Monitoring and adjustments of therapy

Once the preliminary work is done, patients can be started (or continued) on opioid therapy. The starting dose and schedule is based on the drug’s pharmacology; the person’s previous opioid exposure and response; and the presence of such comorbid states as respiratory, renal, or hepatic disorders. Titration or tapering is generally done on a percentage basis and aligned with the patient’s response. As with other long-term medication regimens, half of patients prescribed opioids do not fully adhere to the prescribed regimen. Missed doses or underuse of medicine has been found to be twice as likely as overuse in some populations.21 It is suggested that HCPs provide structure and reinforcement of expectations to improve adherence with the regimen.22

Reassessment using the “4-A” model includes elements of analgesia, activity level, adverse effects, and aberrant behaviors.16 Aberrant behaviors need to be further investigated to distinguish if the underlying motivation is thrill-seeking, relief-seeking, greed, or an addiction disorder. In relief-seeking patients, problematic behaviors generally resolve and functioning improves as opioids are initiated and titrated effectively. Thrill-seeking patients and those driven by financial incentives may be difficult to identify. Those who are drug-seeking because of an addiction disorder will stand out, as increasing access to opioids generally results in poorer functioning.17


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An addiction disorder is a treatable brain illness that precludes the ability to exercise proper judgment or experience normal pleasures. Along with displacing such natural reinforcers as food, family, and friends, drugs of abuse also eventually lose their ability to gratify, and they place the addict on a compulsive quest for more drugs and for greater drug potency as the person’s reward circuitry becomes increasingly blunted and desensitized.13 The hallmarks of an addiction disorder are excessive craving, compulsive use, and continued use of a substance despite its known harmful effects.15 These signs are not to be confused with expected pharmacologic effects or pseudoaddiction.

The term pseudoaddiction describes the clinical observations that patients with severe unrelieved pain act in a way that mimics behaviors interpreted as drug-seeking or an addiction disorder. These patients, desperate for relief, are distraught while escalating their demand for analgesics. Mistrust develops between the patient and caregivers, which undermines the therapeutic process. Not knowing where else to turn, formal complaints may be filed while maladaptive behaviors escalate to the point of aggressive, illicit, or deceptive actions.

The emergence of withdrawal symptoms (dependence) or the tendency to need higher doses over time (tolerance) occur with many types of medicines, including opioids, and should not be considered evidence of addiction.  

Given the difficulty in establishing what motivates these complex and disturbing behavior patterns, HCPs are urged to expand the treatment team and use prescription drug monitoring programs (PDMPs) when available. To curb diversion of prescription drugs, many states have implemented PDMPs to track patterns of prescribers and recipients of controlled medications. Many states have a mechanism whereby HCPs can gain access to their patients’ prescribing information.

Access to a prescribing database allows HCPs to monitor for the development of aberrant drug-seeking behaviors in their patients. These behaviors may include early refills, using multiple simultaneous prescribers, using different pharmacies to obtain the same drug, and paying cash to obtain a larger supply of drugs. This information provides an opportunity for HCPs to identify problem-prone patterns. Unfortunately, PDMPs are not always easily accessible to the prescriber in real time and do not include prescriptions obtained from family members, friends, or rogue Internet pharmacies.  

HCPs can use the identification of problem behaviors as a teachable moment calling for honest dialogue. Treatment decisions must be made to protect patients and the public from potentially harmful drug abuse, misuse, and diversion. A respectful approach helps empower the patient to develop a long-term relationship with a prescriber based on mutual trust and understanding. This strengthened partnership can potentially change the maladaptive behavior.23

Although HCPs are not required by law in most states to report when a patient is suspected of diverting the medication to support criminal activity or misuse, it can be argued that this is the right thing to do ethically. It can also be argued that when a patient has chronic pain and a co-occurring addiction disorder, expanding the treatment team to take care of the problems rather than partially treating the patient or denying them care may be the appropriate course of action.

Documenting adherence to professional standards

All HCPs who have a role in prescribing, dispensing, or administering opioids also have a duty to maintain documentation that demonstrates adherence to related professional standards. Opioids are recognized as being medically necessary to alleviate pain while protecting patients and others from potential harm. The Federation of State Medical Boards has developed a sensible set of precautions that guide practice.15

An initial history and physical evaluation must be performed using diagnostic reasoning to establish a credible diagnosis for which opioids are indicated. This includes evaluating for the risk of mental illness or substance-abuse disorders. Prescriptions and refill records must be kept on file, as should the records for follow-up monitoring of aberrant behaviors that may signal problematic use of pain medication.

When these risks are identified, HCPs have a duty to modify the treatment plan to reduce the risks while maintaining appropriate access to treatment. This modification may include timely referral to pain and/or substance-abuse specialists for patients with worsening pain, disability, or aberrant behaviors despite treatment.24 Documentation in an official medical record needs to describe these steps in sufficient detail for the provider’s integrity to stand up against the scrutiny of regulators.

Conclusion

Balancing the concerns associated with providing opioids to suitable candidates with chronic pain while keeping these medications out of the hands of persons who would use them in unintended ways is a challenge. When used properly in selected patients, opioids can improve physical and mental health, functioning, and quality of life. For others, these same drugs can have the opposite effect. HCPs need updated knowledge and sharpened skills in assessing and treating chronic pain, substance-abuse disorders, and situations in which the two problems coexist. When opioids are indicated, clinical strategies that balance multiple simultaneous concerns are required. This is accomplished by using focused assessments, opioid-sparing multimodal therapies, and vigilant monitoring to guide initiation of treatment and refine therapy based on the individual’s response.

There are a few principles to remember when sifting through the concerns about pain and addiction. First, the majority of pain patients do not have an addiction disorder or intend to sell or abuse prescribed drugs. Second, drug abuse is prevalent, and prescription pain relievers are among the most commonly sought and abused substances.

Finally, HCPs have a duty to balance concerns related to meeting the health and comfort needs of individual patients while protecting them and society from unintended harms that can result from prescription opioids. Balancing these concerns requires a standardized approach as well as attention to individual differences. A detailed and comprehensive assessment is required for any patient considered for chronic opioid therapy. A plan is set in place based on this assessment and tested while balancing efficacy and safety concerns. Patients and significant others must be fully informed that opioids may or may not help and notified that vigilant monitoring is required to evaluate whether harm is occurring.

Given the uncertainty of the harm of high-dose long-term therapy, opioids should be used in the lowest effective dose for the shortest amount of time. This demands multimodal approaches, self-monitoring, vigilant professional monitoring, and a sustained relationship with a HCP built on a foundation of honesty and trust.

Dr. Arnstein is a family nurse practitioner, clinical nurse specialist for pain relief at Massachusetts General Hospital (MGH), Boston, and the Director of the MGH Cares About Pain Relief inititiave.

This educational piece is presented by the Nurse Practitioner Healthcare Foundation through a sponsorship from King Pharmaceuticals, Inc.

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All electronic documents accessed October 15, 2010.