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The distribution of printed information to help patients use prescription drugs correctly is clearly an important element in FDA's and healthcare providers’ goals for improving healthcare. But how will that information be delivered?

Unit-of-use packaging provides certainty that patients will receive patient inserts along with their prescriptions. Printing and labeling companies are offering solutions for including Medication Guides (MedGuides) and other patient product information with unit-of-use bottles or blister packages. Expanded-content labels are one such solution. Many manufacturers of antidepressant and nonsteroidal antiinflammatory drugs (NSAIDs), by all accounts, plan to eventually distribute MedGuides along with their packaging, which may include unit-of-use packaging.

Wyeth Pharmaceuticals, which makes Effexor XR, an antidepressant, for example, is moving in this direction. "Ultimately, the MedGuides will be attached to unit-of-use packaging, which we will be developing for this drug," says Christopher Garland, a Wyeth spokesman.

Unit-of-use packaging presents certain challenges, though. The cost is a particular hurdle for generic companies that use bulk packaging almost exclusively. And pharmacies may face inventory and dispensing issues.

"There is not a uniformity of opinion among the drug chains on unit of use. Chains see drawbacks in the area of inventory management and in filling prescriptions," says John Coster, vice president, policy and programs, National Association of Chain Drug Stores (NACDS).

"If a physician writes for a 40 count, and the unit-of-use package is a 30 count, do you have to call the doctor and ask if you should dispense two 30-count packages, or, do you break a box of 30 and give the patient 10 (from that box), which defeats the purpose of having unit-of-use?" Coster asks.

Unit-of-use issues aside, about 30 antidepressant brand and generic drug manufacturers have adopted an efficient solution for immediately meeting FDA's requirement for MedGuide distribution. The consortium of manufacturers, which includes Wyeth, tapped The Hibbert Group (Trenton, NJ), a literature and product fulfillment company, to handle guide printing, distribution, and fulfillment. The company is providing MedGuides in tear-off pads, with 50 duplex-printed guides per pad. It sent out an initial order of 1 million pads to pharmacies and about 500,000 doctors in April, says Michelle Spedding, vice president of The Hibbert Group.

Since the guides for the antidepressants are generic, it makes sense to use one source for printing. By coordinating with one company, the consortium gets better pricing as well as services, through The Hibbert Group, that include tracking and handling of pad reorders. Also, pharmacies benefit by having one source for the pads. Had the pharmacies received one pad for each drug, "it would have been an administrative nightmare," says Coster.

"This is absolutely an interim step. Our understanding is that the drug companies will eventually include the MedGuides in their labeling," says Spedding.

The tear-off pad approach still puts the burden on pharmacy for leaflet distribution. So will guide distribution with bulk packaging, to the extent that manufacturers chose that approach.

"I think the pharmacies are a little concerned about the operational issue of providing [the guides] to consumers, because they have already been providing [printed patient information] voluntarily. Now they have to provide a separate document that has more risk information in it, and the Cox 2s [NSAIDS] are coming along [and will require the same thing]," Coster says.

Most retail pharmacies hand out consumer medication information (CMI) leaflets covering drug use and safety, with each prescription. Coster says NACDS is working with the database providers of CMI and FDA on the quality of the leaflets. FDA has released guidance on how CMI providers can upgrade the materials to meet federal law on usefulness criteria.

For efficient material distribution, the drug chains are seeking FDA "permission or guidance" on electronically integrating the guide content with the CMI, which pharmacists print out along with labeling when they fill a prescription. "We are trying to work with the agency [on this]. That way [pharmacists] only have to go through one pass," Coster says.

How will the manufacturers of NSAIDs, for which the guides are also generic, handle leaflet distribution? "We are trying to find out now how that is going to work," Coster says.

The consortium of antidepressant drug makers was resourceful, taking matters into their own hands for devising a solution that can immediately reach patients. But unit-of-use packaging needs to be investigated further. Unit of use holds many benefits, including but not limited to delivering key product instruction. Industry needs to come together and work with pharmacies, FDA, and even the doctors that write prescriptions to work out some of the kinks when it comes to devising and dispensing unit-of-use packaging.

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