Two competing high-pressure systems have converged over medical care. A gale of headlines bewails the rampant diversion of prescription drugs onto America’s streets. Meanwhile, a tempest of advocates, reviewers, defenders and regulators bemoans the under-treatment of chronic pain conditions in our communities. From the eye of the storm, physicians may find it difficult to balance these boisterous fronts and accomplish our goal of maximizing patients’ social and physical functions via safe pain relief.

Confronted with the pain care needs of our patients and the attendant hazards of effective analgesic medications, our practice implemented a “medication use agreement” that charts a clear course of treatment and shelters our community from medication misuse.

Assessment and acknowledgement

Our medication use agreement (

) is designed to supplement and not replace appropriate clinical evaluations and accurate documentation. The first step in its application is to fully assess the patient and his or her illness and determine whether the use of long-term pain medications is appropriate.

Several techniques are available to specify a patient’s need for chronic pain medications. These include widely available pain questionnaires and pain scales as well as pain diaries. Additionally, patients may be referred for further psychological evaluation before initiating pharmacotherapy. Such consultation often generates adjunctive treatment options and reinforces the physician’s opinion regarding the patient’s readiness for pain medications. Along with complete, accurate and current progress notes, professional consultation letters help insure clinical care against undue regulatory scrutiny.

Upon completion of the assessment, the physician shares diagnostic information with the patient. Coupled to each assessment is the acknowledgement that the patient has a chronic pain condition that has been resistant to various treatment regimens and that any proposed treatment plan is unlikely to eliminate pain completely.

The physician and patient then jointly develop the treatment plan, setting realistic therapeutic goals in four main areas: physical abilities, social and vocational functioning, medication dosages and amounts, and duration of treatment. Of course, these patient-centered goals must be tempered with federal and state laws and regulations, and adherence must be documented in the chart.

Once the patient and physician have refined the treatment plan, the medication name(s), dosages and amounts and the frequency of reassessment visits are transferred to the written medication use agreement. To preserve as much patient confidentiality as possible, all other aspects of the patient’s history, physical and laboratory examination results, and treatment goals remain in the patient’s chart.

Clarity

The medication use agreement is designed to be clear to the patients and health professionals who share it. Patients are made aware that by entering into the agreement, some of their medication information will be provided to the pharmacy of their choice and potentially to regulatory reviewers. However, they should also understand that nothing in the agreement waives their confidentiality as it pertains to the details of the condition that requires pain medication – or any other conditions they may have.

The “rules” are fully listed within the agreement. The leading theme is exclusivity. The agreement is forged between one patient and one doctor; it applies only to a specific dosage of a specific medication; medications are solely for the use of the patient; a single pharmacy is selected for medication dispensing; and medication or dosage alterations are allowed only via personal appointments, which occur only during regular office hours.

Every member of the practice must be aware of the exclusive approach to this contract. A seemingly innocuous telephone refill invalidates the agreement, diminishes respect for the treatment plan and threatens the patient’s return to optimal functioning. Though the patient agrees not to request additional medications without appointment-based consultation, it behooves groups that employ medication use agreements to communicate clearly to office staff and covering physicians their policies regarding prescription medications.

Verification

“Trust but verify” is an international political cliché that applies to our local construction and enforcement of the medication use agreement. We demonstrate our trust by entering into the agreement and writing prescriptions for individual patients. Linked to individual trust is the need to assure ourselves that patients are using the medications responsibly.

Potential steps in our verification process include assessing compliance with appointments, conducting random drug testing, obtaining copies of police reports for “lost” or “stolen” medications, referring the patient to a pain clinic or to other specialist treatment, and enlisting the cooperation of a pharmacy chosen by the patient.

By agreement and design, the pharmacy the patient selects to dispense medications receives a copy of the medication use agreement with its exclusivity passages and specific medication names, dosages and amounts. By writing “Not valid without medication use agreement” or “Fill only at ____________ pharmacy” on prescriptions, we deter tampering and engage another health care professional in the patient’s treatment plan.

It is important to fit the terms of medication use agreements to the community being served and the available resources of each practice. For example, some groups verify responsible medication use with call-back systems, whereby patients are telephoned and requested to come to the clinic with all their medications. If pill numbers do not correlate with the number of days remaining until the next prescription, the medication use agreement may be discontinued.

We have found that proper patient selection is superior to post-hoc verification. Gathering informed consent for the medication use agreement enhances the patient selection process and, in effect, pre-verifies patients for treatment. Patients who balk at signing a written agreement, or reject reasonable attempts to monitor their medication use, forecast their unfitness for safe analgesic use. Identifying such patients before prescriptions are written averts excessive expectations and medication mal-use.

The medication use agreement’s purpose is protected when it is consistently implemented and reinforced. In the event that a patient breaches the agreement, it is important to follow through with the stated and written results of the breach – up to and including terminating prescriptions and reassigning the patient. Since patients receive a copy of the signed agreement, they are already aware that attempts to thwart the agreement sabotage the therapeutic relationship and erode their care. In these circumstances, rather than reassembling unraveled agreements, the patient may be better served by referral to another physician or specialized clinic.

Results

The consequences of medication use agreements in our practice have been predominantly positive. For patients, shared therapeutic goals are developed in a highly communicative manner and improved functioning and reduced pain are safely supported. Physicians receive the satisfaction of stabilizing patients’ pain, while building a rampart of monitored care that withstands the current regulatory climate. Last, the community benefits from the decreased threat of medication diversion and the increased participation of its members previously sidelined by chronic pain.