As a consultant pharmacist I often hear “USP Chapter <800> on hazardous drugs (HDs) was released for informational purposes only. Do I really need to comply with it?” My short answer is always “yes”, but do you know why and how?
In our September 12th post “Is Your Facility Prepared for USP compliance? Here are Some Suggestions from a Consultant Pharmacist.”, we discussed the release of USP Chapter <800>. Chapter <800> is the chapter providing guidance on hazardous drugs and was implemented December 1, 2019. Enforcement of 800 was originally planned to coincide with the release of chapters <795> (non-sterile compounding), <797> (sterile compounding), and <825> (radiopharmaceuticals). However, because USP received appeals on certain provisions in Chapters <795>, <797>, and <825>, they announced postponement of the official release of the revised <795> and <797>, and the new general Chapter <825> until further notice. As a result, USP Chapter <800> went into effect as scheduled, but for informational purposes only.
This has led to some confusion and has prompted many questions about the necessity to comply with the new standards. So where do we stand today? Let’s take a look at what is currently required and what each facility should do to remain compliant and ensure the safety of patients and staff.
USP Chapter <795>: The appeal on this chapter has been granted and the chapter is being sent to a Compounding Expert Committee for further review. As a result, the current version of the chapter, which was last updated in 2014, will remain in effect and should be followed.
USP Chapter <797>: The appeal on this chapter has been granted and the chapter is being sent to a Compounding Expert Committee for further review. As a result, the current version of the chapter, which was last updated in 2008, will remain in effect and should be followed.
USP Chapter <825>: The appeal on this chapter was denied and the chapter will become official. The new implementation date will be determined by The Chemical Medicines 4 Expert Committee. Once determined, facilities will have at least another six-month to implement changes. Stay tuned for further updates.
USP Chapter <800>: For the time being, this chapter remains informational and not compendially applicable. Although USP does not play a role in enforcement of this chapter, they do encourage compliance for the sake of public health. Additionally, they provide education and updates on the status of the chapter to state agencies such as State Boards of Pharmacy, other regulators such as the Occupational Safety and Health Administration (OSHA) and certification and accrediting agencies such as the Centers for Medicare and Medicaid Services (CMS), Accreditation Association for Ambulatory Health Care (AAAHC) and The Joint Commission (JC).
What’s the bottom line?
There are guidelines we must follow and there are guidelines we should follow. At the present time, USP Chapter <800> technically falls in the “should” category. Although you may get away with non-compliance, here are five reasons I believe you should be fully compliant:
- If you start working on being compliant now, you will be fully prepared when compliance is enforced. As you know, it is very hard to create, implement and educate on new policies in a short period of time. It takes a lot of effort and planning to implement good policies and achieve full competence.
- The purpose of USP Chapter <800> is to help protect healthcare workers from hazardous drugs. Although USP does not enforce this chapter, they do recommend compliance in the interest of public safety.
- Certification and accreditation agencies may choose to enforce these guidelines at any time without warning, leaving you exposed to possible deficiencies.
- OSHA requires protecting employees to the highest standard available. With the USP Chapter <800> guidance being available, we now have a new standard for better protecting our staff and patients.
- From a legal standpoint, implementing the highest standard will go a long way in reducing liability should a lawsuit arise.
Steps you can take now:
- Pick a member of your team to be the USP Chapter <800> expert. This person should be familiar with the standards and able to answer questions to help keep you compliant. If you don’t have a staff member with the expertise, contact us.
- Review your formulary/inventory list and compare it to the NIOSH list of hazardous drugs.
- If you have any HD preparations, remember which NIOSH category each one is in because this will determine what steps you need to take to ensure compliance.
- Update your policy and procedures. Some HDs will require a risk assessment to determine how they will be handled, and others will require use of the full USP Chapter <800> standards.
- Educate your staff. Initial training and annual competency will be required. Make use of all available educational resources including online programs.
- Remember your consultant pharmacist is an expert resource to help guide you.
Adhering to the guidance in USP Chapter <800> will be helpful to protect your staff and patients from unnecessary exposure to HD preparations. Developing and implementing a system of policies and assessments is a critical component.
We are experts at compliance. If you need help developing compliant processes or need someone to assess your current systems, please don’t hesitate to contact us.
The Consultant Pharmacists at OctariusRx provide guidance on safe medication management, survey readiness and cost savings to ambulatory healthcare facilities/surgery centers, senior care facilities and pharmacies We also help individual patients optimize their medications to improve their quality of life and save money. Contact us for assistance.
