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, re-establishing 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.

ESP: an expert system for poisoning diagnosis and management.

We describe a clinical decision support system (CDSS) designed to provide timely information germane to poisoning. The CDSS aids medical decision making through recommendations to clinicians for immediate evaluation. The system is implemented as a rule-based expert system with two major components: the knowledge base and the inference engine. The knowledge base serves as the database which contains relevant poisoning information and rules that are used by the inference engine in making decisions. This expert system accepts signs and symptoms observed from a patient as input and presents a list of possible poisoning types with the corresponding management procedures which may be considered in making the final diagnosis. A knowledge acquisition tool (KAT) that allows toxicological experts to update the knowledge base was also developed. This article describes the architecture of the fully featured system, the design of the CDSS and the KAT as web applications, the utilisation of the inferencing mechanism of C Language Integrated Production System (CLIPS), which is an expert system shell that helps the system in decision-making tasks, the methods used as well as problems encountered. We also present the results obtained after testing the system and propose some recommendations for future work.

Usefulness of monofilament testing for detecting peripheral neuropathy I

BACKGROUND: The monofilament test is a simple and inexpensive tool used for the detection of diabetic peripheral neuropathy in the community setting but it is unclear whether its use can be extended to patients with neuropathy that is not due to diabetes. OBJECTIVE: We aimed to determine the sensitivity and specificity of the monofilament test in detecting peripheral neuropathy, diabetic or non-diabetic, using Nerve Conduction Studies (NCS) as the gold standard. METHODS: In a health assessment activity in Marinduque, patients were assessed by a neurologist as to whether or not they have neuropathy. Monofilament testing was done using the NHANES protocol with a 10-g Semmes Weinstein monofilament. Nerve Conduction Study was used as the gold standard. RESULTS: Fourteen patients were included in the study. A positive monofilament test was found to be significantly associated with a positive NCS result (p CONCLUSION: Monofilament testing was found to be useful in detecting peripheral neuropathy in the community setting. If monofilament testing is positive, then peripheral neuropathy is ruled in. If the test is negative but the clinical suspicion is high, then NCS may be warranted. This cuts back the need for NCS to detect neuropathy in the community setting by more than half.

Environmental and human exposure assessment monitoring of communities near an abandoned mercury mine in the Philippines: a toxic legacy.

Abandoned mines are an important global concern and continue to pose real or potential threats to human safety and health including environmental damage/s. Very few countries had government mine regulation and reclamation policies until the latter part of the century where legal, financial and technical procedures were required for existing mining operations. Major reasons for mine closure may be mainly due to poor economies of the commodity making mining unprofitable, technical difficulties and national security. If the mine is abandoned, more often than not it is the government that shoulders the burden of clean-up, monitoring and remediation. The topic of abandoned mines is complex because of the associated financial and legal liability implications. Abandoned mercury mines have been identified as one of the major concerns because of their significant long-term environmental problems. Primary mercury production is still ongoing in Spain, Kyrgzystan, China, Algeria, Russia and Slovakia while world production declined substantially in the late 1980s. In the Philippines, the mercury mine located southeast of Manila was in operation from 1955 to 1976, before ceasing operation because of the decline in world market price for the commodity. During this time, annual production of mercury was estimated to be about 140,000 kg of mercury yearly. Approximately 2,000,000 t of mine-waste calcines (retorted ore) were produced during mining and roughly 1,000,000 t of these calcines were dumped into nearby Honda Bay to construct a jetty to facilitate mine operations where about 2000 people reside in the nearby three barangays. In October, 1994 the Department of Health received a request from the Provincial Health Office for technical assistance relative to the investigation of increasing complaints of unusual symptoms (e.g. miscarriages, tooth loss, muscle weakness, paralysis, anemia, tremors, etc.) among residents of three barangays. Initial health reports revealed significant elevation of blood mercury levels exceeding the then recommended exposure level of 20ppb in 12 out of the 43 (27.9%) residents examined. The majority of the volunteers were former mine workers. In this study the abnormal findings included gingivitis, mercury lines, gum bleeding and pterydium. The most common neurologic complaints were numbness, weakness, tremors and incoordination. Anemia and elevated liver function tests were also seen in a majority of those examined. The assessment also revealed a probable association between blood mercury level and eosinophilia. The same association was also seen between high mercury levels and the presence of tremors and working in the mercury mine. To date, there are very limited environmental and health studies on the impact of both total and methylmercury that have been undertaken in the Philippines. Thus, this area of study was selected primarily because of its importance as an emerging issue in the country, especially regarding the combined effects of total and methylmercury low-dose and continuous uptake from environmental sources. At present the effects of total mercury exposure combined with MeHg consumption remain an important issue, especially those of low-dose and continuous uptake. Results of the study showed that four (4) species of fish, namely ibis, tabas, lapu-lapu and torsillo, had exceeded the recommended total mercury and methylmercury levels in fish (NV>0.5 microg/gf.w., NV>0.3 microg/gf.w., respectively). Saging and kanuping also exceeded the permissible levels for methylmercury. Total and methylmercury in canned fish, and total mercury in rice, ambient air and drinking water were within the recommended levels, however, additional mercury load from these sources may contribute to the over-all body burden of mercury among residents in the area. Surface water quality at the mining area, Honda Bay and during some monitoring periods at Palawan Bay exceeded total mercury standards (NV>0.002 ng/mL). Soil samples in two sites, namely Tagburos and Honda Bay, exceeded the EPA Region 9 Primary Remediation Goal recommended values for total mercury for residential purposes (NV>23 mg/kg). The hand to mouth activity among infants and children is another significant route for mercury exposure. Statistically significant results were obtained for infants when comparing the results after one year of monitoring for methylmercury levels in hair for both exposed and control sub-groups. Likewise, comparing the initial and final hair methylmercury levels among pregnant women/mothers in the exposed group showed statistically significant (p<0.05) results. Comparing the exposed and control sub-groups' mercury hair levels per sub-group showed statistically significant results among the following: (a) initial and final total mercury hair levels among children, (b) initial and final methylmercury hair levels among children, (c) final total mercury hair levels among pregnant women, (d) initial and final total mercury hair levels among mothers, and (e) initial and final methyl hair levels among mothers.