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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.

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.

Unit-dose medication packaging has been a standard practice for hospital pharmacies since the late 1960s. Since then, pharmaceutical manufacturers and wholesalers have consolidated, resulting in fewer unit-dose drugs being available to hospital pharmacies. This directly caused price increases on unit-dose products, frequent backorders and more limited options.

In today’s health care environment, it’s important to ensure that patients get the best care possible. This can include spending time with the patient to understand his or her needs. It also includes prescribing, dispensing and administering the right drug in the right dose at the right time.

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.

Health care is an ever-changing industry. The fluctuation in technology alone can be hard enough to keep track of, but modern medical institutions also must deal with rapidly increasing costs and ever-shrinking resources. This is especially true of hospital pharmacies where tighter budgets can stretch staff thin and it can be difficult to optimize pharmacy staffing.

Highlights about Our Time at the Event

In case you missed it, the HCP Spring 2018 Hospital Pharmacy Conference kicked off in Atlanta, GA last week – April 30 – May 2, 2018. Our Safecor Health team participated in the Reverse EXPO and accredited educational sessions. Hearing from other hospital pharmacy directors provided valuable insight on trending topics and challenges in the industry.

For many hospitals, in-house repackaging often seems like the most cost-effective way to package drugs into unit-dose. Unfortunately, with limited resources, hospital pharmacies don’t always have the time needed to focus on packaging. To offset staff time spent on packaging, many pharmacies purchase whatever is available in commercial unit-dose. Unfortunately, many of those unit-dose purchases have a significant cost premium versus bulk bottles.

The National Institute for Occupational Safety and Health (NIOSH) developed USP General Chapter <800> to better protect all workers, patients and general public who may potentially come in contact with hazardous drugs. Many hospitals are keeping this top of mind as they try to understand how these requirements impact their pharmacy operations. If your hospital pharmacy currently repackages hazardous drugs in-house, you may need to implement new steps and process changes to be compliant with USP <800> (official December 2019).