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Commentary

High-strength opioid formulations: the case for a ministerial recall

Matthew Herder and David Juurlink
CMAJ December 03, 2018 190 (48) E1404-E1405; DOI: https://doi.org/10.1503/cmaj.181289
Matthew Herder
Health Law Institute and Department of Pharmacology, Faculty of Medicine (Herder), Dalhousie University, Halifax, NS; Division of Clinical Pharmacology and Toxicology, and Medicine, Pediatrics, and Health Policy, Management and Evaluation (Juurlink), University of Toronto; Divisions of General Internal Medicine and Clinical Pharmacology & Toxicology (Juurlink), Sunnybrook Health Sciences Centre, Toronto, Ont.
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David Juurlink
Health Law Institute and Department of Pharmacology, Faculty of Medicine (Herder), Dalhousie University, Halifax, NS; Division of Clinical Pharmacology and Toxicology, and Medicine, Pediatrics, and Health Policy, Management and Evaluation (Juurlink), University of Toronto; Divisions of General Internal Medicine and Clinical Pharmacology & Toxicology (Juurlink), Sunnybrook Health Sciences Centre, Toronto, Ont.
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  • Muddling Health Canada's Powers and Diluting Accountability
    Pamela M. Forward, Reg. N., MA, GCCR
    Posted on: 07 December 2018
  • CSPCP response to Herder & Juurlink's High-strength opioid formulations: the case for a ministerial recall
    Leonie Herx
    Posted on: 07 December 2018
  • RE: High-strength opioid formulations: the case for a ministerial recall
    Kevin Wade
    Posted on: 06 December 2018
  • RE: Editorial assumes "facts" not in evidence
    Dawn Rae Downton, PhD
    Posted on: 06 December 2018
  • Why is 2x40 better than 1 80?
    Stanley Lofsky
    Posted on: 05 December 2018
  • RE: High-strength opioid formulations: the case for a ministerial recall
    Robert A Strang
    Posted on: 04 December 2018
  • Flawed Arguments in this commentary
    Marvin Ross
    Posted on: 04 December 2018
  • Posted on: (7 December 2018)
    Muddling Health Canada's Powers and Diluting Accountability
    • Pamela M. Forward, Reg. N., MA, GCCR, Independent Researcher and Mediator, Mediation Place

    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.

    References
    1. Departmental Consolidation of the Food and Drugs Act and of the Food and Drugs Regulations – with amend...

    Show More

    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.

    References
    1. Departmental Consolidation of the Food and Drugs Act and of the Food and Drugs Regulations – with amendments to May 3, 1990. Issued by Department of National Health and Welfare. Minister of Supply and Services 1981. https://laws-lois.justice.gc.ca/eng/regulations/C.R.C.,_c._870/page-92.html

    Show Less
    Competing Interests: None declared.
  • Posted on: (7 December 2018)
    CSPCP response to Herder & Juurlink's High-strength opioid formulations: the case for a ministerial recall
    • Leonie Herx, President, Canadian Society of Palliative Care Physicians

    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 More

    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 assessment and management (8).

    Limiting the availability of high-strength opioid formulations could create difficulties and barriers for patients with cancer pain and other palliative needs. Having to take multiple doses of a lower strength preparation in the context of complex drug regimens for cancer could increase the risk of errors and poor compliance. This could also create a barrier to obtaining prescriptions from family doctors who are already cautious about prescribing opioids in large quantities. For patients with palliative care needs who also have opioid use disorder, and need high strength additional opioids for pain, it is safer to prescribe a single large once-daily supervised oral ingestion or transdermal application rather than multiple lower dose preparations spread throughout the day (9). Restricting access to products that enable this practice will increase rather than decrease the risk of diversion. The use of multiple lower dose transdermal patches could enable diversion, as the patient may be able to tolerate a small decrease in dose while some of the patches are diverted.

    Ontario’s Palliative Care Facilitated Access program offers a possible solution. As of 2016, prescribing of high-strength opioid formulations is restricted to a prescriber or contact with a prescriber registered by the licensing body as a palliative care physician. This has reduced prescriptions for these formulations while maintaining access for those who need them for palliative care. All practitioners need to continue to work together to ensure the care needs of all patients are met.

    Dr. Leonie Herx
    President, Canadian Society of Palliative Care Physicians

    References:
    1. Herder M, Juurlink D. High-strength opioid formulations: the case for a ministerial recall. CMAJ 2018;190(48):E1404-E1405
    2. College of Physicians and Surgeons of British Columbia. Practice standard - safe prescribing of opioids and sedatives. 2018. [updated 2018 June 4; cited 2018 Dec 6]. Available from www.cpsbc.ca/files/pdf/PSG-Safe-Prescribing.pdf
    3. Canadian Society of Palliative Care Physicians. Position statement on access to opioids for patients requiring palliative care. 2016. [cited 2018 Dec 6]. Available from www.cspcp.ca/wp-content/uploads/2014/10/CSPCP-Position-Statement-on-Acce...
    4. World Health Organization. Cancer pain relief: with a guide to opioid availability, 2nd ed. [Internet]. Geneva: World Health Organization. 1996. [cited 2018 Dec 6]. Available from http://www.who.int/iris/handle/10665/37896
    5. Wiffen PJ, Wee B, Moore RA. Oral morphine for cancer pain. Cochrane Database of Systematic Reviews 2016, Issue 4. Art. No.: CD003868.
    6. Portenoy RK, Ahmed E. Principles of Opioid Use in Cancer Pain. J Clin Oncol 2014;32:1662-1670
    7. Varilla V, Schneiderman H, Keefe S. No Ceiling Dose: Effective Pain Control with Extraordinary Opiate Dosing in Cancer. Connecticut Medicine 2015;79(9):521-524
    8. Passik SD, Kirsh KL. Opioid Therapy in Patients with a History of Substance Abuse. CNS Drugs 2004;18(1):13-25
    9. Kirsh KL, Passik SD. Palliative Care of the Terminally Ill Drug Addict. Cancer Investigation 2006; 24: 425-431

    Show Less
    Competing Interests: None declared.
  • Posted on: (6 December 2018)
    RE: High-strength opioid formulations: the case for a ministerial recall
    • Kevin Wade, Palliative Care R3 Year of Added Competency Resident, University of British Columbia

    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 More

    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 utility in treating cancer, and it remains available for patients with multiple myeloma. The fact that a drug can be harmful in some patients is not a reason to deny it to all patients – if that were the case we’d have no pharmaceuticals at all.

    A ministerial recall is an inappropriate sledgehammer that would have questionable benefit while undoubtedly causing harm to my patients. A more nuanced approach, educating clinicians and patients about the harms of high-dose opioids in chronic non-cancer pain, tracking doses, and optimizing non-opioid management would offer greater benefit while minimizing inadvertent harms of prohibition.

    Show Less
    Competing Interests: None declared.
  • Posted on: (6 December 2018)
    RE: Editorial assumes "facts" not in evidence
    • Dawn Rae Downton, PhD, Writer, Halifax, NS

    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 More

    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. "Pill burden"---making patients take a bunch of pills instead of one---is not a "relatively minor inconvenience"; it's trouble. The fewer pills or patches you use to achieve a dose, the more likely you are to get your dose right. Dr Juurlink, a pharmacist, doesn't seem to know that, nor does he seem to know or care that lower-dose formulations used in multiples cost patients more. That matters, since many Canadians with chronic pain don't have jobs with insurance plans and aren't living large on their disability pensions. What the authors are actually saying is that lower-dose formulations can be weaponized against users when they're employed to prompt patients to taper or end their therapy.

    Whatever we think of the laundry list of "harms" the authors cite, we should be asking every time we hear it---and we hear it frequently---why physical dependence is bad when it involves medical opiates but not when it involves the many other drugs we become dependent on. Note, too, the judicious use of "likely" throughout the piece; it's a proxy for proof. Three of the six papers on opiates the authors cite are Dr Juurlink's own work. Two come from his compatriots. How do we know, then, beyond Dr Juurlink, that these "harms" are dose-dependent?

    Moreover, there's plenty of evidence that doses of 200 to 400 MME afford more benefit than harm, as the AMA told us last month (https://www.cato.org/blog/better-late-never-0). Conversely, there's no evidence, as claimed here, that doses are continually escalated in patients with chronic pain. To the contrary, when effective doses are reached, they plateau.

    But why should we restrict medically-managed opiates at all, when coroners' reports and the RCMP tell us repeatedly that it's not the medical supply but rather Chinese crime rings that are causing our overdose deaths? That's the evidence we should be looking at. Herder and Juurlink are emperors with no clothes, and it's time we stood up and said so.

    Show Less
    Competing Interests: None declared.
  • Posted on: (5 December 2018)
    Why is 2x40 better than 1 80?
    • Stanley Lofsky, Family Physician, North York General Hospital Medical Staff Association Honorary Member

    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.
  • Posted on: (4 December 2018)
    RE: High-strength opioid formulations: the case for a ministerial recall
    • Robert A Strang, Chief Medical Officer of Health, Department of Health and Wellness, Nova Scotia

    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 More

    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 change the highly complex situations of opioid overprescribing and toxic street drugs need careful analysis given the very real risk of creating net harm.

    Show Less
    Competing Interests: None declared.
  • Posted on: (4 December 2018)
    Flawed Arguments in this commentary
    • Marvin Ross, medical writer, Bridgeross Communications

    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 More

    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 responsible for millions of dollars in smuggled drugs into Canada and the police have few resources to fight this. And don't forget about the Ontario pharmacists caught distributing millions of dollars more of opioids into the black market (4).

    It is time to focus on these criminals and not on the pain patients and their doctors who are trying to help them.

    References

    1. BC Coroners Service releases expanded findings into overdose deaths. BC Gov News 2018 Sept 27. https://news.gov.bc.ca/releases/2018PSSG0072-001880

    2. Gomes T, Greaves S, Martins D, et al. Latest Trends in Opioid-Related Deaths in Ontario: 1991 to 2015. Ontario Drug Policy Research Network 2017 April. http://odprn.ca/wp-content/uploads/2017/04/ODPRN-Report_Latest-trends-in...

    3. Cooper S, Bell S, Russell A. Fentanyl kings in Canada allegedly linked to powerful Chinese gang, the Big Circle Boys. Global News 2018 Nov 27. https://globalnews.ca/news/4658158/fentanyl-kingpins-canada-big-circle-b...

    4. Chown Oved M, Cribb R, Jarvis C, Lecce C, Bailey A. Drug-dealing pharmacists are feeding Ontario’s opioid crisis. The Star 2018 Sept 24. https://www.thestar.com/news/investigations/2018/09/24/drug-dealing-phar...

    Show Less
    Competing Interests: None declared.
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Canadian Medical Association Journal: 190 (48)
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3 Dec 2018
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High-strength opioid formulations: the case for a ministerial recall
Matthew Herder, David Juurlink
CMAJ Dec 2018, 190 (48) E1404-E1405; DOI: 10.1503/cmaj.181289

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High-strength opioid formulations: the case for a ministerial recall
Matthew Herder, David Juurlink
CMAJ Dec 2018, 190 (48) E1404-E1405; DOI: 10.1503/cmaj.181289
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  • Opioid Wisely
  • A recall of high-strength opioids would be harmful
  • Recalling high-strength opioid formulations would cause harm
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