Occupational exposures to active pharmaceutical ingredients can have adverse health effects on workers that are employed in the pharmaceutical industry. A classic example of this issue is worker exposure to steroid compounds. Click on the following link for more information on hormonal products.
Overview of Steroid Compounds
A steroid is a type of organic compound that contains a specific arrangement of four cycloalkane rings that are joined to each other as shown to the right. Steroids can include the androgens and the estrogens. Androgen compounds are a group of compounds, either natural or synthetic, that stimulates or controls male characteristics in vertebrates. Common examples of androgens that are available for therapeutic use include the following:
- Oxandrolone; and
Estrogen compounds are a group of compounds named for their importance in the estrous cycle in humans and in animals. Estrogen compounds can be classified as natural or synthetic, and as steroidal or non-steroidal. Common examples of the estrogens that are available for therapeutic use include:
Occupational Exposure to Corticosteroids
Corticosteroids are man-made drugs that resemble cortisol, a steroid that the adrenal glands produce naturally. Occupationally, corticosteroids can cause skin disorders. For example, in Puerto Rico, there were cases of occupational overexposure to corticosteroids in a pharmaceutical manufacturing plant. The humidity of the building caused the insoluble steroid product to remain in contact with the skin – causing dermatitis with moderate to severe edema and acne in the workers.
Occupational Exposure to Estrogens
Occupational over-exposure to estrogens have also been reported. For instance, there was a report of adverse effects related to estrogen in 1942 when Scarff and Smith indicated the development of gynaecomastia and loss of libido in men working with diethylstilboestrol (DES) (Heron, 2003). I should note that DES is a synthetic, non-steroidal estrogen.
Occupational Exposure Limits (OEL) for Steroid Compounds
Steroid compounds can be highly potent, and the majority of steroid compounds have been categorized as Category 4 or 5 potent compounds in most potent compound safety programs. In addition, with a few exceptions, steroid compounds typically have occupational exposure limits near or below 1 ug/cubic meter.
In order to prevent exposure to these highly potent active pharmaceutical ingredients, it is essential to establish effective engineering controls that prevent worker exposure. Prior to use, these engineering controls must be validated using surrogate monitoring or other containment validation techniques. Workers must receive appropriate hazard communication training specific to the steroid compounds that they may handle. Environmental, health and safety personnel must be thoroughly trained in all aspects of potent compound safety. In addition, once manufacturing operations commence, industrial hygiene monitoring should be performed using compound-specific sampling and analytical methods. Compound-specific sampling and analytical methods are available for most potent steroid compounds. Contact Affygility Solutions for more information.
In conclusion, worker exposure to steroids in the pharmaceutical industry can result in significant adverse effects in employees. In order to prevent occupational exposure to steroids, pharmaceutical companies must develop and implement a comprehensive potent compound safety program, including proper engineering controls, administrative practices, and personal protective equipment. If you are interested in developing and implementing any aspect of a potent compound safety program or Affytrac – our comprehensive web-based program that allows management of your potent compound safety program, contact Affygility Solutions today.