What is the USP?

The USP, United States Pharmacopeial Convention, is a scientific nongovernmental organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. It publishes the United States Pharmacopeia (USP) and the National Formulary (NF) compendia of the United States.  The compendia contain general chapters that outline specific procedures and tests referenced in monographs.  Any chapters lower than <999> are legally enforceable, while chapters greater than <999> are informational or recommendations.^1,2

What is USP <800>?

On February 1, 2016, USP <800>, officially titled, “General Chapter <800> Hazardous Drugs-Handling in Healthcare Settings” was approved and made final.  This general chapter describes practice and quality standards for safely handling both sterile and nonsterile hazardous drugs (HDs) to protect personnel, patients and the environment.  These standards identify the requirements for receipt, storage, mixing, preparing, compounding, dispensing, and administration of the hazardous drugs.  USP<800> is established in conjunction with USP general chapter <795> (non-sterile compounding) and USP general chapter <797> (sterile compounding).²

USP <800> applies to all healthcare personnel and patients that may handle or encounter hazardous drugs (HD).  Healthcare personnel includes, pharmacists, technicians, nurses, physicians, physician assistants, home healthcare workers and veterinarians.  All personnel need to receive HD training and understand fundamental practices and precautions regarding HD handling. USP <800> also applies to all institutions that store, prepare, transport or administer HDs, including pharmacies, hospitals, patient treatment clinics, physician practice facilities or veterinarians’ offices.²

When will USP <800> take effect?

Even though the final version of USP <800> was approved February 1, 2016, the implementation date is December 1, 2019.  This delayed implementation date is to allow entities additional time to implement the standard. However, all entities must have USP <800> standards in place by December 1, 2019. It is important to note that implementing USP <800> will take time. Drugs that are considered “hazardous” are not just oncology or institutional drugs, but rather drugs that can be found in a community pharmacy. ^2,4

How is USP <800> enforced?

The enforcement of USP standards can be performed by accrediting bodies such as the Joint Commission, CMS, or state departments of health.  Due to the fact that the FDA has oversight over compounding, they may also be an enforcing agency.  Additionally, since many pharmacy practice acts reference USP standards, state boards of pharmacy may also enforce these standards. ^2,3

The USP website has posted a list of Frequently Asked Questions regarding USP <800>. 

What is a Hazardous Drug (HD)?

The National Institute for Occupational Safety and Health (NIOSH) is the federal agency responsible for conducting occupational safety and health research and training to prevent work related injury and illness.  NIOSH identifies drugs that are hazardous or potentially hazardous and these drugs are listed in USP <800>.

For a drug to be identified as a hazardous drug (HD) by NIOSH, the drug must have at least one of the following six characteristics:  carcinogenicity, teratogenicity, reproductive risk, organ toxicity, genotoxicity, or new drugs that mimic existing hazardous drugs in structure or toxicity.

Based on these criteria, NIOSH has created a list of hazardous drugs.  The list was recently updated in 2016 when 34 additional drugs were added.  NIOSH maintains the hazardous drug list and will update it periodically.  Many drugs considered to be hazardous are those that would be expected such as chemotherapy agents and anti-viral medications.  However, common drugs such as hormones (testosterone and progesterone) and drugs such as tretinoin, fluconazole, and carbamazepine are also listed.^5,6 The current NIOSH hazardous drug list is divided into three groups of drugs.

Group 1: Antineoplastic drugs, including those with manufacturer’s safe handling guidance, that meet one or more of the NIOSH criteria for a hazardous drug. In addition to many of these drugs being cytotoxic they may also pose a reproductive risk for susceptible populations.

Group 2: Non-antineoplastic drugs, including those with manufacturer’s safe handling guidance, that meet one or more of the NIOSH criteria for a hazardous drug. Note that some of these drugs may also pose a reproductive risk for susceptible populations.

Group 3: Non-antineoplastic drugs that primarily meet the NIOSH criteria for reproductive hazards and 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.

Hazardous Drugs in Your Organization

Each organization must create and maintain a list of hazardous drugs based on its own formulary.  The list must include hazardous drugs the organization uses from the NIOSH list and any other item not on the NIOSH list, that the organization feels is appropriate for inclusion.  Additionally, any new drug that becomes available or any newly purchased drug should be reviewed and determination made if it needs to be included on the list.  The organization’s hazardous drug list must be reviewed yearly or more frequently if new drugs are added to the list. ^6,7

Protecting Personnel

Once the organization’s hazardous drug list has been identified, the next step is to assess how to handle these drugs, assess risk and protect personnel. Not all hazardous drugs (non-anti-neoplastic) have the same risk profile.  This is due to how they are supplied or how the drug is to be administered or manipulated.  A risk assessment should be performed to determine alternative containment strategies and work processes that can be safely implemented and enacted.

Risk assessments should include:

• Type of HD (eg, antineoplastic, non-antineoplastic, reproductive risk only)
• Dosage form
• Risk of exposure
• Packaging
• Manipulation⁸

Due to the wide variety of drugs that are considered hazardous, all pharmacies can be affected by USP <800>.  It is important to understand the safeguards that need to be implemented to ensure pharmacy personnel safety.  Handling these hazardous drugs can vary depending on the activity performed and risk involved, whether this is simply dispensing, or compounding the hazardous drug. NIOSH has included general information for possible scenarios that healthcare providers may encounter when handling hazardous drugs.  This table provides guidance on engineering controls and personal protective equipment (PPE) that applies to all drugs that are listed as hazardous.  The information can be accessed here.⁵

REFERENCES

1. US Pharmacopeial Convention website. USP-NF. http://www.usp.org/usp-nf Accessed March 2017
2. US Pharmacopeial Convention. (2016). Frequently Asked Questions: <800> Hazardous Drugs—Handling in Healthcare Settings. Retrieved from http://www.usp.org/frequently-asked-questions/hazardous-drugs-handling-healthcare-settings
3. Priya Sahadeo and Robert J. Weber (2015) USP <800>: Key Considerations and Changes for Health Systems. Hospital Pharmacy: November 2015, Vol. 50, No. 10, pp. 941-949
4. Bonner, L. (2016) Safe Handling of Hazardous Drugs: USP Publishes New Chapter <800>. Pharmacy Times: April 2016, Vol 22, No. 4, Page 42
5. NIOSH [2016]. NIOSH list of antineoplastic and other hazardous drugs in healthcare settings, 2016. By Connor TH, MacKenzie BA, DeBord DG, Trout DB, O’Callaghan JP. Cincinnati, OH: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication Number 2016-161 (Supersedes 2014-138).
6. Bruckart, JL. USP<800>: How Your Pharmacy Can Prepare. National Community Pharmacists Association website. December 2016http://www.ncpa.co/issues/APDEC16-USP_800__How_Your_Pharmacy_Can_Prepare.pdf. Accessed March 2017.
7. Demler, T. (2015) USP<800> and Hazardous Drugs. US Pharmacist website. August 18, 2015. https://www.uspharmacist.com/article/usp800-and-hazardous-drugs Accessed March 2017. Accessed March 2017
8. Aguero,D. and Marge,K. Developing a USP <800> Compliance Gap Analysis. Pharmacy Purchasing and Products website. January 2017 Vol 14, Page10. https://www.pppmag.com/article/1989/?search=usp800 Accessed March 2017
9. Traynor, K. Prepare Now for USP Standard on Handling Hazardous Drugs. American Society of Health System Pharmacists website https://www.ashp.org/news/2015/03/13/prepare_now_for_usp_standard_on_handling_hazardous_drugs Accessed March 2017.
10. Page,MR. (2016) USP<800>: Key Changes and Additions to USP<797> Pharmacy Times website. July 27,2016 http://www.pharmacytimes.com/publications/health-system-edition/2016/july2016/usp-800-key-changes-and-additions-to-usp-797?p=2 Accessed March 2017
11. Professional Compounding Centers of America website. USP<800> Frequently Asked Questions. http://www.pccarx.com/what-is-compounding/usp-800-frequently-asked-questions?highlight=WyJ1c3AiLDgwMCwidXNwIDgwMCJd Accessed March 2017.