The United States Pharmacopeia (USP) <800> standards requiring the safe handling of hazardous medications are currently scheduled to go into effect on December 1, 2019. Do the standards apply to you? If so, do you have a plan in place to be fully compliant?
Your consultant pharmacist should be able to help you answer these questions and quickly guide you in the direction of full compliance. Who do these standards apply to? Is it just compounding pharmacies? What are the basics? What is a hazardous drug (HD) and how do I know if I use HD preparations in my practice?
These standards are comprehensive and wide-ranging. They apply to all healthcare personnel who handle HD preparations and all entities that store, prepare, transport, or administer HDs. This includes all ambulatory healthcare facilities/surgery centers, senior care facilities and pharmacies.
According to the National Institute for Occupational Safety and Health (NIOSH), a hazardous drug is any drug that meets at least one of the following six criteria: carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity in humans, organ toxicity at low doses in humans or animals, genotoxicity, and new drugs that mimic existing hazardous drugs in structure or toxicity. NIOSH maintains a list of antineoplastic and other hazardous drugs used in healthcare settings. You can obtain the list here.
With a little bit of time and effort, you can protect your staff and patients while making your facility fully compliant. Here are some steps to take:
1. Pick a member of your team to be the USP <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.
2. Review your formulary/inventory list and compare it to the NIOSH list of hazardous drugs.
3. 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.
4. 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 <800> standards.
5. Educate your staff. Initial training and annual competency will be required. Make use of all available educational resources including online programs.
6. Remember your consultant pharmacist is an expert resource to help guide you.
You can read a full list of USP <800> frequently asked questions here.
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.
