State efforts to import drugs raise the question – if there are drug shortages in Canada now, will there be enough drugs to export to states? The National Academy for State Health Policy (NASHP), which is working with states to design and implement wholesale prescription drug importation programs, examines Canadian drug shortages in this Q&A.
Will Canadian drug shortages limit state importation efforts, and will state importation aggravate Canadian shortages?
While there are both brand-name and generic drug shortages in Canada, the majority of shortages involve generic drugs. However, most of the drugs that states plan to import are high-cost, brand-name prescription drugs, as these can generate the greatest potential savings for US consumers. A 2018 independent analysis conducted by a Canadian non-profit policy research organization determined that 77 percent of the Canadian drug shortages between 2013 to 2016 impacted generic drugs.
What is considered a drug shortage?
Based on Canada’s drug shortage database, both brand-name and generic drug shortages may be temporary due to shipping delays or may impact only one strength or dosage (e.g., 100 mg tablets) of a drug. In other words, shortages may be partial and limited in duration.
As of January 2020, only two of the brand-name drugs that states have evaluated and targeted for possible importation had an active shortage in Canada.
States can also adjust their programs to import only drugs that have no shortages in Canada.
Are shortages only an issue in Canada?
No, drug shortages are a global challenge, impacting countries beyond Canada, including the United States. An October 2019 report from the US Food and Drug Administration’s Drug Shortages Task Force, requested by Congress to address the US drug shortage crisis, noted that like Canada the majority of US shortages from 2013 to 2017 impacted generic drugs. Civica Rx, the non-profit drug manufacturer formed by several US health systems in 2018, was founded to address the shortage of generic, injectable drugs by manufacturing their own products, primarily in the United States.
What kind of drugs are states planning to import?
While states have not finalized their drug lists for importation, NASHP has helped Maine, Vermont, and Colorado calculate potential savings for specific, select drugs that they may target. States are primarily focusing on high-cost, brand-name drugs, such as those used to treat HIV, hepatitis C, cancer, and multiple sclerosis. States plan to import only a subset of high-cost drugs. To date, of the drugs states have evaluated for potential importation, fewer than one-quarter have ever cited shortages in Canada between March 2017 and January 2020. As of January 2020, only two of the brand-name drugs states have evaluated and targeted for possible importation have an active shortage in Canada.
How can states monitor drug shortages in Canada?
Canadian Food and Drug Regulations require drug sellers to report when they are not able to meet demand for a product or when they stop selling a product. That information is made available on a public website, Drug Shortages Canada, which is a database of manufacturer reported shortages dating back to 2017. States can monitor this database and adapt their list of drugs to import as needed in response to the Canadian market. The United States has a similar database to monitor shortages, FDA Drug Shortages.
https://www.nashp.org/wp-content/uploads/2019/01/rx-bill-calculator-shutterstock_10_15_2018.jpg37445616Melanie Felicianohttps://www.nashp.org/wp-content/uploads/2019/06/NASHP-Logo.pngMelanie Feliciano2020-02-10 20:46:012020-02-13 14:23:56Q&A: The Facts about Canadian Drug Shortages