Safety and Effectiveness of Psychotropic Medicines Essay
Safety and Effectiveness of Psychotropic Medicines Essay
ADD: Safety and Effectiveness of Psychotropic Medicines ay appeared “Many people complain that children in the U. S. Are on too many psychotropic drugs (such as Protozoa and Rattail).
Is this true or are these medications improving the lives of our children who are truly suffering from these disorders (such as depression, obsessive-compulsive disorder, ADD, etc. )? ” Several kids In the US are on psychotropic drugs e. G. Protozoa and Rattail which haven’t undergone full investigation in children clinical trials.
There is a widespread practice where psychiatrists’ prescribe these medications off label. Safety and Effectiveness of Psychotropic Medicines Essay.
This possesses serious consequences; both short and long term for these children. Research shows that USA leads In number of psychotropic usage among pediatrics. Further confirmation suggests that many of the youngsters are put on in excess of one drug at the same time (Morgan 498) Despite having an increase in children receiving psychotropic drugs for attention deficit hyperactive disorder (ADD), COD as well as depression In America, there’s little data on the effectiveness and safety on their use.
There are several studies exploring treatments for ADD. Nevertheless, there’s inadequate information on proper hierological therapies for other psychological health disorders faced by pediatrics.
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Many studies base their Information on adult clinical trials; the reality Is that this Is a limitation when applied to the children population. (Parker 63-64). A looming controversy exists in regards to the application of psychotropic medicines.
There are individuals who consider that these drugs can unlock children’s full potential to develop as well as lead productive, healthy lives; others do believe that Increased usage of these drugs signifies ‘metallization’ of children’s normal behavior without regarding the long term socio-cultural and biological consequences.
Admittedly, majority of Americans don’t have patience or time to withstand the heat. With this at stake, it becomes easier to take sides and also have affirmed beliefs than to critically consider the Issue at hand; whether It’s nice or dreadful to have more kids and youngsters on psychotropic drugs.
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Compelling arguments exist on both sides. However as a custom in American sociopolitical life, moderate voices in the middle are overshadowed by harsh voices of conviction at either end (Aquarius Health Care Media, 2005. Counseling Video Clip; Morgan 499).
Various authors have mentioned factors hindering research on pediatrics which Include smaller subject population, recruitment challenges, high expenses, multifaceted ethical concerns and very few researchers. Glen & Venture) Additionally, the caregivers are always reluctant to register children and adolescents in studies which lack immediate benefits; this can be owed to the lack of understanding on the importance of clinical trials. Safety and Effectiveness of Psychotropic Medicines Essay. It ought to be admitted that limited Information on pediatric drugs Isn’t new to psychological health. This has resulted in relatively a small number of children effectiveness research for the psychotropic drugs.
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Besides, few studies explore the safety and effectiveness of psychotropic therapies or draw a comparison between the efficiencies of psychosocial therapy, medication and blended management approaches over common disorders. Additionally, much proof in support of the use of 1 OFF monitoring quick-fix improvement in disease symptoms rather than lasting changes in cognitive outcomes. For example, in very small children, physicians usually order psychotropic drugs off- label, devoid of knowledge of the possible lasting harmful effects on both growth and development (Testier, Carl & Natalie 250-252; Natural Wars To treat ADD and ADD).
Well, the utilization of psychotropic drugs by adolescents and children as prescribed by competent health personnel has major advantageous effects on the children diagnosed with behavioral and identifiable mental disorders.
The mentioned disorders are increasing in rates and serious consequences exist for both the society and individuals for failure to provide effectual, scientific based medical treatment. Risks associated with psychotropic drug use are well known, comprehensible and controllable. More research ought to be conducted to advance and refine our acquaintance of psychotropic agents. Victoria & Tunneled) On the other hand, the psychotropic drugs used by children and adolescents is beyond proportions owing to the rushed diagnoses, medication to normal behavioral aspects, a temporary culture, an uncontrollable drug business and the call for an instant social rehabilitation and power in case of nonexistence of family connections and the community based concentration in the welfare of their children. Safety and Effectiveness of Psychotropic Medicines Essay. Admittedly, the consequences of psychotropic use in children are unknown, articulacy long term utilization; there’s some evidence of danger associated with its long term use.
Furthermore, ethical issues exist in regards to prescription of these drugs in circumstances where the subjects are incapable of consenting on their own medication (Arizona video clip 28-33).
The fact is that war on drugs is real; prisons have had an overflow because of illegal drugs, notwithstanding this, the war has never ended. With regards to this matter, it can’t go without mention that alcohol and tobacco utilization is accepted in the society. The advertisements for the two are pulled with promises of success and happiness but the truth is that they cause widespread addiction as well as disease and even fatality.
Legal prescription medications e.
G. Painkillers, stimulants as well as pills to allay anxiety are also addictive and dangerous as the banned drugs, even though approved by a physician. There are also other drugs such as lithium, anticonvulsant and narcoleptic drugs that usually have very dangerous adverse effects though they aid in managing dampened consciousness when individuals feel uncontrollable; so these are referred to as ‘mood stabilizers’ and ‘antispasmodics. (Morgan 499; Hall 8-10).
Having drugs in the larger picture, people’s lives are often at stake, be it from adverse drug effects, addiction or the dangers that accompany emotional catastrophe and madness. These, combined with contradicting perceptions from the society on drugs, results in a lot of fear.
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The drugs are either demons or angels. Admittedly, we need live on them by at all expenses or stay away from them at all costs. Mostly, we either tend to focus only at dangers or we are afraid to look at the dangers at all. There shouldn’t be any compromise, its either black or white, have all or nothing (Hall 12; Morgan 500).
It is very simple to fall into conclusive thinking when it is on matters pertaining to psychotropic drugs. The center of attention of pro drug advocates has been on the dangers of severe emotional states, whereas the anti drug advocates major focus has been on the dangers of taking the drugs (Natural Ways to Treat ADD and ADD). Or ‘say no’, a one way ticket for everybody. The fact is that this can be applicable to some individuals but not many. A harm reduction movement is an international movement aimed at educating the community.
It appreciates the reality that no ingle solution exists for each person; besides there’s neither global failure nor success. In this vein, getting rid of this menace is not the only alternative left. Instead the harm reduction Just accepts the way individuals are and gives them education about making informed choices as well as the calculated tradeoffs which lessens risks and raises wellness. Individuals require information, resources, options plus support in order to forge towards a healthy living; and at their own speed and terms (Hall 9).
The application of harm reduction viewpoint to psychological health still remains a new growing approach.
The philosophy is not meant to eradicate or discontinue all the medications but it appreciates the fact that individuals are already on psychotropic drugs and are attempting to withdraw from them. Besides, it recognizes that these individuals are already facing the symptoms in their everyday life; this is sufficient to Justification that psychotropic drug use is a multifaceted reality and individuals are in need of correct help which is nonjudgmental. Safety and Effectiveness of Psychotropic Medicines Essay. Harm reduction normally advocates for the balancing of diverse risks involved; I. .
Harm as a result of extreme states and harm resulting from therapy e. . Severe drug effects, traumatic admissions and disemboweling branding (Hall 18- 22). Nobody has a difference of opinion that there’s indeed an increased consumption of psychotropic drugs in children and adolescents, however prescriptions for antidepressants for patient aged eighteen years and below dropped by about 20% since the FDA gave a warning in 2004 that these drugs can be coupled with an augmented suicide risk in both kids and adults. Nonetheless, the rate of this boost and numbers details may vary extensively hence it’s hard to tell with any exactitude.
The pace of innovation in psychotropic drugs has been rapid over the past 15 years. There also have been unprecedented increases in spending on prescription drugs generally and psychotropic medications specifically. Psychotropic medications are playing a more central role in treatment. They also are receiving close scrutiny from health insurers, state budget makers, and ordinary citizens. Public policy actions regarding prescription drugs have the potential to significantly affect clinical care for mental disorders, the costs of this care to individuals and society at large, and the prospects for future scientific advances. This article outlines the policy issues related to psychotropic drugs with respect to their role in determining access to mental health treatment and the cost and quality of mental health care.
In the past 15 years, the pharmaceutical industry has provided a host of new psychotropic drugs to clinicians treating mental disorders. Two major new classes of psychotropic drugs have been introduced, and nine new antidepressant agents and five new antipsychotic drugs have been approved by the U.S. Food and Drug Administration (FDA) since 1988. Safety and Effectiveness of Psychotropic Medicines Essay.
Psychotropic drugs are playing an increasingly central role in the treatment of mental disorders. By 1996, they were used in 77 percent of mental health treatment cases (Frank and Glied, 2005 tabulations from the Medical Expenditure Panel Survey). This trend has been accompanied by unprecedented rises in spending on prescription drugs generally and psychotropic medications specifically. The amount of money spent on psychotropic drugs grew from an estimated $2.8 billion in 1987 to nearly $18 billion in 2001 (Coffey et al. 2000, Mark et al. 2005), and the amount spent on psychotropic drugs has been growing more rapidly than that spent on drugs overall (IMS Health 2005). For example, spending on antidepressant and antipsychotic medications grew 11.9 percent and 22.1 percent, respectively, in 2003, whereas spending on drugs overall grew at 11.5 percent in 2003 (IMS Health 2005). Safety and Effectiveness of Psychotropic Medicines Essay.
The large shifts in the clinical and economic roles of prescription drugs have been affected by important institutional and policy changes in the general medical and mental health sectors. The expansion of insurance coverage for prescription drugs, the introduction and diffusion of managed behavioral health care techniques, and the conduct of the pharmaceutical industry in promoting their products all have influenced how psychotropic drugs are used and how much is spent on them.
Psychotropic drugs are receiving close scrutiny from health insurers, state budget makers, and ordinary citizens. Actions by the public policy and private sectors regarding prescription drugs can significantly affect clinical care, the cost of that care, and the prospects for future scientific advances and investment in drug development.
In this article, we analyze the economic and policy forces that have produced the high levels of utilization and spending on psychotropic drugs and consider policy issues related to these drugs’ influence on the access to and cost of mental health care, as well as the quality of that care. We begin by presenting data on the level and growth in utilization of and spending on psychotropic drugs. We then review the evidence on the reasons for the rapidly expanding use of these drugs. Safety and Effectiveness of Psychotropic Medicines Essay. Next, we review several public policy challenges and offer some ideas for state and federal policy in this area. Finally, we describe the key institutions governing the production and delivery of psychotropic drugs and how these institutions affect access to these drugs.
Growth in Utilization and Spending on Psychotropic Drugs
The rapid development of new products and the inclusion of the newer psychotropic drugs in the usual treatment for mental illness have translated into large increases in spending on them. Table 1 shows data based on estimates of expenditures on mental health care between 1987 and 2001 (Coffey et al. 2000, Mark et al. 2005). In 2001, the amount of money spent on psychotropic drugs to treat mental disorders was estimated to have been $17.8 billion, or 21 percent of all expenditures for the treatment of mental disorders. This represents more than a sixfold increase in nominal spending (without adjusting for inflation) since 1987. It also means that the amount spent on drugs has risen from a relatively modest share of total spending, 7.7 percent in 1987, to exceed the share of spending traditionally spent for physician services (Coffey et al. 2000). Since 1997, spending on psychotropic medications has outpaced spending on both health and drugs overall. By 2003, more than $18 billion was spent on antidepressant and antipsychotic drugs (IMS Health 2005). Between 1992 and 1997, the amount that the nation spent on psychotropic drugs grew at twice the rate of that spent on drugs overall (Coffey et al. 2000).
TABLE 1
National Expenditures on Psychotropic Drugs
| 1987 | 1992 | 1997 | 2001 | |
|---|---|---|---|---|
| Nominal spending | $2.77 billion | $3.83 billion | $9.04 billion | $17.83 billion |
| Percentage of mental health spending | 7.7% | 7.2% | 12.8% | 21.0% |
Source:Coffey et al. 2000, Mark et al. 2005.
In addition to the growth in spending on psychotropic medications, these drugs also have been playing a more central role in the treatment of mental disorders. Data from national household surveys in 1977, 1987, and 1996 (NMCES, NMES, MEPS) suggest that the treated prevalence of mental disorders (the percentage of the adult population receiving mental health treatment) climbed from 5.2 percent in 1977 to 7.7 percent in 1996 (Frank and Glied 2005). During the same time period, the rate of treatment of mental disorders with psychotropic drugs rose from 3.3 percent in 1977 to 5.9 percent in 1996. Safety and Effectiveness of Psychotropic Medicines Essay. Thus, in 1977 about 63 percent of people treated for a mental disorder were treated with drugs, compared with 77 percent in 1996. These data imply that essentially the entire increase in treated prevalence was due to the expanded use of psychotropic drugs for treating mental disorders.
The two largest (measured in sales) classes of psychotropic drugs are the antipsychotic and antidepressant agents. In 2003, sales of antipsychotic agents amounted to $8.1 billion, representing an increase in spending of 22.1 percent over that of the prior year (IMS Health 2005). In 2003, the sales of antidepressant medications in the selective serotonin reuptake inhibitor class (SSRI) and the serotonin-norepinephrine reuptake inhibitor classes (SNRI) were $11 billion, having grown 11.9 percent over the 2002 levels (IMS Health 2005). More recently, the growth in spending on antidepressants has accounted for 9 to 10 percent of the growth in pharmacy spending overall (Express Scripts 2001; NICHM Foundation 2002). Finally, the sale of antianxiety drugs came to about $2.5 billion in 2001, rising at a much lower average rate of 4 percent per year.
The growth in spending for these three classes of psychotropic drugs has been driven by the introduction of new products selling at higher prices and the greater utilization and higher prices of existing drugs. Overall, nearly half the increases appear to have been due to greater utilization. Roughly 28 percent of the increase was due to the changing mix of drugs (new products) used and 23 percent to the rising prices of existing products (Berndt 2002). The case of antipsychotic medication highlights the impact of products. The sale of atypical antipsychotic drugs (except clozapine) climbed almost 43 percent per year between 1997 and 2001, whereas the sales of traditional antipsychotic drugs and clozapine declined by 11 percent and 1 percent per year, respectively. Thus, overall it appears that all the growth in antipsychotic medication spending over this time period was due to changes in the price and volume of the newer drugs. Specifically, Medicaid spent five times more for antipsychotics in 2001 than it did in 1993, a trend driven mostly by a shift to the use of Zyprexa, Risperdal, and Seroquel (Duggan 2004). Indeed, in regard to Medicaid’s spending overall on prescription drugs, these drugs are now ranked first, second, and eighth, respectively. Safety and Effectiveness of Psychotropic Medicines Essay.
Why Has the Use of Psychotropic Drugs Grown?
In this section we examine the scientific, policy, and market forces that have contributed to the expanded use of psychotropic medications. Table 2 presents the types of pharmaceutical agents currently available and the mental disorders they treat. The drug classes that have been introduced since 1987 include the atypical antipsychotic drugs, SSRIs, SNRIs, and some of the anticonvulsants used to treat bipolar disorder. Given these new product classes, Table 2 serves to highlight how much new product areas have expanded the effective treatment options available to clinicians treating major mental disorders.
TABLE 2
Pharmacotherapy Classes and Mental Disorders
| Drug Class | Disorders |
|---|---|
| Antipsychotics | |
| Typical antipsychotics | Schizophrenia |
| Atypical antipsychotics | Schizophrenia, bipolar disorder |
| Antidepressants | Depression, anxiety disorders |
| Selective serotonin reuptake inhibitors (SSRIs) | |
| Tricyclic and heterocyclic antidepressants (TCA/HCAs) | |
| Monoamine oxidase inhibitors (MAOIs) | |
| Serotonin-norepinephrine reuptake inhibitors (SNRIs) and other antidepressants | |
| Stimulants | Attention deficit–hyperactivity disorder |
| Mood stabilizers | Bipolar disorder |
| Lithium | |
| Anticonvulsants | |
| Thyroid supplementation | |
| Antianxiety medications | Anxiety disorders |
| Benzodiazapines | |
| β-Adrenergic blocking agents | |
Gains in Efficacy and Effectiveness
One reason that psychotropic drugs are being used more is related to the clinical advantages offered by these new agents over older pharmacological treatments (U.S. Department of Health and Human Services 1999). Studies have found that SSRIs and tricyclic antidepressants (TCAs, an older class of antidepressants) are of comparable efficacy. Safety and Effectiveness of Psychotropic Medicines Essay. However, the surgeon general stated that SSRIs are safer, better tolerated by patients, and easier for clinicians to prescribe because they offer simpler dosing schemes, pose less danger from overdose, and have more tolerable side effects (U.S. Department of Health and Human Services 1999). (This conclusion would be sustained today, even though the FDA has issued a “black box warning” of a greater risk of suicidal thoughts in children and adolescents when taking any antidepressant medications.) Three meta-analyses in the 1990s found SSRIs and TCAs to be of comparable efficacy, but the SSRI treatments had significantly lower rates of patient dropout during the clinical trials (Anderson and Tomenson 1994; Le Pen et al. 1994; Montgomery et al. 1994; Song et al. 1993). Another recent meta-analysis found that the overall dropout rates from treatment with SSRIs was 10 percent lower than with TCAs (Anderson and Tomenson 1995). The same analysis also found that dropouts due to side effects were 25 percent lower with SSRIs, compared with TCAs.
A growing body of literature suggests that there are meaningful differences in the way patients take SSRIs as a result of their ease of use and more tolerable side effects. The evidence that SSRI recipients are more likely to take adequate doses of medication and adhere to the prescribed therapy compared with TCA recipients is consistent with the findings from studies of usual care that a higher percentage of patients receive evidence-based treatment when they use new agents (Katon et al. 1992; Montgomery et al. 1994; Simon et al. 1993). One example from this literature compared claims data from a state Medicaid plan for SSRI and TCA users and found better adherence to prescribed treatment by those taking newer antidepressants (Croghan et al. 1998). Those taking SSRIs and adhering to their prescribed treatment regimen substantially improved in the time to relapse or recurrence of depression. Other clinical studies have found that longer lengths of therapy and compliance with prescribed therapy are associated with improved work functioning and reduced likelihood of relapse or recurrence of major depression (Finkelstein, Berndt, and Greenberg 1996; Mintz et al. 1992). Safety and Effectiveness of Psychotropic Medicines Essay.
Although SSRIs are most often prescribed for depressive disorders, they also are used to treat a variety of other psychiatric conditions. Several have received FDA approval for these uses. In fact, some of the most significant clinical gains have come from using SSRIs to treat anxiety disorders, such as obsessive-compulsive disorder. While all SSRIs have antiobsessional effects, only Clomipramine among the TCAs has such properties. There also is growing evidence that SSRIs are effective in treating other anxiety disorders, such as panic disorder, social phobia, and posttraumatic stress disorder (USDHHS 1999).
Schizophrenia is another illness for which novel, pharmaceutical-based treatments have recently been introduced. There is an ongoing debate about whether the new generation of antipsychotic drugs are more efficacious for all patients with schizophrenia. An important exception to this debate, however, is the case of clozapine for patients with refractory schizophrenia (Lehman et al. 1998). For these patients (who account for nearly 30 percent of all patients with schizophrenia), clozapine is more efficacious than traditional antipsychotic agents (Chakos et al. 2001). Furthermore, the effect of the use of newer antipsychotics on schizophrenic patients’ quality of life has been well documented (Rosenheck et al. 1997). There also is widespread agreement that the generations of antipsychotic medications carry less likelihood of neurological (extrapyramidal) side effects. Patients also find them easier to tolerate (Rosenheck et al. 1997). There has been considerable public concern over certain side effects associated with the atypical antipsychotic agents. In particular, case reports note the risks of diabetes, weight gain, and hyperlipidemia. The research to date on the subject is quite mixed. Some studies show weight gain for two specific agents (clozapine and olanzapine) but not others; other studies show no differences; and some observe that the older drugs have higher risks (Allison et al. 1999; Lund, Perry, and Brooks 2001; Newcomer et al. 2002; Wirshing et al. 1999). The methods and data sources used are of varying rigor and reliability.
Expanding Insurance Coverage
The expanded insurance coverage for prescription drugs has also affected the growth in spending and use of psychotropic drugs. Since the late 1970s, insurance coverage for prescription drugs in the United States has grown substantially. Safety and Effectiveness of Psychotropic Medicines Essay. Despite the long history of differential insurance coverage of mental health services, prescription drugs for the treatment of mental disorders are generally covered at “parity” with other medical treatments. Today, all states offer prescription drug coverage to Medicaid recipients, including those dually eligible for both Medicare and Medicaid (Kaiser Family Foundation 2001a). Currently, although Medicare does not cover outpatient prescription drugs, most Medicare recipients have supplemental insurance (so-called Medigap plans), coverage through previous employers, or Medicaid (Gluck and Hanson 2001). In 2006, Medicare is to begin offering eligible recipients prescription drug coverage. Private insurance coverage of prescription drugs has expanded from covering 40 percent of enrollees in 1980 to covering 77 percent in 2000 (Kaiser Family Foundation 2001b). The U.S. Department of Veterans Affairs also provides prescription drugs for a sizable number of veterans each year.
The expansion of insurance coverage has reduced the financial burdens of treating mental disorders and has broadened the use of psychotropic medications. Tabulations from the 1977 National Medical Care Expenditure Survey (NMCES) and the 1996 Medical Expenditure Panel Survey (MEPS) show that the out-of-pocket share of spending on psychotropic drugs declined from 67 percent in 1977 to 34 percent in 1996. This was accompanied by more than a doubling of the number of prescriptions per user and a fivefold increase in total spending (Frank and Glied 2005).
Managed Behavioral Health Carve-outs
Those institutions that are responsible for managing medical care also have contributed to the expanded use of psychotropic medications. Specifically, as managed care has come to dominate the health care delivery system, the managed behavioral health care (MBHC) carve-out has gained a central place in the delivery of mental health care in both the private and public sectors. It is estimated that 60 to 72 percent of people covered by insurance are enrolled in managed behavioral health care arrangements (USDHHS 1999). In addition, as of 2002, 18 states had carved out mental health services for their Medicaid enrollees (Ling, Frank, and Berndt 2002). Carve-outs separate mental health and substance abuse care from the rest of the health insurance benefit and manage those services under a different contract with a specialty vendor. Carve-out contracts rely on economies of scale and specialization in order to provide greater efficiency. Safety and Effectiveness of Psychotropic Medicines Essay.
The typical MBHC carve-out manages inpatient, outpatient, residential, and intensive outpatient services but does not cover prescription drugs, which are paid for under the general medical benefit. In effect, prescription drugs are “free” inputs to the specialty mental health delivery system, and carve-out vendors have a strong economic incentive to substitute drug treatments for other mental health services when possible. They do this by making it easier for patients to obtain referrals for medication management and psychopharmacology than referrals for psychotherapy. The evidence to date suggests that drug spending has increased under carve-out arrangements with private insurance plans when compared with integrated delivery systems (Berndt, Frank, and McGuire 1997; Busch 2002; Rosenthal 1999). A recent study estimated that instituting carve-out arrangements in Medicaid raised the number of both antidepressant and antipsychotic prescriptions (Ling, Frank, and Berndt 2002). Safety and Effectiveness of Psychotropic Medicines Essay.
