Policy and Procedure - midwest-site



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Guidelines, Policy and Procedure

Subject: Guidelines for Management of Patients with Chronic Pain with Controlled Medications

August 30, 2006

Dear Providers,

Our goal for effectively managing chronic pain is to utilize a standardized approach to pain management throughout our entire practice. The following pages contain the guidelines for managing patients with chronic pain with controlled medications.

Marilyn Wissmiller

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Guidelines, Policy and Procedure

Subject: Guidelines for Management of Patients with Chronic Pain with Controlled Medications

Issued By: AHC Policy: Controlled Medication

Prepared By: Marshall, Wissmiller

Approved By: Effective Date:

Draft 2 Page _1__ of _8_

Guideline: Guidelines for Management of Patients with Chronic Pain with Controlled

Medications

Purpose: This guideline has been developed to provide a uniform approach to managing patients

who require chronic use of controlled medications.

PAIN

Persistent pain has been defined as pain that lasts more than 3 to 6 months. The management of persistent pain differs from pain that is self-limited and must take into consideration the complexity of psychosocial and functional factors related to the unremitting pain. If global disability occurs, a multidisciplinary approach may be recommended, which may include cognitive and behavioral therapy, physical rehabilitation and functional restoration, pharmacological therapy, and rarely, more invasive modalities such as surgical interventions.

Regardless of how persistent pain is defined, once pain becomes persistent, specific management strategies are needed. Thus, initiation of pain management interventions at the onset of pain is essential to lessen the establishment of persistent pain. Management goals include restoration and/or improvement of function, mood and sleep patterns, and a realistic reduction in pain severity.

ASSESSING PAIN

Persistent nonmalignant pain conditions comprise a broad clinical group, and the best indicator

of the patient’s pain experience is the patient’s self-report. Identification of pain and its cause—when possible—should be a routine part of any patient assessment and is essential in guiding management strategies.

Any persistent pain that has an impact on physical function, psychosocial function, or other aspects of quality-of-life should be recognized as a significant problem. Assessment should focus on recording the events that led to the present pain and establishing a diagnosis, a management plan, and likely prognosis.

A thorough pain history includes obtaining information about the onset, pattern, duration, location, intensity, and characteristics of the pain, any aggravating or palliating factors and the impact of the pain on the patient’s quality-of-life.

As part of the comprehensive evaluation, careful examination of the site of reported pain, including palpation for trigger and tender points, swelling and inflammation, and range of motion testing should be conducted. The neurological examination should include assessment for signs of sensory, motor and autonomic dysfunction that may suggest neuropathic pain. Medication dependence should be evaluated, as well as the meaning and context of the pain in the patient’s daily life. A functional assessment should include review of the patient’s ability to work, engage in personal relationships, recreation and other physical activities and sleep patterns.

PRESCRIBING CONTROLLED MEDICATIONS

DISPENSING AND ADMINISTERING PRESCRIPTIONS BY PHYSICIANS

R 338.3161 Prescriptions.

Rule 61.

(1) A prescription that is issued for a controlled substance shall be dated and signed when issued and shall contain all of the following information:

(a) The full name and address of the patient for whom the substance is being prescribed.

(b) The prescriber's drug enforcement administration (DEA) registration number, printed name,

address, and professional designation.

(c) The drug name, strength, and dosage form.

(d) The quantity prescribed. For a prescription received in writing, the prescription shall contain

the quantity in both written and numerical terms. A written prescription is in compliance if it

contains preprinted numbers representative of the quantity next to which is a box or line the

prescriber may check.

(e) The directions for use.

(f) If the prescription is for an animal, then the species of the animal and the full name and

address of the owner.

(2) A written prescription for a controlled substance in schedules 2 to 5 shall be written with ink or an indelible pencil, or prepared using a printer and shall be signed by the prescriber.

(3) An agent of the prescriber may prepare a prescription for the signature of the prescriber, but, pursuant to the act, the prescriber is liable if the prescription does not conform to these rules. A pharmacist who dispenses a controlled substance pursuant to a prescription not prepared in the form required by these rules is liable pursuant to the act.

(4) If the controlled substance prescription or order in a medical institution is issued pursuant to delegation under R 338.2304, R 338.2305, R 338.108a, or R 338.108b, then the printed name of the

delegatee, the licensure designation, the delegating prescriber, and the signature of the delegatee shall be on the written prescription. In medical facilities, orders shall contain the signatures of the delegatee and the printed name of the delegating prescriber.

(5) A prescription shall not be issued by a prescriber to obtain a stock of a controlled substance for the purpose of dispensing or administering the substance to patients.

R 338.3168 Refilling of prescriptions.

Rule 68. (1) A prescription for a controlled substance listed in schedule 2 shall not be refilled.

(2) A prescription for a controlled substance listed in schedules 3 and 4 shall not be refilled more than 6 months after the prescription’s date of issuance and shall not be refilled more than 5 times. Renewal of the prescription shall be affected and recorded in the same manner as an original prescription.

(3) A partial filling of a controlled substance prescription in schedules 3, 4, and 5 is permissible if all of the following provisions are met:

(a) Each partial filling is recorded in the same manner as a refilling.

(b) The total quantity dispensed in all partial fillings does not exceed the total quantity prescribed.

(c) No dispensing occurs after 6 months after the date on which the prescription was issued for

schedules 3 and 4.

(4) A prescription for a controlled substance listed in schedule 5 may be refilled only as expressly authorized by the prescriber on the prescription; if no authorization is indicated, then the prescription shall not be refilled.

Source:

R 338.108a Delegation of prescribing of controlled substances to physician's assistants; limitation.

Rule 8a. (1) A physician who supervises a physician's assistant under sections 17548 and 17549 of the code may delegate the prescription of controlled substances listed in schedules 3 to 5 to a physician's assistant if the delegating physician establishes a written authorization that contains all of the following information:

(a) The name, license number, and signature of the supervising physician.

(b) The name, license number, and signature of the physician's assistant.

(c) The limitations or exceptions to the delegation.

(d) The effective date of the delegation.

(2) A delegating physician shall review and update a written authorization on an annual basis from the original date or the date of amendment, if amended. A delegating physician shall note the review date on the written authorization.

(3) A delegating physician shall maintain a written authorization in each separate location of the physician's office where the delegation occurs.

(4) A delegating physician shall ensure that an amendment to the written authorization is in Compliance with subrule (1)(a) to (d) of this rule.

(5) A delegating physician may delegate the prescription of schedule 2 controlled substances only if all of the following conditions are met:

(a) The supervising physician and physician's assistant are practicing within a health facility as defined in section 20106(d), (g), or (i) of the code; specifically, freestanding surgical outpatient facilities, hospitals, and hospices.

(b) The patient is located within the facility described in subdivision (a) of this subrule.

(c) The delegation is in compliance with this rule.

(6) A delegating physician may not delegate the prescription of schedule 2 controlled substances issued for the discharge of a patient for a quantity for more than a 7-day period.

(7) A delegating physician shall not delegate the prescription of a drug or device individually, in combination, or in succession for a woman known to be pregnant with the intention of causing either a miscarriage or fetal death.

R 338.2305 Delegation of prescribing of controlled substances to nurse practitioners or nurse midwives; limitation.

Rule 5. (1) A physician may delegate the prescription of controlled substances listed in schedules 3 to 5 to a registered nurse who holds specialty certification under section 17210 of the code, with the exception of a nurse anesthetist, if the delegating physician establishes a written authorization that contains all of the following information:

(a) The name, license number, and signature of the delegating physician.

(b) The name, license number, and signature of the nurse practitioner or nurse midwife.

(c) The limitations or exceptions to the delegation.

(d) The effective date of the delegation.

(2) A delegating physician shall review and update a written authorization on an annual basis from the original date or the date of amendment, if amended. A delegating physician shall note the review date on the written authorization.

(3) A delegating physician shall maintain a written authorization in each separate location of the physician's office where the delegation occurs.

(4) A delegating physician shall ensure that an amendment to the written authorization is in compliance with subrule (1) (a) to (d) of this rule.

(5) A delegating physician may delegate the prescription of schedule 2 controlled substances only if all of the following conditions are met:

(a) The delegating physician and nurse practitioner or nurse midwife are practicing within a health

facility as defined in section 20106(d), (g), or (i) of the code; specifically, freestanding surgical

outpatient facilities, hospitals, and hospices.

(b) The patient is located within the facility described in subdivision (a) of this subrule.

(c) The delegation is in compliance with this rule.

(6) A delegating physician may not delegate the prescription of schedule 2 controlled substances issued for the discharge of a patient for a quantity for more than a 7-day period.

(7) A delegating physician shall not delegate the prescription of a drug or device individually, in combination, or in succession for a woman known to be pregnant with the intention of causing either a miscarriage or fetal death.

Michigan Automated Prescription System (MAPS) Reports

MAPS requires electronic reporting of all controlled substances in schedules 2 through 5 dispensed by pharmacies, physicians and veterinarians. Controlled substance samples and those administered directly to patients are exempt from reporting.  Also exempt are controlled substances dispensed by a physician in a health facility or agency licensed under article 17 for no more than a 48 hour supply. Reporting of controlled substances dispensed is required by the 15th of the month following the month the controlled substances are dispensed.

MAPS operational procedures can be viewed and downloaded from the Health Services Bureau website at: cis then click on the Family and Health Services button. Questions regarding the waiver process as well as general questions regarding the MAPS program can be sent to MAPSINFO@ or you may contact the Regulatory Division at (517) 373-1737. Data submission and error correction can be directed to MAPSDATA@. The Department of Consumer & Industry Services is in the process of completing the promulgation of new rules clarifying the reporting requirements and processes. The rules can be viewed at the same website by going to the BHSER administrative rules for the Board of Pharmacy.

Guidelines for Implementation of the Controlled Substances Management Agreement

A copy of the Controlled Substances Management Agreement can be found in the Appendix.

The ‘contract’ should be instituted when it is apparent that a controlled medication is going to be used chronically. If one is going to prescribe for an acute injury and only 1-2 courses of the medication will be required, it generally is not necessary to ask the patient to sign a contract. It is also wise to get a contract on the first fill if you are establishing a patient who has been using the controlled medication chronically.

The Agreement is not just for ‘abusers’. The Agreement provides our patients with our expectations of them as users of controlled medications, as well as informs them what they can expect of us. It helps prevent misunderstandings between provider and patient regarding chronic controlled medication use.

A copy of the signed contract should be given to the patient and the original signed document placed in the patient’s chart on the left-hand side of the chart below the blue med refill worksheet. Controlled medication refills can be denied if the patient refuses to sign it.

Urine Drug Testing

The patient consents to urine drug testing when they sign our Controlled Substances Management Agreement. Providers can request the patient submit a urine drug screen anytime they feel it is indicated. If a patient refuses the urine drug screen, the provider may refuse to prescribe the controlled medication for the patient and the refusal may also be grounds for dismissal from the practice.

The patient is responsible for the fees associated with the urine drug screen. Many insurance plans cover this test. If the patient has Sliding Fee, this test can be as low as $7. Alpena Regional Medical Center processes our urine drug screens and will forward the urine specimens to Sparrow Regional Laboratories or to Mayo Clinic Laboratory. This also allows us to give the patient Sliding Fee on the GC/MS analysis performed by Sparrow and Mayo. Medicaid will also pay for urine drug testing.

The urine drug screen should always be sent with the request for GC/MS analysis. This provides results that are of forensic quality and that are virtually irrefutable in their accuracy. The local hospitals in Alpena and Tawas do not have GC/MS and only have the capacity to perform ‘dip tests’ which do not have the same rate of accuracy.

Each site has Sparrow urine drug screen kits available for drug screens. If the patient is not well known to the staff, they are asked to provide a picture ID. The patient is directed to empty their pockets, leave coats and/or purses and bags in the exam room. Children may not accompany them in the bathroom. A dry blue paper towel is placed in the sink and the patient is instructed to not turn on the water until after the urine specimen has been placed in the cupboard or is out of the room. They are given the urine specimen cup. Within 4 minutes of receiving the specimen, the MSS assess and record the temperature of the urine specimen.

The patient leaves the bathroom and is brought to the outside of the lab area. In view of the patient, the support staff person applies a label over the top of the specimen cup. The patient initials the label and the MSS supplies the remainder of the requested information such as date, time, etc. This is proper procedure for chain-of-custody. The specimen is placed in the bag provided within the box and another label applied. This label has the MR number on it. The bag is placed inside the box with the lab requisition forms (1 for ARMC’s lab and 1 for Sparrow/ Mayo) and placed in the refrigerator until it is ready to be sent off to lab for processing. If you are looking for the presence of a particular drug, it is recommended that you enter the name of the expected scheduled drug, as well as the dosing and approximate last time it was taken.

Both Mayo and Sparrow’s toxicologists have been very cooperative about providing assistance in interpreting the test results. There are times that metabolites of a drug will show on the urine drug screen and this can be confusing when trying to determine what medications the patient may be using. Sparrow Toxicologist: 517-364-7800 Mayo Medical Lab (ask for Toxicologist) 800-533-1710.

Face-to-face visits for refills

Patients who chronically receive controlled medications for their pain may be required to be seen face-to-face for evaluation of the condition before authorizing a refill. Determining the frequency of the visits is left to the provider’s discretion. Preferably the patient shall be scheduled with his or her own provider and at their usual clinic. If the patient fails to keep the appointment, the refill may not be authorized.

Refilling of Controlled Medications when the usual Provider is out of the Office

Each site may choose to designate one particular provider to authorize medication refills for their patients when the usual provider is out of the office. In the event a site has opted not to designate one provider for this purpose and when anticipating time out of the office, each provider should clearly note what medication, dosage, and timing the patient should be using to facilitate refills by the partner(s).

With the exception of the usual provider being out of the office, patients shall not seek out other providers for controlled medication refills.

Behavioral Health Referrals as an adjunct to treating chronic pain patients

A psychological assessment is also an important component of the comprehensive evaluation. Because the incidence of depression in patients with persistent pain may exceed 80%, the initial evaluation should include assessment for depression or other psychological co-morbidities.

Common components of behavioral and cognitive-behavioral treatment of persistent pain:

• Promotion of a self-management perspective

• Relaxation skills training

• Cognitive therapy; also known as cognitive restructuring or self-statement analysis

• Behavioral activation and management, including goal-setting and pacing strategies

• Problem-solving skills training

• Other interventions to change perception or emotional response to pain, such as guided

imagery, desensitization, hypnosis, or attention control exercises

• Communication skills training or family interventions

• Habit reversal

• Maintenance and relapse

Our behavioral health team has experience with helping patients with chronic pain. Providers can request a curbside visit and/or refer the patient for more intensive counseling.

Non-compliance Options:

1) Keep the patient but not prescribe controlled drugs

Providers may prefer this option rather than dismiss a patient. When a patient violates their narcotics agreement, providers are within their rights to no longer prescribe controlled medications to the patient. We can continue to monitor them through MAPS reports to be assured they are not obtaining controlled medications. Often, we ask them to sign a patient care agreement that can be drawn up specifically to address the issues at hand. Contact the PI Coordinator for assistance with this option.

This option may be used when a patient is non-compliant with a pain management specialist to whom you have referred the patient for treatment.

2) Dismissal

Dismissals are only performed at the request of the patient’s healthcare provider. Dismissals shall be categorized in three groups; Administrative, Fraud/Misrepresentation, or Urgent/Life Threatening.

Descriptions of each category are detailed below. Documentation is required by Alcona Health Centers and by the Medicaid HMO’s when dealing with such issues:

a. Administrative:

Possible causes for dismissal as it relates to pain management, may include non-compliance with the Controlled Medication Management Agreement. If threatening behavior accompanies the controlled medication abuse issue, the patient is not given 30 days of emergency care; the dismissal would be immediate.

b. Fraud/Misrepresentation

The following examples are considered fraud/misrepresentation and are reasons for dismissal:

1. If the patient is allowing others to use their insurance card to obtain services/ pain medications.

2. Patient alleged to have altered prescription

3. Patient has someone else obtain labs (blood, urine, or other biological substance given by someone other than member) on behalf of the member or tampers with urine drug screen specimen.

When these circumstances occur, submit the following documentation along with the letter of dismissal to the HMO and send a copy of the dismissal letter to the patient. Send a copy of the original prescription written and a copy of the altered prescription, a copy of the forged prescription script pad, documentation of the patient impersonating a provider or pharmacist to obtain a prescription, police report (or policeman’s name and incident report number), office documentation of the counseling that has been done prior to the event or copies of the narcotics contract and patient compliance contract.

When events mentioned above occur, Providers and/or staff are to notify the Performance Improvement Coordinator for case management. The provider should indicate the action they wish to pursue. The P.I. Coordinator will review the case and take appropriate action. If immediate dismissal from the practice is warranted, the P.I. Coordinator, upon request of the provider, will notify the patient either in writing or personally and make a notation in HealthPro to alert staff of the dismissal. Whenever possible, the PI Coordinator will attempt to utilize the services of the Medicaid HMO’s Case Management to educate and resolve the issue with the patient without dismissal. If attempts to do so are unsuccessful or Case Management is not an option, then we will continue with the process of dismissing the patient from the practice.

Dismissal Process

The dismissal process is as follows:

a. The patient is provided with a written letter, usually sent by certified mail, informing them of the reason they are being dismissed from the practice. This letter includes information about how the patient may obtain their medical records and the provision for 30 days of (emergency) care. We waive the offer of 30-days of emergency care if the patient has displayed threatening behavior towards staff.

b. We usually provide the patient with a script for at least 30-days of their chronic medications, but usually NOT narcotics or controlled medications.

c. The patient’s insurance company may be notified, when applicable. We provide notification of dismissal if Community Choice of Michigan, Northern Health Plan, Northeast Health Plan, or Molina insures the patient.

d. Copies of dismissal letters are not kept in the patient’s medical record, but rather are

kept in the locked files of the Performance Improvement Coordinator.

e. Staff is kept aware of the patients who have been dismissed from the practice by a note

placed in our patient database. The note section of this database may also contain information as to the date and terms of dismissal. A flag shall also be placed on the account that says “discharged from practice’.

f. The discharged patient’s name shall be placed on the Discharged Patient List that is maintained on our clinic’s G-Drive. This list is read-only for only designated staff persons. The only people who have administrative rights to this document are Marilyn Wissmiller and Janice Arnold.

RESOURCES:





Substance Abuse and Mental Health Services Administration



Appendix 1

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Controlled Substances Management Agreement

The purpose of this Agreement is to prevent misunderstandings about certain medicines you will be taking. This is to help both you and your doctor to comply with the law regarding controlled pharmaceuticals. I understand that this Agreement is essential to the trust and confidence necessary in a doctor/patient relationship and that my doctor undertakes to treat me based on this Agreement.

I understand that if I break this Agreement, my doctor may stop prescribing these controlled medicines. In this case, my doctor may taper off the medicine over a period of several days, as necessary, to avoid withdrawal symptoms. Also, a drug-dependence treatment program may be recommended.

I will communicate fully with my doctor about the character and intensity of my symptoms, the effect of the pain on my daily life, and how well the medicine is helping to relieve those symptoms.

I will not use any illegal controlled substances, including marijuana, cocaine, etc.

I will not share, sell or trade my medication with anyone.

I will not attempt to obtain any controlled medicines, including opioid pain medicines, controlled stimulants, or anti-anxiety medicines from any other doctor, unless I have been authorized to do so by an Alcona Health Centers provider.

I will safeguard my pain medicine from loss or theft. Lost or stolen medicines will not be replaced.

I agree that refills of my prescriptions for my medications will be made only at the time of an office visit or during regular office hours. No refills will be available during evenings or on weekends.

I authorize the doctor and pharmacy to cooperate fully with any city, state or federal law enforcement agency, including this state’s Board of Pharmacy, in the investigation of any possible misuse, sale, or other diversion of my medicine. I understand that my doctor may provide a copy of this Agreement to the pharmacy. I agree to waive any applicable privilege or right of privacy or confidentiality with respect to these authorizations.

I agree that I will submit to a blood or urine test if requested by my doctor to determine my compliance with my program of controlled medications.

I agree that I will use my medicine at a rate no greater than the prescribed rate, and that use of my medicine at a greater rate will result in my being without medication for a period of time.

I agree to follow these guidelines that have been fully explained to me. All of my questions and concerns regarding treatment have been adequately answered. A copy of this document has been given to me.

I am aware that Alcona Health Centers’ health care providers will follow these guidelines in managing my controlled medications regardless of whether I sign the contract or not. If I disregard the stipulations of this agreement, I know I may be discharged from the practice.

_______________________________ ___________________________________

Patient Signature & Date Witness Signature & Date

Appendix 2

Drugs and the typical length of time they stay in the urine:

Amphetamines: 2-4 days

Anabolic steroids: oral: up to 3 weeks; injected- up to 3-6 months and more

Barbiturates: 1-3 days

Benzodiazepines: 2-4 days

Cocaine: 1-4 days

Codeine: 1-2 days

Ethanol (Alcohol): ½ - 1 day

Fentanyl: 2-4 days

GHB: 1-2 days

Heroin: 1-2 days

Inhalants: just a few hours

Ketamine: 2-4 days

LSD: a few hours or up to 5 days

Marijuana: 2-5 days (the daily, heavy user can sometimes be detected up to 30+ days)

MDMA (Ecstasy): 1-5 days

Methadone: 1-7 days

Methamphetamines: 2-4 days

Methaqualone: 10-15 days

Nicotine (Cigarettes, Cigars, Habitrol patch, Nicorette gum, Nicotrol spray, Prostep patch; Smokeless tobacco, Spit tobacco), 1-2 days

Opiates: 1-4 days

Oxycodone (OxyContin): 1-2 days

PCP: 1-14 days

Propoxyphene: 1-4 days

Appendix 3

Local Drug Treatment Centers:

Sunrise Centre

630 Walnut Street, Alpena, MI 49707 (989) 356-6649 Intake number: 1-(877) 205-5217

Catholic Human Services

154 S. Ripley Blvd., Alpena, MI 49707 (989) 356-6385 Hotline # (800) 420-7506

Au Sable Valley Community Mental Health Services: Substance Abuse Services

(989) 345-5571 West Branch, MI

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