Today - July 11, 2013
Eliminating paper drug labeling such as package inserts in favor of e-labels could compromise the availability of information for some patients, physicians, and pharmacists, a government study found.
Stakeholders provided no consensus on the advantages or disadvantages of relying on drug labeling available only electronically, the Government Accountability Office (GAO) said in a report Monday.Drug manufacturers have supported eliminating paper labels, whereas patient advocates suggest it could adversely affect public health.The GAO sought input on the partial or complete substitution of e-labels from the FDA, patient advocates, pharmacy groups, manufacturers, and medical societies including the American Medical Association, American Congress of Obstetricians and Gynecologists, and American Academy of Physician Assistants.
As a basis for their comments, the groups were asked to consider prescribing information, Medication Guides, and patient package inserts for oral contraceptives and estrogens.
"While stakeholders described a variety of advantages of electronic drug labeling that could improve public health, they also noted disadvantages that could offset advantages gained," the GAO's director of healthcare, Marcia Crosse, PhD, wrote in the report, noting there was no consensus for total elimination of paper labeling.
For instance, e-labeling could allow the FDA to update labels faster than paper records to provide patients, physicians, and pharmacists with the most up-to-date information. The agency updated drug labels more than 1,300 times in 2012.
However, manufacturers can quickly reprint drug labels for package inserts reducing the potential for outdated labels, the GAO found.Similarly, e-labels also can be adjusted to be in a more user-friendly format such as larger font size. The public and providers can also use search functions to quickly find relevant information such as warnings and drug interactions.
There again, the FDA took steps in 2006 to make labels more user friendly by requiring highlights in sections and a table of contents."Stakeholders we spoke with suggested that having drug labeling available in both paper and electronic form would best serve patients because it would allow them to take advantage of both options," Crosse said.
Some patients and providers might also be uncomfortable or find it inconvenient to access labeling information electronically. According to the Federal Communications Commission, 14 million people have inadequate or no access to broadband capabilities, the report noted.Furthermore, websites where e-labels are stored, such as Drugs@FDA, aren't easy to navigate or use, stakeholders told the GAO.The FDA would also have to amend existing regulations to allow for e-labeling which could place greater burdens on the agency and pharmacies, the GAO said.
"Stakeholders said that completely substituting electronic labeling for paper labeling would place an additional burden on pharmacies if they were asked to print drug labeling for patients," Crosse said.