Department of Veterans Affairs Memorandum 626-08-119-04

Department of Veterans Affairs Memorandum 626-08-119-04

Department of Veterans Affairs Memorandum 626-08-119-04

VA TennesseeValley Healthcare System July 31, 2008

1. PURPOSE: To establish a consistent, effective, and safe mechanism for prescribing opioids in the long-term management of patients with chronic pain. To establish and validate compliance with the opioid agreement. To establish policy, procedures, and responsibility of caregivers and patients in the management of chronic pain.

2. POLICY: The Department of Veterans Affairs Tennessee Valley Healthcare System (VA TVHS) is committed to providing timely, appropriate, safe and effective pain management for veterans with chronic pain, defined as patients requiring daily opioid management past 90 days. It is a routine part of the primary care of a patient to control pain. This includes prescribing and administering potentially addicting opioid medications to manage chronic pain over a long period of time under appropriate circumstances.

3. RESPONSIBILITIES:

a. Physicians: All Department of Veterans Affairs (VA) physicians and dentists individually licensed by the Drug Enforcement Agency and/or are assigned a VA Internal Controlled Substance Number to prescribe and administer opioids, are responsible for utilizing opioids to relieve pain according to federal and state guidelines. Maintenance opioid analgesia should be considered for patients with chronic pain who meet the following criteria:

(1) The patient with a significant pain, defined as a score of 4 on the Numerical Rating Scale or greater than that tolerable to the patientand there are no other appropriate treatment alternatives immediately available;

(2) And/or the patient’s medical record clearly documents opioid analgesia as the most clinically appropriate long-term treatment option for the patient’s medical condition. This documentation includes supporting diagnostic examinations and tests, expert medical opinions as well as repeated failure to respond to alternative treatments.

(3) The medical record clearly documents that the patient agrees to include opioid analgesia in the treatment plan, fully understands the risks and benefits, and is informed of the process for dispensing opioids.

(4) A baseline pain clinic drug screen is obtained.

b. Physician Extenders:

(1) Assess and document the appropriateness of their primary patients as candidates for long-term use of opioids for relief of chronic pain according to the above guidelines.

(2) Consult with appropriate physicians and facilitate the prescription process collaboratively with the pharmacy as appropriate to the individual's Scope of Practice.

(3) Monitor the use of opioid prescriptions in collaboration with the primary provider.

c. Pharmacist:

(1) Notify the provider if more than one provider/team is prescribing opioids for the same patient.

(2) Reinforce “Opioid Analgesic Agreement” as appropriate. (See paragraph 4.b.)

(3) Educate the patient about the prescribed medication.

(4) Notify the provider if the patient request refills prior to the allowed time.

(5) Notify the responsible provider if the patient is abusing, deviating from, or having problems adhering to the Opioid Agreement.

d. The Chief of Staff is responsible for overall coordination of opioid medications.

4. PROCEDURES:

a. One provider/team provides opioids for patients with cancer or acute pain. Opioid treatment for acute pain is discontinued within one month, unless there is objective evidence of an ongoing disease process. When opioid analgesics are required on a regular basis (i.e., greater than 240 doses of a short-acting opioid per month), agents with a long duration of action (e.g., morphine sustained-release) should be preferred over short-acting agents (e.g., oxycodone with acetaminophen).

b. The Opioid Analgesic Agreement (Attachment) is triggered for patients receiving opioid medication beyond 90 days. The agreement is executed annually, is reviewed with the patient by the provider and signed by both the provider and the patient. A copy of the agreement isgiven to the patient, retained in the patient record and documented in the CWAD Patient Postings (Crisis Note, Warnings, Allergies, Adverse Reactions, and Advance Directives). The documentation in the CWAD occurs either by the physician or delegated to the nurse practitioner, physician extender, or nurse.

c. A baseline pain clinic drug screen is obtained. Confirmation of a positive pain panel screen will result in discussion of the results by the provider with the patient. All testing results are documented in the patient’s medical record. Patients refusing pain panel screens are not candidates for a controlled substance therapy.

d. After drug selection, doses are administered on a scheduled basis. Several weeks are agreed upon as a period of initial dose titration between the provider and patient. Improvement in function is stressed and the patient and provider agree to at least partial analgesia without escalating doses as the appropriate goal of therapy.

(1) Failure to achieve at least partial analgesia at relatively low initial doses in the non-tolerant patient raises questions about the potential treatability of the pain syndrome with opioids.

(2) Emphasis is given to improved physical and social function as measurements of improved analgesia.

e. Patients are seen by the provider at regularly scheduled appointments, at minimum every six months. Patients are assessed for the efficacy of treatment, adverse drug effects, bowel regimen and the appearance of either misuse or abuse of the drugs at regular scheduled appointments. The results of the assessment are clearly documented in the medical record.

f. Transferring the responsibility of opioid prescription from one provider to another is well documented in the medical record.

g. The primary care team establishes a baseline for implementing pharmacological interventions with an initial pain panel screen using the procedure for specimen collection.

h. Patients with a positive initial urine drug screen receive further education of the risks and benefits and the process for dispensing opioids, with appropriate documentation.

i. Pain medication continues for a period not exceeding one month, allowing patient to cease inappropriate drug use. Reevaluation, by a random urine drug screen is completed. Appropriate pharmacological interventions are then evaluated by the primary care physician.

j. Established patients receiving opioids with an unexpected positive result on the urine drug screen are referred to a drug treatment program.

k. The primary care provider evaluates appropriate pharmacological interventions and alternative treatments. The patient is offered detoxification, consults to Substance Abuse Treatment Program, Mental Health Clinic, other specialties, and other alternatives of treatment, such as: aqua therapy, biofeedback, physical therapy evaluation, among others and if deemed necessary, a consult to the Pain Resource Nurse and a Pain Clinic.

l. Periodic random pain panel screening occurs to assure appropriate medication usage.

m. Substance abuse treatment and /or mental health consultation is requested by the primary care provider in cases of suspected substance misuse or potential addiction.

n. Tapering and discontinuation of opioid therapy is recommended for evidence of drug hoarding, acquisition of drugs from other physicians, uncontrolled dose escalation, drug abuse or other aberrant behaviors. A recent conviction of drug abuse or trafficking shall result in an automatic termination of controlled substances. Alternative pain management strategies are offered.

5. REFERENCES:

a. Addiction: PartI. “Benzodiazepines – Side Effects, Abuse Risk, and Alternative.” The American Family of Physicians. April 2000.

b. Addiction: Part II. “Identification and Management of the Drug-Seeking Patient”, The AmericanFamily of Physicians. April 2000.

c. “Urine Drug Testing in Primary Care, Dispelling the Myths and Designing Strategies”, CaliforniaAcademy of Family Physicians. August 31 2002. Principles of Addiction Medicine. 3rd Edition. American Society of Addiction Medicine. 2003.

6. RESCISSION: Memorandum 626-05-119-04 dated December 27, 2005.

7. RESPONSIBILITY AND REVIEW DATE: The Chief, Pharmacy Service will review annually and reissue no later than by August 31, 2011.

/s/ Juan A. Morales, RN, MSN 7/28/2008

Juan A. Morales, RN, MSN

Health System Director

Attachment: A

ATTACHMENT A

OPIOID ANALGESIC AGREEMENT

This document is the agreement required by VA TVHS for all patients taking opioid pain medication on a regular basis, i.e., daily for more than 90 days. This agreement is between ______(patient) and ______(provider). The purpose of this agreement is to list the details and expectations of the opioid therapy in order to have the best possible pain relief and the least side effects. Failure to abide by this agreement will be the cause for your provider to immediately stop prescribing narcotic pain medications, recommend treatment in a psychiatric, substance abuse, or detoxification program, and/or discharge you from all outpatient clinics at TVHS.

Opioid pain medications include, but are not limited to: Percocet, oxycodone, Oxycontin, morphine, MS Contin, Dilaudid, hydrocodone, hydromorphone, Vicodin, codeine, Stadol, fentanyl, Darvocet, methadone.

1)I agree to take this medication only as prescribed. This means I will take the directed amount prescribed at the directed time as told to me by the provider. I agree not to take more medication than directed without contacting my provider. If I use the medication up sooner than prescribed, I understand it will not be replaced. I understand that the pharmacy will strictly monitor the use of my medications.

2)I agree to obtain this medication only from the provider/team listed in this agreement, or another VA provider covering for my provider. I will not request or accept controlled substance medications from any other VA or non-VA health-care provider or from any individual while I am receiving such medications from this clinic. I understand that narcotic pain medications will not be refilled through the Emergency Room or unscheduled clinics.

3)I agree not to sell or give my medication to another person.

4)I agree to keep the medication in a safe place so that it will not be damaged, lost or stolen. If the prescription is lost, misplaced, or stolen, I understand it will not be replaced. It is my responsibility to protect my medications.

5)I agree not to mix my medication with alcohol or other depressants such as sleep aids or tranquilizers because of increased side effects.

6)I agree not to use any illegal drugs (such as marijuana, cocaine, speed, heroin, etc.) while taking this medication.

7)I agree to provide urine samples at any time I am asked to confirm I am taking my medication and not using illegal drugs. I understand that unexpected results or uncooperative behavior may cause my provider NOT to order my pain medication.

ATTACHMENT A, continued:

8)I agree to bring my medication in whenever asked by my provider.

9)I agree not to drive or operate machinery if I feel drowsy or confused from this medicine.

10)I agree not to stop this medication without contacting my provider.

11)I agree to seek treatment immediately if a problem with addiction is found.

12)I agree to keep my scheduled primary care and specialty clinic appointments. If I miss my clinic appointment, I understand that my provider may require an immediate appointment before rewriting another prescription.

13)I understand that altering or forging a prescription is a felony that will be immediately reported to the authorities, and may result in criminal prosecution.

14)I agree that I cannot request transfer to another provider because of this agreement.

Treatment goals: The goal of treatment with this medicine is not to completely stop your pain as that is impossible. The goal of this medicine is to make pain bearable and to improve your quality of life. The amount of time you will be on the medicine depends on the type of pain and whether you follow the agreement. The dose may need to be adjusted over time in order to improve pain relief. It may take days or weeks to find the right amount of medication. More or less medication may be needed over time. You and your provider agree to work together to find the right amount of medicine.

Side Effects: Opioid medications may cause side effects. Common side effects include constipation, nausea, drowsiness and itchiness. These side effects usually decrease with time or are easily treated. Less common side effects include sedation, confusion, or problems with breathing. These side effects are made worse by mixing the medication with alcohol or illegal drugs or taking the medication in a way other than prescribed. You agree to tell your provider of these side effects. This will allow treatment of the side effects and may require adjustment of the dose. Giving your medication to another person could lead to severe medical problems for that person.

Withdrawal: The body will become used to this medication with time. Because of this withdrawal can occur if the medication is stopped suddenly. Withdrawal symptoms include runny nose, diarrhea, shakes, chills and a general bad feeling. Because of this you and your provider agree not to stop the medication suddenly. If the medication needs to be stopped, the dose will be lowered slowly so that there will be no withdrawal.

Refills: Most opioid medications do NOT have refills. You will need to call your provider for your medicine on a monthly basis. Medications will be mailed and usually cannot be picked up at the pharmacy window. You should call for more medication on a weekday between 8am and 3pm, 7-10 days before the medication runs out. After receiving your call, the provider will make

ATTACHMENT A, continued:

sure the prescription is filled. If your provider will be away he or she will make arrangements for the prescription to be filled by another provider.

Addiction/Abuse: Addiction to this medication is very unlikely to occur if it is used as directed. Addiction means that the patient is abusing the medicine, using too much of it, or is using it to get “high.” Warning signs of addiction are:

1)Buying medicines on the street.

2)Forging prescriptions or stealing medications.

3)Excessive alcohol or illegal drug use.

4)Taking more medicine than prescribed even after warnings.

5)Repeatedly losing medications.

6)Getting medications from other providers even after warnings.

7)Asking for medication early even after warnings.

8)Injecting medications.

9)Not wanting to adjust the medication even if it is causing problems.

10) Appearing drunk or high during office visits.

If addiction, abuse or the described inappropriate use of the medication occurs, the medication will be stopped. You will be offered drug rehab or other treatment. Other forms of pain treatment will be given, but the opioid medication will not be continued.

Selling or giving the medication to another person is illegal and dangerous. If this happens the medication will be stopped and the authorities may be told.

Other Pain Relief Measures: Opioid medication by itself may not be enough to provide pain relief. You must agree to participate in all other forms of treatment recommended by the provider. These may include physical therapy, occupational therapy, relaxation training, psychological therapy, neurosurgical evaluation, referral to the pain clinic, other medications, injections and weight loss. The risks and benefits of these treatments will be talked about with you. No procedures will be done without your consent.

Changes in Opioid Medication: Pain does not always improve with opioid medication. If the first medication does not work other opioid medications may be tried. If none of them work then opioid medicines will be stopped and other therapies will be tried. Medications may work less if you take them a long time. If this happens the dose may be changed, another medicine may be prescribed, or other therapy may be tried.

Changes in Provider: As long as all the requirements are met your provider will continue the medication as long as it works. If your provider leaves VATVHS, he or she will arrange for your new provider to continue the medication.

I understand that if any of the conditions described above are violated the medication may be stopped.

ATTACHMENT A,continued:

I have read this entire agreement and understand it. My provider explained any parts that I didn’t understand. I have received a copy of this agreement, and the original will be maintained in the VA Medical Record.

I understand that this contract must be renewed and signed annually. The terms of this agreement apply to all narcotic pain medications prescribed at the time of signing and to any/all subsequent narcotic pain medications prescribed by your provider prior to the next annual review.

______

Patient’s SignatureDate

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