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Objectives: Competencies refer to the knowledge, skills, attitudes, and behaviors individuals develop through education, training, and experience. These competencies can be formulated into a framework to support practitioner development for effective and sustained performance. In the absence of a national framework for pharmacy education and practice in Lebanon, the Order of Pharmacists of Lebanon (OPL, the official association of pharmacists in Lebanon) pioneered the development of a pharmacy competency framework in 2017. This study aimed to validate and assess the specialized competency framework for pharmacists in sales and marketing (SCF-PSM) after updating the framework previously published by the OPL. The secondary objective was to assess, in a pilot survey, the personal characteristics associated with these competencies., Methods: After validating the content of the specialized competency framework, a survey involving Lebanese pharmacists was performed through a 15-min online questionnaire distributed over social media platforms, groups of pharmacists, and individual pharmacists' contact numbers., Key Findings: Pharmaceutical knowledge, communication, emergency response, and operation management during emergencies were satisfactory (more than 80/100). Other activities during emergencies, such as patient care and population health interventions and evaluation, research, and dissemination of research outcomes, received a moderate score (75-78/100), similar to legal practice (78/100), teamwork (76/100), and management skills (75/100). The lowest reported confidence was related to professional communication skills (other than communication per se), mainly negotiation, data processing skills, information technology, self-management, and ethical practice (< 75/100). This study reported deficiencies between what is acquired during undergraduate, postgraduate, and continuing education on the one hand and the competency framework suggested by the OPL on the other hand, showing a mismatch between the competencies of working pharmacists acquired during education and the market needs., Conclusions: This study validated a competency framework for pharmacists in sales and marketing and explored the current gaps in self-reported competencies. It also identified areas necessitating reinforcement to optimize professional practice and underscored the need for improvement in undergraduate, postgraduate, and continuing professional education., (© 2023. The Author(s).)

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., Competing Interests: No potential conflict of interest was reported by the author(s)., (© 2024 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.)

Background: Withdrawals of drug indications may reveal potential inadequacies in the regulatory approval processes of new drugs. Understanding potential weaknesses of the regulatory approval process is paramount given the increasing use of expedited pathways. In this paper, we focus on three poly-ADP-ribose polymerase inhibitors (olaparib, rucaparib and niraparib) for the treatment of women with heavily pretreated, recurrent ovarian cancer, which were eventually withdrawn., Methods: We use a comparative case study approach to evaluate the regulatory histories of these drug indications in the US and Europe., Results: Two drug indications benefited from the FDA's accelerated approval pathway, which explicitly lowers the bar for evidence of efficacy at the time of approval. Following accelerated approval, manufacturers are mandated to conduct post-marketing studies to confirm clinical benefit. The FDA granted accelerated approval to olaparib and rucaparib based on data on surrogate endpoints and converted the approval to regular approval after the submission of additional data on surrogate endpoints from one of two required confirmatory trials, that is, without data on clinical benefit. Niraparib directly received regular approval based only on data on a surrogate endpoint. By contrast, the EMA granted conditional marketing authorisation to rucaparib and was quicker to restrict usage than the FDA., Conclusion: The regulatory histories of these drug indications highlight the need to reform the accelerated approval pathway by ensuring that post-marketing requirements are followed, and that regular approval is only based on evidence of clinical benefit., Competing Interests: No potential conflict of interest was reported by the author(s)., (© 2024 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.)

Objectives: The objectives of this paper are to (a) explore stakeholders' opinions regarding Nepal's existing medicines pricing practices/situation and (b) build and present a set of medicines pricing policies for Nepal., Methods: A review of the literature and field visits to community retail pharmacies, hospital pharmacies, wholesalers, and distributor outlets in Kathmandu were conducted to assess the medicines pricing situation. Following the literature review, preliminary meetings with stakeholders and field visits were held and a draft interview guide was prepared. Consultative sessions subsequently were undertaken in Kathmandu, Nepal, in January 2023 with representatives from the Department of Drug Administration, Ministry of Health and Population, Association of Pharmaceutical Producers of Nepal, consumer groups, Transparency International, Medicines Importers Association of Nepal/ Pharmaceutical Distributors Association of Nepal, Nepal Chemist and Druggist Association, and Nepal Pharmaceutical Association. Notes were taken during these meetings regarding issues and concerns raised as well as experiences and recommendations for the future, as outlined in the interview guide., Results: The stakeholders in general stated that they do not have any objection to price regulation; however, they believe such regulation should be subject to periodic review. Both the importers and the Ministry of Health and Population have the view that an independent body/authority should be charged with regulating the prices of medicines. A set of policy options to be considered for use in Nepal include cost-plus pricing, external price referencing, internal reference pricing, and mark-up regulations., Conclusion: Key issues related to pricing were identified and suggest that a set of pricing policies and updated regulations need to be considered to establish changes that are transparent, rational, and acceptable to the related stakeholders. Hence, suggestions made in this paper could be useful to inform a rational and fair pricing structure and to improve access to medicines., Competing Interests: No potential conflict of interest was reported by the author(s)., (© 2024 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.)

Introduction: Diabetes increases preventative sickness and costs healthcare and productivity. Type 2 diabetes and macrovascular disease consequences cause most diabetes-related costs. Type 2 diabetes greatly costs healthcare institutions, reducing economic productivity and efficiency. This cost of illness (COI) analysis examines the direct and indirect costs of treating and managing type 1 and type 2 diabetes mellitus., Methodology: According to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, Cochrane, PubMed, Embase, CINAHL, Scopus, Medline Plus, and CENTRAL were searched for relevant articles on type 1 and type 2 diabetes illness costs. The inquiry returned 873 2011-2023 academic articles. The study included 42 papers after an abstract evaluation of 547 papers., Results: Most articles originated in Asia and Europe, primarily on type 2 diabetes. The annual cost per patient ranged from USD87 to USD9,581. Prevalence-based cost estimates ranged from less than USD470 to more than USD3475, whereas annual pharmaceutical prices ranged from USD40 to more than USD450, with insulin exhibiting the greatest disparity. Care for complications was generally costly, although costs varied significantly by country and problem type., Discussion: This study revealed substantial heterogeneity in diabetes treatment costs; some could be reduced by improving data collection, analysis, and reporting procedures. Diabetes is an expensive disease to treat in low- and middle-income countries, and attaining Universal Health Coverage should be a priority for the global health community., Competing Interests: No potential conflict of interest was reported by the author(s)., (© 2024 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.)

Objective: To estimate the economic impact of the developed antimicrobial stewardship program (ASP) versus the preliminary ASP use, in the adults' general medicine settings in Qatar., Methods: Patient records were retrospectively reviewed during two periods: preliminary ASP was defined as the 12 months following ASP implementation (i.e. May 2015-April 2016), and developed ASP was defined as the last 12 months of a 5-year ASP implementation in Hamad Medical Corporation (HMC) (i.e. February 2019-January 2020). The economic impact was the overall cost savings in resource use, including operational costs, plus the cost avoidance associated with ASP., Results: A total of 500 patients were included in the study. The operational costs decreased with the developed ASP. Whereas antimicrobial consumption and resource utilisation, and their associated costs, appear to have declined with the developed ASP, with a cost saving of QAR458 (US$125) per 100-patient beds, the avoided cost was negative, by QAR4,807 (US$1,317) per 100-patient beds, adding to a total QAR4,224 (US$1,160) increase in the 100-patient beds cost after ASP development., Conclusions: Despite that the developed ASP attained a total cost saving QAR458 (US$125) per 100-patient beds, the avoided cost was QAR-4,807 (US$-1,317) per 100-patient beds, which exceeded the cost savings achieved., Competing Interests: No potential conflict of interest was reported by the authors.The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2024 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.)

Successful Vaccine uptake relies heavily on the effectiveness of vaccination services. Expanding the scope of pharmacists' involvement in vaccination services can significantly improve vaccination coverage. The level of pharmacists' engagement in immunization services varies globally. The aim of this paper is to describe the current role of pharmacists in vaccination services in the Middle Eastern countries. The provision of vaccination services by pharmacists in the region has evolved notably in recent years. The extent of pharmacists' involvement in immunization services varies from one country to another in the region. They play a more active role in the delivery of vaccinations, not only facilitating but also administering vaccines. Future studies on pharmacist-led vaccination services in these countries are necessary to assess the value of the expanded practice of pharmacists in this field, especially due to the scarcity of evidence., (© 2023. The Author(s).)

Background: Public health emergencies raise significant concerns about corruption and accountability; however, these concerns can manifest in different ways across diverse locations. For instance, more developed countries with a stronger rule of law may experience more corruption in vaccine procurement, whereas developing countries may experience more corruption at the point of distribution and delivery to end users. This research focuses on corruption concerns in Nigeria, specifically examining the procurement and distribution of COVID-19 vaccines., Methods: This paper utilizes a scoping review and a qualitative research approach. Key informants (n = 40) involved in the procurement and distribution of COVID-19 vaccines across two states in Nigeria were interviewed. Findings from the scoping review were summarized, and collected data were inductively coded and analysed in themes, revealing clear examples of implementation irregularities and corruption in the country's COVID-19 vaccination processes., Results: Vaccination programme budgeting processes were unclear, and payment irregularities were frequently observed, resulting in vaccinators soliciting informal payments while in the field. Recruitment and engagement of vaccination personnel was opaque, while target vaccination rates incentivized data falsification during periods of vaccine hesitancy. Accountability mechanisms, such as health worker supervision, vaccination data review, and additional technical support provided by donors were implemented but not effective at preventing corruption among frontline workers., Conclusions: Future accountability measures should be evidence-driven based on findings from this research. Personnel recruitment, contracting, budgeting, and remuneration should focus on transparency and accountability., (© 2023. The Author(s).)

Background: In India, states have licensed the manufacture of large numbers of fixed-dose combination (FDC) drugs without the required prior approval of the central regulator. This paper describes two major regulatory initiatives to address the problem, which began in 2007 and 2013, and examines whether they have been sufficient to remove centrally unapproved systemic antibiotic FDCs from the market., Methods: Information was extracted from documents published by the central regulator and the ministry of health, including the National List of Essential Medicines (NLEM), and court judgments, and analysed alongside sales volume data for 2008-2020 using PharmaTrac market dataset., Results: The regulatory initiatives permitted 68 formulations to be given de facto approvals ('No Objection Certificates') outside the statutory regime, banned 46 FDCs and restricted one FDC. Market data show that FDCs as a proportion of total antibiotic sales increased from 32.9 in 2008 to 37.3% in 2020. The total number of antibiotic FDC formulations on the market fell from 574 (2008) to 395 (2020). Formulations with a record of prior central approval increased from 86 (2008) to 94 (2020) and their share of the antibiotic FDC sales increased from 32.0 to 55.3%. In 2020, an additional 23 formulations had been permitted de facto approval, accounting for 10.6% of the antibiotic FDC sales. Even in 2020, most marketed formulations (70.4%, 278/395) were unapproved or banned, and comprised a 15.9% share of the antibiotic FDC sales. The share of NLEM-listed antibiotic FDC sales increased from 21.2 (2008) to 26.7% (2020)., Conclusion: The initiatives had limited impact. Regulatory enforcement has been slow and weak, with many unapproved, and even banned, FDCs remaining on the market., (© 2023. The Author(s).)

Background: Medication-related problems (MRPs) contribute significantly to preventable patient harm and global healthcare expenditure. Vulnerable populations, including Indigenous Australians (please note that the use of the term 'Indigenous' in this paper includes all Aboriginal and Torres Strait Islander people and acknowledges their rich traditions and heterogenous cultures.) and people living with severe and persistent mental illness (SPMI), may be at increased risk of MRPs. Pharmacist-led medication reviews can identify MRPs for targeted action., Objective: To characterize MRPs identified and recommendations made by community pharmacists during medication reviews conducted with Indigenous Australians and people living with SPMI., Methods: Participants were recruited through two Australian trials testing the feasibility and/or effectiveness of novel community pharmacist-led interventions, the Indigenous Medication Review Service (IMeRSe) feasibility study (June 2018-July 2019) and Bridging the Gap between Physical and Mental Illness in Community Pharmacy (PharMIbridge) randomized controlled trial (September 2020-December 2021). Trained community pharmacists conducted medication reviews responsive to the cultural and health needs of participants. MRPs, MRP severity and pharmacist recommendations were documented and classified using an established classification system (DOCUMENT). MRP severity was assessed by pharmacists and an independent assessor. Data were analysed descriptively, and paired t-tests were used to compare severity ratings., Results: Pharmacists identified 795 MRPs with 411 participants across both trials (n = 255 IMeRSe, n = 156 PharMIbridge). Non-adherence to medication was the most common (n = 157, 25.1%) and second-most common (n = 25, 14.7%) MRP in IMeRSe and PharMIbridge, respectively. Undertreatment was the second-most common MRP in the sample of Indigenous Australians (n = 139, 22.2%), and reports of toxicity/adverse reactions were most common in people living with SPMI (n = 41, 24.1%). A change in pharmacotherapy was the most frequent recommendation made by pharmacists (40.2% and 55.0% in IMeRSe and PharMIbridge, respectively). Severity ratings varied, with the majority being 'Mild' or 'Moderate' in both groups. Significant differences were found in the severity rating assigned by trial pharmacists and the independent assessor., Conclusions: Community pharmacists identified a range of MRPs experienced by two at-risk populations, most commonly non-adherence and toxicity or adverse reactions, when conducting medication reviews and proposed diverse strategies to manage these, frequently recommending a change in pharmacotherapy. These findings highlight the opportunity for more targeted approaches to identifying and managing MRPs in primary care and tailored community pharmacist-led interventions may be of value in this space., Trail Registration: Australian and New Zealand Clinical Trial Registry records (IMeRSe ACTRN12618000188235 registered 06/02/2018 & PharMIbridge ACTRN12620000577910 registered 18/05/2020)., (© 2023. The Author(s).)

Background: MyDispense is a free online virtual simulation software developed by Monash University. The software facilitates students to practise, apply and hone the skills of a pharmacist in a realistic environment without the potentially life-threatening consequences of a real-life error. Although the focus of MyDispense was initially on exposure to community pharmacy practice scenarios, its modular build and customizability, indicate that there are a wide range of applications that could be incorporated into pharmacy education. Therefore, this study reviews and appraises the literature on the use of MyDispense within pharmacy education., Methods: A scoping review was conducted. The electronic databases (CINAHL, Ovid Embase, Ovid Medline, Google Scholar, and Scopus) were searched to identify scholarly articles related to MyDispense in pharmacy education from January 2011 and August 2022., Results: Forty-three papers met the inclusion criteria and were analysed in this scoping review. A total of 418 key sentences and segments of text were extracted from the papers and subsequently categorized into 10 subthemes. The 10 subthemes were dispensing skills, communication skills, decision-making/problem-solving skills, student performance, pharmacy law, applying theoretical knowledge, support educators, pharmacy practice, feedback/reflection and practice in a risk-free environment. In total, four overarching themes summarize how MyDispense is supporting pharmacy education: supporting education; skill development; application of knowledge and student outcomes., Conclusion: The scoping review found that MyDispense was mostly used to support education and student skill development. These findings can be used to support pharmacy educators globally on the various uses and applications of MyDispense in their teaching., (© 2023. Dr. Zaheer-Ud-Din Babar and Auckland UniServices Ltd.)

Introduction: Buyers of medicines and vaccines are increasingly interested in pooling their procurement to improve access to affordable and quality-assured health commodities. However, the academic literature has provided no detailed description of how pooled procurement mechanisms are set up and develop over time. These insights are valuable as it increases our understanding of implementing and operating pooled procurement mechanisms successfully. Therefore, the aim of this paper is twofold. First, to explore how such mechanisms evolve over time. Second, to clarify the work that is needed to set up and sustain a pooled procurement mechanism. These findings have been translated into our Pooled Procurement Guidance document., Methods: This qualitative study draws upon theoretical insights from organizational life cycles, collaborative and network governance, semi-structured interviews with procurement experts and academic and grey literature documents on pooled procurement of medicines and vaccines., Results: We identified four general developmental stages of pooled procurement mechanisms: promise, creation, early operational and mature. The promise stage is characterized by initiating engagement between participating actors, while they try to convert their perceived problem(s) or opportunities into a shared vision. The creation stage is where the participating actors formalize and design the mechanism through consensus-building, articulation of a shared plan, and mobilize resources to put the shared plan into action. The early operational stage is where the shared plan is being executed. The newly established or appointed procurement organization is required to learn fast from experience while showing flexibility to the changing needs of buyers and suppliers. Once operations are routinized, the mechanism enters the mature stage. During this stage, the pooled procurement organization develops into a trusted player that provides sufficient incentives for all actors involved. Importantly, pooled procurement mechanisms can stagnate or turn inactive at any time during the developmental process when alignment between actors is threatened., Conclusions: Pooled procurement mechanisms evolve over time. Setting up such mechanisms is a collaborative process that relies on intentional efforts by key actors involved. To increase the lifespan of pooled procurement mechanisms, key actors need to sustain a relative alignment of goals, needs, motivations and purpose of the mechanism throughout its entire life cycle., (© 2023. The Author(s).)

Background: A series of Community Pharmacy Agreements (Agreements) between the Federal government and a pharmacy-owners' body, the Pharmacy Guild of Australia (PGA) have been influential policy in Australian community pharmacy (CP) since 1990. While ostensibly to support the public's access and use of medicines, the core elements of the Agreements have been remuneration for dispensing and rules that limit the establishment of new pharmacies. Criticism has focused on the self-interest of pharmacy owners, the exclusion of other pharmacy stakeholders from the Agreement negotiations, the lack of transparency, and the impact on competition. The objective of this paper is to determine the true nature of the policy by examining the evolution of the CPA from a policy theory perspective., Methods: A qualitative evaluation of all seven Agreement documents and their impact was undertaken using policy theories including a linear policy development model, Multiple Streams Framework, Incremental Theory, the Advocacy Coalition Framework, the Theory of Economic Regulation, the Punctuated Equilibrium Framework, and Elite Theory. The Agreements were evaluated using four lenses: their objectives, evidentiary base, stakeholders and beneficiaries., Results: The PGA has acted as an elite organisation with long-standing influence on the policy's development and implementation. Notable has been the failure of other pharmacy stakeholders to establish broad-based advocacy coalitions in order to influence the Agreements. The incremental changes negotiated every 5 years to the core elements of the Agreements have supported the publics' access to medication, provided stability for the government, and security for existing pharmacy owners. Their impact on the evolution of pharmacists' scope of practice and through that, on the public's safe and appropriate use of medication, has been less clear., Conclusions: The Agreements can be characterised predominantly as industry policy benefiting pharmacy owners, rather than health policy. An emerging issue is whether incremental change will continue to be an adequate policy response to the social, political, and technological changes that are affecting health care, or whether policy disruption is likely to arise., (© 2023. The Author(s).)

Early access programs (EAPs) generally refer to patient access to medicines/indications before marketing authorization, possibly extended to price and reimbursement approval. These programs include compassionate use, which is usually covered by pharmaceutical companies, and EAPs reimbursed by third-party payers. This paper aims at comparing EAPs in four European countries (France, Italy, Spain, UK) and providing empirical evidence on EAPs in Italy. The comparative analysis was conducted through a literature review (including scientific and grey literature), complemented by 30-min semi-structured interviews with local experts. The Italian empirical analysis employed data available on the National Medicines Agency website. Although EAPs are very different across countries, they exhibit some common features: (i) eligibility criteria refer to the absence of valid therapeutic alternatives and a presumed favourable risk-benefit profile; (ii) payers do not allocate a pre-determined budget to these programs; (iii) total spending on EAPs is unknown. The French EAPs seem to be the most structured, financed through social insurance, covering pre-marketing, post-marketing and pre-reimbursement phases and providing for data collection. Italy's approach to EAPs has been varied, with several programs covered by different payers, including the cohort-based 648 List (for both early access and off-label use), the nominal-based 5% Fund, and Compassionate Use. Most applications to EAPs are from the Antineoplastic and immunomodulating drug class (ATC L). Some 62% of indications in the 648 List are either not under clinical development or have never been approved (pure off-label use). For those subsequently approved, most approved indications coincide with those covered through EAPs. Only the 5% Fund provides data on economic impact (€ 81.2 million in 2021; average cost per patient € 61.5K). Diverse EAPs are a possible source of inequalities in access to medicines across Europe. A harmonization of these programs, though difficult to achieve, could be modelled on the French EAPs and provide key advantages, not least of which a common effort to collect real-world data in parallel with clinical trials and clear separation between EAPs and off-label use programs., (© 2023. The Author(s).)

Background: Universal health coverage has gained significant momentum internationally as the policy solution to address healthcare system deficiencies and promote equitable distribution of quality healthcare. The South African government has adopted this option and developed policy papers for discussion on a National Health Insurance (NHI) system for South Africa. A large part of the policy has been focused on promoting functionality of the primary healthcare system (PHC); to promote an efficient referral pathway. This study sought to explore potential barriers perceived by policy developers that could hinder achieving the NHI goal. Furthermore, given that a large focus is centred on PHC re-engineering, it was imperative to understand participant's opinions and perspectives on the role of a pharmacist at this level., Methods: A qualitative research design was adopted in this study. Semi-structured interviews were conducted with ten policy developers that were selected via a referral technique. These were audio recorded using a digital voice recorder on an online platform, transcribed verbatim and saved on Microsoft Word ® documents. NVivo ® , was utilized to facilitate the analysis of data. A thematic analytical approach was used to categorize codes into themes., Results: The findings revealed that participants were in agreement that healthcare system reform is crucial in promoting equitable distribution of healthcare services in South Africa. However, the reality of this is dependent on addressing key concerns perceived by participants that have been reported as three major themes: (1) the benefit of NHI implementation; (2) concerns about NHI implementation; (3) implications for pharmacy., Conclusions: South Africa is in the second phase of NHI implementation. This phase is focused on the development of sound NHI legislation and structures. This study identified a number of concerns regarding legislative anomalies and role-player involvement that could compromise the efficient implementation of NHI., (© 2023. The Author(s).)

Background: Insurances in high-income countries (HIC) often contract with private community pharmacies to dispense medicines to outpatients. In contrast, dispensing of medicines in low- and middle-income countries (LMICs) often lacks such contractual arrangements. Furthermore, many LMICs lack sufficient investment in supply chains and financial and human resources to guarantee stock levels and services at public medicine-dispensing institutions. Countries striving to achieve universal health coverage (UHC) can, in principle, incorporate retail pharmacies into their supply chains to expand access to essential medicines (EMs). The objectives of this paper are (a) to identify and analyze key considerations, opportunities and challenges for public payers when contracting out the supply and dispensing of medicines to retail pharmacies and (b) to provide examples of strategies and policies to address these challenges., Methods: A targeted literature strategy was used to conduct this scoping review. We created an analytical framework of key dimensions: (1) governance (including medicine and pharmacy regulation); (2) contracting (3) reimbursement; (4) medicine affordability (5) equitable access; and (6) quality of care (including 'patient-centered' pharmaceutical care). Using this framework, we selected a mix of three HIC and four LMIC case studies and analyzed the opportunities and challenges encountered when contracting retail pharmacies., Results: From this analysis, we identified a set of opportunities and challenges that should be considered by public payers considering public-private contracting: (1) balancing business viability with medicine affordability; (2) incentivizing equitable access to medicines; (3) ensuring quality of care and delivery of services; (4) ensuring product quality; (5) task-sharing from primary care providers to pharmacies and (6) securing human resources and related capacity constraints to ensure sustainability of the contract., Conclusion: Public-private partnerships offer opportunities to improve access to EMs. Nonetheless, managing these agreements is complex and is influenced by a variety of factors. For effective contractual partnerships, a systems approach is needed in which business, industry and regulatory contexts are considered in tandem with the health system. Special attention should be devoted to rapidly changing health contexts and systems, such as changes in patient preferences and market developments brought about by the COVID-19 pandemic., (© 2023. The Author(s).)

Background: Inappropriate prescription of antibiotics is a global public health challenge. Widespread use, misuse, or inappropriate prescribing has resulted in unnecessary expenditure on drugs, raised risk of adverse reactions, the development of antimicrobial resistance, and increment in health care costs. There is a limited practice in rational prescribing of antibiotics in the management of Urinary tract infection (UTI) in Ethiopia., Objective: To assess antibiotic prescribing practice in the treatment of patients with UTI at outpatient department (OPD), Dilchora referral hospital, Eastern Ethiopia., Methods: A retrospective cross-sectional study was conducted from January 7 to March 14, 2021. Data were collected from 600 prescription papers using systematic random sampling method. World Health Organization's standardized core prescribing indicators was used., Results: A total of 600 prescriptions containing antibiotics prescribed for patients with UTIs were observed during the study period. Of these, 415 (69.19%) were females and 210 (35%) were in the age group of 31-44 years. The number of generic drugs and antibiotics prescribed per encounter was 1.60 and 1.28, respectively. The percentage of antibiotics per prescription was found to be 27.83%. About 88.40% of antibiotics were prescribed by generic names. Fluoroquinolones were the most frequently prescribed class of drugs for the treatment of patients with UTIs., Conclusion: The prescribing practice of antibiotics in patients with UTIs was found to be good as the drugs were prescribed in generic name., (© 2023. The Author(s).)

Background: This paper reviews the regulations of over-the-counter (OTC) medicines in 30 European countries with the goal of identifying the regulatory trends and clusters as of May 2022., Methods: To that end, we reviewed the regulation that directly or indirectly might have an impact on OTC medicines. The data were gathered from the national legislation, reports from international organizations, and the existent literature. The 12 regulatory items obtained were classified into four categories: price, pharmacy ownership, distribution modes, and dispensing restrictions. In addition, these items were also employed in the cluster analysis., Results: Pharmacy ownership is mainly private, and in the majority of countries, OTC medicines are not subject to any pricing system. Almost every country studied allows online selling of OTC medicines, and 16 countries allow non-pharmacy retail to sell OTC medicines as well. The dispensing restrictions applicable in pharmacy retail are similar in the countries studied: they rely on the staff, OTC medicines are placed behind the counter and the doses dispensed tend to be restricted. Concerning non-pharmacy retail, additional dispensing restrictions might be imposed, such as the establishment of buyers' minimum age, the requirement of a pharmacist to supervise the operations, a regulation on the location in the store, and further restrictions on the package sizes, strength, or pharmaceutical form. The cluster analysis resulted in an initial division between countries that widely allow the sale of OTC medicines in non-pharmacy retail and countries, where pharmacy retail has an OTC monopoly. Based on the regulations, 7 subsequent groups were identified evidencing wide regulatory heterogeneity within the countries studied., Conclusions: Our findings point out that OTC medicines are in general not subject to pricing systems, selling is allowed online, and ownership of pharmacies is mostly private. However, regarding dispensing restrictions, pharmacy chains, and establishment restrictions of pharmacies, we found heterogeneity that is also visible in our cluster analysis, since we identified 7 clusters., (© 2023. The Author(s).)

Background: The uniqueness of the physician-patient relationship and the latter's lack of medical experience and knowledge necessitate providing patients with accurate and timely information necessary to engage them in treatment decision-making. Without detailed information from their physicians, patients cannot understand their medical condition, assess treatment options, and participate meaningfully in their care., Objectives: The present research determines the main factors influencing physicians' attitudes toward health information exchange with patients in Jordanian hospitals. The fundamental question addressed by this paper is why Jordanian physicians are reluctant to provide their patients with detailed health information about the potential risks, complications, and benefits of proposed treatments and other recognised alternative therapies., Method: This study is qualitative in nature, adopting face-to-face interviews as the key instrument of data collection in two hospitals in Jordan. The chief consideration of the sampling process was to select direct informants whose input would generate accurate results that might be generalised or translated to other contexts or settings. Thematic analysis was then used, and all participants' opinions, answers, and interactions were transcribed and then reduced into themes and patterns for research, as per similarities and relationships, through coding and representing the data., Key Findings: The findings show that most patients in government hospitals, especially those elderly, poorly educated, or inexperienced, choose practitioners based solely on medical service fees and costs rather than quality and convenience. On the other hand, the large number of patients attending public hospitals and the insufficiency of physicians' financial incentives in such hospitals may discourage physicians from providing patients with detailed health information. Matters, however, take a different turn in private hospitals, in which many physicians improve the patient experience to keep him and attract others by sharing information with patients about their health and treatment. However, it was noted that some physicians at such hospitals still rely heavily on their relations with health insurance companies to attract patients rather than on meaningful communication with their patients. Finally, the present findings reveal that the absence of a clear legal duty of medical disclosure negatively influences the amount of information received during the clinic visit., Conclusions: The fact that the level of communication in Jordanian healthcare settings has not been determined in detail opens the door to unnecessary healthcare expenditure and creates uncertainty concerning the amount of information that patients need to know in order to be involved in their treatment decision-making. The lack of proper control and quality monitoring may also negatively affect the interests of patients and their rights to receive adequate information about their health status., (© 2023. The Author(s).)

Background: Medical devices provide a great number of medical treatments and have an important role in patients' healthcare; however, there are certain risks, sometimes even serious incidents, associated with their usage. To ensure that benefits of medical device usage always outweigh associated risks, it is necessary to closely monitor known risks post-market and detect new ones as early as possible. Among others, valuable instrument of post-market surveillance is manufacturer incident report. Yet to accomplish its intended use, such report must be sufficiently populated and supplied with correct information. Aim of this paper is to assess the quality of manufacturer's incident reports received in HALMED since 2012 to May 2021., Methods: The study included 578 initial reports and 566 final reports that were scored according to the evaluating system we designed and categorized as Excellent, Good, Medium, Qualified and Unqualified. For each report medical device risk class was also extracted to calculate the frequency of report occurrence per risk class and time that passed between the initial and final report. Difference in quality of the reports between manufacturers based on EU countries and countries outside the EU was determined by Mann Whitney U test., Results: Most of initial and final reports fall into two highest quality category level, which means that a sufficient amount of reports are of good/excellent quality and quality of reports prevails. However, the study's results indicate the need for higher scores, especially in critical fields of the form., Conclusions: Data obtained from the manufacturer can be scarce and insufficient, causing negative influence on Competent Authority's investigation procedure. Another issue we recognized is extensive underreporting in Croatia, which can seriously undermine the established system., (© 2023. The Author(s).)

Background: Antimicrobial resistance (AMR) is a global public health issue. Physicians should play a key role to fight AMR, and medical education is a fundamental issue to combat it. Understanding the knowledge, attitudes and practices of physicians regarding antibiotic prescription and antibiotic resistance is fundamental for controlling the irrational antibiotic use. This study was conducted to assess the knowledge, attitudes and the practices of physicians in Iran with respect to antibiotic resistance and usage., Methods: A cross-sectional study was performed from June to October 2021 among physicians at primary care centers and academic hospitals in the region of Isfahan, Iran. A total of 182 physicians were surveyed. Participants were invited to complete a self-reported questionnaire (paper based or online questionnaire). The questions were based on knowledge, attitude, and practice toward antibiotic usage and AMR. Data were analyzed using SPSS version 18 software following the objective of the study., Results: Out of 182 study participants, 100, 50 and 32 responders were medical doctors (MD), internist and other specialists, respectively. Regarding the knowledge section of the questionnaire, almost less than 10% of participants declared to know the antibiotics of Iran's antimicrobial stewardship program. Also, the percentage of participants who correctly responded to clinical quizzes was 23% for treatment of extended-spectrum beta-lactamase (ESBL) producers, 59.3% about the treatment of severe sepsis, 22% about the intrinsic resistance of Proteus mirabilis and 43.4% for experimental treatment with vancomycin in community-acquired pneumonia. Regarding attitude, most participants (97.2%) were aware of the antimicrobial resistance problem in Iran, and 95.6% agreed that prescribing antimicrobials was not the appropriate in our country. Regarding practice, only 65.9% of participants said that before prescribing antibiotics they use of local and international antimicrobial therapy guidelines and less than 50% of physicians were in contact with a microbiology laboratory., Conclusion: This data revealed that our physicians' level of knowledge about AMR and antimicrobial stewardship is poor, so there is the need to increase training on antibiotic resistance and antimicrobial stewardship., (© 2022. The Author(s).)

Background: Evidence has shown that there is a significant problem with medication safety when patients are transferred between settings. The role of community pharmacists and hospital pharmacists in facilitating transition of care has been well-researched. However, with the developing role of pharmacists in general practice as part of a multi-disciplinary team, little is known about their role in improving transition of care when patients move from secondary to primary care. The key objective of this scoping review is to understand the nature and extent of the role of primary care pharmacists for patients recently discharged from secondary care., Methods: This scoping review will follow the Joanna Briggs Institute (JBI) methodology for scoping review underpinned by the Arksey and O'Malley methodology and reported in accordance with the Preferred Reporting Items for Systematic Reviews Extension for Scoping Reviews (PRISMA-ScR) guidelines. The following electronic databases will be systematically searched: MEDLINE, EMBASE, PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), Web of Science and NICE Evidence. Reference lists of included full texts will be searched for relevant papers, in addition to grey literature which includes websites of relevant professional organisations. Primary studies, published in the English language that involved a primary care pharmacist-led intervention post-hospital discharge will be included. Two independent reviewers will screen studies against eligibility criteria and use a piloted data extraction form to extract data related to the review questions. The data will be presented in tabular form and assessed for key themes to identify gaps and inform future research., Discussion: This scoping review will map current evidence surrounding the role of primary care pharmacists in the post-hospital discharge care of patients. Findings will inform ongoing research to support safer transfer-of-care post-hospital discharge and identify ways in which collaboration between healthcare professionals can be improved. This review anticipates guiding the inclusion of patient and public involvement (PPI) at the consultation stage to validate and build on the findings., (© 2022. The Author(s).)

Background: Lack of transparency around manufacturing costs, who bears the bulk of research and development costs and how total costs relate to the pricing of products, continue to fuel debates. This paper considers the case of olaparib (Lynparza®), recently indicated for use among BRCA-mutant breast cancer patients, and estimates the extent of public and philanthropic R&D funding., Methods: We know from previous work that attempting to ascertain the amount of public and philanthropic funding using purely bibliographic sources (i.e., authors' declarations of funding sources and amounts traced through funders) is limited. Since we knew that a publically funded research unit was pivotal in developing olaparib, we decided to supplement bibliographic data with a Freedom of Information request for administrative records on research funding data from this research centre., Research: In terms of stages of product development, work conducted in the pre-clinical research stage was the most likely to report non-industry funding (> 90% of pre-clinical projects received public or philanthropic funding). Clinical trials were least likely to be funded through non-industry sources-although even here, contrary to the popular assertion that this is wholly industry-financed, we found public or philanthropic funding declared by 23% of clinical trials. Using information reported in the publications, we identified approximately £128 million of public and philanthropic funding that may have contributed to the development of olaparib. However, this amount was less than one-third of the total amount received by one research institute playing a pivotal role in product discovery. The Institute of Cancer Research reported receiving 38 funding awards to support olaparib work for BRCA-mutant breast cancer totalling over £400 million., Conclusions: Government or charitable funding of pharmaceutical product development is difficult to trace using publicly available sources, due to incomplete information provided by authors and/or a lack of consistency in funding information made available by funders. This study has shown that a Freedom of Information request, in countries where such requests are supported, can provide information to help build the picture of financial support. In the example of olaparib, the funding amounts directly reported considerably exceeded amounts that could be ascertained using publically available bibliographic sources., (© 2022. The Author(s).)

Background: In 2019, more than $34.5 billion was spent on prescription drugs in Canada. However, little is known about the distribution of this spending across medications and settings (outpatient and inpatient) over time. The objective of this paper is to describe the largest expenditures by medication class over time in inpatient and outpatient settings. This information can help to guide policies to control prescription medication expenditures., Methods: IQVIA's Canadian Drugstore and Hospital Purchases Audit data from January 1, 2001, to December 31, 2020, were used. In this dataset, purchasing was stratified by outpatient drugstore and inpatient hospital. Spending trajectories in both settings were compared to total expenditure over time. Total expenditure of the 25 medications with the largest expenditure were compared over time, stratified by setting. Nominal costs were used for all analysis., Results: In 2001, spending in the outpatient and inpatient settings was greatest on atorvastatin ($467.0 million) and erythropoietin alpha ($91.2 million), respectively. In 2020, spending was greatest on infliximab at $1.2 billion (outpatient) and pembrolizumab at $361.6 million (inpatient). Annual outpatient spending, although increasing, has been growing at a slower rate (5.3%) than inpatient spending (7.0%). In both settings, spending for the top 25 medications has become increasingly concentrated on biologic agents, with a reduction in the diversity of therapeutic classes of agents over time., Discussion: Identification of the concentration on spending on biologic agents is a key step in managing costs of prescription medications in Canada. Given the increases in spending on biologic agents over the last 20 years, current cost-control mechanisms may be insufficient. Future research efforts should focus on examining the effectiveness of current cost-control mechanisms and identifying new approaches to cost control for biologic agents., (© 2022. The Author(s).)

Background: Currently, the private healthcare sector's role in healthcare delivery is growing in Ethiopia. However, there are limited studies on private healthcare sector drug use patterns. This study aimed to evaluate the private healthcare sector prescribing practices and adherence to prescription format, using some of the World Health Organization (WHO) core drug use indicators in Addis Ababa, Ethiopia., Methods: A retrospective cross-sectional study design was used to collect quantitative data from prescriptions prescribed and dispensed by private healthcare sectors in the Lemi-Kura sub-city, Addis Ababa. The study was conducted from June to July 2021. The WHO criteria were used to evaluate prescribing and prescription completeness indicators. Prescriptions, kept for the last 1 year that were prescribed between January 1, 2020, to January 1, 2021, by private drug outlets, were analyzed. Simple random and systematic sampling procedures were employed in selecting drug outlets and prescriptions, respectively., Results: Of a total of 1,200 prescriptions, 2,192 drugs were prescribed and the average number of drugs per prescription was 1.83. Generic names, antibiotics, injections, and drugs on the Ethiopian essential medicines list accounted for 77.4, 63.8, 11.5, and 80.6% of all prescriptions, respectively. Among the patient identifiers, the patient card number (54.3%), weight (2.3%), and diagnoses (31.7%) were less likely to be completed. In terms of the drug-related information, the dosage form (35.5%) was the least likely to be completed. Only 36.6 and 25.8% of prescriptions contained the names and qualifications of the prescribers, respectively. It was difficult to obtain prescription papers with the dispenser identifier., Conclusion: The study findings indicated prescribing and prescription completeness indicators all considerably deviated from WHO standards and hence unsuitable. This situation could be critical since a similar pattern is reported from public healthcare sectors, which might imply the extent of non-adherence to WHO core drug use standards. Consequently, it could play a considerable role in increasing irrational medicine use in Ethiopia., (© 2022. The Author(s).)

Background: The improper disposal of unused drugs can harm the environment and living beings. Programs such as drug take-back bins encourage people to dispose of unused medication at designated locations have increased. Unfortunately, awareness and participation is low, especially in ethnically and culturally diverse communities. The purpose of this paper is to describe the implementation of the Knock Talk and Toss (KTT), a drug take-back program aimed at taking unused drugs out of circulation and building police-resident connections in the housing authority of Framingham, MA., Methods: Multi-lingual brochures on the dangers of unused drugs and safe disposal were distributed on residents' doors via the police department and/or listservs to residents living in the housing authority. Awareness efforts were then followed-up by teams of individuals, including the police, going door-to-door to collect any unused drugs, no questions asked. During the visits, one team member observed resident characteristics, whether drugs were disposed, including the estimated quantity and type, and police/resident interactions. Interviews were conducted with key staff and Chi-square analyses were used to assess socio-demographic differences in proportions of individuals willing to toss drug(s)., Results: A total of 27 h were spent going door-to-door and 33 pounds of drugs were disposed. Households with observed adults aged 65 years or older and children/teenagers were twice as likely to dispose drugs compared to households, where these populations were not present., Conclusion: Initiatives, such as KTT, where police go door-to-door in areas with a higher concentration of families and elderly may help take unused drugs out of circulation while also enabling the police to have a positive presence in the community., (© 2022. The Author(s).)

Background: Indonesia is the second country with the highest number of malaria cases in Southeast Asia. Private health providers including community pharmacies often become the first point of care for the population seeking malaria treatment; however, public-private partnerships for malaria control are not widely implemented. This paper explores the acceptability of  a public-private partnership program on the  provision of subsidized artemisinin-based combination therapies (ACTs) in community pharmacies from the perspectives of private health providers, patients, and program implementers., Methods: The study was conducted in Manokwari District in West Papua Province, one of the highest endemic districts in Indonesia. Qualitative methods using interviews and focus group discussions (FGDs) were employed to explore the following dimensions of acceptability: affective attitude, burden, ethicality, intervention coherence, opportunity cost, perceived effectiveness, and self-efficacy. Study participants were program implementers, private health providers, and pharmacy clients. Audio-recorded interviews were transcribed and analyzed using thematic analysis. Secondary data on malaria cases and the use of ACTs reported by community pharmacies were also recorded., Results: Only one-fourth of the total community pharmacies in Manokwari participated in the partnership, suggesting low coverage of the program. The proportion of malaria cases reported by community pharmacies increased from 6.9% in 2018 to 30.7% of cases. Most participants had a positive attitude towards the program, which might be associated with the perceived effectiveness of the partnership in improving access to ACTs. Despite the good understanding of the intervention by the participating pharmacies, limited involvement of private physicians often resulted in non-standardized treatment practices. The partnership also imposed a burden on private health providers in terms of human resources and time which entailed significant opportunity costs. A number of ethical issues might undermine the equity of access to ACTs., Conclusion: Despite the positive attitude to the partnership, the perceived burden might outweigh the tangible benefits, posing threats to scaling up the intervention and sustainability. Innovations to simplify the administrative procedures in combination with performance-based incentives are needed to improve implementation. Engagement of patients and physicians is needed to increase the effectiveness of the partnership., (© 2021. The Author(s).)

Background: The National Drug Policy in Bangladesh prohibits the sale and distribution of antibiotics without prescription from a registered physician. Compliance with this policy is poor; prescribing antibiotics by unqualified practitioners is common and over-the-counter dispensing widespread. In Bangladesh, unqualified practitioners such as drug shop operators are a major source of healthcare for the poor and disadvantaged. This paper reports on policy awareness among drug shop operators and their customers and identifies current dispensing practices, barriers and facilitators to policy adherence., Methods: We conducted a qualitative study in rural and urban Bangladesh from June 2019 to August 2020. This included co-design workshops (n = 4) and in-depth interviews (n = 24) with drug shop operators and customers/household members, key informant interviews (n = 12) with key personnel involved in aspects of the antibiotic supply chain including pharmaceutical company representatives, and model drug shop operators; and a group discussion with stakeholders representing key actors in informal market systems namely: representatives from the government, private sector, not-for-profit sector and membership organizations., Results: Barriers to policy compliance among drug shop operators included limited knowledge of government drug policies, or the government-led Bangladesh Pharmacy Model Initiative (BPMI), a national guideline piloted to regulate drug sales. Drug shop operators had no clear knowledge of different antibiotic generations, how and for what diseases antibiotics work contributing to inappropriate antibiotic dispensing. Nonetheless, drug shop operators wanted the right to prescribe antibiotics based on having completed related training. Drug shop customers cited poor healthcare facilities and inadequate numbers of attending physician as a barrier to obtaining prescriptions and they described difficulties differentiating between qualified and unqualified providers., Conclusion: Awareness of the National Drug Policy and the BPMI was limited among urban and rural drug shop operators. Poor antibiotic prescribing practice is additionally hampered by a shortage of qualified physicians; cultural and economic barriers to accessing qualified physicians, and poor implementation of regulations. Increasing qualified physician access and increasing training and certification of drug shop operators could improve the alignment of practices with national policy., (© 2021. The Author(s).)

Background: Private sector retail pharmacies, or drug shops, play an important role in access to essential medicines and services in low-and-middle-income countries. Recognising that they have the potential to contribute to health system strengthening efforts, many recent initiatives to engage with drug shops have been launched. These include initiatives that focus on changes in policy, regulation and training. However, the specific factors that influence their success remain poorly understood. Seven country case studies supported under the Alliance's programme of work 'Strengthening health systems: the role of drug shops' help to explore this issue., Methods: Country case studies from the above programme of research from Bangladesh, Indonesia, Myanmar, Nigeria, Tanzania and Zambia were used as the main sources of data for this paper. A modified version of Bigdeli et al.'s Access to Medicines framework was applied within a partially grounded approach to analyze each country case study and compare themes between countries., Results: Many factors may help initiatives targeting drug shops successfully achieve their intended outcomes. At the micro level, these include community demand for drug shops and a positive relationship between drug shops and their clients. At the meso level, facilitators of initiative success include training and positive attitudes from drug shops towards the initiative. Barriers include client pressure, procurement challenges and financial and administrative costs associated with initiatives. At the macro level, collaboration between stakeholders, high-level buy in and supervision, monitoring and regulation may influence initiative success. These factors are inter-dependent and interact with each other in a dynamic way., Conclusions: Using a framework approach, these country case studies demonstrate common factors that influence how drug shops can strengthen health systems. These learnings can help inform the design and implementation of successful strategies to engage drug shops towards sustainable systems change., (© 2021. The Author(s).)

Background: Immunization supply chains (iSCs) move vaccines from manufacturer to point of use with the added complexities of requiring cold chain and an increasing need for agility and efficiency to ensure vaccine quality and availability. Underperforming iSCs have been widely acknowledged as a key constraint to achieving high immunization coverage rates in low- and middle-income countries. This paper details the system design approach used to analyze the iSC network in Sierra Leone, Madagascar, Niger and Guinea and documents six lessons., Methodology: Between 2018 and 2020, these countries implemented the system design approach, involving four key steps: (1) advocate and introduce to engage stakeholders and prioritize identification of modeling scenarios; (2) collect data and plan analysis through document review and key informant interviews; (3) analyze system design scenarios using computer software modeling tools (LLamasoft's Supply Chain Guru and AnyLogic's AnyLogistix) for optimization and simulation modeling as well as further analysis with Excel, Google maps, and OpenStreetMap; and (4) build consensus on optimized model and implementation roadmap using the Traffic Light Analysis tool and building on stakeholder input., Findings: Key lessons include the following: (1) define system design objectives based on country priorities; (2) establish consensus with stakeholders on scenarios to model; (3) modeling provides the evidence but not the answer; (4) costs should not be weighted above other decision criteria; (5) data collection-work smarter, not harder; (6) not all questions can be answered with a computer model., Discussion: A system design approach can identify changes to the design of the supply chain that can introduce efficiencies and improve reliability. This approach can be more effective when these lessons and principles are applied at the country level. The lessons from these four countries contribute to global thinking and best practices related to system design. The modeling and system design approach provides illustrative results to guide decision-makers. It does not give a "final answer", but compares and contrasts., (© 2021. The Author(s).)

Mammalian pregnancy is a curious life phenomenon. Immunologically, the mechanism of pregnancy is difficult to explain because it involves the coexistence of an external foreign body (the embryo) and the host (the mother) for a period of time. How did mammals acquire the ability to become pregnant in parallel with altered immunity? Sex in the evolution of life and its impact on anthropology are major topics of discussion. In this paper, we outline (1) sex and evolution in mammals after the advent of our direct ancestors (apes) up to humans (i.e., the Cenozoic Quaternary), including anthropological aspects such as the development of the central nervous system; (2) the development of reproductive immunity during the Paleozoic era, when biodiversity developed explosively (and many sexually reproducing organisms have emerged); and (3) the characteristic reproductive strategies of mammals, including humans with the immunological aspects of viviparity. We present an overview of mammalian reproductive immunity, which is a heretical aspect of immunology.

Background: Globally, non-communicable diseases (NCDs) are recognised as a leading cause of morbidity and mortality. Medications and medicines optimisation play an important role in the management of modifiable physiological risk factors and NCDs. The importance of lifestyle interventions in prevention of modifiable risk factors is also well established. The aim of this paper was to describe the quantity of type 2 diabetes mellitus (T2DM), hypertension and dyslipidaemia prescribing in Qatari primary care settings. Its findings will provide necessary information to inform pharmaceutical policy and practice., Methods: The study was undertaken in Qatar's publicly funded primary health care centres. Data sources for this study comprised electronic medical records. The Anatomical Therapeutic Chemical (ATC) drug classification system was used to classify the medications prescribed. The number and proportion of medications by age, sex, nationality and diagnosis (T2DM, hypertension and dyslipidaemia) were reported., Results: A total 81,569 individuals were included (18-29 years 2.4%; 30-39 years 11.7%; 40-49 years 25.4%; 50-59 years 31.9% and ≥ 60 years 28.6%). 55.6% participants were male. On average 10.2 medications were prescribed per person and 2.3 medications were included in each prescription. T2DM medications were most prescribed (N = 361,87780,799; 43.2%) followed by hypertension (N = 303,086; 36.2%) and dyslipidaemia (N = 172,163; 20.5%). Of the total medications prescribed, 72% (N = 605,488) were prescribed in individuals aged 50 years and above. Men were prescribed 62% (N = 515,043) medications while women were prescribed 38% (N = 322,083) medications. Southern Asians (N = 330,338; 39%) were prescribed most medication followed by Qataris (N = 181,328; 22%) and Northern African (N = 145,577; 17%)., Conclusions: In Qatar's primary care settings, average medications prescribed per patients were found to be higher compared to other populations. While medications were actively prescribed for the 3 conditions, the study found variations by medication type, age, gender and nationality. Rational guidelines for the utilisation of medications need to be established with the support of real-world evidence., (© 2021. The Author(s).)

Background: Measuring access to medicines has often been limited to assessing availability and affordability, while little is known regarding other dimensions of access including geographical accessibility. Our study aims to provide a systematic review of literature on the accessibility of medicines by studying the geographical distribution of pharmacies using Spatial Analytical methods., Methods: As systematic review of scientific peer-reviewed literature between 2000 and 2018 was carried out using PubMed, Web of Science, Google Scholar, Google and the Preferred Reporting items for Systematic Reviews and Meta-Analyses (PRISMA). Data regarding pharmacy density, distance to pharmacies in relation of pharmacy to sociodemographic factors and pharmacy characteristics were extracted from studies that meet the inclusion criteria., Findings: Twenty papers fulfilled our inclusion criteria, of which only three were from middle income countries and rest from high-income economies. Pharmacy density per population was reported in 15 studies. Although geographical information was utilized in all studies, only 14 studies reported distance to pharmacies represented as Euclidean (straight line) distance. Disparities in accessibility was reported according to population income and rural or urban location. Seven studies described additional pharmacy characteristics including opening hours, presence of a pharmacist and delivery services., Conclusions: Geographical accessibility is a key dimension of access to medicines. Pharmacy density per population is a relevant indicator to assess geographical accessibility which should be complemented by an equity analysis using socio-demographic information and population perception of accessibility.

Background: Increasingly, there has been recognition that siloed approaches focusing mainly on human health are ineffective for global antimicrobial resistance (AMR) containment efforts. The inherent complexities of AMR containment warrant a coordinated multisectoral approach. However, how to institutionalize a country's multisectoral coordination across sectors and between departments used to working in silos is an ongoing challenge. This paper describes the technical approach used by a donor-funded program to strengthen multisectoral coordination on AMR in 11 countries as part of their efforts to advance the objectives of the Global Health Security Agenda and discusses some of the challenges and lessons learned., Methods: The program conducted a rapid situational analysis of the Global Health Security Agenda and AMR landscape in each country and worked with the governments to identify the gaps, priorities, and potential activities in multisectoral coordination on AMR. Using the World Health Organization (WHO) Joint External Evaluation tool and the WHO Benchmarks for International Health Regulations (2005) Capacities as principal guidance, we worked with countries to achieve key milestones in enhancing effective multisectoral coordination on AMR., Results: The program's interventions led to the achievement of key benchmarks recommended actions, including the finalization of national action plans on AMR and tools to guide their implementation; strengthening the leadership, governance, and oversight capabilities of multisectoral governance structures; establishing and improving the functions of technical working groups on infection prevention and control and antimicrobial stewardship; and coordinating AMR activities within and across sectors., Conclusion: A lot of learning still needs to be done to identify best practices for building mutual trust and adequately balancing the priorities of individual ministries with cross-cutting issues. Nevertheless, this paper provides some practical ideas for countries and implementing partners seeking to improve multisectoral coordination on AMR. It also demonstrates that the WHO benchmark actions, although not intended as an exhaustive list of recommendations, provide adequate guidance for increasing countries' capacity for effective multisectoral coordination on AMR in a standardized manner.

Background: To strengthen medicines management capacity, including supply chain management, at public sector health facilities in Uganda, the Ministry of Health introduced a multipronged supervision, performance assessment, and recognition strategy (SPARS). The aim of this study was to assess the impact of SPARS on improving supply chain management. A series of four papers on SPARS described the SPARS concept, its impact on overall and domain practices and appropriate medicines use, and now in the fourth paper describing the effect on supply chain management., Methods: District-based health workers trained as supervisors build facility-level capacity in medicines management using an indicator-based performance assessment followed by targeted supervisory visits. From 2010 to 2013, 1222 SPARS visits were implemented, and the SPARS performance indicator scores determined. This article assesses impact on 13 indicators in three of the five SPARS domains-stock management, storage management, and ordering and reporting quality-using a pre-post design. We also explored factors that may have influenced these outcomes., Results: Between the first and last visit within one year of SPARS implementation, we found an average improvement of 16 percentage points (p < 0.001) in supply chain management measures across all levels of care. The improvement in scores for stock management, storage management, and ordering and reporting was 22 (ns), 16 (p < 0.001), and 11 (p = 0.032) percentage points, respectively. The study identified the key predictors of positive change as a low initial indicator score, frequent supervisory visits, and engagement of the district health officer., Conclusions: The multipronged SPARS approach was effective in building supply chain management capacity in lower-level health care facilities with statistically significant improvements in supply chain management overall and in almost all stock and storage- management and ordering and reporting measures after one year of implementation. We recommend broad dissemination of the SPARS approach as an effective strategy to strengthen supply chain management in low-income countries., Trial Registration: The study did not involve or use human participants or identifiable personal data, human tissue, or animals and thus did not require ethical approval or a waiver. It is a study implemented in collaboration with the Ministry of Health and does not require trial registration.

Background: Medications are crucial for maintaining patient wellness and improving health in modern medicine, but their use comes with risks. Helping patients to understand why they are taking medications is important for patient-centered care and facilitates patient adherence to prescribed medications. One strategy involves enhancing communication between patients, physicians, and pharmacists through the sharing of reason for use (RFU) information or the indication for medications., Methods: Semi-structured interviews were conducted with 20 patients in Ontario, Canada, to gain perspectives on how patients currently store their medication information and benefits and disadvantages of adding RFU to prescriptions and medication labels. An interview guide was used by the two interviewers, and the interviews were recorded, transcribed, and thematically coded., Results: The analysis yielded three main themes: patient decision making with RFU, RFU in modern, patient-centered care, and logistical aspects of communicating RFU. The patients that were interviewed expressed the value of having RFU when deciding if a medication was effective or to stop taking the medication. Patients felt comfortable with RFU being added to prescriptions and acknowledged the value in adding RFU to medication labels, helping patients and others identify and distinguish medications. Patients generally expressed interest in having RFU written in lay language and identified strengths and weaknesses of having access to RFU via a website or app., Conclusions: Patients rated the importance of knowing RFU very highly, identified the value in sharing RFU with pharmacists on prescriptions, and in having RFU on medication labels. These results can be used to inform policy on the addition of RFU on prescriptions and medication labels and support improved communication between patients, pharmacists, and physicians about RFU., Competing Interests: Competing interestsThe authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. This study was approved by the University of Waterloo research ethics board (ORE #31591). The authors declare that they have no competing interests., (© The Author(s) 2020.)

With a scientific background from filoviruses, paramyxoviruses, SARS-CoV, and MERS-CoV, remdesivir entered into the COVID-19 battle to become one of the favorable therapeutic candidates with potential antiviral activity in the treatment of this disease. Globally, remdesivir was accessed and investigated through clinical research (clinical trials) and clinical practice (compassionate use, expanded access, early access scheme, and emergency use). Currently, remdesivir approval status differs between states. This paper aims to review and analyze regulatory approaches for accessing and investigating remdesivir, by communicating regulatory variability between countries in terms of terminology, modalities, and protocols., Competing Interests: Competing interestsVesa Halimi, Armond Daci, Nevenka Ridova, Irina Panovska-Stavridis, Milena Stevanovic, Venko Filipce, Aleksandar Dimovski, and Aleksandra Grozdanova declare that no competing interests exist., (© The Author(s) 2020.)

Competing Interests: Competing interestsRR is the last author of the paper of Schiavetti et al. (J Pharm Policy Practice 2020; 13:9) on which this letter is commenting.

Background: To strengthen appropriate medicine use (AMU) including the prescribing and dispensing quality at public sector health facilities in Uganda, the Ministry of Health introduced a multipronged approach known as the Supervision, Performance Assessment, and Recognition Strategy (SPARS). This paper assesses the impact of the first year of SPARS implementation on key AMU indicators., Methods: District-based health workers trained as supervisors provide in-service training in medicines management complemented by indicator-based performance assessment and targeted supervision during each SPARS facility visit. From 2010 to 2013, health facilities that started the SPARS intervention were assessed during the first and last visit during a period of 12 months of implementing SPARS. This study examines 12 AMU indicators with 57 individual outcomes covering prescribing and dispensing quality. We also explored factors influencing 1-year improvement., Results: We found an overall increase in AMU indicators of 17 percentage points ( p < 0.000) between the first and last visit during a period of 12 months of supervisions, which was significant in all levels of health care facilities and in both government and private not-for-profit faith-based sectors. Appropriate dispensing (25 percentage points, p < 0.005) improved more than appropriate prescribing (12 percentage points, p = 0.13). Specific facilities that reached an average score of over 75% across all AMU measures within the first year of supervision improved from 3 to 41% from the first visit (baseline). The greatest overall impact on AMU occurred in lower-level facilities; the level of improvement varied widely across indicators, with the greatest improvements seen for the lowest baseline measures. Supervision frequency had a significant impact on level of improvement in the first year, and private not-for-profit faith-based health facilities had notably higher increases in several dispensing and prescribing indicator scores than public sector facilities., Conclusions: The multipronged SPARS approach was effective in building appropriate medicine use capacity, with statistically significant improvements in AMU overall and almost all prescribing and dispensing quality measures after 12 months of supervision. We recommend broad dissemination of the SPARS approach as an effective strategy to strengthen appropriate medicine use in low-income countries., Competing Interests: Competing interestsThe authors declare that they have no competing interests., (© The Author(s) 2020.)

Coronavirus disease 2019 (COVID-19) is an infectious disease that has become a global pandemic. COVID-19 is spreading in Africa, and Zimbabwe has not been spared. The cases in Zimbabwe are mainly from imported cases due to high volume of travellers from the COVID-19 hotspots. In Zimbabwe, local transmission is also anticipated due to inter- and intracity travelling. Frontline health workers are at risk of infection due to contact with infected people as they discharge their duties. In this setting, the risk to community pharmacists and pharmacy personnel is poorly understood and characterised. This paper looked at the risks of infection that are peculiar to community pharmacy personnel and suggested some recommendations to reduce the risk to COVID-19 infection., Competing Interests: Competing interestsThe authors declare that they have no competing interests., (© The Author(s) 2020.)

Background: The affordability of essential medicines is a challenge in achieving Universal Health Coverage (UHC). One of The Lancet Commission's recommendations on financing of essential medicines is to ensure governments and national health systems include essential medicines in the benefit packages provided by public and private healthcare sectors. Currently in South Africa (SA), there is a dearth of information on the processes for medicines selection for private sector medical scheme formularies. This study aimed to improve the understanding of how formulary managers of selected medical schemes made decisions for the selection of medicines for their formularies. This paper described their opinions obtained from in-depth interviews., Methods: Qualitative in-depth interviews were conducted with 10 individuals from 7 private sector medical schemes and administrators in SA. All participants interviewed were involved in formulary development and management. Interviews were conducted from June 2013 - January 2015. Interviews were guided by a discussion guide and audio recorded. Recorded interviews were transcribed verbatim. Transcripts were coded by the first author, corroborated by the second author, reconciled, and imported into NVIVO for data analysis., Results: Schemes and administrators had similar formulary decision making and management committees in place (viz. Clinical and Therapeutics committees). The process of and criteria for medicines selection and evidence based review of formularies were also similar. Selection of medicines was inherent in the formulary review process. Medicine price was important in the decision taken to list medicines. Most schemes expressed a difficulty with lack of information to support pharmacoeconomic evaluations of medicines for inclusion on the formulary. This together with the basic monitoring of use of medicines by patients for most schemes left room for improvement in the decision making process for those schemes., Conclusions: This is one of the first studies in SA describing interviews with private sector medical scheme Formulary managers. It contributes to an increased understanding of how decisions are taken to include/exclude medicines on private sector medical scheme formularies. It provides insight into the medicine selection and review processes, including processes on monitoring and evaluation of medicines use by the private sector which serve as lessons for Low-Middle income countries moving towards UHC., Competing Interests: Competing interestsThe authors declare that they have no competing interests., (© The Author(s) 2020.)

Background: The use of quality injectable oxytocin effectively prevents and treats postpartum hemorrhage, the leading cause of maternal death worldwide. In low- and middle-income countries (LMICs), characteristics of oxytocin-specifically its heat sensitivity-challenge efforts to ensure its quality throughout the health supply chain. In 2019, WHO, UNFPA and UNICEF released a joint-statement to clarify and recommend that oxytocin should be kept in the cold chain (between 2 and 8 °C) during transportation and storage; however, confusion among stakeholders in LMICs persists., Objectives and Methods: To further support recommendations in the WHO/UNFPA/UNICEF joint-statement, this paper reviews results of oxytocin quality testing in LMICs, evaluates product stability considerations for its management and considers quality risks for oxytocin injection throughout the health supply chain. This paper concludes with a set of recommended actions to address the challenges in maintaining quality for a heat sensitive pharmaceutical product., Results: Due to the heat sensitivity of oxytocin, its quality may be degraded at numerous points along the health supply chain including: At the point of manufacture, due to poor quality active pharmaceutical ingredients; lack of sterile manufacturing environments; or low-quality manufacturing processesDuring storage and distribution, due to lack of temperature control in the supply chain, including cold chain at the end user health facilitySafeguarding the quality of oxytocin falls under the purview of national medicines regulatory authorities; however, regulators in LMICs may not adhere to good regulatory practices., Conclusions: Storing oxytocin from 2 to 8 °C throughout the supply chain is important for maintaining its quality. While short temperature excursions may not harm product quality, the cumulative heat exposure is generally not tracked and leads to degradation. National and sub-national policies must prioritize procurement of quality oxytocin and require its appropriate storage and management., Competing Interests: Competing interestsDr. Evans III reports grants from United States Agency for International Development (USAID), during the conduct of the study. Mrs. Theunissen reports grants from MSD for Mothers, a division of Merck and Co., Inc., U.S.A., during the conduct of the study. Dr. McIntosh reports grants from McCall MacBain Foundation, grants from Grand Challenges Canada, grants from Saving Lives at Birth, during the conduct of the study; grants from Reproductive Health Supplies Coalition Innovation Fund, outside the submitted work; In addition, Dr. McIntosh has a patent Method and Formulation for Inhalation’ (WO 2013/016754) licensed to Patent is licensed to GSK. The author is part of a team at Monash university that, in partnership with GlaxoSmithKline, is developing a heat stable inhaled oxytocin product for the prevention of postpartum haemorrhage in resource poor settings. The project aims to expand access to oxytocin in usage settings where high quality oxytocin injection is not reliably available. Dr. Lambert reports grants from McCall MacBain Foundation, grants from Grand Challenges Canada, grants from Saving Lives at Birth, during the conduct of the study; grants from Reproductive Health Supplies Coalition Innovation Fund, outside the submitted work; and The author is part of a team at Monash university that, in partnership with GlaxoSmithKline, is developing a heat stable inhaled oxytocin product for the prevention of postpartum haemorrhage in resource poor settings. The project aims to expand access to oxytocin in usage settings where high quality 55 oxytocin injection is not reliably available. The other authors have nothing to disclose., (© The Author(s) 2020.)

Competing Interests: Competing interestsThe authors declare that they have no financial or none-financial competing interests. This study was funded by the United States Agency for International Development (USAID). USAID did not have any role in the study design, data analysis, or writing of this paper or in the decision to submit the paper for publication.