Lexchin Joel
School of Health Policy and Management, York University, Toronto, Ontario, Canada.
Emergency Department, University Health Network, Toronto, Ontario, Canada.
Int J Risk Saf Med. 2015;27(3):135-42. doi: 10.3233/JRS-150655.
Drugs are approved for formulary listing based on limited knowledge of their safety. Serious safety issues are often identified after a drug is marketed.
To determine whether the listing status of drugs on the Ontario Drug Benefit (ODB) Formulary changes following the identification of safety concerns by Health Canada and whether the results of reviews by people responsible for the ODB Formulary are made public.
All new active substances (NAS) approved by Health Canada from January 1, 2002 to March 31, 2012 that subsequently had a warning issued about a serious safety concern were identified. Editions of the ODB Formulary were searched to find which of these drugs were listed on the Formulary before the safety warning was issued.
A total of 263 NAS were approved of which 42 subsequently acquired one or more serious safety warnings and 15 of these were listed on the ODB Formulary before the safety warning was issued. The listing status of 14 of the 15 drugs was unchanged after the release of the safety warning. No information is available about whether the listing status of these 14 drugs was reassessed.
The ODB Formulary should develop a set of criteria to determine whether the listing status of drugs should be reviewed after Health Canada issues a serious safety warning. The results of any reconsiderations should made public so that prescribers and patients alike know that the ODB Formulary officials still regard the drugs as having a positive benefit to harm ratio.
药物基于有限的安全性知识被批准列入处方集。严重的安全问题往往在药物上市后才被发现。
确定在加拿大卫生部识别出安全问题后，安大略药物福利（ODB）处方集上的药物列名状态是否会改变，以及ODB处方集负责人的审查结果是否公开。
识别出2002年1月1日至2012年3月31日期间被加拿大卫生部批准的所有新活性物质（NAS），这些物质随后被发布了关于严重安全问题的警告。检索ODB处方集的各版本，以找出在安全警告发布之前哪些药物被列入了处方集。
总共批准了263种NAS，其中42种随后获得了一个或多个严重安全警告，其中15种在安全警告发布之前被列入了ODB处方集。15种药物中有14种在安全警告发布后的列名状态没有改变。没有关于这14种药物的列名状态是否被重新评估的信息。
ODB处方集应制定一套标准，以确定在加拿大卫生部发布严重安全警告后是否应审查药物的列名状态。任何重新审议的结果都应公开，以便开处方者和患者都知道ODB处方集官员仍然认为这些药物的利弊比是积极的。
