What is USP 800?
What is USP 800? If you own or manage a pharmacy, you’ve probably heard about the USP 800, the newest chapter issued by the United States Pharmacopoeial Convention. Although USP guidelines typically apply to compounding pharmacies and drug manufacturers, the USP 800 guidelines apply to any facility which handles hazardous drugs; so if you own or operate a pharmacy, these rules apply to you.
In this blog series, we will be conducting a brief review of the USP 800 and discussing what it means to independent community pharmacies. In this first installment, we’ll discuss the basics of compliance for USP 800.
What is USP 800?
USP 800 – formally known as the USP General Chapter 800 Hazardous Drugs — Handling in Healthcare Settings – is a set of standards regarding the safe handling of hazardous drugs in any healthcare setting. This includes compounding pharmacies, retail pharmacies, long-term care pharmacies, hospital/clinical pharmacies, patient treatment facilities, veterinary clinics, and any other entity which may handle a hazardous drug in any way.As such, the USP 800 applies to all workers and employees who may come into contact with hazardous drugs – pharmacists, pharmacy technicians, nurses, home healthcare workers, physician assistants, veterinarians, and veterinary technicians.
The USP 800 includes a description of the practices and quality standards for the handling of hazardous drugs. These guidelines apply to the different activities that typically take place in a pharmacy including receipt, storage, compounding, dispensing, administration, and disposal of sterile as well as non-sterile products. The purpose of USP 800 is to ensure “patient safety, worker safety, and environmental protection” at all times, especially during activities pertaining to hazardous drugs in a pharmacy.
By now, every pharmacy should be aware that the USP 800 is NOT just for compounding.
When is the USP 800 Compliance Deadline?
The big day is December 1, 2019.
The USP 800 was scheduled to be implemented on December 1, 2019 but there has been a delay due to the appeals against some of the standards.
This is the official date when the new USP <800> standards will become enforceable by those entities which require compliance, although some state boards of pharmacy have already adopted the guidelines set forth in these chapters of the USP.
USP <800>: A summary
The purpose of USP <800> is to set forth standards which will limit patient and worker exposure to hazardous drugs.
If you are a compounding pharmacy, the requirements are somewhat tedious because compounding with hazardous drugs is inherently more risky than simply counting and repackaging a drug. Both initial implementation and subsequent day-to-day operations may be time-consuming in order for compounding pharmacies to comply with the new guidelines, but the majority of compounding pharmacies probably already meet most of the requirements.
Who enforces USP <800>?
Ultimately, the United States Pharmacopeia has no role in enforcement; they simply set the standards. It’s up to state boards of pharmacy, accreditation organizations, and other regulatory entities to decide whether they will enforce the standards set forth in the USP 800.
Because the USP 800 may be enforced by each state’s Board of Pharmacy, as well as accreditation organizations and third-parties, each pharmacy must determine which regulatory agencies – if any – will require their compliance with the USP 800 Standards.
At a minimum, each pharmacy should check with the following respective entities:
If you get lucky, and your pharmacy is not required to comply with the USP <800>, OSHA still requires compliance with the Hazard Communication Standard (HCS) for all hazardous drugs if there is a potential for employee exposure.
It’s worth noting, however, that the overall requirements for the HCS are not as restrictive as those set forth in USP <800>; it’s possible that OSHA will adopt the USP <800> guidelines where applicable, as part of its HCS compliance requirements. Be sure to check back with us often to stay up to date with all compliance regulations as they apply to your pharmacy!
What does the USP 800 mean for my pharmacy?
So…you have determined that you need to comply!
The good news is that compliance is fairly easy for non-compounding retail pharmacies as they do not have to deal with the compounding of HDs. Therefore, while it can be time-consuming up to a certain extent, compliance for non-compounding pharmacies is not as tedious as that for compounding pharmacies. So, don’t let other consultants convince you that compliance is difficult and that you need to pay them thousands of dollars to avoid penalties.
In order to comply with the USP <800>, a pharmacy must ensure – at a minimum – that the following are in place:
There are certain steps that every pharmacy must take in order to ensure that the above requirements are met. PRS is here to help you meet the requirements listed above, by walking you through each stage of the steps listed below.
Step 1: Designate a person to be in charge of your USP 800 Compliance Program
No matter how simple or complicated your operational practices may be, each pharmacy must designate a Hazardous Drug Compliance (HDC) Manager to oversee the development and implementation of entity-specific policies and procedures in order to comply with the USP <800>guidelines.
The HDC Manager must report directly to the upper management of the pharmacy concerning all matters pertaining to HDs including any potential hazardous situations. Furthermore they have the authority to oversee and direct all employees involved with the handling of hazardous drugs and their training on the right ways to handle HDs and the precautions necessary to contain them.
An HDC Manager can be a pharmacist or pharmacy technician who:
It is recommended that all designated HDC Managers attend webinars and other educational programs offered by Pharmacy Professional/Educational Groups.
Clinical understanding of hazardous drugs is not necessarily essential for the HDC Manager. The overall goal is to prevent or limit exposure to any and all hazardous drugs, because there are no allowable limits of exposure to any hazardous drug. If (or when) clinical understanding is required, the HDC Manager – if he/she is not a Pharmacist – should work with the pharmacist as necessary.
The HDC Manager should oversee the implementation of the remaining steps, and should involve any other management or operational personnel as necessary.
Step 2: Identify the hazardous drugs in your inventory
All pharmacies are different, but the vast majority of retail pharmacies stock a number of the same common hazardous drugs, such as Clonazepam or Warfarin.
The HDC Manager will oversee the process of documenting all hazardous drugs in your pharmacy. It is important to clearly label all hazardous drugs to ensure that employees can easily determine the group to which the hazardous drug belongs to and the type of toxicity it causes.
Any pharmacy’s unique list of HDs should be compiled based on the NIOSH List of Antineoplastic and Other Hazardous Drugs.
NIOSH defines a hazardous drug as any drug which exhibits one or more of the following characteristics:
NIOSH organizes hazardous drugs meeting the above criteria into the following three groups:
Step 3: Identify the activities that lead to exposure
Once you identify the HDs in your inventory, the next step is to identify all of the activities in your pharmacy that could result in exposure to one of these hazardous drugs. To accomplish this, the pharmacy needs to understand the different types of exposures through which hazardous drugs can enter the human body.
In general, these include “dermal and mucosal absorption, inhalation, injection, and ingestion (e.g., contaminated foodstuffs, spills, or mouth contact with contaminated hands” (USP <800> Standard 3).
Taking this evaluation one step further, you must then identify which specific activities in your pharmacy could lead to these kinds of exposure.
The USP <800> provides the following list of examples that match up pretty well with basic routine tasks which occur day-to-day in a typical retail pharmacy:
Each pharmacy must establish policies and procedures which cater to the specific types of exposure likely to occur in their facility, and based on the specific HDs which they handle.For instance, the guidelines for avoiding spillage state that pharmacies should not store HDs on the floor or any other area prone to earthquakes or other natural disasters. It’s also prohibited for sterile and non-sterile HDs to be stored together to further contain HDs.
Step 4: Identify the personal protective equipment (PPE) that your employees should use
There are several ways to protect an employee from exposure: engineering controls, administrative controls (policies and procedures), and personal protective equipment (PPE). We will cover the basics of engineering controls and administrative practices in our next post. For now we will discuss PPE.
The USP defines PPE as “items such as gloves, gowns, respirators, goggles, face shields, and others that protect individual workers from hazardous physical and chemical exposures” – pretty straight forward.
The USP goes one step further and prescribes the specific type of PPE that must be used in various situations. It’s up to the HDC Manager to make sure the PPE is available, to ensure employee training regarding PPE usage has been conducted, and that the employees are actually using the PPEs as mandated.
The USP <800> Standards are written to protect the employee from exposure by designating certain PPEs as required. Because of this, some of the PPE requirements can be excessive for typical retail pharmacies.
To limit the disruption to operations that these changes might cause, the USP <800> allows for an HDC Manager to perform an “Assessment of Risk” for the specific HDs and dosage forms dispensed by that pharmacy, in order to create alternate strategies to protect employees from exposures. We will cover more on Assessments of Risk in our next post.
We hope we fully answered the question “What is USP 800” and addressed any doubts you may have had with regards to its basic practices and guidelines.In Part 2, we’ll discuss several other elements of USP <800> Compliance that pharmacies will need to address, including engineering controls, administrative controls, and Assessments of Risk in order to determine the different types of items, equipment, and processes your pharmacy should have in place.
As always, if you have any questions related to the ownership and compliance services provided by PRS, don’t hesitate to give us a call at 1-800-338-3688, send us an email at [email protected], or visit our website at prsrx.com.