Caring for COVID-19 patients – Will we have access to enough safe, quality medicines? | Quality Matters | U.S. Pharmacopeia Blog
 // April 06, 2020

Caring for COVID-19 patients – Will we have access to enough safe, quality medicines?

Contributors:

As the impact of the COVID-19 pandemic continues to unfold, each day brings to light new realizations of just how interconnected, and sometimes vulnerable, the global supply chain for medicines is.

In New York City – the epicenter of the COVID-19 outbreak in the U.S. – much attention has been focused on the desperate need for ventilators for COVID-19 victims.

But now a new, related concern has emerged: potential shortages of medicines such as muscle relaxants, sedatives, and painkillers that are critical in managing the pain and comfort of patients on ventilators.

Many of these are older, well-known medicines that are available as generics. And like most generics, many are manufactured outside of the U.S. Not only do the finished products come from different countries, but also their ingredients are sourced from chemical suppliers that are scattered around the globe.

As the world has come to see, medicine supply chains are complex. And when even one or two links in these chains are disrupted by events like the COVID-19 outbreak, access to critical medicines can be jeopardized.

Having created quality standards for medicines in and outside of the U.S. for 200 years, USP has a unique lens into the global medicine supply chain. Today, we provide thousands of manufacturers around the world with critical standards for ensuring the safety and quality of their medicines.

Anticipating the ripple effect that COVID-19 could have on supply chains, USP took measures early on to ensure the availability of standards we identified as being critical in the fight against this growing pandemic.

This has meant prioritizing the availability of our standards for medicines such as those used for respiratory and pulmonary care, to fight opportunistic infections that can threaten the health of immune-compromised patients and to alleviate pain for those suffering the secondary ailments associated with COVID-19.

Making sure that these standards are available to manufacturers and regulators will also play an important role in another challenge that USP anticipates.  In the past, as drugs have approached “near shortage” levels, there have been surges in poor quality (falsified or substandard) medicines.

Sadly, during times of crisis like this one, there is an increased opportunity for substandard and falsified medicines and ingredients to enter the complex supply systems – as a result of human error or intentional adulteration for economic gain.

As manufacturers race to meet the demand for these important medicines, they will likely need to expand their list of ingredient suppliers to include new or less-known sources.  This introduces a new element of risk, as certain ingredients can very challenging to validate for quality. Suppliers and manufacturers around the world are now operating in new and untested ways, making the need for vigilance and attention to quality of medicines and their ingredients all the more important.

As the world comes together in a collective effort to combat this global pandemic, USP stands ready to support and secure the medicine supply chain by ensuring the availability of standards that will help manufacturers, regulators and other stakeholders protect against poor-quality medicines and ingredients.

Now is the time for all of us to do whatever we can—however we can—to anticipate problems that will arise and be prepared.

For more information about USP’s response to COVID-19, go to https://www.usp.org/about/public-policy/covid-19.