Background: Despite a growing burden of childhood cancer globally and disparities in childhood cancer mortality rates between high income and LMICs, there is limited information on trends and disparities in access to essential medicines indicated for the treatment of childhood cancers between high income low and middle income countries (LMICs).

Aims: 1. To investigate trends and disparities in the use of oral childhood cancer medicines in high income and LMICs by geographic region between 2015-2020.

Methods: We analyzed quarterly sales data from IQVIA's MIDAS for oral childhood cancer medicines between January 1st 2015 to October 31st 2020. We included a total of 25 oral childhood cancer medicines indicated for the treatment of common childhood cancers (i.e., leukemia, lymphoma, brain and nervous system cancers). Average quarterly sales trends of cancer medicines were expressed as standard units (SUs) or tablets per 100,000 children aged < 20 years per day.

Results: Although the use of childhood cancer medicines increased significantly in LMICs between 2015 and 2019 (from 122 to 172 tablets per 100,000;p< 0.01), LMICs accounted for only ¼ of childhood cancer medicines in 2019. Although the use of childhood cancer medicines increased only 4.7%, use was nearly 20-times greater in high income countries (3,104 tablets per 100,000 ) in 2019. Use also varied substantially between and within regions of LMICs; Turkey (1,798 per-capita) and Romania (2,408 per-capita) with the highest rates and West Africa and Thailand the lowest rates (2.5 and 7.4 per-capita, respectively). In 2019, High Income Countries with the lowest number of deaths from childhood cancer had the largest volume of childhood cancer medicines.

Discussion/Conclusions: Although access to oral childhood cancer medicines has steadily increased in LMICs since 2015, there is still widespread inequitable access to these essential medicines when compared to high income countries.

Introduction: Monoclonal antibodies (mAb) and Antibody-Drug Conjugates (ADC) have revolutionized cancer therapy due to their targeted action and improved efficacy compared to chemotherapies. Many patients have benefited from these therapies since the first one was approved. Studies on which mAb and ADC are accessible for cancer treatment in Indonesia were limited.
Aims: To investigate the accessibility of mAb and ADC-based products for cancer treatment in Indonesia based on marketing authorization data from the Indonesian Food and Drug Authority (BPOM).
Methods: This study retrospectively identified mAb and ADC for cancer indication in Indonesia using marketing authorization data from the Indonesia Food and Drug Authority (BPOM) until 17th November 2023. Data were extracted and coded using the World Health Organization Anatomical Therapeutic Chemical (WHO ATC) classification system. Products of mAb and ADC were identified using the L01F code for monoclonal antibodies and antibody-drug conjugates. The study evaluates conformity of these products with the Indonesia National List of Essential Medicine (NLEM) 2021, Indonesia National Formulary 2021, and World Health Organization Essential Medicine List (WHO EML) 2019.
Results: As many as 16,115 medicine products were identified from the BPOM database. Of those, there were 1,260 active ingredients. Eleven mAb were identified, namely atezolizumab, bevacizumab, brentuximab vedotin, daratumumab, durvalumab, obinutuzumab, pembrolizumab, pertuzumab, ramucirumab, rituximab, and trastuzumab. There is one ADC, namely trastuzumab emtansine. There are no mAb or ADC included in the Indonesian NLEM 2021. Two mAb, rituximab and trastuzumab was included in the Indonesia National Formulary 2021. These two were also included in the WHO EML 2019 on the complementary list.
Discussion/Conclusion: Indonesia is improving access to targeted therapies for cancer patients as can be seen from the twelve approvals of mAb and ADC. Two of them, rituximab and trastuzumab were included in the Indonesia National Formulary and covered by the national health insurance.

Introduction:
Post-marketing database studies (PMDS) are pharmacovigilance activities encouraged since a regulatory revision issued in 2018 by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. However, a comprehensive review of outcomes of interest in PMDS does not exist.
Aims:
To describe and analyze outcomes of interest and types of databases being utilized in PMDS.
Methods:
All risk management plans (RMPs) listed in the PMDA website from April 2013 to December 2023 were extracted. Two researchers systematically and independently identified PMDS listed in RMPs. Outcomes of interest in PMDS were summarized according to their study objectives and were analyzed in conjunction with the databases being utilized.
Results:
Among 648 RMPs retrieved and reviewed, 85 PMDS were identified within 63 RMPs. Eighty-one out of 85 PMDS targeted 138 outcomes for safety objectives and 5 targeted 5 outcomes for effectiveness objectives. In total, 138 outcomes for safety objectives were investigated, including 122 identified as important identified risks (IR)/important potential risks (PR)/others and 16 as important missing information (MI). Of the 122 IR/PR/others, the most common targets (system organ class level of the Medical Dictionary for Regulatory Activities) were “Infections and infestations” (n=18, 14.8%), “Metabolism and nutrition disorders” (n=17, 13.9%), “Cardiac disorders” (n=15, 12.3%), and “Vascular disorders” (n=15, 12.3%). Among 122 IR/PR/others, 47 (38.5%) were investigated using the Medical Data Vision database, 23 (18.9%) used registries and 17 (13.9%) used the Medical Information Database Network (MID-NET®). Sixteen MIs included usage for patients with renal dysfunction (n=5) followed by long-term use (n=3), and safety of medication switching (n=3) mainly.
Discussion:
This is the first study to comprehensively describe and analyze outcomes of interest and data sources in PMDS conducted in Japan. Elucidated insights about combinations between outcomes of interest and databases should be informative for pharmaceutical companies to plan additional pharmacovigilance activities.

Introduction: In 2019, ranitidine was withdrawn from the global market due to the detection of the probable carcinogen N-nitrosodimethylamine. This is expected to have led to a shift in the prescription of medications for acid-related disorders.

Aims: To identify prescription amounts of acid-suppressants following the withdrawal of ranitidine in Korea.

Methods: National claims data from January 2016 to May 2023 was utilized to count for the prescriptions of histamine h2 receptor antagonists (H2RA) and proton pump inhibitors (PPI) in the patients with acid-related diseases. The number of claims and the amounts of prescriptions based on defined daily dose (DDD) were calculated for each drug. An interrupted time series analysis was conducted using piecewise linear regression and autoregressive integrated moving average model to evaluate the change in prescriptions after ranitidine recall.

Results: A total of 483,556,858 claims for H2RA and 246,946,250 claims for PPI were made during the study period. Following the withdrawal of ranitidine, the number of monthly claims for all H2RAs decreased by 4,180,035 (95% CI: 3,763,723 to 4,596,347), while the number of monthly claims for all PPIs increased by 256,275 (95% CI: 104,823 to 407,726), immediately. Among PPIs, esomeprazole and rabeprazole showed the most pronounced increases, with 16.5 and 11.0 DDD prescribed in 2022, respectively. For H2RAs, famotidine exhibited the largest increase, with 11.0 DDD prescribed in 2022.

Discussion: There was a significant decrease in the prescription of H2RA and prominent increase in the prescription of PPI after the withdrawal of ranitidine in Korea. Given the potential harms of PPI, further research in needed to evaluate the public health implications of changes in the utilization of acid-suppressants.

Introduction: Women's autonomy is very important in health decision-making but most studies focused solely on fertility, children, or maternal healthcare use. Due to this reason, the magnitudes and factors associated with women’s autonomy in other types of healthcare remain unclear. Therefore, this study aimed to estimate the magnitude and identify factors associated with decision-making autonomy on healthcare use among married women in Indonesia.

Methods: A national cross-sectional study was conducted among married women using the Indonesia Demographic and Health Surveys 2017. Women's autonomy in healthcare decision-making was measured based on responses regarding the individual typically responsible for making healthcare decisions on behalf of the respondent. Potential factors, such as intrapersonal, interpersonal, community, and policy-related were obtained. Multinomial logistic regression was used to determine the associations between potential factors and outcomes. The odds ratio (OR) and 95% confidence intervals (CI) of the analysis were reported.
Results: The respondents in this study comprised 34,467 married women across 34 provinces in Indonesia. Most of the respondents had joint health decisions with the husbands (45.7%). The result showed that several factors were associated with either women’s full autonomy or jointly with the husbands in the healthcare decision-making. These factors included secondary or higher education, ownership of mobile telephones, higher household wealth index, urban living, residency in Java or Bali provinces, participation of women in decision-making, and independence in visiting a medical center.
Conclusions: The majority of married women made joint health decisions with the husbands. Public health interventions should focus on vulnerable women, such as those who are uneducated, poor, participate less in household decision-making, face barriers in accessing healthcare services, and live in urban to increase autonomy in healthcare decision-making.

Background: - Nationwide, childhood-immunization exhibits altered vaccine demands and uneven utilization patterns. These variabilities may stem from various internal and external factors influencing parental preferences. Regular checks and balances are necessary to ensure equal accessibility for all sections of society.

Aim:
To assess childhood vaccine usage trends over five-years (2018-2022) and monitor instances of delayed or incomplete immunization within the community.

Methodology:
This ambispective study recorded childhood-vaccine utilization trends over five-years. Immunization details from 2018-2020 were retrieved retrospectively, while data from 2021-2022 were collected prospectively through an immunization registry. Trends in vaccine utilization, delays, and incomplete vaccinations among children were analyzed and compared.

Results:
The study profiled 32,085 children who received 87,782 vaccine doses over five years. Optional vaccines were less utilized (18.12% of doses by 25.14% of children) compared to mandatory vaccines (81.88% of doses by 74.86% of children). The most utilized mandatory vaccine was Oral Polio (17.48%), and for optional vaccines, it was MMR (28.31%). Boys had higher utilization rates (55.97%), with a significant male preponderance in optional vaccine utilization (p < 0.05). There was a 26.12% decline in vaccine utilization in 2022 compared to 2018. Among children with delayed immunization (6.02%), 3.38% were on catch-up schedules, and 2.45% were not. The most commonly delayed vaccines were DTP boosters (30.90%), Tdap (26.19%), and MMR (20.65%). Influenza vaccines (28.08%) and varicella vaccines (20.92%) were the most partially utilized optional vaccines. Significant predictors of deviated immunization status included gender (female), age over one year, rural residence, and low to middle-income families.

Conclusion:
The study mapped the utilization trends in a South Indian community over five years, including during COVID-19. Gender inequality in the utilization of optional vaccines is a concern warranting further research and redressal. Timely childhood vaccinations are crucial for reducing susceptibility to vaccine-preventable diseases and promoting overall well-being.