Pink Sheet Daily
July 9, 2013
Executive Summary
In study mandated by FDASIA, GAO says there are advantages and disadvantages to switching to an electronic-only system for distributing drug label information, but offers no conclusions.
A Government Accountability Office report on electronic labeling did not appear to embolden either side in the debate over whether to do away with paper requirements.
The issue of cost, which likely would greatly affect decisions on whether to increase reliance on electronic labels, also was not addressed in the report, despite a congressional mandate that it be considered.
GAO found “no consensus” on eliminating paper labels in favor of an entirely electronic system, saying there were “a variety of advantages … that could improve public health,” but also “disadvantages that could offset advantages gained.”
While there were positives to relying on an electronic system, including allowing quicker updates so the most current information reaches patients and providers, negatives such as access limitations also were described.
The report , released July 8, offered no conclusions after interviews with a number of government agencies and stakeholders, including FDA, the Biotechnology Industry Organization, Pharmaceutical Research and Manufacturers of America, National Community Pharmacists Association, and Pharmaceutical Printed Literature Association.
GAO also interviewed Elsevier / Gold Standard, a clinical and pharmaceutical price information service, in compiling the report. “The Pink Sheet” DAILY is published by Elsevier Business Intelligence, which is also part of Elsevier.
Pharmacy groups cited cost as a potential problem with an electronic-only system, saying some pharmacists would have to purchase new computers, printers, paper, ink and toner so they could print labels for patients who demanded them or did not have Internet access.
GAO did not definitively address the cost of a move to an entirely electronic labeling system or the potential savings it could generate because agency officials were “unable to obtain reliable cost data.”
“We also did not evaluate stakeholders’ assertions about the consequences of changing to exclusively electronic drug labeling because they were unable to provide us with objective data on the implications of such a change,” GAO said in the report.
The study, which was mandated as part of the 2012 FDA Safety and Innovation Act, specifically asked for an assessment of “the implementation costs to the different levels of the distribution system” as well as benefits and efficiencies that could be achieved, according to the legislation.
FDASIA, which also reauthorized the prescription drug user fee act and created user fee programs for generic drugs and biosimilars, required a number of drug-related GAO and other studies.
Reliable Internet Source Needed For Labels
Stakeholders told GAO that substituting paper labels for electronic versions could improve public health by making the most recent information about the drug available in a more user-friendly format.
Paper updates can take time to complete and add to packaging, meaning in some instances drug shipments reach the market with out-of-date information in the label.
The number of required label changes also is growing. It increased nearly 82% between 2010 and 2012, from 747 to 1,357, respectively, according to the report.
Pharmacists and physicians could make more informed decisions with electronic labels that are more frequently updated, which would help patients, according to the report.
Labels also could become more patient-friendly in an electronic format and enhance their knowledge of the drug. Stakeholders told GAO that hyperlinks could be included that point to definitions of key terms or additional information and font sizes can be adjusted to make the material easier to read. Translation into other languages also may be easier with an electronic version, according to the report.
Still, access limitations threaten the value of an electronic-only system, GAO said in the report.
Today, there is no one “reliable and unbiased” source for electronic label information, stakeholders said. Multiple websites are available, but are limited either by their target audience or data quality, according to the report.
The National Institutes of Health’s DailyMed website includes electronic labels, but is targeted toward providers and was described as not having the most current labels easily available. FDA’s Drugs@FDA site was said to have label versions organized better, but a stakeholder group said it is not user-friendly.
Non-government websites also provide access to electronic drug labels, but are not standardized, according to the report.
An electronic-only system also could force physicians, patients and pharmacists to use the Internet, a medium “with which they might be uncomfortable, they might find inconvenient, or that might be unavailable,” according to the report.
Internet access may be down, such as during a natural disaster or power outage, or not accessible in some rural areas, restricting label access. Drug labeling manufacturers told GAO that in some cases it also may be faster to review a paper label than to access it electronically.
Regulatory Changes Would Be Needed
FDA indicated switching to electronic labels would require changes to regulations seemingly written with only paper in mind.
Existing rules require drug prescribing information and patient package inserts to be included “on or within” or “in or with” the drug packaging, respectively, according to the report. Medication Guide regulations do allow for electronic distribution, FDA told GAO.
FDA also said that the changes that likely would be made would allow, but not require, electronic-only label distribution.
The agency continues to review a study about its proposed patient medication information (PMI) format to make drug information more understandable. Results are forthcoming, the agency told GAO.
The PMI is intended to be a one-page alternative to the lengthy and complicated documents that patients often receive with their prescriptions. The study was intended to test how patients comprehend drug information using different formats.
Executive Summary
In study mandated by FDASIA, GAO says there are advantages and disadvantages to switching to an electronic-only system for distributing drug label information, but offers no conclusions.
A Government Accountability Office report on electronic labeling did not appear to embolden either side in the debate over whether to do away with paper requirements.
The issue of cost, which likely would greatly affect decisions on whether to increase reliance on electronic labels, also was not addressed in the report, despite a congressional mandate that it be considered.
GAO found “no consensus” on eliminating paper labels in favor of an entirely electronic system, saying there were “a variety of advantages … that could improve public health,” but also “disadvantages that could offset advantages gained.”
While there were positives to relying on an electronic system, including allowing quicker updates so the most current information reaches patients and providers, negatives such as access limitations also were described.
The report , released July 8, offered no conclusions after interviews with a number of government agencies and stakeholders, including FDA, the Biotechnology Industry Organization, Pharmaceutical Research and Manufacturers of America, National Community Pharmacists Association, and Pharmaceutical Printed Literature Association.
GAO also interviewed Elsevier / Gold Standard, a clinical and pharmaceutical price information service, in compiling the report. “The Pink Sheet” DAILY is published by Elsevier Business Intelligence, which is also part of Elsevier.
Pharmacy groups cited cost as a potential problem with an electronic-only system, saying some pharmacists would have to purchase new computers, printers, paper, ink and toner so they could print labels for patients who demanded them or did not have Internet access.
GAO did not definitively address the cost of a move to an entirely electronic labeling system or the potential savings it could generate because agency officials were “unable to obtain reliable cost data.”
“We also did not evaluate stakeholders’ assertions about the consequences of changing to exclusively electronic drug labeling because they were unable to provide us with objective data on the implications of such a change,” GAO said in the report.
The study, which was mandated as part of the 2012 FDA Safety and Innovation Act, specifically asked for an assessment of “the implementation costs to the different levels of the distribution system” as well as benefits and efficiencies that could be achieved, according to the legislation.
FDASIA, which also reauthorized the prescription drug user fee act and created user fee programs for generic drugs and biosimilars, required a number of drug-related GAO and other studies.
Reliable Internet Source Needed For Labels
Stakeholders told GAO that substituting paper labels for electronic versions could improve public health by making the most recent information about the drug available in a more user-friendly format.
Paper updates can take time to complete and add to packaging, meaning in some instances drug shipments reach the market with out-of-date information in the label.
The number of required label changes also is growing. It increased nearly 82% between 2010 and 2012, from 747 to 1,357, respectively, according to the report.
Pharmacists and physicians could make more informed decisions with electronic labels that are more frequently updated, which would help patients, according to the report.
Labels also could become more patient-friendly in an electronic format and enhance their knowledge of the drug. Stakeholders told GAO that hyperlinks could be included that point to definitions of key terms or additional information and font sizes can be adjusted to make the material easier to read. Translation into other languages also may be easier with an electronic version, according to the report.
Still, access limitations threaten the value of an electronic-only system, GAO said in the report.
Today, there is no one “reliable and unbiased” source for electronic label information, stakeholders said. Multiple websites are available, but are limited either by their target audience or data quality, according to the report.
The National Institutes of Health’s DailyMed website includes electronic labels, but is targeted toward providers and was described as not having the most current labels easily available. FDA’s Drugs@FDA site was said to have label versions organized better, but a stakeholder group said it is not user-friendly.
Non-government websites also provide access to electronic drug labels, but are not standardized, according to the report.
An electronic-only system also could force physicians, patients and pharmacists to use the Internet, a medium “with which they might be uncomfortable, they might find inconvenient, or that might be unavailable,” according to the report.
Internet access may be down, such as during a natural disaster or power outage, or not accessible in some rural areas, restricting label access. Drug labeling manufacturers told GAO that in some cases it also may be faster to review a paper label than to access it electronically.
Regulatory Changes Would Be Needed
FDA indicated switching to electronic labels would require changes to regulations seemingly written with only paper in mind.
Existing rules require drug prescribing information and patient package inserts to be included “on or within” or “in or with” the drug packaging, respectively, according to the report. Medication Guide regulations do allow for electronic distribution, FDA told GAO.
FDA also said that the changes that likely would be made would allow, but not require, electronic-only label distribution.
The agency continues to review a study about its proposed patient medication information (PMI) format to make drug information more understandable. Results are forthcoming, the agency told GAO.
The PMI is intended to be a one-page alternative to the lengthy and complicated documents that patients often receive with their prescriptions. The study was intended to test how patients comprehend drug information using different formats.