Back in 2021, the Secretary of the federal Department of Health and Human Services authorized licensed pharmacists to independently order and administer any COVID-19 therapeutic, subject to certain conditions ( under the Ninth Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19).
Recently – on July 6, 2022 – the FDA amended the Emergency Use Authorization (EUA) for Paxlovid, an orally-administered COVID-19 therapeutic drug. The amended EUA expressly permits licensed pharmacists to independently order Paxlovid for individual patients under certain conditions.
The FDA has authorized the emergency use of PAXLOVID – an investigational medicine – for the treatment of mild-to-moderate COVID-19 symptoms in adults and children (12 years of age and older weighing at least 88 pounds) with a positive test for COVID-19, and who are at high risk for progression to severe COVID-19, including hospitalization or death.
In addition, the California State Board of Pharmacy has waived certain provisions of Business and Professions Code to the extent these provisions prohibit pharmacists from independently initiating and furnishing Paxlovid. To access Board’s waiver, click here.
In its waiver the Board lists the following requirement that must be observed by the pharmacists independently initiating and furnishing Paxlovid, such as:
(i) pharmacists must assess renal and hepatic function of the patient through health records less than 12 months old or by a consultation with the patient’s physician, and
(ii) pharmacists must obtain a comprehensive list of medications that the patient is taking to assess potential drug interaction through medical records or a consultation with the patient’s physician, and
(iii) if no sufficient information is available to determine patient’s medical history and potential drug interaction, or if the pharmacist determines that taking Paxlovid may cause adverse reaction, the pharmacist must refer the patient for clinical evaluation.
Due to potential side effects and investigational nature of Paxlovid, pharmacists initiating and furnishing Paxlovid should require an informed consent and release signed by their patients taking Paxlovid. This form should notify patients of potential side effects, drug interactions, and other information pertaining to taking Paxlovid. If you need assistance with drafting such informed consent and release, please contact our office or your healthcare attorney. We also plan to make such forms available on our website: RxPolicyStore.com.