After the report released, the EPA immediately called for hospital pharmaceutical waste compliance programs as a part of regulators’ inspections. Responsible healthcare leaders responded by starting to build comprehensive programs focused on compliance, safety and preventing pharmaceuticals from reaching public water supplies.
Hospital staff prescribes and administers the largest amount of pharmaceuticals out of all U.S. healthcare facilities. A hospital’s formulary can range between 1,400 and 4,000 drugs. Three quarters of these drugs are characteristically hazardous and not listed by the EPA. Therefore it is crucial for leaders to prioritize a pharmaceutical waste compliance program, leaning on the counsel of third-party experts. As a first step, every responsible healthcare leader should understand major trends and 10 key insights about their hospital’s pharmaceutical waste. This article focuses on what leaders should know.
Know your pharmaceutical waste
Start with the characterization of the hospital’s drug formulary.
“Most hospital teams do not have the in-house expertise or the bandwith to comb through the thousands of drugs in their formulary and determine which ones are regulated. It is far better to utilize a third party partner whose software can match the NDC code for each drug with the corresponding waste code. An annual analysis of the formulary with a focus on any new drugs should be conducted,” said John Hudgens, sustainability manager for Children’s Hospital of Colorado.
Once characterization is done, specific container locations for the pharmaceutical waste are strategically discussed with staff and then placed throughout the facility near where the waste is generated such as in medication rooms, soiled utility rooms, operating rooms, and emergency rooms although locations vary by hospital.
Ultimately, there is a balance between the need for multiple waste containers for segregation with available wall or floor space. Once in practice, permanent locations can be refined, possibly with a partner whose service technicians help move the containers throughout the hospital. A partner can simplify complicated regulations, provide training throughout the hospital and bring best practices learned by working with hundreds of health systems.
Consider the new proposed EPA rule
In August, the Environmental Protection Agency (EPA) released its highly anticipated proposed rule on the management of hazardous waste pharmaceuticals. Under the new rule, pouring unused or expired hazardous waste pharmaceuticals down sinks or toilets—a practice some facilities still use—would be banned. Also, pharmaceutical hazardous waste, including P-listed waste, would not count toward a hospital’s generator status. In addition, the facilities would not have to specify hazardous waste codes on manifests. They could accumulate hazardous waste pharmaceuticals on site for a year rather than the current 90-to-180-day requirements for Large Quantity Generators and Small Quantity Generators, respectively.
Recognize pharmacists’ top compliance-related challenges
Experts indicate that complex regulations for pharmaceutical disposal methods can prevent accomplishing full regulatory compliance.1 These experts believe at least one-quarter of all facilities struggle to manage RCRA-related waste, controlled substances, and non-hazardous waste.
Pharmacy Purchasing and Products published this year the top five reasons cited by hospital pharmacists for compliance-related challenges, including the complexity of regulations, staff training challenges and lack of in-house expertise.
“Pharmaceutical waste is complicated more by the fact that some drugs are hazardous and others nonhazardous. It can be difficult to create a comprehensive process for segregating waste on the different floors. A critical piece is to initially identify what is hazardous waste or not. Once this decision is determined it can be properly separated,” said Tom Johnson, Pharm.D., assistant vice president of hospital pharmacy, Avera Health, Sioux Falls, South Dakota.
Waiting means falling behind
Smart practices include conducting an annual audit of the pharmaceutical waste program that may dictate additional training. Although hazardous pharmaceutical waste is a newer category for health facility pharmacists, this stream is now a priority for teams to proactively manage given pressure by community members to do the right thing when it comes to safety and environmental responsibility. Those hospitals that have “watched and waited” while their peers sought to formalize a program are “now behind the eight ball” according to a director of pharmacy operations at one of the largest hospital systems in the Midwest that established a pharmaceutical waste compliance program five years ago.
Ensure training programs cover all units and shifts
Teams benefit by training during the implementation that is specific to pharmacy, the OR, ER, environmental services, clinicians and education staff who work on all units and shifts. Custom and proprietary training material can be shaped for a “train-the-trainer program.” Additional training occurs during implementation and within 90 days for all departments after the installation.
A partner can help set up a central accumulation area for storing highly regulated hazardous waste, as well as packaging and labeling it for shipment. DOT regulations require staff that packages, labels, marks, or prepares hazardous waste for transport must be trained properly. Hospitals must put controls in place to ensure that manifests for hazardous pharmaceutical waste are signed only by properly trained personnel. Manifests are used as proof of transport and proper disposal.
Keep up with changing regulations
Ongoing support and information to sustain program compliance and maximize your investment can serve as a reputation enhancer. It is critical to keep up with changing regulations and identify how the facility is performing after implementation. Hospital leaders often desire ongoing support and consultation regarding compliance with regulatory agencies like The Joint Commission or keeping up with changing regulations.
Leaders of hospitals, no matter the size, are recognizing that they can no longer delay implementing a comprehensive pharmaceutical waste program. As health systems continue to expand their infrastructure and acquire new facilities, a formalized program becomes an extension for hospital owned off-sites to improve compliance as well.
While hospital leaders should try to replicate pharmaceutical waste compliance programs in their off-site facilities, each location must be evaluated individually to determine if modification of the program is warranted. The rules governing how waste is managed differ depending on the type and volume of waste generated.
A review of 10 insights that hospital executives should know before they try to manage a pharmaceutical waste compliance program on their own
1. Characterize your drug formulary
2. Strategically place containers throughout a facility
3. Segregate waste including what is hazardous, non-hazardous, and incompatible
4. Identify the percentage of hazardous pharmaceutical waste that is regulated as toxic, corrosive, ignitable or reactive (few drugs are considered reactive).
5. Determine whether more resources are necessary to manage pharmaceutical waste in-house or to partner with a third party expert
6. For sustained success, make training mandatory for pharmacy, OR, ER, environmental services, clinicians and education staff
7. Prepare for an annual audit of your program by a partner that can expose gaps, help correct any deficiencies, and prepare for the inevitable audit by a regulatory agency
8. Certify staff on signing manifest documents as proof of transport and proper disposal
9. Seek ongoing support and information to sustain program compliance and real-time awareness of regulatory changes
10. Formalize an extended program for your off-sites
1 Pharmacy, Purchasing & Products, December, 2014
The views, opinions and positions expressed within these guest posts are those of the author alone and do not represent those of Becker’s Hospital Review/Becker’s Healthcare. The accuracy, completeness and validity of any statements made within this article are not guaranteed. We accept no liability for any errors, omissions or representations. The copyright of this content belongs to the author and any liability with regards to infringement of intellectual property rights remains with them.
