If you own or manage a Pharmacy, you’ve probably heard about USP <800>, the newest chapter issued by the United States Pharmacopoeial Convention. Although USP guidelines typically apply to compounding Pharmacies and drug manufacturers, USP <800> guidelines apply to any facility which handles Hazardous Drugs; if you own or operate a Pharmacy, that means YOU.

In this blog series, we will be conducting a brief review of 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 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.

The purpose of USP <800> is to ensure “patient safety, worker safety, and environmental protection” during the “receipt, storage, compounding, dispensing, administration, and disposal” of Hazardous Drugs.

By now, every pharmacy should be aware that USP <800> is NOT just for compounding.

When is the USP <800> Compliance Deadline?

The big day is December 1, 2019. 

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 USP <800>.

Because 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 USP <800> Standards.

At a minimum, each Pharmacy should check with the following respective entities:

  • Your state board of Pharmacy;
  • Other state agencies responsible for employee health and occupational safety;
  • Business and/or workers’ compensation insurance;
  • Accreditation organizations;
  • Payer sources

If you get lucky, and your pharmacy is not required to comply with 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 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 USP <800> mean for my pharmacy?

So…you have determined that you need to

The good news is that compliance is fairly easy for non-compounding retail Pharmacies. It can be time-consuming, but don’t let other consultants convince you that compliance is difficult and you need to pay them thousands of dollars to avoid penalties.

In order to comply with USP <800>, a Pharmacy must ensure – at a minimum – that the following are in place:

  • A list of all HDs handled by the Pharmacy;
  • Any necessary facility and engineering controls;
  • The competency of any personnel involved in the handling of HDs;
  • Safe work practices;
  • Proper use of Personal Protective Equipment (PPE) where necessary;
  • Policies for the safe segregation and disposal of HD waste

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 USP <800>.

The HDC Manager must report directly to Pharmacy Upper Management and have authority to oversee and direct all employees involved with the handling of Hazardous Drugs.

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 any Hazardous Drugs to ensure that employees can easily determine the group to which the Hazardous Drug belongs 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:

  • Carcinogenicity, teratogenicity, or other developmental toxicity;
  • Reproductive toxicity;
  • Organ toxicity at low doses (<10 mg or <1mg/kg);
  • Genotoxicity;
  • New drugs that mimic the structure or toxicity profiles of drugs currently determined to be hazardous based on these criteria

NIOSH organizes Hazardous Drugs meeting the above criteria into the following three groups:

  • Group 1: Antineoplastic drugs (may also have reproductive risk)
  • Group 2: Non-Antineoplastic drugs (may also have reproductive risk)
  • Group 3: Reproductive Risk

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 exposure 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.

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:

  • Receipt of medication;
  • Dispensing of medication;
  • Compounding and other manipulations;
  • Administration of medication;
  • Patient-care activities;
  • Spills;
  • Transport (from one area of the Pharmacy to another);
  • Waste Disposal

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.

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.

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.

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 happened, and that the employees are actually using 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, 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.

Stay tuned...

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 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 prsinfo@prsrx.com or visit our website at prsrx.com.


 

On 9/4/2019, we released the USP800Track Program in the same format, design, and thoroughness as all of our COMPLIANCETrack programs.