Access To Medicines Research Articles

E-solutions in Estonian community pharmacies: A literature review.

ObjectiveEstonian innovative electronic solutions have long been leading the way in the healthcare sector. This article aims to give an overview of all e-solutions and their usability in community pharmacies in Estonia and how they compare and operate with the wider e-health system.MethodsA comprehensive literature review was conducted on publicly accessible information regarding Estonian e-health and electronic community pharmacy solutions.FindingsWhile Estonian e-health system, including the e-prescription system is developed and maintained by the nationally funded Health and Wellbeing Infosystem Center, community pharmacy owners have established many noteworthy systems such as the e-pharmacist decision-support system, commodities info systems, online pharmacies, a telehealth prescription reminder service, and an automated dosage dispense system. Some pharmacies are collaborating with private healthcare service providers to allow quick and easy prescription renewal through an electronic channel.ConclusionDifferent electronic systems have overall greatly improved Estonian pharmacy services, accuracy and flow of consultations, and accessibility of medicines. In some cases, more support and active involvement is still needed from government agencies for full implementation.

Evaluation of Drug Pricing in Nigeria: A Focus on Affordability and Availability of Essential Medicines in Federal Capital Territory Abuja

Critical to the success of a country’s healthcare delivery services is the affordability, availability, and accessibility of essential medicines to the populace irrespective of their income status. The price of medicines is an important determinant of medicines affordability and accessibility. Due to seeming inefficient health insurance programs, medicine financing in Nigeria is generally out-of-pocket. In Nigeria, drug prices are set mostly by market forces, with government tariffs, taxes, and distribution mark-ups accounting for a significant proportion of the final price.The following thematic areas of interest to were the focus in evaluating the current situation of drug pricing: National Drug Policy and Drug Pricing; National Drug Distribution Guideline and Drug Pricing; National Policy Framework on Drug Revolving Fund and Drug Pricing; Nigerian Pharmaceutical Market and Drug Pricing.The study evaluated drug pricing in Nigeria by comparing the availability and prices of various brands of a chosen set of essential medicines in different parts of the health sector and different types of health facilities in the Federal Capital Territory Abuja to assess the availability and affordability of these medicines.The study design used a questionnaire format data collection tool based on the 2nd edition of the World Health Organization (WHO) and Health Action International manual for measuring medicine prices, availability, affordability, and price components. The survey was carried out within the Federal Capital Territory Abuja at both public and private health facilities, including community pharmacies. A total of 145 facilities were enumerated and 20% were successfully surveyed. Key data collected included; percentage availability, price of originator brand and generics, price ratio to the international reference price, and the economic effect of current drug prices on the populace.The results showed varied and fantastic outcome, on inferential statistics in comparative analysis; Firstly, for the Public hospital vs Private hospital Medicines’ Prices, there was a significant difference (P<0.05) between the price of medicines in private hospital and the median price of medicines in public hospitals. Also, price of medicines in private hospital was 2.9 times higher than the median price of medicine in public hospital ( p=0.013, t=2.9); Secondly, for the Innovator brand vs Most sold generic brand in community pharmacy, there was a significant difference between the median price of innovator brands of medicines and the median price of the most sold generics. The median price of the innovator brands was approximately 5 times the median price of the most sold generics (p=0.000291, t=4.689); Thirdly, for the Price of medicines across community pharmacies (innovator brand), there was no significant difference (p>0.05) in the prices of innovator brands across the community pharmacies assessed. (p=0.459); Fourthly, for the Price of medicines across community pharmacies (Most sold generic), there was no significant difference (p>0.05) in the prices of the most sold generic brands of medicines across community pharmacies assessed (P=0.915); Fifthly, for the Price of medicine across public hospitals, there was no significant difference (p>0.05) between the prices of medicines across the public hospitals assessed. (p=0.877).There exists a huge price disparity between public and private health facilities, hence there is an overarching need to regulate drug prices in the health sector so as to ensure affordability and availability of essential medicines and other healthcare commodities. There is poor availability of some essential medicines particularly in the public health pharmacies, it is imperative that appropriate measures be put in place to ensure medicine availability. Improving access to medicines is key to attainment of Universal Health Coverage and Patients’ satisfaction of the healthcare delivery system. Keywords: Drug Pricing, Essential Medicines, Affordability, Availability, Nigeria, FCT Abuja DOI: 10.7176/JHMN/97-01 Publication date: January 31 st 2022

Affordability and accessibility of antimicrobial medicines in Bangladesh Market: Paving the way for Universal health coverage (UHC) and antimicrobial resistance combat

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How can humanitarian services provision during mass displacement better support health systems? An exploratory qualitative study of humanitarian service provider perspectives in Cox's Bazar, Bangladesh

Health services provision in mass displacement settings is a humanitarian imperative and essential to promoting international and regional security. Internationally displaced populations experience a range of issues pre-, peri-, post-displacement and residing in host countries that affect their health and well-being. This study examined links between humanitarian and government health services provision for forcibly displaced Myanmar nationals (FDMN) in Cox's Bazar to consider how improved knowledge sharing and collaboration might better support health systems during mass displacement. We conducted a qualitative descriptive study, interviewing 25 humanitarian service providers in-person in Bangladesh in early 2021 and analysing data thematically. We found that government restricted what essential services humanitarian health actors could provide and FDMN had to undergo stringent screening and referral to receive tertiary healthcare. Concurrently, the government health system was challenged by accessibility, affordability and availability of medicines, equipment, and trained staff. Humanitarian health service providers augmented government responses by working with community groups, recruiting and training Rohingya volunteers, and involving religious leaders. Findings suggest that easing barriers to a fuller range of health services, allowing access to digital devices, and hiring FDMN to support their communities would improve health system responsiveness to the legitimate needs of FDMN displaced around Cox's Bazar. It is imperative to amplify and listen to the voices of FDMN and collaborate in addressing structural and social barriers constraining their access to effective health services, both to increase trust in and responsiveness of the health system.

Towards 4th industrial revolution efficient and sustainable continuous flow manufacturing of active pharmaceutical ingredients

The convergence of end-to-end continuous flow synthesis with downstream processing, process analytical technology (PAT), artificial intelligence (AI), machine learning and automation in ensuring improved accessibility of quality medicines on demand.

Government confirms increase in tax rate for branded drug manufacturers

Drug manufacturers that are signed up to the Voluntary Scheme for Branded Medicines Pricing and Access (VPAS) will see their tax rates increase by more than 11 percentage points in 2023, the government has said. The new rate, confirmed on 15 December 2022, means that manufacturers will need to pay the government 26.5% of their […]

Managing pharmaceutical shortages during the COVID pandemic: An exploratory analysis of European collective and national government responses.

Prior to the outbreak of the COVID pandemic, pharmaceutical shortages were already recognised as a major policy problem by most, if not all, European governments; and virtually all European national governments today publicise official shortage lists. Policy making in the area has been centred on the national government level, which meant that the understanding, definition, and response to shortages has remained highly heterogeneous. When the advent of the COVID pandemic exacerbated shortages, this situation continued against a background of a weak collective European response. As part of their responses to COVID-shortages, the medicines regulators of European countries expanded the range of products pharmacies could manufacture, process and distribute as well as their procedural authority in issuing, handling and processing prescriptions. While these measures were fairly common across Europe and alleviated some bottlenecks or improved medicine access for some patient groups, other responses were highly individualistic and included export bans of certain medications as well as efforts to draw on veterinary supplies. Our own data analysis of officially recorded shortage data during the first COVID wave (to October 2020) indicates that countries that had prepared for these types of crisis and maintained an active policy stance (e.g. Germany and Norway) were more likely to encounter fewer shortages than others. We also note that there is no direct correlation between officially recorded numbers of shortages and the ways in which national governments responded to these – which indicates that cultural expectations also might have been a significant policy driver.

Study on Protection of the Right to Health, Access to Medicines and the Construction of the Rule of Law for Medicine Patents

The Access to Medicines is related to the basic rights of people's rights to life and health. It has been widely recognized by international conventions and has become a basic duty of the state to ensure and improve the level of citizens' access to medicines. At the same time, in the face of increasingly widespread uncertainties in modern society, building a fair and efficient legal system for medicines access is a necessary measure to promote citizens' trust in the government and maintain the legitimacy of power. In the conditions of 1.3 billion population and an unbalanced and inadequate economic development, China strives to ensure that its citizens’ medicines are economically affordable through continuous improvement of the legal system and arrangements, and to encourage local pharmaceutical companies to develop and manufacture better-quality medicines. On the premise of respecting the status of market players and property rights of pharmaceutical companies, China comprehensively uses diversified tools such as information, standards, market access, and competition law enforcement to establish a legal system for medicines accessibility from two channels: supply guarantee and price control. Particular attention is paid to the adjustment of the medical and social insurance and essential medicines systems. In recent years, China has focused on improving the pharmaceutical patent system, promoting the balanced development of local original research medicines and generic medicines, as well as the overall optimization and upgrading of the pharmaceutical industry through the protection of patent rights and appropriate restrictions. Driven by the economic and trade agreement reached between China and the United States in 2020, China's Patent Law will introduce a drug patent term extension system and a drug patent linkage system, and further improve the legal mechanism to encourage innovative activities of pharmaceutical companies.

The European framework for intellectual property rights for biological medicines

Introduction: The Pharmaceutical Strategy for Europe (2020) proposes actions related to intellectual property (IP) rights as a means of ensuring patients’ access to medicines. This review aims to describe and discuss the European IP framework and its impact on accessibility of biological medicines and makes some recommendations. Methods: A non-systematic literature review on IP for biological medicines was conducted. Data on authorizations and patent and exclusivity expiry dates of biological medicines obtained from the European Medicines Agency’s (EMA) website and literature was analysed quantitatively and qualitatively. Results: The analysis showed that as at end July 2021, 1,238 medicines were authorized in Europe, of which 332 (26.8%) were biological medicines. There were only 55 biosimilars for 17 unique biologicals. There is an increasing trend in biological authorizations but signifi cant delays in submission of applications for marketing authorization of biosimilars, with no signifi cant diff erences in the time for assessment for marketing authorization between originator biologicals and biosimilars. For some of the more recent biosimilars, applications for authorization were submitted prior to patent and exclusivity expiry. COVID vaccines confi rmed the impact of knowledge transfer on accessibility, especially when linked to joint procurement. Discussion: IP protects originator products and impacts the development of biosimilars. Strategies to improve competition in the EU biological market are discussed. Pricing policies alone do not increase biosimilar uptake since patients are switched to second generation products. Evergreening strategies might be abusing the IP framework, and together with trade secrets and disproportionate prices compared to R & D and manufacturing costs lead to an imbalance between market access and innovation. Conclusion: The European Pharmaceutical Strategy should focus on IP initiatives that support earlier authorization of biosimilars of new biologicals. Recommendations include knowledge sharing, simplifi cation of the regulatory framework and transparency of prices and R & D costs.

NQPC-10 (Rare) Cancer patients’ unmet needs (patient-focused healthcare needs) survey

Background: Rare Cancers Japan (RCJ) consists of members of 20 rare cancer patient groups and individual rare cancer patients, including the Japan Brain Tumor Alliance (JBTA), the Pediatric Brain Tumor Network, and the DIPG Symposium Organizing Committee, and aims to solve the challenges of rare cancers. RCJ, together with the National Cancer Center Japan and the Japan Federation of Cancer Patient Groups is currently conducting a survey to clarify unmet needs of patients, as a follow-up survey to surveys conducted in 2018. Since then, a major paradigm shift happened in Japan, with the advent of genomic medicine and development of new treatments. This study plans to identify the latest unmet needs of cancer patients and to clarify the differences between cancer types to provide data for the improvement of healthcare systems.Purpose: Focusing on unmet needs of cancer patients, we conduct an online questionnaire survey of a total of 1,600 cancer patients (including brain tumor patients) regarding the following endpoints (1) detection and diagnosis, (2) treatment, (3) genomic medicine (access to genetic mutation testing), (4) clinical trials, (5) necessary information, medical care and support systems and (6) quality of life. The collected information will be analyzed to clarify the needs of patients and the nature of patient-centered healthcare. Method: The survey will be administered online, including a mix of open-ended and multiple-choice questions. The total number of questions, including respondent demographics, is 38, and the time required to answer them is expected to be between 15 and 20 minutes. Data analysis will take into account cancer type of cancer, gender, age group and region of residence of the respondent.Expected results: By February 2022, the results of the survey are expected to be available, as basis of discussion to improve brain tumor treatment and follow up, from a multidisciplinary perspective.

Clinical comprehensive evaluation of Diemailing~® Kudiezi Injection in treatment of cerebral infarction

Clinical comprehensive evaluation was conducted in "6+1" dimensions(safety, effectiveness, economy, innovation, suitability, accessibility, and characteristics of traditional Chinese medicine) to reflect the advantages and characteristics of Diemai-ling~® Kudiezi Injection in the treatment of cerebral infarction. This study adopted a combination of qualitative and quantitative evaluation methods. Based on the methodologies of evidence-based medicine, epidemiology, clinical medicine, evidence-based pharmacy, pharmacoeconomics, mathematical statistics, and health technology assessment(HTA), experts gave weight to the criterion layer and index layer, and multi-criteria decision analysis(MCDA) model and CSC v2.0 were used for calculations to evaluate the clinical value of Diemailing~® Kudiezi Injection. The existing evidence showed that active monitoring and a number of randomized controlled trials(RCTs) have been carried out after the listing of Diemailing~® Kudiezi Injection. Since the total incidence of adverse reactions is 0.099% and the incidence of adverse drug reactions(ADR) is rare, the safety evaluation is grade A. The evidence value of effectiveness demonstrated that Diemailing~® Kudiezi Injection combined with conventional western medicine improves the total effective rate of neurological deficit score and quality of daily life in the acute stage of cerebral infarction, which is superior to that in the conventional western medicine treatment group, and the level of evidence is high. Therefore, its efficacy is assessed as grade A. According to the results of economic research, when Diemailing~® Kudiezi Injection combined with conventional western medicine treatment is compared with conventional western medicine treatment, the Diemailing~® Kudiezi Injection group has a greater incremental effect, but the cost is affordable. Given the overall quality evaluation results of economic report is clear, it is evaluated as grade B. The innovation is grade A. The drug is favorable for clinical operation by medical staff and can be accepted by patients due to easy usage without special technical and management requirements. Since the drug exhibits good suitability for clinicians, nurses, pharmacists, and patients, it is evaluated as grade B. Considering its moderate price among similar drugs and good affordability and availability, it is evaluated as grade B. Diemailing~® Kudiezi Injection can evidently improve the clinical symptoms and neurological deficits of fire toxin syndrome of acute cerebral infarction, and this medicine belongs to ethnic medicine. Large-sample active monitoring research has been conducted with rich experience in human use. Therefore, the characteristics of traditional Chinese medicine are evaluated as grade A. The comprehensive clinical evaluation of Diemailing~® Kudiezi Injection is class A. We suggest that it can be directly transformed into relevant policy results of basic clinical medication management by procedure.

Clinical comprehensive evaluation of Naoxintong Capsules in treatment of cerebral infarction with Qi deficiency and blood stasis syndrome and coronary heart disease angina pectoris

Through investigating the current research on the effect of Naoxintong Capsules in the treatment of cerebral infarction with Qi deficiency and blood stasis syndrome and coronary heart disease angina pectoris, this study conducted a clinical comprehensive evaluation in "6+1" dimensions [safety, effectiveness, economy, innovation, suitability, accessibility, and characteristics of traditional Chinese medicine(TCM)], so as to highlight the advantages and clinical value of Naoxintong Capsules. By combining qualitative and quantitative methods, we used the multi-criteria decision analysis(MCDA) model to measure each dimension, and the results thereby were divided into four grades of A, B, C, and D in high-to-low order. Through literature review and evaluation, the adverse effects of Naoxintong Capsules are mainly caused by the gastrointestinal system. Since the safety risk is controllable based on current research, the safety evaluation is grade B. The effectiveness of Naoxintong Capsules combined with conventional western medicine in the treatment of cerebral infarction with Qi deficiency and blood stasis syndrome and coronary heart disease angina pectoris is evaluated as grade A, as compared with conventional therapy alone. The economy of Naoxintong Capsules, compared with Tongxinluo Capsules, is assessed as grade B. According to literature reports, Naoxintong Capsules exhibits outstanding clinical innovation in optimizing the current anti-platelet therapy strategy for patients with coronary heart disease after percutaneous coronary intervention(PCI), and the innovation is class A. Given the capsule formulation is convenient for storage and transportation, and its usage is easy for patients to grasp and accept, the suitability is grade B. The accessibility is grade A considering the price level, availability, and affordability, and the characteristics of TCM are evaluated as grade A from the perspectives of theoretical characteristics and human experience. The results of the comprehensive drug evaluation showed that the clinical value of Naoxintong Capsules is class A for treating cerebral infarction with Qi deficiency and blood stasis syndrome and coronary heart disease angina pectoris. According to the Guidelines for the Management of Comprehensive Clinical Evaluation of Drugs(trial 2021 version) issued by the National Health Commission, relevant policy results for basic clinical drug management can be formulated directly by procedure.

Community involvement and awareness raising for better development, access and use of medicines: The transformative potential of photovoice.

Photovoice is a qualitative research method where people, through images (photography, drawings or paintings), capture, represent, and communicate their experiences and perspectives about issues that are important to them with the final goal of raising awareness and triggering social change. Photovoice is informed by participatory action research approaches, feminist theory, Paulo Freire's critical pedagogy, and the theory of photography. Developed with the explicit purpose of gathering voices to advocate for structural social change in the early 1990s, the application of Photovoice in projects related to social pharmacy research started approximately 15 year later. The first Photovoice studies within social pharmacy aimed at understanding patients' experiences with their medications. Photovoice has also been integrated in interventions mainly focused on enhancing adherence to pharmacological treatments. There is still, however, room to fully unfold the empowering and emancipatory potential of Photovoice within social pharmacy research. This article briefly presents the theories underlying Photovoice, a guide for its appropriate methodological and ethical implementation, and with the aim to serve as inspiration for future social pharmacy research projects, it also includes three previously published studies that used Photovoice to understand, raise awareness and trigger social change to facilitate better lives when in need of pharmacological treatments.

Clinical comprehensive evaluation of Mudan Granules in treatment of diabetic peripheral neuropathy with Qi-deficiency and collateral stagnation syndrome

This study explored the clinical comprehensive evaluation of Mudan Granules, aiming to promote the safe, effective and rational use of Mudan Granules, reflect its clinical value and provide a basis for medical decision-making. The safety, effectiveness, economy, innovation, suitability, accessibility, and characteristics of traditional Chinese medicine of Mudan Granules were combed, and the multi-criteria decision analysis(MCDA) model was used to carry out comprehensive evaluation on each dimension. In terms of safety, multiple sources of evidence showed that the adverse reactions of Mudan Granules mainly involved gastrointestinal system, with controllable safety risk rated as grade B. In terms of effectiveness, Mudan Granules can significantly alleviate the diabetic peripheral neuropathy(Qi-deficiency and collateral stagnation syndrome), limb and trunk numbness, pain and sensory abnormalities and other clinical symptoms, exhibiting positive curative effect rated as grade A. In terms of economy, Mudan Granules combined with Mecobalamin and other conventional western medicines is economical compared with the western medicine alone group, which is supported by sufficient evidence and clear results, rated as grade B. In terms of innovation, Mudan Granules is the only Chinese patent medicine with the indication of benefiting Qi for activating blood circulation and dredging collaterals in the Medicine Catalogue for National Basic Medical Insurance, Industrial Injury Insurance, and Maternity Insurance. It has important clinical innovation and is evaluated as grade A. In the aspect of suitability, Mudan Granules has good suitability in ADR treatment, drug characteristics and usage, and is rated as grade B. In terms of accessibility, Mudan Granules has the price level comparable to that of similar drugs, with good affordability. The resources of medicinal materials for the preparation of Mudan Granules are abundant and available, which is rated grade B. Moreover, Mudan Granules, as a hospital preparation with both functions of tonification and purgation, reflects the combination between syndrome differentiation and disease differentiation as well as the combination between overall and local characteristics, and has prominent Chinese medicine features. According to the above dimensions, we suggest to classify Mudan Granules as a class A preparation which can be directly included the policy results of basic clinical drug administration.

Clinical comprehensive evaluation of Danhong Injection in treatment of stroke with blood stasis syndrome

This study systematically reviewed the existing research on Danhong Injection in the treatment of stroke with blood stasis syndrome. The methods of evidence-based medicine, epidemiology, clinical medicine, evidence-based pharmacy, drug economics, mathematical statistics, and health technology assessment(HTA) were employed to qualitatively and quantitatively evaluate the "6+1" dimensions(safety, effectiveness, economy, innovation, suitability, accessibility, and characteristics of traditional Chinese medicine) of Danhong Injection through questionnaire survey, public information, real world data, and secondary evaluation of literature. With the weights given by experts, the multi-criteria decision analysis(MCDA) model was employed to measure each dimension and highlight the clinical value of Danhong Injection. Multi-source safety evidence showed that Danhong Injection had been fully monitored and studied. The severity of adverse reactions was mostly moderate or mild, and the prognosis was good. So it was rated as grade A for safety. Compared with Ligustrazine Injection, Fufang Danshen Injection and conventional treatment of western medicine, Danhong Injection had obvious advantages in clinical response rate and NIHSS score improvement in the treatment of stroke with blood stasis syndrome. So it was rated as grade A for effectiveness. Compared with Ligustrazine Injection and Yinxing Damo Injection, Danhong Injection had a cost-effectiveness advantage in the treatment of stroke with blood stasis syndrome, and the economic results were good. According to the existing evidence, the Danhong Injection was rated as grade B for economy. Danhong Injection had won a number of national patents, which was rated as grade A for its good innovation in guaranteeing supply measures, scalability of production capacity, and production process. It had good suitability for clinicians, nurses, pharmacists, and patients using the drug, and met the needs of clinical medication, so it was rated as grade B for suitability. Danhong Injection is rich in medicinal materials, stable in price, and sustainable. However, its availability needed to be further improved due to the limitation of prescription use, so it was rated as grade B for accessibility. Danhong Injection can promote blood circulation, resolve blood stasis, warm vessels, and smooth collaterals. It had accumulated more than 30 000 pieces of empirical evidence for human use in the real world. It had prominent characteristics of traditional Chinese medicine and was rated as grade B. CSC v2.0 was used for calculation, and the clinical value of Danhong Injection was comprehensively evaluated as class A, which could be directly translated into relevant policy results of basic clinical medication management according to the Guidelines for the Management Clinical Comprehensive Evaluation of Drugs(trial version 2021).

Clinical comprehensive evaluation of Wenxin Granules in treatment of arrhythmia with deficiency of Qi and Yin

This study evaluated the safety, effectiveness, economy, innovation, suitability, accessibility, and characteristics of traditional Chinese medicine of Wenxin Granules in the treatment of arrhythmia(ventricular premature beat and atrial premature beat) with deficiency of Qi and Yin. The multi-criteria decision analysis(MCDA) model was adopted, and the criterion layer and index layer were weighted by experts. CSC v2.0 was used for clinical comprehensive evaluation. This study embodies the clinical value of Wenxin Granules, promotes its safe, effective and rational use, and provides a basis for national medical decision-making. The multi-source evidence shows that the major adverse reaction of Wenxin Granules is gastrointestinal damage. According to the available studies, Wenxin Granules has controllable risk and thus is rated as grade B in terms of safety. The systematic evaluation of effectiveness shows that compared with antiarrhythmic western medicine, Wenxin Granules demonstrates improved clinical efficacy and electrocardiogram efficacy, which is supported by high-quality evidence, and thus the effectiveness of Wenxin Granules is evaluated as grade A. Economic research shows that Wenxin Granules is more economical than antiarrhythmic western medicine, which is supported by sufficient evidence and clear results, and thus the economy of this preparation is rated as grade B. The indications and contraindications of Wenxin Granules are clear and detailed to different types of arrhythmia, which, together with the precise positioning and prominent clinical innovation and industrial innovation, rates it as grade A in terms of innovation. The suitability of drug storage, prescription circulation, dosage form and course of treatment basically meet the clinical medication needs of doctors and patients, and thus the suitability of Wenxin Granules is evaluated as grade B. Because of the few restrictions and the sustainable resources of medicinal materials, the accessibility of Wenxin Granules is evaluated as grade A. The prescription compatibility focuses on the pathogenesis characteristics of deficiency of Qi and Yin, and there are more than 3 000 cases studied. Therefore, the characteristics of traditional Chinese medicine of Wenxin Granules are evaluated as grade B. Based on the evidence from all the above dimensions, Wenxin Granules has the clinical comprehensive value of class A and prominent characteristics of traditional Chinese medicine. It is suggested to include Wenxin Granules into the policy results related to basic clinical medication management according to the procedure.

Development of biosimilaries and biosimilar growth hormone

In this article, an informative presentation was made about the development of biosimilar and biosimilar growth hormone in Europe and the Republic of Moldova following the selection and analysis of 37 bibliographic sources from the PubMed database and from specialized journals. Human growth hormone was approved by the EMA in 2006 as the world’s first biosimilar drug. Recombinant growth hormone therapy is currently approved for growth hormone deficiency, Turner syndrome, chronic kidney failure, in children/adolescents born young for gestational age and Prader-Willi syndrome. At the same time, biosimulation therapy is very expensive. In the Republic of Moldova but also in Eastern Europe, the accessibility of biological medicines is extremely low due to the lack of local or regional producers. Th e development of the biosimilar production branch, including the biosimilar growth hormone in the Republic of Moldova, will be an attractive and pharmacoeconomically advantageous option for the therapeutic arsenal.

PP89 The Investigation And Development Of A National Formulary Monitoring System Across Wales

IntroductionThe New Treatment Fund (NTF), launched in January 2017, aims to support the faster introduction of new medicines recommended by the National Institute for Health and Care Excellence (NICE) and the All Wales Medicines Strategy Group (AWMSG). The NTF requires seven health boards and one trust to make recommended medicines available within 60 days of any positive recommendation decision. The project goal was to develop a system for demonstrating how monitoring the NTF improves medicines access for the people of Wales.MethodsThe process was derived via a series of task and finish group meetings with relevant stakeholders. The monitoring criteria were agreed through a collaborative expert approach using a nominal group technique. This determined a minimal dataset of formulary status, which included time to formulary addition. Pre-NTF medicines data (n = 59) were available for a six-month period.ResultsBy the three-year milestone of the NTF, the average time taken for newly recommended medicines (n = 219) to become available to patients across Wales had decreased by eighty-five percent from 90 to 13 days (p < 0.01).ConclusionsAn innovative and robust system has been created for accurately monitoring the formulary addition of medicines within the NTF, supporting the rapid and comprehensive uptake of medicines deemed clinically and cost effective by NICE and the AWMSG.

(De)constructing ‘therapeutic itineraries’ of hypertension care: A qualitative study in the Philippines

Hypertension, a major risk factor for non-communicable diseases, remains poorly controlled in many countries. In the Philippines, it is still one of the leading causes of preventable deaths despite the accessibility and availability of essential technologies and medicine to detect and treat hypertension. This paper characterizes the ‘therapeutic itineraries’ of people with hypertension from poor communities in rural and urban settings in the Philippines. We employ longitudinal qualitative methodology comprised of repeat interviews and digital diaries using mobile phones from 40 recruited participants in 12 months. Our findings demonstrate that therapeutic itineraries, rather than being organized according to categories that stem from the structure of the health system (i.e., diagnosis, treatment, follow-up, adherence), diverge from clinical pathways. Therapeutic itineraries begin at a stage we label as ‘pre-diagnosis’ (PD). Following this, itineraries diverge according to two possible entry points into the healthcare system: via incidental diagnosis (ID) whereby participants were diagnosed with hypertension without deliberately seeking care for hypertension-related symptoms and symptom-driven diagnosis (SD) whereby their diagnosis was obtained during a clinical encounter specifically prompted by hypertension-related symptoms. Participants whose itineraries follow the SD route typically oscillated between periods of regular and intermittent medical treatment, while participants who were diagnosed incidentally (ID) typically opted for self-care As we follow our participants' therapeutic itineraries, we explore the confluence of factors informing their care journey, namely, their conceptions of hypertension, their social relationships, as well the choices and trade-offs they make. We conclude with policy implications from our findings, chief of which is our proposition that models of care based on mere access and availability of clinical interventions fail to reflect the complexity of people's lay understanding and their lived experiences of hypertension and are thus ultimately unhelpful in improving its control.

Factors Associated with Free Medicine Use in Patients with Hypertension and Diabetes: A 4-Year Longitudinal Study on Full Coverage Policy for Essential Medicines in Taizhou, China.

Full coverage policies for medicines have been implemented worldwide to alleviate medicine cost burden and promote access to medicines. However, few studies have explored the factors associated with free medicine use in patients with chronic diseases. This study aimed to analyze the utilization of free medicines by patients with hypertension and diabetes after the implementation of the full coverage policy for essential medicines (FCPEM) in Taizhou, China, and to explore the factors associated with free medicine use. We conducted a descriptive analysis of characteristics of patients with and without free medicine use and performed a panel logit model to examine factors associated with free medicine use, based on an electronic health record database in Taizhou from the baseline year (12 months in priori) to three years after FCPEM implementation. After FCPEM implementation, the proportion of patients without any free medicine use decreased from 31.1% in the baseline year to 28.9% in the third year, while that of patients taking free medicines rose from 11.0% to 22.8%. Patients with lower income or education level, those with agricultural hukou, patients aged 65 and above, married patients, and patients in the Huangyan district were more likely to take free medicines. In conclusion, FCPEM contributed to improved medicine access, especially in vulnerable populations. Local policy makers should consider expanding the coverage of FCPEM to other types of medicines and cultivate the potential of social supports for patients to enhance the effectiveness of FCPEM policies.