Journal of Pharmaceutical Policy and Practice最新文献

Background: The proliferation of substandard and falsified medical products (SFM) poses a significant threat to public health globally. Despite rigorous surveillance and law enforcement efforts, risk of exposure to SFM is on the rise, notably through online pharmacies. The current interventions predominantly target the pharmaceutical supply chains through legal and regulatory frameworks, while there is a noticeable deficiency in focusing on interventions for healthcare providers and consumers. This scoping review aims to summarise the current literature on SFM, focusing on their health and economic consequences, and to assess the knowledge, attitudes, and practices of healthcare providers and the general public.

Methods: A comprehensive literature search was conducted across PubMed, Embase, and Scopus databases, focusing on studies from the past 15 years that provided estimates on mortality, morbidities and economic impacts of SFM and covered the following topic areas: knowledge, attitudes and practices of healthcare providers, patients and general public; and population level interventions regarding SFM. We exclude non-peer-reviewed literature.

Results: A total of 78 studies met the inclusion criteria and were analyzed. These studies suggest that the data on adverse effects on health and economic impact of SF medicines are predominantly based on statistical models, and empirical data are grossly lacking. Knowledge of risks, identification of SFM, and reporting to regulatory authorities are substantially low among healthcare providers and general public.

Discussion: This review highlights the need for innovative, targeted strategies - such as digital health interventions, enhanced training programs for healthcare providers, and context-specific public awareness campaigns - to bridge the gap between awareness and effective practice.

Conclusions: Our study underscores that a multifaceted approach must not only reinforce regulatory frameworks and surveillance systems for protecting the supply chains but also proactively empower both health providers and consumers to identify and combat SFM in today's rapidly evolving digital landscape.

Background: As a key component of China's healthcare reform, the national centralized drug procurement (NCDP) policy has significantly influenced physician behavior regarding generic substitution. Therefore, it is essential to investigate the mechanisms underlying physicians' decisions to prescribe bid-winning generics under the NCDP, to provide empirical evidence for policy optimization, and to support the broader implementation of generic substitution strategies.

Methods: Drawing upon the theory of planned behavior (TPB), a conceptual model was developed, and a corresponding scale was constructed. Structural equation modelling (SEM) was employed to examine the influencing mechanisms, focusing on the relationships among subjective attitude, subjective norms, perceived behavioral control, subjective willingness, and actual prescribing behavior.

Results: The findings indicated that subjective attitude was the primary driver of physicians' intentions to prescribe bid-winning generics. Subjective norms did not exert a statistically significant effect on prescribing willingness, while perceived behavioral control was found to have a negative influence on intention and minimal impact on actual substitution behavior. Subjective willingness has emerged as a critical mediating factor that directly shapes physicians' substitution behavior.

Conclusion: This study highlights the importance of enhancing physicians' positive attitudes towards bid-winning generics, fostering a supportive normative environment, and mitigating excessive perceived behavioral control. These strategies may strengthen prescribing intentions, support effective and sustainable implementation of the NCDP, promote generic substitution, and reduce patients' medication costs.

Background: Medicine affordability is a critical component of a country's redistributive health policies aimed at ensuring equitable access to healthcare. This study aims to investigate key stakeholders' perspectives on pharmaceutical pricing control in Malaysia as the country is moving towards sustainable healthcare.

Methods: Semi-structured interviews (n = 16) were conducted with a purposive sampling of key stakeholders, which included practitioners and policymakers engaged in Malaysia's public health policy. Data were analysed using thematic analysis guided by Walt and Gilson's [(1994). Reforming the health sector in developing countries: The central role of policy analysis. Health Policy and Planning, 9(4), 353-370. https://doi.org/10.1093/heapol/9.4.353] Health Policy Triangle framework.

Results: The findings indicate a range of opinions among stakeholders, with most generally favouring the implementation of pharmaceutical pricing regulation. However, concerns have been raised about potential cost transfer, where medication expenses may be shifted to other medical services. Furthermore, there are apprehensions that price controls could adversely affect the profitability of the pharmaceutical industry and impede the development of innovative drugs. Proposed measures include the introduction of price controls and the enhancement of price transparency for specific medications used to address acute and major health issues.

Conclusion: Our study contributes to the current understanding of the formation of public health policies to improve social welfare through stakeholder engagement to ensure that it reflects public needs. Malaysia is a valuable example for developing countries seeking equitable access to manage rising healthcare costs. The study is crucial for understanding country-specific experiences and stakeholders' views on pharmaceutical pricing regulations.

Background: Although the 12-item Short Form Health Survey version 2 (SF-12v2) is suitable for measuring health status in the general Thai population, it has been evaluated using classical test theory. Rasch analysis, however, offers a psychometric testing method that converts ordinal scales to interval-level data without breaching parametric assumptions. Thus, this study aimed to assess the measurement properties of Thai SF-12v2 and SF-6D items derived from it among the general Thai population.

Methods: Rasch analysis was performed on 300 participants randomly selected from a pool of 1200 general Thai population. The initial SF-12v2 items, physical component summary (PCS), mental component summary (MCS), and SF-6D items were evaluated for overall fit to the Rasch model using the Chi-square test and several key elements of Rasch measurement properties, including unidimensionality, reliability (internal consistency), local independence, ordering thresholds, targeting, and item invariance (differential item functioning [DIF]).

Results: The two-domain subtests of the SF-12v2 showed an acceptable fit to the Rasch model (χ²[12] = 20.16, p = 0.06), unidimensionality, satisfactory reliability (PSI = 0.72), local independence, and no significant DIF. Although five items initially misfitted the Rasch model, these issues were resolved in the subtest analysis. Individual PCS and MCS were not recommended for measuring health status due to inadequate reliability. The SF-6D items demonstrated a good overall model fit (χ²[20] = 23.18, p = 0.28), unidimensionality, local independence, and good internal consistency (PSI = 0.73). However, all scales showed poor targeting for the person-item threshold distribution.

Conclusions: Rasch analysis supports the use of two-domain subtests of the SF-12v2 questionnaire for between-group analysis in the general Thai population. However, it does not support the use of individual PCS and MCS due to poor reliability. The SF-6D, achieving satisfactory reliability, was endorsed for eliciting utility scores for between-group analysis.

Background: Hypertension is a major global risk factor for cardiovascular disease and mortality. In Greece, prevalence is about 40%, with many cases undiagnosed or poorly managed. While doctors remain central to diagnosis and treatment, community pharmacists, as accessible healthcare professionals, can support early detection and ongoing management. This study assesses Greek community pharmacists' knowledge of hypertension detection and management, focusing on their ability to measure blood pressure accurately, categorise hypertension, and understand lifestyle factors.

Methods: A cross-sectional survey was conducted with 92 community pharmacists in Greece, using a structured questionnaire to assess knowledge of blood pressure measurement, hypertension categorisation, and lifestyle influences. The instrument collected demographic data and responses on hypertension management practices. Data were gathered between December 2022 and April 2023 and analysed using SPSS v22.

Results: The survey revealed moderate to good knowledge levels among pharmacists, particularly in blood pressure measurement (mean score: 71.74%, SD = 16.08) and hypertension categorisation (mean score: 76.9%, SD = 8.48). Knowledge about lifestyle impacts on blood pressure was lower (mean score: 53.57%, SD = 15.65). Younger pharmacists (26 36 years old) demonstrated significantly higher lifestyle impact knowledge (p = 0.013) and overall knowledge scores (p = 0.012) compared to the rest of the age groups, whereas pharmacists with postgraduate degrees had significantly higher scores in blood pressure measurement (p = 0.009) and overall knowledge scores (p = 0.002) compared to those with only a tertiary education.

Conclusion: Findings underscore early undergraduate training and continuous professional development to strengthen pharmacists' hypertension-management role. Targeted programmes should deepen understanding of lifestyle determinants. Greek community pharmacists are well positioned for early detection within multidisciplinary care, yet more education is needed to optimise impact. The Panhellenic Pharmaceutical Association and Federation of Cooperative Pharmacists of Greece advocate recognising pharmacists' role in structured, advanced services, including hypertension management, to improve public health in Greece.

Background: The Market Authorization Holder (MAH) system in China, which separates marketing authorisation from production authorisation, was piloted in 2016 across 10 provinces and cities and was fully implemented at the end of 2019 with the new revision of the 'Drug Administration Law of the People's Republic of China'. This study examines the impact of the MAH system on innovation in China's pharmaceutical industry.

Methods: Using data from A-share pharmaceutical enterprises between 2009 and 2023, this study employs a Propensity Score Matching Difference-in-Difference (PSM-DID) design. The sample includes 134 Chinese listed enterprises, with 73 in the treatment group and 61 in the control group.

Results: The PSM-DID model, based on 1,310 observations, yields a significant DID coefficient of 0.5394. Enterprise size negatively correlates with R&D investment (-0.640), while Tobin's Q (0.153) and Top10 (0.0104) positively correlate with R&D. The MAH policy significantly reduces financing constraints (-3.556), and management incentives positively moderate the impact of the MAH system (0.0121).

Conclusion: The findings suggest that the MAH system significantly enhances pharmaceutical innovation. Management incentives strengthen this effect, while financing constraints serve as an intermediary. The MAH system effectively stimulates innovation in the pharmaceutical industry, with management incentives playing a critical moderating role.

Background: The use of new oral anticoagulants (NOACs) is becoming increasingly widespread, but data on their adverse reactions are still incomplete. Further analysis based on data from the Drug Adverse Reaction Center is needed to guide safe clinical use.

Methods: A retrospective analysis was performed on 281 cases of rivaroxaban and 48 cases of dabigatran etexilate-related ADR reported by medical institutions collected by a provincial Food and Drug Administration from 2018 to 2023.

Results: Of the 329 ADRs, 164 males and 165 females were reported. Among the rivaroxaban-related ADRs, 271 were administered orally, 6 were given nasogastric feeding, 2 were given tube feeding, and 2 were intravenously instilled. Among the ADRs associated with dabigatran etexilate, 48 cases were administered orally. Serious adverse drug reactions were reported in 21.6% of cases (71 out of 330). The clinical manifestations of ADR of NOACs mainly include blood in the stool, blood in the urine, bleeding gums, coagulation disorders and ecchymosis. The causal relationship between serious adverse reactions and drugs was judged to be very likely in 24, 43 cases was judged to be probable, and 4 cases were unknown.

Conclusions: Attention should be paid to the clinical use of NOACs in elderly patients, and pharmacovigilance should be strengthened, and the implementation of individualised medication regimen should be used to promote clinical safety and rational drug use.

Over the past few decades, the emergence of irrational medicine use has become a significant global health challenge. It has contributed to medication errors, adverse drug reactions, higher treatment costs, increased morbidity, and mortality. Problems with irrational prescribing are a matter of concern in low and middle-income countries, where regulatory control is underdeveloped, healthcare systems are constrained by economic pressures, and there is a shortage of trained personnel. The World Health Organization (WHO) developed core prescribing indicators to assess and promote rational medication use for healthcare settings. These include indicators measuring polypharmacy, antibiotic use, injectable use, generic prescribing, and adherence to essential medicine lists. This narrative commentary explores the potential of WHO prescribing indicators in promoting the rational use of medicines, highlighting their role in patient safety and supporting evidence-based prescribing practices. The five key areas of these indicators provide valuable insights into prescribing practices in healthcare settings of low and middle-income countries. These indicators also support the WHO's initiative of Medication without Harm. Despite their potential strengths, there are some potential limitations, such as failing to capture the data behind the prescribing practices of prescribers and their utility in specialised healthcare settings. The future of rational prescribing lies in adapting these tools through qualitative assessments, comprehensive data collection methods that include qualitative study design approaches, and targeted training interventions to ensure safe, effective, and equitable medication practices across healthcare systems globally.

Background: Management of non-communicable diseases (NCDs), including hypertension (HT) and diabetes mellitus (DM), was significantly impacted by the COVID-19 pandemic. Many institutions adopted alternative care pathways, e.g. pharmacy at home (PAH), and the deferred care (DC). While PAH has been studied for clinical outcomes, evaluation of the DC remains limited. Consequently, this study evaluates both the clinical and economic outcomes of the PAH and DC as alternatives to usual care.

Method: A retrospective study was conducted at a tertiary care hospital in Thailand from 1 July 2021, to 30 June 2023. Data from outpatients with HT and DM were classified into PAH, DC, or discharged home with follow-up at the hospital. Clinical outcomes included changes in systolic blood pressure (SBP), diastolic blood pressure (DBP), and fasting blood sugar (FBS), calculated from baseline to follow-up. Economic outcome was the cost of illness (COI) per patient visit. Multivariate multilevel mixed-effects linear regression assessed clinical outcomes, while log-linear regression evaluated economic outcome.

Results: There were 3,518 patients in the pandemic period and 4,135 patients in the post pandemic period. There was no statistically significant impact of PAH and DC on changes in SBP, DBP, and FBS. However, both care pathways significantly reduced COI during both periods (p < 0.001). During the pandemic period, COI reductions were 32.3% in PAH and 93.5% in DC compared to usual care. Similar trends were observed in the post pandemic period, with COI reductions of 40.0% for PAH and 96.1% for DC.

Conclusion: PAH and DC pathways did not worsen the clinical outcomes and reduced costs during and following the pandemic. As a result, these two pathways, developed during the COVID-19 pandemic, can be adapted for regular use. When these pathways are integrated into regular use, they can be promptly and fully reactivated in future emergencies.

Background: The National Natural Science Foundation of China (NSFC) plays a pivotal role in supporting basic medical research and shaping national funding priorities. As clinical and scientific demands in obstetrics and gynecology grow, particularly in areas closely tied to pharmacological interventions and maternal-fetal health, understanding funding patterns is essential for guiding research strategy and health policy. This study aimed to evaluate NSFC funding trends in obstetrics and gynecology from 2011 to 2020 and examine their alignment with research output and policy-relevant themes.

Methods: Data from 2011 to 2020 were collected from official public sources. Descriptive analyses were conducted to assess funding trends by volume, project type, institutional and regional distribution, and research focus. SCI-indexed publication data were retrieved to evaluate the consistency between funding levels and high-impact scientific productivity.

Results: NSFC funding in obstetrics and gynecology increased steadily over the decade, with a notable rise in support for early-career researchers through the Young Scientists Fund. Funding was geographically concentrated in eastern China, particularly in Beijing, Shanghai, and Guangzhou, with limited representation from central and western regions. Priority research themes included gestational diseases, reproductive health, and prenatal diagnostics. The average overlap between top-funded institutions and those with high SCI publication output was 61%, indicating only partial alignment between funding distribution and scientific productivity.

Conclusions: While NSFC funding has played a critical role in advancing obstetrics and gynecology research in China, structural challenges persist. These include limited investment in high-tier and translational projects, regional disparities, and a mismatch between funding and publication output. The evolving focus of the NSFC on innovation and long-term impact over traditional publication metrics underscores the need for strategic reforms. Enhancing interdisciplinary integration, promoting equitable resource allocation, and adopting outcome-based evaluation frameworks are essential to better support pharmacological research and policy-driven improvements in maternal and reproductive health.