Journal of Pharmaceutical Policy and Practice最新文献

Background: Herbal medicines are widely used in Indonesia and other LMICs, yet their integration into national health systems relies on coherent regulatory oversight, reliable evidence generation, functional pharmacovigilance (PV), and alignment with health technology assessment (HTA) and financing processes. Existing evidence varies in rigour and maturity, creating uncertainty for regulators and policymakers. A consolidated understanding of how available evidence informs regulatory, HTA, PV, and financing decisions is needed to guide a more predictable, evidence-informed governance framework for herbal medicines in Indonesia.

Methods: An integrative review was conducted using Scopus, PubMed, Google Scholar, WHO IRIS, the ASEAN TMHS repository, and national regulatory portals for literature published between 2015 and 2025. Thirty-seven studies met eligibility and WHO-based methodological quality criteria. Data were extracted using a structured matrix, synthesised thematically, and deductively mapped to five analytic domains: evidence generation, regulatory pathways, HTA processes, pharmacovigilance systems, and financing-governance alignment.

Results: Three system-level themes emerged. First, substantial misalignment exists between available evidence and regulatory requirements, driven by heterogeneous clinical methods, limited comparator data, and variable standardisation. Second, HTA remains weakly integrated into decision-making due to gaps in clinical effectiveness, limited economic evidence, and challenges in assessing multi-component interventions. Third, PV and governance systems show fragmentation, weak inter-agency coordination, and inadequate safety signal detection. These interdependent weaknesses reduce regulatory predictability, constrain HTA feasibility, and limit informed financing decisions.

Conclusion: This review provides the first integrated synthesis of evidence generation, regulatory pathways, HTA processes, PV systems, and financing-governance alignment for herbal medicines in Indonesia. Findings highlight the need to strengthen evidence standards, adapt HTA methodologies, reinforce PV and laboratory capacity, and improve regulatory-financing linkages. Implementing the proposed framework can enhance policy coherence, regulatory transparency, and safety oversight, supporting more credible and evidence-informed integration of herbal medicines into Indonesia's health system.

[This corrects the article DOI: 10.1080/20523211.2024.2415416.].

Background: Non-adherence to medication can reduce therapeutic effectiveness in breast cancer patients, thereby increasing the risk of disease progression or recurrence. This study aimed to systematically review the existing scientific literature on the impact of mHealth interventions on medication adherence among breast cancer patients.

Methods: This systematic review was conducted following PRISMA guidelines and focused on randomised clinical trials published in English. The review evaluated the effectiveness of mHealth interventions in improving medication adherence in breast cancer patients from their inception through June 2025. The databases searched included PubMed, Medline, Cochrane, and Scopus. Study selection, data extraction, and quality assessment were performed by two independent reviewers using Cochrane Risk-of-Bias version 2. The protocol was registered in the INPLASY database (INPLASY2024100061).

Results: The review included six randomised controlled trials that met the inclusion criteria. Various mHealth interventions were utilised to improve medication adherence among breast cancer patients. Examples included a smart pill bottle connected to the Pillsy mobile application, SMS reminders, text messaging, phone call reminders, and mobile games. Notably, most mHealth interventions were associated with significant improvements in medication adherence compared to traditional healthcare approaches; however, two studies reported no significant adherence benefits from text messaging compared with standard care. Three out of six studies measured adherence using self-administered questionnaires. For quality assessment, all trials demonstrated adequate randomisation techniques, appropriate allocation concealment, and used appropriate analysis to estimate the effect of assignment to intervention.

Conclusion: Breast cancer patients who received mHealth interventions such as SMS reminders, phone call reminders, a smart pill bottle connected to the Pillsy application, and mobile games showed better medication adherence. To implement mHealth interventions, it is crucial to understand key factors that may influence outcomes, including the timing and frequency of interventions, the methods of measuring adherence, patients' preferences, and the duration of intervention assessment.

Introduction: Type 2 diabetes (T2D) is a critical public health crisis in Pakistan, which currently holds the highest age-standardised prevalence globally. While semaglutide significantly improves glycemic control and weight, high costs limit access to the innovator molecule in low - and middle-income countries. Biosynthetic semaglutide provides an affordable local alternative, yet real-world evidence regarding its clinical performance and impact on quality of life (QoL) is currently lacking.

Methods and analysis: The BIOSURE study is a 30-week, multicenter, prospective, non-interventional, single-arm observational protocol evaluating biosynthetic semaglutide in 268 adults with T2D across Pakistan. The primary objective is to quantify the absolute change in glycated hemoglobine (HbA1c) from baseline to 30 weeks. Secondary objectives include assessing changes in body weight, waist circumference, blood pressure, lipid profiles, and safety. Patient-centered outcomes will be measured via the Diabetes Treatment Satisfaction Questionnaire, Morisky Medication Adherence Scale, and SF-36v2 health survey. Statistical analysis will utilise mixed-effects modelling and multiple imputation for missing data.

Ethics and dissemination: Ethical approval has been obtained from the USM Human Research Ethics Committee and local IRBs. The study is registered with the ANZCTR (ACTRN12625000610437). Findings will be disseminated through peer-reviewed journals and policy forums to provide a clinical and assistive framework for scalable diabetes care in resource-constrained settings.Trial registration: Australian New Zealand Clinical Trials Registry identifier: ACTRN12625000610437.

Background: Biosimilars present a significant opportunity for cost savings. However, the uptake of biosimilars has been inconsistent across different regions and drugs, highlighting the need for effective policy interventions. This study aimed to investigate the impact of Japan's reimbursement incentive policy on the utilisation of etanercept and infliximab biosimilars among patients with rheumatoid arthritis.

Methods: We conducted an interrupted time-series (ITS) analysis using data extracted from the JMDC claims database in Japan. Participants included those prescribed either the brand-name biologics or their biosimilars. The primary outcome was the proportional use of biosimilars relative to the total use of both biosimilars and originator drugs.

Results: The ITS analysis demonstrated varied responses to the reimbursement policy across the two biosimilars. For infliximab, although the policy did not result in a significant level change (0.14%; 95% confidence interval [CI]: -2.83, 3.11), there was a positive but nonsignificant slope change of 0.21% per month (95% CI: -0.13, 0.55). In contrast, for etanercept, the policy led to a significant level change, with an immediate increase in use by 13.48% (95% CI: 7.82, 19.14). However, the slope change showed a significant decrease by -1.09% per month (95% CI: -1.50, -0.68).

Conclusion: The results indicate that while the reimbursement policy was associated with a short-term increase in the uptake of etanercept biosimilars, it had limited impact on infliximab biosimilars. This variation suggests that financial incentives alone may not be sufficient to enhance biosimilar adoption and that policies must consider drug-specific and healthcare setting-specific factors.

Background: Health Technology Assessment (HTA) is increasingly recognised as an essential tool for directing decisions on health policy, particularly those concerning coverage, reimbursement, price and value, especially in nations aiming for Universal Health Coverage (UHC). Jordan is a middle-income country with limited resources for the health sector and rising needs; thus, despite its significant progress toward institutionalising HTA, there are still many gaps.

Objectives: To assess the present situation of HTA in Jordan, pinpoint the main facilitators and obstacles, and suggest a plan for enhancing HTA at Jordan University Hospital so that it can more methodically influence Jordanian health policy.

Methods: Stakeholder studies, policy documents and published literature on HTA were reviewed, along with lessons learned from similar contexts.

Results: Jordan's progress in HTA has been noteworthy. The Jordan Food and Drug Administration has specific requirements for pharmacoeconomic data in pricing and reimbursement, for instance, and university programs are providing capacity building. Other pioneers include the Ministry of Health, Royal Medical Services and the King Hussein Cancer Center's Centre for Drug Policy and Technology Assessment (KHCC CDPTA). However, funding for HTA is unstable, transparency and stakeholder engagement are uneven, institutional roles are fragmented, there is no national HTA methodological guideline or comprehensive, mandated legal framework, and data infrastructure (especially local cost, outcomes and real-world evidence) is limited.

Conclusions: A strategic plan is required for all institutions to achieve the potential benefits of HTA in Jordan, including more equitable access, better prioritisation, more efficient spending and contributions to UHC. Formalising legal requirements, creating national methodological guidelines, enhancing institutional and human capacity, enhancing data systems, obtaining long-term funding, establishing precise decision criteria and thresholds and boosting transparency and stakeholder participation are important stages.

Background: The remit of pharmacists' vital role in the healthcare system is expanding, and continuous professional development (CPD) of pharmacists is critical. While CPD is mandatory in the UK, a lack of protected learning time (PLT) hinders engagement, particularly in community pharmacies. In Wales, UK, a national PLT programme was piloted to address this, involving funding for 12-15 days of PLT for community pharmacists. This study investigated whether PLT provision can benefit both community pharmacists and their pharmacy, and explored opportunities for upscaling PLT provision.

Method: A realist qualitative approach was adopted across four phases. Community pharmacists participating in the PLT programme submitted monthly diary entries and engaged in one-off group and individual interviews. Employer perspectives were collected via an online survey. Education and Training Leads reflected on preliminary findings and their comments were captured via group interview. Data were coded and analysed thematically through a constant comparative approach.

Results: Thirty participants contributed data, including 96 diary entries from 20 pharmacists, interviews with 15 pharmacists, survey responses from 12 employers, and input from 3 education leads. The PLT promoted both individual professional development and organisational capacity, and also enhanced pharmacists' personal wellbeing. Nonetheless, challenges for employers were prevalent, including rising costs of locum cover and service disruptions. Participants proposed two scalable PLT models: pre-scheduled PLT slots and non-patient-facing hours.

Conclusion: PLT improves pharmacist professional development and personal wellbeing and enables broader service provision in their pharmacy. However, upscaling of PLT requires addressing financial and logistical barriers. Structured and equitable PLT models, such as routine closures or non-patient-facing hours, warrant further research and piloting to assess feasibility, acceptability and impact both for pharmacists and patient care.

Background: Several trials demonstrated improvements in clinical outcomes associated with cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors in breast cancer patients. The challenge remains regarding their high costs. Ribociclib and Abemaciclib are cost-effective in Qatar. Yet, their affordability was not studied. This budget impact analysis (BIA) is to assess the affordability of adopting CDK4/6 inhibitors in Qatar over five years duration (2024-2028).

Methods: We ran a BIA to evaluate two scenarios: (1) Increasing abemaciclib's market share from 20% to 60%, replacing both palbociclib and ribociclib. (2) Assuming equal market share for both ribociclib and abemaciclib up to 80%, reducing palbociclib's share. The analysis considered treatment costs, patient population, and disease prevalence. All data were retrieved from the National Center for Cancer Care and Research, and costs were presented in Qatari Riyals (QAR). Sensitivity analyses were run to ensure the robustness of the conclusion. All results were compared to Qatar's budget threshold, which is QAR 453,822.

Results: Based on a total of 173 patients using CDK4/6 inhibitors, increasing abemaciclib's market share to 60% yielded cumulative savings of QAR 14 million over five years, which is around QAR 14,613 per patient per year. However, equally increasing ribociclib's and abemaciclib's market share to 80% resulted in a modest budget increase, remaining within acceptable thresholds. Sensitivity analyses confirmed the robustness of these findings, showing that cost reductions and higher uptake rates further enhanced savings.

Conclusion: Abemaciclib is a budget-saving option for HR+/HER2- breast cancer in Qatar, should it replace the market share by up to 60% over five years. In addition, ribociclib and abemaciclib are affordable treatment options if they equally contributes to up to 80% of the market share for the eligible advanced breast cancer patients. The results supported the concept of allocating CDK4/6 inhibitors as they were found to be affordable to the Qatari healthcare system.

Background: Self-medication given by parents or caregivers is a common practice among children. Several frequently used drugs are often administered without professional supervision. This study compares regulatory classifications of common paediatric self-medication drugs across ten countries, aiming to uncover trends based on product type and national policies.

Methods: Data were primarily collected from official drug regulatory agency websites and supplemented from other relevant sources. Twelve widely used drugs were reviewed, by focusing on classification status, approved indications, and paediatric age restrictions. Content and comparative analyses were conducted.

Results: The findings revealed that drugs indicated for fever, pain, mucolytic effects, and non-sedating antihistamines were mostly classified as non-prescription. For drugs with the same active ingredient, but different strengths or dosage forms, compared within the same country, the classification status generally remained unchanged, even across different paediatric age groups. Drugs for asthma and topical corticosteroids were likely to be classified as prescription drugs. In some countries, such as the United Kingdom, Australia, and Singapore, the same drug preparation had different classification statuses which were based on factors such as approved indication and pack size. Additionally, Singapore and Indonesia implement prescription-exemption systems. These allow supply of certain prescription drugs without a prescription under specific conditions.

Conclusion: Commonly used drugs for paediatric self-medication are classified as both non-prescription and prescription. This reflects diverse regulatory approaches across countries. Regulators play a key role in ensuring safe use of self-medication in children. Lack of harmonisation address a critical need for globally consistent paediatric drug classification scheme. They empower consumers through mechanisms such as clear, accessible patient information leaflets and other educational tools.

Background: Pharmacy workforce intelligence (PWI) involves the development, implementation, and evaluation of effective strategies and tools to ensure the availability and quality of pharmacy workforce (PW). Academic capacity (AC) is essential in producing graduates for PW, while quality assurance (QA) in education is crucial in developing competent PW. There is a lack of information about PWI in the Eastern Mediterranean Region (EMR). Based on the available data, there is a notable imbalance in PW distribution in EMR. This study aimed to evaluate the status of AC and QA of pharmacy education in the EMR using the International-Pharmaceutical-Federation (FIP)'s Development-Goals and their associated mechanisms as a framework.

Methods: An explanatory sequential mixed-methods approach was used. The quantitative phase involved distributing a validated questionnaire among pharmacy leaders of all accessible pharmacy schools in the EMR. The qualitative phase involved the conduct of semi-structured interviews with pharmacy leaders, and the data were thematically analysed.

Results: Of 112 identified pharmacy leaders, 61 participated in the survey (response rate, 55%) and 14 participated in the interviews. Most data were consistent among the quantitative and qualitative results. In both phases, most participants reported implementing a student - teacher ratio (70%), periodic accreditation (82%), adoption of global QA standards (67%), and involving key stakeholders in programme development. Enrolment planning based on workforce needs (51%) and capacity-building for teacher-practitioners (47%) were less common and less emphasised in interviews.

Conclusion: Although some AC and QA mechanisms are achieved, many require further improvement. Policymakers could establish a national body representing PW, improve workforce data systems for evidence-based enrolment planning, invest in faculty development, and standardised QA frameworks. Standardising stakeholder engagement and enhancing graduate tracking would further ensure that programmes remain aligned with workforce and health system needs.