# Presentation: 388997

## Opioid Therapy in Chronic Pain Management: Minimizing Risk and Improving Outcomes in Primary Care 

- Nancy Wiedemer, CRNP
- Philadelphia VA Medical Center

## Pain Assessment and Management in the last decade

- Emphasis is on evidence and cost- effectiveness
- Evidence is strong for cancer and acute pain management
- Standard of care for chronic noncancer pain management is evolving

## Prevalence of chronic non-cancer pain in Primary Care 

- 44% (VA); 25 %(university, PCC)
-              (Reid et al,2002 )
- 48%   VA Primary Care - Palo Alto VA
-               (Clark, JD, 2002)
- 71 % VA Primary Care – Western New York
-                    (Crosby et al 2006)

## Managing PAIN in Primary Care: 

***Brief Visits***
***Complicated***
***Patients***
***Clinical Reminders***
***Minimal Resources***

***JCAHO & VHA***
***Mandate to***
***Manage pain***
***Policies***
***Guidelines***
***Expectations***

- Managing **PAIN** in Primary Care:
- Issues and Challenges

## Goal of this presentation

- To present outcome data from the
*Opioid Renewal Clinic** *
- A primary care based program developed to support primary care providers in the management of chronic noncancer pain with opioids.

## Incorporating Consensus Guidelines into Primary Care Practice at PVAMC

- Chronic Narcotic Use Policy 1998
- Chronic Opioid Use Policy 2000
-                    _Major Principles _
-     Assessment  diagnosis
-     Use of Opioid Treatment Agreement
-     One Provider responsible for Rx
-     Urine Drug Testing
-     Documentation

## The Problem

- Guidelines and policies available but      “they take too much time “ !
- Reluctance of PCPs, who care for the majority, to prescribe opioids
- Concern about diversion, abuse, addiction and regulatory scrutiny, particularly in a high risk population
- Prescribing opioids  without assessment and without monitoring treatment outcomes

## The Problem

- The Oxycontin Media Blitz
- Visit from the Investigator General
- Pharmacy Budget “crisis”
-      $ 237,830 – 6 month (in 2001) cost of Oxycontin

## The Need

- Cost-effective strategies to support PCPs’ management of these patients.
- Action plan:
- Focus group meetings with PCPs
- Review of Literature for guidelines and evidence-based strategies

## Results of review of the literature formed the foundation of our program

## Definition of Terms

- Physical Dependence
- Tolerance
- Abuse
- Addiction

- Withdrawal syndrome in response to abrupt dose reduction
- Pharmacologic property, dose may need to be increased to maintain effect
- The intentional misuse of a medication for nonpresribed effects ( e.g. mood alteration)
- Chronic neurobiologic disorder characterized by loss of control,
-     craving, compulsive use despite
-     harm

- Consensus Document: The American Academy of Pain Medicine,
- The American Pain Society, The American Society of Addiction Medicine

## Pseudoaddiction

- Aberrant behavior that seems similar to addiction, but is due to unrelieved pain
- Behavior stops once the pain is relieved, often through an increase in the opioid dose.
- Misunderstanding of this phenomenon may lead the clinician to inappropriately label the patient an “addict”

- Weissmann & Haddox,1989

## Definition of Terms

*Spectrum of Drug Misuse*
- Self medication: mood, sleep, memories 
-                “chemical coppers”
- Sharing medications
- Recreation: euphoria, rush high
- Addictive use
- Diversion for profit
- Criminal business
- Support medication costs
-                                                       Savage , 2001

## Opioid Renewal Clinic Procedure

-  You need a proactive plan in place for nonadherence to the Opioid Treatment Agreement

- Portenoy, 2001

## The Opioid Renewal Clinic: A Primary Care, Managed Approach to Opioid Therapy for Chronic Pain

- A Nurse Practitioner and Clinical Pharmacist managed service at the Philadelphia VA Medical Center
*Start-up date: September 2001*

## Opioid Renewal Clinic:  Services

- Assist with management of ***challenging ***patients requiring structured prescribing and monitoring of long-term opioid therapy
- Patients with aberrant drug related behaviors
-    r/o substance misuse vs. pseudoaddiction  vs. addiction
- Patients with h/o addiction, recent addiction, active addiction

## Opioid Renewal Clinic:  Services

- Assist with opioid titration and rotation
- Assist with routine opioid renewals
- Patients who have stabilized
- Part-time providers

## Opioid Renewal Clinic Goals

-  Facilitate appropriate treatment for each patient
- 	    - opioid therapy if indicated and/or
-        - addiction treatment
-  Improve PCP confidence in prescribing opioids
-  Improve monitoring and documentation
- Provide cost-effective care by decreasing miss-utilization of resources

## Opioid Renewal Clinic Procedure

- Consult from PCP
- Eligibility
-        Workup and pain dx
- 		Opioid Treatment Agreement
- 		Baseline urine drug test
- THE PCP CONTINUES TO BE RESPONSIBLE TO PRESCRIBE OPIOIDS

## Opioid Renewal Clinic Procedure

-   Initial Appointment with clinical pharmacist
- Assessment and documentation
- Review current treatment plan including opioids
- Review/introduce Opioid Treatment Agreement
- Patient Education

## Opioid Renewal Clinic Strategies

- Examples of strategies
- Opioid Treatment Agreement
-             Second Chance Agreement
- Frequent visits
- Prescribing opioids on a short term basis (i.e. weekly or bi-weekly)
- Periodic urine drug testing
- Pill counts
- Co-management with addiction services

## Opioid Renewal Clinic Procedures

-           For “high risk patients”
- Opioid Treatment Agreement
- 	reviewed and individualized
- Frequent visits
- Prescribing opioids weekly or bi-weekly
- Frequent urine drug testing

## Opioid Renewal Clinic Procedure

- For routine monthly renewals
- Calls taken Monday and Tuesday
-             3 days ahead for pick-up
-           10 days ahead for mail
- Telephone assessment of 4 As
- PCP notified to forward Rx
- Clinical pharmacist monitors adherence including ordering urine drug testing

## Monitor and Document the 4 “As”

***A***nalgesia                    (pain relief )
***A***DL’s                         (functional ability)
***A***dverse Effects           (constipation, nausea...)
***A***berrant behavior       (drug seeking or seeking
-                                       pain relief)
- 					        (Passick & Weinreb, 2000)

## Documentation – Opioid Renewal Note

- Opioid Treatment Plan Provider/Team:
- Diagnosis:
- Level of Analgesia (Pain Scale –NRS)
-          Average:    Best:    Worse:    Goal:
- Functional Ability:
- Adverse Drug Effects/Side Effects:
- Current Medications:
- Aberrant Behavior:
- Recommendations/Comments:

## Monitoring Aberrant Drug-Related Behaviors:Urine Drug Testing

- Important tool for assessing aberrant behaviors and monitoring safety of treatment
- Consistent  Policy   
-          *Why* test             *Who* to test            *When* to test
-                 *What* will you do with abnormal results
- UNDERSTAND the TECHNOLOGY
-                      Methods used in your lab
-                      Drugs analyzed
-                      Detection cut-off
-                      Detection period for metabolites
-                      What test to order

## Differential Diagnosis of aberrant drug-related behavior

- Addiction
- Under-treated pain (Pseudoaddiction)
- Other psychiatric disorders( e.g.. Borderline personality disorder)
- Mild encephalopathy
- Family disturbances
- Criminal intent

- Portenoy,2003;Passik & Kirsh,2004

## Outcome Measures

**PCPs variables:**
- Increase in use of the Opioid Treatment Agreement
- Increase in Urine Drug Testing by PCPs
- Satisfaction with the program
**Patient variables:**
- Adherence to the Opioid Treatment Agreement
- Reduction of inappropriate clinical visits and contacts

## Outcome Measures

**Pharmacy budget goals:**** **
- Decrease Oxycontin use to 3 % of all opioids prescribed

## Results

**     ****Aberrant behavior **
**               ****366 (47%)**
**        **
- UDT **  + **for illegal drugs or
- unprescribed** **drugs,
- negative for prescribed drugs,
- overusing prescribed opioids

**    ****No  Aberrant Behavior  **
**              ****418 (53 %)**
**         **
-    Opioid rotation or titration
-                                                                             H/O of recent substance abuse**                     **
**          **                                                                        Conflicts with providers
-                                                                                    Part-time clinicians- referred for assistance with monthly monitoring

**784 referrals  1/2/02 – 12/6/06**

## Results  (n= 784)366 (47%)   Documented aberrant behavior

- Resolution of aberrant behavior
- Discharge from ORC
-             n=101 (28 %) self-discharged
-             n=  86 (23 %) ORC discharged
- Referred for addiction therapy
- Consistently negative UDT
-         weaned from opioids
- Undeclared – still monitoring

- 147 (40.2%)
- 187 (51 %)
- 24  (6.6 %)
- 7   (1.9 %)
- 1  ( 0.3%)

## Results  (n= 784)418 (53%) no documented aberrant behaviors 

- Adherence to Opioid Treatment Agreement – 100 %

## Increase in Urine Drug Testing

## Increase in use of Opioid Treatment Agreements

## Comments from PCP Satisfaction Survey

- “This program has made my life and my patients life easier. It gives me time to address all the other important health care issues during the visit.”
- “Before this service, patients seeking opioids would disrupt the delivery of care .”
- “It has helped me to improve my relationship with my chronic pain patients.”
- “...the single most important contribution to the quality pf primary care since the electronic medical record

## Who needs more structure ???? 
do we know up front ?

- do we know up front ?

## Lessons Learned

- Lack of tools with sufficient sensitivity and specificity to identify patients with chronic noncancer pain who will abuse medications or use illicit drugs  Arnold,et al 2006
- Studies have shown that neither clinical judgment nor patient report identifies patients who are non-adherent in the use of their medications
-     Katz et al 2002, 2003

## Lessons Learned 

- Structured approach to opioid prescribing:
- Facilitates treatment of high risk patients
- Structure can be tightened or loosened based on the patient’s behavior
- Eliminates prejudice
- Preserves the therapeutic relationship

## Conclusion

- Opioids should be considered for treatment of chronic noncancer pain within a comprehensive individualized treatment plan
- Appreciate the potential for side effects
-          including substance abuse & diversion
- Develop a practice policy that informs the patient regarding risks and expectations
-                                    AND
- is implemented with *consistency*, *empathy* and *respect*

## 
Thank You

Questions ???

- Thank You
- Questions ???