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Safecor Health Introduces SafecorLogics

Posted on December 01, 2022

New program enables health systems a more strategic approach to reducing drug spend and building system-wide supply chain solutions

Columbus, Ohio – Dec. 1, 2022 – Safecor Health today announced SafecorLogics, a new program for health systems to reduce drug spend, build system-wide supply chain solutions and improve value-based care. SafecorLogics allows a health system to consolidate order volume across numerous hospitals and store packaged product in Safecor Health’s warehouses. Combined with Safecor Health’s drug spend analysis, SafecorLogics drives standardization and significant reduction in drug and packaging costs across multi-site and multi-state facilities.

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Seven Tips to Help You Avoid Cross-Contamination During Unit-Dose Drug Repackaging

Posted on August 12, 2021

Originally posted on April 05, 2018


Updated August 2, 2021 

While the COVID-19 pandemic has contributed to medication shortages, the FDA acknowledges that drug shortages can occur almost any time, due to factors such as manufacturing delays, quality issues, or discontinuations. In fact, the FDA now offers a Drug Shortages Mobile App to receive notifications within selected therapeutic categories.

As a result of pandemic-related shortages, some hospitals and health systems have opted to establish a combination of in-house and outsourced unit-dose drug repackaging to ensure supply availability and to keep costs in check. Regardless of which approach a facility chooses, cross-contamination remains a vitally important consideration for every hospital's unit-dose repackaging strategy.

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What Is Unit-Dose Repackaging and What Does It Mean for Your Hospital or Health System?

Posted on February 01, 2021

In its simplest form, unit-dose repackaging means placing every individual medication dose into its own package, labeled and bar-coded. The pharmacist must repackage a bulk shipment of drugs (for example, a bottle of 100 tablets) into 100 separate doses. Sound simple? Maybe, but think about everything that’s involved in that process.

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FDA Label Changes for Vitamins A, D and E

Posted on October 18, 2018

The U.S. Food and Drug Administration (FDA) now requires that manufacturers change their product labels from international units (IU) to metric units of measurement — micrograms (mcg) or milligrams (mg). This comes as a result of the FDA’s final rule, “Food Labeling: Revision of the Nutrition Supplement Facts Labels,” published on May 27, 2016.

Pharmacies can expect to start seeing these label changes come through on all over-the-counter (OTC) fat-soluble vitamin A, D and E products. We understand that this change can be difficult when trying to determine the metric equivalent for IUs. For a safer transition to metric labeling, Safecor Health will begin including both the IU and metric measurements on its labels, when possible.

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Is Your Pharmacy Ready to Meet FDA Unit-Dose Repackaging Guidelines?

Posted on January 14, 2018

Here’s a checklist to help you determine if your hospital pharmacy would comply with upcoming FDA unit-dose repackaging guidelines.

Do you have stability studies to justify your expiration dating (beyond-use date) on repackaged drugs?

  • FDA July 2020 guidance states six months dating (or 25 percent of the remaining manufacturer expiration date, whichever is less) in the absence of a risk-based approach to stability studies for oral solids.
  • The FDA has not given any guidance on allowable expiration dating for repackaged oral liquids.

Do you know what class of packaging materials you use?

  • USP Class A materials can support one year dating with stability studies.
  • USP Class B materials can only support six months dating.
  • USP Class D materials can only support 30 days dating.

Does your pharmacy’s unit-dose packaging process comply with cGMP requirements?

  • Proposed FDA guidelines ensure packaging and dating consistency regardless of location.
  • Cleaning validation to prevent cross-contamination.
    • Did you know? Many high-speed oral solid packagers use a common chute resulting in a high chance of cross-contamination among drugs dispensed.
  • Packaging materials must comply with FDA guidelines for water vapor and light transmission.
  • Canisters in packaging machines should be proven as capable to protect the stability of the product while in storage. Canisters would be considered a container closure system and comply with USP requirements for light resistance.

Do you have a separate quality team overseeing your packaging operation?

 

If you answered “NO” to any of these questions, here’s what it could mean for your pharmacy:

More packaging. More labor. Shorter dating. More waste. Higher costs.

Proposed changes in pharmacy packaging requirements could have a significant impact on your operations and budget. Shorter dating and more regulations could mean more time spent on packaging, more waste due to shorter dating, more personnel needed for packaging and higher costs.

As the world of hospital pharmacy unit-dose repackaging changes, will you be ready?

Lower your risk. Improve medication safety. Extend your dating. Reduce your waste.

Contact us today to learn how Safecor Health can help.

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