What NCPA Got Wrong With Their Assessment of Risk Template

What’s the the old adage?

“You know what happens when you ASSUME?”

You make an assessment of risk that isn’t up to par.

Ok, maybe that’s not how it exactly goes, but track with me. NCPA recently provided a free Assessment of Risk (AoR) template and completed example. Most of us would assume that it’s perfect. If you were to assume that… well… keep reading.

Without getting into every boring detail, we’ve highlighted the sections below that need to be addressed if you decide to use their template.

  1. Some dosage forms you will need to add if you use them:

    1. For Compounding

      1. API’s

      2. Tablets/Capsules

      3. Creams

    2. Retail

      1. Eye/ear drops

  2. Risk exposure: PROBLEM - what’s on NCPA’s document are BLANKET STATEMENTS for an entire category. That won’t work. Risk of exposure depends on dosage form.

    1. An AoR is more detailed and based on a drug’s package Insert/SDS and NIOSH category

    2. If you are PCAB accredited, this will not suffice. It’s not robust enough.

    3. Some quick questions to ask yourself while performing an AoR:

      1. Does this final dosage form have residue/powder?

      2. What ‘Alternative Containment Strategies” (ACS) works best for MY facility?

      3. How will this affect my workflow, formulary, operations, etc..?

3. Alternative Containment Strategies (ACS): before we dive in, here’s a link with an overview

  1. If you’re dosage form qualifies for an ACS, you need to define what that looks like.

  2. This entire section fails to mention some important items

    1. You can use dedicated trays, spatulas and tools

    2. Cleaning and decontamination

    3. Using different types of PPE for different dosage forms

Looking at it as a whole, it’s not a true assessment of risk. It’s certainly a good start for most people, but if you’re going to do it, you might as well do it right.

A Better Way

The following image is a sample of why I like doing assessment of risks in excel format. Everything in one nice, organized table. Plus your staff can filter the electronic version for drug, dosage form, etc.

This format is easier to edit and easier to understand. Few of us have time to read through novels of AoR’s, so having it in this clean format makes it simple.

Not every state will implement USP <800>, but that doesn’t mean your facility shouldn’t do an AoR. Your employees deserve it. Future attorneys will be salivating at the opportunity to go after owners who compound BHRT or other hazardous drugs. Why wait?

And if you want to gauge where you are for USP 800, take our 3 minute quiz to find out!

USP 800, PharmacyVanessa BrownUSP 800