Pharmaceuticals are chemicals, often hazardous, which have not in the past received the attention given to other hazardous chemicals with respect to their impact on either employee safety during transport preparation and administration or their impact on human health and the environment when discarded. Recent studies in the US and Europe have demonstrated the presence of common pharmaceuticals in waste waters, surface waters, and drinking waters, focusing attention on their disposition as waste. Other studies on a category of chemicals known as endocrine disruptors have demonstrated that these chemicals, which include some pharmaceuticals, can have a devastating and irreversible effect on the human fetus and new born, causing gender related dysfunction, including cancers, and neurological damage.
The Resource Conservation and Recovery Act, RCRA, was enacted in 1976 to regulate the disposal of solid and hazardous waste in the United States and is enforced by the Environmental Protection Agency (EPA). The RCRA criteria of hazardous waste apply to waste pharmaceuticals in addition to other chemicals. It is very difficult to apply these criteria to finished dosage forms, such as tablets, capsules, liquids and injectables because the regulation was written for bulk chemicals. In addition, healthcare personnel, including pharmacists and nurses, have not received training on RCRA in their professional curricula and are unaware of the regulation and need to comply. Due to both ignorance of the regulation and the difficulty in complying, many waste pharmaceuticals are being disposed through sewering, landfilling, or inadequate incineration in violation of RCRA.
No commercially available system exists at this time to assist healthcare organizations, pharmacies, drug wholesalers, manufacturers or other interested parties in determining if the pharmaceutical products they are discarding meet the definition of hazardous waste under RCRA. In addition, no system exists at this time to assist researchers in the areas of occurrence, concentrations, and ecotoxicologic data for waste pharmaceuticals in the environment. Finally, no existing system defines which pharmaceuticals are considered hazardous materials under OSHA (Occupational Safety and Health Administration) regulations with respect to employee safety in their handling, preparation and administration.
Thus, there is a need for a system and method for identification and management of pharmaceutical hazardous waste. Further, there is a need for a system that aids health care providers, researchers, and others in handling, preparing, and administering pharmaceutical products. Even further, there is a need to accurately provide safe disposal procedures for pharmaceutical hazardous waste.
USPTO Backgrounds
USPTO Backgrounds