Magazine article Drug Topics

Do Combination Products Spark Turf Wars?

Magazine article Drug Topics

Do Combination Products Spark Turf Wars?

Article excerpt


Is it a drug or a device? Consider the drug-eluting stent being developed by Johnson & Johnson's subsidiary Cordis Corp. Is it a stent with a pharmaceutical kicker, or a drug piggybacking on a stent for more precise delivery? The question has already crept into hospital pharmacies and ambulatory care clinics.

Consider these other products:

* Intravenous sets and catheters are routinely coated with heparin and other drugs.

*Refillable pumps, both freestanding and implantable, are widely used for long-term pain relief.

* Wafers impregnated with carmustine (BICNU, Bristol-Myers Squibb) are surgically implanted to deliver precise low-dose chemotherapy after excision of a brain tumor. Yet while carmustine is traditionally administered as an IV drug and handled by pharmacy, the wafers are ordered by and billed through the OR, said Dominic Solimando, president of Oncology Pharmacy Services Inc. and a pharmacist at Walter Reed Army Medical Center. "Pharmacy doesn't touch them."

Pharmacists tell Drug Topics that combination products generate few arguments between departments. Most items that might spark a dispute, such as drug-coated IV sets, are clearly either device or drug.

In the case of refillable pumps, responsibility is often divided. At Walter Reed, pharmacy is responsible for the drug, refilling pumps as needed, Solimando said. The clinic is responsible for the pump, tubing, and other supplies. At other clinics, he added, medicine is responsible for both pump and drug. Others put pump, drug, and supplies under pharmacy.

"It's not a big turf battle," he explained. "It's more a matter of who has money in their budget. Most pharmacies don't see catheters and TV sets as their area. They're part of hospital supply. An IV set is an IV set, even if it's coated with a drug."

The Food & Drug Administration uses that logic in initially approving a product. "FDA assigns it to device review or drug review based on the primary mode of action," explained Gary Stein, director of federal regulatory affairs for ASHP.

But the lines between drug and device can be fuzzy. Pfizer and at least four other pharmaceutical firms are developing inhalable insulin. They are creating novel forms of insulin and novel types of inhalers to deliver it.

So what's more important, the novel drug formulation, the novel delivery system, or the drug-device combination? …

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