Many clinicians cringe at the thought of
prescribing or dispensing opioids, especially in high doses. The
reasons for such trepidation are real, with rampant abuse and even
fraudulent prescriptions, but the prevalence of misuse makes it more
difficult for the legitimate pain patient to obtain appropriate and
necessary therapy. The clinician must educate himself to recognize
legitimate applications of even very high doses of opioids, not only
for terminal illness, but for the patient with severe and unremitting
pain who is expected to live for many years with the disability of
chronic pain. He must also obviously be able to defend his
prescribing or dispensing activities to regulatory agencies by
appropriate documentation. A working knowledge of the rational
clinical guidelines governing basal and breakthrough analgesia are
essential for any clinician involved in such regimens.
While C-II agents are significantly more
problematic when it comes to record-keeping and documentation, it
must be recognized that they are also often substantially safer in
long-term therapy than combination products incorporating
acetaminophen, aspirin, or ibuprofen with an opioid. Physiological
dependence is certainly a valid concern with pure opioids, especially
in high doses and long-term therapy; but the end-organ liabilities
and drug interactions of the additive agents (acetaminophen, aspirin,
and ibuprofen) in high doses generally obviate the concern over
dependence for the patient enduring appropriate long-term opioid
therapy. Physiological dependence becomes a minor concern when
suicide pursuant to an inability to live and function with severe and
unrelenting pain becomes a patient’s only viable alternative. That
may sound dramatic, but suicide is almost a ubiquitous ideation among
patients enduring severe unrelenting pain, especially those for whom
there may be no hope of improvement with modalities other than pain
management.
Table 1: Combination analgesics can often produce more harm
than benefit.
Aspirin and NSAIDs (even the COX-II inhibitors to some extent
in high doses and prolonged therapy) can cause GI bleeding
gastropathy, and ulceration;
NSAIDs can affect renal function, especially in the elderly;
and their cardiovascular effects must also be considered; and
Acetaminophen in high doses and prolonged therapy should
prompt evaluation of hepatic function, especially when given with
other medications that might affect hepatic function and regular
alcohol intake.
While it is legally no less essential to
document the clinical necessity for combination opioid products, the
clinician must assiduously document the clinical necessity for high
doses of pure opioid products, as well as develop a professional
relationship with prescribers of such regimens, in order to justify
frequent or continued dispensing of such agents. Recording diagnoses
and documenting reasons for dosage adjustments can go a long way
toward such justification when under scrutiny.
Similarly, the patient on high-dose opioids
must get extra attention to be properly counseled on the potential
consequences of long-term opioid therapy, including not only the
bugaboo of physiological dependence; but the concepts of opioid
tolerance, hormonal effects (effects on sex hormones and need for
optimum thyroid function), and increased susceptibility to dental
caries must also be brought to the patient’s attention. Most
available patient information monographs fall woefully short in
counseling the patient with chronic pain, a fact particularly true
with adjuvant agents like anti-seizure or anti-epileptic drugs
(AEDs), a plethora of anti-depressant agents routinely used in the
control of chronic neurogenic pain syndromes, and seemingly unrelated
agents like dextromethorphan/guaifenesin employed increasingly in
treatment of various types of neuropathic pain.