Drug formulary listing decision - Tramadol

Indication(s)

Treatment of moderate to moderately severe pain.

Formulary status

The Drug Advisory Committee (DAC) recommended that tramadol be covered for people with workplace injuries or illnesses and musculoskeletal (02WS), CNS/PNS (03WS), facial/EENT injury (04WS), burn (05WS), cancer (19WS) and Initial (25WS) formulary entitlement if the following criteria are met:

  • Short-acting tramadol: after failure of non- pharmacological treatment and when non-opioids (e.g., acetaminophen, non-steroidal anti-inflammatory drugs-NSAIDs and short-acting opioids such as codeine, tylenol 3®) have been trialed and are not effective, not tolerated or are contraindicated.
  • Long-acting tramadol: for treatment of chronic musculoskeletal pain when first- and second-line treatments (e.g., NSAIDs, injectable steroids) or neuropathic pain when first-line agents (e.g., tricyclic antidepressants, SNRI’s, gabapeninoids) have been trialed and are not effective, not tolerated or are contraindicated. Prescriber must also provide rationale for use of tramadol over other opioid analgesics.

The WSIB accepts the DAC recommendation for listing.

Recommendation highlights

  • Tramadol is a centrally-acting opioid analgesic which also inhibits reuptake of neurotransmitters norepinephrine and serotonin.
  • Tramadol provides analgesia effect similar to codeine.
  • The DAC considered external, independent reviews of single-blind or double-blind randomized-controlled trials of tramadol in 2008 and 2017. Internal claim review was completed in 2020. Tramadol with or without acetaminophen continues to be a reasonable therapeutic option for the treatment of chronic non-cancer pain; however, there is no advantage to using tramadol over other pain relievers, including narcotic analgesics, when efficacy in relieving pain, increase in functional ability or quality of life are considered. There is conflicting evidence for the past claim that tramadol is less abuse-prone than other opioids. Recent reports suggest that there may be more abuse potential than previously recorded due to past scheduling of tramadol as non-opioid and its wide availability.
  • There is no evidence that tramadol is superior to other opioids in opioid rotation to facilitate opioid dose reduction, or in managing opioid withdrawal. The use of tramadol to lower exposure to potent opioids warrants more investigation.
  • The side effect profile of tramadol is similar to other opioids; however, there are more drug interactions, contraindications, precautions and warnings to be considered when prescribing.
  • Recent Canadian and international opioid pain treatment guidelines consider tramadol together with other opioid pain relievers.
  • Provincial formularies in Canada do not include tramadol as a benefit due to availability of more cost-effective listed opioids.

Drug profile

Products available in Canada:

Short-acting

  • Tramadol 37.5mg/acetaminophen 325mg tablets (tramacet® and generics)
  • Tramadol 50mg tablets (ultram® and generics)

Long-acting

  • Tramadol 100mg, 200mg, 300mg ER tablets (ralivia®
  • Tramadol 100mg, 200mg, 300mg ER tablets (tridural® and generics)
  • Tramadol 75mg, 100mg, 150mg, 200mg, 300mg, 400mg XL tablets (zytram XL®)
  • Tramadol 100mg, 200mg, 300mg ER capsules (durela®)