This page gives a capsule history of the problem in Canada.
For links to lists of shortages in Canada and USA scroll to the bottom of the page.
The Canadian Pharmacists Association tabled a report in December 2010. This report confirmed that the shortage is serious and growing. But it did not clarify that the majority of missing drugs are generic. Nor did it offer much insight on the possible causes. Click here for the Report, visit the CPhA chronology of action posted May 2011, or go to the CPhA website.
The Canadian Medical Association conducted a survey in January 2011 that confirmed the existence of a nationwide problem of generic drug shortages affecting 74% of respondents.
Health Canada issued a warning in August 2011 and by October the pharmaceutical industry had responded with a plan intended to provide more information about forthcoming shortages; however, the brand name and generic industry reports dating only from late October 2011 were not actually posted until December and they do not encompass the entire problem.
Also in October 2011, the Canadian Generic Pharmaceutical Association issued a statement about the problem.
On 23 November 2011, after much goading over the course of a year, Health Canada finally posted a web page purporting to offer information about the shortages. Originally, it listed only some of the possible causes–those mooted by industry. For example, it did not even mention the fact that it is the older, cheaper generic drugs that are missing, nor did it question the possibility of causes originating in profit-motive within the global pharmaceutical industry. It referred citizens to the same information resources that have been linked at this site since summer 2011.
On 24 November 2011, the Liberal Party convened a Roundtable discussion of the matter in Ottawa, involving pharmacists, industry, health professionals, and academics. For more on this meeting see the press release.
By December, both the brand name pharmaceuticals and the generic industry finally began posting lists of shortages and anticipated dates of resupply. (The two sites were not combined into one until April 2012: Canadian Drug Shortage Database. For some unexplained reason, the health Minister “introduced” the same site again in late September 2012 as if it was new.) The database at that site is incomplete.
The shortages continued.
Reports in early January 2012 suggested that they would be worse in the coming year. By February a slowdown, owing to an FDA warning letter (18 Nov 2011) and then a fire at the Sandoz plant in Boucherville, Quebec, provoked a crisis in the supply of generic injectable drugs. The situation attracted media attention as surgeries were cancelled and patient care compromised. Many people first learned of the 2-year old problem at this point. Several sources including a US Congressional committee blamed the FDA inspections. But the FDA strongly disputed these charges for more on the reasons for the warning to Sandoz see page 5 of this letter (23 July 2012). It is true that FDA inspections and warnings have increased after contamination of heparin made in China and after the global economic crisis of 2008-9.
On the evening of 12 March 2012, an emergency debate on the drug shortages took place in the House of Commons. On that same day Health Canada’s web page on drug shortages was dramatically altered from this to this. The federal government blamed the Sandoz company (although its shortages are only part of the problem), and it blamed the provinces for failing to diversify their suppliers. If the federal government is responsible for safety and licensing of drug products, then why does it not alert all Canadians about the paucity of suppliers?
On 14 March the House of Commons passed a motion to make reporting of shortages mandatory. No details were made available and it was not clear how the rule could be enforced.
On 27 March 2012 the federal Standing Committee on Health (HESA) began hearings on this matter with 3 days of witnesses. Testimony is posted for 27 March, for 29 March and for 3 April. The Report of these hearings was released in early June 2012 with Appendices including critical statements by the NDP and Liberal opposition parties. They included the recommendation that Canada establish an Essential Medicines list— a recommendation that has not been followed.
Meanwhile the online reporting sites failed to track all the shortages — see Story 27.
By June 2012, Europe’s experience of drug shortages deepened in 5 countries suffering from the economic crisis. The pharmaceutical industry contends that the EU is lowering prices to the extent that the drugs will not be available. That same month legislation passed in the US to examine the problem and an absurd report from a US Congress committee blamed the problem on the FDA. The FDA defended itself vigorously.
Increasingly, investigators in the USA have cited the role of anti-trust behaviour by large Group Purchasing Organizations (GPOs), but there seems to be little political will to pursue and fix this possible cause. (For more on GPOs go to the bottom of our Causes page.)
In July 2012, the Canadian provinces announced a plan to bulk buy and share “five or six” generic drugs. By September, the drugs had not been selected, the prices had not been identified, and the mechanism of purchase had not been defined: see response to drug-shortage webmaster’s questions sent on 27 July, answered on 14 September 2012 (item will download to your computer). The list of drugs was not announced until 18 January 2013.
Also in July, a large drug company was convicted in Pennsylvania for paying a generic competitor to keep its product off the market.
In early September, two large private insurers announced to their Canadian clients with drug plans that they would no longer cover costs of brand name drugs if a generic existed. The role of the generic shortage in the timing of the decision was not revealed. Will it mean more market scrambling for fewer drugs? Or will it simply mean that those who are lucky enough to have a drug plan will have to pay more out of pocket, because the generics that they should buy are not available?
By mid-September 2012 The Canadian government had taken no action at all on its resolutions of the previous March, for example to ensure at least six months advance notification. Some crucial drugs, such as disopyramide for a specific heart disease, had vanished without warning. The company just stopped making it because it was not profitable.
Furthermore, the Conservative government was holding up to half or more of its committee meetings in camera, so that the public had no idea of voting patterns on motions. According to the House rules, in camera meetings should be used only on occasion for matters of national security. Why would the Health Committee (HESA) ever need to hold in camera meetings?
Strangely in late September 2012 the federal Minister of Health once again announced the list of drugs in short supply as if it was a new action. Her announcement resulted in erroneous reports in Sun Media and elsewhere. That incomplete list of drugs in short supply has been linked at our own site since April 2012 as described above. The website was announced again in Edmonton in September 2013, as if it was new, although nothing had changed.
In early October 2012, several cases of meningitis in at least 5 American states were caused by impure products for spinal injections used as substitutes owing to the drug shortage problem. Over the next year more than 700 people were affected and 64 died. The FDA tracks the outbreak here.
Meanwhile, over the course of 2010-2012 the brand name pharmaceutical industry has closed many Canadian centres of production resulting in the loss of upwards of 1000 jobs. The issue expressed by industry is the difficulty in conducting research for new molecules. However many of the new products are simply invented as “follow on” drugs — designed to do what the generic product would do but new enough to be patented and more expensive and profitable, without necessarily being any better.
In January 2013, the Canadian Pharmacists Association and the Canadian Medical Association announced the results of their second, joint survey conducted in October 2012. It showed that more than two thirds of respondents claimed that the problem has grown worse in the previous two years. 94% of pharmacists were dealing with shortages on at least a weekly basis and 78% had such a problem on their last shift. Over half (55%) claimed that the problem has had a significant negative impact on patient health. When asked a question in the House of Commons about the matter on 31 January 2013, the Health Minister expressed no interest in either solving the problem or exploring its causes and resorted the the inadequate and old method of voluntary advance warnings. A year later on 12 February 2014, the Conservative majority voted down a private member’s Bill C-523 to make advance notification mandatory, a plan that they had approved un 14 March 2012 (Hansard).
In June 2013, the results a survey of 1200 Canadian anesthesiologists revealed that the chronic shortages persist. Two thirds were dealing with a shortage when they answered, at least half had to use inferior drugs and some had seen errors, increased suffering, delayed surgeries and possibly four deaths.
In September 2013, Health Canada released a “toolkit” designed to help manage and prevent shortages. It was the product of deliberations of the “Multistakeholder Steering Committee” involving industry, government, and the health professions, that had been meeting since August 2012. The impact of the toolkit is unknown and it is not clear if it is being measured. No further press releases have appeared, and the meeting schedule is not available.
By February 2014, the US FDA released its first legally required, annual report on the state of drug shortages, claiming that the problem continues but the number of new shortages is declining. However, a US Government Accountability Office (GAO) report in the same month revealed that when new shortages are combined with old and persistent shortages, the total number continues to rise (see Figure 4, p. 14).
In April 2014, a crisis arose around the cancer drug paclitaxel, made by Canadian company Biolyse, when Health Canada suspended the company’s license owing to what it contended were violations of manufacturing standards. The company contested this decision and threatened legal action in May 2014. The licence was eventually restored in August of that same year.
The Canadian government is doing nothing to solve the crisis. In February 2014, it defeated a private member’s bill to mandate advance notification of shortages. By June the Minister of Health Rona Ambrose, was reconsidering the decision to keep voluntary reporting and conducted consultations about the matter. She conducted consultations during the summer. Your webmaster was invited to participate in a telephone interview with Health Canada, which she followed with this letter of suggestions for improving information. On CBC evening news 15 September 2014, Minister Ambrose was reported as saying that she favoured mandatory reporting, but no trace of the statement could be found on later editions or in the print media. Mandatory reporting may help alleviate shortages, but it does not address the causes. In any case, it is still not implemented in Canada.
Meanwhile, in fall 2014 an acute shortage of BCG for bladder cancer briefly captured media interest.
Finally, on 10 February 2015, following consultations dating back to June 2014, Health Minister Rona Ambrose announced that companies would be required to post information about shortages — with details to come “later.” This reversed the position long held by the Harper government, that reporting should be voluntary–but it is only a tiny slow step forward that reflects a decision taken by President Obama in October 2011.
Mandatory reporting will not solve the drug shortage. It will not even measure the drug shortage. With changes yet to be implemented, Health Canada repeated the announcement in late June 2015 and the proposed new regulations were posted to the Canada Gazette, but have yet to be registered. The election ensued in October and nothing was done.
Health Canada now has a link to a Public Register developed to list manufacturers who hold Drug Indentification Numbers and have committed to notification of shortages. Health Canada admits that this site is run by industry, not by the government. The site is also supposed to reveal letters sent to companies that fail to report shortages in a timely fashion. As of 21 June 2015, only two such letters had appeared (both from September 2014 concerning nitroglycerin), although many more makers have been equally negligent before and since that time. In that same week (June 2015), 42 items were added to the drug shortage database and a document was released by the Multistakeholder Task Force laying out procedures for mitigating shortages.
A year later on 19 May 2016, the announcement for mandatory reporting was made yet again, four years after the first motion for mandatory reporting passed unanimously in the House of Commons. This time it came with news the that the government is calling for tenders for a third party by inviting “proposals to develop and maintain a website” to “eventually replace’ the reporting website that has been maintained since 2012 by Rx&D industry (now renamed Innovative Medicines Canada).
The Canadian government is not even attempting to track or measure the shortages in the same manner as the US FDA and GAO. It has failed to establish an Essential Medicines list. We do know that the problem persists, and we have the impression that it affects a different set of pharma products than those in the USA, but without more accurate information on the numbers, nature, and duration of shortages, solutions are quixotic at best.
Canada cannot solve this problem in isolation. With little pharmaceutical manufacturing of its own, it is difficult to learn what leverage could be used by the federal or provincial governments to ensure more information and solutions. The industry’s position is that there is already too much government involvement in Canadian health industries. Lobbying activities of the pharmaceutical industry increased sharply from October 2010 and into 2012. What were these meetings about? Shortages? Compulsory Licences? European Trade Deals? We do not know.
- Friday PM Drug Shortages in Canada
- Vendredi PM Ruptures d’approvisionnement
- University of Saskatchewan’s list of drugs in short supply and alternatives
- Health Canada’s warning to hospitals and list of drugs from Ben Venu lab in Ohio, 17 Aug 2011
- Canadian Drug Shortage Database (Merger of Rx & D and Generic professional associations) WARNING!! THIS SITE IS INCOMPLETE.
- Food and Drug Administration, Department of Health and Human Services, REPORT TO CONGRESS. First Annual Report on Drug Shortages for Calendar Year 2013, February 2014
- Government Accountability Office (GAO), Drug Shortages. Public health threat continues, despite efforts to ensure product availability, February 2014
- Bryan A Liang, MD, JD, PhD; Tim K Mackey, MAS, Online Availability and Safety of Drugs in Shortage: A Descriptive Study of Internet Vendor Characteristics, Journal of Medical Internet Research, 14(1): 327, 2012.
- American Society of Hematology, Status of Drugs in Short Supply, regularly updated.
- Vital Drugs in Short Supply, New York Times, 2 November 2011
- Mandy L. Gatesman et al. Shortage of Essential Chemotherapy Drugs in the United States, New England Journal of Medicine, 31 October 2011
- B. A Chabner, Drug Shortages A Critical Challenge for the Generic Drug Industry, New England Journal of Medicine, 31 October 2011
- The US Food and Drug Administration keeps a list of drugs in short supply in that country.
- The American Society of Health-System Pharmacists maintains a site on US drug shortages
- University of Utah, College of Pharmacy, drug shortages page.
- Zachary Brennan, WHO offers new plan to limit drug shortages, RAPS, 29 January 2016