Monitoring Of Side Effects Research Articles

Time patterns of recurrence and second primary tumors in a large cohort of patients treated for oral cavity cancer.

IntroductionRoutine follow‐up after curative treatment of patients with oral squamous cell carcinoma (OSCC) is common practice considering the high risk of second primaries and recurrences (ie second events). Current guidelines advocate a follow‐up period of at least 5 years. The recommendations are not evidence‐based and benefits are unclear. This is even more so for follow‐up after a second event. To facilitate the development of an evidence‐ and personalized follow‐up program for OSCC, we investigated the course of time until the second and subsequent events and studied the risk factors related to these events.Materials and methodsWe retrospectively studied 594 OSCC patients treated with curative intent at the Head and Neck Cancer Unit of the Radboud University Medical Centre from 2000 to 2012. Risk of recurrence was calculated addressing death from intercurrent diseases as competing event.ResultsThe 1‐, 5‐ and 10‐year cumulative risks of a second event were 17% (95% CI:14%;20%), 30% (95% CI:26%;33%), and 37% (95% CI:32%;41%). Almost all locoregional recurrences occurred in the first 2 years after treatment. The incidence of second primary tumors was relatively stable over the years. The time pattern of presentation of third events was similar.DiscussionOur findings support a follow‐up time of 2 years after curative treatment for OSCC. Based on the risk of recurrence there is no indication for a different follow‐up protocol after first and second events. After 2 years, follow‐up should be tailored to the individual needs of patients for supportive care, and monitoring of late side‐effects of treatment.

Urinary incontinence in geriatric patients: pharmacological Therapy

1/2019 we presented an update of the AWMF guideline 'urinary incontinence in frail elderly - diagnostics and therapy'. Since its introduction in 2015 the guideline has been under a continuous revision process by the working group 'Incontinence' of the German Society for Geriatrics (DGG). From this guideline which is accredited as an official guideline of the DGG we present here the chapter about pharmacological therapy. A profound literature search was done in a structured evaluation process in the context of a 'frail elderly'. Most medical societies define a 'frail elderly' as someone older than 70 years and multimorbide or older than 80y. We focused on randomized, double blind, placebo controlled studies as well as already published guidelines in this field. In the case no studies were available or not feasible other publications such as not randomized studies or case reports were taken into consideration for our guideline. Recommendations resulted from a structured voting process and the results are stated as percentage of members who agreed. Pharmacological therapy of OAB, stress incontinence and overflow incontinence as well as unspecific treatment with antidiuretics was evaluated with special focus on vulnerable, potentially cognitively impaired frail elderly. We took a closer look on special side effect profile of the above mentioned drugs with regard to the individual multimorbidity and multimedication. Pharmacological therapy of urinary incontinence in frail elderly needs strict indication. Knowledge about drug metabolization and substance interactions as well as close monitoring of possible side effects are indispensable in this vulnerable group of patients.

Increasing Monitoring and Management of Side Effects from Atypical Antipsychotic Medications in Children with Developmental Disabilities

Background: Behavior difficulties such as irritability, aggression, and repetitive and challenging behaviors are common in children with Autism Spectrum Disorder (ASD) and other developmental disabilities (DD). Atypical antipsychotic medications (AAPM) are currently first-line pharmacological agents for treatment of these behaviors. However, there are significant associated adverse effects of AAPM in children, including excessive weight gain, abnormal involuntary movements, and laboratory abnormalities. A recent chart review of children with ASD treated with AAPM revealed that 40% had overweight or obesity (OW/OB). Problem: Despite significant long-term health risks, the Division of Developmental and …

Increasing Monitoring and Management of Side Effects from Atypical Antipsychotic Medications in Children with Developmental Disabilities

Increasing Monitoring and Management of Side Effects from Atypical Antipsychotic Medications in Children with Developmental Disabilities

To treat or not to treat: Patient exclusion in immune oncology clinical trials due to preexisting autoimmune disease.

Newly developed immune checkpoint inhibitors (ICIs) demonstrate impressive clinical activity. However, they can also cause life-threatening side effects. The efficacy and toxicity associated with ICIs both derive from unregulated, enhanced immune activation. Health care providers have been hesitant to prescribe these medications to patients who have preexisting autoimmune disease (AD) because of concerns that this may exacerbate their underlying immune condition. These patients have also been excluded from ongoing ICI clinical trials. However, new data suggest that the potential benefits of ICI treatment may outweigh the potential risks for this patient group as long as physicians also provide sufficient monitoring for AD exacerbations or other side effects. Therefore, it may be appropriate to include patients with advanced malignancies and preexisting AD in ICI clinical trials when no other effective cancer treatment options exist. Overall, physicians should avoid excluding patients from ICI therapy unnecessarily when the potential benefits outweigh the potential risks.

Comparison of fluconazole and itraconazole for treatment of rhinomaxillary mucormycosis

Aim: Rhinomaxillary mucormycosis (RMM) is a detrimental and progressive deep fungal infection which predominantly affects immunocompromised patients. The disease has heterogeneity in clinical manifestation and presents with unfavorable consequences. Despite recent advances in the diagnosis and treatment, the disease has inadequate prognosis overall. The aim of our study is to compare Fluconazole vs. Itraconazole for the management of RMM.Methods: We retrieved demographic, clinical, radiological and histopathological data of patients affected with osteomyelitis in head and neck region and 33 patients exclusively affected with RMM were separated from departmental records. Several characteristics such as Gender, age, Diabetic status, co-morbidity were observed. Patients were randomly distributed in two groups with respect to the azole drug prescribed to them. Group A was given Fluconazole while group B was given Itraconazole. Aggressive surgery with concomitant use of antifungal drug was the mandatory treatment in all patients. Regular monitoring of side effects of drugs and recurrence was carried out for prolonged time.Results: Overall, 18 patients were male and 15 patients were female with a ratio of M:F 1.2. Mean age of patients was 48.21 (11.66) with the age range from 25 years to 70 years. Out of 33 patients, 30 of the patients (90.9%) were diabetic. Fifteen patients in Group A were managed with Fluconazole while 18 patients in group B were treated with Itraconazole. There was no statistically significant difference observed in most of the clinical signs and symptoms presented in both groups as p>0.05 except for bone necrosis (P=0.381). In group A, 4 patients exhibited recurrence (26.6%) while in group B, 5 (27.7%) patients presented with recurrence (p=0.943).Conclusion: Aggressive surgical approach along with supportive antifungal medication remained the mainstay of the treatment. Between Fluconazole and Itraconazole there was no difference observed.

From Sleeplessness to Slumber: Person-Centered Approach to Insomnia

From Sleeplessness to Slumber: Person-Centered Approach to Insomnia

Non-nucleoside reverse transcriptase inhibitor levels among HIV-exposed uninfected infants at the time of HIV PCR testing - findings from a tertiary healthcare facility in Pretoria, South Africa.

IntroductionTo date, very little programmatic data has been published regarding serial antiretroviral (ARV) levels in infants exposed to maternal treatment and/or infant prophylaxis during the first months of life. Such data provide the opportunity to describe the proportion of infants exposed to virologically suppressive levels of ARVs and to gauge adherence to the prevention of mother‐to‐child transmission of HIV (PMTCT) programme.MethodsFrom August 2014 to January 2016, HIV‐exposed infants born at Kalafong Provincial Tertiary Hospital in Pretoria, South Africa were enrolled as part of an observational cohort study. Plasma samples from HIV‐exposed uninfected infants were obtained at birth, 6‐weeks, 10‐weeks and 14‐weeks of age and quantitative efavirenz (EFV) and nevirapine (NVP) drug level testing performed using liquid chromatography‐mass spectrometry, irrespective of maternal ARV regimen. Descriptive analysis of EFV and NVP levels in relation to self‐reported maternal and infant ARV exposure was performed. EFV levels >500 ng/mL and NVP levels >100 ng/mL were reported based on studies suggesting that trough levels above these thresholds are associated with virological suppression and PMTCT respectively.ResultsAmong 66 infants exposed to maternal EFV in utero, 29 (44%) had virologically suppressive plasma EFV levels at birth, with a median level of 1665 ng/mL (IQR: 1094 to 3673). Among infants who were exclusively breastfed at 6‐, 10‐ and 14 weeks, 13/48 (27%), 5/25 (25%) and 0/21 (0%) had virologically suppressive EFV levels. Among 64 infants whose mothers reported administering daily infant NVP at time of their 6‐week HIV PCR test, only 45 (70%) had NVP levels above the minimum prophylactic trough level.ConclusionsDuring the first 10‐weeks after delivery, a quarter of breastfed infants born to women on an EFV‐containing treatment regimen maintained virologically suppressive EFV plasma levels. This finding highlights the importance of both careful monitoring of ARV side effects and repeat HIV PCR after the first few months of life among HIV‐exposed uninfected infants. As 30% of infants had inadequate NVP plasma levels at 6‐weeks of age, adherence counselling to caregivers regarding infant prophylaxis needs to be enhanced to further reduce mother‐to‐child transmission of HIV.

The Effect of Laboratory Test-Based Clinical Decision Support Tools on Medication Errors and Adverse Drug Events: A Laboratory Medicine Best Practices Systematic Review.

Laboratory and medication data in electronic health records create opportunities for clinical decision support (CDS) tools to improve medication dosing, laboratory monitoring, and detection of side effects. This systematic review evaluates the effectiveness of such tools in preventing medication-related harm. We followed the Laboratory Medicine Best Practice (LMBP) initiative's A-6 methodology. Searches of 6 bibliographic databases retrieved 8508 abstracts. Fifteen articles examined the effect of CDS tools on (a) appropriate dose or medication (n = 5), (b) laboratory monitoring (n = 4), (c) compliance with guidelines (n = 2), and (d) adverse drug events (n = 5). We conducted meta-analyses by using random-effects modeling. We found moderate and consistent evidence that CDS tools applied at medication ordering or dispensing can increase prescriptions of appropriate medications or dosages [6 results, pooled risk ratio (RR), 1.48; 95% CI, 1.27-1.74]. CDS tools also improve receipt of recommended laboratory monitoring and appropriate treatment in response to abnormal test results (6 results, pooled RR, 1.40; 95% CI, 1.05-1.87). The evidence that CDS tools reduced adverse drug events was inconsistent (5 results, pooled RR, 0.69; 95% CI, 0.46-1.03). The findings support the practice of healthcare systems with the technological capability incorporating test-based CDS tools into their computerized physician ordering systems to (a) identify and flag prescription orders of inappropriate dose or medications at the time of ordering or dispensing and (b) alert providers to missing laboratory tests for medication monitoring or results that warrant a change in treatment. More research is needed to determine the ability of these tools to prevent adverse drug events.

MON-517 Treatment of Gorham-Stout Disease with Combination Sirolimus and Denosumab

Background: Gorham-Stout Disease (GSD), or vanishing bone disease, is a rare condition characterized by lymphatic vessel proliferation associated with progressive, sometimes massive bone resorption. The underlying mechanism of osteolysis in this condition remains unclear; prevailing theories suggest that the disease is driven by lymphovascular growth factors, increased osteoclastic activity, and absence of osteoblast repair. Clinical Case: A 44-year-old Caucasian male was found to have an absent right scapula and multiple right rib fractures on an x-ray performed to evaluate chest discomfort. Notably, 3 years prior, a right shoulder MRI showed normal anatomy. He has no family history of bone disease. Physical exam showed soft tissue swelling in the area of the right scapula and limited range of motion of the right arm to 60 degrees in all directions. Serum calcium, phosphorous, and iPTH were normal. Bone resorption marker C-Telopeptide (CTx) was elevated to 722 pg/mL (93-630 pg/mL) while bone formation marker Procollagen I intact N-terminal (P1NP) was within normal limits. CT and MRI confirmed the absence of the body of his right scapula and identified posterior right rib lesions with overlying fractures. The remnant scapula and rib foci showed abnormally elevated activity on 18F-sodium fluoride (18F-NaF) PET/CT scan. Given his clinical and imaging findings, he was diagnosed with GSD. Treatment included two years of monthly denosumab (120 mg) and sirolimus (trough goal 7-13 mcg/L), followed by zoledronic acid infusion every 2 months for 3 doses to prevent the rebound bone resorption associated with denosumab cessation. After therapy, CTx was suppressed to 70 pg/mL and P1NP to 15 mcg/L (22-87 mcg/L). Serial imaging showed one new posterior right rib lesion noted after 6 months of treatment, but no further bone loss. He noted no pain or new weakness. Adverse events included worsening hypertriglyceridemia due to sirolimus as well as denosumab-induced hypocalcemia and hypophosphatemia. Discussion: There is no consensus on the optimal treatment of GSD. Medical therapy usually includes an antiproliferative agent (usually sirolimus or interferon 2b) and an antiresorptive agent (usually a bisphosphonate). The RANK-ligand inhibitor denosumab, the most potent osteoclast inhibitor, may be a more effective agent in preventing bone resorption in GSD. This case demonstrates the effective use of sirolimus and denosumab in GSD, but further study and careful monitoring for mineral metabolism side effects and rebound are needed.

Effectiveness and side effects of psychopharmacotherapy in individuals with 22q11.2 deletion syndrome with comorbid psychiatric disorders: a systematic review.

22q11.2 deletion syndrome (22q11.2DS) is the most common microdeletion in humans and is associated with high rates of attention deficit/hyperactivity disorder (ADHD), psychotic spectrum disorders and mood and anxiety disorders. The objective of the study was to systematically review studies regarding pharmacological treatments for psychiatric disorders in individuals with 22q11.2DS and to provide practical guidelines for the psychiatric management and side effect monitoring in 22q11.2DS. A literature search was conducted using the databases PubMed, PsycINFO and Embase. Information regarding study population, drug treatment, side effect profile and efficacy for each trial was extracted. Data collection was completed on May 2018. The search identified 705 studies. A total of seven studies, describing 182 individuals, were included. Pharmacological interventions included three studies for antipsychotic treatment, two studies for stimulants, one study for selective serotonin reuptake inhibitors (SSRIs), one study for S-adenosyl-L-methionine (SAMe), and one case series for metyrosine. The presented data support the clinical impression that individuals with 22q11.2DS and comorbid psychiatric disorders are treated in a manner comparable to non-22q11.2DS individuals. However, distinct medical comorbidities common in individuals with 22q11.2DS may complicate the administration of pharmacotherapy. Further trials with RCT design, larger sample sizes and more syndrome-specific pharmacological agents are needed to improve evidence-based psychiatric care of 22q11.2DS individuals with comorbid mental disorders.

An examination of the incidence and nature of chemical restraint on adult acute psychiatric inpatient units in Adelaide, South Australia.

Reducing and/or eliminating the use of coercive measures in psychiatric services is a priority worldwide. Chemical restraint is one such measure, yet to date has been poorly defined and poorly investigated. The aim of this study was to examine chemical restraint use in 12 adult acute inpatient psychiatric units in Adelaide, South Australia. Methods involved the analysis of all reported chemical restraint events occurring over a 12-month period analysed using a descriptive quantitative design. There were 166 chemical restraint events involving 110 consumers. The highest prevalence rate in an individual unit was 28.78 events per 1000 occupied bed days, with the lowest being 0.12 events per 1000 occupied bed days. More males (n=69, 57.5%) were involved in chemical restraint than females. Schizophrenia, schizotypal, and delusional disorders were the predominant diagnoses among consumers who were chemically restrained. The most events occurred during three time blocks: 14.00-14.59pm, 16.00-16.59pm, and 21.00-21.59pm. The two most common medications used were olanzapine and clonazepam. The study presents a general picture of the practice of chemical restraint in Adelaide and identifies areas of concern in relation to the need for monitoring of side effects and completion of systematic processes of documentation regarding chemical restraint events. Findings highlight the need for sustained focus on reducing the need for chemical restraint and exploring less restrictive measures with those most likely to receive medication against their will.

Attenuation of haemodynamic responses of laryngoscopy and endotracheal intubation: An evaluation of efficacy of single intravenous dose of esmolol hydrochloride

Attenuation of haemodynamic responses of laryngoscopy and endotracheal intubation: An evaluation of efficacy of single intravenous dose of esmolol hydrochloride - IJCA- Print ISSN No: - 2394-4781 Online ISSN No:- 2394-4994 Article DOI No:- 10.18231/2394-4994.2019.0009, Indian Journal of Clinical Anaesthesia-Indian J Cl

QIM19-128: Improving Oral Chemotherapy Safety in Adult Neuro-Oncology Clinics

Background: The development of oral chemotherapies (OC) have transformed cancer care for millions of patients. Most patients with brain tumors have temozolomide (TMZ) delivered to their home. While this has improved the patient experience, it presents significant challenges to safety of prescription, administration, and side effect monitoring. While there are guidelines for documentation, there is not a best practices system for managing OC. This project identified areas of latent errors and implemented a standardized process for OC management. Methods: After review of the literature, we developed a process map for our institution’s practice and performed hazard analysis. We then evaluated the process at 3 other neuro-oncology practices. Based on these evaluations, changes were implemented at several stages (Table 1). Objective binary measures that could be recorded for every TMZ prescription were collected by chart review of the 6 months prior to process change. These measures were monitored every 2 weeks after process change implementation using run charts. A baseline process mean was calculated for each measure from the 6 months before program implementation. Successful change implementation was defined as 7 consecutive 2-week averages that were continually on one side of the process mean. Results: At the time of this abstract submission, we had successfully reduced refills for OC and increased documentation of dose calculation and dose ordered. There is improvement in independent dose calculation by 2 providers and dedicated chemotherapy teaching visits; however, these have not yet reached criteria for process change. Additionally, oral chemotherapy order sets were created in the electronic medical records system and an on-site specialty pharmacy was added as another safety measure in OC management. Conclusions: This project used published studies and multi-institutional process mapping and hazard analysis to implement a standardized ordering of TMZ for patients with brain tumors. This process can be implemented for OC management in other oncology practices.

Bipolar Disorders and Their Clinical Management, Part II: Diagnosis, Differential Diagnosis, and Treatment

Bipolar disorder is a biologically and phenotypically diverse disorder and its diagnosis and treatment provides a significant challenge to even the most seasoned clinician. We provide an update on the diagnosis and differential diagnosis of bipolar disorder, reflecting recent changes in DSM-5. Our review provides a succinct summary of the treatment literature, encompassing pharmacologic and psychosocial interventions for bipolar depression, mania/hypomania, mixed states, and prevention of disease recurrence. We provide a brief critical review of emerging treatment modalities, including those used in treatment resistance. Challenges involved in maintaining adherence are further discussed. Additionally, we review common treatment adverse effects and provide recommendations for proper side effect monitoring. There is evidence of significant functional impairment in patients with bipolar disorder and we conclude with a discussion of the impact of impairment on prognosis and quality of life. This review contains 4 figures, 7 tables, and 45 references. Key Words: bipolar disorders, differential diagnosis, maintenance pharmacotherapy, prognosis, psychosocial interventions, treatment, quality of life

Bipolar Disorders and Their Clinical Management, Part II: Diagnosis, Differential Diagnosis, and Treatment

Bipolar disorder is a biologically and phenotypically diverse disorder and its diagnosis and treatment provides a significant challenge to even the most seasoned clinician. We provide an update on the diagnosis and differential diagnosis of bipolar disorder, reflecting recent changes in DSM-5. Our review provides a succinct summary of the treatment literature, encompassing pharmacologic and psychosocial interventions for bipolar depression, mania/hypomania, mixed states, and prevention of disease recurrence. We provide a brief critical review of emerging treatment modalities, including those used in treatment resistance. Challenges involved in maintaining adherence are further discussed. Additionally, we review common treatment adverse effects and provide recommendations for proper side effect monitoring. There is evidence of significant functional impairment in patients with bipolar disorder and we conclude with a discussion of the impact of impairment on prognosis and quality of life. This review contains 7 tables and 45 references. Key Words: bipolar disorders, differential diagnosis, maintenance pharmacotherapy, prognosis, psychosocial interventions, treatment, quality of life

Bipolar Disorders and Their Clinical Management, Part II: Diagnosis, Differential Diagnosis, and Treatment

Bipolar disorder is a biologically and phenotypically diverse disorder and its diagnosis and treatment provides a significant challenge to even the most seasoned clinician. We provide an update on the diagnosis and differential diagnosis of bipolar disorder, reflecting recent changes in DSM-5. Our review provides a succinct summary of the treatment literature, encompassing pharmacologic and psychosocial interventions for bipolar depression, mania/hypomania, mixed states, and prevention of disease recurrence. We provide a brief critical review of emerging treatment modalities, including those used in treatment resistance. Challenges involved in maintaining adherence are further discussed. Additionally, we review common treatment adverse effects and provide recommendations for proper side effect monitoring. There is evidence of significant functional impairment in patients with bipolar disorder and we conclude with a discussion of the impact of impairment on prognosis and quality of life. This review contains 4 figures, 7 tables, and 45 references. Key Words: bipolar disorders, differential diagnosis, maintenance pharmacotherapy, prognosis, psychosocial interventions, treatment, quality of life

Design and methods of the \u2018monitoring outcomes of psychiatric pharmacotherapy\u2019 (MOPHAR) monitoring program \u2013 a study protocol

BackgroundAt many outpatient departments for psychiatry worldwide, standardized monitoring of the safety of prescribed psychotropic drugs is not routinely performed in daily clinical practice. Therefore it is unclear to which extent the drugs used by psychiatric outpatients are prescribed effectively and safely. These issues warrant structured monitoring of medication use, (pre-existing) co-morbidities, effectiveness and side effects during psychiatric outpatient treatment. Improvement of monitoring practices provides an opportunity to ensure that somatic complications and adverse drug effects are detected and dealt with in a timely manner. Structural support for data collection and follow-up tests seems essential for improvement of monitoring practices in psychiatric outpatients. The implementation of a structured somatic monitoring program as part of routine clinical practice, as we describe in this study protocol, may be a solution.MethodsIn order to address these issues, we developed the innovative program ‘Monitoring Outcomes of Psychiatric Pharmacotherapy (MOPHAR)’. MOPHAR is an infrastructure for implementation of standardized routine outcome monitoring (ROM; including standardized monitoring of treatment effect), monitoring of adverse psychotropic medication effects in psychiatric outpatients, encompassing both somatic adverse effects (e.g. metabolic disturbances) and subjective adverse effects (e.g. sedation or sexual side effects) and medication reconciliation.DiscussionIn the MOPHAR monitoring program, a nurse performs general and psychotropic drug-specific somatic screenings and provides the treating mental health care providers with more and better information on somatic monitoring for treatment decisions. Given our experience regarding implementation of the MOPHAR program, we expect that the MOPHAR program is feasible and beneficial for patients in any MHS organisation. This paper describes the objectives, target population, setting and the composition and roles of the treatment team. It also indicates what measurements are performed at which time points during outpatient treatment in the MOPHAR monitoring program, as well as the research aspects of this project.Trial registrationMOPHAR research has been prospectively registered with the Netherlands Trial Register on 19th of November 2014. (NL4779).

Методические подходы к разработке структурно-логической схемы персонализированного подбора лекарственных препаратов для онкологических больных

The article investigated the issues of the arrangement of personalized selection of drugs for cancer patients. The potential economic efficiency of the use of molecular genetic studies for the prescription of drugs and the cost-effectiveness was calculated using antitumor drugs as an example. A sociological survey of medical professionals on personalized selection of drugs in medical practice was conducted. A statistical link has been established between the practice of prescribing drugs according to the pharmacogenetic testing results and such indicators as side effects monitoring, pharmacoeconomic analysis of the use of drugs in medical organizations. The structural-logical scheme of interaction between the subjects of healthcare and the drug provision system for personalized therapeutic drug management for cancer patients has been developed based on scientific research.

Pharmaceutical companies vow to improve monitoring of medicine side effects

Pharmaceutical companies vow to improve monitoring of medicine side effects