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Journal of Pharmaceutical Policy and Practice

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https://www.readbyqxmd.com/read/28261487/drug-pricing-and-reimbursement-decision-making-systems-in-mongolia
#1
Gereltuya Dorj, Bruce Sunderland, Tsetsegmaa Sanjjav, Gantuya Dorj, Byambatsogt Gendenragchaa
BACKGROUND: It is essential to allocate available resources equitably in order to ensure accessibility and affordability of essential medicines, especially in less fortunate nations with limited health funding. Currently, transparent and evidence based research is required to evaluate decision making regarding drug registration, drug pricing and reimbursement processes in Mongolia. OBJECTIVE: To assess the drug reimbursement system and discuss challenges faced by policy-makers and stakeholders...
2017: Journal of Pharmaceutical Policy and Practice
https://www.readbyqxmd.com/read/28250958/capacity-for-ethical-and-regulatory-review-of-herbal-trials-in-developing-countries-a-case-study-of-moringa-oleifera-research-in-hiv-infected-patients
#2
Tsitsi G Monera-Penduka, Charles C Maponga, Gene D Morse, Charles F B Nhachi
BACKGROUND: Lack of regulatory capacity limits the conduct of ethical and rigorous trials of herbal medicines in developing countries. Sharing ethical and regulatory experiences of successful herbal trials may accelerate the field while assuring human subjects protection. The methods and timelines for the ethical and regulatory review processes for the first drug regulatory authority approved herbal trial in Zimbabwe are described in this report. METHODS: The national drug regulatory authority and ethics committee were engaged for pre-submission discussions...
2017: Journal of Pharmaceutical Policy and Practice
https://www.readbyqxmd.com/read/28239479/the-changing-landscape-of-expanded-access-to-investigational-drugs-for-patients-with-unmet-medical-needs-ethical-implications
#3
EDITORIAL
Eline M Bunnik, Nikkie Aarts, Suzanne van de Vathorst
When patients are told that standard medical treatment options have been exhausted, their treating physicians may start looking for promising new drugs that are not yet approved, and still under investigation. Some patients can be included in clinical trials, but others cannot. It is not widely known that these patients might still be eligible for trying investigational drugs, in a therapeutic context. Worldwide, public and private parties are seeking to change this by informing patients and physicians about opportunities for expanded access and/or by facilitating its processes...
2017: Journal of Pharmaceutical Policy and Practice
https://www.readbyqxmd.com/read/28191318/structured-pharmaceutical-care-improves-the-health-related-quality-of-life-of-patients-with-asthma
#4
Philip O Anum, Berko P Anto, Audrey G Forson
BACKGROUND: Asthma as a chronic health condition can be controlled when in addition to clinical care, adequate education and support is provided to enhance self-management. Like many other chronic health conditions improved self-management positively impacts the health-related quality of life (HRQoL). It can therefore be said that a well-structured pharmaceutical care delivery that addresses the issues related to patient education and support towards self-management stands a good chance of positively impacting asthma control...
2017: Journal of Pharmaceutical Policy and Practice
https://www.readbyqxmd.com/read/28116107/prices-and-availability-of-locally-produced-and-imported-medicines-in-ethiopia-and-tanzania
#5
M Ewen, W Kaplan, T Gedif, M Justin-Temu, C Vialle-Valentin, Z Mirza, B Regeer, M Zweekhorst, R Laing
BACKGROUND: To assess the effect of policies supporting local medicine production to improve access to medicines. METHODS: We adapted the WHO/HAI instruments measuring medicines availability and prices to differentiate local from imported products, then pilot tested in Ethiopia and Tanzania. In each outlet, prices were recorded for all products in stock for medicines on a country-specific list. Government procurement prices were also collected. Prices were compared to an international reference and expressed as median price ratios (MPR)...
2017: Journal of Pharmaceutical Policy and Practice
https://www.readbyqxmd.com/read/28116106/engagement-of-the-private-pharmaceutical-sector-for-tb-control-rhetoric-or-reality
#6
Niranjan Konduri, Emily Delmotte, Edmund Rutta
BACKGROUND: Private-sector retail drug outlets are often the first point of contact for common health ailments, including tuberculosis (TB). Systematic reviews on public-private mix (PPM) interventions for TB did not perform in-depth reviews specifically on engaging retail drug outlets and related stakeholders in the pharmaceutical sector. Our objective was to better understand the extent to which the World Health Organization's (WHO) recommendation on engaging retail drug outlets has been translated into programmatic policy, strategy, and intervention in low- and middle-income countries...
2017: Journal of Pharmaceutical Policy and Practice
https://www.readbyqxmd.com/read/28070340/civil-society-engagement-in-multi-stakeholder-dialogue-a-qualitative-study-exploring-the-opinions-and-perceptions-of-meta-members
#7
Gemma L Buckland-Merrett, Catherine Kilkenny, Tim Reed
BACKGROUND: The Medicines Transparency Alliance (MeTA) is an initiative that brings together all stakeholders in the medicines market to create a multi-stakeholder dialogue and improve access, availability and affordability of medicines. Key to this multi-stakeholder dialogue is the participation of Civil Society Organisations. A recent MeTA annual review, identified uneven engagement of civil society organisations in the multi-stakeholder process. This study was designed to explore the engagement of Civil Society Organisations in the MeTA multi-stakeholder process and the factors influencing their participation...
2017: Journal of Pharmaceutical Policy and Practice
https://www.readbyqxmd.com/read/28070339/approval-status-and-evidence-for-who-essential-medicines-for-children-in-the-united-states-united-kingdom-and-japan-a-cross-sectional-study
#8
Rumiko Shimazawa, Masayuki Ikeda
BACKGROUND: The WHO Model List of Essential Medicines for Children (EMLc) covers medicines for globally high-burden diseases. Regulatory approval in high-income countries ensures evidence and dosage form but usually focuses on diseases common in those countries and not in low- and middle-income countries. METHODS: This cross-sectional study assessed supporting evidence for the 346 medicines in the 5th WHO EMLc and their approval data from the United States, United Kingdom, and Japan...
2017: Journal of Pharmaceutical Policy and Practice
https://www.readbyqxmd.com/read/27446593/the-global-intellectual-property-ecosystem-for-insulin-and-its-public-health-implications-an-observational-study
#9
Warren A Kaplan, Reed F Beall
BACKGROUND: Lack of access to insulin and poor health outcomes are issues for both low and high income countries. This has been accompanied by a shift from relatively inexpensive human insulin to its more expensive analogs, marketed by three to four main global players. Nonetheless, patent-based market exclusivities are beginning to expire there for the first generation insulin analogs. This paper adds a global dimension to information on the U.S. patent landscape for insulin by reviewing the patent status of insulins with emphasis on the situation outside the US and Europe...
2017: Journal of Pharmaceutical Policy and Practice
https://www.readbyqxmd.com/read/27446592/economic-contributions-of-pharmaceutical-interventions-by-pharmacists-a-retrospective-report-in-japan
#10
Daiki Yasunaga, Yuichi Tasaka, Satoshi Murakami, Akihiro Tanaka, Mamoru Tanaka, Hiroaki Araki
BACKGROUND: Pharmacists in Japan currently play a key role in patient hospital care. Their responsibilities include filling prescriptions, checking a patient's medication history, and providing appropriate information to other health care workers. More importantly, pharmacists' interventions can also result in reductions in adverse drug reactions (ADRs) and, ultimately, in cost savings. This study aimed to determine the economic value of such interventions at a hospital in Japan. METHODS: At a single Japanese hospital, we analyzed 1452 pharmaceutical interventions by pharmacists, including recommending antibiotic dosage regimens, attending ward rounds with multidisciplinary health providers, providing drug information, and reporting ADRs...
2017: Journal of Pharmaceutical Policy and Practice
https://www.readbyqxmd.com/read/27446591/assessment-of-current-prescribing-practices-using-world-health-organization-core-drug-use-and-complementary-indicators-in-selected-rural-community-pharmacies-in-southern-india
#11
Anandhasayanam Aravamuthan, Mohanavalli Arputhavanan, Kannan Subramaniam, Sam Johnson Udaya Chander J
BACKGROUND: Due to the lack of clear, comprehensive, and rational drug policy, the production of pharmaceutical preparations in India is distorted for the most part. Indian markets are flooded with more than 70,000 formulations, compared to approximately 350 formulations listed in the World Health Organization (WHO) Essential Drug List. Studies have indicated that majority of prescriptions in India are of drugs of "doubtful efficacy." To promote rational drug use in developing countries, assessment of drug use patterns with the WHO drug use indicators is becoming increasingly necessary...
2017: Journal of Pharmaceutical Policy and Practice
https://www.readbyqxmd.com/read/28050254/the-choice-between-a-ritonavir-boosted-protease-inhibitor-and-a-non-nucleoside-reverse-transcriptase-inhibitor-based-regimen-for-initiation-of-antiretroviral-treatment-results-from-an-observational-study-in-germany
#12
Jörg Mahlich, Mona Groß, Alexander Kuhlmann, Johannes Bogner, Hans Heiken, Matthias Stoll
BACKGROUND: This study aims at identifying predictors of the treatment decision of German physicians with regard to a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a ritonavir-boosted protease inhibitor (PI/r) -based initial treatment regimen. METHODS: The study is based on a sub analysis of a nation-wide multi-centre, non-interventional, prospective cohort study. 133 patients were identified, who received antiretroviral first-line therapy. By means of a logistic regression, factors that determine the treatment strategy for treatment-naïve patients were analysed...
2016: Journal of Pharmaceutical Policy and Practice
https://www.readbyqxmd.com/read/27933178/assessing-medication-packaging-and-labelling-appropriateness-in-sri-lanka
#13
N Athuraliya, E J Walkom, S Dharmaratne, J Robertson
BACKGROUND: There is substantial evidence of poor dispensing practices with inadequate packaging and labelling of medicines, and limited advice on their usage in low and middle-income countries (LMICs). We examined the labelling and packaging of medicines identified during a survey of 1322 households in six regions of Sri Lanka between 2010 and 2013 conducted using the World Health Organization (WHO) methodology for household surveys. We compared medicines obtained from public and private sources and asked interviewees if they understood how to take the medicines...
2016: Journal of Pharmaceutical Policy and Practice
https://www.readbyqxmd.com/read/27891235/interaction-and-medical-inducement-between-pharmaceutical-representatives-and-physicians-a-meta-synthesis
#14
REVIEW
Shahrzad Salmasi, Long Chiau Ming, Tahir Mehmood Khan
BACKGROUND: It has been proven that the interaction between pharmaceutical representatives and physicians can directly influence the latter's prescribing behaviour. This meta-synthesis aims to explore the available studies regarding the nature of the interaction that takes place between pharmaceutical representatives and physicians. It highlights the different aspects of that interaction by investigating the reasons why these meetings happen in the first place, their benefits and drawbacks and their impact on patients' health and, ultimately, the health of the public...
2016: Journal of Pharmaceutical Policy and Practice
https://www.readbyqxmd.com/read/27843547/fighting-poor-quality-medicines-in-low-and-middle-income-countries-the-importance-of-advocacy-and-pedagogy
#15
EDITORIAL
Raffaella Ravinetto, Daniel Vandenbergh, Cécile Macé, Corinne Pouget, Brigitte Renchon, Jean Rigal, Benedetta Schiavetti, Jean-Michel Caudron
The globalization of pharmaceutical production has not been accompanied by a strengthening and harmonization of the regulatory systems worldwide. Thus, the global market is characterized today by a situation of multiple standards, and patients in low- and middle-income countries are exposed to the risk of receiving poor-quality medicines. Among those who first raised the alarm on this problem, there were pioneering humanitarian groups, who were in a privileged position to witness the gap in quality of medicines between high-income countries and low- and middle-income countries...
2016: Journal of Pharmaceutical Policy and Practice
https://www.readbyqxmd.com/read/27800166/an-assessment-of-the-future-impact-of-alternative-technologies-on-antibiotics-markets
#16
Ejike Nwokoro, Ross Leach, Christine Årdal, Enrico Baraldi, Kellie Ryan, Jens Plahte
BACKGROUND: The increasing threat of antimicrobial resistance combined with the paucity of new classes of antibiotics represents a serious public health challenge. New treatment technologies could, in theory, have a significant impact on the future use of traditional antibiotics, be it by facilitating rational and responsible use or by product substitution in the existing antibiotics markets, including by reducing the incidence of bacterial infections through preventative approaches. The aim of this paper is to assess the potential of alternative technologies in reducing clinical use of and demand for antibiotics, and to briefly indicate which segments of the antibiotics market that might be impacted by these technologies...
2016: Journal of Pharmaceutical Policy and Practice
https://www.readbyqxmd.com/read/27800165/medicine-and-the-future-of-health-reflecting-on-the-past-to-forge-ahead
#17
EDITORIAL
Dale Fisher, Paul Wicks, Zaheer-Ud-Din Babar
The development of new therapies has a rich history, evolves quickly with societal trends, and will have an exciting future. The last century has seen an exponential increase in complex interactions between medical practitioners, pharmaceutical companies, governments and patients. We believe technology and societal expectations will open up the opportunity for more individuals to participate as information becomes more freely available and inequality less acceptable. Corporations must recognize that usual market forces do not function ideally in a setting where health is regarded as a human right, and as modern consumers, patients will increasingly take control of their own data, wellbeing, and even the means of production for developing their own treatments...
2016: Journal of Pharmaceutical Policy and Practice
https://www.readbyqxmd.com/read/27795831/impact-of-switching-from-intravenous-to-oral-linezolid-therapy-in-japanese-patients-a-retrospective-cohort-study
#18
Akihiro Tanaka, Akiko Yano, Shinichi Watanabe, Mamoru Tanaka, Hiroaki Araki
BACKGROUND: High oral bioavailability of antimicrobial agents can result in the replacement of intravenous (IV) therapy with oral therapy when a patient meets defined clinical criteria. However, few studies have evaluated the effects of switching antibiotic administration route in Japan, especially for linezolid. This study evaluated an IV-to-oral antibiotic switching program for linezolid treatment at a university hospital in Japan. METHODS: In a retrospective cohort study of 73 patients, we assessed the efficacy and safety of IV-to-oral linezolid therapy (n = 21 patients) compared with IV therapy alone (n = 52 patients)...
2016: Journal of Pharmaceutical Policy and Practice
https://www.readbyqxmd.com/read/27777781/impact-of-pharmacists-as-immunizers-on-influenza-vaccination-coverage-in-the-community-setting-in-nova-scotia-canada-2013-2015
#19
Jennifer E Isenor, Jessica L Killen, Beverly A Billard, Shelly A McNeil, Donna MacDougall, Beth A Halperin, Kathryn L Slayter, Susan K Bowles
BACKGROUND: Annual immunization is the most effective way to prevent influenza and its associated complications. However, optimal immunization rates are not being met in Nova Scotia, Canada. Additional providers, such as pharmacists, may improve access and convenience to receive vaccines. Pharmacists began immunizing patients 5 years of age and older within the publicly funded universal influenza vaccination program during the 2013-2014 influenza season. The objective of this study was to evaluate influenza immunization coverage rates before and after pharmacists in Nova Scotia gained authority to immunize as part of the publicly funded universal influenza vaccination program...
2016: Journal of Pharmaceutical Policy and Practice
https://www.readbyqxmd.com/read/27761263/towards-the-just-and-sustainable-use-of-antibiotics
#20
Gemma L Buckland Merrett, Gerald Bloom, Annie Wilkinson, Hayley MacGregor
The emergence and spread of antibiotic resistant pathogens poses a big challenge to policy-makers, who need to oversee the transformation of health systems that evolved to provide easy access to these drugs into ones that encourage appropriate use of antimicrobials, whilst reducing the risk of resistance. This is a particular challenge for low and middle-income countries with pluralistic health systems where antibiotics are available in a number of different markets. This review paper considers access and use of antibiotics in these countries from a complex adaptive system perspective...
2016: Journal of Pharmaceutical Policy and Practice
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