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«Michigan Board of Dentistry Guidelines for the Use of Controlled Substances for the Treatment of Pain Section I: Preamble The Michigan Board of ...»

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STATE OF MICHIGAN

JENNIFER M. GRANHOLM JANET OLSZEWSKI

DEPARTMENT OF COMMUNITY HEALTH

GOVERNOR DIRECTOR

LANSING

Michigan Board of Dentistry Guidelines for the Use of Controlled Substances for the Treatment of Pain Section I: Preamble The Michigan Board of Dentistry recognizes that principles of quality dental practice dictate that the people of the State of Michigan have access to appropriate and effective pain relief. The appropriate application of up-to-date knowledge and treatment modalities can serve to improve the quality of life for those patients who suffer from pain as well as reduce the morbidity and costs associated with untreated or inappropriately treated pain. The Board encourages dental care practitioners to view effective pain management as a part of quality dental practice for all patients with pain, acute or chronic, and it is especially important for patients who experience pain as a result of terminal illness. All dental care practitioners should become knowledgeable about effective methods of pain treatment as well as statutory requirements for prescribing controlled substances.

Inadequate pain control may result from a dental care practitioner’s lack of knowledge about pain management or an inadequate understanding of addiction. Fears of investigation or sanction by federal, state and local regulatory agencies may also result in inappropriate or inadequate treatment of chronic pain patients. Accordingly, these guidelines have been developed to clarify the Board’s position on pain control, specifically as related to the use of controlled substances, in order to alleviate uncertainty and encourage better pain management by dental care practitioners.

The Board recognizes that controlled substances, including opioid analgesics, may be essential in the treatment of acute pain due to trauma or surgery and chronic pain, whether due to cancer or non-cancer origins. Dental care practitioners are referred to the U.S. Agency for Health Care and Research Clinical Practice Guidelines for a sound approach to the management of acute1 and cancer-related pain.2 The medical management of pain should be based on current knowledge and research and include the use of both pharmacologic and non-pharmacologic modalities. Pain should be assessed and treated promptly, and the quantity and frequency of doses should be adjusted according to the intensity and duration of the pain. Dental care practitioners should recognize that tolerance and physical dependence are normal consequences of sustained use of opioid analgesics and are not synonymous with addiction.

The Board is obligated under the laws of the State of Michigan to protect the public health and safety. The Board recognizes that inappropriate prescribing of controlled substances, including opioid analgesics,

BUREAU OF HEALTH PROFESSIONS

611 W. OTTAWA • P.O. BOX 30670 • LANSING, MICHIGAN 48909-8170 www.michigan.gov • (517) 335-0918 may lead to drug diversion and abuse by individuals who seek them for other than legitimate medical use.

Dental care practitioners should be diligent in preventing the diversion of drugs for illegitimate purposes.

Accordingly, the Board of Dentistry expects dental care practitioners to incorporate safeguards into their practices to minimize the potential for abuse and diversion of controlled substances.

The following are reference sources that provide sound approaches to the management of pain:

1. Acute Pain Management Guideline Panel. Acute Pain Management: Operative or Medical Procedures and Trauma. Clinical Practice Guideline. AHCPR Publication No. 92-0032. Rockville, Md., Agency for Health Care Policy and Research. U.S. Department of Health and Human Resources, Public Health Service. February 1992.

2. Jacox A, Carr DB, Payne R, et al. Management of Cancer Pain. Clinical Practice Guideline No. 9.

AHCPR Publication No. 94-0592. Rockville, Md., Agency for Health Care Policy and Research.

U.S. Department of Health and Human Resources, Public Health Service. March 1994.

Dental care practitioners should not fear disciplinary action from the Board or other state regulatory or enforcement agency for prescribing, dispensing or administering controlled substances, including opioid analgesics, for a legitimate dental/medical purpose and in the usual course of professional practice. The Board will consider prescribing, ordering, administering or dispensing controlled substances for pain to be for a legitimate medical purpose if based on accepted scientific knowledge of the treatment of pain or if based on sound clinical grounds. All such prescribing and/or administration must be based on clear documentation of unrelieved pain and in compliance with applicable state or federal law. In addition, dental care practitioners will have taken steps in good faith to assure safe and effective medication use and to prevent possible drug diversion.

Each case of prescribing for pain will be evaluated on an individual basis. The board will not take disciplinary action against a dental care practitioner for failing to adhere strictly to the provisions of these guidelines, if good cause is shown for such deviation. The dental care practitioner’s conduct will be evaluated to a great extent by the treatment outcome, taking into account whether the drug used is medically and/or pharmacologically recognized to be appropriate for the diagnosis, the patient’s individual needs—including any improvement in functioning—and recognizing that some types of pain cannot be completely relieved.





The Board will judge the validity of prescribing based on the dental care practitioner’s treatment of the patient and on available documentation, rather than on the quantity and chronicity of prescribing. The goal is to control the patient’s pain for its duration while effectively addressing other aspects of the patient’s functioning, including physical, psychological, social and work-related factors. The following guidelines are not intended to define complete or best practice, but rather to communicate what the Board considers to be within the boundaries of professional practice.

Section II: General Guidelines The Board of Dentistry has adopted the following guidelines when evaluating the use of controlled

substances for pain control:

1. Evaluation of the Patient An appropriate medical history and dental examination must be conducted and documented in the dental/medical record. The dental/medical record should document the nature and intensity of the pain, current and past treatments for pain, underlying or coexisting diseases or conditions, the effect of the pain on physical and psychological function, and history of substance abuse.

The dental/medical records also should document the presence of one or more recognized dental indications for the use of a controlled substance.

2. Treatment Plan The written treatment plan should state objectives that will be used to determine treatment success, such as targeted pain relief and improved oral-facial, physical, and psychosocial function, and should indicate if any further diagnostic evaluation or other treatments are planned.

After treatment begins, the dental care practitioner should adjust drug therapy to the individual patient needs. Other treatment modalities or a rehabilitation program may be necessary depending on the etiology of the pain and the extent to which the pain is associated with physical and psychosocial impairment.

3. Informed Consent The dental care practitioner should discuss the risks and benefits of the use of controlled substances with the patient, persons designated by the patient, or with the patients’ surrogate or guardian if the patient is incompetent or a minor. The patient should receive prescriptions from one dental care practitioner and one pharmacy where possible. If the patient is determined to be at high risk for medication abuse or have a history of substance abuse, the dental care practitioner may employ the use of a written agreement between the dental care practitioner and patient outlining patient responsibilities, including

• number and frequency of all prescription refills; and

• acknowledging reasons for which drug therapy may be discontinued (i.e., violation of agreement).

4. Periodic Review At reasonable intervals based on the individual circumstances of the patient, the dental care practitioner should review the course of treatment and any new information about the etiology of the pain. Continuation or modification of therapy should depend on the dental care practitioner’s evaluation of progress toward stated treatment objectives, such as improvement in the patient’s pain intensity and improved physical and/or psychosocial function, i.e. ability to work, need of health care resources, activities of daily living and quality of social life. If treatment goals are not being achieved despite medication adjustments, the dental care practitioner should reevaluate the appropriateness of continued treatment. The dental care practitioner should monitor patient compliance in medication usage and related treatment plans.

5. Consultation The dental care practitioner should be willing to refer the patient for additional evaluation and treatment as necessary in order to achieve treatment goals. Special attention should be given to those pain patients who are at risk for misusing their medications and those whose living arrangement pose a risk for medication misuse or diversion. The management of pain in patients with a history of substance abuse or with a comorbid psychiatric disorder may require extra care, monitoring, documentation and consultation with or referral to an expert in the management of such patients.

6. Dental/Medical Records

The dental care practitioner should keep accurate and complete records to include:

• the medical history and dental examination;

• diagnostic, radiographic, therapeutic, and laboratory results;

• evaluations and consultations;

• treatment objectives;

• discussion of risks and benefits;

• treatments;

• medications (including date, type, dosage, and quantity prescribed);

• instructions and agreements; and

• periodic reviews.

Records should remain current and be maintained in a recognized “SOAP” (subjective, objective, assessment plan) format and be accessible and readily available for review.

7. Compliance With Controlled Substances Laws and Regulations To prescribe, dispense or administer controlled substances, the dental care practitioners must be licensed in the state and comply with applicable federal and state regulations. Dental care practitioners are referred to The Physicians Manual of the U.S. Drug Enforcement Administration (and any relevant documents that may be issued by the state dental board) for specific rules governing controlled substances as well as applicable state regulations. Dental care practitioners are encouraged to use the Michigan Automated Prescription System to monitor and report suspected diversion activities involving their patients.

8. Anesthesia When administering any type of sedation or general anesthesia to a dental patient, dental care practitioners shall refer to the American Dental Association’s “Guidelines for the Use of Sedation and General Anesthesia by Dentists” and to the Board of Dentistry’s Administrative Rules on sedation and general anesthesia (R 338.11601).

Section III: Definitions

For the purposes of these guidelines, the following terms are defined as follows:

Acute Pain Acute pain is the normal, predicted physiological response to an adverse chemical, thermal or mechanical stimulus and is associated with surgery, trauma and acute illness. It is generally timelimited and is responsive to opioid therapy, among other therapies.

Addiction Addiction is a neurobehavioral syndrome with genetic and environmental influences that results in psychological dependence on the use of substances for their psychic effects and is characterized by compulsive use despite harm. Addiction may also be referred to by terms such as "drug dependence" and "psychological dependence." Physical dependence and tolerance are normal physiological consequences of extended opioid therapy for pain and should not be considered addiction.

Analgesic Tolerance Analgesic tolerance is the need to increase the dose of opioid to achieve the same level of analgesia. Analgesic tolerance may or may not be evident during opioid treatment and does not equate with addiction.

Chronic Pain A pain state which is persistent and in which the cause of the pain cannot be removed or otherwise treated. Chronic pain may be associated with a long-term incurable or intractable medical condition or disease.

Controlled Substance A controlled substance is a drug, substance, or immediate precursor included in schedules 1 to 5 of Article 7, part 72, of Public Act 368 of 1978 as amended (the Michigan Public Health Code).

Dental Care Practitioners The term dental care practitioners includes dentists, endodontists, oral-maxillofacial surgeons, oral pathologists, orthodontists, pediatric dentists, periodontists, prosthodontists, dental hygienists and registered dental assistants licensed under part 166, of Public Act 368 of 1978 as amended (the Michigan Public Health Code). For the purpose of establishing guidelines for the dental profession, dental hygienists and registered dental assistants are included in the definition of dental care practitioners although it is recognized that they do not have prescribing authority.

Dispense Dispense means to deliver or issue a controlled substance to an ultimate user or research subject by or pursuant to the lawful order of a practitioner, including prescribing, administering, or compounding necessary to prepare the substance for the delivery or issuance.

DispenserDispenser means a practitioner that dispenses.



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