Okay, I admit, I have always had a type ‘A’ personality, I prefer multitasker, and I do not believe Oral Health would print what my kids call it. For years, I had a to-do-list scrawled on a piece of paper in my pocket, a blueprint for daily tasks. With the advent of technology and the App revolution, it became easier to note, detail, categorize and hopefully complete these activities of daily living. I don’t know ultimately if there will be a sense of accomplishment once completed, as one thing is crossed off the list it usually leads to another addition. My wife has always been, let’s say, a preacher of patience. Why worry, even when you die there will still be things on that list to do. Perhaps, it is that attention to detail, which inspired a colleague to suggest I compose an editorial on the current drug supply crisis. I would have a list of those to be held accountable: the drug industry, the government, the healthcare delivery system itself; however, I have elected to side with patience.
Sandoz Canada, a subsidiary of the Swiss corporation Novartis, is part of the world’s second largest producer of generic drugs. Sandoz develops, produces and distributes products used in anesthesia, infectious diseases, oncology, cardiology and pain management. Their manufacturing plant in Boucherville, Quebec specializes in injectable medicines. This plant supplies ninety percent of the generic injectable products (forty percent of which are not made by any other Canadian manufacturer) utilized in Canadian hospitals and outpatient healthcare facilities.
November 18, 2011 the United States Food and Drug Administration issued a warning letter to Sandoz Canada regarding a deficiency in production methods at the Boucherville, QC site. Allegations involved the company failing to properly investigate the appearance of crystals in a drug sold only in the US. February 29, 2012 Sandoz provided a media release explaining the cancelled manufacture of some drugs and a reduced production of others to allow upgrades and improve quality control procedures to comply with the FDA requests. This has produced a disruption and necessitated the redistribution of certain injectable drugs to health care providers. March 4, 2012 a fire at this Boucherville plant suspended all production, intensifying the problem of shortages. At this time, Sandoz has resumed some production but these events have triggered a nationwide drug shortage that by some estimates may last twelve months.
As it stands, a monopoly’s alteration in production and the allocation of their current inventory mostly to primary care institutions has effectively ceased the supply to out of hospital venues including our ambulatory surgical facilities. There is no dispute that patients with critical medical conditions continue to receive the necessary injectable medications required for treatment, but it does not negate the collateral effects. Hospitals have announced the drug shortage is affecting the ability to deliver normal health care and elective surgeries are being cancelled. In private practice, our attempt to utilize drugs not produced by Sandoz has led to a diminished supply of these substitution alternatives due to an increase in demand. An internet survey of Ontario oral surgeons revealed that about 75 percent of practitioners responding anticipate an inability to provide an intravenous anesthetic to their patients within eight weeks.
I commend Taylor McGuire, the president of the Ontario Society of Oral and Maxillofacial Surgeons and Lynne Sweeney, the professional affairs policy manager of the Ontario Dental Association for their open dialogue to provide their members a distribution of current information on the shortage and updates from the provincial Ministry of Health and Long-Term Care on the governmental health system response. It has provided some transparency to the cloud of misinformation surrounding this issue. Benjamin Davis, the president of the Canadian Association of Oral and Maxillofacial Surgeons sent correspondence to the Federal Minister of Health, regarding the critical shortages of drugs essential to patient care. Aside from the understanding that a solution will require the cooperation of industry and government, it questions how a single drug supplier could be allowed to put the Canadian public at risk. There are currently no safeguards to alert the system of a potential drug shortage or provisions for an alternative supply in the event of a true or predicted interruption. Currently manufacturers only voluntarily report any anticipated drug shortages, but historically and unfortunately doctors and pharmacists are frequently not informed.
Even today, with the idea of a continued drug shortage looming, there is evidence of an influence on the patient management process and a factor to consider in our standard of care. This not only involves the ethics of patient care, but potentially if many of us can continue to practice without interruption. The allocation of a supply to provide priority care to those in need and at the expense of elective treatments must be met with understanding from all parties, patients and their health care providers. Whether we are general dental practitioners or managing a specialty practice our livelihood relies on patients and having patience is important during this trying time. Hopefully the current unfortunate situation will be quickly rectified and safeguards will be put in place so that it cannot happen again. I guess we all need to practice patience, I think I’ll put that at the top of my list. OH
