additional 90 day extension to complete the national exam because the testing centers have discontinued testing. He/she will receive an email from the Board notifying them of this information.

Pharmacy Emergency Closure

In the event that a pharmacy must close due to illness or staff shortages, the pharmacy must notify the WV BOP within 48 hours at krista.d.capehart@wv.gov.

SAMSHA and WV State Opioid Treatment Authority

WV Opioid Treatment Programs and Office-based Medication Assisted Therapy have provided additional waivers.

Pharmacists Willing to Help List

There has been interest in compiling a list of pharmacists and pharmacy technicians willing to help out in case of worker shortages. The link for signing up for this will be on the WV BOP Facebook page.

Questions?

Pharmacists with immediate concerns or questions can contact the Director of Professional and Regulatory Affairs, Krista Capehart, at 304-206-5767.