Recently, the Food and Drug Administration (FDA) expanded access to COVID-19 treatment by authorizing state-licensed pharmacists to prescribe Paxlovid to eligible patients. However, this expansion is limited by a requirement that pharmacists access patient records and the absence of a pathway to reimbursement for the required patient assessment. If left unresolved, these barriers could undermine the Biden administration’s goals of providing equitable and timely access to this potentially life-saving therapy.
COVID-19 Treatment at the Pharmacy Counter, Authorized but Not Always Accessible
Patient Assessment Barriers
For patients seeking COVID-19 treatment through pharmacy channels, many community pharmacies offer the option to self-screen for COVID-19 symptoms and make an appointment, or they may visit a pharmacy. Pharmacists must first determine whether a patient is eligible for Paxlovid. This includes assessing for potential drug interactions, as well as renal and hepatitic function that may contraindicate prescribing Paxlovid. However, unlike other health care providers, patient self-reporting does not suffice under the FAQs for pharmacists to assess renal and hepatitic function. Instead, according to the FAQs, a pharmacist must rely solely on health records. Health records include “an electronic health record system containing this information in progress notes of laboratory records” within the past 12 months. This may include a printed laboratory report provided by the patient or reviewing records “the patient may have access to through a phone app or other means.”
For several reasons, these requirements may be unmanageable at the pharmacy counter.
First, lack of access to patient health information in the pharmacy setting is a known barrier. The pharmacist may attempt to contact an office-based provider to obtain patient health records, but that provider must have “an established provider-patient relationship with the individual patient.” Twenty-five percent of Americans do not have an established relationship with a primary care provider. Even if the patient does have a primary care provider “cumbersome communication between pharmacists and prescribers” is known to hinder pharmacist access to patient health information.
Second, patient lab values within the past 12 months may not exist or they may not be readily accessible to the patient. Many patients have in fact delayed primary care during the pandemic, and 34 percent of patients with a primary care provider do not have labs within the past 12 months. Even if they do have recorded lab values, patients may not have ready access to lab reports or a patient portal. Indeed, a recent news report observed, “vulnerable populations, such as those that are minority populations who maybe are undocumented or who don’t have regular access to healthcare, unfortunately, and may not have those updated records.” Attempting to access a patient portal at the pharmacy counter may entail the need to retrieve a forgotten password or register for portal access, perhaps wait for an email to reset the password, or confirm the registration. The infected patient’s phone may even be passed over the counter to the pharmacist to help navigate an application or portal.
If no record can be provided, a pharmacist is required under the FAQs to refer a patient to a physician, advance practice registered nurse, or physician assistant; never mind that the patient may have chosen to seek care at a pharmacy because they do not have a primary care provider or due to difficulty scheduling an appointment. Unable to care for the patient due to these barriers, the pharmacist may also not be able to provide a referral. The risk of patient attrition under these circumstances—especially considering the patient is suffering from COVID-19 symptoms while actively seeking treatment and encountering multiple barriers—is particularly problematic given the short five-day window from symptom onset in which the Paxlovid course should begin.