Introduction
Pharmaceutical wastes contain ingredients that are designed to have pharmacological effects and provide benefits to the society (WHO, 2012). Pharmaceutical wastes include illegal drugs, pharmaceutical products, and pharmaceutical ingredients. Regulations dealing with pharmaceutical wastes resulted from studies indicating that fish and wildlife were suffering from an increase in the content of drugs in the water resources. A study conducted by the Geological Society in the United States, in 2002, indicated an increase in the percentage pharmaceuticals released to water streams (Smith, 2002). This indicated a clear lack of a proper disposal system for pharmaceutical wastes.
RCRA
This refers to Resource Conservation and Recovery Act. (Lauer, 2010). This act was formed to protect human beings and the environment from potential dangers of waste disposal, reduce the amount of waste generated, and make certain that wastes are managed in an environmentally sound manner. Additionally the act seeks to ensure the preservation of energy and natural resources. The Environmental Protection Agency (EPA) provides guidance on the implementation of the RCRA and ensures that polices outlined in the act are adhered. According to the RCRA, almost 5% of all pharmaceutical agents are considered hazardous (ASHP, 2007). Recently, some states and the EPA have introduced stricter enforcement of the RCRA. Additionally, fines relating to the violation, negligence and noncompliance of the RCRA have been increased to the extent of including prison sentences. Corporate fines can add up to $37,500 per violation per day. Violations according to the EPA include incorrect waste determination, insufficient training of affected employees, inappropriate disposal of drugs down the drain, incorrect labeling of hazardous waste, poor management of expired pharmaceuticals, missing hazardous waste manifest and poor disposal of a chemotherapy drug.
EPA classifies hazardous pharmaceutical wastes under the P list and the U list and based on ignitability, corrosivity, toxicity and reactivity (Smith, 2002). The EPA considers P-listed chemicals to be extremely hazardous. Some of the pharmaceuticals on this list include nicotine, epinephrine, arsenic trioxide, physostigmine, warfarin>0.3% and nitroglycerine. U-listed chemicals are classified based on the sole ingredient contained in the pharmaceuticals. For example, trichloromonofluoromethane, chloroform, mercury, formaldehyde, cyclophosphamide, lindane, selenium, uracil, warfarin<0.3%, streptozocin, phenol, reserpine, mitomycin, resorcinol and chlorambucil.
Collection and Disposal of Pharmaceutical Waste
Pharmaceutical wastes need to be disposed in most appropriate in accordance with the EPA guidelines. There exist a number of approaches involved in the collection and disposal of unwanted pharmaceuticals from patients, hospitals and expired pharmacy stock (Appelbe, Wingfiled, and Dale, 2005). In the hospitals, pharmacists should ensure that standard operating procedures relating to pharmaceutical waste management are followed. Additionally, a contract needs to be made with an authorized carrier for the collection and disposal of pharmaceutical waste at regular intervals. Further, pharmaceutical wastes needs to be separated from the pharmacy stock and immediately transferred to disposal containers. Moreover, the pharmacists must ensure that all proper documentations are filled to comply with the legal requirements.
Hospitals are charged with the responsibility of ensuring that every new drug that is introduced has a proper waste stream disposal system. In case a hazardous pharmaceutical waste is infectious, there is a high chance that a double hazard exists. This scenario requires a separate waste stream that will be used for the infectious pharmaceutical waste (ASHP, 2007). However, presence of such a waste stream may prove to be expensive in the end.
Hospitals that are planning to use a waste stream program need to ensure the extent of its generator capacity. A facility’s generator status as per RCRA depends on the amount and type of waste generated over time. For a large quantity generator, the amount of waste generated is more than 1000kg per month. For a small quantity generator, the amount of waste generated is less than 1000kg per month. The large quantity and small quantity generator must to have an EPA identification number.
Hospitals main waste streams include municipal incineration of the pharmaceutical packaging, plastic bottles, and ointments, and incineration of chemotherapy sharps and soft waste in a medical incinerator (ASHP, 2007). RCRA regulates the use of these two waste streams to ensure no harmful outcomes. According to the RCRA, waste must be incinerated by a facility that has been approved by EPA for managing that specific waste.
This implies that a company cannot be established to declare RCRA waste EPA-safe.
Some states have adopted the use of color-coded containers for disposal of pharmaceutical wastes, which makes their disposal simpler. For instance, black coded containers are used for disposal of hazardous pharmaceutical wastes, yellow coded are used for disposal of trace chemotherapy waste, red for regulated medical waste and the white containers for non-hazardous pharmaceutical wastes (Smith, 2012) .
Challenges associated with compliance with RCRA regulations
According to ASHP (2007), compliance with the RCRA regulations regarding pharmaceutical waste disposal is bound to bring financial and operational challenges. Operational challenges result from processes that involve manual sorting of the pharmaceutical waste. This process is time consuming, labor intensive and poses serious danger to the sorter. This may result to noncompliance of the regulations. A significant cause of noncompliance to state and federal regulations emanates from the general lack of knowledge regarding these regulations.
Hospitals and pharmacies need to have clear guidelines regarding the safe disposal of expired medication. According to ASHP (2007), a survey conducted on consumers and pharmacies revealed a variety of disposal methods that are not compliant with the RCRA regulations. There has been absence of proper guidelines, in most pharmacies and hospitals, on the proper disposal of expired pharmaceuticals. To be able to ensure that there is appropriate disposal of pharmaceutical wastes, there is a need to educate health care professionals about pharmaceutical waste disposal. This needs to be done concerning the relevant state and federal regulations, placing an emphasis on the outcome that may result from noncompliance.
The emergence of new and toxic pharmaceutical may add a financial burden to a hospital in regards to pharmaceutical waste disposal. For the hospital to be able to comply with the RCRA regulations more finances are required to develop intensive methods of waste disposal. Fines are bound to arise because the hospital may fail to conform to the regulations. Failure to comply with regulations results to a fine of $32,500 per day. Additionally, lack of instituting guidelines regarding separation of waste and education of staff may be quite costly. This will depend on the type of pharmaceutical waste involved. Processing cost for RCRA hazardous waste ranges from $2 to $4 per pound whereas that for infectious hazardous waste ranges from $4 to $8 per pound.
EPA best management practices for Pharmaceutical waste
According to EPA (2010), believes that a large amount of pharmaceuticals in rivers is because of disposal of the pharmaceuticals in public water systems. As a means of curbing this issue, EPA studied pharmaceutical waste disposal in most health facilities as a way of developing best management practices. Furthermore, EPA developed best management practices for the disposal of pharmaceutical wastes based on data collected from twelve health care facilities and consultations with more than seven hundred health professionals. The pharmaceutical waste may be generated at a health facility during or after treatment. Additionally, it may be generated when stocking activities are undertaken to ensure that there are enough pharmaceuticals for patient care (EPA, 2010).
One of the best management practices that EPA recommends is the carrying out an inventory of the pharmaceuticals and unused pharmaceuticals to be able to compute the amount of pharmaceuticals to be disposed off. Secondly, EPA recommends that unused pharmaceuticals be properly managed by identification of the pharmaceuticals based on the state and federal requirements. Emphasis is placed on disposal of pharmaceuticals waste in accordance with the EPA’s recommended practices. Thirdly, EPA recommends that a review in the purchasing practices is essential in reducing the quantity of pharmaceuticals at a health facility. Fourthly, waste should be segregated to ensure that costs are reduced and regulations are met. Costs may be reduced by disposing non-hazardous pharmaceutical waste in a solid waste landfill instead of using a waste hauler. Hospital staff needs to be properly trained on issues regarding disposal of pharmaceutical wastes (EPA, 2010). For instance, nursing practices play a significant role in the disposal of pharmaceutical wastes. Training of nurses on the proper disposal methods will ensure that pharmaceutical wastes are properly disposed. Training courses are available for nurses concerning disposal of pharmaceutical waste.
References
Appelbe, G. E., Wingfield, J., & Dale, J. R. (2005). Dale and Appelbe's pharmacy law and ethics
(8th Ed.). London: Pharmaceutical Press.
ASHP. (2007). Managing Pharmaceutical Waste. Retrieved from
http://www.ashpadvantage.com/docs/PharmaWaste-Discussion-Guide.pdf
EPA. (2010). Draft Guidance Issued on Best Management Practices for Unused
Pharmaceuticals. Hazardous Waste Consultant, 28(6), 2.8-2.11
Massoomi, F. (2011). Managing Pharmaceutical Waste: A Regulatory Review to Define
Practice. Retrieved from http://youtu.be/FwhVR5l-Jss.
Smith, C. (2012). Management of Pharmaceutical Waste. Retrieved from
http://youtu.be/ghBfur7xWqA.
Smith, C. (2002). Managing Pharmaceutical Waste: What Pharmacists Should Know. Retrieved
WHO. (2012). Pharmaceuticals in drinking Water. Retrieved from
http://apps.who.int/iris/bitstream/10665/44630/1/9789241502085_eng.pdf
