[acb-hsp] FW: [CCB-L] FW: [acb-l] Fwd: Proposed Drug Label Standards Need YourInput

[Baracco, Andrew W]

Tell Them Your Story:
Proposed Drug Label Standards Need to Work for People with Vision Loss

For further information, contact: 

Mark Richert, Esq.
Director, Public Policy, AFB
(202) 469-6833
MRichert at afb.net 

For the first time, model standards are being proposed on a national
level to guide the content, language, format and appearance of
prescription medication labels to reflect how patients read and
understand medication instructions. The newly proposed model standards,
developed by the U.S. Pharmacopeial Convention (USP) are the result of a
broad effort initiated by the Institute of Medicine (IOM) to improve
health literacy in the United States. The USP is the nonprofit
scientific organization with narrow legal authority to set
FDA-enforceable standards for the quality, purity and strength of
medicines in the United States. 

Developed by a multi-disciplinary group of independent experts convened
by USP across the fields of pharmacy, medicine, health literacy, patient
safety, human factors research, drug database software and chain drug
retail operations, the proposed model standards could be adopted by
state boards of pharmacy, other governmental authorities, or conformity
assessment bodies into state laws, regulations, guidelines or other
documents. Adoption of USP's standards at the state level is common,
such as in the cases of USP's widely recognized standards for sterile
and nonsterile pharmaceutical compounding to help ensure safe
preparation of these customized medications. 

It is unclear whether the Food and Drug Administration (FDA) currently
has sufficient authority to regulate patient-specific drug container
label content, meaning that any model standards ultimately adopted by
the USP may still require action by Congress to make the FDA's authority
unequivocal and to require the FDA to use the USP model standards. 

Generally, the proposed model standards provide that prescription
container labels generated by pharmacies would be expected to be
organized in a patient-centered manner, prominently display information
that is critical to patient's safe and effective use of the medicine,
give explicit instructions, Include purpose for use, improve
readability, and limit inclusion of nonessential information. 

With respect to readability, the proposed model standards provide that
the label type should use high-contrast print (e.g. black print on white
background); large font size (e.g., minimum 12-point Times New Roman or
11-point Arial); and horizontal text only. Beyond these limited
readability expectations, the proposed model standards do not account
for the needs of people with vision loss. 

The USP is accepting comment from the public about its proposed
standards through March 31, 2011. Advocates are encouraged to let USP
know that any model standards proposed should, at a minimum, provide
that pharmacies make nonvisual and enhanced visual access to medication
labels available to customers upon request. Nonvisual and enhanced
visual access should be illustrated through examples of low tech and
high tech solutions currently available. The USP could incorporate such
illustrative examples along with an overall expectation of upon-request
label accessibility in their final model standards. The USP updates its
extensive standards periodically; the revisions being proposed now by
the USP will constitute the thirty-fifth iteration of such standards. 

Commenting on the proposed model label standards is a simple process.
Commenters can email comments of any length to: 

17PrescriptionContainerLabeling at usp.org 

Commenters should be sure to include their name, organization if
applicable, and contact information along with comments submitted. To
view detailed information on the proposed labeling standards, go to: 

http://www.usp.org/USPNF/notices/generalChapter17.html 

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list, or to find out what other newsletters are available from AFB,
visit http://www.afb.org/myAFBNewsletter2.asp. 

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