The pharmaceutical waste management market is expected to increase from $1.19 billion in 2017 to $1.98 billion by 2025, positioning it as a global health, safety, and environmental concern.
The U.S. reportedly ranks as the number one producer of pharmaceutical waste. That’s why government bodies such as the Food and Drug Administration (FDA), Environment Protection Agency (EPA) Drug Enforcement Administration (DEA), and Department of Transportation (DOT), among others, have enacted pharmaceutical waste regulations to deal with hazardous materials disposal. From controlled substances to chemicals used in cosmetics, pharmaceutical waste guidelines have been developed to ensure hard-working community members and the environment do not suffer unnecessary harm.
Despite the laser focus on managing hazardous materials, too many organizations make mistakes, such as failing to provide PPE for handling medical waste. If you are a decision-maker or someone who works close to medical waste, the following insights about pharmaceutical waste and common mistakes could prove invaluable.
What is Pharmaceutical Waste?
Pharmaceutical waste is typically classified into two categories — hazardous and non-hazardous materials. These may include a wide range of expired or unused medications that require specific disposal because they pose a risk to human beings or the environment. It’s essential to identify and classify these materials to avoid contamination and ensure that workers tasked with the disposal process follow safety regulations and have access to appropriate personal protective equipment (PPE) and disposable clothing.
How are Pharmaceutical Waste Materials Classified?
Before a material can be classified as hazardous or non-hazardous, pharmaceutical waste guidelines regarding toxicology must be considered. The EPA publishes and updates what industry insiders call the P and U lists. A product is usually deemed hazardous if it contains a chemical on the list, the waste is unused, and it is a commercial chemical product. In terms of unsafe characteristics of waste, these usually involve concentrations of the following properties.
- Ignitability: The potential for a material to ignite remains a determining factor in making a hazardous materials’ judgment. Seemingly common products such as alcohol-based cough syrups and aerosol products may have a flashpoint that makes them increasingly dangerous to transport, house, handle, and dispose of effectively.
- Corrosivity: Pharmaceuticals that rely on nitric acid are a prime example of a potentially corrosive material. Items that utilize acids, or health hazards such as glutaraldehyde, require diligent care. Workers are usually required to wear pharmaceutical PPE and clothing when handling corrosive materials.
- Reactivity: Although wide-reaching materials are relatively safe to handle alone, some interact poorly with others. This often proves challenging for pharmaceutical organizations and disposal specialists. Because reactive substances may not rise to the level of hazardous, pharmaceutical waste regulations dictate decision-makers must refer to the Safety Data Sheet to identify potentially dangerous interactions with other materials the element may encounter.
- Toxicity: The EPA requires companies to follow pharmaceutical waste guidelines that determine the toxicity of a given material based on concentration. It may seem almost counterintuitive, but many waste materials people think of as hazardous may not necessarily qualify. A significant part of the categorization process involves leveraging a test called the Toxicity Characteristic Leaching Procedure. Chemicals such as selenium, silver, and mercury are usually classified as hazardous pharmaceutical waste.
Materials and products that have passed their expiration date, are unnecessary, or have been compromised, may also fall under the hazardous materials list. Organizations may not always need to require workers to practice the highest safety protocols when a material falls outside the hazardous paradigm. However, insisting on PPE for handling medical waste is a better safe than sorry policy companies would be wise to adopt.
What Constitutes a Pharmaceutical Waste Generator?
Much of the EPA’s disposal regulations and pharmaceutical PPE guidelines focus on the process that starts with what industry insiders called “waste generators.” The organizations that fit into this select group are not necessarily all large multi-national corporations. That’s primarily because pharmaceutical waste covers wide-reaching products and materials throughout the supply chain. The following short-list of generators highlight just how pervasive pharmaceutical waste remains in our communities.
Pharmaceutical Manufacturing Plants
Perhaps the largest generator of this class of waste, pharmaceutical plants routinely put workers in close proximity to hazardous materials. Along with unused and expired chemicals, spills and residue require ongoing clean-up. That means dangerous materials taint mops, buckets, bins, as well as the pharmaceutical PPE and disposable clothing worn while cleaning the facility.
Health and Extended Care Facilities
The bright-colored biohazard disposal bins in healthcare and extended care facilities are where many pharmaceutical materials are placed. Expired drugs, used syringes, and chemical contaminants, require safe handling. Many of the products placed in red, orange, or yellow containers and bags are typically marked with a biohazard symbol. That’s primarily because the materials often pose a danger to the environment and human beings.
One of the most concerning pharmaceutical waste products these facilities routinely throw out is opioid painkillers. Opioids can result in further addiction in the wrong hands, and expired medications could prove fatal to users. Those are reasons why health and extended care facilities are generally required to provide employees with PPE for handling medical waste.
Cosmetics and Personal Care Manufacturers
The cosmetics and personal care product industries generate an enormous amount of pharmaceutical waste when making perfumes, lotions, and body creams, among others. It’s also not unusual for spent containers to be laced with sometimes hazardous chemicals.
Just as human-centered health care facilities use wide-reaching medications and chemicals, veterinarians generate waste as well. The animal care sector also utilizes a supply chain that involves manufacturing, distribution, and end-user locations such as the local vet’s office.
These and many other major waste generators are required to follow stringent regulations when handling or disposing of pharmaceutical waste. But not every organization must comply. For example, the conditionally exempt small quantity (CESQ) rule allows organizations that generate less than 220 pounds of hazardous waste, spillage, or 2.2 pounds of acutely hazardous waste per month to self-manage disposal in some cases. Large generators typically must follow more stringent guidelines and work with hazardous waste specialists.
What Are Impacts of Improperly Disposed of Medical Waste?
Pharmaceutical waste regulations require that hazardous materials are treated and rendered non-infectious. The process may involve steam sterilization, deploying chemical agents, or incineration, among others. When appropriate guidelines are not followed, these contaminants can leak into the soil, groundwater, and impact wildlife and humans alike. Other outcomes include debilitating health conditions and infection. Those rank among the critical reasons why the EPA diligently updates hazardous waste disposal regulations.
EPA Issues 2019 Pharmaceutical Waste Regulations
Under the 2019 rule change, the EPA homed in on hazardous pharmaceutical waste generated by healthcare facilities. Referred to as Subpart P, the new pharmaceutical waste guidelines provide enhanced direction regarding management and disposal. Chief among them are rules in which small and large waste generators are tasked with waste management under this subpart. It disallows flushing or any method that allows medical waste to enter sewers or waterways. Very small quantity generators must also follow the updated regulations. Furthermore, controlled substances fall largely under the regulations of the DEA.
Most Common Mistakes Throughout the Waste Disposal Process
The environmental and human health implications associated with pharmaceutical waste misuse are troubling. Federal agencies such as the EPA, Occupational Safety and Health Administration, U.S. Department of Transportation, and even the DEA are prepared to level hefty fines and prosecute individuals who willfully contaminate. But one of the disheartening issues surrounding a clean, safe environment is that human error leads to too many disposal mistakes. These rank among the more prevalent errors that result in everyday people and nature suffering harm.
1) Improper Classifications
Hazardous pharmaceutical waste must be categorized under the D-list, U-list, or P-list. These designations need to be correctly labeled or applied to align with disposal protocol. When they are not, highly toxic materials put lives in danger. Consider regularly scheduled reviews with colleagues regarding best practices and employ double-checking safeguards.
2) Incorrect Labeling
An organization’s containers must carry the appropriate hazardous waste label. This protects law enforcement officers making roadside checks as well as others in the disposal supply chain. Failing to label containers properly could result in substantial fines. It may be wise to consider assigning people to label containers and others to check their work.
3) Disposing of Waste in Sewers
The EPA focused on the problem of sewer disposal in its 2019 rule changes. The danger is considered so high that state and federal agencies prosecute offenders. That’s why it’s essential to educate team members that pouring chemicals down the drain is not an option.
4) Improper Disposal of Chemo Medications
Chemo waste results from the clean-up after these sometimes life-saving medications are used. That clean-up process, however, typically transfers chemicals to the pharmaceutical PPE and disposable protective clothing. These must also be disposed of in accordance with pharmaceutical waste regulations. Consider revising the company’s waste disposal plan and include more definition regarding how used PPE is managed.
5) Lack of Hazardous Waste Training and Personal Protective Equipment
It’s crucial that every employee who could come in contact with hazardous waste undergoes training. Supervisors and company leaders who sidestep employee training do a disservice to hard-working people. Without adequate training and access to disposable protective clothing, employees remain at risk. Industry leaders have an opportunity to require employees to complete a seminar on hazardous waste management.
6) Failure to Follow Through with Inspections
Supervisors who fail to ensure hazardous waste containers are inspected on a regular basis are courting a fine. Regulations task companies with documenting inspections. It may be worthwhile to consider placing a sign-off sheet near bins and containers that require routine inspections.
7) Inadequate Manifests
The EPA and other agencies require updated and accurate manifests detailing the waste disposal chain of custody and disposal. Incomplete paperwork typically results in a penalty. Consider reviewing manifests before loading and unloading hazardous waste containers. Truck drivers typically conduct their due diligence during required hours-of-service breaks.
8) Inadequate Emergency Plan
In the event of a chemical spill or other incident, companies are required to have an emergency plan that documents employee safety procedures and a strategy to clean up the hazard. Proactive business leaders typically bring key stakeholders together and update the emergency plan every six months.
9) Inadequate Handling of Expired Pharmaceuticals
The EPA expects companies to file the appropriate DEA 222 form indicating medications are timing-out. It may seem like tedious paperwork, but documentation is crucial to pharmaceutical waste management. Consider setting aside a specific time each week for this purpose.
10) Failure to Provide PPE for Handling Medical Waste
Industry leaders sometimes think in terms of only supplying PPE, and disposable protective clothing to employees they believe have direct contact with hazardous materials. While people on a manufacturing plant’s production area and clean-up crews require a complete inventory and accessories, other workers may find themselves in harm’s way as well. This safety gap can be closed by stockpiling PPE and protective clothing and accessories such as the following.
- Aprons that protect against chemical splashes
- Head-to-ankle coveralls that stop hazardous waste from making skin contact
- Eye protection from chemical splashes and other risks
- Breathable masks to protect against inhaling dangerous agents
- Gloves, shoe covers, or other accessories like chemical splash sleeves
Pharmaceutical PPE should be worn at every phase of the waste disposal process. From safe, certified gloves for people who remove biohazard bins and bags, to coveralls and goggles for those at heightened risk. The solution is to invest in a healthy inventory of industry-leading PPE and disposable protective clothing. International Enviroguard produces and distributes products that exceed safety standards for the pharmaceutical industry.