Guidance sharpens drug distribution

HOLLIS, NH - Like the case with drug-manufacture outsourcing, handoffs are critical in drug distribution. Especially for drugs that require cold. But in contrast to highly regulated and scrutinized drug manufacturing, the so-called last mile of a drug's journey to the patient is a kind of regulatory Wild West.

"The challenges are in the handoffs between modes: shipper to truck, truck to air, air to truck. These are the areas where operations and logistics planners need to focus," says Anthony Rizzo, a strategic account engineer at Cold Chain Technologies. And contingency planning is important to reducing risk. "The ultimate goal is to protect product integrity," says Rizzo.

He and members of a Parenteral Drug Association task force authored the recently published 38-page TR-46, Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to the End User. Rizzo spoke last night to about 75 members of PDA's New England chapter.

Despite the prominent role of drug wholesalers in U.S. drug distribution, the regulations and guidelines governing them are vague. "There's not enough detail," he says. Some of the guidelines even include such terms as "adequate" and "appropriate" as specifications. "Once a product entered the supply chain, it was a crapshoot."

Rizzo places good distribution practices at the end of the GxP chain. "They are a natural extension of good manufacturing, clinical, and lab practices."

- see the TR-46 Intro and Contents pages (PDF)