Hazardous drugs in healthcare settings
In the course of providing care, health care workers (HCWs) handle, prepare, administer, dispose or are exposed to hazardous drugs (HDs). HCWs potentially exposed to hazardous drugs include:
- operating/procedure/radiology room personnel;
- environmental services workers;
- workers in research laboratories; and
- shipping and receiving personnel.
Workplace exposures to HDs can lead to both acute and chronic health effects, such as skin rashes, adverse reproductive outcomes (including infertility, spontaneous abortions and congenital malformations), and possibly leukemia and other cancers. Protection from exposures requires proper protective equipment, as well as engineering, design, structural, workflow and administrative controls, such as policies and procedures.
Any healthcare entity potentially handles HDs, including acute care settings; ambulatory settings, including infusion and oncology centers; long term care; pharmacies; and home health. Several services that most commonly use HDs include: oncology, medical-surgical, Emergency Departments and the Operating Room. Spills can happen anywhere there are HDs.
CDC – NIOSH – Hazardous drugs in healthcare settings
The Centers for Disease Control and Prevention (CDC)’s National Institute for Occupational Safety and Health (NIOSH) was established in 1970 as a research agency focused on the study of worker safety and health, with a goal of creating safe and healthy workplaces. NIOSH has deemed certain groups of human drugs as “hazardous drugs” (HD) based on at least one of six criteria:
- carcinogenicity – a drug that tends to produce cancer;
- teratogenicity or developmental toxicity – causes malformations to embryos or fetuses;
- reproductive toxicity in humans – adverse effects on sexual function and fertility in adult males and females, as well as adverse effects on development of the offspring;
- organ toxicity at low doses in humans or animals;
- genotoxicity – drug that damages the genetic information within a cell; may lead to cancer; and
- new drugs that mimic existing hazardous drugs in structure or toxicity.
There are 3 main categories of HDs in healthcare:
Group 1: Antineoplastic drugs aka “cancer chemotherapy” drugs, e.g., anastrozole, cisplatin, methotrexate, vincristine, etc.
Group 2: Non-antineoplastic drugs that meet one or more of the NIOSH criteria for a hazardous drug, e.g., estrogens (conjugated), sirolimus, risperidone, etc.
Group 3: Drugs that primarily pose a reproductive risk 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, e.g., alitretinoin, clonazepam, finasteride, etc.
Compounding refers to combining, mixing or altering ingredients of a drug to create a medication tailored to the needs of an individual patient; it affords a given patient tailored therapy when a commercially available formulation may not be available. Reasons for compounding include a patient with an allergy and needs a drug to be made without a certain dye, or an elderly patient or a child who cannot swallow a tablet or capsule and needs a medicine in a liquid dosage form. Ensuring consistency and quality in compounding is essential for patients to receive medications of the correct strength, quality and that are free from contaminants.
United States Pharmacopeia (USP®)
USP is a scientific, nonprofit organization that sets public standards for identity, strength, quality and purity of medicines, food ingredients and dietary supplements. USP standards are recognized in various provisions of the federal Food, Drug and Cosmetic Act (FDCA) and in laws, regulations and policies promulgated by states. These standards are enforced by the U.S. Food and Drug Administration (FDA), states and other oversight organizations/regulatory bodies, e.g., state boards of pharmacy.
USP <800> Safe Handling of Hazardous Drugs Standards
USP General Chapter <800> released in 2016 and harmonized with <795> and <797> provides standards for safe handling of hazardous drugs in healthcare settings to minimize the risk of exposure to personnel, patients and the environment. Requirements include: responsibilities of personnel handling hazardous drugs; facility and engineering controls; procedures for deactivating, decontaminating and cleaning; spill control; and documentation. New and revised USP <800> standards become effective December 1, 2019.
USP <795> Pharmaceutical compounding – Nonsterile preparations; <797> Pharmaceutical compounding- Sterile preparations Standards
These standards describe minimum expectations for preparing nonsterile medications in healthcare settings and preparation of compounded sterile products, respectively. Revised USP <795> <797> standards become effective December 1, 2019.
Personal Protective Equipment (PPE)
NIOSH’s Hazardous Drugs, 2016 (Table 5) provides general guidance on PPE for a myriad of typical scenarios; it cannot address all possible circumstances. In general, the drug and the activity drive what PPE is most safe. Lower risk activities, such as administration of a single dose, intact pill to a patient may warrant wearing of a glove, whereas compounding a powder/solution for inhalation/ aerosol treatment requires double chemotherapy gloves; eye/face protection; protective gown; respiratory protection; and ventilated engineering controls.
Premier healthcare alliance – Hazardous drugs and compounding resources
- Advisor Live® Webinar: “USP <800> Hazardous Drugs: Overview and the Road to Readiness” 7.17.2019. Download the presentation here.
- Advisor Live® Webinar: “USP Compounding Standards <795> <797> Updates Summary and Impact” 6.13.2019. Download the presentation here
- Are you ready for USP <800>? Download Premier’s USP <800> Preparation checklist
- For more information and to help ensure that your practice site is ready by December 1st, please contact: Premier Solution Center
- Premier Pharmacy Education (member login required)
Other key resources
- ASHP – Guidelines on handling hazardous drugs, 2018 (Site accessed 6.6.2019)
- CDC – The National Institute for Occupational Safety and Health (NIOSH) (Site accessed 6.6.2019)
- CDC – NIOSH: Hazardous drug exposures in healthcare (Site accessed 6.6.2019)
- CDC – NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016 (Site accessed 6.6.2019)
- FDA – Human Drug Compounding (Site accessed 6.6.2019)
- FDA – Info for consumers and healthcare professionals (Site accessed 6.6.2019)
- USP – <800> Handling of hazardous drugs (Site accessed 6.7.2019)
- USP <795> Pharmaceutical compounding – Nonsterile preparations (Site accessed 6.7.2019)
- USP – <797> Pharmaceutical compounding- Sterile preparations (Site accessed 6.7.2019)