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If your doctor's office or hospital is a fully functioning clinic, it's very likely you periodically need to dispose of expired medications and biohazardous waste. When it comes to disposal of expired medications, staff need to follow specific regulations and restrictions regarding such waste and what kinds of medications get disposed of and in what fashion.
Violations for non-compliance can cost a doctor’s office or hospital with massive fines that might exceed $70,000 per day, per violation. Dispose of expired medications the right way to avoid not only fines, but damage to your reputation that can lead to financial ruin.
Know the difference between red bag waste and pharmaceutical waste guidelines that will keep your facility or hospital compliant.
01 / What Is Red Bag Waste?
In the past, a common practice used by doctors' offices and hospitals alike was to simply put expired medication in red bag waste. This is not the protocol for properly disposing of hazardous waste, though, and could lead to fines being levied against the facility.
Red bag waste is a term that defines biohazardous waste that contains anything contaminated with blood, components of blood, as well as other materials that might pose a significant risk for transmission of bacterial, viral, or fungal properties.
Sharps, which includes needles, scalpel blades, pipettes, slides (or anything that has a potential to slash, poke, or cut) and other types of regulated medical waste must be disposed of safely and properly. That includes contaminated gloves, gowns, wound dressings, and so forth.
This type of waste is typically called ‘red bag’ waste because it is disposed of in plastic bags, solid plastic containers, or other bins or boxes that are red or reddish-orange in color and clearly marked as ‘Biohazard’ waste. Sharps containers, boxes and bins are commonly found in doctor’s examination rooms as well as throughout hospital or clinical facilities.
Items contaminated with possible bloodborne pathogens or infectious agents are the only items that are supposed to go in regulated medical waste (red) bags, which means no expired medicines and no pharmaceuticals of any kind. The Resource Conservation and Recovery Act (RCRA) laid out this policy.
The RCRA policy stipulated that biomedical waste and drugs had to be separated and disposed of through different methods. Failure to do so now constitutes improper hazardous waste disposal. Remember however, that medicines or pharmaceuticals can also be categorized as either hazardous or non-hazardous depending on their components.
02 / What exactly is a Pharmaceutical Waste?
A pharmaceutical waste is defined as one that can be or is no longer used for a specific purpose, such as in a treatment or procedure. Many such drugs or pharmaceuticals are not generally returnable to a reverse distributor for credit, such as opened but unused medicines. Most in this category are intended for discarding or destruction. Some types of pharmaceutical waste from a physician’s office or hospital or clinical environment might include:
A half-filled or pre-filled syringe
A medicine that has not been dispensed or a pre-filled syringe that has not been used
A discontinued medicine
Patient prescriptions
A physician’s drug samples
Prefilled IVs
The RCRA defines a hazardous drug as one that is known to be dangerous to human or animal health, or the environment if improperly disposed of. Refer to the listed wastes (P- or U-list) or the characteristics of a hazardous waste (toxic, ignitable, corrosive, or reactive) here.
Per the RCRA, a U-listed waste such as a chemotherapy drug must be disposed of as a hazardous pharmaceutical waste. A P-listed drug can also be deemed hazardous, such as Coumadin (warfarin) or epinephrine.
What about expired medicines? Expired medicines (such as those that remain in vials or manufacture packaging) are NOT to be disposed of in red bag waste. While the bulk of pharmaceutical waste is non-hazardous, it’s important to know the difference.
03 / Why Does Improper Drug Disposal Occur?
Why does improper drug disposal occur? Lack of knowledge. Regulations regarding pharmaceutical or expired or unused medications can be confusing. Numerous agencies are involved in pharmaceutical waste disposal, such as:
EPA
RCRA
Department of Transportation (DOT)
Occupational Enforcement Agency (OSHA)
Drug Enforcement Agency (DEA) – especially in regard to controlled substances
State regulatory agencies
Publicly owned treatment works (POTW)
Every state also has their own guidelines for such disposal, as well as requirements to follow the rules of the federal government as proposed in the Final Rule, ‘Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine’ which when into effect in 2018.
In the past, rules regarding pharmaceutical waste disposal were rather vague. For example, unused or expired medicines and drugs were often simply dumped and flushed down a toilet or sink or floor drain. This is no longer legal. Today, management of hazardous waste pharmaceuticals must follow the regulations of the EPA’s Resource Conservation and Recovery Act guidelines.
Per newer guidelines of the RCRA, healthcare facilities are encouraged to send any unused and hazardous prescription waste pharmaceutical to reverse distributors whenever possible for credit back from the drug manufacturer.
Violations and fines for non-compliance today are severe. Rules for how such drugs are to be stored, how long they can be stored prior to transportation off-site for incineration, or for return via reverse distributor can be accessed from state government websites as well as those of the federal government.
Rules for accumulation as well as proper labeling must also be followed. Review the EPA’s rules found under Title 40 CFR §262.34 for the length of time you can store hazardous waste prior to transportation off-site. Also pay attention to regulatory information found in the Federal Register (80 FR 58014 – Management Standards for Hazardous Waste Pharmaceuticals).
04 / Laws have Changed, Fines Increased for Non-Compliance
Physician offices, clinics, care facilities, and hospitals must remain up-to-date regarding medicinal or pharmaceutical waste management and documentation. They must also know the difference between various waste streams, including ‘red bag’ waste. What was allowed in the past is not always allowed today.
In recent years, such laws have been more aggressively enforced, with fines for non-compliance to match. Fines for improper drug disposal can range from $10,000 per day, per violation, up to or exceeding $25,000. In addition, other agencies such as DOT can impose their own penalties of up to $15,000 per day, per violation. Those penalties apply not only to the transportation company but the generator of that waste as well, so it’s important to make sure the waste management company you choose knows the law.
If you're overwhelmed by the prospect of learning all the rules of proper medication and pharmaceutical disposal in your physician’s office, clinic, or hospital, and implementing those rules throughout your facility, contact a hazardous waste company like MCF Environmental Services to provide guidance.
A proper waste management company will be familiar with current regulations and protocols, with the ability to provide pertinent information to the proper parties within the clinic or hospital. It's also a good idea to find a company that has both a hazardous waste and a biomedical waste transportation license. That way, the same company can dispose of your properly sorted, correctly handled regulated medical waste and expired medications.
For more information about expired medication or hazardous pharmaceutical waste and red bag waste and how to compliantly dispose of both, contact a representative of MCF Environmental Services, providing professional medical and hazardous waste services for healthcare providers.
Robert Losurdo
President, COO
