Consequences of unsafe prescribing of transdermal fentanyl

Lucyk, Scott; Nelson, Lewis S.

doi:10.1503/cmaj.160291

Cited by 5 publications

(6 citation statements)

References 6 publications

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“…The introduction, approval, and widespread use of controlled‐release (CR) oxycodone were central to the iatrogenic opioid crisis 27,53 . Following the enactment of oxycodone‐focused restrictions, hydromorphone and fentanyl prescriptions increased in Canada, as did heroin and illicit synthetic opioid use 19,21,54 . In a Canadian multi‐centre study of opioid‐related hospitalizations (2015‐2016), 34% to 52% of 2599 patients had an active prescription for opioids; the most common were hydromorphone, codeine, oxycodone and methadone 26 .…”

Section: Resultsmentioning

confidence: 99%

The iatrogenic opioid crisis: An example of ‘institutional corruption of pharmaceuticals’?

Makhinson

Seshia

Young

et al. 2021

Evaluation Clinical Practice

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Rationale Prescribed opioids are major contributors to the international public health opioid crisis. Such widespread iatrogenic harms usually result from collective decision failures of healthcare organizations rather than solely of individual organizations or professionals. Findings from a system‐wide safety analysis of the iatrogenic opioid crisis that includes roles of pertinent healthcare organizations may help avoid or mitigate similar future iatrogenic consequences. In this retrospective exploratory study, we report such an analysis. Methods The study population encompassed the entire age spectrum and included those in whom opioids prescribed for chronic pain (unrelated to malignancy) were associated with death or morbidity. Root cause analysis, incorporating recent suggestions for improvement, was used to identify possible contributory factors from the literature. Based on their mandated roles and potential influences to prevent or mitigate the iatrogenic crisis, relevant organizations were grouped and stratified from most to least influential. Results The analysis identified a chain of multiple interrelated causal factors within and between organizations. The most influential organizations were pharmaceutical, political, and drug regulatory; next: experts and their related societies, and publications. Less influential: accreditation, professional licensing and regulatory, academic and healthcare funding bodies. Collectively, their views and decisions influenced prescribing practices of frontline healthcare professionals and advocacy groups. Financial associations between pharmaceutical and most other organizations/groups were common. Ultimately, patients were adversely affected. There was a complex association with psychosocial variables. Limitations The analysis suggests associations not causality. Conclusion The iatrogenic crisis has multiple intricately linked roots. The major catalyst: pervasive pharma‐linked financial conflicts of interest (CoIs) involving most other healthcare organizations. These extensive financial CoIs were likely triggers for a cascade of erroneous decisions and actions that adversely affected patients. The actions and decisions of pharma ranged from unethical to illegal. The iatrogenic opioid crisis may exemplify ‘institutional corruption of pharmaceuticals’.

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Section: Resultsmentioning

confidence: 99%

The iatrogenic opioid crisis: An example of ‘institutional corruption of pharmaceuticals’?

Makhinson

Seshia

Young

et al. 2021

Evaluation Clinical Practice

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“…3 As an opioid prescribing educator, I agree with Lucyk and Nelson's contention in their linked commentary 4 that we require improved prescriber education. However, given the breadth of the crisis, our approach to unsafe prescribing needs to be far more comprehensive, rational and coordinated.…”

Section: National Opioid Crisismentioning

confidence: 85%

“…In no other area of medicine do we see, or would we tolerate, such divergence and inconsistency of prescribing practices. 7 As we continue to recognize the lack of good evidence for the use of strong opioids in chronic noncancer pain (despite what Lucyk and Nelson claim about the effectiveness of fentanyl 4 ) and the substantial harms associated with their use, it is time that policy-makers, regulators, educators, prescribers and the public come together to form a consistent, rational and safe approach to the use of these potent medications.…”

Section: National Opioid Crisismentioning

confidence: 99%

National opioid crisis

Sud

2016

CMAJ

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“…FTS is an extended‐release opioid analgesic formulation that is intended only for patients with prior opioid tolerance. The potential life‐threatening or fatal respiratory depression associated with use of FTS in opioid‐naïve patients is due to its relative potency, long duration of effect, and unpredictable individual‐level variation in serum concentrations …”

Section: Introductionmentioning

confidence: 99%

“…with use of FTS in opioid-naïve patients is due to its relative potency, long duration of effect, and unpredictable individual-level variation in serum concentrations. 1 In July 2012, the US Food and Drug Administration (FDA) approved a Risk Evaluation and Mitigation Strategy (REMS) for extended-release or long-acting (ER/LA) opioid analgesics which requires their manufacturers to fund provider education on safe prescribing, though provider participation is not mandatory. 2 The intent of the REMS is to reduce serious adverse outcomes resulting from inappropriate prescribing, misuse, and abuse of these products and includes a requirement that manufacturers make prescriber training on appropriate prescribing of these medications available-including, but not limited to, training on opioid tolerance.…”

mentioning

confidence: 99%

Assessment of prior opioid tolerance among new users of fentanyl transdermal system in FDA's Sentinel System

Cocoros

Larochelle

Popovic

et al. 2018

Pharmacoepidemiology and Drug

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Purpose Fentanyl transdermal system (FTS) is intended only for patients with prior opioid tolerance. The purpose of this study is to identify the proportion of new FTS users who had evidence of prior opioid tolerance, by dosage strength, in FDA's Sentinel System. Methods We identified new FTS episodes (183‐day washout) from 2009 through 2013. Members were <65 years and enrolled in medical and pharmacy coverage for 183 days prior to initial FTS dispensing (index). We assessed the proportion of users with prior tolerance stratified by dosage strength of FTS using four definitions of opioid tolerance: ≥30‐mg oxycodone equivalents/day in each of 7 consecutive days immediately prior to index; ≥30‐mg oxycodone equivalents/day for any 7 days in the 30 days prior to index (secondary); any dose in each of 7 days in the 7 consecutive days immediately prior to index (tertiary); and any dose for any 7 days in the 30 days prior to index (quaternary). Results Of 44 450 episodes of 25 mcg/hr FTS, 37% met the primary definition, and 77% met the quaternary definition. Of 3507 episodes of 100 mcg/hr FTS, 57% and 74% met the primary and quaternary definitions, respectively. Those aged 25 to 34 years had the highest proportion of episodes with prior tolerance; those aged 55 to 64 accounted for more of the episodes overall. Conclusions In Sentinel, many new users of FTS did not have evidence of prior opioid tolerance by the primary definition, ie, the product label definition, which is the minimum standard for the lowest FTS dose (12 mcg/hr), especially at the highest strength (100 mcg/hr). Validation of this metric is warranted, but our findings suggest the need for further prescriber education regarding appropriate prescribing of FTS.

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Consequences of unsafe prescribing of transdermal fentanyl

Cited by 5 publications

References 6 publications

The iatrogenic opioid crisis: An example of ‘institutional corruption of pharmaceuticals’?

The iatrogenic opioid crisis: An example of ‘institutional corruption of pharmaceuticals’?

National opioid crisis

Assessment of prior opioid tolerance among new users of fentanyl transdermal system in FDA's Sentinel System

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