Many different types of regulations face hospitals and healthcare facilities. This is especially true when it comes to managing pharmaceutical waste, specifically controlled substances.
Controlled substances are categorized into five schedules depending upon the drug’s acceptable medical use and the drug’s abuse or dependency potential.
- Schedule I – These substances have no accepted medical use, are unsafe, and hold a high potential for abuse. Examples include heroin, LSD, marijuana, peyote, and ecstasy.
- Schedule II – These narcotics and stimulants have a high potential for abuse and engender severe psychological or physical dependence. Examples include Dilaudid, methadone, Demerol, OxyContin, Percocet, morphine, opium, codeine, amphetamine (Dexedrine, Adderall), and methamphetamine
- Schedule III – These are substances that have less potential for abuse but can still lead to moderate or low physical dependence and high psychological dependence. They include Vicodin, Tylenol/Codeine, Suboxone, ketamine, and anabolic steroids.
- Schedule IV – These ubstances have a lower potential for abuse than Schedule III drugs, and include Xanax, Soma, Klonopin, Valium, Ativan, Versed, Restoril, and Halcion.
- Schedule V – These are primarily preparations that contain limited quantities of narcotics, including cough syrups that contain codeine.
Hospitals today manage large formularies that can include up to 4,000 drugs. On average, about 5 percent are regulated under the Environmental Protection Agency as hazardous materials and less than 1 percent are controlled substances. Hospitals and offsite facilities have a new responsibility to safely manage this waste stream as many pharmacy leaders seek diversion prevention strategies to combat healthcare workers and staff taking used or expired drugs.
Recently Health Facilities Management magazine featured an article written by Gerry van Domelen, Senior Manager of Rx Waste Compliance for Stericycle, called “Safely Managing Controlled Substances: Effective strategies to help facilities maintain regulatory compliance.”
Due to the increasing use of pharmaceuticals, Gerry sees health leaders recognizing the need for new strategies because healthcare workers have numerous opportunities to access medications during patient care and drug waste disposal.
In this article he discusses four factors that make the initiative challenging, ranging from complicated regulations, abuse of controlled substances, lack of processes for proper disposal, and current practices that may harm the environment.
When surveyed about pharmaceutical waste, many hospital leaders cite the complexity of regulations as their No. 1 concern, closely followed by staff training to help clear up perceived contradictory federal, state and local regulatory requirements for management and disposal. These leaders understand that there is significantly increased risk without a proactive plan for making sure that leftover or unused drugs end up with the intended patient or in a secure waste container.
Gerry highlights the first challenge to properly handling and disposing of controlled substances to avoiding fines and reputational risk is understanding the regulatory requirements indicated in a 2014 regulation by the Drug Enforcement Agency.
Diversion risks are too high for providers to wait for government agencies to provide more clarity on handling disposal. Janice Vadas, inpatient pharmacy manager, Indiana University Health North, describes how even though government agencies do not prohibit flushing or require a formal process for controlled-substance waste occurring on the floors, she wants to proactively prevent incidents and to safely manage the disposal of controlled substances because it ‘affects anyone who walks through the facility’s doors.’
Practitioners who focus on patient care are finding it increasingly difficult to adhere to current regulations. In this article, Gerry encourages pharmacists to consider disposal services designed to change human behavior, starting with documented training.
Healthcare leaders are beginning to build comprehensive programs to address these challenges, including components that deactivate controlled substances, deter ingestion and apply specifically labeled and secure controlled-substance containers which is new to most facilities. Read more here.