1,721,022 research outputs found
Effectiveness of Compounded Bioidentical Hormone Replacement Therapy: An Observational Cohort Study
Full text linkAbstract Background Bioidentical Hormone Replacement Therapy (BHRT) is believed it to be a safer and equally effective alternative to Conventional Hormone Therapy for the relief of menopausal symptoms; however, data are needed to support these claims. The objective of this study is to evaluate the effectiveness of compounded BHRT provided in six community pharmacies. Methods This was an observational cohort study of women between the ages of 18-89 who received a compounded BHRT product from January 1, 2003 to April 30, 2010 in six community pharmacies. Data included patient demographics, comorbidities, therapeutic outcomes, and hormone therapies. Women self-rated menopausal symptoms as absent, mild, moderate, or severe. Descriptive statistics were used to characterize the patient population, BHRT use, and adverse events. Patient symptom severity was compared at baseline and 3 to 6 months follow-up using the Wilcoxon signed-rank test. Results Women (n = 296) receiving BHRT at Oakdell Pharmacy had a mean (standard deviation) age of 52 (9) years. The most common BHRT dosage forms utilized were topical (71%) and oral (43%). Compounded BHRT regimens were generally initiated at low doses regardless of route. Women experienced a 25% decrease in emotional lability (p Conclusions This study demonstrates that compounded BHRT improves mood symptoms. Larger studies are needed to examine the impact on vasomotor symptoms, myocardial infarction and breast cancer.</p
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Use of antihypertensive agents and the incidence of Type 2 diabetes: a retrospective analysis
No full texttextThe effect of major antihypertensive medications on blood glucose and newonset
diabetes was assessed using medical data from the Central Texas Veterans
Health Care System (CTVHCS). Veterans were followed for an average of 3.6 years
(total of 51,549 person-years) between 1995 and 2004. The average age of the
participants (N=11,187) was 60.7 (SD: 12.7) years; the majority (78.7%) were =50
years of age, White (73.8%) males (95.3%). Commonly used antihypertensive
therapies appeared to increase veterans’ blood glucose levels significantly more than
what was observed in the control group; i.e., patients who were not treated with
medications. The only exception was beta-blocker therapy, which showed similar
effect to the control group. Presence of impaired glucose tolerance, higher BMI,
“high risk” therapies, and dyslipidemia at baseline significantly increased the risk of
developing diabetes. Non-thiazide ‘diuretics’ were associated with the highest risk
as indicated by a hazard rate of 1.48 (95% CI: 1.21-1.80). Statistically significant,
protective effect was found with ‘alpha-blocker’ therapy: 23 percent reduced risk to
develop diabetes (95% CI:0.63-0.93). When ‘dual’ and ‘three or more therapies’
were included into the model, the effect of ‘alpha-blockers’ became non-significant
(p=0.196); whereas ‘ACEI’ and ‘CCB’ therapies became significantly associated
with an increased risk for diabetes (p-values: 0.003 and 0.008, respectively). The
corresponding hazard rates were 1.29 (95% CI: 1.09-1.53) and 1.26 (95% CI: 1.06-
1.50), respectively. The simultaneous use of three or more antihypertensives
appeared to be protective against the development of new-onset diabetes (hazard
rate: 0.60; 95% CI: 0.43-0.83; p=0.002).
This finding conflicts with the majority of previous studies and may have
been the result of selection bias (also called “channeling”), in which patients with
higher baseline ris k to develop diabetes were “channeled” towards ACEIs and CCBs
and away from beta-blockers. Several animal and small clinical trials showed the
beneficial effect of ACEIs on carbohydrate metabolism, so our findings might have
been the result of confounding by uncontrolled risk factors, such as genetic
predisposition for diabetes, lifestlyle habits, and other unmeasured biological
differences.Pharmaceutical Science
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Patient experience and factors influencing willingness to utilize the emergency department among individuals living with sickle cell disease
Full text linkThe purpose of this study was to describe the experiences of patients with sickle cell disease (SCD) in the emergency department (ED), and to determine the factors that influence their willingness to use the ED when in pain. This study tested the significance of the Theory of Planned Behavior (TPB) constructs (attitude, subjective norms, and perceived behavioral control) in predicting intention (willingness), and the contribution of additional constructs (prior patient experience and stigma) to the TPB model. The relationships between study constructs and covariates were also assessed. This mixed-methods study sample included SCD patients ≥ 18 years who had previously used the ED. For the qualitative portion, three focus group sessions (N=21 participants) were conducted to elicit the salient beliefs regarding patient experience when seeking care for pain in the ED. Salient beliefs were elicited by asking nine open-ended questions to assess the indirect constructs of the TPB (behavioral beliefs (BBs), normative beliefs (NBs) and control beliefs (CBs)). Eleven BBs, four NBs and ten CBs were identified as salient. The quantitative portion was conducted using a web-based survey that was developed using the TPB constructs and salient beliefs from the focus groups. A total of 114 survey responses were included in the data analyses. Data analyses were conducted using descriptive, bivariate and multivariate methods. The overall TPB model was significant and explained 61% of the variance in participants’ willingness to use the ED while in pain (adjusted R² =0.6102, p<0.0001). Of the TPB constructs, only attitude (b=0.57, p<0.0001) was significant while subjective norms and perceived behavioral control were not significant. ED use was the only significant covariate (b=0.57, p=0.0005). The additional constructs prior patient experience and stigma did not significantly contribute to the TPB model. The findings from this study support the utility of the TPB in describing the experience of SCD patients in the ED, and in predicting the factors that influence their willingness to use the ED when in pain. Interventions that focus on SCD patients’ attitude may be beneficial in increasing their willingness to use the ED when in pain.Pharmaceutical Science
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Safety, effectiveness, and cost among Texas Medicaid patients with Diabetic Macular Edema (DME) or Age-Related Macular Degeneration (AMD)
Full text linktextAlthough bevacizumab is one of the most commonly used treatments for DME and AMD, there are concerns regarding safety and effectiveness due to its off-label use. The study objectives were to determine if: 1) the risk of cardiovascular/ hemorrhagic events (safety) and visual impairment (effectiveness) differed by bevacizumab use (i.e., use vs. non-use and number of treatments) among DME and AMD patients; and 2) direct medical costs differed between DME and DME control patients. A retrospective cohort analysis was conducted with Texas Medicaid medical and prescription data (9/1/07-12/31/12) for patients: 18- 63 years, continuously enrolled 1-year pre- and post-index, and diagnosed with DME or AMD. The index date was the first date of diagnosis. The dependent variables were: 1) cardiovascular/hemorrhagic risk; 2) visual impairment; 3) direct medical costs. The independent variables were bevacizumab use and number of bevacizumab treatments. Covariates were disease state, Charlson Comorbidity Index (CCI) score, total medication use, number of laser treatments, and demographics. Propensity scoring technique was used to match: 1) bevacizumab users and non-users; and 2) DME and DME control cohorts. Descriptive analyses, logistic regression, Cox-regression, and generalized linear models were employed. A final cohort of 3,647 DME, 297 AMD, and 57,897 DME control patients were included. The majority (DME and AMD) was between 45-63 years of age (86.6%), Hispanic (54.0%), and female (65.1%). The mean total number of unique medications and mean CCI were 2.7 ± 3.4 and 6.0 ± 3.3, respectively. Total direct medical costs/person (Mean (±SD)) incurred by DME, DME control, and AMD subjects in the post-index period were 5,495(±10,153), and $4,935(±12,702), respectively. No differences in cardiovascular/ hemorrhagic risk were found between bevacizumab users and non-users. The claims data lacks the detail to determine the effectiveness of bevacizumab. DME control patients had lower overall direct medical costs than DME patients (p<0.0001). In conclusion, although bevacizumab is a less expensive off-label alternative of ranibizumab, the choice between bevacizumab and ranibizumab should be made through careful consideration. However, as the use of anti-VEGF agent increases, further research should be conducted to determine if any changes in cardiovascular adverse events occur.Pharmaceutical Science
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Medication adherence, persistence, switching and dose escalation with the use of tumor necrosis factor (TNF) inhibitors among Texas Medicaid patients diagnosed with rheumatoid arthritis
Full text linktextThe main purpose of this study was to evaluate medication use patterns (i.e., dose escalation, medication adherence, persistence, and switching) of rheumatoid arthritis (RA) patients on etanercept (ETN), infliximab (IFX) or adalimumab (ADA) and the associated healthcare utilization costs using Texas Medicaid data. Study participants were Medicaid beneficiaries (18-63 years) with an RA diagnosis (ICD-9-CM code 714.0x) who had no claim for a biologic agent in the 6-month pre-index period (July 1, 2003 - Dec 31, 2010). The index date was the first date when the patient had the first fill for any of the study TNF inhibitors (ETN, ADA or IFX) within the study identification period (Jan 1, 2004 – Aug 31, 2010). Data were extracted from July 1, 2003 to August 31, 2011. Prescription and medical claims were analyzed over an 18-month study period (i.e., 6-month pre-index and 12-month post-index periods). The primary study outcomes were adherence, persistence, dose escalation, switching and cost (i.e., total healthcare, RA-related and TNF inhibitor therapy cost). The study covariates were demographic factors (age, gender, race/ethnicity), pre-index use of other RA-related medications (pain, glucocorticoids and disease modifying antirheumatic drugs), total number of non-study RA-related medications used at index, pre-index RA and non-RA related visits, pre-index healthcare utilization cost and Charlson Comorbidity Index score. Conditional regression analyses, which accounts for matched samples, were used to address the study objectives.
After propensity score matching, 822 patients (n=274/group) comprised the final sample. The mean age (±SD) was 48.9(±9.8) years, and the majority of the subjects were between 45 and 63 years (69.2%), Hispanic (53.7%) and female (88.0%). Compared to patients on ETN, the odds of having a dose escalation were ≈ 5 [Odds Ratio= 4.605 [95% CI= 1.605-12.677], p=0.0031] and ≈ 8 [Odds Ratio=7.520, [95% CI= 2.461-22.983], p=0.0004] times higher for IFX and ADA patients, respectively, while controlling for other variables in the model. Compared to ETN, patients on IFX (p=0.0171) were more adherent while adherence was comparable with patients on ADA (p=0.1144). Compared to patients on ETN, the odds of being adherent (MPR ≥ 80%) to IFX was ≈ 2 times higher [Odds Ratio= 2.437, [95% CI=1.592-3.731], p < 0.0001] while controlling for other variables in the model. Persistence to index TNF inhibitor therapy and likelihood to switch or discontinue index TNF inhibitor therapy were comparable among the 3 study groups. In addition, the duration of medication use (i.e., persistence) prior to switching or discontinuation of index therapy was comparable among the 3 study groups. Furthermore, for each of the cost variables (total healthcare, RA-related and TNF inhibitor therapy cost), costs incurred by patients on ETN were significantly lower (p < 0.01) than those incurred by ADA patients but significantly higher (p < 0.01) than those incurred by IFX patients. Finally, a positive and significant relationship (p < 0.0001) was found between RA-related healthcare cost, adherence and persistence to TNF inhibitor therapies.
In conclusion, ETN was associated with lower rates of dose escalation compared to ADA or IFX. However, adherence was better and associated healthcare costs were lower with IFX. Clinicians should endeavor to work with each individual patient to identify patient-specific factors responsible for poor medication use behaviors with TNF-inhibitor therapies. Reducing the impact of these factors and improving adherence should be included as a major part of the treatment plan for each RA patient. RA patients need to be adequately educated on the importance of adhering and persisting to their TNF-inhibitor therapy as poor medication adherence/persistence negatively impacts the RA disease process.Pharmaceutical Science
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Medication utilization, adherence and use of relief agents among Texas medicaid patients with persistent asthma
Full text linktextAsthma is a prevalent chronic disease with high health care utilization and excessive costs. Adherence to asthma long-term controller medications is one of the key drivers to improve asthma management. The purpose of this study was to investigate how patient characteristics and medication regimens, including adherence, impact asthma-related outcomes, which was represented by the use of quick-relief medications: oral corticosteroids (OCSs) and short-acting [beta]2-agonists (SABAs). Texas Medicaid prescription claims from July 1, 2008 to August 31, 2010 were retrospectively analyzed. Patients aged 5-63 years with a primary diagnosis of asthma (ICD-9 code 493) and four or more prescription claims for any asthma medication in one year (persistent asthma) were included. The primary outcomes were adherence to asthma long-term controller medications estimated by Proportion of Days Covered (PDC) and asthma control defined by the number of OCS and SABA claims. A total of 32,172 patients were included in the study. The majority of the patients were on monotherapy (58.9%), with leukotriene receptor antagonists (LTRAs) being most commonly prescribed (65.6%). Among patients on combination therapy (41.1%), fixed dose combinations of inhaled corticosteroids (ICSs) plus long-acting β-agonists (LABAs) were most commonly prescribed (51.9%). Mean (±SD) adherence to controller therapy was 32.2% (±19.7). Patients on LTRAs were 7.7% more adherent compared to patients on ICS therapy, and patients on fixed dose combination therapy were 4.5% more adherent compared to patients on concurrent therapy, while controlling for covariates (age, gender, race, number of non-study medications) (p<0.0001). The likelihood of having 6 or more claims for SABA in one year was significantly higher for adherent (PDC≥50%) patients (p<0.0001). However, the likelihood of OCS use was significantly higher for nonadherent (PDC<50%) patients compared to those who were adherent (p<0.0001). In conclusion, adherence to long-term controller medications was low among patients with asthma. Healthcare providers should emphasize adherence to controller therapy among patients with asthma. Being adherent is critical in prevention of asthma exacerbations requiring OCS use. As frequent SABA use signals poor asthma control, healthcare providers and patients (both adherent and nonadherent) should be educated/re-educated about SABA inhaler use.Pharmaceutical Science
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Use of medications and services for the management of sickle cell disease
Full text linkSickle cell disease (SCD) is an inherited chronic disease with recurrent complications, high health care utilization and excessive costs. Preventative therapies, such as hydroxyurea, are known to prevent or reduce the frequency of SCD complications. The purpose of this study was to determine medication and healthcare services utilization for the management of SCD, in terms of index and subsequent therapies and services. This thesis also examined whether there were differences SCD-related prescription and healthcare utilization among patients of different age groups. Texas Medicaid prescription and medical claims from September 1, 2011 to August 31, 2016 were retrospectively analyzed. Patients aged 2-63 years with a primary diagnosis of SCD (ICD-9: 282.6x, ICD-10: D57.1) and receiving one or more SCD-related medications (hydroxyurea, opioid or non-opioid analgesics) were included. The primary outcomes were type of SCD index drug, adherence to hydroxyurea, days’ supply of opioid and non-opioid analgesics, utilization of SCD-related emergency department, inpatient and outpatient visits, and type of SCD index and subsequent healthcare services. A total of 2,339 patients were included in the study. For the index drug, the majority of the patients were prescribed opioid analgesics (45.7%), followed by non-opioid analgesics (36.6%), and only 6.5 percent were prescribed hydroxyurea. Only 20.7 percent had a hydroxyurea medication possession ratio (MPR) ≥ 80%, with highest mean adherence among children. Days’ supply of opioid and non-opioid analgesics was highest in older adults of age group 41-63. Healthcare service utilization was relatively high (compared to the general population) among age groups 2-12, 18-25 and 26-40. Slightly over one-third of the population (N=801; 34.3%) had either an index ED visit (74.7%) or ≥1 hospitalization (25.3%). In conclusion, patients with SCD enrolled in Texas Medicaid have low utilization of and adherence to hydroxyurea. Interventions to increase its adoption and adherence could benefit patients by helping them better managing their SCD complications. Opioid use is prevalent among all patients with SCD, and generally, opioid use increased with increasing age groups. Patients with SCD also have a high use of healthcare services such as emergency department, inpatient and outpatient visits, especially among adolescents and young adults. Further research is needed to determine how to better manage patients with SCD, particularly adolescents and young adults who may be transitioning from pediatric to adult carePharmaceutical Science
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Antipsychotic drug utilization patterns and treatment-emergent diabetes: a methodological comparison of incidence using a claims database
Full text linktextThe study purposes were to: 1) examine antipsychotic utilization trends; and 2)
evaluate relationships between antipsychotic utilization and treatment-emergent
diabetes when methodologies varied while controlling for covariates.
Claims databases from North and South Texas Veterans Administration
(1993-2004) were used to identify adults newly initiated on antipsychotics. For
Purpose 2, only patients with no previous diabetes were eligible. Seven models were
created based on the following methodological variations: 1) study designs
(retrospective cohort and case-control); 2) treatment exposure assignment (intent-totreat
(ITT) and as-treated (AT)); and 3) statistical approaches (propensity scoring,
standard and conditional logistic regression, and Cox proportional hazards function).
Covariates included: demographics, general health comorbidities, mental health
comorbidities, drug utilization patterns, treatment duration, medication re-exposure,
and treatment initiation year.
Regarding Purpose 1, from 1997-2003, antipsychotic utilization shifted from
first to second generation, with olanzapine and risperidone most frequently prescribed.
Monotherapy was the predominant utilization pattern with switching and combination
therapy used infrequently. Of the eligible patients (N=8,949) for Purpose 2,
regardless of variations in methodologies of the seven tested models (eight models
were proposed), there were no significant differences in diabetes risk among patients
who were: 1) initiated on SGAs compared to those on FGAs; 2) initiated on
olanzapine compared to those on risperidone; and 3) exposed to olanzapine or
quetiapine compared to those exposed to FGAs. Inconsistent results among the seven
models were observed when comparisons were made between: 1) patients initiated on
quetiapine compared to those on risperidone; and 2) patients exposed to risperidone
compared to those exposed to FGAs. Differences occurred among the following
methods: ITT retrospective cohort and ITT case-control; and AT retrospective cohort
and AT case-control.
With respect to antipsychotic utilization, results of the various models using
different methodologies were largely consistent.Pharmaceutical Science
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The impact of pharmacist provision of medication therapy management (MTM) on medication and health-related problems, medication knowledge, and medication adherence among Medicare beneficiaries
Full text linktextThis study used the Andersen Model for Health Services Utilization to examine a pharmacist-provided telephone MTM program among Medicare Part D beneficiaries. Predisposing (age, gender, race) and need factors (number of medications, number of chronic diseases, medication regimen complexity) were assessed. The health behavior, MTM utilization, distinguished the intervention and control groups. The health outcomes were change in number of medication-related problems, change in medication adherence [using the medication possession ratio (MPR)], and change in total drug costs. Medication knowledge, medication adherence (using the Morisky Scale), and patient satisfaction were also measured in the intervention group. The intervention and control groups were not significantly different in age (71.2 ± 7.5 vs. 73.9 ± 8.0 years), number of medications (13.0 ± 3.2 vs. 13.2 ± 3.4), number of chronic diseases (6.5 ± 2.3 vs. 7.0 ± 2.1), and medication regimen complexity [21.5 (range 8 – 43) vs. 22.8 (range 9 – 42.5)], respectively. For the subset of problems that was evaluated in the intervention and control groups, 4.8 (± 2.7) and 9.2 (± 2.9) problems were identified at baseline and 2.7 (± 2.3) and 8.6 (± 2.9) problems remained at the 3-month follow-up, respectively. Cost-related and preventative care needs and drug-drug interactions were the three most common problems identified. Multivariate regression analysis revealed that the intervention group had significantly more problems resolved (p < 0.0001) when compared to the control group, while controlling for predisposing and need factors. Significantly fewer problems were resolved (p = 0.01) as number of diseases increased and significantly more problems were resolved (p = 0.01) as medication regimen complexity increased. There were no significant predictors of change in MPR or total drug costs from baseline to the 3-month follow-up. Medication knowledge and medication adherence measured by the Morisky scale did not change significantly from baseline to the 2-week follow-up. However, patients were very satisfied with the service. A pharmacist-provided telephone MTM program was an effective method for identifying and resolving medication and health-related problems. A longer follow-up period may be necessary to detect the impact of pharmacist provision of MTM on adherence, total drug costs, and knowledge.Pharmaceutical Science
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Prevalence of and factors associated with gabapentinoid use and misuse among Texas Medicaid recipients
Full text linkGabapentinoids include drugs such as gabapentin and pregabalin, which are both approved by the FDA for the treatment of neuropathic pain, as well as other conditions. Rising prescribing trends and fatalities due to concurrent opioid overdose have created public health concerns regarding gabapentinoid misuse and abuse in the United States (US). Gabapentin prescriptions in the US increased from approximately 39 million (2012) to 67 million (2018) and pregabalin sales more than doubled from 4.4 billion (2016). This study aimed to assess the prevalence of and factors associated with gabapentinoid use and misuse.
This was a retrospective database study using Texas Medicaid prescription and medical claims from 1/1/12-8/30/16. Subjects were included if they: were between 18–63 years at index date, had at least one gabapentinoid prescription, and were continuously enrolled for 6 months pre-index and 12 months post-index. The dependent variable in this study was gabapentinoid misuse while age, gender, concurrent opioid use, neuropathic pain diagnoses and gabapentinoid type were independent variables.
Of included subjects (N=39,000), 0.2% (N=81) were gabapentinoid misusers. The majority (76.4%) of gabapentinoid users were 41–63 years with a mean±SD age of 48.2±10.7 years. Gabapentinoid misusers were significantly younger than gabapentinoid non-misusers (45.1±11.0 vs. 48.2±10.7, p=0.0084). The majority were female (68.1%), and a significantly higher proportion of males misused gabapentinoids compared to females (0.3% vs. 0.2%, p=0.0079). Over one-half (51.9%) of the study sample had neuropathic pain and gabapentinoid misuse was significantly higher in neuropathic pain patients compared to those without neuropathic pain (0.3% vs. 0.1%, p=0.0078). Over three-quarters (77.4%) of patients were using gabapentin, however, gabapentinoid misuse was significantly higher among pregabalin users compared to gabapentin users (0.4% vs. 0.2%, p=0.0003). About one-sixth (17.3%) of gabapentinoid users had at least 90 days of concurrent opioid use. However, there was no significant difference in gabapentinoid misuse among patients with concurrent opioid use compared to patients without (0.3% vs. 0.2%, p = 0.1440).
The prevalence of gabapentinoid misuse was low (0.2%) among Texas Medicaid recipients and younger age, male gender, neuropathic pain diagnosis and pregabalin use were significantly associated with gabapentinoid misuse.Pharmaceutical Science
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