The U.S. Pharmacopeial Convention (USP) issued its Chapter 800 guidelines on hazardous drug handling in healthcare settings in February 2016, and its Compounding Expert Committee has set an implementation deadline of July 1, 2018.
Recently, Eric S. Kastango, president and CEO of Clinical IQ LLC and CriticalPoint LLC, took part in a webinar sponsored by Wolters Kluwer clinical surveillance solution Pharmacy OneSource to help professionals understand what is required for USP 800 compliance since, as he said, “800 doesn’t give us clear guidance.”
USP 800 involves those hazardous drugs as defined by NIOSH, the National Institute for Occupational Safety and Health. NIOSH defines a hazardous drug as a medication that has one of these six characteristics:
- Carcinogenicity
- Teratogenicity of developmental toxicity
- Reproductive toxicity in humans
- Organ toxicity in low levels in human or animals
- Genotoxicity
- New drugs that mimic hazardous drugs in structure or toxicity
Handling antineoplastic and other hazardous drugs is known to increase risk of reproductive issues, fetal development toxicity, and cancer. While there are guidelines for limiting exposure to patients, after 40 years, there are still no occupational exposure limits established for hazardous drugs by any of the appropriate, recognized agencies to help protect pharmacists, nurses, pharmacy and veterinary technicians, healthcare volunteers, and those performing waste removal.
“No other industry comes close to healthcare regarding the number of hazardous agents handled by a variety of different professionals,” Kastango said.
The risks of handling hazardous drugs
While the issue of occupational exposure first came to attention in the 1970s when secondary cancers and other ill effects of hazardous drug handling were observed in patients, NIOSH didn’t issue a warning on the subject until 2004, Kastango noted. Since then, there have been some 400 new publications on hazardous drugs.
Kastango cited two studies on surface contamination related to hazardous drugs. The first, conducted in 1999, reported 75% of samples contaminated above the limit of detection in pharmacies and 65% of samples in nursing and patient areas. The second, conducted over a decade later in 2010, revealed 75% of samples contaminated above the limit of detection in pharmacies and 45% in nursing and patient areas. This, Kastango said, shows that not much has been done to improve conditions.
Factors affecting workplace contamination
Pharmacists are the “MacGyvers of healthcare,” Kastango said, because they are used to improvising with less than inadequate space and resources within the hospital. That means compounding pharmacies often do not have the proper facilities and procedures in place.
Skin contact is one way to spread contamination, and it affects workers in various job categories, including less obvious positions like volunteers, pharmacy receivers, and transporters. Surface contamination, common in pharmacy and nursing/patient areas, as previously noted, has been well documented with around 5% of hazardous drugs in use. The other 95% have not been examined.
Additionally, drugs are coming into the pharmacy already contaminated, Kastango explained, largely because the contamination is on the exterior of drug vials — unbroken, seemingly safe vials.
Kastango said there have been increases in exposure risks in recent years due to:
- An increase in overall number of hazardous drugs in use in both oral and injectable dosage forms
- More patients outside oncology receiving hazardous drugs
- New applications and procedures for hazardous drugs
Antineoplastic drugs target rapidly dividing cells, like fetuses, Kastango explained, making reproductive effects among the most prevalent risks posed by hazardous drugs. This could include disruptions to the menstrual cycle, male and female infertility, low birth weight, congenital abnormalities, and spontaneous abortions.
Today, two-thirds of pregnant women work during their first trimester, and 55% of births are to working mothers, he noted. That means female healthcare workers are more likely to be on job and exposed to contamination while pregnant than in past decades.
However, Kastango also noted several factors that can and have helped contribute to decreases in contamination:
- Better awareness
- Improved engineering controls
- New and updated guidelines to creating safer work environments
- Closed-system transfer devices for hazardous drugs
- Robotics (although this is a developing technology and not yet widely available)
- Legislation
An action plan for USP 800 compliance
Kastango recommended healthcare organizations that handle hazardous drugs should take the following steps to achieve USP 800 compliance:
- Make a hazardous drug list: Which drugs you have on formulary will inform your strategy. Consult the NIOSH list of hazardous drugs.
- Assessment of risk: Not all drugs need to be handled by USP 800. Review risk of exposure, packaging, and manipulation procedures.
- Personnel training: Cover handwashing, storage, handling, and disposal. Include nurses, housekeeping staff, and others in training.
- Personal protective equipment (PPE): Train staff on use of impermeable gowns, double gloves, double shoe covers, engineering controls, and proper removal and disposal of PPE.
- Facilities: Review venting, hazardous drugs handling rooms, negative pressure, and exhausting.
- Decontaminating and cleaning: Keep sodium hypochlorite solutions and hydrogen peroxide for decontamination. For cleaning, use germicidal soap and water on hoods, floors, and all surfaces every day. Also keep on hand disinfectants and the compounds labeling recommends to deactivate the specific drugs you handle.
- Environmental monitoring: Perform surface sampling to detect hazardous substances in your environment. He warned that some studies have found residue on elevator buttons and door handles.
Taking a closer look at PPE, Kastango reminded listeners that, in addition to providing employees with impervious gowns and gloves that have been tested against the ASTM 6978 standard, healthcare institutions need to provide clear policies on where and when PPE should be used. That should include procedures for drug receiving, non-sterile compounding, administration, and disposal.
He also advised that all pharmacies dealing with hazardous drugs run spill management drills and simulate use of the spill kit with baby powder of baby Tylenol in order to feel comfortable with the process and to test if there is enough PPE to cover all involved employees.
Looking more closely at facility management, Kastango noted that the July 1, 2018, deadline was necessary to allow enough time for healthcare institutions to fix some potentially major flaws in the design and layout of their facilities. An optimal floor plan, he noted, would include an ISO Class 7 anteroom between hazardous drug and non-hazardous drug-handling areas.
“The solution to pollution is dilution,” Kastago said, noting that HEPA filters, while good for blocking harmful particles, don’t stop gases. Hazardous drug-handling areas need an exhaust hood that vents to the roof, which he pointed out, you can’t install if you’re stationed “55 floors below” your hospital’s highest floor. Roof access is also necessary for the required use of Biological Safety Cabinets A2 or B2, which are designed to exhaust through the roof.
He also suggested two other ways to help reduce contamination:
- Medical surveillance: Keep track of how many hazardous drug doses you make a day so you know the amounts of each hazardous drug (e.g., methotrexate) that should be in play. Also survey and monitor drug handlers for recent health changes as well as medical, reproductive, and occupational history
- Work with wholesalers: Wholesalers are not held accountable to USP 800, but pharmacists can make enough noise to encourage wholesalers to follow certain handling protocols to help avoid exterior vial contamination and spills.
The best way to effect change and encourage safe practices is simply for pharmacists to keep their eyes open and offer collegial suggestions, Katango said. “People respect when other people inspect.”
Kastango’s recommened sites for USP 800 assistance
