Potent Compound Corner

Post Covid-19 Environmental Health and Safety in the Pharmaceutical Industry

May 1, 2020

At the time of this writing, according to the John Hopkins Covid-19 dashboard, over 3.1 million people in the world have been confirmed to have the disease Covid-19, and more than 227,000 people have died. Hospitals and other healthcare facilities are overwhelmed with Covid-19 patients and many sectors of the economy have been shut down, resulting in 26 million layoffed workers.

Despite all the bad news, environmental health and safety (EH&S) professionals need to see the current Covid-19 crisis as an opportunity. An opportunity for greater involvement rather than a crisis. An opportunity that is not about making predictions - since we don’t know what is going to happen in 6 months, 12 months, or 3 years - no one can do that. This opportunity should be about the contributions that EH&S departments can make in building a more resilient and agile organization, so when the next crisis occurs we will be better prepared

Since I started my EH&S career, and for well over thirty years, EH&S professionals have been asking for management participation and involvement, but these requests have largely fallen on deaf ears. While the efforts of non-governmental organizations like AIHA, GEMI, NAEM, and many others have all been helpful, none have consistently struck a chord with executive management. Today’s Covid-19 crisis has offered us an opportunity that few of us will ever experience. This opportunity will, despite social distancing, provide us a seat at the table with other business executives. Today’s challenges will separate those who want to lead vs. those who wish to follow. The urgency presented by the Covid-19 health emergency will put all parts of the organization to the test. As environmental, health and safety professionals in the pharmaceutical industry, we must perform, and we must be able to perform under conditions of great stress, ambiguity and uncertainty. This is not an easy task. So, how will things change for EH&S professionals in the pharmaceutical industry.

Move faster, save lives

The rise of the Covid-19 pandemic has caused regulatory agencies and pharmaceutical companies to rethink their regulatory approval and drug development strategies. For a highly contagious, high death rate, economy crushing virus like COVID-19, the former “one-step-at-a-time” drug development path will no longer be sufficient. We must move away from the 9 am to 5 pm, have a meeting, then schedule another meeting, 5-day/week business model to something that moves significantly faster. We must work with a renewed sense of urgency and must develop more agile parallel drug development path systems that can accelerate on demand. Regulatory agencies must be properly funded and have the personnel for making decisions no matter the hour of the day or the day of the week. Fortunately, we are already starting to see this approach play out. In the March 31st, 2020 edition of Yale Insights, the authors indicated that “We are seeing an acceleration in the rolling out and scaling up of internal R&D digital transformation efforts such as remote monitoring using platforms such as virtual clinical trials.” And in a recent U.S. Department of Health and Human Services press release, clinical trials are being accelerated for a new vaccine in parallel to the approval of large-scale manufacturing, even before Phase I trials are completed. In addition, with the creation of the U.S. Food and Drug Administration’s Coronavirus Treatment Acceleration Program (CTAP), we can expect this to be a continued trend.

EH&S professionals in the pharmaceutical industry must be able to adapt to this new regulatory and drug development environment. We must be able to withstand the pressures of a rapidly changing development path, and be able to have occupational hazard categorization (OHC) and permitted daily exposure (PDE) values done in days, not weeks. We cannot hold progress up and it won’t be easy, but it can be done.

Corporate Occupational Health Programs

Back in the mid-1980’s, when I first started in the EH&S field, it was quite common for large corporations to have corporate medical directors on staff. However, over the past several decades, due to cost-cutting and other efficiency efforts, the number of corporate medical directors has declined. The role of occupational medicine has largely become an outsourced position. With the occurrence of the Covid-19 pandemic this is about to change. With the rise in pre-entry testing and clearance protocols, corporations will be tasked with implementing and executing many new occupational health procedures. And, while pre-entry temperature screening has increasingly become the current practice, as indicated by Dr. Mark Cunningham-Hill, President of Worldwide Health Consulting, LLC, “The benefit of identifying someone with a temperature and excluding them from the workplace needs to be weighed against its efficacy, legal and privacy issues, the logistics of implementation, and the perception of employees, contractors and visitors.” Temperature screening alone is not the quick-fix solution to the current problem. It will take a much more comprehensive approach.

We can also expect that many corporations will have to make significant decisions regarding pre-entry clearance of their customers. For example, it was just recently announced that Etihad Airlines would begin pre-boarding temperature screening and health questionnaires of its airplane passengers. In addition, for certain flights, Emirates Airlines has begun pre-boarding blood testing for Covid-19 antibodies.

In addition, we should expect employee contact tracking applications to make its way into employee identification badges. Systems for contact tracking are already in use in countries like Singapore, and Apple and Google have announced contact tracing tools for broader use by developers. The analysis of this data and its impact should not be left up to the untrained eye.

Business Travel and Conferences

According to FiercePharma, as early as February of this year, Big Pharma companies were implementing significant travel restrictions. In addition, almost all major EH&S conferences have been either cancelled, rescheduled, or gone to a 100% virtual means of delivery. In a recent Los Angeles Times article, Robert Cole, a senior analyst at Phocuswright stated, “Group meetings and conventions are going to be changed forever. Corporations are going to take a scalpel to their travel budgets.” These changes will require EH&S professionals to reconsider how they perform critical items such as facility EH&S audits, professional development, training, and industrial hygiene monitoring projects. We should anticipate that many of these items will move to a virtual environment and require less “in-real-life” collaboration, or be performed by onsite personnel. Virtual audits for low-risk facilities can be done…it’s just not something that we’re accustomed to in the past.

Rapid Deployment of Personal Protective Equipment Programs

As we have seen from the recent shortages in N95 respirators and other personal protective equipment (PPE), pharmaceutical companies will need to have backup supplies of all types of respiratory protection, coveralls, shoe covers, and gloves. The former cost-saving practice of sole-sourced, just-in-time (JIT) supplies of PPE may not be adequate when there are disruptions in the supply chains. With China producing the majority of the world’s PPE, pharmaceutical companies cannot rely on a single supplier, that is half-way around the world. While there are stockpiles of PPE under the Biomedical Advanced Research and Development Authority stockpile program, these are generally not available for the private sector. This has an additional impact on the required facility space that companies will need to store these backup supplies.

Manufacturing and Supply Chain

As indicated in a recent Chemical & Engineering News article, the Covid-19 pandemic has put pharmaceutical companies on alert for supply risks and many pharmaceutical companies in India and China have been forced to stop operations due to containment zone orders. Relying on sole-source suppliers in one geographical region of the world may create an unacceptable risk for many companies. We should anticipate that programs like the Pharmaceutical Supply Chain Initiative will play a much larger role in evaluating supply chain risks.

We should also expect further automation of pharmaceutical manufacturing operations, and the use of artificial intelligence. Reducing manual interaction and hand-offs, thus reducing transmission risks.

Conclusion

While all of us would hope that the current Covid-19 crisis would quickly end and that we could just return to normal, that will not be the case. After a significant impact on our public health and economy, corporations will need to replace outdated practices and rethink existing strategies. EH&S professionals in the pharmaceutical should be part of that process and contribute where they can.

The expert toxicologists at Affygility Solutions have significant experience in preparing occupational health categorization reports, permitted daily exposure monographs, and safety data sheets for clients throughout the world. If you have any questions please contact us.

Published May 1, 2020

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