Safely Handling Hazardous Drugs: A Guide for Community Pharmacies
Key takeaways:
Exposure to hazardous drugs can cause a wide variety of health problems, including cancer, infertility, birth defects, and heart and kidney problems.
To prevent exposure, it is important for pharmacy leadership and staff to be aware of, implement, and adhere to best practices for hazardous drug handling.
Thinking about the entire life cycle of the medication, from receipt to dispensing or disposal, can help pharmacists address weak points in their system that could pose a risk for staff exposure.
Every year, around 8 million healthcare workers are exposed to hazardous drugs in the U.S., putting them at risk for both acute and chronic health problems. They can be exposed through inhalation, ingestion, needlesticks and injections, and skin contact. While it is the organization’s responsibility to have standards in place, pharmacy staff can take steps to protect themselves from possible exposure.
Here, we’ll look at the most important things to know about handling hazardous drugs in the community pharmacy setting.
What are hazardous drugs?
Released in 2020, USP 800 creates guidelines for hazardous drugs management in healthcare settings, which includes community pharmacies. Though, USP 800 is not the first time hazardous drugs in the healthcare setting have been addressed. In fact, concerns about healthcare worker exposure to hazardous drugs first arose in the 1970s, after secondary cancers were observed in patients who underwent chemotherapy treatment.
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In 1981, the National Institute for Occupational Safety and Health (NIOSH) released “Recommendations for Safe Handling of Antineoplastic Drugs.” In 1985, the American Society of Health-System Pharmacists (ASHP) released a technical bulletin on handling cytotoxic drugs, which was updated in 1990. Since then, ASHP’s guidelines have continued to be updated.
According to NIOSH, a hazardous drug is one that has any of these six characteristics in humans or animals:
Carcinogenicity (causes cancer)
Teratogenicity (causes developmental toxicity)
Reproductive toxicity
Organ toxicity at low doses
Genotoxicity
Similar in structure or characteristic to existing drugs that are considered hazardous
Every year, more than 12 billion doses of hazardous drugs are handled by healthcare workers in the U.S. If exposed, these drugs can cause:
Cancer
Infertility
Heart and kidney damage
Hearing loss
Hair loss
Nausea
Rashes
The first major step in making sure your pharmacy is up to date with best practices in handling hazardous drugs is to create a site-specific list. To do so, you’ll want to look at the medications you dispense and compare them against the NIOSH tables.
Other places to look include a drug’s package insert, the Safety Data Sheet (SDS), and the International Agency for Research on Cancer (IARC).
How should community pharmacies handle hazardous drugs?
One of the best ways to think about hazardous drug handling is to look at the drug’s entire life cycle — from receipt to either dispensing or disposal. During this time, it is received, stored, dispensed, or disposed of. And each one has steps that should be taken to protect workers.
Also, it’s important that all staff are trained, including non-clinical staff who might occasionally be in the pharmacy, like maintenance staff and housekeeping. Another commonly missed area is making sure that those taking inventory of the pharmacy know where the hazardous drugs are and what personal protective equipment (PPE) they should wear while counting them.
Receiving
When receiving medications that are hazardous, pharmacy staff should be wearing chemotherapy gloves. “Chemo gloves” are those that comply with ASTM D6978 or equivalent standards. This standard measures a glove’s ability to prevent a hazardous drug from penetrating it while under continuous exposure.
If the gloves comply with this standard, the box should be clearly marked. It is also common to see a long list of medications on the box that were tested on the gloves. If the box is not clearly marked as meeting ASTM D6978 standards, don’t use the gloves for hazardous drugs.
When ordering gloves from the distributor, remember they will likely offer both non-sterile and sterile chemo gloves. Sterile gloves are far more expensive and not required for non-sterile dosage forms.
USP 800 also recommends a spill kit — although most community pharmacies don’t order liquid hazardous drugs often. So, you might not need to have a spill kit on hand. But spill kits are very inexpensive. And in the rare case you get a prescription for a liquid, hazardous drug, keeping one spill kit might be a good choice.
Storing
Hazardous drugs, other than those that only require counting or repackaging of final dosage forms, must be stored separately from other medications. Most community pharmacies only dispense final dosage forms that just need to be counted.
While USP 800 does not require these medications to be stored separately, it’s a good idea to have them at least on a separate shelf that’s clearly marked for hazardous drugs.
That’s because a separate, clearly marked shelf will make it easier for staff to recognize the bottle or box as a hazardous drug. When picking out which shelf (or shelves) to use, another tip is to use one below eye level. This way the medication won’t fall on anyone when they try to pull it off the shelf.
Dispensing
Section 12 of USP 800 addresses dispensing. It also notes that final dosage forms can usually be dispensed “without any further requirements for containment.” But, the bottom of the NIOSH document has a guide to PPE based on the type of activity done. While dispensing is not specifically addressed, they recommend gloves for handling uncoated tablets. This includes when counting the medicine on a tray.
Considering the possible exposure and very low cost of gloves, it’s a good idea to at least require gloves when dispensing final dosage forms. Another good idea is to buy the plastic bags used to transport hazardous drugs. Then, have the person filling the medication put the vial in that bag afterward. This will prevent contamination in the rest of the pharmacy. But it will also let the pharmacist know that it is hazardous before they open the vial to do the final check.
What’s more, it will help pharmacies comply with USP 800, which requires hazardous drugs to be clearly labeled when they are being transported.
Another common mistake is using rubbing alcohol to clean the counting tray. This tends to spread the contamination. Instead, choose chemicals that deactivate and decontaminate the tray.
The chemical should not be sprayed though. Spraying it could blow dust from the tray into the air and expose the worker. Instead, spray a paper towel, cotton ball, or disposable cloth. Then, use that to wipe the tray.
Disposing
If a hazardous drug expires before it is dispensed, it can usually be sent back through the reverse distributor. All PPE and wipes with deactivating and decontaminating chemicals can typically be discarded in a trace chemotherapy (yellow) bin.
Broken, dropped, or crushed tablets usually cannot be returned through a reverse distributor. In this case, they can be placed in a RCRA-regulated hazardous waste bin.
Where can pharmacists learn more?
The NIOSH guide and USP 800 are the best places to learn more about hazardous drug handling in your pharmacy. Also, make sure to check if your organization has current policies and procedures in place for handling hazardous drugs.
For more information, the EPA has a website dedicated to the management of hazardous waste pharmaceuticals.
The bottom line
Hazardous drugs can put healthcare workers at risk for a wide range of both acute and chronic health problems. It’s critical that both organizations and healthcare workers understand — and comply with — best practices in handling them. In the community pharmacy, staff handle mostly solid, oral hazardous drugs. And the best practices when handling them include wearing the appropriate gloves, segregating the hazardous drug area, and disposing of waste properly.
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