SCGhealth Blog

New Hazardous Drugs Standards of Care for Your Employees

Tuesday, November 22, 2016

Written by: Ben Regalado, contributing writer

If you thought OHSA and Biohazards were all you had to be concerned about, it’s time to think again. The US Pharmacopeial Convention, or USP, standard published this past spring by National Institute of Occupational Safety & Health (NIOSH), established increasing requirement for healthcare providers when it comes to establishing processes and enhancing staff training when it comes to the handling of specific types of hazardous drugs. 

Healthcare providers need to examine the entire process of handling of these drugs, from arrival to dispensation, in addition to ensuring there are processes in place to deal with unexpected potential exposures. 

While hospitals and other providers frequently have pharmacists or other resources on site they can rely on, the lack of resources in physician practices does not create an excuse for lack of attention. In fact, it may require thoughtful consideration as to whether you will continue to handle these drugs.

NIOSH notes that “drugs considered hazardous include those that exhibit one or more of the following six characteristics in humans or animals: carcinogenicity, teratogenicity or other developmental toxicity, reproductive toxicity, organ toxicity at low doses, genotoxicity (and) structure and toxicity profiles of new drugs that mimic existing drugs determined hazardous by the above criteria.”

Even though the effective date of the new, higher standards isn’t for another 18 months (July 2018), you need to use the time now to prepare. How?

First, start with a comprehensive review of the (34 page) NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings for 2016. In the document, providers can find the drug name, comments, and a links to key information.

Second, review Table 5 of the document, which is on pages 32-34. This chart gets into the specifics of why type of Personal Protective Equipment (PPE) you need to have for employees at each stage in the process, beginning with receiving, then continuing through normal handling, compounding, administration through various methods, disposal and cleaning.

PPE necessary, depending on the activity, includes double chemotherapy gloves, protective gown, eye/face protection, respiratory protection and ventilated engineering control. 

Third, while many practice may have a “spill kit” for handling biohazards and/or chemical hazards (e.g., mercury), it may be necessary to specifically create and set aside a kit related to these hazardous drugs.

Remember, OSHA inspectors (and, heaven forbid if anything were to happen, plaintiff attorneys) are not just looking for boxes on a checklist. They will want to know that your staff has been trained, and that they have acknowledged and retained the training provided. This goes hand in hand with the OSHA HAZCOM (or Hazard Communication) Standard.

As hopefully you are aware, in updating HAZCOM, several years ago OSHA transitioned from the familiar Material Safety Data Sheet (MSDS) to now follow the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS), and adopted the universal and standardized Safety Data Sheets (SDS). At the very minimum, you should check your policy handling books to assure that you have these new documents, because while they are nearly identical to the ANSI Standard 16 section MSDS there are a few modifications.

While many of these SDS documents and even the NIOSH document is available online, this is one instance where a practice may want to go through the process of assembling paper copies in a readily accessible binder. Why? Because in an emergency situation, speed matters.

Healthcare is truly one of the most highly regulated industries on many levels. This is just another one you need to know about and add to your continuous New Year’s Resolutions list.

USP Chapter 800 and What it means to you

Thursday, September 29, 2016

By: Elizabeth Lauzon, Public Relations Coordinator

A new general chapter from the U.S. Pharmacopeial Convention (USP) will do more to ensure hazardous drugs are handled properly. But do you know what that means for your office and how to prepare for it?

General Chapter 800, Hazardous Drugs—Handling in Healthcare Settings, published in February 2016, was developed to protect healthcare workers, including pharmacists, from residual exposure in medical settings. The mandatory rule applies to every site that handles hazardous drugs, as defined by the National Institute for Occupational Safety and Health (NIOSH). The new standard will go into effect July 2018, but now is the time to plan for compliance with the chapter.

What is the purpose of Chapter 800?
The USP website explains that the purpose of the chapter is to describe practice and quality standards for handling hazardous drugs in healthcare settings and help promote patient safety, worker safety, and environmental protection. It applies to all healthcare personnel who handle hazardous drug preparations (e.g. pharmacists, pharmacy technicians, nurses, physicians, physician assistants, home healthcare workers, veterinarians, and veterinary technicians), and also to entities that store, prepare or transit hazardous drugs.

How should you prepare?
Storage of hazardous drugs is likely to be the biggest compliance hurdle for healthcare providers. Healthcare facilities should use the NIOSH list to determine which hazardous drugs and dosage forms of the drugs are in use and then identify where new storage space is needed.

Facilities also need to be aware of the new compounding requirements in Chapter 800. Under chapter 800, all compounding of hazardous drugs must be done in an appropriate ventilated device housed in a negative-pressure room that is separate from other drug preparation areas.

Beyond compounding, Chapter 800 requires that packages containing hazardous drugs be opened in a neutral- or negative-pressure area. The packages may not be opened in a sterile compounding area or positive-pressure environment. The chapter also requires the use of closed-system transfer devices for drug administration "when the dosage form allows." And chapter 800 emphasizes the appropriate use of personal protective equipment, including two pairs gloves, when administering, cleaning up spills of and disposing hazardous drugs.

Once you have identified the updates or changes you need to make at your facility, be sure to train (and document the training) your staff on the new requirements.

The challenge in healthcare is that providers have worked with these substances for so long that people have gotten desensitized to the risks of them. This new chapter is a wake-up call to really recognize the need for safety and preparedness in handling hazardous drugs. And although July 2018 might seem far off, the USP specifically chose this timeline in order for facilities to have ample time to prepare and make any necessary updates. Don’t wait! Start to implement what you can now, and then start to formulate your longer-term plans for any facility changes that may be needed.

No LEIE — you MUST do background and exclusion checks

Tuesday, August 09, 2016

by Ben Regalado, Contributing Writer

The résumé was a match. The interview was great. You’ve made an offer and they’re eager to join you. You probably checked references, but you know how those go. You may or may not have run a criminal background check, or looked for outstanding litigation in county or state databases. All good, right?

Consider this. In March, a Pennsylvania woman was indicted for health care fraud. Why did this catch our eye? Because she’d been convicted twice before.

It’s a scary scenario, but you may be thinking, “Well, if that happens to us, we’ll just fire her.”

If only it was that simple. This woman was on the List of Excluded Individuals and Entities (LEIE) maintained by the Department of Health & Human Services Office of the Inspector General. The regulations are clear: Anyone who hires or contracts with an individual or entity on the LEIE may be subject to civil monetary penalties of up to $10,000 for each item or service, plus three times the amount claimed for payment. You may even face your own exclusion.

Although the individual in the case above was providing clinical care, Poyner & Spruill attorney Kenneth L. Burgess wrote, “An excluded individual does not have to be performing direct patient care or services” for there to be an impact on the practice.FN1

In healthcare, the talk is focused more and more on preventative medicine. So why not take the preventative step and check all your employees and contractors against the LEIE at hire and annually thereafter?

Best of all − it’s free and as easy as pointing your web browser to Make sure, however, to use the individual’s full legal name − the one you confirmed on E-Verify. (You do use E-Verify when you hire, don’t you?) Not using the correct name can result in a false negative, and that alone isn’t a sufficient defense. You may want to check for other names listed on your employment application, such as maiden names or aliases.

If your potential clinical or administrative employee is on the LEIE, it’s probably best to steer clear, no matter how earnest the explanation, unless you – and your legal counsel – can clearly separate the individual’s compensation from federal funds. The sanctions to your practice could be substantial.

To be sure, you should still check for any history of non-healthcare related issues that put your practice at risk. Some areas to look for are theft or cases involving the mishandling of money or other resources, or even a history of filing employment related litigation. Other areas relate to assault, abuse or domestic violence, or issues related to drug diversion.

Involvement in a case doesn’t mean your potential employee isn’t a candidate for hire. In some cases, your potential employee may be the victim, or the case may be unrelated to the duties he or she will perform.

We think we live in an all-exposed world. From social media to referrals from friends, we think we can easily know everything we need to know to stay out of trouble. But that’s often not the case. We all must take appropriate steps to protect ourselves and our practices.

1 Kenneth L. Burgess, “Hiring or Contracting with Excluded Individuals or Entities: Checking the OIG’s Exclusion List Can Avoid Harsh Sanctions,” p.s. Poyner Spruill, last modified November 1, 2011,

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