Safety First Blog

Q&A: USP <800> Lunch+Learn on April 20

Posted by Laura Paxton on Apr 21, 2023 1:55:39 PM
Laura Paxton
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Following are the questions posed and answers given by Rpharmy's Customer Experience Specialist Sherlene Christen on the April 20th USP <800> Lunch + Learn.

Q: What drugs need assessments of risk?

A: An AoR is not allowed for any hazardous active pharmaceutical ingredient (HD-API). Those are usually seen in compounding facilities designated as 503b facilities, but occasionally, you may see some active pharmaceutical ingredients in the inpatient pharmacy and your infusion clinics. As well as any antineoplastics that are being compounded or manipulated prior to dispensing them, an AoR is not allowed for those.

You can provide an AoR for any final dosage forms and/or conveniently manufactured products you dispense in the package, such as unit dose products.

Q: Are you seeing hospitals hire someone to write assessments of risk? Do you know of any companies or consultants that can write those for our organization? 

A: I have not seen any company offering to write assessments at risk, but I have seen quite a few sites providing template examples to create your own. There may be some consultants out there that are offering that service, but I'm not aware of them. We do not necessarily write the AoRs, but we can assist in the process when we take on a new client. Many times we receive spreadsheets that are directly related to AoRs, and we decipher that information to make it easily readable and accessible for AoRs. 

Q: Does Rpharmy provide AoRs or could you help us write them? 

A: We do not provide AoRs because they must be created based on decisions within your organization that include site-specific design. However, we can show you what other people have done to help you create your own. There's so much information out there about AoRs. Also review the SOPs in your organization, then the examples of AoRs can help you make more informed decisions on which drugs need an AoR and which do not. 

Topics: Rhazdrugs, Policy, USP <800>, Formweb

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