PDMPs in recent years. Since 2009, 13 states have received supplemental funding through the National All Schedules Prescription Electronic Reporting Act to bolster their PDMPs, such as the accessibility of prescription data and the capacity for interstate information exchange (Alliance of States with Prescription Drug Monitoring Programs 2013). Third, drug overdose mortality in this study is based on ICD-10 codes X40–X44 and Y10–Y14, which include overdose deaths involving prescription drugs as well as overdose deaths involving other substances. While prescription drugs are not always identified in death cer- tificate data and 60% of overdose deaths are thought to be related to prescription drugs, drug overdose mortality in this study may include deaths caused by methampheta- mine, cocaine, heroin, and other illicit drugs, which are beyond the purview of PDMPs. There is preliminary evi- dence that as prescription drugs become more difficult to procure, illicit drugs such as heroin may be substituted. Because the outcome definition in this analysis does not distinguish between illicit and prescription drugs, if there were fewer deaths resulting from prescription drugs with the implementation of PDMP programs, this effect would not be detected in this analysis. Fourth, this study con- trolled for ICD-10 codes X60–X64 (suicide by “drug” overdose) and X86 (homicide by “drug” overdose), as well as overdose/poisoning of other substances (e.g., X65–X69), which may or may not involve drugs. Suicide by drug overdose and homicide by drug overdose are likely more relevant to PDMPs than poisoning from other substances. Finally, this study assessed the pos- sible impact of implementing PDMPs on drug overdose mortality only. It is noteworthy that the primary purpose of PDMPs is to prevent diversion of controlled substances, not drug overdose per se. Although the majority of drug overdose deaths involve the use of diverted drugs (Hall et al. 2008), targeting drug diversion alone through law enforcement may not be sufficient to reduce drug over- dose mortality. To control the ongoing drug overdose epidemic, a multifaceted approach is needed. Recent re- ports and commentaries have called for using prescrip- tion data and insurance restrictions to help prevent procurement of controlled substance prescriptions from multiple healthcare providers, augmenting healthcare provider training on pain management, implementing evidence-based guidelines for the management of pain, and improving access to drug treatment and expanding community-based harm reduction programs (Centers for Disease Control and Prevention 2012b; United Nations Office on Drugs and Crime UN ODC 2013; Volkow and McLellan 2011).
An important part of therapeutic drug monitoring is the timing of the blood collection. The importance of proper timing of a sample is not given sufficient attention while ordering measurement of a plasma concentration. When a drug is administered, the blood concentration increases until it reaches a peak and then the concentration begins to fall. The lowest concentration (trough) is usually just before the next dose. The time required for the serum concentration of a drug to decrease by 50% is called the halflife of the drug. When a drug is administered in intervals approximately equal to its half-life, a steady state concentration will be achieved after 4-5 half-lives. For drugs with a long half-life, there is little difference between the steady state peak and trough concentrations. For drugs with a short half-life, the differences between the peak and trough concentrations can be significant and both are usually measured (i.e. Aminoglycosides). Drugs that are given intravenously require time to redistribute into the different body compartments. In general, intravenous medications can be sampled 30-60 minutes post administration.
16 Read more
Clinical pharmacy services have been implemented in some public and private hospitals in Indonesia. Nonetheless, little research has been undertaken to investigate the extent of clinical pharmacy services provided by those hospitals. In addition, the level of documentation of the services is variable and highly dependent on each hospital as there is no standardization established by Indonesian government. The study hospital has used therapeutic drug monitoring (TDM) form since 2014 to document clinical pharmacists’ recommendation. To date, there is no evaluation to assess the effectiveness of the form to facilitate the documentation. Therefore, this study aimed to develop TDM form based on analysis of pharmacists’ recommendation documentation to address DRPs in patients with CKD.
Introduction: Imatinib mesylate is the standard of care in the treatment of chronic myeloid leukemia. Therapeutic drug monitoring (TDM) can be used as a tool to cross-check treatment adherence or toxic manifestations to imatinib mesylate in chronic myeloid leukemia patients. The study aimed to develop a simple, cost effective and rapid method for quantification of imatinib mesylate and desmethyl imatinib in human plasma using LC-MS/MS. Methods: The biological samples were prepared by a simple protein precipitation method and separated using an XTerra MS C18 column. Imatinib and its metabolite desmethyl imatinib was quantiﬁed using multiple reaction monitoring (MRM) with a triple quadrupole tandem mass spectrometer working in the positive electrospray ionization (ESI+) mode using verapamil as internal standard. RESULTS: The method was validated and found to be precise and accurate within the dynamic range of 5ng-8µg/mLfor the drug and 5ng-1µg/mL for the metabolite. The method was then applied to routine therapeutic drug monitoring of CML patients and the mean±SD trough level concentration was found to be 1437±459 ng/mL.
Therapeutic drug monitoring is used in pharmaceutical services to enhance patient care. It was first introduced to the clinical practice in the early 1970s. Since the initiation of this service, different studies evaluating Therapeutic Drug Monitoring laboratory activities, studying the impact of the service on patient outcome, surrogate endpoints, and pharmacoeconomic evaluations have been done worldwide Therapeutic drug monitoring is the measurement of specific drugs at intervals in order to maintain a relatively constant concentration of the medication in the bloodstream. Drugs that are monitored tend to have a narrow “therapeutic range” – the quantity required to be effective is not far removed from the quantity that causes significant side effects and/or signs of toxicity 1 . Maintaining this steady state is not as simple as
The present study uses cost effective analysis by comparing the guideline treatment used in this study versus the empirical treatment of the patients which were being followed prior to the study. The result showed that the guideline treatment used had the least cost per outcome and is the effective alternative. The medical cost and laboratory charges are more in case of the study treatment due to the costly inhaled corticosteroids and reliever medication used as per the guideline for the moderate and severe patients and due to the laboratory charges for the conduct of therapeutic drug monitoring. But the overall cost was comparatively more for the patients when they were following the empirical treatment for the asthma prior to the study. The reason observed is that the patients, while in the empirical therapy had more number of indirect medical and non- medical costs due to the more number of hospital visits, hospital admissions, loss of working days, food expenses, etc. In case of the guideline treatment using theophylline and additional drugs which was in the alternative choice and of lesser cost, it was found that the indirect medical and non-medical costs were very less. The efficacy parameter measured using the FEV 1 showed a better response by the guideline treatment with
139 Read more
38 | P a g e immediate concerns were the recurrence of frequent and severe convulsions. As a result, plans were made to send the patient home with strong considerations of the application of the principles of therapeutic drug monitoring. In addition, magnetic resonance imaging of the brain and spinal cord was sought.
Results: A total of 130 women were randomised to the therapeutic drug monitoring group and 133 to the clinical features monitoring group; 294 women did not have a reduction in serum AED level. A total of 127 women in the therapeutic drug monitoring group and 130 women in the clinical features monitoring group (98% of complete data) were included in the primary analysis. There were no significant differences in the time to first seizure (HR 0.82, 95% CI 0.55 to 1.2) or timing of all seizures after randomisation (HR 1.3, 95% CI 0.7 to 2.5) between both trial groups. In comparison with the group with stable serum AED levels, there were no significant increases in seizures in the clinical features monitoring (odds ratio 0.93, 95% CI 0.56 to 1.5) or therapeutic drug monitoring group (odds ratio 0.93, 95% CI 0.56 to 1.5) associated with a reduction in serum AED levels. Maternal and neonatal outcomes were similar in both groups, except for higher cord blood levels of lamotrigine (MD 0.55 mg/l, 95% CI 0.11 to 1 mg/l) or levetiracetam (MD 7.8 mg/l, 95% CI 0.86 to 14.8 mg/l) in the therapeutic drug monitoring group than in the clinical features monitoring group. There were no differences between the groups on daily AED exposure or quality of life. An increase in exposure to lamotrigine, levetiracetam and carbamazepine significantly increased the cord blood levels of the AEDs, but not maternal or fetal complications. Women with epilepsy perceived the need for weighing up their increased vulnerability to seizures during pregnancy against the side effects of AEDs.
180 Read more
Ellington C et al.,(2006) study revealed that insufficient information were provided when SDC was ordered by clinician . Mordasini et al.,(2002) assessed the appropriateness of digoxin monitoring practice on 210 plasma samples based on a certain criteria: there is appropriate indication for digoxin monitoring, blood sample had been taken at least six hours after the last dose , laboratory results had to be assessed by a physician and digoxin therapy should be conducted based on patient's individual status.
16 Read more
outcome among critically ill patients. Further studies are needed to address this point in large ICU cohorts. Fourth, in one-third of the patients, AMK was initiated only when MIC was obtained by Etest. Thus, this could be considered as being in contrast to common recom- mendations, which suggest early administration of appro- priate antibiotic therapy to improve survival rates in septic patients . Nevertheless, the benefits of this approach have not been clearly demonstrated for combi- nation therapy and this strategy would have resulted in patients with pathogens resistant to the drug being exposed to potentially undesirable adverse events of the drug without likely benefit. In addition, for patients with- out positive microbiological samples, no microbiological assessment would have been possible. Fifth, we could not provide any data on the appropriateness of the first-line therapy (that is b -lactams) concentrations, which could have been an additional determinant in the evaluation of microbiological eradication and clinical cure. Sixth, the ranges of delivered dose of AMK were quite large in each group. Thus, it is possible that more precise regimens (that is 20 mg/kg vs. 30 mg/kg) would have resulted in different results. Also, the quite limited number of patients included over a 3-year period was related to the strict inclusion and exclusion criteria; this may have introduced a selection bias in this study. Finally, we did not specifically calculate a sample size to estimate the number of patients to be included in this study, as we could not identify any previous data describing the effects of initial optimal C peak values on clinical and microbiolo-
10 Read more
Opioid abuse is currently the most significant public health problem in the US. Many US states have implemented prescription drug monitoring programs (PDMPs) in response. In the rst paper, I use a new micro-level medical claims database to exploit state-level and time-series variations in PDMP implementation and shed light on the impacts of these programs. My results show that PDMPs have led to an overall 14% reduction in the odds ratio of abuse/addiction. Also, there is evidence of substantial heterogeneity in impacts, with larger impacts for females and minorities. Another nding is that at least 23% of opioid abuse is a result of drug diversion to nonmedical opioid users. PDMPs were not successful in decreasing the rate of abuse for this group, and, in fact, there is some evidence that they increased the diversion to heroin. Finally, I show that PDMPs' eectiveness varies by type of insurance and that they are more eective in reducing abuse rates in the general population as compared with Medicare Part D recipients. I use my estimates to analyze the potential eects of modifying PDMPs to include giving insurance providers access to electronic databases, providing educational programs for less-educated people, and expanding their \must access" requirement. In the second chapter, I estimate dierent models for opioid demand and compare their performance. My results suggest that the NB2 and Poisson FE models best match the data. Using these models for
73 Read more
A Prospective observational study was carried out in medicine department of private tertiary care hospital over the period of six months. Before initiation of the study independent ethical committee’s approval was obtained (SL / IEC /10 Jan 2011). All patients who were admitted to the study wards during the study phase were included in the study. The oral informed consent was obtained from patients who were interviewed during the study phase. The researcher reviewed drug charts, medical and nursing notes of all the patients who were admitted in the study ward. The review was conducted to screen case records for the presence of any evidence of ADRs. Objective markers of ADRs, e.g. laboratory results, were identified from the case notes and the hospital computer system and the subjective markers of ADRs like headache, nausea and rash were identified through patient progress notes, discussion with the medical team and patient interview. After completion of data collection, case note analysis was performed to assess patient outcomes and to ensure that all the available details regarding the ADR had been collected. The collected data was documented separately in ADR documentation form for further assessment. An ADR alert card was provided to those patients who experienced such ADRs which by their nature cautions against re-exposure of the suspected drug. All ADRs were assessed by a panel of experts including the investigator. The panel assessed the causality, predictability and preventability using appropriate scales (Fig: 1)
A clinical research assistant mandated by the sponsor will ensure the successful completion of the study and the col- lection of data generated by writing, documentation, re- cording, and report, in accordance with the standard operating procedures implemented at the Hospices Civils de Lyon and in accordance with good clinical practice and regulatory legislation. An independent Data and Safety Monitoring Board (DSMB) external to the trial investiga- tors has been established specifically to monitor data throughout the study to determine if it is appropriate, from both scientific and ethical standpoints, to continue the study as planned. The DSMB will meet every year to review serious adverse events and propose continuing or stopping the study. The DSMB is made up of three ex- perts in epilepsy (A. Rossetti, Department of Clinical Neurosciences, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland), anesthesiology (Dr. A. Charton, Strasbourg University Hospital, Strasbourg, France), and methodology in clinical research (S. Chabaud, Centre Leon Berard, Lyon, France).
Faith plays a big part in Muslim drug users thinking and way of life, even if they are no longer practising and have rebelled against their upbringing. So says Syed Tohel Ahmed, manager of Nafas in Tower Hamlets. "They will have massive guilt about letting their family down and will know religiously that it is wrong.That is why you need key workers with an Islamic perspective on drugs so they know what the issues are and can be sensitive to them, but also so they can use faith positively to help people overcome their drug use".
16 Read more
Pharmacovigilance play an important role in meeting the challenges offered by the increased range and potency of medicines. After the appearance of adverse effects and drug toxicities, it is essential that these are reported, analyzed and communicated to the general public having knowledge to interpret the information. Although, a significant amount of information regarding the effective use and adverse reactions has been collected, but more information is required in order to offer effective drug use in specific populations like children, pregnant women and the elderly. Moreover, providing the regulators with the necessary information to amend the recommendations on the use of the medicines; improving communication between
It has been estimated that MREs are a significant problem in term of impact of consultations in Emer- gency Department (ED) and hospital admission in pediatric patients, contributing to overall pressures on health care system [3–5]. Previous studies focused on adverse drug events (ADEs) involved different method- ologies and a spectrum of different inclusion criteria, ranged from studies of narrowly defined adverse drug re- actions (ADRs) to more broadly defined medication- related events” [4, 6–44].
New drugs and more effective and/or shorter regimens for the treatment of drug-resistant tuberculosis (DR-TB) have recently become available. Multidrug-resistant tuberculosis (MDR-TB) is the resistance of Mycobacterium tuberculosis to the two most potent first-line drugs: rifampicin and isoniazid. Because rifampicin is the most potent drug, and rifampicin resistance (RR) does not often occur without concomitant isoniazid resistance, RR-TB is often seen as a proxy for MDR-TB. A shorter (9 months) treatment regimen (STR) for RR-/MDR-TB without additional resistance or intolerance against the key second-line anti-TB drugs [1 – 5] is now available and, for RR-/MDR-TB that cannot be treated with the STR, new drugs such as bedaquiline (Bdq) [6, 7] and delamanid (Dlm) [8, 9] and repurposed drugs including clofazimine, linezolid (Lzd) and carbapenems can be added to a longer, individualised regimen. In clinical trials, Bdq has been associated with hepatotoxicity and QT prolongation in a small proportion of patients [6, 10]. An unexplained increased mortality rate found in the intervention arm of a phase IIb trial compared to the placebo arm  has not, however, been reported in later publications [10 – 20], including use in children , in regimens combining Bdq and Dlm [15, 22, 23] or with use of Bdq beyond the recommended 24 weeks . A systematic review concluded that Bdq is well tolerated, with only 3.5% of patients discontinuing treatment because of an adverse event (AE), and in only 0.6% did this concern QT prolongation . Dlm has been associated with mild QT prolongation but is generally well tolerated, including by children [8, 9, 25–31].
14 Read more
In the case group, hepatitis occurred during the treatment period for 42 patients (46.15%) and after cessation of therapy for 49 patients (53.85%). Among these patients, hepatitis was identified as mild in 69 patients (75.82%), moderate in seven patients (7.70%) and severe in 15 patients (16.48%). Regard- ing the pattern of hepatitis, 41 patients (45.06%) were diag- nosed with hepatocellular injury, 35 patients (38.46%) were diagnosed with cholestatic injury, and 15 patients (16.48%) were diagnosed with mixed injury. The median time from fluoroquinolones use to developing acute liver injury was 7 days (IQR 4–12). Only four patients (4.40%) developed jaundice during and after therapy. Fever was observed in 21 patients (23.08%). Nine patients (9.89%) had eosinophilia, and two patients (2.20%) experienced skin rash. No patients developed encephalopathy. After intervention therapy (such as for drug withdrawal and prescriptions of hepatoprotectant), 72 patients (79.12%) recovered from liver injury, 18 patients (19.78%) had poor outcomes (liver enzymes and bilirubin levels remained unchanged or continued to rise), and one patient (1.10%) died of liver failure.
Background: Non-Hodgkin’s lymphoma (NHLs) is a prevalent type of cancer for which Intravenous (IV) Rituximab is a widely used treatment option. Nevertheless, IV infusions can lead to intense resource use and, subsequently, costs. Given that a subcutaneous (SC) therapeutically equivalent formulation of the drug is currently available, this study aimed to examine the potential clinical and economic value of the introduction of the SC formulation for the Greek healthcare setting. Methods: A cost-minimization and budget-impact analysis contributed to comparing staff, patient time and resource utilization and estimating the clinical effects and associated costs in the IV and SC ad- ministration. A questionnaire-based survey was used to provide data regard- ing the local treatment patterns and the resource use associated with each treatment in the Greek NHS. The analysis followed the third-party payer perspective, and cost data relevant to personnel salaries, pharmaceuticals and resource utilization were obtained from official government sources. Results: SC administration was associated with time savings in activities such as pre-medication administration (3 minutes saved with the SC use), monitoring during infusion (12 minutes for physicians and 3 minutes for nurses) as well as time-savings in the preparation of the drugs, the actual dispensing process and the post-injecting monitoring processes. A significant decrease was ob- served in the nursing and chair time (57% and 90% per case, respectively) and a higher level of services could be secured in terms of hospital capacity with the SC use. SC administration was found to generate budget savings of 618,708€ per 1000 patients/3 years over the full course of treatment. Conclu- sions: Switching IV to SC administration, as demonstrated in the case of Ri- tuximab for NHLs in Greece, can reduce staff time and administration costs, improve the capacity of the system and, possibly, improve resource allocation in the healthcare system.
Before constructing our survey, we conducted a litera- ture search of peer-reviewed articles specific to warfarin management to develop a comprehensive list of activities performed by nurses during the course of managing new and stable warfarin residents in LTC facilities. We vali- dated the accuracy of our findings by surveying a group of registered or licensed LTC nurses who were selected from a proprietary database including nurses throughout the United States. Nurses were contacted directly by e-mail, and respondents were screened to ensure that licensure requirements were met. Nurses who responded to the survey helped to refine the list of tasks and were also given the opportunity to propose adding or deleting tasks from the list. Based on nurses’ feedback, we cre- ated a follow-up survey (Additional file 1), in which 20 nurses (15 RNs, five LPNs) in LTC facilities were asked to (1) confirm these steps and procedures with respect to their individual responsibilities, and (2) provide an estimate of total completion times for each task, and report how often they perform each task each week for each resident receiving warfarin. For residents newly initiated on warfarin therapy, survey respondents were asked to report three categories of tasks: initiation (ac- tivities or tasks to start patients on warfarin), monitoring (INR testing and monitoring for bruising), and manage- ment (activities or tasks related to monitoring docu- mentation, patient education, and physician/pharmacist consultation). For stable warfarin residents, only moni- toring and management had to be reported. Participants were required to spend at least 50% of their daily time in direct patient care, per their assessment, and to have previous experience managing warfarin treatment. Re- spondents were asked to only estimate and self-report time that was actively spent documenting/performing warfarin-related procedures or educating residents (e.g. dietary consultations to discuss any potential drug-food interactions, medication profiles to account for potential drug-drug interactions, health education, and the need for ongoing monitoring). This time was self-reported and estimated. Rather than report the number of beds in their facilities, this was reported as a range: small (1–99 beds), medium (100–199 beds), and large (≥200 beds). To minimize geographical bias, only two nurses per state were permitted to participate in the survey.