June 1, 2015
by Kevin McCann, DDS, FRCD(C)
In February of 2012, many Canadians became aware of an issue that had been lying dormant for many years: drug shortages. Sandoz, a division of the Swiss giant pharmaceutical company, Novarits International, and located in Boucherville, QC, was forced to close much of its production due to regulatory pressure by the United States Federal Drug Administration. Prior to the warnings by the FDA, Sandoz had invested over $170 million USD to develop a state-of-the-art production facility for generic injectable drugs. What was created, however, was a facility that was cited as being both sloppy and error prone. Not something that we expect when it comes to producing drugs used to treat disease. To add insult to injury, the Sandoz plant experienced a major fire later that year that forced closure of even more production lines. The problem of drug shortages existed long before the Sandoz quality control issues and fire. Three years later, while Sandoz is ‘back to work’, drug shortages continue and will likely remain part of the fabric of health care in Canada for years to come.
In June 2013, I was privileged to attend the International Summit on Medicines Shortages that was hosted by the International Pharmaceutical Federation (FIP) and the Canadian Pharmacists Association. The purpose of the summit was to provide a forum to discuss the causes, impacts, and solutions to address the global issue of medicine shortages through a multi-stakeholder approach, involving representatives from governments, healthcare practitioners and professional bodies, industry, and patients. The meeting highlighted the complexity of pharmaceutical production and distribution, not only in Canada, but globally. I must admit, in attending the summit, I was self-absorbed in the issue as it applied to my profession, specifically oral surgery, and to dentistry in general. However, in networking with other professionals, I became sensitive to the plight of many others that experience drug shortages. Many oncology drugs are in shortage. Imagine how difficult it would be to tell a patient that the drug or drugs that are needed to treat their cancer are on ‘backorder’? Many families deal with shortages of medicines used to treat seizure disorders for their children. These families often have to deal with the added stress that a sufficient supply of these medicines may not be available at the end of the month. If you think that Canada has it bad, imagine what it would be like to live in a developing country where the cost of medicines can be staggering, especially if you earn in a year what many of us earn in a day!
The issue of drug shortages is multi-faceted and beyond complex. The problems begin at the very start of the chain with the API: Active pharmaceutical ingredient. There are only a handful of plants that produce these ingredients worldwide. Many are located in India or China. While these plants are subject to the same inspections that Sandoz experienced, the image of the Bangladesh garment factory is still something that that taints my image of such production plants. If the world looses one such production plant, the ripple effect would likely be enormous. API’s are then shipped globally to once again, a small number of pharmaceutical giants that will produce a finished product. As we have seen, issues at these plants can give rise to major headaches. Unfortunately, the industry is based on just a few sole producers of pharmaceuticals. All of big pharma is big business. These companies have a dual responsibility. One is the fiducial responsibility to shareholders, and second is the ethical responsibility to the end user of their products. On the other hand, there are big governments that have a responsibility to their citizens. At the end of the day, however, it is the clinician that is left holding the responsibility of treating the patient.
What are the effects of drug shortages? They have increased the cost of doing business, they have increased stress levels, and they potentially create room for drug errors. In the practice of oral surgery, multiple drugs are used on a daily basis to provide sedation and anesthesia. When a drug is in shortage, many are forced to look for alternatives, and ones that may not be used with frequency. In this fashion, there is a learning curve with the new or different drug. This lack of familiarity can result in errors, and unfortunately, some can be tragic. Injectable clindamycin has often been on backorder. What choices are left for the penicillin allergic patient that requires antibiotic prophylaxis? Can you imagine a day without local anesthetics, antibiotics or analgesics?
While dentistry is a relatively small consumer of pharmaceuticals, we must remain vocal on the issue. We provide care that affects people profoundly. We need the tools to treat patients safely and effectively. We need to continue the pressure on both governments and the pharmaceutical industry to recognize the importance of patient care, and that medicine shortages should not only be a part of a re-election platform, or an annual report to shareholders.OH
Kevin McCann, DDS, FRCD (C), Private practice, Waterloo, ON, Canada.
Oral Health welcomes this original article.