E-DRUG: US FDA Approved Drug Risk Information for Patients in Local Languages
-------------------------------------------------------------
Dear Colleagues,
This is a description of a pilot Web based project to provide US FDA
approved drug risk information written for patients for ibuprofen
containing products marketed in Saudi Arabia in Arabic. The project is
based on free publicly available information from the US government.
The rational for undertaking this project is that patients have both a need
and right to accurate, thorough and understandable risk information about
the drugs they are prescribed and sold. Others have said that the lack of
relevant reliable information should no longer be a major contributor to
avoidable death and injury; this would include adverse drug reactions.
The definition a Medication Guide is needed before proceeding. A
Medication Guide is defined in US regulations and under these regulations
Medication Guide written in non-technical language can be required for
drugs that present significant public health concerns to aid patients in
deciding to take a new drug or continue taking an old drug. There are
currently over 200 drugs that require Medication Guides in the US.
The basis for the pilot is the US National Library of Medicines DailyMed
Web site (http://dailymed.nlm.nih.gov/dailymed). This site contains the
professional product labels, analogous to summary of product
characteristics (SPC) for over 44,000 US drugs. A Medication Guide is part
of a drug’s professional product label. This information is updated in
almost real time on DailyMed.
Turning to the ibuprofen example. This is the permanent link to the
ibuprofen professional product label:
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=a8207fbd-f307-4120-95f7-4276a63bd4a1
[Fix URL in brower if broken - moderator; the medication guide is at the end of the professional product label]
The location of the information remains constant after updates. The
Medication Guide for ibuprofen is the same for all non-steroidal
anti-inflammatory drugs (NSAIDs) marketed is the US.
Only the Medication Guide was translated into English. [Into Arabic? - moderator]
A database, or a simple table, was created listing all the trade names of
ibuprofen containing products on the Saudi Market. The ibuprofen English
information permanent link from DailyMed was pasted for all of these
products. A separate link is pasted for the Arabic Medication Guide.
This gives users access to both English and Arabic information.
We estimate that for all NSAIDs marketed in Saudi Arabia a single Arabic
Medication Guide would provide patient information for approximately 90
drug products.
The English information is automatically updated and the US FDA sends
quarterly notices when changes are made in Medication Guides.
We are very interested in feedback and colleagues experiences in
implementing such a project.
Best,
Larry
--
Larry D. Sasich, PharmD, MPH, FASHP
Consultant,
Saudi Food and Drug Authority
3292 Northern Ring Rd., Al Nafal Dist,
Riyadh 13312-6288,
Saudi Arabia
Cell Phone Local: 056 985 6819
Cell International: 011 966 56 985 6819
Office Phone: +966 1 275-9222 Ext. 5164
E-Mail: lsasich@sfda.gov.sa
E-Mail: larry.sasich@gmail.com