Cisapride and patient information leaflets
==========================================

* Wendy Arnott

Sana Sukkari and Larry Sasich raise some important issues that need to be addressed, but their letter obscures a very important distinction between patient leaflets created by the company that discovered and developed a medicine and those distributed by commercial pharmacy information companies.

Janssen-Ortho's patient leaflets are submitted to and reviewed by Health Canada and form part of the official product monograph. Leaflets provided by commercial pharmacy information companies may or may not be considered with the monograph and are not controlled by the drug's manufacturer.

Sukkari and Sasich do not indicate whether the patient leaflets they compared were all in use in the same time period. As additional information becomes available to manufacturers and Health Canada, changes may be made to monographs and manufacturers' patient leaflets.

Sukkari and Sasich seem to imply, incorrectly, that because the Canadian patient leaflet is different from that used in the United States, it is somehow inferior. Patient leaflets often vary in different countries because of differences in the conditions of use approved by local regulatory authorities. For example, the Canadian Janssen-Ortho leaflet for Prepulsid (cisapride) includes fewer contraindicated drugs than the US one for Propulsid because some drugs mentioned in the US leaflet are not available in Canada or are more commonly referred to by their generic names.

We, like other manufacturers, provide physicians and pharmacists with more detailed information, through product monographs and periodic updates, that allow them to weigh the benefits and risks of a drug for any particular patient. The patient leaflet is not intended to supplant the patient– physician discussion or the detailed information provided to medical professionals in the product monograph.

We agree that some form of additional controls over commercial pharmacy information and other third-party publications should be considered. The accuracy of patient information is an important issue for the pharmaceutical industry. Janssen-Ortho would be pleased to participate in the discussion of this subject.