Podcast: Preparing the Hazardous Drugs Assessment of Risk

You may wonder why I keep referring the USP <800> as guidelines. USP or United States Pharmacopeia creates international guidelines or standards for government and industry to follow. When written, they are not regulatory by nature, however, when the Food and Drug Administration (FDA) adopts the guidelines as a “rule”, well now we have a regulation. In addition, USP <800> is not just a US guideline, it is a worldwide guideline. So our friends to the north in Canada are working through the same process as we are. Same over in Europe, Asia, Africa, Cantal and South America. Even the Aussies from down under can’t escape this one.

Today we are going to talk about the single most important document for Hazardous Drugs in a retail or a Long Term Care Pharmacy. It is called, an Assessment of Risk.

Is there any designations for Hazardous Drugs?

Yes. Pharmacy management must appoint a Hazardous Drug Designee who is qualified and trained to be responsible for developing and implementing procedures and overseeing compliance. This will normally fall to the Pharmacist-In-Charge, but can be a pharmacist or in rare cases a highly qualified Certified Pharmacy Technician.

Well what is an Assessment of Risk?

An Assessment of Risk is a document designed for any hazardous drug that meets the requirements of a “Final Dose Form”. These are drugs the manufacturer created that require little to no handling during the dispensing process. USP <800> term is “manipulation”. These are the drugs we talked about on the last podcast that are inventoried and segregated in the pharmacy. We use the Hazardous Drug Inventory as our starting point for completing this assessment.

What is an Assessment of Risk Comprised of?

Probably the most important fact to start with is an Assessment of Risk does not have to be complicated. This document does not need to impress anyone. It is a functional document to provide information to your employees and the inspectors to indicate you have implemented appropriate protective measures. I personally like the assessment broken into four (4) sections.

1. The Drug Name. List the drug name with the table number or the table name. This is important to know. All table 1 HDs must have their own Assessment of Risks. However, Table 2 and Table 3 HDs that are the same, i.e. brand and generics, only need one Assessment of Risk for the entire group.
2. Risk of Exposure. Here the HD is identified if it is in manufacturer’s packaging, i.e. birth control pills; the form of the HD, i.e. tablet, capsule, liquid and whether there is dust present, if there is any “Manipulation” required. Emulsification is not manipulation, but mixing creams is. Finally any other information concerning the HD that is relevant.
3. Containment Strategies or work practices. This is generally the easiest part. Kept in a segregated and marked part of the pharmacy, counted on designated counting trays with tools and any other specific requirement needed for this HD for containment.
4. Finally, an Assessment signature and date. The Assessment is signed by the Hazardous Drug Designee and maintained for a period of time, which we recommend for six (6) years.

Now the Assessment is completed, where do you put them? 

This has become an important set of documents. You will want to place the Assessments of Risk in document protector and then place them in a binder. This binder should be marked, “Hazardous Drugs – Assessment of Risks” and kept with your other compliance binders/documents. The entire pharmacy staff must know where the binder is kept so they can get it quickly when asked.

Why is this so important?

When any of these inspectors walk into your pharmacy, this is the first document, they will ask for. The Assessment of Risk is a mandated document for the pharmacy to have completed, available and annually reviewed for the pharmacy to be able to dispense a Hazardous Drug. Without the Assessment of Risk, the retail or LTC pharmacy is forbidden to dispense the hazardous drug or even have it in stock.

This is crazy, the pharmacies have been dispensing these drugs since their creation.

This is the sad truth of today’s reality.

While the inspectors are in the pharmacy will they ask for other information?

Yes. In some states they are already doing this. Inspectors will ask where you are keeping your hazardous drugs. What do you with expired hazardous drugs? Do you have a Quarantine area? Do you have an EPA Generator permit? On this one, the answer is NO. You only this this permit if you are generating 220 lbs. of Hazardous Waste per month. Your Hazardous Communications Plan and training cover this requirement; and this needs updated as well.

Jeff, when it comes to compliance, you always have a solution and it is always easy to follow and very reasonable in price. How can you help our listeners today?

We have two programs for pharmacies. The first is for the retail and LTC pharmacy. Our Hazardous Drug Program is a complete, customize, ready to go program. My staff will prepare it for each pharmacy and we have a step-by-step process. All the training requirements are contained within the program, with updates and personal assistance. We also have a second program available and this program is for non-sterile compounder. It is complete with USP <795> and <800> guidelines, plus all of the hidden USP guidelines that have been added.

The retail & LTC program can be ordered on-line at www.RJHedges.com/HazardousDrugs. The Non-Sterile compounding program as well as all of our other compliance programs are found on our website at www.RJHedges.com or call 724-357-8380.