The International Association of Diecutting and Diemaking (IADD) has produced a Braille standard for pharma packaging in North America that it plans to publish at the 2009 IADDFSEA Odyssey show in May, according to a report in Packaging News.
Since 2005 it has been mandatory in the European Union to include Braille wording on the pack of every newly approved medicine, including uncontracted forms of the drug name and its strength if more than one is made available. By October 30, 2010, the requirement will be applied to all products, regardless of when they were approved. The European Commission published revised guidance on Braille in January.
The US Food and Drug Administration (FDA) currently has no such requirement, and to date has not specific regulations or guidelines to guarantee that prescription drug information intended for patients is accessible for people with vision loss.
Policy review did not change industry
The agency did undertake a review of its policy for visually-impaired people as part of the Medicare Prescription Drug Improvement and Modernization Act of 2003 but a report filed to Congress in 2005 – while acknowledging that changes were needed - did not provide sufficient detail in terms of regulatory processes and standards to encourage industry to move forward, according to the American Federation for the Blind.
The new standard is said to be modelled on the European model and has been developed with the Braille Authority of North America.
The standard was developed over an 18-month to two-year period and was approved by the IADD executive committee and board of directors in January.