Journal of Pharmaceutical Policy and Practice最新文献

Introduction: The East African Community (EAC) has been facing challenges in ensuring access to affordable and quality-assured medicines. To address these problems, the EAC Partner States have been working on implementing an inter-country pooled procurement mechanism since 2005. However, with limited progress to date. The aims of this study were to explore how the EAC pooled procurement mechanism has been developing over time, and to clarify the work and efforts made during this development process to draw lessons for enhancing such collaborative efforts.

Methods: For this study, we carried out a multi-method qualitative case study. We used the Pooled Procurement Guidance to collect and structure our data drawn from academic papers, grey literature documents, observations and field notes. For the analysis, we used an inductive thematic analysis approach.

Results: Over the past two decades of the EAC's pooled procurement journey, we have identified two developmental stages so far: the promise stage and the creation stage. The promise stage was characterised by initial engagement and alignment efforts between Partner States. However, the lack of dedicated funding and ownership to drive the project forward led to stagnation of the process for some years. Following the establishment of a dedicated organisation, the pooled procurement mechanism entered the creation stage. This stage has been characterised by continuous alignment work consisting of project management, efforts to build inter-personal relationships, and facilitation of negotiations to harmonise goals, needs and operations. This process has been aided by broad and recurring involvement of regional experts.

Conclusion: To successfully implement a pooled procurement mechanism, we suggest EAC Partner States to continue their alignment efforts, sustain political will and allocate sustainable funding using a phased implementation approach towards pooled procurement.

Background: Regulatory pathways adopted by the United States Food Drug and Administration (FDA) and Australian Therapeutic Goods Administration (TGA) enable expedited approval of medicines that are thought to offer significant clinical advantage over existing options for severe diseases.

Objectives: To review Australian accessibility to medicines approved through the FDA breakthrough therapy designation (BTD) process including timelines and approvals by the TGA and Pharmaceutical Benefits Advisory Committee (PBAC) for listing on the Pharmaceutical Benefits Scheme (PBS).

Methods: Retrospective review of published reports from the FDA, TGA, PBAC and PBS for BTDs from 1 January 2013-31 August 2023. Uniform data about BTD and milestone dates were collected. Analysis included all BTDs approved by FDA until 31-August-2022. Main outcome measures: Rates of approval by TGA and PBAC, and PBS-listing; and median (interquartile range, IQR) time from FDA submission to FDA approval, and FDA approval to TGA approval, PBAC approval and PBS listing for cancer and non-cancer medicines.

Results: Of 237 BTDs across 156 medicines, 68% were approved by the TGA, and 37% were listed on the PBS. Median (IQR) time from FDA submission to FDA approval was shorter for cancer compared to non-cancer; 179 days (140-210) vs 232 days (181-245), p < 0.02. Time from FDA approval to PBS listing was similar for cancer and non-cancer; median 744 days (IQR, 549-1136) and 733 days (IQR 440-960) respectively, with improvements for cancer BTDs noted for 2018-2022 compared to 2013-2017; 566 days (IQR 319-831) vs 880 days (IQR 620-1362), p < 0.02 but not for non-cancer BTDs.

Conclusion: BTD medicines are accessible in Australia approximately 2 years after FDA approval. Since 2018, time to PBS listing for cancer therapies improved, mirroring shorter FDA approval times for this category. Further understanding of clinical studies and context by therapeutic area may improve timely and safe access to life-saving medicines.

Background: The clinical characteristics and associated risk factors for recipients who experience multidrug-resistant organism (MDRO) bloodstream infections after liver transplantation are poorly understood. This study aimed to analyse the clinical characteristics and epidemiology of pathogenic bacteria and identify associated risk factors in patients who underwent MDRO after liver transplantation.

Method: We retrospectively collected data on recipients who developed bloodstream infections after liver transplantation between 2018 and 2023. Recipients were divided into MDRO and non-MDRO groups based on blood culture results. We explored the risk factors for MDRO bloodstream infections post-transplantation and summarised the clinical features, pathogen epidemiology, and prognosis. A multivariate logistic regression analysis was conducted to identify significant risk factors.

Results: A total of 463 liver transplant recipients were studied, and 73 developed blood infections. There were 29 MDRO cases. The mean duration of the episodes was 26 days (range: 1-474 days). Among these patients, 22 (30.1%) developed blood infections without fever (temperature < 37.3°C), and 33 patients (45.2%) had a white blood cell count between 4 and 10 × 10⁹/L. Among the 108 positive blood cultures, 29 genera were detected, predominantly gram-negative bacilli (n = 64, 58.2%). The detection rate for multidrug-resistant bacilli was 31.8% (35/110), with the abdomen being the most common site of origin (21.3%). Factors such as a history of preoperative intensive care unit (ICU) hospitalisation (p < 0.001) and a preoperative international normalised ratio (INR) > 2 (p < 0.048) were identified as risk factors in multivariate regression analysis.

Conclusion: Multidrug-resistant bacterial bloodstream infections after liver transplantation tend to occur early in the postoperative period (<30 days) and are associated with high mortality and a lack of specific clinical manifestations. A history of preoperative intensive care unit (ICU) hospitalisation and an international normalised ratio (INR) > 2 may be risk factors for multidrug-resistant bacterial bloodstream infections after liver transplantation.

Background: In recent decades, there has been an interest in clinical pharmacy practice in Türkiye with emerging studies in this area. Despite the recent emergence of diverse pharmacy practice studies in Türkiye, a comprehensive assessment of overall typology of studies and impact has not been conducted thus far.

Objectives: This systematic review aims to document and assess pharmaceutical policy and practice literature published within the last 5 years in Türkiye. The other aim is to summarise the expected impact of published studies on policy and practice research.

Methods: The systematic review was conducted according to the guidelines described in the PRISMA Statement. A comprehensive search approach, incorporating Medical Subject Headings (MeSH) queries and free-text terms was employed to locate pertinent literature related to pharmacy practice and policy in Türkiye. The search covered the period from January 1, 2019, to January 1, 2024, and involved electronic databases including PubMed, Medline Ovid, Scopus, ScienceDirect, Springer Link, PlosOne, and BMC.

Results: In the final grouping, 73 articles met the inclusion criteria and were selected for this review. Among the quantitative studies, majority studies were cross-sectional survey studies. Through the rigorous thematic content analysis seven research domains were developed from the selected literature: drug utilisation and rational drug use, the emerging role of pharmacist, access to medicines and generic medicines, community pharmacy practice, pharmacovigilance/adverse drug reactions, and pharmacoeconomic studies.

Conclusions: The pharmacist role is evolving; however, several challenges remain in fully realising the potential of pharmacists. These include regulatory barriers, limited public awareness of pharmacists' expanded roles, workforce capacity issues, and the need for ongoing professional development and training. Research studies are needed in the areas of generic prescribing, medicine adherence, intervention studies in community and hospital pharmacy practice, and on pharmacoeconomics and pharmacovigilance.

Background: Over the past decade, Canada has witnessed a shift of several drugs from prescription-only to behind-the-counter (BTC) and over-the-counter (OTC) status. This work examined community pharmacists' agreement with the current scheduling of agents used in the management of allergic rhinitis, heartburn, and vulvovaginitis.

Methods: From September to October 2022, an online survey was administered to pharmacists practicing in in Ontario and Québec. The survey aimed to gather insights into their preferred scheduling for 15 medicines commonly used to manage the three selected conditions. Pharmacists were asked whether they agreed with the current scheduling status of each and, if not, how they feel it should be scheduled.

Results: 715 pharmacists completed the survey, 462 from Ontario and 253 from Québec. Most were staff pharmacists working 30 or more hours per week, having been a pharmacist for 1-10 years. Ontario pharmacists expressed a preference for scheduling change for five drugs (four prescription [terconazole for intravaginal use, famotidine, rupatadine, mometasone nasal spray] and one unscheduled [ranitidine 75 mg]), while Québec pharmacists expressed preference for scheduling change for three prescription drugs (terconazole for intravaginal use, famotidine, rupatadine).

Discussion: As pharmacy practice continues to evolve, pharmacists' comfort with initiating previously prescription-only therapy independently or assisting patients with self-selection may similarly evolve. Of the five drugs identified as having a discrepancy between current status and pharmacist preference, four are prescription and may be candidates to consider for prescription to OTC switch.

Conclusion: Pharmacists in Ontario and Québec have expressed preference for most products used in the treatment of allergic rhinitis, heartburn, and vulvovaginitis to be categorised as Schedule II (BTC) or Schedule III (OTC) available only in pharmacies.

Introduction: Hypertension significantly impacts the global cardiovascular disease burden, presenting a pronounced challenge within Latin America and the Caribbean. The Pan American Health Organization's (PAHO) HEARTS initiative endeavours to meet this challenge by enhancing comprehensive cardiovascular risk management, inclusive of improved access to antihypertensive medications. This study scrutinises the challenges and barriers in accessing these medications, which are crucial for effective hypertension management in these regions.

Methods: The research employed a two-phase approach: an initial analysis of National Essential Medicines Lists (NEMLs) from 22 countries involved in the HEARTS initiative for the presence of antihypertensive medications, followed by an in-depth pharmaceutical market analysis in six selected countries to evaluate the availability, pricing, and procurement practices of these medications.

Results: The study revealed notable inconsistencies in the inclusion of recommended antihypertensive medications across NEMLs, particularly the lack of fixed-dose combinations (FDCs). The market analysis brought to light significant limitations in medicine registration and substantial variations in pricing, which adversely impact the accessibility and affordability of essential antihypertensive treatments. Furthermore, an examination of procurement practices identified considerable diversity across countries, highlighting potential areas for optimisation, including the use of the PAHO Strategic Fund.

Conclusions: The barriers to accessing essential antihypertensive medications in Latin America and the Caribbean are multifaceted, stemming from outmoded NEMLs, limited market availability of advised medications, and disparate procurement processes. Leveraging pooled procurement mechanisms such as the PAHO Strategic Fund, coupled with vital updates to NEMLs, stands to markedly improve both the accessibility and affordability of these treatments.

Introduction: Vitamin D deficiency is a serious health problem that is associated with many health consequences. The study aimed to assess the knowledge, attitudes, and practices of medical students at Qassim University, Saudi Arabia, regarding vitamin D deficiency.

Methods: An observational cross-sectional study was conducted among students of Unaizah Colleges of Pharmacy (UCP) and Medicine (UCM) at Qassim University, Saudi Arabia, over a period of 3 months. A well-structured self-administered questionnaire was used for the data collection. Statistical analysis was applied by using SPSS version 22. A 0/1 scoring process was employed to assess the KAP of the participants. The midpoint is considered the cutoff point.

Results: A total of 337 complete responses were received. The majority of participants (62.3%) were female. 291 (86.3%) were considered to have good knowledge, with a mean score of 6.326 out of 9. Moreover, 220 (65.2%) of participants had positive attitudes, with a mean score of 4.077 out of 7. Unfortunately, only 9 (2.6%) participants demonstrated satisfactory practices, with a mean score a 0.911 out of 6. Female participants were significantly better than male participants in terms of knowledge and attitudes, but worse in terms of practices. Sun exposure during safe daytime hours is considered the main cause of vitamin D deficiency. Nearly 60% confirmed that KSA indoor activities and the COVID-19 lockdown might maximise vitamin D deficiency.

Conclusion: The study reveals a gap in vitamin D knowledge among participants influenced by gender and study year. It suggests educational initiatives for male students to enhance their knowledge regarding vitamin D, while female students are encouraged to prioritise safe sun exposure, minimising the use of umbrellas and sunscreen. It also highlights the role of educational institutions as reliable sources of information and the influence of the COVID-19 pandemic on participants' attitudes and practices towards vitamin D.

Introduction: Although psychoactive medicines (PMed) are needed in several psychiatric conditions, their use and misuse bear risks. We aimed at estimating the prevalence of PMed use and misuse.

Methods: Data on all PMed prescribed in 2017 and dispensed in community pharmacies of the Lisbon and Tagus Valley region of Portugal (ARSLVT) were extracted from ARSLVT medicines' dispensing database. For 21 PMed among prescription opioids, benzodiazepines and z-drugs (BZDR), antidepressants (AD) and anticonvulsants (AC), we estimated the number of users of each PMed, and assessed PMed misuse by a set of proxy indicators for studying this practice: chronic use (use of ≥180 DDD during the study period) of PMed intended for short-term treatments, concomitant use of several PMed, in particular if involving long-term (≥ 30 days) opioid analgesic (OA) use, and doctor shopping (patients consulting several physicians in order to have access to a quantity higher than intended by each prescriber). Data were analysed using descriptive statistics and hypothesis testing, and multivariate logistic regression was used to explore potential factors affecting long-term concomitant treatment of chronic OA with other PMed.

Results: PMed use prevalence was 21.7%: 6.6% for OA, 12.7% for benzodiazepines (BZD), 5.3% for AD and 2.8% for AC. BZDR were mainly prescribed in primary care and OA in hospital outpatients. Chronic use of PMed was observed in 25%, especially with sertraline and buprenorphine for opioid use disorder (long-term treatment), and lorazepam (short-term treatment). About 56.6% of OA chronic users were long-term concurrent users with other PMed, mainly BZDR. Risk of abuse was low for BZDR, whilst four opioids had meaningful doctor shopping indicators - fentanyl, opioid use disorder buprenorphine, morphine and hydromorphone.

Conclusions: BZD are the main PMed used in ARSLVT, often chronically, especially lorazepam. Prevalence of OA use is low, although with higher risk of misuse than BZDR. Concomitant use of several PMed is frequent.

Introduction: The patient satisfaction questionnaires in literature are according to the community pharmacies services in the authors' countries and not all have psychometric reports to support the results. We designed a questionnaire specific to the services of community pharmacies in Romania to evaluate the level of patient satisfaction.

Methods: We carried out a cross-sectional study on voluntary patients. The questionnaire consisted of 22 items, grouped into three domains corresponding to patient satisfaction with pharmacies, pharmaceutical staff and medication availability, and four subdomains related to pharmaceutical staff skills. The 5-point Likert scale was used. Statistical analysis was done in SPSS 27.0.

Results: The Cronbach's Alpha was 0.861. The Inter-rater Agreement was 72.0%, the Item Content Validity was 97.6% and the completeness index was 100%. The factor analysis indicated 6 factors (Eigen values >1.0). The 809 patients had a median of overall satisfaction score of 3.77; the median was 4.0 regarding satisfaction score with pharmaceutical staff skills. Respondents characteristics varied the patient's satisfaction level (p ≤ 0.05).

Conclusions: The reliability and validity of the questionnaire have been demonstrated. Overall patient satisfaction with community pharmacy services had a moderate level, but the attitude and confidence in the pharmacist had a high level of satisfaction.

Introduction: Heart failure (HF) is a chronic condition associated with substantial mortality and hospitalisation, resulting in costly inpatient visits. The healthcare systems of several countries, including Vietnam, experience considerable difficulty in dealing with the enormous fiscal burden presented by HF. This study aims to analyse the direct medical costs associated with HF inpatient treatment from the hospital perspective.

Materials and methods: This study retrospectively analysed the electronic medical records of patients diagnosed with HF from 2018 to 2021 at Military Hospital 175 in Vietnam. The sample consisted of 906 hospitalised patients (mean age: 71.2 ± 14.1 years). The financial impact of HF was assessed by examining the direct medical expenses incurred by the healthcare system, and the costs of pharmaceutical categories used in treatment were explored.

Results: The cumulative economic burden of HF from 2018 to 2021 was US$1,068,870, with annual costs ranging from US$201,670 to US$443,831. Health insurance covered 72.7% of these costs. Medications and infusions, and medical supplies accounted for the largest expenses, at 29.8% and 22.1%, respectively. The medication HF group accounted for 13.01% of these expenses, of which the costliest medications included nitrates (2.57%), angiotensin II receptor blockers (0.51%), ivabradine (0.39%), diuretics (0.24%), and mineralocorticoid receptor antagonists (0.23%). Comorbidities and the length of hospital stay significantly influenced annual treatment costs.

Conclusion: The study reveals that HF significantly impacts Vietnam's healthcare system and citizens, requiring a comprehensive understanding of its financial implications and efficient management of medical resources for those diagnosed. This study highlights the substantial economic burden of HF on Vietnam's healthcare system, with medication costs, particularly antithrombotic drugs, representing the largest expense. Most healthcare costs were covered by health insurance, and expenses were significantly influenced by comorbidity and length of hospital stay. These findings can inform healthcare policy, resource allocation and optimise management strategies in Vietnam.