1) California Evaluation Specialist in Richmond CA
Under the general direction of the Branch Chief of the Communicable Disease Emergency Response Branch at the California Department of Public Health. The incumbent performs a variety of duties and conducts activities related to the evaluation and analysis of the outbreak and surveillance systems and programs in the Division of Communicable Disease Control, including 1) assessing the effectiveness of the current surveillance system(s); 2) Identifying critical gaps that impact public health surveillance and ability to conduct timely public health activities; 3) Identify the functionalities and efficiencies are needed to support coordinated surveillance; 4) Assess the benefits and challenges of a coordinated, centralized surveillance system.
For more information, please visit: https://www.appone.com/MainInfoReq.asp?R_ID=733654
2) Qualitative Lead Researcher for the Center for Innovation to Implementation (Ci2i) of the Department of Veterans Affairs (VA) in Menlo Park, CA
The person who fills this position should have experience conducting research in health care settings, a range of interests, and a willingness to learn about new areas of health services research. In addition, the person should be knowledgeable about both the theoretical foundations of qualitative research and diverse qualitative data collection and analysis methods. He/she is expected to provide consultation and assistance to colleagues interested in incorporating qualitative data collection and analysis into their research designs, assist with data analysis, and contribute to manuscripts. There will be opportunities for the qualitative lead to write his/her own grants as a principal investigator as well as collaborate with others as a co-investigator on grants.
If you have questions about the position, please e-mail Eleanor Lewis at Eleanor.Lewis@va.gov. The exact timing of the job announcement is uncertain, please set up an account at usajobs.gov and register to receive automated notices on positions at the Menlo Park VA.
Thursday, September 26, 2013
Wednesday, September 25, 2013
Senior Staffer Position for Nutrition and Obesity Policy
The Center for Science in the Public Interest (CSPI) on nutrition and obesity policy is looking for a senior staffer.
The Senior Nutrition Policy Manager advocates for improved nutrition and obesity policies with local, state, and federal policy makers, encourages the food industry to improve their products and practices, and engages health professionals, academics, and concerned citizens in supporting nutrition policy.
Essential Duties and Responsibilities:
Qualifications:
To Apply:
Please send your application materials, which should include a cover letter indicating relevant experience and interest, writing sample, and résumé, to Margo G. Wootan, D.Sc at hr@cspinet.org
Include “Attn: SNPA” in the subject line.
See http://www.cspinet.org/nutritionpolicy/ for information about CSPI
The Senior Nutrition Policy Manager advocates for improved nutrition and obesity policies with local, state, and federal policy makers, encourages the food industry to improve their products and practices, and engages health professionals, academics, and concerned citizens in supporting nutrition policy.
Essential Duties and Responsibilities:
- Lobby policy makers, build coalitions, and organize grassroots in support of nutrition policies, programs, and funding.
- Manage nutrition policy projects.
- Conduct policy research and write reports, fact sheets, and other advocacy materials.
- Develop and maintain relationships with national, state, and local policy makers and advocates.
- Cultivate support for nutrition policies from health professionals, university faculty, organizations, and concerned citizens.
- Represent CSPI at conferences, meetings, and in coalitions.
Qualifications:
- Doctoral (PhD, MD, JD) or master’s degree (MS, MPH, MPP) in health, policy, or nutrition plus at least 7 years of professional policy experience or a BS degree in one of these areas and at least 10 years of experience.
- Excellent research and writing skills with the ability to define problems, collect data, establish facts, and draw valid conclusions.
- Excellent communication and interpersonal skills including public speaking experience.
- Knowledge of the legislative process; lobbying or other legislative experience desirable.
- Excellent organizational skills and attention to detail.
- Ability to work effectively in a fast-paced environment with multiple priorities and frequent deadlines.
- Ability to work additional hours as needed.
- Interest and commitment to CSPI’s work and mission.
To Apply:
Please send your application materials, which should include a cover letter indicating relevant experience and interest, writing sample, and résumé, to Margo G. Wootan, D.Sc at hr@cspinet.org
Include “Attn: SNPA” in the subject line.
See http://www.cspinet.org/nutritionpolicy/ for information about CSPI
Monday, September 23, 2013
Breaking Bad? How Compounding Pharmacies are Coming Under the Federal Regulatory Microscope
A couple weeks ago following an inspection by the Food and Drug Administration (FDA) of Front Range Laboratories, Leiter’s Compounding Pharmacy issued a nationwide recall of a non-sterile injectable product that exposes patients to the risk of contracting serious life-threatening injuries. This incident is just a latest among a string of episodes not even a year after 700 people fell ill after receiving tainted steroid injections from the New England Compounding Center (NECC) resulting in a nationwide outbreak of fungal meningitis. Back in 2005, the Centers for Disease Control and Prevention (CDC) responded to a multistate outbreak of Serratia marcescens bloodstream infection , which was linked to contaminated intravenous magnesium sulfate, again from a compounding pharmacy. At present, the regulatory landscape remains grossly inadequate to conduct effective surveillance and monitoring, but that may soon change upon passage of the federal Pharmaceutical Compounding Quality and Accountability Act (PCQAA).
Historically, compounding manufacturers have evaded federal oversight because they are not registered with the FDA as drug manufacturers. They do not have to report adverse events and the FDA does not approve prescriptions before they are marketed to the general public. Common sense would dictate that the consequences of such lax oversight would give way to unpredictable and, at times, deadly incidents that would beg the question as to why more was not done in anticipation of such events. The PCQAA attempts to fill those gaps.
Key features of the act, which replaces section 503A of the current Federal Food, Drug, and Cosmetic Act (FFDCA), establish clear boundaries between traditional compounders and compounding manufacturers who sell products across state lines. While preserving states’ authority to regulate pharmacies, the federal legislation is intended to contain the potentially widespread impact of unregulated practices that have given way to a series of tragic outbreaks. Compounding manufacturers would be defined as those entities that compound a sterile drug prior to or without receiving a prescription and introduces such drug into interstate commerce, i.e. across state lines (with the exception that the shipment within a hospital system will not result in the hospital pharmacy being labeled a compounding pharmacy). Moreover, a corporation that repackages sterile, “preservative-free” vials would also be considered a compounding manufacturer. This latter provision is in direct response to the NCCC, whose tainted injections led to the outbreak of fungal meningitis, because their version of methylprednisolone acetate did not contain preservatives. Since it was commercially available from an FDA-regulated facility, the law enabled NCCC to evade the regulatory process.
Under the PCQAA, compounding manufacturers must: (1) ensure that a pharmacist licensed in the State where the compounding manufacturers is located exercises direct supervision over its operations; (2) register with the Secretary its name, place of business, unique facility identifier, and point of contact e-mail address; (3) submit twice during the year a report identifying the drugs that it compounded over the previous 6-month period and provide the active ingredient, source of the ingredient, the National Drug Code number, the strength of the ingredient per unit, the dosage form and route of administration, the package description, and the number of individuals units produced, (4) be subject to inspection in accordance with a risk-based schedule established by the Secretary based on the compliance history of the manufacturer, the record and nature of recalls linked to the manufacturer, the inherent risk of the drug compounded, and a host of other factors; (5) report adverse events to the Secretary of each instance as soon as practicable but no later than 15 days after the initial receipt of the applicable information; and (6) adhere to drug labeling requirements, including an explicit statement that ‘This is a compounded drug’ or a reasonably comparable alternative statement.
Absent from the PCQAA is a former provision that sought to regulate the advertising of compounded drugs. This was not an oversight on the part of the Senate, but was in response to a ruling by the U.S. Supreme Court. In 2002, in Thompson v. Western States Medical Center (535 U.S. 357 (2002)), a number of licensed pharmacies brought suit after provisions of the Food and Drug Administration Act prohibited advertising and promotion of their products. The Court held that the prohibitions were unconstitutional restrictions on commercial speech. Under the 1st Amendment, compounding manufacturers have a right to advertise their products.
Nonetheless, the PCQAA is far more stringent than a status quo that represents a hodgepodge of state laws that to date have been simply ineffective in responding to severe outbreaks. At the very least, passage of the act may be an example of cooperative federalism whereby states and the federal government may work together to improve surveillance and monitoring, which in turn may strengthen efforts to mitigate widespread errors.
Historically, compounding manufacturers have evaded federal oversight because they are not registered with the FDA as drug manufacturers. They do not have to report adverse events and the FDA does not approve prescriptions before they are marketed to the general public. Common sense would dictate that the consequences of such lax oversight would give way to unpredictable and, at times, deadly incidents that would beg the question as to why more was not done in anticipation of such events. The PCQAA attempts to fill those gaps.
Key features of the act, which replaces section 503A of the current Federal Food, Drug, and Cosmetic Act (FFDCA), establish clear boundaries between traditional compounders and compounding manufacturers who sell products across state lines. While preserving states’ authority to regulate pharmacies, the federal legislation is intended to contain the potentially widespread impact of unregulated practices that have given way to a series of tragic outbreaks. Compounding manufacturers would be defined as those entities that compound a sterile drug prior to or without receiving a prescription and introduces such drug into interstate commerce, i.e. across state lines (with the exception that the shipment within a hospital system will not result in the hospital pharmacy being labeled a compounding pharmacy). Moreover, a corporation that repackages sterile, “preservative-free” vials would also be considered a compounding manufacturer. This latter provision is in direct response to the NCCC, whose tainted injections led to the outbreak of fungal meningitis, because their version of methylprednisolone acetate did not contain preservatives. Since it was commercially available from an FDA-regulated facility, the law enabled NCCC to evade the regulatory process.
Under the PCQAA, compounding manufacturers must: (1) ensure that a pharmacist licensed in the State where the compounding manufacturers is located exercises direct supervision over its operations; (2) register with the Secretary its name, place of business, unique facility identifier, and point of contact e-mail address; (3) submit twice during the year a report identifying the drugs that it compounded over the previous 6-month period and provide the active ingredient, source of the ingredient, the National Drug Code number, the strength of the ingredient per unit, the dosage form and route of administration, the package description, and the number of individuals units produced, (4) be subject to inspection in accordance with a risk-based schedule established by the Secretary based on the compliance history of the manufacturer, the record and nature of recalls linked to the manufacturer, the inherent risk of the drug compounded, and a host of other factors; (5) report adverse events to the Secretary of each instance as soon as practicable but no later than 15 days after the initial receipt of the applicable information; and (6) adhere to drug labeling requirements, including an explicit statement that ‘This is a compounded drug’ or a reasonably comparable alternative statement.
Absent from the PCQAA is a former provision that sought to regulate the advertising of compounded drugs. This was not an oversight on the part of the Senate, but was in response to a ruling by the U.S. Supreme Court. In 2002, in Thompson v. Western States Medical Center (535 U.S. 357 (2002)), a number of licensed pharmacies brought suit after provisions of the Food and Drug Administration Act prohibited advertising and promotion of their products. The Court held that the prohibitions were unconstitutional restrictions on commercial speech. Under the 1st Amendment, compounding manufacturers have a right to advertise their products.
Nonetheless, the PCQAA is far more stringent than a status quo that represents a hodgepodge of state laws that to date have been simply ineffective in responding to severe outbreaks. At the very least, passage of the act may be an example of cooperative federalism whereby states and the federal government may work together to improve surveillance and monitoring, which in turn may strengthen efforts to mitigate widespread errors.
Friday, September 20, 2013
Administrative Fellowship Program at Loyola
The Loyola University Medical Center (LUMC) Administrative Fellowship is a one-year program structured to develop the leadership skills of future health-care administrators. The program promotes learning and application of practical skills in operations, strategy and front-line management to prepare fellows for leadership careers in the academic health-care environment. The competency-based curriculum is tiered to provide a broad educational experience in the first three months and front-line operational experience in a chosen area during the last nine. The LUMC fellowship offers the unique opportunity to work closely with administrative and clinical leaders in a fast-paced, ever-changing environment.
Loyola University Medical Center administrators and physicians are dedicated to the development and education of future health-care executives. This team will convey the complexities of the academic health-care environment and provide opportunities at all levels to develop leadership skills.
For more information see: http://loyolamedicine.org/about/administrative-fellowship-program
Thursday, September 19, 2013
MPH Job Opening in Southern California
Assistant Undergraduate Advisement Coordinator/Lecturer
The Department of Health Science at California State University, Fullerton (CSUF), invites applications for a full-time Lecturer (Non-Tenure Track) position that combines a .5 academic year teaching position with a .5 year-round undergraduate advising position. The Department offers a B.S. in Health Science (with focus areas in health promotion and disease prevention, and environmental and occupational health and safety), and a Masters in Public Health (with focus areas in health promotion, environmental and occupational health, gerontological health).
The posting can be found at: http://diversity.fullerton.edu/jobs/ft/asst_undegrad_advisement_coord.asp
Visit the web site for more information about the department: http://hdcs.fullerton.edu/hesc
The Department of Health Science at California State University, Fullerton (CSUF), invites applications for a full-time Lecturer (Non-Tenure Track) position that combines a .5 academic year teaching position with a .5 year-round undergraduate advising position. The Department offers a B.S. in Health Science (with focus areas in health promotion and disease prevention, and environmental and occupational health and safety), and a Masters in Public Health (with focus areas in health promotion, environmental and occupational health, gerontological health).
The posting can be found at: http://diversity.fullerton.edu/jobs/ft/asst_undegrad_advisement_coord.asp
Visit the web site for more information about the department: http://hdcs.fullerton.edu/hesc
Wednesday, September 18, 2013
MPH Leadership Day Saturday, September 28
Come to the MPH program's First Public Health Leadership Day. It will be held in Room 150 at the Loyola Stritch School of Medicine on September 28 (Saturday) from 8:30 am to 3:00 pm and includes a light breakfast from 8 to 8:30 am and catered lunch.
Featured speakers for the day include:
• Susan Wortman, MEd, LUC Career Development Center, speaking on job searching techniques, strategies, and resources
• Diana Hackbarth, PhD, RN, FAAN, LUC Public Health Nursing Educator, speaking on the importance of air quality issues
• Michael Meinhardt, PhD, LUC Instructor of English, presenting on professional writing and speaking (e-mail etiquette, statement of intent, contacting potential employers, etc)
• Cortland Lohff, MD, Director of Environmental Health, City of Chicago Department of Public Health, talking about what a Public Health Director looks for in job applicants.
Please contact Holly Kramer at hkramer@lumc.edu to RSVP or for more information
Featured speakers for the day include:
• Susan Wortman, MEd, LUC Career Development Center, speaking on job searching techniques, strategies, and resources
• Diana Hackbarth, PhD, RN, FAAN, LUC Public Health Nursing Educator, speaking on the importance of air quality issues
• Michael Meinhardt, PhD, LUC Instructor of English, presenting on professional writing and speaking (e-mail etiquette, statement of intent, contacting potential employers, etc)
• Cortland Lohff, MD, Director of Environmental Health, City of Chicago Department of Public Health, talking about what a Public Health Director looks for in job applicants.
Please contact Holly Kramer at hkramer@lumc.edu to RSVP or for more information
Saturday, September 14, 2013
Public Health Presentation at Loyola: Vietnam
Public Health in Vietnam: The Response
of the Pasteur Training Center
Hoang Quoc Cuong, M.D. Director
Pasteur Training Center Oxford University Clinical Research Unit Hospital for Tropical Diseases, Viet Nam
When: Monday, September 16, 2013 11:00 a.m. - Noon
Where: Room 0505 Marcella Niehoff School of Nursing
For more information: Dennis J. Yesalonia, S.J., COO-HSD dyesalonia@lumc.edu 708-216-8210
Hoang Quoc Cuong, M.D. Director
Pasteur Training Center Oxford University Clinical Research Unit Hospital for Tropical Diseases, Viet Nam
When: Monday, September 16, 2013 11:00 a.m. - Noon
Where: Room 0505 Marcella Niehoff School of Nursing
For more information: Dennis J. Yesalonia, S.J., COO-HSD dyesalonia@lumc.edu 708-216-8210
Wednesday, September 11, 2013
Workshop for Graduate Student Funding Opportunities: External Funding Grants
Master’s and Doctoral Students from The Graduate School who are interested in applying for external funding, this workshop can help you get started.
Location/time:
Lake Shore Campus Friday
September 27, 2013 1:00 – 2:30 PM
Room 210, Cuneo Hall
Workshop Agenda:
Please email your full name, student ID#, academic program, and degree pursuing to register at gradschool@luc.edu. Your registration will be confirmed by email.
Location/time:
Lake Shore Campus Friday
September 27, 2013 1:00 – 2:30 PM
Room 210, Cuneo Hall
Workshop Agenda:
- Go over the eligibility guidelines for some upcoming national funding competitions
- Learn about the COS (formerly “Community of Science”) search engine for grant funding searches
- Explore strategies for seeking funding opportunities in your discipline or specialty
- Go over the Research Incentive Award for Graduate Students (RIAGS) guidelines. RIAGS website: www.luc.edu/gradschool/RIAGS.shtml
Please email your full name, student ID#, academic program, and degree pursuing to register at gradschool@luc.edu. Your registration will be confirmed by email.
Thursday, September 5, 2013
Health Assurance vs. Sickness Insurance: Resurrecting an Old Tale 95 Years Later
This week, healthcare reform took on a quintessentially American character with the availability of none other than a toll-free hotline to acquire information on how to navigate the newfound exchanges. I must admit that I was skeptical at first, but after dialing 1-800-318-2596, I was immediately welcomed by an automated message to “the new health insurance marketplace.” Some states, like California and Maryland, are operating their own exchanges and also have call centers open to the general public. Enrollment will begin October 1st and every state must offer insurance by way of a state-run exchange, a partnership with the federal government, or otherwise delegate it to the latter to ensure compliance with the January 1, 2014 deadline. This flurry of activity makes for good headlines but is also timely for our reflections on how entangled our public health and healthcare priorities have become under the sweeping—and at times, misleading—label of “health insurance.”
Words matter. Almost a century ago (April 18, 1919 to be exact), B.S. Warren, the Assistant Surgeon General, and Edgar Sydenstricker, the Public Health Statistician, of the U.S. Public Health Service published a commentary in the now famous ‘Public Health Reports’ that focused on the ‘health insurance, the medical profession, and the public health.’Public Health Reports, Vol. 34, No. 16 (April 18, 1919) They remind us that “health insurance” was formerly termed ‘sickness insurance,’ a method by which the economic loss caused by sickness is distributed among a group of persons. In other words, it was what we have come to know as health or healthcare insurance in common parlance. But for Warren and Sydenstricker, this was inadequate, for:
“proposals for governmental health insurance…not only adopt the principles just mentioned [relating to sickness insurance], but include…provisions for rendering the health insurance system an aid to disease prevention...by linking the health-insurance system to the existing public health agencies. In this sense, ‘sickness insurance,’ it is believed, would become a real health measure.”
History teaches us that interdisciplinary teams and collaborations among the public and private sectors are not new, but we have become accustomed to thinking they are because we have failed to prioritize disease prevention as part and parcel of meaningful health reform. For the moment, let’s put aside the political issues regarding support for (or opposition to) a single payer system or whether the Affordable Care Act is simply an insurance reform bill. The take home message is that disease prevention, which is the heart of public health, has become a secondary issue in our national debate. So it is incumbent on those of us (all of us?!) who want to advance population health to remember the Institute of Medicine’s landmark report in 1988 that defined public health as what we do collectively to “assure the conditions for people to be healthy.”The Future of Public Health (January 1, 1988) And, perhaps more importantly, the IOM’s follow up report 15 years later that found that the governmental public health infrastructure had been neglected, and required a significant overhaul of components, specifically, the workforce, laboratories, and public health law.Assuring the Health of the Public in the 21st Century (November 11, 2002) This last point is particularly noteworthy because for decades, the role of law in public health was woefully undeveloped in public health scholarship and research; but thankfully, over the past decade, there has been a tremendous surge among researchers and practitioners to collaborate and tackle issues at the interface of both disciplines to advance population health. In doing so, we begin to appreciate the multitude of stakeholders and partners who must collaborate beyond the modern healthcare system to secure population health.
With this background, perhaps “health assurance” would be a more purposeful guide to lead our efforts, consistent with the IOM’s findings, and rooted in a prescient characterization 95 years ago—long before the advances of modern medicine and public health—that prevention and treatment must go hand in hand to assure the conditions for people to be healthy. So as we go forward, let’s take a tip from history and not repeat our prior mistakes.
Words matter. Almost a century ago (April 18, 1919 to be exact), B.S. Warren, the Assistant Surgeon General, and Edgar Sydenstricker, the Public Health Statistician, of the U.S. Public Health Service published a commentary in the now famous ‘Public Health Reports’ that focused on the ‘health insurance, the medical profession, and the public health.’Public Health Reports, Vol. 34, No. 16 (April 18, 1919) They remind us that “health insurance” was formerly termed ‘sickness insurance,’ a method by which the economic loss caused by sickness is distributed among a group of persons. In other words, it was what we have come to know as health or healthcare insurance in common parlance. But for Warren and Sydenstricker, this was inadequate, for:
“proposals for governmental health insurance…not only adopt the principles just mentioned [relating to sickness insurance], but include…provisions for rendering the health insurance system an aid to disease prevention...by linking the health-insurance system to the existing public health agencies. In this sense, ‘sickness insurance,’ it is believed, would become a real health measure.”
History teaches us that interdisciplinary teams and collaborations among the public and private sectors are not new, but we have become accustomed to thinking they are because we have failed to prioritize disease prevention as part and parcel of meaningful health reform. For the moment, let’s put aside the political issues regarding support for (or opposition to) a single payer system or whether the Affordable Care Act is simply an insurance reform bill. The take home message is that disease prevention, which is the heart of public health, has become a secondary issue in our national debate. So it is incumbent on those of us (all of us?!) who want to advance population health to remember the Institute of Medicine’s landmark report in 1988 that defined public health as what we do collectively to “assure the conditions for people to be healthy.”The Future of Public Health (January 1, 1988) And, perhaps more importantly, the IOM’s follow up report 15 years later that found that the governmental public health infrastructure had been neglected, and required a significant overhaul of components, specifically, the workforce, laboratories, and public health law.Assuring the Health of the Public in the 21st Century (November 11, 2002) This last point is particularly noteworthy because for decades, the role of law in public health was woefully undeveloped in public health scholarship and research; but thankfully, over the past decade, there has been a tremendous surge among researchers and practitioners to collaborate and tackle issues at the interface of both disciplines to advance population health. In doing so, we begin to appreciate the multitude of stakeholders and partners who must collaborate beyond the modern healthcare system to secure population health.
With this background, perhaps “health assurance” would be a more purposeful guide to lead our efforts, consistent with the IOM’s findings, and rooted in a prescient characterization 95 years ago—long before the advances of modern medicine and public health—that prevention and treatment must go hand in hand to assure the conditions for people to be healthy. So as we go forward, let’s take a tip from history and not repeat our prior mistakes.
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