Worldwide Phenomenon of Prescription Drug Shortages

"[When regulators find a problem and a company has to curb or shut down production to fix it, the impact] cascades in a domino effect throughout the global supply chain, affecting many countries and many end users."
"If you can draw a direct line between the opioid crisis and OxyContin, you can draw a direct line between heparin and drug shortages."
Canadian multi-stakeholder group

"In many cases, there are one or two plants that produce the world supply for a single drug. When you only have one or maybe two manufacturing sources, they are much more vulnerable to disruptions."
Barry Power, Canadian Pharmacists Association

"People have forgotten that it wasn't always there [a now-major issue of drug shortages]."
"It wasn't like this ten years ago. We didn't have these problems. Why do we have them now?"
"[The] vast majority [of shortages relate to medicines with expired patents, enabling generic makers to compete in the pharmaceutical marketplace and roughly 70 percent of shortages relate to generic companies.]"
Dr.Jakalyn Duffin, hematologist, professor emerita, Queen's University

"We carried products that were losing money for a long time. Companies leave the market because they can't afford to make products at a loss."
"[The shortage began when the largest, Apotex, decided to change its manufacturing and formulation process at an Ontario-based plant]."
Jordan Berman, spokesman, Apotex, Canadian generic giant

There has been of late an alarming scarcity of the drug tamoxifen -- prescribed for post-breast-cancer patients to avoid recurrences -- among other scarcities where a shortage of almost two thousand drugs are currently listed on Health Canada's site as being in short supply -- also affecting children with leukemia, Parkinson's patients, and depression patients. Scarcity is nearing chronic status in Canada, as it is in various other parts of the world, causing no little amount of consternation and fear on the part of patients reliant on the drugs to extend and give quality to their lives.

In an effort to lay blame and avoid any themselves, governments and industry point the finger at a litany of production glitches such as factory shutdowns, regulatory interventions and a lack of raw ingredients. Despite that drug shortages only began to evidence as an issue in 2010, affecting the worldwide community. One explanation that mirrors reality is that there has been a dramatic consolidation within the pharmaceutical industry and globalization of the medicine supply chain.

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This, while government agencies and private-sector health groups have been working to drive down the price of generic medications; a situation offering relief from increasing health budgets, but which also has the effect of curbing any incentive for suppliers to produce drugs. The number of suppliers is being reduced not only through consolidation but because some generic makers decide to drop certain drugs when it no longer seems feasible to profit, with driven-down prices.

The world has gone from a situation of numerous drug-manufacturing competitors copying any off-patent drug or its raw constituents, to add to the current situation of endemic shortages. There were no fewer than 800 mergers and acquisitions in the drug manufacturing industry in 2008, inclusive of 15 "megadeals", resulting in "fewer options for end customers" according to Canada's "multi-stakeholder" drug-shortage committee.

A recall of various brands of heart medicine last year by Health Canada, the FDA and other regulators containing a tainted version of valsartan where the raw ingredients were issued from a single producer in China, a case in point. Increasingly manufacturing all manner of consumer goods has been relegated to low-cost-production locales. Currently, an estimated 80 percent of raw ingredients for the world's drug production come out of China and India, two countries whose industries are well known for a tendency toward a casual attitude in critical production issues.

A recent U.S. Food and Drug Administration report noted the drug supply chain is "longer, more complex and fragmented" so that it is more difficult to respond to a production disruption. In 2008 the United States experienced the heart drug heparin being imported with tainted versions traced to a factory used by Baxter International Inc. in China. As a result, over 80 patients died, prompting the FDA to increase inspections of foreign drug suppliers.

According to the Patented Medicine Price Review Board in Ottawa, Canadian provinces have been mandating or negotiating prices as low as ten percent of the brand product, resulting in the cost of generics falling by 60 percent from 2007 to 2018. In the U.S. a handful of private-sector "group purchasing organizations" have used leverage to price down generics with a "race to the bottom" providing little incentive for producing companies to turn out low-profit medicines representing "root cause 1" for drug shortages the FDA report concluded.

So what is the solution?

"We cannot talk about the drug-shortage problem until we know what it is and how it changes over time."
"It blows me away that in a country like Canada with intellectual capital and human resources, we don't just start making them [through government auspices]."
"When there are only a few makers, the margin in the system is narrow. Any manufacturing problem will result in shortage."
"We as a society accept the notion that drug marketing and drug development belongs in the private sector. These private companies are not charities; if they are losing money, they stop making the drug so that they can keep paying their employees and their stakeholders."
Jacalyn Duffin, professor emerita, Queen's University 

Breast cancer treatment Tamoxifen is in short supply.JB Reed/Bloomberg

Yet, according to Health Canada:
"Many shortages can be resolved through supply management measures without their effect ever being felt by patients. Health Canada works closely with the Canadian companies that supply drugs, the provinces and territories, and health stakeholders across the supply chain to identify and facilitate mitigation measures, as needed."
What shortages? Well, remember the Health Canada note to consumers on their website, listing close to 2,000 medications in short supply? They don't seem to recall that.

"There are different situations leading to out of stock of medicines. Some of them can be solved without causing obstacles to health care provision or in the availability of the best therapeutic option, whereas others may require additional efforts and ways to overcome affected health conditions. There have been several important efforts to document countries’ experiences and potential ways forward to address concerns with medicine shortages. The study of ISAGS UNASUR published in 2017 characterized and analyzed the situation among eight South American countries: Bolivia, Chile, Colombia, Ecuador, Paraguay, Peru, Venezuela, and Uruguay (ISAGS, 2017). In 2018, Bochenek et al. (2018) systematically characterized, compared, and evaluated current measures, as well as legislative and organizational frameworks, to address medicines shortages among a wide range of European and Western Asian countries. These included 20 countries of the European Union (EU) and the European Free Trade Association (EFTA)—Austria, Belgium, Croatia, the Czech Republic, Estonia, France, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Malta, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, and Switzerland. In addition, eight non-EU/EFTA countries: Albania, Azerbaijan, Israel, Kosovo, Montenegro, Republic of Srpska (Bosnia and Herzegovina), Serbia, and Turkey."
Research article: Frontiers in Pharmacology, July 19, 2019