Blockchain Papers

Abderahman Rejeb, Liam Bell

No abstract is available for this record.

Kevin A. Clauson, Elizabeth A. Breeden, Cameron Davidson, Tim K. Mackey

Background: Effective supply chain management is a challenge in every sector, but in healthcare there is added complexity and risk as a compromised supply chain in healthcare can directly impact patient safety and health outcomes. One potential solution for improving security, integrity, data provenance, and functionality of the health supply chain is blockchain technology. Objectives: Provide an overview of the opportunities and challenges associated with blockchain adoption and deployment for the health supply chain, with a focus on the pharmaceutical supply, medical device and supplies, Internet of Healthy Things (IoHT), and public health sectors. Methods: A narrative review was conducted of the academic literature, grey literature, and industry publications, in addition to identifying and characterizing select stakeholders engaged in exploring blockchain solutions for the health supply chain. Results: Critical challenges in protecting the integrity of the health supply chain appear well suited for adoption of blockchain technology. Use cases are emerging, including using blockchain to combat counterfeit medicines, securing medical devices, optimizing functionality of IoHT, and improving the public health supply chain. Despite these clear opportunities, most blockchain initiatives remain in proof-of-concept or pilot phase. Conclusion: Blockchain technology has the unrealized promise to help improve the health supply chain, but further study, evaluation and alignment with policy mechanisms is needed. Keywords: Blockchain, Distributed Ledger, Pharmacy, Pharmaceutical, Supply chain

Patrick G. Sylim, Fang Liu, Alvin Marcelo, Paul Fontelo

BACKGROUND Drug counterfeiting is a global problem with significant risks to consumers and the general public. In the Philippines, 30% of inspected drug stores in 2003 were found with substandard/spurious/falsely-labeled/falsified/counterfeit drugs. The economic burden on the population drug expenditures and on governments is high. The Philippine Food and Drug Administration (FDA) encourages the public to check the certificates of product registration and report any instances of counterfeiting. The National Police of Philippines responds to such reports through a special task force. However, no literature on its impact on the distribution of such drugs were found. Blockchain technology is a cryptographic ledger that is allegedly immutable through repeated sequential hashing and fault-tolerant through a consensus algorithm. This project will develop and test a pharmacosurveillance blockchain system that will support information sharing along the official drug distribution network. OBJECTIVE This study aims to develop a pharmacosurveillance blockchain system and test its functions in a simulated network. METHODS We are developing a Distributed Application (DApp) that will run on smart contracts, employing Swarm as the Distributed File System (DFS). Two instances will be developed: one for Ethereum and another for Hyperledger Fabric. The proof-of-work (PoW) consensus algorithm of Ethereum will be modified into a delegated proof-of-stake (DPoS) or practical Byzantine fault tolerance (PBFT) consensus algorithm as it is scalable and fits the drug supply chain environment. The system will adopt the GS1 pedigree standard and will satisfy the data points in the data standardization guidelines from the US FDA. Simulations will use the following 5 nodes: for FDA, manufacturer, wholesaler, retailer, and the consumer portal. RESULTS Development is underway. The design of the system will place FDA in a supervisory data verification role, with each pedigree type–specific data source serving a primary data verification role. The supply chain process will be initiated by the manufacturer, with recursive verification for every transaction. It will allow consumers to scan a code printed on the receipt of their purchases to review the drug distribution history. CONCLUSIONS Development and testing will be conducted in a simulated network, and thus, results may differ from actual practice. The project being proposed is disruptive; once tested, the team intends to engage the Philippine FDA to discuss implementation plans and formulate policies to facilitate adoption and sustainability. REGISTERED REPORT IDENTIFIER RR1-10.2196/10163

George Robert Barker

No abstract is available for this record.

Timothy Nugent, David M. Upton, Mihai Cimpoeşu

The scientific credibility of findings from clinical trials can be undermined by a range of problems including missing data, endpoint switching, data dredging, and selective publication. Together, these issues have contributed to systematically distorted perceptions regarding the benefits and risks of treatments. While these issues have been well documented and widely discussed within the profession, legislative intervention has seen limited success. Recently, a method was described for using a blockchain to prove the existence of documents describing pre-specified endpoints in clinical trials. Here, we extend the idea by using smart contracts - code, and data, that resides at a specific address in a blockchain, and whose execution is cryptographically validated by the network - to demonstrate how trust in clinical trials can be enforced and data manipulation eliminated. We show that blockchain smart contracts provide a novel technological solution to the data manipulation problem, by acting as trusted administrators and providing an immutable record of trial history.

Jani Kurki

In this thesis, I explore how blockchain technology can improve pharmaceutical supply chain operations and discuss how the technology should be implemented. Furthermore, I study how the life science company Bayer's pharmaceutical division can utilize blockchain technology in its supply chain operations. I begin by defining the concepts of blockchain technology, smart contracts and pharmaceutical supply chain. Then I discuss the benefits and implementation in different sections: participating entities and information flow, contracts and payments, logistics, transparency and product security and blockchain infrastructure and governance. Both Bayer and the industry as a whole can benefit from blockchain technology. Blockchain enables for example efficient, safe and private transactions, product transparency and security and open information sharing without exposing trade secrets. For the first time a platform for all stakeholders can be developed that enables transacting information and value simultaneously.

Max Joseph Herman

Background: Accessibility to essential drugs is a public right, therefore it's the government responsibility to make them available.Previously before the era of regional autonomy, public drug management in all districts/cities was performed by the so-called District Pharmaceutical Warehouses (GFK).However, nowadays the situation has changed because of the difference in vision and perception of each regional government on the former warehouses.Some public drug management units in certain districts/cities are not functioning optimally.Inefficient drug procurement regarding the number and kind of drugs as well as timeliness results in gap between drug need and procurement.Furthermore, loosening in drug supply procedure makes essential drugs more unavailable to public.On the other hand, decentralization policy in drug management also undeniably brings advantages to the districts, for example capacity building in drug procurement, increasing capability in budget management and negotiation with district decision makers as well as enhancing regional economic activity.In revitalizing district pharmaceutical warehouses so as to attain minimal health care standards in districts/cities, baseline data in drug management and financing in several districts/cities should make a valuable contribution.Methods: A cross sectional descriptive study had been carried out during July-December 2006 in 26 districts/cities out of 11 provinces.Samples were 26 district health offices (Dinas Kesehatan Kabupaten/Kota) and 26 District Pharmaceutical Warehouses (GFK) where as respondents were head of drug section and head of warehousing respectively.Data were collected by means of structured questionnaires and in-depth interviews as well as the collection of secondary data of drug logistics.Qualitative and quantitative analysis was performed. Results:The study shows that: 1) although health budget in general had risen, the average percentage of drug budget allocation from 21 district health authorities was only 12.06%, reflecting the low drug priority in district health policy because drug expenditures may amount up to 40% of the total health budget.2) Public drug management was mostly performed by the so-called regional technical provider unit (UPTD) with some limitations concerning human resources and material in achieving an effective and efficient drug management, and 3) there was still lack of pharmacist assistants to manage drugs in primary health care (Puskesmas) up to 20% and even more piteously the lack of pharmacist in district drug management unit (GF/UPOP Kabupaten/Kota, 12,5%).Conclusions: Apart from the achievement of predetermined indicators stated in minimal health care standards in districts/ cities, especially regarding essential and generic drugs, drug management in general has been well performed concerning planning and drug availability.More support and commitment from the district government is a must considering that regional development can not be separated from the health development of the subject themselves.

Li Yang, Ying Cui, Guo Sufang, Philippa Brant · 6 authors

OBJECTIVE: To evaluate implementation of the National Essential Medicines Scheme (NEMS) in rural China. METHODS: Two rural counties/districts in each of three provinces where NEMS had been implemented were surveyed. Information was collected from NEMS staff at the province, county/district, township and village levels; patients with chronic disease were also interviewed. Service provision, finances, prescriptions, inpatient records and the expenditures of patients with certain diagnoses were investigated in township hospitals and village clinics. The results were compared with the corresponding data recorded before NEMS was introduced. FINDINGS: Following the introduction of NEMS, drug procurement in each study location was systematized. Total drug costs declined. This, and improved prescribing, reduced the costs of outpatient and inpatient care and led, apparently, to increased uptake of health services. However, the prices of some drugs had increased and the availability of others had declined. The compensation of health-care providers for NEMS-related reductions in their incomes had been largely ineffective. As a result of the introduction of NEMS, health facilities relied more on public financing. Many health-care providers complained about higher workloads and lower incomes. CONCLUSION: Although it was well conceived, the introduction of NEMS into China's decentralized, fee-for-service system of health care has not been straightforward. It has highlighted the problems associated with attempts to modernize health care and health financing for patients' benefit. Sustainable mechanisms to compensate health-care providers for lost income are needed to ensure that NEMS is a success.

Heiner K. Berthold, Olivier Descamps, Ioanna Gouni‐Berthold

Lipoprotein(a) has been associated with cardiovascular disease risk, but no randomized study has shown yet that lowering Lp(a) decreases cardiovascular risk. One treatment option for lowering Lp(a) in high-risk patients is lipoprotein apheresis, which has been approved for reimbursement now in Germany. This decision has been coupled with the mandate to perform a controlled endpoint trial. The ELAILa trial protocol has been filed (NCT01064934), but the study is on hold because of a negative ethics committee vote after strong opposition of part of the medical community due to ethical concerns. The authors argue that a randomized trial is necessary to investigate the effectiveness of the invasive, life-long and costly therapeutic procedure. Meanwhile, reimbursement continues. The study would be the first endpoint trial investigating whether lowering isolated Lp(a) elevation decreases cardiovascular endpoints. The association between lipoprotein(a) [Lp(a)] and cardiovascular disease (CVD) risk has generated much interest in the last few years [1]. However, randomized controlled trials examining the effects of Lp(a) lowering on cardiovascular outcomes are lacking, and thus, an assumption of a beneficial effect remains speculative. In Germany, there was recently an opportunity to perform such a trial using lipoprotein apheresis to investigate whether decreasing Lp(a) improves cardiovascular outcomes in patients with isolated elevated Lp(a) concentrations and progressive cardiovascular disease. Lipoprotein apheresis for this indication is reimbursable in Germany. The study is presently on hold due to the strong opposition of part of the medical community questioning the ethical justification of randomization. The aim of this study is to raise the discussion to an international level, to foster the debate across healthcare systems and to discuss the ethical considerations of not performing such a study. Lp(a) is a low-density lipoprotein (LDL)-like particle consisting of an apolipoprotein-B100 molecule covalently linked to the large glycoprotein apolipoprotein(a) (apo(a)) [2]. The precise physiological role of these particles remains unclear. The distribution of plasma Lp(a) levels in the population is skewed, ranging from <0·1 to >300 mg/dL, and there is an interindividual variation by a factor of ∼1000 [3]. In Caucasians, the 80th percentile of Lp(a) concentrations is 50 mg/dL [1]. Numerous prospective epidemiological studies and meta-analyses [4–6] have reported associations between Lp(a) concentrations and CVD [7]. Two recent studies provided strong evidence for a causal association between increased levels of Lp(a) and coronary heart disease [8,9]. However, it remains unclear whether lowering Lp(a) concentrations reduces atherosclerosis and CVD outcomes. This situation recalls the situation at the end of the last century when many physicians refused to accept that lowering LDL was beneficial until the results of the 4S study [10] unequivocally established that it was. With Lp(a), a major problem in proving such an effect is the lack of an agent specifically and substantially decreasing Lp(a) levels [2]. The current drug treatment of choice for elevated Lp(a), niacin [1], decreases its concentrations by only 20–30% [11] and may reduce cardiovascular events [12], but at the same time affects other lipoprotein fractions so that its overall effects cannot be solely attributed, if at all, to the modest decreases in Lp(a) concentrations. Lipoprotein apheresis, besides decreasing LDL cholesterol, is able to decrease Lp(a) concentrations by 50% to 70% [13]. In Germany, the Federal Joint Committee (Gemeinsamer Bundesausschuss; G-BA), the highest decision-making body of the so-called self-governing health system, decided in 2008 to approve the reimbursement of lipoprotein apheresis for individual patients with isolated hyperlipoproteinaemia(a) (Lp(a) >60 mg/dL) and progressive CVD when all other measures to stop disease progression have failed. This reimbursement decision was coupled with a mandate to perform a controlled trial which would definitely prove (or disprove) the benefit of Lp(a)-lowering using apheresis in these patients. An independent steering committee was created, and an investigator-initiated study protocol for such a study (ELAILa trial; http://www.clinicaltrials.gov identifier NCT01064934) was duly submitted to the competent ethics committee (EC). The study was rejected, however, after lengthy discussions with and appeals from various groups of medical professionals, mainly associated with the procedure. Their criticism was based on the argument that randomization for the study is not ethically justified. The EC eventually decided that it was indeed unethical to perform a randomized trial because an observational trial addressing this issue existed [14], and the data it provided deemed adequate proof of benefit of apheresis. However, this observational study did not include a control group. The question remains whether there is enough evidence to support that Lp(a) apheresis improves the outcomes of patients with isolated elevation of Lp(a) and progressive CVD, thus obviating the need for a randomized trial. To us, the answer is a clear no, as uncontrolled observations do not fulfil the criteria of evidence-based medicine in 2012. The ELAILa trial was designed as a hybrid trial, consisting of both, a randomized controlled trial (RCT) and an observational trial (OT) for the patients not willing to be randomized. In addition, patients having reached a nonfatal endpoint in the RCT could be switched over to the OT for long-term follow-up (Fig. 1). The OT would thus also serve the purpose of establishing a national registry of Lp(a) apheresis patients, another mandate of G-BA (the respective documents can be found on http://www.g-ba.de). Flow of participants. Primary outcome measure of the trial was a composite endpoint, defined as first occurrence of one of the following: myocardial infarction, interventional coronary therapeutic procedure, coronary artery bypass grafting (CABG), cerebrovascular accident, hospitalization due to acute coronary syndrome (ACS), peripheral arterial revascularization and death from cardiovascular cause. Secondary outcome measures were the components of the primary endpoint considered individually and death from any cause. Safety of the procedure and quality of life were also to be investigated. The trial would enrol male and female patients ≥18 years of age having Lp(a) concentrations ≥60 mg/dL, LDL cholesterol <100 mg/dL and progressive CVD. As demanded by G-BA, CVD progression despite maximally tolerated conservative therapy would have to be determined not only clinically but also with imaging methods. Patients with LDL cholesterol of <100 mg/dL were selected for the trial since the effect of lowering Lp(a) and not of lowering LDL cholesterol on cardiovascular outcomes was to be investigated. After randomization (1 : 1 ratio stratified by centre), patients would be treated by lipoprotein apheresis (all approved apheresis methods will be allowed in the trial). In the control arm, patients will be treated with maximally tolerated conservative treatment to reduce cardiovascular risk. Lp(a) concentrations would be measured in a central accredited laboratory with an isoform-insensitive assay, and changes in Lp(a) levels would be modelled as a covariate. In preparation of a reliable estimate of the predicted number of events and for calculating the required sample size, statistical considerations were hampered by a lack of data on the parameters of interest. A 50% risk reduction was considered to be clinically relevant, a decision based on the effect sizes usually observed in statin trials (about one-third event reduction) and on the high-risk state of the study population. The assumptions for the final sample size calculation for the primary outcome included equal allocation of patients to the apheresis or control group, an accrual time of 48 months and an additional follow-up of 12 months, a median event-free time for the control group of 24 months and an event-free time twice as large for the apheresis group. It was furthermore assumed that patients will be accrued uniformly over time. Calculating the sample size, a relative risk reduction of 50% can be detected at a two-sided significance level of 0·05 and with a power of 80% by evaluating a total number of 135 patients. The observational trial (OT) would also consist of two arms (see Fig. 1), an apheresis arm and a control arm (for patients unwilling to either be randomized or to receive apheresis treatment). If patients in the RCT would reach a nonfatal endpoint, they would be able to switch over to the OT arm. In December 2008, G-BA had agreed to the general outline of the ELAILa trial. Moreover, the German Cardiac Society and the German Society for Nephrology supported this trial. Financing would be supplied by four of the largest manufacturers of lipoprotein apheresis systems in Germany, which have established a consortium that would sponsor the organizational part of the trial. Importantly, in an additional decision of July 2009, G-BA ascertained that reimbursement of the treatment costs was granted for study participants by mandatory health insurance coverage. This decision has been endorsed by the Federal Ministry of Health. In January 2010, the finalized study protocol was submitted to the ethics committee (EC) at Charité University Medicine in Berlin. After several hearings and after having been contacted by groups of medical professionals who strongly opposed the study, the EC decided that it was crucial for their final decision to have an independent biostatistical expertise on a retrospective cohort study by Jaeger et al. [14], presumably showing a reduction of major coronary events with lipoprotein apheresis. Such a report was obtained, and a final decision was made in July 2010, ruling that the proposed RCT is unethical, while the OT received a positive vote. The EC came to the conclusion that it is unethical to randomize patients ‘as long as there is no active, probably effective control group and as long as there are no data from new cohort studies that question the results of the study of Jaeger et al.’. An appeal of the study trialists against the decision of the EC was rejected. The study has been ‘on hold’ since then. We believe that this decision is very unfortunate as (i) it deprives both patients and the scientific community of the true answer to a significant question and (ii) the study on which it was based [14] has significant limitations, most importantly because it is retrospective and uncontrolled. This nonrandomized retrospective cohort study in 120 subjects showed that decreasing Lp(a) levels by 73% using apheresis associates with decreases in the annual rate of major adverse cardiovascular events (MACE) from 1·056 to 0·144 before and after starting apheresis [14]. At first sight, this finding seems very persuasive; however, potential limitations in design and statistical methodology should be considered. For example, in time-to-failure data (or person–time data in general), the basic assumption is that the risk of failure (event) in one group is the same constant multiple of the other group at any point in the follow-up time. The study violated the principle of independence of observations and used a questionable statistical test. Other problematic issues with this study are the fact that the patients were not maximally treated (e.g. only 8·3% were receiving niacin and only 3·3% cholestyramine), that there was no prospective documentation of events (events were retrospectively assigned as such) and that events were not adjudicated independently. Calculating intraindividual ‘event rates’ is a statistically dubious concept [15]. In summary, the conclusions of this study are limited by its design, and it does not meet the criteria of evidence-based medicine in 2012. We thus believe that, although laudable, this study cannot be considered as an adequate alternative to a randomized controlled trial as proof of the effectiveness of Lp(a) apheresis. Moreover, a recent small randomized trial from Italy showed that in 21 patients with angiographically documented CHD apheresis decreased Lp(a) by 57% but showed no difference in the rate of cardiovascular events in a follow-up of 1 year [16]. While in their demand for a controlled trial, the G-BA did not specifically request a randomized trial, they characterize such as the ideal design. A nonrandomized trial design bears substantial selection bias (confounding by indication). In such a study, it cannot be excluded (not to say it would be rather likely) that patients with higher cardiovascular risk will be allocated to apheresis treatment while the ones with lower cardiovascular risk will receive standard care. In conclusion, another uncontrolled trial (or registry) will not be able to prove the effectiveness of apheresis over conservative treatment. We acknowledge that the decision in Germany to reimburse this procedure, suggesting to both, medical professionals and patients, that the required evidence for superiority of apheresis exists, would make randomization and therefore recruiting difficult. On the other hand, it could be argued that it is difficult to defend offering patients an invasive, expensive, life-long procedure without having high-quality, evidence-based, proof of benefit. Even the Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs of the Institute of Medicine [17] concludes that ‘… the FDA may be justified in requiring studies that could expose patients to heightened risk–but only if a public health question of pressing importance is at stake, if no other study design could supply the needed evidence,…’. We believe that this approach exactly reflects the situation with Lp(a) apheresis. Of note, any cost-effectiveness data regarding Lp(a) apheresis for this indication are also lacking. Although observational data suggest that lipoprotein apheresis to decrease elevated Lp(a) concentrations may improve CVD risk, observational data cannot adjust for unmeasured confounders. However, they have been accepted in this particular case as adequate proof of beneficial effects of a life-long invasive procedure. How can this be explained? Certainly, the aspect of the ‘rare disease’ state of the patients was an argument involved in the decision. There is a clear need for guidance or guidelines evaluating the treatment of rare diseases to help health professionals navigate through the maze of various purportedly effective therapeutic options. On the other hand, one might ask why the scientific standards (and statistical methods) for investigating rare and common diseases should be different. Moreover, the decision may be a reflection of what has been described as ‘the illusion of validity’, the phenomenon of unwarranted confidence on a specific outcome which is produced by a good fit between the input information (significant decrease in Lp(a) concentrations) and the predicted outcome (decrease in cardiovascular events). Interestingly, this ‘illusion’, which has been observed even among the most experienced of researchers, persists even when the scientist is aware of the factors that limit the accuracy of his/her predictions [18]. The ethical basis for entering patients in randomized trials has been in general under debate. Some doctors espouse the uncertainty principle whereby randomization to treatment is acceptable when an individual doctor is genuinely unsure which treatment is best for a patient. Others believe that clinical equipoise, reflecting collective professional uncertainty over treatment, is the soundest ethical criterion [19]. Numerical modifications of surrogate markers of CVD risk do not automatically translate to an actual reduction of CVD events, as has been recently shown, for example, with CETP inhibitors, drugs that increase HDL-C and decrease LDL-C [20]. Observational and randomization data have often reached surprisingly disparate conclusions, and effects of surrogate markers were misleading in the field of cardiology, as we have seen, for example, with hormone replacement therapy and intensive glycaemic control in patients with diabetes. A randomized controlled trial to investigate the effects of lipoprotein apheresis to decrease Lp(a) needs to be performed sooner than later. Randomization is a powerful tool that cannot be reliably reproduced by statistical modelling, and therefore, observational data cannot be used as substitutes for randomized trial results [21]. The ELAILa trial may be an illustrative example where selectively missing information on a research subject does not only pertain to studies that have already been performed but for the much greater challenge to understand how many potential studies do not exist when they could readily have been conducted [22]. Drs. Heiner K. Berthold and Ioanna Gouni-Berthold are members of the ELAILa trial steering committee. The views expressed here are those of the authors and do not necessarily reflect the views of the other members. The authors have no conflict of interest associated with the subject matter. Charité University Medicine Berlin, Virchow Clinic Campus, Lipid Clinic at the Interdisciplinary Metabolism Center, Berlin, Germany (H. K. Berthold); Evangelical Geriatrics Center Berlin (EGZB), Berlin, Germany (H. K. Berthold); Département de Médecine Interne et Centre de Recherche Médicale de Jolimont, Hôpital de Jolimont, Haine Saint-Paul, Belgium (O. S. Descamps); Center for Endocrinology, Diabetes, and Preventive Medicine, University of Cologne, Cologne, Germany (I. Gouni-Berthold).

Peter Roderick, Allyson M Pollock

No abstract is available for this record.

Martínez Giralt, Xavier, Barros, Pedro Pita

Under traditional health insurance arrangements, citizens were covered by some insurance scheme.When sick, insurance arrangements allowed citizens to go to a health care provider, pay the price of the care received and be reimbursed later.Alternatively, the care provider would be owned by the insurer (like in integrated national health systems) and the patient paid nothing at the moment of consumption.In such arrangements, providers would freely set their prices or have no price to set at all (in an NHS-like system).Recent developments in health care financing include independent institutions that negotiate the prices with the financing institution.This is true with respect to health maintenance organizations (HMOs), managed care in general, but also in national health systems where decentralization and the split between provision and financing is implemented.In this scenario, negotiation over contractual terms, including prices as one major element, becomes a relevant issue in the analysis of performance of health care systems.Both empirical and theoretical analyses have been produced, and are reviewed below.This chapter reflects our views and preferences.It does not aim to be an encyclopaedic view of the existing literature on bargaining in health care.Instead, we try to highlight the new developments associated with explicit bargaining between third-party payers and providers of health care (a relation which is, in itself, only one of many that exist in the health care sector).Bargaining theory has a long tradition in the economics literature.However, it is only recently that this approach has found space in the analysis of the health care sector.The recognition of the strategic interaction among agents in the health care sector (patients, providers and third-party payers) came with the application of models borrowed from the industrial organization tradition dating from the 1970s.It was in the early 1990s when a step forward was taken with the eruption of the models of bargaining (see for example, Osborne and Rubinstein, 1990, for a nice presentation) In many situations the health care sector has the structure of a bilateral monopoly/oligopoly.In this context, bargaining becomes the natural way to approach the interactions among agents.Most economic analyses of contract design in health care in fact assume that the party that moves first, typically the payer, proposes a take-it-or-leave-it offer to the provider.We take here a broader view, looking at other types of negotiation procedures.We do not discuss issues related to contract design, which are taken up in chapter 22 by Chalkley in this Companion.We focus here on models of explicit bargaining between two parties, which we call the payer and the provider.On theoretical grounds, simple bargaining models can have their results transposed in a straightforward way: higher bargaining power and higher M2835-JONES9781849802673PRINT.

Idham dan Ali Ghufron Mukti

Implementation of decentralized drug policy brings an impact in the form of finance mechanism changes. Before decentralization, drug budget was calculated by the amount of resident and indigent resident percentage. After decentralization, the budget is specified by each regional government according to needs and existing health problems. This change leads to problems of allocation and distribution especially in some areas where Original Earnings of Area (PAD) is relatively small. The allocation is strongly influenced by the amount of Common Allocation Fund (DAU) and the drug manager ability in the area to manage the fund of drugs as efficient and effective as possible to assure the availability and sustainability of health service. The aim of the study was to calculate the adequacy rate of drug cost before and after decentralization and to determine the influence of decentralization itself toward the adequacy of drug cost in the area.\nA case study was conducted using quantitative data and the result was analyzed with regard to drug cost adequacy. The study began with calculating indicator of drug management and drug cost requirement on the therapy of top 10 diseases using morbidity method during 1999-2002. The result was analyzed with ABC analysis and compared to realization of drug cost on the same periode and interpreted to assess the drug cost adequacy before and after decentralization.\nThe result showed that the average of ability on the drugs cost procurement based on comsumtion method to fullfill drug cost requirement based on morbidity method before decentralization was 31,33%, after decentralization increased to 78,51%. And then the average of ability on the drugs cost based on comsumtion method to fullfill drug cost requirement based on morbidity method before decentralization was 15,14%, after decentralization increased to 60,67%. Nevertheless, the increase of fund adequacy and drug cost rate was not significant (p&gt;0,05) between before and after decentralization. It was concluded that although the adequacy rate of drugs cost and fund has increased significantly after decentralization, it was not able to fulfill the requirement up to 100%. In other words, decentralization has not influenced the cost adequacy rate of primary health care drugs in the area.\n\nKeywords: availability –adequacy –decentralization –cost of drugs.

Fernando Antoñanzas

No abstract is available for this record.

WR Simons

No abstract is available for this record.

Richard Graham Halliday, A.L. Drasdo, Cynthia E. Lumley, Stuart Walker

A survey of 45 leading pharmaceutical companies has been used to investigate aspects of their Research and Development (R&amp;D) strategies, the allocation of resources including the financing and staffing of R&amp;D functions, and the numbers of New Chemical Entities (NCEs) in the development process. The companies included the top ten by R&amp;D expenditure in 1992 (top 10 companies). The study identified characteristics of leading companies and provided comparative data. The principal findings are that: top ten companies had the highest R&amp;D to sales ratios, progressed more NCEs after the drug candidate selection stage in 1992 and had achieved a greater geographical decentralization of staff than any other company. Japanese companies differed in some respects from western companies, even those of a similar size. They operated with smaller clinical and regulatory affairs functions and made detailed plans for R&amp;D expenditure further ahead than western companies, on average, more than 5 years compared with 3 years. an increase in aggregated R&amp;D staffing had occurred between 1990 and 1992 in 33 companies for which data for both years were available and staff numbers had decreased in only five of those companies. top ten companies differed from others in their apparent productivity measured in terms of staff or R&amp;D expenditure per NCE after the drug candidate selection stage, utilizing more staff and having greater R&amp;D expenditure per NCE. The results also appear to indicate early signs of a change in the structure of the industry according to R&amp;D expenditure, which has since become more apparent. There was a distinct polarization by R&amp;D budget size among the respondent companies: five companies were spending $900m or more on R&amp;D in 1992 while the majority of the rest were spending less than a third of that amount.