3 pharmacists dispel USP myths and share best practices for success

United States Pharmacopeia (USP) <800> standards highlight the need for healthcare facilities to protect clinicians from exposure to hazardous drugs. Determining how to update operating procedures to comply with the new standards has the potential to overwhelm healthcare facilities. 

During an Aug. 13 webinar sponsored by Cardinal Health and hosted by Becker's Hospital Review, three pharmacists from Cardinal Health discussed hazardous drug classification, dispelled common misconceptions that generate confusion for healthcare staff, and offered insights for facilities looking to address compliance in an assured and efficient manner. These clinical experts included:

  • Patricia Kienle, RPh, MPA, FASHP, Director of Accreditation and Medication Safety, Cardinal Health Innovative Delivery Solutions
  • Karen Kellogg, PharmD, Director of Practice Consulting, Cardinal Health Specialty Solutions
  • Richard Green, BS Pharm, RPh, BCNP, FAPhA, Director of Radiopharmacy Practice, Cardinal Health Nuclear & Precision Health Solutions

USP <800> is the standard for handling hazardous drugs in healthcare settings and will take effect Dec. 1, 2019. It describes quality-of-practice standards for handling hazardous drugs that promote the safety of patients, the environment and healthcare staff who are regularly exposed to these drugs.

What is considered a hazardous drug?

The National Institute for Occupational Safety and Health (NIOSH) defines hazardous drugs as any that illustrate one or more of the following characteristics in animals or humans: carcinogenicity, teratogenicity, reproductive toxicity, organ toxicity at low doses, genotoxicity, or new drugs with a structure or toxicity profile similar to existing drugs already classified as hazardous drugs.

Chemotherapy drugs aren't the only types of drugs considered hazardous by NIOSH. Hazardous drugs can be broken down into three major categories:

  • Antineoplastic drugs, such as fluorouracil and methotrexate
  • Non-antineoplastic drugs, such as phenytoin and estrogen 
  • Drugs posing reproductive risks to men and women, including clonazepam

"It's not just intravenous chemotherapy, but also tablets, capsules and hormonal therapies as well," Dr. Kellogg said. "The standards also pertain to anywhere else hazardous drugs are being handled — such as urology, rheumatology and dermatology."

Some healthcare organizations tend to think compliance is too complicated; this overcomplication is often fueled by common misconceptions.

3 common misconceptions related to USP <800>

  1. The focus on handling hazardous drugs is new. Incorrect. USP <800> was published on Feb. 1, 2016, with two public comments versions prior to that. "Discussions around the safe handling of hazardous drugs have been taking place as far back as the 1970s in medical literature … and there is more recent information in Occupational Safety and Health Administration (OSHA) regulations and from NIOSH," Ms. Kienle said.

  2. USP <800> only applies to pharmacy. USP <800> standards apply not only to drug compounding and manipulations in the pharmacy but also to receipt, dispensing, administration, patient care, activities, spills, transport and waste wherever they occur in the healthcare setting. "It is a healthcare occupational safety standard that applies to every setting where hazardous drugs exist," Dr. Kellogg said.

  3. USP <800> approves products for use. USP <800> includes practice and quality standards for healthcare settings but "USP has no regulatory authority over the manufacturing, marketing and use of personal protective equipment," Mr. Green said. "It sets standards that apply to the safe handling of hazardous drugs, which are then enforceable by accreditation and regulatory bodies."

Healthcare facilities can establish a strategy for achieving compliance by reading the USP <800> standards, auditing and assessing the risk of their current use of hazardous drugs and applying the NIOSH hierarchy of controls to help manage the risk.

Strategy for achieving USP <800> compliance

To conduct an audit of a healthcare facility's use of hazardous drugs, examine the workflow cycle, identify the exposure risks, and create a plan to minimize them. Plans can include efforts to determine when a member of staff should wear chemotherapy-rated gloves, provide separate storage spaces for drugs, and deliver new training to encourage adoption of safe handling best practices.

The hierarchy of controls outlines that physically removing a hazard is the most effective way to mitigate risk. However, in healthcare, "we usually cannot do this because we are taking care of patients who may need these drugs," Ms. Kienle said. 

Engineering controls, such as mixing hazardous drugs in the proper environment and ensuring the proper use of closed system drug-transfer devices (CSTDs) when administering antineoplastic drugs, are important because they can help isolate staff and patients from exposure.

Administrative controls must be established to guide the way healthcare staff work and ensure the appropriate use of personal protective equipment such as gloves and gowns.

"You need to wear personal protective equipment not just when compounding and administering hazardous drugs, but any time you're in contact with them," Dr. Kellogg said. "The need for personal protective equipment during all of these steps is often overlooked and can put staff members at risk of exposure."

Find out more about Cardinal Health by clicking the link. View the full webinar here.

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