- The number and frequency of substance prescriptions, including the rules for refills, should be outlined;
- The treatment goals should be clearly articulated;
- The measures for outcomes should be clearly defined;
- The risks and benefits of the use of the specific controlled substances should be identified;
- The patient’s responsibilities for the use of controlled substances should be identified (e.g., safeguarding the medication, not attempting to get pain medication from another provider without approval from the present provider, not to use any illegal substances, and not sharing, selling, or trading the medication)
- The single pharmacy the patient will use to fill the prescription should be identified;
- Permission to allow the physician to require the patient to undergo a random blood or urine drug test should be granted;
- Permission to allow the physician to consult with the dispensing pharmacist and any other professional who has provided healthcare to the patient should be given; and
- The consequences of contractual violation—including that if the patient breaches the agreement, the physician may stop prescribing the pain-control medicines or terminate the physician–patient relationship—should be delineated.
The controlled substance agreement should also remain a flexible document so as not to lead to unintended consequences. For example, if a patient requires an emergency procedure that requires the patient to take a controlled substance that is not included on the controlled substance agreement, the agreement should not be so rigid so that this situation results in a breach of the agreement.
Specifics for Opioids
There are also some key standards of practice for prescribing opioids that should be followed in conjunction with the execution of the pain contract, such as:
- Evaluation of the patient, including a pain history and assessment of the impact of pain on the patient, a directed physical examination, a review of previous diagnostic studies, a review of previous interventions, a drug history, and an assessment of coexisting diseases or conditions;
- Consultation with a specialist in pain medicine or with a psychologist, when necessary. Patients with signs or symptoms of substance abuse should be immediately referred to a pain management specialist, an addiction specialist, or an addiction facility as it pertains to drug abuse or addiction;
- Review of treatment efficacy should occur periodically to assess the functional status of the patient, the patient’s progress toward treatment objectives, opioid side effects, quality of life, and indications of medication misuse; and
- Documentation is essential to support the evaluation, the reason for prescribing an opioid, the nature and intensity of the pain, the overall pain management treatment plan, the presence of any recognized medical indications for the use of a controlled substance, any consultations received, and a periodic review of the status of the patient. Chart everything. The medical record should include, at a minimum:
- The complete medical history and a physical examination, including history of drug abuse or dependence;
- Diagnostic, therapeutic, and laboratory results;
- Evaluations and consultations;
- Treatment objectives;
- Discussion of risks and benefits;
- Medications, including date, type, dosage, and quantity prescribed;
- Instructions and agreements;
- Periodic reviews;
- Results of any drug testing;
- A photocopy of the patient’s government-issued photo identification; and
- If a written prescription for a controlled substance is given to the patient, a duplicate of the prescription.
Physicians who have these safeguards in place will be in a sounder position in the event they find themselves the target of the ongoing crackdown on physicians who are prescribing opiates outside the bounds of accepted medical practice. Also, be sure to check your state’s laws, as these agreements may be legally required. If you are using a controlled substance agreement template, now is the time to review it to ensure that all parties are best protected. If your practice has not yet started using a controlled substance agreement, now is the time to consult with a healthcare lawyer.