The recent shortage of a medication used to treat high blood pressure and other heart conditions is calling attention to the greater problem of drug shortages in Canada.
In July, pharmaceutical company Bayer Canada reported it was experiencing shortages of its extended-release Adalat XL tablets in the 20 milligram and 60 milligram dosages.
Adalat XL, or nifedipine, belongs to a class of medications called calcium channel blockers that are used to control high blood pressure and prevent chest pain from angina by relaxing the blood vessels.
According to , a third-party website launched by Health Canada that pharmaceutical manufacturers are required to report their shortages to, Adalat XL is in short supply due to 鈥渄isruption of the manufacture of the drug.鈥�
There is no other information on the website about what is responsible for the disruption or when the issue might be resolved.
In an emailed statement, Bayer said it received a warning letter from the U.S. Food and Drug Administration (FDA) regarding its supply center in Leverkusen, Germany in January of 2017. The company said the letter concerned 鈥渃ertain items鈥� in their 鈥済ood manufacturing practices鈥� area.
鈥淪ince the routine GMP inspection by the FDA, Bayer has and continues to implement remediation and modernization activities in a timely manner,鈥� the statement read.
Bayer went on to say that remediation efforts may result in 鈥減otential disruptions鈥� in supply.
鈥淲e are committed to helping patients and healthcare professionals access these products, and will provide updates as new information becomes available,鈥� the company said.
Dr. Jacalyn Duffin, a physician, hematologist, and the creator of , a website dedicated to tracking drug shortages in Canada, said Adalat XL is representative of a much larger problem and is just one of more than 1,800 current shortages in the country. She said these kinds of disruptions can be incredibly destabilizing for patients, particularly those with long-term conditions.
鈥淚t鈥檚 very, very upsetting for people to suddenly lose a drug they鈥檝e come to rely on,鈥� she told CTVNews.ca during a telephone interview on Friday. 鈥淚n conditions like high blood pressure, but also in conditions like epilepsy or arthritis, for example, these are problems that sometimes take a long time to stabilize.鈥�
Even though nifedipine is available from several other manufacturers in Canada, Duffin warns there is a risk those, too, will become in short supply due to the sudden increase in demand. For example, there are currently 10 shortages of nifedipine in Canada, including the ones from Bayer Canada. The affected manufacturers include Apotex, Mylan, AA Pharma, and Pharmascience.
In cases where nifedipine is unavailable, Duffin said patients will have to resort to other 鈥渃alcium channel blockers鈥� that may not be as effective for them.
鈥淪ome medications can鈥檛 be tolerated,鈥� she said. 鈥淪ome medications that the patient has never been exposed to before have to be titrated to find the right dose that鈥檚 going to work to control that person鈥檚 blood pressure. So you can end up spending weeks chasing your tail trying to find something that will work instead.鈥�
Duffin called the problem 鈥渇rustrating beyond belief鈥� because it consumes so much time for pharmacists, doctors, and patients to find a solution.
鈥淚t strikes me, [as someone] who has been looking at this problem for nine years, that it鈥檚 so unnecessary,鈥� she said.
Barry Power, senior director of digital content for the Canadian Pharmacists Association (CPhA), said pharmacists reported spending about 20 per cent of their time dealing with drug shortages they conducted.
鈥淚t鈥檚 over a day a week in a typical seven-day pharmacy week,鈥� he told CTVNews.ca on Friday. 鈥淚t鈥檚 taking up a huge amount of time.鈥�
The CPhA also echoed Duffin鈥檚 concerns in a letter sent to the prime minister earlier this month.
, the association warned of 鈥渟ignificant increases鈥� in drug shortages in the last three to five years. In some cases, pharmacists have reported not being able to fill 50 per cent of their weekly order, the organization stated.
鈥淭his trend has also been confirmed by patients with one in four Canadians saying that they have experienced a shortage, either personally or a family/friend,鈥� the association wrote.
A global problem
When it comes to why these shortages are happening in the first place, Duffin said there isn鈥檛 one simple explanation. In fact, on her website, for the recurring drug shortages in Canada.
These include growing demand for certain drugs, breakdowns in manufacturing or quality control, shortages in raw materials used to make the medications, the pricing of generic drugs, and the competition between big pharmaceutical companies and generics.
Duffin said it鈥檚 not as easy as blaming pharmaceutical companies for the disruptions because in actuality, it鈥檚 in their best interest to supply these medications if the demand is there.
鈥淚t doesn鈥檛 make sense because if there鈥檚 a desire to have a drug, there鈥檚 money to be made by making it,鈥� she said.
Drug shortages aren鈥檛 just affecting Canada, either. Duffin said she鈥檚 listed more than 100 countries with reported shortages on her website.
鈥淭his is a global problem. The problem is not residing here in Canada. The problem is something to do with the international pharmaceutical market well beyond our borders,鈥� she said.
Power said the globalization of manufacturing processes over the last couple of decades means the production of certain ingredients for medication is often concentrated to one or two plants in the entire world.
鈥淭he vulnerabilities are more obvious because there isn鈥檛 necessarily built-in redundancies in the production chain or the supply chain,鈥� he explained. 鈥淪o if there鈥檚 a problem in one step it can have quite significant consequences downstream that can result in shortages.
As things have become more global we鈥檙e starting to see that they鈥檙e also becoming more fragile.鈥�
For example, when Puerto Rico was hit with a devastating hurricane in 2017, Power said there was worldwide concern there would be a shortage of Tylenol, or acetaminophen, because a large supply of the drug is manufactured in the country.
As for finding solution, Duffin said she doesn鈥檛 think one individual country will be able to fix it and it will require international collaboration. However, that doesn鈥檛 mean she doesn鈥檛 think the Canadian government should take a more active role in measuring the reasons behind the shortages and trying to find a solution.
鈥淐anada should be standing up and leading the world in investigation to figure it out,鈥� she said.
The Canadian Pharmacy Association is also urging the government to conduct research on the underlying causes of the shortages in Canada and around the world and to take a leadership role in launching a global task force to look at the problem.
鈥淚t鈥檚 not just a Canada issue,鈥� Power said. 鈥淭hey [affected countries] may have to look at making some changes to some of the regulatory processes that are used to assess the manufacturing plants. They鈥檇 have to be done in conjunction with other groups, like the European Medicines Agency, the Food and Drug Administration in the States, so that everybody is in synch.鈥�
CPhA has also asked for more resources and tools to support front-line health-care workers to mitigate the shortages and recalls.
, Health Canada said it鈥檚 鈥渨orking with stakeholders throughout the supply chain to better prevent, mitigate and communicate shortages.鈥� The agency described drug shortages as a 鈥渃omplex, global problem鈥� that may arise from any number of possible causes. These causes include production issues, sole source contracting, unexpected surges in demand for a drug, and difficulties accessing raw supplies.
As of 2016, Health Canada said it introduced new regulations requiring manufacturers to report actual and anticipated drug shortages as well as discontinuations to the website .
In 2012, the health agency also created the Multi-Stakeholder Steering Committee on Drug Shortages (MSSC), comprised of industry and health-care representatives, which is aimed at working towards a more 鈥渞igorous and coordinated approach鈥� to the problem.
Duffin said she鈥檇 like to see the government go one step further and study the reasons behind the shortages that are reported on the online database.
鈥淭hey鈥檝e got this website and it says 鈥極h, there are 1,800 shortages,鈥� but they aren鈥檛 measuring them through time. So they aren鈥檛 summarizing how many per month or how many per year. They鈥檙e not finding out if they鈥檙e seasonal. They鈥檙e not finding out if they鈥檙e getting worse or getting better. They鈥檙e just reporting them.鈥�
To find a solution, Duffin said the number one focus for all countries experiencing drug shortages should be to understand the different causes behind each shortage.
鈥淲e can鈥檛 fix something if we don鈥檛 know what the cause is,鈥� she said.
