December 10, 2013 – Counting today there are six days until Indiana’s Emergency Pain Regulations go into effect (on December 15, 2013).
The Painful Truth (my opinion) examines section FIVE.
Although the term “Informed Consent” (IC) is not mentioned, this section clearly deals with elements of informed consent in discussing the requirement for a treatment agreement (TA).
Both the PATIENT and the PHYSICIAN must sign the “agreement.” A copy must be kept in the patient’s chart.
The document(s) must attest to a “simple and clear” explanation of:
- Risks and benefits (IC)
- Alternatives to opioid treatment (IC)
- Consent to drug monitoring and random pill counts (TA)
- The requirement to take the drugs as prescribed (TA)
- Prohibition of the sharing of drugs (TA)
- “That the patient inform the physician about any other controlled substances prescribed or taken” (TA)
- Treatment goals (TA)
- Reasons opioid therapy may be changed or discontinued (TA)
- COUNSELING FOR WOMEN: Particular attention must be given to “women between the ages of 14 and 55 with child bearing potential” (e.g., has not had a hysterectomy). They must be counseled regarding RISKS TO THE FETUS, specifically including the risks of “fetal opioid dependency and neonatal abstinence syndrome.” (IC)
The Painful Truth recommends combining the treatment agreement and the informed consent into one document.