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FAQs About Pain Management Agreements and Informed Consent

Informed Consent

Q: What is the start talking form?

A: “Before issuing for a minor the first prescription in a single course of treatment for a controlled substance containing an opioid, regardless of whether the prescriber modifies the dosage during the course of treatment.” A “Start Talking Consent Form” is required to be signed acknowledging the receipt and discussion of specified information.

Before an opioid is prescribed, patients need to sign a form created by the Michigan Department of Health and Human Services acknowledging that he/she received information regarding the danger of opioid addiction, how to properly dispose of unused controlled substances, the fact that the delivery of a controlled substance is a felony under MI law, and the short- and long term effects of exposing a fetus to a controlled substance (if the patient is pregnant or a female of reproductive age).

Link to LARA / Start Talking form

https://www.michigan.gov/lara/0,4601,7-154-89334_72600_72603_55478_85991—,00.html

Q: Do I need to obtain informed consent each time I prescribe an opioid? Does this include refills?

Q: How often must information regarding the dangers of opioids, etc. be provided? Once? Annually? Every opioid prescription? Even if a refill?

A: Until the law is clarified or authoritative guidance is issued, the best practice would be to do so each time a new opioid prescription is given. If it is a stable prescription with refills, this is at the discretion of the provider but once a year, when renewing Provider-Patient pain agreements would be appropriate.

Q: How exactly do I obtain acknowledgment that patients received the information about the dangers of opioids?

A: The law requires that following your providing the information on the dangers of opioids to a patient you must obtain the patient’s signature on the Start Talking form (prescribed by the Michigan Department of Health and Human Services) indicating that the patient received the information. This signed form is to be included in the patient’s medical record.

Q: Where can I find the required informed consent forms and where should they be stored and for how long?

A: MSMS Legal Counsel has drafted a Start Talking Consent Form that is available at http://MSMS.org/BeAWARE.

See the LARA website for a sample form.

Patient-Provider Agreements

Q: Why a patient-provider agreement?

A: The purpose of this agreement is to protect your access to controlled substances and to protect our ability to prescribe for you. The use of medications such as opioids (narcotic analgesics) is controversial because there is uncertainty regarding the extent to which they provide long term benefit. There is also the risk of developing an addiction or of relapse occurring in a person with a history of prior addiction. The extent of this risk is not certain. Because these drugs have potential for abuse or diversion, strict accountability is required by State of Michigan law.

We used to believe that using opioids for long-term pain was safe. We now know that opioids can be harmful. Our office reviews this agreement with all patients to educate about and hopefully lower harm risks. This agreement also lays out the rules for receiving opioids followed by all our providers and sites.

Q: What can I expect from the clinic?

A: Our clinic agrees to provide you with appropriate doses of medication in a timely fashion and on an ongoing basis as long as there are no contraindications. You will be treated respectfully and professionally

Q: What are the consequences of not following these agreements?

A: Your clinician has agreed to provide you with these medications as long as necessary, but also has the obligation to protect you and the community from abuse of these substances. In the event of suspected misuse, your provider may insist on a referral to a specialist in the assessment and treatment of drug dependency, or may immediately discontinue prescribing. Lack of improvement in function or to achieve adequate pain control may also necessitate the discontinuing of opioid medications.