Occupational Health and Exposure Limits for APIs – The Future

Many Drugs in need of Occupational Exposure Limits (OELs)

occupational exposure limits pharmaceuticals

Like many occupational health professionals, I read a lot of material. Early today I was reading a 1961 Time magazine article titled, “Medicine: Too Many Drugs.” In this article, Dr. Walter Modell of Cornell University Medical College, one of America’s foremost drug experts, was quoted as saying. “No fewer than 150,000 preparations are now in use, of which 90% did not exist 25 years ago, and 75% did not exist ten years ago.” Just think, that was over 50 years ago. Based on that quote, I decided to explore a little deeper and find out how many drugs are today actually on the market. I went to the FDA’s National Drug Code (NDC) Directory and downloaded their spreadsheet of all approved drugs in the United States. Based on this spreadsheet there are 55,782 drugs listed. While certainly there is some duplication of active pharmaceutical ingredients due to different formulations, the number of active pharmaceutical ingredients is still easily in the tens of thousands. In addition, it is my understanding, that the NDC directory does not include vaccines, biologics, animal therapeutics,  and pharmaceuticals that are approved outside to the United States.

OELs: A Significant Challenge for Occupational Health Professionals in the Pharmaceutical Industry

As many occupational health professionals in the pharmaceutical industry know, this many drugs on the market presents a significant challenge to the profession in preventing occupational exposures. While establishment of a potent compound safety program and placement or categorization of APIs in an appropriate exposure control banding strategy is an important first step, ultimately, if the drug is successful in the marketplace, in order to ensure that occupational exposure are prevented, you will need to develop an occupational exposure limit for the active pharmaceutical ingredient.

Internal Occupational Health Resources are Stretched Thin

For the larger pharmaceutical companies, they typically have access to internal occupational health resources to have occupational exposure limits developed for their later stage compounds. But even then, with many compounds being looked at everyday, their resources are stretched thin. This leaves as the only option, to use external resources to perform the review and the preparation of the occupational exposure limit monograph. Unfortunately, this takes qualified occupational health professionals, with advanced degrees and years of industry experience. In addition, the number of college graduates with advanced degrees in the toxicology field is not keeping pace with those toxicology professionals that are retiring.

Development of Occupational Exposure Limits is not a Trivial Activity

occupational exposure limits pharmaceuticals

Development of a robust occupational exposure limit and preparation of the supporting documentation is not a trivial activity. It requires reviewing a significant amount of pre-clinical and clinical data, as well as external sources of information. All of this information can be very challenging to read and should be left up to occupational health professionals with advance degrees and experience. Here at Affygility Solutions, we have seen very talented EHS professionals make attempts at developing their own OELs. Unfortunately, more often than not, the Dunning-Kruger effect takes a strong-hold, and people tend to overestimate their own level of skill in this area. In addition, many of OELs that are developed by pseudo-toxicologists lack internal review. This presents several problems for the organization’s potent compound safety program:

  1. If the OEL is too conservative, significant amounts of money are spent of engineering controls that are not necessary or productivity is lost; or
  2. The potential for employees to experience an occupational exposure to a potent compound exists; or
  3. Valuable drug development time is lost while they are trying to figure it all out.

Taking a cookie-cutter approach to development of occupational exposure limits for active pharmaceutical ingredients is not an adequate approach in any potent compound safety program.

Solving the Occupational Exposure Limit Challenge

So, what can be done to solve the occupational exposure limit challenge in the pharmaceutical industry? Several steps can be taken:

  • Encourage young people to pursue advanced degrees in occupational toxicology or related fields.
  • Mentor the undergraduates: Offer internships, speak at student chapters, etc.
  • Ensure that you have a robust potent compound safety program in place.
  • Use technology to make OELs affordable to smaller pharmaceutical manufacturers. Here at Affygility Solutions, in order to make high-quality occupational exposure limit monographs affordable to smaller companies, we have developed OEL Fastrac. OEL Fastrac is a convenient way to obtain OEL monographs for common active pharmaceutical ingredients. These OEL monographs have been prepared by occupational health professionals with advanced degrees, professional certifications, and decades of industry experience. Each of these monographs are available for instant download. To search for an OEL monograph for your compound, go to the OEL Fastrac search engine.

occupational exposure limits pharmaceuticals

Occupational exposure to active pharmaceutical ingredients can be prevented, but it does require a good understanding of potent compound safety, control banding principles and ultimately the development of occupational exposure limits.

Read more: http://www.time.com/time/magazine/article/0,9171,872488,00.html#ixzz26jo5MEzk


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About Dean Calhoun

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Dean is the President and CEO of Affygility Solutions. Affygility Solutions provides environmental, health and safety software, potent compound safety, industrial hygiene, containment validation services to the pharmaceutical, biotechnology, and medical device industry. "Dean's Google+ Profile"

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