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.

Scabies in the Philippines: A Secondary Analysis of Local Patient Registries.

Background: Scabies is the second most common cause of disability among skin diseases in the Philippines as of 2019. There is no large nationwide study describing the epidemiologic profile of scabies in the country. Objective: This study aimed to describe the demographic, seasonal, and geographic profile of scabies in the Philippines. Methods: We compared secondary data of two local patient registries (Philippine Dermatological Society, PDS, 2010 to 2021; and Philippine Pediatric Society, PPS, 2009 to 2021) for reported cases of scabies in the Philippines. We reported the frequency and percentage distribution according to age, sex, month, year, and type of diagnosis, and region. Results: The median annual frequency of scabies cases (mostly outpatient) for PDS (from year 2010) was 4087 (range ([QR], 342-6422 [3271.5]), while it was 183 (range [IQR], 64-234 [96.5]) (all inpatient) for PPS (from year 2009). There was a reduction to one-third (PDS) and one-fourth (PPS) of pre-pandemic numbers during the pandemic years (2020-2021). The peak months for scabies cases were the cooler months: January (median, 12.1% of annual cases; range [IQR], 2.6%-31.4% [3.6%]) to February (median, 10.0% of annual cases; range [IQR], 1.5%-27.8% [2.5%]) based on PDS data, and November (median, 10.0% of annual cases; range [IQR], 0.0%-24.3% [7.0%]) to January (median, 9.0% of annual cases; range [IQR], 0.0%-24.3% [6.6%]) for PPS data. Overall, for PDS, age 1-4 years is the most affected age group (median, PDS, 17.5% of annual cases; range [IQR], 11.9%-25.4% [8.1%]), while it was the less than 1-year-olds (median annual cases, 48.9%; range [IQR], 29.1%-67.3% [13.20%]) among PPS pediatric population aged 0 to 18 years. Males (median, 53.9% of annual cases; range [IQR], 45.0%-67.2% [8.8%]) were more affected than females in PPS. While for PDS during earlier years (prior to 2015), males (median, 51.6% of annual cases from 2010 to 2014; range [IQR], 47.4%-52.9% [0.2%]) were more affected than females. However, males became less affected than females with median, 44.7% of annual cases from 2015 onwards (range [IQR], 43.4%-46.5% [1.2%]). NCR was the region with the highest frequency of cases in PPS (median, 52.6% of annual cases; range [IQR], 22.7%-75.0% [20.4%]). The 2nd most affected regions were Central/Eastern Visayas (34.2%, 2009-2013; range [IQR], 17.9%-54.1% [5.3%]), Bicol region (12%; 2014 to 2018; range [IQR], 17.9%-54.1% [7.4%]), Central Luzon (18%; 2019), Central/Eastern Visayas (29%, 2020), and Northern/Central Mindanao (17%, 2021). Conclusion: Scabies was commonly seen in the younger age group, slightly more in females in the PDS, while slightly more among males in the PPS, in the cooler months of the year, and in the urbanized NCR.

Factors associated with having COVID-19 among unvaccinated pregnant and non-pregnant women in Metro Manila, Philippines: a multicentre longitudinal cohort study.

OBJECTIVE: To determine the potential risk factors associated with having COVID-19 among unvaccinated pregnant and non-pregnant women. DESIGN: A multicentre prospective cohort study among eligible women in Metro Manila, Philippines, from 2020 to 2022. SETTING: Five national and local hospital research sites altogether recruited and screened 500 consenting eligible individuals. PARTICIPANTS: Pregnant and non-pregnant participants meeting the eligibility criteria were admitted for a reverse-transcription PCR determination of SARS-CoV-2, pregnancy testing and ultrasound, and an interview with an administered questionnaire. EXPOSURES: Primary exposure was pregnancy; secondary exposures involve sociodemographic, lifestyle and obstetric-gynaecologic factors. OUTCOME MEASURE: Outcome being measured was COVID-19 status. RESULTS: The significant COVID-19 risk factors were: pregnancy (PR=1.184, 95% CI 1.096, 1.279), having a white-collar job (PR=1.123, 95% CI 1.02, 1.235), travelling abroad (PR=1.369, 95% CI 1.083, 1.173) and being infected by at least one vaccine-preventable disease (VPD) (PR=1.208, 95% CI 1.113, 1.310). Protective factors included having graduate-level education (PR=0.787, 95% CI 0.649, 0.954), immunisation against a VPD (PR=0.795, 95% CI 0.733, 0.862) and practising contraception (PR=0.889, 95% CI 0.824, 0.960). CONCLUSION: This study is the first in the country to determine the risks influencing COVID-19 infection among unvaccinated pregnant and non-pregnant women. Pregnancy is a significant risk for COVID-19 among women in Metro Manila. Educational attainment and positive health behaviours seem to confer protection. Occupations and activities that increase the frequency of interactions, as well as history of communicable diseases may predispose women to COVID-19. Further studies are needed to elucidate the development of the disease in pregnant women, including the maternal and neonatal effects of COVID-19 via potential vertical mechanisms of transmission.

Attitudes of Filipino parents of children with Down syndrome on noninvasive prenatal testing.

Globally, there has been an increasing uptake of noninvasive prenatal testing (NIPT). In the Philippines, the test is currently available through private laboratories and can be availed by families who can afford the out-of-pocket cost. In a country where elective termination of pregnancy is not an option, the question arises as to the relevance of this testing, even among health professionals. This is an exploratory qualitative study that explored the attitudes of Filipino parents of children with Down syndrome (DS) toward NIPT using thematic analysis of in-depth interviews. Study participants acknowledged the value of NIPT in providing early diagnosis and, subsequently, emotional, mental, spiritual, and financial preparation. This said, they also emphasized that such early detection may cause anxiety and even thoughts of termination for some, despite abortion being against the law and predominant religious beliefs. For those undergoing NIPT and receiving positive results, study participants highlighted the need to receive proper and nonbiased counseling from both health professionals and parents who have children with DS.

Risk factors of COVID-19 vertical transmission among pregnant and non-pregnant Filipinos in Metro Manila: a multicentre cohort study protocol.

INTRODUCTION: The novel (COVID-19 was first reported to have originated in Wuhan, China, in December 2019. This new strain, SARS-CoV-2, has spread rapidly worldwide, prompting the WHO to declare the COVID-19 outbreak a global pandemic. The main objective of this cohort study is to determine the risk factors of COVID-19, the modes of COVID-19 vertical transmission, and the maternal and fetal outcomes among non-pregnant and pregnant women and their fetuses. METHODS AND ANALYSIS: This is a multicentre epidemiological study that will involve a prospective cohort. COVID-19 status among consulting non-pregnant and pregnant women in public hospitals in Manila, Philippines, will be determined and monitored for 6-12 months. Swab specimens from the nasopharynx, cervix, rectum, amniotic fluid, placenta, cord blood and breastmilk will be collected during consult and admission for reverse transcription-PCR (RT-PCR) testing. Blood will be collected during the postdelivery period to monitor the women and their neonates for any undue development and determine the antibody development to indicate an infective or non-infective state. Evidence of vertical transmission will be explored with the presence or absence of the virus using the maternal and fetal neonatal RT-PCR and lateral flow antibody status. Descriptive and inferential statistics will be done, including the associations between exposures and risk factors, description of clinical characteristics, and the COVID-19 status of the participants. ETHICS AND DISSEMINATION: The Single Joint Research Ethics Board of the Department of Health has approved this protocol (SJREB 2020-30). The study results will be disseminated through conference presentations, peer-reviewed articles, and various stakeholder public forums and activities.

Molar pregnancy in the last 50 years: A bibliometric analysis of global research output.

Molar pregnancy is a gestational trophoblastic disease characterized by an abnormal growth of placental tissues because of a nonviable pregnancy. The understanding of the pathophysiology and management of molar pregnancy has significantly increased in the recent years. This study aims to determine the characteristics and trends of published articles in the field of molar pregnancy through a bibliometric analysis. Using the Scopus database, we identified all original research articles on molar pregnancy from 1970 to 2020. Bibliographic and citation information were obtained, and visualization of collaboration networks of countries and keywords related to molar pregnancy was conducted using VOSviewer software. We obtained a total of 2009 relevant papers published between 1970 and 2020 from 80 different countries. The number of publications continued to increase through the years. However, the number of publications in molar pregnancy is still low compared to the other research fields in obstetrics and gynecology. The USA (n = 421, 32.1%), Japan (n = 199, 15.2%), and the UK (n = 191, 14.6%) contributed the greatest number of publications in this field. The top journals which contributed to the field of molar pregnancy include AJOG (n = 91), Obstetrics and Gynecology (n = 81), and the Gynecologic Oncology (n = 57). The most cited articles in molar pregnancy include papers on the genetics and chromosomal abnormalities in molar pregnancies. The focus of current research in this field was on elucidating the molecular mechanism of hydatidiform moles. Our bibliometric analysis showed the global research landscape, trends and development, scientific impact, and collaboration among researchers in the field of molar pregnancy.