E-DRUG: Arabic Language Patient Drug Information Leaflets
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Dear Colleagues,
Below is the abstract of a recently published article on the usefulness and
accuracy of Arabic language drug information leaflets produced by a US
based drug information vendor. We found the Arabic leaflets contained
substantially less information compared to the standard used in the study.
In our view, incomplete, out of date written drug information is
potentially dangerous.
This is the link to the full article
http://dx.doi.org/10.1016/j.jsps.2012.01.006
We are aware that commercial private sector information vendors are
offering patient drug information leaflets in multiple languages. We would
suggest that colleagues in countries where commercial leaflets are being
distributed systematically examine the quality and completeness of
commercial leaflets. We would also suggest that national drug or health
regulatory authorities are made aware and consider establishing content
quality standards for patient drug information leaflets.
Those who may be interested in evaluating commercial leaflets in their
native languages and questions on methodology should feel free to contact
us.
Best regards,
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: 0556 556 819; Cell International: 011 966 556 556 819
E-Mail: lsasich@sfda.gov.sa
E-Mail: larry.sasich@gmail.com
The Usefulness and Scientific Accuracy of Private Sector Arabic Language
Patient Drug Information Leaflets
Sana R. Sukkari, BScPharm, MPhil, PharmD; Abdullah S. Al Humaidan, PharmD,
FCCN, MPH, Larry D. Sasich, PharmD., MPH, FASHP
Background
Inadequate access to useful scientifically accurate patient information is
a major cause of the inappropriate use of drugs resulting in serious
personal injury and related costs to the health care system. The
definition of useful scientifically accurate patient information for
prescription drugs was accepted by the US Secretary of the Department of
Health and Human Services in 1996 as that derived from or consistent with
the US FDA approved professional product label for a drug. Previous
quality content studies found that English language patient drug
information leaflets distributed by US pharmacies failed to meet minimum
criteria defining useful and scientifically accurate information.
Method and Findings
Evaluation forms containing the explicit elements that define useful
scientifically accurate information for three drugs with known serious
adverse drug reactions were created based on the current US FDA approved
professional product labels. The Arabic language patient drug information
leaflets for celecoxib, paroxetine, and lamotrigine were obtained locally
and evaluated using a methodology similar to that used in previous quality
content patient drug information studies in the US.
The Arabic leaflets failed to meet the definition of useful scientifically
accurate information. The celecoxib leaflet contained 30% of the required
information and the paroxetine and lamotrigine leaflets contained 24% and
20%, respectively.
There are several limitations to this study. The Arabic leaflets from only
one commercial North American vendor was evaluated and the evaluation
included a limited number of drugs. A larger study is necessary to be able
to generalize these results.
Conclusions
The study results are consistent with those of previous quality content
studies of commercially available English patient drug information
leaflets. The results have important implications for patients as access to
a reliable source of drug information may prevent harm or limit the
suffering from serious adverse drug reactions.