FDA revoked Plaquinil emergency use auth!!

NOW FDA revoked Plaquinil emergency use authorization

- Since Trump has touted hydroxychloroquine as the lifesaving treatment for Covid-19, our SNFist group have been getting hundreds of request from nursing homes to start Patients on this.

( See sample STANDING ORDER used by our group providers https://www.hubchart.io/post/our-nursing-home-protocol-for-pui-and-confirmed-covid-19-cases)

STRATIFICATION:

We categorize the Covid-19 (+) Patients based on 3 scenarios:

1. Aymptomatic (contact spread) —> NO TREATMENT, SUPPORTIVE CARE (prophylaxis is not approved)

2. Patients with mild to moderate symptoms

—> SUPPORTIVE CAREj

3. Patients who were sent to the ER due to significant symptoms but were sent back because “they are not too sick“ to be admitted. —> This is the biggest dilemma we face a lot when the ER and hospital Covid beds become overwhelmed beyond capacity. FDA only approved these meds for critically ill hospitalized Patients. But, essentially, some of these patients are considered critically ill and should have been hospitalized. CMS even gave the 3 day qualifying hospital day waiver so these patients can be treated at the Nursing home.

FDA revoked Plaquinil emergency use authorization

SHOULD WE TREAT SIGNIFICANTLY ILL PATIENTS AT THE NURSING HOME?

Cant find any management approach guidelines for this. But, In some cases, the very ill Patients at the Nursing home who have been sent back from the ER and have been ”opted out“ for hospitalization because they may either be too frail to benefit from intensive care or are deemed to have lower chances of survival with aggressive treatment, may benefit (albeit still unproven) from these “potential” treatments at the Nursing home. ONE OF THE BIGGEST CHALLENGES IS THE ORAL DOSING FOR PTS WHO CAN NOT SWALLOW DUE TO FRAILTY. SHOULD WE RISK NGT INSERTION AND EXPOSING DROPLET SPREAD TO BEDSIDE NURSING STAFF UNNECESSARILY ? Also crushing tabs not advisable. As for now, its still considered “off label” and, thus, the Physician’s judgement to treat at the Nursing home could probably be justified by giving STANDING ORDERS based on what FDA has approved.

PUI (COVID-19 SUSPECT) STANDING ORDERS

* IF STABLE, follow the standing orders below:

1. Isolate based on Airdroplet precaution guidelines

2. Test for Covid-19 RNA PCR (nasopharyngeal/oropharyngeal swabbing) send out to contracted lab. DO NOT SEND antibody tests IgG/IgM

3. Stat CXR

4. Stat labs: cbc. Cmp. Lactic acid. Ddimer. PTT/INR, CRP, BNP

5. Albuterol MDI 2 puffs + Atrovent MDI 2 puffs Q6q6 with spacer

( Nebulizer is now not advise apparently because this could potentially aerosolize the airdroplets (controversial)

CONFIRMED *COVID-19 BY PCR TEST

STANDING ORDERS

* If the Pt is full code and critically ill with unstable vital signs (respiratory distress and hypoxic), call 911 or transfer to nearest ER or urgent care.

I. SEVERE SYMPTOMS AND CAN NOT TRANSFER TO HOSPITAL: Persistent high grade fever, RR> 20 HR> 100, O2 sat <92% on room air or persistent hypoxemia despite O2

1. Solumedrol IV or prednisone PO

2. DC NSAIDS. start tylenol 650 mg po q6 prn fever

3. ACE inhibitors may potentiate severity of Covid-19 infection (controversial)

4. Albuterol MDI 2 puffs q6 (if HR >100, Xopenex MDI 0.6mg 2 puffs q6) with spacer

5. Atrovent MDI 2 puffs Q6 with spacer

6. Additional labs: G6PD (quantitative), RSV, influenza A & B, procalcitonin

7. O2 2 liters NC and titrate up as needed keep O2 >92

8. cont IVF 1/2 NS 100 cc/hr

9. To preserve PPE and avoid staff exposure: DC non-essential meds.

10. Consolidate or decrease med dosing frequency. Use long acting QD dosing if possible

11. (Pharm to Review drug to drug interaction)

12. (Social worker or staff to initiate discussion of code status with family)

13. Consider referral to palliative Care and reassess code status

II. CONFIRMED *COVID-19 BUT STABLE PATIENTS:

1. Albuterol MDI 2 puffs q6 (if HR >100, Xopenex MDI 0.6mg 2 puffs q6) with spacer

2. Atrovent MDI 2 puffs Q6 with spacer

3. RSV, influenza A & B

4. O2 2 liters NC and titrate up as needed keep O2 >92

5. cont IVF 1/2 NS 100 cc/hr (optional)

6. DC NSAIDS. start tylenol 650 mg po q6 prn fever

7. To preserve PPE and avoid staff exposure: DC non-essential meds. Consolidate or decrease med dosing frequency. Use long acting QD dosing if possible

8. (Pharm to Review drug to drug interaction)

9. (Social worker or staff to initiate discussion of code status with family)

** if the pt is full code and becomes unstable e.g. persistent for hypoxemia and resp distress, transfer via 911

** keep Family updated

(Get the healthcare staff abreast on minute by minute status by creating a Patient Hub on Hubchart App. Team Care coordination and Telemed Apps. www.hubchart.io )