UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.

Objectives: Cancer diagnosis is increasing day by day all over the world. Deaths due to cancer are among the most common causes of death. Access to cancer drugs is a priority of health policies. The aim of this study is to evaluate access to cancer drugs through drug box sales data by modeling population growth, cancer incidence, and Fixed Euro Exchange (FEE) rate parameters used in drug pricing in Türkiye. Methods: Access to cancer drugs was evaluated by drug box sales figures obtained from IQVIA. Box sales data were classified according to diagnosis codes (ICD-10), reference, or generic status. Consumption of cancer drugs was examined over time with panel regression analysis, taking into account variables of population growth, cancer incidence, and the FEE rate in drug pricing in Türkiye. Results: The incidence of cancer in Türkiye was 215.1 in 2010 and 223.1 (per hundred thousand) in 2017. Whereas there was a 127.02% increase in the real euro exchange rate, there was an 89.6% increase in the FEE rate. With the regression approach, there is a negative relationship between the real and fixed exchange rate difference (RFED) and reference and generic drug consumption data. Medicine access is affected depending on diagnosis codes at different levels. Colorectal cancer medicine sales had negative correlations for each variable, namely, exchange rate, population growth, and cancer incidence. On the contrary, there was a positive correlation between non-small-cell lung cancer and relevant variables. Innovative medicine groups such as monoclonal antibodies and protein kinase inhibitor consumption showed a negative correlation. Conclusion: According to our results, pricing strategy may be an access barrier for oncology medicines in Türkiye. It should be reviewing the pricing policy that is beneficial for oncology medicine access in Türkiye.

UNASSIGNED: Community pharmacies provide access to medicines and pharmaceutical services. Consequently, adequate availability and sufficient workforce capacity must be ensured for effective healthcare delivery. This study assessed the community pharmacy sector in Saudi Arabia, including density, workforce capacity, and evolution from 2007 to 2022.
UNASSIGNED: This retrospective study measured community pharmacy infrastructure and workforce capacity using international indicators and standardized measures, including community pharmacy and community pharmacist density per 10,000 people and ratio of community pharmacists per pharmacy. Several data sources and platforms were used to collect the data including the Ministry of Health, Saudi General Authority for Statistics, and Ministry of Human Resources and Social Development.
UNASSIGNED: The number of community pharmacies increased by 89.30%, from 5466 in 2007 to 10,347 in 2022, and density increased from 2.25 to 3.22. However, density varied by region, from 3.97 to 1.95. The number of community pharmacists increased by 98.02%, from 10,932 in 2007 to 21,648 in 2022, and community pharmacist density increased from 4.51 to 6.73. However, the ratio of community pharmacists per pharmacy remained unchanged (2.0 in 2007 and 2.1 in 2022). Female pharmacists were first issued licenses to practice in community pharmacies in 2016, and the proportion of female pharmacists to total increased from 0.29% (n=42) in 2016 to 10.95% (n=2370) in 2022. The nationalization policy for community pharmacies was implemented in 2020, and the proportion of Saudi pharmacists increased from 3.08% (n=581) in 2019 to 19.90% (n=4306) in 2022, while proportion of expatriate pharmacists decreased from 96.92% (n=18,292) to 80.10% (n=17,342).
UNASSIGNED: The findings showed that the community pharmacy sector in Saudi Arabia recently experienced substantial growth comparable to high-income countries. However, further improvements are required in some regions to increase community pharmacy density. Moreover, the ratio of pharmacists per pharmacy should be improved to meet the healthcare system needs.

BACKGROUND: This study aimed to assess the general public\'s perception of services provided by community pharmacies, their willingness to utilize these services, their satisfaction with and understanding of community pharmacists, and their views on dispensing separation and pharmacy medicines (P medicines).
METHODS: An online cross-sectional study was conducted, in which questionnaires were distributed among the general public. A novel questionnaire was designed and validated specifically for this study. It was composed of six sections: demographics, pharmacy usage and service preferences, understanding and satisfaction with pharmacists, views on dispensing separation, private community pharmacies, and knowledge of P medicines. Statistical analyses such as one-way ANOVA, independent t test, and binary logistic regression were employed, with a p value of < 0.05 considered statistically significant.
RESULTS: The study received 222 responses. The majority of the respondents were females within the 20-29-year-old age group (62.2%). Most respondents preferred to consult doctors for medical treatment, with their primary reason for visiting community pharmacies being to collect prescribed medicines. About 52.7% of respondents expressed their willingness to avail of screening services and treatment for minor illnesses at community pharmacies. A statistically significant difference was found among different age groups regarding their views on the dispensing separation system, with those aged 41-50 years demonstrating higher scores. However, the binary logistic regression analysis did not reveal any statistical significance when comparing the understanding of P medicines among respondents.
CONCLUSIONS: In general, the public prefers to consult doctors for medical treatment and visit community pharmacies predominantly to collect prescriptions or purchase over-the-counter medications. Nonetheless, they are also open to utilizing services provided by community pharmacists, particularly screening services and treatment for minor illnesses.

In health care, innovation is a core part of the process that pushes advances forward. Drug and device development follow a step-by-step process from the discovery of a molecule to the final product. While patent filing and preclinical studies are usually performed by academic centers or start-ups, the clinical development is usually performed by pharmaceutical companies. To assess safety, efficacy and fulfil regulatory demands, clinical trials must be performed in sequential Phase I, II, and III stages prior to market access. In this context, clinical research centers have been established around the globe, also outside traditional academic centers, aiming to increase the access for patients to participate in clinical trials and the capacity for clinical development. The increasing number of clinical trial sites across the world, gives pharmaceutical companies, investigators and developers an improved access to properly test the exponentially increasing number of potential medicinal products and treatment approaches in trials in different parts of the world. Historically, Low- and Middle-Income Countries (LMIC) did not significantly take part in clinical trial development. As participation in all steps of clinical research provides earlier access to novel treatment options in LMIC along with creating data on efficacy and toxicity within more diverse populations, it is warranted to improve clinical trial access in LMIC. With the goal to provide input on how to tackle the challenges during the built of a clinical research center, we here describe the experience from setting up a clinical trial unit within a private hospital network in Brasília, Brazil, a Middle-Income country, to provide inspiration, \"how to\" knowledge and a recipe for those with a similar road ahead in LMIC.

OBJECTIVE: Spanish Lung Cancer Group (SLCG) conducted a review to analyze the barriers to access to innovative targeted therapies for non-small cell lung cancer (NSCLC) in clinical practice in Spain.
METHODS: Review all relevant content published on websites of European Commission, European Medicines Agency, and Spanish Agency of Medicines and Medical Products regarding the authorization and access to oncology treatments.
RESULTS: More than 20 targeted therapies are available to treat different molecular alterations in patients with NSCLC. European Commission has approved treatments for genomic alterations involving the following genes: ALK, RET, ROS1, EGFR, BRAF, NTRK, KRAS, MET. However, the availability of these therapies in Spain is not complete, as innovative treatments are not reimbursed or funded late, with only five of these alterations currently covered by National Health System.
CONCLUSIONS: SLCG considers imperative to improve the access in Spain to innovative treatments for NSCLC to reduce inequity across European countries.

BACKGROUND: Pharmacy medicine (P) is obtained exclusively from a pharmacy under the supervision of a pharmacist. This study aims to understand the perception of healthcare professionals towards the dispensing separation, as well as the dispensing of pharmacy medicine by community pharmacies to enhance patient health outcomes in Brunei Darussalam.
METHODS: A cross-sectional study was conducted between 1st March 2023 and 20th April 2023 among healthcare professionals. A newly designed and validated questionnaire was used. Its face and content validity, along with internal consistency, was adequately established. Convenient sampling was employed to recruit participants for the study. Statistical analysis using one-way ANOVA was performed, considering a p-value < 0.05 as statistically significant.
RESULTS: The study compiled data from 108 participants, comprising doctors (38.9%) and pharmacy technicians (45.4%). Approximately 28.7% of respondents had 11-20 years of healthcare experience, while 25.9% had less than 5 years. Nearly all respondents (98.1%) agreed on the vital role pharmacists and pharmacy technicians play in prescription checks. A significant number of participants (93.5%) agreed that Brunei\'s current medicine dispensing system needs improvement. The mean total score for the perception of medicine dispensing in Brunei was 3.79 ± 1.103. A statistically significant difference was found between the perception score and the respondents\' profession (p = 0.018), but not with their age, experience, or place of work. Respondents\' awareness score showed no statistically significant correlation with their profession, age, experience, or place of work.
CONCLUSIONS: The study underscores the necessity for more patient-centered care in community pharmacies in Brunei Darussalam. The country\'s healthcare professionals should recognize the potential advantages of expanding pharmacy services. However, to implement these services successfully, regulatory restrictions and infrastructure limitations must be addressed.

The WHO Model List of Essential Medicines for Children (EMLc) has not been systematically revised in the last few years. We conducted a survey addressed to healthcare professionals prescribing, preparing, or administering medicines to children and a narrative review to identify problematic paediatric formulations or missing medicines in all therapeutic fields to inform the review of the EMLc in 2023. A total of 285 physicians (63%), 28 nurses (6%) and 142 pharmacists (31%), mostly working in the hospital setting, reported at least one problematic medicine. 290 medicines were reported as missing (completely or the child-appropriate formulation). The top three most mentioned were ciprofloxacin together with phenobarbital and omeprazole. 387 medicines were reported as problematic (34% were oral liquid formulations, 34% tablets, 18% parenteral preparations. Mostly of the products were antibacterials (27%), cardiovascular medicines (11%) and antivirals (11%). The obtained responses show the perspective of healthcare workers working around the world, particularly in the European region (25%), in the African region (24%), and in the Region of the Americas (19%), with limited representation from Northern Africa and the Middle East. Our results need to be analysed with the outputs of other ongoing works before specific products can enter the WHO-hosted Global Accelerator for Paediatric formulations network prioritisation process. Efforts to develop appropriate formulations for children should be accelerated so that the uncertainties associated with off-label drug preparation and use are minimised, and therapeutic benefits are optimised.

UNASSIGNED: Pharmacists\' knowledge of the differences in the characteristics between generic drugs and biosimilars is essential to ensure good practice and lower pharmaceutical bills.
UNASSIGNED: This study aimed to evaluate community pharmacists\' knowledge and perception of using and substituting biosimilars and generic drugs.
UNASSIGNED: A pilot cross-sectional study was performed over 2 months (August-September 2022) targeting community pharmacists in their work site.
UNASSIGNED: Data were collected using a uniform survey given to 75 pharmacists. Afterward, a knowledge score was generated by summing several individual scores of statements regarding generic drugs and biosimilars.
UNASSIGNED: Overall, pharmacists had moderate to low knowledge scores, namely, with the statements tackling biosimilars. No significance was reported between these scores and their general characteristics. As regards their substitution, most pharmacists agreed to substitute generic drugs if the brand was not available, while the doctor\'s approval was crucial for biosimilar switching. Most participants perceived equal effectiveness of generic drugs but similar to a lower one for biosimilars compared to the reference medication. Pharmacists highlighted the need to include generic drugs and biosimilars in the continuing education program and workshops.
UNASSIGNED: To promote their use, improving pharmacists\' knowledge can help overcome misconceptions about generic drugs and biosimilars. It is recommended that health care stakeholders focus on fostering good understanding among pharmacists to enhance access to medication.

The Organization for Professionals in Regulatory Affairs (TOPRA) celebrated its 2022 Annual Symposium, which took place in Vienna, Austria, from October 17 to 19, 2022, to discuss most relevant current issues and debate the future of healthcare regulatory affairs for medicinal products, medical devices/in vitro diagnostics (IVDs) and veterinary medicines.