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Analyzed the data: YT WK. Wrote the paper: The objective of this study is to assess the value for money of introducing pneumococcal conjugate vaccines as part of the immunization program in a lower-middle income country, the Philippines, which is not eligible for GAVI support and lower vaccine prices. It also includes the newest clinical evidence evaluating the efficacy of PCV10, which is lacking in other previous studies. A cost-utility analysis was conducted.

It was assumed that only one infection per cycle could occur. The analysis adopted a health system perspective, which includes direct costs of PCV related treatments and of the vaccination program. An annual discount rate of 3. All costs are presented for the year The effects of switching from no vaccination to either PCV10 or PCV13 were evaluated, alternatively with and without indirect effects. For this study, a 2-dose primary series at 1. The study employs two potential policy scenarios, which examine the impact of different vaccination coverage rates on health outcomes, cost-effectiveness and government budget.

Scenario 1 Universal coverage: Scenario 2 Partial coverage , status quo: A summary of the epidemiological parameters used in the analysis is provided in Table 1. No published data were available on the IPD incidence among Filipinos older than 5 years of age. Due to the lack of local information of sequelae, Thai data were used.

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All-cause hospitalized pneumonia incidences were gathered from the PneumoNet study and anonymized insurance claims were obtained from the Philippine Health Insurance Corporation PhilHealth [ 16 ]. Data on non-hospitalized pneumonia was unavailable; thus, information was obtained through an expert panel of infectious disease specialists who estimated a The probability of dying from hospitalized pneumonia was estimated as 2.

All-cause AOM incidence was derived from the national cross-sectional survey of 2, children in community health centers and schools in the Philippines [ 20 ]. It was assumed that none of the AOM cases were severe enough to require hospitalization or to cause death. According to global estimates, AOM occurs regularly in younger age groups [ 26 ]; thus, incidence of AOM was assumed to be zero for individuals that were 12 years or older.

The distribution of serotypes in invasive disease was taken from a comprehensive laboratory-based surveillance study involving 42 hospitals across the Philippines Fig 2 [ 27 ]. All efficacy estimates were based on the intention-to-treat ITT population.

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For PCV13, demonstration of VE is based on non-inferior immunogenicity compared with PCV7 rather than efficacy trials measuring clinical endpoints [ 28 , 29 ]. However, evidence supporting the effectiveness of PCV13 for covered serotypes has been documented in various settings [ 30 — 33 ].

In Filipino children below 5 years of age, serotypes 6B and 23F comprised The percentage change in IPD infections among unvaccinated individuals was based on the percentage decline of IPD incidence in the United States following the introduction of routine vaccination of PCV7 for infants and young children [ 4 ], adjusted for the difference between the USA and the Philippine serotype coverage.

In order to estimate the percentage change for pneumonia among unvaccinated populations, it was assumed that pneumonia incidence decreases proportionally to the IPD fall for respective age groups, adjusted by the ratio of pneumococcal pneumonia to hospitalized pneumonia cases. Duration of vaccine protection was assumed to be 5 years for both direct and indirect effects, which is in line with other PCV economic evaluations [ 40 — 42 ].

Additional costs for syringe, storage, warehousing, delivery and program implementation were considered Table 1. Taxes, handling fee and freight cost incurred through UNICEF procurement were excluded since the national program is considering local bidding as its mode of procurement. Individuals vaccinated through PhilHealth coverage received the vaccine including its administration free of charge.

Only a single-dose vial presentation is currently available for PCV13, whereas PCV10 is available as a single dose and a two-dose vial presentation, with all presentations of both vaccines being prequalified by the WHO. The two dose preservative-free presentation of PCV10 is only available through UN procurement; the implementation of this vaccine presentation requires specific training for immunization staff as well as formal post-introduction monitoring [ 45 ].

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For this analysis, it was assumed that a single-dose vial presentation for both vaccines would be procured. Insurance claims data from were provided by PhilHealth and used to calculate the unit cost of hospitalized bacterial meningitis, hospitalized all-cause pneumonia, hospitalized all-cause sepsis and bacteremia Table 1. WHO ICD 10 codes were used as reference to extract the total medical cost for each disease presentation. Each insurance claim reflected both the actual total cost per case and the amount reimbursed by PhilHealth, excluding professional fees and other administration costs.

For the base case analysis, the average of the actual total cost of all claims from public hospitals were considered, since PhilHealth reimbursement typically only covers a certain amount of the actual total cost per claim. Private hospital cost significantly exceeded public hospital cost and were not regarded to be a reasonable proxy of actual medical cost. In sensitivity analysis, private hospital costs were taken into account by using a weighted average of public and private hospital costs.

Due to a lack of local studies and considering that the number of claims for relatively rare sequelaes due to S.

Due to absence of local utility parameters, Thai values using the Health Utilities Index Mark 3 were adopted [ 47 ]. One-way sensitivity analysis was performed to explore the robustness of the results to variations in uncertain key assumptions. The following alternative scenarios were assessed: Probabilistic sensitivity analysis was conducted using the Monte Carlo simulation using Microsoft Office Excel According to the feasible range of values each parameter could attain, the following probability distributions were used: The gamma distribution was used when parameter values ranged between zero to infinity, and the normal distribution was used when data were symmetrically distributed.

A 1, iterations were run to yield possible values for costs, health outcomes and incremental cost-effectiveness ratios ICERs. Acceptability curves were generated, showing the probability of each intervention being cost-effective at different ceiling threshold values.

A ceiling threshold of one per capita gross domestic product or Php , per QALY gained was used to determine the cost-effectiveness of each intervention as recommended by the FEC [ 49 ]. Budget impact analysis was performed to forecast the financial impact for a 5-year horizon of implementing PCV for either universal or partial coverage.

Universal child vaccination with PCV would reduce both the clinical and the economic burden caused by S. Indirect benefits of vaccination among the unvaccinated population, including the elderly, would prevent an additional 1, and 1, episodes of IPD meningitis, bacteremia.

In scenario 2, where indirect effects of vaccination were excluded due to partial vaccination coverage that is fully funded by the government, ICER values of PCV10 Php , and PCV13 Php 84, increased significantly, yet were still below the cost-effectiveness threshold of Php , In one-way sensitivity analysis for scenario 1, selected parameters had a significant impact on ICERs, except serotype coverage, treatment cost weighted average of public and private , and ratio of inpatient to outpatient pneumonia cases Substantial variations in ICER values were obtained with vaccine cost, exclusion of indirect effects, vaccine efficacy, and duration of vaccine protection.

The discount rate may be considered as the single most significant parameter affecting the value for money of both vaccines. A small change in the discount rate resulted in a disproportionately larger change in the ICERs. Fig 5 demonstrates that adopting either universal or partial access to PCV as compared to no vaccination offers good value for money for the DOH, given the current ceiling threshold of Php , per QALY gained.

This study is the first economic evaluation conducted in the Philippines and to our best knowledge, it is the first in the world conducted after the release of the newest clinical evidence on efficacy of PCV10 published in [ 13 ]. It shows that at current vaccine pricing and ceiling threshold, introducing universal vaccination with either PCV10 or PCV13 would be cost-effective, compared to no vaccination. Introducing universal PCV vaccination throughout the country would cost Php 3.

Hence, universal vaccination will only be feasible if additional budget for the EPI program is allocated, or vaccine prices are lowered. The model was very sensitive to vaccine price and indirect effects herd protection. However, while the use of current market prices for PCV10 and PCV13 made vaccination cost-ineffective, excluding herd protection generated ICER values that remained below the country-specific threshold.

Apart from economic reasons, PCV13 is superior to PCV10 in terms of its broader coverage of serotypes; a universal vaccination program with PCV13 would lower the potential for serotype replacement. This phenomenon has been experienced in many countries including the USA and UK, where a dramatic increase in IPD caused by non-vaccine serotypes following PCV7 introduction offset some of the benefits of vaccination [ 5 , 50 ].

Serotype replacement was particularly observed for the multi-resistant serotype 19A [ 51 — 53 ], which is only covered by PCV As a consequence, many Western countries replaced the earlier version of PCV7 with PCV13 in their national immunization programs due to the rapid rise of this virulent serotype in invasive pneumococcal isolates [ 54 ].

Serotype 19A was also one of the more commonly isolated serotypes in Filipino children under 5 years of age [ 27 ]. This cost-effectiveness study used a similar analytic approach to that used in Thailand [ 14 ], in terms of the static model structure and utility values considered, and methods used to derive vaccine efficacy and indirect effects.

The differences may be explained by differences in vaccine price, epidemiological parameters, and vaccine efficacy used in the model. Results of this study are similar to previous studies conducted in Taiwan and Singapore, which found PCV13 to be cost-effective [ 9 , 11 , 42 ].

This study has some limitations. First, due to lacking clinical trial data against final clinical endpoints, vaccine efficacy for PCV13 was extrapolated from PCV10 efficacy trials, which may under- or overestimate its efficacy. Second, this study did not employ dynamic modeling, which is generally recommended by cost-effectiveness analysis guidelines in order to account for externalities. However, this study used an excel-based static model Markov , which accounted for indirect effects of vaccination.

The use of static model facilitated transparency in terms of the methods used in this study because many local decision makers are familiar with this type of modeling. Third, since no local data on indirect vaccine effects were available, US data were used and adjusted to local serotype coverage. However, US findings showed a statistically significant decline in IPD incidence among unvaccinated persons aged 20 years and above only. Thus, our study did not include indirect effects among populations under 20 years.

Fourth, the only available study on IPD incidence in the country was hospital-based [ 16 ], with incidences weighted by the number of children in the at-risk population, which may have led to an overestimation of IPD incidence rates used in the model.

On the contrary, lower bacterial isolation rates attributed to high rates of antimicrobial use by parents of young children in the Philippines may have led to an underestimation of IPD [ 16 ]. Fifth, results of this study are dependent on the local serotype distribution and on the country-specific ceiling threshold, with the latter being based on the preferences of decision makers in the Philippines.

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Therefore, applying results of this study to other settings or populations should be performed with caution. Sixth, we assumed all AOM cases are treated on an outpatient basis, resulting in an underestimation of the cost of AOM treatment because in some severe cases, hospitalization for tube replacement may be required. However, including hospitalization cost for AOM will not change our overall conclusion as higher treatment cost will result in a lowering of the ICERs, which will further favor vaccination.

Lastly, differences in pathogenicity between pneumococcal serotypes are important when evaluating the benefits of pneumococcal conjugate vaccines of different valency [ 57 ]. This model did not account for differences between serotypes in terms of their propensity to cause morbidity or death. We would also like to thank Dr. Anna Melissa Guerrero, Dr. Cecilia Maramba-Lazarte, Dr. Maria Joyce Ducusin, Engr. Gloria Nenita Velasco, Dr.

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The views expressed in the publication are those of the authors and not necessarily those of the supporting institutions. WHO and Rockefeller Foundation had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. All relevant data are within the paper and its Supporting Information files. National Center for Biotechnology Information , U.

PLoS One. Published online Jul 1. Bernard Beall, Editor. Author information Article notes Copyright and License information Disclaimer.

Competing Interests: The authors have declared that no competing interests exist. Received Feb 25; Accepted May This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are properly credited.

This article has been cited by other articles in PMC. S2 Table: Abstract Objectives The objective of this study is to assess the value for money of introducing pneumococcal conjugate vaccines as part of the immunization program in a lower-middle income country, the Philippines, which is not eligible for GAVI support and lower vaccine prices. Methods A cost-utility analysis was conducted. Conclusion The inclusion of PCV in the national immunization program is recommended.

Introduction Streptococcus pneumoniae S. Open in a separate window.

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Fig 1. Intervention The effects of switching from no vaccination to either PCV10 or PCV13 were evaluated, alternatively with and without indirect effects.

Policy scenarios The study employs two potential policy scenarios, which examine the impact of different vaccination coverage rates on health outcomes, cost-effectiveness and government budget.

Model input parameters Epidemiological parameters A summary of the epidemiological parameters used in the analysis is provided in Table 1.

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