Notes on pharmaceutical waste

Pharmaceuticals form a group of substances that are of considerable importance for society as healthcare tools. Given the fact that a variety of pharmaceuticals can now be detected in surface, ground, and drinking waters, there are valid concerns about the potentially adverse environmental consequences of this contamination. The risk is directly proportional to the active concentration of the chemical substances in various environmental compartments, and pharmaceutical waste adds to that risk if it is not managed properly.

Pharmaceuticals are widely distributed, and there is a consistent global increase in the use of potent pharmaceuticals driven by drug development, an aging population in Western countries and the efforts to improve health in developing countries. Following this use is a corresponding increase in the generation of pharmaceutical waste.

The waste and disposal problem starts with the production of the active pharmaceutical ingredient and finishes with the final disposal of a pharmaceutical product. During the manufacture and use of pharmaceuticals, lots of materials become contaminated with an active pharmaceutical ingredient increasing the waste volume.

Pharmaceutical waste is not only an environmental issue. Like other waste management, it is part of many peoples’ working conditions in respect to how it is handled, contained and disposed of. When the material entails a serious hazard, it requires special handling to ensure safety. Where there are issues with higher risk products, e.g., controlled drugs, increased security in handling pharmaceutical waste is also required.

Proper pharmaceutical waste management is a new and highly complex frontier in environmental management. Occupational health and safety is a highly integrated issue in the management of certain pharmaceuticals like chemotherapeutics, and the waste generated from these involve a significant hazard.

The handling and disposal problems of finished pharmaceutical products in the EU and US is an emerging field, irrespective of being used or unused, and some related contamination problems.

Pharmaceutical waste may be present in any of the common physical forms like solids, liquids and gases. The waste can be categorized in several ways, e.g., depending on source, physical state, hazard, security, handling and disposal.

Pharmaceutical means any chemical product, vaccine or allergenic (including any product with the primary purpose to dispense or deliver a chemical product, vaccine or allergenic), not containing a radioactive component, that is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or injury in man or other animals; or any chemical product, vaccine or allergenic (including any product with the primary purpose to dispense or deliver a chemical product, vaccine or allergenic), not containing a radioactive component, that is intended to affect the structure or function of the body in man or other animals. This definition includes products such as transdermal patches, and oral delivery devices such as gums or lozenges. This definition does not include sharps or other infectious or biohazardous waste, dental amalgams, medical devices not used for delivery or dispensing purposes, equipment, contaminated personal protective equipment or contaminated cleaning materials.

A pharmaceutical waste is defined as a pharmaceutical that is a hazardous waste. According to USEPA, there are approximately 31 commercial chemical products listed on RCRA‘s P- and U-lists that have pharmaceutical uses. As the P- and U-lists are based on chemical designations, this number does not completely represent the total number of brand name pharmaceuticals that may actually be listed hazardous wastes. For example, the following chemotherapy drugs, CTX, Cytotoxan, Neosar and Procytox, are U058 (cyclophosamide).

In addition, waste pharmaceuticals may also be hazardous because they exhibit one or more of the four characteristics of hazardous waste: ignitability, corrosivity, reactivity and toxicity. Characteristic pharmaceutical wastes include those that exhibit the ignitability characteristic, such as solutions containing more than 24% alcohol. An example of a pharmaceutical that may exhibit the reactivity characteristic is nitroglycerine. Pharmaceuticals exhibiting the corrosivity characteristic are generally limited to compounding chemicals, including strong acids, such as glacial acetic acid, and strong bases, such as sodium hydroxide. Depending on the concentration in different pharmaceutical preparations, pharmaceuticals may also exhibit the toxicity characteristic because of the use of arsenic (D004), barium (D005), cadmium (D006), chloroform (D022), chromium (D007), lindane (D013), m-cresol (D024), mercury (D009), selenium (D010), and silver (D011).

As thousands of over-the-counter or prescription drugs are currently approved for sale in the our country, it is difficult to provide a precise number of pharmaceuticals that can be listed.

Hazardous pharmaceutical wastes are generated by the following types of facilities: pharmacies, hospitals, physicians’ offices, dentists’ offices, other health care practitioners, outpatient care centers, ambulatory health care services, residential care facilities, veterinary clinics and reverse distributors. This rule does not apply to pharmaceutical manufacturing or production facilities.

Hazardous waste generation and management practices at health care facilities and other generators of hazardous pharmaceutical wastes differ from practices of industrial hazardous waste generators in several ways. Pharmaceutical waste is typically generated at a large number of points in relatively small quantities across a facility, such as at nursing stations, pharmacies, and patient, emergency and operating rooms. Furthermore, generators of hazardous pharmaceutical wastes tend to generate hundreds of different types of pharmaceutical waste while, in contrast, many industrial generators tend to generate only a few predictable waste streams in large quantities at relatively few generation points. Some of the difficulties that generators of hazardous pharmaceutical wastes have expressed concerning the current hazardous waste generator regulations relate to making the waste determination, generator status upgrade due to generation of acutely hazardous waste, hazardous waste listings, and accumulation time limits.

USEPA believes that hazardous pharmaceutical wastes meet the factors considered when determining whether a waste is appropriate for inclusion in the Universal Waste Rule. Specifically, most hazardous pharmaceutical wastes present a relatively low risk during accumulation and transport due to their form and packaging, which is typically in small, individually packaged dosages, such as pills or capsules. Hazardous pharmaceutical wastes are frequently generated in a wide variety of settings, including hospitals, pharmacies, long-term care facilities, veterinary offices and by reverse distributors, as well as in households. They also are generated by several different types of personnel at these facilities, including pharmacists, doctors, nurses, and patients. Finally, overall, hazardous pharmaceutical wastes are present in significant volumes in non-hazardous waste management systems. For instance, pharmaceutical wastes are generated by households and, therefore, end up in the municipal waste stream or going to publicly-owned treatment works (POTWs).

Should pharmaceutical waste be disposed of down the drain or via sewer systems?

In many instances, at health care facilities and pharmacies, pharmaceuticals are sent to a regulated medical waste incinerator. Additionally, many pharmaceutical wastes are disposed of down the drain. USEPA generally considers sewer disposal inadvisable for pharmaceuticals and discourages this practice, unless specifically required by the label on the particular pharmaceutical. More information on proper drug disposal. In hospitals and other health care facilities, the practice of disposing of pharmaceuticals to sewers has taken place. This has occurred despite the potential adverse effects of introducing waste pharmaceuticals into the environment, and the inability of wastewater treatment plants to treat some pharmaceuticals effectively.

Recent studies have documented the presence of various pharmaceutical chemicals and metabolic by-products in surface waters and groundwater in the United States, and the issue of pharmaceutical use and management has become increasingly important. EPA is conducting research on the presence of pharmaceutical compounds in waterbodies and any ecological effects the compounds may be causing, as well as research directed towards improving water treatment capabilities. Information on EPA’s research in pharmaceuticals and personal care products in the environment. For these and other reasons, pharmaceutical waste management has become an increasingly critical issue in environmental management for health care facilities.

These days U.S. Environmental Protection Agency (EPA) has proposed adding hazardous pharmaceutical waste to the Universal Waste Rule (UWR).

The proposed rule encourages generators to dispose of pharmaceutical waste that is classified as non-hazardous under the Resource Conservation and Recovery Act (RCRA) as universal waste. The proposal will also facilitate the collection of personal medications that are classified as household hazardous waste so they can be managed properly.

The proposed rule applies to pharmacies, hospitals, physicians’ offices, dentists’ offices, outpatient care centers, ambulatory health care services, residential care facilities and veterinary clinics, as well as other facilities that generate hazardous pharmaceutical waste. It does not apply to pharmaceutical manufacturing or production facilities.

Currently, the federal UWR includes batteries, pesticides, mercury-containing equipment and lamps. Universal wastes typically are generated in a variety of settings including industrial settings and households, by many sectors of society and may be present in non-hazardous waste management systems, said the USEPA.

There are three categories of RCRA hazardous waste generators, according to the EPA. A facility's generator status depends on the total amount of hazardous waste generated at the entire site in a calendar month, which then determines the waste management requirements applicable to the facility under RCRA.

Facilities that generate 1,000 kilograms (kg) or more of hazardous waste per month or greater than 1 kg of acute hazardous waste per month are considered large quantity generators (LQGs).

Other facilities qualify as small quantity generators (SQGs) if they generate more than 100 kg per month, but less than 1,000 kg per month of hazardous waste. SQGs are subject to fewer requirements than LQGs.

For example, SQGs do not need to complete a biennial report and have fewer personnel training and contingency planning requirements than LQGs (see 40 CFR 262.34(d) (5)).

Additionally, facilities qualify as conditionally exempt small quantity generators (CESQGs) if they generate less than or equal to 100 kg of hazardous waste per month, or less than or equal to 1 kg of acutely hazardous waste per month.

CESQGs are not subject to the RCRA subtitle C hazardous waste regulations provided that they comply with the requirements set forth in 40 CFR 261.5(f)(3) and (g)(3), said the EPA.

Finally, under the household hazardous waste exclusion in 40 CFR 261.4(b) (1), hazardous wastes generated by households are not subject to the hazardous waste regulations.

Because RCRA generator status is determined on a monthly basis, it is possible that a generator's status can change from one month to the next depending on the amount of hazardous waste generated in a particular month, said the EPA.

This is commonly referred to as "episodic generation."' If a generator's status does change, the generator is required to comply with the respective regulatory requirements for that class of generators for any hazardous waste generated in that particular month.

The EPA requests comments on the proposed definition of "pharmaceutical." Specifically, the EPA seeks comment on whether the definition of "pharmaceutical" is clear and appropriate and whether it encompasses the full range of pharmaceuticals available.

In addition, the EPA seeks comment on whether this definition inadvertently includes items not intended to be incorporated into the universal waste system, such as dental or medical devices.

The EPA also requests comment on, in order to add hazardous pharmaceutical wastes to the UWR, whether additional elements not included in this proposal need to be added to this proposed definition.

Finally, the EPA requests comment on whether the proposed definition of "pharmaceutical universal waste" is clear and appropriate.

For more information, go to http://www.epa.gov/fedrgstr/EPA-WASTE/2008/December/Day-02/f28161.htm.

Pharmaceuticals in the Environment (PIE) has been an emerging issue for some decades but this topic is currently gaining unprecedented attention from many groups including environmental advocates, the scientific community, and government regulators. The primary reason is that
pharmaceutical products can now be detected in the environment and recent studies have garnered media attention. Naturally, there is concern that human health and aquatic life may be impacted as a result of exposure to pharmaceutical compounds. In the past half century, there has been an enormous increase in the use of pharmaceuticals in humans; the application of drugs in veterinary medicine, farming practices, and aquaculture has also grown.

The production of pharmaceuticals forms an ill-defined waste stream of end of life byproducts that
include active ingredients, excipients, sharps, and all forms of packaging. Although similar, it is not to be confused with “Biomedical” waste. Rather it is a sub-category of medical wastes.
Historically, it has been simpler and easier to define all pharmaceutical waste as hazardous. In
broad terms there are two regulated forms of hazardous wastes: Listed Hazardous and
Characteristic Hazardous (e.g. waste material that is ignitable, corrosive, reactive or leachate
toxic).

A January 2006 report issued by the Canadian Institute for Environmental Law and Policy says that while many contaminants enter the environment through sink and shower drains, flushing old medications down the toilet is another significant contributor. Municipalities have begun to recognize and classify pharmaceutical waste as a hazard. Some have lumped this waste into the Household Hazardous Waste stream to help consumers to define and dispose of it properly. Medicine cabinet clean-up days are organized sporadically across the country and are primarily initiated by chain drug stores.

Waste management in the pharmaceutical sector is particularly complex.

In India, pharmaceutical waste has not been dealt with except as hpart of end of pipe health-care waste management under the Biomedical Wastes (Management & Handling) Rules, 1998. The prevailing situation is analysed covering various issues like quantities and proportion of different constituents of wastes, handling, treatment and disposal methods in various health-care units (HCUs). The waste generation rate ranges between 0·5 and 2·0 kg bed−1day−1. It is estimated that annually about 0·33 million tonnes of waste are generated in India. The solid waste from the hospitals consists of bandages, linen and other infectious waste (30–35%), plastics (7–10%), disposable syringes (0·3–0·5%), glass (3–5%) and other general wastes including food (40–45%). In general, the wastes are collected in a mixed form, transported and disposed of along with municipal solid wastes.