Medicine Policy Research Articles

Transition From Site-Based to System-Wide Policies

Implementation of a system-wide policy approval policy that changes a culture of “they implemented a policy” to “we engaged in implementing the best-practice policy for our site–system to decrease variation and align practice.” This was especially helpful when initiating a new electronic medical record and then a new policy program systemwide. The proposed change was going from site-specific policies to evidence-based, best practice, system-wide policies. Implementation was based on identification of high-risk/liability policies to expired policies and evaluation of sites with no site-specific policies in perinatal or newborn medicine that were acquired by the health system. The outcomes for the performance improvement project included the number of site-specific policies to system, the number of policies in the 360 program to clinical skills, and the policy and order alignment before the EPIC system’s (Epic Systems Corp., Verona, WI) go-live date. Audits also measure clinical implementation success rates. There is currently a policy structure for the St. Luke’s Health System obstetric inpatient units. The implications for nursing practice include alignment of best practices throughout the perinatal and newborn units, sites that did not have policies for reference now have policies for quality and safety reference for practice to partner with their providers and oversight with their patient care, policy structure for the St. Luke’s Health System obstetric inpatient nursing staff for chain of command use when needed.

The implementation of the bioequivalence certification policy in Chile: An analysis of market authorization data.

BackgroundAffordability is a key barrier to access to medicines. Generic medicines policies can address this barrier and promote access. Successful uptake of generic medicines depends, in part, on ensuring that these products are interchangeable with reference products. Typically, bioequivalence certification is established in order to demonstrate such interchangeability.ObjectiveTo study the implementation of the bioequivalence certification policy in Chile.MethodsWe used Chilean Market Regulatory Authority data for analysis to study the number of products that obtained bioequivalence certification, the time until bioequivalence certification and associated factors to obtain bioequivalence.ResultsAs of January 2017, out of 2,336 products with a valid market authorization containing at least one of the 167 APIs that required BE certification, 1,026 products actually have BE certification (1,026/2,336, 43.9% compliance). Where data were available, the time between submission of the market authorization as a bioequivalent product to final authorization by the national medicine regulatory authority for most products varied between 4–6 months. The fraction of all BE products containing a given API out of the total marketed products containing that API varies considerably, e.g. for the API olmesartan there was only a single BE product marketed, the API diclofenac had none.ConclusionsAlthough the implementation of Chile’s bioequivalence policy increased the number of bioequivalent products, over 50% of generic products requiring bioequivalence that did not obtain this certification. Also for some of the API none or very few BE products are marketed which limits the success of a substitution policy. Further studies are required to identify the apparent lack of incentives to obtain bioequivalence certification. Studies of sales volumes and prices of the products are needed to identify whether generic products without bioequivalence certification either become bioequivalent or eventually exit the market.

Introduction to the special issue on child and family health: the role of behavioral medicine in understanding and optimizing child health.

Health promotion during early life and childhood can reduce the prevalence and impact of acute and chronic health conditions later in life. Research regarding factors that influence child and family health, prevention, and intervention programs that address them, and policies that promote implementation of best practices are needed to efficiently and effectively address the multi-faceted, biopsychosocial influences on child health, especially among youth from underserved backgrounds. The current special issue dedicated to child and family health offers a series of articles that illustrate how explanatory studies and targeted intervention programs for children, families, health care providers, and communities can be used to improve child health. Articles in this special issue are organized into three areas related to child and family health: (i) diet and nutrition, (ii) cancer prevention and control, and (iii) social determinants of health and health care. The articles included in this special issue underscore that behavioral medicine practitioners, researchers, and policy makers are well poised to lead innovative efforts to promote child health across clinical, community, health care, and population settings.

A PERSPECTIVE ON AUSTRALIA’S NATIONAL MEDICINES POLICY

There is international interest in Australia's health care system for prescription medicines. The issue is particularly topical in Canada with the debate following publication of the Romanow Report into the future of health care in Canada. This Report recommended a new National Drug Agency. Australia has a National Medicines Policy with four arms-quality, safety and efficacy of medicines; equity of access; a viable and responsible pharmaceutical industry; quality use of medicines. The four arms of the Policy are interlinked and interdependent for optimal functioning. In this paper, an overview of how the prescription drug system in Australia works is presented. The manuscript focuses upon specific aspects of the Policy, describing how it functions and some of the processes integral to success, from the viewpoint of the author. The discussion includes some of the advantages of Australia's system for pharmaceuticals as well as some of the problems, as these present opportunities for development and change.

A logic model for precision medicine implementation informed by stakeholder views and implementation science

PurposePrecision medicine promises to improve patient outcomes, but much is unknown about its adoption within health-care systems. A comprehensive implementation plan is needed to realize its benefits. MethodsWe convened 80 stakeholders for agenda setting to inform precision medicine policy, delivery, and research. Conference proceedings were audio-recorded, transcribed, and thematically analyzed. We mapped themes representing opportunities, challenges, and implementation strategies to a logic model, and two implementation science frameworks provided context. ResultsThe logic model components included inputs: precision medicine infrastructure (clinical, research, and information technology), big data (from data sources to analytics), and resources (e.g., workforce and funding); activities: precision medicine research, practice, and education; outputs: precision medicine diagnosis; outcomes: personal utility, clinical utility, and health-care utilization; and impacts: precision medicine value, equity and access, and economic indicators. Precision medicine implementation challenges include evidence gaps demonstrating precision medicine utility, an unprepared workforce, the need to improve precision medicine access and reduce variation, and uncertain impacts on health-care utilization. Opportunities include integrated health-care systems, partnerships, and data analytics to support clinical decisions. Examples of implementation strategies to promote precision medicine are: changing record systems, data warehousing techniques, centralized technical assistance, and engaging consumers. ConclusionWe developed a theory-based, context-specific logic model that can be used by health-care organizations to facilitate precision medicine implementation.

The Socialist Camp's North Korean Medical Support and Exchange (1945-1958): Between Learning from the Soviet Union and Independent Course.

This study focused on the socialist camp's North Korean medical support and its effects on North Korean medical field from liberation to 1958. Except for the Soviet assistance from liberation to the Korean War, existing studies mainly have paid attention to the 'autonomous' growth of the North Korean medical field. The studies on the medical support of the Eastern European countries during the Korean War have only focused on one-sided support and neglected the interactions with the North Korean medical field. Failing in utilizing the materials produced in North Korea has led to the omission of detailed circumstances of providing support. Since the review of China's support and the North Korea-China medical exchanges has been concentrated in the period after the mid-1950s, the impacts of China's medical support on North Korea during the Korean War period and the post-war recovery period have not been taken into account. In terms of these limitations, this study examined the medical activities by the Socialist camp of the Eastern European countries in North Korea after the Korean War. The medical aid teams from Hungary, Romania, Bulgaria, Czechoslovakia, Poland, and East Germany that came to North Korea in the wake of the Korean War continued to stay in North Korea after the war to build hospitals and train medical personnel. In the hospitals operated by these countries, cooperative medical care with North Korean medical personnel and medical technology education were conducted. Moreover, medical teams from each country in North Korea held seminars and conferences and exchanged knowledge with the North Korean medical field staffs. These activities by the Socialist countries in North Korea provided the North Korean medical personnel with the opportunity to directly experience the medical technology of each country. China's support was crucial to North Korea's 'rediscovery' of Korean medicine in the mid-1950s. After the Korean War, North Korea began to apply the Chinese-Western medicine integration policy, which was performed in China at that time, to the North Korean health care field through China's medical support and exchanges. In other words, China's emphasis on Chinese medicine and the integration of the Chinese-Western medicine were presented as one of the directions for medical development of North Korea in the 1950s, and the experiences of China in this process convinced North Korea that Korean medicine policy was appropriate. The decision-makers of the North Korean medical policies, who returned to North Korea after studying abroad in China at that time, actively introduced the experiences from China and constantly sought to learn about them. This study identified that a variety of external stimuli had complex impacts on the North Korean medical field in the gap between 'Soviet learning' in the late 1940s and the 'autonomous' medical development since the 1960s. The North Korean medical field was formed not by the unilateral or dominant influences of a single nation but by the stimulation from many nations and the various interactions in the process.

Complementary medicine policies: findings from a national cross-sectional survey of hospital-based cancer services in Australia

Complementary medicine policies: findings from a national cross-sectional survey of hospital-based cancer services in Australia

Strategies for improving medication safety in hospitals: Evolution of clinical pharmacy services.

Medication safety risks are the most important preventable factors jeopardizing patient safety. To manage these risks, extending pharmacists' involvement in patient care and patient safety work has been systematically addressed in patient safety initiatives since the early 2000s. To explore the extent and range of clinical pharmacy services in Finnish hospitals to promote medication safety: 1) in 2011, when the first National Patient Safety Strategy, the new Health Care Act and the Medicines Policy 2020 had been recently enacted; and 2) five years later in 2016. The study was conducted in 2011 and 2016 as a national online survey targeted to hospital pharmacies (n = 24) and medical dispensaries (n = 131 in 2011; n = 28 in 2016). The questions were analyzed using descriptive statistics and qualitative content analysis. Overall response rate was 60% in 2011 and 52% in 2016. Clinical pharmacy services were provided by 51% of the responding units in 2011, whereas by 85% in 2016. The reported number of clinical pharmacists had increased during the five years. The most notable increase in reported tasks occurred in conducting medication reconciliations (+63% increase in the number of providing units). By 2016 pharmacists had extended their tasks particularly towards system-based medication safety work: e.g. developing instructions for medication-use (91% of the responding units), creating and updating medication safety plans (87%) and using medication error reports in developing the process of medication use safer (78%). Pharmacists' participation in long-term continuing education became more common in 2016, which was perceived as helpful in extending their responsibilities to improve medication safety. Pharmacists' involvement in patient care and system-based medication safety work was reported to become more common in Finnish hospitals during 2011-2016. This development is in line with patient safety policy initiatives and its impact on patient care outcomes should be followed up.

An analysis on rational use and affordability of medicine after the implementation of National Essential Medicines Policy and Zero Mark-up Policy in Hangzhou, China.

BackgroundThe National Essential Medicine Policy and the Zero Mark-up Policy was introduced to improve the rational use and affordability of medicine. This study analyzed the changes of medicine use at different Health Care Institutions in Hangzhou city after the implementation of National Essential Medicine Policy and the Zero Mark-up Policy.MethodsFacility based survey was conducted in 17 Health Care Institutions and 16406 outpatient prescriptions in 2011 and 2013 were collected. Average number of medicines, average number of antibiotics and average expenditure per prescription were analyzed. Comparisons between 2011 and 2013, among different levels of Health Care Institutions and age groups were conducted.ResultsThe average number of medicines per prescription, use of antibiotics, intramuscular (IM) injections and intravenous (IV) injections decreased while the use of hormones increased. No significant change of the average medicine expenditure per prescription was observed. Disparities among different levels of Health Care Institutions and different age groups existed.ConclusionThe problems of poly-pharmacy, overuse of antibiotics, intramuscular (IM) injections and intravenous (IV) injections and hormones still existed, however mitigated after the implementation of The National Essential Medicine Policy and the Zero Mark-up Policy.

3312 Understanding Community-engaged Research at an Academic Medical Center and Learning Healthcare System in the US South

OBJECTIVES/SPECIFIC AIMS: Wake Forest Baptist Health (WFBH) is an Academic Learning Healthcare System (aLHS) serving 24 counties in North Carolina and Virginia. Like many aLHSs, WFBH experiences strained community relationships attributable to a history of medical and research abuses against marginalized populations. This legacy accompanies longstanding community mistrust in the healthcare system and research. To overcome these challenges, community-engaged research (CEnR) approaches have potential to repair community-academic relationships, improve public health, and empower groups that traditionally have been neglected by or overlooked in research. To develop and revise our understanding of how CEnR is harnessed at WFBH, semi-structured interviews were conducted with investigators and study staff experienced in CEnR approaches. In-depth interview guides were designed iteratively to capture socio-contextual and detailed descriptions of perceptions, experiences, and strategies specific to the use of CEnR. METHODS/STUDY POPULATION: A keyword search performed within WFBH study records identified 51 investigators whom had submitted research proposals related to CEnR within the past ten years. Sixteen were confirmed eligible based on a review of proposal abstracts, of which 14 responded to email invitations agreeing to participate. Four additional participants were referred by initial participants. Eighteen investigators (16 faculty and 2 research associates) provided consent and completed Interviews. RESULTS/ANTICIPATED RESULTS: The participant sample was 50% female with a mean age of 55 years, 11% Black and 89% White, with representation across various academic backgrounds (e.g., anthropology, medicine, psychology, and public health) A majority of participants (89%) hold doctoral degrees (i.e., PhD, DrPH, EdD, MD, and MD-PhD). On average, participants had been employed at WFBH for 13.9 years, and represented various departments including dermatology, epidemiology and prevention, family medicine, neurology, social sciences and health policy, and psychiatry. Nearly all participants (89%) indicated they had never received formal education or training in CEnR, though 100% reported “on-the-job” training in CEnR. Interviews were audio-recorded, transcribed, coded, and analyzed following an inductive thematic approach, from which twenty-two themes emerged across six domains related to CEnR (Table 2), including: Conceptualization and Purpose, Value and Investment, Community-Academic Partnerships, Sustainability, Facilitators, and Challenges. Results also provided key characteristics that define CEnR (Table 3), and yielded 11 emerging needs necessary to enhance CEnR within aLHSs (Table 4). DISCUSSION/SIGNIFICANCE OF IMPACT: The results of this study provide information critical to understanding how CEnR frameworks and approaches can be harnessed not just in Schools of Public Health, but within aLHSs to build and repair community-academic partnerships, inform research and institutional priorities, and address community health concerns. Despite the small sample size, the number of participant interviews was sufficient to achieve saturation while also providing broad and unique perspectives across various fields and CEnR approaches. Overall, participants conceptualized the purpose and goals of CEnR quite similarly, though there was a great deal of variance in how CEnR was defined and operationalized across interviews, indicating a need to more clearly articulate important features that enhance understanding of what CEnR is and what it is not (Table 3). These discrepancies and inconsistencies indicate a potential need for additional formal training in the understanding and use of CEnR approaches, which is supported by the fact that nearly all participants reported receiving no formal training in CEnR. Across all interviews, participants expressed a need for health care providers and researchers to better understand community contexts, social determinants of health, and historical factors influencing community health and participation in research (Table 4). This work and the data presented here are important for informing CEnR approaches and will be useful for guiding the development of a model incorporating the core tenets of CEnR within the mission, vision, and priorities of aLHSs.

A Therapeutic Machine-Learned Triage Methodology for Moderate to Severe Asthmatics

Background: Current at-home asthma management protocols are crowded with paper guidelines and exploratory health apps that lack rigor and validation at the level of the individual patient. No clear medical consensus has emerged regarding the efficacy of such approaches. We developed a novel digital therapeutic application that uses machine learning predictions for real-time detection of exacerbations and on-demand decision support while obviating the need for burdensome daily symptom entry. Methods: Physician opinion on a statistically and clinically comprehensive set of simulated patient cases was used to train a set of prediction algorithms. The accuracy of the models was assessed by comparison to physician panel consensus in a representative, out-of-sample validation set of 100 vignettes. Algorithms were subsequently deployed in a mobile application and evaluated in a 6 month, pre-post, observational trial of 25 patients with persistent asthma. Outcome data was collected using scored assessments of asthma control (ACT), quality of life (EQ5D5L) and anxiety (AIR). Findings: Algorithm accuracy and safety indicators surpassed all individual pulmonologists in both identifying exacerbations and identifying the consensus triage. The algorithm was also the top performer in sensitivity, specificity, and PPV when predicting a patient's need for emergency care. The observational trial yielded statistically and clinically significant improvement in mean difference scores in asthma control, 4.8 [95\% CI 2.1 - 7.5] (p = 0.004); quality of life, 15.7 [8.0 - 23.3] (p = 0.001); and anxiety, -3.1 [(-5.2) - (-1)] (p = 0.001). Interpretation: A mobile application equipped with a highly accurate machine-learning triage algorithm presents a promising and viable support tool with strong early indications of therapeutic value to patients. A randomized control trial is required to prove causality. Funding: Revon Systems Inc, eThera Technologies, NSF Award No. (FAIN):1820049. Declaration of Interest: We would like to disclose that Anthony N. Gerber is a consultant for eThera Inc and holds stock options. This does not alter our adherence to the Lancet Respiratory Medicine policies on sharing data and materials. Ethical Approval: The study was approved by Quorum Review, an independent Ethics Review Board.

The impacts of national essential medicine policies on the rational use of medicines in China: A cross-sectional study in primary health care institution

The impacts of national essential medicine policies on the rational use of medicines in China: A cross-sectional study in primary health care institution

Reuse of patients\u2019 own drugs in hospitals in Ghana; the evidence to support policy

BackgroundGiven the documented benefits of Patient Own Drugs (PODs) in most developed countries and scanty data on PODs management in developing countries the aim of the study was to evaluate the assessment, quality and extent of PODs use among hospitalised patients. Furthermore the perceived benefits and challenges in executing PODs management by the pharmacy staff in the hospital setting were explored.MethodThis was a cross-sectional descriptive study. Three hundred patients with chronic diseases admitted in a teaching hospital were purposively sampled. Quality assessment criteria was developed as part of the data collection tool for assessing the quality of PODs. Furthermore, two ward pharmacists and two in-charge nurses at the medical ward were purposively sampled for a face to face interview using an interview guide to find out the hospitals’ medicines management system and policy for PODs. In addition, 130 pharmacy staff were interviewed using a structured questionnaire to find out how PODs were managed. Data was analysed with SPSS version 17.ResultsThe study showed that 140 (46.6%) of patients brought their PODs on admission. Of these, only 38 (12.7%) were told to bring them whenever they were on admission. Of the 115 (38.3) patients whose PODs were documented as part of medication history, 28 (24.3%) of them had their PODs continued whilst on admission and 11(9.5%) of discharged prescription included PODs. In assessing the quality of PODs 61.6% of 845 PODs were suitable for reuse. Only 19.8% of pharmacy staff attested to the fact that all PODs identified were assessed. The common benefit of PODs cited by pharmacy staff was improving medication history taking whilst the major challenge was difficulty in determining the expiry dates of PODs without original packages.ConclusionAbout a half of patients with chronic diseases brought PODs with them on admission. The majority of PODs appeared to be suitable for use as presented but only a few were actually used for the patients. Most pharmacy staff were not involved in patients own drugs management at the hospital. There is the need for a policy to streamline PODs management in the teaching hospital.

The "Elderly" in Medicine: Ethical Issues Surrounding This Outdated and Discriminatory Term.

The objective of this study was to investigate and describe how the use of the term “elderly” contributes to bias and problems within the medical system. A systematic review of the relevant literature and history was conducted. The term “elderly” does not define age accurately and carries bias and prejudice that lead to harm through discriminatory practices, institutional prejudices, and “ageist” policies in society and medicine. Doctors and healthcare providers seldom intentionally try to harm any patient, but might do so through unconscious anti-elderly bias. Studies indicate that medical students already demonstrate anti-elderly bias; researchers may lump patients aged 65 and over together, confounding specific information needed for individualized treatments; and out of unwarranted concern, medical and surgical treatments may be denied, despite minimal increased risk of mortality. When the cost of healthcare rises, it is the elderly against whom rationing is suggested. The term “elderly” has no place in medicine. Anti-elderly health care rationing is as unethical as rationing targeted against any group. It is reverse paternalism to make rules that limit others’ medical care, happiness, and life span without their consent. Medicine is the science and art of individual communication, evaluation and treatment. Once we deny care to any one group, we open the door to denial to others.

Critical Evaluation of a Survey Claiming “Long-Term Adverse Outcomes from Neonatal Circumcision”*

We critically evaluate an online “Global survey of circumcision harm” that gauged beliefs of men who thought that their neonatal circumcision had harmed them. Sequential evaluation of the survey data and claims reveal numerous serious flaws that are at odds with strong scientific evidence. Moreover, the one-sided study design and “loaded” survey title meant the findings were not representative of the general population of circumcised males. None of the participants’ claimed physical problems were confirmed by a health practitioner. Belief in this seriously flawed survey has potential to cause psychological harm to vulnerable men influenced by anti-circumcision claims, and as such has serious detrimental implications for male sexual health. The survey appears driven less by empiricism and more by psychological forces, as we show in de-tail. The overwhelming body of high quality medical scientific evidence finds no adverse effect of male circumcision on sexual function and pleasure, but strong evidence for a wide array of lifetime benefits in protection against infections, dermatological problems, and genital cancers. Consistent with the United Nations Convention on the Rights of the Child, children are entitled to low risk procedures that are beneficial to their health. In conclusion, the survey and its uncritical presentation do a disservice to evidence-based medicine, sexual health, mental health, public health, human rights, and pediatric policy development. It should therefore be dismissed as unreliable.

2019 WACEM - Academic College of Emergency Experts Consensus Recommendations on Admission Criteria to Pediatric Intensive Care Unit from the Emergency Departments in India.

There is a global variation in policies that define clear indications for pediatric intensive care unit (PICU) admissions. In resource-limited countries where PICU service availability is limited, the admission criteria to PICU are urgently needed to optimize the utilization of available intensive care services and to maximize patient benefit. The objective of these consensus recommendations on PICU admission criteria is to provide a framework and reference for future policy development by professional societies and governments.Design:The consensus recommendations were developed by a multidisciplinary consensus task force comprised of international experts in pediatric critical care, emergency medicine, trauma, critical care, and health policy stakeholders during the 2016 annual INDUSEM WORLD CONGRESS in Bengaluru, India.Measurements and Main Results:A task force steering committee completed a global literature search about PICU admission criteria development, reviewed PICU admission guidelines published by a variety of professional organizations worldwide, and performed a literature review of relevant publications. The objectives of this task force is to provide a framework for validated approach to determine appropriateness of intensive care unit (ICU) admission in India (resource-limited setting) based on (a) prioritization modeling; (b) general clinical criteria; (c) clinical and objective parameters; and (d) other criteria. The expert consensus panel then discussed and ranked proposed criteria according to scientific evidence, the current standard of care, and expert opinion in the context of the Indian health system. The general subject was addressed in sections: admission criteria and benefits of different levels of care. Following the appraisal of the literature, discussion, and consensus, recommendations were written.Conclusion:Although these are consensus recommendations, the subjects addressed encompass complex ethical and medicolegal aspects of patient care that affect daily clinical practice. The scarcity of high-quality evidence made it difficult to answer all the questions asked related to ICU admission. Despite these limitations, the members of the task force believe that these recommendations provide a comprehensive framework to guide practitioners in making informed decisions during the admission process. This publication is designed to assist in future development of health policies to ensure effective resource allocation, maximize healthcare benefits, and improve access to quality care for children.

Implementation of principles of pharmacoeconomics and pharmacovigilance to achieve optimal financial and therapeutic benefits through WHO - Essential medicine policy and adoption of NLEM-Based hospital formulary policy.

Context:WHO in its development of the roadmap on access to medicines and vaccines 2019–2023 has emphasized that the greatest challenge in achieving Universal Health Coverage (UHC) stem from persistent barriers to accessing health services and to accessing affordable and quality assured health products. In this context, WHO introduced the concept of essential medicines in 1977, and since then, this concept, has been revised every 2 years and is accepted by many countries as guideline to develop National Drug Policy. The concept emphasizes that all aspects of drug management, including procurement, storage, distribution, and use, are easier if fewer essential medicines/items must be dealt with. Essential Medicines are those that satisfy the priority healthcare needs of the population.Aims:During 2017-18, based on the principles of Essential Medicines Concept, we decided to develop and implement “Quality Procurement Management Policies’(QPMP) at Sir Sundar Lal Hospital, at Varanasi. The Pharmaco-econmics and Pharmacovigilance tools are also used to further maximize financial and therapeutic benefits.Materials and Methods:This is evidence based, an observational, and retrospective study. Initially, the analysis of current data on sales of antibiotics during November 2017, December 2017, and January 2018, the procurement practices, selection of medicines, and pattern of use was studied and based on these findings reforms were designed and implemented through the Hospital Formulary Committee.Results:This study revealed that- By the application of QPMP, both the Cost and Quality factors of Medication Management can be dealt with very effectively. And it is possible to make available Quality Assured Medicines at most economic prices, resulting in substantial savings. This study has further, shown that the confidence of physicians also improved as quality assured medicines are provided.Conclusion:The study at Sir Sundar Lal Hospital is thus worth emulating and shown that a doable roadmap with signposts at each and every turn can be designed and can be effectively implemented so that the goal of UHC can be achieved.

Implementation of Principles of Pharmaco-economics and Pharmacovigilance to Achieve Optimal Financial and Therapeutic Benefits through WHO- Essential Medicine Policy

It is evident and revealed by the experience of State of Maharashtra during 2007-2011, that the Effective Application of principles of pharmaco-economics & pharmacovigilance in Medication Management, not only gives assurance about the all-time availability and quality of essential medicines but also saves substantial amount of government exchequer, by procuring the Assured Quality Generic Medicines at most economic rates. These policies were based on following principles of Pharmaco-economic: 1. Selection of Generic Medicines based on W.H.O. Essential List of Medicines. 2. Pooling of need of medicines of all state run hospitals at state level to obtain lowest rates through economies of scale. 3. Selection of “Quality Assured Generic Medicines-through Pre-Qualification conditions. 4. Selection of multiple suppliers per medicine to improve all time availability of essential medicines. 5. Reducing expenditure and workload of procurement, storage and inventory of medicines. 6. Curtailing wastage of funds on procurement of non-essential medicines. Pharmacovigilance-The policy of limited number of essential medicines had been further helped in improving the health care services in the state of Maharashtra, by: 1. Promoting Ethical & Rational use of medicines at physicians, nurses & pharmacists level through publication of “State Hospital Formulary”. 2. Protecting the health of patients from use of harmful effects of non-essential medicines & irrational Fixed Dose Combinations (FDCs). 3. Improving patient compliance to the therapy by patients through establishment of “Patient Counseling Centers” at Out Patient Departments in the hospitals and by optimal utilization of pharmacy services. The overall boost in the Image of public healthcare services–The availability of quality assured generic medicines, had gained the confidence of physicians, and had reduced the expenditure on hospital stay of the patients because of fast recovery. And all these benefits together had boosted overall image of the hospital in the society.

Metabolic effects occurring in irradiated and non-irradiated red blood cellular components for clinical transfusion practice: An in vitro comparison.

BackgroundStorage lesions occur in red blood cell products when potassium ions, haemoglobin and lactate dehydrogenase are released into the extracellular plasma due to post-irradiation storage or cellular degeneration. The South African blood transfusion establishments do not comply with the universal leucocyte-reduction policy due to cost and the current HIV pandemic. Various studies regarding storage lesions have been completed in well-developed countries but not in Cape Town, South Africa.ObjectiveThis study aimed to determine cellular degeneration occurring in non-irradiated and irradiated red blood cells (RBC) by comparing the measured biochemical and haematological indices during storage of up to 42 days.MethodEighty whole blood units were collected from voluntary, non-remunerated donors. Blood components tested weekly until expiry were whole blood, RBC concentrate, leucocyte-reduced RBC concentrate (pre-storage) and paediatric RBC concentrate (n = 20). Ten units per product were irradiated and 10 were not. Evaluations included potassium, sodium, glucose, lactate dehydrogenase, phosphate, haemoglobin, haematocrit, mean corpuscular haemoglobin, mean corpuscular haemoglobin concentrate, mean cell volume and plasma haemoglobin. Plasma haemolysis levels were calculated using an approved formula.ResultsThe haemolysis levels evaluated on Day 35 and Day 42 were higher than the recommended 0.8%, whereas results for the non-irradiated components up to expiry were all below 0.8%.ConclusionThis study confirms that gamma irradiation aggravates the RBC storage lesions. The products tested yielded similar results to other studies in developed countries, however the South Africa transfusion medicine policy should remain unchanged.

European Federation of Societies for Ultrasound in Medicine and Biology (EFSUMB) Policy Document Development Strategy - Clinical Practice Guidelines, Position Statements and Technological Reviews.

This document summarizes principles and methodology to guide the creation of Clinical Practice Guidelines, Position Statements und Technological Reviews of the European Federation of Societies for Ultrasound in Medicine and Biology (EFSUMB). The purpose of EFSUMB Clinical Practice Guidelines is to provide physicians and sonographers performing or requesting diagnostic and interventional ultrasound examinations with evidence-based recommendations. Position Statements summarize EFSUMB opinions on important current issues in clinical applications, education and training of ultrasound techniques or health care policy related to ultrasound-based imaging and ultrasound-guided interventions. The third type of EFSUMB policy document is the Technological Review, which describes ultrasound techniques and technologies for physicians, medical technicians, engineers and physicists developing ultrasound technology. The whole process of development of EFSUMB policy documents is explained beginning with the decision regarding topics, selection of authors, funding, and planning of the developmental process. Further steps described in this document are the review of the evidence, creation of recommendations, statements and comments, grading of level of evidence and strength of recommendations, and consensus process. Finally, rules for the creation, review, approval, publication and update of EFSUMB policy documents are described.