Allergic Reactions Common to the Pharmaceutical Industry
Pharmaceutical manufacturing facilities and laboratories handle a wide variety of active pharmaceutical ingredients that may produce allergic reactions. These allergic reactions may include:
- Allergic Respiratory Reactions; and
- Skin (or Dermal) Reactions.
Allergic Respiratory Reactions Resulting from Exposure to Active Pharmaceutical Ingredients
The most common route of occupational exposure to active pharmaceutical ingredients is the respiratory system. Occupational exposure via the inhalation route may result in a variety of allergic reactions. Allergic reactions can include, but not limited to, sensitization reactions and bronchoconstriction reactions. Examples of active pharmaceutical ingredients that cause sensitization reactions due to occupational exposure include penicillin and cephalosporin antibiotics, and enzymes such as lactase. Examples of active pharmaceutical ingredients that can cause bronchoconstriction include the opiates (fentanyl, morphine, condeine). Opiates are known to have a histamine releasing effect and it is suspected to be the cause of their broncho-constrictive properties.
If you would like more information on allergic reactions via the respiratory route, please contact Affygility Solutions.
Allergic Skin Reactions
There are several types of allergic skin reactions that may occur from occupational exposure to active pharmaceutical ingredients (APIs). The intensity of these allergic reactions depends largely on the degree of absorption of the chemical. The factors that influence the amount of the active pharmaceutical ingredient absorbed include: (a) physicochemical properties such as molecular weight, volatility and polarity; (b) environmental conditions such as temperature, humidity and protective clothing; and (c) and the condition of the exposed skin (damaged, dry etc.).
Numerous instances of pharmaceutical workers experiencing dermal allergic reactions from direct contact with active pharmaceutical ingredients have been cited. According to Ryan, allergic contact dermatitis has occurred from dermal exposure to ranitidine hydrochloride (also known as Zantac™). Also, cimetidine (also known as Tagamet™) is a pharmaceutical that has been know to cause an acute multiforme like reaction. Cytotoxic active pharmaceutical ingredients have also been reported to cause allergic contact dermatitis. There is significant evidence suggesting that dermal exposure and thus dermal reactions are prevalent in the pharmaceutical industry. For example, according to one study conducted to monitor the exposure to methotrexate (used to treat severe psoriasis) at a pharmaceutical manufacturing facility, the employees wore a high degree of respiratory protection and skin absorption was a major factor in exposure. In another example, according to Sessink, significant dermal exposure to 5-fluorouracil in the dispensing area of a pharmaceutical manufacturing facility was found as well as a significant amount of contamination of the work surfaces, which would provide opportunity for skin absorption.
If you would like more information about dermal exposure to active pharmaceutical ingredients, please contact Affygility Solutions about our webinar on Dermal Exposure and Absorption of Active Pharmaceutical Ingredients.
Conclusion
Based on studies completed and incidences of accidental exposure to active pharmaceutical ingredients in pharmaceutical manufacturing plants, allergic reactions have become common to the pharmaceutical industry. Therefore, allergic reactions such as those mentioned above have necessitated the use of engineering and administrative controls. Containment validation or surrogate monitoring should be performed to ensure that the engineering controls are adequate, and industrial hygiene monitoring for active pharmaceutical ingredients should be performed to further ensure a safe working environment. The use of personal protective equipment should only be used as a tertiary means of protection.
Contact the environmental, health and safety, and occupational toxicology experts at Affygility Solutions today!