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September 10, 2008
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Assessing Drug Risks: The Way Forward
Jerry Avorn, MD
Professor of Medicine, Harvard Medical School
Chief, Division of Pharmacoepidemiology and Pharmacoeconomics
Brigham and Women's Hospital
Readings:
J Avorn In Defense of Pharmacoepidemiology - Embracing the Yin and Yang of Drug Research NEJM 2007.pdf
J Avorn FDA Standards - Good Enough for Government Work NEJM 2005.pdf
Click here to view the September 12, 2008 Seminar Slide Presentation
To borrow a DVD of this seminar please contact the Seminar Coordinator, Joyce Cheatham, at joyce_cheatham@hphc.org or 617-509-9881
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September 24, 2008
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Unhealthy Health Policy Research: “You Can’t Fix by Analysis What You Bungled by Design”
Stephen B. Soumerai, ScD
Professor of Ambulatory Care and Prevention
Director, Drug Policy Research Group
Harvard Medical School and Harvard Pilgrim Health Care
ABSTRACT
Health policies represent massive social experiments with poorly understood risks and benefits. Unfortunately, many researchers stray from the core principles of research design required to provide valid evidence. The result is that policy-makers and the public do not know what to believe or disbelieve. We illustrate the problem in several fields, including pay-for-performance and cost-sharing. A recurring theme is that popular statistical adjustments cannot compensate for a bungled design. We suggest ways to improve health policy research, including training in quasi-experimental study designs in order to provide better advice for policymakers and the health of the public.
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October 8, 2008
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Data Mining in Insurance Claims
Alexander Walker, MD, DrPH
Principal
World Health Information Science Consultants, LLC
Professor of Epidemiology
Harvard School of Public Health
Insurance claims data provide a wealth of longitudinal information. These transactional records track all aspects of medical care, and form data resources that are assembled without prior hypotheses. As such they would appear ideal for data mining. Systematic, propensity-adjusted cohorts, all-possible pairs analyses with DuMouchel's gamma Poisson shrinker and systematic rescreening using Kulldorf's MaxSPRT technology all provide possibilities for database searches. However, unless each of these methods is heavily seasoned with an application of epidemiologic principle, medical insight and a thorough understanding of the source data, the results are likely to bring the field into disrepute.
Click here to view the October 8, 2008 Seminar Slide Presentation in PDF format
To borrow a DVD of this seminar please contact the Seminar Coordinator, Joyce Cheatham, at joyce_cheatham@hphc.org or 617-509-9881
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October 22, 2008
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Impact of Prior Approval of Antidepressants among Dual Medicaid and Medicare Enrollees
Alyce Adams, PhD
Research Scientist
Division of Research
Kaiser Permanente
Oakland, CA
Prior authorization is a popular, but understudied strategy for reducing medication costs. We evaluated the impact of a controversial prior authorization policy in Michigan Medicaid on antidepressant use and health outcomes among dual Medicaid and Medicare enrollees with an SSDI designation of disability. This presentation provides preliminary findings and suggestions for future research.
Readings:
Soumerai SB, Zhang F, Ross-Degnan D, Ball DE, LeCates RF, Law MR, Hughes TE, Chapman D, Adams AS. Use of atypical antipsychotic drugs for schizophrenia in Maine Medicaid following a policy change. Health Affairs 2008.
Soumerai_et_al.pdf
To be announced
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October 29, 2008
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Incentivizing Development of New Antibiotics: The Antibiotic Conservation and Effectiveness Program
Kevin Outterson, JD, LLM
Director, Health Law Program
Associate Professor
Boston University School of Law
Click here to view the October 29, 2008 Seminar Slide Presentation
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November 12, 2008
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Clinical Trials, the Market for Observations, and the Cost of Medical R & D
Anup Malani, PhD, JD
Professor of Law
Aaron Director Research Scholar, University of Chicago
Roscoe Pound Visiting Professor, Harvard Law School
Visiting Director of the Petrie Flom Center for Health Law, Policy, Bioethics and Biotechnology
There is a lively debate about the productivity of medical R and D spending. The major component of drug R & D is the time and cost of conducting the necessary clinical trials to gain market approval by regulatory bodies, such as the FDA in the US. However, there is there is little economic analysis of what determines the length and costs of clinical trials, that would complement the voluminous normative literature on experimental design. This paper offers a positive theory of clinical trials that stresses two features of the implicit labor market for observations between subjects and investigators. First, costly search is a central aspect of this market – patients looking for trials and trials looking for patients. Unlike other markets, however, bioethical rules impose wage caps that prevent the market from clearing. Second, medical R & D has the unique feature that the input supply market (subjects) and the output demand market (patients) coincide. Unlike other markets, aspects of output markets, such as the number or insurance coverage for approved drugs, has a direct effect on the cost of R & D. We present suggestive evidence that these two aspects of the market for observations are important for understanding the speed of cancer trials in 1996-2008. Other things constant, trials have been completed faster due to reduced search costs enabled by the public internet site clinicaltrials.gov. This has been offset by a reduced speed of trials due to the larger number of competing cancer trials.
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November 26, 2008
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- No Seminar
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December 10, 2008
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Andreas Seiter, MD
Presentation date changed to February 4, 2009
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December 24, 2008
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- No Seminar
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January 14, 2009
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Making Reimbursement Decisions Transparent: A Role for Comparative Effectiveness
Joshua Cohen, PhD
Senior Research Fellow
Tufts Center for the Study of Drug Development
Tufts University
Boston, MA
Today’s buzzword in health policy circles is comparative effectiveness. Though its meaning and objectives are somewhat ambiguous, there is consensus that comparative effectiveness research could improve the prescribing decision-making process as well as the reimbursement decision-making process. Here, I’ll focus on possible reimbursement policy implications of comparative effectiveness, specifically as they relate to patient access to biopharmaceuticals.
Click here to view the January 14, 2009 Seminar Slide Presentation
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January 28, 2009
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Antibiotic use in Mexico: An Analysis of Problems, Policies and Politics
Anahí Dreser, MD, MSc, PhD candidate
Researcher
National Institute of Public Health, Mexico
In this presentation, I consider the factors that affect the development of policies for the appropriate use of antibiotics in Mexico. The inappropriate use of antibiotics signifies a risk for individual health and a waste of health resources. Furthermore, it triggers the development of antibiotic resistance, which is considered a serious public health problem. The World Health Organization has called for international action directed to improve antibiotic use and contain antimicrobial resistance, recommending also a series of strategies to be included within national medicines policies. However, only few countries have fully incorporated these strategies into their national policies.
This presentation situates the problem of inappropriate antibiotic use within a political agenda-setting and agenda-denial framework. Using Kingdon´s three-stream model for agenda setting* (problem recognition, development and diffusion of policy alternatives, and political context), I explain how diverse factors affect the issues of inappropriate antibiotic use and antibiotic resistance to reach the policy agenda in Mexico. Some of these factors are: 1) Low problem recognition; 2) Framing of the problem in cultural and structural spheres which are difficult to act upon; 3) Unawareness of international policy recommendations on this matter; 4) The lack of recognition of responsibility regarding this problem and its solutions. These factors can help understanding barriers to action and could be considered to bring the issue of inappropriate antibiotic use to the health policy agenda in other developing countries.
(*) Kingdon, J. (1995). Agendas, alternatives and public policies. 2nd ed. New York: HarperCollins College Publishers.
Readings:
A Shrinking window of opportunity_BMJ 2009.pdf
7-antibioticos_Salud pública de México_2008.pdf
Click here to view the January 28, 2009 Seminar Slide Presentation
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Added Date
February 4 , 2009
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Improving Access to Medicines for Better Health Outcomes - What Role Does the World Bank Play?
Andreas Seiter, MD
Senior Health Specialist - Pharmaceuticals
The World Bank
Washington, DC
The World Bank is a large development institution with operations in most
developing countries as well as a significant presence on the global arena.
From its work with client countries, the Bank has a good understanding of the
complex patterns of dysfunction that often prevent poor people from getting the
medicines they need or using them in ways that lead to the desired treatment
outcomes. The presentation will explore the underlying causes and discuss
policy options - illustrated with examples from current project work - to
overcome the chronic performance problems in the pharmaceutical sector in
developing countries.
Click here to view the February 4, 2009 Seminar Slide Presentations
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February 11, 2009
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Access to Medicines in Brazil
Vera Lucia Luiza, ScD
Senior Researcher
Department of Nucleus for Pharmaceutical Policies
National School of Public Health/ Fiocruz, Rio de Janeiro, Brazil
Adjunct Coordinator, PAHO-WHO Collaborating Center on Pharmaceutical Policies
Dr. Luiza will present the main strategies used in Brazil to improve access to medicines within the WHO framework of a reliable health and pharmaceutical system; selection of essential medicines; financing; and affordability. She will discuss results of recent studies on aspects of medicines access: availability, affordability, geographical accessibility and acceptability.
Click here to view the February 11, 2009 Seminar Slide Presentations
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February 25, 2009
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Access: How do good health technologies get to poor people in poor countries?
Michael Reich, PhD
Taro Takemi Professor of International Health Policy
Department of Global Health and Population
Harvard School of Public Health
Many people in developing countries lack access to health technologies, even basic ones. Why do these problems in access persist? What can be done to improve access to good health technologies, especially for poor people in poor countries? This talk will address these questions by presenting a recent book with a comprehensive analytical framework for access and six case studies. The analytic framework is based on four A’s- Architecture, Availability, Affordability, and Adoption. The six technologies are: praziquantel (for the treatment of schistosomiasis), hepatitis B vaccine, malaria rapid diagnostic tests, vaccine vial monitors for temperature exposure, the Norplant implant contraceptive, and female condoms. The full text of the book is downloadable for free at www.accessbook.org, and the authors are Laura J. Frost and Michael R. Reich. The research was supported by the Bill & Melinda Gates Foundation.
Readings:
Frost LJ, Reich MR. How do good health technologies get to poor people in poor countries? Harvard University Press, Cambridge, MA, 2009.
http://www.accessbook.org/download_access.asp
Click here to view the February 25, 2009 Seminar Slide Presentations
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Added Date
March 4, 2009
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Managing the Massachusetts Medicaid Pharmacy Benefit
Paul L. Jeffrey, PharmD
Senior Director, Office of Clinical Affairs, Commonwealth Medicine
Director of Pharmacy, MassHealth
This seminar will cover a high level view of the policy and management strategies for providing pharmaceutical services to a large population supported by public funding. A brief description will be provided of the populations served, other stakeholders involved, the cost drivers, and the tools available, as well as the successes and caveats. The seminar will emphasize the importance of clinical priority, data-driven, evidence-based practices in crafting a clinically sound, cost-effective pharmacy benefit for Medicaid beneficiaries.
Readings:
Prescription Drug Trends. Kaiser Family Foundation. September 2008
http://www.kff.org/rxdrugs/upload/3057_07.pdf
Medicaid and Outpatient Prescription Drugs. March 2005
http://www.kff.org/medicaid/upload/1069_03.pdf
Click here to view the March 4, 2009 Seminar Slide Presentations
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March 11, 2009
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Access to Medicines by Health Service Users in Mexico: 1994 to 2006
Veronika Wirtz, MSc, PhD
Researcher
National Institute of Public Health, Mexico
Presentation broadcast via video link from National Public Health Institute, Mexico
Objective: To analyse the current level of drugs prescription, prescription filling, payment and expenditure for medicines by ambulatory health service users (HSU) in Mexico, and to evaluate its evolution in the last twelve years.
Methods: Primary data were extracted from the National Health Surveys 1994, 2000 and 2006 in Mexico and the variables identified which were associated with the prescription rate, prescription filling and payment.
Results: The type of health service provider and geographical region was found to be the most important predictors of access to medicines. Although the proportion of patients obtaining and paying for drugs has broadly stayed the same as in 1994, the percentage of health services users paying for their prescribed medicines decreased from 70% in 1994 to 42% at Ministry of Health institutions.
Conclusion: The progress in prescription and population access to medicines has been uneven across Mexican states and health service providers.
Key words: drugs, access, primary health care, Mexico
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March 25, 2009
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Improving the Quality of Pharmacotherapy in the Elderly Myths and Challenges
Jerry Gurwitz, MD
Professor of Medicine and Chief, Division of Geriatric Medicine
University of Massachusetts Medical School
Executive Director of the Meyers Primary Care Institute
Dr. Jerry Gurwitz will provide an overview of the pharmacologic and epidemiologic data that inform the development of clinical decision support (CDS) to improve the safety of medication use in older adults. The experience of early efforts to test the effectiveness of computerized CDS in the long-term care setting will be discussed.
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April 8, 2009
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Essential Medicine Use in the Philippines: Understanding the Relationship between Need, Affordability and Access
Sheila K. Reiss, MSc, RPh
PhD Program in Health Policy
Harvard University
Thomas O. Pyle Fellow
Department of Ambulatory Care and Prevention
Harvard Medical School and Harvard Pilgrim Health Care
It is commonly reported that one-third of the world's population lacks regular access to essential medicines. This estimate, which was derived from high-level WHO data, has given rise to the concern that individuals in low and middle-income countries may be most at risk for not having access to essential medicines. Health care affordability is a key component of access in these settings, as high out-of-pocket health care costs, due to insurance coverage that is unavailable or ineffective, may hinder immediate or future access to health care and medicines.
This presentation covers preliminary work on the determinants of access to medicines in the Philippines. Using 2002 World Health Survey data, I examine whether health care affordability -- measured at the household level -- relates to access to essential medicines for individual household members with chronic conditions or with reported use of the health care system.
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April 22, 2009
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Models for Expenditure and Cost Data
Alan M. Zaslavsky, PhD
Professor
Department of Health Care Policy
Harvard Medical School
Regression modeling of cost and expenditure data (as well as income data) is challenging for several reasons: (1) restriction of data to non-negative values, (2) nonlinearity of the regression relationship, (3) the presence of many zero values, and (4) heteroscedasticity and skewness of conditional distributions. Several modeling approaches have been used to accommodate these typical data features. One-part models include both zero and nonzero expenditures in the same model, while two-part models consist of a binary model for presence of nonzero expenditures together with a continuous model for the magnitude of the expenditures. An older approach to modeling of magnitude is to fit an ordinary least squares (OLS) model to transformed data. However, predicted values from these models can be sensitive to violations of model assumptions (the "retransformation problem"). Generalized linear quasilikelihood models (nonlinear least squares) offer another strategy that avoids the retransformation problem but requires further choices for model specification. I will compare these approaches and describe some diagnostics and graphical methods that can aid model selection.
Click here to view the April 22, 2009 Seminar Slide Presentations
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May 6, 2009
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High-dimensional propensity score adjustment in studies of treatment effects using health care claims data
Sebastian Schneeweiss, MD, ScD
Associate Professor of Medicine and Epidemiology, Harvard Medical School
Vice Chief, Division of Pharmacoepidemiology
Department of Medicine, Brigham & Women's Hospital
Background: Adjusting for large numbers of covariates ascertained from patients’ health care claims data may improve control of confounding, as these variables may collectively be proxies for unobserved factors.
Objective: To develop and test an algorithm that empirically identifies candidate covariates, prioritizes covariates, and integrates them into a propensity score-based confounder adjustment model.
Methods: We developed a multi-step algorithm to implement high-dimensional proxy adjustment in claims data. Steps include 1) identifying data dimensions, e.g. diagnoses, procedures, and medications, 2) empirically identifying candidate covariates, 3) assess recurrence of codes, 4) prioritizing covariates, 5) selecting covariates for adjustment, 6) estimating the exposure propensity score, and 7) estimating an outcome model. This algorithm was tested in Medicare claims data, including a study on the effect of Cox-2 inhibitors on reduced gastric toxicity compared to non-selective (ns)NSAIDs.
Results: In a population of 49,653 new users of coxibs or nsNSAIDs, a crude association with upper GI toxicity of RR = 1.09 (95% CI: 0.91-1.30) was initially observed; adjusting for 15 predefined covariates resulted in a possible gastroprotective effect (RR=0.94; 0.78-1.12). A gastroprotective effect became stronger when adjusting for an additional 500 algorithm-derived covariates (RR=0.88; 0.73-1.06). Results of a study on the effect of statin on reduced mortality were similar. Using the algorithm adjustment confirmed a null finding between influenza vaccination and hip fracture (RR=1.02; 0.85-1.21).
Conclusion: In typical pharmacoepidemiologic studies, the proposed high-dimensional propensity score resulted in improved effect estimates compared to adjustment limited to predefined covariates, when benchmarked against results expected from randomized trials.
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May 13, 2009
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Medical visit companions for vulnerable older adults: Do the benefits of having a medical visit companion extend beyond the visit?
Ashley Beard, PhD
Fellow in Pharmaceutical Policy Research, DACP
Harvard Medical School and Harvard Pilgrim Health Care
Increasing numbers of older adults in the United States are living with chronic illness and disability. For older adults with multiple chronic illnesses, fragmented care and suboptimal rates of preventive service delivery raise concerns about quality. Innovations in care delivery and physician payment have attempted to address deficiencies in the quality of care but these interventions are rarely focused on vulnerable, multi-morbid, older adults. Further, interventions infrequently involve family and friends despite the fact that these informal caregivers often accompany vulnerable older adults to medical visits. Some research has suggested that medical visit companions can be important advocates for patients. However, not much is known about the influence of caregivers and their roles in medical visits on the outcomes of care. This study uses data from the Medicare Current Beneficiary Survey (MCBS) to examine the relationships among the presence of a companion in the medical visits of vulnerable older adults, the activities performed by companions, and outcomes such as receipt of preventive care.
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May 27, 2009
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Analyzing policy impacts on postpartum mental health care among
low-income women
Katy Backes Kozhimannil, MPA, PhD
Fellow in Pharmaceutical Policy Research, DACP
Harvard Medical School and Harvard Pilgrim Health Care
Description: Postpartum depression may affect up to 20% of mothers and, if untreated, can have long-term negative impacts on women, children, and families. National legislation to address this issue is currently under consideration. This presentation presents 3 stages of work aimed at informing the policy debate on this topic. The first stage is a nearly completed paper which examines the impact of New Jersey’s statewide postpartum depression initiative on mental health care following delivery. In this paper, interrupted time series and patient-level longitudinal models are used to estimate policy impacts on initiation, follow-up, and receipt of guideline-consistent depression care. Initial findings indicate that postpartum depression is under-recognized and under-treated among low-income women. Improvements in the quality of care are both necessary and feasible in this vulnerable population. The second and third stages of work are being planned and include measuring the impact of a mandatory postpartum depression screening law and an analysis of racial disparities in postpartum mental health care.
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June 10, 2009
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Commonalities in Multi-Disease Drug Resistance and the Role of Global Collective Action
Rachel Nugent, PhD
Deputy Director, Global Health Program
Center for Global Development
Washington, DC
Drug resistance is a major impediment to the successful treatment of common infections worldwide. It is a naturally-occurring phenomenon, but is accelerated by socioeconomic, health system, and behavioral conditions that deter appropriate drug use across a range of high-burden diseases. Rapid advances in global drug access have had the unintended consequence of posing greater risk of drug resistance. Donors and the private sector both invest in drug R&D for poor country populations but have different incentives to prevent resistance emergence and spread. The Center for Global Development's Drug Resistance Working Group was created in late 2007 to identify practical and feasible ways that global actors and policymakers can work together to prevent or contain the emergence of drug resistance affecting high-burden diseases in developing countries through improvements in common property management, information flows and R&D investments. The aim of this presentation is to share and welcome input on the Working Group's draft recommendations - in particular those pertaining to industry and R&D.
Readings:
Access research papers commissioned by the DRWG
View editions of the DRWG's monthly e-newsletter on resistance.
Subscribe
Click here to view the June 10, 2009 Seminar Slide Presentations
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June 24, 2009
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The Implications of an Individual Mandate
Michael Doonan, PhD
Assistant Professor
Executive Director Massachusetts Health Policy Forum
Schneider Institute for Health Policy
The Heller School for Social Policy and Management
Brandeis University
An individual health insurance mandate is essential to achieve universal coverage if health reform builds off the existing system. A mandate would expand coverage to the millions of uninsured who are eligible for but not enrolled in public and private health insurance. We show public buy-in programs have low enrollment, but coupled with a mandate could extend affordable insurance options. A workable mandate requires a government defined benefits package and an affordability schedule with reasonable subsidies. Setting these standards demands tradeoffs among benefits, premium levels, cost sharing, and subsidies. Massachusetts offers insight, but implementation nationally will be far more challenging.
Click here to view the June 24, 2009 Seminar Slide Presentations
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