Could Unit-of-Use Packaging Deliver Standardized Prescription Drug Info to Patients?

Has the scarcity of unit-of-use packaging hindered the distribution of medication guides? Could its prevalence increase if FDA develops a standardized document for written prescription information?

During FDA's public workshop, Providing Effective Information to Consumers about Prescription Drug Risks and Benefits, Deborah Henderson, director, Office of Executive Programs, FDA's Center for Drug Evaluation and Research, reported that the agency has received “an awful lot of anecdotal information . . . that patients are not always leaving the pharmacy with their Med Guide, even though this is a federally mandated system.”

FDA organized the workshop to reexamine the process by which patients receive written prescription information and to explore whether “one document” could be developed for dispensing with prescription drugs. Workshop discussions covered consumer medication information (CMI) provided by pharmacies as well as Medication (Med) Guides. The agency presented four prototypes for discussion at the workshop and said that characteristics from each could be blended.

One challenge seems to lie in the pharmacy process needed to match Med Guide to dispensed package: “We have a big enough challenge trying to store the Med Guides that we have now, and we would certainly not want to move in that direction for all medications, from a storage and logistics and workflow challenge,” explained Marcie Bough, Pharm. D., director, federal regulatory affairs, American Pharmacists Association.

Added Nick Ratto, Pharm. D., manager, Consumer Drug Information Group, First Data Bank: “When a pharmacist has to open a larger bottle . . . and create a different prescription vial, there's nothing in the workflow to present them with that CMI . . . . They'd have to go to a separate pile of paper, which you can imagine if you've got thousands of drugs, it's totally untenable.”

Relying on electronic information dissemination for pharmacy printing was discussed for ensuring prescriptions are coupled with the required details. However, there are challenges to such an approach, especially if FDA decides to push a standardized printed format for a “one document” system. “One of the things we would have to consider is if we had a single document of standard format, we would need some guidelines or guidance that somehow portrays what you can do with that for retrofitting a document into the existing printing systems within pharmacies where there may be a one-print mechanism, so that the label is part of a different stock of paper than what is just a ream of paper we're buying at the print store,” Bough said. And later she added: “If you think of the Med Guide systems, there's some very strict standards and problems that have been somewhat overcome on how to print those, but I think we would need clear guidance of what could or could not be done to that information from a data perspective to retrofit it into the printing options.”

Other speakers spoke of the challenges to printing colors or high resolutions with “legacy printing systems” at pharmacies as well as the trouble maintaining the high print quality currently expected of the pharmaceutical industry.

Ron Salzano from the Pharmaceutical Printed Literature Association pointed out that “if the manufacturer provides a combination of a patient insert, a Med Guide, a CMI, there's really very little restrictions. . . . There's no graph that can't be printed and supplied on this all-purpose or one document insert. There's no picture that can't be printed. Everything can be done and attached with the final dispensing pack.”

Ilisa Bernstein, Pharm.D., J.D., director of pharmacy affairs, FDA's Office of Policy, explained that FDA has discussed unit-of-use packaging throughout the years. She asked speakers whether “it could or could not help with respect to getting the patient medication guide information or drug information or PPIs or whatever that is.”

Speakers acknowledged benefits, but pointed to limitations. “We believe that there would be some improvement in delivery of paper documents under a unit of use activity,” said Gordon Johnston, R.Ph., M.S., vice president of regulatory sciences, Generic Pharmaceutical Association. However, “there are a lot of different drug products that don't lend themselves to unit of use . . . . and there are certain practice environments where unit of use may not be practical.”

Added Alan Goldhammer, Ph.D., vice president, scientific and regulatory affairs, Pharmaceutical Research and Manufacturers of America (PhRMA): “It's an appealing concept and I did try to address this at PhRMA some years ago. . . . We went to our lawyers and the lawyers quickly said, it's a commercial decision on the part of the company as to whether they are going to package things unit of use.” He added that “there probably are some large purchasers who want things unit of use, and I think the companies would be responsive to purchasers.”

However, if FDA does standardize the content and format under a “one document” system that must be followed exactly by all producers--pharmacies and manufacturers included--unit-of-use packaging may be the surest route to ensuring consistency. “We don't have any control over the printing capacity of pharmacies,” said FDA's Deborah Henderson, concluding the workshop. “We don't oversee pharmacies, and so we really have to work collaboratively with the pharmacy groups, because the truth of the matter is, some of the CMI that was produced and looked pretty good from the data vendors looked pretty awful when it came out of these, you know, the poor capacity of the pharmacy systems.”

You've got until November 25 to provide your own comments on improving printed prescription drug information and on statements made in the workshop. Be sure to read the transcripts from September 24 and 25 to understand the scope of the discussions.

from the November 4, 2009, ePackage Newsletter by Daphne Allen, Editor, PMP News