Economic Stimulus Bill May Help Drug Shortages, But Pharmacy Groups Say More Work is Needed

A $2 trillion economic stimulus bill that was passed by the House of Representatives on Friday¹ and was signed into law by President Donald Trump, ¹ includes provisions pertaining to medications that have been endorsed by pharmacy and other health care professionals to address the coronavirus disease 2019 (COVID-19) pandemic.^2-4

According to the American Society of Health-System Pharmacists (ASHP) and the American Hospital Association (AHA), the Coronavirus Aid, Relief, and Economic Security (CARES) Act offers some provisions that address shortages of drugs and medical devices. However, according to both organizations, there’s more work to be done.

Tom Kraus, vice president of government relations for ASHP, noted that pharmacists have always known drug shortages and worked to mitigate them. During the COVID-19 pandemic, pharmacists are concerned not only about shortages in drugs that could treat the virus, but also medications for managing other conditions, as well as devices such as ventilators and personal protection equipment (PPE), Kraus said in an interview with Pharmacy Times^®.

Kraus said the provisions included in the bill will help manage shortages going forward and provide the FDA with increased visibility to the supply chain.

“[The provisions] all speak to the ability of pharmacists and the FDA to mitigate drug shortages,” Kraus said. “Right now, we’re hearing all these concerns about drugs being hoarded, and a lot of that is all in anticipation of shortages. A lot of that is driven by a lack of visibility into the supply chain.”

Among the provisions supported by the CARES Act:

• Prioritizing reviews of drug applications, including expediting inspections.²
• Mandatory manufacturer reporting of some drug shortage information that is currently reported on a voluntary basis.² This includes the cause of an interruption in manufacturing and a timeline for resolution.³
• Expansion of current manufacturer reporting requirements to include interruptions or disruptions in the availability of a drug's active pharmaceutical ingredient.²
• Requiring manufacturers to develop risk management and redundancy plans for their supply chains.²
• Including medical devices in shortage reporting requirements during a public health emergency and allow for expedited inspection and review for curbing potential shortages. These devices would include those that sustain life, such as ventilators used for COVID-19.^2,4
• Requiring certain medical supplies and drugs to be included in the national strategic stockpile, such as PPE, ancillary medical supplies, and supplies necessary for administering medications, vaccines, and diagnostic tests.⁴

ASHP acknowledged some progress with policies pertaining to pharmacists, but Kraus said the CARES Act lacks some expansion of pharmacists’ roles in providing services to patients during the pandemic. He said clarification specific to pharmacists is needed to expand virtual visits with patients and telemedicine.

"It’s a challenge. You don’t want people coming into a clinic if they can be managed online, right now,” Kraus said.

And although some states are expanding the role of pharmacists, Kraus said more is needed at the federal level. “Medicare will not directly pay for pharmacist services. That’s a continuing frustration,” he added.

The AHA also acknowledged the positive steps taken with the CARES Act, while indicating a need for more to be done in dealing with the pandemic.

“We will continue to work with Congress to make sure providers on the front lines—hospitals, physicians and nurses—remain prioritized for future federal assistance as the COVID-19 pandemic spreads,” the organization wrote on its website.⁴

In addition to working together, ASHP and AHA, have been advocating alongside the American Society of Clinical Oncology and the American Society of Anesthesiologists for passage of drug shortage mitigation policies.

REFERENCES

• Kane P, DeBonis M, Werner E. House passes $2 trillion coronavirus bill as problems for households and businesses continue to mount. Washington Post website. https://www.washingtonpost.com/us-policy/2020/03/27/congress-coronavirus-house-vote/ Published March 27, 2020. Accessed March 27, 2020.
• American Society of Health-System. COVID-19 Legislation Includes Critical Drug Shortages Provisions. ASHP email. Created March 27, 2020. Accessed March 27, 2020.
• American Society of Health-System. Drug Shortage Legislative Objectives. ASHP website. https://www.ashp.org/Advocacy-and-Issues/Key-Issues/Drug-Shortages/Drug-Shortage-Legislative-Objectives Accessed March 27, 2020.
• American Hospital Association. Special Bulletin: Senate Passes the Coronavirus Aid, Relief, and Economic Security (CARES) Act. AHA website. https://www.aha.org/special-bulletin/2020-03-26-senate-passes-coronavirus-aid-relief-and-economic-security-cares-act Accessed March 27, 2020.