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Facing the unmet need for new, affordable medicines for public health crises, how should states' duty to ensure that everyone shares in the benefits of science be understood in relation to pandemic vaccine supply, and how has the United Nations Committee on Economic, Social and Cultural Rights monitored the implementation of this right? In this paper, we examine the contours and content of state obligations with regard to pandemic vaccine supply under the right to science (article 15(1)(b) of the International Covenant on Economic, Social and Cultural Rights), focusing on three aspects of state obligations: mobilizing public resources for developing and disseminating the benefits of scientific progress in areas of public health need; preventing unreasonably high medicines prices; and international cooperation, particularly in a globalized health emergency. The committee regularly assesses state parties' implementation of their obligations under the covenant, culminating in the issuing of concluding observations, which often serve as a basis for the next round of periodic reporting by states and can thereby direct future state action. Our analysis of the committee's concluding observations reveals that the committee has inconsistently applied its own guidance on the right to science regarding medicines and intellectual property in these monitoring exercises. These findings inform a rights-based response to medical innovation for health crises and advance the Sustainable Development Goal target on medicines research and development.

Le faible acces aux medicaments pour plus d’un million de Canadiens represente bien plus qu’un risque pour leur sante et un fardeau economique; il s’agit d’une violation de leurs droits. L’objectif de developpement durable en matiere de sante met en evidence le lien qui existe

Universal health coverage (UHC) aims to ensure that all people have access to health services including essential medicines without risking financial hardship. Yet, in many low- and middle-income countries (LMICs) inadequate UHC fails to ensure universal access to medicines and protect the poor and vulnerable against catastrophic spending in the event of illness. A human rights approach to essential medicines in national UHC legislation could remedy these inequities. This study identifies and compares legal texts from national UHC legislation that promote universal access to medicines in the legislation of 16 mostly LMICs: Algeria, Chile, Colombia, Ghana, Indonesia, Jordan, Mexico, Morocco, Nigeria, Philippines, Rwanda, South Africa, Tanzania, Turkey, Tunisia and Uruguay. The assessment tool was developed based on WHO’s policy guidelines for essential medicines and international human rights law; it consists of 12 principles in three domains: legal rights and obligations, good governance, and technical implementation. Relevant legislation was identified, mapped, collected and independently assessed by multi-disciplinary, multi-lingual teams. Legal rights and State obligations toward medicines are frequently codified in UHC law, while most good governance principles are less common. Some technical implementation principles are frequently embedded in national UHC law (i.e. pooled user contributions and financial coverage for the vulnerable), while others are infrequent (i.e. sufficient government financing) to almost absent (i.e. seeking international assistance and cooperation). Generally, upper-middle and high-income countries tended to embed explicit rights and obligations with clear boundaries, and universal mechanisms for accountability and redress in domestic law while less affluent countries took different approaches. This research presents national law makers with both a checklist and a wish list for legal reform for access to medicines, as well as examples of legal texts. It may support goal 7 of the WHO Medicines & Health Products Strategic Programme 2016–30 to develop model legislation for medicines reimbursement.

The COVID-19 pandemic illuminates the need to move away from the current social contract, which focuses on the nation-state’s responsibility for protecting the health of its own population, including by providing essential medicines and health technologies.We argue for embracing a global social contract, which is a governance concept that lays the foundation for how states should act as members of the international community, as regulators of the private pharmaceutical industry and as guarantors of public goods benefiting people worldwide.A global social contract should be based on a set of four principles: collective state stewardship of the pharmaceutical and health technology; equity and the protection of health as a human right; an effective global polity; and governmental transparency and democratic accountability.This foundation can serve as a basis for a future pandemic treaty and as a model to address the much broader global crisis of inequitable access to medicines and health technologies for infectious and non-communicable diseases.

A critical debate in the race to develop, market, and distribute COVID-19 vaccines could define the future of this pandemic: How much evidence demonstrating a vaccine’s safety and efficacy should be required before it is considered “essential”? If a COVID-19 vaccine were to be designated an essential medicine by the World Health Organization, this would invoke special “core” human rights duties for governments to provide the vaccine as a matter of priority irrespective of resource constraints. States would also have duties to make the vaccine available in adequate amounts, in the appropriate dosage forms, with assured quality and adequate information, and at an affordable price. This question is especially critical and unique given that COVID-19 vaccines have in many cases been authorized for use via national emergency use authorization processes—mechanisms that enable the public to gain access to promising medical products before they have received full regulatory approval and licensure. In this paper, we examine whether unlicensed COVID-19 vaccines authorized for emergency use should ever be considered essential medicines, thereby placing prioritized obligations on countries regarding their accessibility and affordability.

Background Adverse drug reactions (ADRs) are common and have serious repercussions for older-adults. This descriptive-analysis elucidates clinical presentations, severity and responsible drugs of incident ADRs in the SENATOR (Software ENgine for the Assessment & optimization of drug and non-drug Therapy in Older peRsons) phase I feasibility study. Methods SENATOR-phase-I was a European multicentre-prospective-observational study. Participants were ≥ 65 years, experiencing acute-hospitalisation and on pharmacological treatment for ≥ 3 conditions. Adverse events (AEs) were identified by trigger list at recruitment, day-14/discharge and classified as ADRs when association with an administered drug was adjudicated as being probable/certain, according to the World Health Organization Uppsala Monitoring Centre ADR causality criteria. Results Of 644 participants recruited, 382 (59.1%) experienced 732 AEs, 363 AEs (49.6%) being incident. 139 participants (21.6%) experienced 177 (48.8%) ADRs. Full drug details were recorded in 156 patients (88%). Cardiovascular-system drugs accounted for one-third of ADRs (55, 35.3%). Five drug classes caused three-quarters of ADRs (135, 76.3%); diuretics 28.2% (furosemide 24.4%), opioid analgesics 16.7%, anti-bacterials for systemic use 14.1%, anti-thrombotic agents 10.3%, and drugs used in diabetes 7%. 68 patients (10.6%) experienced 81 (45.8%) clinically significant moderate-severe ADRs. Significant serum electrolyte disturbance (32, 18.1%), acute kidney injury [AKI] (22, 12.4%), unspecified adverse event (UAE; 21, 11.9%), dyspepsia/nausea/vomiting (20, 11.3%), new-onset major constipation (19, 10.7%) were the most common presentations of ADRs, accounting for 114, (64.4%) of all ADRs. In moderate-severe ADRs; AKI (12, 14.8%), acute bleeding (11, 13.6%), new-onset major constipation (11, 13.6%), UAE (11, 13.6%), significant serum electrolyte disturbance (10, 12.4%) were the most common presentations. Conclusion This analysis highlights that; 1-in-5 older adults will experience an incident ADR during acute hospitalisation. 1-in-10 patients experience moderate-severe incident ADRs. 3-of-4 ADRs were caused by 5 drug classes (diuretics, opioids, anti-bacterials, anti-thrombotics and anti-diabetic agents). This study allows for identification of potentially high risk medications which could be targeted for future ADR prevention.

In 2008 the UN Special Rapporteur on the Right to Health published 72 right to health indicators in 194 health systems. We present a follow-up report of eight indicators for access to medicines to serve as a reference point for progress towards SDG Target 3.8 on essential medicines. Data for these eight indicators in 2015 were collected and compared with the 2008 report. Between 2008 and 2015 we observed increased numbers of constitutions recognising access to medicines (7-13 countries), countries with a national medicine policy (118-122) and with a national list of essential medicines (78-107). Public spending on pharmaceuticals decreased or rose modestly in most of the 44 countries. Median availability of a basket of lowest-priced generics increased in the public (63%-70% n = 9 countries) and private (84%-92% n = 10) sectors. Median child immunisation rates remained constant for measles (around 90%) and improved for three doses of diphtheria-tetanus-pertussis (79%-86%). These eight indicators are useful and feasible, but should be further strengthened and expanded. Future monitoring exercises should use these indicators to screen progress and guide national governments' action to ensure universal access to essential medicines as part of the right to health.

Scaling up access to new COVID-19 vaccines and therapies (‘medicines’) and medical technologies is essential to move from pandemic response to recovery. One of the key conditions for governments to produce and/or procure a sufficient supply of COVID-19 medicines is access to their intellectual property (IP). Although the research and development (R&D) of many vaccine and therapeutic candidates has been partially or entirely publicly funded, the resulting products will be owned by the companies that bring them to market. Therefore, intellectual property rights will be a significant determinant of global access to COVID-19 medicines. Intellectual property rules aim to compensate inventors for their investments in R&D, while also making innovations available for use by the public. The underlying premises of this system have been called into question for, among other reasons, the disconnect between growing public-funding for drug R&D resulting in privately-owned medicines. In 1995, a set of global trade rules in the World Trade Organization (WTO) Agreement on the Trade-Related Aspects of Intellectual Property (TRIPS Agreement) established the minimum standards for protecting intellectual property worldwide (see box 1). These trade rules drastically impacted human health: introduced near to the 2000s HIV/AIDS global epidemic, owners of patents and other forms of intellectual property hampered access to lifesaving antiretrovirals to people infected with HIV through excessive monopolistic prices.1 Box 1 How patents influence access to new medicines Patents on pharmaceuticals and medical technologies are an important aspect of intellectual property. The Trade-Related Aspects of Intellectual Property Agreement requires the 164 countries that are members of the World Trade Organization, with the exception of Least Developed Countries, to make 20-year patents available for inventions in all fields of technology. These patent rules aim to compensate inventors (ie, patent holders) for their innovative processes and products. During this period of time, the patent holder has the sole right to produce, import, offer to sell and sell the medicine, unless the patent holder or the government chooses otherwise (see two approaches below). This arrangement often gives the patent holder a market monopoly and the power to ask any price it chooses. Voluntary licensing and compulsory licensing/government use are two approaches to increase competition in the pharmaceutical market while a patent is still valid.

Very few studies exist of legal interventions (national laws) for essential medicines as part of universal health coverage in middle-income countries, or how the effect of these laws is measured. This study aims to critically assess whether laws related to universal health coverage use five objectives of public health law to promote medicines affordability and financing, and to understand how access to medicines achieved through these laws is measured. This comparative case study of five middle-income countries (Ecuador, Ghana, Philippines, South Africa, Ukraine) uses a public health law framework to guide the content analysis of national laws and the scoping review of empirical evidence for measuring access to medicines. Sixty laws were included. All countries write into national law: (a) health equity objectives, (b) remedies for users/patients and sanctions for some stakeholders, (c) economic policies and regulatory objectives for financing (except South Africa), pricing, and benefits selection (except South Africa), (d) information dissemination objectives (ex. for medicines prices (except Ghana)), and (e) public health infrastructure. The 17 studies included in the scoping review evaluate laws with economic policy and regulatory objectives (n = 14 articles), health equity (n = 10), information dissemination (n = 3), infrastructure (n = 2), and sanctions (n = 1) (not mutually exclusive). Cross-sectional descriptive designs (n = 8 articles) and time series analyses (n = 5) were the most frequent designs. Change in patients&rsquo, spending on medicines was the most frequent outcome measure (n = 5). Although legal interventions for pharmaceuticals in middle-income countries commonly use all objectives of public health law, the intended and unintended effects of economic policies and regulation are most frequently investigated.

Background Uganda has one of the highest maternal deaths at a ratio of 336 per 100,000 live births. As Uganda strives to achieve sustainable development goals, appropriate antenatal care is key to reduction of maternal mortality. We explored women’s reported receipt of seven of the Uganda guidelines components of antenatal care, and associated factors in hard to reach Lake Victoria island fishing communities of Kalangala district. Methods A cross sectional survey among 486 consenting women aged 15–49 years, who were pregnant at any time in the past 6 months was conducted in 6 island fishing communities of Kalangala district, Uganda, during January–May 2018. Interviewer administered questionnaires, were used to collect data on socio-demographics and receipt of seven of the Uganda guidelines components of antenatal care. Regression modeling was used to determine factors associated with receipt of all seven components. Results Over three fifths (65.0%) had at least one ANC visit during current or most recent pregnancy. Fewer than a quarter of women who reported attending care at least four times received all seven ANC components [(23.6%), P Conclusions We observed that the delivery of antenatal care components per Ugandan guidelines is poor in these communities. Cost effective endeavors to improve components of antenatal care received by women are urgently needed. Task shifting some components of ANC to community health workers may improve care in these island communities. Trial registration PACTR201903906459874 (Retrospectively registered).

This Scoping Review synthesises evidence of the impacts of European Union (EU) law, regulation, and policy on access to medicines in in non-EU low- and middle-income countries (LMICs), and the mechanisms and nature of those impacts. We searched eight scholarly databases and grey literature published between 1995-2021 in four languages. The EU exerts global influence on pharmaceuticals in LMICs in three ways: explicit agreements between EU-LMICs (ex. accession, trade, and economic agreements); LMICs' reliance on EU internal regulation, standards, or methods (ex. market authorisation); 'soft' forms of EU influence (ex. research funding, capacity building). This study illustrates that EU policy makers adopt measures with the potential to influence medicines in LMICs despite limited evidence of their positive and/or negative impact(s). The EU's fragmented internal and external actions in fields related to pharmaceuticals reveal the need for principles for global equitable access to medicines to guide EU policy.Esta revisión exploratoria sintetiza la evidencia disponible sobre el impacto que ejercen las leyes, las políticas y las regulaciones de la Unión Europea (UE) sobre el acceso a los medicamentos en países de bajo y mediano ingreso (PBMI) que no pertenecen a la UE. La búsqueda se realizó en ocho bases de datos académicas, incluyendo literatura gris. Se incluyeron publicaciones en cuatro idiomas entre 1995 y 2021. Como resultado principal se encontró que la UE ejerce su influencia sobre los productos farmacéuticos en los PBMI a través de tres mecanismos principales: i) acuerdos explícitos entre la UE y los PBMI, por ejemplo, acuerdos de ascensión a la UE o tratados comerciales, ii) utilización de la normativa, estándares o métodos de la UE por parte de los PBMI (reliance) para, por ejemplo, autorizar el ingreso de nuevos medicamentos a partir de la autorización previa por parte de la UE) y, iii) formas blandas de influencia de la UE, por ejemplo, a través de financiación a la investigación o al desarrollo de capacidades locales. Esta revisión revela que los tomadores de decisión de la UE adoptan medidas que, a pesar de la escasa evidencia que sustenta su impacto, positivo o negativo, tienen el potencial de influir en el acceso a los medicamentos de los PBMI. El accionar fragmentado de la UE respecto a los productos farmacéuticos, tanto a nivel interno como externo, son una clara muestra de la necesidad de crear principios que guíen las políticas de la UE frente al acceso equitativo a los medicamentos a nivel global.Это обзорное исследование обобщает данные о глобальном регуляторном влиянии Европейского Союза (ЕС) на доступ к лекарственным средствам в странах с низким и средним уровнем доходом (СНСД), которые не входят в ЕС. Был осуществлен поиск словосочетаний «развивающиеся страны», «Европейский Союз», «лекарственные средства» в восьми базах данных (OvidMedline, Scopus, Web of Science, Epistemonikos, HeinOnline, LILACS, E-library, Научный архив) и серой литературе. Были рассмотрены документы на английском, испанском, португальском и русском, опубликованные между 1995-2021, которые касались права ЕС, регуляторной политики относительно доступа к лекарственным средствам в СНСД. Было отобрано 3954 публикаций, из которых 109 включены (13 научных статей). ЕС оказывает глобальное влияние на лекарственные средства в СНСД тремя способами: определенные соглашения между ЕС-СНСД; использование СНСД внутренних норм, стандартов и методов ЕС; «мягкие» формы влияния ЕС. Данное исследование демонстрирует, что разработчики политики ЕС принимают меры с потенциальным влиянием на лекарственные средства в СНСД, несмотря на ограниченные данные об их положительном и/или негативном влиянии (- ях).

Persistent barriers to universal access to medicines are limited social protection in the event of illness, inadequate financing for essential medicines, frequent stock-outs in the public sector, and high prices in the private sector. We argue that greater coherence between human rights law, national medicines policies, and universal health coverage schemes can address these barriers. We present a cross-national content analysis of national medicines policies from 71 countries published between 1990-2016. The World Health Organization's ( WHO) 2001 guidelines for developing and implementing a national medicines policy and all 71 national medicines policies were assessed on 12 principles, linking a health systems approach to essential medicines with international human rights law for medicines affordability and financing for vulnerable groups. National medicines policies most frequently contain measures for medicines selection and efficient spending/cost-effectiveness. Four principles ( legal right to health; government financing; efficient spending; and financial protection of vulnerable populations) are significantly stronger in national medicines policies published after 2004 than before. Six principles have remained weak or absent: pooling user contributions, international cooperation, and four principles for good governance. Overall, South Africa ( 1996), Indonesia and South Sudan ( 2006), Philippines ( 2011-2016), Malaysia ( 2012), Somalia ( 2013), Afghanistan ( 2014), and Uganda ( 2015) include the most relevant texts and can be used as models for other settings. We conclude that WHO's 2001 guidelines have guided the content and language of many subsequent national medicines policies. WHO and national policy makers can use these principles and the practical examples identified in our study to further align national medicines policies with human rights law and with Target 3.8 for universal access to essential medicines in the Sustainable Development Goals.

We finally have a vaccine for the COVID-19 crisis. However, due to the limited numbers of the vaccine, states will have to consider how to prioritise groups who receive the vaccine. In this paper, we argue that the practical implementation of human rights law requires broader consideration of intersectional needs in society and the disproportionate impact that COVID-19 is having on population groups with pre-existing social and medical vulnerabilities. The existing frameworks/mechanisms and proposals for COVID-19 vaccine allocation have shortcomings from a human rights perspective that could be remedied by adopting an intersectional allocative approach. This necessitates that states allocate the first COVID-19 vaccines according to (1) infection risk and severity of pre-existing diseases; (2) social vulnerabilities; and (3) potential financial and social effects of ill health. In line with WHO’s guidelines on universal health coverage, a COVID-19 vaccine allocation strategy that it is more consistent with international human rights law should ensure that vaccines are free at the point of service, give priority to the worst off and be allocated in a transparent, participatory and accountable prioritisation process.

Objectives: The psychotropic education and knowledge test for nurses in acute geriatric care (PEAK-AC) measures knowledge of psychotropic indications, doses and adverse drug reactions in older inpatients. Given the low internal consistency and poor discrimination of certain items, this study aims to adapt the PEAK-AC, validate it in the nursing home setting and identify factors related to nurses’ knowledge of psychotropics. Method: This study included nurses and nurse assistants employed by nursing homes (n = 13) and nursing students at educational institutions (n = 5) in Belgium. A Delphi technique was used to establish content validity, the known groups technique for construct validity (nrespondents = 550) and the test–retest procedure for reliability (nrespondents = 42). Internal consistency and item analysis were determined. Results: The psychotropic education and knowledge test for nurses in nursing homes (PEAK-NH) (nitems = 19) demonstrated reliability (κ = 0.641) and internal consistency (Cronbach's α = 0.773). Significant differences between-group median scores were observed by function (p < 0.001), gender (p = 0.019), educational background (p < 0.001), work experience (p = 0.008) and continuing education (p < 0.001) for depression, delirium and pharmacotherapy topics. Items were acceptably difficult (nitems = 15) and well-functioning discriminators (nitems = 17). Median PEAK-NH score was 9/19 points (interquartile range 6–11 points). Respondents’ own estimated knowledge was related to their PEAK-NH performance (p < 0.001). Conclusion: The PEAK-NH is a valid and reliable instrument to measure nurses’ knowledge of psychotropics. These results suggest that nurses have limited knowledge of psychotropic use in nursing homes and are aware of their knowledge deficits. The PEAK-NH enables educational initiatives to be targeted and their impact on nurses’ knowledge to be tracked.

A constitutional guarantee of access to essential medicines has been identified as an important indicator of government commitment to the progressive realization of the right to the highest attainable standard of health. The objective of this study was to evaluate provisions on access to essential medicines in national constitutions, to identify comprehensive examples of constitutional text on medicines that can be used as a model for other countries, and to evaluate the evolution of constitutional medicines-related rights since 2008. Relevant articles were selected from an inventory of constitutional texts from WHO member states. References to states’ legal obligations under international human rights law were evaluated. Twenty-two constitutions worldwide now oblige governments to protect and/or to fulfill accessibility of, availability of, and/or quality of medicines. Since 2008, state responsibilities to fulfill access to essential medicines have expanded in five constitutions, been maintained in four constitutions, and have regressed in one constitution. Government commitments to essential medicines are an important foundation of health system equity and are included increasingly in state constitutions.

Uruguay has witnessed an ever-increasing number of domestic court claims for high-priced medicines despite its comprehensive universal coverage of pharmaceuticals. In response to the current national debate and development of domestic legislation concerning high-priced medicines, we review whether Uruguayan courts adequately interpret the state's core obligations to provide essential medicines and ensure non-discriminatory access in line with the right to health in the International Covenant on Economic, Social and Cultural Rights. Using a sample of 42 amparo claims for the reimbursement of medicines in 2015, we found that the circuits of appeal fail to offer predictable legal argumentation, including for nearly identical cases. Moreover, the judiciary does not provide an interpretation of state obligations that is consistently aligned with the right to health in the International Covenant on Economic, Social and Cultural Rights. These findings illustrate that medicines litigation in Uruguay offers relief for some individual claims but may exacerbate systemic inequalities by failing to address the structural problems behind high medicines prices. We recommend that the judiciary adopt a consistent standard for assessing state action to realize the right to health within its available resources. Moreover, the legislature should address the need for medicines price control and offer a harmonized interpretation of the right to health. These transformations can increase the transparency and predictability of Uruguay's health and legal systems for patients and communities.

Background: Adverse drug reactions (ADRs) are common in older adults and frequently have serious clinical and economic consequences. This study was conducted as a feasibility study for a randomized control trial (RCT) that will investigate the efficacy of a software engine to optimize medications and reduce incident (in-hospital) ADRs. This study’s objectives were to (i) establish current incident ADR rates across the six sites participating in the forthcoming RCT and (ii) assess whether incident ADRs are predictable. Methods: This was a multicentre, prospective observational study involving six European hospitals. Adults aged ⩾ 65 years, hospitalized with an acute illness and on pharmacological treatment for three or more conditions were eligible for inclusion. Adverse events (AEs) were captured using a trigger list of 12 common ADRs. An AE was deemed an ADR when its association with an administered drug was adjudicated as being probable/certain, according to the World Health Organization Uppsala Monitoring Centre causality assessment. The proportion of patients experiencing at least one, probable/certain, incident ADR within 14 days of enrolment/discharge was recorded. Results: A total of 644 patients were recruited, evenly split by sex and overwhelmingly of White ethnicity. Over 80% of admissions were medical. The median number of chronic conditions was five (interquartile range 4–6), with eight or more conditions present in approximately 10%. The mean number of prescribed medications was 9.9 (standard deviation 3.8), which correlated strongly with the number of conditions ( r = 0.54, p < 0.0001). A total of 732 AEs were recorded in 382 patients, of which 363 were incident. The majority of events were classified as probably or possibly drug related, with heterogeneity across sites (χ2 = 88.567, df = 20, p value < 0.001). Out of 644 patients, 139 (21.6%; 95% confidence interval 18.5–25.0%) experienced an ADR. Serum electrolyte abnormalities were the most common ADR. The ADRROP (ADR Risk in Older People) and GerontoNet ADR risk scales correctly predicted ADR occurrence in 61% and 60% of patients, respectively. Conclusion: This feasibility study established the rates of incident ADRs across the six study sites. The ADR predictive power of ADRROP and GerontoNet ADR risk scales were limited in this population.

Background: Discrepancies between actual home medication and those recorded at admission are a recognised safety concern for older inpatients. Few studies have investigated discrepancies on nongeriatric wards where pharmaceutical care may be less tailored to the needs of older patients. Purpose: To assess home medication discrepancies categorised by type and clinical impact and, to explore the relationship with patients’ clinical profiles. Materials & methods: This was an observational study in non-geriatric wards in a single hospital without electronic communication with community pharmacies. Subjects were inpatients 70 years. Home medication assessment occurred through standard care (physician/nurse) and structured medication reconciliation (hospital pharmacist). Discrepancies, defined as any difference in the medications lists resulting from the two methods, their relationship with patient profiles and their potential clinical impact were assessed. Results: Patients’ (n = 78) mean age was 79 years and 63% were females; 60% of patients (n = 47) were affected by 92 discrepancies, mean 1.96/affected patient (range 1–6). Predominant discrepancies were doses or medications (errors of omission or commission). Discrepancies of moderate clinical impact (31% of affected patients) concerned the majority of respiratory and cardiovascular drugs. The proportion of discrepancies was higher in patients with polypharmacy (P = 0.001) and with an indication of lower functional status (P = 0.032). Discussion & conclusion: Medication discrepancies occurring at admission to non-geriatric wards are common in older inpatients and their potentially moderate clinical impact reinforces their importance to patient safety.

In recent years, pharmaceutical companies have introduced new expensive medicines, some of which target only small patient populations. For example, trastuzumab (Herceptin*), imatinib (Glivec[R]) and sofosbuvir (Sovaldi[R]) are high-priced medicines that have been shown to be effective and safe for treating cancer or hepatitis C, diseases for which no effective treatment existed previously. In 2015, the World Health Organization included several such expensive medicines in their model list of essential medicines, (1) despite current prices of 60000-100 000 United States dollars per treatment. The initial public enthusiasm for these medicines' therapeutic value is now tempered by practical concerns about how patients and health systems can afford them. Even in high-income countries the affordability is a concern. Ethical and economic dilemmas arise when decision-makers must ration an expensive, life-saving or life-extending medicine. We contend that not funding an effective essential medicine contradicts Article 12 in the International Covenant on Economic, Social and Cultural Rights, which declares "the States Parties to the present Covenant recognize the right of everyone to the enjoyment of the highest attainable standard of physical and mental health." By September 2016, over 160 countries have ratified or acceded to the Covenant. (2) In many countries, such as Argentina, Brazil, Latvia, New Zealand and Uruguay, patients have used Article 12 to litigate through domestic courts for the reimbursement of expensive medicines. (3) In the Netherlands, advocates of patients with Pompes disease --a rare muscle disease--based part of their arguments on the fact that it was the patients' right to receive continued reimbursement of an expensive treatment with marginal health benefits. Decision-makers decided to continue reimbursement, despite the fact that many other patients in the country were not reimbursed for more cost-effective treatments. How can governments with finite public health budgets ensure fair access to expensive, new and essential medicines as part of the right to health? Is the right to health equally important for all patients? Governments' efforts to prioritize access to essential medicines could be supported by a human rights approach and specifically by the principle of the progressive realization of the right to health. The United Nations Committee on Economic, Social and Cultural Rights describes progressive realization as States Parties' obligation to use the maximum of its available resources to move as expeditiously and effectively as possible towards achieving the highest attainable standard of health for everyone. (2,4) The approach does not necessarily create an immediate right for everyone to receive treatment at any cost. Instead, progressive realization means that access to health care is gradually fulfilled for all patients. All Parties have an immediate obligation to take deliberate, concrete and targeted steps towards progressive realization. (3) However, providing immediate universal health care with all possible treatments for all people is not a legal obligation. (5) For prioritization, a transparent and independent reimbursement ranking process of medical treatments, largely based on estimates of comparative cost-effectiveness, presents a concrete and practical tool for decision-makers. Progressive realization justifies such ranking of treatments by ensuring that governments use available resources as effectively as possible and thereby progressively realizing the right to health for the largest number of people at the lowest possible cost and without discrimination against patients. This duty of efficiency is also in line with the authoritative interpretation by the Committee on Economic, Social and Cultural Rights of governments' legal obligations under the human rights treaties in General Comment 3, as well as a well-founded set of principles adopted by a group of scholars and policy-makers in the Limburg Principles. …

Annemie Somers,1 Hugo Robays,1 Peter De Paepe,2 Georges Van Maele,3 Katrina Perehudoff,4 Mirko Petrovic41Department of Pharmacy, Ghent University Hospital, Ghent, Belgium; 2Department of Emergency Medicine, Ghent University Hospital, Ghent, Belgium; 3Department of Medical Statistics, Ghent University Hospital, Ghent, Belgium; 4Department of Geriatrics, Ghent University Hospital, Ghent, BelgiumObjective: To evaluate the type, acceptance rate, and clinical relevance of clinical pharmacist recommendations at the geriatric ward of the Ghent university hospital.Methods: The clinical pharmacist evaluated drug use during a weekly 2-hour visit for a period of 4 months and, if needed, made recommendations to the prescribing physician. The recommendations were classified according to type, acceptance by the physician, prescribed medication, and underlying drug-related problem. Appropriateness of prescribing was assessed using the Medication Appropriateness Index (MAI) before and after the recommendations were made. Two clinical pharmacologists and two clinical pharmacists independently and retrospectively evaluated the clinical relevance of the recommendations and rated their own acceptance of them.Results: The clinical pharmacist recommended 304 drug therapy changes for 100 patients taking a total of 1137 drugs. The most common underlying drug-related problems concerned incorrect dose, drug–drug interaction, and adverse drug reaction, which appeared most frequently for cardiovascular drugs, drugs for the central nervous system, and drugs for the gastrointestinal tract. The most common type of recommendation concerned adapting the dose, and stopping or changing a drug. In total, 59.7% of the recommendations were accepted by the treating physician. The acceptance rate by the evaluators ranged between 92.4% and 97.0%. The mean clinical relevance of the recommendations was assessed as possibly important (53.4%), possibly low relevance (38.1%), and possibly very important (4.2%). A low interrater agreement concerning clinical relevance between the evaluators was found: kappa values ranged between 0.15 and 0.25. Summated MAI scores significantly improved after the pharmacist recommendations, with mean values decreasing from 9.3 to 6.2 (P < 0.001).Conclusion: In this study, the clinical pharmacist identified a high number of potential drug-related problems in older patients; however, the acceptance of the pharmacotherapy recommendations by the treating physician was lower than by a panel of evaluators. This panel, however, rated most recommendations as possibly important and as possibly having low relevance, with low interrater reliability. As the appropriateness of prescribing seemed to improve with decreased MAI scores, clinical pharmacy services may contribute to the optimization of drug therapy in older inpatients.Keywords: clinical pharmacist, drug-related problems, geriatric inpatients

Introduction: In Belgium, psychotropic drug use is high among older people. With low proven long-term effectiveness and possible severe side effects, psychotropic drugs in geriatric patients should be prescribed with utmost caution. Nursing staff’s knowledge on psychotropic drugs can be crucial in the appropriate prescribing and reduction of these drugs. Since knowledge assessment instruments on psychotropic drugs are scarce, a Dutch knowledge test, the Psychotropic Education and Knowledge (PEAK) test, was designed using a prospective psychometric instrument validation study. Methods: Factors relevant for nursing practice on psychotropic drugs were identified. A Delphi expert panel (n = 10) evaluated face and construct validity. Internal consistency was assessed using the known groups’ method. Reliability and stability were assessed using a test-retest procedure in nursing students (n = 52). Item analysis included difficulty index and discrimination value. Results: Twenty-four items were retained after the Delphi panel. The discrimination value was acceptable [0.05–0.27] and difficulty index showed good results [0.10–0.89]. A good stability, r = 0.80 (95% CI = 0.68-0.88, P < .001] and a good internal consistency (Cronbach’s a = 0.76) were found. The mean knowledge of respondents (n = 317) was low, with nurses (46.0%) scoring better than nursing students (37.9%, P < .001). Having a Bachelor degree and graduating in geriatric specialisation was associated with higher results. Conclusion: This is the first knowledge assessment instrument on psychotropic drugs for nurses in an acute geriatric care setting. Mean test scores were low, indicating a knowledge deficit among nurses and nursing students. Further refining of the test and validation in other care settings is needed.

The causes of most cases of Parkinson's disease (PD) are still poorly understood. Here we show that chronic stress and elevated corticosterone levels exaggerate motor deficits and neurodegenerative events in a Parkinson's disease rat model. Animals were tested in skilled and non-skilled movement while being exposed to daily restraint stress or oral corticosterone treatment. Stress and corticosterone compromised normal motor function and exaggerated motor deficits caused by unilateral 6-hydroxydopamine lesion of the nigrostriatal bundle. Moreover, stress and corticosterone treatments diminished the ability to acquire compensatory strategies in limb use during skilled reaching and skilled walking. In contrast, lesion control animals were able to significantly improve in the ability of skilled limb use during the repeated test sessions. The exaggerated motor impairments in stress-treated animals were related to accelerated loss of midbrain dopamine-producing neurons during the first week postlesion. Correlation analysis revealed a significant connection between loss of tyrosine hydroxylase-positive cells and increase in Fluoro-Jade-positive cells only in stress- and corticosterone-treated animals. Furthermore, stress and elevated corticosterone levels caused greater permanent loss of midbrain neurons than found in non-treated lesion animals. These findings demonstrate that stress and elevated corticosterone levels can exaggerate nigral neuronal loss and motor symptoms in a rat analogue of PD. It is therefore possible that stress represents a key factor in the pathogenesis of human PD by impeding functional and structural compensation and exaggerating neurodegenerative processes.

Background Cervical cancer claims 311,000 lives annually, and 90% of these deaths occur in low- and middle-income countries. Cervical cancer is a highly preventable and treatable disease, if detected through screening at an early stage. Governments have a responsibility to screen women for precancerous cervical lesions. Yet, national screening programmes overlook many poor women and those marginalised in society. Under-screened women (called hard-to-reach) experience a higher incidence of cervical cancer and elevated mortality rates compared to regularly-screened women. Such inequalities deprive hard-to-reach women of the full enjoyment of their right to sexual and reproductive health, as laid out in Article 12 of the International Covenant on Economic, Social and Cultural Rights and General Comment No. 22. Discussion This article argues first for tailored and innovative national cervical cancer screening programmes (NCSP) grounded in human rights law, to close the disparity between women who are afforded screening and those who are not. Second, acknowledging socioeconomic disparities requires governments to adopt and refine universal cancer control through NCSPs aligned with human rights duties, including to reach all eligible women. Commonly reported- and chronically under-addressed- screening disparities relate to the availability of sufficient health facilities and human resources (example from Kenya), the physical accessibility of health services for rural and remote populations (example from Brazil), and the accessibility of information sensitive to cultural, ethnic, and linguistic barriers (example from Ecuador). Third, governments can adopt new technologies to overcome individual and structural barriers to cervical cancer screening. National cervical cancer screening programmes should tailor screening methods to under-screened women, bearing in mind that eliminating systemic discrimination may require committing greater resources to traditionally neglected groups. Conclusion Governments have human rights obligations to refocus screening policies and programmes on women who are disproportionately affected by discrimination that impairs their full enjoyment of the right to sexual and reproductive health. National cervical cancer screening programmes that keep the right to health principles (above) central will be able to expand screening among low-income, isolated and other marginalised populations, but also women in general, who, for a variety of reasons, do not visit healthcare providers for regular screenings.

The European Union (EU) has a potential major influence on patients' global access to medicines. Historically, this influence most notably came through the EU's trade and aid agendas that intentionally targeted foreign markets. Now, the EU's own internal pharmaceutical policy appears to indirectly shape global access to medicines (ex. EU's large-scale Covid-19 vaccine procurement and export bans). To understand the ways the EU's internal and external policies impact on global access to medicines, this Scoping Review synthesises evidence of the EU's global regulatory influence and its impacts on access to medicines in non-EU low- and middle-income countries (LMICs). By searching 8 databases and grey literature, documents published in English, Spanish, Portuguese, or Russian between 1995-2021 that addressed an EU law, regulation, or policy in relation to access to medicines in LMICs were included. This review identifies three mechanisms through which EU action impacts on medicines in LMICs. One, the EU's external, treaty-based agreements with LMICs can affect their pharmaceutical trade, sales, and use. Two, EU's internal market regulation, standards, and methods are used as models or sources of inspiration for pharmaceutical governance in LMICs. Three, ‘soft' forms of EU influence manifest through the EU's technical assistance, its research and development (aid) funding, and its ‘capacity building' activities towards LMIC actors in the field of pharmaceuticals. Examples of impacts of EU action ranged from the development of new medicines primarily for LMICs, to changes in the availability of generics and on medicines spending in LMICs, and the potential for a more efficient yet less autonomous local market approval process. Most evidence of impact was not peer reviewed. This study raises the question of how to support resilient and efficient global pathways for drug development and regulation while still being responsive and accountable to the local public interest. Key messages There are 3 mechanisms through which EU action impacts on medicines in LMICs: treaty-based agreements, EU internal market regulation, and ‘soft' EU influence. EU decision makers need a reliable understanding of how the EU’s internal and external policies impact on pharmaceuticals globally.