Paxlovid: Pharmacists’ Prescribing Authority Putting Patients First
This past week we had a “big win” for pharmacy practice when the FDA revised the Emergency Use Authorization (EUA) for Paxlovid (nirmatrelvir and ritonavir) to authorize state-licensed pharmacists to prescribe Paxlovid to eligible patients, with certain limitations to ensure appropriate patient assessment and prescribing of the antiviral. Unfortunately, not all groups were as ecstatic about this news including the American Medical Association (https://www.pharmacypracticenews.com/Covid-19/Article/07-22/FDA-Authorizes-PharmDs-to-Prescribe-Paxlovid-AMA-Takes-Umbrage/67436).
It saddens me to hear a national medical organization say it is beyond the pharmacists’ scope and training to adequately assess and monitor a patient for Paxlovid. And yet, as an owner of a community pharmacy that has been providing this treatment to patients for the past year, this is what we have been doing. AND, in fact, providing education to our physician colleagues about appropriate prescribing of Paxlovid.
After multiple calls from multiple prescribers, we developed a Paxlovid clinical pearls and prescriber order form that we shared with the prescribers so they could assess their patients for appropriateness of therapy (Figures 1 and 2). We didn’t stop there as we also created our own Paxlovid dispensing check list that we used before providing the treatment to patients. (Figure 3). Additionally we educated our own staff about Paxlovid to ensure everyone was fully aware of its appropriate use.
As far as our scope and training as pharmacists, we have been trained to develop therapeutic relationships with patients, collect clinically relevant patient histories, work collaboratively with other providers, assess patients for medication-related problems, develop patient care plans to ensure attainment of therapeutic goals, provide ongoing monitoring and follow-up services, and document our clinical activities. My practice is based on that training. We regularly assess our patients for medication-related problems and develop solutions to resolve them whether it be with the patient, the prescriber, or in most cases both patient and prescriber. In other words we “intervene” to ensure our patients’ medications are optimized, they are achieving their therapeutic goals, and their medications are safe and effective.
As part of our training, we were taught the importance of the health care team—each team member providing their expertise to optimize patient care. I have worked collaboratively with physicians and other providers, providing them with my clinical recommendations, and ensuring I am following through with my clinical responsibilities. I communicate to prescribers regularly providing them with progress notes and updated patient medication lists.
I have been practicing this way for thirty-five years and yet we still get this kind of push back from the AMA. It’s time we put the patient first and stop protecting professional “turf”.
Figure 1
Paxlovid Clinical Pearls
Purpose: For the treatment of mild to moderate COVID-19, patients must have tested positive for COVID-19 and are at high risk of progression to hospitalization and/or death (ie. elderly age, high risk conditions, and/or weakened immune system) and for whom alternative COVID-19 treatment options are not accessible or clinically appropriate. This is not for pre or post exposure. Treatment should be initiated within 5 days of symptom onset.
Age Requirement: 12 years and older
Dosing and Administration: 300mg nirmatrelvir (#2 150mg tablets) with 100mg ritonavir (#1 100mg tablet) ORALLY twice daily for 5 days
Side Effects: altered taste, diarrhea, hypertension, myaglia
Efficacy: Adjusted relative risk reduction of Paxlovid compared to placebo for all randomized subjects was 88%.
Clinical Pearls
● Renal dose adjustments: Dose adjust for renal impairment for eGFR <60 and ≥ 30 mL. Patients with eGFR <30 mL NOT recommend.
● Severe hepatic impairment (Child Pugh Class C): NOT recommended
● Do not chew, crush, or break capsules
● Instruct patients that if they miss a dose of PAXLOVID within 8 hours of the time it is usually taken, the patient should take it as soon as possible and resume the normal dosing schedule. If the patient misses a dose by more than 8 hours, the patient should not take the missed dose and instead take the next 5 dose at the regularly scheduled time. The patient should not double the dose to make up for a missed dose.
● Many drug interactions may be associated with Paxlovid. Pharmacist will verify for drug interaction at time of dispensing. A pharmacist will verify with patients medications list (provided from provider or patient)
At this point in time, supply is extremely limited, so prescriptions for oral COVID-19 treatment will not be filled until we speak to the patient/caregiver to confirm eligibility. Patients will be called in the order in which prescriptions are received and oral therapeutics will be filled in the order in which we speak to patients. All patients will be provided with a copy of the Patient EUA Fact Sheet, and every course will be tagged “Do not dispense after XX date” to prevent dispensing outside of the 5-day treatment window. We will enforce contactless dispensing of COVID therapeutics, so please ask your patients to remain outside of the pharmacy and to call us if they have any questions.
Thank you for your partnership with Towncrest Pharmacy!
Please call us with any questions and feel free to fax prescriptions using the provided template on the next page.
P: (319) 337-3526 F: (319) 337-5271
Figure 2
Paxlovid Order Form
Patient Name:________________________________________DOB:_________________
Address: ______________________________________Phone #: (____) _____ -__________
Sex: M / F / Prefer not to answer
Response Inclusion Criteria (All must apply)
Yes No. Authorized for use under an EUA for treatment of mild to moderate COVID-19 in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age *Date of symptom onset: ____________ (Must be filled in to ensure dispensed within 5 days of onset)
Yes No. Symptomatic from SARS-CoV-2 ≤ 5 days of direct SARS-CoV-2 viral testing
Yes No. Are at high risk for progressing to severe COVID-19 and/or hospitalization. (must meet 1 or more; select from below)
Yes No. Patient eGFR ≥ 30 mL
Yes No. Patient weight ≥ 40 kg
Yes No. Patient is not hospitalized due to COVID-19.
Yes No. Alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate
High Risk Criteria
Yes No. Older age (for example age ≥65 years of age)
Yes No. Obesity or being overweight (for example, adults with BMI >25 kg/m2, or if age 12-17, have BMI ≥85th percentile for their age and gender based on CDC growth charts, https://www.cdc.gov/growthcharts/clinical_charts.htm)
Yes No. Chronic kidney disease
Yes No. Pregnant/Breast feeding
Yes No. Diabetes
Yes No. Immunosuppressive disease or immunosuppressive treatment
Yes No. Cardiovascular disease (including congenital heart disease) or hypertension
Yes No. Chronic lung diseases (for example, chronic obstructive pulmonary disease, asthma [moderate-to- severe], interstitial lung disease, cystic fibrosis and pulmonary hypertension)
Yes No. Sickle cell disease
Yes No. Neurodevelopmental disorders (for example, cerebral palsy) or other conditions that confer medical complexity (for example, genetic or metabolic syndromes and severe congenital anomalies)
Yes No. Having a medical-related technological dependence (for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19))
Paxlovid Order
Paxlovid: 300mg nirmatrelvir (#2 150mg tablets) with 100mg ritonavir (#1 100mg tablet) ORALLY twice daily for 5 days. Dispense 1 pack with 0 refills
Paxlovid: 150mg nirmatrelvir (#1 150mg tablet) with 100mg ritonavir (#1 100mg tablet) ORALLY twice daily for 5 days. Dispense 1 pack (with modifications) with 0 refills
Prescriber Name/Signature: Date:
Address: NPI:
Figure 3
Paxlovid Dispensing Checklist:
□ RX obtained from prescriber (not RPh)
□ Positive Sars-Cov2 Test
□ Within 5 days of symptom onset (Date of Symptom onset: ______)
□ Age 12 or older
□ eGFR has been checked
□ Checked for drug interactions
□ Alternative COVID-19 tx authorized by FDA not accessible or clinically appropriate
□ High risk criteria met: ________________________________________________
□ Symptoms consistent with mild to moderate COVID-19
□ Not hospitalized due to COVID-19
□ Counsel on medication
Altered taste, diarrhea, hypertension, myaglia
□ Dispense by Date: ___________________
□ Pharmacy Staff: Please file this document in PharmClin