Federal government makes two announcements with major pharmacy implications in 24 hours

September 9, 2021, was a busy day for the federal government and pharmacy stakeholders alike: Just a few hours apart, we saw significant developments in pharmacists’ COVID-19 pandemic practice authorities and prescription drug pricing. Both items yielded positive news for pharmacists and their patients.

Pharmacists authorized to order COVID-19 therapeutics
HHS made its ninth amendment to the Public Readiness and Emergency Preparedness (PREP) Act, this time to expand the authority of licensed pharmacists, as well as certain pharmacy interns and pharmacy technicians, to deliver COVID-19 therapeutics, such as monoclonal antibodies. Pharmacists can order (prescribe) certain COVID-19 therapies, under conditions outlined in the ninth amendment. The authorities also apply to any future intramuscular, subcutaneous, or oral COVID-19 therapeutics that receive FDA’s OK.

APhA recommended the change to HHS and expressed its gratitude that the agency took its advice. “We thank HHS for recognizing the value of pharmacists’ services in efforts to end the COVID-19 pandemic,” the organization wrote in a statement.

The amendment gives pharmacists, pharmacy technicians, and interns across the country the authority to provide patients crucial access to monoclonal antibody COVID-19 treatment and post-exposure prophylaxis. Evidence has shown the latter to be extremely effective if administered soon after symptoms appear. It also eases the burden on hospitals and infusion centers that have been stretched thin as they accommodate the growing number of individuals receiving the treatment.

The PREP Act now allows eligible licensed pharmacists to order and administer COVID-19 therapeutics that FDA has approved, authorized, cleared, or licensed. Pharmacy interns and technicians who are directly supervised by a licensed pharmacist and who meet other criteria can administer the treatments.

The federally granted authorities apply even when state laws place restrictions on licensing or dictate narrow scopes of practice that would effectively prohibit a qualified person from prescribing, dispensing, or administering covered COVID-19 therapeutics.

HHS’s amendment provides liability immunity to and expands the scope of authority for licensed pharmacists, pharmacy technicians, and pharmacy interns if

• FDA has authorized, approved, or licensed the COVID-19 therapeutic.
• The licensed pharmacist orders the therapeutic for subcutaneous, intramuscular, or oral administration in accordance with FDA approval, authorization, or licensing.
• The licensed pharmacist, licensed or registered pharmacy intern, and qualified pharmacy technician administer the therapeutic subcutaneously, intramuscularly, or orally in accordance with FDA approval, authorization, or licensing.
• Qualified pharmacy technicians’ and interns’ supervising pharmacist is readily and immediately available.
• The licensed pharmacist, licensed or registered pharmacy intern, and qualified pharmacy technician complete a practical training program that is approved by the Accreditation Council for Pharmacy Education, or ACPE (see below to learn about APhA's offerings). This training program must cover
  • Hands-on injection technique.
  • Clinical evaluation of indications and contraindications of COVID-19 therapeutics.
  • Recognition and treatment of emergency reactions to COVID-19 therapeutics.
  • Any additional training required by FDA approval, authorization, or licensing.
• The licensed pharmacist, licensed or registered pharmacy intern, and qualified pharmacy technician have a current certificate in basic cardiopulmonary resuscitation.
• The licensed pharmacist complies with the recordkeeping and reporting requirements of the jurisdiction in which they administer COVID-19 therapeutics. These include informing the patient’s primary care provider when available and complying with adverse event reporting requirements.
• The licensed pharmacist, licensed or registered pharmacy intern, and the qualified pharmacy technician comply with any relevant requirements or conditions of use that apply to the administration of COVID-19 therapeutics.

As awareness of the PREP Act amendment spreads, many pharmacists, pharmacy interns, and pharmacy technicians have begun seeking training that fulfills its criteria.

APhA's Pharmacy-based Immunization Delivery Certificate Training Program already meets the amendment’s requirements for education on hands-on injection technique and the recognition and treatment of emergency reactions to products such as COVID-19 therapeutics.

Development of training that addresses clinical evaluation of indications and contraindications of COVID-19 therapeutics and the “any additional training required in the FDA approval, authorization, or licensing” component is currently underway.

APhA will keep members apprised of the training’s progress and any other information they should know.

Federal drug pricing plan includes PBM transparency, other APhA recommendations

HHS Secretary Xavier Becerra released his much anticipated comprehensive plan to lower drug prices, which he was tasked with developing in a July 2021 executive order. The secretary solicited APhA's input on potential strategies to reduce drug prices during the creation of the plan, and the organization released a statement thanking him for taking several of the recommendations they made.

Secretary Becerra’s plan included some measures that require PBMs to operate in a more transparent manner, such as submitting data to CMS. The plan also supports legislation to ban spread pricing, where PBMs pocket more money for drugs than they pay the pharmacies that dispense them, in Medicaid contracts.

Pharmacy has long decried secrecy that allows PBMs to profit “at the expense of patients, pharmacies, and the health care system,” APhA wrote in its September 10, 2021, statement. In its work with HHS, APhA shared several examples of PBMs engaging in business practices that “generate revenue for themselves without passing most of these savings along to patients at the pharmacy counter.”

The statement calls the plan’s inclusion of PBM transparency a positive step forward for pharmacies, pharmacists, and patients. “[APhA applauds] Secretary Becerra for taking the next steps to … shine the light on PBMs’ deceptive and anticompetitive business practices,” it reads.

HHS also took an APhA recommendation that the federal government speed the entry of interchangeable biosimilars and generic drugs into the marketplace. The plan encourages the passage of legislation that would make it happen. The HHS plan also indicated support for the 340B Drug Pricing Program, which provides access to affordable medications for many of the nation’s most vulnerable and underserved individuals. “We appreciate [Becerra’s] endorsement.”

The drug pricing plan includes a strategy to which APhA is strongly opposed, however. Its statement expressed disappointment that HHS will pursue drug importation in its efforts. APhA maintains that drug importation threatens patient safety and drug supply chain integrity without effectively reducing prices. “[We] will continue to work with Secretary Becerra and others at HHS to provide education about the pitfalls of [drug importation].”

Despite that, APhA is unequivocal in its appreciation for the opportunity to participate in the plan’s development and HHS’s “[recognition of] the value of the pharmacist perspective and the insights gleaned from our experience and expertise.”

“Today we reiterate our thanks for a seat at the table and reaffirm our willingness to advise and support the federal government as it pursues much needed drug-price solutions.”

Rachel Balick, director of strategic communications