/ IN THIS BLOG
Numerous federal laws on the books determine how certain pharmaceuticals are to be disposed of. Such regulations apply to any medical facility—from doctors' offices to outpatient surgery centers to long term care facilities and large or small hospitals. Failure to comply with pharmaceutical (or any medical waste) regulations can trigger heavy penalties (financial and otherwise).
It’s important for every facility to know these federal (and state) regulations. It’s even more important that everyone in that facility follows them to the letter. Education, training, and documentation are all important aspects of compliant pharmaceutical waste management and disposal.
01 / What Pharmaceuticals are we talking about?
Pharmaceutical waste typically defines and includes a used or expired prescription drug, but can also imply some personal care products used in the average home. A few examples of such medications include but are not limited to:
Any P-listed waste found under the Code of Federal Regulations (CFR) Title 40, Part 261.30 (Subpart D) listing hazardous wastes. Pay special attention to the list of chemicals found in 261.33 which includes discarded commercial chemical products.
Cytotoxic medications used in chemotherapy treatments
Medications used in cancer treatment such as fluorouracil creams
Anti-viral agents
Anesthetic agents
Prescription hormone creams or products (topical or pill form)
Medications like warfarin
Hazardous drugs are most simply defined as those that have certain characteristics such as toxicity – with the potential to cause injury or organ damage – or those that might impair fertility, or have other negative effects on the body. Such pharmaceuticals must be properly disposed of for safety of humans and the environment.
Turn to the Environmental protection Agency (EPA) as well as the Resource Conservation and Recovery Act (RCRA) for more in-depth information regarding hazardous and non-hazardous wastes. The National Institute for Occupational Safety and Health (NIOSH) also provides detailed information on the dangers of hazardous drug exposure.
Compliant disposal processes also apply to any pharmaceutical that a medical provider no longer needs. In the vast majority of cases, that means expired medications, samples, or unused medication often returned by patients.
02 / What's the Wrong Thing to Do?
Laws pertaining to pharmaceutical disposal have changed over the years, not only to enhance safety and reduce risk of exposure or injury due to improper disposal methods, but to protect the environment as well.
Sometimes the best way to know what to do is to realize what not to do when it comes to pharmaceutical drug disposal, regardless whether they are hazardous or non-hazardous. In terms of pharmaceuticals, that can mean the following:
Dumping expired medications down the drain (illegal as of early 2019. More details on that here.)
Throwing any pharmaceuticals (expired or not) directly in the trash
Putting pharmaceuticals in red bag waste (Not only is this not recommended, but doing so can also artificially inflate regulated medical waste disposal costs.)
Stay up to date on pharmaceutical waste management and disposal regulations of the federal government and your state. Be aware of the difference between regulated and non-regulated pharmaceutical waste. Even a drug or medicine that is not hazardous must be disposed of properly based on the regulations of the RCRA and the Drug Enforcement Agency (DEA). Also be aware that individual states may also have laws that are more stringent than those of the federal government for this type of waste.
In many cases, lack of knowledge or education has been the culprit for improper pharmaceutical waste, but so too is outright non-compliance. Every staff member of a healthcare or medical facility, pharmacy, or care provider should know and follow the law. Failure to do so can result in daily fines of $10,000 to $25,000 per violation until the problem has been rectified!
Fines are also imposed for non-compliant transportation of pharmaceuticals off-site. Per the Department of Transportation, penalties of $15,000 per violation (per day) may also become the generator’s responsibility.
No excuses. Know the laws and follow them. Properly dispose of pharmaceutical waste.
03 / Why Does Proper Pharmaceutical Waste Management Matter?
In addition to increasing the risk of fines and damage to reputation due to non-compliant pharmaceutical waste management and disposal, improper disposal often allows hazardous pharmaceuticals to pollute or contaminate water sources or landfills. Such waste can potentially leach into the soil and water tables, leading to often devastating environmental risk to local and distant flora and fauna.
Since 2008, the EPA has cautioned that contaminants of emerging concern (CECs) of pharmaceutical and personal care products are being found in ever lower levels of surface water, and can potentially damage aquatic life. Other studies have suggested that pharmaceutical effluents have been shown to damage wildlife and also contribute to antimicrobial resistance.
To reduce such contamination and preserve human health and safety as well as the environment, take steps to remain in compliance when it comes to pharmaceutical waste management and disposal.
04 / Tips to Remain in Compliance
Tip #1: Reach Out to Expert Waste Management Waste Facilities
Work with a qualified, experienced, and reputable medical waste management company such as MCF Environmental Services, with the experience to handle all types of healthcare waste, including pharmaceutical waste. Make sure that any company you decide to work with has the appropriate permits and insurance coverage.
A hazardous waste manifest (EPA Form 8700-22) is required by federal government to ensure adequate tracking and disposal of hazardous wastes. A Bill of Lading is required for non-hazardous or biomedical waste transport, so any waste management company that agrees to pick up your medical waste must possess those documents. It is the responsibility of the waste generator to ensure that these documents are current and accurate regarding contents transported off-site.
In addition to manifests, be knowledgeable and diligent about shipping and transportation of such waste, and of compliant disposal of pharmaceutical waste. You and your waste management company must know these regulations, from township to county to federal level.
Finally, work with a full-service medical waste management company. That way, one company can process all paperwork, provide all containers, and complete every step in the medical and pharmaceutical waste management and disposal chain, ensuring that your pharmaceutical waste is properly treated and disposed of.
Tip #2: Identify What You Have
Any medical care facility that receives or dispenses pharmaceuticals must be aware of the scope of those drugs, from hazardous to over-the-counter. Your facility’s formulary should contain a full list of pharmaceutical agents depending on focus of care (cancer, infectious disease, cardiology, etc.). By providing a copy of the formulary to your pharmaceutical waste company, they can ensure that the medicines are properly and compliantly contained, stored, transported, and disposed of based on their hazardous or non-hazardous components.
Smaller medical facility can give the waste management company an inventory list of pharmaceuticals or medicines used. A knowledgeable and reputable waste management company can then create a waste profile to identify what you have and how to properly dispose of it. This ensures safety for the waste transporters as well.
Tip #3: Use Compliant Pharmaceutical Waste Containers
A waste management company like MCF Environmental Services provides specialized containers to store pharmaceutical waste. These containers already have required placards and labels, and will be UN-rated and Department of Transportation (DOT)-approved. When that container is full, simply call your waste management company to come and take it away.
It is not uncommon for a medical waste management company to combine all pharmaceuticals (hazardous and non-hazardous) and process everything as hazardous. This means everything is disposed of safely in a medical incinerator to ensure that no hazardous pharmaceuticals slip through the waste disposal process – and ensures compliance.
For more information about proper expired medication disposal, contact a representative of MCF Environmental Services, a medical waste management company based in Atlanta, Georgia and serving states throughout the country.
Robert Losurdo
President, COO
