Understanding USP <800> and Hazardous Drugs: A Closer Look
With the upcoming implementation of USP <800> on December 1, 2019, the practice for handling hazardous drugs will be impacted across the continuum of care. SoftWriters is committed to keeping your pharmacy informed of future changes in regulations.
Hazardous Drugs
The Centers for Disease Control and Prevention (CDC) posted the list of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, in 2016 and the 2018 update as completed by the National Institute for Occupational Safety and Health (NIOSH).
Additional updates since publication can be found on this website under Notice. The medications on this list include carcinogens, and drugs that cause developmental, reproductive, organ, and genotoxicity. Oral, intravenous, and topical formulations of these drugs are all considered hazardous.
Identify Your Compliance Manager
The Accreditation Commission for Health Care (ACHC) hosts workshops to assist pharmacies in becoming USP <800> ready and becoming certified by the Pharmacy Compounding Accreditation Board (PCAB) for Handling Hazardous Drugs. All facilities will be required to name a compliance manager to oversee and ensure compliance.
A hazardous drug designated person (HDDP) will be responsible for creating, implementing, reviewing, and updating policies and standard operating procedures (SOPs), employee training and competencies, and ensuring “environmental control” of locations where HDs are stored and handled. These documents should be reviewed annually.
The PCAB has a certification course for the employee to become the HDDP.
Identify Medications
Pharmacies should identify medications included on the NIOSH list in inventory and assess the risk of handling these HDs. Assessment of Risk should include the considerations of receiving, storage, compounding, transporting, and disposal.
Additionally, the administration could be an additional risk for antineoplastics that do not come in final dosage forms. Closed-system drug-transfer devices (CSTD) are required for administration and should be attached prior to the addition of the hazardous drug.
Although not all drugs defined as hazardous may pose a definite risk based on their final dosage form, any manipulations of these forms may involve risk - including cutting, crushing, dissolving, opening, or compounding.
An important consideration is that tablet and capsule forms of antineoplastic hazardous drugs must NOT be placed in automated counting or packaging machines, which subject them to stress and may create powered contaminants.
For compounding pharmacies, there are many new requirements for cleanrooms, which may result in existing cleanrooms needing to be redesigned. USP <800> does not replace USP <797> for sterile compounding or USP <795> for non-sterile compounding, but rather provides additional guidelines for hazardous drugs.
Handling Hazardous Drugs
Medications that are on the Hazardous drug list are to be labeled, stored, and handled according to regulations. Containers that are resistant to breakage and leakage should be used in the transporting of these hazardous medications and prevent the exposure of the individuals transporting the drugs. If a container contains a hazardous drug, it should be labeled as such.
Team SoftWriters is continuously monitoring the ever-changing landscape of regulatory requirements. At present, we are reviewing the potential impact of USP <800> regulations on LTC Pharmacy Operating System workflows. Enhancements to the FrameworkLTC suite of products, if any, to support these changes are being investigated. Stay tuned for more updates on this issue and other relevant topics.
Resources
For additional information on the USP <800> chapter, pharmacies can consult
The upcoming revisions of USP chapters <795> and <797> seem to have been postponed until further notice. During the time of postponement and pending the resolution of Chapters <795> and <797>, USP <800> has been labeled as “informational and not compendiously applicable.”
This new information raises some questions and has caused some uncertainty among pharmacies and the state boards that are tasked with enforcing the USP <800> standards for handling hazardous drugs.
In the interest of keeping our long-term care pharmacy customers up to date with the status of this regulatory development, we reached out to the various state boards of pharmacy for clarification on how they were handling this matter.
Enforcement of USP<800>
Enforcement of USP <800> is left to the individual state boards of pharmacy. Most have planned to implement the regulations fully, while some have delayed the date of enforcement.
Some states have indicated that they will not enforce USP <800> at all. Nearly all the state boards we contacted indicated that they were watching and waiting to see what happens with USP <795>, <797>, and <800>.
We recommend that our customer pharmacies reach out to their individual state boards, as applicable, for clarification on when and how USP <800> will be enforced in their state.
While enforcement may be delayed, the guidelines set forth in USP <800> can help protect healthcare workers from exposure to hazardous drugs. Pharmacies should still work towards achieving compliance with USP <800>, in accordance with their respective state boards and other regulatory bodies.
FrameworkLTC Supports USP<800>
But the good news is that FrameworkLTC supports the current USP <800> requirements related to the identification of hazardous drugs starting from our September 2019 release. Reach out to SoftWriters Support or review the document “What's New in FrameworkLTC Suite of Products in Sept 2019 Release” available on SoftWriters’ Customer Engagement Zone to know more.
SoftWriters will continue to educate our LTC pharmacies as future developments unfold with the goal of helping you stay up-to-date and compliant.