Pharmaceutical manufactures use potency classifications to protect the health of their employees.
To protect pharmaceutical workers from overexposure to an active pharmaceutical ingredient (API) during the manufacture of medicines, a potency classification system was developed. This classification system takes into consideration acceptable occupational exposure limits (OEL) during initial manufacturing, tablet or capsule formation and final packaging.
History
In the late 1980's Syntex Inc., Merck and Company, Inc., Eli Lilly and Company, Abbott Labs and The Upjohn Company, five of the largest pharmaceutical companies in the world, met to discuss the need to classify the potency and toxicity of drugs during manufacturing to help protect their employees from dangerous occupational exposure levels. As a framework, they adopted the U.S. Center for Disease Control and Preventions four-category model for biosafety. From that came the SafeBridge four-category system of potency classification. Though they recognized the need to establish this system, the pharmaceutical industry has not declared a definitive system. While the SafeBridge classification system is widely used throughout the pharmaceutical industry, many companies modify this system to cut finer lines depending on the type and quantity of API they handle. In addition, different countries develop additional categorizations to meet their national health requirements.
Category 1
This classification of pharmaceuticals is the least potent. These medications produce immediate symptoms if ingested, have no lasting side effects and do not possess the ability to cause mutations, cancer or reproductive anomalies. When exposed to powder or gas forms of the API, the chemical should have good warning properties, such as smell or visual appearance, preferably at concentrations below toxic. Exposure to Category 1 API does not require medical intervention.
Category 2
This potency classification possesses moderate to high systemic toxicity, such as cardiac or liver. Constant contact with the chemical may be corrosive. Exposure to powder or gaseous forms will cause weak sensitivity, particularly in those who show an allergy to it or similar chemicals. Any side effects from exposure will produce immediate or delayed effects, and overexposure may require medical intervention. Like Category 1 API, this classification should also be free of mutation and cancer causing effects, as well as reproductive consequences.
Category 3
This classification is also the default classification for new pharmaceuticals without defined occupational exposure limits, unless clinical research indicates that the medicine is potent at 10 ug/kg of body weight, which would put the API in Category 4. This classification of API indicates that at a potency of 0.1 to 1 mg/kg of body weight the medicine has mutagenic, carcinogenic and reproductive effects. API in this classification are easily absorbed though the lungs or skin and produce immediate sensitization at low doses. Constant exposure will produce acute, irreversible and systemic effect with the potential to need immediate medical intervention. Work with this and Category 4 API must be contained in negative or positive air pressure clean room and degowning is necessary to keep from transferring minute amounts into the rest of the facility.
Category 4
This is the most highly potent classification of API. These API have working dosages from clinical trials at 10 ug/kg of body weight. The most common type of drug in the category would be chemotherapy drugs. Regular doses have known mutagenic, carcinogenic and reproductive consequences, with long-term side effects at higher doses. These API are easily absorbed through occupational exposure, so automation of manufacturing and handling is recommended.
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