In 2001, we published a letter criticizing the poor quality of drug information available to the Canadian public,1 using as an example cisapride, a drug that had been withdrawn from the market for safety reasons in August 2000. In response, an official from the Therapeutic Products Programme (now the Therapeutic Products Directorate) of Health Canada agreed on the need for high-quality written patient information but lamented Health Canada's lack of regulatory authority to ensure public access to such information;2 he also noted that an initiative was under way “to improve the format and content of product monographs and to make their contents available to the Canadian public.”2
Drug information for patients, approved by Health Canada and designated as part of the official product monograph, is published in the Compendium of Pharmaceuticals and Specialties (CPS).3 The patient monograph is claimed to be a “direct equivalent of the prescribing information,” and “contains information, in lay language, that is required by the patient for safe and effective use of the drug.”3
To assess the quality and usefulness of patient information appearing in the CPS, we compared the information in the nefazodone (Serzone) monograph intended for health care professionals4 with that contained in the patient monograph for the same drug,5 both published in the 2003 edition of the CPS. We looked for the most serious risk associated with the use of nefazodone and explicit instructions to be followed if specific adverse events were experienced. Nefazodone was withdrawn from the Canadian market in November 2003 because of hepatotoxicity.6
Nefazodone was approved for use in Canada in 1994. In 1999 the professional product monograph was amended to warn of hepatotoxicy, including increased liver enzymes, hepatitis, jaundice, liver failure, liver necrosis, liver damage and the possibility of liver transplantation or death.4 However, the patient monograph5 published in the 2003 CPS does not reflect the 1999 amendment to the professional monograph and remained unchanged from 1994 until the drug was removed from the market in November 2003. Patients were simply instructed to tell their physicians if they had a history of seizures, liver disease, or heart or blood pressure disorders. The patient monograph contained no warning of potentially permanent or fatal liver toxicity. No information was provided to allow patients to identify early signs of liver toxicity, and explicit instructions on the steps to be taken if symptoms of liver toxicity developed were simply absent.5
The Serzone patient monograph illustrates the glacial pace of the Therapeutic Products Directorate, if there is any movement at all, toward improving patient access to useful, accurate drug information. Clearly, the Serzone patient monograph was incomplete and not a “direct equivalent of the prescribing information” for almost 4 years. Patients might rightfully assume that drug information approved by the government is all that is necessary to use a drug effectively and safely. If a patient makes such an assumption, then patient drug information that is incomplete is inherently misleading and dangerous.
Sana R. Sukkari Oncology-Palliative Care Pharmacist Joseph Brant Memorial Hospital Burlington, Ont. Larry D. Sasich Public Citizen Health Research Group Washington, DC