Journal of Pharmaceutical Policy and Practice最新文献

Background: Currently, no nationwide reports exist that describe the effects of drug shortages on the work of hospital pharmacists in Japan. Using a questionnaire survey, we evaluated here the impact of recent drug shortages on the work of hospital pharmacists in Japan.

Methods: We distributed a questionnaire to the directors of the pharmacy departments of 853 hospitals belonging to the Japan Municipal Hospital Association. The questionnaire consisted of questions on the situation regarding recent drug shortages at the responding hospitals and the time spent by hospital pharmacists dealing with drug shortages between February 13, 2024, and March 15, 2024.

Results: The proportion of hospitals that answered at least one survey question was 25.7% (219/853). Almost all respondents (98.1% [214/218]) answered that the recent drug shortages negatively affected other practices of the hospital pharmacy. The median time spent dealing with drug shortages in all responding hospitals was 19.5 h of 32 days (including 23 weekdays). The estimated annual labour cost of hospital pharmacists required to deal with the recent drug shortages in the 8,110 hospitals of Japan amounted to 7.1 billion JPY/year (approximately 50 million USD/year).

Conclusions: A survey of directors of hospital pharmacy revealed that recent drug shortages have been a burden on pharmacists at most hospitals, as they have spent a notable amount of time dealing with such drug shortages.

Background: Health Technology Assessment (HTA) supports optimal healthcare resource allocation by providing evidence-based input for decision-making. The manuscript aims to: (1) summarise the development process of methodological guidelines for Oman with involvement of key stakeholders to facilitate consistency, transparency and robustness in technology appraisal, and (2) present the features of the accepted HTA guidelines.

Methods: Guideline development included five steps: (1) learnings from international HTA guidelines; (2) multistakeholder workshop on key components of the Omani methodological guidelines; (3) survey to facilitate consensus on most critical elements; (4) drafting the guidelines based on collected observations; and (5) validation through feedback from policy-makers and HTA experts.

Results: The Omani HTA guidelines consist of six sections: target indication, medical assessment, economic evaluation, budget impact analysis, social and ethical considerations, and transparency. Health benefit evaluation should prioritise policy-relevant outcomes, including mortality, morbidity, and quality of life. Using clinical assessment reports published by reputable HTA agencies is advocated. When added value is demonstrated over a policy-relevant comparator, cost-utility analysis with QALYs calculation, a 3% discount rate, and cost-effectiveness thresholds is the preferred approach. Budget impact analysis should cover a four-year horizon. Full disclosure of conflicts of interest, expert contributions, and public availability of HTA dossiers are mandatory to enhance transparency.

Conclusion: Acceptance of Omani HTA methodological guidelines by the Ministry of Health represent an important milestone in improving the evidence base of policy decisions in Oman. The guidelines offer a standardised, transparent framework to judge the value and affordability of health technologies in alignment with international standards and local healthcare needs and priorities.

Background: Despite established guidelines recommending cardioprotective medications for patients with type 2 diabetes mellitus (T2DM) and atherosclerotic cardiovascular disease (ASCVD), prescribing practices often fall short of recommendations. In this study we aimed to assess the prescribing trends of guidelines-recommended cardioprotective medications, including sodium-glucose cotransporter-2 inhibitors (SGLT2i), glucagon-like peptide-1 receptor agonists (GLP-1RA), angiotensin-converting enzyme inhibitors/angiotensin receptor blockers (ACEi/ARB), and high-intensity statins, among patients with type 2 diabetes mellitus (T2DM) and atherosclerotic cardiovascular disease (ASCVD) in Qatar's primary health care corporation (PHCC).

Methods: This retrospective cross-sectional study analysed electronic medical records data from 29 PHCC centres in Qatar for the period January-December 2021. Prescription rates of SGLT2i/GLP-1RA, ACEi/ARB, and high-intensity statin were assessed based on documented medication usage. Logistic regression was used to identify factors associated with guideline-directed prescribing. The study received ethics approval from the PHCC in Qatar, with de-identified data accessible only to the Principal Investigator.

Results: Among the 2,870 eligible subjects, only 10% (n = 292) were prescribed high-intensity statins, 12% (n = 357) received SGLT2i/GLP-1RA, and 56% (1,617)were prescribed ACEi/ARB. Male gender, higher HbA1c, and a diagnosis of dyslipidaemia were positively associated with increased likelihood of adherence to relevant clinical practice guidelines. However, these factors only explained only 16% of the observed variance.

Conclusion: The majority of patients with T2DM and ASCVD did not receive the completed guideline-recommended regimens of cardioprotective medications, suggesting a significant gap in clinical practice. Urgent implementation of multifaceted strategies is warranted to address barriers and clinical inertia, thereby optimising cardiovascular risk reduction and secondary prevention therapies.

Background: As the population ages, addressing potentially inappropriate medications (PIMs) for patients with heart failure (HF) is extremely important, and many medical professionals are working on this issue. However, it is unclear whether the various PIM countermeasures being implemented throughout Japan are leading to the suppression of PIMs for patients with HF. The characteristics of hospitalised patients with HF and prescription patterns of PIMs over the past decade were investigated.

Method: Data from the Japanese Cardiovascular Disease Registry Database and the Diagnostic Procedure Combination Database of 1,452,034 inpatients aged ≥18 years diagnosed with HF between April 2012 and March 2022 were analysed. The study was stratified into three periods: 2012-2015, 2016-2019, and 2020-2022.

Results: Typical PIMs, such as benzodiazepine, anxiolytics medications, α-glucosidase inhibitors, thiazolidine, sulfonylurea, non-dihydropyridine calcium antagonists, digoxin, non-steroidal anti-inflammatory drugs, anticholinergics, and β2 agonists showed decreased prescription trends over the years (P for all trends <0.01). Inpatient PIM prescriptions rarely continued at discharge.

Conclusion: These results suggest that typical PIMs for hospitalised patients with HF have declined during the past decade. Medical providers should contribute to optimising medications that minimise PIM administration to patients with HF. In the future, PIMs for patients with HF may need to be monitored as a safety indicator.

Background: The internet has become a critical resource for accessing health information worldwide. Online health information seeking (OHIS) is increasingly common among hospitalised patients, particularly those with chronic conditions. While prior studies have explored OHIS in individual countries, limited evidence exists comparing behaviours across different sociocultural and healthcare contexts. This study compared patterns of internet use for health information among hospitalised patients in Switzerland and Qatar.

Methods: A comparative cross-sectional study was conducted between January and June 2016 in two tertiary hospitals in Switzerland, and Qatar. Eligible patients (18-80 years) admitted to internal medicine, visceral surgery, or orthopaedics wards completed a 33-item structured questionnaire, available in French and Arabic, covering sociodemographic characteristics, internet access, health information-seeking behaviour, and use during hospitalisation. Both descriptive and inferential statistics were applied to identify predictors of OHIS.

Results: A total of 820 patients participated (617 Swiss, 203 Qatari). Swiss patients were older (mean age 57 ± 15) than Qataris (44 ± 16, p ≤ 0.001). Qatari patients were more likely to search for health information online compared with Swiss patients (85% vs 65%, p ≤ 0.001). They searched more frequently for information on diseases (74% vs 56%), treatments (59% vs 41%), healthcare professionals (40% vs 20%), and hospitals (41% vs 18%). Online health information had greater reported impact among Qataris, prompting them to ask further questions to doctors (75% vs 50%, p ≤ 0.001) and influencing decisions to consult physicians (33% vs 22%, p ≤ 0.05). Both cohorts expressed interest in reliable, tailored online resources, with Qataris showing stronger preference for interactive and video-based platforms.

Conclusion: This study highlights significant cross-country differences in OHIS behaviour among hospitalised patients, shaped by sociodemographic, cultural, and healthcare system contexts. Findings underscore the need for culturally relevant, trustworthy, and patient-centred digital health resources to enhance patient empowerment, improve clinician-patient communication, and reduce risks of misinformation.

Background: The U.S.-Thai Consortium for Pharmacy Education is a long-standing collaboration between the U.S. and Thailand that primarily focuses on faculty development. The success of this partnership has contributed to the improvement of pharmacy education and the advancement of pharmacy practice in Thailand. It may also serve as a model for collaborative efforts in pharmacy education and practice across Association of Southeast Asian Nations (ASEAN) countries. This study was designed to explore the views and perceptions on goals, directions, and trends for the new U.S.- ASEAN Consortium for Pharmacy Education.

Methods: A qualitative study was used. A focus group with semi-structured questions was conducted with 12 representative faculty members from nine ASEAN countries and the U.S. Verbatim transcriptions were used to perform thematic analysis with investigator triangulation.

Results: Four key themes emerged: perceptions, challenges, expectations, and directions. Participants perceived the U.S.-ASEAN Consortium as a strategic networking platform for expanding international collaborations. Challenges were identified at both the institutional and national levels, with curriculum differences, financial constraints, and administrative issues affecting institutions, while cultural and language differences pose further obstacles. At the national level, top-down administrative structures were identified as restrictions. The main expressed benefit of joining the Consortium was enhancement of student experiences, including student exchange programmes. Gaining insights into organisational administration was also perceived as one of the benefits. Participants recognised that a successful collaboration required identifying common interests, setting goals, and proposing strategies, including developing a master plan, harmonising programmes, and establishing a uniform competency framework. Regular meetings and resource-sharing were identified as also essential to maintaining the engagement of Consortium members.

Conclusion: The U.S.-ASEAN Consortium was perceived as a platform to increase opportunities to collaboratively connect with other pharmacy schools internationally. The establishment of common interests and strategies was recommended to keep the collaboration moving forward.

Background: The pharmaceutical sector in Pakistan has grown over a period; however, there are certain barriers within the framework that regulate the growth and export of pharmaceuticals in the country. The purpose of this study was to highlight the current challenges for the pharmaceuticals' export from Pakistan, especially to countries with stringent regulatory authorities (SRAs), from a regulatory perspective, and to identify the facilitators that may help resolve these challenges.

Methods: In this qualitative study, data were collected from the participants from the regional offices of Drug Regulatory Authority of Pakistan (DRAP), located in Lahore, Islamabad, and Quetta. Regulatory participants with a minimum experience of 6 years and the designation of an assistant director or above were recruited through purposive sampling. Semi-structured interviews were used to collect information from regulatory experts. Inductive thematic content analysis was employed to conclude the data.Data analysis generated 5 themes and 20 categories/codes. Poor export performance and pharmaceutical growth was attributed to barriers such as: inadequate industrial research and development, non-compliance with the current standards of good manufacturing practices (cGMP), absence of regulatory requirements for high-tech equipment, insufficient academia-industry collaboration, shortage of locally manufactured active pharmaceutical ingredients and lack of support from the government. Accreditation with international organisations such as the World Health Organisation and the Pharmaceutical Inspection Co-operation Scheme was considered deficient. DRAP, in coordination with the Trade Development Authority, could enhance pharmaceutical exports. Addressing the above challenges could boost the export and expand international market share of Pakistani Pharmaceuticals in countries with SRAs.

Conclusion: The cGMP compliance, regulatory assistance, and appropriate research and development, including bioequivalence studies, could contribute to export enhancement to SRA countries. Further, the exports from Pakistan to countries with SRAs could be enhanced with DRAP's coordination with the trade development authority of Pakistan.

Introduction: Inappropriate polypharmacy is prevalent among patients with chronic kidney disease (CKD), and can be mitigated by deprescribing. We aim to evaluate the clinical and economic impact of a multidisciplinary deprescribing programme in Qatar's healthcare system.

Methods: This randomised controlled trial will be conducted at ambulatory dialysis centres, with an internal pilot to assess the feasibility of recruitment, intervention implementation, and safety measures. Patients will be randomised to usual care or an intervention group where a clinical pharmacist, in collaboration with a multidisciplinary healthcare team, will deliver a structured deprescribing intervention, including periodic monitoring over six months. Outcomes will be measured at baseline, three, and six months. The primary outcome is the proportion of patients with at least one potentially inappropriate medication (PIM). Secondary outcomes include pill burden, treatment burden, hospitalisations, emergency department visits, quality of life, and adherence. A cost-benefit analysis will also be performed. A total of 250 patients provides 90% power to detect a 50% reduction in PIM prevalence (α = 0.05). The statistical analysis will be based on the intention-to-treat principle, using mixed-effects models to account for repeated measures.

Discussion: Findings will provide novel evidence on deprescribing in CKD, informing future clinical and policy interventions.

Trial registration: ClinicalTrial.gov. NCT06324045. Registered on 15 March 2024.

Background: The European Union (EU) has introduced several changes to its chemicals policy and legislation with an ambition to transform society greener. This study examined selected changes introduced in EU chemicals policy and legislation and how they may affect the pharmaceutical sector. The objective was to find out whether structural changes in one political sphere (chemicals) influence the other political sphere (health).

Methods: First, concrete changes to EU chemicals legislation or its implementation were identified. Then, qualitative content analysis was used to analyse how these changes are reflected in EU pharmaceutical policy, legislation and related guidance documents. Data was analysed using both deductive and inductive approaches. The concrete changes identified were used as codes for the deductive classification of quotations. The analysis continued inductively by examining these quotations for the topics they raise in EU pharmaceutical policy, legislation and related guidance.

Results: The results imply that structural changes in EU political sphere of chemicals may have a range of implications for the pharmaceutical sector. The need for derogations in certain cases regarding medicinal products was recognised, but in general, the pharmaceutical sector will not be exempted from the application of the new provisions. However, changes to EU chemicals legislation were rarely referred to in pharmaceutical policy, legislation and guidance. An inductive analysis of the quotations revealed that some changes (such as substances with endocrine-disrupting properties and changes to EU water legislation) have got more prominence in the pharmaceutical sector than others.

Conclusion: The analysis indicated that the pharmaceutical sector is taking a defensive approach to changes in EU chemicals legislation. This may be partly because many changes occur simultaneously, creating uncertainty about their combined and cumulative impacts. Closer cooperation between the Environment and Health Directorates-General is needed to steer more coherent transformation governance across different policy sectors in the EU.

Background: Low- and middle-income countries (LMICs) shoulder a disproportionately high amount of death and disability caused by both communicable and non-communicable diseases. As a result, there is a higher occurrence of serious illness in these countries. Intensive Care Units (ICUs) have emerged in the past twenty years in LMICs. However, the World Health Organization (WHO) Model List of Essential Medicines lacks many common medicines used in critical care, and the lack of necessary medications to treat critical illnesses has hindered the function of these ICUs. This study aimed to develop a list of commonly used essential medications in the ICU to serve as the foundation for a multi-phase project.

Methods: This was an observational cross-sectional survey of all the program directors of all the Critical Care fellowship training programs in the United States of America. The study surveyed a multidisciplinary group of critical care providers to assess the first, second, and third-line preferred medication use in 10 categories of medications: sedatives, vasopressors, inotropes, antiarrhythmics, intravenous antihypertensives, neuromuscular blocking agents, medications for the management of ICU delirium, stress ulcer prophylaxis (SUP), deep vein thrombosis prophylaxis, and analgesics, to create a list of 26 commonly used critical care medicines.

Results: Of the 588 contacted programs, 133 completed the survey questionnaire, representing a 23% response rate with an over-representation from the East Coast and the Midwest. Seven medication categories had a clear first-line preference, while only three had clear second-line preference respondents.

Conclusion: This survey successfully identified the 26 most commonly used medications in the ICU grouped into 10 categories. This list will serve as a foundational reference for future phases of the research project, which will include engagement with stakeholders from LMICs to refine and adapt the list to regional realities.