January 15, 2024

Prioritizing Compliance and Sustainability in Pharmaceutical Waste Programs

Healthcare workers balance many responsibilities, among those being the management of healthcare waste. Pharmaceutical waste is a healthcare waste that includes medications that have been designated for disposal. Depending on your formulary and state, different regulatory requirements may apply. These requirements can be complex, however, it is important to remember that they are in place to protect environmental and human health as well as to support sustainable business outcomes. Following a standardized process that factors in compliance and sustainability as outlined below will help support successful programs.

Sustainability, as defined by the Environmental Protection Agency (EPA), rests on the principle that our survival and well-being hinge directly or indirectly on our natural environment, supporting both present and future generations. The World Health Organization (WHO) estimates that at least 15% of healthcare waste is considered hazardous, that may pose a risk to human health, the environment, and the economy. In order to support a successful, sustainable program for management of healthcare waste, understanding the various applicable regulations and how to apply and adhere to them will be critical.

Key Components for a Compliant and Sustainable Pharmaceutical Waste Program

Designing and maintaining a compliant and sustainable waste program can be complex. It requires generators to delineate specific objectives and, with leadership support, identify key stakeholders and program components. These components include understanding the capital and resources you have available or may need, understanding all requirements surrounding the waste stream and stakeholders, establishing a strategy and formal program design, building out and executing an implementation plan, and fostering ongoing program maintenance.  A successful pharmaceutical waste program plan will require:

1. Capital: This encompasses more than just finances or budget; it may include resources such as knowledge, people, supply chain, technology, and real estate. For a pharmaceutical waste program, capital may include:

  • Knowledge of applicable requirements for stakeholder role functions and waste.
    • Example: Knowledge of regulatory requirements to understand minimum program objectives and  business requirements to make a determination on program type.
  • People including labor to set up and maintain the program as well as engagement of internal and external stakeholders. Collaboration between compliance function stakeholders (policy owners and subject matter experts that drive program direction) and front-line function stakeholders with daily responsibilities to maintain the program is essential for effective program management.
    • Example: Clinical and Environmental Service (EVS) leaders should communicate with front-line clinical and environmental staff about workflow to determine the most effective location for waste containers for disposal and exchange.
  • Supply chain includes access and availability of suppliers, materials, and products to support the program.
    • Example: Supplier with a permit to accept and treat hazardous waste pharmaceuticals and disposal container availability.
  • Technology can be used to support aspects of the program, such as compliant and sustainable waste segregation.
    • Example: Integration of alerts to notify clinical staff of medication disposal requirements such as segregating non-hazardous from hazardous wastes.
  • Real estate includes space to support program products or materials.
    • Example: Space for centralized waste storage and container placement in satellite accumulation areas. 
  • Financial implications include costs of the program and the cost of potential non-compliance.
    • Example: The cost to set up and maintain the program (containers, training, and disposal) as well as considering the cost of not having a program, which could include fines and bad public relations impacting patient census.

2. Operating Framework: Compliance with regulations, industry standards, waste acceptance or supplier policies, and business requirements is fundamental for a successful waste management program for any organization. These requirements may impact how materials may be used, handled, and discarded by your organization and should establish the framework your program will need to operate within to be sustainable long term. Examples of requirements in a pharmaceutical waste program may include:

  • Regulations, which may include requirements promulgated by state and federal EPA, Drug Enforcement Administration (DEA), State Boards of Pharmacy, Department of Transportation, and various local, state, and federal agencies.
  • Industry standards and best practices such as the National Institute for Occupational Safety and Health (NIOSH), USP<800>, accreditation organizations (e.g., The Joint Commission, DNV), and recognition (e.g., Magnet, Environment Excellence).
  • Waste acceptance policies are part of supplier requirements and outline what wastes the supplier accepts. These requirements tie into supplier permitting and other business requirements, such as safety.
  • Organizational policies, which encompass all other policies implemented to reduce risk such as medication management, infection prevention, employee safety and culture, as well as patient and community considerations.

3. Strategy: Develop a strategy based on available capital and resources, your operating framework and any requirements, stakeholder support, and understanding of workflows and processes. It is important for the strategy to consider:

  • Identification of program needs and objectives.
  • Identification of capital and resource needs.
  • Identification and engagement of supporting stakeholders (internal and external).
  • Creation of a high-level proposal for senior leadership buy-in.
  • Finalization of strategy details with key internal and external stakeholders, supported by leadership.

4. Implementation: Document a comprehensive plan outlining execution strategy, key steps and corresponding timelines, and stakeholder responsibilities to implement and then maintain the program. Initiate the program with clear, manageable objectives and maintain regular communication with stakeholders.

5. Measure, Reinforce, and Re-evaluate: Continuously assess the program’s success against initial baselines and established key performance indicators (KPIs). Regularly reinforce program objectives through education, communication, and business reviews. Identify gaps and collaborate with stakeholders to address any issues that arise.

Management of Pharmaceutical Waste Generated in Home Settings

Addressing pharmaceutical waste generated in home settings requires a nuanced approach to understand the applicability of regulatory requirements and how to design appropriate programs for different waste generators—whether the generators be healthcare professionals, patients, or family members.

Unlike healthcare facilities, patients in home settings are not subject to specific regulatory requirements for managing pharmaceutical waste. However, some supplier-specific requirements exist for controlled substances like opioids, mandating the availability of disposal programs including for patients use in the home.

In certain states, healthcare providers administering in-home care may need to adhere to medication waste management regulations. Establishing programs for managing home-generated pharmaceutical waste is essential for several reasons:

  • Impact on patient safety and health: Controlled substances, if mishandled, may contribute to drug misuse, posing risks to patient safety.
  • Impact on the environment: Inappropriate disposal of pharmaceutical waste can have adverse effects on the environment.
  • Potential impact on cost of care: Accessibility and misuse of medication can lead to chronic health conditions that lead to higher costs of care for patients as well as for providers and payors.

The steps for implementing programs for managing pharmaceutical waste in home settings should mirror the fundamental elements required in larger healthcare facilities—capital, operating framework, strategy, implementation, and ongoing evaluation. Each program aspect should be considered as you design your programs. For instance, a program designed to support disposal of medications from home users would include a method to collect specific types of medication in an appropriate packaging for transport as delineated in the operating framework. Collection of pharmaceutical wastes from home users in mail back programs such as Seal&Send™ must meet various requirements:

  • DEA requirements: Schedule I drugs have specific handling requirements due to their high abuse potential.
  • USPS requirements: Container and waste types (e.g., no needles in a medication envelope) need to comply with USPS regulations.
  • Permitting requirements: Waste disposal facilities may have specific permitting requirements influencing the acceptance of certain types of waste.
  • Organizational policies: Program design should align with the internal policies of the organization concerning waste disposal and community programs.

Establishing a compliant and sustainable pharmaceutical waste program requires a multi-faceted approach that integrates regulatory compliance, stakeholder engagement, strategic planning, and ongoing evaluation.  It is a crucial step towards ensuring the safety of society, protecting the environment, and maintaining a healthy economy.

Learn more about the role Stericycle can play in your organization’s sustainable pharmaceutical waste management program.

Frequently Asked Questions

Who Regulates the Disposal of Pharmaceutical Waste?

Pharmaceutical waste is subject to regulation by various local, state, and federal agencies. This includes, but is not limited to, the Environmental Protection Agency (EPA) and its state counterparts, the US Drug Enforcement Administration (DEA), State Boards of Pharmacy, Department of Transportation (DOT), and other entities such as the  US Pharmacopeia (USP), National Institute for Occupational Safety and Health (NIOSH), USP<800>, accreditation organizations, among others.

What Are EPA Subpart P Regulations and How Do They Relate to Sustainability?

EPA Subpart P contains healthcare-specific regulations for hazardous waste pharmaceuticals generated at healthcare facilities. The EPA is revising regulations to reflect the unique nature of healthcare waste, aligning them with sustainability principles. EPA Subpart P went into effect on August 21, 2019, though it has not been universally adopted by all states. Some requirements include:

  • Sewer ban: This ban prohibits the disposal of any hazardous pharmaceutical waste through sewers by healthcare facilities, irrespective of generator size or Subpart P adoption.
  • Generator status: By adopting Subpart P, a generator’s pharmaceutical waste no longer counts toward their generator status.
  • Storage time: The storage time commences upon waste discard, regardless of whether it's satellite accumulation areas (SAA) or central accumulation area (CAA), with adjusted time limits.
  • P-Listed waste: This type of waste is subject to different requirements.

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