Preparing Packaging for a Pandemic

SARS and H5N1 bird flu may not be grabbing headlines these days, but some experts argue that the threat of an influenza pandemic is stronger than ever. Packaging will play a role in equipping communities for response.

In May, FDA released its guidelines for expediting vaccine approvals, and in March the agency released its “Pandemic Influenza Preparedness Strategic Plan.” FDA’s Center for Drug Evaluation and Research (CDER) leads the Task Force’s Anti-Viral Drug Development, Production, and Regulatory Review Subgroup. The group is working with the Department of Defense (DOD), FDA’s Shelf Life Extension Program, and the HHS-managed Strategic National Stockpile to push for stockpile-specific packaging and labeling of antiviral drug products.

George Abercrombie, president and chief executive officer of Hoffman-La Roche Inc., has been preparing his company’s products for pandem­­ic. Abercrombie spoke to Town Hall Los Angeles in April. Based on his predictions, packaging may help hospitals and others meet the needs of infected patients.

“A global influenza pandemic is indeed at the top of my list because I believe an influenza pandemic is one of the most important health concerns facing businesses,” he said.

Hoffman-La Roche manufactures Tamiflu. “My company has more to offer the business community than our products,” Ambercrombie explained. “In developing a comprehensive pandemic plan for our own business, we have covered much of the ground all businesses need to cover as specified in the federal government’s National Strategy for Pandemic Influenza introduced by President Bush at the NIH in November 2005. It outlines the im­portant roles to be played not only by the federal government but also by state and local governments, private industry, international partners, and individual citizens.”

Shortages will be rampant during a pandemic. Most hospitals will run out of supplies within one week, reported hospital material managers in a recent Novation (Irving, TX) study.

Abercrombie pointed out that professionals would also be absent. “If 20–40% of people are sickened in the first wave, 20–30% of doctors, nurses and other essential healthcare personnel will be missing from their jobs,” he said.

With these forecasts in mind, Hoffman-La Roche geared up. “To stockpile enough to treat 25% of the U.S. population, the federal government’s ultimate goal, about 80 million courses of therapy are needed, representing a phenomenal increase over usual seasonal demand,” reported Abercrombie. “So my company literally went into overdrive. Without affecting the production or availability of our other lifesaving medicines, we doubled our production capacity for Tamiflu in 2004 and doubled it again in 2005. The government asked for special packaging; we made special packaging. They asked for studies on mixing Tamiflu with flavored syrups for children. We’ve conducted the studies. They asked that we consider extended dating and now the shelf life has been extended to five years.”

As other companies begin building or contributing to pandemic stockpiles, they may want to look to barrier packaging to extend shelf life. Transport packaging may also need boosting to withstand shipping delays caused by staffing issues or quarantines. And if nonpractitioners will need to be relied upon during the absence of ailing doctors and nurses, packaging and labeling must be designed to encourage safe and effective product administration.

FDA presented two draft guidances for public comment in March 2006— one for seasonal influenza vaccines and another for pandemic influenza vaccines. The finalized documents, which FDA says take into account public and manufacturer comments, outline specific approaches for manufacturers to develop new vaccines that are safe, pure, and potent. Packagers can support the delivery of those vaccines.