Canada to Require Drugmakers to Publicly Disclose Drug Shortages
Posted 13 March 2017 | By
Beginning on Tuesday, 14 March, amendments to Canada’s Food and Drug Regulations will come into force making it mandatory for drug authorization holders to publicly report drug shortages and discontinuations to two websites, DrugShortagesCanada.ca and PenuriesDeMedicamentsCanada.ca.
“As soon as a market authorization holder knows that it will take longer than 20 days to supply a drug to meet expected patient volumes on an ongoing basis, they will report this as a shortage on the communications platform,” the public-facing website, www.drugshortages.ca, says.
Health Canada also notes that the posting of discontinuances on the shortages website “does not alter nor affect regulatory obligations under the Food and Drug Act Regulations to inform Health Canada within 30 days of any drug discontinuances.”
In June 2016, final regulations were posted to the Canada Gazette, making it mandatory for drug authorization holders to report drug shortages and discontinuations of sale:
- no less than six months in advance if it is likely to begin in more than six months, or
- within five days of becoming aware of the drug shortage or discontinuation of sale if it will begin within six months and updated online within two days of becoming aware of a change.
The following types of medical products are impacted by amended regulations:
- Drugs included in Schedule I, II, III, IV or V to the Controlled Drugs and Substances Act
- Prescription drugs
- Drugs listed in Schedule C or D of the Food and Drugs Act
- Drugs permitted to be sold without a prescription but that are administered only under the supervision of a practitioner.
Non-compliance includes a company's failure to (1) report and update drug shortage and discontinuation information within prescribed timelines and (2) provide complete and accurate information about a drug shortage or discontinuation.
Health Canada says it will take a stepwise approach to compliance and enforcement of the regulations, and it expects authorization holders to have documentation available to support their decisions on reporting and updating drug shortages and discontinuations. Regulatory compliance letters, warning letters and public communications will be used.
Non-compliance with the new regulations will likely be brought to Health Canada’s attention via complaints, according to the agency, as well as through ongoing case management work and through periodic trend analysis of website data.