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Formulary status of drugs in Ontario after Health Canada has issued a serious safety warning: a cohort study.
Int J Risk Saf Med. 2015; 27(3):135-42.IJ

Abstract

BACKGROUND

Drugs are approved for formulary listing based on limited knowledge of their safety. Serious safety issues are often identified after a drug is marketed.

OBJECTIVE

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.

METHODS

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.

RESULTS

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.

CONCLUSIONS

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.

Authors+Show Affiliations

School of Health Policy and Management, York University, Toronto, Ontario, Canada. Emergency Department, University Health Network, Toronto, Ontario, Canada. Department of Family and Community Medicine, University of Toronto, Toronto, Ontario, Canada.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

26410247

Citation

Lexchin, Joel. "Formulary Status of Drugs in Ontario After Health Canada Has Issued a Serious Safety Warning: a Cohort Study." The International Journal of Risk & Safety in Medicine, vol. 27, no. 3, 2015, pp. 135-42.
Lexchin J. Formulary status of drugs in Ontario after Health Canada has issued a serious safety warning: a cohort study. Int J Risk Saf Med. 2015;27(3):135-42.
Lexchin, J. (2015). Formulary status of drugs in Ontario after Health Canada has issued a serious safety warning: a cohort study. The International Journal of Risk & Safety in Medicine, 27(3), 135-42. https://doi.org/10.3233/JRS-150655
Lexchin J. Formulary Status of Drugs in Ontario After Health Canada Has Issued a Serious Safety Warning: a Cohort Study. Int J Risk Saf Med. 2015;27(3):135-42. PubMed PMID: 26410247.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Formulary status of drugs in Ontario after Health Canada has issued a serious safety warning: a cohort study. A1 - Lexchin,Joel, PY - 2015/9/28/entrez PY - 2015/9/28/pubmed PY - 2016/7/13/medline KW - Drug formulary KW - Ontario KW - drug safety KW - formulary management SP - 135 EP - 42 JF - The International journal of risk & safety in medicine JO - Int J Risk Saf Med VL - 27 IS - 3 N2 - BACKGROUND: Drugs are approved for formulary listing based on limited knowledge of their safety. Serious safety issues are often identified after a drug is marketed. OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. SN - 1878-6847 UR - https://www.unboundmedicine.com/medline/citation/26410247/Formulary_status_of_drugs_in_Ontario_after_Health_Canada_has_issued_a_serious_safety_warning:_a_cohort_study_ L2 - https://content.iospress.com/openurl?genre=article&issn=0924-6479&volume=27&issue=3&spage=135 DB - PRIME DP - Unbound Medicine ER -