'In 1979, the US FDA proposed regulations that would have required the distribution, by pharmacists, of drug information written specifically for patients. The information would be in a nontechnical language; would not be promotional in tone or content; and would be based on a drug's approved professional product labeling (Department of Health and Human Services, 1979). The regulations were opposed by pharmacy, medicine, and the pharmaceutical industry (Sasich, 2007). The day after President Reagan's inauguration in 1981, the White House called the US FDA to make it clear that the patient drug information regulation was not to be enforced. In 1982, US FDA officially canceled the regulation in favor of a plan under which pharmaceutical companies and the private sector drug information publishers would voluntarily make information about drugs available to patients (Pines, 1999).'
The usefulness and scientific accuracy of private sector Arabic language patient drug information leaflets
CITATION: Sana R. Sukkari, Abdullah S. Al Humaidan, Larry D. Sasich. The usefulness and scientific accuracy of private sector Arabic language patient drug information leaflets. Saudi Pharm J. Jul 2012; 20(3): 211-215. Published online Jan 28, 2012. (full text is freely available)
Abstract / Summary:
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 were 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.
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