Check your states for deadlines on the new hazardous waste pharmaceuticals rule
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April 1, 2019
Let your pharmacists and anyone else in your organization who handle hazardous waste pharmaceuticals know that the ban on flushing those drugs down a drain or toilet will be specifically prohibited as of August 2019. The EPA’s new final rule on the management of hazardous waste pharmaceuticals was published on February 22 in the Federal Register.
The ban on sewering hazardous waste pharmaceuticals is “long overdue,” said Kristin Fitzgerald, with the EPA Office of Resource Conservation and Recovery on February 14 during the first of what could be several informational webinars the agency plans on the long-awaited rule.
Sewering “is a common practice in many healthcare facilities and it needs to stop,” said Fitzgerald, noting that the while the new prohibition applies only to hazardous waste drugs and only to those organizations covered under the new rule, the EPA strongly discourages the flushing of any pharmaceuticals by anyone anywhere.
Controlled substances part of ban
While the final rule creating a new Subpart P to the federal Resource Conservation and Recovery Act (RCRA) does exempt controlled substances that are under the Drug Enforcement Administration’s jurisdiction from the new hazardous waste regulations, even those controlled drugs still are banned under the no-flushing rule.
While the rule as a whole is not effective until six months after it is published in the Federal Register, there are some limitations. For instance, states that have their own RCRA programs will be allowed time to update their regulations to meet the new standards.
However, the no-sewering rule is being declared under the authority of the federal Hazardous and Solid Waste Amendments, so it goes into effective as soon as the rule does.
“That’s the one exception everybody has to get ready for sooner than later,” Fitzgerald stated.
The final rule, “Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine,” was signed in mid-December and prepublished on the EPA’s website. However, with the partial government shutdown it was never formally posted in the Federal Register, which by regulation is what kicks off any stated deadlines.
The rule was published in the Federal Register on February 22.
Overall, the final rule creates more stringent requirements for handling the drugs covered under Subpart P as well as the sewering ban, but eases rules on the disposal of certain nicotine-replacement products, such packaging for nicotine gums or patches.
While everyone is looking forward to the less stringent rules on nicotine-replacement products, don’t act yet, warns Fitzgerald.
Because the rules are less stringent, states are not required to adopt the exemption, she said. “We do expect most states will pick it up, but they are not required to.”
But the more stringent rules of Subpart P must be adopted, she noted. To that end, all states except the two states without authorized RCRA programs — Iowa and Alaska — will be allowed time to incorporate the new rule into their programs. (Iowa and Alaska along with along with U.S. and Indian territories must comply by August 2019, or six months after publication in the Federal Register.)
Adoption can happen earlier
For states and territories with authorized RCRA programs that do not need to have legislative action to adopt the more stringent rules, they have until July 1, 2021, to do so.
In states and territories that require legislative action for a statutory amendment, the deadline is July 1, 2022.
Be aware of what’s happening in your locality, though. States are allowed to adopt the programs ahead of deadline.
“We do expect some states to adopt earlier,” says Fitzgerald. For instance, Mississippi and Pennsylvania always adopt earlier than required, she noted. And the states of Washington and Connecticut have indicated they might as well.
EPA main home page on final rule: https://www.epa.gov/hwgenerators/final-rule-management-standards-hazardous-waste-pharmaceuticals-and-amendment-p075
How to prepare for 2019: Determining what drugs are hazardous to workers
In December, the United States Pharmacopeia (USP) is expected to implement its new Chapter <800> standards for requirements workers handling hazardous drugs.
But what is a hazardous drug for USP <800> purposes? In this excerpt from HCPro’s newly published book,“USP <800>: How to Prepare for the New Hazardous Drug Requirements,” we offer you some help in taking the first steps for compliance.
The author is Kurt Patton, MS, RPh, a pharmacist and former director of accreditation services for The Joint Commission, as well as founder of Patton Healthcare Consulting, in Naperville, Illinois.
What is a hazardous drug?
The National Institute for Occupational Safety and Health (NIOSH), a section of the Centers for Disease Control and Prevention (CDC), publishes the authoritative listing of hazardous drugs in the United States. The context for the term “hazardous” is that the drug is potentially hazardous to workers. The Environmental Protection Agency (EPA) maintains other lists of drugs that may be hazardous to the environment. The NIOSH list is updated approximately every two years, and a new version is anticipated later in 2018. At present, the 2016 edition is the official guidance document, although a list of proposed additions identified by NIOSH has already been published in the Federal Register. To find the latest publication, simply place the phrase “NIOSH list of hazardous drugs” into your search engine.
On April 4, 2011, hospitals received a joint letter from NIOSH, the Occupational Safety and Health Administration (OSHA), and The Joint Commission advising “that some medications have been known to cause cancer, reproductive and developmental problems, allergic reactions and other adverse effects that can be irreversible even after low level exposures.” The three agencies encouraged hospitals to address safe drug handling by taking two actions.
- Commit management staff to taking a leadership role in worker safety and health
- Offer opportunities for meaningful employee participation in your efforts to identify and remediate hazards, develop and offer training, and evaluate your injury and illness prevention program for continuous improvement
If you heeded this advice, you undoubtedly have a head start on compliance with United States Pharmacopeia (USP) Chapter <800>. If you did not take these two actions previously, now is a great time to do so, because you are going to have a very busy year preparing for implementation of USP <800> by December 1, 2019.
NIOSH divides its list of hazardous medications into three groups. The first of these is antineoplastic agents, many of which also pose a reproductive risk for susceptible populations. The second is nonantineoplastic agents that meet one or more NIOSH criteria for a hazardous drug. They state that some of these agents also pose a reproductive risk. The third hazardous group is drugs that pose a reproductive risk primarily to men and women who are actively trying to conceive and women who are pregnant or breast-feeding, because some of these drugs may be present in breast milk. NIOSH borrowed from and refined definitions developed by the American Society of Health System Pharmacists as far back as 1990. The characteristics that NIOSH is looking for in defining a hazardous medication include carcinogenicity, teratogenicity or other developmental defect, reproductive toxicity, organ toxicity at low doses, genotoxicity, and structure and toxicity profiles of new drugs that mimic existing drugs already determined to be hazardous.
There is also a requirement in the Joint Commission standards for hospitals to identify their list of hazardous medications. NIOSH has a large national list, and any individual hospital is likely to have only a portion of the drugs identified by NIOSH. When staff are handling one of those hazardous drugs, they need to know it is hazardous and what precautions they need to take to protect themselves.
The third agency contributing to that 2011 letter to hospitals is OSHA, a division of the Department of Labor. OSHA is involved in regulating worker safety and, in this context, worker safety when handling hazardous drugs. OSHA has regulatory authority and the ability to fine organizations that are not compliant with its regulations. One regulation of particular importance to the discussion of hazardous medication is the OSHA Hazard Communication Standard 29 CFR 1910.1200. This standard requires that all staff who handle hazardous drugs must receive information and training to inform them of the hazards in the workplace.
OSHA expects organizations to develop a written hazard communication program regarding warning labels, access to safety data sheets, and training. OSHA is also the entity that establishes the requirements for respirator fit testing of employees, while NIOSH rates the effectiveness of different respirators.
The CDC has published what it calls the Hierarchy of Controls for hazardous medications.
As you are developing your plans for implementation of USP <800> and identifying your list of hazardous medications, think about this CDC hierarchy graphic. Think about eliminating some hazardous drugs if possible or substituting alternatives to hazardous drugs. You will note in the graphic that CDC perceives elimination and substitution as significantly more effective measures than the other controls we put into place. Also note in the graphic that personal protective equipment (PPE) is the least effective measure or last line of defense after implementation of all the other control mechanisms. Small and rural organizations in particular should carefully consider elimination and substitution. It may not be required that your organization provide certain medication treatments that are readily available at the larger facility that is a 40-minute drive away. Nursing homes and home care agencies that may not have in-house pharmacy support may want to seriously consider elimination or substitution also. If you can’t eliminate or substitute, you may need to negotiate with your external pharmacy provider for some support, in addition to needing to implement workplace controls to keep employees safe. There is no small-volume exception in USP <800>, as there was in USP <797>. Doing a small amount of hazardous medication preparation in unsafe conditions is not an option.
As you move forward with your analysis and implementation of USP <800>, make sure you have also studied, evaluated, and implemented the requirements of NIOSH and OSHA. OSHA has had a long-standing focus on hazardous chemicals in the workplace, and it is likely that your facility’s management team already has hazardous materials plans and familiarity with their requirements. USP and NIOSH do not conduct surveys in healthcare facilities. OSHA conducts some surveys based on worker complaints. In addition, in accredited healthcare facilities, the accrediting body will routinely survey, and CMS may also survey based on complaints or when conducting a validation survey, evaluating the accrediting body’s thoroughness.
(For a copy of HCPro’s USP <800>: How to Prepare for the new Hazardous Drug Requirements go to http://hcmarketplace.com/usp-800.)