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Various forms of this treatment have been stud- Concerns should include whether a patient has ied in the United States and found to be safe been using illicit drugs or taking other medica- and efficacious (King et al cheap amantadine 100 mg with amex hiv infection rates us map. Patient selection for this treatment option should focus on a history of negative drug tests cheap amantadine antiviral chicken pox, One dose missed purchase amantadine on line antiviral resistant herpes. Outcomes have been out of treatment for a significant time and uniformly positive purchase amantadine once a day antiviral medication for cats, with few relapses and little might have lost tolerance, dosage reduction or or no diversion reported (King et al. Level of care refers to the intensity of a ChapterÖ treatment (in terms of frequency, type of serviceóindividual, group, familyóand medication) and the type of setting needed for treatment Steps in delivery. The chapter also provides information on developing a treatment plan with short- and long-range goals for each patient. In general, patientñtreatment matching involves individualizing, to the extent possible, the choice and application of treatment resources to each patientís needs. The chapter explains recommended elements of a patientñtreatment-matching process, including ways to accommodate special populations with distinct needs and orientations that affect their responses to specific treatments and settings. Many also have co-occurring medical and mental health conditions that can be lifelong. M utual-help program s Steps in Although not a form of treatment, mutual-help programs (e. Such pro- Patient Assessm ent grams provide social support from others who Patientñtreatment matching begins with a thor- are in recovery from addiction (W ashton 1988). However, patients with opioid are matched to appropriate levels of care and addiction who are maintained on treatment types of services. Assessment should include medication can feel out of place in some group the extent, nature, and duration of patientsí settings where continued opioid pharmacother- opioid and other substance use and their treat- apy may be misunderstood. Researchers have ment histories, as well as their medical, psychi- described a variety of specialized groups and atric, and psychosocial needs and functional inventive strategies for mutual-help programs status. Chapter 8 presents some of language, motivation to comply with treatment, these strategies. Some programs may provide psy- and behavioral needs as part of addiction chosocial services to patients in other settings. Based on its assessments of patients, withdrawal or residential treatment programs), the treatment team should collaborate with and those who require opioid pharmacothera- patients to determine the most appropriate py for long-term stabilization. Therefore, medical and psy- required to help treatment matching in some cases can lead to chosocial treatment multiple settings for an individualís treatment. For all phases of treatment and at most levels of example, one report from a 16-month prospec- care. At this writing, settings, such as those described below, for ser- the number of hospital-based programs offer- vices that match patient needs. A work in conjunction with fixed-site outpatient residential treatment programs that offer medical care and counsel- The success of setting is indicated ing and other psychosocial services, while for patients who medication is delivered via the mobile units. Such patients gener- only for patients who meet State and Federal accessibility as a regulations for weekend take-home medications. In these settings, patients sive outpatient pro- receive the same level of monitoring and inter- grams (Margolis and vention as patients receiving other types of Zweben 1998). Other corrections facilities provide rapid Disorders medically supervised withdrawal from mainte- If a serious medical condition is discovered nance medication to patients. Chapters 3 and 5 provide more details about Many studies have focused on the co- the pharmacology and appropriate use of occurrence of substance use and mental methadone, levo-alpha acetyl methadol, disorders (see chapter 12). Most treatment planning, implementation, and staff members can be trained to recognize and referrals should address the distinct needs of flag major symptoms of co-occurring disorders. PatientñTreatm ent M atching 91 Patients W ith Housing, Fam ily, treatment options for patients with disabilities (Fiellin and OíConnor 2002; Greenfield et al. Such discussions or dysfunctional family relationships should balance the medical needs of these patients and the safety issues involved in pro- ï Poor social skills and lack of a supportive viding take-home medications for patients with social network disabilities who continue to engage in substance ï Unemployment; lack of employable skills. Case peer affiliations, and aspects of the ìyouth management duties should include arrange- cultureî require staff training and special ments for provision of psychosocial care when expectations from both staff and patients. These youth may be more dif- tions for these patients usually include voca- ficult to evaluate, because, as a result of other tional rehabilitation, physical therapy, and modes of administration (i. Some needs are related to identity for- for persons with disabilities (see chapter 10). Buprenorphine may be a particularly satisfac- tory treatment for some adolescents. Providers onsite childcare should help patients obtain appropriate medi- opioids for pain services are available cal care and secure their safety if, for example, in few programs they are threatened. Providers need education working with elderly patients: about maintaining current opioid levels while ï Monitoring the increased risk for dangerous adding sufficient immediate-release treatment drug interactions; elderly patients often are agents to manage acute or chronic pain. Referrals to specialty pain clinics and symptoms and disorders associated with often provide patients a full spectrum of pain aging (including dementia) (Lawson 1989). These services most often are acces- ï Screening for and treating physical and sible through hospital-based programs or refer- sexual abuse (see chapter 4). Based on a thorough patient denied medication for acute or chronic pain history and assessment, a treatment plan management (Compton and Athanasos 2003). Good treatment plans contain both short- drug-seeking behavior, in part because of and long-term goals and specify the actions patientsí higher tolerance for opioids and, usu- needed to reach each goal. Treatment plans should contain specific, choices, cultural background, age, and medical measurable treatment objectives that can be status or disability. Other factors in plan Role of the counselor in plan form ulation form ulation Treatment plans should incorporate an Counselors should ensure that treatment plans assessment of linguistic and cultural factors incorporate strategies to develop therapeutic that might affect treatment and recovery either relationships with patients, based on respect positively or negatively (U. Department of for patientsí autonomy and dignity, while Health and Human Services 2001). This role, patients to identify health-related cultural which places great responsibility on the coun- beliefs, values, and practices and to decide how selor, usually incorporates cognitive behavioral to address these factors in the treatment plan approaches in which providers strive to (U. Department of Health and Human enhance patient motivation for change by Services 2001). To engage M otivation for treatm ent patients in the process of treatment planning, counselors should encourage the inclusion of Patient motivational strategies should be incor- motivational enhancement strategies that high- porated throughout the treatment plan. As part light appropriate, realistic treatment goals (Di of this process, the treatment team can benefit Clemente 1991). Research has shown that con- from an understanding of stages of change and frontational counseling or the use of negative their effects on patient progress. Prochaska contingencies often predicts treatment failure and colleagues (1982, 1986, 1992), who formu- (Miller and Rollnick 2002). Patients determined by identifying the patientís stage-of- who agree with the treatment rationale or ther- change readiness. The stages-of-change model apeutic approach tend to experience increased and corresponding counseling responsibilities determination to improve (Hubble et al.
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Generally order amantadine 100mg amex antiviral yonkis, conditions that began more than 1 year after the administration of study drug were not considered related to study drug buy amantadine line hiv infection gay. For this analysis order amantadine 100mg line anti viral hpv, all classification categories of drug relatedness were combined 100 mg amantadine with mastercard antiviral use in pregnancy. It should be noted that arthritis was summarized in a descriptive fashion with other adverse events. Additionally, due to coding conventions, decreased range of motion and movement in the hip coded to movement disorder, therefore, all events of movement disorder (08020760) were also reviewed. Due to coding conventions, ankle and hand swelling are coded to peripheral edema (02030425), so these events were added for review. Selected accidental injuries (01030015) were reviewed if they related to joints or the extremities. Clinical Reviewer’s Comment: At the end of the study, 116 patients were identified using the arthropathy algorithm. Four patients were removed due to changes or clarifications in the data, which modified the adverse events such that they no longer fit the definition of arthropathy). An additional 21 patients were identified by the applicant, who were not already identified by the algorithm. Of the 689 patients, 337 were in the ciprofloxacin group, and 352 were in the comparator group. As shown, 58 ciprofloxacin and 56 comparator patients did not complete study drug as planned. The most common reason for discontinuation was protocol violation (9% in each group). The majority of these protocol violations were absence of a causative organism (negative culture or no urine culture obtained), insufficient colony counts, and organisms resistant to study drugs. There were more ciprofloxacin patients (10) than comparator patients (5) who discontinued therapy due to adverse event. The two treatments groups had very similar rates of discontinuation due to the other reasons. Overall, 307 (92%) of ciprofloxacin patients and 314 (90%) of comparator patients completed 1-year post-treatment follow-up. For 5 patients (2 ciprofloxacin, 3 comparator), it could not be confirmed that any study medication was taken. There were 82 patients who were valid for safety, but not efficacy between the two arms. The clinical significance of these findings is difficult to pinpoint, but may have to do with investigators not adequately screening patients prior to enrollment or following the protocol. The potential for patient unblinding was relevant since study drug was dispensed in commercial packages and since the study drugs have different tastes and textures and different solutions (oil-based for ciprofloxacin, water-based for the comparator). At the request of the Division, an item was added to the Caregiver Questionnaire as to whether the patient/caregiver believed they knew which study drug that they received. Overall, 29 ciprofloxacin patients and 19 comparator patients answered “yes” to this question. Overall, 17 ciprofloxacin patients and 11 comparator patients answered the follow-up question. Of those patients, 10 (59%) ciprofloxacin patients and 6 (55%) comparator patients correctly identified study drug. Clinical Reviewer’s Comment: Although unblinding was a potential problem, very few patients thought they knew which study drug they received and only about half of them correctly identified study drug. Therefore, patient unblinding is not considered by the reviewer to have significantly affected the study. Valid for Safety (Intent to Treat population): Two patients in the ciprofloxacin group and 3 patients in the comparator group were randomized but it could not be confirmed by the applicant that they received study medication. Therefore, there were 335 patients in the ciprofloxacin group and 349 patients in the comparator group valid for the analysis of safety. Therefore, the valid for efficacy population included 442 patients total, 211 in the ciprofloxacin group and 231 in the comparator group. Protocol violations (28 in the ciprofloxacin group and 25 in the comparator group) included the following: • Clinical symptoms assessed outside (either too early or too late) of the Test-of-Cure visit window (Day +5 to +9) (24 ciprofloxacin group versus 21 comparator group) • Test-of-Cure visit was actually performed during the study drug administration period (3 ciprofloxacin group versus 2 comparator group) • Elevations in liver enzyme test pre-therapy (1 each in the ciprofloxacin group and the comparator group) • Pre-therapy urine culture was not obtained (1 patient in the comparator group) The following patients were inclusion/exclusion criteria violations, but the applicant allowed them to remain in the study and analysis populations: Five patients were enrolled despite the fact they were non-ambulatory at baseline. Additionally, 1 ciprofloxacin patient (301-100) had a severe baseline gait abnormality (later diagnosed as Duchenne’s disease). Patients with known underlying rheumatological disease, joint problems secondary to trauma or pre-existing conditions known to be associated with arthropathy were to be excluded from the study. Overall, 27 (8%) ciprofloxacin patients and 26 (7%) comparator patients had a medical history of any abnormal musculoskeletal or connective tissue finding. At study entry, 28 ciprofloxacin patients and 12 comparator patients had an abnormal gait assessment at baseline and 10 ciprofloxacin patients and 7 comparator patients had an abnormal joint appearance at baseline. These baseline abnormalities and medical histories may have rendered it difficult to assess any potential drug effect on gait or joint appearance. As per the caregiver questionnaires, 8 patients (3 ciprofloxacin [16001, 401074, 701034], 5 comparators [103015, 204035, 307008, 705010, 705017]) had a baseline history of seizures. These patients should have been excluded as they could have been placed at risk for seizures during therapy. Additionally, Patient 307-008 was receiving phenytoin concomitantly with study drug. Clinical Reviewer’s Comment: These baseline abnormalities make an assessment of the potential adverse effects of the drug on the musculoskeletal and neurologic systems difficult. However, given the small numbers and the roughly equal distribution across the two treatment groups, the overall impact on the interpretation of safety is minimal. Therefore, these patients will remain in the reviewer’s valid for efficacy population and will be noted for patients assessed to have arthropathy. The majority of patients enrolled are female (85% in the ciprofloxacin arm and 86% in the comparator arm). Of note, three race groups contributed the vast majority of patients: Caucasian, Hispanic and “uncodable. None of the differences between treatment groups was determined to be statistically significant, and in general the distribution of demographic variables was similar in the two groups, although there were more patients in the ciprofloxacin group than in the comparator group with severe infections (7% versus 3%). For more complete information on the enrollment of patients by age group, see Table 11. None of the differences between treatment groups was determined to be statistically significant, and in general the distribution of demographic variables was similar in the two groups, although there were more patients in the ciprofloxacin group than in the comparator group with severe infections (7% versus 4%). The distribution of patients by age group in the valid for efficacy population is shown in Table 11. Patients less than or equal to 5 years comprised 51% (108/211) of patients in the ciprofloxacin group and 43% (99/231) of patients in the comparator group. The rates of use of anti- inflammatory and antirheumatic products in the musculoskeletal system were lower in the ciprofloxacin group (9% versus 12% comparator) as were the rates of use of analgesics (14% versus 19% comparator) in the nervous system. The remaining rates of use of each medication class were fairly consistent in the two groups.