1.Research needs in Philippine pharmaceutical sciences: A qualitative perspective from regulatory and clinical research sectors of the pharmaceutical industry.
Imelda G. Peñ ; a ; Honeymae C. Alos ; Nicole Kaye R. Calara ; Hilary Grace C. Pavia ; Bryan Paul I Bulatao
Acta Medica Philippina 2026;60(9):7-24
OBJECTIVES
This study aimed to identify problems and highlight opportunities for pharmaceutical sciences research in the Philippine pharmaceutical industry's regulatory and clinical research sectors that might have been previously overlooked or underrepresented. It identified current issues that can be addressed by research covering four areas of pharmaceutical sciences: drug design and discovery, pharmacokinetic/pharmacodynamic studies, formulation design and pharmaceutical technology, and regulatory science.
METHODSA descriptive qualitative approach was used in this study. Data collection was facilitated by key informant interviews (KII) using a standardized interview guide with open-ended questions to identify the pharmaceutical science research needs of the specific sectors. A purposive sampling method was employed, with five key informants (KIs), including the company vice president, director, and top-level managers from different local and multinational pharmaceutical companies. ATLAS.ti software was utilized to facilitate thematic synthesis for qualitative data analysis.
RESULTSThirteen common themes were identified from the KIs, such as (1) incomplete development of therapeutic compounds, (2) sustainability of raw materials supply, (3) regulation of herbal medicines versus food supplements, (4) mapping disease priorities through the Philippine pharmaceutical roadmap, (5) government incentives and policies to support research, (6) technical personnel, (7) suboptimal regulatory process, approvals, and implementation, (8) gap in utilization of acquired knowledge on regulations, (9) regulatory governance, (10) passive regulatory action on counterfeit drugs, (11) PIC/S GMP version 14 adaption, (12) formulation optimization, and (13) active pharmaceutical ingredient (API) sourcing and regulation. Based on insights from the International Pharmaceutical Federation regarding anticipated hurdles in pharmaceutical sciences over the next 5-10 years, priority research needs were identified through KIs' input. Relevant action plans were developed, including the creation of research proposals to isolate, purify, and determine chemical structures of natural products, as well as analyzing recent Philippine Health Statistics to help assess the appropriateness of new drug releases for patient needs. Other action plans include forecasting future disease burdens in the country, performing toxicology studies (Health-Based Evaluation Levels/No Observed Adverse Effect Level or HBEL/NOAEL) for common generic drugs, and ensuring that research efforts are directed toward addressing the Philippine pharmaceutical regulatory and clinical research sector's most pressing needs practically and feasibly.
CONCLUSIONThis study offers valuable insights into pharmaceutical sciences research and development initiatives within the regulatory and clinical research sectors in the Philippine pharmaceutical industry. These findings have the potential to catalyze transformative advancements in healthcare delivery and outcomes, positioning the Philippines for global excellence and competitiveness.
Occupational Groups ; No-observed-adverse-effect Level ; Social Control, Formal ; Patients ; Pharmaceutical Preparations
2.From humble beginnings to nursing luminary: A life of grace and purpose
Philippine Journal of Nursing 2025;95(2):4-11
Nursing leadership and scholarship in the Philippines have evolved alongside the country's shifting socio-political and educational landscape. This feature article presents a first-person narrative of a nurse leader's journey from humble beginnings in Santiago, Isabela, to national and global leadership roles in education, regulation, and advocacy. This article aimed to illustrate how personal vocation, grounded in service and faith, can transform into professional leadership and scholarship that shape institutions, influence policy, and nurture future generations of Filipino nurses. Using autobiographical lens, I recounted formative experiences across clinical practice, education, administration, and regulation. These reflections are interwoven with leadership theories and scholarly evidence from global nursing literature that demonstrate how enduring principles such as servant leadership, integrity, resilience, compassion, and mentorship can guide professional practice. This narrative highlighted milestones such as pioneering collegiate nursing education at UERMMC, spearheading faculty and curricular reforms as Dean, championing ethical practice during the nursing licensure examination scandal, and advancing professional regulation through initiatives like the Career Progression and Specialization Program. It also underscored the role of resilience in overcoming personal affliction, the importance of mentorship in sustaining legacy, and the impact of integrity in safeguarding nursing's credibility. From the parable of the mustard seed to the reality of nation-building through nursing, this life story affirmed that leadership and scholarship are not individual achievements but collective legacies. By embracing lifelong learning, ethical practice and a commitment to national service, Filipino nurses can continue to grow as competent practitioners, compassionate caregivers, and visionary leaders who contribute to equitable and sustainable health systems. In telling this story, I also sought to situate my journey within the broader context of nursing leadership in the Philippines, where enduring challenges and emerging opportunities continue to call for vision, resilience, and integrity.
Human ; Scholarship ; Fellowships And Scholarships ; Resilience ; Resilience, Psychological ; Regulation ; Social Control, Formal ; Mentorships ; Mentors ; Education, Nursing ; Philippines
3.Pediatric Injuries in Kids Cafés and Risk Factors for Significant Injuries: a 6-Year Cross-Sectional Study Using a Multicenter Injury Registry in Korea
Ik Chang CHOI ; Joong Wan PARK ; Jae Yun JUNG ; Do Kyun KIM ; Young Ho KWAK ; Dongbum SUH ; Se Uk LEE
Journal of Korean Medical Science 2020;35(6):37-
BACKGROUND: A kids café is a popular indoor playground in Korea that combines a playground for young children and a café for their caregivers. There have been no national reports about kids café-related injuries in Korea. This study investigated kids café-related injuries in Korea registered in a multicenter injury surveillance database and analyzed the risk factors for significant kids café-related injuries.METHODS: A multicenter cross-sectional study was performed using the Emergency Department-based Injury In-depth Surveillance registry in Korea between 2011 and 2016. Significant injury was defined as an injury requiring hospitalization or surgery. A multivariable logistic regression model was used to obtain the adjusted odds ratios (aORs) for factors associated with significant kids café-related injuries.RESULTS: Among 1,537,617 injured patients, we extracted 891 patients who were injured in kids cafés. Of these, 46 (5.2%) were admitted, and 39 (4.4%) underwent surgery. The most common injured anatomical site, injury type, and mechanism were lower extremity (28.2%), superficial injury (27.2%), and slip (27.1%), respectively. Among injury-inducing factors, significant injuries were most commonly caused by a trampoline (28.1%), and rock climbing equipment was the only risk factor in a kids café that led to significant injury after adjusting for age, sex, injury mechanism, and injured anatomical sites (aOR, 14.94; 95% confidence interval, 1.51–147.72).CONCLUSION: The rock climbing equipment in a kids café can cause serious injury to children. Establishing safety regulations for rock climbing equipment in kids cafés may have the greatest impact in reducing significant injuries requiring hospitalization or surgery.
Caregivers
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Child
;
Cross-Sectional Studies
;
Emergencies
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Hospitalization
;
Humans
;
Korea
;
Logistic Models
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Lower Extremity
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Odds Ratio
;
Play and Playthings
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Risk Factors
;
Social Control, Formal
;
Wounds and Injuries
4.E-cigarette from the point of view of harm reduction
Journal of the Korean Medical Association 2020;63(2):105-111
One person dies every six seconds from a smoking-related disease and this problem is likely to worsen. While many people try to quit smoking on their own or with using medicinal products, many of them fail. There is an ongoing debate within the public health community about e-cigarettes on whether they have a potential role in smoking cessation, whether their use can reduce harm for individual users, whether the widespread use of these devices has the potential to reduce or increase population-level harm, and how best to regulate e-cigarette use to minimize both individual and population-level harm. Although the long-term effects of e-cigarette use among smokers and non-smokers are not known, nicotine aerosol produced from a solution, rather than from burning tobacco, releases fewer harmful substances than cigarette smoke does. Some experts advocate wider availability and softer regulations regarding e-cigarette use and perceive them as having the potential to help smokers quit or switch to a harm-reducing means of consuming nicotine. Based on scientific evidence on e-cigarettes, this article explores its pros and cons to public health in order to guide practice, policy, and regulation through reviews of debate articles. ‘Quit or die’ is no longer the only option for those who cannot quit. Safer nicotine products offer another way. There is substantial international and independent evidence that these products are safer than cigarettes.
Burns
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Electronic Cigarettes
;
Harm Reduction
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Humans
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Nicotine
;
Public Health
;
Smoke
;
Smoking
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Smoking Cessation
;
Social Control, Formal
;
Tobacco
;
Tobacco Products
5.Factors Affecting the Practice of Accident Prevention Behavior in Middle-school Students
Child Health Nursing Research 2019;25(4):388-397
PURPOSE: This study aimed to identify the degree of accident prevention behavior, self-esteem, self-regulation ability, and social support among middle-school students, and investigate factors influencing their practice of accident prevention behaviors.METHODS: The participants were 174 students from two middle schools located in J city. Data were collected from December 28, 2017 to February 9, 2018 using self-reported questionnaires.RESULTS: The mean score were 3.08±0.37 of 4 for practice of accident prevention behaviors, 3.07±0.57 of 4 for self-esteem, 3.69±0.48 of 5 for self-regulation ability, and 3.38±0.75 of 5 for social support. Positive correlations were found among self-regulation ability, self-esteem, social support, and practice of accident prevention behaviors. The factors influencing the practice of accident prevention behaviors were personality (being ‘haste’) (β=−.20, p=.003), self- regulation ability (β=.48, p<.001), and social support (β=.23, p<.001). These factors explained 39.0% of the variance in practice of accident prevention behaviors.CONCLUSION: It was found that the middle-school students engaged in prevention behavior to an extent that was insufficient to prevent accidents. Therefore, it is necessary to develop intervention strategies to improve the practice of accident prevention behavior among middle-school students, considering self-regulation ability, social support, and personality, which affect the practice of accident prevention behaviors.
Accident Prevention
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Humans
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Self Concept
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Self-Control
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Social Control, Formal
6.Correlations between a Flexible Parental Visiting Environment and Parental Stress in Neonatal Intensive Care Units
Su Jin LEE ; Eun Kyoung CHOI ; Jeongok PARK ; Hee Soon KIM
Child Health Nursing Research 2019;25(4):377-387
PURPOSE: The purpose of this study was to examine the correlation between a flexible parental visiting environment and parental stress in neonatal intensive care units (NICUs).METHODS: The study participants included 60 parents of premature infants in NICUs. Structured questionnaires and interviews, as well as observations by researchers using a caregiving behavior checklist, were used to measure the flexibility of the parental visiting environment and parents' stress levels. Quantitative and qualitative data were collected concurrently and were initially analyzed as separate data sets. Data collection extended from March 11, 2018 to June 30. 2018 and the data were analyzed using descriptive statistics, the independent t-test, one-way analysis of variance, and Pearson correlation coefficients.RESULTS: There was a negative correlation (r=−.30, p=.021) between parental stress and the total number of visits in 7 days. We also found that the average duration of each visit and the number of caregiving behaviors performed by parents were positively correlated (r=.73, p<.001).CONCLUSION: When designing a flexible visiting environment for parents, parents should be encouraged to visit their babies. By doing so, stress can be reduced both for babies and for parents. Therefore, it is suggested that the related polices and regulations in South Korea should be changed to provide more a flexible visiting environment to promote better parent-child attachment and family adjustment.
Checklist
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Data Collection
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Dataset
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Family Nursing
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Humans
;
Infant, Newborn
;
Infant, Premature
;
Intensive Care Units, Neonatal
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Intensive Care, Neonatal
;
Korea
;
Parents
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Pliability
;
Social Control, Formal
;
Stress, Psychological
;
Visitors to Patients
7.Hearing Outcome of Patients with Acute Noise-Induced Hearing Loss
Byung Gil CHOI ; Sung Kwang HONG ; Hyung Jong KIM ; Hyo Jeong LEE
Korean Journal of Otolaryngology - Head and Neck Surgery 2019;62(3):151-156
BACKGROUND AND OBJECTIVES: Although poor hearing outcomes have been associated with acute noise-induced hearing loss (ANIHL), only limited studies exist on this issue. This study evaluated the prognosis of ANIHL in comparison to idiopathic sudden sensorineural hearing loss (ISSNHL) and investigated the types of noise causing these disorders. SUBJECTS AND METHOD: Patients with sudden sensorineural hearing loss due to noise exposure were included in the ANIHL group if the threshold shift was more than 30 dB in three or more consecutive frequencies within the study period (from January 2010 to December 2016). The ANIHL group included 19 patients. As a matched-control group, treated patients with ISSNHL (n=95) were selected as a way of controlling the known prognostic factors that were evenly distributed between groups. Selected prognostic variables used for matching included age, sex, the degree of initial hearing loss, the number of days before the start of treatment, and treatment method. RESULTS: The overall hearing recovery rate of ANIHL was 11% and that of the control group was 80% (p<0.001). Noise exposure in military service (37%) and leisure activities (37%) was the most prominent cause of ANIHL. CONCLUSION: The hearing outcome of ANIHL was worse than that of ISSNHL. It is thus necessary to establish national guidelines for environmental noise regulations and to raise awareness of hazardous noise exposure.
Hearing Loss
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Hearing Loss, Noise-Induced
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Hearing Loss, Sensorineural
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Hearing Loss, Sudden
;
Hearing
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Humans
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Leisure Activities
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Methods
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Military Personnel
;
Noise
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Prognosis
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Social Control, Formal
8.Awareness and Usage Patterns of Housewives in Busan for Consuming Marine Products
Journal of the Korean Dietetic Association 2019;25(3):199-216
We conducted this study to compare the awareness and attitude of Busan housewives about consuming marine products. The survey was conducted from April 10 to May 31, 2019 by using a questionnaire. The degree of preference of seafood was higher among individuals in their 40s than those in the other age groups. Among the women in their 30s, 40s, 50s and 70s, the reason for liking seafood was ‘taste’, and for those in their 60s it was ‘nutrition’. Overall the most common reason for disliking seafood was the ‘fishy smell (37.4%)’. Conception degree of nutritive value of seafood was higher among individuals in their 30s and 40s than that for those individuals in their 50s, 60s and 70s. As for the price of seafood, the wives over 40s thought seafood was more expensive than did those wives in their 30s. The younger the individuals were, the lower was the perceived degree of safety was 49.8% of the subjects reported that the main concern for purchase was ‘freshness’. The perceived degree of safety for imported seafood was better for the wives in their 60s and 70s than that for those wives in their 30s, 40s and 50s. The confidence level for local Korean seafood was higher for the wives in their 60s than that for the wives in their 50s. The degree of preference for seafood was moderate overall, except for Jellyfish. Age was positively correlated with conception for safety and dietary attitude (P<0.01), whereas age was negatively correlated with monthly food expenditure, nutrition knowledge and intake requirements (P<0.01). Preference for seafood was positively correlated with conception for safety (P<0.05), nutrition knowledge (P<0.05), dietary attitude (P<0.01), awareness for nutritive value (P<0.01) and intake requirements (P<0.01). Laws and regulations should be reinforced in order to promote eating more seafood and periodic research to determine the actual amount of consumed seafood and people's preferences should be conducted.
Busan
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Eating
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Female
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Fertilization
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Health Expenditures
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Humans
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Jurisprudence
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Nutritive Value
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Seafood
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Smell
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Social Control, Formal
;
Spouses
9.Withdrawal of life-prolonging medical care and hospice-palliative care
Journal of the Korean Medical Association 2019;62(7):369-375
Hospice and palliative care can help terminal patients and their family members to face the natural end of life more comfortably, by providing them with an environment to address psychosocial and spiritual problems, as well as physical symptoms. However, most patients and their caregivers have the misconception that hospice care means the withdrawal of all treatments. Many physicians also consider hospice care to be a form of terminal care after all treatments are finished. Laws regulating the withdrawal of life-prolonging treatment came into effect in Korea in 2018, and these regulations also apply to most terminal stages of benign diseases. The withdrawal of futile life-prolonging treatment is quite different from euthanasia or negligence. At the last stage of disease, treatment aimed at alleviating various symptoms can make critically ill patients more comfortable and thereby help them to die with dignity. Patients with a terminal illness should receive hospice and palliative care, instead of futile life-prolonging treatment. Therefore, education and training programs to promote a proper understanding of hospice and palliative care should be considered mandatory.
Caregivers
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Critical Illness
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Education
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Euthanasia
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Hospice Care
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Hospices
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Humans
;
Jurisprudence
;
Korea
;
Malpractice
;
Palliative Care
;
Social Control, Formal
;
Terminal Care
;
Withholding Treatment
10.Medical device adverse effects
Journal of the Korean Medical Association 2019;62(9):480-485
This study aimed to describe adverse effects or reactions by medical devices. There may be unexpected effects caused by medical devices that can often be harmful to the patient. This is defined as a medical device adverse event or adverse effect (MDAE). We should prevent the recurrence of MDAEs by reporting them to regulatory authorities and device manufacturers. This reporting requires that manufacturers check the manufacturing process and update the medical device. However, it is difficult for both patients and medical persons to recognize and report MDAEs because adverse effects can be ambiguous to them in many cases. In addition, many medical persons lack an understanding of the role of this reporting. In Korea, the Ministry of Health and Welfare enacted laws and regulations for MDAE reporting in 2005. However, the number of MDAEs reported was still very small. The Ministry of Food and Drug Safety started the Medical Device Safety Monitoring Center project in 2011, with the purpose of promoting MDAE reporting. Since the Medical Device Safety Monitoring Center project began, the number of reported MDAEs rapidly increased from 137 in 2010 to 6,078 in 2017. Medical persons and device manufacturers should be encouraged to voluntarily report MDAEs and provide useful information. Korea is an important member of the International Medical Device Regulators Forum and leader of the Asia-Pacific Economic Cooperation Regulatory Committee. There should be medical device vigilance with global cooperation.
Equipment and Supplies
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Equipment Safety
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Humans
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Jurisprudence
;
Korea
;
Mandatory Reporting
;
Recurrence
;
Safety Management
;
Social Control, Formal


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