(2004; 102 pages)
4.6 Guidelines for package inserts and compendia
It seems that in the USA, FDA control over the content of Physicians’ Desk Reference (PDR, the commonly used compendium of prescribing information) leads to greater inclusion of important information. Alloza and Lasagna found that compared to compendia in Spain, Brazil and Mexico, the PDR included three times as many precautions as the mean for the other three countries, and four times the number of adverse effects. Their study focused on anti-inflammatory drugs marketed in the four countries224.
From 1976 the Nigerian Government required pharmaceutical manufacturers to produce leaflets and package information to be included with medicines. These were to be inspected before medicines were registered. Osifo225 compared the content of package inserts found in 28 prescription drugs obtained from pharmacies in Benin City with the American PDR. Those for the four products from American firms were the same or similar to the PDR entries. Those from foreign subsidiaries and affiliates of US firms included more indications and fewer precautions. Osifo suggests that the Nigerian health authorities have failed to adequately enforce the drug labelling controls.
A major study by the Office of Technology Assessment of the US Congress226 in 1993 found that the label and package inserts for at least half of a sample of 241 products sold by US-based companies in four countries - Brazil, Kenya, Panama and Thailand - failed to provide sufficient information for doctors to use the drugs safely and effectively.
CONCLUSION: Product inserts tend to be more informative in the USA than in other countries.