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Unused Medication and Sharps Disposal (Web Exclusive) By Dr. Burton J. Kunik, Chairman and CEO, Sharps Compliance Corp.Lost in the debate over changes that the health care system needs is a growing problem that directly impacts the environmental concerns and waste disposal programs of every municipality: how to dispose of medical and pharmaceutical waste. There are a variety of state and federal regulations that focus on the disposal of needles, syringes, scalpel blades and other medical sharps. But an entirely different, and often hidden, concern is the improper disposal of unused medications, which can create major issues for municipal solid waste and sewage treatment.
Health and Safety Issues
It is estimated that four billion prescriptions are written in the U.S. annually, and 35 to 40 percent of dispensed pharmaceuticals outside the hospital setting go unused, generating more than 200 million pounds of pharmaceutical waste a year. They create both home safety and environmental safety concerns for municipal services. At home, unused pharmaceuticals in the medicine cabinet are one of the leading causes of accidental poisonings in the United States. Deaths from accidental overdose of narcotics, from teenagers to senior citizens, rose more than 80 percent from 1999 to 2005 due to both misunderstanding and misuse of proper drug consumption. These are often potent drugs that once were mainly confined to hospitals
Pharmaceuticals, antibiotics, steroids and similar substances also create environmental issues as they enter the water system through improper disposal by flushing through sewer systems which cannot, with current technology, remove them. The federal government does not require any testing for pharmaceuticals in water and has not set safety limits on concentrations. Various studies by organizations ranging from the U.S. Geological Survey to the Associated Press suggest that one or more of these substances can be found in the majority of groundwater streams and in the drinking water of over 40 million Americans. There are no proven human health effects from such low-level exposures in drinking water, but research is accelerating.
Disposal Options
The volume of pharmaceutical waste generated at health care facilities and in individual homes has yet to be adequately documented. Based on a small sample, though, the Associated Press in a 2008 investigatory report (reported in many publications, such as USA Today on 9/14/08) projected an annual national estimate of at least 250 million pounds of waste pharmaceuticals and contaminated packaging. Some contaminated packaging and drug waste are incinerated; more is sent to landfills. But it is believed that most unused pharmaceuticals from health care facilities are dumped down sinks or toilets, usually without violating state or federal regulations. One water utility surveyed 45 long-term care facilities in 2006 and calculated that two-thirds of their unused drugs were scrapped this way, according to a National Association of Clean Water Agencies report cited by the AP.
As noted, incineration is an effective disposal option, and the advantages associated with it, as well as its long history as an effective method of waste management, mean it is used to treat and dispose of medical waste at approved facilities. However, this method typically requires use of a collection agency rather than being accessed directly, and it does not address the substantial problem of household medical waste generation. Unused pharmaceuticals have already been noted as one problem. Another is disposal of sharps (used syringes, needles, and lancets) by consumers, which is largely unregulated and has become a major concern for recycling operations. Three percent of the U.S. population (approximately 9 million people) self-inject medications outside of healthcare settings, producing some three billion syringes that are discarded each year.
Regulatory Initiatives
Landfills are another disposal option, and the EPA’s Resource Conservation and Recovery Act (RCRA) controls the management and disposal of hazardous pharmaceutical waste produced by pharmaceutical manufacturers and the health care industry. In December 2008, the EPA proposed a rule to allow handling of hazardous pharmaceuticals as Universal Waste, not as RCRA waste – a less stringent and less costly method of disposal that would not require segregating hazardous drugs from those not classified as hazardous. By reducing the cost of handling pharmaceutical waste, this lessens the potential for improper disposal. Currently, Michigan and Florida allow pharmaceuticals to be managed using those states’ Universal Waste rules. Hazardous drug disposal in healthcare, however, generates only a small portion of pharmaceutical waste potentially discarded into sewers and landfills daily. Consumer disposal of unused medications is a much bigger dilemma.
There are several examples of states restricting disposal of pharmaceuticals by both healthcare and consumers. For example, California has passed SB 996 which requires the California Department of Resources, Recycling and Recovery to develop, in consultation with appropriate government agencies, criteria and procedures for model programs for the collection and proper disposal of pharmaceutical waste. As part of SB 966, the Board is required to address home-generated pharmaceutical disposal. SB 966 directs the Department to develop criteria and procedures for model programs that collect these unused or expired pharmaceuticals from consumers. The Department is required to report to the Legislature by December 1, 2010 on its evaluation of the efficacy, safety, statewide accessibility, and cost effectiveness of participating model programs, as well as provide recommendations for potential implementation of a statewide program
Illinois has taken its own initial steps to deal with the issue of unused medications from households. In June of 2008, SB0178 passed both houses of the legislature and was signed by the Governor early in August, becoming Public Act 96-0121 and amending the Illinois Environmental Protection Act. It authorizes, but does not require, the Illinois Environmental Protection Agency to adopt regulations governing the operation of household waste drop-off points, specifying that the location of prescription pharmaceutical product drop-off points should be at a site or facility where prescription pharmaceutical products are sold, distributed or dispensed (including hospitals and nursing homes). It also authorizes the IEPA to approve the operation of one-day household waste collection events, and to make available on its website signs and information that Illinois pharmacies can use to inform individuals on the proper storage and disposal of drugs.
Proactive Solution
The Illinois program is certainly less extensive than that of California, but in its use of drop-off points and educational materials at the point of sale it indicates one method of disposal that municipalities should consider encouraging: the use of take-back and disposal by mail programs. These programs are designed for individual consumers and community facilities, such as assisted living, long-term care, hospice and correctional operations, to dispose of unused medications other than controlled substances. Programs use a variety of sizes of containers and return packaging with pre-paid postage to approved disposal facilities. The programs can work through designated collection points or through pharmacies, both of which are alternatives provided for in the Illinois law.
As Illinois Public Act 96-0121 shows, concern over the implications of medication disposal is growing. State Senator Susan Garrett, who sponsored the initial legislation, was publicly quoted as saying that, “In the past, residents across the state have simply flushed unused medicines and poured harmful chemicals down the drain causing environmental risk. The practice of flushing medicines into our waterways cannot continue any longer.” Such statements reinforce past experience that, once the dimensions of an environmental concern are apparent, regulation follows. Municipalities that proactively support disposal by mail and take-back programs for unused pharmaceutical disposal are proactively getting ahead of the regulatory curve, and contributing to both a workable and cost-effective solution. |