Supermarkets have been at the forefront of recycling efforts even before the first bottle-return bill was passed in Oregon in 1971. Yet, missing in retailers' consumer recycling efforts are pharmaceuticals and personal care products (PPCPs), which includes prescription and over-the-counter medicines as well as veterinary drugs, fragrances and cosmetics.
At first glance, the supermarket, specifically the pharmacy counter, appears to be a logical and convenient collection point for patients to bring back their unused and expired drugs for inclusion in a pharmacy's reverse distribution of unused medications shipped back to drug manufacturers. But in the highly regulated world of pharmaceuticals, laws at local, state and federal levels either prohibit such efforts or make the process logistically too complex for supermarkets to conduct consumer take-back programs when drugs are determined controlled substances. Then there is the issue of who pays for the cost of such programs.
However, various governmental agencies are looking into the matter. Several legislative proposals under consideration would facilitate consumer drug take-back programs. Some organizations are advocating for the pharmacy to be the collection point.
While applauding initiatives to control consumer drug wastes from entering the environment, the retail pharmacy industry has voiced concern over the feasibility and cost of such take-back efforts.
Several large chains contacted by SN declined comment on the issue, including Wegmans Food Markets, Rochester, N.Y., which last month hosted a pharmaceutical collection at its Penfield, N.Y., location in Monroe County. In a press release, Wegmans pharmacist Rosanna Carbone said, “We hope that this event will raise awareness among our customers that you should not simply throw away or flush medicines. The safest option is to bring them to a pharmaceutical collection program where they can be properly destroyed.”
In a written statement from Supervalu Pharmacies, Franklin Park, Ill., Victor Vercammen, director of professional services and government relations, said, “Issues related to pharmaceutical waste are fairly complex and carry several layers. An important aspect deals with patient care. In many cases, patients are left with unused medications because they are not able to fully comply with their prescribed medication therapy. Therefore at Supervalu Pharmacies, we see that one logical approach that can help limit the amount of unused medications needing disposal is to educate our patients about the importance of taking their prescribed medications.”
IN THE HEADLINES
Last year's well-publicized Associated Press investigation into trace pharmaceuticals, including antibiotics, anti-convulsants, mood stabilizers and sex hormones, found in the drinking water of 24 major metropolitan areas serving an estimated 41 million Americans drew the attention of local governments, the Environmental Protection Agency and the pharmaceutical industry.
Pharmaceutical Research and Manufacturers of America (PhRMA) issued a statement in response to the AP report and cited the industry's safety and compliance when it comes to human health and the environment.
PhRMA noted that despite the trace amounts of pharmaceuticals found in water, “scientific studies conducted to date have not indicated any appreciable risk to human health. The small amounts of pharmaceuticals being measured in surface water come primarily from patient use. … The amounts detected in untreated water used for drinking have been very small — the equivalent of a single cube of sugar dissolved in two and a half million gallons of water.”
Long-term effects of low concentrations of PPCPs in the water supply on humans is unknown. However, researchers have reported harmful effects to aquatic species, affecting reproduction and development. The current consensus among environmentalists and others is that disposal of unwanted drugs down the toilet is not a preferred method of disposal and even disposal in trash is only an interim fix since drugs can seep through landfills into the water supply.
Aside from PPCP dumping into the environment, unused medications in households also present safety and societal risks such as accidental poisoning; prescription drug abuse by teenagers; illegal diversion of drugs; and information and identity theft. However, it is the potential impact of PPCPs on the environment, especially the freshwater supply, that has caught the attention of lawmakers, environmental advocates and the public.
A number of agencies such as the U.S. Drug Enforcement Administration, EPA and the Department of Health & Human Services are involved in regulating disposal of prescription medications. “Federal laws are often not compatible with each other and state laws introduce additional complexities,” according to a report by the Northeast Recycling Council, Brattleboro, Vt., a non-profit organization that has set up pilot community take-back medication programs.
The issue becomes even more complex when the unwanted medication is a controlled substance like Valium, Oxycontin, Percocet or codeine. DEA law prohibits return of dispensed controlled substance back to the pharmacist. Reverse distributors, who take unused or expired drugs from the pharmacy and ship it for disposal or back to manufacturers for credit, are not allowed to handle controlled substances. Only law enforcement officials can take custody of these drugs.
Presently, there is no good system in place for consumers to dispose of partially used or unused medicines. “Locally organized, one-time collection events have provided an interim solution to the problem, but many people are calling for a disposal system that would be continuously available, such as a mail-back system or ongoing collections through pharmacies,” stated the Illinois-Indiana Sea Grant College, University of Illinois, Urbana, in a report.
The pharmacy industry is monitoring legislation designed to implement consistent federal policy and streamline management of pharmaceutical waste. Among the proposed regulations that American Pharmacists Association (APhA) considers important is EPA's bid to add hazardous pharmaceutical wastes to the Universal Waste Rule (UWR).
Last December, the EPA released this proposed rule that establishes a set of requirements for the collection of certain hazardous wastes, called universal wastes. Among other benefits, EPA said the change would facilitate the implementation of pharmaceutical take-back programs and the collection of pharmaceutical waste from households, including non-hazardous waste. The agency is now considering comments submitted by interested parties to the proposed change to the regulation.
APhA commented with specific recommendations and supported the general intent to facilitate management of hazardous pharmaceutical waste by streamlining requirements so that generators, including pharmacies in any practice setting, could have the flexibility to voluntarily choose to manage such waste under the provision of the UWR.
Cathy Polley, vice president, pharmacy services, Food Marketing Institute, Arlington, Va., noted the difference between pharmaceutical wastes and universal wastes. “The issues of drug diversion and the handling of medical waste must be considered as the EPA moves forward,” she said in a written reply to SN.
“The current drug distribution supply chain is very highly regulated. Therefore, any entities engaged in the collection of pharmaceutical waste must receive proper oversight and regulation. The EPA's encouragement of drug take-back programs does give our industry some concern. Currently, the DEA does not allow pharmacies to ‘take-back’ controlled substance medications from patients. Additionally, if a pharmacy were to take drugs back from a consumer there is no way to determine where the drugs have been stored or if they are contaminated with infectious matter. It would not be appropriate to expose pharmacy staff or in-stock medications to this potentially hazardous waste. Storage space, administrative costs and taking pharmacy personnel away from their main duty of patient care all raise additional concerns,” she stated.
In commenting to the EPA on the proposed change, the National Association of Chain Drug Stores, Alexandria, Va., pointed to competing federal regulations and also voiced concern about consumer drug take-back programs to reduce pharmaceutical waste in the municipal solid waste stream.
“Retail pharmacies have limited space and have not been designed to store potentially hazardous waste or large volumes of returned drugs. In addition, pharmacies are very busy with dispensing prescriptions to their patients and assisting them with their medication therapy. Taking pharmacists and other pharmacy staff away from these patient care dispensing functions is not recommended when other more workable options exist through existing or potential disposal programs. Another concern is the substantial costs for funding take-back disposal programs which pharmacies cannot absorb,” NACDS stated in a letter to the EPA.
Other proposed legislation that has the potential to change the system include:
The Drug Free Water Act of 2009 (H.R. 276)
Rep. Candice Miller, R-Mich., sponsored a bill in January that would require the EPA director to convene a task force to develop recommendations on the proper disposal of unused pharmaceuticals by consumers, health care providers and others. It would limit the ability of individuals and others to dispose of pharmaceuticals through sewer systems, and would establish a task force consisting of EPA and Food and Drug Administration representatives to provide a report to Congress on efforts to improve disposal options.
The Safe Drug Disposal Act of 2009
Sponsored by Jay Insell, D-Wash., this bill supports drug take-back programs by amending the Controlled Substance Act to provide a means to dispose of controlled substances through initially adopting take-back programs in five states that avoid flushing through sewer systems. The goal of these programs would be to avoid the need for law enforcement involvement in the disposal of controlled substances by consumers. The legislation would also require the secretary of the Department of Health and Human Services to enforce labeling requirements for new drugs and biologicals to indicate the medications should not be flushed. For previously marketed medications, FDA would conduct a review and require a change in product labeling.
For now, supermarket pharmacies remain on the periphery of the issue. “We are following the issue closely and listening to our customers,” said Supervalu's Vercammen. “For now, we believe that prescription drugs, along with other hazardous wastes, are best handled in the solid waste disposal processes in local communities. To that end, we are working with our industry partners and regulators to address ways that consumers can safely dispose of prescription drugs along with all other household contaminants.”
FMI endorses the SMARxT Disposal campaign, a joint effort of the APhA, PhRMA and the U.S. Fish and Wildlife Service, to raise public awareness of proper disposal of household medications.
The National Community Pharmacists Association, Alexandria, Va., also introduced this year a prescription disposal program that offers information and resources for pharmacies to create prescription drug disposal programs for consumers as part of the Protect Your Pharmacy Now! program. In testimony earlier this year before a hearing of the U.S. House of Representatives Committee on the Judiciary on secure and responsible drug disposal, Cheri Garvin, chief executive officer of Leesburg Pharmacy, Leesburg, Va., said on behalf of the NCPA, “As active members in the community, pharmacists are in a prime position to ensure the safe and proper handling of medications, from dispensing to disposal. Participating in a medication take-back program is a great opportunity for pharmacists to lead the way in pharmaceutical waste disposal that highlights their role as a respected and knowledgeable resource on medications.”