The USP will become binding on installations once the revisions are approved.

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Kevin Straughn, PharmD, clinical pharmacist at Duke Regional Hospital, said that once the 2 chapters of preparation, and become enforceable, there will be a 6 month grace period before the USP does not become enforceable.

In a presentation at the American Association of Pharmacy Technicians’ 2022 Pharmacy Technician Annual Convention, Kevin Straughn, PharmD, clinical pharmacist at Duke Regional Hospital, explained what pharmacists should know about USP .

“The purpose of the USP is to protect the pharmacy department, the nursing department, everyone working in the hospital, and all hospital patients from unnecessary exposure to hazardous drugs,” Straughn said in his presentation.

“It gets a bad rap because there are a lot of implementations required, but it’s for us. It’s not like USP , which is to protect patients from infection. It’s for us, so we should really invest in it and do our best to make sure everyone is safe.

Straughn said the USP revisions are not yet binding, but once the revisions become binding, USP will also become binding on establishments that compound non-sterile products, including all compounding community pharmacies.

He said that once the 2 chapters on composition, and become enforceable, there will be a 6 month grace period before the USP does not become enforceable.

His presentation highlighted a list of hazardous drug types, specifically from the National Institute of Occupational Safety and Health (NIOSH), which the USP refers to. .

“USP 800 also says you can’t just take the NIOSH list and say, ‘Oh, that’s our hazardous drug list. We could have medicine here. They say you need to take the drugs off the NIOSH list from your facility and list them separately so your staff knows what to look out for, Straughn said during the presentation.

Hazardous drugs that NIOSH refers to include carcinogenicities, developmental toxicities, reproductive toxicities, low-dose organ toxicities, and genotoxicities.

There are 3 categories on the NIOSH list. Category 1 includes antineoplastic drugs, i.e. chemotherapy; category 2 includes non-antineoplastic drugs deemed unsafe by other NIOSH criteria; and Category 3 includes drugs that pose a reproductive risk and are only harmful to women of childbearing age, pregnant women, or women trying to become pregnant.

Straughn also mentioned that in 2022-23, NIOSH will remove all antibody drugs from its list, which will include cancer drugs, which are still dangerous.

“My recommendation is that your institutions will go through all this work to implement the USP . You should all include these other drugs that might not be on this NIOSH list but are still dangerous, Straughn said during the presentation.

A pharmacy’s hazardous drug list must be revised every 12 months with a review of documents, when a new agent or dosage form is added, or if the storage, preparation, or administration of the hazardous drug does not does not meet USP standards and a risk assessment must be done.

USP Elements include receiving, storage, preparation, distribution, administration, disposal and cleanup.

When receiving hazardous drugs, they must be unpacked in a neutral or negative pressure room and cannot be unpacked in sterile preparation areas.

“Shipping containers should come to you intact, ready to unpack. It should say dangerous on them, and you should know that,” Straughn said during the presentation. the bottle is there, it leaked…you should contact the manufacturer and see if they can be returned.”

When storing hazardous drugs, they should be stored to prevent spills or breakage, ideally in a negative pressure room vented to the outside. For preparation, the C-PEC is used as a ventilated device controlled by primary engineering and the C-SEC is the secondary engineering control in the room where the C-PEC resides.

There are also closed-system transfer devices to help prevent chemotherapy spills, provide more protection, and should be used when administering the drug.

It provides more protection as an individual is never exposed to liquid, and although there is no universal performance standard, it is recommended to be used when preparing.

For chemotherapy drugs, USP also indicates that a second pair of chemotherapy gloves, a second gown and a second pair of shoe covers should be used. Eye and face protection should also be used where there is a risk of spills and splashes.

Hazardous personal protective equipment (PPE) should be disposed of as chemotherapy waste and a person should clean the secondary layer in the same room as the chemotherapy.

When dispensing hazardous drugs, they must be labeled as hazardous and packaged to protect them from damage and leakage. They must also be transported in acceptable containers to minimize the risk of breakage and leakage.

When administering hazardous drugs, PPE should be used. The individual should prime the intravenous line in the C-PEC and the closed system drug transfer device should be used when the dosage form permits.

It is also suggested to avoid handling dangerous drugs when possible, such as crushing tablets and opening capsules.

Hazardous drugs should be disposed of in designated yellow bins. Cleaning is also up to standard and , including deactivation, decontamination, cleaning and disinfection. Additional requirements include spill kits where hazardous drugs are administered, prepared, or received.

Documentation and standards of practice must be maintained for all stages of handling hazardous drugs. Additionally, medical surveillance as an evaluation and documentation of evidence suggesting potentially harmful hazardous drugs should be used.

Community pharmacies that do not perform compounding activities are not required to follow the USP however, they require a risk assessment that includes the type of hazardous drug, dosage, risk of exposure, packaging, and handling.

References

Straughn K.USP : protects you and your colleagues from dangerous drugs. Raleigh-Durham, NC: 2022 AAPT Pharmacy Technician Annual Convention; July 23, 2022.

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