A feasibility study on re-establishing the Bioavailability/Bioequivalence unit of the Department of Pharmacology and Toxicology, College of Medicine-University of the Philippines Manila

Objectives@#The Bioavailability/Bioequivalence Unit (BA/BE Unit) of the Department of Pharmacology and Toxicology, College of Medicine, University of the Philippines Manila which has not been operational since 2012, is due for renewal of its accreditation. To date, there are only three Philippine Food and Drug Administration-accredited laboratories that perform bioequivalence studies in the Philippines. One of the prerequisites of registering specific generic medicines is the conduct of Bioequivalence (BE) studies which are performed to ensure that the generic drug is at par with the innovator drug. Thus, this study aimed to determine the feasibility of re-establishing the BA/BE Unit as a bioequivalence testing center. @*Methods@#The feasibility study done is a qualitative descriptive analysis based on expansive literature review and performance of SWOT analysis within the BA/BE unit. Literatures were selected based on its assessed relevance to the study. The databases checked were PubMed and Google Scholar. The terms used were from the Medical Subject Heading (MeSH) including feasibility studies, therapeutic equivalency, and generic drugs. Literature review was performed on the factors affecting the four types of feasibility studies (market, technical, financial, and organizational). A SWOT analysis of the BA/BE Unit was done through the review of records and documents of previous BE studies and focus group discussion among the BA/BE Unit team members. @*Results@#The BA/BE Unit conducted 24 bioequivalence studies from 2006-2009 and still receives inquiries from drug companies. It implements its QMS throughout the pre-analytical, analytical, and post-analytical stages of the workflow. Its organizational structure consists of qualified professionals with updated GCP and GLP certificates. Because of the adequately equipped facility, lower honoraria for government-employed personnel, and lower expenses for laboratories and in-patient admissions, the cost of conducting a bioequivalence study in the BA/BE Unit will be lower than in other BE centers. @*Conclusion@#Based on the SWOT analysis and market, technical, financial, and organizational considerations, reestablishing the BA/BE Unit as a bioequivalence testing center is feasible.

Description of core performance measures and indicators of patient safety used by select government and private hospitals in the Philippines

Background@#In 2008, the Department of Health (DOH) issued Administrative Order 2008-0023 that called for an “effective and efficient monitoring system that will link all patient safety initiatives”. However, there are still no explicit and harmonized targets to measure effectiveness and to provide benchmarks that assess whether previous efforts were helpful. @*Objective@#The study aimed to describe the status of patient safety performance measures and indicators on the international patient safety goals (IPSGs) in select hospitals in the Philippines. @*Methods@#Descriptive, cross-sectional design was used to investigate currently used performance measures and indicators. Data collection included administration of a Hospital Patient Safety Indicators Questionnaire (HPSIQ) that summarized the currently used patient safety measures and indicators in the sampled Level 2 and level 3 hospitals and triangulation by review of documents such as hospital databases, protocols on reporting, and manuals for information gathering regarding patient safety. Performance measures were categorized using the Donabedian framework. Core indicators were identified through review of standards that cut across the six IPSGs and evaluation of overarching processes and concepts in patient safety. @*Results@#Forty-one level 2 and 3 hospitals participated in the study. Most performance indicators were process measures (52%), while structure (31%) and outcome measures (17%) accounted for the rest. There is an obvious lack of structural requirements for patient safety in the hospitals included in this study. Less than half the hospitals surveyed implement risk assessment and management consistently. Reporting of events, near- misses, and patient safety data are widely varied among hospitals. Data utilization for quality improvement is not fully established in many of the hospitals. Patient engagement is not integrated in service delivery and performance measurement but is crucial in promoting patient safety. @*Conclusion@#Mechanisms to improve hospitals’ capacity to monitor, anticipate, and reduce risk of patient harm during the provision of healthcare should be provided. Having a unified set of definitions and protocols for measurement will facilitate reliable monitoring and improvement. Leadership and governance, both internal (e.g., hospital administrators) and external (e.g., DOH) that recognize a data-driven approach to policymaking and improvement of service delivery are crucial in promoting patient safety

In vitro antibacterial and antibiofilm activities of Piper betle L. ethanolic leaf extract on staphylococcus aureus ATCC 29213

Background and Objective@#Staphylococcus aureus is the leading cause of skin and soft tissue infections such as abscesses, furuncles, and cellulitis. Biofilm forming strains of S. aureus have higher incidence of antimicrobial resistance to at least three or more antibiotics and are considered as multidrug resistant. Since S. aureus biofilm-producing strains have higher rates of multidrug and methicillin resistance compared to non-biofilm-producing strains, the need for alternative therapeutic option is important. Furthermore, rates of methicillin-resistant Staphylococcus aureus (MRSA) in Asia remain high. Results of the study may provide support for the clinical uses of P. betle as a topical antibacterial and antiseptic in the treatment and prevention of infections involving the skin, mouth, throat, and indwelling medical devices. Thus, this study aimed to evaluate the in vitro antibacterial and antibiofilm activities of Piper betle L. ethanolic leaf extract (PBE) against a biofilm-forming methicillin-sensitive Staphylococcus aureus ATCC 29213 (MSSA).@*Methods@#The minimum inhibitory concentration (MIC) and minimum bactericidal concentration (MBC) of PBE against MSSA were determined using the agar dilution assay. The biofilm inhibition and eradication assays using crystal violet were done to quantify the antibiofilm activities of PBE on MSSA biofilm.@*Results@#PBE showed activity against MSSA in agar dilution assay with MIC and MBC values of 2500 μg/mL and 5000 μg/mL, respectively. At subinhibitory concentrations, PBE showed biofilm inhibition activity at 1250 μg/mL but a lower percent eradication of biofilms as compared to oxacillin was noted.@*Conclusion@#PBE showed antibacterial activities including biofilm inhibition against methicillin-sensitive Staphylococcus aureus ATCC 29213 (MSSA).

In Vitro Antibacterial and Antibiofilm activities of Piper betle L. Ethanolic Leaf Extract on Staphylococcus aureus ATCC 29213

Background and Objective@#Staphylococcus aureus is the leading cause of skin and soft tissue infections such as abscesses, furuncles, and cellulitis. Biofilm forming strains of S. aureus have higher incidence of antimicrobial resistance to at least three or more antibiotics and are considered as multidrug resistant. Since S. aureus biofilm-producing strains have higher rates of multidrug and methicillin resistance compared to non-biofilm-producing strains, the need for alternative therapeutic option is important. Furthermore, rates of methicillin-resistant Staphylococcus aureus (MRSA) in Asia remain high. Results of the study may provide support for the clinical uses of P. betle as a topical antibacterial and antiseptic in the treatment and prevention of infections involving the skin, mouth, throat, and indwelling medical devices. Thus, this study aimed to evaluate the in vitro antibacterial and antibiofilm activities of Piper betle L. ethanolic leaf extract (PBE) against a biofilm-forming methicillin-sensitive Staphylococcus aureus ATCC 29213 (MSSA).@*Methods@#The minimum inhibitory concentration (MIC) and minimum bactericidal concentration (MBC) of PBE against MSSA were determined using the agar dilution assay. The biofilm inhibition and eradication assays using crystal violet were done to quantify the antibiofilm activities of PBE on MSSA biofilm. @*Results@#PBE showed activity against MSSA in agar dilution assay with MIC and MBC values of 2500 μg/mL and 5000 μg/mL, respectively. At subinhibitory concentrations, PBE showed biofilm inhibition activity at 1250 μg/mL but a lower percent eradication of biofilms as compared to oxacillin was noted. @*Conclusion@#PBE showed antibacterial activities including biofilm inhibition against methicillin-sensitive Staphylococcus aureus ATCC 29213 (MSSA).

HPLC method for ethylenethiourea in biological and environmental samples

@#<p style="text-align: justify;"><strong>OBJECTIVE:</strong> In view of both the economic importance of ethylenebisdithiocarbamate (EBDC) fungicides in the current agricultural practice and the potential health hazards associated with ethylenethiourea (ETU) exposure, this study aimed to develop and validate a high-pressure liquid chromatography (HPLC) method to determine ETU in biological and environmental samples.</p><p style="text-align: justify;"><strong>METHODS:</strong> The samples were pre-treated according to sample types and were analyzed for ETU using a reversed-phase HPLC system (JASCO?) equipped with UV detector set at 230 nm using C18 bonded silica column and a mobile phase of 0.05M ammonium acetate in methanol (95:5).</p><p style="text-align: justify;"><strong>RESULTS:</strong> The method showed a limit of detection of 0.2 ug/L, with a precision of 3.33 to 12.86 %CV and an accuracy of >90% at 1, 10 and 100 ug/L of ETU in all sample types. The calibration curve was linear from 1 to 200 ug/L for blood, air and water samples and 1 to 2000 ug/L for urine.</p><p style="text-align: justify;"><strong>CONCLUSION:</strong> This method showed an acceptable accuracy, precision, sensitivity and specificity and was used subsequently to determine ETU levels in blood, urine, air, soil and water samples among banana plantation workers.</p>

Effects of Aqueous Quassia Amara l. (Korales) leaf extract on the cardiovascular and respiratory functions of male Sprague-Dawley rats

@#<p><strong>OBJECTIVE:</strong> To evaluate potential effects of the aqueous extract of Quassia amara L. leaves on the cardiovascular and respiratory systems of adult male Sprague- Dawley rats.</p><p><strong>METHODS:</strong> The cardiovascular and respiratory effects of the Quassia amara L. leaf extract on adult male Sprague-Dawley rats were assessed using non-invasive blood pressure (NIBP) determination and head-out plethysmography, respectively, in a randomized, parallel group study. Mean observations of blood pressure and heart rate were recorded at different time periods after dosing. Respiratory flow and irritation effects were evaluated using mean observations of respiratory rate (RR), tidal volume (TV), mid-expiratory flow rate (EF50), time of inspiration (TI) and expiration (TE), and time of break (TB) and pause (TP).</p><p><strong>RESULTS:</strong> There were no significant differences among the control and the treatment groups in SBP, DBP and HR parameters. The extract showed statistically significant effect on mean RR by time period (F=2.45, p=0.0234), trends over time of TV among the dose groups (F=2.00, p=0.0202), and EF50 among dose groups ((F=3.11, p=0.0422). However, these did not correlate with the changes in the time of break (TB) and time of pause (TP) which are more sensitive and specific tests for respiratory irritation.</p><p><strong>CONCLUSION:</strong> Aqueous leaf extract of Quassia appeared to have no significant effects on SBP, DPB, Pulse pressure, and HR. There are no conclusive dose-related respiratory flow or pulmonary irritation effects.</p>