USP's COVID-19 Public Health Response

Ronald Piervincenzi

CEO, U.S. Pharmacopeia (USP)

The COVID-19 pandemic is a public health crisis that has challenged global economies, supply chains, and especially the health of people around the world. We are grateful to the many practitioners, including our stakeholders like physicians, pharmacists, nurses, and others who are on the front lines working to treat the sick, all around the world. Meanwhile, millions are being encouraged to 'shelter in place' to contain the spread of the virus.

USP has been working quickly in our response to the COVID-19 pandemic and solutions we can offer our stakeholders including international and U.S. regulators, manufacturers, practitioners, and others to ensure the continued access to quality medicines for healthcare workers to deploy in managing this pandemic.

I am very proud of the agile efforts of USP staff, with over 70% of our staff working remotely around the world, as well as our on-site staff in laboratory, facility, and distribution functions working through adapted operations and social distancing to deliver on our critical public health mission to ensure the quality of medicines around the world.

Highlights of USP's COVID-19 Response

Our response to this pandemic brings together our coordinated portfolio of standards, training or capability building efforts, and our advocacy work as the global voice for medicine quality around the world.

I. Supporting healthcare workers

- Responding to shortages of Personal Protective Equipment (PPE) to protect healthcare workers, including working to donate 4,000 critical N-95 and surgical masks to practitioners directly involved in the care of COVID-19 patients

- Toolkit for hand sanitizer compounding to support pharmacies, manufacturers, and others, including distillers

II. Supporting manufacturers in the development of COVID-19 treatments, vaccines, and essential medicines

- Sharing our expertise to accelerate development of treatments and vaccines

- Making available critical monographs and general chapters for medicines that are essential for the COVID-19 response

III. Supporting regulators around the world

- Strengthening pandemic response in low- and middle-income countries

- Supporting regulatory pathways that enable new manufacturing technologies

USP's COVID-19 Response

USP's COVID-19 public health response is focused on how we bring together our coordinated portfolio of over 6,800 documentary and reference standards, training or capability building efforts, as well as our voice as the leading advocate of quality around the world. In delivering these integrated solutions to our stakeholders around the world, our intent is to offer agile solutions building on our 200-year history of ensuring the quality of medicines--now, all around the world.

Through this lens, our staff and expert volunteers have expedited a wide range of measures to address the COVID-19 pandemic that span the length of the supply chain, from development to delivery of medicines. We recognize that our policies and procedures have flexibility built in them to address times of crises that impacts patient safety—and this is very much one of them. We acted quickly to convene expert committees virtually and proactively reach out to manufacturers of vaccines and critical drug products as well as regulators around the world so that our public quality standards can support promising medicines that alleviate COVID-19 to ensure their quality as well as continued access. I am proud to share examples of this work below.

Supporting healthcare workers

Responding to shortages of Personal Protective Equipment (PPE) to protect healthcare workers.

Weeks ago, as concerns about shortages of PPEs came to bear, USP quickly convened the Compounding Expert Committee, and, in a matter of days, we published guidance for the conservation of PPEs in the handling & preparation of sterile medicines so it could be prioritized for direct patient care activities.

In addition, I am very proud to share that USP has donated 3,000 N-95 masks and 1,000 surgical masks to healthcare practitioners that are in direct patient care activities. We feel that it is critical to our public health mission that we support these practitioners during this public health crisis.

Toolkit for hand sanitizer production to support pharmacies, manufacturers, and others.

Part of our support in collaboration with the U.S. FDA during this time includes facilitating action on FDA's guidance on enforcement discretion related to the compounding of hand sanitizers. We again convened our expert committees virtually in creating these guidelines in a manner of days. This week, we launched a toolkit to support pharmacies, manufacturers, and others, including distillers, to facilitate the usage of relevant USP-NF and FCC standards, formulations, stakeholder information, and other resources. We are heartened at the positive response to this toolkit and are actively working to revise based on availability of ingredients. This medical product enables our first responders and others to have critical support in their direct patient care activities.

We also recognize that in times of public health crises and potential drug shortages, compounding is often looked upon to help mitigate such disruptions. Thus, the compounding expert committee is meeting regularly to continue to provide guidance in this critical time.

Supporting manufacturers in the development of COVID-19 treatments, vaccines, and essential medicines

Sharing expertise to accelerate development of vaccines and treatments.

Studies have shown that using our standards, drug developers can speed up their timelines in bringing therapies to market, particularly in repurposing treatments or pursuing combination therapies. To expedite this effort, USP is offering free technical support to manufacturers and developers of COVID-19 vaccines and treatments. In addition to providing access to and assistance in the use of our standards, USP is offering technical assistance with the design of tests that will help drug developers ensure the quality of emerging treatments and speed the market availability of their products.

Making available critical monographs and general chapters for medicines that are essential for the COVID-19 response.

There is understandably an increased demand for critical medicines, including pain relievers, muscle relaxants, analgesics and fever reducers, antivirals, and other medicines. In response to this, USP has made available critical general chapters and monographs for these medicines available outside of our paywall. This is to ensure that manufacturers looking to ramp up their production can have available USP's trusted standards that have been shown to facilitate faster entry to market.

Supporting regulators around the world

The COVID-19 pandemic has raised the need for increased transparency into where Active Pharmaceutical Ingredients (APIs) and medicines are formulated. It is critical that countries do not respond with calls to close their borders and hinder transport of pharmaceuticals around the world during this crisis. The supply chain is both complex and globally interconnected and such disruptions are short-sighted, impractical, and lead to hindered access to quality medicines.

Instead, USP is calling for a coordinated effort to ensure production of essential medicines is more evenly distributed in multiple locations around the world. This way, when a crisis hits one region, facilities in unaffected areas can ramp up production to minimize disruptions to the supply chain for all. In addition, we are in active dialogue with regulators around the world, including the U.S. FDA to act quickly in support of their COVID-19 activities and immediate needs.

Strengthening health systems in low- and middle-income countries.

The medicine supply chain is interconnected and global. When substandard or falsified medicines appear in one part of the world, it can quickly appear in another part of the world as a result of the interconnected supply chain. Medicines made in countries with weaker regulatory systems or capabilities may not have mechanisms in place to prevent the proliferation of substandard and falsified medicines before they can infiltrate the supply chain. The presence of weak regulatory systems also increases the risk that poor quality or falsified medicines or ingredients will enter the supply chain as bad actors seek to take advantage of increased demand with falsified medicines.

USP produced a white paper for "Pandemic Preparedness for Regulators in Low- and Middle-Income Countries." This white paper highlights actions that international regulators may take to mitigate the impact of the pandemic, ensure access to quality medicines, support local manufacturers to utilize quality standards, and keep patients safe.

We also continue our work to support strengthening health systems in low- and middle-income countries and expanding the supply of safe, quality medicines through the Promoting the Quality of Medicines Plus program (PQM+), funded by USAID and implemented by USP.

Supporting regulatory pathways that enable new manufacturing technologies.

USP is actively exploring ways to support advanced pharmaceutical manufacturing technologies (e.g. continuous manufacturing) in developing standards and other solutions that will help ensure quality production at potentially lower costs and faster production. Many advanced technologies allow for smaller production yields and allow greater flexibility to increase geographic diversity in manufacturing to strengthen the global supply chain.

The above is just a sampling of USP's many activities in response to the COVID-19 pandemic. We have been in active dialogue with our stakeholders on their needs and are working faster than ever before to leverage our 200-year history of ensuring the quality of medicines around the world in response to this global COVID-19 pandemic.