Guidelines for Management of Patients with Chronic Pain with Controlled Medications
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
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: http://michigan.gov/documents/cis_fhs_bhser_mapsrules_54758_7.pdf
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: www.michigan.gov/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 or you may contact the Regulatory Division at (517) 373-1737. Data submission and error correction can be directed to . 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.