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- Muddling Health Canada's Powers and Diluting Accountability
The opioid crisis is indeed serious and there is an urgent need to propose and consider options for dealing with it. It is fair to suggest Health Canada, as our regulator of drug safety should play a major role in such considerations. However, the truth is, in the past, Health Canada has not served us well in regard to drug safety. It does not help matters when the powers of our regulator to oversee drug safety are characterized incorrectly as in this article. While the Department in 2014 "spun" Vanessa's Law as giving them new powers to recall pharmaceuticals from the market, the truth is they always had the power to stop sales if there was even a whiff of a safety concern. See the Food and Drugs Act section C.01.013, or C.08.006 or C.08.003 (h)iv for example (1). The problem was - they rarely used it. Medical researchers have suggested a possible reason. There is a closely inter-connected relationship between Health Canada and the pharmaceutical industry that calls for an in-depth analysis of the culture within Health Canada and the political system within which it exists. To perpetuate the myth that Health Canada only had the power to take unsafe drugs off the market since the 2014 Vanessa's Law relieves the regulator of accountability for past regulatory failures and the unacceptable state of drug safety today.
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1. Departmental Consolidation of the Food and Drugs Act and of the Food and Drugs Regulations – with amend...Competing Interests: None declared. - CSPCP response to Herder & Juurlink's High-strength opioid formulations: the case for a ministerial recall
Dear Editor,
The Canadian Society of Palliative Care Physicians would like to comment on the proposal by Herder and Juurlink that the federal Minister of Health should recall from the Canadian market all high strength opioid formulations equal to 100mg morphine equivalent dose and above (1).
While we acknowledge the current opioid crisis and the recently revised opioid prescribing guidelines that apply to non-cancer pain, we have serious concerns about this proposed recall in the context of cancer pain and patients with palliative care needs including those who also suffer from opioid use disorder. The BC Practice Standard specifically indicates that such patients should not be included in the guideline (2). Our own position statement on access to opioids for patients requiring palliative care (3) and the WHO cancer pain relief document (4) recommend the use of opioids for cancer pain at doses that are titrated up to effect and tolerability with no maximum dose. We are currently producing Opioid Wisely guidelines regarding this matter for Choosing Wisely Canada.
Patients with cancer pain sometimes require large doses of opioids to control their pain, even well above 200mg oral morphine equivalent (5-7). Patients with opioid use disorder and cancer pain are often treated in addition to their Opioid Agonist Therapy with long acting oral once daily or transdermal opioid preparations (8), often at high doses due to opioid tolerance, following careful risk...
Show MoreCompeting Interests: None declared. - RE: High-strength opioid formulations: the case for a ministerial recall
As a family doctor and palliative care enhanced competency resident, I was frustrated to read Herder and Juurlink’s editorial recommending a ministerial recall for high-strength opioid formulations. The authors’ well-intentioned suggestion would bring considerable harm to patients suffering with pain from incurable diseases, particularly advanced cancer.
Many of my patients have metastatic disease characterized by extensive bone disease and soft tissue invasion. They are able to maintain good quality of life and function at home, partly through the benefits provided by the very high-dose opioid formulations demonized in the article. Without them, they suffer from debilitating pain, and associated anxiety, depression, and loss of function which can lead to hospital admission and even earlier death.
The authors cite recent clinical practice guidelines on chronic noncancer pain to support their recommendation. These guidelines remain controversial, based on consensus and not on evidence, and they specifically exclude cancer pain from their scope. While we might wish cancer did not exist, 1 in 2 Canadians will develop cancer in their lifetimes, half of those will die from it, and many of them will have pain requiring opioid analgesia. Dismissing the pill burden in these patients as a “relatively minor inconvenience” trivializes the constant pall of medical care over their daily lives.
The comparison to thalidomide is pertinent because it too is a drug with...
Show MoreCompeting Interests: None declared. - RE: Editorial assumes "facts" not in evidence
This marks a new low in the discussion of the so-called perils of therapeutic opiates. The authors advise Ottawa to recall "high dose" formulations of medical opiates. But what constitutes a "high" dose, when opiate dosing is properly done on a customized basis?
Whatever "high" means here, recent research suggests, not for the first time, that lower, not higher, doses wreak greater harm (https://ajph.aphapublications.org/doi/abs/10.2105/AJPH.2018.304590?journ...). In an open letter he signed last week disparaging forced tapering (https://academic.oup.com/painmedicine/advance-article/doi/10.1093/pm/pny...), Dr Juurlink himself acknowledges this.
Research also shows that prescribed opiates are not particularly lethal at any dose. The largest study to date, of nearly 2.2M Americans, pegs the annual overdose death rate from prescribed opiates at a mere 0.022% (https://academic.oup.com/painmedicine/article/17/1/85/1752837).
Truly confounding and downright weird is the authors' claim that more is less: that, say, two 50 mcg patches of transdermal fentanyl are safer than one 100 mcg patch. They're not, of course. "Pil...
Show MoreCompeting Interests: None declared. - Why is 2x40 better than 1 80?
Unquestionably some "legacy patients" were gradually increased to large doses but many have been stable and functional. In response to the new guidelines, Many such patients are successfully undergoing slow reductions. The initial reductions will see the continued use of high dose products until the total opioid burden begins to decrease. My concern is the financial difficulty these patients will incur as double the number of tablets will be more expensive. They already feel stigmatised by media coverage as they attempt to reduce or convert.
The message of the opinion piece is not that one high dose tablet is more dangerous than two lower dose tablet, but that it looks more dangerous; more a problem of cosmetics.
As patients reduce or convert, as new patients are not having the same dose escalations, the high dose products will eventually fade away. The main concern I have with the authors' recommendations is the increased economoc burden to current patients or their insurers.
Competing Interests: None declared. - RE: High-strength opioid formulations: the case for a ministerial recall
In response to Herder and Juurlink's call for the federal Minister of Health to recall high-strength opioid formulations, I argue that the risk of injury to the health of Canadians from such a policy would be greater than any such risk from these medications themselves.
In my opinion, recalling high-strength opioids is unlikely to change opioid prescribing patterns to any great extent. It does, however, have the very real potential to increase the amount of opioids being diverted to street use by increasing the number of opioid pills being prescribed and dispensed. It is also likely to further limit access to opioids for individuals dealing with chronic pain without addressing their underlying dependency or the tremendous lack of access to other chronic pain therapies that exist across Canada, leaving these individuals vulnerable to seeking opioids from street sources and placing themselves at a much greater risk of overdose. Last, recalling high-strength opioids may place another barrier in the way of increasing access to prescribed opioids as a harm reduction measure, a necessary step in dealing with the ongoing crisis of overdose deaths due to contaminated street drug supplies.
The authors themselves cite the 2012 move to change the formulation of OxyContin, which had the unintended consequence of increasing the demand for fentanyl and creating a black market opportunity. I hope we have learned from this example that isolated policy initiatives to...
Show MoreCompeting Interests: None declared. - Flawed Arguments in this commentary
With all due respect, there are many serious flaws in this commentary. To begin with, Health Canada has always had the ability to issue warnings about drugs and to recall drugs. The fact that Health Canada has not done this with higher doses of opioids is likely because there is no reason to do so. Vanessa's Law came into force in 2014 but it was 2000 when the young lady who unfortunately passed away from a reaction to Cisapride. That same year, Health Canada requested that it be removed from the market and it was.
According to Health Canada in response to my question, the agency has never had to invoke this legislation. See https://www.painnewsnetwork.org/stories/2018/12/3/prop-in-canada
Ontario removed high doses of opioids from the drug formulary a few years ago. The higher doses are no longer covered for those on social assistance or the elderly. As a result, doctors now prescribe lower doses in combination to make up for that. Now, instead of a 100 mcg patch of fenetanyl, patients are prescribed 2 50 mcg patches. How is this safer?
The real problem with overdose deaths in this country is illicit fentanyl. The BC coroner is the only coroner that rules on the source of opioids in overdose deaths and finds consistently that it is illicit fentanyl and not prescribed opioids (1, 2). Further, as Global News has just revealed (3), one Chinese criminal enterprise is respon...
Show MoreCompeting Interests: None declared.