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Health Care Professionals
Brief Description of Proposed FDA Regulation
On December 18, 2014, the Food and Drug Administration (FDA) posted a Notice of Proposed Rulemaking entitled,
“Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products”, in the
Federal Register. The rule would require that the prescribing information (also known as the package insert, professional
labeling, content of labeling, physician labeling, direction circular, circular of information, or package circular) that is
intended for health care professionals will no longer be permitted to be distributed in paper form with the package from
which a prescription drug or biological product is dispensed.
In other words, the package would include a statement directing the health care professional (mainly the pharmacist) to
an FDA web site repository to search/access the information or to call an 800-number managed by the drug
manufacturer and request that a copy be emailed, faxed, or mailed to the professional.
FDA’s only justification for proposing this rule so the “most current prescribing information for distributed prescription
drugs will be available and readily assessable to health care professionals at the time of clinical decision making and
dispensing”. If the website repository is unavailable to the professional for any reason (internet/power outage, slow
connection, etc.), they can either call the manufacturer for an emailed, faxed, or mailed copy or utilize 3rd party
electronic or paper compendia (example, PDR).
This initiative would shift the cost of supplying critical information about prescription drugs from the manufacturer to
the end users, the health care professionals.
I do not believe this rule is in the best interest of public health and safety. If the repository is not available email, fax and
mail are not always viable options and could delay treatment or could result in adverse events experienced by patients.
Public comments on the proposed rule are due March 18, 2015 (an extension of the comment period has been
requested, but is not guaranteed). Please consider reviewing these materials and posting a comment to the docket in
support of the continued, mandatory requirement that prescribing information be printed and accompany the product
through the distribution chain.
Link to full proposed rule:
https://federalregister.gov/a/2014-29522
Instructions for comments:
 To submit comments:

Electronic Submissions:
 Federal eRulemaking Portal: http://www.regulations.gov
 Search for the specific rule by title: Electronic Distribution of Prescribing Information for Human Prescription
Drugs, Including Biological Products
 Or, docket number: FDA-2007-N-0363
 Or, RIN number: 0910-AG18
 Follow the instructions for submitting comments

Written Submissions:
 Mail/hand delivery/courier (for paper submissions)
 Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
MUST include: Docket No. FDA-2007-N-0363
 All comments will be posted without change to the website above, including any personal information you
provide
 Comments do not need to be long or too involved
 A few sentences to a couple paragraphs can work
Advice for Comments:
 Prescribing Information is critical information that should ALWAYS accompany the physical drug product
 Cost:
 Pharmacies will incur net costs:
 To access the information
 Internet access, additional computer terminals, systems security, etc.
 Drug manufacturers should be responsible for supplying information that can be accessed 100% of the
time, 24/7/365
 Increased search time when accessing the information
 More time to search for information, less time to fill prescriptions and counsel patients
 Printing cost when a request is received for the information in printed form
 Additional printers, supplies, time to possibly switch paper, etc.
 Unfair burden to place on drug dispensers for the benefit of drug manufacturers
 FDA needs to study and quantify the potential costs/benefits to public health
 Potential Issues with accessing the information:
 Currently no or limited internet access
 Possible loss of internet connectivity and/or slow internet connections
 If cannot access, additional references may not be available as well depending on nature of access loss
 If call the manufacturer to request info, email and/or fax might not be an option, and mail would take too
long
 Emails could be sent to the wrong address or do not have access to email at pharmacy
 Faxes could jam, errors can result and incomplete information is received
 Potential issues switching between various pharmacy software
 What if cannot access?
 Withhold medications? Distribute without verifying information?
 Disruption to workflow
 Increased time to switch between various pharmacy systems and/or search time
 Interruptions to workflow decrease time available to counsel patients (GAO report, key points attached)
 Interruptions to workflow have been shown to increase the risk for errors made when dispensing a drug (GAO
report, key points attached)
 Instructions for administering, assembling, reconstituting, mixing, diluting, or other preparations done prior to
dispensing to a product to a patient
 Critical information that needs to ALWAYS accompany the physical product to ensure 100% access to avoid
potential errors
 Cybersecurity Issues
 Many stories on the news regarding attacks against Federal agency websites and systems
 What is FDA’s plan for guaranteeing absolute security of the information?
 Health practice systems contain patient’s sensitive, personal, and confidential health information
 Opening systems to the internet could allow intrusions by nefarious actors
 Liability if information is compromised and used?
 The paper insert cannot be hacked and improperly changed
 Even if support electronic labeling
 Still believe printed inserts should still remain available as they are currently
 They are the unquestioned health firewall
United States Government Accountability Office
Electronic Drug Labeling: No Consensus on the Advantages and Disadvantages of Its Exclusive Use
July 2013
GAO-13-592
Link to full report: http://www.gao.gov/products/GAO-13-592
Key Findings with Regard to Patient Safety:
GAO findings

The GAO states, “Relying on electronic labeling as a complete substitute for paper labeling could adversely
impact public health by limiting the availability of drug labeling for some physicians, pharmacists, and patients
by requiring them to access drug labeling through a medium with which they might be uncomfortable, that they
might find inconvenient, or that might be unavailable. (GAO, What GAO Found & page 10)

The GAO reported, “We found no consensus among stakeholders on the advantages and disadvantages of
eliminating paper labeling and relying instead on electronic labeling as a complete substitute for paper labeling”
(GAO, page 8).

The GAO report mentioned possible electronic advantages. However, the report further stated “…noted
disadvantages that could offset advantages gained from relying on electronic drug labeling as a complete
substitute for paper labeling” (GAO, page 8 & 10).
Overall Access

GAO noted, “In certain situations, the availability of technology is limited”, especially “areas with limited
internet access, such as rural areas” (according to a Federal Communications Commission study, 14 million
Americans have inadequate access or no access to adequate broadband capabilities) and “times when such
technology is simply not available, due to temporary power outages or during the aftermath of natural disasters,
such as Hurricanes Sandy and Katrina” (GAO, page 11).
Physicians

GAO referenced an Institute of Medicine report finding that “the way in which drug information is
communicated to physicians can directly affect their knowledge of how the drugs they are prescribing will
work in patients, particularly in specific populations, such as children and the elderly” (GAO, page 1).

Physicians, might “require additional training on where and how to access prescribing information electronically.
Studies have shown that physicians might not access the most reliable resources on the Internet in order to find
the information they need”. Specifically, GAO sourced a study in The Journal of the Medical Library Association
which found that “in some cases, physicians based clinical decisions on websites that ranked lower than other
sources in measures such as reliability and relevance” (GAO, page 12).

Also, GAO cited an American Medical Informatics study found that “the websites used by emergency room staff,
residents, and medical students to obtain clinical information were not the highest quality in terms of evidencebased medicine” (GAO, page 12).
Pharmacies/pharmacists

In 2011, retail pharmacies filled approximately 3.8 billion prescriptions for drugs (GAO, What GAO Found & page
15).

GAO highlighted an Institute of Medicine report which found that “drug information communicated to
pharmacists is critical to helping them appropriately fill prescriptions and to check for potential safety concerns
for a specific patient” (GAO, page 1).

Pharmacists said they “are familiar with using paper labeling,” and they find it “easier, when counseling
patients, to take the paper version of the labeling directly from the drug packaging and show it to the patient at
the counter rather than searching for the labeling on a computer and then showing the patient the computer
monitor or printing the labeling” (GAO, page 13).

A study from The Annals of Pharmacotherapy and noted by GAO found that if “pharmacists’ workflow is
disrupted because they need to print drug labeling for patients, it could reduce the time available for patient
consultations” and the previously mentioned Institute of Medicine report showed “interruptions to pharmacists’
workflow have been shown to increase the risk for errors made when dispensing a drug” (GAO, page 13).

Moreover, “pharmacies said that most pharmacies, in order to protect their systems from potential threats like
computer viruses, do not have Internet access” (GAO, page 15).

A shift in responsibility from the drug manufacturer to pharmacies would result in pharmacies needing to
“purchase additional resources, such as computer terminals, printers, and other office supplies, such as paper,
ink, and toner” (GAO, page 15).
Pharmacy Practice: A Report on Pharmacists’ Use of Printed Package Inserts
Highlights of Results:

National sample of 400 pharmacists across the United States
o 286,000 employed pharmacists in U.S. in 2012 (Bureau of Labor statistics)
o Currently employed as a pharmacists
o Geographically distributed relative to U.S. pharmacist population

Surveyed regarding:
o Internet access in the workplace
o Use of professional printed insert (professional PI)
o Awareness of electronic labeling (e-labeling) initiative
o Attitude toward printed, electronic, or both

Internet Access in the Workplace
o 27% indicate their pharmacy either does not have internet or that they cannot browse the internet (pg. 7)
o 82% of respondents with access have experienced a loss of internet connectivity (pg. 7)

Use of Professional Printed Insert (professional PI)
o 88% indicate they have used the professional PI when filling or dispensing a prescription (pg. 8)
o 55% have provided the professional PI to patients (pg. 8)
o How they use (pg. 8):
 Help in counseling patients, look for inactive ingredients (possible allergic reaction), evaluate safety
of drug for different types of patients (ex: pregnant woman), determine of drug can be safely split or
crushed
 “Quick” or easily accessed source of information
 Alternative to insufficient online information
 Preferable to trying to retrieve information using a slow internet connection
 88% use as a means to check dosing
 83% used for information about drug indications and usage
o How regularly they use (pg. 9):
 Majority indicated using within the most recent week
 More than 80% have checked it within the last month
o Pharmacists who consults professional PI on a weekly basis:
 Dispense an average of 155 prescriptions per day (pg. 9)

Awareness of electronic labeling (e-labeling) initiative
o Nearly 75% of pharmacists surveyed have NOT heard of any exclusive e-labeling initiative for professional PI
(pg. 10)

Attitude toward printed, electronic, or both
o Less than 20% believe e-labeling is more trustworthy (pg. 10)
o Only 25% believe that e-labeling would provide more accurate information (pg. 10)
o More than 50% indicate that they either prefer professional PI or that professional PI and e-labeling are
about the same (pg. 11)
o Of those preferring e-labeling (pg. 11):
 37% would want to continue to have professional PI provided as they are now
o Of all 400 pharmacists surveyed (pg. 11):
 80% view professional PI as a source of information equal to e-labeling or believe that professional
PI should remain available as they are now in addition to e-labeling
Conclusions (pg. 17)

The NERA survey and other data reviewed suggests that exclusive e-labeling would NOT necessarily bring about the
benefits to public health asserted by the FDA and others

The absence of internet or reliable connectivity is likely to render some pharmacists and their patients without
reliable information on drugs prescribed if exclusive e-labeling is enforced.

Current practice shows that pharmacists rely on, are comfortable with, and look to professional PIs frequently

Even pharmacists who see e-labeling as a better means of providing information generally prefer to have both
online information and the professional PI available as they are now.