This article examines the risks involved in prescribing psychotropic medication and offers suggestions for managing those risks to ensure the best possibility for a favorable outcome.
This article examines the risks involved in prescribing psychotropic medication and offers suggestions for managing those risks to ensure the best possibility for a favorable outcome. The major areas covered include:
Psychotropic medications of major concern primarily include benzodiaze- pines, psychostimulants, and narcotic analgesics,1 although common adjuncts such as benztropine can also have moderate abuse potential.2 Two common pitfalls in prescribing these medications are supplying too much or supplying too little. It is the former that concerns us most, but the latter presents an equal risk to the prescribing physician.
Managing the risk of overprescribing or underprescribing psychotropic medication is dependent on the physician having a clear understanding of the terms "overuse," "abuse," and "addiction."3 It is not always easy to identify problem patients. As pointed out by Kirsh and Passik,4 "Traditional definitions of addiction that include phenomena related to physical dependence or tolerance cannot be the model terminology for medically [or psychiatrically] ill populations that receive potentially abusable drugs for legitimate medical purposes."
Empirical studies have shown the value of increased success in both psychotherapy and pharmacotherapy when there is a stronger therapeutic alliance.5 Without adequate medication, a patient may lose faith in his or her physician, thereby uncoupling a therapeutic alliance or eliminating the chance of building one. Moreover, the patient may be made to feel guilty or ashamed that he needs to entreat his doctor for more medication-producing the very emotions that we so often seek to diminish.
Medication misuse Benzodiazepines
Misinformation about this class of medication abounds in the lay press and on the Internet.6-9 One reader's comment on the book by Gadsby9 states, "[H]alfway through the book the author started citing evidence how benzodiazepines cause permanent brain damage. Some of the evidence she presents states that benzodiazepines actually shrink the human brain." Because of these widespread misgivings about benzodiazepines, effective management of the actual risks compels clarification.
When it was observed that diazepam was the most widely prescribed drug in the United States in the early 1970s, we began to question how we became "a nation of addicts."10 The more accurate question was, "Why is anxiety so prevalent in our society?" Physicians began to eschew prescribing this class of drug and attempted to substitute other medications for anxiety and panic disorder, such as antihistamines, b-blockers, and antidepressants.
Both doxepin and diazepam were sought-after medications in the prison setting for facilitating sleep. Yet, even though doxepin could be far more lethal than diazepam, one federal prison in New York began automatically substituting doxepin whenever an inmate arrived with a prescription for diazepam.11
Another example of medical misconception about benzodiazepines is illustrated in a 2005 research study, wherein illicit drug users taking prescribed diazepam were to undergo mandatory reductions of 10% per month.12 After 6 months, the initial mean daily dose of 29 mg was reduced by approximately 6%. The researchers concluded that it is possible to reduce prescribed diazepam among illicit drug users-but not at the rate of 10% per month set by the study. Moreover, the therapeutic dosage range for diazepam is up to 40 mg/d, so why attempt to reduce doses that are already less than three fourths of the maximum allowable dose?
The risk posed by the compelling desire to reduce or discontinue benzodiazepines is perhaps best illustrated by the following case vignette.
A 60-year-old woman had been taking 5 mg of diazepam 4 times a day, prescribed by her general practitioner for an anxiety disorder, for more than 30 years. When her doctor died, a young family practitioner took over the practice. He was aghast that the woman was "addicted" to diazepam and scheduled a withdrawal regimen. Within a few weeks the woman was nearly psychotic and required hospitalization. Nonbenzodiazepine substitutions were tried, to no avail. When her 2 adult children brought her in to see me, I restarted diazepam, and she was back to a functioning baseline within a couple of weeks.
The safety and efficacy of benzodiazepines is unsurpassed for treating anxiety and panic disorders, and the abuse potential is much lower than widely believed.13 Newer drugs that are touted to have no abuse or dependence potential can eventually reveal the opposite, as shown in a 2003 review of zolpidem and zopiclone.14 In extreme cases, dose increases reached a factor of 30 to 120 times the recommended doses. The majority of patients in these cases had a history of former drug or alcohol abuse and/or other psychiatric conditions. The risk of inadequately prescribing benzodiazepines stems from exaggerating their potential adverse effects and minimizing their beneficial effects. Be evenhanded when informing patients about these medications.
Psychotropic medications are designed to help patientsthink and feel better. It is the latter goal that becomes problematic. "We have this Calvinistic view about treating pain in the long-term care setting: we must not give them too much analgesia because-you never know-grandma might become addicted."15 The media-reinforced mindset that one should not need medication to feel better is an attitude that unfairly stigmatizes anxiolytics and antidepressants in particular. The other extreme is promoted by patients who label their illicit drug and alcohol use as "self-medication," a term that has even gained acceptance in some medical circles.16
The psychiatrist's role is limited to the evaluation and diagnosis of psychological contributions to pain, rather than to treating the pain itself: "Psychotropic medications, psychotherapy, behaviour therapy, biofeedback, and distractional methods are the tools available to the psychiatrist."17 Therefore, psychiatrists who do prescribe pain medication are shouldering a heavier potential risk. Yet we have all seen patients who have been denied pain medication or who have been so limited in their analgesic prescriptions by their physician that it is useless to try to treat their depression without addressing this aspect of their treatment.18
The reticence to prescribe adequate analgesia is in large part due to the difficulty in defining "aberrant behavior" that can distinguish abuse and addiction from physical dependence and tolerance: "The differential diagnosis for aberrant drug-taking attitudes and behavior includes (1) addiction, (2) pseudoaddiction (inadequate analgesic), (3) other neurologic and psychiatric diagnoses, and (4) criminal intent."19
Reduced analgesic efficacy because of tolerance-loss of a drug's therapeutic effect over time-makes the treatment of chronic pain with opioids more difficult. However, the clinician should not avoid prescribing opioids just because it may eventually be necessary to increase the dose. "Unlike the chemically dependent patient whose level of function is impaired by substance use, the chronic pain patient's level of function may improve with adequate, judicious use of . . . opioids."20
Diversion and abuse of prescription drugs is costly in terms of addiction, overdose, death, and related criminal activity, but chronic pain carries significant economic, social, and health impact as well.21 Criminal commerce can actually be fostered and promoted as a result of physicians' common reluctance to prescribe analgesics for patients who experience severe chronic pain. Turning to illicit substances and alcohol can be the result of receiving inadequate doses of pain medication.
Because psychiatrists are not trained or experienced in pain management, they put themselves at grave risk if they do prescribe narcotic analgesics. One way a psychiatrist can manage the risk of prescribing pain medication is to be part of a multidisciplinary team that includes primary care physicians, neurologists, pharmacists and, if available, pain specialists. If that is not feasible, then ongoing consultation with a primary care physician should be standard practice. Substance misuse is not going to be eliminated by multidisciplinary teams or consultation22; however, working with such a team dilutes the risk to the physician.
Primarily prescribed for children and adolescents with attention deficit disorder with or without hyperactivity (ADD/ADHD), psychostimulants can produce a "high" or feeling of elation, followed by withdrawal/depression, which can initiate a reward cycle of abuse and addiction. Moreover, these medications tend to reduce the appetite and promote weight loss. The adventuresome tendencies of adolescents, combined with the near-epidemic prev-alence of obesity, sets the stage for a slippery slope of attraction, abuse, and addiction.
ADHD is considered the most common neurobehavioral disorder in children, affecting an estimated 4% to 12% of children aged 6 to 12 years.23 Approximately one third to one half of all pediatric mental health referrals are for treatment of ADHD,24 and it is unwise to withhold medication when clinical experience has demonstrated that 70% to 90% of children will respond favorably to at least 1 psychostimulant if the dosage is titrated properly.25
In managing the risk of prescribing psychostimulant medication it is essential for the prescribing physician to collaborate with parents, guardians, and teachers. Problem behavior may not be observable during the office visit, so collateral contacts are very important.
With all abusable prescription medication, managing the double-edged sword of denying needed treatment versus unintentionally abetting abuse need not be exceptionally difficult, if good practice standards are followed. Recommended steps for reducing the overall risk of abuse, overuse, or addiction are listed in Table 1.
The effect ofchlorpromazine on agitation and psychosis was serendipitously discovered by a Parisian surgeon, Henri Laborit, in 1952, who was using it to reduce the amount of anesthesia needed to sedate surgical patients. He was so impressed that he passed it along to psychiatrists: "The results were stunning. Patients who had stood in one spot without moving for weeks, patients who had to be restrained . . . could now make contact with others and be left without supervision."26 Another psychiatrist reported, "For the first time we could see that they were sick individuals to whom we could now talk."26 Chlorpromazine and the newer antipsychotics that followed may be bona fide miracle drugs and should always be considered for psychotic patients, but they have a considerable downside.
First-generation antipsychotics (FGAs) have been notorious for producing extrapyramidal syndrome (EPS) and tardive dyskinesia (TD). Second-generation antipsychotics (SGAs) were touted as having little or no risk for causing EPS or TD, but these adverse effects have been observed.27 Moreover, the SGAs have been associated with a metabolic syndrome of abdominal weight gain, dyslipidemia, and insulin resistance.28 The FGAs have also been known to increase insulin resistance and foster new cases of diabetes but to a lesser extent.29
Adverse drug reactions are the fifth most common cause of death in the United States, following heart disease, cancer, stroke, and pulmonary disease.30,31 Psychotropics are often associated with adverse effects, including cardiac toxicity, confusion, and unwanted sedation. People taking psychotropics for mental illnesses may be especially susceptible,32 and not surprisingly, the elderly are the most susceptible.33 Finally, one of the most confounding problems in psychopharmacology is the paradoxical potential of antidepressants to promotesuicidal ideation.34
The risk of adverse effects may be minimized by:
DOCUMENTATION: Informed consent
Informed consent is the sine qua non of risk management and possibly the most sticky wicket in the realm of psychopharmacology. Since the psychiatric disorders themselves often compromise the patient's ability to give informed consent,35 it presents a formidable concern not just for psychiatrists, but for physicians of all disciplines.36 Every psychiatrist who has ever tried to get a patient with paranoia to take psychotropic medication has experienced this conundrum. Off-label use of psychotropic medication is quite common, yet fewer than one third of patients are informed when their prescriptions are for off-label uses.37 It is of utmost importance that patients clearly understand the risks and benefits of the treatment being proposed, the risks and benefits of any available alternative treatments, and the risks and benefits of no treatment.38
Nowhere is this more important than with off-label use of psychotropic medication in the pediatric population. A study that spanned residential treatment facilities in 4 states revealed that antipsychotic prescriptions are used frequently with youth for off-label indications such as attention deficit/impulsivity, physical aggression, and sexually abusive and other criminal behavior.39 It is essential that parents, guardians, and administrators-as well as the prescribing psychiatrists themselves-be absolutely clear about the indications and need for such off-label use.
Much has been written on the therapeutic effects of fully informed consent. Simply stated, the very act of disclosure results in less anxiety, increased trust in the integrity of the physician, a smoother clinical course, and better patient understanding should anything go awry.40
The recommendation for obtaining consent from paranoid patients is to acknowledge their paranoid ideation, rather than discounting it, ignoring it, or trying to talk them out of it. Patients appreciate having their fears acknowledged, which can tip the balance toward compliance. For example, "I know you are doubtful about taking medication, Mr Jones-and medication certainly can cause adverse effects-but I just hope you'll put your fears aside and try this because it has the potential to provide a great deal of relief from the voices."
In addition, confirm that the patient clearly understands you and is competent to understand the risks versus benefits of taking psychotropic medication; speak in lay terms and have the patient repeat the relevant points back to you; and ask the patient to write down his understanding of the benefits, possible adverse effects, and any off-label uses that you have explained.
Appropriate and full disclosure
When a patient is harmed by an error or negligence, doctors and hospitals tend to treat the patient as an adversary. There is now theoretical and experiential evidence indicating that full disclosure, apologies, and fair compensation may protect all parties at lower cost.41 Recent findings suggest that patients respond favorably to full disclosure, with a lower likelihood of changing physicians, and that they show higher satisfaction, greater trust, more positive emotional response, and less support for sanctions against the physician.42
In this day of "managed care," with medication management visits limited to 15 or 20 minutes and limited formulary medications, it is extremely important to pay attention to the risks and to try to avoid them. More face-to-face time increases the opportunity to develop a stronger therapeutic alliance, and a stronger therapeutic alliance reduces the likelihood that a patient will become an adversary if treatment produces adverse events rather than relief.43 Tips for overall risk management are listed in Table 2.
If informed consent is the sine qua non of risk management, then good record keeping is the cornerstone. In the event of medical litigation, comprehensive patient records-written legibly and in lay terms-are a physician's best defense.44 A progress note should be written as though it will be shown from an overhead projector in a courtroom. It can explain to the jury why the physician did what he or she did; what he based his medical decision on; why he discarded other treatment options; and what the patient's reaction to the plan was at the time.
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