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.

METHODS

A 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.

RESULTS

Thirteen 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.

CONCLUSION

This 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

OBJECTIVES

Patients undergoing modified radical mastectomy (MRM) often experience significant preoperative anxiety. Effective preoperative education could alleviate anxiety and improve patient outcomes. This research aimed to evaluate whether audiovisual aids during preoperative education correlated with decreased anxiety levels among female MRM patients, and it also aimed to investigate if enhanced preoperative education could lead to reduced anxiety and improved postoperative outcomes.

METHODS

A randomized controlled trial was conducted comparing anxiety levels in MRM patients receiving audiovisual aids versus verbal instructions. Purposive sampling selected female breast cancer patients scheduled for MRM. Data was collected using pre- and post-intervention questionnaires, and statistical analysis was used to test hypotheses.

RESULTS

There was no significant difference in pre-intervention anxiety levels between the control group (mean = 2.77 ± 0.32) and the experimental group (mean = 2.49 ± 0.27; t = 1.49, p = 0.176), indicating comparable baseline anxiety between groups. Following the intervention, the experimental group exhibited a significant reduction in anxiety (mean = 1.83 ± 0.20) compared to the control group (mean = 2.59 ± 0.16; t = 2.79, p = 0.046). Pearson correlation analysis revealed a moderate negative correlation between the use of audiovisual aids and preoperative anxiety levels (r = –0.643, p = 0.017), suggesting that audiovisual education was significantly associated with reduced preoperative anxiety among patients scheduled for MRM.

DISCUSSION

The study found that audiovisual aids significantly reduced anxiety levels in the experimental group but had no effect on the control group. This suggested that such interventions could be effective in reducing preoperative anxiety, particularly in females undergoing MRM. However, further research with larger and more diverse samples was needed to confirm these findings and explore influencing factors in clinical settings

CONCLUSION

The study findings suggested that incorporating audiovisual aids in preoperative education for MRM effectively reduced anxiety levels, warranting further research with larger and more diverse participant groups to validate these results

Human ; Female ; Adult: 25-44 Yrs Old ; Middle Aged: 45-64 Yrs Old ; Audiovisual Aids ; Breast Neoplasms ; Control Groups ; Neoplasms ; Mastectomy, Radical ; Mastectomy, Modified Radical ; Volition ; Female ; Breast ; Acquired Immunodeficiency Syndrome

Randomized controlled trial(RCT) is considered to represent the gold standard for evaluating the efficacy of interventions and has been widely used to evaluate the clinical efficacy of traditional Chinese medicine(TCM). However, there are unique challenges in implementing RCT in TCM. Patients seeking TCM treatment often have preferences for TCM due to the unsatisfactory therapeutic effect of western medicine, their personal intolerance, and their rejection of certain drugs, medical devices, or surgery. Patients are generally reluctant to be randomly assigned to a group, making it challenging to enroll patients in the control group of western medicine during the implementation of RCT in TCM. This has become a prominent problem restricting the implementation of RCT in TCM and needs to be solved urgently. Therefore, this paper introduced commonly used research designs used in solving the problem of enrolling patients in control group during the implementation of RCT in TCM, including Zelen design, partially randomized patient preference trial(PRPP), single-arm objective performance criteria(OPC), cohort studies, single-arm clinical trials using real world data(RWD) alone as the external control group, and the design method based on RWD-augmented control group samples in RCT. The paper outlined the definitions and principles of these methods, evaluated their advantages, disadvantages, and applicable scenarios, and explored their applications in the TCM field, so as to offer insights for solving the difficulty in enrolling patients in the control group during the implementation of RCT in TCM.
Humans ; Medicine, Chinese Traditional/methods* ; Randomized Controlled Trials as Topic/methods* ; Research Design ; Patient Selection ; Drugs, Chinese Herbal/therapeutic use* ; Control Groups

A study was conducted on rural women of childbearing age aged 20-49 who underwent the National Free Preconception Health Examination Project (NFPHEP)in Yunnan Province from 2013 to 2019. Descriptive analysis was conducted to determine the negative rate of IgG antibodies against the rubella virus and its differences among various socio-demographic characteristics. Among the 1 511 203 study subjects, the negative rate of IgG antibodies against the rubella virus was 24.36%. Only 2.64% of the population had received rubella virus vaccine. The negative rate of IgG antibodies among rural childbearing-age women in the preconception period in Yunnan Province decreased with age and educational level (P_trend<0.001). The negative rate of IgG antibodies in ethnic minority women of childbearing age in the preconception period (25.19%) was higher than that of Han women (23.88%). Among the 22 ethnic groups with over 1 000 participants, the negative rates of IgG antibodies in women of childbearing age from the Blang (32.85%), Bouyei (31.03%), Zhuang (31.01%), and Miao (30.70%) ethnic groups were higher than those of women from other ethnic groups. Among the 16 states (cities) in Yunnan Province, the negative rate of IgG antibodies in pregnant women of childbearing age in Wenshan Zhuang and Miao Autonomous Prefecture (38.06%) and Lincang City (32.63%) was higher than that in other states (cities). The negative rate of serum IgG antibodies in women who reported having received rubella virus vaccine (18.60%) was lower than that in other non-vaccinated populations (24.52%). The proportion of rural women of childbearing age in Yunnan Province who were susceptible to the rubella virus before pregnancy was still high. It is necessary to promote rubella vaccination among people susceptible to rubella, especially pregnant women, to prevent rubella virus infection and reduce the incidence rate and disease burden of rubella people.
Pregnancy ; Female ; Humans ; Rubella virus ; Immunoglobulin G ; Ethnicity ; Minority Groups ; China ; Rubella/prevention & control* ; Antigens, Viral ; Vaccines

A study was conducted on rural women of childbearing age aged 20-49 who underwent the National Free Preconception Health Examination Project (NFPHEP)in Yunnan Province from 2013 to 2019. Descriptive analysis was conducted to determine the negative rate of IgG antibodies against the rubella virus and its differences among various socio-demographic characteristics. Among the 1 511 203 study subjects, the negative rate of IgG antibodies against the rubella virus was 24.36%. Only 2.64% of the population had received rubella virus vaccine. The negative rate of IgG antibodies among rural childbearing-age women in the preconception period in Yunnan Province decreased with age and educational level (P_trend<0.001). The negative rate of IgG antibodies in ethnic minority women of childbearing age in the preconception period (25.19%) was higher than that of Han women (23.88%). Among the 22 ethnic groups with over 1 000 participants, the negative rates of IgG antibodies in women of childbearing age from the Blang (32.85%), Bouyei (31.03%), Zhuang (31.01%), and Miao (30.70%) ethnic groups were higher than those of women from other ethnic groups. Among the 16 states (cities) in Yunnan Province, the negative rate of IgG antibodies in pregnant women of childbearing age in Wenshan Zhuang and Miao Autonomous Prefecture (38.06%) and Lincang City (32.63%) was higher than that in other states (cities). The negative rate of serum IgG antibodies in women who reported having received rubella virus vaccine (18.60%) was lower than that in other non-vaccinated populations (24.52%). The proportion of rural women of childbearing age in Yunnan Province who were susceptible to the rubella virus before pregnancy was still high. It is necessary to promote rubella vaccination among people susceptible to rubella, especially pregnant women, to prevent rubella virus infection and reduce the incidence rate and disease burden of rubella people.
Pregnancy ; Female ; Humans ; Rubella virus ; Immunoglobulin G ; Ethnicity ; Minority Groups ; China ; Rubella/prevention & control* ; Antigens, Viral ; Vaccines

BACKGROUND: The risk factors for renal cancer include smoking, obesity, hypertension, and exposure to trichloroethylene. Recent studies have shown that low sunlight exposure increases the risk of developing a range of cancers, including renal cancer. Given that most of the daytime is spent at work, a lack of occupational sunlight exposure can be a risk factor for renal cancer. Therefore, this study examined the relationship between occupational sunlight exposure and the incidence of renal cancer. METHODS: This was a university hospital-based case-control study on renal cancer. Of the 706 newly diagnosed patients with renal cell carcinoma (RCC), 633 cases were selected; 73 who had no occupational history were excluded. In addition, 633 controls were selected from the general population after 1:1 matching with respect to sex, age (within 5 years), and residential area (constituency-level). Information on sunlight exposure by the occupational group was referred to data from France. To estimate the association between occupational sunlight exposure and the RCC risk, the odds ratios (ORs) were calculated using conditional logistic regression analysis. RESULTS: Sunlight exposure was divided into quartiles and the risk of RCC was analyzed. The adjusted OR of RCC (OR: 0.664, 95% confidence interval: 0.449–0.983) was significantly lower for the Q4 group than Q1 group but the Q2 and Q3 groups did not show significant results. The risk of RCC tended to decrease with increasing exposure to sunlight (p for trend < 0.028). CONCLUSIONS: Higher occupational sunlight exposure reduces the risk of RCC.
Carcinoma, Renal Cell ; Case-Control Studies ; France ; Humans ; Hypertension ; Incidence ; Kidney Neoplasms ; Logistic Models ; Obesity ; Occupational Groups ; Odds Ratio ; Risk Factors ; Smoke ; Smoking ; Sunlight ; Trichloroethylene

The purpose of this study was to investigate the effects of isoflavone on serum lipids and antioxidant enzymes activities in growing rats fed high lard diet. Twenty four female Sprague-Dawley rats (body weight 50–60 g) were divided into three groups, control, high fat (HF, lard 200 g/kg diet) and high fat + isoflavone (HFI, lard 200 g/kg diet + isoflavone 310.9 mg/kg diet) for 4 weeks. The results of study indicated that body weight gain was not different by isoflavone diet. Mean intake was significantly lower in HF group and HFI group than control group. Food efficiency ratio was significantly higher in HF group and HFI group than control group. The level of serum triglyceride and total cholesterol were significantly lower in HFI group than control group and HF group. The level of high-density lipoprotein cholesterol, was significantly higher in control group than HF group and HFI group. The level of low-density lipoprotein cholesterol was not significantly different by experimental diets, but atherogenic index (AI) was significantly lower in control group and HFI group than HF group. Contents of total cholesterol and triglyceride in liver tissues were found to be insignificant. The concentration of lipid peroxidation, malondialdehyde was significantly lower in control groups and HFI group than HF group. And antioxidant enzymes in liver tissue were not significantly different by lard and isoflavone supplemented diets. In conclusion, it seems possible that isoflavone supplemented high fat diet may produce positive results on level of serum triglyceride, serum total cholesterol, AI and concentration of malondialdyhyde.
Animals ; Antioxidants ; Body Weight ; Cholesterol ; Control Groups ; Diet ; Diet, High-Fat ; Female ; Humans ; Isoflavones ; Lipid Peroxidation ; Lipoproteins ; Liver ; Malondialdehyde ; Rats ; Rats, Sprague-Dawley ; Triglycerides

PURPOSE: In the nursing profession, it is imperative that students are able to transfer their undergraduate knowledge and skills into practice to become competent nurses. The aim of this study was to illuminate how infection prevention and control (IPC) education would be conducted in undergraduate nursing programs. METHODS: A qualitative design utilizing focus group interviews as its data collection method was employed. Twelve professors from twelve South Korean universities that have undergraduate nursing programs were recruited as research participants and divided into two focus groups. RESULTS: Focus group interview analysis showed that IPC education in undergraduate nursing programs for fostering IPC competency was composed of two categories: a pre-clinical course and a clinical course. Each included three subcategories-education contents, education strategies, and considerations of how infection control is taught to students as they continue from beginning to advanced-and the themes of each subcategory were derived. CONCLUSIONS: The findings of this study can provide an overview of how nursing professors should teach IPC education to undergraduates. As IPC education for nurses is very important, more in-depth discussions that include educators, clinical mentors, and nursing students regarding IPC education are needed to ensure patients' safety in clinical settings.
Data Collection ; Education ; Focus Groups ; Foster Home Care ; Humans ; Infection Control ; Korea ; Mentors ; Nursing ; Students, Nursing

OBJECTIVES: In the Republic of Korea (ROK), the notified incidence of tuberculosis in foreign-born individuals (NITFBI) has increased recently, as has the rate of multidrug-resistant (MDR) and rifampicin-resistant (RR) tuberculosis in foreigners staying in the ROK. As Jeju Province in ROK has a no-visa entry policy, control programs for NITFBI should be consolidated. The aim was to evaluate the status of NITFBI, with a focus on the distribution of MDR/RR tuberculosis by nationality. METHODS: Data on tuberculosis incidence in individuals born in Jeju Province and in foreign-born individuals were extracted from the Korean Statistical Information Service of Statistics Korea, and the Infectious Disease Surveillance Web Statistics of the Korea Centers for Disease Control and Prevention, respectively. RESULTS: Among all notified incident cases of tuberculosis, the proportion of NITFBI increased from 1.46% in 2011 to 6.84% in 2017. China- and Vietnam-born individuals accounted for the greatest proportion of the 95 cases of NITFBI. Seven cases of MDR/RR tuberculosis were found, all involving patients born in China. CONCLUSIONS: In Jeju Province, ROK, NITFBI might become more common in the near future. Countermeasures for controlling active tuberculosis in immigrants born in high-risk nations for tuberculosis should be prepared in Jeju Province, since it is a popular tourist destination.
Antitubercular Agents ; Centers for Disease Control and Prevention (U.S.) ; China ; Communicable Diseases ; Disease Management ; Drug Resistance ; Emigrants and Immigrants ; Ethnic Groups ; Humans ; Incidence ; Information Services ; Internationality ; Korea ; Mycobacterium tuberculosis ; Republic of Korea ; Tuberculosis

Objective: The Prostate Cancer Prevention Trial risk calculator (PCPT-RC) is an online tool for assessing the risk of prostate cancer (PCa) based on age, race, serum PSA, biopsy history, family history, and other factors. This study aimed to investigate the value, sensitivity and specificity of the PCPT-RC 2.0 in assessing the risk of PCa in the Chinese high-risk population. METHODS: This study included 622 patients with the high risk of PCa characterized by high serum PSA (PSA >3 μg/L) or abnormality in digital rectal examination or imaging of the prostate. According to the results of prostate biopsy, we divided the patients into a PCa and a non-PCa group and used the PCPT-RC 2.0 for evaluation of all the cases followed by statistical analysis. RESULTS: PCa was detected in 264 (42.4%) of the 622 patients, including 126 cases of high-grade malignancy. Compared with the non-PCa group, the PCa patients showed a significantly older age (［68.40 ± 7.30］ vs ［72.80 ± 7.20］ yr, P <0.001), higher serum PSA level (［11.20 ± 7.76］ vs ［15.06 ± 10.65］, P <0.001), and higher PCPT risk score (［37.0 ± 10.8］% vs ［44.4 ± 12.6］%, P <0.001). The PCPT risk score exhibited a greater area under the ROC curve than the level of serum PSA in evaluating the risk of PCa (0.67 vs 0.61, P <0.05), but no statistically significant difference between the two in predicting the risk of high-grade malignancy (0.67 vs 0.66, P >0.05). CONCLUSIONS The PCPT risk score is valuable in predicting the risk of PCa in China, which may play a better role than the serum PSA level in screening PCa and avoid unnecessary prostate biopsy, though its advantage is not so obvious in identifying high-grade malignancy. A prediction tool needs to be established for evaluating the risk of PCa in the Chinese population.
Age Factors ; Aged ; Asian Continental Ancestry Group ; Biopsy ; China ; Continental Population Groups ; Digital Rectal Examination ; Humans ; Male ; Prostate ; pathology ; Prostate-Specific Antigen ; blood ; Prostatic Neoplasms ; blood ; pathology ; prevention & control ; ROC Curve ; Risk Assessment ; methods ; Risk Factors