Coronavirus (COVID-19) Update for Pharmacy Professionals - - PowerPoint PPT Presentation

Coronavirus (COVID-19) Update for Pharmacy Professionals

COVID-19 Symptoms

HTTPS://WWW.HOPKINSMEDICINE.ORG/HEALTH/CONDITIONS-AND-DISEASES/CORONAVIRUS/CORONAVIRUS-FACTS- INFOGRAPHIC

Where is Tennessee at Today?

HTTPS://WWW.TN.GOV/HEALTH/CEDEP/NCOV.HTML

Testing Location Total Tests Completed Number Negative Number Positive TN State Public Health Laboratory 497 464 33 All other commercial and private laboratories

• 121

Total positives in TN 154 Age Ranges of Confirmed Cases 0-10 2 11-20 9 21-30 43 31-40 32 41-50 24 51-60 18 61-70 10 71-80 8 81+ 8

TDH COVID-19 Assessment Sites

https://www.tn.gov/health/cedep/ncov/remote-assessment-sites.html Carter Claiborne Davidson Greene Hawkins Montgomery Shelby Sullivan Sumner Unicoi Washington Williamson Wilson

TN Department of Health

COVID-19 Public Information (State-Wide): 877.857.2945 (10 a.m. – 10 p.m. CST Daily)

• Hamilton County: 423.209.8383
• Shelby County: 901.692.7523
• Knox County: 865.215.5555

To request testing at the TN Department of Health, please call 615.741.7247

Considerations for Pharmacists and Pharmacy Professionals

COVID-19 Treatment Considerations

Medications being evaluated

• Hydroxychloroquine/Chloroquine
• Antivirals (Remdesivir, Lopinavir/ritonavir)
• Tocilizumab (IL-6 inhibitor)
• Other agents

Fever

• Tylenol
• Ibuprofen/NSAIDs (?)

Fluids/Nutritional Support/Oxygen/Ventilator Vaccines (under development)

https://www.idstewardship.com/coronavirus-covid-19-resources-pharmacists/

Disclaimer: These resources are provided as information only and are not recommendations for treatment. Each patient should be individually evaluated for symptoms and severity to determine needs for treatment.

HCP Exposure Risks and Considerations

Low Risk: Low-risk exposures generally refer to brief interactions with patients with COVID-19 or prolonged close contact with patients who were wearing a facemask for source control while HCP were wearing a facemask or respirator. Medium Risk: Medium-risk exposures generally include HCP who had prolonged close contact with patients with COVID-19 who were wearing a facemask while HCP nose and mouth were exposed to material potentially infectious with the virus causing COVID-19. High Risk: High-risk exposures refer to HCP who have had prolonged close contact with patients with COVID-19 who were not wearing a facemask while HCP nose and mouth were exposed to material potentially infectious with the virus causing COVID-19.

https://www.cdc.gov/coronavirus/2019-ncov/hcp/guidance-risk-assesment-hcp.html

HCP Exposure Risks and Considerations

Close contact for healthcare exposures is defined as follows: a) Being within approximately 6 feet (2 meters), of a person with COVID-19 for a prolonged period of time (such as caring for or visiting the patient; or sitting within 6 feet of the patient in a healthcare waiting area or room); or b) Having unprotected direct contact with infectious secretions or excretions of the patient (e.g., being coughed on, touching used tissues with a bare hand). HCP not using all recommended PPE who have only brief interactions with a patient regardless of whether patient was wearing a facemask are considered low-risk.

• Examples of brief interactions include: brief conversation at a triage desk; briefly entering a

patient room but not having direct contact with the patient or the patient’s secretions/excretions; entering the patient room immediately after the patient was discharged.

https://www.cdc.gov/coronavirus/2019-ncov/hcp/guidance-risk-assesment-hcp.html

HCP Exposure Risks and Considerations

Low Risk: Perform self-monitoring with delegated supervision until 14 days after the last potential exposure. Asymptomatic HCP in this category are not restricted from work. They should check their temperature twice daily and remain alert for respiratory symptoms consistent with COVID-19 (e.g., cough, shortness of breath, sore throat). Medium and High Risk: Undergo active monitoring, including restriction from work in any healthcare setting until 14 days after their last exposure. If they develop any fever (measured temperature >100 F or subjective fever) OR respiratory symptoms consistent with COVID-19 (e.g., cough, shortness of breath, sore throat), they should immediately self-isolate.

https://www.cdc.gov/coronavirus/2019-ncov/hcp/guidance-risk-assesment-hcp.html

USP: Personal Protective Equipment (PPE) Shortage

PPE SHORTAGE Implementing the strategies described may not be aligned with provisions in General Chapter <797>. Reuse of garb and lack of garb may increase the risk of microbial contamination of the CSP and the environment. Facilities should carefully consider the impact

• n the CSP and the environment and

implement risk-mitigating strategies to help ensure quality CSPs CONSERVE GARB AND PPE Garb for direct patient care personnel should take priority. Limit staff performing sterile compounding.

• Schedule staff to maximize compounding time

and limit number of compounders per day or shift.

• Modify staging activities to minimize passage

into and out of the compounding areas.

If necessary, establish and document deviations from existing Standard Operating Procedures (SOPs).

https://www.usp.org/sites/default/files/usp/document/about/public-policy/usp-covid19-garb-and-ppe.pdf

USP: Personal Protective Equipment (PPE) Shortage

FOR SHORTAGES OF GARB USED FOR STERILE NON-HD COMPOUNDING Face mask

• Reuse of face masks is not recommended

because of the risk of introducing microbial bioburden from used masks. Storage in bags (e.g., plastic or paper) is not recommended because they may contain bioburden and may generate particles and microbial contamination.

• Use clean fabric (e.g., polyester) to cover nose

and mouth (e.g., bandana, washable face mask). Don a clean face cover each time before entering the compounding area.

• Exclude HCP at higher risk for severe illness

from COVID-19 from contact with known or suspected COVID-19 patients.

Gown

• Use clean, washable, dedicated non-disposable

garments (e.g., gowns, lab coats). Long-sleeved garments are preferred, and if not available, wear sleeve covers. Preferably, wash garments after each shift or sooner when visibly soiled.

• Retain and reuse disposable gowns as long as

they are intact and not visibly soiled. Preferably, discard used disposable gowns each day.

• Store garments in a manner that minimizes

contamination.

• Maintain garments inside of classified area or within the

perimeter of the segregated compounding area (SCA)

https://www.usp.org/sites/default/files/usp/document/about/public-policy/usp-covid19-garb-and-ppe.pdf

USP: Personal Protective Equipment (PPE) Shortage

Shoe Cover Shortages

• Implement dedicated shoes for the

compounding area. Preferably, dedicated shoes should be cleaned regularly.

Head and Hair Cover

• Use clean fabric to cover head and hair.

Preferably, wash after each shift or sooner when visibly soiled.

FOR SHORTAGES OF PPE USED FOR STERILE HD COMPOUNDING Prioritize gowns and chemotherapy gloves for preparing antineoplastic agents in Table 1 of the NIOSH list. PPE is designed to minimize exposure of healthcare personnel to HDs. PPE should not be reused when compounding antineoplastic drugs in Table 1 of the NIOSH list. FOR SHORTAGES OF GARB USED FOR STERILE NON-HD COMPOUNDING

https://www.usp.org/sites/default/files/usp/document/about/public-policy/usp-covid19-garb-and-ppe.pdf

USP: Personal Protective Equipment (PPE) Shortage

IF FACILITIES ARE NOT ABLE TO OBTAIN GARB OR PPE Adopt a risk-based approach and limit anticipatory compounding. Storage times should be assigned conservatively based on patient need and the type of garb mitigation strategy that is used. Use the shortest feasible beyond-use dates (BUDs) while giving consideration to avoiding drug shortages and maintaining patient access to essential medications. Where feasible, increase cleaning and disinfecting frequency. Consider increasing frequency of surface sampling in the primary engineering control to determine effectiveness of cleaning procedures and work practices.

• If any changes are needed, promptly remediate

and consider assigning shorter BUDs. https://www.usp.org/sites/default/files/usp/document/about/public-policy/usp-covid19-garb-and-ppe.pdf https://peernetwork.criticalpoint.info/storage/files/COVID- 19%20Garbing%20Shortage%20Recommendations%2020200313.pdf CriticalPoint Recommendations:

FDA: Compounding Hand Sanitizer

FDA does not intend to take action against compounders that prepare 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, provided the following circumstances are present: The hand sanitizer is compounded using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations: a) Alcohol (ethanol) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20; or Isopropyl Alcohol (75%, v/v) in an aqueous solution. b) Glycerol (1.45% v/v). c) Hydrogen peroxide (0.125% v/v). d) Sterile distilled water or boiled cold water. The compounder does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product. All labeling requirements in the guidance are followed. https://www.fda.gov/media/136118/download

CMS Infection Control Guidance

• Infection Control Guidance for Health Care Facilities
• Infection Control Guidance for Hospitals
• Infection Control Guidance for Long-Term Care Facilities
• Infection Control Guidance for Hospice Agencies
• Infection Control Guidance for Home Health Agencies
• Infection Control Guidance for Dialysis Facilities

https://www.tnpharm.org/events-resources/practice-based-resources/covid-19/

Infection Control Guidance for Specific Practice Sites and Facilities:

Pharmacy-Specific Recommendations

Policy Considerations for Optimizing Pharmacy Practice in COVID-19

Governor Lee’s Executive Order #15

• Modifies current law in Section 63-10-207 (72-hour emergency

dispensing) to allow a pharmacist to dispense up to a 90 day supply of maintenance prescriptions without proper authorization to persons as is necessary to respond to and prevent the spread of COVID-19 in

• Tennessee. [NO CONTROLLED SUBSTANCES]
• Suspends Section 68-11-201(20) licensing requirements to allow

health care professionals who would otherwise be subject to licensing requirements to provide localized treatment of patients in temporary residences.

• Allows professionals licensed in other states to practice in Tennessee.
• Prohibits price gouging.
• Extends license, certificate, or registration renewal deadline for 3

months from May 18, 2020 (may be extended further depending on renewal of executive order) https://publications.tnsosfiles.com/pub/execorders/exec-orders-lee15.pdf

Governor Lee’s Executive Order #15

• Permits pharmacy technicians and pharmacists to complete computer-

based prescription processing of prescriptions at alternative practice locations, including residence. Must be HIPAA-compliant.

• Allows COVID-19 testing at alternative testing sites without prior

approval by the Medical Laboratory Board.

• Suspends Certificate of Need requirements to allow hospitals to

temporarily increase the number of licensed hospital beds

• Directs the Tennessee Department of Health and the Tennessee

Department of Commerce and Insurance to continue working with health insurance plans operating in the state to identify and remove any burdens to responding to COVID-19 and improve access to treatment options and medically necessary screening and testing for COVID-19. https://publications.tnsosfiles.com/pub/execorders/exec-orders-lee15.pdf

TPA Policy Recommendations to TN Department

• f Health and

State Legislators

Ensure uninterrupted patient access to life- sustaining medication therapies:

• Allow pharmacists to initiate prescriptions for up

to a 90-day supply of maintenance medications (excluding controlled substances), regardless of whether or not the patient has refills remaining.

• Allow pharmacies to utilize all available options

regarding prescription delivery services, such as drive-thru, home delivery, or delivery to a parked car if patient drives to the pharmacy.

• Allow patients to have access to medication

therapies from the pharmacy of their choosing without penalty, regardless of limitations or network restrictions imposed by payers, insurers, or pharmacy benefits managers.

TPA Policy Recommendations to TN Department

• f Health and

State Legislators

Increase access to care and services provided by pharmacists:

• Authorize the Chief Medical Officer for the

Tennessee Department of Health to implement and sign statewide collaborative pharmacy practice agreements authorizing pharmacists to provide designated services and allow for increased patient access to testing, screening, or prescribing of medications and therapies intended to prevent, treat, or mitigate COVID-19.

• Authorize pharmacists to perform therapeutic

substitution of medications within the same therapeutic class, without prescriber authorization, if disruptions in the pharmaceutical supply chain or prescription drug shortages should occur.

• Allow pharmacists to practice without having to be

located within the walls of licensed facilities (e.g., licensed pharmacies).

• Allow pharmacists to deliver Board-required

medication counseling, drug utilization review, and

• ther face-to-face patient care services through

electronic technology or telehealth.

TPA Policy Recommendations to TN Department

• f Health and

State Legislators

Decrease state-specific regulatory burdens to align pharmacy focus on patient care and services:

• Temporarily suspend all Board of Pharmacy

regulatory deadlines related to licensing, audits, documentation requirements, inspections, and continuing education requirements, until after the end of the emergency period, except in instances of protecting patient safety, suspected fraud, or as required by federal law.

• Authorize the Board of Pharmacy to waive any

applicable Board rules which may impede or delay patient access to pharmacist-provided care and services, when in the best interest of the health and safety of patients.

• Remove pharmacy technician-to-pharmacist ratios.
• Allow non-registered or non-certified pharmacy staff

to assist with pharmacy operations under the direct supervision of a pharmacist.

• Allow pharmacy locations outside of the state to

enter into agreements with Tennessee-licensed pharmacies to permit the sale, transfer, and delivery

• f prescription drugs which may be in short supply.

TPA Policy Recommendations to TN Department

• f Health and

State Legislators

Decrease state-specific regulatory burdens to align pharmacy focus on patient care and services:

• Suspend Tennessee Board of Pharmacy rules to allow

for remote processing and review of prescription

• rders, both in Tennessee and outside of Tennessee.
• Suspend Tennessee Board of Pharmacy enforcement
• f applicable rules and regulations related to USP

797 standards on use of personal protective equipment (PPE) in non-hazardous sterile product preparation.

• PPE resources are in short supply and are greatly needed in

the healthcare system. Suspending Board enforcement of applicable USP 797 standards related to PPE in non- hazardous sterile product preparation would allow health systems and compounding pharmacies to develop and implement common-sense PPE policies, guided by CDC recommendations and best practices, and allocate PPE resources to where they are needed most.

TPA Policy Recommendations to TN Department

• f Health and

State Legislators

Remove “red tape” policies imposed on patients and pharmacies by payers, insurers, and pharmacy benefits managers:

• Waive requirements for pharmacies to collect signature upon

delivery or “proof of delivery” from patients to prevent the spread of coronavirus through contamination of pens or electronic signature devices.

• Authorize patients to refill their prescription medications

early, without penalty from payers, insurers, or pharmacy benefits managers.

• Require payers, insurers, and pharmacy benefits managers to

suspend system edits and software functions, such as “refill too soon”, prior authorizations, and other edits, which may impede patient access to medication therapies.

• Require payers, insurers, and pharmacy benefits managers to

remove any policies or restrictions which prohibit or discourage certain methods of delivery of medications to patients by pharmacies that have the capacity to accommodate prescription delivery services.

• Require payers, insurers, and pharmacy benefits managers to

temporarily suspend any routine or scheduled audits of pharmacies by payers, insurers, or pharmacy benefits managers until after the end of the emergency period, except in instances of suspected fraud or as required by federal law.

TENNCARE

Guide for TennCare pharmacies: https://www.tnpharm.org/wp- content/uploads/TennCare_Provider_Notice_COVID-19_Notice_031620.pdf Recent Actions:

• Out-of-network pharmacy and provider fills are allowed
• Copays for medications designated as Attestation and Auto-Exempt are

waived

• Refill-too-soon edits are temporarily suspended
• Exceptions: Opioids and other controlled medications. Call the Pharmacy Support Center to

request an exception review.

• Pharmacy lock-in location changes are overridden where applicable. Call the

Pharmacy Support Center to request an exception review.

Questions and Discussion

ALL PRACTICE-BASED RESOURCES USED IN THIS PRESENTATION CAN BE FOUND ON THE TPA WEBSITE

https://www.tnpharm.org/events- resources/practice-based-resources/covid-19/