english.prescrire.org > Annual Prescrire Awards > The Prescrire Awards for 2008 > The 2008 Prescrire Awards for Drugs, Packaging and Information > A look back at drug developments in 2008 > Pharmaceutical quality: vigilance needed

The Prescrire Awards for 2008

The 2008 Prescrire Awards for Drugs, Packaging and Information

A look back at drug developments in 2008
Pharmaceutical quality: vigilance needed

Marketing authorisation offers certain guarantees in terms of pharmaceutical quality, as regulatory agencies inspect the production sites and impose controls during the manufacturing process. In contrast, other product categories such as dietary supplements, medical devices, and cosmetics, are less strictly regulated.

Two major incidents involving pharmaceutical quality
In 2007 and 2008 there were 2 serious incidents involving lapses in the control of pharmaceutical quality.

Some batches of heparin manufactured in China were contaminated with chondroitin sulfate, which can cause serious allergic reactions (la revue Prescrire 297, p. 497-498).

Similarly, certain batches of nelfinavir, an antiretroviral drug, were contaminated with large amounts of ethyl mesilate, a genotoxic substance, during their manufacture in Switzerland (la revue Prescrire 303, p. 13).

These problems were missed by the various controls in place during manufacturing, but were detected by patients and healthcare professionals. Whether they were due to sabotage or technical errors, these incidents serve as reminders of the need for continued vigilance when it comes to drug manufacturing.

©Prescrire April 2009

Source: Prescrire Int 2009; 18 (100): 84-88.