Managing your pharmaceutical waste is critical not only because of the strict regulations governing its disposal but also to maintain high internal standards.
Compliance with laws helps you avoid fines, legal issues and environmental harm. However, beyond regulatory obligations, consistently upholding your own waste management standards ensures that your operations remain safe, efficient and audit-proof.
By fostering a culture of accountability and continual improvement, you protect your organization from risks and demonstrate a commitment to responsible pharmaceutical waste management. Here’s how to ensure your pharmaceutical waste program is running smoothly and compliant:
While pharmaceutical waste can require the experience of a hazardous waste transporter, it’s critical in this industry to understand that not all transporters can handle pharmaceutical waste.
Only certain types of waste transporters are legally allowed to handle pharmaceutical waste. There are many types of pharmaceutical waste, from sharps to expired medications and controlled substances. Pharmaceutical waste may include chemotherapy products, compounded drugs and waste, and contaminated gloves, gowns and packaging.
If you’re a medical facility, you may also generate waste that includes biohazardous materials or even radioactive substances. That means you may require different types of transporters. Typically, regulated medical waste transporters or hazardous waste transporters can handle your pharmaceutical waste. However, it’s important to ensure you’re not making any mistakes that the waste transporter you work with can handle the type of medical waste you generate.
This is where expertise in the pharmaceutical waste sector is crucial. Make sure you work with a waste transporter that has a proven track record in working with hospitals, drug manufacturers or other healthcare organizations that generate pharmaceutical waste.
Proper record-keeping is a cornerstone of any audit-proof waste management program. You need to track every stage of the waste disposal process, from generation and collection to transport and final disposal.
It’s important to work with a pharmaceutical waste disposal company that uses a reliable system to maintain accurate records, including manifests, waste logs and disposal certificates.
Keeping organized internally can also help you when auditing your own waste management processes. Any type of system or internal process requires regular review to look for improvement and any potential gaps in the waste management process. If relevant, setting up automated reminders for compliance deadlines, reviews and audits can keep your facility proactive in managing its waste disposal processes.
An effective pharmaceutical waste program must include a clear waste segregation process. As we outlined above, there are many different types of waste that medical facilities can generate, including pharmaceutical businesses themselves.
For example, here are just a few types of waste that a pharmacy generates:
Different types of waste—hazardous, non-hazardous, and controlled substances—must be separated appropriately to prevent cross-contamination and ensure they are handled according to regulatory requirements. Misclassification can lead to improper disposal, which increases the risk of non-compliance.
It’s easy to focus on the physical aspects of pharmaceutical waste like drugs, sharps and hazardous materials, but facilities that generate pharmaceutical waste also handle significant amounts of sensitive patient data.
This data, which may include personal health information (PHI), must be managed with just as much care as any other type of waste. Whether it’s labels on medication bottles, prescription records or digital patient files, the improper disposal of these materials can lead to serious privacy violations and legal repercussions under regulations like HIPAA (Health Insurance Portability and Accountability Act).
Earlier this year, California Attorney General Rob Bonta announced a $5 million settlement with Quest Diagnostics, Inc., that resolved allegations that the diagnostic laboratory company illegally disposed of hazardous waste, medical waste and protected health information at its facilities.
The settlement came after more than 30 inspections conducted at different Quest Diagnostics laboratories and Patient Service Centers statewide found unredacted medical information (as well as hazardous chemicals and other medical waste) had been disposed of improperly.
To ensure compliance, facilities should have clear procedures in place for the secure destruction of documents and data containing PHI. By incorporating data security into your waste management plan, you not only protect your patients’ privacy but also safeguard your organization from costly fines and damage to its reputation.
Conducting regular internal audits is an excellent way to review your waste management practices and ensure that they align with both regulatory requirements and your organization’s internal standards.
These audits allow you to identify gaps, inefficiencies or areas of non-compliance in your system before external auditors or regulators discover them. By addressing these issues promptly, you not only avoid potential fines but also enhance the overall efficiency and safety of your waste disposal processes.
Internal audits also provide an opportunity for you to review training programs, assess the performance of waste transporters, and verify that documentation is up-to-date and accurate.
Establishing a cycle of continuous improvement ensures that your pharmaceutical waste management program remains adaptable, responding to changes in regulations, operational needs or technology. Regularly refining your procedures based on audit findings allows your program to stay compliant, cost-effective and environmentally responsible throughout the year.