E-labeling beats paper PI, study finds

September 12, 2005

Pharmacists who tested an electronic system to access package inserts liked the touch screen device's ease of use, readability, up-to-date drug information, and safety alerts, compared with paper sheets, according to a survey.

Pharmacists who tested an electronic system to access package inserts liked the touch screen device's ease of use, readability, up-to-date drug information, and safety alerts, compared with paper sheets, according to a survey.

Sixty-nine percent of the pharmacists using Thomson Corp.'s PDR On-Demand electronic PI device said they would "definitely" or "probably" use it more frequently than they currently use the traditional paper information sheets if the database were comprehensive, according to a survey conducted by Michael Rupp, Ph.D., R.Ph., managing director, Desert Mentors, a community pharmacy research firm headquarterd in Glendale, Ariz. Out of the 88 pharmacies in the field test, 75 completed the fax and mail survey, for a response rate of 85%.

"When compared with paper labeling, our sample particularly liked the improved legibility because the device lets you zoom in and increase the font size," said Rupp, who is also professor of pharmacy administration at Midwestern University, Glendale. "In addition, ease of use was clearly important. Navigation is fairly quick. You can go right to the section you want, such as side effects or dosing. They really appreciated the fact that the information was current at the time the device dialed in to get updates. That included any labeling changes, plus new warnings or alerts from the Food & Drug Administration or manufacturers."

The pharmacists' complaint that the test database contained only 800 prescription drugs will become moot when the device goes into general use, according to Mukesh Mehta, R.Ph., VP, Thomson PDR. The database will include all drug PIs. However, the firm's hands are legally tied when it comes to the pharmacists' complaint that they would like to be able to print out only part of a PI.

"We will take into consideration what pharmacists in the field test had to say, but there are certain things we cannot do, such as print out a section," said Mehta. "However, if the drug industry and FDA allowed pharmacists to do that, we would definitely make the change."

The field test was conducted at the request of a task force created by the Pharmaceutical Research & Manufacturers of America, which is backing the paperless PI initiative. The goal is to improve patient safety by getting more up-to-date information into provider hands and to reduce inefficiencies in drug labeling distribution and liability. In addition to the PDR On-Demand system, Etreby Computer is developing a Web-based electronic PI solution.

The next e-labeling steps will be taken when PhRMA makes the test results public and submits a proposal to the FDA to change its labeling regulations, said Mehta. "The pharmaceutical industry will soon be able to deliver electronic versions of prescribers' labels to pharmacies, and this change will speed updated labels to pharmacies within 24 hours of any change," he added. "PDR On-Demand enhances FDA's labeling initiatives to improve patient safety."