January 29, 2009
COLLECTING AND DISPOSING OF UNUSED MEDICATION AND RECYCLING PRESCRIPTION BOTTLES
By: Paul Frisman, Principal Analyst
You asked about (1) collecting and disposing of unused medication and (2) recycling prescription bottles.
Recent research has shown that flushing unwanted medication can contribute to water pollution and interfere with the health of fish and wildlife. Thus, health and environmental officials are recommending that unwanted medication be collected and disposed of in compliance with federal and state laws affecting public health, public safety, controlled substances, hazardous waste, and pharmacy regulation.
The Product Stewardship Institute (PSI) http://www.productstewardship.us/displaycommon.cfm?an=1&subarticlenbr=181), a national nonprofit organization, is working with state and local governments on how best to prevent unwanted medications from entering the environment. At least two states are considering proposals to have drug manufacturers fund disposal programs. The Connecticut Department of Environmental Protection (DEP) is assessing the feasibility of take back programs and producer responsibility models through PSI.
In the meantime, the federal government and DEP have issued guidelines on how best to dispose of unwanted medication. The Department of Consumer Protection (DCP) is also working on similar guidelines with CVS Pharmacy.
The Northeast Recycling Council, Inc. (NERC) a nonprofit organization that has conducted a number of prescription drug collections, states that, while desirable from a strictly environmental standpoint, recycling empty prescription vials raises concerns about the lack of a market for the type of plastic from which most vials are made, the ability to sufficiently clean the vials to prevent contamination from medication, and the possible disclosure of personal information from hard-to-remove prescription labels. In addition, some prescription drug containers are not readily recyclable. DEP and DCP share these concerns, although DEP states that, if feasible, it supports recycling clean, empty prescription containers whose contents have been appropriately discarded.
DRUG COLLECTION AND DISPOSAL
A 2002 study by the U.S. Geological Survey found a broad range of chemicals, including human and veterinary drugs, downstream from highly developed areas and areas of livestock production. One or more of these chemicals was found in 80% of the streams sampled. Researchers suspect that hormones and medicines in the water may interfere with the health and reproduction of fish and wildlife. Some officials are therefore proposing that consumers turn in unwanted medications for collection and disposal, instead of flushing them down the drain or placing them in the trash. (Throwing out medication can cause problems if the drugs leach into water supplies from landfills, or animals ingest them while rooting through garbage.)
Drug Collection Proposals in Other States
Several states, including Maine and Washington, have begun looking at ways to encourage residents to safely return unwanted medication for collection and disposal.
Maine has established an Unused Pharmaceutical Disposal Program administered by the state's Drug Enforcement Agency (22 MRSA § 2700). Under the program, residents can place unused drugs in pre-paid mailing envelopes and mail them to a collection location. The Maine
legislature is considering a proposal that would require drug manufacturers to pay for a permanent disposal program for their unused products. More information is available at: http://www.innovations.harvard.edu/news/139581.html.
The state of Washington is considering legislation to require drug producers to create and fund product stewardship programs to collect unwanted drugs from consumers and dispose of them at hazardous waste facilities. Under the proposal, by January 1, 2012, all producers of drugs sold in Washington must participate in a drug return program, in which they pay all costs of collecting, transporting, and disposing of unwanted drugs. More information on the proposal can be found at http://apps.leg.wa.gov/billinfo/summary.aspx?bill=1165&year=2009.
More information on how other states are addressing the problem can be found on the website of the National Conference of State Legislatures (NCSL) at: http://www.ncsl.org/programs/health/shn/2008/sn513b.htm, and at the website of the Illinois Indiana Sea Grant Program at:
Collection and Disposal Guidelines
Both the federal government and DEP provide guidance on how to dispose of unwanted prescription medication. DCP, which has collaborated on unwanted medication collections with CVS and NERC, is currently working on similar guidelines with CVS.
The federal Office of National Drug Control Policy guidelines (attached) recommend that consumers:
1. remove unwanted prescription drugs from their containers and throw them in the trash;
2. mix the unwanted drugs with such substances as used coffee grounds or kitty litter, and place them in empty cans or sealable bags to further prevent them from being misused;
3. flush prescription drugs only if the label or accompanying patient information instructs them to do so; and
4. take advantage of pharmaceutical take-back programs.
DEP guidelines (attached) are similar, but warn against flushing any medication, instead recommending they be placed in the trash in their original containers to prevent them from being misused or misidentified. The guidelines also recommend removing the label or making it unreadable, and mixing the medications with other substances such as water, salt, or charcoal to discourage people from taking them. They advise against recycling the containers.
NERC'S EXPERIENCE IN MEDICATION COLLECTIONS
NERC has conducted seven medication collections throughout the northeast, three of them in Connecticut. According to NERC, the key elements to a successful collection include:
1. the participation of law enforcement officials, who take possession of controlled substances and are responsible for their destruction;
2. the segregation of controlled from non-controlled substances by a licensed pharmacist; and
3. the appropriate destruction of all medication.
At these collections:
1. individuals arrive to drop off unwanted medication at a particular location (e.g., a fire department);
2. a pharmacist sorts and categorizes the medication as controlled or non-controlled substances (unidentified medications are managed as controlled substances);
a. the non-controlled substances are put in hazardous waste containers;
b. controlled substances are inventoried and given to law enforcement personnel;
3. a controlled substance inventory is signed by the law enforcement official and pharmacist;
4. a hazardous waste hauler removes the non-controlled substances for transport to a high-temperature, hazardous waste incinerator; and
5. a law enforcement official secures controlled substances for their eventual destruction (at a local Resources Recovery Facility if disposed of in Connecticut).
NERC notes that a number of issues must be resolved to ensure the efficacy of these collections. Federal and state laws affecting public health, public safety, controlled substances, and pharmacy regulation must be considered. For example, prescription drug collections are complicated by the fact that this medication includes (1) both controlled and non-controlled substances and (2) hazardous wastes.
IMPEDIMENTS TO PHARMACEUTICAL COLLECTIONS
Controlled substances are specifically defined and regulated under the federal Uniform Controlled Substances Act (21 USC § 801 et seq.). Under the act, only the person for whom a prescription has been written can legally possess it (21 USC § 844(a)). However, a controlled substance may be placed under the control and custody of law enforcement officials specifically authorized to receive and possess it. Under state law, the officials would be members of DCP's Drug Control Division (CGS § 21a-262). The law enforcement officials must dispose of controlled substances according to specific regulations (21 CFR § 1307.21).
NERC found it impractical to ask people to refrain from bringing unwanted controlled substances to collections, and therefore states that it is essential that law enforcement personnel be present to handle and dispose of these materials (Operating Unwanted Medication Collections, available on-line at http://www.iisgcp.org/unwantedmeds/updatedToolkitMaterials/3.1NERCadvisory.pdf and Best Management Practices for Holding Unwanted Medication Collections, online at http://www.nerc.org/documents/unwanted_medication_collection_bmp_11_08.pdf).
The federal Resource Conservation and Recovery Act (RCRA) (42 USC 6901 et seq.) regulates the transport, treatment, and disposal of hazardous waste. RCRA affects medication collections because some medications (e.g., unused nitroglycerin, NicoDerm patches, and Coumadin) are specifically listed as hazardous wastes; others are characterized as hazardous waste because they are toxic or can be ignited (e.g., Paclitaxel, used in cancer chemotherapy.)
Although RCRA exempts waste generated by individuals, state law requires that companies that collect these hazardous wastes obtain a DEP permit (CGS § 22a-454).
Because of these and other concerns, a NERC advisory committee has concluded that all unwanted medication should be disposed of as a hazardous waste, with incineration and solid waste landfills as the second and third choices. For more information on NERC's conclusion, please see http://www.iisgcp.org/unwantedmeds/updatedToolkitMaterials/3.1NERCadvisory.pdf, at page 10.
John Gadea, director of DCP's Drug Control Division, believes this may be unnecessary, as long as the unwanted drugs are disposed of properly. He says that treating all collected drugs as hazardous waste would add significantly to the cost of disposal and could deter pharmacies from participating in collections.
DEP's Robert Isner states that his department would prefer to see pharmaceuticals classified as universal waste, a type of hazardous waste that is subject to less stringent handling and disposal requirements. A universal waste must be (1) very common, (2) significant in the waste stream, and (3) generated by a wide variety of users. Classifying prescription medication as a universal waste could be achieved through the regulatory process.
According to NERC, because of concerns that a pharmacist is not permitted to possess a controlled substance, the sponsors of a collection event should obtain prior approval from the state pharmacy commission (located in DCP).
NERC states that recycling clean, empty medication containers is preferable from a purely environmental viewpoint and that municipal recycling programs should encourage the recycling of empty containers where possible within the guidelines of existing programs. NERC says consumers should be encouraged to remove prescription labels from the bottles.
But a NERC study (attached) also found several significant impediments to recycling. These include its findings that (1) many prescription vials are made from a plastic resin (polypropylene or type #5) that is not currently included in municipal recycling programs, (2) their size and method of manufacture may pose a problem for some recyclers, and (3) there is no readily available recycling market for them. NERC Executive Director Lynn Rubinstein states she does not believe it would be cost effective to separate out prescription bottles even if there were no health or safety concerns.
More information on NERC's study of medication bottle disposal and recycling is available at http://www.nerc.org/documents/plastic_medication_container_bmp.pdf.
Even if a market existed for recycling prescription bottles, DCP's Gadea cautions that they may be impossible to clean sufficiently for recycling, and that recycling would also raise patient confidentiality issues because of the difficulty of removing the prescription labels from the bottles. DEP supports recycling of empty containers if feasible, and if the drugs have been disposed of appropriately, but shares the concerns about privacy and potential contamination that DCP raises.