WV: Best Practices for Prescribing Controlled Substances and Preventing Drug Diversion, 3 unitsPage 8 of 13

6. Informed Consent and Prescribing Agreements

As part of any treatment plan, providers must educate patients on the prescription opioid, its safe use (including dosage, frequency of use, expected therapeutic effects, risks, and side effects); its potential interactions with other drugs and alcohol; its proper storage according to manufacturer instructions; and the proper disposal of the medication. As we have mentioned, diversion of opioids by family members, caregivers, or visitors can be a serious problem with serious consequences for the patient, who should be using the drug as directed, and for the nonmedical user, who may be risking injury or accidental death by illegally using a drug not prescribed.

It is imperative that patients receive education so that they may give informed consent to the treatment plan recommended by the physician.

What Is Informed Consent?

Informed consent involves informing the patient about the risks and benefits of the proposed therapy and the legal obligations such therapy imposes on both physician and patient. Informed consent serves multiple purposes: (1) it provides the patient with information about the risks and benefits of opioid therapy; (2) it fosters adherence to the treatment plan; (3) it limits potential for inadvertent drug misuse; and (4) it improves the efficacy of the treatment program. (SAMHSA, 2016a)

Health providers have the responsibility of informing patients about opioid pain medications. The Federation of State Medical Boards specifies that informed consent documents typically address the following points:

  • The limited evidence as to the benefit of opioids or other pharmaceutical therapies in the management of chronic pain (except for cancer)
  • The potential risks and anticipated benefits of chronic opioid therapy
  • Potential side effects (both short- and long-term) of the medication, such as constipation and cognitive impairment
  • The likelihood that tolerance to and physical dependence on the medication will develop
  • The risk of drug interactions and over-sedation
  • The risk of impaired motor skills (affecting driving and other tasks)
  • The risk of substance use disorder, overdose, and death
  • The clinician’s prescribing policies and expectations, including the number and frequency of prescription refills, as well as the clinician’s policy on early refills and replacement of lost or stolen medications
  • Specific reasons for which drug therapy may be changed or discontinued (including violation of the treatment agreement) or that treatment may be discontinued without agreement by the patient
  • Education of the patient that the complete elimination of pain is not to be expected (FSMB, 2017; WVBM, 2017)

Patients need to understand that opioid pain medications work to relieve pain by binding to specific receptors in the brain, spinal cord, and gastrointestinal tract. But stimulating the receptors, or reward centers, in the brain can also affect other body systems, such as those responsible for regulating mood, breathing, and blood pressure.

Signs of Overdose

Opioids can cause pleasure, nausea, vomiting, allergic reaction, and even overdose, which can cause breathing and heartbeat to slow or stop. Opioids may significantly reduce pain, but they may not eradicate all pain.

Life-threatening overdose can occur when:

  • A patient accidentally takes an extra dose or doses
  • A patient accidentally takes doses more frequently than prescribed
  • A patient deliberately takes more medication than prescribed
  • A patient takes the medication in combination with other drugs or alcohol
  • Any person who is not prescribed the medication takes it

Patients and their caregivers must be taught that an overdose of opioid pain medication is an emergency. If an overdose is suspected, immediately call 911. Signs of overdose include:

  • Slow or stopped breathing
  • Slow or stopped heartbeat
  • Limp body
  • Extremely pale and/or clammy face
  • Blue or purple lips or fingernails
  • Vomiting or emitting gurgling noises
  • Cannot be awakened
  • Unable to speak

Signs of Overmedication

Overmedication is a condition that may progress to life-threatening overdose. Signs of overmedication include:

  • Slow or shallow breathing
  • Slow heartbeat
  • Low blood pressure
  • Unusual sleepiness, nodding off
  • Confusion
  • Slurred speech
  • Behavior resembling intoxication
  • Pupils pinpoint size
  • Difficulty awakening from sleep

Patient education must include the following points:

  • Take medicine only if it has been prescribed by a doctor.
  • Do not take more medicine or take it more often than instructed.
  • Call a doctor if pain gets worse.
  • Never mix pain medicines with alcohol, sleeping pills, or any illicit substance.
  • Store medicine in a safe place where children and pets cannot reach it.
  • Know the signs of overdose and how to use naloxone to keep it from becoming fatal.
  • Teach family and friends how to respond to an overdose.
  • Dispose of unused medication properly. (SAMHSA, 2016a)

Patient–Prescriber Agreements

The use of a patient–clinician agreement, or treatment agreement, helps to reinforce patient education. The FDA has convened a working group to develop tools for patients and prescribers when considering opioid analgesics for the treatment of pain, including a model opioid patient-prescriber agreement (PPA) that is patient-focused to increase awareness of risks and benefits of opioid analgesics and serve to emphasize the responsibilities of both patient and prescriber (FDA, 2014). Although the FDA’s Safe Use Initiative Opioid Patient-Prescriber Agreement is in progress, at the time of this writing it was not yet finalized.

SAMSHA’s Opioid Overdose Prevention Toolkit outlines what such an agreement should include.

  • The agreement instructs the patient to stop taking all other pain medications, unless explicitly told to continue by the physician. Such a statement reinforces the need to adhere to a single treatment regimen.
  • The patient agrees to obtain the prescribed medication from only one physician and, if possible, from one designated pharmacy.
  • The patient agrees to take the medication only as prescribed (for some patients, it may be possible to offer latitude to adjust the dose as symptoms dictate).
  • The agreement makes it clear that the patient is responsible for safeguarding the written prescription and the supply of medications and arranging refills during regular office hours.
  • This responsibility includes planning ahead so as not to run out of medication during weekends or vacation.
  • The agreement specifies the consequences for failing to adhere to the treatment plan, which may include:
    • Signature of the physician
    • Name and quantity of the drug prescribed
    • Directions for use
    • Refill information
    • Effective date if other than the date on which the prescription was written (SAMHSA, 2016a)
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