Development of clinical pharmacy services at King Khalid University Hospital and its impact on the quality of healthcare provided

Clinical pharmacy is a unique service provided by the leading pharmacy departments in the United States. The concept of clinical pharmacy evolved after the significant increase in number of pharmaceuticals in the market and the increasing potential of drug interactions. However, the clinical pharmacists are not merely the individuals who advise on the drug interactions. There are number of functions which include but not limited to; design of appropriate drug therapy, pharmacokinetics assessment and evaluation to optimize drug therapy, drug information dissemination to the physicians and other healthcare providers and participate as toxicology consultant in poison management. At King Khalid University Hospital (KKUH), the first clinical pharmacy services program began in 1983. The aim of this study is to evaluate the impact of our clinical pharmacy program on the patients’ care as well as its perception by the medical staff that came from different parts of the World. Our clinical pharmacists were asked to record any suggestions or interventions in the form. The forms were all collected at the end of each day and entered into a database for analysis. Each intervention was analyzed in order to assess the merit of the action in terms of the therapeutic, financial and direct cost impact. The study showed a positive impact on the patients’ care as well as on the economy of drugs prescribing. Meanwhile, the service was very much appreciated by the medical staff as well as other healthcare providers.

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Hotline calling services of national drug information center in Saudi Arabia

National Drug Information Center has started providing services since January 2013; and started answering public and professional inquires through Ministry of Health Hotline Calling Services (937) since December 2013. Ten on call clinical pharmacist and expert trained pharmacist over 24/7 received calls asking about drug information, through manual documentation system of drug information inquiries. It consisted of type and qualification of caller, type of inquiries, and medications and cost avoidance of expected results of drug related problems sequel of drug information inquires if drug information services did not exist and were not answered using USA model. After 12-months of providing services, the total number of answered calls were 976 calls with 264 (27%) answered calls documented; with 300 answered drug inquires. 60% of inquiries were from the public and 40% were from professionals. The most type of inquiries were about medication identification and dose standardization, followed by drugs in pregnancy, the most medications were asked in both public and professional were antimicrobial. The average costs avoidance per each answered call received was (415.78 USD), and total estimated cost avoidance was (405.801 USD) per year. Hotline calling services of National Drug Information Center is costefficient in Saudi Arabia, it was associated with preventing drug related problems and cost savings per each receiving call. Expanding drug information services with electronic documentation excepted healthcare improvement and better care, better patient outcomes, and reduced costs.

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Managing Drug Dosage in the ICU – is Augmented Renal Clearance what we really want to Know?

Clearance (CL) is often felt to be the most physiologic parameter to describe elimination of substances from the body, and to be an independent parameter. However, there is an intimate relationship between CL, apparent volume of distribution (V) and the rate constant for elimination (K), in which CL = V times K, K = CL/V, and V = CL/K. Clearly none is independent. If one looks at general ways of describing similar systems, radioactive decay for example, there is no V, and K is the parameter giving accurate information about disappearance. In general, one can describe the behavior of a system as amount in a compartment, and the rate of movement from one compartment to another in terms of rate constants K. Observations of concentrations can be made as amount/V. CL is never needed. Further, since CL = KV, and since K has units of 1/time and V has units of volume, the units of CL are volume/time, and the actual information of rate of movement of drug becomes obscured when CL is used. However, V and K each give direct information about drug behavior. CL is not needed at all. CL is an unnecessary parameter. Further, since unstable ICU patients often have both rapidly changing renal function and unstable fluid balance at the same time, CL comingles and obscures the information of V and K, while V and K carry the needed information directly. This also facilitates separation of the two clinical issues of fluid balance and drug dosage for optimal management of these separate problems. Further, since ICU patients are so often unstable, conventional software for analyzing data of therapeutic drug monitoring (TDM) is no longer very useful, as it assumes that all the patent’s pharmacokinetic (PK) parameters are fixed and unchanging over the period of the data analysis. However, the interacting multiple model (IMM) algorithm developed in the aerospace community for tracking hostile targets most precisely has been developed [1] and implemented in the Bestdose clinical software [2] specifically to deal with this clinical situation. It tracks gentamicin and vancomycin in post-cardiac surgical ICU patients better than other methods [3]. It tracks changes in V and K as each new data point becomes available, resulting in the most recent Bayesian posterior parameter distributions. These then provide the foundation for dosage regimens to achieve desired target drug concentrations in the near future with maximum precision, using multiple model (MM) dosage design [4]. Illustrative clinical cases will be presented and discussed.

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Coffee consumption: A genetic approach

Coffee is among the most widely consumed beverages in the World. Coffee consumption has been receiving a lot of attention in regards to its potential health benefits and risks as well. Caffeine, polycyclic phenols such as chlorogenic acids are some of the most studied constituents from coffee. It has been attributed to various properties to those compounds such as central nervous system stimulant and antioxidants respectively. Coffee is in fact a very complex mixture that varies according with the origin of the beans and roasting process. A new approach to look into possible effects of drugs is through genetic and genomic studies. Actually, it was recently created The Coffee and Caffeine Genetics Consortium with the purpose to identify DNA loci associated with habitual coffee consumption. The technique utilized is called genome-wide meta-analysis (GWMA). This seminar intends to briefly review the results obtained so far. Following the presentation of this seminar, we will open a workshop that will focus in 3 main areas of interest: • Pharmacogenomics of coffee consumption • What’s inside a cup of coffee? • Epidemiology of coffee consumption

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BP-C1 in treatment of metastatic breast cancer: A randomised, double blinded and placebo controlled clinical study

Aim: The aim was to compare the efficacy and tolerability of a new benzene-poly-carboxylic acids complex with cisdiammineplatium (II) (BP-C1) versus equal looking placebo in treatment of metastatic breast cancer patients. Material & Methods: A randomized, double blind, placebo controlled multi-center study was performed with semi-cross-over design. Patients allocated to placebo switches to BP-C1 after 32 days of treatment. Thirty patients were given daily intramuscular injection of 0.035 mg/kg bw BP-C1 or placebo in 32 days. Biochemistry, hematology, NCI Bethesda (CTC-NCI), EORTC QOL-C30 & BR23 recorded at screening and after every 16 days of treatment. CT performed at screening and every 32nd day. Results: The sum of target lesions increased 2.4% in the BP-C1 group and 14.3% in placebo. The increase in the placebo group was significant (p=0.013) but not in BP-C1. The difference between the group was significant in favor of BP-C1 (p=0.04). Significant difference (p=0.026) in favor of BP-C1 regarding RECIST classification. CTC-NCI toxicity score increased nonsignificantly in the BP-C1 group, but significantly in placebo (p=0.05). “Breast cancer related pain and discomfort” and “Breast cancer treatment problem last week” were significantly reduced (p=0.02) in the BP-C1 group and slightly increased in placebo. Significant difference in favor of BP-C1 (p=0.05). “Breast cancer treatment problem last week” was significantly reduced in the BP-C1 group (p=0.02) and slightly increased in placebo. “Breast cancer related pain and discomfort”. Conclusion: BP-C1 reduces the cancer growth, is well tolerated, improves quality-of-life and has few mainly mild AE in patients suffering from stage IV MBC.

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Pharmacodynamic Profiling of Antibiotics Used in the Treatment of MRSA-Infected ICU Patients

Background: Appropriate initial treatment choices for methicillin resistant Staphylococcus aureus (MRSA) infections are very critical especially in the intensive care units (ICU) settings. The aim of this study was to compare the ability of ceftobiprole, dalbavancin, daptomycin, tigecycline, linezolid and vancomycin to achieve their requisite pharmacokinetic/pharmacodynamic (PK/PD) targets against MRSA isolates collected from ICU settings. Methods: Monte Carlo Simulations were performed to simulate the PK/PD indices of the investigated antimicrobials. Probability of target attainment (PTA) was estimated at MIC values ranging from 0.03-32 μg/ml to define the PK/PD susceptibility breakpoints. Cumulative fraction of response (CFR) was computed using MIC data from the Canadian National Intensive Care Unit (CAN-ICU) study. Results: Analysis of the simulation results suggested the breakpoints of 8 μg/ml for ceftobiprole, 0.12 μg/ml for dalbavancin, daptomycin and tigecycline, and 1 μg/ml for linezolid and vancomycin. The estimated CFR were 100, 100, 70.8, 87.6, 88.7, 82.4, 89.4, 98.3 % for ceftobiprole, dalbavancin, daptomycin (4mg/kg/day), daptomycin (6mg/kg/day), linezolid, tigecycline, vancomycin (1gm BID) and vancomycin (1.5gm BID), respectively. Conclusions: Ceftobiprole and dalbavancin have the highest probability of achieving favorable outcome against MRSA infections in the ICU. The susceptibility results suggested a further reduction of the vancomycin breakpoint to 1 μg/ml. Keywords: MRSA, Monte-Carlo simulation, ceftobiprole, dalbavancin, vancomycin

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Efficacy and safety of interleukin-1 antagonists in rheumatoid arthritis: a systematic review and meta-analysis

Abstract

Rheumatoid arthritis patients have a high level of pro-inflammatory interleukin-1. Augmenting the blockade of interleukin-1 receptors by external interleukin-1 receptor antagonist modifies the progression of the disease. Therefore, the aim of this study was to evaluate the clinicalefficacy and safety of interleukin-1 receptor antagonist (anakinra) in the treatment of rheumatoid arthritis. Clinical trials and extension studies that compared anakinra with placebo or other medications were included. Electronic bibliographic databases: PubMed, Scopus, and Web of Sciences were searched from inception to November 2017. The American College of Rheumatology 20% (ACR20) improvement was the primary efficacy outcome measure. Total number of adverse drug events, serious adverse drug events, total treatment withdrawals, and treatment-related withdrawals were safety outcome measures. Ten studies were included in this review. One study did not fulfil quantitative criteria and was assessed qualitatively. Six clinical trials and three extension studies were included in meta-analysis. Patients treated with anakinra are 42% more likely to have ACR20 response than patients without IL-1Ra (pooled RR 1.42; 95% CI 1.01, 2.00). Patients on 30-150 mg anakinra have lower Health Assessment Questionnaire (HAQ) score than patients without IL-1Ra (SMD - 0.28; 95% CI - 0.53, - 0.03). The inflammatory marker erythrocyte sedimentation rate (ESR) was significantly lower among patients treated with 30-150 mg anakinra (SMD - 0.44; 95% CI - 0.65, - 0.23). Patients on anakinra have a 34% more risk of treatment-related withdrawal than placebo. The other parameters were not found to be statistically significant. Anakinra has a significant improvement in ACR20, HAQ, and ESR. The ACR20 response is maintained after 48 weeks of treatment. Anakinra shows higher episodes of treatment-related withdrawals than placebo

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