Pharmacovigilance

Pain has reached pandemic proportions in the United States and worldwide, with an estimated 100 million persons afflicted with chronic pain in the United States alone [IOM 2011]. Pharmacotherapy — particularly, but certainly not exclusively, involving opioid analgesics — remains a central component of many approaches to pain management. Yet, data from various sources have underscored increasing problems associated with the nonmedical use, abuse, and diversion of opioid analgesics by persons of all ages, including alarming rates of opioid addiction, as well as emergency department visits and deaths due, at least in part, to opioid overdose [FDA 2012; Schonwald 2012].


This morbidity and mortality associated with opioid analgesic misuse and abuse focuses negative attention on the dangers of these medications while overshadowing awareness of the very real and important role that they play in improving the quality of life for millions of patients genuinely suffering from chronic pain. As Cheatle and Savage [2012] recently noted:

“One of the barriers to effective pain management across the spectrum of pain conditions (acute, chronic noncancer, and cancer pain) is the clinician’s fear of prescribing opioids beyond that merited by the actual risks. This has led to the under treatment of pain, including cancer-related pain. Trepidation regarding the prescription of opioids has been reinforced recently by the rise in the nonmedical use of prescription opioids, resulting in increasing opioid-related harm and deaths, as well as an increased demand for treatment of prescription opioid addiction. It is important to appreciate the actual risks associated with opioids and accommodate these when prescribing, but it is not appropriate to abandon the use of opioids because of misperceptions, as many pain experts agree that opioids remain the most effective analgesics available.”

Simple solutions to the complex problems associated with opioid analgesics are quixotic, and numerous patient assessment and management approaches have been developed in an effort to mitigate risks and ensure that patients with pain have continued access to appropriate treatments, including opioids, to help alleviate suffering. One of the most important approaches incorporates principles of pharmacovigilance [Fishman 2012].

Pharmacovigilance is a clinical discipline in its own right, and it is of vital importance for helping to assure effective and safe pain care. Medication monitoring and drug detection via clinical drug testing is a key, although not sole, component of pharmacovigilance in pain management. Urine Drug Testing, or UDT for short, and sometimes called Urine Drug Monitoring, or UDM, which is the approach most commonly used in everyday clinical practices [Peppin et al. 2012].

To accurately interpret UDT results and understand the role of UDT in pharmacovigilance, clinicians must be familiar with the pharmacokinetics, pharmacodynamics, and pharmacogenetics of the many medications and other drugs that may be involved in pain management.


Furthermore, practitioners can and should use additional methods or approaches besides UDT as components of a comprehensive pharmacovigilance approach. These may include [Gourlay et al. 2010; SAMHSA 2012]:

  • Data from electronic prescription drug monitoring programs (PDMPs);
  • patient history and self-reports; > pill counts of prescribed medications;
  • clinical signs/symptoms of medication effects or substance abuse;
  • screening and behavioral assessment questionnaires;
  • collateral information from a patients’ family (obtained with patient permission);
  • the practitioner’s clinical judgment.

Most experts [eg, Peppin et al. 2012; SAMHSA 2012] agree that UDT is the most practical and objective clinical tool available to prescribers for medically assessing at a given point in time whether patients are:

a. taking prescribed medications,

b. taking unauthorized controlled medications,

c. using illicit substances, or

d. taking combinations of medications/substances that may induce adverse drug-drug interactions, either pharmacokinetically or pharmacodynamically.

Equipped with the objective documentation of UDT results, pain-care providers can more confidently prescribe pharmacotherapy, including opioids, for patients who may benefit.