Informed Consent Forms and Controlled Substances: A Checklist

Before prescribing patients controlled substances, most of you require them to sign some sort of informed consent form. Do your forms contain enough information?

Before prescribing your patients controlled substances, most of you require them to sign some sort of pain contract or informed consent form. Do your forms contain the right information? 

Though there are many examples of informed consent forms out there, many fail to include four essential items, Theodore Parran, a Cleveland-based internal and addiction medicine physician, who is also a professor at Case Western University School of Medicine, told Physicians Practice. They are:

1. Permission to contact references

Forms should indicate that you and/or your staff will contact two to three of the patient’s significant others to gather data about the patient, Parran said. That way, once the patient signs the form, you can contact his references to see if they can corroborate the patient’s history. In addition, you can routinely contact these references while the patient is taking the medication to help you assess how the patient is responding to the medication.

You should not prescribe controlled substances to patients who fail to agree to this, said Parran. “Patients who demand secrecy of their physician, and at the same time expect their physician to prescribe them controlled drugs over a long period of time, are patients with an inappropriate expectation of the doctor patient relationship,” he said.

2. Permission to contact prior physician and pharmacy

Forms should indicate that you and/or your staff will contact the patient’s previous pharmacy and his previous prescribing physician’s practice. That way, once the patient has signed the form, you can contact these entities to help determine if it is appropriate to prescribe the patient controlled substances.

“It’s certainly the patient’s right to say ‘no,’” said Parran, “But it’s also the physicians right to say, ‘I can’t safely prescribe you long-term controlled drugs unless you give me permission to contact a couple significant others, contact your previous prescribing doctor, and contact your pharmacy.’”

3. Screening information

Though the form currently used in your practice likely contains information about screening and monitoring the patient, pay attention to the wording in this section. Many forms state that the physician and his staff may check the patient’s urine toxicology screens. Instead, the forms should state that the physician will check these screens, said Parran. “Not checking urine tox screens in a patient who’s being prescribed long-term controlled drugs occasionally is like not checking a hemoglobin A1C in a diabetic, it just doesn’t make sense in today’s world,” he said.
4. Pharmacy board website review information

Forms should indicate that you will be checking your state’s pharmacy board website - if it has one - at least a once a year, if not two to three times a year, to ensure that the patient is not obtaining controlled prescriptions from other providers, said Parran.

Finally, if the title of your form includes the word “agreement” or “contract,” Parran suggested altering it to state: “Informed Consent Form.”

“A doctor should never put anything in a chart that he and a patient sign that says contract - you have a contract with a plumber or an electrician, not with a patient,” he said. And he added, “even an 'agreement' doesn’t really fit well within the ethical construct of a doctor-patient relationship.”