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Roche and colleagues proposed but the concentration was very low cheap 100mcg proventil otc, and no adverse effects a model for an integrated addiction treatment strategy that were observed in the infants (68) cheap 100mcg proventil with mastercard. HIV infection is seen in incorporates harm reduction and use reduction with absti- about one-third of infants born to HIV-positive mothers purchase 100 mcg proventil fast delivery, nence and nonuse (75), in addition to other critical elements but this incidence can be reduced to about 10% if HIV- such as factors related to culture and gender. Additionally, positive pregnant women are given zidovudine before deliv- MacCoun provided a template for integrating harm reduc- ery (69). HIV can also be transmitted by breast-feeding, tion with prevalence reduction (discouraging the engage- and thus infant formula feeding is recommended for babies ment in drug use) and quantity reduction (encouraging the of HIV-positive mothers, except in some developing coun- reduction in frequency or extent of drug use) (76). Thor- With regard to opioids, much of the health-related harm ough washing of infants born to HIV-infected mothers im- from their improper or illicit use is secondary to elements Chapter 105: Treatment of Opioid Addiction 1515 other than the substances themselves (77). Funds saved from these hygienic methods of administration and poor injection cost reductions have often not been invested in outpatient technique are typically more serious than the constipation treatment. A good example is the VA, which administers or other side effects of the drugs themselves, acute overdoses the largest network of substance abuse treatment programs notwithstanding. With regard to opioid addiction treat- in the United States. Since the application of managed care ment, medications such as methadone, LAAM, and bupre- policies, the overall amount spent on substance abuse treat- norphine, among others (including supervised heroin sub- ment declined by 41%, from $597 million in 1993 to $351 stitution) used for maintenance agonist treatment, may be million in 1999. Measured as a percentage of overall VA considered harm reduction measures. All have the potential health care costs, specialized substance abuse care decreased to reduce morbidity, mortality, and crime associated with from 4. However, in this sense they are no differ- VA health care expenditures increased 10% between 1993 ent from other medical therapies such as those used for the and 1999 (85). Most of these reductions were achieved by treatment of hypertension, diabetes, or asthma. The result has been an overall reduction cates that these types of programs may have beneficial effects in the total number of veteran patients treated and in the in numerous areas, including a reduction in the spread of amount of drug counseling provided. As a result, no new blood-borne infectious disease such as hepatitis and HIV, methadone programs were opened in the VA despite the and acting as a conduit to more comprehensive drug-abuse recent increase in heroin addiction, evidence of waiting lists treatment services (78). In one study (79), the initiation for methadone treatment, and cities (such as Portland, Ore- and continuation of syringe exchange program participation gon) with serious heroin problems but no agonist mainte- among high-risk injection drug users were independently nance programs in spite of recent increases in heroin over- associated with a cessation of syringe sharing. Not all that changes in resource allocation have caused programs findings have been positive, however. In a study designed to become vulnerable to service disruptions, poor morale, to assess the association between risk behaviors and HIV burnout, and reduced motivation and quality of perfor- seroprevalence and incidence among injection drug users, mance and characterized by failures to maintain service lev- risk elevations for HIV associated with needle exchange pro- els in accord with the mandates of law (86). However, an examination of to integrate medical and psychiatric services into agonist potential bias in nonrandomized comparisons (82) sug- maintenance programs. Thus, both old and new pharmaco- gested that injection drug users participating in needle ex- therapies for opioid addiction described earlier are un- change programs at a given point may include a high pro- derused in the VA, the largest substance abuse treatment portion of persons whose pattern of drug use puts them system. There is every indication that penetration of these at greater risk for blood-borne viral infections. Further, a new treatments into the opiate treatment field at large has prospective cohort study found no evidence of a causal asso- also been slow. Harm reduction related to psychoactive substance abuse has gone through numerous stages. The current phase has SUMMARY been described as the development of an integrated public health perspective for all drugs in which a multifaceted, New pharmacotherapies, behavioral therapies, and treat- strategic approach is taken (84). The direction of this ap- ment strategies are being developed for opioid addiction. As described earlier, various treatments can be combined to IMPACT OF MANAGED CARE produce better patient outcomes. However, the overall ef- fect of these developments on addiction treatment and pub- Efforts to control costs by managed care have resulted in a lic health is very dependent on funding support, which has marked reduction in use of inpatient or residential treat- become a serious problem. Parity legislation may help to 1516 Neuropsychopharmacology: The Fifth Generation of Progress solve funding problems and result in the expansion of treat- 19.

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During the second trial with depot fluphenazine in which a dose–response rela- year effective proventil 100 mcg, no additional relapses occurred on clozapine order proventil 100mcg overnight delivery, whereas tionship only emerged during the second year of follow-up the rate of relapse on risperidone increased from roughly (121 purchase 100 mcg proventil with visa,122). Depot preparations have significantly lowered 13% to 34%. In the only published comparison between relapse rates by an average of 15% compared to oral neuro- risperidone and olanzapine, rates of exacerbation (increase leptics in six double-blind, randomized trials (123). The in PANSS score by 20%) were significantly higher at 28 advantage of depot administration may be understated in weeks in patients who had responded to risperidone (mean these trials, however, because research subjects were proba- dose 7 mg per day) compared to olanzapine (mean dose 17 bly poorly representative of typical clinical samples and most mg per day) (63). It will be important to determine whether specific drugs differ in prophylactic efficacy against relapse trials did not extend beyond 1 year. Research comparing when compliance is controlled and issues of dosing equiva- low and standard-dose maintenance with depot neuroleptics lence are addressed. It is possible that clozapine and perhaps has demonstrated a trade-off between adverse effects with other atypical agents are more effective in suppressing re- higher doses, including neurologic side effects and dys- lapse; this effect may be relatively independent of antipsy- phoria, versus increased relapse rates with lower doses (122, chotic efficacy and mediated by different neurotransmitter 124). Continued development of psychosocial interven- with an unacceptable rate of hospitalizations, whereas re- tions to improve compliance and monitor and respond to lapses associated with low-dose depot medication generally early signs of relapse will be equally important. Carpenter and colleagues (125) reported that adminis- A diverse range of psychosocial interventions has been tration of diazepam at the earliest sign of exacerbation in shown to reduce relapse rates. In over 20 controlled trials, medication-free patients was more effective than placebo family therapies emphasizing psychoeducation and support and comparable to fluphenazine in preventing relapse. This have reduced relapse rates for schizophrenia patients who work suggests that lower doses of depot neuroleptic may have regular contact with family members (129,130). Al- provide acceptable protection against relapse if accompanied though differences in theoretical orientations and intensity of treatment have not produced consistent differences in by close monitoring and rapid psychosocial and pharmaco- efficacy, recent evidence has suggested that multiple-family logic intervention at the first sign of relapse. These measures psychoeducation groups may be particularly effective (131). Social skills training improves role functioning trial, Essock and colleagues (126) found that chronically of patients with schizophrenia, but has not substantially hospitalized patients randomized to clozapine were not reduced symptoms or reduced relapse rates compared to more likely to be discharged than patients receiving treat- control conditions in most studies (134). In an illuminating ment as usual, but once discharged, relapse rates were signif- study, Herz and colleagues (135) found that a relatively icantly lower with clozapine. Pooled results from three dou- simple, weekly monitoring of schizophrenia patients in psy- ble-blind extension studies revealed that relapse rates were choeducation groups in conjunction with the availability of significantly lower with olanzapine (20%) compared to rapid pharmacologic and psychosocial interventions at the haloperidol (28%) in patients with schizophrenia and re- first sign of decompensation substantially reduced relapse lated psychoses (97). Until depot preparations of atypical rates, by approximately fourfold, compared to treatment as agents are available for study, it will be difficult to determine usual. It is clear from depot Pharmacotherapy neuroleptic studies that large numbers of patients relapse despite adequate compliance; relapse in medication-com- Cramer and Rosenheck (136) surveyed the literature on pliant patients is often associated with depression and re- antipsychotic medication and found that compliance rates 784 Neuropsychopharmacology: The Fifth Generation of Progress averaged 42%. Similar surveys have not been conducted hospitalizations. In a randomized, controlled trial, compli- looking specifically at atypical agents, although it is gener- ance therapy was found to improve insight and observer- ally believed that reduced relapse rates reported with olan- rated adherence to treatment over an 18-month treatment zapine and clozapine may reflect, in part, improved compli- period (147). Patients in the compliance therapy group also ance (97,126). Compliance can be compromised by Cramer and Rosenheck (148) demonstrated that interven- psychosis, agitation, and comorbid substance abuse (137, tions that assist patients in remembering to take medica- 138). Van Putten (139) studied compliance in 85 schizo- tions, such as placing microchip schedulers on pill bottles, phrenia patients chronically treated with conventional neu- can also substantially improve compliance. Medication refusal was associ- Treatment Resistance ated with an early dysphoric response, which Van Putten attributed to subtle akathisia. Analysis of responses by 150 Estimates of the incidence of treatment resistance have var- schizophrenia patients to a 'Drug Attitude Inventory' re- ied with changes in the diagnostic classification of schizo- vealed that, based on responses to 10 items, 89% of patients phrenia and definitions of treatment response (149), which could be correctly assigned to compliant versus non- have tended to obscure potential improvements in outcome compliant categories as determined by clinician assessment associated with advances in pharmacologic and psychosocial of compliance (140). For example, Hegarty and colleagues (150) re- was a positive experience with medication—this factor ac- viewed results of 320 clinical trials and found that, since the counted for 60% of the total variance, whereas the factor introduction of modern antipsychotics in the mid-twentieth representing a negative subjective experience accounted for century, about 50% of patients were improved at follow- 12%. Factors representing attitudes and beliefs about medi- up, whereas the rate of improvement dropped to 35% in cation had minimal predictive power. Rates of response have tended to be higher in first- Whereas many clinicians expect atypical agents to achieve episode psychosis, although dropout rates have been high higher levels of compliance by virtue of reduced or absent in this population, particularly with conventional agents EPS, this view may seriously underestimate the impact of (102,107). Persistence of psychotic symptoms is more com- other side effects. Two studies have found that clinicians mon in drug trials involving chronic patients, presumably tend to misjudge the relative distress produced by different reflecting progression of the illness as well as a possible selec- medication side effects (142,143).

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In many cases making a clear distinction viewed as well as the instruments for evaluating humanistic between these consequences of pharmaceutical use is proba- outcomes in mental health care populations cheap 100 mcg proventil with visa. For example generic proventil 100mcg without a prescription, a score PHARMACOECONOMICS on a depression inventory is probably closer to an intermedi- ate variable purchase proventil 100 mcg amex, whereas events such as rehospitalization or sui- In the current health care environment, many decisions are cide reflect the 'end results' or outcomes one would like driven by costs. Although Chapter 39: The Role of Pharmaceuticals in Mental Health Care Outcomes 527 the fraction of the health care dollar spent on pharmaceuti- tion, then the decision is based entirely on the costs of the cals is low, it is clear that as both the pressure to reduce inputs. The classic example of a cost minimization analysis costs and the percentage of health care dollars spent on is the use of generic versus branded products. If the chemical pharmaceuticals grow, so does interest in the costs of medi- entities and formulations are identical, then there is no rea- cations. Economists, however, are quick to point out that son to suspect that the outcomes associated with the use of the acquisition cost of the pharmaceutical is not the most either product would be different. In this case, the decision appropriate unit of analysis. It is possible that the acquisition is based solely on the costs of the inputs. The difficulty with cost of many pharmaceuticals may be offset by reductions cost-minimization analysis is establishing that outcomes are in other more expensive forms of care. Even in the case of generic pharmaceuticals there are expensive atypical antipsychotic leads to reductions in hos- examples where alternative formulations have been ques- pitalizations, then the 'value' of the pharmaceutical from tioned. Additionally, products may be equivalent on some a total cost perspective is greater than the acquisition cost outcomes such as clinically significant improvement in of the pharmaceutical. This is a key idea behind pharmaco- depression, but not with regard to others such as side-effect economics. These natural units may include outcomes such as Studies are typically categorized by whether they consider years of life saved, hospitalizations avoided, or scores on a costs, outcomes, or both cost and outcomes. For example, traditional clinical trials vere disease state. This information was incorporated into focus on comparing the consequences of alternatives when a Markov state transition model to compare the cost-effec- one of the alternatives is typically a placebo. In many cases it is possible a regulatory agency striving to meet its special mandate, to develop several cost-effectiveness ratios for a comparison from the perspective of many health care decision makers a of relevant treatment alternatives. For example, in a compar- comparison with placebo is meaningful only if it is a relevant ison of atypical and conventional antipsychotics, cost-effec- treatment alternative. Pharmacoeconomic studies best pro- tiveness ratios such as cost per hospitalization avoided, cost vide a comparison of relevant alternatives. Other studies may also con- A recent cost-effectiveness study for the treatment of sider consequences. In these cases the study would describe depression provides an excellent example of how decision both the costs and consequences of a single alternative lead- makers can utilize these tools to best allocate scarce re- ing to a cost-outcome description. Nuijten and colleagues (8) developed a Markov compared but only costs are considered, then the study is process to model the cost-effectiveness of long-term treat- a cost evaluation. However, the primary concern of pharma- ment with a new antidepressant compared to standard treat- coeconomics is the comparison of both costs and conse- ment with TCAs. The outcomes were time without depres- quences simultaneously for two for more relevant alterna- sion, direct costs, and indirect costs (lost workdays). There are four specific techniques that are typically data were obtained from the published literature and costs used when conducting pharmacoeconomic studies (20): were measured from the perspective of the German health care system. The new antidepressant was found to be associ- Cost-minimization analysis ated with a 1. In Cost-utility analysis this case the new drug was less costly and more effective; Cost-benefit analysis thus by definition it is a more cost-effective choice. In each of these cases the numerators are the costs of Cost-utility analysis is a special case of cost-effectiveness inputs for a given decision. For example, if the total cost analysis, in which the denominator is quality-adjusted life of care for the treatment of depression is considered, input years (or something conceptually similar). The quality-ad- costs might include cost of drug, cost of physician visits justed life year may, for example, be calculated using patient (family practitioner, internist, and specialist), behavioral utilities (from zero to one) for being in a given health state therapy, hospitalization, and emergency department use. This analysis priate outcomes or consequence must be specified in the benefits from combining length of life with quality of life.

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Measurement of 24-hour urinary creatinine clearance improves the accuracy but is also subject to the same non-renal and analytical influences compounded by inaccuracies in urine collection discount proventil 100 mcg amex, to say nothing of the inconvenience associated with 24-hour urine collections buy proventil 100 mcg. An alternative and more accurate endogenous marker is cystatin C discount 100mcg proventil with amex, a 13 kDa cationic protein produced by all nucleated cells. Serum cystatin C levels are chiefly determined by GFR. Potential limitations of cystatin C as a marker of GFR include lack of assay standardisation, the requirement for a dedicated analytical system, and increased costs relative to serum creatinine (approximately £3/assay compared to <£0. A further alternative is to measure serum creatinine and estimate GFR using an equation which corrects for some of the more significant non-renal influences. This approach is known to be more sensitive for the detection of CKD than serum creatinine and more accurate than creatinine clearance. The SIGN guidelines32 recommended use of prediction equations in place of 24-hour creatinine clearance or serum creatinine alone and preferred prediction equations to cystatin C on the grounds of practical and resource considerations. The Modification of Diet in Renal Disease (MDRD) equation was preferred to the Cockcroft-Gault formula. The UK CKD guidelines and the UK consensus conference recommended use of the 4-variable MDRD equation using zero biased creatinine methods. For studies comparing the MDRD predictive equation with other equations, the serum creatinine measurements had to be calibrated to the MDRD laboratory reference standard. Two exceptions to the sample size cut-off were the studies that evaluated the GFR equations in older people. Five studies40–44 that evaluated the accuracy of serum cystatin C were excluded because gold standard tests were not used as the comparator or because creatinine (the MDRD equation) was not calibrated properly to the MDRD laboratory reference values. Nine studies38–41,45–49 that evaluated the accuracies of predictive equations in estimating GFR were excluded due to methodological limitations or because the serum creatinine measurements were not calibrated to the MDRD assay as determined by isotope-dilution mass spectrometry. Five studies50–54 assessing the accuracies of the MDRD equation and the Cockcroft-Gault equation in predicting the glomerular filtration rate were included. These were conducted in large sample sizes (N=219 to 2095) and were quite heterogeneous in terms of the population studied: older populations, diabetic nephropathy, mild renal impairment, moderate renal impairment, or healthy populations. Differences in performances of the equations may be explained by the different populations in which the equations were derived, and multiple sources of measurement variation when measuring creatinine. The estimated reagent costs for some of the tests were presented to the GDG. Cystatin C was the most expensive followed by the creatinine-based technology. However these costs do not take into account all overheads. Furthermore, there are economies of scale if reagents are used in large quantities. The values of several diagnostic parameters are summarised in Table 4. Bias was greater CG (43%) in across the People with for MDRD equation stage 5 CKD 5 stages of CKD GFR <60 ml/min/ (–6. The MDRD equation was less biased than the Cockcroft-Gault equation in patients with stage 3, 4, or 5 CKD. The MDRD equation was significantly less biased than the Cockcroft-Gault equation when patients were analysed by age (above or below 65 years) and gender (p<0. Two studies50,52 showed that both the MDRD and Cockcroft-Gault equations correlated highly with the measured GFR in people with CKD, often with no statistical difference between the correlation coefficients for the MDRD and Cockcroft-Gault equations. Both MDRD and Cockcroft-Gault equations correlated poorly with the gold standard test in renal donors. The Cockcroft-Gault equation often overestimated the GFR. The MDRD equation was also significantly less biased than the Cockcroft-Gault equation in the nondiabetic CKD (N=579) subgroup, the diabetic CKD (N=249) subgroup, and in people with a measured GFR <30 ml/min/1. The MDRD equation underestimated the measured GFR, while the Cockcroft-Gault equation significantly overestimated the GFR (–3. In the kidney donor control group (N=459), the Cockcroft-Gault equation was superior to the MDRD equation in terms of bias (1. The MDRD had higher sensitivity than the Cockcroft-Gault equation.

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