Patients prescribed opioids for the treatment of CNCP should be fully informed of the potential consequences of this therapy.

Verbal consent may be sufficient for some patients, or a consent form can be presented in the form of a contract. Fishman et al.149 and Gitlin150 recently reviewed the possible contents of a consent form, and observed that the contract is an attempt to improve care through the use of an educational vehicle and to facilitate a course of treatment that has been mutually endorsed. It also provides a mechanism for obtaining informed consent.

Most importantly, the consent form should clearly define the goals of therapy. These goals may need adjustment as treatment progresses; however, the importance of unambiguous end points cannot be overstated, particularly if problems with prescribing develop. An information leaflet can be usefully incorporated into a consent form.

Informed consent should include the following:

• aims should be set for less pain rather than no pain;

• realistic functional goals should be set;

• there should be discussion regarding the likelihood of dependence and the risk of addictive behavior, i.e. that all patients will become dependent and are likely to experience withdrawal symptoms if opioids are suddenly ceased;

• there is lack of data on the long-term outcome of the effects of medically prescribed opioids;

• the potential for cognitive impairment should be discussed, including:

- driving motor vehicles while commencing opioid therapy;

- temporary worsening around the time of dose escalation;

- the likelihood of increased sedation if benzodiazepines and/or alcohol are used;

• patients should be alerted to the possibility (for women) of physical dependence of children born to them if they continue to take opioids in late pregnancy;

• indications should be identified for the cessation of treatment with opioids and an indication of unacceptable behavior (included here could be practice rules about repeat prescriptions and amount of notice required);

• patients must accept responsibility for:

- ensuring that their supply of medication does not run out after hours;

- the security of their medication;

- keeping review appointments;

- using only one doctor (or their nominee in case of leave) to supply this medication.

• side effects and their management should be discussed, e.g. constipation, nausea, sedation, dry mouth, urinary hesitancy, possible hormonal effects;

• if methadone is the drug to be prescribed, emphasis on the risks of cessation and restarting, and unapproved dose escalations must be made.

In selected patients, it may be appropriate to discuss the definitions of the following terms and to include them in the information/consent form in order to increase compliance and ensure a more thorough understanding of consent.

Tolerance refers to decreasing pain control with the same dose of opioid over a given time period. Tolerance to side effects, such as sedation and nausea, appears earlier than it does to analgesia. It usually occurs in the first six months of dosing. Tolerance does not imply addiction.

Physical dependence refers to a constellation of physiological signs and symptoms seen on abrupt withdrawal of an opioid. The severity of symptoms varies between patients. They include coryza, tremor, sweating, abdominal cramps, arthralgia, myalgia, vomiting, and diarrhea. Patients can be reassured regarding this phenomenon. It is the same for opioids as it is for many other medications, e.g. antihypertensives, antiepileptics, or insulin.

Addiction is a psychosocial disorder characterized by the compulsive use of a substance and preoccupation with obtaining it. This is despite evidence that continued use results in physical, emotional, social, or economic harm.

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