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Drug Policy Research Group - Seminars
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2009-2010 Pharmaceutical Policy Research Seminar Schedule
Seminars are held the second and fourth Wednesday's of each month, with some exceptions, from 2-3pm at the Department of Population Medicine(DPM) 6th floor Large Conference Room.
Click here to view the background on the seminars.
Please click here to view the next seminar
Please click here to view the archive of past seminars
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September 23, 2009
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What was your question again? The perils of using observational data to answer questions other than the one you wish to ask.
Miguel Hernán, MD, MPH, ScM, DrPH
Associate Professor of Epidemiology
Harvard School of Public Health
SEMINAR DESCRIPTION:
Observational studies are often used to make causal inferences. However, in the absence of well-defined causal questions, it is difficult to assess the validity and implications of a particular analysis of observational data. This problem is more severe when estimating effects from complex longitudinal data with time-varying treatments as is common in pharmacoepidemiology.
READINGS:
hernan_epidemiology08c.pdf
hernan_epidemiology08d.pdf
OTHER NOTES:
Click here to view slides from presentation
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October 7, 2009
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*Special Presentation*
Community-based surveillance of antimicrobial use in resource-constrained settings
Dr. Anita Kotwani
Associate Professor
Department of Pharmacology
Vallabhbhai Patel Chest Institute
University of Delhi
Delhi, India
SEMINAR DESCRIPTION:
Antimicrobial resistance in microorganisms is a major public health problem worldwide. The increased resistance is a result of many factors, but the foremost cause is the overall volume of antibiotic consumption, particularly for indications that do not require such therapy. Enhanced antimicrobial surveillance is one of the strategies to control antimicrobial overuse or misuse in the community. In a number of developed countries, extensive surveillance programmes have been developed to study patterns of antimicrobial resistance and antibiotic use. However, the problem of antimicrobial resistance has received relatively little recognition in developing countries and the ability to undertake extensive surveillance is lacking in resource-constrained countries. There is a lack of community-based databases on antimicrobial resistance and antibiotic use in developing countries. WHO collaborated and funded five pilot projects, three in India and two in South Africa (2002-2005) for developing validated reproducible and sustainable surveillance methodologies to quantify antimicrobial resistance and antibiotic use in the community. The pilot project conducted in New Delhi, India utilized a methodology that monitored antimicrobial use in the community through patient exit interviews at private retail pharmacies. The second phase of surveillance (2007-2008) expanded the established methodology at three types of facilities: private retail pharmacies, public sector facilities, and private clinics. Antibiotic use was measured as daily
defined dose (DDD)/1000 patients visiting the facility and also as percent of patients receiving an antibiotic. 39% of the patients who visited during data collection period had encountered with at least one antibiotic in public sector and at private retail pharmacies whereas 43% of patients visiting private clinics were prescribed antibiotics. Methodology established and trend and pattern of antibiotic use observed in the community will be discussed.
READINGS:
1. Kotwani A, Holloway K, Chaudhury R R. Methodology for surveillance of antimicrobials use among out-patient in Delhi. Indian Journal of Medical Research 2009; 129: 555-60. Methodology for surveillance of antimicrobials use among out-patient in Delhi.pdf
2. World Health Organization. Community-based surveillance of antimicrobial use and resistance in resource-constrained settings. Report on five pilot projects. http://www.who.int/medicines/publications/who_emp_2009.2/en/index.html
3. Wattal C, Raveendran R, Kotwani A, Sharma A, Bhandari SK, Sorensen TL, Holloway K. Establishing a new methodology for monitoring of antimicrobial resistance and use in the community in a resource poor-setting. Journal of Applied Therapeutic Research 2009; 7: 37-45. Establishing a new methodology for monitoring of antimicrobial resistance and use in the community in a resource poor-setting.pdf
OTHER NOTES:
Slides: Click to view presentation
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October 14, 2009
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*Rescheduled to 3/24/2010*
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October 28, 2009
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Wireless adherence monitoring for antiretroviral therapy in resource limited settings
Jessica Haberer, MD, MS
Research Scientist, Harvard Initiative for Global Health
Assistant in Health Decision Sciences, Massachusetts General Hospital
Instructor, Harvard Medical School
SEMINAR DESCRIPTION:
HIV antiretroviral therapy adherence is tightly linked to viral suppression and drug resistance. Current adherence monitoring strategies detect missed doses several weeks to months after they occur and are unable to direct adherence interventions before virologic failure develops. Novel approaches are needed to prevent drug resistance and the loss of treatment effectiveness. Dr. Jessica Haberer will discuss the use of cell phone technology, including interactive voice response and short message service, as well as a wireless adherence device called Wisepill, for real-time adherence monitoring in resource limited settings. She will review the current use, advantages, and disadvantages of each technology, as well as present preliminary data from her research group in Mbarara, Uganda.
OTHER NOTES:
Slides:
WirelessAdherence_Haberer.pdf
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November 4, 2009
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Using technology to facilitate family and friend support for medication use in adults with chronic kidney disease
Ashley J. Beard, PhD
Fellow in Pharmaceutical Policy Research, DPM
Harvard Medical School and Harvard Pilgrim Health Care Institute
SEMINAR DESCRIPTION:
Over 16 million Americans have mild to moderate chronic kidney disease (CKD). Patients with CKD are at increased risk for cardiovascular disease, kidney failure, and other serious and costly complications. In response to the increasing prevalence and impact of CKD, reducing the rates and complications of CKD is one of the goals of Healthy People 2010. Appropriate medication use in patients with early stage CKD can slow the progression to end-stage renal disease. Yet, consistent, appropriate medication use can be a challenge for adults with CKD. Patients with CKD may have other chronic conditions, take a number of medications, and lack social support for treatment adherence. Informal support from family and friends may be important for patient medication management but much still remains unknown about such support and how to best promote it. Innovations in use of communication technologies show promise for facilitating social support and improving patient disease management but need further evaluation. In collaboration with a local, private health technology company and Harvard Pilgrim Health Care (HPHC), we are conducting a pilot randomized controlled-trial (RCT). Our aims are to better understand medication use in patients with CKD, barriers to medication use, and to evaluate an innovative, communication technology-driven intervention that engages friends and family to improve patient medication use. Details of the intervention, study design, and progress and challenges to date will be discussed.
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November 18, 2009
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The Path From Research-Based Interventions to Policies Aimed at Improving Prescribing Practices in Family Medicine Clinics
Ricardo Pérez-Cuevas, MD, MSc, MHS, DrPH
Epidemiology and Health Services Research Unit
Mexican Institute of Social Security (IMSS), Mexico
SEMINAR DESCRIPTION:
The ongoing epidemiological changes that result in an increase of chronic conditions such as diabetes and hypertension and the substandard performance to care for the most common diseases in family medicine settings have prompted to look for evidence-based interventions that help to tackle these problems and to improve institutional performance.
The presentation addresses the progress made in the Mexican Social Security System Health Insurance Program (IMSS) (which covers about 45 million individuals) from research-based multifaceted continuing medical education interventions aimed at improving family doctors’ prescribing practices to large-scale multidimensional education and feedback programs. The results of small-scale research projects encouraged decision-makers to implement and evaluate large-scale comprehensive programs as part of the efforts to build the institutional capacity to improve quality and allowed the design and implementation of quality of care indicators.
In addition, the presentation describes ongoing research projects to improve prescribing practices and quality of care through innovative tools that take advantage of the IMSS electronic medical record and the institutional health information system. These tools will allow evaluating prescribing practices, providing feedback to family doctors about their performance and implementing efficient and effective continuing medical education activities.
OTHER NOTES:
Slides:
RPerez-Cuevas slides.pdf
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December 2, 2009
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*Rescheduled to 3/3/2010*
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December 16, 2009
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States In The Vanguard: Advancing Evidence-Based Prescribing And Curbing Inappropriate Marketing Tactics
Maine State Representative Sharon Anglin Treat, JD
Executive Director of the National Legislative Association on Prescription Drug Prices,
Hallowell, ME
SEMINAR DESCRIPTION:
“Overview of State Initiatives Advancing Evidence-Based Prescribing and Reducing Conflicts of Interest in Medical Care.”
States are at the forefront of efforts to limit pharmaceutical and medical device industry financial influence on prescribing and medical care. Legislation enacted in the states includes prescriber education programs, disclosure of industry payments and gifts to prescribers, gift bans, licensing and regulation of industry sales detailers, limiting the use of prescriber data for marketing purposes, and marketing to children. This presentation will present an overview of these state initiatives and emerging trends in the states.
OTHER NOTES:
Harvard_States in Vanguard_Treat 12-09.pdf
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January 13, 2010
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The role of routinely collected health care data in comparative effectiveness research
Richard Platt, MD, MSc
Professor and Chair, Department of Population Medicine
Harvard Pilgrim Health Care Institute and Harvard Medical School
SEMINAR DESCRIPTION:
The seminar will address some of the strengths and weaknesses of routinely collected data for both observational and intervention studies.
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January 27, 2010
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High deductible health plans and the cost and utilization of maternity care services
Katy Backes Kozhimannil, PhD, MPA
Research Fellow, Department of Population Medicine
Harvard Medical School and Harvard Pilgrim Health Care Institute
SEMINAR DESCRIPTION:
Childbirth is the leading reason for hospitalization in the United
States, and maternity care comprises a major expenditure for many
American families and health insurance programs. The rapid growth of
high deductible health plans may impact out-of-pocket costs and
quality of maternity care. This study uses a pre/post study design
with a control group and a difference-in-differences analysis to
examine the effect of an employer-mandated insurance transition on
total costs (sum of expenditures by insurer and member) and
out-of-pocket costs (member copayment and deductible expenditures) for
maternity and delivery care, and also utilization of prenatal,
delivery, and postpartum services.
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February 10, 2010
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Rescheduled to 4/21/10
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March 3, 2010
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*New Date*
Fake and Substandard Drugs: Causes, Consequences and Possible Solutions
Roger Bate, PhD, MPhil, MSc
Legatum Fellow in Global Prosperity
American Enterprise Institute
Washington, DC
SEMINAR DESCRIPTION:
There are myriad reasons for the proliferation of substandard medications, some of them are well understood, others are rarely acknowledged and a few are even suppressed. Dr Roger Bate will explore the topic with examples of poor products from substandard antibiotics in Africa to fake Viagra in America, and discuss some of the efforts to combat such products.
READINGS:
http://www.washingtonpost.com/wp-dyn/content/article/2008/07/18/AR2008071802446.html
The Deadly World of Fake Drugs , Foreign Policy, 1 November 2008
The Wrong Message in a Bottle New York Times November 14, 2008
OTHER NOTES:
Click here to view slides from presentation
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March 10, 2010
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Policy without evidence? The impact of a pay-for-performance program (and evidence based clinical guidelines) on blood pressure, prescribing patterns and major adverse outcomes for patients with hypertension in the UK.
Brian Serumaga, MPH
Research Fellow, Department of Population Medicine
Harvard Medical School and Harvard Pilgrim Health Care Institute
SEMINAR DESCRIPTION:
Recent trends in health care have seen an upsurge in the implementation of pay-for-performance (PFP) programs in both developed and developing countries. Proponents of such programs, who have mainly been government policy makers, private payers and some professional bodies, have claimed pay-for-performance can increase the quality of patient care and mitigate the occurrence of undesirable patient level outcomes. Little evidence exists to sustain or rebut this claim. Few studies of explicit financial incentives to improve quality of care and patient outcomes are available to date.
This presentation will focus on an example from the United Kingdom (UK) where one of the most extensive PFP programs was introduced in primary care in June 2004. (Around the same time, there was a major update to the clinical guidelines for management of hypertension). Using 7 years of data on prescribing, health care utilization and hospitalizations for approximately 400,000 patients with essential hypertension, results from an analysis using a quasi-experimental design on prescribing patterns, blood pressure levels and hypertension related outcomes (myocardial infarction, stroke, heart failure and renal failure) will be presented.
READINGS:
1) Dept. Of Health. The Quality and Outcomes Framework. 2004, Department of health: London. P. Available at : Quality and outcomes framework
Guidance – Updated August 2004.
2) Shekelle P. New contract for general practitioners. BMJ, 2003.326:p457-8.
3) Roland M. Linking physician pay to quality of care - a major experiment in the United Kingdom. N Eng J Med, 2004. 351: p. 1448-54.
4) NICE, Hypertension: Management of adults in primary care, clinical guideline 18. July, 2004, The National Institute of Health and Clinical Excellence.
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March 24, 2010
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*New Date*
Access to Medicines in the Americas, Context and Challenges.
James Fitzgerald, PhD
Senior Advisor, Essential Medicines and Biologicals
PANDRH Secretariat
Pan American Health Organization (PAHO)/World Health Organization (WHO)
Washington, DC
SEMINAR DESCRIPTION:
This presentation provides a brief overview of the advances and challenges that countries face in the Region in ensuring access to Medicines, as well as presenting how PAHO provides support to countries in addressing these challenges.
READINGS:
To be announced
OTHER NOTES:
Click here to view slides from presentation
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March 31, 2010
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Access to Medicine Index: Multi stakeholder diplomacy; how establishing and promoting multi stakeholder partnerships created the methodology
Wim Leereveld (Chair)
Founder, Access to Medicine Foundation
Former Director, Bugamor Pharma
Former CEO, Walsh Netherlands
Co-founder, Walsh International and Pharmaceutical Marketing Services Inc (PMSI)
SEMINAR DESCRIPTION:
The Access to Medicine Foundation aims to increase access to medicines for societies in need. This is done by creating and publishing “The Access to Medicine Index”, a ranking system that captures the activities of the pharmaceutical industry in this area. The aim of the Index is to stimulate companies to improve, and perhaps in some cases, create policies, procedures and practices to improve access to medicines for countries in need.
In order to create a research model that was both transparent and methodologically sound, the foundation employed an extensive multi stakeholder review process that captures and represents the combined efforts, interests, voices and expertise of a diverse audience of stakeholders.
Together with the foundation, these stakeholders that include experts from academia, governments, intergovernmental organizations, institutional investors, ngo’s and the pharmaceutical industry, joined to discover a common ground on which the parameters for measuring the Industry could be agreed upon. Through a process of meetings, online questionnaire, data collection analysis and consensus building the foundation was able to agree upon methodological guidelines that results in the formation of the Access to Medicine Index I and II (Index II will be published in the course of 2010) .
During this presentation, we will discuss the process, outcomes, analysis and results of the multi stakeholder approach and how the resulting consensus building was achieved from this process. In addition, the different stakeholder views on the role pharmaceutical companies should take within the access to medicine discussion will also be presented.
READINGS:
Scoping Report, Industry and Stakeholder review, Industry Engagement second Interim, 2008 Index report and in mid-February 2010 the Methodology report.ATM Index Methodology and Stakeholder Review March 2010.pdf
OTHER NOTES:
www.atmindex.org
Click here to view slides from presentation
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April 14, 2010
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Prescription Drug Use Before and After Switching to a High-Deductible Health Plan
Sheila K. Reiss, MS, RPh
PhD Candidate in Health Policy, Harvard University
Fellow in Pharmaceutical Policy Research, Department of Population Medicine
Harvard Medical School and Harvard Pilgrim Health Care Institute
SEMINAR DESCRIPTION:
Employers are increasingly turning to high-deductible health plans (HDHPs) to control rising health care costs. Although HDHPs reduce expenditures and premiums, concerns exist that members might underutilize necessary care due to increased cost sharing. Research has demonstrated that HDHPs that subject prescriptions to a deductible alter use of essential chronic medications. However, no previous studies have assessed whether “value-based” HDHPs that selectively exclude medications from full cost sharing preserve utilization.
This presentation will focus on a new study on the impact of increased cost sharing due to transition from traditional HMOs to value-based HDHPs on the use of essential medications. The talk will include a discussion of our findings and key policy implications of this research.
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April 21, 2010
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*New Date*
Realistic Assessment of Untreatable Tuberculosis: The Urgency and Realistic Challenges in Developing New Drugs
Gail Cassell, PhD
Vice President of Scientific Affairs and
Distinguished Research Scholar for Infectious Diseases
Eli Lilly and Company
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April 28, 2010
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Drug Safety Data Mining with a Tree-Based Scan Statistic
Martin Kulldorff, PhD
Associate Professor, Department of Population Medicine
Harvard Medical School and Harvard Pilgrim Health Care Institute
SEMINAR DESCRIPTION:
In post-marketing drug safety surveillance, data mining can potentially detect rare but serious adverse events. Such surveillance is traditionally based on a predefined collection of drug-event pairs, but it is unknown whether a drug cause a very specific or a set of related adverse events, such as a specific form of liver failure, liver failure in general or several different liver diseases. This methodological paper explores using the tree-based scan statistic data mining method to address this limitation. We use a three million member electronic health records database from the HMO Research Network. Using the tree-based scan statistic, we assess the safety of selected antifungal and diabetes drugs, evaluating hundreds of overlapping diagnosis code groups, properly adjusting for multiple testing. We identified potential adverse events by calculating expected and observed counts, adjusting for age, sex, and health plan, producing a log likelihood ratio test statistic, and conducting Monte Carlo hypothesis testing. Only a few statistically significant signals were found out of hundreds of comparisons. Some signals are known adverse effects; others are likely due to confounding by indication, while some signals may warrant further investigation. The tree-based scan statistic can be successfully applied as a data mining tool in drug safety surveillance using observational data. The total number of signals was modest. Results do not imply a causal relationship. Rather, data mining results should be used to generate candidate drug-event pairs for rigorous epidemiological studies to evaluate the individual and comparative safety profiles of drugs.
OTHER NOTES:
Click here to view slides from presentation
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May 12, 2010
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How to Make (Pharmaceutical, Health Care) Policy Research Accessible to Policy Makers
Ms. Martha Bebinger
Fellow, Nieman Foundation for Journalism at Harvard
State House Reporter, WBUR in Boston
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May 19, 2010
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Impact of the Financial Crisis on Use of Medicines Worldwide (tentative title)
Dr. Richard Laing (Team Leader)
Medicine Information and Evidence for Policy
Department of Essential Medicines and Pharmaceutical Policies
World Health Organization
Geneva, Switzerland
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June 9, 2010
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Insurance Coverage, Access, Equity: Impact of Massachusetts Health Insurance Reform
Aakanksha Pande, MS
PhD Candidate in Health Policy, Harvard University
Research Fellow, Department of Population Medicine
Harvard Medical School and Harvard Pilgrim Health Care Institute
SEMINAR DESCRIPTION:
The effect of a universal health insurance mandate on health outcomes is a timely, but understudied question. This paper evaluates the effect of the Massachusetts health reform enacted in April 2006 and characterized by a legal mandate, on a range of health system outcomes including access to insurance, access to health care, and equity of access.
READINGS:
To be announced
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June 16, 2010
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Access to medicine in an Acute condition: Case Study in three Central America Low Income Countries
Isabel Emmerick, MPH
Visiting Research Fellow
Department of Population Medicine
Harvard Medical School and Harvard Pilgrim Health Care Institute
PhD Candidate, National School of Public Health/Oswaldo Cruz Foundation
Rio de Janeiro, Brazil
SEMINAR DESCRIPTION:
"The study denominated “Estudio del impacto de la exclusión de la atención de salud sobre el acceso a medicamentos en Honduras, Guatemala y Nicarágua”, had the objectives to know how different population groups obtain medicines for their health needs and to establish the relation between the exclusion from health care services and the access to medicines This study was a PAHO/WHO initiative, jointly with Oswaldo Cruz Foundation and Ministries of Health of the Honduras, Guatemala and Nicaragua.
A cross sectional multicentre data collection approach was applied in the above mentioned countries. Two main approaches strongly based on the WHO Level II methodology were used: a household survey and a health care facilities survey. In the Household survey the lowest level of the analysis was the household and was considered to each health care condition (acute, chronic, pregnancy and health status self evaluated as bad).
This presentation will focus on the determinants to access to medicines in an acute condition across these countries."
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June 23, 2010
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International Perspectives on Adherence and Resistance to HIV Antiretroviral Therapy
David Bangsberg, MD, MPH
Director MGH Center for Global Health
Harvard Medical School
SEMINAR DESCRIPTION:
Public health debates about providing HIV antiretroviral therapy to impoverished HIV+ populations are based on the relationship between adherence and risk of drug resistance to HIV antiretroviral therapy. Early justifications for withholding antiretroviral therapy from marginalized domestic populations, such as drug users and the homeless, were mistaken for two reasons. First, levels of adherence in marginalized populations were not much different than the general HIV+ population, and second, early single protease-based antiretroviral therapy lead to drug resistance predominately in highly (80-95%) adherent individuals. In retrospect, HIV antiretroviral drug resistance during the first decade of effective therapy was not driven by poor adherence, but rather by the fact that early regimens were not potent enough to fully suppress the virus in patients who took most, if not all, of their medications. The introduction of more potent ritonavir-boosted protease inhibitor and non-nucleoside reverse transcriptase inhibitor regimens have shifted this relationship towards full viral suppression and cessation of drug resistance at high levels of adherence.
Similar concerns slowed the provision of HIV antiretroviral therapy in resource-limited settings based on the expectations that extreme poverty would lead to poor adherence and the global spread drug resistant virus. Data from most studies indicate that these concerns were overstated. Individuals in resource-limited settings consistently take >90% of their medication, compared to 70% in resource-rich settings. Furthermore, full viral suppression is possible in antiretroviral naïve patients on non-nucleoside reverse transcriptase inhibitors regimens, typical of resource-limited settings, at moderate levels of adherence. Rather, the risk of drug resistance in resource-limited settings appears to be more related interruptions in therapy due to structural and financial barriers to drug supply and distribution. These interruptions in therapy lead to nevirapine monotherapy as nucleoside antiretroviral drug levels (stavudine and lamivudine) decay more rapidly than non-nucleoside reverse transcriptase inhibitor drug levels (nevirapine) following a treatment interruption (“the nevirapine tail”). The sensitivity to treatment interruptions in resource-limited settings may be further accentuated by ethnic pharmacogenomic differences in drug metabolism, leading to more extended periods of nevirapine monotherapy during an interruption. While efforts to sustain and prevent declines in adherence will be important in resource-limited settings, resistance will have less to do with forgotten doses, than ensuring a reliable drug supply and distribution system.
READINGS:
1. Bangsberg DR, Kroetz DL, Deeks SG. Adherence-resistance relationships to combination HIV antiretroviral therapy. Curr HIV/AIDS Rep. 2007 May;4(2):65-72.
BangsbergKroetzDeeksAdhere-ResistReview.pdf
2. Bangsberg DR, Moss AR, Deeks SG. Paradoxes of HIV antiretroviral adherence and drug resistance. JAC. 2004;53(5):696-699.
Bangsberg DR, et al. JAC 2004.pdf
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