Access to medicine and the dangers of patent linkage : lessons from Bayer Corp v. Union of India

In February 2010, the Delhi High Court delivered its decision in Bayer Corp v Union of India in which Bayer had appealed against an August 2009 decision of the same court. Both decisions prevented Bayer from introducing the concept of patent linkage into India’s drug regulatory regime. Bayer appealed to the Indian Supreme Court, the highest court in India, which agreed on 2 March 2010 to hear the appeal. Given that India is regarded as a global pharmaceutical manufacturer of generic medications, how its judiciary and government perceive their international obligations has a significant impact on the global access to medicines regime. In rejecting the application of patent linkage, the case provides an opportunity for India to further acknowledge its international human rights obligations.

Comparison of access to medicines between Klang Valley and East Coast of peninsular Malaysia for children living in poor households

Purpose: To compare access to medicines in children living in poor households (income of USD1/person/day) between urbanised Klang Valley and rural East Coast of Peninsular Malaysia. Methods: A semi-structured interview was conducted with caregivers to determine demographics, access to medicines, knowledge, attitude and practice of parents in obtaining medicines for children. Results: There was no significant difference socio-demographically between poor households in Klang Valley (N = 58) and East Coast (N = 40). The study found that access to medicine for children (N = 325) in the households was adequate, where all households that reported illness in the children over the last 1 month and the last 6 month periods, obtained medicines and 99 % of the children were fully immunized. Qualitative analysis showed that poor households face several barriers in accessing medicines for their children such as financial, transportation, physical and attitudinal. Conclusion: Access to medicines for children living in poor households in both areas were similar and adequate. However, barriers to access remain and further studies are required.

A secure framework and related protocols for ubiquitous access to electronic health records using Java sim cards

Ubiquitous access to patient medical records is an important aspect of caring for patient safety. Unavailability of sufficient medical information at the point-ofcare could possibly lead to a fatality. The U.S. Institute of Medicine has reported that between 44,000 and 98,000 people die each year due to medical errors, such as incorrect medication dosages, due to poor legibility in manual records, or delays in consolidating needed information to discern the proper intervention. In this research we propose employing emergent technologies such as Java SIM Cards (JSC), Smart Phones (SP), Next Generation Networks (NGN), Near Field Communications (NFC), Public Key Infrastructure (PKI), and Biometric Identification to develop a secure framework and related protocols for ubiquitous access to Electronic Health Records (EHR). A partial EHR contained within a JSC can be used at the point-of-care in order to help quick diagnosis of a patient’s problems. The full EHR can be accessed from an Electronic Health Records Centre (EHRC) when time and network availability permit. Moreover, this framework and related protocols enable patients to give their explicit consent to a doctor to access their personal medical data, by using their Smart Phone, when the doctor needs to see or update the patient’s medical information during an examination. Also our proposed solution would give the power to patients to modify the Access Control List (ACL) related to their EHRs and view their EHRs through their Smart Phone. Currently, very limited research has been done on using JSCs and similar technologies as a portable repository of EHRs or on the specific security issues that are likely to arise when JSCs are used with ubiquitous access to EHRs. Previous research is concerned with using Medicare cards, a kind of Smart Card, as a repository of medical information at the patient point-of-care. However, this imposes some limitations on the patient’s emergency medical care, including the inability to detect the patient’s location, to call and send information to an emergency room automatically, and to interact with the patient in order to get consent. The aim of our framework and related protocols is to overcome these limitations by taking advantage of the SIM card and the technologies mentioned above. Briefly, our framework and related protocols will offer the full benefits of accessing an up-to-date, precise, and comprehensive medical history of a patient, whilst its mobility will provide ubiquitous access to medical and patient information everywhere it is needed. The objective of our framework and related protocols is to automate interactions between patients, healthcare providers and insurance organisations, increase patient safety, improve quality of care, and reduce the costs.

Nurses driving change to improve access to education and quality in lcinical teaching : A partnership between Australia and Viet Nam

In Viet Nam, standards of nursing care fail to meet international competency standards. This increases risks to patient safety (eg. hospital acquired infection), consequently the Ministry of Health identified the need to strengthen nurse education in Viet Nam. This paper presents experiences of a piloted clinical teaching model developed in Ha Noi, to strengthen nurse led institutional capacity for in-service education and clinical teaching. Historically 90% of nursing education was conducted by physicians and professional development in hospitals for nurses was limited. There was minimal communication between hospitals and nursing schools about expectations of students and assessment and quality of the learning experience. As a result when students came to the clinical sites, no-one understood how to plan their learning objectives and utilise teaching and learning approaches appropriate to their level. Therefore student learning outcomes were variable. They focussed on procedures and techniques and “learning how to do” rather than learning how to plan, implement and evaluate patient care. This project is part of a multi-component capacity building program designed to improve nurse education in Viet Nam. The project was funded jointly by Queensland University of Technology (QUT) and the Australian Agency for International Development. Its aim was to develop a collaborative clinically-based model of teaching to create an environment that encourages evidence-based, student-centred clinical learning. Accordingly, strategies introduced promoted clinical teaching of competency based nursing practice utilising the regionally endorsed nurse core competency standards. Thirty nurse teachers from Viet Duc University Hospital and Hanoi Medical College participated in the program. These nurses and nurse teachers undertook face to face education in three workshops, and completed three assessment items. Assessment was applied, where participants integrated the concepts learned in each workshop and completed assessment tasks related to planning, implementing and evaluating teaching in the clinical area. Twenty of these participants were then selected to undertake a two week study tour in Brisbane, Australia where the clinical teaching model was refined and an action plan developed to integrate into both organisations with possible implementation across Viet Nam. Participants on this study tour also experienced clinical teaching and learning at QUT by attending classes held at the university, and were able to visit selected hospitals to experience clinical teaching in these settings as well. Effectiveness of the project was measured throughout the implementation phase and in follow up visits to the clinical site. To date changes have been noted on an individual and organisational level. There is also significant planning underway to incorporate the clinical teaching model developed across the organisation and how this may be implemented in other regions. Two participants have also been involved in disseminating aspects of this approach to clinical teaching in Ho Chi Minh, with further plans for more in-depth dissemination to occur throughout the country.

Application of Geographic Modeling Techniques to Quantify Spatial Access to Health Services Before and After an Acute Cardiac Event: The Cardiac ARIA Project

Background: Access to cardiac services is essential for appropriate implementation of evidence-based therapies to improve outcomes. The Cardiac Accessibility and Remoteness Index for Australia (Cardiac ARIA) aimed to derive an objective, geographic measure reflecting access to cardiac services. Methods: An expert panel defined an evidence-based clinical pathway. Using Geographic Information Systems (GIS), a numeric/alpha index was developed at two points along the continuum of care. The acute category (numeric) measured the time from the emergency call to arrival at an appropriate medical facility via road ambulance. The aftercare category (alpha) measured access to four basic services (family doctor, pharmacy, cardiac rehabilitation, and pathology services) when a patient returned to their community. Results: The numeric index ranged from 1 (access to principle referral center with cardiac catheterization service ≤ 1 hour) to 8 (no ambulance service, > 3 hours to medical facility, air transport required). The alphabetic index ranged from A (all 4 services available within 1 hour drive-time) to E (no services available within 1 hour). 13.9 million (71%) Australians resided within Cardiac ARIA 1A locations (hospital with cardiac catheterization laboratory and all aftercare within 1 hour). Those outside Cardiac 1A were over-represented by people aged over 65 years (32%) and Indigenous people (60%). Conclusion: The Cardiac ARIA index demonstrated substantial inequity in access to cardiac services in Australia. This methodology can be used to inform cardiology health service planning and the methodology could be applied to other common disease states within other regions of the world.

Access to cardiac rehabilitation does not equate to attendance

Background/Aims Timely access to appropriate cardiac care is critical for optimizing positive outcomes after a cardiac event. Attendance at cardiac rehabilitation (CR) remains less than optimal (10%–30%). Our aim was to derive an objective, comparable, geographic measure reflecting access to cardiac services after a cardiac event in Australia. Methods An expert panel defined a single patient care pathway and a hierarchy of the minimum health services for CR and secondary prevention. Using geographic information systems a numeric/alpha index was modelled to describe access before and after a cardiac event. The aftercare phase was modelled into five alphabetical categories: from category A (access to medical service, pharmacy, CR, pathology within 1 h) to category E (no services available within 1 h). Results Approximately 96% or 19 million people lived within 1 h of the four basic services to support CR and secondary prevention, including 96% of older Australians and 75% of the indigenous population. Conversely, 14% (64,000) indigenous people resided in population locations that had poor access to health services that support CR after a cardiac event. Conclusion Results demonstrated that the majority of Australians had excellent ‘geographic’ access to services to support CR and secondary prevention. Therefore, it appears that it is not the distance to services that affects attendance. Our ‘geographic’ lens has identified that more research on socioeconomic, sociological or psychological aspects to attendance is needed.

Access to Cardiac Rehabilitation does not Equate to Attendance. (On Behalf of the Cardiac ARIA Project. Winner Nursing/Allied Health Professional Investigator Award)

Background/Aims Timely access to appropriate cardiac care is critical for optimizing positive outcomes after a cardiac event. Attendance at cardiac rehabilitation (CR) remains less than optimal (10%–30%). Our aim was to derive an objective, comparable, geographic measure reflecting access to cardiac services after a cardiac event in Australia. Methods An expert panel defined a single patient care pathway and a hierarchy of the minimum health services for CR and secondary prevention. Using geographic information systems a numeric/alpha index was modelled to describe access before and after a cardiac event. The aftercare phase was modelled into five alphabetical categories: from category A (access to medical service, pharmacy, CR, pathology within 1 h) to category E (no services available within 1 h). Results Approximately 96% or 19 million people lived within 1 h of the four basic services to support CR and secondary prevention, including 96% of older Australians and 75% of the indigenous population. Conversely, 14% (64,000) indigenous people resided in population locations that had poor access to health services that support CR after a cardiac event. Conclusion Results demonstrated that the majority of Australians had excellent ‘geographic’ access to services to support CR and secondary prevention. Therefore, it appears that it is not the distance to services that affects attendance. Our ‘geographic’ lens has identified that more research on socioeconomic, sociological or psychological aspects to attendance is needed.

Access to commercial destinations within the neighbourhood and walking among Australian older adults

BACKGROUND: Physical activity, particularly walking, is greatly beneficial to health; yet a sizeable proportion of older adults are insufficiently active. The importance of built environment attributes for walking is known, but few studies of older adults have examined neighbourhood destinations and none have investigated access to specific, objectively-measured commercial destinations and walking. METHODS: We undertook a secondary analysis of data from the Western Australian state government's health surveillance survey for those aged 65--84 years and living in the Perth metropolitan region from 2003--2009 (n = 2,918). Individual-level road network service areas were generated at 400 m and 800 m distances, and the presence or absence of six commercial destination types within the neighbourhood service areas identified (food retail, general retail, medical care services, financial services, general services, and social infrastructure). Adjusted logistic regression models examined access to and mix of commercial destination types within neighbourhoods for associations with self-reported walking behaviour. RESULTS: On average, the sample was aged 72.9 years (SD = 5.4), and was predominantly female (55.9%) and married (62.0%). Overall, 66.2% reported some weekly walking and 30.8% reported sufficient walking (>=150 min/week). Older adults with access to general services within 400 m (OR = 1.33, 95% CI = 1.07-1.66) and 800 m (OR = 1.20, 95% CI = 1.02-1.42), and social infrastructure within 800 m (OR = 1.19, 95% CI = 1.01-1.40) were more likely to engage in some weekly walking. Access to medical care services within 400 m (OR = 0.77, 95% CI = 0.63-0.93) and 800 m (OR = 0.83, 95% CI = 0.70-0.99) reduced the odds of sufficient walking. Access to food retail, general retail, financial services, and the mix of commercial destination types within the neighbourhood were all unrelated to walking. CONCLUSIONS: The types of neighbourhood commercial destinations that encourage older adults to walk appear to differ slightly from those reported for adult samples. Destinations that facilitate more social interaction, for example eating at a restaurant or church involvement, or provide opportunities for some incidental social contact, for example visiting the pharmacy or hairdresser, were the strongest predictors for walking among seniors in this study. This underscores the importance of planning neighbourhoods with proximate access to social infrastructure, and highlights the need to create residential environments that support activity across the life course.

Open Access to the Scientific Journal Literature: Situation 2009

Background: The Internet has recently made possible the free global availability of scientific journal articles. Open Access (OA) can occur either via OA scientific journals, or via authors posting manuscripts of articles published in subscription journals in open web repositories. So far there have been few systematic studies showing how big the extent of OA is, in particular studies covering all fields of science. Methodology/Principal Findings: The proportion of peer reviewed scholarly journal articles, which are available openly in full text on the web, was studied using a random sample of 1837 titles and a web search engine. Of articles published in 2008, 8,5% were freely available at the publishers’ sites. For an additional 11,9% free manuscript versions could be found using search engines, making the overall OA percentage 20,4%. Chemistry (13%) had the lowest overall share of OA, Earth Sciences (33%) the highest. In medicine, biochemistry and chemistry publishing in OA journals was more common. In all other fields author-posted manuscript copies dominated the picture. Conclusions/Significance: The results show that OA already has a significant positive impact on the availability of the scientific journal literature and that there are big differences between scientific disciplines in the uptake. Due to the lack of awareness of OA-publishing among scientists in most fields outside physics, the results should be of general interest to all scholars. The results should also interest academic publishers, who need to take into account OA in their business strategies and copyright policies, as well as research funders, who like the NIH are starting to require OA availability of results from research projects they fund. The method and search tools developed also offer a good basis for more in-depth studies as well as longitudinal studies.

Perceived and reported access to the general practitioner: an international comparison of universal access and mixed private/public systems.

Timely and convenient access to primary healthcare is essential for the health of the population as delays can incur additional health and financial costs. Access to health care is under increasing scrutiny as part of the drive to contain escalating costs, while attempting to maintain equity in service provision. The objective was to compare primary care services in Republic of Ireland and Northern Ireland, and to report on perceived and reported access to GP services in universal access and mixed private/public systems. A questionnaire study was performed in Northern Ireland (NI) and the Republic of Ireland (ROI). Patients of 20 practices in the ROI and NI were contacted (n = 22,796). Main outcome measures were overall satisfaction and the access to GP services. Individual responses and scale scores were derived using the General Practice Assessment Questionnaire (G-PAQ). The response rate was 52% (n = 11,870). Overall satisfaction with GP practices was higher in ROI than in NI (84.2% and 80.9% respectively). Access scores were higher in ROI than in NI (69.2% and 57.0% respectively) Less than 1 in 10 patients in ROI waited two or more working days to see a doctor of choice (8.1%) compared to almost half (45.0%) in NI. In NI overall satisfaction decreased as practice size increased; 82.8%, 80.4%, and 75.8%. In both systems, in large practices, accessibility is reduced when compared to smaller practices. The faster access to GP services in ROI may be due to the deterrent effect of the consultation charge freeing up services although, as it is the poorest and sickest who are deterred by the charge this improved accessibility may come at a significant cost in terms of equity. The underlying concern for policy makers centres around provision of equitable services.

Access to medical records for research purposes:Varying perceptions across research ethics boards

Introduction: Variation across research ethics boards (REBs) in conditions placed on access to medical records for research purposes raises concerns around negative impacts on research quality and on human subject protection, including privacy. Aim: To study variation in REB consent requirements for retrospective chart review and who may have access to the medical record for data abstraction. Methods: Thirty 90-min face-to-face interviews were conducted with REB chairs and administrators affiliated with faculties of medicine in Canadian universities, using structured questions around a case study with open-ended responses. Interviews were recorded, transcribed and coded manually. Results: Fourteen sites (47%) required individual patient consent for the study to proceed as proposed. Three (10%) indicated that their response would depend on how potentially identifying variables would be managed. Eleven sites (38%) did not require consent. Two (7%) suggested a notification and opt-out process. Most stated that consent would be required if identifiable information was being abstracted from the record. Among those not requiring consent, there was substantial variation in recognising that the abstracted information could potentially indirectly re-identify individuals. Concern over access to medical records by an outside individual was also associated with requirement for consent. Eighteen sites (60%) required full committee review. Sixteen (53%) allowed an external research assistant to abstract information from the health record. Conclusions: Large variation was found across sites in the requirement for consent for research involving access to medical records. REBs need training in best practices for protecting privacy and confidentiality in health research. A forum for REB chairs to confidentially share concerns and decisions about specific studies could also reduce variation in decisions.