Important to Share with Patients and Communities
Stay home as much as possible!
Talking points for your patients and for pharmacists
Recommendations for Minimizing Exposure from COVID-19 at Home and in Outpatient Settings
ASHP has developed a checklist for pharmacists and pharmacy technicians to minimize exposure to COVID-19 in the workplace and at home. For pharmacy personnel working in inpatient settings, decisions related to personal protective equipment (PPE) and infection prevention should be guided by infection control leadership and institutional policies.
Personal Protective Equipment (PPE)
At this time, with PPE in VERY short supply, PSW recommends all pharmacy personnel (regardless of practice setting) follow CDC and FDA recommendations for the conservation of PPE. In general, there are a number of strategies pharmacy practice teams can use to minimize or eliminate the need for PPE use through alternative methods of patient interaction. Individual practice setting needs should be considered, but PPE should be conserved for frontline clinicians treating, testing, or ruling out patients with or with suspected COVID-19.
Information is also available from CPESN USA on strategies for keeping your community pharmacy practice staff and patients safe. Click here to access.
The CDC has released Guidance for Pharmacists and Pharmacy Technicians in Community Pharmacies during the COVID-19 Response.
The CDC recognizes community pharmacies has a vital part of the healthcare system and that ensuring continuous function of pharmacies during COVID-19 is important.
The recommendations for community pharmacies include:
- Implementing universal use of face coverings
- Advising staff who are sick to stay home
- Filling prescriptions in ways that maintain social distancing and minimize risk of exposure for pharmacy staff and patients
- Using engineering controls and administrative controls to minimize close contact between pharmacy staff and patients and between patients
- Following guidance for collecting respiratory specimens if offering COVID-19 testing
- Providing adult vaccinations based on local conditions
The CDC also provides a Framework for Healthcare Systems Providing Non-COVID-19 Clinical Care During the COVID-19 Pandemic they recommend all healthcare providers use when making decisions about delivering non-COVID-19 care based on local conditions.
Fraudulent Tests for COVID-19
Pharmacies are being inundated with companies promoting potentially fraudulent materials related to COVID-19 testing, including marketing FDA certification. The FDA is still in the process of reviewing many of these authorizations and have shared with a few key points to help discern whether a company is legitimate.
The FDA list of all current authorized tests, updated daily, is available here.
These FDA pages address available diagnostic and therapeutic medical devices to diagnosis and respond to COVID-19:
As of March 29, 2020:
- There is no “Home Test” authorized for SARS-CoV-2 (COVID-19)
- There are emergency use authorized (EUA) point of care (POC) tests, but these tests are not CLIA waived
Any additional diagnostic questions should be submitted to: COVID19DX@fda.hhs.gov
Any concerns regarding fraudulent products, including tests, should be sent to: FDA-COVID-19-Fraudulent-Products@fda.hhs.gov
DEA Responds Increases CII Quotas and Allows Flexibility for Satellite Locations
The Drug Enforcement Administration (DEA) is increasing Aggregate Production Quotas for the manufacturing of drugs needed to treat COVID-19 patients. Additionally, the DEA announced flexibilities for satellite hospitals or clinics to respond more effectively to the COVID-19 pandemic. Flexibilities include allowing a DEA-registered hospital or clinic to handle controlled substances at a satellite hospital or clinic location under current registrations and providing flexibility to allow distributors to ship controlled substances directly to satellite hospitals or clinics.
DEA Issues Guidance Regarding Early Refills of Controlled Substances
The DEA has issued guidance regarding the early refills of controlled substances during the COVID-19 public health emergency.
- Schedule II prescriptions cannot be refilled, but a practitioner may issue multiple prescriptions for up to a 90-day supply and write on the prescription the earliest date the prescription can be filled. There are no Wisconsin or federal quantity limits on a single CII prescription order if only one prescription is issued.
- Schedule III through V prescriptions can be refilled early if the pharmacist’s professional judgement deems the dispensing to be “in the usual course of professional pharmacy practice.”
DEA Issues Guidance Regarding Oral CII Prescriptions
The DEA has issued guidance regarding oral CII prescriptions, which per federal law can only be dispensed “in emergency situations.”
In it’s guidance, DEA has announced two temporary exceptions to current regulations, which are valid for the duration of the public health emergency:
- Practitioners now have 15 days, rather than 7, to follow up an emergency prescription with a paper prescription.
- Practitioners may send a fax, photo, or scan of a prescription order instead of following up an oral prescription with a paper prescription
Joint Statement on Medication Supply for COVID-19
Recently, the AMA, APhA, and ASHP worked together to craft a joint statement on the ordering, prescribing and dispensing of COVID-19 medications. PSW and the Wisconsin Medical Society partnered to prepare a Wisconsin statement that echoes the themes of this national statement. The statement includes the following themes:
- We will do this as a team
- Pharmacists can refuse to fill prescribed medications if they are, in the professional judgement of the pharmacist, inappropriate
- All healthcare providers should act ethically
- These medications have important patient care uses that are nuanced and professional judgement vs. blanket statements is important
- Preserving integrity of the supply chain in critical
Wisconsin Pharmacy Point-of-Care Testing
PSW has created a CE webinar and FAQ (updated version to be posted soon) on Wisconsin pharmacy point-of-care testing for COVID-19. Due to the rapidly changing environment with COVID-19, this document is subject to change. Questions on point-of-care testing can be sent to email@example.com.
Read the State of Wisconsin Testing Framework from DHS here.
Compounding Hand Sanitizer
FDA announced that they will take no enforcement action against licensed professionals, like pharmacists, who make and sell hand sanitizer as long as they use high-quality ingredients and follow the FDA rules. National organizations are seeking further clarification from FDA. In the meantime, FDA has offered the following email address to pose specific questions: firstname.lastname@example.org.
The FDA’s guidance for the temporary compounding of hand sanitizer can be found here.
During this pandemic, USP supports State Board and other regulators using risk-based enforcement discretion related to the implementation of USP compounding standards and the compounding of alcohol-based hand sanitizers for consumer use. (questions for USP should be directed to CompoundingSL@usp.org)
A USP toolkit is available here.
FDA’s List of Drugs for Temporary Compounding
The FDA has released lists of drugs that can be temporarily compounded by outsourcing facilities and other pharmacy compounders to help fight COVID-19. Please refer to the FDA guidance documents for outsourcing facilities and non-outsourcing facility compounders to determine when your pharmacy may apply these temporary rules.
The lists are updated as new COVID-19 treatments emerge:
Emergency Regulatory/Statutory Relief
The following is a growing list of waivers from the Pharmacy Examining Board providing regulatory or statutory relief in the public health emergency.
Rule being waived: When compounding personnel exit the buffer or segregated compounding area, a gown may be removed and retained in the ante area or segregated compounding area if not visibly soiled, to be worn again during the same work shift. Coveralls, shoe covers, hair and facial hair covers, face masks, eye shields, and gloves shall be replaced with new ones before re−entering the compounding area.
Because this rule has been waived, coveralls, shoe covers, hair and facial covers, face masks, eye shields, and gloves may be reused.
Because this rule has been waived, pharmacists may dispense prescription medications and devices in locations that are not licensed as pharmacies.
Governor Evers issues executive order relating to healthcare licensure
On March 27, Governor Evers issued an executive order
relating to healthcare provider, including pharmacist, licensure.
Per the order, pharmacists who are licensed in good standing in another state may practice under that license and within the scope of practice for a pharmacist in Wisconsin without needing to first obtain a Wisconsin pharmacist license. The pharmacist must apply for a temporary license
with DSPS within 30 days of beginning work in Wisconsin and the pharmacy or facility at which they practice must inform DSPS by emailing email@example.com within 10 days of practicing. Temporary licenses are valid for 30 days past the expiration of the declared public health emergency.
Additionally, pharmacists who have recently retired or let their license lapse may reapply without needing to pay a late renewal fee or certify completion of 30 hours of continuing education. This does not apply to pharmacists whose licenses have been suspended or revoked for disciplinary reasons.
Pharmacy Examining Board Issues Variance Relating to Counseling & Delivery Requirements
Effective April 15, the Pharmacy Examining Board has issued a variance to temporarily relax counseling and delivery requirements for pharmacies. The waiver will allow pharmacies to compensate for workforce and personal protective equipment shortages during the COVID-19 public health emergency.
Under the variance:
- Pharmacists may use their professional judgement to determine if and how consultation is provided; verbal counseling on all prescriptions is not mandatory
- The transfer of the prescription to the patient or agent of the patient may take place at any appropriate location and may be done by a delegate of the pharmacist
Wisconsin law allows pharmacists to dispense a 7-day supply of a prescription without refill authorization if the following conditions are met:
- the pharmacist attempts to get authorization for a refill, but cannot reach the prescriber.
- the patient is on a consistent drug therapy.
- the patient has previously filled the prescription at the same pharmacy or within the same chain.
- the drug is not a controlled substance.
- the patient may receive one emergency supply per drug per year.
- if the prescriber has indicated “no extensions” on the prescription order or has told the pharmacy it cannot extend the prescription, the pharmacy may not dispense an emergency supply
- the emergency supply is for a maximum 7-day supply (exception: insulin/other drugs not packaged for 7-day supply).
Medicaid Policy Changes
As of March 20, 2020, providers will be allowed to override the overuse precaution (early refill or ER) prospective drug utilization review (DUR) alert for all drugs, except for controlled substances that are currently listed on the drug authorization and policy override center early refill drugs list.
Additionally, providers are encouraged to review the three-month supply drugs table, which is a list of drugs that are either allowed or required to be dispensed in a three- month supply. Providers are encouraged to dispense drugs in a three-month supply when possible.
In emergency situations, pharmacy providers are able to dispense a 14-day emergency supply of a drug when a member receives a prescription for a covered drug with prior authorization restrictions. Drugs dispensed in emergency situations do not require prior authorization. Providers should review the expedited emergency supply request drugs table for additional information.
Providers and members are also encouraged to consider mail delivery services for prescription drugs. Wisconsin medicaid-enrolled pharmacies are permitted to dispense and deliver prescription or over-the-counter medication to members via the mail when program requirements for coverage are met.
ForwardHealth update here.
ForwardHealth has Expanded the List of Drugs Available Through Expedited Emergency Supply
Effective for dates of service on and after April 1, 2020, ForwardHealth, which has an expedited emergency supply policy dispensing option available for certain drugs, has expanded the list of drugs available through expedited emergency supply and will allow most drugs to be dispensed in up to a 100-day expedited emergency supply. A table with the expanded list of drugs available by expedited supply is included below and is also available on the pharmacy resources page of the ForwardHealth portal. Pharmacy providers should continue to follow the current processes for requesting an expedited emergency supply of drugs detailed in the emergency medication dispensing topic (#1399) of the ForwardHealth online handbook.
Wisconsin Medical Reserve Corps
The Wisconsin Emergency Assistance Volunteer Registry (WEAVR) is Wisconsin Department of Health Services’ volunteer registration system for health care professionals, including pharmacists and pharmacy technicians, interested in filling critical response and recovery roles following a major public health emergency. Both student and retired pharmacists are able to volunteer. For more information or to register, click here.
PSW is aware that many health plans require signature upon pick up or delivery of medications. PSW is pursuing regulatory/contractual relief of signature requirements. In the interim, please consider how proper hand hygiene can be practiced and infection control can take place at point of signature to protect pharmacy staff and patients.
CMS has issued guidance stating, "We are making clear that HHS does not require and will not audit for patient signatures as proof of delivery for any medications, including for controlled substances." Though CMS does leave it up to plan sponsors (health plans/PBMs) on how they proceed.
Will Pharmacies Need to Close?
Healthcare facilities, including pharmacies, are exempt from the current Wisconsin prohibition on gatherings of more than 10 people. In other states and municipalities where shelter-in-place or broader restrictions on individuals leaving their homes have been enacted, pharmacies have consistently been considered an “essential service” that is not subject to these closure requirements.
Returning to Work
The CDC has released interim guidance “Criteria for Return to Work for Healthcare Personnel with Confirmed or Suspected COVID-19”
From Wisconsin Department of Health Services Bureau of Communicable Diseases on 3/20/20...
Recommendations for active symptom monitoring for employees in health care settings where community transmission of COVID-19 is occurring:
- DHS recommends that all health care providers, including inpatient, outpatient, and residential care facilities, actively monitor staff for symptoms consistent with COVID-19.
- Employers should ensure that staff involved in patient care are systematically evaluated for symptoms of respiratory infection, including temperature monitoring and query for specific symptoms before every shift.
- Providers who develop fever or respiratory symptom must be excluded from work for at least 7 days. If testing for COVID-19 is performed and is negative, staff may return to work after they have been afebrile for 72 hours.
- Health care providers who have been exposed to COVID-19 but are asymptomatic do not need to be excluded from work, but should self-monitor symptoms.
Health care workers must stay home when they are sick.
It is critically important at this time that all providers assume personal responsibility for reducing the spread of respiratory viruses by not reporting to work when ill, including if they only have mild symptoms that would not normally cause them to miss work. Employers should reinforce the message that during the current pandemic, the usual tendency for staff to “push-through” and come to work when mildly ill is not acceptable. To support staffing needs, employers should explore available resources for back-up coverage and discourage vacations during the next 60 days. When possible, employers should re-evaluate existing sick leave policies to ensure they do not pose unnecessary burdens on essential staff who must miss work due to illness.
There is nothing in Wisconsin state law that prohibits a pharmacist from remotely completing DURS or prescription verification. Pharmacy technicians may complete tasks under the general supervision of a pharmacist. General supervision does not require on-site supervision; therefore, technicians are able to complete order entry and other tasks remotely if the supervising pharmacist is regularly available to coordinate, direct, and inspect the work of the technician.
Student Experiential Rotation Contacts
The COVID-19 public health emergency has raised a great deal of questions related to experiential rotations, student roles, and graduation requirements. PSW is in close communication with Wisconsin’s schools of pharmacy and facilitating dialogue between the schools and the Wisconsin Pharmacy Examining Board. Site specific experiential education questions related to the COVID-19 pandemic should be directed to the following individuals.
To bring attention to the well-being of pharmacists, student pharmacists, and pharmacy technicians during the COVID-19 response, PSW encourages members to refer to WHO guidance and CDC information on mental health and coping in the context of COVID-19.
Resilient Wisconsin offers us a way forward as we all work towards a healthier Wisconsin. For more information, please visitresilient.wisconsin.gov.